[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Florida\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":661},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,202,0,25,[9,63,85,108,136,164,190,214,243,270,298,319,339,359,384,409,434,454,490,518,539,569,596,613,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100053405","phase-1-atezolizumab-plus-tivozanib-in-immunologically-cold-tumor-types-100053405",false,"NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","ALL","18 Years","99 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[28,29,30,31,32,33,34,35,36],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[38,39,40,41,42,43,44,45,46,47,48,49],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor","RECRUITING","2026-07-10",{"date":53,"type":54},"2026-07-13","ACTUAL",{"date":56,"type":54},"2021-12-07",{"date":58,"type":21},"2027-06",{"name":60,"class":61},"University of Florida","OTHER",1,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":62},"100053546","the-effect-of-the-reflux-band-upper-esophageal-sphincter-ues-assist-device-on-reflux-for-lung-transplant-recipients-100053546","NCT03886961","The Effect of the Reflux Band™ Upper Esophageal Sphincter (UES) Assist Device on Reflux for Lung Transplant Recipients","Reflux Band","Inclusion Criteria:\n\n* Clinically stable lung transplant patients(single lung, double lung, or re-transplant) as defined by stable FEV1 over the prior two visits\n* 13 Abnormal pH impedence or esophagram or documented gastric reflux at pre-transplant evaluation\n* Patient must be willing and able to provide informed consent\n* Understands the clinical study requirements and is able to comply with follow-up schedule\n\nExclusion Criteria:\n\n* Currently being treated with another investigational medical device and\u002For drug\n* Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP)\n* Previous head or neck surgery \u002F radiation\n* Carotid artery disease, thyroid disease, or history of cerebral vascular disease\n* Nasopharyngeal cancer\n* Suspected esophageal cancer","80 Years",{"count":72,"type":21},20,[74],"NA","A prospective, open label, study designed to assess the affect of the Reflux Band® UES Assist Device (Reflux Band) on reflux in patients that have undergone lung transplantation.",[77,78],"Lung Transplant","GERD",{"date":53,"type":54},{"date":81,"type":54},"2019-05-17",{"date":83,"type":21},"2027-12-20",{"name":60,"class":61},{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":62},"100054048","phase-1-novel-rna-lipid-particle-rna-lp-vaccine-for-anti-pd-1-antibody-therapy-sensitization-100054048","NCT05264974","Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* ECOG performance ≤ 2\n* Lab values within the specified ranges:\n\n  * Hemoglobin ≥ 8G\u002FDL\n  * Platelets ≥ 100 thou\u002Fcumm\n  * Absolute Neutrophil Count (ANC) ≥ 1000 thou\u002Fcumm\n  * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN\n  * Creatinine clearance (CrCl) ≥ 15 ml\u002Fmin (based on modified Cockcroft and Gault formula)\n* Must have measurable disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles\n* Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included)\n* Written informed consent obtained from the subject.\n* Participants of childbearing potential must have a negative serum pregnancy test at screening\n* Participants of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least four months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, participants of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for four months following the last dose of study treatment and must agree to not donate sperm during the study treatment period or for four months following the last dose of study treatment.\n\nAdditional eligibility criteria for subjects with melanoma:\n\n* Patients with stage II, stage III, or resected stage IV melanoma who received anti-PD-1-based therapy in the adjuvant or neoadjuvant setting (either monotherapy or combination therapy) and experienced progressive disease (PD) per RECIST 1.1 during treatment or within 6 months of completing the planned course of therapy. This includes patients who:\n\n  * Were planned to receive approximately 1 year of anti-PD-1-based therapy in the adjuvant setting but discontinued early due to toxicity and relapsed within 6 months of discontinuation;\n  * Received neoadjuvant anti-PD-1-based therapy (with or without subsequent surgery), including patients planned to complete approximately 1 year of total perioperative anti-PD-1-based therapy (neoadjuvant ± adjuvant), and experienced PD during therapy or within 6 months of completion or discontinuation;\n  * Received short-course neoadjuvant anti-PD-1-based therapy (including combination regimens), underwent surgery, were subsequently managed with surveillance (including those achieving pathologic complete response), and experienced relapse within 6 months of completion of neoadjuvant therapy.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who experienced PD per treating physician while receiving anti-PD-1-based therapy (either monotherapy or combination therapy) in any line of treatment.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who:\n\n  * Completed a planned course of anti-PD-1-based therapy (monotherapy or combination), including planned treatment durations of approximately 1 year or 2 years, and experienced PD within 6 months of completion; or\n  * Were planned to receive anti-PD-1-based therapy (for either 1 year or 2 years) but discontinued early due to toxicity and experienced PD within 6 months of discontinuation.\n* Both cutaneous and non-cutaneous melanoma subtypes (including uveal, mucosal, and acral lentiginous) are eligible.\n* Patients must:\n\n  * Have no contraindication to continued immune checkpoint therapy;\n  * Not have rapidly progressive disease requiring urgent alternative therapy; and\n  * Have no other viable approved salvage treatment options available, or decline currently approved salvage therapies.\n\nAdditional eligibility criteria for subjects with soft tissue sarcoma:\n\n* Evidence of spindle cell, pleomorphic, round cell, or epithelioid morphology on pathology suggestive of sarcoma as determined by a sarcoma pathologist\n* Evidence of progression or resistance to therapy as defined by the treating physician.\n* Must have measurable disease per RECIST 1.1\n* Original tumor site from soft tissue location i.e. lipomatous tissue, musculature, skin\n* Evidence of unresectable stage II disease; stage III or stage IV disease\n* Subjects with prior exposure to an immune checkpoint inhibitor (ICI) are eligible for enrollment; however, prior ICI therapy is not required unless receipt of an ICI constitutes part of the FDA-approved standard of care for their disease.\n\nExclusion Criteria:\n\n* Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed\n* Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy\n* Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.\n* If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.\n* Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study\n* Patients must not have required systemic corticosteroids (anything greater than 10mg of prednisone of equivalent, daily) or other immunosuppressive medications within 14 days of the start of trial treatment.\n* Subjects with known active infection or immunosuppressive disease within seven days prior to tissue collection for vaccine creation or within seven days prior to vaccine administration (subjects on prophylactic agents are acceptable)\n* Subjects with any known life-threatening illness, medical condition, or organ system dysfunction (aside from their cancer), which in the investigator's opinion, could compromise subject safety\n* Subjects with known active hepatitis B virus or untreated hepatitis C virus, and, patients with previous history of hepatitis C who completed treatment for HCV are not excluded as long as they have no detectable viral load.\n* Subjects with known human immunodeficiency virus with CD4+T cells ≤ 350 cells\u002Ful, a positive viral load as determined by institutional standard testing, or a known history of AIDS defining opportunistic infection within the last 12 months per subject medical records.\n* Known clinically relevant active autoimmune disease that would pose significant risk to the patient's life should a flare ensue. Patients with chronic autoimmune rheumatologic endocrine, or psoriatic skin diseases may still be eligible pending they are not receiving systemic immunosuppression at the time of treatment as previously described and that patients are aware of the increased risk of flare provocation with treatment.\n* Symptomatic congestive heart failure (NYHA Class 3 or 4)\n* Subjects with unstable angina pectoris\n* Known unstable cardiac arrythmias, abnormalities or transmural myocardial infarction within the last 6 months of treatment\n* Subjects who are post-splenectomy, otherwise asplenic, or have moderate to severe splenomegaly (defined as a spleen larger than 13 cm in cranial-caudal height or longest diameter)\n* Personal history of anaphylactic reaction to previous vaccination\n* Known hypersensitivity to the active substance or to any of the excipients\n* Participants of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 months after the last dose of study treatment\n* Participants who are confirmed to be pregnant or breastfeeding\n* Known history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with sarcoma originating from bone or cartilage\n* Sarcomatous malignancies lacking metastatic potential i.e. well-differentiated liposarcoma, dermatofibrosarcoma protuberans, desmoid fibromatosis, etc.",{"count":92,"type":21},18,[24],"The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.",[96,34],"Melanoma",[98,99,100,101,45],"melanoma","immunotherapy","vaccines","RNA-NP",{"date":53,"type":54},{"date":104,"type":54},"2026-03-17",{"date":106,"type":21},"2026-12",{"name":60,"class":61},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":135,"locationsCount":62},"100600317","respark---brain-q-for-chronic-stroke-100600317","NCT07095920","RESPARK - Brain Q for Chronic Stroke","Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke","Inclusion Criteria:\n\n1. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.\n2. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.\n3. Age 18 to 80 years of age (inclusive).\n4. Stroke due to ischemia or to intracerebral hemorrhage.\n5. \\>6 months to 5 years from stroke onset.\n6. Box \\& Block Test score with affected arm is ≥1 block in 60 seconds.\n7. Able to sit with the investigational system for 40 consecutive minutes.\n8. Can follow a 3-step command, such as \"take the paper, fold it in half, and return it to me\", or a non-verbal equivalent.\n9. Willingness to participate in physical exercises during study intervention sessions.\n10. Availability of a relative or other caregiver that is able to participate in training and assist during treatment sessions at Brooks and home during the study duration.\n11. If female, not pregnant or breastfeeding or planning pregnancy during the study period.\n12. The subject is able to provide Informed consent.\n\nExclusion Criteria:\n\n1. Severe neglect impairment interfering with assessments or treatments.\n2. Severe depression, defined as Geriatric Depression Scale (GDS) Score \\>10\u002F15\n3. Presence of implanted or retained MR-incompatible devices or materials, or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).\n4. Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years\n5. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit\n6. Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis\n7. Pre-existing neurological condition (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and\u002For confound neurological or functional evaluation.\n8. Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and\u002For confound neurological or functional evaluation.\n9. Unstable serious illness\u002Fcondition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.\n10. Alcohol abuse and\u002For illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.\n11. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.\n12. Active participation in an upper extremity rehabilitation program provided by a licensed provider within 4 weeks from the screening visit and until the primary endpoint visit.\n13. Employee of the Sponsor.\n14. Prisoner.",{"count":7,"type":21},[74],"This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. This trial is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the rehabilitation of people with chronic stroke.",[119,120,121],"Stroke","Chronic Stroke Patients","Cerebrovascular Accident (CVA)",[123,124,125,126,127,128],"BrainQ","Electromagnetic Stimulation","upper extremity","rehabilitation","exercise","mobility","2026-07-01",{"date":131,"type":54},"2026-07-02",{"date":133,"type":54},"2025-08-27",{"date":106,"type":21},{"name":60,"class":61},{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":4},"100567638","using-ecological-momentary-data-to-inform-a-web-intervention-for-romantic-partners-concerned-about-their-loved-ones-drinking-100567638","NCT06670794","Using Ecological Momentary Data to Inform a Web Intervention for Romantic Partners Concerned About Their Loved Ones' Drinking","CP Inclusion Criteria:\n\n* be at least 18 years old\n* be in a romantic relationship with their partner\n* be living with their partner,\n* have a computer, tablet, or mobile phone with Internet access\n* have no plans to separate from their partner in the next 60 days\n* indicate no concerns they would be physically hurt by their partner on the Intimate Partner Screen\n\nCP Exclusion Criteria:\n\n* drinking scores at or above the threshold for DP participation\n\nDP Inclusion Criteria:\n\n* be at least 18 years old\n* misuses alcohol as defined by their scores (4+ for women\u002Fnon-gender confirming, 5+ for men) on the consumption portion of the Alcohol Use Disorder Identification Test (AUDIT-C) (Dawson et al., 2005)\n* has a computer, tablet, or mobile phone with Internet access\n* indicates no concerns they would be physically hurt by their partner\n\nDP Exclusion Criteria:\n\n* current alcohol treatment\n* currently concerned about their partner's drinking",true,{"count":144,"type":21},160,[74],"Aim 1. Couples (N=50 dyads) with a Concerned Partner (CP) and a Drinking Partner (DP) will independently complete baseline and follow-up surveys and a 21-day EMA with three daily reports on their communication and DP's drinking. Aim 2. Iteratively develop a four-session web based intervention and evaluate the WBI's feasibility and acceptability with 15 CPs. Aim 3. Perform a pilot randomized controlled trial (RCT) comparing WBI to psychoeducation control in 110 couples.",[148,149],"Experimental","Control Condition",[151,152,153,154,155,156],"alcohol","alcohol use disorder","community reinforcement and family training","concerned partners","concerned significant others","communication","NOT_YET_RECRUITING",{"date":131,"type":54},{"date":160,"type":21},"2026-09-29",{"date":162,"type":21},"2027-02-28",{"name":60,"class":61},{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":142,"sex":171,"minAge":172,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":62},"100557461","adding-polyphenol-rich-pulses-to-daily-diet-improves-skin-health-by-reshaping-the-skin-microbiome-100557461","NCT06538415","Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome","To Determine Whether Adding Polyphenol-rich Pulses to Daily Diet Improves Skin Health by Reshaping the Skin Microbiome and Lipids, and Reducing Oxidative Stress and Inflammation in Women","Inclusion Criteria:\n\n* BMI (18.5-29.9)\n* Body weight ≥110 pounds\n* Fitzpatrick skin type 1,2 and 3.\n\nExclusion Criteria:\n\n* pregnancy\n* breast-feeding\n* impaired fasting glucose\n* frequent alcohol use\n* history of skin cancer\n* sunbathing and the use of tanning bed, intake of vitamin\u002Fmineral supplements\n* habitual high intake of fruits (≥ 2 cups daily)\n* intake of medication that might influence the outcome of the study","FEMALE","45 Years","65 Years",{"count":175,"type":21},50,[74],"Skin health is influenced by the microbiome, lipids, oxidative stress, inflammation, and UV exposure. A 12-week trial with 48 women aged 45-65 will test if polyphenol-rich pulses improve skin health by affecting these factors. Using a white rice control diet, the study will measure skin parameters and analyze correlations with changes in lipids and microbiome, potentially proving the benefits of pulses.",[179],"Healthy",[181,182,183],"Pulse","Women","Skin health",{"date":131,"type":54},{"date":186,"type":54},"2026-05-12",{"date":188,"type":21},"2026-12-31",{"name":60,"class":61},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":62},"100610576","respiratory-muscle-strength-training-to-prevent-respiratory-muscle-weakness-in-adults-newly-diagnosed-with-breast-cancer-100610576","NCT07229378","Respiratory Muscle Strength Training to Prevent Respiratory Muscle Weakness in Adults Newly Diagnosed With Breast Cancer","Respiratory Muscle Strength Training to Prevent Dyspnea in the Newly Diagnosed Breast Cancer Patient Prior to Surgery\"","Inclusion Criteria:\n\n* Community-dwelling adults (\\>18 years)\n* Recently diagnosed with breast cancer\n* Scheduled for breast cancer surgery\n* English speaking, and can follow the protocol\n\nExclusion Criteria:\n\n* Individuals who have already completed respiratory muscle strength training exercises\n* Pregnancy,\n* Recent pneumothorax\n* Ruptured eardrum\n* Uncontrolled hypertension, or uncontrolled reflux.\n* Individuals who cannot complete at least ten exercise sessions","100 Years",{"count":199,"type":21},40,[74],"The goal of this clinical trial is to learn if respiratory muscle strength training can prevent respiratory muscle weakness in adults who are newly diagnosed with breast cancer and are planning to have surgery. The main question it aims to answer is:\n\n* Does respiratory muscle strength training in adults preparing for breast cancer surgery reduce the weakness that often occurs with surgery.\n\nResearchers will compare Guided Imagery exercises to respiratory muscle strength training to see which is more helpful.\n\nParticipants will:\n\n* Carry out respiratory muscle strength training or Guided Imagery exercises for at least 2 weeks at home.\n* Meet with the researcher at home to complete breathing measurements before starting the exercises, after completing the exercises, and again after surgery.\n* Keep a diary of the exercises that have been completed.",[30],[204,30,205,206],"Respiratory muscle weakness","Breast Cancer Surgery","Respiratory strength training","2026-06-30",{"date":129,"type":54},{"date":210,"type":21},"2026-08",{"date":212,"type":21},"2027-12",{"name":60,"class":61},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":16,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":231,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":62},"100588843","phase-1-il-8-receptor-modified-cd70-car-t-cell-therapy-in-cd70-newly-diagnosed-and-recurrent-pediatric-high-grade-glioma-phgg-and-newly-diagnosed-diffuse-intrinsic-pontine-glioma-nddipg-100588843","NCT06946680","IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)","Peds IMPACT: Phase I Study -To Assess Safety and Feasibility of IL-8 Receptor Modified Patient-derived Activated CD70 CAR T Cell Therapy in Newly Diagnosed and Recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)","Peds IMPACT","Inclusion Criteria:\n\nAt enrollment:\n\n* Patients with a histologically confirmed diagnosis of:\n\n  * Newly diagnosed high-grade glioma (WHO Grade III or IV)\n  * Newly diagnosed DIPG (after first 2 HGG patients are treated)\n  * Recurrent or progressive high-grade glioma\n* Age 4-18 years old for ndHGG. Age 4-30 for rHGG. Age 4-30 for nd DIPG.\n* Patients with M+ disease without gliomatosis cerebri (see definition under exclusion criteria) ARE eligible.\n* Patients with primary spinal cord tumors ARE eligible.\n* CD70 positive (≥5%, 1+) The tumors from the surgical resection by immunohistochemistry will be confirmed by validated assay performed at UF Health Pathology, CLIA certified Lab.\n* CD70 tumor expression performed on paraffin-embedded tumor specimens will be evaluated. Tumor expression will be scored on a scale of 0 to 3 staining intensity:\n\n  0 = Negative\n  1. = Low level\n  2. = Moderate level\n  3. = High level The criteria for inclusion will be at least 5% of the cells scoring 1+ staining intensity (\\> 5%, 1+).\n* Karnofsky Performance Status (KPS, for patients \\>16yo) or Lansky Performance Score (LPS, for patients ≤16yo) of \\> 60% (Appendix C)\n* Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score provided the neurological deficit is stable.\n\nOrgan Function:\n\n* CBC with differential with adequate bone marrow function as defined below:\n* Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3.\n* Platelet count ≥ 75,000 cells\u002Fmm3. (Unsupported, no transfusion within 4 days.)\n* Hemoglobin ≥ 8 g\u002Fdl. (May receive transfusions)\n* Adequate renal function as defined below:\n* Serum creatinine \\\u003C 1.5 x institutional upper limit of normal for age and gender. Patients who do not meet the criteria but have a 24-hour Creatinine Clearance or GFR (radioisotope or iothalamate) ≥ 70 mL\u002Fmin\u002F1.73 m2 are eligible.\n* Adequate hepatic function as defined below:\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) for age\n* ALT ≤ 3 times institutional upper limits of normal for age\n* AST ≤ 3 times institutional upper limits of normal for age\n* Patients with neurological deficits should have deficits that are stable for a minimum of 7 days prior to enrollment.\n* Signed parental permission and, as appropriate, assent from pediatric patients age ≥14. If the patient's mental status precludes their informed consent, the legally authorized representative may give informed consent. Consent or permission\u002Fassent will be obtained at screening (before PBMC collection) and before treatment with CAR T-cells.\n* For females with childbearing potential, a negative serum pregnancy test at enrollment.\n* Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of the study drug.\n* Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of the study drug.\n* Prior Therapy for recurrent Cohort only:\n* Patients with recurrent or progressive disease must have received prior radiotherapy +\u002F- chemotherapy.\n* Patients must have recovered from the acute treatment related toxicities (≤ Grade 1) prior to enrollment.\n* Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment. Patients must have received their last dose of non-myelosuppressive chemotherapy at least 7 days prior to enrollment.\n* Patients must have received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment. Monoclonal antibody treatment and agents with known prolonged half-lives: Patient must have received their last dose of the agent ≥ 28 days prior to study enrollment.\n* Patients with recurrent or progressive HGG must have had their last fraction of:\n* Craniospinal irradiation, whole brain radiation, total body irradiation or radiation to spine ≥ 6 weeks (42 days) prior to enrollment.\n* Focal irradiation ≥ 14 days prior to enrollment.\n* ≥ 12 weeks (84 days) since autologous stem cell transplant prior to enrollment.\n* \\> 42 days since completion of any other type of adoptive cellular therapy prior to enrollment\n\nPrior to lymphodepletion and therapy:\n\n* Appropriate bridging therapy (radiation\u002Fre-irradiation and\u002For salvage chemotherapy, dependent on cohort) was initiated within 7 weeks of surgery RT or other protocol directed anti-cancer therapy is without significant toxicity that persisted over 4 weeks.\n* Early postoperative progression: Patients who progress during radiation treatment that are clinically stable and meet eligibility criteria prior to the start of lymphodepletion may continue on study. If these criteria are not met, these patients will be withdrawn from the study.\n* Neurologic Status\n* In patients with neurological deficits, deficits should be stable for a minimum of 7 days prior to the start of treatment. A baseline detailed neurological exam should clearly document the neurological status of the patient prior to the start of treatment.\n* In patients with seizure disorders, seizures must be well controlled prior to the start of treatment.\n* Performance Status Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) (Appendix C) assessed within one week prior to the start of treatment must be ≥ 60%.\n* Organ Function Patients must have adequate organ and bone marrow function as defined in Section 3.1.\n* Pregnancy Testing Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Corticosteroids: A maximum dose of 0.75 mg\u002Fkg\u002Fday with maximum of 4mg\u002Fday.\n* No active infection: No fever exceeding 38.5 °C and no acute antibiotics, antiviral, or antifungal PO or IV therapy.\n\nExclusion Criteria:\n\n* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease-free for ≥ 3 years. (In situ cancer is permissible)\n* Spinal metastasis or gliomatosis cerebri. Gliomatosis cerebri - clear tumor involvement of multiple areas (\\>3 lobes), OR presence of clinical and\u002For radiographic evidence of impending herniation or spinal cord compression.\n* The patient is not a candidate for cellular therapy as assessed by the study bone marrow transplant physician.\n* Known immunosuppressive disease or human immunodeficiency virus (HIV) infection.\n\nHIV-positive patients are ineligible due to the unknown safety and efficacy of infusing these patients with CAR T cells genetically modified using retroviral vectors. Additionally, the immunosuppression used for treatment in this study will pose an unacceptable risk.\n\n• Concurrent illness: Patients with active autoimmune disease, documented history of autoimmune disease\u002Fsyndrome, or any other condition that requires ongoing systemic steroids or systemic immunosuppressive agents, except\n\n* Patients with vitiligo or resolved asthma\u002Fatopy\n* Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome\n* Patients requiring physiologic doses of corticosteroids (up to 0.5 mg\u002Fm2\u002Fday dexamethasone equivalent)\n* History of or ongoing pneumonitis or significant interstitial lung disease.\n* Ongoing or active uncontrolled infection.\n* Patients 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 patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n* Patients with any of the following cardiac diseases:\n* New York Heart Association (NYHA) functional class III or IV\n* Clinically significant cardiac arrhythmia including, but not limited to, Torsade de pointes or requiring a pacemaker\n* Left ventricular ejection fraction below 50% as determined by echocardiography (ECHO)\n* Pregnant or lactating women due to possible adverse effects on the developing fetus or infant.\n* Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n* Patients who have received the last vaccination of a live vaccine ≤ 30 days prior to enrollment are ineligible.\n* Patients who have received an inactivated virus, peptide, or mRNA vaccine within 14 days of the start of protocol therapy are ineligible.\n* Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity of therapy or to adhere to drug administration plan, other study procedures, and study restrictions.\n* Patients treated on any other therapeutic clinical protocols within 30 days prior to enrollment.\n* For females of childbearing potential, a negative serum pregnancy test at enrollment.","4 Years","30 Years",{"count":225,"type":21},24,[24],"This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in newly diagnosed and recurrent CD70+ Pediatric High-Grade Gliomas (pHGG) and Diffuse Intrinsic Pontine Glioma (ndDIPG)",[229,230],"High-grade Glioma","Diffuse Intrinsic Pontine Glioma",[232,233,234,235,236],"CAR T Cell","Brain Tumor","Brain Cancer","Immunotherapy","Glioblastoma",{"date":129,"type":54},{"date":239,"type":21},"2026-07",{"date":241,"type":21},"2045-12",{"name":60,"class":61},{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":142,"sex":16,"minAge":223,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":62},"100627815","cranberry-polyphenols-and-stress-resilience-during-multitasking-in-healthy-adults-100627815","NCT07453537","Cranberry Polyphenols and Stress Resilience During Multitasking in Healthy Adults","Cranberry Polyphenols and Human Stress Resilience: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Integrating Cognitive, Physiological, and Microbiome Adaptations Underlying Nutritional Neuroprotection and Multitasking Performance in Healthy Adults.","CRAN-MULTI","Inclusion Criteria:\n\n* At least 110 pounds\n* Between 30 and 55 years\n* BMI between 18.9 and 29.9 kg\u002Fm²\n* A minimum education level of high school or above\n\nExclusion Criteria:\n\n* Heavy caffeine users (consuming more than 300 mg\u002Fday or more than two cups of coffee per day)\n* Alcohol consumption exceeding three drinks per week\n* A smoking history of 10 years or more, or current use of cannabis products\n* Uncontrolled hypertension\n* Clinically diagnosed illnesses such as diabetes, cardiovascular disease, neurological disorders, or mental health conditions\n* Participants currently taking prescribed anti-inflammatory medications, antibiotics, or antidepressants that may affect study outcomes, particularly those related to blood and fecal sample analysis\n* Individuals who regularly take vitamin or mineral supplements and are unwilling to discontinue them for the duration of the study will not qualify.\n* Participants must be willing to maintain their current daily routine and lifestyle, undergo body weight and height measurements, and notify study coordinators of any illnesses or significant adverse life events during the study period\n* Those with specific dietary restrictions that prevent them from consuming the standardized breakfast sandwich required in the study protocol\n* Participants must successfully complete the on-site multitasking task as a screening measure prior to signing consent.\n* Beck's Depression Inventory score of 21 or higher\n* Beck's Anxiety Inventory score of 21 or higher\n* A history of severe suicidal tendencies, or seasonal depression\n* Pregnancy and breastfeeding (Female participants must complete four pregnancy tests throughout the study and track their menstrual cycle. Those unwilling to comply with these requirements will not be eligible.)\n* Potential participants must not have taken any anti-inflammatory medications, antibiotics, or antidepressants within the past three months prior to the start of the study\n* Individuals who were previously enrolled in IRB#202300950 will be excluded due to the learning effect of cognitive tests, ensuring accurate data collection for this study","55 Years",{"count":253,"type":21},84,[74],"This randomized, double-blind, placebo-controlled clinical trial evaluates whether 70 days of daily cranberry juice consumption improves cognitive performance and motor accuracy and reduces psychological and physiological stress responses during a motor-cognitive dual-task multitasking challenge in healthy adults aged 30-55 (Aim 1). It is hypothesized that chronic cranberry juice intake will enhance dual-task performance and attenuate stress reactivity (Hypothesis 1). It is further hypothesized that cranberry juice will mitigate multitasking-related fatigue, mood fluctuations, and cognitive impairment, accompanied by favorable changes in circulating stress biomarkers and stress-regulatory neurochemical pathways (Aim 2\u002FHypothesis 2). Finally, the study incorporates gut analysis to determine whether cranberry juice induces beneficial shifts in the gut microbiota and microbial metabolites (e.g., SCFAs) and whether these changes are associated with improved cognitive and stress-related outcomes, consistent with a microbiome-gut-brain axis mechanism (Aim 3\u002FHypothesis 3).",[257,258,259,260,261,262],"Stress Response","Mental Stress","Multitasking Behavior and Multitasking Ability","Physiological Stress","Cognitive Symptoms","Motor Activity","2026-06-29",{"date":207,"type":54},{"date":266,"type":21},"2026-08-01",{"date":268,"type":21},"2029-08-01",{"name":60,"class":61},{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":142,"sex":276,"minAge":17,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":285,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":4},"100614575","reducing-co-occurring-substance-use-and-hiv-risk-among-stimulant-using-men-at-high-risk-for-hiv-in-the-united-states-of-america-100614575","NCT07281378","Reducing Co-occurring Substance Use and HIV Risk Among Stimulant-using Men at High Risk for HIV in the United States of America.","Inclusion Criteria:\n\n1. be 18 years of age or older;\n2. be sexually active cisgender men at high risk for HIV (foreign and US-born, residing in the US)-reporting any condomless anal sex (CAS) in the past three months with a man;\n3. report use of stimulant (i.e., methamphetamine, powder cocaine, or crack-cocaine) at least one day in the past three or six month;\n4. have HIV-negative serostatus;\n5. be bilingual (Spanish and English), or Spanish or English monolingual;\n6. meet CDC criteria for PrEP eligibility.\n\nExclusion Criteria:\n\n1. display diminished capacity to consent (e.g., cognitive impairment); or\n2. severe psychiatric symptoms (e.g., psychosis) that require more intensive treatment;\n3. if they are HIV positive or living with HIV;\n4. if they are already taking PrEP; and\n5. if the participant can't consent to participate in English or Spanish.","MALE",{"count":253,"type":21},[74],"This intervention will focus on stimulant-using men at high risk for HIV who are in need of tailored behavioral interventions to mitigate co-occurring stimulant use and HIV risk in the era of pre-exposure prophylaxis (PrEP). The study is a pilot randomized controlled trial to evaluate the adaptation, feasibility, acceptability, and preliminary efficacy of a behavioral intervention.",[281,282,283,284],"Drug Use Disorders","PrEP Uptake","PrEP Adherence","HIV Risk Behavior",[286,287,288,289,290,291],"PrEP","PrEP uptake","HIV","substance use","stimulant use","men at high risk for HIV",{"date":207,"type":54},{"date":294,"type":21},"2026-07-20",{"date":296,"type":21},"2027-12-31",{"name":60,"class":61},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":16,"minAge":306,"maxAge":223,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100426787","phase-1-peach-trial--precision-medicine-and-adoptive-cellular-therapy-100426787","NCT04837547","PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy","PEACH TRIAL- Precision mEdicine and Adoptive Cellular tHerapy for the Treatment of Recurrent Neuroblastoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)","PEACH","Inclusion Criteria:\n\n* Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence\u002Fprogression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies fitting into one of the following categories:\n* Disease Status:\n\nHigh Risk Neuroblastoma-\n\n1. Patients that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive\u002Fprogressive to accepted curative chemotherapy.\n2. Neuroblastoma must be age \\>12 months at enrollment\n\nDiffuse Intrinsic Pontine (or other brain stem) Glioma\n\n1. Newly-diagnosed patients willing to undergo biopsy\n2. Must be within 2 months of diagnosis and prior to starting radiation\n3. DIPG must be ≥ 3 years of age at enrollment\n\n   * All subjects must be age ≤ 30 years at enrollment\n   * Patient and\u002For parents\u002Fguardian willing to consent to biopsy for obtaining tumor material for confirmatory diagnosis and\u002For tumor RNA extraction and amplification.\n   * Subjects must have measurable disease as defined Per section 8 at the time of biopsy and tumor or bone marrow must be accessible for biopsy. Tumor or bone marrow samples submitted for analysis must contain \\>20% viable tumor tissue to qualify. Note: Subjects with NB who are expected to have no evidence of disease after surgical removal of their tumor are still eligible for this trial if their disease would normally require adjuvant chemotherapy treatment after surgery despite NED status.\n   * Current disease state must be one for which there is currently no known effective therapy\n   * Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.\n   * Lansky or Karnofsky Score must be ≥ 60\n   * Bone Marrow:\n\n     1. ANC (Absolute neutrophil count) ≥ 1000\u002Fµl (unsupported- \\>24 hrs off G-CSF and 7 days off neulasta)\n     2. Platelets ≥ 100,000\u002Fµl (can be transfused)\n     3. Hemoglobin \\> 8 g\u002FdL (can be transfused)\n   * Renal: Serum creatinine ≤ upper limit of institutional normal.\n   * Adequate liver function must be demonstrated, defined as:\n\n     1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND\n     2. ALT (SGPT) ≤ 3 times upper limit of normal (ULN) for age\n     3. AST (SGOT) ≤ 3 times upper limit of normal (ULN) for age.\n   * Subjects with CNS disease currently taking steroids must have been on a stable dose of steroids for at least one week prior to their biopsy and must not have progressive hydrocephalus at enrollment.\n   * A negative serum pregnancy test is required for female participants of childbearing potential (≥13 years of age or after onset of menses)\n   * Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives (\"the pill\"), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.\n   * Informed Consent: All subjects and\u002For legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines\n   * Post-Biopsy: Patients with post-biopsy neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.\n\nExclusion Criteria:\n\n* Absence of tumor on biopsy specimen or a diagnosis other than NBL or glioma on biopsy\n* Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection.\n* Subjects with significant renal, cardiac, pulmonary, hepatic or other organ dysfunction.\n* Prior allergic reaction to GM-CSF or Td.\n* Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to biopsy or focal radiotherapy in the case of patients with diffuse intrinsic pontine (or other brain stem) gliomas\n* Subjects with NBL who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy).\n* Subjects receiving any investigational drug concurrently.\n* Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor)\n* Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study","1 Year",{"count":225,"type":21},[24],"A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs) (TTRNA-DCs), Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) and Autologous G-CSF mobilized Hematopoietic Stem Cells (HSCs)).",[311,230],"Neuroblastoma",{"date":129,"type":54},{"date":314,"type":54},"2021-09-20",{"date":316,"type":21},"2032-09",{"name":60,"class":61},3,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":327,"targetDuration":4,"studyType":328,"phases":4,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":4},"100645367","infant-diet-and-caregiver-resistome-100645367","NCT07680972","Infant Diet and Caregiver Resistome","Breastfeeding and Its Impact on the Infant-caregiver Resistome","IDCR","Inclusion Criteria:\n\n* Employment at a childcare facility or home daycare at time of sampling\n* Participant works and interacts with infants under the age 6 months old, including responsibility for changing diapers\n* Participant \\>18 years old\n\nExclusion Criteria:\n\n* Participant has a history or presence of a medical condition including Ulcerative Colitis, Crohn's Disase, Inflammatory Bowel Disease, colon cancer, Celiac's disease, or other GI disordrs\n* Current priobitic use or probiotic use within the last 4 weeks\n* Participant is currently pregnant or breastfeeding\n* Participant has an infant \\\u003C12 months old at home for 3 or more days per week\n* Enrollment in a clinical trial involving an invstigational drug or dvic\n* Antibiotic use within the past 3 months\n* Participant working exclusively with infants \\>6 months old at time of stool sample collection",{"count":199,"type":21},"OBSERVATIONAL","Antimicrobial resistance genes (ARGs) are the genes that allow bacteria to survive antibiotic treatments. These genes can be found in beneficial gut microbes, and occur more frequently in infants than adults. These genes can also transmit between different bacterial species. Exclusively breastfed infants carry fewer ARGs than formula fed infants. We are trying to find out if care-givers working with exclusively breastfed infants have fewer ARGs than those working with formula fed infants.",[331],"Professional Caregivers Working With Infants Under Age 6 Months","2026-06-26",{"date":131,"type":54},{"date":335,"type":21},"2026-08-20",{"date":337,"type":21},"2029-05-31",{"name":60,"class":61},{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":16,"minAge":222,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":62},"100630795","phase-1-rna-lipid-particle-rna-lp-vaccines-for-recurrentprogressive-medulloblastoma-mb-100630795","NCT07492316","RNA-lipid Particle (RNA-LP) Vaccines for Recurrent\u002FProgressive Medulloblastoma (MB)","A Phase I\u002FII Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM), and Recurrent\u002FProgressive Medulloblastoma (MB)","PNOC020 rMB","Inclusion Criteria:\n\n* Age \\> 3 and \\\u003C\u002F= 39 years.\n* Histologically confirmed or suspected recurrent\u002Fprogressive MB in first or second relapse.\n* Patients must have received radiation therapy as part of prior therapy.\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Prior Therapy: Patients must have fully recovered from all acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.\n\n  * XRT\u002FExternal Beam Irradiation, including Protons: ≥ 90 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis.\n  * Other therapeutic clinical trials: ≥ 14 days after last dose of investigational agent, unless otherwise defined above.\n  * Patients must not have received prior exposure to pp65-directed therapy or any RNA-LP therapy.\n* A diagnostic contrast-enhanced MRI of the brain and spine must be performed preoperatively, and diagnostic contrast-enhanced MRI of the area biopsied or resected must be performed postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery.\n* Performance Score: Karnofsky ≥ 60 for participants \\> 16 years of age and Lansky ≥ 60 for participants \\\u003C 16 years of age (See Appendix A) assessed within 2 weeks prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  d. ANC (Absolute neutrophil count) ≥ 1,000\u002Fμl (unsupported) e. Platelets ≥ 100\u002Fμl (unsupported for at least 7 days) f. Hemoglobin \\> 8 g\u002FdL (may be supported)\n* Renal: Creatinine clearance or radioisotope GFR ≥ 70mL\u002Fmin\u002F1.73 m2\n* Hepatic:\n\n  d. Bilirubin ≤ 3 times upper limit of institutional normal for age. e. SGPT (ALT) ≤ 5 times upper limit of institutional normal for age. f. SGOT (AST) ≤ 5 times upper limit of institutional normal for age.\n* Participants who are receiving systemically-administered steroids must be on a stable or decreasing dose for \\>1 week prior to enrollment. The patient steroid dose should be no more than a dexamethasone-equivalent of 2.8 mg\u002Fm2\u002Fday. Corticosteroid physiologic replacement therapy for management of pituitary\u002Fadrenal axis insufficiency and\u002For topical administration (e.g. inhaled or dermatologic) is allowed.\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations\n* A legal parent\u002Fguardian or patient must be able to understand and be willing to sign a written informed consent document\n* For women of childbearing potential (WOCBP), negative serum\u002Furine pregnancy test at enrollment\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.\n* Males of child-fathering potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n* Patients must be enrolled on PNOC COMP prior to enrollment on PNOC020 if PNOC COMP is open to accrual at the enrolling institution.\n\nExclusion Criteria:\n\n* Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+\n* Bulky disease, defined as:\n\n  * Tumor with evidence of clinically significant uncal herniation, midline shift, tonsillar herniation, or brainstem infiltration, or that shows significant mass effect in either brain or spine\n  * Tumor with extensive and diffuse multilobular involvement (\\>3 lobes)\n  * Tumor with extracranial disease (with the exception of spinal metastases in Stratum 3)\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Uncontrolled seizure disorder\n* History of myocarditis\n* Receipt of any live vaccine within 30 days prior to enrollment\n* Known active infection or immunosuppressive disease.\n* Participants with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.\n* Severe or unstable concurrent medical conditions.\n* Women must not be pregnant or breast-feeding.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations.","39 Years",{"count":225,"type":21},[24],"The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in pediatric patients with recurrent\u002Fprogressive Medulloblastoma (MB)",[352],"Recurrent Medulloblastoma",{"date":263,"type":54},{"date":355,"type":54},"2026-04-24",{"date":357,"type":21},"2031-03-31",{"name":60,"class":61},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":142,"sex":171,"minAge":367,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":62},"100619937","improving-cervical-cancer-prevention-among-women-living-with-chronic-conditions-100619937","NCT07351110","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions.","Improving Cervical Cancer Prevention Among Women Living With Chronic Conditions. Aim 3: Assess the Feasibility and Acceptability of the PINPOINT Intervention.","PINPOINT","Inclusion Criteria:\n\nThe following eligibility criteria will be used to determine inclusion into the study:\n\n1. Using the American Cancer Society (ACS) screening recommendations, adults aged over the age of 25 will be eligible\n2. Active UF Internal Medicine patient and has had an appointment in the last 2 months.\n3. Assigned sex at birth is female\n4. Have Obesity or Type 2 Diabetes\n5. Not currently pregnant (self-report)\n6. Have not given birth in the prior 12 weeks\n7. No previous history of cervical cancer\n8. No previous history of a hysterectomy\n9. Have not undergone cancer screening in the past 3 years or more\n10. Reside in the UFHCI Catchment Area (Alachua, Baker, Bradford, Citrus, Clay, Columbia, Dixie, Gadsden, Gilchrist, Hamilton, Jefferson, Lafayette, Lake, Leon, Levy, Madison, Marion, Putnam, Sumter, Suwannee, Taylor, UnioF1n, or Wakulla County).\n11. Have a mobile phone or access to a mobile phone that can be used to receive messages, or a valid email address.\n12. Are not currently scheduled to receive cervical cancer screening via clinician sampling (pap smear).\n\nExclusion Criteria:\n\n* Previous history of cervical cancer\n* Total hysterectomy\n* Pregnant","25 Years",{"count":72,"type":21},[74],"Our overarching goal is to adapt and test the PINPOINT intervention -PatIent Navigation for the Prevention of CervIcal CaNcer inTervention. We will test the PINPOINT intervention among patients with high-risk profiles for cervical cancer who do not meet the recommended screening for cervical cancer.",[372,373,374],"Diabetes","Cervical Cancer (Early Detection)","Obesity & Overweight",[376,377,378],"cervical cancer screening","self-collection","self-sampling",{"date":207,"type":54},{"date":207,"type":21},{"date":382,"type":21},"2027-03-24",{"name":60,"class":61},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":408,"locationsCount":62},"100591182","journaling-intervention-for-temporomandibular-disorder-tmd-and-chronic-overlapping-pain-100591182","NCT06977100","Journaling Intervention for Temporomandibular Disorder (TMD) and Chronic Overlapping Pain","Examining the Feasibility and Acceptability of a Journaling Intervention in Alleviating Temporomandibular Pain","Inclusion Criteria:\n\n* participants between the ages of 18 and 80\n* pain in the temporomandibular (TMD) region (jaw and\u002For temple area)\n* duration of pain is at least 3 months\n* average pain score ≥4 on a 0-10 numerical rating scale over the past week\n* have at least one additional chronic overlapping pain condition (COPC) including fibromyalgia, irritable bowel syndrome, migraine-type headache, tension-type headache, low back pain, interstitial cystitis\u002Fpainful bladder syndrome or chronic prostatitis, myalgic encephalomyelitis\u002Fchronic fatigue syndrome, vulvodynia, and painful endometriosis.\n* able to read, understand, and write in English.\n\nExclusion Criteria:\n\n* history of TMD surgery\n* neoplasm or injury\u002Ftrauma to the TMD area\n* cancer-related pain\n* scheduled for any surgeries during the study time-frame\n* current participation in another clinical trial or psychological treatment for any pain-related condition that would interfere with study outcomes\n* pregnant or lactating\n* severe motor impairments (e.g., muscular dystrophy)\n* severe psychiatric conditions (e.g., uncontrolled mood disorders)\n* severe neurological or cognitive impairments (e.g., uncontrolled Parkinson's disease)\n* any other conditions that in the opinion of study investigators could make participation in the study unsafe\n* use of opioids within 48 hours prior to laboratory visit",{"count":392,"type":21},60,[74],"The goal of this clinical trial is to learn whether a 2-week gratitude journaling activity is feasible and acceptable for individuals with Temporomandibular Disorder (TMD) and chronic overlapping pain. The study will also look at whether this activity is helpful in reducing pain and how much it interferes with daily life.\n\nThe primary aims of this study are to:\n\n* Assess whether individuals with TMD and chronic overlapping pain are able to complete the 2-week gratitude journaling activity as planned (feasibility).\n* Evaluate how acceptable participants find the gratitude journaling activity (acceptability).\n\nThe secondary aim of this study is to:\n\n• Explore whether the gratitude journaling activity reduces pain and its impact on daily life, compared to a general wellness journaling activity.\n\nParticipants will:\n\n* Attend two in-person visits to complete questionnaires and take part in tests that measure how sensitive they are to pressure and heat.\n* Complete a 2-week journaling activity at home, writing in their journal on three days of their choice per week.",[396],"Temporomandibular Disorders (TMD)",[398,399,400,401,402,403],"Temporomandibular Disorder","Gratitude Journaling","Resilience","Pain Intensity","Pain Interference","Chronic Pain",{"date":263,"type":54},{"date":406,"type":54},"2025-08-11",{"date":106,"type":21},{"name":60,"class":61},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":16,"minAge":417,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":433},"100644549","phase-3-prise-personalized-response-and-immunologic-surveillance-of-endogenous-c-peptide-preservation-in-new-recent-and-established-onset-type-1-diabetes-treated-with-human-anti-thymocyte-globulin-h-atg-study-100644549","NCT07670650","PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset T1D, Recent Onset T1D, and Established T1D","PRISE-hATG","Inclusion Criteria:\n\n1. Participant and\u002For appropriate legal guardian for participants below the legal age of consent must have given written informed consent and\u002For assent according to local, regional and\u002For country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.\n2. Males and females 5-40 years old\\*, inclusive, at the time of randomisation.\n\n   \\* Note: Age step-down rules apply, as described in protocol Section 6.1.\n3. Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) between 16 to 32 (inclusive).\n4. Participant has received a diagnosis of T1D according to American Diabetes Association criteria (refer Section 22.1) as following:\n\n   * For Cohort 2: within \\>100 days but \\\u003C1 year (365 days) of randomisation;\n   * For Cohort 3: within ≥1 year (365 days) but \\\u003C2 years (730 days) of randomisation. For participants who were initially misdiagnosed with Type 2 diabetes (T2D), time from misdiagnosis with T2D to randomisation is up to 1 and 2 years.\n\n   Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy the time of randomisation.\n5. Participant has random C-peptide levels of \\>0.2 nmol\u002FL, measured during Screening. One random C-peptide retest during screening period is allowed.\n6. Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.\n7. Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:\n\n   * Glutamic acid decarboxylase 65 (GAD65)\n   * Islet antigen 2 (IA-2)\n   * Zinc transporter 8 (ZnT8)\n   * Insulin autoantibodies (if testing within the first 14 days of insulin treatment)\n8. Female participants:\n\n   1. Must be of nonchildbearing potential, i.e., pre-pubertal\\*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle -stimulating hormone \\[FSH\\] level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i.Have a negative result on a serum (beta human chorionic gonadotropin \\[β-hCG\\]) at screening and a negative urine β-hCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.\n\n   ii.Agree not to become pregnant or donate ova from the time of signing the consent form until the end of the study visit.\n\n   iii.If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception \\[Section 11.3.1\\]) from the time of signing the consent and for the duration of the study.\n\n   \\* Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)\u002Fguardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.\n9. Male participants, if not biologically or surgically sterilised, must:\n\n   1. Agree not to donate sperm from the time of signing the consent form until End of Study (EOS).\n   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception \\[refer to Section 11.3.1\\]) from the time of signing the consent form until EOS.\n   3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from the time of signing the consent form until EOS.\n10. Prior to receiving study drug, participant must agree to receive locally, regionally and\u002For country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and\u002For country-specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.\n11. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and\u002For stimulate pancreatic β cell regeneration or insulin secretion.\n12. Participant has suitable venous access for blood sampling.\n13. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria:\n\n1. Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications). This includes participants with Hereditary Fructose Intolerance.\n2. Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.\n3. Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.\n4. Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.\n5. Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and\u002For efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.\n6. Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematosis) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.\n7. Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.\n8. Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.\n9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and\u002For TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n10. Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalisation or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active CMV, EBV as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative (defined as PCR \\\u003C1000 copies\u002FmL or its equivalent in plasma or serum based on the site-specific PCR assay) test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I\u002FE are met. Participants who have an active infection and\u002For fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.\n11. Participant has a diagnosis of significant liver disease or at screening ALT and\u002For AST \\>2× or total bilirubin of \\>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the site laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant may be eligible for randomisation. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and\u002For indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.\n12. An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:\n\n    * Lymphocyte count: \\\u003C1000\u002FμL\n    * Neutrophil count: \\\u003C1500\u002FμL\n    * Platelet count: \\\u003C100 000 platelets\u002FμL\n    * Haemoglobin: \\\u003C10 g\u002FdL\n\n    Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and\u002For is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the references ranges.\n13. Current or prior (within 5× half-lives before SV2) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.\n14. Current or prior (within 5× half-lives before SV2) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists \\[glucagon-like peptide-1\\], dipeptidyl peptidase-4 \\[DPP-IV\\] inhibitors, or amylin).\n15. Current or prior (within 5× half-lives before SV2) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).\n16. Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact on the investigational drug.\n17. Recent or planned vaccinations as follows:\n\n    Countries within the EU member states only:\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): from 30 days before dosing through 6 months following administration of SAB-142 for each TP;\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: from 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of each TP.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of each TP.\n18. Female is lactating and\u002For plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.\n19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and\u002For country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit\u002Fhyperactivity disorder (ADHD) or others are allowed to participate in the study.\n20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.\n21. An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site. Note: Investigators should ensure that all study inclusion criteria and no study exclusion criteria have been met at screening. If a participant's clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study drug is given such that he or she no longer meets all eligibility criteria, then the participant should be excluded from participation in the study.\n22. An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI or if participation in the study may place the participant at risk.\n23. An individual who has been placed in an institution by official or court order.","5 Years","40 Years",{"count":420,"type":21},108,[422],"PHASE3","This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with Stage 3 type 1 diabetes (T1D). The study will enroll participants with recent-onset T1D (\\>100 days to \\\u003C1 year from diagnosis) and established-onset T1D (≥1 year to ≤2 years from diagnosis) who retain residual beta-cell function as demonstrated by stimulated C-peptide levels \\>0.2 nmol\u002FL. Participants will be randomized in a 2:1 ratio to receive SAB-142 or placebo in addition to standard diabetes care. The primary objective is to determine whether SAB-142 preserves beta-cell function over 12 months as measured by stimulated C-peptide response during a mixed meal tolerance test (MMTT). External data from the SAB-142-201 SAFEGUARD study will be incorporated to include participants with new-onset T1D (\\\u003C100 days from diagnosis) in the primary efficacy analysis.",[425],"Type 1 Diabetes (T1D)","2026-06-25",{"date":332,"type":54},{"date":429,"type":21},"2026-09-01",{"date":431,"type":21},"2030-09-01",{"name":60,"class":61},4,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":453,"locationsCount":62},"100592097","compassion-strikes-back-100592097","NCT06988995","Compassion Strikes Back","Compassion Strikes Back: Improving Dyadic Quality of Life for LVAD Patients and Caregivers","Inclusion Criteria:\n\n* LVAD implantation or caregiver or patient with LVAD; over 18 years old; primary caregiver is a family member\n\nExclusion Criteria:\n\n* Currently or in the past 3 months received psychotherapy or psychosocial or peer support; hospitalized for psychiatric reasons in the past 6 months; current, active suicidal thoughts or a reported suicide attempt within the past year; a current alcohol\u002Fsubstance use disorder that required immediate treatment; or a current or past thought disorder, psychosis, or unmanaged bipolar disorder; enrolled in another investigational research\u002Fclinical trial; toxic\u002Fnegative dynamic between pt and caregiver; extended post-LVAD implantation course (i.e., more than 2 months in the hospital).",{"count":199,"type":21},[74],"Research has shown that LVAD patients and their caregivers typically experience increased mental health concerns and decreased quality of life following LVAD implantation and hospital discharge. The purpose of this study is to explore how to improve quality of life for LVAD patients and their caregivers in the initial transition from hospital to home after LVAD implantation.\n\nOver the course of the study, participants will complete 2 surveys: one when participants are in the hospital and one at a 2-month post-hospital follow-up appointment with the participants' cardiologist. Participants may be contacted if there is data missing from surveys.\n\nParticipants may also be provided with information on improving mental health in the form of handouts or a brief meeting with a psychology provider.",[445,446,447,448],"LVAD Caregivers","LVAD (Left Ventricular Assist Device)","Quality of Life (QOL)","Self-Compassion",{"date":263,"type":54},{"date":451,"type":54},"2025-12-01",{"date":106,"type":21},{"name":60,"class":61},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":16,"minAge":461,"maxAge":367,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":480,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":62},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132","NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\n* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included.)\n* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","6 Months",{"count":463,"type":21},27,[24,25],"Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[311,467,468,469,470,471,472,473,474,475,476,477,478,479],"Rhabdomyosarcoma","Synovial Sarcoma","Peripheral Nerve Sheath Tumors","Clear Cell Sarcoma","Alveolar Soft Part Sarcoma","Desmoplastic Small Round Cell Tumor","Chordoma","Rhabdoid Tumor","Epithelioid Sarcoma","Myoepithelial Tumor","Osteosarcoma","Ewing Sarcoma","Wilms Tumor",[481,482,483],"pediatric solid tumors","stem cell transplantation","graft manipulation",{"date":207,"type":54},{"date":486,"type":54},"2026-02-11",{"date":488,"type":21},"2030-02",{"name":60,"class":61},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":142,"sex":16,"minAge":497,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":506,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":62},"100515939","a-mechanistic-study-to-investigate-tdcs-and-working-memory-in-mci-patients-100515939","NCT05998031","A Mechanistic Study to Investigate tDCS and Working Memory in MCI Patients","AIM","Inclusion Criteria\n\n* Age 60-95 years\n* Montreal Cognitive Assessment (MoCA) score 18 and above (scores will be adjusted for education)\n* Able to receive electrical stimulation\n* Ability to comprehend conversational voices\n* Adequate motor capacity to operate computer mouse and click-button in-scanner\n* Ability to participate in the intervention and attend training sessions Exclusion Criteria\n* Failure to provide informed consent\n* Contraindications to MRI recording (e.g., any kind of ferrous metallic stents or ferrous metal objects in the body, heart valve prosthesis, or other metal implants, claustrophobia, neurostimulation system, defibrillator, pacemaker, or other implanted device)\n* Left-handed, or left hand dominant\n* History of neurological, seizures, and psychiatric disorders, traumatic brain injury, incidence of stroke involving large vessel\n* Terminal illness with life expectancy less than 12 months, as determined by physician\n* Brain tumor or malformation or any foreign body known or previously identified in brain\n* Cancer in active treatment, besides skin cancer\n* Currently on GABAergic or glutamatergic medications, or on calcium or sodium channel blockers, which alter or block the ability of tDCS to facilitate tissue excitability\n* Unable to communicate because of severe hearing loss or speech disorder\n* Severe sensory impairment\n* Inability to communicate in English\n* Severe visual impairment, which would preclude completion of the assessment and\u002For intervention\n* No physical impairment precluding motor response or lying still for an hour in the scanner that could confound study findings\n* Moderate-to-severe depressive symptoms as defined by scoring 10 or above on the Geriatric Depression Scale (GDS)","60 Years","95 Years",{"count":500,"type":21},110,[74],"The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control",[504,505],"Cognitive Impairment","Cognitive Decline",[507,508,509,510,511],"Cognitive Aging","Brain Stimulation","functional MRI","Computational Modeling","Finite Element Method (FEM)",{"date":332,"type":54},{"date":514,"type":54},"2024-04-24",{"date":516,"type":21},"2029-11-30",{"name":60,"class":61},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":524,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":538},"100256803","early-phase-1-melatonin-as-a-neuroprotective-therapy-in-neonates-with-hie-undergoing-hypothermia-100256803","NCT02621944","Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia","Inclusion Criteria:\n\n* Eligible infants are \\>36 0\u002F7th weeks gestation,\n* pH (cord or neonatal) \\\u003C7.0,\n* base deficit \\>16 mEq\u002FL,\n* no available blood gas,\n* a cord blood\u002Ffirst hour of life blood gas with pH \\> 7.0 and \\\u003C 7.15,\n* base deficit between 10 and 15.9 mEq\u002FL,\n* infants must have a history of an acute perinatal event,\n* either a 10-minute Apgar \\\u003C 5 or a continued need for ventilation,\n* All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,\n* neonates cooled within 6 hours of birth will be included in the study.\n\nExclusion Criteria:\n\n* suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,\n* clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,\n* a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and\u002For chromosomal abnormalities.","6 Hours",{"count":526,"type":21},70,[528],"EARLY_PHASE1","Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury. Melatonin serves as a free radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes. Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in turn minimizing cell death and improving outcomes. The research study will evaluate the neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy.",[531],"Hypoxic Ischemic Encephalopathy",{"date":263,"type":54},{"date":534,"type":54},"2016-11-09",{"date":536,"type":21},"2027-03",{"name":60,"class":61},2,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":16,"minAge":546,"maxAge":547,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":550,"briefSummary":551,"conditions":552,"keywords":555,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":62},"100617966","interposed-nucleus-adbs-for-ataxia-100617966","NCT07325487","Interposed Nucleus aDBS for Ataxia","Adaptive Deep Brain Stimulation Targeting the Interposed Nucleus to Treat Spinocerebellar Ataxia","Inclusion Criteria:\n\n* A diagnosis of SCA6 by a movement disorders specialist following established criteria recommended by the Movement Disorders Society\n* A positive genetic test for SCA6\n* A total score ≥ 8 on the Scale of the Assessment and Rating of Ataxia (SARA) rating scale\n* Ability to walk with or without support (score \\\u003C8 on the 'gait' subsection of the SARA rating scale)\n* Age ≥ 21 years and \\\u003C89 years\n* Ability to give informed consent for the study\n* Ability to understand the study protocol\n\nExclusion Criteria:\n\n* Inability or unwillingness to comply with the study protocol\n* History of previously implanted neurostimulators, pacemakers, defibrillators, or metallic head implants\n* Severe cognitive impairment or dementia, defined as a score \\\u003C21 on the Montreal Cognitive Assessment (MOCA)\n* Evidence of ataxia due to other etiologies, including but not limited to:\n\n  * Genetic\u002Finherited disorders other than SCA6\n  * Acquired causes: traumatic brain injury, multiple sclerosis, paraneoplastic cerebellar degeneration, infections or post-infectious cerebellitis, autoimmune ataxias (e.g., anti-GAD, gluten ataxia)\n  * Toxic\u002Fmetabolic causes: alcoholic cerebellar degeneration, vitamin deficiencies\n  * Structural, vascular, or neoplastic causes: cerebellar stroke, tumors, congenital malformations\n  * Suspected multiple system atrophy-cerebellar type (MSA-C)\n* Presence of active and untreated psychiatric illness, severe depression (Beck Depression Inventory ≥ 21), or personality disorder at the discretion of the study team\n* Coagulopathy, uncontrolled epilepsy, or other medical conditions that are considered to place the patient at elevated risk for surgical complications\n* Presence of a concomitant medical condition that, in the investigator's opinion, may interfere with the study participation or gait\u002Fbalance, for example, severe arthritis\n* Requirement of diathermy, electroconvulsive therapy, or transcranial magnetic stimulation\n* Pregnancy or lactation\n* Active suicidal ideation, defined as fined as a \"Yes\" response to questions #2-5 within the past one month on the Columbia Suicide Severity Rating Scale, C-SSRS\n* Refractory epilepsy","21 Years","89 Years",{"count":549,"type":21},5,[74],"This is a single-center, open-label study designed to evaluate the feasibility, safety, and preliminary efficacy of cerebellar adaptive deep brain stimulation (aDBS) in adults with spinocerebellar ataxia type 6 (SCA6). A total of 5 participants will be enrolled.\n\nParticipants will undergo surgical implantation of deep brain stimulation (DBS) leads targeting the motor interposed nucleus of the cerebellum. The leads will be connected to one or two implantable pulse generators capable of delivering stimulation to deep brain structures and recording neural activity.\n\nParticipants will complete up to 18 in-person study visits over a 24-month follow-up period. During these visits, neural signals will be recorded under varying behavioral tasks and stimulation conditions.\n\nEarly study visits will be used to identify optimal stimulation parameters and neural biomarkers associated with disease state. These biomarkers will subsequently be used to implement adaptive DBS, in which stimulation amplitude is automatically adjusted in response to recorded neural activity.\n\nStudy outcomes will include assessments of safety and feasibility of cerebellar aDBS, as well as preliminary evaluation of its effects on clinical measures.",[553,554],"Spinocerebellar Ataxia (SCA)","Spinocerebellar Ataxia Type 6",[556,557,558,559,554,560,561],"SCA6","Spinocerebellar Ataxia","adaptive deep brain stimulation","aDBS","DBS","deep brain stimulation","2026-06-24",{"date":263,"type":54},{"date":565,"type":54},"2026-06-02",{"date":567,"type":21},"2031-06",{"name":60,"class":61},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":16,"minAge":418,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":579,"briefSummary":580,"conditions":581,"keywords":584,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":538},"100644726","cross-system-effects-of-acute-intermittent-hypercapnia-based-interventions-in-pd-100644726","NCT07674264","Cross-System Effects of Acute Intermittent Hypercapnia-Based Interventions in PD","A Pilot Study of Acute Intermittent Hypercapnia-Based Interventions on Upper Airway and Axial Motor Function in Parkinson's Disease","Inclusion Criteria:\n\n1. adults 40 to 75 years of age (the latter to reduce the likelihood of cardiovascular disease)\n2. diagnosis of idiopathic Parkinsonism with Hoehn and Yahr stages 2-4\n3. medically stable with physician clearance\n4. ability to ambulate at least 10 feet with\u002Fwithout assistance\n5. ability to follow directions\n6. willing to abstain from blood donation for the duration of the study\n\nExclusion Criteria:\n\n1. additional neurologic conditions\n2. severe illness or infection, including respiratory\u002Fcardiovascular\u002Flung disease, or uncontrolled hypertension\n3. inspiratory stridor\n4. pregnancy due to unknown tAIH effects on a fetus, although females of childbearing age will not be excluded\\*\n5. cigarette smoking or vaping within 5 years\n6. history of head\u002Fneck\u002Flung cancer with the exception of basal cell carcinoma\n7. is currently participating in another research study that could influence the results from this study\n8. has deep brain stimulation electrodes implanted or has a history of deep brain stimulation\n9. faints or becomes lightheaded at the sight of blood\n\n   * If a female of childbearing potential indicates there is a chance she could be pregnant, she will be provided a pregnancy test and allowed to continue in the study if negative. This is because the fetal risks associated with intermittent hypoxia are unknown.","75 Years",{"count":578,"type":21},32,[74],"Parkinsonism impairs upper airway and axial motor control, leading to disordered breathing, reduced speech volume, and ineffective cough. Symptoms are poorly addressed by current therapies. This randomized pilot trial tests whether a single session of acute intermittent hypercapnic hypoxia (AIHH) or hypercapnic normoxia (AIHN) improves upper airway and axial motor function in Parkinsonism, and explores biomarker correlates of intervention responsiveness.",[582,583],"Parkinson Disease","Parkinsonism",[585,586,587,588],"Axial function","Upper airway","Breathing","Acute Intermittent Hypercapnic Hypoxia","2026-06-23",{"date":263,"type":54},{"date":592,"type":21},"2026-06-20",{"date":594,"type":21},"2028-12-31",{"name":60,"class":61},{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":142,"sex":16,"minAge":173,"maxAge":547,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":157,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":610,"leadSponsor":612,"locationsCount":62},"100623359","high-frequency-stimulation-to-improve-cognition-mobility-and-affect-in-individuals-with-and-without-subjective-cognitive-decline-100623359","NCT07395609","High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With and Without Subjective Cognitive Decline","Inclusion Criteria:\n\n* Community dwelling men and women 65-89 years old\n* Ability to walk unassisted for 10 min\n* English speaking\n\nAdditional Inclusion Criteria for SCD:\n\n* No evidence of dementia or MCI based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms8\n* Global Clinic Dementia Rating (CDR) score must be 0 or 0.531\n* Subjective report of cognitive complaints with scores \\>20 on the Cognitive Change Index (CCI-20), a validated scale of subjective cognitive decline6; this scale consists of 20 items that are rated on a 5-point Likert scale, where 1= \"Normal: No change compared to 5 years ago\", 3= \"Mild Problem: Some change compared to 5 years ago) and 5=\"Severe Problem: Much worse compared to 5 years ago\"\n* Family history of dementia\u002Fprobable AD in first degree relative (parents, children, siblings)\n* Normal functional behavior in terms of daily activities, based on the Functional Activities Scale32\n* In line with recommendations of the SCD task force33 an informant must be available for two reasons: a) to provide information about the participant's cognition using the informant version of the CDR and CCI-20, and b) to corroborate normal IADL's on the Functional Activity Questionnaire32 (informant data will be collected via a phone call and linked by code with the participant data).\n\nExclusion Criteria:\n\n* If participants score less than 21 on the Telephone Interview for Cognitive Status (TICS)\n* Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.)\n* Severe visual impairment or corrected visual acuity less than 20\u002F40, which would preclude completion of assessments\n* Inability to undergo MRI brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, certain non-removable body jewelry, or shrapnel containing ferromagnetic metal\n* History of severe stroke\n* Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer)\n* Report of lower extremity pain due to osteoarthritis that significantly limits mobility\n* Diagnosis or treatment for rheumatoid arthritis\n* Known neuromuscular disorder or overt neurological disease (e.g. Multiple Sclerosis, Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, Parkinson's Disease, ALS etc.)\n* Unable to communicate because of severe hearing loss or speech disorder\n* Planned surgical procedure or hospitalization in the next 4 months (joint replacement, coronary artery bypass graft, etc.)\n* Severe pulmonary disease, requiring the use of supplemental oxygen\n* Terminal illness, as determined by a physician\n* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina\n* Use of walker or wheelchair",{"count":392,"type":21},[74],"The goal is to determine whether three months of at least three times \u002F week of sensory flicker stimulation improves cognition, mobility, and affect in healthy older adults and older adults with and without Subjective Cognitive Decline (SCD). Investigators will also determine whether the intervention slows cortical thinning and declines in brain functional network segregation and changes in blood biomarkers of Alzheimer's Disease (AD).",[606,607],"Subjective Cognitive Decline (SCD)","Healthy Subjects",{"date":332,"type":54},{"date":239,"type":21},{"date":611,"type":21},"2028-10-31",{"name":60,"class":61},{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":344,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":16,"minAge":222,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":22,"phases":622,"briefSummary":623,"conditions":624,"keywords":628,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":538},"100406493","phase-1-a-study-of-rna-lipid-particle-rna-lp-vaccines-for-newly-diagnosed-pediatric-high-grade-gliomas-phgg-and-adult-glioblastoma-gbm-100406493","NCT04573140","A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)","PNOC020","Stratum 1 (Adult GBM)\n\n* Age ≥ 21 years.\n* Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma, secondary GBM not eligible) that is MGMT low level or unmethylated.\n* The tumor must have a supratentorial component.\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Residual post-surgical disease burden ≤ 3 cm as defined by longest perpendicular diameter of tumor on post-operative MRI.\n* Patients must have recovered from the effects of surgery, postoperative infection, and other complications.\n* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery. Preoperative and postoperative scans must be the same type.\n* Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  * ANC (Absolute neutrophil count) ≥ 1,000µl (unsupported)\n  * Platelets ≥ 150\u002Fµl (unsupported for at least 7 days)\n  * Hemoglobin \\> 8 g\u002FdL\n* Renal:\n\n  * BUN ≤ 25 mg\u002Fdl\n  * Creatinine ≤ 1.7 mg\u002Fdl\n* Hepatic\n\n  * Bilirubin ≤ 2.0 mg\u002Fdl\n  * ALT ≤ 5 times institutional upper limits of normal for age\n  * AST ≤ 5 times institutional upper limits of normal for age\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations\n* Signed informed consent. If the patient's mental status precludes his\u002Fher giving informed consent, written informed consent may be given by the legally authorized representative.\n* For women of childbearing potential (WOCBP), negative serum\u002Furine pregnancy test at enrollment (test will be repeated within 72 hours prior to starting TMZ in Stratum 1 patients).\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. Refer to Appendix F for definition of WOCBP and guidance on acceptable contraceptive methods.\n* Males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n\nStratum 2 (Newly-diagnosed Pediatric HGG)\n\n* Age \\> 3 and ≤ 25 years.\n* Histologically confirmed WHO Grade III or IV malignant glioma\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Residual post-surgical disease burden ≤ 3 cm as defined by longest diameter of tumor on post-operative MRI.\n* Patients must have recovered from the effects of surgery, postoperative infection, and other complications.\n* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery. Preoperative and postoperative scans must be the same type.\n* Performance Score: Karnofsky ≥ 60 for participants \\> 16 years of age and Lansky ≥ 60 for participants \\\u003C 16 years of age assessed within 2 weeks prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  1. ANC (Absolute neutrophil count) ≥ 1,000\u002Fµl (unsupported)\n  2. Platelets ≥ 100\u002Fµl (unsupported for at least 7 days)\n  3. Hemoglobin \\> 8 g\u002FdL (may be supported)\n* Renal: Creatinine clearance or radioisotope GFR ≥ 70mL\u002Fmin\u002F1.73 m2 or acceptable serum creatinine based on age\u002Fgender\n* Hepatic:\n\n  1. Bilirubin ≤ 3 times upper limit of institutional normal for age.\n  2. SGPT (ALT) ≤ 5 times upper limit of institutional normal for age.\n  3. SGOT (AST) ≤ 5 times upper limit of institutional normal for age.\n* Participants who are receiving systemically-administered steroids must be on a stable or decreasing dose for \\>1 week prior to enrollment. The patient steroid dose should be no more than a dexamethasone-equivalent of 2.8 mg\u002Fm2\u002Fday. Corticosteroid physiologic replacement therapy for management of pituitary\u002Fadrenal axis insufficiency and\u002For topical administration (e.g. inhaled or dermatologic) is allowed.\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations.\n* A legal parent\u002Fguardian or patient must be able to understand and be willing to sign a written informed consent and assent document, as appropriate.\n* For women of childbearing potential (WOCBP), negative serum\u002Furine pregnancy test at enrollment\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. Refer to Appendix F for definition of WOCBP and guidance on acceptable contraceptive methods.\n* Males of child-fathering potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n* Patients must be enrolled on PNOC COMP prior to enrollment on PNOC020 if PNOC COMP is open to accrual at the enrolling institution.\n\nExclusion Criteria:\n\nStratum 1 (Adult GBM)\n\n* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)\n* MGMT Methylated tumors\n* Gliomatosis Cerebri\n* Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.\n* Recurrent or multifocal malignant gliomas.\n* Metastatic or leptomeningeal disease\n* Residual post-surgical disease burden \\> 3 cm as defined by longest perpendicular diameter on MRI.\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Known active infection or immunosuppressive disease.\n* Participants who require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination.\n* Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region, other than TMZ prescribed during radiation for GBM (prior chemotherapy for a different cancer is allowable).\n* Prior radiotherapy to the head or neck, resulting in overlap of radiation fields. Radiosurgery is not permitted.\n* Severe, active co-morbidity, defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization.\n  * Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of XRT\u002FTMZ.\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT\u002FTMZ.\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects.\n  * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n  * Patients with autoimmune disease requiring medical management with immunosuppressants.\n  * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.\n  * Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity.\n  * Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.\n* Women of childbearing potential must not be pregnant or breast-feeding.\n* Prior history of brachial neuritis or Guillain-Barré syndrome.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations\n\nStratum 2 (Pediatric HGG)\n\n* Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+\n* Bulky disease, defined as:\n\n  * Tumor with evidence of clinically significant uncal herniation, midline shift, tonsillar herniation, or brainstem infiltration, or that shows significant mass effect in either brain or spine\n  * Tumor with extensive and diffuse multilobular involvement (\\>3 lobes)\n  * Tumor with extracranial disease\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Uncontrolled seizure disorder\n* History of myocarditis\n* Receipt of any live vaccine within 30 days prior to enrollment\n* Known active infection or immunosuppressive disease.\n* Participants with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.\n* Severe or unstable concurrent medical conditions.\n* Women must not be pregnant or breast-feeding.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations.",{"count":621,"type":21},28,[24],"The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD",[625,626,627],"Adult Glioblastoma","High Grade Glioma","WHO Grade III or IV Malignant Glioma",[235,233,629,630,631,632],"Adult","newly diagnosed","clinical trial","Pediatric brain tumor",{"date":426,"type":54},{"date":635,"type":54},"2021-12-13",{"date":637,"type":21},"2029-07-01",{"name":60,"class":61},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":171,"minAge":17,"maxAge":70,"enrollmentInfo":645,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":649,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":62},"100551558","preoperative-nicotine-cessation-for-women-with-breast-cancer-recommended-for-reconstruction-100551558","NCT06461650","Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction","Inclusion Criteria:\n\n* Adults ≥ 18 years of age and ≤ 80 years of age.\n* Women who are diagnosed with Stage 0 - 3 breast cancer confirmed by biopsy\n* Women who have been recommended to have reconstruction at time of mastectomy or oncoplastics at time of lumpectomy\n* Participants who actively use nicotine products defined as any self-reported nicotine use within the past month\n* Participant agrees to comply with all the study-related procedures.\n\nExclusion Criteria:\n\n* Patients not eligible for reconstruction or oncoplastics for other reasons including BMI\\>35 or inflammatory breast cancer or based on surgeon discretion.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Patients unable to complete the sessions because of language, travel or technology barriers\n* Patients already actively participating in another cessation program\n* Patients who are pregnant.",{"count":72,"type":21},[74],"Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications. Nicotine cessation is rarely addressed in breast cancer patients at the time of diagnosis and may be a missed opportunity to optimize patient outcomes. Patients that use nicotine products are not offered reconstruction at time of mastectomy or oncoplastics at the time of lumpectomy, which can be emotionally distressing in women with breast cancer. Reconstruction could be an additional motivating factor in nicotine cessation success.\n\nThis study aims to evaluate the feasibility of a nicotine cessation program designed by Area Health Education Center (AHEC) in the target population. The study is designed to test the acceptability, and preliminary efficacy of a formal nicotine cessation program in women actively using nicotine products with breast cancer recommended for reconstructive or oncoplastics surgery.",[30],[39,650,651,652,653],"nicotine cessation","mastectomy","reconstruction","smokers","2026-06-22",{"date":426,"type":54},{"date":657,"type":54},"2024-11-14",{"date":659,"type":21},"2029-03",{"name":60,"class":61},""]