[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Maryland, Baltimore\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":620},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,127,0,25,[9,46,73,86,117,145,165,197,218,240,261,282,306,325,351,378,398,424,445,471,496,520,540,562,593],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053325","phase-1-facilitating-neuroplastic-changes-of-acute-stroke-survivors-100053325",false,"NCT06404268","Facilitating Neuroplastic Changes of Acute Stroke Survivors","Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia","Inclusion Criteria:\n\n* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)\n* Hemiplegia or hemiparesis\n* 0≤Manual Muscle Testing (MMT)\\\u003C=2\n* Age 30-85\n* Ankle impairments including stiff calf muscles and\u002For inadequate dorsiflexion\n\nExclusion Criteria:\n\n* Medically not stable\n* Associated acute medical illness that interferes with ability to training and exercise\n* No impairment or very mild ankle impairment of ankle\n* Severe cardiovascular problems that interfere with ability to perform moderate movement exercises\n* Cognitive impairment or aphasia with inability to follow instructions\n* Severe pain in legs\n* Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)\n* Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee","ALL","30 Years","85 Years",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.",[29],"Stroke",[29,31,32],"Paraplegia","Acute","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2025-07-01",{"date":41,"type":22},"2028-12-31",{"name":43,"class":44},"University of Maryland, Baltimore","OTHER",3,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100053800","the-volunteering-in-place-program-for-apathetic-assisted-living-residents-with-adrd-100053800","NCT06735950","The Volunteering-in-Place Program for Apathetic Assisted Living Residents With ADRD","Inclusion Criteria:\n\n* age 55 years or older;\n* English speaking;\n* live in the included AL community\n* have mild to moderate cognitive impairment based on a SLUMS score of 26 or below and the ability to follow a one-step command.\n* have apathy based on a \"yes\" answer to at least 2 questions on the apathy subscale of the Neuropsychiatric Inventory (NPI) completed by a family or staff member who has had close contact with the resident in the past month;\n* have an anticipated length of stay of 12 months.\n\nExclusion Criteria:\n\n\\- refusal to assent","55 Years",{"count":54,"type":22},200,[56],"NA","This is a research study to test two different interventions to decrease apathy in assisted living residents with some memory issues. Apathy makes older adults not feel like doing much activity. This study is completely voluntary and will not affect the care you receive at your assisted living community.\n\nThe two possible interventions are 1) participation in a volunteering opportunity within the assisted living community OR 2) participation in a guided current events group within the assisted living community. These activities would be in addition to any other regular activities you participate in within the assisted living community. Both activities would take place three days per week for approximately 30 minutes. You would be randomly assigned (like a coin flip) to which intervention you would do. You do not get to choose. You would participate in the activity for a total of 6 months.\n\nIn addition to participating in the intervention (either volunteering or current events), you will be asked to answer some questions about your memory, level of activity, mood, confidence in your ability to do a volunteer job, and feelings of usefulness. You will answer these questions at baseline (before the activity begins, at 3 months after doing the intervention activity, and aging at 6 months after starting the interventions activity. You will also be asked to wear a MotionWatch for 5 days at each time point (baseline, 3months and 6 months). A motion watch measures your level of activity. It feels like wearing a regular watch. You will be in the study for 6 months total.\n\nRisks to participating in this study are minimal and include privacy (other people may find out you are in the study), confidentiality of the data collected if someone other than study staff accesses your records, fatigue with answering the questionnaires, and some mild discomfort with wearing the MotionWatch. This is also a minor risk that you could fall or otherwise harm yourself getting to or participating in your intervention activity.\n\nThe benefit of participating in this study include possible enjoyment of participating in the intervention activity.",[59],"Apathy in Dementia",[61,62,63,64],"apathy","assisted living","dementia","volunteering","NOT_YET_RECRUITING","2026-07-09",{"date":36,"type":37},{"date":69,"type":22},"2026-07-30",{"date":71,"type":22},"2027-08-31",{"name":43,"class":44},{"id":74,"slug":4,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":57,"conditions":77,"keywords":78,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100572644",{"count":54,"type":22},[56],[59],[61,62,63,64],"2026-07-01",{"date":81,"type":37},"2026-07-02",{"date":69,"type":22},{"date":84,"type":22},"2027-08",{"name":43,"class":44},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100602823","phase-2-ketones-for-opioid-craving-100602823","NCT07128524","Ketones for Opioid Craving","Ketone Supplementation for Opioid Craving and Withdrawal","Inclusion Criteria:\n\n* Age 18-75 years\n* Meets currents DSM-5 criteria for OUD and admitted for opioid withdrawal management treatment at Caron Treatment Center\n* Willingness to provide signed, informed consent and commit to completing the procedures in the study\n\nExclusion Criteria:\n\n* Current severe gastrointestinal (GI), liver, or other clinically significant physical disease that may interfere with the intake of the ketone supplement (e.g., sever inflammatory bowel disease, cirrhosis).\n* Currently taking (within the past two weeks) GLP-1 receptor agonist medications, e.g. semaglutide, which can interfere with the absorption of the ketone supplement\n* Currently pregnant or lactating, for people of childbearing potential\n* Judged by the principal investigator. study physician, or their designee to be an unsuitable candidate for the study","18 Years","75 Years",{"count":96,"type":22},50,[26],"The goal of this clinical trial is to learn if ketone supplementation (KS) works to reduce craving for opioids for adults with opioid use disorder (OUD) undergoing in-patient acute withdrawal management. The main questions it aims to answer are:\n\n* Does KS reduce craving for opioids in patients with opioid use disorder?\n* Does KS reduce symptoms of opioid withdrawal such as low mood and pain? Researchers will compare KS to a placebo to see if KS works to reduce craving for opioids and reduce withdrawal symptoms in adults entering in-patient acute withdrawal management for opioid use disorder.\n\nParticipants will:\n\n* Be given KS or a placebo three (3) times daily for seven (7) days\n* Complete mood, pain tolerance, and subjective opioid withdrawal assessments",[100],"Opioid Use Disorder",[102,103,104,105,106,107,108],"opioid use disorder","OUD","ketone","ketone supplement","ketone supplementation","craving","withdrawal","2026-06-30",{"date":81,"type":37},{"date":112,"type":22},"2026-07",{"date":114,"type":22},"2027-09",{"name":43,"class":44},1,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":17,"minAge":93,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":116},"100495044","ocular-blood-flow-imaging-for-glaucoma-assessment-100495044","NCT05726058","Ocular Blood Flow Imaging for Glaucoma Assessment","Inclusion Criteria:\n\n* Age 18 and older with binocular vision\n* Able to provide informed consent\n* Patient is a healthy control OR is recommended for glaucoma assessment OR diagnosed with moderate to severe glaucoma in at least one eye as determined by Hodapp Anderson Criteria\n\nExclusion Criteria:\n\n* The subject has significant media opacity (e.g., a visually significant cataract or significant corneal scar)\n* The subject has previous ocular surgery other than uncomplicated cataract extraction, laser trabeculoplasty (ALT or SLT), or YAG capsulotomy\n* The subject has prior ocular disease other than glaucoma\n* The subject has anatomically narrow angles or a prior adverse reaction to administration of Tropicamide or fluorescein dye\n* The subject has more than 15 diopters of refractive error\n* The subject is a female who is pregnant or nursing\n* The subject has diabetes mellitus",true,"88 Years",{"count":126,"type":22},150,[56],"The goal of this clinical trial is to investigate the use of an FDA-cleared retinal blood flow imaging instrument called the XyCAM RI and XyCAM FC (Vasoptic Medical, Inc., Columbia, MD) in glaucoma management.\n\nThe main question it aims to answer are:\n\n* Can the investigators use blood flow to discriminate between eyes with early-stage glaucoma and variable-matched controls?\n* Can the investigators validate that the XyCAM FC simultaneously captures both stereo fundus photography and ocular blood flow monitoring?\n\nParticipants will be\n\n* measured for their blood pressure, heart rate, height, and weight\n* dilated with tropicamide\n* imaged using the XyCAM RI, fundus photography, optical coherence tomography, and standard automated perimetry\n* imaged using the XyCAM RI while inhaling 100% oxygen through a mask",[130],"Glaucoma",[132,133,134,135,136,137,138],"glaucoma","xycam","blood flow","imaging","ophthalmology","retinal blood flow","eye disease",{"date":81,"type":37},{"date":141,"type":37},"2023-03-30",{"date":143,"type":22},"2028-04-30",{"name":43,"class":44},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100393358","phase-4-measuring-the-effects-of-netarsudil-latanoprost-and-combination-therapy-on-episcleral-and-retinal-blood-flow-in-ocular-hypertension-and-glaucoma-suspects-100393358","NCT04401982","Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects","Measuring the Effects of Netarsudil, Latanoprost, and Combination Therapy on Episcleral and Retinal Blood Flow in Ocular Hypertension and Glaucoma Suspects Using Erythrocyte Mediated Angiography In Vivo","Inclusion:\n\n* Patients are at least 18 years of age.\n* Patients must have ocular hypertension or be a glaucoma suspect.\n* Patient must not have used any IOP-lowering medication (topical or systemic) within the past 6 months\n* Patients must have open angles on gonioscopy.\n* All patients will have at least one recorded visual field examination within 6 months of enrollment in the study. Visual fields will be assessed using the Hodapp-Andersen-Parish criteria.\n\nExclusion:\n\n* Participation in other investigational studies, unless such participation does not involve the administration of any drugs or agents that could impact the results of this study or have an effect on episcleral flow, as determined by the Investigator.\n* Prior intraocular surgery other than uncomplicated cataract surgery.\n* Allergy or history of adverse reaction to ICG, shellfish, or Iodine.\n* Significant liver disease or uremia.\n* Secondary glaucoma including exfoliation glaucoma, pigmentary glaucoma, or history of acute angle closure.\n* Moderate or severe visual field deficits as per Hodapp-Anderson-Parish criteria.\n* Any condition precluding imaging including reliable visual fields, disc photography, or use of study treatments including media opacity or tilted optic disk\n* Pregnant or nursing patients.",{"count":96,"type":22},[154],"PHASE4","The goal of this clinical trial is to compare participants treated with latanoprost to those treated with Rocklatan (netarsudil\u002Flatanoprost) to determine whether the addition of netarsudil results in greater improvements in episcleral venous blood flow in adults with glaucoma or ocular hypertension. Episcleral venous blood flow will be measured using erythrocyte-mediated angiography (EMA) and laser speckle contrast imaging (LSCI).\n\nThe main questions this study aims to answer are:\n\n* Does Rocklatan produce greater increases in episcleral venous blood flow than latanoprost alone?\n* Can EMA and LSCI reliably detect changes in episcleral venous blood flow following treatment with these medications?\n\nParticipants will:\n\n* Be randomized to receive either latanoprost or Rocklatan\n* Undergo imaging of the episcleral veins using EMA and LSCI before, during, and after treatment, and\n* Complete study visits that include standard ophthalmic examinations and intraocular pressure measurements.\n\nHypothesis: The investigators hypothesize that latanoprost, which primarily increases uveoscleral outflow, will not significantly affect the distal episcleral circulation. In contrast, Rocklatan, through its netarsudil component, is expected to produce measurable increases in episcleral venous flow.",[157,158],"Ocular Hypertension","Suspect Glaucoma",{"date":81,"type":37},{"date":81,"type":22},{"date":162,"type":22},"2027-03-17",{"name":43,"class":44},4,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":173,"targetDuration":175,"studyType":176,"phases":4,"briefSummary":177,"conditions":178,"keywords":184,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":116},"100377049","improving-outcomes-for-patients-with-life-threatening-neurologic-illness-100377049","NCT04189471","Improving Outcomes for Patients With Life-Threatening Neurologic Illness","Recovery After Cerebral Hemorrhage--Improving Outcomes for Patients With Life-Threatening Neurologic Illness","REACH","Inclusion Criteria:\n\n* clinical diagnosis of potentially life-threatening neurological illness\n* admitted to Neuro ICU within 14 days of initial injury\n\nExclusion Criteria:\n\n* known pre-existing neurological deficits related to a developmental disorder\n* prior severe stroke\n* prior severe dementia\n* prior severe head injury\n* prisoners",{"count":174,"type":22},5000,"12 Months","OBSERVATIONAL","Background:\n\nWhile the intensive care of patients with life-threatening brain illnesses has advanced tremendously, a large number of therapies are still without proper scientific support.\n\nThis can be partly explained by the fact that mechanisms of initial brain injury are still not well understood. Why additional neurological injury occurs during a patient's stay in the NeuroCritical Care Unit (NCCU) despite current best, evidence-based clinical practices, is also not well understood. However, over the past decade, better tools have become available to measure and monitor the impact of our clinical care on the rapidly changing physiology and chemistry of the injured brain. Some of these tools are CT, MRI, ultrasound, and catheter-based technology measuring blood flow and metabolism. These tools have enabled earlier detection of injury and complications and newer therapeutic strategies.\n\nPurpose:\n\nExamine disease pathways common to all brain injuries seen in the University of Maryland's 22-bed NCCU. Life-threatening neurological illnesses cared for in the NCCU include massive stroke, bleeding in and around the brain (subarachnoid hemorrhage, intracerebral hemorrhage, subdural hemorrhage, intraventricular hemorrhage), brain tumors, difficult to control seizures, neurologic infections, nerve and muscle diseases (such as myasthenia gravis or Guillain-Barre Syndrome), and spinal cord disorders among others. Many NCCU patients are comatose or paralyzed and may suffer injuries in other parts of the body as well.\n\nThis effort will require the creation of a robust clinical database for the capture of data including patient characteristics (age, sex), clinical characteristics, medical treatments, surgical interventions, physiological data (such as vital signs, cerebral blood flow, intracranial pressure, cerebral oximetry, etc), laboratory data, and standard-of-care diagnostic studies such as electroencephalography (EEG), ultrasound, CT, MRI, and angiograms. Similar databases exist at other major centers for neurocritical care and have been instrumental to the identification of characteristics both predictive of and associated with outcomes of patients long after their stay in the NCCU.\n\nIn addition, the samples collected will be included in the University of Maryland Medicine (UMM) Biorepository which is a shared resource to enable biomedical research by University of Maryland faculty.",[179,180,181,182,183],"Intracerebral Hemorrhage","Subarachnoid Hemorrhage","Intraventricular Hemorrhage","Nontraumatic Haemorrhage","Status Epilepticus",[185,186,187,182,188,189,190],"hemorrhage","intracerebral hemorrhage","SAH","ICH","subarachnoid hemorrhage","status epilepticus",{"date":81,"type":37},{"date":193,"type":37},"2014-09-08",{"date":195,"type":22},"2034-01-01",{"name":43,"class":44},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":116},"100645091","phase-2-gcc-2545--improving-post-radiotherapy-respiratory-function-through-sparing-serial-and-parallel-components-in-the-lung-100645091","NCT07679607","GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung","INSPIRE","Inclusion Criteria:\n\n* Step 1- Inclusion Criteria\n\n  1. Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage III NSCLC per AJCC ver 9\n  2. Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemothrapy, immunotherapy).\n  3. No restrictions on number radiotherapy fractions, or location\u002Fnumber of lesions\n  4. ECOG performance status ≤ 3\n  5. Ability to hold breath for ≥ 15 seconds\n  6. Patient has signed informed consent document and agreed to study procedures\n\nStep 2- Inclusion Criteria 1. Patient has completed 4DCT and BHCT with subsequent plans created and Radiation Oncologist has determined that patient would benefit from INSPIRE RT.\n\nExclusion Criteria:\n\n* Step 1- Exclusion Criteria\n\n  1. Prior lung cancer-directed radiotherapy\n  2. Recent (\\\u003C 12 mo) or planned lung surgery (which would confound pre- and post-RT lung function measures)\n  3. Patients with metal implants or metal stents in the thoracic region\n  4. Known severe chronic obstructive pulmonary disease or interstitial lung disease\n  5. Women who are pregnant or trying to get pregnant\n\nStep 2- Exclusion Criteria\n\n1\\. Patient found to not benefit from INSPIRE RT after comparison of treatment plans.",{"count":205,"type":22},70,[26],"Decreased respiratory function is a common side effect experienced by non-small cell lung cancer (NSCLC) patients who receive radiation therapy. In current clinical practice when treating cancerous lesions in the lung, it is not standard to explicitly try and avoid excessive radiation dose and therefore radiation injury to smaller airways. However, because of this patients may obtain damage to an airway segment can cause downstream regions in the lung to lose their \"supply line\" and, therefore, cause patients to lose the ability to exchange oxygen with the blood. The purpose of this clinical trial is to systematically compare post-treatment lung function of those who receive regular clinical radiation therapy (standard of care \\[SoC\\]) versus those who receive the airway-sparing radiation therapy regimen. The investigators hope to show that, by preserving airways and connected lung regions, participants will be able to retain a larger amount of their lung function, which will have a direct, positive impact on their post-treatment quality of life.",[209,210],"Lung Cancer (NSCLC)","Radiation","2026-06-29",{"date":79,"type":37},{"date":214,"type":22},"2026-08",{"date":216,"type":22},"2030-08",{"name":43,"class":44},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":123,"sex":17,"minAge":93,"maxAge":124,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":116},"100497550","phase-4-ct-tavr-abdomen-study-100497550","NCT05758701","CT TAVR Abdomen Study","Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR","CT TAVR","Inclusion Criteria:\n\n* scheduled to receive TAVR abdominal CT\n\nExclusion Criteria:\n\n* cannot undergo CT scan\n* Allergy to intravenous contrast not controlled by steroids or benadryl\n* GFR\\\u003C30",{"count":227,"type":22},164,[154],"A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.",[231],"Transcatheter Aortic Valve Replacement",[233],"Dual energy CT",{"date":79,"type":37},{"date":236,"type":37},"2023-09-19",{"date":238,"type":22},"2028-03-01",{"name":43,"class":44},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":116},"100366362","phase-2-clag-go-for-patients-with-persistent-relapsed-or-refractory-aml-100366362","NCT04050280","CLAG-GO for Patients With Persistent, Relapsed or Refractory AML","A Phase II Study of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor With Fractionated Gemtuzumab Ozogamicin (CLAG-GO) for the Treatment of Patients With Persistent, Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Adult patients age 18 years or older, with a pathologically confirmed diagnosis of AML \\[excluding acute promyelocytic leukemia (APL)\\] according to WHO criteria. AML may be de novo, or following a prior hematologic disease and\u002For therapy-related.\n2. Patients must have relapsed after or be refractory to at least one course of an intensive chemotherapy regimen, for example anthracycline\u002Fcytarabine (\"7+3\" or daunorubicin and cytarabine liposome). Patients with residual disease on day 13-22 of initial induction chemotherapy are eligible, provided the bone marrow cellularity is ≥ 30% AND bone marrow blasts are ≥ 20%. Hypomethylating agents such as azacitidine or decitabine are allowed as a prior therapy, but are not considered an intensive chemotherapy regimen.\n3. Eastern Cooperative Oncology Group performance status of 0-2.\n4. Any systemic chemotherapy and any radiotherapy must be completed at least 7 days prior to initiation of protocol therapy, with the exception of hydroxyurea or 6-mercaptopurine for cytoreduction.\n5. At least 20% expression of CD33 as determined by flow cytometry or immunohistochemical staining.\n6. Adequate renal function, defined as a serum creatinine less than 1.8 mg\u002FdL.\n7. Adequate hepatic function, defined as a direct bilirubin less than 2 times the institutional upper limit of normal (ULN) and AST, ALT and Alkaline Phosphatase less than 3 times the ULN.\n8. Patients who relapse after allogeneic hematopoietic stem cell transplantation are eligible, provided they are at least 60 days from stem cell infusion, do not have \\> grade 1 graft versus host disease, and have been off all immunosuppressive therapy for at least 2 weeks.\n9. Female patients of childbearing potential must have a negative pregnancy test and agree to use an adequate method of contraception as defined by the protocol. This must persist through the treatment period until at least 6 months after the last dose of chemotherapy or GO.\n10. Male subjects who are able to father children and are having intercourse with females of childbearing potential must also agree to an acceptable method of contraception through the treatment period until at least 3 months after the last dose of chemotherapy or GO, and must refrain from sperm donation during this period.\n11. Ability to give written informed consent.\n\nExclusion Criteria:\n\n1. Patients with acute promyelocytic leukemia (FAB-M3) or chronic myelogenous leukemia in blast phase.\n2. Isolated myeloid sarcoma. Patients must have marrow involvement with AML to enter the study.\n3. Patients with known active AML involvement of the central nervous system.\n4. Prior treatment with gemtuzumab ozogamicin or cladribine for AML. Prior treatment with cytarabine is permitted.\n5. As patients will be receiving G-CSF prior to chemotherapy, patients presenting with symptomatic leukostasis (as judged by the investigator) are excluded. Hydroxyurea, 6-mercaptopurine and\u002For leukapheresis for blast count control (see inclusion criterion #4) for patients with asymptomatic hyperleukocytosis is permitted before starting treatment, but must be stopped for at least 24 hours prior to starting protocol treatment.\n6. Active uncontrolled infection. Patients on prophylactic antibacterial, antifungal, and\u002For antiviral agents and patients whose infections are controlled with these agents are eligible.\n7. Known active hepatitis B or C or other known active hepatic disorder.\n8. Any history of veno-occlusive disease (VOD)\u002Fsinusoidal obstruction syndrome (SOS).\n9. Active concurrent malignancy, unless disease-free for at least 3 years. Subjects with treated non-melanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been treated surgically or with definitive radiotherapy.\n10. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that per investigator's judgment would limit compliance with study requirements.",{"count":248,"type":22},39,[26],"This study involves evaluating a combination of chemotherapy drugs known as \"CLAG-GO\" \\[cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)\\] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has returned after an initial remission (relapsed). The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). Potential participants will go through a screening period to see if they are eligible to join the study. If eligible, participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO, called induction chemotherapy. If tests show that the cancer is in remission after induction chemotherapy, participants may undergo further chemotherapy (known as consolidation) or may proceed with bone marrow\u002Fstem cell transplantation. Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy. A cycle lasts about 28 days. All participants will be monitored carefully for both side effects and to see if the study treatment is working. Lab tests and exams will be conducted throughout the entire study. In addition, special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best.",[252,253,254],"Acute Myeloid Leukemia, Adult","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, Relapsed, Adult",{"date":79,"type":37},{"date":257,"type":37},"2019-11-01",{"date":259,"type":22},"2028-02",{"name":43,"class":44},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":124,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":116},"100645403","docktales-for-chronic-pain-100645403","NCT07680894","DockTales for Chronic Pain","Evaluating Feasibility and Acceptability of DockTales for Chronic Pain","Inclusion Criteria:\n\n* Age ( 18-88 years old)\n* English speaker (written and spoken)\n* Chronic pain for at least 3 months\n* Smartphone\u002Ftext messaging capability\n\nExclusion Criteria:\n\n* Any personal history of mania, schizophrenia, or other psychoses\n* Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.\n* Pregnancy or breast feeding\n* Impaired or uncorrected hearing",{"count":269,"type":22},60,[56],"This study will evaluate the feasibility and acceptability of DockTales, a mobile health tool designed for adults with chronic pain. DockTales supports pain and sleep tracking through brief diaries, body-map pain reporting, reflective journaling, visual summaries, and optional AI-supported interaction. The study will be conducted completely remotely. Participants will complete 2 weeks of DockTales use and 2 weeks of REDCap-based daily monitoring, with the order randomized. The main goal is to determine whether DockTales is usable, acceptable, engaging, and practical for adults with chronic pain compared with standard REDCap monitoring.",[273,274],"Chronic Pain","Chronic Pain Syndrome","2026-06-25",{"date":81,"type":37},{"date":278,"type":22},"2026-07-17",{"date":280,"type":22},"2027-10-24",{"name":43,"class":44},{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":116},"100644758","virtual-reality-for-scd-voc-100644758","NCT07674277","Virtual Reality for SCD VOC","Randomized EvaLuation of ImmErsive Virtual Experiences in Sickle Cell Disease (RELIEVE-SCD)","RELIEVE-SCD","Inclusion Criteria:\n\n* Adult (age ≥ 18 years) patients\n* History of sickle cell disease\n* Treatment plan by clinical care team includes the use of intravenous opioids to -treat acute pain.\n* Receiving treatment from the Stoler Infusion center\n\nExclusion Criteria:\n\n* Prior enrollment in this study\n* Presenting with a chief complaint suggestive of a complicated crisis (such as concern for acute chest syndrome, splenic sequestration, hepatic sequestration, pulmonary embolism) as determined by the clinical care provider\n* Not being treated with intravenous opioids for the vaso-occlusive crisis\n* Patients who lack the capacity to provide informed consent\n* Medical history of seizures or known intolerance to virtual reality devices\n* In the opinion of the investigator and based on chart review and direct questioning of the patient, there are preexisting disabilities like vision and hearing defects that preclude the use of a head mounted virtual reality device.\n* Known to be pregnant\n* Incarcerated at the time of evaluation\n* Over the age of 89 years old","89 Years",{"count":7,"type":22},[56],"This pilot study will evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality interventions for adults with sickle cell disease experiencing vaso-occlusive crisis treated in an infusion center. Participants will be enrolled during routine outpatient sickle cell clinic visits and may receive study interventions during future qualifying infusion center visits for vaso-occlusive pain. Using a randomized, two-period crossover design, each participant will be assigned to receive two of three headset-based conditions across separate visits: sham 2D headset control, passive immersive 3D virtual reality, or active immersive interactive 3D virtual reality. The primary outcome is pain burden during the first 60 minutes after intervention start, measured as area under the curve of 0-10 numeric rating scale pain scores. Secondary outcomes include feasibility of intervention delivery, headset tolerability, pain at 120 minutes, opioid use, and participant-reported immersion and acceptability.",[295],"Sickle Cell Disease",[297,295,298],"virtual reality (VR)","vaso-occlusive crisis","2026-06-23",{"date":211,"type":37},{"date":302,"type":22},"2026-08-01",{"date":304,"type":22},"2027-12",{"name":43,"class":44},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":116},"100623559","gcc-2546--motion-management-100623559","NCT07398209","GCC 2546- Motion Management","Combining 4D MRI and 4DCT for Personalized Volumetric Motion Monitoring in Lung Radiation Therapy","Inclusion Criteria:\n\n1. Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage II-IIIb NSCLC\n2. Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemotherapy, immunotherapy).\n3. No restrictions on number radiotherapy fractions, or location\u002Fnumber of lesions\n4. ECOG performance status ≤ 3\n5. Ability to undergo MRI scans\n6. Patient has signed informed consent document and agreed to study procedures\n\nExclusion Criteria:\n\n1. Pre-existing contraindications for MRI, such as any MRI-conditional or MRI-unsafe foreign objects within the body, non-removable ear cochlear or eye implant, aneurysm clip, cardiac pacemaker\u002Fwires, internal defibrillator, tissue expander, recent stent placement, penile prosthesis, medication patch, artificial limb, pregnancy, and claustrophobia\n2. Women who are pregnant or trying to get pregnant (self-reported)\n3. Pain in supine position or inability to raise arm above head in supine position",{"count":314,"type":22},44,[56],"The purpose of this study is to assess a real time motion tracking of lung tumors and important organs next to the tumor while breathing during a participant's radiation treatment. This will be assessed through a four-dimensional magnetic resonance imaging (MRI) scan before starting your radiation treatment and x-ray fluoroscopy images that are taken during radiation",[209,210],{"date":319,"type":37},"2026-06-26",{"date":321,"type":37},"2026-04-14",{"date":323,"type":22},"2029-04",{"name":43,"class":44},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":123,"sex":17,"minAge":93,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":340,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100524514","early-biomarker-kidney-injury-assessment-after-acumen-directed-fluid-management-in-cardiac-surgery-100524514","NCT06109714","Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery","BE-KIND","Inclusion Criteria:\n\n* Adult patients undergoing cardiopulmonary bypass\n* Procedure coronary artery bypass grafting, aortic valve replacement, or both\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years old\n* Emergent surgery\n* Preoperative kidney disease (Cr \\> 2.0 or on renal replacement therapy)\n* Ejection fraction \\\u003C 40%\n* Incomplete data in medical record","90 Years",{"count":334,"type":22},100,[56],"This study is to assess the benefits of goal-directed fluid management with ACUMEN in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.",[338,339],"Renal Injury","Acute Kidney Injury",[341,342,343],"Cardiac Surgery","Cardiac Surgery Induced Kidney Injury","Kidney Biomarkers","2026-06-19",{"date":299,"type":37},{"date":347,"type":22},"2026-09-01",{"date":349,"type":22},"2030-12-31",{"name":43,"class":44},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":359,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":368,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":116},"100514337","dietary-intervention-to-mitigate-post-acute-covid-19-syndrome-100514337","NCT05977179","Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome","A Diet Intervention Study To Mitigate Fatigue Symptoms And To Improve Muscle And Physical Function In Older Adults With Post-Acute COVID-19 Syndrome","Long-COVIDiet","Inclusion Criteria:\n\n1. Age of 50 years or older\n2. No known active infectious disease (COVID-19 or other).\n3. Participant diagnosed with long-COVID\u002F post- acute COVID-19 syndrome (PACS) \u002FICD-10-CM codes U09.9\n4. Moderate\u002Fsevere fatigue Brief Fatigue Inventory (BFI)≥4\n5. Poor diet quality assessed by the short Healthy Eating Index (HEI)\\\u003C70\n\nExclusion Criteria:\n\n1. Participants with a home oxygen requirement or requiring chronic ventilator support\n2. Participants diagnosed with diabetes who do not have a recent HbA1c level or with HbA1c \\> 9%\n3. Participants diagnosed with Congestive Heart Failure (CHF New York Heart Association) \\> class 2\n4. Participants with dietary restrictions due to medication use that affects blood clotting, such as Warfarin or other reasons.\n5. Evidence of any condition as determined by a physician or the study team that would lead to an increased risk of illness due to any aspect of proposed testing and interventions, or introduce unanticipated confounding of study results.\n6. Participants diagnosed with uncontrolled hypertension that will be defined as:\n\n   1. Systolic blood pressure consistently equal to or higher than 190 mmHg.\n   2. Diastolic blood pressure consistently equal to or higher than 110 mmHg.\n   3. Participants with a recent history of hypertensive crisis (severe elevation in blood pressure requiring immediate medical intervention), regardless of current blood pressure levels.\n7. Participants with diet restrictions or allergies that can affect adherence to the diet, such as allergy to fish or shellfish.\n8. Participation in another trial in which active intervention is being received.\n9. Participants with active drug or alcohol use\u002Fdependence that would interfere with adherence to the study.\n10. Participants scheduled for surgical procedures within the next 6 months.\n11. Participants diagnosed with active cancer.\n12. Participants diagnosed with liver diseases.\n13. Participants diagnosed with kidney-related conditions, including Chronic Kidney Disease (CKD) \\> stage 3.\n14. Below the age of 50 years.","50 Years","94 Years",{"count":362,"type":22},56,[56],"The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole-Diet Approach when following a healthy US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in adults aged 50 years and older.\n\nThe main research questions this study aims to answer are:\n\n1. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS?\n2. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate declines in muscle function and physical performance in adults with PACS?\n\nAt the beginning of the study, eligible participants will be randomly assigned to either the Dietary Intervention Group, where they will receive personalized dietary plans and weekly sessions, or the Attention Control Group, where they will attend general health sessions on a weekly basis as well.\n\nThis research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes of the two groups, we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS.",[366,367],"Post-Acute COVID-19 Syndrome","Fatigue",[369,370,371],"COVID","long-COVID","DIET",{"date":299,"type":37},{"date":374,"type":37},"2025-05-12",{"date":376,"type":22},"2028-09-30",{"name":43,"class":44},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":123,"sex":17,"minAge":93,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":116},"100503007","early-phase-1-measuring-acute-drug-demand-in-humans-100503007","NCT05829655","Measuring Acute Drug Demand in Humans","Inclusion Criteria:\n\n* Age between 18 and 65 years old\n* Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)\n* Lifetime substance use history criterion \\[blinded\\]\n* Medically cleared to take suvorexant and blinded study medications\n* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Seeking opioid use treatment\n* Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff\n* Known contraindications or allergies to suvorexant and\u002For the blinded study medications","65 Years",{"count":386,"type":22},75,[388],"EARLY_PHASE1","This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.",[100,391],"Opioid Dependence",{"date":299,"type":37},{"date":394,"type":37},"2023-08-08",{"date":396,"type":22},"2028-01-01",{"name":43,"class":44},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":4},"100644121","phase-1-gut-permeability-and-microbiome-in-preterm-infants-100644121","NCT07667049","Gut Permeability and Microbiome in Preterm Infants","Gut Permeability and Microbiome in Very Low Birth Weight Preterm Neonates.","Inclusion Criteria:\n\n\\\u003C5 days Gestational age 24-32 weeks\n\nExclusion Criteria:\n\nNonviable or planned withdrawal of care\n\n* Significant GI dysfunction (e.g. heme-positive stools, abdominal distension (girth \\>2 cm baseline), or bilious emesis\u002F aspirates.\n* Triplet or higher order multiple\n* Severe asphyxia\n* Lethal chromosome abnormalities\n* Cyanotic congenital heart disease\n* Intestinal atresia or perforation\n* Abdominal wall defects\n* Known galactosemia or other galactose intolerance","4 Days",{"count":126,"type":22},[25],": NEC, a life-threatening, GI emergency characterized by increased IP, affects approximately 7 to 10% of preterm neonates, and typically occurs within 7 to 14 days of birth (37, 38) with mortality as high as 30-50% (39). NEC symptoms mainly involve GI dysfunction, such as abdominal distension and feeding intolerance, but the presentation can be non-specific with few warning signs. Current therapies may be invasive, including surgical interventions that are often ineffective due to the rapid progression of the disease. Prematurity is the greatest risk factor for development of NEC (40, 41), due to physiological immaturity of the GI tract and altered levels of the normal GI microbiota. Several studies suggest that the initiation of an intense systemic and local inflammatory cascade leads to intestinal necrosis (42-47). Antenatal exposure to infection\u002Finflammation may predispose the developing intestinal mucosa to subsequent injury or dysregulated inflammatory responses. Previous studies have linked presence of amniotic fluid infection\u002Felevated cytokines, (48) cord blood cytokines, (49, 50) and umbilical cord inflammation (51) with risk for NEC in preterm neonates. In a rat model of NEC, maternal prenatal exposure to microbial LPS led to increased frequency and severity of intestinal injury (52). Taken together, these observations suggest that intestinal injury may be initiated in utero and contributes to increased IP at birth in the preterm neonate. Many of the defense mechanisms present in the mature intestine, such as peristalsis and tight junctions between intestinal epithelial cells (37) are decreased in an immature intestine, and thus bacteria normally confined to the intestinal lumen are able to reach systemic organs and tissues. Bacterial translocation triggers the activation of an exaggerated inflammatory response, which leads to further epithelial damage. Our analysis of the initial cohort of 43 preterm infants, and others' previous studies have shown that IP is high at birth in preterms (\\\u003C33wk gestation) with a rapid maturation of the intestinal barrier over the first 2 weeks. However, in some infants, high IP persisted and\u002For recurred in association with altered levels of the normal microbiota (bacteria community composition). Specifically, we observed that (1) rapid maturation of intestinal barrier function, characterized by decreased IP, correlates with increased microbial community diversity (Figure 1), and most outstandingly, the increased abundance of beneficial bacteria Clostridiales (Figure 2); (2) Clostridiales is highly transcriptionally active and co-active with the probiotic bacterium Bifidobacterium; (3) neonatal factors, including early introduction of breast milk, shorter period of antibiotic exposure, and later gestational age, favor the early colonization of the gut microbiota by members of Clostridiales and Bifidobacterium, which altogether are associated with improved intestinal barrier in preterm infants; (4) low Clostridiales spp. abundance (\\\u003C5%) and early gestational age (\\\u003C31.7wk) were identified to be the most discriminatory features for elevated IP by supervised learning scheme, reaching an accuracy of 86.1%. (5) Clostridiales and Bifidobacteriales are the most abundant bacteria groups in later stages (phase II\u002FIII at 6-18 months of age) as shown in Figure 2, suggesting a process of gaining prosperity of these two bacterial groups during intestine development after birth. Altogether our preliminary results suggest the early colonization of the natural occurring probiotics strains Clostridiales and Bifidobacterium strongly associate with rapid maturation of intestinal barrier function, and their measurement are highly promising for early detection and as potential nutritional supplement to prevent NEC in the high-risk preterm population. We propose in this study to recruit additional 150 mother-infant dyads (justified in study size analysis in research design), to address our hypothesis that the two naturally occurring beneficial bacteria Clostridiales and Bifidobacterium are rapidly gaining prosperity during normal intestine development in association with improved barrier function measured by La\u002FRh ratio. This continuation of the initial study builds on the previous findings that identified commensal bacteria Clostridiales and Bifidobacterium species as a strong indicator to the lowered IP and rapid maturation of intestinal barrier, to substantiate measurement of these probiotic strains combined with associated neonatal factors to form an accurate, rapid detection of intestinal permeability abnormality. We propose in this study to recruit additional 150 mother-infant dyads (justified in study size analysis in research design), to address our hypothesis that the two naturally occurring beneficial bacteria Clostridiales and Bifidobacterium are rapidly gaining prosperity during normal intestine development in association with improved barrier function measured by La\u002FRh ratio.",[410],"Prematurity Complications",[412,413,414,415],"Intestinal permeability","necrotizing enterocolitis","preterm infants","dual sugar probe test","2026-06-18",{"date":418,"type":37},"2026-06-24",{"date":420,"type":22},"2026-07-15",{"date":422,"type":22},"2027-06-30",{"name":43,"class":44},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":124,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":116},"100533438","placebo-impacts-sleep-and-pain-modulation-in-chronic-pain-100533438","NCT06225817","Placebo Impacts Sleep and Pain Modulation in Chronic Pain","The Impact of Open-label Placebo on Sleep and Pain Modulation","Inclusion Criteria:\n\n* Age ( 18-88 years old)\n* English speaker (written and spoken)\n* TMD for at least 3 months\n* Grade Chronic Pain Scale (GCPS) ≥1\n* Smartphone\u002Ftext messaging capability\n\nExclusion Criteria:\n\n* Present or past degenerative neuromuscular disease\n* Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years\n* Any personal (or family first degree) history of mania, schizophrenia, or other psychoses\n* Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.\n* Lifetime alcohol\u002Fdrug dependence or alcohol\u002Fdrug abuse in past 3 months\n* Pregnancy or breast feeding\n* Impaired or uncorrected hearing",{"count":432,"type":22},111,[56],"The goal of this free-choice parallel design clinical trial is to examine the potential beneficial effects of using open-label placebo (OLP) in improving chronic pain related outcomes and sleep quality in people with temporomandibular disorders. This study will enroll a cohort of participants with temporomandibular disorders (TMD) which lasts for more than 3 months. The main questions it aims to answer are:\n\n1. Will participants with TMD be more likely to take open-label placebo pills if they are introduced to the effects of placebo (e.g., going through an expectation management session)?\n2. Will taking open-label placebo plus expectation management improve chronic pain related outcomes, such as chronic pain intensity, interference, levels of anxiety and depression, in the cohort of TMD?\n3. Will open-label placebo plus expectation management improve sleep quality in participants suffering from TMD?\n\nTo answer the above questions, participants with TMD will be randomly assigned to three groups: 1. Open-label placebo plus expectation management group, where participants will complete a 1-hour discussion session about their expectations toward open-lable placebo intervention, and then take 1 open-labe placebo pill per day for a total of 45 days. 2. Open-label placebo only group where participants will be asked to take open-label placebo pills, one pill per day, for a total of 45 days. 3. standard of care group where participants will maintain their usual care without introducing open-label placebo to them during the 45 days monitoring. Researchers will compare the chronic pain intensity, interference, mood, anxiety, and sleep quality between the open-label placebo group and the wait-list group. Daily chronic pain will be measured using visual analog scale (VAS) ranging from 0=no pain at all to 100=maximum tolerable pain. Chronic pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference and pain behavior. Anxiety and depression will be measured using PROMIS-anxiety, and PROMIS-depression scales respectively. Finally, sleep quality will be quantified using the objective measurement Motion Watch during the 45 days intervention and monitoring. In order to have a rigorous measurement of the baseline pain and sleep fluctuation, this study will include a 7-day phenotyping period before the starting of the 45-day intervention and monitoring. During the 7-day phenotyping period, participants will record their daily chronic pain and sleep quality using polysomnography.",[273,436],"Headache","2026-06-15",{"date":439,"type":37},"2026-06-17",{"date":441,"type":37},"2025-04-21",{"date":443,"type":22},"2028-07-30",{"name":43,"class":44},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":452,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":176,"phases":4,"briefSummary":455,"conditions":456,"keywords":459,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":116},"100619938","assessment-of-treatment-variability-for-pelvic-ring-fragility-fractures-100619938","NCT07351123","Assessment of Treatment Variability for Pelvic Ring Fragility Fractures","Pelvis ATV","The inclusion criteria are:\n\n1. Patient 60 years of age or older.\n2. Low energy injury mechanism.\n3. LC1 pelvis fracture (AO\u002FOTA 61B1.1,61B2.1, or 61B3.2) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.\n4. Fracture displacement of \\\u003C10 mm of the posterior pelvic ring on computed tomography of the pelvis.\n5. Injury occurred within 21 days of screening.\n\nThe exclusion criteria are:\n\n1. Patient did not ambulate prior to injury.\n2. Severely frail patients (Clinical Frailty Scale ≥7).\n3. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.\n4. Retained implants around the pelvis that precludes or limits either study treatment.\n5. Infection around the hip (soft tissue or bone).\n6. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.\n7. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.\n8. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.\n9. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.\n10. Expected injury survival of less than 12 months.\n11. Terminal illness with expected survival of less than 12 months.\n12. Currently enrolled in a study that does not permit co-enrollment.\n13. Prior enrollment in the study.\n14. Unable to obtain informed consent due to language barriers.\n15. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.\n16. Did not provide informed consent (declined participation).\n17. Patient or LAR not approached to participate in the trial (missed patient).\n18. Other reason to exclude the patient, as approved by the Principal Investigator.","60 Years",{"count":454,"type":22},120,"Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. This multicenter prospective cohort study will evaluate 120 patients to determine the feasibility of a randomized controlled trial comparing operative and nonoperative treatment, by evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.",[457,458],"Pelvic Fractures","Fragility Fractures of the Pelvis (FFP)",[460,461,462],"Pelvic fracture","Fragility fracture of the pelvis","Pelvic ring injury","2026-06-04",{"date":465,"type":37},"2026-06-08",{"date":467,"type":37},"2026-05-25",{"date":469,"type":22},"2027-09-30",{"name":43,"class":44},{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":116},"100553163","phase-2-take-the-reins-the-effects-of-nutrient-timing-on-cancer-related-fatigue-100553163","NCT06482515","Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue","Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue Among Blood Cancer Survivors (2458GCCC)","Inclusion criteria (Participants must…):\n\n* Have a diagnosis of a hematologic neoplasm (e.g., leukemia, lymphoma, multiple myeloma);\n* Be at least 2 months post-treatment with chemotherapy, radiation, targeted therapy, chimeric antigen receptor (CAR)-T cell therapy, stem cell transplant, or another therapy (maintenance therapies are okay; steady unchanged treatment for relapsed disease for \\>2 months and expected to stay on it until progression is okay);\n* Have a baseline level of fatigue, as determined by at least one of the following:\n\n  1. Reporting a score of 4 or higher in response to the question, \"What was your worst fatigue in the last week, on a scale of 0-10, where 0 is no fatigue and 10 is the worst fatigue?\"\n  2. In the habit of taking daytime naps,\n  3. Have fatigue that interferes with their ability to work, engage in social events, or is more than would be expected from physical exertion,\n* Be able to speak and\u002For read and write in English or Spanish;\n* Be at least 18 years old; and\n* Be able to provide informed consent.\n\nExclusion criteria (participants must not…)\n\n* Be underweight, as defined as a body mass index \\\u003C18.5 kg\u002Fm2;\n* Already eat all their food within a window that is 10 h or shorter most (6\u002F7) days of the week;\n* Be employed in a job where they regularly work away from the home at night (e.g., night shift);\n* Have surgery planned during the study duration;\n* Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder);\n* Be taking insulin; or\n* Be on enteral or parenteral nutrition.",{"count":479,"type":22},96,[26],"Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism.",[483,484,367,485,486,487],"Neoplasms","Blood Cancer","Diet Habit","Survivorship","Fasting, Intermittent","2026-06-03",{"date":490,"type":37},"2026-06-05",{"date":492,"type":37},"2024-11-04",{"date":494,"type":22},"2028-08-31",{"name":43,"class":44},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":509,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":519,"locationsCount":116},"100604708","older-adults-methadone-and-cognitive-function-100604708","NCT07153029","Older Adults, Methadone, and Cognitive Function","Cognitive Functioning Among Older Adults in Methadone Treatment for Opioid Use Disorder","Inclusion Criteria:\n\n* age 55 and older\n* currently in outpatient methadone treatment for opioid use disorder\n* participant is alert\u002Fable to communicate\u002Fable to give acceptable answers on the \"Evaluation to Sign Consent form\n* participant has normal or correct to normal vision\n\nExclusion Criteria:\n\n* age 54 or younger\n* not in methadone treatment for opioid use disorder",{"count":504,"type":22},30,[56],"The increasing prevalence of opioid use disorder (OUD) among older adults, coupled with high overdose rates and cognitive impairments associated with opioid use, highlights a critical gap in addiction treatment. Cognitive impairments can persist despite treatment and negatively impact recovery outcomes, yet cognitive screening and interventions are rarely integrated into OUD care. This study aims to evaluate the feasibility of remotely delivered, smartphone-based cognitive assessments (administered through NeuroUX web-based software) for older adults (55+) in methadone treatment. The tasks have been \"gamified\" to make them engaging and brief, which could be appealing to patients. They will complete the tasks for 15 days using the phone provided or their own phone. During days 6-15 of testing, tasks will become incrementally more difficult based on participant performance to assess the feasibility of cognitive training. Cognitive training uses engaging games or tasks to strengthen thinking skills like memory and focus, much like physical exercise strengthens the body. Adherence, acceptability, and usability of the tasks will be assessed. Secondary analyses will explore relationships between task performance and participant characteristics (e.g., baseline cognitive functioning, methadone dose, timing of methadone dose). Findings from this pilot study will provide foundational data for a future grant application to develop and test digital cognitive assessment and training interventions tailored to older adults in addiction treatment. By addressing a critical yet understudied aspect of OUD care this research has the potential to enhance treatment engagement, improve clinical outcomes, and support long-term recovery in the growing older population.",[100,508],"Cognitive Ability General",[510,511,512,513],"older adults","cognition","feasibility","ecological momentary assessment","2026-06-01",{"date":488,"type":37},{"date":517,"type":37},"2024-12-03",{"date":79,"type":22},{"name":43,"class":44},{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":332,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":116},"100597023","external-facilitation-to-increase-prescribing-of-aud-medications-in-the-psychiatric-setting-100597023","NCT07053098","External Facilitation to Increase Prescribing of AUD Medications in the Psychiatric Setting","Inclusion Criteria:\n\n* For prescribers: working as a prescriber, non-prescribing clinician, or administrator at one of the three participating clinics.\n* For patients: has major mental illness (major depressive disorders, bipolar disorder, schizophrenia spectrum disorders, other psychotic disorders; posttraumatic stress disorder)\n* For patients: has Alcohol Use Disorder and is being treated in one of the three participating clinics.\n\nExclusion Criteria:\n\n* For all: age is less than 18 years old\n* For all: not able to complete informed consent",{"count":527,"type":22},40,[56],"This project will pilot test an implementation facilitation intervention to increase prescribing of medications for alcohol use disorder (MAUD) in patients with major mental illness and alcohol use disorder in three psychiatry treatment clinics.",[531,532],"Alcohol-Related Disorders","Psychiatric Disorder","2026-05-29",{"date":488,"type":37},{"date":536,"type":37},"2025-03-18",{"date":538,"type":22},"2027-05-31",{"name":43,"class":44},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":547,"minAge":93,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":561},"100456454","phase-2-terps-trial-for-de-novo-oligometastic-prostate-cancer-100456454","NCT05223803","TERPS Trial for de Novo Oligometastic Prostate Cancer","Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial","Inclusion Criteria:\n\n1. Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.\n\n   1. CT or MRI scan within 6 months of enrollment\n   2. Bone scan within 6 months of enrollment\n   3. Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT\u002FMRI scan and bone scan)\n2. Histologic confirmation of malignancy (primary or metastatic tumor).\n3. Patient may have had prior systemic therapy and\u002For ADT associated with treatment within 9-months of enrollment.\n4. PSA \\> 0.5 but \\\u003C100.\n5. Patient must be ≥ 18 years of age.\n6. Patient must have a life expectancy ≥ 12 months.\n7. Patient must have an ECOG performance status ≤ 2.\n8. Patient must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n1. Castration-resistant prostate cancer (CRPC).\n2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy\n3. Spinal cord compression or impending spinal cord compression.\n4. Suspected pulmonary and\u002For liver metastases (greater \\>10 mm in largest axis).\n5. Patient receiving any other investigational agents.\n6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .\n7. Unable to lie flat during or tolerate PET\u002FMRI, PET\u002FCT or SABR.\n8. No radiographical evidence of cranial metastasis.\n9. Refusal to sign informed consent.","MALE",{"count":549,"type":22},122,[26],"This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.",[553,554],"Prostate Cancer","Oligometastatic Disease",{"date":488,"type":37},{"date":557,"type":37},"2022-10-18",{"date":559,"type":22},"2029-07-31",{"name":43,"class":44},10,{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":116},"100639479","phase-2-efficacy-and-speed-of-response-of-lebrikizumab-in-high-burden-prurigo-nodularis-patients-100639479","NCT07620561","Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients","Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study","Inclusion Criteria:\n\n* Age 18-80\n* Diagnosis of Prurigo Nodularis (PN) for at least 1 year\n* Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body\n* Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug\n* Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug\n\nExclusion Criteria:\n\n* Prior participation in a lebrikizumab study\n* History of anaphylaxis\n* History of or active HIV\n* Active hepatitis or known liver cirrhosis\n* History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.\n* Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma\n* Current or recent parasitic infection\n* Immunocompromised individuals\n* Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period\n* Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments\n* Current or recent treatment with biologic drugs\n* Use of drugs that have an effect on the immune system during the study and within 4 weeks of starting the study\n* Receipt of phototherapy or light-based therapy within 4 weeks before starting the study\n* Regular use of tanning booths or parlors within 4 weeks before starting the study\n* Receipt of a live vaccine within 12 weeks before starting the study or planned receipt during the study\n* Recent use of an experimental drug\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply.","80 Years",{"count":571,"type":22},15,[26],"The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).",[575],"Prurigo Nodularis (PN)",[577,578,579,580,581,582,583,584],"prurigo nodularis","prurigo","lebrikizumab","ebglyss","itch","pruritus","dermatitis","skin diseases","2026-05-26",{"date":587,"type":37},"2026-06-02",{"date":589,"type":22},"2026-06",{"date":591,"type":22},"2028-03",{"name":43,"class":44},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":600,"maxAge":601,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":608,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":613,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":619,"locationsCount":116},"100560906","hub-based-engagement-navigator-service-to-reduce-csc-disengagement-100560906","NCT06583239","Hub-Based Engagement Navigator Service to Reduce CSC Disengagement","Developing and Evaluating a Hub-Based Engagement Navigator Service to Reduce CSC Disengagement","Inclusion Criteria:\n\n* Patients receiving services at Coordinated Specialty Care programs for the treatment of early episode psychosis\n* Age 13-35\n\nExclusion Criteria:\n\n* Do not meet inclusion criteria","13 Years","35 Years",{"count":603,"type":22},555,[56],"This project will develop a hub-based engagement navigator service for participants and families at high risk for disengagement. The investigators will use robust Participatory Research methods to ensure integration of Coordinated Specialty Care (CSC) program staff, participants, and family members in developing all aspects of and materials for the service, conduct feasibility\u002Facceptability testing in three CSC programs, and use this information to guide refinements. This will be followed by a mixed methods hub wide evaluation using a hybrid type I open cohort stepped wedge design to examine feasibility, acceptability, and effectiveness to improve disengagement outcomes and address target mechanisms.",[607],"Disengagement",[609,610,611,612],"first episode psychosis","Coordinated Specialty Care","treatment disengagement","mental health services","2026-05-24",{"date":615,"type":37},"2026-05-28",{"date":617,"type":37},"2026-02-02",{"date":559,"type":22},{"name":43,"class":44},""]