[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Milton S. Hershey Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":600},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,63,0,25,[9,40,70,97,129,153,177,195,218,239,263,281,304,324,348,370,389,409,438,456,476,497,519,543,572],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100053421","in-patients-with-corneal-abrasions-treated-with-collagen-corneal-shields-in-the-emergency-department-setting-100053421",false,"NCT07225699","IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING","A SINGLE-CENTER, DOUBLE-ARM, PATIENT MASKED, PROSPECTIVE RANDOMIZED CLINICAL TRIAL TO EVALUATE PATIENT REPORTED OUTCOMES IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING","Inclusion Criteria\n\n* Each of the following criteria must be met for study participation:\n\n  1. Male or female, age 18 or older at the time of study enrollment.\n  2. Corneal abrasion in one eye.\n  3. Willingness to sign the IRB-approved informed consent form (ICF) for study participation.\n  4. Availability, willingness, and sufficient cognitive awareness to return for study-required visits and comply with examination procedures.\n\n     Exclusion Criteria:\n\n     Patient candidates presenting any of the following characteristics will not be eligible for study participation:\n\n  \u003C!-- -->\n\n  1. Corneal abrasion in both eyes.\n  2. Allergy to moxifloxacin or other fluoroquinolone antibiotics.\n  3. Allergy to ibuprofen or other non-steroidal anti-inflammatory drugs.\n  4. History of neurotrophic cornea for any reason, in the study eye.\n  5. History of medical conditions known to cause decreased corneal sensation in the study eye including but not limited to HSV, HZO, and diabetes.\n  6. History of extraocular surgical procedures known to cause decreased corneal sensation in the study eye, including but not limited to trigeminal nerve clamp.\n  7. Any anterior segment pathology in the study eye that could significantly affect corneal wound healing (e.g. aniridia, clinically significant corneal dystrophies \\[ABMD\\], etc.)\n  8. Any visually significant intraocular media opacity other than corneal abrasion in the study eye (as determined by the investigator). Such opacities might include corneal scar or vitreous hemorrhage.\n  9. History of any clinically significant retinal pathology or ocular diagnosis in the study eye that could, in the investigator's best judgement, alter or limit visual acuity (e.g. ischemic disease, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, aniridia, epiretinal membrane, etc.).\n  10. History of uveitis in either eye.\n  11. History of intraocular or corneal surgery in the study eye besides laser peripheral iridotomy (LPI), retinal barrier laser.\n  12. Current ocular infection in the study eye.\n  13. Presence of uncontrolled systemic disease that could limit capacity to sign consent or comply with treatment schedule (e.g. mental illness, dementia, etc.).\n  14. Unsuitable for study participation for any other reason, as determined by the Investigator's clinical judgement","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-center, double-arm, patient masked, randomized controlled trial. Subjects will be enrolled in the Emergency Department at the Penn State Milton S. Hershey Medical Center. Eligible subjects must present to the ED and be diagnosed with a traumatic corneal abrasion. One eye from each patient will be considered the study eye.",[27],"Corneal Abrasions","NOT_YET_RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":21},"2026-11-15",{"date":36,"type":21},"2029-01-30",{"name":38,"class":39},"Milton S. Hershey Medical Center","OTHER",{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100557680","phase-1-silmitasertib-cx-4945-in-combination-with-chemotherapy-for-relapsed-refractory-solid-tumors-100557680","NCT06541262","Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors","Phase I\u002FII Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors","Inclusion Criteria:\n\n1. Age: Less than 30 years old at initial diagnosis\n2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed\u002Frefractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma\n\n   Phase II:\n   * Relapsed\u002Frefractory Neuroblastoma\n   * Relapsed\u002Frefractory Ewing sarcoma\n3. Tumor assessment:\n\n   Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed\u002FRefractory Neuroblastoma Relapsed disease defined as neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol) and has now relapsed and is in any number of relapses.\n\n   Refractory disease defined as High-risk neuroblastoma (as defined by INRG) that failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy or with disease remaining after standard immunotherapy.\n\n   International Neuroblastoma Risk Group Staging System (INRG) High Risk NB defined as one of the following:\n   1. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification\n   2. Age ≥ 547 days and INRG Stage M regardless of biologic features\n   3. Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy\n   4. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy\n\n   Relapsed\u002Frefractory Sarcoma Subjects that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for sarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n5. Measurable or evaluable disease, including at least one of the following:\n\n   * Measurable tumor by CT or MRI\n   * MIBG or PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n6. Timing from prior therapy:\n\n   Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer therapy and be within the following timelines:\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study.\n   2. Small Molecule Inhibitors (anti-neoplastic agent): At least 2 weeks from the completion of therapy with a small molecule inhibitor.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells, anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.).\n   4. Radiotherapy: At least 30 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n   5. Stem Cell Transplant:\n\n      * Allogeneic: No evidence of active graft vs. host disease\n      * Allogeneic\u002FAutologous: ≥ 2 months must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n7. Subjects must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 50.\n8. Subjects must have adequate organ function at the time of enrollment:\n\n   * Cardiac: Subjects must have a QTcF ≤ 480 msc.\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C5x upper limit of normal\n   * Renal: Subjects must have adequate renal function defined as:\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (for subjects \\\u003C 17 years old) (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (for subjects ≥17 years old (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n9. Subjects of childbearing potential must have a negative serum pregnancy test. Subjects of childbearing potential must agree to use effective measures to avoid pregnancy.\n10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).\n\nExclusion Criteria:\n\n1. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.\n2. Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior therapy.\n3. Subjects who are currently receiving Vitamin K antagonists (warfarin).\n4. Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).\n5. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n7. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n8. Subjects with any of the following gastrointestinal disorders:\n\n   1. Active malabsorption (e.g. short gut) syndrome.\n   2. Uncontrolled diarrhea (excess of 4 stools\u002Fday)\n   3. Gastritis, ulcerative colitis, Chron's disease or hemorrhagic coloproctitis\n   4. History of gastric or small bowel surgery involving any extent of gastric or small bowel resection\n9. Lactating subjects are not eligible unless they have agreed to not breastfeed their infants. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing subject with silmitasertib. (NOTE: breast milk cannot be stored for future use while the nursing subject is being treated on study.)\n10. Subjects with a history of any other malignancy.","30 Years",{"count":49,"type":21},104,[51,52],"PHASE1","PHASE2","The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of silmitasertib in combination with chemotherapy\n* Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[55,56,57,58,59],"Neuroblastoma","Ewing Sarcoma","Osteosarcoma","Rhabdomyosarcoma","Liposarcoma","RECRUITING","2026-06-30",{"date":63,"type":32},"2026-07-02",{"date":65,"type":32},"2024-10-30",{"date":67,"type":21},"2035-11-01",{"name":38,"class":39},22,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100551831","phase-1-eflornithine-dfmo-and-amxt-1501-for-neuroblastoma-cns-tumors-and-sarcomas-100551831","NCT06465199","Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas","A Phase I\u002FII Study Using Eflornithine (DFMO) and AMXT 1501 for Relapsed and Refractory Neuroblastoma, CNS Tumors, and Sarcomas","Inclusion Criteria:\n\n1. Age:\n\n   All participants : Must be a maximum of 26 years of age at diagnosis\n\n   Age at enrollment by Phase:\n   1. Safety Run-in (Dose level 1)-The first three (3) participants enrolled will be ≥ 12 years of age at enrollment. Once evaluated for safety by DSMB, we will move on to the next three (3) participants enrolled who will be ≥6 years of age at enrollment. Once evaluated for safety by DSMB, we will move on to the Phase I.\n   2. Phase I and II: ≤ 26 years of age at diagnosis.\n2. Pathology\n\n   All participants must have a confirmed pathologic diagnosis of tumor type (except for DIPG):\n   * Relapsed\u002Frefractory Neuroblastoma (NB)\n   * Relapsed\u002Frefractory Embryonal tumor with multilayer rosettes (ETMR)\n   * Relapsed\u002Frefractory Atypical teratoid rhabdoid tumor (ATRT)\n   * Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)- radiologic diagnosis acceptable\n   * Relapsed\u002Frefractory Ewing Sarcoma (EWS)\n   * Relapsed\u002Frefractory Osteosarcoma (OST)\n3. Tumor assessment:\n\n   Disease staging must be performed at baseline during the 28 day screening period prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed or Refractory Neuroblastoma Relapsed disease defined as: High-risk neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation, surgery, and immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol).\n\n   Refractory disease defined as: High-risk neuroblastoma that 1) failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol, or 2) progression during upfront therapy or 3) with disease remaining after standard immunotherapy.\n\n   Eligible NB participants may have active disease or no active disease.\n\n   NB participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   NB participants with active disease need to meet the following criteria:\n   * Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n   * Participants must not have disease in any organs (including lungs, liver, or brain).\n\n   Relapsed or refractory ETMR\u002FATRT Participants that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive\u002Fprogressive to accepted curative therapy, including up-front chemotherapy and radiation and\u002For high-dose chemotherapy with stem cell rescue.\n\n   ETMR\u002FATRT participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   ETMR\u002FATRT participants with active disease need to meet the following criteria:\n\n   • Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n\n   Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) Participants with DIPG to start greater than 30 days, and no longer than 60 days, after standard of care radiation therapy.\n\n   Participants with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of the pons on at least 1 axial T2-weighted image, are eligible. No histologic confirmation is required. Participants with metastatic disease are not eligible. Participants with a biopsy and no evidence of H3K27m mutations are eligible as long as they meet radiographic criteria. Participants with H3K27m altered DMG outside of the brainstem are not eligible. Participants with progression or recurrence after initial standard of care radiation are ineligible.\n\n   Relapsed or refractory Ewing sarcoma and osteosarcoma Participants that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for Ewing sarcoma and osteosarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n\n   EWS\u002FOST Participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   EWS\u002FOST Participants with active disease need to meet the following criteria:\n\n   • Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n5. Participants must be able to swallow capsules.\n6. Participants with CNS disease currently taking steroids must have been on a stable dose of steroids for at least one week and must not have progressive hydrocephalus at enrollment.\n7. Participants must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:\n\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).\n   2. Small Molecule Inhibitor (anti-neoplastic agent): At least 7 days since the completion of therapy with a small molecule inhibitor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells except for anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.) which should be at least 2 weeks since prior treatment with a monoclonal antibody.\n   4. XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n\n      Note: Participants with DIPG will be required to have had up front standard of care radiation. As above, participants with DIPG must be between 30-60 days post initial up- front radiation therapy.\n   5. Stem Cell Transplant:\n\n      1. Allogeneic: No evidence of active graft vs. host disease\n      2. Allo\u002FAuto: ≥ 45 days must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n8. Participants must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 60\n9. Participants must have adequate organ function at the time of enrollment:\n\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL (unsupported- \\>24 hrs off G-CSF and 7 days off neulasta)\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C10x upper limit of normal\n   * Cardiac: all participants must have:\n\n     1. Normal serum Cardiac Troponin Concentration\n     2. Normal BNP (B-type natriuretic peptide) Level\n     3. A QTcF ≤ 470 msec (or EKG with no significant findings)\n     4. Normal ECHO defined as:\n\n     i. Shortening fraction of ≥ 27% by echocardiogram, or ii. Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n   * Renal: Participants must have adequate renal function defined as:\n\n     1. For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     2. For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n10. Participants of childbearing potential must have a negative pregnancy test. Participants of childbearing potential must agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n11. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n4. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n5. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.","26 Years",{"count":79,"type":21},289,[51,52],"The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of AMXT 1501 in combination with DFMO\n* Test the safety and tolerability of AMXT 1501 in combination with DFMO\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[83,84,56,85,57,55,86],"Atypical Teratoid\u002FRhabdoid Tumor","Embryonal Tumor With Multilayered Rosettes","Diffuse Intrinsic Pontine Glioma","DIPG Brain Tumor",[88],"DFMO",{"date":90,"type":32},"2026-07-01",{"date":92,"type":32},"2026-05-13",{"date":94,"type":21},"2035-05",{"name":38,"class":39},12,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100641417","virtual-reality-to-reduce-anxiety-agitation-and-delirium-in-critically-ill-patients-100641417","NCT07649876","Virtual Reality to Reduce Anxiety, Agitation and Delirium in Critically Ill Patients","Inclusion Criteria:\n\n1. Aged ≥ 18 years old admitted to the Surgical Intensive Care Unit (SICU) at Penn State Health Milton S. Hershey Medical Center.\n2. No significant uncorrectable visual or auditory impairments\n3. Estimated ICU length of stay \\> 48h\n4. At the time of each VR session, able to keep eyes open for at least 30 seconds, follow simple commands and able to indicate discomfort or request to stop.\n5. English speaking\n\nExclusion Criteria:\n\n1. Significant hemodynamic instability\n2. Known psychotic disorders associated with delusions (e.g. schizophrenia)\n3. Severe dementia (e.g. inability to communicate or follow simple commands)\n4. History of disequilibrium syndrome or vertigo\n5. Acute hyperactive delirium, requiring physical restraints",true,{"count":105,"type":21},30,[24],"This is a pilot feasibility study examining the use of immersive virtual reality (VR) in adult intensive care unit (ICU) patients. The study evaluates whether brief, non-interactive VR sessions delivered using a commercially available standalone head-mounted display with calming, nature-based content can be delivered safely and effectively within routine SICU workflow. Exploratory objectives assess whether VR sessions are associated with changes in anxiety, agitation, delirium, pain, and sedative medication requirements. This research is not intended to evaluate the safety or effectiveness of the headset and\u002For the specific VR software used for the research",[109,110,111,112],"Delirium in the Intensive Care Unit","Sleep Quality in Adult ICU Patients","Agitation Associated With Critical Illness","Anxiety Acute",[114,115,116,117,118,119],"Virtual reality","Intensive care unit","Pain","Agitation","Anxiety","Sleep Quality","2026-06-17",{"date":122,"type":32},"2026-06-22",{"date":124,"type":32},"2026-06-02",{"date":126,"type":21},"2026-09",{"name":38,"class":39},1,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":128},"100642355","impact-of-electronic-cigarette-temperature-and-solvent-on-biomarkers-100642355","NCT07612696","Impact of Electronic Cigarette Temperature and Solvent on Biomarkers","Clinical Study on the Impact of Electronic Cigarette Temperature and Solvent on Biomarkers of Oxidant Exposure","Inclusion Criteria:\n\n* 21 years of age or older\n* Normal pulmonary and cardiovascular function with no history of COPD or cardiovascular disease (excluding hypertension)\n* Current exclusive use of a sub-ohm\u002Fmod or pod EC devices (≥ 1mL e-liquid\u002Fper day, ≥6 mg\u002Fml nicotine concentration, EC for ≥ 1 year)\n* No plan on quitting nicotine use over the course of the study\n* All other forms of nicotine must be used \\\u003C5 days out of the past 28 days.\n* Able to read and write in English\n* Have access to email and a smartphone\u002Fcomputer that has reliable internet connection\n\nExclusion Criteria:\n\n* Women who are pregnant and\u002For nursing or trying to become pregnant\n* Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)\n* Respiratory diseases (e.g., exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV\u002FAIDS, multiple sclerosis symptoms) or any medical disorder\u002Fmedication that may affect participant safety or biomarker data\n* Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months\n* Have immediate family or household members currently participating in this trial","21 Years",{"count":138,"type":21},50,[24],"This project seeks to determine how e-cigarette (EC) physical design features, including those that allow the user to manipulate the quality and quantity of aerosols, affect exposure and toxicity from oxidants and other aerosol constituents.",[142,143,144],"Oxidative Stress","Tobacco Use","Electronic Cigarettes","2026-06-12",{"date":147,"type":32},"2026-06-16",{"date":149,"type":21},"2026-07-15",{"date":151,"type":21},"2028-12",{"name":38,"class":39},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":128},"100628402","penn-state-emergency-medicine-cares-care-partner-evaluation-and-sourcing-in-the-emergency-department-100628402","NCT07461168","Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department","Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the ED","CarES","Inclusion Criteria:\n\n* Person completed the CarES Observational Study.\n* Person is a care partner and:\n* Lives with the person living with dementia or\n* Checks on them at least once per week in person or by phone\n* Person is willing and able to participate in study assessments\n\nExclusion Criteria:\n\n* Person is no longer a care partner for a person living with dementia\n* Person declines participation","60 Years",{"count":163,"type":21},20,[24],"Care partners of people living with dementia often experience ongoing stress and unmet support needs. This study evaluates the feasibility of a low-intensity, supportive education and resource intervention for care partners who previously participated in an observational study.\n\nParticipants complete a baseline phone interview and a short stress journaling activity, followed by a six-week series of automated educational and supportive messages delivered by text message or email. Participants may also take part in an optional peer support focus group. The study examines caregiver stress, resilience, engagement with resources, and participant feedback to inform future caregiver support interventions.",[167,168,169,170],"Dementia","Caregiver Stress","Caregiver Burden","Caregiver Burden of People With Dementia",{"date":172,"type":32},"2026-06-15",{"date":90,"type":21},{"date":175,"type":21},"2026-12-30",{"name":38,"class":39},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":128},"100539926","little-cigar-oxidants-100539926","NCT06310187","Little Cigar Oxidants","Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars","Inclusion Criteria:\n\n1. Aged 21 - 65 years old\n2. Daily cigarette smoker (\\>= 1 cigarette per day);\n3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter\n4. No current or past use of Little Cigars\n5. All other forms of nicotine must be used \\\u003C6 days out of the past 30 days.\n6. Able to read and write in English\n7. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days\n8. No plan to quitting smoking in the next 3 months\n\nExclusion Criteria:\n\n1. Women who are pregnant and\u002For nursing or trying to become pregnant\n2. Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)\n3. Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV\u002FAIDS, multiple sclerosis symptoms) or any medical disorder\u002Fmedication that may affect participant safety or biomarker data\n4. Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months\n5. Exhaled Carbon Monoxide (CO) measurement of \\>= 17 parts per million","65 Years",{"count":138,"type":21},[24],"Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.",[143,142],{"date":147,"type":32},{"date":191,"type":32},"2026-03-25",{"date":193,"type":21},"2029-08",{"name":38,"class":39},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100617691","phase-2-eflornithine-dfmo-for-ewing-sarcoma-and-osteosarcoma-100617691","NCT07321912","Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma","A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma","Cohort 1:\n\nInclusion Criteria:\n\n1. Participants must be ≤50 years of age at enrollment.\n2. Histologically confirmed Ewing sarcoma that is refractory or in first or subsequent relapse. Histological confirmation either at initial diagnosis or disease progression.\n\n   * Relapsed: Participants that have achieved CR at any point and then relapsed following\u002Fduring standard of care therapy.\n   * Refractory: Participants that failed to achieve CR after standard of care therapy or having progressed during standard of care therapy.\n   * Note: Standard of care therapy for Ewing sarcoma includes multi-agent chemotherapy with local control consisting of either surgery and\u002For radiation therapy.\n3. Extent of disease is judged by treating team to be amenable to the delivery of definitive local control (either definitive radiation, surgery, or a combination of these) at the time of study enrollment (to be completed after protocol defined Cycle 2).\n4. Participants may enroll anytime during Cycle 1 or 2, prior to local control, as long as they received the same treatment during Cycle 1 and 2 as prescribed in this protocol.\n5. Relapsed or refractory disease, including at least one of the following:\n\n   * Tumor by CT or MRI\n   * FDG-PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n\n   Organ Function Requirements:\n6. Participants must have adequate renal function as defined as:\n\n   * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n7. Adequate liver function defined as:\n\n   1. Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and\n   2. SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT \\\u003C 5 times ULN for age).\n8. Adequate cardiac function defined as:\n\n   1. Shortening fraction of ≥27% or\n   2. Ejection fraction of ≥50%\n9. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n10. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n11. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n12. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Participants with current CNS disease.\n3. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n4. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n5. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n\nCohort 2:\n\nInclusion Criteria:\n\n* Age\n\n  1. Participants must be ≤50 years of age at enrollment.\n\n     Note:\n\n     • Infants and small children are eligible for this study, however, the treating physicians and family must be prepared to deliver adequate local control as required in this study (see BCC Surgical and Imaging Guidelines).\n\n     Diagnosis\n  2. Participants with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site.\n\n     For the purpose of this study, metastatic disease is defined as one or more of the following:\n     * Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases. If there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed.\n     * Contralateral pleural effusion and\u002For contralateral pleural nodules.\n     * Distant lymph node involvement.\n     * Participants with pulmonary nodules are considered to have metastatic disease if the participant has:\n\n       * Solitary nodule ≥0.5 cm or multiple nodules of ≥0.3 cm unless lesion is biopsied and negative for tumor;\n       * Participants with solitary nodule \\\u003C0.5 cm or multiple nodules \\\u003C0.3 cm are not considered to have lung metastasis unless biopsy documents tumor.\n     * Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on H\\&E stains. In the absence of morphologic evidence of marrow involvement on H\\&E, participants with bone marrow involvement detected ONLY by flow cytometry, RT PCR, FISH, or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study.\n\n     For participants that have a positive FDG-PET scan at study enrollment, a bilateral bone marrow biopsy will be required at study entry. If a bone marrow is required, the suggested approach for participants with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy).\n\n     • Bone metastasis: This study utilizes whole body FDG-PET scans to screen participants for bone metastases. Areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or CT (whole body FDG-PET\u002FCT or FDG-PET\u002FMR scan acceptable). Whole body technetium bone scans may be performed at the discretion of the investigator and are not required. For participants without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry.\n\n     Prior Therapy\n  3. Participants must have completed 6 cycles of Induction therapy with VDC\u002FIE per US standard of care (including standard modifications). Participants will enroll after the 6th cycle prior to local control.\n\n     Organ Function Requirements\n  4. Adequate renal function defined as:\n\n     * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n     * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n  5. Adequate liver function defined as:\n\n     * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and\n     * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT \\\u003C 5 times ULN for age).\n  6. Adequate cardiac function defined as:\n\n     * Shortening fraction of ≥27% or\n     * Ejection fraction of ≥50%\n  7. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n  8. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n  9. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n  10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Participants with regional node involvement as their only site of disease beyond the primary tumor.\n5. Participants whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord).\n6. Participants with current CNS disease\n7. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n8. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n\nCohort 3:\n\nInclusion Criteria:\n\n* Age\n\n  1. Participants must be less than 30 years of age at enrollment.\n\n     Diagnosis\n  2. Participants must have histologic diagnosis of osteosarcoma at original diagnosis.\n  3. Participants must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria:\n\n     * Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment\\*\n     * Pathologic confirmation of metastases from at least one of the resected sites.\n     * No local recurrence or metastatic disease elsewhere. \\*For participants with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery. No evidence of pulmonary metastatic disease; participants may have no visible lung nodules greater than 3 mm, and not considered to be disease.\n\n     Note: If surgery related changes such as atelectasis are seen on the post-operative CT scan, participants will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected. Participants with positive microscopic margins will be eligible to enroll.\n\n     Performance Level\n  4. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n\n     Timing from Prior Therapy\n  5. Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n     * Myelosuppressive anti-cancer therapy: Must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea).\n     * Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.\n     * Radiation therapy (RT): ≥2 weeks for local palliative RT (small port); ≥6 weeks must have elapsed if prior craniospinal RT or if ≥50% radiation of pelvis; ≥6 weeks must have elapsed if other substantial BM radiation.\n     * Surgery: ≥2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies.\n\n     Organ Function Requirements\n  6. Hematological:\n\n     * Platelet count ≥50,000\u002FμL without transfusion in last 7 days\n     * Hgb ≥8.5 without transfusion in last 7 days\n  7. Adequate renal function defined as:\n\n     * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n     * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n  8. Adequate liver function defined as:\n\n     * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age.\n     * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age.\n  9. Adequate cardiac function defined as:\n\n     * Shortening fraction of ≥27%, or\n     * Ejection fraction of ≥50%.\n  10. Adequate pulmonary function defined as:\n\n      o No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry \\>94%.\n  11. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n  12. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Participants with distant bone metastases at original diagnosis or any subsequent relapse (participants with only skip lesions will be eligible).\n5. Participants with concurrent local and pulmonary recurrence at the time of most recent episode of disease recurrence preceding enrollment.\n\n   Note: participants who had local recurrence previously that has been treated and then presented with an isolated pulmonary recurrence and met the surgical resection criteria stated above will be eligible (see IC #3 above).\n6. Participants with primary refractory disease with progression of the primary tumor on initial therapy.\n7. Participants with other sites of extra-pulmonary metastases at the time of any episode of disease recurrence preceding enrollment.\n8. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n9. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.\n\nCohort 4A\u002FB:\n\nInclusion Criteria:\n\nDiagnosis Both Cohorts\n\n1. Participants must have high grade osteosarcoma and received gross total resection prior to start of Cycle 3 MAP therapy. Participants with positive margins are eligible and may receive radiation therapy. This includes secondary malignancies.\n\n   o Note: craniofacial osteosarcoma is NOT permitted.\n2. The primary tumor was resectable after the initial 2 cycles of MAP chemotherapy.\n3. Participants must have had a non-contrast chest CT and primary tumor site imaging consisting of an MRI or CT for optimal visualization of primary tumor site prior to local control. Physical scans and scan reports must be available to submit to BCC.\n\n   Note: Two-view plain radiographs of the primary tumor site can be performed for participants who have a metallic prosthetic implant instead of CT or MRI if a significant metal artifact would occur by those imaging modalities;\n\n   Cohort A only\n4. Participant must have poor response to induction chemotherapy (those with 10% or more viable tumor remaining after surgery) and localized tumor.\n\n   Cohort B only\n5. Have an initial diagnosis of high-grade metastatic extremity or axial osteosarcoma resectable by the treating team.\n\n   o Note: Metastatic pulmonary disease is defined as 3 or more lesions \\>5 mm or 1 lesion \\>1 cm or biopsy proven pulmonary metastatic disease if not meeting these radiographic criteria;\n6. No definite progression of metastatic disease and no evidence of new metastatic disease.\n7. Following definitive primary surgery, complete removal of all metastases or complete removal planned and deemed feasible.\n\n   Non-Diagnostic Inclusion Criteria, Both Cohorts Age\n8. Participants must be ≥5 years and ≤40 years on date of diagnostic biopsy. Performance Level\n9. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60. Participants whose performance status is adversely affected by a pathologic fracture but who are able to undergo treatment are eligible.\n\n   Prior Therapy\n10. Participants must have completed standard induction therapy for initial diagnosis osteosarcoma (2 cycles \\[10weeks\\]) of MAP, Local control (surgery, assessment of histologic response), and a post-surgery 3rd cycle (5 weeks) of MAP. Participants will enroll after the 3rd cycle of MAP.\n\n    Organ Function Requirements\n11. Participants must have adequate renal function defined:\n\n    * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n    * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n    * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n12. Adequate cardiac function defined as:\n\n    * Shortening fraction of ≥28%, or\n    * Ejection fraction of ≥50%\n13. Adequate liver function defined as:\n\n    * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age\n    * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age.\n14. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n15. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n16. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n5. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.","0 Years","50 Years",{"count":205,"type":21},406,[52],"Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and\u002For maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.",[57,56,209],"Ewing Sarcoma Metastatic","2026-06-10",{"date":145,"type":32},{"date":213,"type":32},"2026-06-05",{"date":215,"type":21},"2036-06-01",{"name":38,"class":39},2,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":128},"100342336","phase-4-liposomal-bupivacaine-versus-plain-bupivacaine-after-intercostal-injections-for-pain-management-after-thoracoscopy-100342336","NCT03737292","Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy","Comparison of Plasma Concentration And Efficacy Of Liposomal Bupivacaine And Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy","Inclusion Criteria:\n\n1\\. Male or female patients over age 18 undergoing minimally invasive thoracic surgeries including but not limited to:\n\n1. VATS wedge resection \u002Fsegmentectomy\n2. VATS lobectomy.\n3. Robot assisted thoracoscopic wedge resection\u002Fsegmentectomy.\n4. Robot assisted thoracoscopic lobectomy procedures.\n\nExclusion Criteria:\n\n1. Patients under18 years of age\n2. Patients weighing less than 48 kg\n3. Pregnant and lactating females will be excluded from the trial\n4. Patients preoperatively taking narcotics for chronic pain in proximity to surgical site\n5. Patients with previous ipsilateral thoracic surgery\n6. Patients undergoing pleurectomy\u002Fmechanical pleurodesis.\n7. Patients with high likelihood of conversion from thoracoscopic procedure to open thoracotomy as determined by an operating surgeon\n8. Patients with pre-existing painful conditions (CRIPS, fibromyalgia, neuropathy)\n9. Patients unable to reliably communicate pain scores such as patients with dementia, alterations in mental status\n10. Patients with hypersensitivity to local anesthetics and pain medications used in the study\n11. Patients with previous thoracic spine surgeries\n12. Patients with increased creatinine (over 1.5mg\u002Fdl)\n13. Patients with liver dysfunction\n14. Non-English speaking patients",{"count":226,"type":21},40,[228],"PHASE4","The purpose of this study is to assess pharmacokinetics of liposomal bupivacaine (Exparel) after multilevel intercostal injections of this local anesthetic for pain control during and after thoracoscopic surgeries.\n\nThe specific aim of this study is to evaluate plasma concentration of bupivacaine after intraoperative intercostal injections of 266 mg of liposomal bupivacaine and compare it to plasma concentrations of bupivacaine after intercostal injections of 2mg\u002Fkg of 0.5% plain Bupivacaine with maximal dose of 30 ml or 150 mg.\n\nThe hypothesis of the study is that plasma concentration of bupivacaine after intercostal injections of 266 mg of liposomal bupivacaine will be similar to concentrations after injections of plain bupivacaine, and will remain below the toxic level threshold range of 2000-3000 ng\u002FmL (2-3 mg\u002FL) at which central nervous system and cardiovascular adverse events would be expected to occur.\n\nThe secondary objective is to evaluate if intercostal injections of 266 mg of liposomal bupivacaine will significantly reduce opioid consumption and postsurgical pain, within the first 48 hours and up to 3 months after minimally invasive thoracic surgeries, to determine if both acute and chronic post-thoracotomy pain can be decreased by intraoperative intercostal injections of liposomal bupivacaine.\n\nAdditionally, the rate of pneumonia, the rate of atrial fibrillation and length of hospital stay will be assessed as secondary outcomes after thoracic surgeries. These outcomes can be affected by the level of postoperative pain and inflammation.\n\nSignificance of this study: If positive, the results of this research have the potential to significantly improve pain management after thoracoscopic surgery.\n\nBased on prior experience, prolonged analgesia after liposomal bupivacaine injection is safe, and may help reduce perioperative opioid consumption and decrease opioid related complications. It will improve patient comfort, eliminate need for indwelling neuraxial catheters and risks associated with them.",[231,232],"Pain, Postoperative","Pharmacokinetics",{"date":145,"type":32},{"date":235,"type":32},"2019-04-09",{"date":237,"type":21},"2026-12",{"name":38,"class":39},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":103,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":4},"100594374","mitigating-burnout-in-nursing-and-associated-healthcare-staff-100594374","NCT07018609","Mitigating Burnout in Nursing and Associated Healthcare Staff","The Zen Den - Mitigating Burnout in Nursing and Associated Healthcare Staff","Inclusion Criteria:\n\n\\- English-speaking employees or students at Penn State Health and College of Medicine.\n\nExclusion Criteria:\n\n\\- Non-English speaking individuals",{"count":247,"type":21},300,[24],"Workplace stress for healthcare workers is at an all-time high and the COVID-19 Pandemic magnified and amplified the impact of stress and burnout on health care workers, especially for frontline staff such as nurses. There are multiple external and individual factors that affect clinician well-being, and organizational factors are an important aspect to address when attempting to mitigate nurse burnout and improve well-being. This project seeks to expand two interventions that were piloted in the last few years since the Covid-19 Pandemic, validated to show improvement in staff well-being and decreased feelings of burnout following the interventions, and are easily implemented to benefit nurses and other multidisciplinary health care workers and students in both the inpatient and outpatient settings.",[251,252],"Burn Out","Nurses",[254,252,255],"Burnout","Music Therapy","2026-06-04",{"date":213,"type":32},{"date":259,"type":21},"2027-09-01",{"date":261,"type":21},"2028-04-30",{"name":38,"class":39},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":128},"100535594","ultrasound-us-guided-external-ventricular-catheter-placement-100535594","NCT06253858","Ultrasound (US) Guided External Ventricular Catheter Placement","Inclusion Criteria:\n\n* Decision made to perform the procedure by the primary consultant\n* Age 18 or older\n* Neuro ICU stay\n* Newly diagnosed hydrocephalus\n* Has a recent CT within the past 24 hrs\n* Normal platelets and coagulation profile\n* No active infection or currently on antibiotics\n* The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging\n\nExclusion Criteria:\n\n* Age \\\u003C18\n* Not in Neuro ICU setting\n* Previous placement of a ventricular catheter\n* More than 50 percent of the fluid compartment is filled with blood by CT scan\n* Time to include in the trial prohibited by clinical personnel",{"count":270,"type":21},10,[24],"To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.",[274],"Hydrocephalus",{"date":213,"type":32},{"date":277,"type":32},"2026-04-01",{"date":279,"type":21},"2026-12-01",{"name":38,"class":39},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":128},"100356510","evaluation-of-structural-and-functional-integrity-of-the-rotator-cuff-after-total-shoulder-arthroplasty-100356510","NCT03921944","Evaluation of Structural and Functional Integrity of the Rotator Cuff After Total Shoulder Arthroplasty","Inclusion Criteria:\n\n* age \\>45yrs\n* primary diagnosis of osteoarthritis of the shoulder\n* total shoulder replacement performed by Dr. Armstrong\n* administered a local anesthetic mixture and not regional anesthesia\n* all genders\n* Fluent in written and spoken English\n* Patients capable of giving informed consent\n\nExclusion Criteria:\n\n* Known contraindications to CT\u002FEMG\n* Inability to provide informed consent\n* History of recent trauma to the shoulder\n* Atypical shoulder pain\n* Other suspected shoulder pathology (i.e. tumor, infection)\n* Pregnancy\n* Bilateral total shoulder arthroplasty","45 Years",{"count":105,"type":21},[24],"The purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.",[292],"Osteoarthritis of Shoulder",[294,295,296],"shoulder surgery","arthritis","rotator cuff","2026-06-03",{"date":213,"type":32},{"date":300,"type":32},"2024-05-02",{"date":302,"type":21},"2027-12",{"name":38,"class":39},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":310,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":323,"locationsCount":4},"100637460","transdiagnostic-sleep-and-circadian-treatment-for-autistic-adolescents-100637460","NCT07612111","Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents","Inclusion Criteria:\n\n1. Autistic adolescents diagnosed with Autism Spectrum Disorder (ASD).\n2. Between the ages of 13 and 17 years.\n3. English-speaking\n4. Sufficient verbal communication skills to participate in interviews, surveys, or tasks.\n5. Ability to provide informed assent with guardian consent.\n6. One or more sleep or circadian problem(s) for a period of at least 3 months assessed with the Sleep and Circadian Problems Interview.\n\nExclusion Criteria:\n\n1. A history of Intelligent Quotient (IQ) \\\u003C 70.\n2. A history of psychotic, bipolar or seizure disorders as per medical record.\n3. Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome, as per structured interview based on risk screeners.","13 Years","17 Years",{"count":96,"type":21},[24],"Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adolescents, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will help to address a critical need for accessible transdiagnostic sleep interventions for autistic adolescents, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.",[316,317,318],"Sleep","Autism Spectrum Disorder","Transdiagnostic",{"date":256,"type":32},{"date":321,"type":21},"2026-09-01",{"date":259,"type":21},{"name":38,"class":39},{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":103,"sex":17,"minAge":136,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":128},"100325189","early-phase-1-autonomic-control-of-the-circulation-and-vdr-100325189","NCT03513770","Autonomic Control of the Circulation and VDR","Autonomic Control of the Circulation and the Venous Distension Reflex","VDR","Inclusion Criteria\n\n* Are capable of giving informed consent\n* Are any race or ethnicity\n* Are fluent in written and spoken English\n* Have a satisfactory history and physical exam to meet inclusion\u002Fexclusion criteria\n* Are free of acute or chronic medical conditions\n* Are 21 - 35 years of age (inclusive)\n* Weigh over 50 kg\n\nExclusion Criteria\n\n* Are less than 21 or over 35 years of age\n* Are Pregnant or nursing women\n* Are prisoners or institutionalized individuals or unable to consent\n* Any chronic diseases (hypertension, heart, lung, neuromuscular disease, kidney disease, diabetes or cancer).\n* Are taking medications that may affect their cardiovascular or nervous system\n* Has taken an NSAID within 48 hours of any visit (visit will need to be rescheduled)\n* Has never taken NSAIDs and therefore would not know if they are allergic to it\n* Have a supine BP \\>140\u002F90 mmHg\n* Have known allergy to ibuprofen-like drugs (NSAIDS) or aspirin\n* Have history of asthma or nasal polyps\n* Have history of GI bleeding or ulcers\n* Subjects with ferromagnetic metal implants\n* Subjects who are claustrophobic","35 Years",{"count":334,"type":21},18,[336],"EARLY_PHASE1","The study objective of this project is to examine the mechanisms of the venous distension reflex (VDR) in humans. We hypothesize that COX blockade with ketorolac tromethamine, an intravenous NSAID, will attenuate the muscle sympathetic nerve activity (MSNA) response to limb venous distension. To gain further insight into whether the COX byproducts directly stimulate chemically-sensitive afferents, or enable venodilation and indirectly evoke afferent stimulation, we will measure vein size using 3T MRI during venous distention with and without ketorolac infusions.",[339,340],"Venous Distension Reflex","Blood Pressure","2026-05-29",{"date":124,"type":32},{"date":344,"type":32},"2019-08-14",{"date":346,"type":21},"2027-08-31",{"name":38,"class":39},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":332,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":361,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":128},"100627886","aya-peerconnect-a-communication-coaching-intervention-for-adolescentyoung-adult-cancer-survivors-ayacs-100627886","NCT07454460","AYA-PeerConnect: A Communication Coaching Intervention for Adolescent\u002FYoung Adult Cancer Survivors (AYACS)","Inclusion Criteria:\n\n* Participant is currently ≥18-35 years old\n* Participant is receiving cancer-directed care at Penn State Cancer Institute or Penn State Children's Hospital\n* Participant has completed all cancer-directed therapy and is at least 1 year from end of cancer treatment (based on date of last cancer-directed treatment)\n* Participant has access to a computer with internet capability\n* Participant is fluent in written and spoken English\n\nExclusion Criteria:\n\n* Participant is not fluent in written and spoken English\n* Participant with cognitive inability to participant in the study as determined by the study team\n* Participants with history of relapsed cancer",{"count":270,"type":21},[24],"This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent\u002Fyoung adult cancer survivors (AYACS) and their friends\u002Fpeers. The results of the study will help to understand how to best support adolescent\u002Fyoung adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.",[358,118,359,360],"Communication","Depression","Social Isolation",[358,118,359,360],"2026-05-20",{"date":364,"type":32},"2026-05-22",{"date":366,"type":32},"2026-04-14",{"date":368,"type":21},"2026-07-30",{"name":38,"class":39},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":287,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":381,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":128},"100559109","the-impact-of-yoga-on-endometriosis-related-pain-100559109","NCT06559852","The Impact of Yoga on Endometriosis-Related Pain","Inclusion Criteria:\n\n1. Reproductive aged women 18-45\n2. Self-reported prior surgery with pathology confirming a diagnosis of endometriosis\n3. No current use of yoga\n4. Baseline moderate pain, score greater than or equal to 5 on VAS scoring\n5. Access to internet with wifi capability for zoom platform and completion of weekly surveys\n6. Access to items required for yoga session participation (2 blankets or towels, firm pillow, stable chair, wall space, comfortable clothing, water)\n7. Ability to commit to duration of 12-week yoga course\n\nExclusion Criteria:\n\n1. Pregnant patients\n2. Established yoga participation or moderate exercise regimen\n3. Physical trauma or disability\n4. Planned surgery or hormonal medication change during study\n5. Non-English speaking patients",{"count":105,"type":21},[24],"The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.",[380],"Endometriosis",[382],"Pelvic Pain",{"date":364,"type":32},{"date":385,"type":21},"2026-08-15",{"date":387,"type":21},"2026-09-15",{"name":38,"class":39},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":4},"100595321","phase-4-amino-acid-infusion-in-cardiac-surgery-100595321","NCT07030933","Amino Acid Infusion in Cardiac Surgery","Inclusion Criteria:\n\n* Male and female patients 18 years of age or older undergoing elective cardiac surgery requiring cardiopulmonary bypass.\n* Anticipated stay of at least one night in the ICU following cardiac surgery.\n* Eligible patients must have a baseline serum creatinine measurement obtained during the current hospitalization, or within 365 days of the current hospitalization.\n* Patients agree to participation and completed informed consent process.\n\nExclusion Criteria:\n\n* Preoperative or planned post-operative need for renal replacement therapy.\n* Stage IV or greater chronic kidney disease, defined as estimated glomular filtration rate of less than 30 mL\u002Fminute per 1.73 M\\^2 of body surface area as calculated by the Cockcroft-Gault equation.\n* Emergent cardiac surgical patients and patients undergoing orthotopic heart transplant.\n* Any patient who has a history of renal transplant.\n* Patients who have a documented allergy or hypersensitivity to one or more of the amino acids.\n* Patients with cognitive impairment who cannot provide consent.\n* Patients with congenital alteration of amino acid metabolism.\n* Any patient who declines to participate in the study.",{"count":396,"type":21},130,[228],"The goal of this study is to see if an infusion of amino acids given to adult male and female patients during cardiac surgery can help prevent acute kidney injury that commonly occurs when patients undergo cardiac surgery needing cardiopulmonary bypass. The main question the study aims to answer is if a short infusion of amino acids given to study participants during their scheduled heart surgery can decrease rates of acute kidney injury - which will be measured by biological markers of kidney injury in the urine.\n\nThe study will be conducted in 2 phases. Participants in the first phase will receive the current standard of anesthetic care for patients having heart surgery and markers of acute kidney injury will be measured before and after their surgery. Participants in the second group will receive the anesthetic standard of care plus a short infusion of amino acids during their surgery. They will also have markers of kidney injury measured before and after their surgery. This study is based on prior studies that showed amino acid infusions are protective against kidney injury; however, these past studies did not look at markers of kidney injury in the urine.",[400,401],"Acute Kidney Injury","Cardiac Surgery","2026-05-12",{"date":92,"type":32},{"date":405,"type":21},"2026-10-01",{"date":407,"type":21},"2027-11-01",{"name":38,"class":39},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":426,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":217},"100473662","diabetes-clinical-decision-support-100473662","NCT05447806","Diabetes Clinical Decision Support","Glucose Management Clinical Decision Support to Improve Outcomes in Academic and Community Hospitals","Inclusion Criteria:\n\n* Hospitalized adult (\\>18 years) patients at Penn State Health, Hershey Medical Center, St. Joseph's Hospital, Hampden Medical Center, Holy Spirit Medical Center, and Lancaster Medical Center\n* Ambulatory adult (\\>18 years) patients at Penn State Health, Hershey Medical Center, St. Joseph's Hospital, Hampden Medical Center, Holy Spirit Medical Center, and Lancaster Medical Center\n* Trigger of an alert or a disease management message\n\nExclusion Criteria:\n\n* Children (\\\u003C18 years)",{"count":417,"type":21},15732,[24],"The purpose of this study is to determine the impact of an electronic medical record clinical decision support tool on rates of dysglycemia in the hospital, and its clinical and economical outcomes. The study also evaluates the perspectives of providers regarding the tool's usefulness on disease management support, knowledge, and practice performance.",[421,422,423,424,425],"Hyperglycemia","Hyperglycemia Stress","Diabetes","PreDiabetes","Hypoglycemia",[427,428,429,430],"Clinical Decision Support","Electronic Medical Records","Health Systems Science","Hospital Management",{"date":432,"type":32},"2026-05-14",{"date":434,"type":32},"2022-07-15",{"date":436,"type":21},"2026-10-16",{"name":38,"class":39},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":455,"locationsCount":128},"100537884","comparative-effectiveness-of-two-different-approaches-to-radiofrequency-ablation-of-lumbar-medial-branch-nerves-100537884","NCT06283628","Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves","LMB-RFA","Inclusion Criteria:\n\n1. Bilateral equally intense axial low back pain\n2. Pain duration of ≥ 6 months\n3. Three-day average NRS scores of ≥ 3\u002F10\n4. Age greater than 18 years\n5. Failure of conservative treatment, including nonsteroidal anti-inflammatory medications and physical therapy\n6. Positive response to a series of two bilateral diagnostic lumbar medial branch nerve blocks (≥ 80% pain relief). This is the current standard of care.\n\nExclusion Criteria:\n\n1. Radicular pain below the knee\n2. Systemic infection or localized infection at the anticipated introducer entry site\n3. Pregnancy\n4. Allergy to Lidocaine\n5. Bleeding dyscrasias\n6. Patients unable to give informed consent\n7. History of lumbar spine surgery at the affected levels\n8. History of previous bilateral lumbar RFA of medial branches within the past six months.\n9. Significant comorbid somatization or widespread pain with central sensitization\n10. Secondary gain identified due to ongoing legal proceedings or worker's compensation\n11. Cognitive impairment\n12. Any pre-existing condition at the discretion of the provider that may confound interpretation of results -",{"count":7,"type":21},[24],"The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.",[449],"Lumbar Spondylosis","2026-05-07",{"date":402,"type":32},{"date":453,"type":21},"2026-05",{"date":175,"type":21},{"name":38,"class":39},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":128},"100594248","phase-1-cbgcbd-oil-for-chemotherapy-induced-peripheral-neuropathy-100594248","NCT07016971","CBG\u002FCBD Oil for Chemotherapy-Induced Peripheral Neuropathy","A Pilot Study to Evaluate the Feasibility, Safety, and Efficacy of Cannabigerol\u002FCannabidiol Oil for Chemotherapy-Induced Peripheral Neuropathy","Inclusion Criteria:\n\n* Adults aged 21 years or older.\n* Patients with grade 1 or greater CIPN symptoms, such as neuropathic pain, paresthesia, or muscle weakness, persisting for more than 2 weeks as defined by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 5.\n* Patients who have completed platinum-based chemotherapy for colorectal carcinoma, biliary tract carcinoma, pancreatic carcinoma, esophageal carcinoma, gastric carcinoma, or small intestinal carcinoma within the past 2 years.\n* Patients currently taking any treatment for CIPN must discontinue such treatments at least 2 weeks prior to enrollment.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (A pregnancy teste will be performed during screening (up to 28 days before treatment and repeated within 7 days prior to study drug initiation to confirm baseline status and minimize risk of unrecognized pregnancy).\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy. Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* Patients from Penn State Health.\n\nExclusion Criteria:\n\n* Patients under the age of 21 years.\n* Patients with a history of preexisting neuropathy prior to chemotherapy.\n* Pregnant and nursing women.\n* Patients with hypertension that, in the investigator's judgement, is uncontrolled despite the use of anti-hypertensives, or with hypotension (systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure \\\u003C60 mmHg).\n* History of or active arterial thromboembolic event (e.g. stroke, myocardial infarction).\n* Patients who have used an investigational drug within 30 days prior to the screening visit or are currently participating in another interventional investigational study.\n* Patients who have liver function tests AST\u002FALT \\> 3 times above the upper limits of normal (ULN) in the past year.\n* Patients who have suicidal ideation or uncontrolled depression within the past year.\n* Patients with known sensitivity to any components of CBG\u002FCBD hemp extract.\n* Patients with known sensitivity to coconut oil.\n* Patients currently receiving active systemic anti-cancer therapies, including but not limited to chemotherapy, immunotherapy, targeted therapy (e.g., tyrosine kinase inhibitors, anti-HER2 therapy), or any other ongoing systemic treatment intended to control or reduce tumor burden.\n* Current use of moderate or strong inhibitors or inducers of CYP3A4 or CYP2C19.\n* Current use of sensitive CYP2C19 substrates with narrow therapeutic indices (e.g., diazepam, clobazam), unless the subject's primary physician agrees to adjust the dose and provide close therapeutic monitoring.\n* Current use of valproate or other medications known to significantly increase the risk of liver enzyme elevations when co-administered with cannabidiol.\n* Current use of medications that are primarily metabolized by CYP1A2 (e.g., theophylline) or CYP2B6 (e.g., bupropion, efavirenz) that cannot be safely monitored or dose-adjusted per the discretion of the study investigator. Occasional or dietary caffeine intake is permitted.\n* Current use of medications that are substrates of UGT1A9 (e.g., diflunisal, propofol, fenofibrate), UGT2B7 (e.g., gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8, or CYP2C9 (e.g., phenytoin) that cannot be safely monitored or dose-adjusted per the discretion of the study investigator.\n* Current use of other known hepatotoxic drugs unless the potential risk has been evaluated and deemed acceptable by the study investigator.",{"count":96,"type":21},[51],"The goal of this clinical trial is to learn if a commercially available cannabigerol (CBG)\u002Fcannabidiol (CBD) oil is safe, feasible to use, and can help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in adults who have completed platinum-based chemotherapy for gastrointestinal cancers. The main questions it aims to answer are:\n\nIs CBG\u002FCBD oil safe and well-tolerated over a 12-week treatment period?\n\nCan participants with CIPN use CBG\u002FCBD oil consistently as part of their care?\n\nDoes CBG\u002FCBD oil help reduce pain, numbness, or other symptoms of CIPN?\n\nParticipants will:\n\nTake CBG\u002FCBD oil under the tongue (sublingually) twice daily for 12 weeks\n\nComplete regular symptom assessments and functional tests during study visits\n\nProvide blood samples for cannabinoid and metabolite level testing",[467],"Chemotherapy-Induced Peripheral Neuropathy","2026-05-06",{"date":470,"type":32},"2026-05-11",{"date":472,"type":32},"2026-04-03",{"date":474,"type":21},"2029-07-03",{"name":38,"class":39},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":486,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":128},"100565680","ssvc-ci-during-cabg-100565680","NCT06645327","SSVC-CI During CABG","Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization","SVC-CI","Inclusion Criteria:\n\n1. Age ≥ 18\n2. Participants with CAD undergoing CABG utilizing cardiopulmonary bypass\n3. Participants who are able to consent for themselves\n4. Primary language is English\n\nExclusion Criteria:\n\n1. Age less than 18 years of age\n2. Participants with CAD undergoing off-pump coronary artery bypass (OP-CAB)\n3. Severe cardiac valvular pathologies or active congestive heart failure\n4. Participants in active arrhythmia such as atrial fibrillation and atrial flutter at the time of data collection.\n5. Participants who are unable to consent for themselves\n6. Primary language is something other than English",{"count":485,"type":21},120,"OBSERVATIONAL","To investigate the superior vena cava collapsibility index (SVC-CI), measured via transesophageal echocardiography (TEE), as a marker of fluid responsiveness. Two groups will be compared in this study. Groups will be identified by obtaining cardiac output (CO) by standard means using the TEE or pulmonary arterial catheter (PAC). Both of these monitors are considered standard for patient's undergoing coronary artery bypass grafting surgery (CABG) and recording initial CO readings. Based on CO, the patient's will be placed in study groups one or two. Participants with normal and mildly reduced left ventricular ejection fraction (LVEF \\>40%) for group one and those with moderately to severely reduced LVEF (\\<40%) in the second group.\n\nFollowing group separation, we will measure the SVC-CI and CO metric in both groups. The intervention will be an operating room table tilt test (head up and then head down) to artificially simulate giving the patient additional fluid. Before and after table tilt, the SVC-CI and CO will be obtained and measured. The SVC-CI is a mathematical equation determined by distance measurements taken via TEE to identify how much the superior vena cava has collapsed following table tilt. Participants will be considered responders if the CO increases by 12% following intervention. Non responders less than 12% change in CO following intervention. Our hypothesis is that the SVC-CI can differentiate responders vs non-responders with regards to fluid responsiveness with adequate sensitivity and specificity in participants with CAD undergoing isolated CABG. The SVC-CI numerical values for the two groups, responders and non-responders, will calculate a threshold of sensitivity and specificity percentages for future patients undergoing CABG.",[489],"Coronary Artery Bypass Grafting Surgery (CABG)","2026-05-01",{"date":450,"type":32},{"date":493,"type":32},"2025-02-24",{"date":495,"type":21},"2029-01",{"name":38,"class":39},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":486,"phases":4,"briefSummary":506,"conditions":507,"keywords":511,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":128},"100494295","pain-and-disability-outcomes-in-post-amputation-patients-100494295","NCT05716321","Pain and Disability Outcomes in Post Amputation Patients","Inclusion Criteria:\n\n1. Ages between 18 and 89 years old, inclusive\n2. Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center\n\nExclusion Criteria:\n\n1. Patients who cannot cooperate or consent\n2. Patients who cannot understand or speak English\n3. Patients with a history of chronic regional pain syndromes\n4. Patients suffering from alcohol and\u002For drug abuse -based on previous Dx listed in the MRN\n5. BMI \\>50","89 Years",{"count":505,"type":21},350,"The objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain after surgical amputation of a limb. The primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on Numerical Rating Scale (NRS) 0 to 10, where 0 is not pain and 10 is the worst pain possible, taken on post-operative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+\u002F- 3 days at each time point).",[508,509,510],"Limb Pain, Phantom","Residual Limbs Pain","Disability Physical",[512],"Amputation",{"date":450,"type":32},{"date":515,"type":32},"2023-04-05",{"date":517,"type":21},"2028-11",{"name":38,"class":39},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":527,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":128},"100462296","impact-of-parental-emotion-regulation-on-the-treatment-of-adhd-100462296","NCT05299814","Impact of Parental Emotion Regulation on the Treatment of ADHD","The Impact of Parental Emotion Regulation Capacity on Behavioral Treatment for Pediatric ADHD","PERS","Inclusion Criteria:\n\n* Parent of a child ages 5-12 with ADHD\n* Parent must report that the child has at least a mild level of symptoms at home of Oppositional Defiant Disorder (ODD) on the Disruptive Behavior Disorder Rating Scale (DBDRS)\n\nExclusion Criteria:\n\n1. Not being the parent of a child ages 5-12 who meets diagnostic criteria for ADHD.\n2. Non English Speaking\n3. the child with ADHD has a diagnosis of intellectual delay or has prominent autistic traits\n4. Another child in the same family participating in this study already\n5. Parent does not have a smartphone or tablet device to complete EMA ratings or does not reside with child for the majority of the time.","5 Years","12 Years",{"count":530,"type":21},65,[24],"Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions.\n\nH1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.\n\nH2: Increased parental emotional reactivity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.",[534],"ADHD",[536],"oppositional behaviors, conduct problems",{"date":450,"type":32},{"date":539,"type":32},"2017-04-13",{"date":541,"type":21},"2026-10-31",{"name":38,"class":39},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":550,"minAge":551,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":128},"100562248","phase-1-safety-and-efficacy-of-agn-inm176-in-prostate-patients-with-rising-psa-100562248","NCT06600698","Safety and Efficacy of AGN-INM176 in Prostate Patients With Rising PSA","Evaluate Safety and Efficacy of Daily Oral Angelica Gigas Nakai (AGN)-INM176 in Prostate Patients With Rising Plasma PSA (Phase I\u002FII Trial)","Inclusion Criteria:\n\nPhase I Inclusion Criteria\n\n* Willingness and ability to give informed consent.\n* Agree to comply with all study procedures and attend all study visits.\n* Male aged \\>=40 years.\n* History of prostate cancer diagnosis: Subjects with treated prostate cancer are eligible. Prior prostate cancer treatments must be clearly defined. Acceptable treatment modalities include surgery, radiation therapy, and previous use of antiandrogen therapy. Subjects with localized prostate cancer in low-risk group who were not on treatment or declined any treatment are eligible. Subjects with localized prostate cancer in the favorable intermediate-risk group who declined any treatment are eligible. Subjects with localized prostate cancer in the high-risk or unfavorable intermediate-risk group who have declined definitive therapy, including surgery, radiation therapy, or androgen deprivation therapy (ADT), are eligible.\n* Subjects must not be undergoing concurrent radiation therapy or androgen deprivation therapy (ADT) at the time of enrollment.\n* ECOG performance status 0-2.\n* Subjects must have normal liver and kidney function at baseline: Total bilirubin within normal institutional limits. AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X upper limit of normal (ULN). Creatinine \\\u003C 1.5 ULN or creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m2. Adequate bone marrow function: Hgb ≥ 9.0 g\u002FdL, Platelets ≥ 100 x 109\u002FL, absolute neutrophil count of ≥ 1.0 x 109\u002FL).International Normalized Ratio (INR), Prothrombin Time (PT), and Partial Thromboplastin Time (PTT)within normal institutional limits.\n* Subjects and their partners must agree to use two medically accepted methods of contraception and must agree to continue use these methods during the trial and for at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception.\n* Subjects taking strong inhibitors or inducers of CYP3A4 or CYP2C19 must be evaluated for potential drug interactions with the study drug. Essential medications, such as statins, that cannot be discontinued may be allowed at the investigator's discretion.\n* Subjects currently taking herbal supplements containing AGN extract, such as Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, must discontinue these or any other supplements containing these products at least 4 weeks prior to starting study drug.\n\nPhase II Inclusion Criteria\n\n* Willingness and ability to give informed consent.\n* Agree to comply with all study procedures and attend all study visits.\n* Male aged \\>=40 years.\n* Histologically confirmed adenocarcinoma of prostate (neuroendocrine or small cell prostate cancer excluded).\n* Any T stage, N0-1, M0, any Gleason grade.\n* Subjects must meet one of the following: Post-radical prostatectomy (RP) and\u002For post-radiation therapy (RT), including those with local recurrence declining further treatment. Localized prostate cancer who declined any treatment after physician discussion. Non-castrate status required: eligible subjects must have a serum total testosterone \\>50 ng\u002FdL measured within 6 months prior to enrollment and must not have received systemic ADT (LHRH agonist\u002Fantagonist) within the prior 6 months. Subjects with bilateral orchiectomy are ineligible.\n* No distant metastases disease confirmed by imaging (CT or MRI and bone scan or prostate-specific PET scan such as PSMA PET scan or Axumin PET scan) within 5 years prior to enrollment.\n* Blood PSA level rising over 2 consecutive tests within the past 6 months, at least one week apart, with values ≥ 0.1 ng\u002FmL.\n* Not currently receiving concurrent androgen deprivation therapy (ADT). For subjects with a prior history of ADT, screening testosterone levels must be obtained and must be within a non-castrate range (\\>50 ng\u002FdL) to be eligible for Phase II. Subjects without a history of ADT are not required to undergo testosterone screening.\n* ECOG performance status 0-2.\n* Subjects must have normal liver, kidney, and bone marrow function at baseline: Total bilirubin within institutional limits. AST(SGOT)\u002FALT(SGPT) \\\u003C 2.5 X upper limit of normal (ULN). Creatinine \\\u003C 1.5 ULN or creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m2. Adequate bone marrow function: Hgb ≥ 9.0 g\u002FdL, Platelets ≥ 100 x 109\u002FL, absolute neutrophil count ≥ 1.0 x 109\u002FL.\n* No evidence of any active secondary malignancy requiring ongoing treatment.\n* Subjects must agree to use two medically accepted method of contraception and must agree to continue use this method while on the trial and through at least one week after the last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) withdrawal, spermicides only, or lactational amenorrhea are not acceptable methods of contraception.\n* Subjects taking strong inhibitors or inducers of CYP3A4 or CYP2C19 will be evaluated for potential drug interactions with the study drug. Essential medications, such as statins, that cannot be discontinued may be allowed at the investigator's discretion.\n* Subjects currently taking herbal supplements containing AGN extract, including Cogni.Q, Decursinol-50, Ache Action, Fast-Acting Joint Formula, must discontinue these or any other supplements containing these products at least 4 weeks prior to starting study drug.\n* Prior Phase I subjects: must have completed ≥90 days washout from the last investigational product dose and meet all of the following: No treatment-related Grade 3 or higher adverse events occurred during Phase I, Any treatment-related adverse events have resolved to Grade 1 or less prior to Phase II enrollment, hepatic and renal function tests within protocol-defined limits, and investigator confirmation of clinical stability.\n\nPhase I and II Exclusion Criteria:\n\n* Subjects with distant metastatic cancer. Node-positive prostate cancer patients are allowed after completion of treatment.\n* Subjects who are receiving systemic treatments such as chemotherapy, androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens, or immunotherapy (checkpoint inhibitor) or investigational agents.\n* Participants will be excluded if they have any uncontrolled intercurrent illness at the discretion of the treating investigator. This may include, but is not limited to, the following conditions: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus (DM) with an HbA1C \\>9, uncontrolled asthma, or significant psychiatric illness that would limit compliance with study requirements.\n* History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, or any other cardiac-related problem that would be considered a contraindication for participation in the opinion of the treating physician.\n* Any active secondary malignancy requiring treatment.\n* Chronic kidney disease with calculated GFR \\\u003C30 mL\u002Fmin\u002F1.73 m(2) using Cockcroft-Gault formula, or measured GFR \\\u003C30 mL\u002Fmin\u002F1.73 m(2) using a 24-hour urine collection. The hospital's lab measured GFR can be used if a 24-hour collection is not possible.\n* Subjects who are taking Warfarin\u002Fcoumadin.","MALE","40 Years",{"count":553,"type":21},45,[51,52],"This Phase I\u002FII open-label trial aims to evaluate the safety and efficacy of the herbal supplement INM176 in patients with a history of prostate cancer or low-risk disease under active surveillance. The study will determine the recommended Phase II dose (RP2D) and assess the efficacy of INM176 in stabilizing or decreasing plasma PSA levels in post-radical prostatectomy (RP) and post-radiation therapy (RT) patients with rising PSA levels.",[557],"Prostate Cancer",[559,560,232,561,562,563],"Angelica gigas Nakai","INM 176","Decursin","decursinol","prostate specific antigen (PSA)","2026-04-20",{"date":566,"type":32},"2026-04-23",{"date":568,"type":32},"2025-05-07",{"date":570,"type":21},"2028-05-01",{"name":38,"class":39},{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":184,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":581,"briefSummary":582,"conditions":583,"keywords":586,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":128},"100634466","impact-of-loss-aversion-messaging-and-anticipated-regret-for-inaction-on-exercise-adherence-in-older-adults-100634466","NCT07540052","Impact of Loss Aversion Messaging and Anticipated Regret for Inaction on Exercise Adherence in Older Adults","Testing the Impact of Loss Aversion Messaging and Anticipated Regret for Inaction on Exercise Adherence in Older Adults: A Randomized Pilot Trial","Inclusion Criteria:\n\n* Completed 12 months of FAST intervention\n\nExclusion Criteria:\n\n* No planned surgeries within the upcoming 4 months",{"count":580,"type":21},148,[24],"The goal of this clinical trial is to learn if messages focused on not losing the functional benefits of exercise can help older adults with walking difficulty continue to exercise regularly. The main questions it aims to answer are:\n\nDo these messages make people more likely to anticipate regretting it if they do not exercise? Does more anticipated regret make it more likely they will exercise more regularly?\n\nResearchers will compare two versions of messages to see if the content of these one of these message types is more effective than the other.\n\nParticipants will complete a daily 5-minute at home exercise program for 4 months and complete regular online surveys to track their progress and report their feelings regarding regret.",[584,585],"Mobility Disability","Walking Difficulty",[587,588,589,590,591,592],"exercise adherence","older adults","mobility disability","walking difficulty","pilot study","randomized controlled trial","2026-04-16",{"date":564,"type":32},{"date":596,"type":21},"2026-06",{"date":598,"type":21},"2027-07",{"name":38,"class":39},""]