[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Arizona\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":708},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,70,0,25,[9,43,71,100,120,146,171,198,226,254,287,304,329,365,392,415,446,478,507,545,569,598,627,645,669],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100591044","radiographic-findings-and-clinical-outcomes-after-bone-grafting-patellar-defect-in-acl-reconstruction-100591044",false,"NCT06975306","Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction","BTB BackFill","Inclusion Criteria:\n\n* 18-40 years old,\n* male\u002Ffemale\u002Fgender neutral,\n* all races not including vulnerable\u002Fspecial consideration populations,\n* candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft,\n* compliant post operative course.\n\nExclusion Criteria:\n\n* \\\u003C 18, \\>41 years of age,\n* prior bone patellar bone anterior cruciate ligament reconstruction,\n* non-compliance post-operatively,\n* nicotine dependence.","ALL","18 Years","40 Years",{"count":21,"type":22},75,"ESTIMATED","INTERVENTIONAL",[25],"NA","All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.",[28,29],"Bone Graft; Complications","ACL Injuries","RECRUITING","2026-08-12",{"date":33,"type":34},"2026-08-14","ACTUAL",{"date":36,"type":34},"2025-02-11",{"date":38,"type":22},"2027-04-30",{"name":40,"class":41},"University of Arizona","OTHER",3,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100537833","phase-1-safety-and-efficacy-of-angiotensin-1-7-in-persons-with-moderate-to-severe-traumatic-brain-injury-100537833","NCT06282965","Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury","A Randomized, Double-blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury (TBI)","ANGel T","Inclusion Criteria:\n\n* Participant or representative willing to provide informed consent.\n* Age 18 years or older at time of enrollment.\n* Traumatically induced head injury resulting from insult to head from an external force.\n* Clinical diagnosis of acute intracranial lesion based on neuroradiologist report. CT scan and report must be available.\n* Moderate or severe traumatic brain injury (TBI) defined as Glasgow Coma Scale (GCS) score on trauma presentation of 12 or less. In general: Moderate TBI will be defined as loss of consciousness between 30 minutes and 24 hours and GCS between 9 and 12. Severe TBI will be defined as loss of consciousness \\> 24 hours and GCS ≤ 9.\n* Enrollment within 48 hours of TBI.\n\nExclusion Criteria:\n\n* Time of injury cannot be determined.\n* Neurosurgery within the last 30 days.\n* History of neurodegenerative disease or disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors that would impact cognitive testing.\n* Contraindication to having an MRI.\n* Pregnant or lactating female.\n* Female of childbearing potential or sexually active male who is not willing to use an acceptable method of birth control for the treatment period and 7 days after the last dose of the study drug.\n* Participation in another clinical study involving investigational product within 30 days prior to study enrollment.\n* If in the opinion of the investigator, candidate is unsuitable for participation in the study.",{"count":52,"type":22},90,[54,55],"PHASE1","PHASE2","The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).\n\nThe main questions this trial aims to answer are:\n\n* Is Angiotensin (1-7) safe?\n* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?\n\nParticipants will:\n\n* Complete 21 days of study treatment consisting of a once-daily injection.\n* Provide blood samples.\n* Undergo two magnetic resonance imaging (MRI) scans of the brain.\n* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.\n\nResearchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI.",[58],"Traumatic Brain Injury",[60,61],"renin angiotensin system","cognition","2026-08-07",{"date":64,"type":34},"2026-08-11",{"date":66,"type":34},"2024-05-28",{"date":68,"type":22},"2027-09",{"name":40,"class":41},1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100649538","early-phase-1-acute-effects-of-estradiol-administration-on-brain-function-during-fear-learning-100649538","NCT07737613","Acute Effects of Estradiol Administration on Brain Function During Fear Learning","Neuroimaging Study of Fear Learning: Effects of Estrogen","EstroFearGen","Inclusion Criteria:\n\n* post-menopausal\n* normal or corrected-to-normal vision\n* English speaking\n* stable medication use (no changes in the past three months)\n\nExclusion Criteria:\n\n* use of hormone therapy containing synthetic estrogen\n* MRI contraindications (e.g., irremovable ferrous metal in body, claustrophobia)\n* history of neurological disorder (including mild cognitive impairment) or moderate to severe traumatic brain injury\n* use of antipsychotic, opiate, or mood stabilizer (i.e., lithium) medication\n* history of blood clots\u002Fdeep vein thrombosis, prior stroke or TIA, uncontrolled hypertension\n* history of migraine with aura\n* severe liver disease\n* history of breast, endometrial, or ovarian cancer\n* smoking \\>10 cigarettes\u002Fday",true,"FEMALE","60 Years",{"count":83,"type":22},30,[85],"EARLY_PHASE1","The goal of current study is to better understand how fear is processed in the brain and how these processes are influenced by cognition and hormones. This research will focus specifically on postmenopausal female adults, because age-related changes in cognition and declining estrogen levels may contribute to anxiety symptoms and PTSD risk later in life.",[88,89,90],"PTSD and Trauma-related Symptoms","Cognitive Decline in Older Adults","Post Menopausal Women","NOT_YET_RECRUITING","2026-07-27",{"date":94,"type":34},"2026-07-30",{"date":96,"type":22},"2026-08",{"date":98,"type":22},"2027-12",{"name":40,"class":41},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":79,"sex":80,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100647071","clinical-feasibility-study-of-upright-low-dose-high-resolution-3d-breast-ct-ubct-100647071","NCT07705100","Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT).","UBCT","Inclusion Criteria:\n\nFor the screening cohort, the inclusion criteria are, women:\n\n* (1) who were 40 years of age or older (typical screening age range), and,\n* (2) who were asymptomatic, and,\n* (3) who underwent or scheduled to undergo a standard-of-care 2-view bilateral digital breast tomosynthesis screening exam.\n\nFor the diagnostic cohort, the inclusion criteria are, women:\n\n* (1) who were 40 years of age or older, and,\n* (2) who underwent a standard-of-care 2-view bilateral digital breast tomosynthesis exam, and,\n* (3) who were assigned BI-RADS category 4 or 5 after diagnostic work-up and are scheduled for biopsy.\n\nExclusion Criteria:\n\n* Males\n* Women less than 40 years old\n* pregnant or lactating women\n* women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam\n* women who have received radiation treatments to the thorax\n* women who have participated in a prior breast clinical trial that gave additional radiation dose\n* women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as tuberculosis, and severe scoliosis.",{"count":108,"type":22},50,[25],"The investigators are doing this study to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap.\n\nThe breast imaging device that will be used in this study (UBCT) is not FDA-approved, so this is a research study. The machine has been designed to remove mammography-like breast compression and use radiation dose comparable to mammography. The breast CT device will take multiple x-ray pictures of the subjects breast in approximately 20 seconds and create a 3-D image of the breast. It does not compress or squish the breast like a mammogram.",[112],"Breast Cancer Detection","2026-07-24",{"date":92,"type":34},{"date":116,"type":22},"2026-08-01",{"date":118,"type":22},"2026-12-31",{"name":40,"class":41},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":70},"100587702","functional-electroanatomic-isochronal-late-activation-mapping-for-empiric-vt-ablation-trial-100587702","NCT06931821","Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial","FACILE-VT","Criteria\n\nTo participate in this clinical investigation, the subjects must meet all of the following inclusion criteria:\n\n1. Patient is ≥18 years of age.\n2. Able and willing to comply with all study requirements.\n3. At least one documented episode of sustained MMVT (\\>30 sec) by either EGM or ECG (including Holter, or loop recorder) in the 6 months prior to enrollment.\n4. Informed of the nature of the study, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board\u002FEthics Committee (IRB\u002FEC) of the respective clinical study site.\n5. Refractory (i.e., not effective, not tolerated, or not desired) to at least one anti-arrhythmic medication (including, but not limited to beta blocker, mexiletine, amiodarone or sotalol) for treatment of MMVT.\n6. Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c):\n\n   1. Evidence of myocardial scar by echocardiography (segmental wall motion or wall thinning), CT (wall thinning) and\u002For MRI (presence of delayed enhancement \u002Flate gadolinium enhancement) . CT or MRI with scar is mandatory for inclusion of NICM., or\n   2. Left ventricular ejection fraction (EF) \\\u003C50% \\[documented within the last 6 months via transthoracic echocardiogram (TTE), MRI\\] with presence of scar, or\n   3. Arrhythmogenic RV cardiomyopathy\u002Fdysplasia (per 2010 ARVC\u002FD Task Force Criteria)\n\nExclusion Criteria\n\nSubjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:\n\n1. Active infection (positive blood culture).\n2. Patient is pregnant or nursing.\n3. Cardiac surgery via sternotomy (CABG or valve repair\u002Freplacement) within 30 days prior to enrollment.\n4. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor).\n5. Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD).\n6. Left Ventriclar ejection fraction \\\u003C 15%.\n7. Stroke within 30 days or presence of LV thrombus within 1 month prior to enrollment.\n8. Idiopathic VT or preprocedural imaging without scar (MRI or CT).\n9. Limited life expectancy of 1 year or less.\n10. Presence of mitral and aortic valves both mechanical.\n11. Ventricular tachycardia secondary to electrolyte imbalance or any other reversible or non-cardiac cause.\n12. Severe aortic stenosis or flail mitral valve with severed mitral regurgitation.\n13. Thrombocytopenia (defined as platelet count \\\u003C50,000\u002Fμl ) or coagulopathy.\n14. Ventricular arrhythmias secondary to underlying channelopathies (LQTS, Brugada Syndrome).\n15. Enrolled in an investigational study evaluating another device or drug that would confound the results of this study.\n16. Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirement of 1 year, or impact the scientific integrity of the study results.",{"count":128,"type":22},360,[25],"This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (\\\u003C1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters).\n\nIn the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.",[132,133],"Sustained Monomorphic VT (MMVT)","Recurrent Ventricular Tachycardia",[135,136,137,138],"Ventricular Tachycardia","Isochronal Late Activation Mapping","high-density mapping","deceleration zone","2026-07-23",{"date":92,"type":34},{"date":142,"type":34},"2025-04-15",{"date":144,"type":22},"2029-04-30",{"name":40,"class":41},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":161,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":70},"100606527","same-day-colectomy-is-it-safe-for-patients-100606527","NCT07176715","Same-Day Colectomy: is it Safe for Patients?","Inclusion Criteria:\n\n* Ages 18-70\n* Undergoing robotic-assisted right colectomy, sigmoidectomy, or low anterior resection.\n* Able to perform greater than 4 metabolic equivalents (METS) without shortness of breath\n* Must have a designated adult who can care for them at home postoperatively until their in-person clinic visit\n* Access to a cell phone or computer and running water.\n* Successfully completed pre-operative and post-operative education\n* Medical criteria:\n* Well controlled hypertension with systolic blood pressure \\\u003C 140 controlled by less than two medications which they are compliant with\n* Well controlled diabetes on oral agents only with blood glucose level \\\u003C 180 on daily checks\n* Anti-platelet agents including aspirin, clopidogrel, prasugrel, ticagrelor or ticlopidine will be stopped 7 days preoperatively and restarted on postoperative day 1. See exclusion criteria 7 for specific exclusion criteria regarding antiplatelet agents.\n\nExclusion Criteria:\n\n* Medical criteria:\n* Neurocognitive deficits not allowing for adequate preoperative education\n* Congestive heart failure with EF \\\u003C 45%\n* Symptomatic aortic stenosis causing heart failure, syncope, dyspnea or angina\n* Pulmonary fibrosis or pulmonary hypertension\n* COPD or home oxygen use \\> 2L\n* Chronic kidney disease of any stage.\n* Lack of a caregiver at home or functionally bed-bound\n* Ultralow pelvic resection\n* Need for ostomy creation intraoperatively\n* Operative time greater than 5 hours as this likely indicates a complex case and dissection necessitating closer monitoring in the hospital\n* Conversion to open procedure intraoperatively\n* Patients receiving antiplatelet agents such as clopidogrel, prasugrel, ticagrelor or ticlopidine within one year of coronary or carotid stent implantation, TAVR or LAAO placement.\n* Patients on therapeutic anticoagulation medications such as warfarin, Eliquis, Xarelto, Enoxaparin\n* Current tobacco use\n* Patients who were unable to complete preoperative education, do not feel comfortable with care at home, or do not have an available caregiver for the first 7 postoperative days\n* Any surgical history that would preclude safe abdominal entry for robotic surgery","70 Years",{"count":154,"type":22},150,[25],"This is a prospective cohort study of outcomes of patients undergoing outpatient colorectal surgery at a single institution to study outpatient colectomy as a viable treatment option for a select group of patients requiring colon and rectal surgery.",[158,159,160],"Colorectal","Colectomy","Colectomy Left\u002FRight\u002FTotal Under Laparotomy",[162,163],"Same Day Colectomy","outpatient Colectomy","2026-07-22",{"date":139,"type":34},{"date":167,"type":34},"2025-09-25",{"date":169,"type":22},"2030-09-01",{"name":40,"class":41},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100603903","early-phase-1-carrier-care-an-innovative-approach-to-support-small-babies-in-the-nicu-100603903","NCT07142564","Carrier Care: An Innovative Approach to Support Small Babies in the NICU","Inclusion Criteria:\n\nNeonates who:\n\n* are admitted to the hospital\n* who have an estimated length of stay equal to or greater than fifteen (15) days\n* weighing greater than or equal to 1800 grams at the time of enrollment\n* that are medically stable (free of significant apnea, bradycardia, or desaturations) within the past 48 hours\n\nExclusion Criteria:\n\n* infants who require oxygen therapy or positive pressure respiratory support\n* infants who have central intravenous lines (e.g., Broviac or peripherally inserted central catheter)\n* caregivers who are prisoners\n* caregivers who cannot read or speak English","9 Months",{"count":179,"type":22},100,[85],"The significance of skin-to-skin care (SSC) for neonatal infants is well-documented, highlighting its benefits for both the infant and the caregiver. The World Health Organization (WHO) has emphasized the necessity of positioning the infant on the mother after birth in a manner to prevent Sudden Unexpected Postnatal Collapse (SUPC) and accidental drops and falls. SSC is also recommended for 8 hours a day for the first few weeks of life to promote a secure attachment in the infant and bonding with the caregiver.\n\nDespite these established benefits, some families hesitate to engage in skin-to-skin care (SSC) because it is often only done in private settings and requires the caregiver to use their arms to hold the infant in place. Babywearing, or holding the infant to the body of the caregiver using a cloth or infant carrying device, can promote prolonged contact between the caregiver and infant without requiring the caregiver to hold the infant in place with their arms. Babywearing can also be done in more public settings (e.g., grocery store) as the caregiver can remain clothed during babywearing. The purpose of this study is to investigate whether babywearing using a babywearing device, referred to in this study as Carrier Care (CC), is at least as feasible and effective as SSC. This research will evaluate several physiological parameters of the infant, including cardiorespiratory stability, thermoregulation, and oxygen saturation levels. Certified babywearing educators will instruct research participants to ensure proper use of baby carriers and the safety of infants as outlined by the current hospital policy for babywearing.\n\nThis study will utilize an amplitude-integrated electroencephalogram (aEEG), a non-invasive, bedside monitoring tool commonly used in neonatal intensive care units (NICUs) to assess brain activity, particularly in premature infants. The aEEG provides a simplified and continuous recording of cortical activity, offering valuable insights into neurological development, including sleep-wake cycling. In this study, the aEEG will be used to evaluate the presence of sleep-wake patterns as a proxy for brain maturation. Data will be collected by placing EEG electrodes on the infant for a total duration of 12 hours: 4 hours prior to the intervention (baseline), 4 hours during the intervention (defined as skin-to-skin contact or carrier care), and 4 hours post-intervention. Recordings will occur on day 3 of the randomized activity to assess potential changes in brain activity associated with the intervention during this critical period of neurodevelopment. Dau 4 or 5 will be used as backup.",[183,184],"Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family Choice","Group 2: Skin-to-Skin Care (SSC) Followed by Carrier Care (CC) Followed by Family Choice",[186,187,188,189],"carrier care","skin-to-skin care (ssc)","infant carrier","babywearing","2026-07-17",{"date":192,"type":34},"2026-07-20",{"date":194,"type":22},"2026-09-01",{"date":196,"type":22},"2028-09-30",{"name":40,"class":41},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":214,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":225,"locationsCount":70},"100624894","symptom-management-and-survivorship-plus-coaching-for-advanced-cancer-survivors-and-their-caregivers-100624894","NCT07415564","Symptom Management and Survivorship Plus Coaching for Advanced Cancer Survivors and Their Caregivers","Symptom Management and Survivorship Plus Coaching to Reduce Symptom Severity and Improve Health Related-quality of Life (HR-QOL) for Breast, GI and Melanoma Cancer Survivors and Their Caregivers","SMSH and SMSH+","Inclusion criteria for cancer survivors:\n\n* Age 18 or older\n* Diagnosed with metastatic or stage IV breast, gastrointestinal (GI), and melanoma cancer\n* Able to perform basic activities of daily living\n* Cognitively oriented to time, place, and person (recruiter determined)\n* Able to speak and understand English or Spanish\n* Access to a telephone\n* Has a caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can.\n\nInclusion criteria for the caregivers:\n\n* Age 18 or older\n* Able to speak and understand English or Spanish\n* Telephone access\n* Not currently treated for cancer\n\nExclusion criteria:\n\n* Nursing home resident\n* Bedridden\n* Hospice care\n* Currently receiving a symptom management intervention",{"count":207,"type":22},200,[25],"The protocol will include a 10-week Symptom Management and Survivorship Handbook (SMSH) intervention to address informational needs for the management of physical and psychological symptoms, bundled with telephone delivered health coaching to address their symptom interference with physical, psychological and social functioning. The SMSH intervention, which includes both symptom assessment and management, is simple to implement, scalable, and evidence-based will be delivered to all survivors and caregivers (dyads) in this study, and will serve as an active control. In addition to the SMSH, intervention arm dyads will receive health coaching to address symptom interference and reduce social isolation. Symptom burden is more pronounced in marginalized populations such as Latina\u002Fo, rural, older age survivors and their caregivers.18-20 Many health disparities in these populations are underwritten by social isolation due to lack of access, disconnection from linguistically competent health care, mobility, and geographic proximity,21-23 and health coaching can address these issues.\n\nThe specific aims of the proposed feasibility study are to determine among survivors with metastatic or stage IV cancer and their caregivers (dyads):\n\nAim 1: Demonstrate SMSH plus health coaching feasibility (recruitment, retention, satisfaction (acceptability and appropriateness) for cancer survivors and their caregivers. Benchmarks: Recruitment 70% approached, Retention 75%, and participant satisfaction through qualitative exit interviews in week 11.\n\nAim 2: Collect preliminary data for the intervention impact on whether the SMSH + health coaching results in lowered burden of 24 symptoms (primary outcome) over weeks 1-10, and improved HRQoL (social, physical, psychological) (secondary outcome) at week 11, compared to SMSH alone.\n\nAim 3. Examine the enactment of self-management strategies in SMSH+health coaching versus SMSH alone.\n\nThe proposed pilot trial will provide proof of concept for the SMSH coupled with a live telephone delivered health coaching intervention to improve symptom management and HRQoL for metastatic breast, GI, and melanoma cancer survivors and caregivers. By addressing physical and psychological symptoms and survivorship using scalable, accessible interventions delivered via telephone, within reach of traditionally underserved populations, the findings have the potential to lay the foundation for the dissemination and implementation of a practical solution to meet survivor-caregiver needs both locally and nationally.",[211,212,213],"Cancer Metastatic","Symptoms and Signs","Quality of Life",[215,216,217,218,219],"cancer","Metastatic cancer","Symptom management","Cancer survivorship","Cancer caregivers","2026-07-16",{"date":192,"type":34},{"date":223,"type":34},"2026-05-06",{"date":68,"type":22},{"name":40,"class":41},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":70},"100610443","phase-2-nac-repair-for-post-surgical-pain-100610443","NCT07227649","NAC-REPAIR for Post-surgical Pain","NAC-REPAIR: N-Acetylcysteine-facilitated Redox-Immune Modulation for Post-surgical Analgesia and Injury Recovery","Inclusion Criteria:\n\n* Elective outpatient hand\u002Fupper-extremity or foot\u002Fankle surgery (single site; same-day discharge)\n* Baseline visit feasible ≤14 days pre-op\n* Can complete surveys\u002Fblood draw\n* Provides informed consent\n* Willing to follow dosing schedule and avoid restricted supplements\u002Fmeds\n\nExclusion Criteria:\n\n* Allergy to NAC\u002Fcapsule components □ NAC or high-dose antioxidants in past 14 days (unwilling to stop)\n* Chronic daily opioids ≥3 months or OUD\u002Fmaintenance therapy □ Pregnant\u002Fbreastfeeding or no contraception as applicable\n* Daily nitrates (nitroglycerin\u002Fisosorbide) □ Planned \\>24h admission, multistage\u002Ftrauma case □ Other interventional study within 30 days\n* Unable to swallow capsules \u002F malabsorption surgery affecting oral meds","75 Years",{"count":235,"type":22},80,[55],"This pilot asks whether peri-operative N-acetylcysteine (NAC) improves recovery after common outpatient hand\u002Ffoot-ankle surgery-specifically, does NAC reduce pain and opioid use and enhance function by modulating redox-inflammatory pathways? Primary objectives are to establish feasibility (accrual, adherence, follow-up), estimate NAC vs placebo effects on pain, function, and opioid consumption, and characterize inflammatory signatures that may predict response.\n\nMethods: a single-site, double-blind, 1:1 randomized trial (N≈80) comparing NAC 1,200 mg twice daily for 14 days (starting pre-op) vs matching placebo; daily e-diaries for POD0-14; standardized outcomes (PROMIS Pain Interference; QuickDASH or FAAM; PGIC; opioid MME); and small blood draws pre-surgery and at two follow-up visits for cytokine profiling.",[239,240,241,242,243,244,245,246,247],"Carpal Tunnel Surgery","Trigger Finger Disorder","De Quervain Syndrome","Guyon's Canal","Dupuytren Contracture","Morton Neuroma","Tarsal Tunnel Syndrome","Plantar Fasciopathy","Peroneal Nerve Entrapment",{"date":190,"type":34},{"date":250,"type":22},"2026-10-15",{"date":252,"type":22},"2027-07-15",{"name":40,"class":41},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":278,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},"100578684","phase-1-radiation-combined-with-bispecific-t-cell-engager-in-dll3-expressing-tumors-100578684","NCT06814496","Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors","RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I\u002FII Study of AMG757 \u002F Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3","RABBIT","Inclusion Criteria:\n\n1. Subject has provided informed consent\u002Fassent prior to initiation of any study specific activities\u002Fprocedures.\n2. Subjects ≥ 18 years of age at the time of signing the informed consent.\n3. Histologically or cytologically confirmed relapsed\u002Frefractory:\n\n   1. SCLC\n   2. Other tumors of small cell histology\n   3. High grade \u002F poorly differentiated neuroendocrine histology tumor histologies with high prevalence of DLL3 (≥50% prevalence of ≥1% positivity), including but not limited to: melanoma, medullary thyroid cancer, esthesioneuroblastoma, bladder cancer, testicular cancer, glioblastoma multiforme, cervical cancer; large cell neuroendocrine tumor of lung, non-small cell lung cancers with mixed neuroendocrine features, and Merkel cell carcinoma OR\n   4. DLL3+ (≥1% by IHC) Note: If patients are DLL3 negative per IHC but have a DLL3 prevalant tumor type, they will be allowed to enroll on the study.\n4. Subjects who progressed or recurred after at least one line of therapy and are considered treatment refractory per standard of care.\n5. Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded \\[FFPE\\] sample). If no archived tumor tissue is available, we request to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable or unwilling to undergo a pretreatment tumor biopsy due to extenuating circumstances (i.e., cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement with sponsor.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n7. Minimum life expectancy of 12 weeks.\n8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n9. Measurable lesions as defined per RECIST 1.1 within 28 days prior to the first dose of tarlatamab.\n10. Eligible for external beam radiation therapy to a previously unirradiated, measurable lesion as per standard of care.\n\n    a. For the concurrent \u002F sequential cohort of extracranial RT sites: i. A minimum of 10 subjects with thoracic lesions (lung, mediastinum, thoracic spine, rib, or other thoracic sites) will be treated ii. Subjects with treated brain metastases are eligible (untreated brain metastases are ineligible) provided they meet the following criteria:\n\n\u003C!-- -->\n\n1. Definitive therapy was completed at least 2 weeks prior to the first dose of tarlatamab.\n2. There is no evidence of radiographic central nervous system (CNS) progression following therapy and by the time of study screening.\n3. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means.\n4. Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.\n\n   b. For the concurrent\u002Fsequential cohort of cranial RT sites: i. Previously untreated brain lesions \u002F metastases are eligible ii. Subjects with previously irradiated brain lesions are eligible provided they meet one of the following criteria:\n\n\u003C!-- -->\n\n1. Prior PCI or whole brain radiation therapy per standard of care with new and\u002For recurrent brain metastases to be treated with SRS or hfSRT\n2. Prior course(s) of SRS or hfSRT or other localized therapy with new lesion(s) to be treated with whole brain radiation therapy iii. Whole brain re-irradiation will be ineligible iv. Re-irradiation with SRS or hfSRT of previously irradiated lesion with SRS or hfSRT will be ineligible v. Craniospinal irradiation will not be allowed c. For the tarlatamab monotherapy cohort: i. Patient must have at least one measurable lesion, however that lesion does not need to be amenable to RT\n\n1\\. Patients with previously irradiated lesions that have recurred or progressed are eligible 11. Adequate organ function, defined as follows:\n\na. Hematological function: i. Absolute neutrophil count ≥ 1.5 x 109\u002FL ii. Platelet count ≥ 100 x 109\u002FL iii. Hemoglobin \\> 9 g\u002FdL (90 g\u002FL) b. Coagulation function: i. Prothrombin time (PT)\u002Finternational normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor.\n\nc. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation \\> 30 mL\u002Fmin\u002F1.73 m2 d. hepatic function: i. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) \\\u003C 3 x ULN (or \\\u003C 5 x ULN for subjects with liver involvement) ii. Total bilirubin \\\u003C 1.5 x ULN (or \\\u003C 2 x ULN for subjects with liver metastases) e. Pulmonary function: i. No clinically significant pleural effusion ii. Baseline oxygen saturation \\> 90% on room air f. cardiac function (if obtained as part of standard of care): i. Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings\n\nExclusion Criteria:\n\nRe-irradiation, unless it is SRS\u002FhfSRT after whole-brain radiation therapy (WBRT) or PCI or WBRT after SRS\u002FhfSRT; re-irradiation of same lesion, unless verified with the Principal Investigator; patients with lesions not amenable to RT (including previously irradiated) will be only allowable on the tarlatamab monotherapy cohort.\n\nDisease Related\n\n1. Subjects are excluded from the study if any of the following criteria apply:\n\n   a. No lesion(s)\u002Fsite(s) amenable to radiation therapy (only eligible for tarlatamab monotherapy if open) b. Planned re-irradiation of a previously irradiated site c. Leptomeningeal disease requiring craniospinal irradiation\n2. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.\n3. Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n4. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \\> 21 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.\n\nOther Medical Conditions\n\n1. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 12 months of first dose of tarlatamab.\n2. History of arterial thrombosis (i.e., stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.\n3. Subject with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab.\n\n   NOTE: Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis and have no clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for \\> 48 hours.\n4. History of hypophysitis or pituitary dysfunction.\n5. Exclusion of hepatitis infection based on the following results and\u002For criteria:\n\n   a. Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).\n\n   b. Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.\n\n   c. Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.\n\n   NOTE: Testing required as per standard of care in suspected or known patients.\n6. Major surgery requiring hospitalization for more than 3 days within 28 days of first dose of tarlatamab.\n7. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n8. Human immunodeficiency virus (HIV) infection. a. Subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines.\n\nNOTE: Testing required as per standard of care in suspected or known patients.\n\nPrior\u002FConcomitant Therapy\n\n1. Subject received prior therapy with tarlatamab.\n2. Prior anti-cancer therapy within 30 days prior to first dose of tarlatamab.\n\n   Exceptions:\n\n   a. Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade ≤ 1.\n3. Has a diagnosis of immunodeficiency (i.e., positive\u002Fnon-negative test for human immunodeficiency virus) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab.\n4. The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods:\n\n   1. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study.\n   2. Live viral non-replicating vaccine (i.e., Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care (SOC) and institutional guidelines.\n   3. End of study treatment: Live and live-attenuated vaccines can be used when at least 60 days (5 x half-life of tarlatamab) have passed after the last dose of tarlatamab.\n\nOther Exclusions\n\n1\\. Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab. Contraception methods for female subjects include:\n\n1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)\n2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, and implantable)\n3. Intrauterine device\n4. Intrauterine hormonal-releasing system\n5. Bilateral tubal ligation\u002Focclusion\n6. Vasectomized partner (provided that partner is the sole sexual partner of the female subject of childbearing potential and that the vasectomized partner has received medical assessment of the surgical success)\n7. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments; the reliability of sexual abstinence must be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject) 2. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.\n\n   3\\. Female subjects planning to become pregnant while on study through 60 days after the last dose of tarlatamab.\n\n   4\\. Female subjects of childbearing potential with a positive pregnancy test assessed at screening and\u002For day 1 by a highly sensitive urine or serum pregnancy test.\n\n   5\\. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception (use a condom) during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   6\\. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.\n\n   7\\. Male subjects unwilling to abstain from donating sperm during treatment and for an 60 days after the last dose of tarlatamab.\n\n   8\\. Subject has known sensitivity to any of the products or components to be administered during dosing.\n\n   9\\. Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n\n   10\\. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.","99 Years",{"count":83,"type":22},[54,55],"Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites.\n\nI) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting.\n\nIII) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT.\n\nA nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.",[267,268,269,270,271,272,273,274,275,276,277],"Melanoma","Medullary Thyroid Cancer","Sinonasal Undifferentiated Carcinoma","Esthesioneuroblastoma","Bladder Cancer","Testicular Cancer","Glioblastoma Multiforme","Cervical Cancer","Large Cell Neuroendocrine Carcinoma of the Lung","Non Small Cell Lung Cancer","Merkel Cell Carcinoma",[279],"DLL3 Expressing tumors",{"date":192,"type":34},{"date":282,"type":34},"2025-09-08",{"date":284,"type":22},"2030-05",{"name":40,"class":41},2,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":294,"phases":4,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":70},"100377005","point-of-care-ultrasound-in-the-assessment-of-snake-bite-100377005","NCT04188899","Point-of-care Ultrasound in the Assessment of Snake Bite","Inclusion Criteria:\n\n* Adult patients (18 years and older)\n* Both genders\n* Complaint of snake bite\n\nExclusion Criteria:\n\n* If they are unwilling to provide informed consent\n* Hemodynamically unstable patients (shock respiratory distress, altered mental status, and cardiorespiratory arrest)\n* All vulnerable patient populations, e.g., children, pregnant patients, prisoners, and patients unable to verbally consent due to cognitive impairment",{"count":154,"type":22},"OBSERVATIONAL","Early identification of tissue injury from a rattlesnake bite is critical to prevent complications and reduce health care costs. Given the limitations of clinical assessment, there is a need to develop a more objective reproducible, anatomically detailed diagnostic tool for to accurately assess tissue damage and assist with timely administration of antivenom, if needed. Emergency physician performed point-of-care ultrasonography has been shown to be beneficial in the diagnosis and management of skin and soft tissue infections. The innovative use of bedside ultrasound technology can provide new information to individualize antivenom treatment and to improve patient outcomes. The objectives of this study is to compare clinical assessment and bedside ultrasound findings in the detection of tissue injury in emergency department patients with rattle snakebite and determine if bedside ultrasound can alter management (antivenom dosing) in emergency department patients with rattle snakebite.",[297],"Rattlesnake Bite (Diagnosis)",{"date":190,"type":34},{"date":300,"type":22},"2026-08-31",{"date":302,"type":22},"2030-08-31",{"name":40,"class":41},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":320,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":70},"100558859","methadone-patient-access-to-collaborative-treatment-100558859","NCT06556602","Methadone Patient Access to Collaborative Treatment","Methadone Patient Access to Collaborative Treatment (MPACT)","MPACT","Inclusion Criteria:\n\n* Staff providing methadone treatment services at the enrolled opioid treatment programs\n\nExclusion Criteria:\n\n* Patients receiving methadone treatment at the enrolled opioid treatment programs",{"count":313,"type":22},1080,[25],"The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose.\n\nIt will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.",[317,318,319],"Opioid Use Disorder","Staff","Patients",[321],"Methadone","2026-07-14",{"date":220,"type":34},{"date":325,"type":34},"2026-02-05",{"date":327,"type":22},"2029-06-30",{"name":40,"class":41},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":348,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":70},"100612531","phase-1-prophylactic-and-therapeutic-dli-x-for-leukemia-relapse-after-hct-100612531","NCT07254793","Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT","A Feasibility\u002FPilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation","DLI Recipient Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 0-65 years\n* Diagnosis of acute leukemia (lymphoid, myeloid or undifferentiated) myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) or non-Hodgkin's lymphoma (NHL)\n* Undergoing myeloablative or reduced intensity matched sibling donor (MSD) HCT or haploidentical HCT\n* Have a locally available healthy matched or haploidentical (≥5\u002F10 HLA antigen matched) related donor between 12 and 50 years of age, consented and able to perform the exercise sessions. (see donor inclusion criteria)\n* The familial donors will first complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Donor Inclusion Criteria:\n\n* Matched sibling donor or HLA-haploidentical relatives of the patient, including biological parents, siblings, or children, half-siblings, cousins or aunts and uncles\n* Weight is greater than 30 kg\n* Age 12 and 50 years\n* Ability to undergo phlebotomy\n* Cardiac, renal, pulmonary, and hepatic function within normal limits\n* Complete blood count (CBC) with differential and platelet count within normal limits, and CMP within normal limits as deemed acceptable by the Principal Investigator and provider evaluating donor.\n* The familial donors should be able complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Recipient Exclusion Criteria:\n\n* Acute grade III-IV aGvHD or moderate\u002Fsevere chronic GvHD.\n* Requiring immunosuppression therapy for treatment of GvHD.\n* Co-morbidities: AST\u002FALT greater than 5 x ULN; Bilirubin greater than 2 x ULN; Creatinine greater than 2 x ULN for age or creatinine clearance\u002FGFR \\\u003C40 ml\u002Fmin\u002F1.73m2; Pulmonary function: DLCO less than 40% of normal or O2 Sat less than 92%; Cardiac: left ventricular ejection fraction less than 35%; active infection; HIV positive; Karnofsky score (adults) less than 60% or Lansky score less than 50% (pediatrics)\n* Uncontrolled or severe bacterial, fungal or viral infection.\n* Positive serum or urine pregnancy test for girls post menarche or women of childbearing age.\n* Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and\u002For informed consent impossible.\n* Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.\n\nDLI Donor Exclusion Criteria:\n\n* Unable to perform graded exercise test\n* Cardiac or pulmonary disease restricting exercise\n* Positive anti-donor HLA antibody\n* Pregnant or lactating\n* Active infection\n* Positivity for HIV, hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I\u002FII)\n* Severe psychiatric illness or mental deficiency making compliance with donation unlikely and\u002For informed consent impossible.","65 Years",{"count":338,"type":22},94,[54],"The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone.\n\nWe hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).",[342,343,344,345,346,347],"Acute Lymphoid Leukemia","Acute Myeloid Leukemia","Acute Undifferentiated Leukemia (AUL)","Myelodysplastic Syndrome","Chronic Myeloid Leukemia","Non-Hodgkin Lymphoma",[349,350,351,352,353,354,355,356],"Exercise","Donor Lymphocyte Infusion","Allogeneic Hematopoietic Stem Cell Transplantation","Hematologic Malignancies","Matched Sibling Donor","Haploidentical","Hematopoietic Cell Transplantation","DLI-X","2026-07-10",{"date":359,"type":34},"2026-07-13",{"date":361,"type":22},"2026-10-31",{"date":363,"type":22},"2030-06-01",{"name":40,"class":41},{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":70},"100647548","phase-3-apixaban-versus-warfarin-for-left-ventricular-thrombus-100647548","NCT07709780","Apixaban Versus Warfarin for Left Ventricular Thrombus","Apixaban vs. Warfarin in Left Ventricular Thrombus: A Randomized, Noninferiority Trial","APEX","Inclusion Criteria:\n\n* Age ≥18 years\n* LV thrombus confirmed within 14 days prior to randomization by CMR or contrast TTE or cardiac CT; baseline CMR required pre-randomization (or ≤7 days post-randomization if clinically unavoidable)\n* Candidate for oral anticoagulation for ≥3 months\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Absolute indication for VKA (mechanical valve, moderate-severe rheumatic MS and antiphospholipid syndrome) or clear preference or contraindication for one of the study drugs precluding randomization (see below)\n* Antiphospholipid syndrome\n* Estimated CrCl \\\u003C15 mL\u002Fmin or dialysis\n* Severe hepatic impairment (ICD-10: K70.40, K70.41, K71.10, K71.11, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91)\n* Active clinically significant bleeding\n* Platelets \\\u003C50,000\u002FµL\n* Pregnancy or lactation; women of childbearing potential unwilling to use contraception\n* Life expectancy \\\u003C1 year or other conditions compromising follow-up\n\nAdditional contraindications to use of warfarin or apixaban. This includes, but is not limited to:\n\n* Active pathological bleeding, major bleeding diathesis, or known blood dyscrasia\n* Recent or planned surgery involving the central nervous system or eye, traumatic surgery with large open surfaces, or procedures (spinal\u002Fepidural puncture or major regional block anesthesia) where bleeding cannot be safely controlled.\n* Conditions associated with high risk of bleeding such as threatened abortion, eclampsia, severe preeclampsia, or malignant\u002Funcontrolled hypertension.\n* History of severe hypersensitivity or allergy to warfarin or apixaban.\n* Ongoing treatment with a combined P-gp and strong CYP3A4 inhibitor or inducer that cannot be safely discontinued or substituted. Examples include strong combined inhibitors such as ketoconazole, itraconazole, ritonavir or posiconazole, and strong combined inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.",{"count":374,"type":22},218,[376],"PHASE3","Left ventricular thrombus is a blood clot that forms in the left ventricle and is associated with risk of systemic embolism and ischemic stroke. Warfarin has historically been used for anticoagulation in this condition, but it requires frequent international normalized ratio monitoring and is affected by dietary and drug interactions. Apixaban is a direct oral factor Xa inhibitor with fixed dosing and no routine anticoagulation monitoring requirement, and it is increasingly used in clinical practice for left ventricular thrombus, although definitive randomized evidence remains limited.\n\nThis randomized, noninferiority trial will compare apixaban with warfarin for treatment of left ventricular thrombus. Eligible adults with recently confirmed left ventricular thrombus will be randomized 1:1 to apixaban or warfarin. The primary endpoint is complete left ventricular thrombus resolution at 3 months assessed by cardiac magnetic resonance imaging. Participants will be followed through 12 months for thrombus-related, bleeding, cardiovascular, and mortality outcomes.",[379],"Left Ventricular Thrombus",[381,382,383,384],"Cardiac Thrombus","Intracardiac Thrombus","Systemic Embolism","Stroke","2026-07-09",{"date":190,"type":34},{"date":388,"type":22},"2026-06-22",{"date":390,"type":22},"2029-07-01",{"name":40,"class":41},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":17,"minAge":399,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":70},"100510036","the-effect-of-semantic-support-on-word-learning-100510036","NCT05921214","The Effect of Semantic Support on Word Learning","Identification of Treatment Parameters That Maximize Language Treatment Efficacy For Children","Inclusion Criteria:\n\n* Native English Speaking\n* Pass pure tone hearing screening or medical report of normal hearing\n* 2-3 Years of age\n* MCDI expressive scale \\\u003C10th percentile\n\nExclusion Criteria:\n\n* Parental report of other diagnoses\n* Enrolled in concurrent treatment elsewhere\n* Nonverbal IQ \\\u003C75 as measured by the Bayley scales\n* Parents unable to consistently bring child to treatment sessions","2 Years","4 Years",{"count":402,"type":22},32,[25],"The goal of this clinical trial is to compare word learning outcomes in late talking toddlers who are taught different types of words. The main question it aims to answer is if teaching words that come from categories that children already know (e.g., animals) will aid overall word learning. Children will take part in the Vocabulary Acquisition and Usage for Late Talkers (VAULT) word learning treatment and be taught words from more familiar or less familiar categories to see which group learns more words overall.",[406],"Language Development Disorders",[408],"Late Talkers",{"date":359,"type":34},{"date":411,"type":34},"2025-06-10",{"date":413,"type":22},"2026-12-01",{"name":40,"class":41},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":79,"sex":17,"minAge":18,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":433,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":70},"100645589","pilot-feasibility-study-of-a-dyadic-culinary-nutrition-intervention-100645589","NCT07702864","Pilot Feasibility Study of a Dyadic Culinary Nutrition Intervention","CHEF","Inclusion Criteria: Survivors\n\n* History of prostate cancer diagnosis at any stage (I-IV)\n* Identifies as Hispanic\n* Completed primary curative treatment (e.g., chemotherapy, radiation, surgery) 6 weeks prior to enrollment.\n\nNote: Men on continuing hormone therapy (ADT) or immunotherapy as maintenance or consolidation treatment are eligible. Men on active surveillance only (no treatment) are not eligible.\n\nInclusion Criterion: Caregivers\n\n* Provides unpaid support for the cancer survivor\n* No prior history of cancer (except non-melanoma skin cancer) Note: Caregivers do not need to identify as Hispanic to be eligible\n\nInclusion Criteria: Survivors and Caregivers\n\n* Aged 18-90 years\n* Reports low fruit and vegetable intake\n* Able to write, read, and speak in English or Spanish\n* Access to a mobile device with Internet and a camera\n* Co-residing and able to participate at the same time and location\n\nExclusion Criteria: Survivors and Caregivers\n\n* Cognitive difficulties that preclude answering the survey questions, that answering survey questions or participating in study activities, or providing informed consent.\n* A medical condition, movement or neurological disorder, or medication use that contraindicates participation in meal preparation.\n* Not co-residing (live in the separate households).\n* No survivor or caregiver available or willing to participate simultaneously.\n* Less than 18 years or greater than 90 years of age.","90 Years",{"count":424,"type":22},40,[25],"This study will determine the feasibility and acceptability of a 12-week dyadic culinary nutrition program among Hispanic prostate cancer survivor\u002Fcaregiver dyads using a randomized controlled trial design.",[428,429,430,431,432],"Neoplams","Prostate Cancer (Adenocarcinoma)","Cancer Survivors","Caregiver Burden","Nutrition Therapy",[218,434,435,436,437,438],"Caregivers","Hispanic","Men's Health","Nutrition","Pilot study","2026-07-08",{"date":322,"type":34},{"date":442,"type":22},"2027-01-01",{"date":444,"type":22},"2028-04-30",{"name":40,"class":41},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":79,"sex":17,"minAge":454,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":294,"phases":4,"briefSummary":457,"conditions":458,"keywords":462,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":70},"100646661","thrive-belize-a-school-based-life-skills-program-to-support-teen-health-in-toledo-district-belize-feasibility-100646661","NCT07687199","THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility)","THRIVE-Belize: A Single-School Mixed-Methods Feasibility Trial of a Multi-Component Life-Skills Curriculum for Adolescent Health Promotion at Toledo Community College, Belize","THRIVE-Belize","Inclusion Criteria:\n\n* Students: enrolled at Toledo Community College in Forms 1-4; ages 12-18 years; able to read and comprehend English at grade level; provides written assent; has active written parental\u002Fguardian consent\n* Teachers: currently employed at TCC; teaches students in Forms 1-4; provides written informed consent\n* Parents\u002FGuardians: parent or legal guardian of an eligible TCC student; age 18 years or older; able to communicate in English, Spanish, or Q'eqchi'-Mopan Maya; provides written informed consent\n* School Principal and Administrative Staff: currently serving as principal or administrative staff at TCC; provides written informed consent\n* Community Stakeholders: recognized expertise in adolescent health, education, or youth services (e.g., healthcare providers, religious leaders, village council members, youth organization leaders); resident of Toledo District, Belize; provides written informed consent\n\nExclusion Criteria:\n\n* Cognitive or developmental limitations preventing informed assent or participation (students)\n* Declines to participate (students or parents\u002Fguardians)","12 Years",{"count":456,"type":22},280,"THRIVE-Belize is a school-based program being developed to support the health and well-being of adolescents in the Toledo District of southern Belize. The program covers seven topics: communication and emotional regulation, healthy expressions of masculinity, sexual and reproductive health, healthy relationships, mental and physical health, substance use prevention, and environmental health.\n\nBefore testing whether the program works, the research team needs to learn whether students, teachers, parents, school staff, and community members find it acceptable, appropriate, and practical to deliver at Toledo Community College. This study (Phase I) does not deliver the program to anyone. Instead, it gathers feedback through surveys, focus groups, and interviews with about 280 participants across these five groups.\n\nThe information collected will be used to refine the program and decide whether to move forward to a future pilot study. No medical or educational intervention is given to participants in this phase.",[459,460,461],"Health Behavior","Adolescence","Feasibility Studies",[463,464,465,466,467,468,469],"feasibility study","school-based intervention","life skills","adolescents","Belize","implementation science","acceptability","2026-07-03",{"date":472,"type":34},"2026-07-07",{"date":474,"type":22},"2026-07",{"date":476,"type":22},"2026-09",{"name":40,"class":41},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":79,"sex":80,"minAge":18,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":493,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":70},"100646800","early-phase-1-breathing-for-two-inspiratory-muscle-strength-training-for-supporting-healthy-blood-pressure-in-pregnancy-100646800","NCT07687745","Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pregnancy","Inclusion Criteria:\n\n* Female sex\n* Pregnant (32 to 34 weeks of gestation, confirmed by ultrasound, at the time of first training session, eligible patients may consent\u002Fenrolled earlier in pregnancy)\n* Singleton pregnancy\n* Age 18 to 55\n* Able to read English and provide consent\n* Possess smartphone for syncing the AiroFit and Omron devices using Bluetooth and completing online surveys\n* Smartphone updated to iOS 12+ or Android 11+\n* No contraindication for moderate exercise at time of enrollment\n* Not planning delivery for at least one month at time of enrollment (\\\u003C 38 weeks of gestation)\n* Willing to adhere to AiroFit device use throughout study period\n* Must already be scheduled, or in the process of scheduling, for weekly NST appointments by 32 to 34 weeks gestational age (per provider order \u002F due to obstetric indication)\n\nLower-Risk Pregnancy Cohort Inclusion Criteria:\n\n* No history or evidence of hypertensive disorders of pregnancy\n* May be undergoing antenatal testing for:\n* Conception via in vitro fertilization, BMI ≥ 35, an advanced maternal age (age \\>\u002F=35), or other condition not listed in exclusion criteria or 'higher risk for HDP group' but is recommended for antenatal testing.\n\nHigher-Risk Pregnancy Cohort Inclusion Criteria:\n\n* Conditions associated with higher risk of developing HDP, including:\n* Gestational diabetes mellitus, chronic hypertension, gestational hypertension, or a history of preeclampsia in a previous pregnancy\n\nExclusion Criteria:\n\n* Younger than 18 or older than 55 years of age\n* Multiple gestation (twin or higher-order pregnancy)\n* Fetal chromosomal abnormalities or major anatomical anomalies\n* Planning to deliver earlier than 38 weeks or within 4 weeks of study enrollment\n* Any contraindication for moderate exercise (e.g., cardiomyopathy, congenital cardiac conditions)\n* Deep vein thrombosis\n* Complications in current pregnancy including intrauterine growth restriction (IUGR), oligohydramnios, preeclampsia, or severe-range blood pressures (\\>\u002F=160\u002F110 or \\\u003C100\u002F60)\n* Active vaginal bleeding, or history of coagulopathy\n* Placenta previa or other placental abnormalities (including placental cyst or abruption)\n* Signs of labor\n* Current substance use disorder\n* History of neurological, respiratory, head\u002Fneck, or thoracic surgeries, or conditions such as collapsed lung or perforated eardrum\n* Individuals with any of the following:\n* Chronic obstructive pulmonary disorder (COPD)\n* Severe asthma\n* Severe ischemic heart disease\n* Left-sided heart failure\n* Chronic laryngitis, chronic bronchitis, emphysema, pneumonia\n* Latent or active tuberculosis\n* Chronic cough\n* Neurological problems (e.g. seizure disorder)\n* Severe scoliosis with no history of surgical correction or management.\n* Organ transplant\n* HIV or other immunocompromising conditions\n* Autoimmune disease with possible vascular complications (e.g. Lupus)\n* Significant respiratory compromise (e.g., severe dyspnea, O₂ saturation \\\u003C95%, uncontrolled asthma, history of pneumothorax)","55 Years",{"count":235,"type":22},[85],"This is an interventional study that will test whether a breathing exercise called Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood pressure during late pregnancy. The goal is to see if a home-based breathing training can help prevent or reduce high blood pressure disorders in pregnancy. The main objectives are to make sure the training is safe and tolerable for pregnant women and to examine blood pressure and blood vessel health. Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks.",[489,490,491,492],"Hypertension Disorders in Pregnancy","Blood Pressure Measurement in Pregnancy","Inspiratory Strength Training (IST)","Pregnancy",[494,495,496,497,498,499],"pregnancy","blood pressure","hypertensive disorders of pregnancy","imst","hdp","inspiratory muscle strength training","2026-07-01",{"date":472,"type":34},{"date":503,"type":34},"2026-06-08",{"date":505,"type":22},"2027-09-30",{"name":40,"class":41},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":79,"sex":17,"minAge":336,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":532,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":542,"leadSponsor":544,"locationsCount":70},"100628685","feasibility-of-breathwork-intervention-with-older-adults-after-knee-surgery-100628685","NCT07464860","Feasibility of Breathwork Intervention With Older Adults After Knee Surgery","A Box Breathing Intervention and the Surgical Stress Response in Older Adults Undergoing Total Knee Arthroplasty: A Randomized Controlled Feasibility Trial","Adults aged 65 years or older of any sex, gender and ethnic background who meet the following criteria will be eligible to enroll in the present study:\n\nInclusion Criteria:\n\n* scheduled for elective TKA within the next week to two months (can be second knee, but cannot be a revision of the original knee)\n* self-reported good health, including denial of debilitating illness that may affect participation in or be potentially exacerbated by deep, controlled breathing (i.e., chronic obstructive pulmonary disorder \\[COPD\\], symptomatic or advanced heart failure, complete heart block, glaucoma, epilepsy)\n* denial of conditions that alter cortisol release or that require corticosteroid therapy (i.e., Cushing's syndrome, Addison's disease, pituitary tumors, adrenal gland tumors, asthma)\n* denial of severe psychiatric or cognitive conditions that warrant the need for a durable power of attorney (DPOA)\n* able to understand written and verbal English.\n\nExclusion Criteria:\n\n* currently taking oral, injectable, intranasal, topical, or inhaled corticosteroid medications (i.e., prednisone, hydrocortisone, dexamethasone, methylprednisolone, methylprednisolone acetate, triamcinolone, betamethasone, mometasone, fluticasone, budesonide, clobetasol)\n* do not have the technology requirements to complete data collection (i.e., participant does not have a smartphone, tablet, laptop, or desktop computer; lack of reliable internet)\n\nThe following exclusion criteria may affect participants' ability to remain in the study following enrollment:\n\n• Development of complications during surgery that require prolonged hospitalization into Postoperative Day (POD) 2 (e.g., postoperative intubation and ventilation requirements, intractable pain, intractable nausea\u002Fvomiting, signs of infection or sepsis)",{"count":402,"type":22},[25],"Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population.\n\nThe body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.",[518,519,520,521,522,523,524,525,526,527,528,529,530,531],"Surgical Stress Response","Stress Physiological","Stress Physiology","Stress Psychological","Breathing Techniques","Breathing Exercises","Hypothalamic Pituitary Adrenal","Relaxation","Relaxation Therapy","Cortisol","Postoperative Pain","Postoperative Anxiety","Postoperative Depression","Quality of Recovery (QoR-15)",[518,533,534,535,523,522,536,528,529,530,537,538],"Total Knee Arthroplasty","Hypothalamic-Pituitary-Adrenal Axis","Breathwork","Postoperative Complications","Quality of Recovery","Diurnal Cortisol Rhythm",{"date":540,"type":34},"2026-07-06",{"date":500,"type":34},{"date":543,"type":22},"2026-11-30",{"name":40,"class":41},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":262,"enrollmentInfo":552,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":559,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":566,"leadSponsor":568,"locationsCount":70},"100643558","early-phase-1-glp-1-ra-plus-soc-treatment-in-first-line-metastatic-pancreatic-colorectal-or-hepatocellular-cancer-100643558","NCT07627191","GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer","GLP-1 Receptor Agonist Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer","Inclusion Criteria:\n\n* Histological or cytological diagnosis of pancreatic adenocarcinoma or colorectal adenocarcinoma. Previous tumor tissue testing is acceptable. Please refer to the \"additional HCC cohort criteria\" below.\n* The subject has disease that is not amenable to curative-intent management (e.g., oligometastatic disease)\n* Measurable disease per RECIST v1.1 as determined by the investigator\n* Patients must be appropriate candidates for first-line, SOC treatment.\n\n  * SOC treatment as defined by NCCN® guidelines or institutional standard is allowable, however, options restricted to:\n\n    * Colorectal: FOLFOX or FOLIFIRI +\u002F- bevacizumab\n    * Pancreatic: mFOLFIRINOX\n    * HCC: Tremelimumab\u002FDurvalumab\n  * Patients are eligible who received prior perioperative chemotherapy for curative intent treatment and recurred ≥ 6 months since last dose of chemotherapy.\n* ≥ 18 years old on day of consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least 15 unstained slides and\u002For tumor block)\n* Adequate hematologic and organ function laboratory values as follows:\n\n  * The ANC ≥ 1500\u002Fmm3 without colony stimulating factor support;\n  * Platelets ≥ 75,000\u002Fmm3;\n  * Hemoglobin ≥ 9 g\u002FdL;\n  * Bilirubin ≤ 1.5 ´ the ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL;\n  * Serum albumin ≥ 2.8 g\u002Fdl;\n  * ALT and AST ≤ 3.0 ´ ULN;\n  * Serum creatinine ≤ 1.5 ´ ULN or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:\n\n    * Male: CrCl (mL\u002Fmin) = (140 - age) × wt (kg) \u002F (serum creatinine × 72);\n    * Female: Multiply above result by 0.85;\n* The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document\n* Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control or practice abstinence during the study and for 4 months after the last dose of study drug(s);\n\nAdditional Inclusion Criteria for HCC Cohort ONLY:\n\n* Histologically or radiologically confirmed hepatocellular carcinoma (per AASLD\u002FEASL criteria)\n* Unresectable or advanced HCC not amenable to curative surgery or locoregional therapy.\n* Barcelona Clinic Liver Cancer (BCLC) stage B or C.\n* Child-Pugh Score Class A; or Child-Pugh Class B7 or B8 at discretion of treating physician\n* Patients with HBV infection, characterized by positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU\u002FmL or above the limit of detection per local or central lab standard), must be treated with antiviral therapy, as per institutional practice to ensure adequate viral suppression (HBV DNA \\\u003C2000 IU\u002FmL) before enrolment. Patients must remain on antiviral therapy for the duration of their participation in the EAP and for 6 months after the last dose of EAP medication. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (\\\u003C10 IU\u002FmL or under the limit of detection per local or central lab standard) do not require anti-viral therapy before enrolment. These participants will be tested at every cycle to monitor HBV DNA levels and initiate anti-viral therapy if HBV DNA is detected (≥10 IU\u002FmL or above the limit of detection per local or central lab standard). HBV DNA detectable patients must initiate and remain on anti-viral therapy for time they are on the EAP and for 6 months after the last dose of EAP medication.\n\n  o Note: Testing required for subjects with a known history otherwise not required.\n* Patients with HCV infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrolment (management of this disease is per local institutional practice).\n\nExclusion Criteria\n\n* The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) for metastatic and\u002For unresectable disease.\n* BMI \\\u003C 25 kg\u002Fm2\n* For colorectal cancer only - Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) tumors.\n* For colorectal cancer only - BRAF V600E mutant tumors.\n* A personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).\n* A prior hypersensitivity reaction to semaglutide or any of the excipients in WEGOVY®. Serious hypersensitivity reaction, including anaphylaxis and angioedema, have been reported with WEGOVY®.\n* Cachexia\n* Subjects on insulin.\n* Subjects with a history of diabetic retinopathy\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  o Cardiovascular disorders including:\n  * For patients being considered for bevacizumab (or bevacizumab biosimilar) only:\n* Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment;\n* thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (eg, vena cava filter) within 6 months before the first dose of study treatment.\n\n  * Any of the following within 6 months before the first dose of study treatment:\n* unstable angina pectoris;\n* clinically-significant cardiac arrhythmias;\n* stroke (including transient ischemic attack (TIA), or other ischemic event);\n* myocardial infarction;\n\n  * GI disorders particularly those associated with a high risk of perforation or fistula formation including:\n\n    * Unresolved abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess.\n    * Uncontrolled nausea, vomiting, or abdominal pain.\n  * Other clinically significant disorders that would preclude safe study participation\n* Major surgery within 8 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n* Females who are known or suspected to be pregnant or lactating. Women of childbearing potential must have a negative serum pregnancy test result within screening.\n* Female patients planning on becoming pregnant while on study.\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment.\n* Male subjects unwilling to abstain from donating sperm during treatment.\n* Inability to comply with self-administration of GLP-1 RA subcutaneous injections.\n* Subject has known sensitivity to any of the products or components to be administered during dosing.\n* Concurrent use of other semaglutide containing products or any other GLP-1 receptor agonist.\n* Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.\n* Subject likely to not be available to complete all protocol-required study visits or procedures and\u002For to comply with all required study procedures to the best of the subject and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.\n\nAdditional Exclusion Criteria for HCC Cohort ONLY:\n\n* Child-Pugh Score Class B9; or Child-Pugh Class C\n* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of EAP treatments.\n* History of allogenic organ transplantation (e.g., liver transplant).\n* History of hepatic encephalopathy within the past 12 months or requirement for medications to prevent or control encephalopathy (e.g., no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy.\n* Clinically meaningful ascites, defined as any ascites requiring non-pharmacologic intervention (e.g., paracentesis) to maintain symptomatic control, within 2 months before the first EAP treatment dose. Patients on stable doses of diuretics for ascites for ≥2 months are eligible.\n* Patients with main portal vein thrombosis (i.e., thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.\n* Active or previously documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[except for diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). Patients without active disease in the last 5 years are excluded unless discussed with the Treating Physician and considered appropriate for EAP participation. The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients with celiac disease controlled by diet alone\n* Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV). HBV positive (presence of HbsAg and\u002For anti-HBcAb with detectable HBV DNA); HCV positive (presence of anti-HCV antibodies); HDV positive (presence of anti-HDV antibodies).\n\n  o Note: Testing required for subjects with a known history otherwise not required.\n* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.\n* History of active primary immunodeficiency.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of EAP treatment. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as pre-medication for hypersensitivity reactions (e.g., CT scan pre-medication)\n* Receipt of live attenuated vaccine within 30 days before first dose of treatment. Note: patients, if enrolled, should not receive live vaccine while receiving study treatment, and up to 30 days after the last dose of study treatment.\n* Previous randomization or treatment in a previous durvalumab and\u002For tremelimumab clinical study regardless of treatment arm assignment.\n* Patients who have received anti-PD-1, anti-PD-L1, or anti-CTLA-4 before the first dose of EAP treatment.",{"count":83,"type":22},[85],"There is a growing number of patients diagnosed with gastrointestinal cancers who are also simultaneously being treated with GLP-1 Receptor Agonists (RA)s. To date, no clinical trial data exists to establish safety and\u002For feasibility with use of GLP-1 RAs during chemotherapy in the metastatic setting. The goal of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and correlative analyses of combining GLP-1 RAs with standard chemotherapy in patients with metastatic pancreatic, colorectal, or hepatocellular cancers in the first-line setting.",[556,557,558],"Pancreatic Cancer","Colorectal Cancer","Hepatocellular Carcinoma",[560,561],"GLP1 receptor agonists","gastrointestinal cancer","2026-06-30",{"date":564,"type":34},"2026-07-02",{"date":357,"type":22},{"date":567,"type":22},"2028-06-30",{"name":40,"class":41},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":583,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":70},"100624280","phase-1-ph-iii-sodium-thiosulfate-for-otoprotection-during-cisplatin-stop-cis-100624280","NCT07407582","Ph. I\u002FII Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)","Phase I\u002FII Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)","Inclusion Criteria:\n\n* Participants have provided informed consent prior to initiation of any study-specific activities.\n* At least 18 years of age, male or female, at the time of signing the informed consent.\n* ECOG Performance Status 0-1\n* Histologically or cytologically confirmed treatment-naïve cancer.\n* Scheduled to receive an FDA-approved, on-label indication, standard of care systemic cisplatin-based regimen (at least 200 mg\u002Fm2 cumulative dose) for any untreated any solid malignancy deemed by the treating physician\n\nExclusion Criteria:\n\n* Prior cisplatin exposure due to a cancer treatment history\n* Concurrent ototoxic medication unable to be safely discontinued or switched to a non-toxic alternative\n* Planned radiation to the head or neck prior to, during, or within 3 months of completion of cisplatin\n* History of severe hypersensitivity to sulfite, sodium thiosulfate, or any components\n* Baseline serum sodium \\> 145 mmol\u002FL or any grade ≥ 3 electrolyte abnormality\n* Cisplatin infusion duration greater than 6 hours\n* Females during pregnancy or breastfeeding, and childbearing potential, unwilling to use a method of contraception during treatment\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment\n* Subject likely not to be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject's and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.",{"count":7,"type":22},[54,55],"The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.",[580,272,581,582],"Solid Tumor Malignancies","Head and Neck Cancer","Thoracic Cancer",[584,585,586,587,588,589,590],"Cisplatin","Otoprotectant","Cancer","Hearing Impairment","Sodium Thiosulfate","Adults","Solid Tumor","2026-06-16",{"date":593,"type":34},"2026-06-18",{"date":595,"type":34},"2026-05-18",{"date":444,"type":22},{"name":40,"class":41},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":79,"sex":80,"minAge":19,"maxAge":422,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":616,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":4},"100641575","veda-study-dhea-vs-estradiol-100641575","NCT07574216","VEDA Study (DHEA vs Estradiol)","The Use of Vaginal Estrogen vs DHEA in Perimenopausal and Menopausal Women","Inclusion Criteria:\n\n* Peri- or post-menopausal status\n* Presence of any genitourinary or vaginal symptom (e.g., dryness, itching, discomfort, dyspareunia)\n* Willingness and ability to use vaginal therapy\n* Ability to provide informed consent\n* English speaker\n* Ages 40-90\n\nExclusion Criteria:\n\n* Use of systemic hormone therapy within the last 6 months\n* Gynecologic malignancy\n* Known allergy to study medications\n* Active vaginal infection at enrollment\n* Prior pelvic radiation",{"count":606,"type":22},324,[25],"This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.",[610,611,612,613,614,615],"Post-menopause","Pre-menopause","Sexual Function","Menopause","Vaginal Dryness","Painful Intercourse",[617,618],"DHEA","vaginal estrogen","2026-06-15",{"date":621,"type":34},"2026-06-17",{"date":623,"type":22},"2026-06-01",{"date":625,"type":22},"2031-12-31",{"name":40,"class":41},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":635,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":641,"completionDateStruct":642,"leadSponsor":644,"locationsCount":70},"100642429","progressive-muscle-relaxation-delivered-via-virtual-reality---an-intervention-for-patients-undergoing-cellular-therapy-100642429","NCT07649512","Progressive Muscle Relaxation Delivered Via Virtual Reality - an Intervention for Patients Undergoing Cellular Therapy","PMR Delivered Via VR - a Cellular Therapy Intervention","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Age greater than or equal to 18 years old\n3. Either have a planned admission or already be admitted to the in-patient oncology ward (3NW) with cellular therapy needs.\n4. Able to understand English\n5. Able to sit-up in bed or bedside chair space to utilize VR device at the time of enrollment\n6. Able to utilize VR device and computer\u002Flaptop to access necessary resources for participation\n7. Performance Status as defined by European Cooperative Oncology Group (ECOG) score of 0-2\n\nExclusion Criteria:\n\n1. Poor performance status of ECOG 3-4\n2. Recent use of immersive VR programs for stress relief and\u002For entertainment (more than 2 days\u002Fweek within the past 3 months)\n3. Participation in another stress-reduction type interventional study within the past 3 months\n4. Current or history of seizure, epilepsy, or other known severe neurological or mental health disorders\n5. Clinical Sensitivity to flashing light or motion or having balance disorders previously diagnosed\n6. Having another medical condition or co-morbidity that may prevent use of VR program or physical materials (e.g., visual or hearing problems, open sores, wounds, skin rash on face, or active infection)\n7. Patients with concern for neurotoxicity or acute treatment related neurological issues such as ICANS. ICANS grade 1 maybe eligible to re-enter trial. ICANS grade 2 or greater would be permanently excluded.",{"count":424,"type":22},[25],"Patients planned for cellular therapy supplementation such as CAR-T or stem cell transplant who are admitted for atleast 7 days in patient. During that time of admission, patients enrolled will complete a once daily, virtual reality guided progressive muscle relaxation program. Various validated QOL tools will be utilized to assess study results.",[638],"Heme Malignancy","2026-06-09",{"date":591,"type":34},{"date":96,"type":22},{"date":643,"type":22},"2027-05-01",{"name":40,"class":41},{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":4,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":262,"enrollmentInfo":652,"targetDuration":4,"studyType":23,"phases":653,"briefSummary":654,"conditions":655,"keywords":657,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":70},"100636382","social-optimization-study-100636382","NCT07564960","Social Optimization Study","Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity","Inclusion Criteria:\n\n1. Adults (18 Years or Older)\n2. History of lung cancer\n3. at least 12 months since cancer diagnosis\n4. fluent in English\n5. able to attend virtually or in person sessions at the University of Arizona.\n\nExclusion Criteria:\n\n1. Less than 12 months of cancer diagnosis at time of enrollment\n2. undergoing treatment for mood or anxiety health issues at time of enrollment\n3. unable to provide informed consent.",{"count":83,"type":22},[25],"This study tests whether clinical interventions to optimize support receptivity lead to improvements in social integration and quality of life (QOL) amongst long-term lung cancer survivors. The feasibility and acceptability of the intervention and assessment procedures will be examined. Thirty long-term lung cancer survivors will be randomized to a support receptivity intervention or an attention-control condition. Our intervention draws on cognitive behavioral therapy (CBT) strategies to reduce social anxiety, improve social awareness, and promote social integration. We will use two novel in vivo sampling methods using a mobile phone platform to assess social engagement and QOL improvements: 1) recording via the Electronically Activated Recorder to capture daily social interactions, and 2) repeated self-report sampling where participants answer questions about their social engagement experiences via their personal cell phone.",[656],"Lung Cancer",[658,659,660],"Social support","Psycho-oncology","Lung neoplasms","2026-06-03",{"date":663,"type":34},"2026-06-05",{"date":665,"type":34},"2026-04-27",{"date":667,"type":22},"2026-07-31",{"name":40,"class":41},{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":79,"sex":17,"minAge":677,"maxAge":484,"enrollmentInfo":678,"targetDuration":4,"studyType":23,"phases":679,"briefSummary":680,"conditions":681,"keywords":687,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":702,"startDateStruct":703,"completionDateStruct":705,"leadSponsor":707,"locationsCount":70},"100565518","early-phase-1-exercise-as-an-immune-adjuvant-for-allogeneic-cell-therapies-100565518","NCT06643221","Exercise as an Immune Adjuvant for Allogeneic Cell Therapies","Exercise-induced Adrenergic Receptor Signaling as an Immune Adjuvant for Allogeneic Cell Therapies","Allo-X","Procedures are in place for protecting against or minimizing the risks to the healthy volunteers recruited for this study. Physical risk to volunteers and matched related donors will be protected through health screening to determine study eligibility, and medical monitoring with an established test termination criterion during the exercise and isoproterenol infusion trials.\n\nTo protect against the remote risk of an adverse cardiac event occurring during exercise and isoproterenol infusion, the study will only enroll volunteers who are considered \"low risk\" for maximal stress testing in accordance with the guidelines published by the American College of Sports Medicine (ACSM) and American Heart Association (AHA). Individuals who are considered \"low risk\" are men and women who are asymptomatic and have no more than one risk factor for cardiovascular disease (CVD). The risks to subjects are therefore extremely low. All infusions will take place in the Clinical and Translational Sciences Research Center (CATS) Infusion Suite, which is a designated University of Arizona campus facility for infusion trials and equipped with appropriate medical personnel and monitoring equipment (i.e. ECG). The graded exercise tests and isoproterenol infusions procedures will be performed under the direction of a licensed and board-certified cardiologist\n\nInclusion Criteria:\n\nParticipants must:\n\n* Be between 21 and 55 years of age.\n* Be classified as 'low-risk' for graded exercise\u002Fstress testing according to ACSM-AHA criteria.\n* Have no contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast as per FDA guidelines.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n* Currently use tobacco products or have quit within the last 6 months.\n* Have a body mass index (BMI) greater than 34 kg\u002Fm² or waist circumference exceeding 102 cm for men and 88 cm for women.\n* Use any medications known to affect the immune system or regularly take ibuprofen\u002Faspirin, antidepressants, or medications that alter blood pressure or cardiovascular function.\n* Use of hormone replacement therapy.\n* Are pregnant or breastfeeding.\n* Have chronic or debilitating arthritis or have been bedridden in the past three months.\n* Experienced a common illness (e.g., colds) within the past 6 weeks.\n* Have central or peripheral nervous disorders, a history of stroke, or major affective disorder.\n* Are infected with HIV or hepatitis or have any autoimmune disease.\n* Have known cardiovascular disease or contraindications for the use of isoproterenol, carvedilol, bisoprolol, nadolol, or roflumilast.\n* Use any prescription medications or have an allergy to beta-blockers.\n* Have a resting heart rate of less than 50 beats per minute.\n* Suffer from asthma, emphysema, bronchitis, kidney disease, pheochromocytoma, diabetes, overactive thyroid, or a history of severe anaphylactic reactions.\n* Are scheduled for surgery.\n\nAdditionally, participants who meet the inclusion criteria but present with more than one of the following cardiovascular disease (CVD) risk factors will be excluded unless cleared by a cardiologist:\n\n* Family History: Myocardial infarction, coronary revascularization, or sudden death before 55 years of age in a father or male first-degree relative, or before 65 years of age in a mother or female first-degree relative.\n* Hypertension: Systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg.\n* Dyslipidemia: Total serum cholesterol exceeding 200 mg\u002Fdl.\n* Pre-diabetes: Fasting blood glucose levels between 100 mg\u002Fdl and 126 mg\u002Fdl.","21 Years",{"count":207,"type":22},[85],"This study aims to improve the treatment of blood cancer by using exercise to collect healthier immune cells from donors. Allogeneic adoptive cell therapy is a treatment where immune cells from a healthy donor are given to a cancer patient, usually to help prevent or treat cancer relapse after a stem cell transplant. These donor cells can either be directly infused into the patient or grown in a lab to create more specialized immune cells that target and kill cancer. While this therapy has been helpful for many patients, there is a need to make it more effective for a larger group and reduce side effects like graft-versus-host disease (GvHD), where the donor's immune cells attack the patient's healthy tissue.\n\nThis Early Phase 1 trial will test whether exercise can help produce better immune cells from donors. The investigators will recruit healthy participants for three study groups:\n\n1. Exercise Group: Participants will complete a 20-minute cycling exercise session. The investigators will collect blood samples before, during, and after exercise to study the number and quality of immune cells. The investigators will also use the collected cells to create immune therapies and test their ability to kill cancer cells in the lab and control cancer growth in mice.\n2. Exercise and Beta Blocker Group: In this group, participants will complete up to five cycling sessions, with at least a week between each session. Before each session, participants will take either a placebo or a drug (beta blocker) that blocks stress hormones like adrenaline. The investigators will collect blood samples before and during exercise to see how blocking these hormones changes the effect of exercise on immune cells.\n3. Isoproterenol Group: Participants in this group will receive a 20-minute infusion of isoproterenol, a drug that mimics the effects of adrenaline. The investigators will collect blood samples before, during, and after the infusion to see if the drug causes similar immune changes to those caused by exercise.\n\nParticipants can join one, two, or all three groups. This research will help understand whether exercise can improve immune cell therapies for treating blood cancer and reduce the risk of GvHD, making these treatments safer and more effective.",[682,683,350,684,685,686],"Leukemia","Hematopoetic Stem Cell Transplantation","CAR T-Cell Therapy","Lymphoma","Cell Therapy",[688,689,690,691,692,693,694,695,696,697,698,699,700,701],"exercise","cell therapy","beta-blockers","immune function","phosphodiesterase inhibitor","CAR T-cells","NK-cells","cytokine-induced killer cells","cytokine-induced memory-like NK-cells","monoclonal antibodies","leukemia","lymphoma","donor lymphocyte infusion","gamma-delta T-cells",{"date":663,"type":34},{"date":704,"type":34},"2018-01-24",{"date":706,"type":22},"2031-05-31",{"name":40,"class":41},""]