[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":678},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,95341,0,25,[9,41,72,97,123,150,175,205,229,261,285,308,328,354,375,403,429,452,483,518,548,575,601,633,656],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":24,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":37,"locationsCount":40},"100053613","expanded-access-to-bezuclastinib-for-patients-with-nonadvanced-systemic-mastocytosis-or-advanced-systemic-mastocytosis-100053613",false,"NCT06915766","Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis","Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis","Key Inclusion Criteria:\n\n* Able to provide written informed consent and commit to EAP assessments.\n* ≥18 years of age.\n* Able to swallow tablets.\n* Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM\n* Not receiving adequate disease control on current therapy(ies).\n* Have clinically acceptable laboratory screening results.\n\nExclusion Criteria:\n\n* Patients who are eligible for and\u002For enrolled in an on-going bezuclastinib clinical trial.\n* Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.\n* Pregnant or currently breastfeeding.\n* Prior or ongoing clinically significant illness or medical or physical condition\n\nOther protocol-defined criteria apply.","ALL","18 Years","EXPANDED_ACCESS","The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and\u002For have no comparable or satisfactory alternative therapy options.",[22,23],"Systemic Mastocytoses, Indolent","Systemic Mastocytoses, Aggressive",[25,26,27,28,29,30,31],"Systemic Mastocytosis","NonAdvanced Systemic Mastocytosis","Advanced Systemic Mastocytosis","Systemic Mastocytosis with an associated hematologic neoplasm (SM-AHN)","Aggressive Systemic Mastocytosis (ASM)","Mast Cell Leukemia (MCL)","Bone Marrow Mastocytosis (BMM)","AVAILABLE","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"name":38,"class":39},"Cogent Biosciences, Inc.","INDUSTRY",23,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100053587","phase-1-combination-of-gns561-and-trametinib-in-patients-with-advanced-kras-mutated-cholangiocarcinoma-100053587","NCT05874414","Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma","Phase 1b\u002F2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma","Inclusion criteria:\n\n1. Histologically confirmed intrahepatic CCA with a documented KRAS mutation.\n2. Patients greater than or equal to 18 years of age.\n3. Patients must have disease progression that is not amenable to potentially curative treatment.\n4. Patients must have received one or two lines of chemotherapy.\n5. Patients must have at least one measurable disease by RECIST v1.1.\n6. Performance status (ECOG) 0-1.\n7. Adequate organ baseline function defined as follows: absolute neutrophil count ≥1000 cells\u002FμL, platelet count ≥75,000 cells\u002FμL, hemoglobin ≥9 g\u002FdL, aspartate aminotransferase or alanine aminotransferase less than or equal to 3 × upper limit of normal, estimated glomerular filtration rate ≥60 mL\u002Fmin, corrected QT interval by Fridericia's (QTcF) interval ≤470 msec.\n8. Women of childbearing potential must present with a negative serum pregnancy test and agree to use adequate contraception during the study and until 6 months after the end of treatment. Male patients with women partners of childbearing potential must agree with the contraception procedures of the study protocol.\n9. Patients must be able to understand and be willing to comply with the requirements of the study protocol.\n10. Patients participate voluntarily and sign informed consent form(s).\n\nExclusion criteria:\n\n1. Previous treatment with a MEK inhibitor or autophagy inhibitor.\n2. Previous treatment with three or more lines of prior chemotherapy.\n3. Extrahepatic CCA with recent (within 6 weeks) placement of a stent or episodes of unstable biliary stents (manifest as obstruction, migration of the stent, infevtion or mechanical failure of the stent) within 6 weeks according to investigator's judgement.\n4. Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n   1. Cardiovascular disorders: congestive heart failure New York Heart Association ≥ class 2 or left ventricular ejection fraction (LVEF) \\\u003C50%, arrythmias or cardiac conduction abnormalities. Uncontrolled arterial hypertension or inadequately controlled arterial hypertension, at the discretion of the investigator, based on an average of = \\>3 BP readings over = \\>2 sessions.\n   2. Patients who have retinal condition (retinal tear, exudate, hemorrhage) or history of retinal vein occlusion or central serous retinopathy or retinal pigment epithelial detachment.\n   3. History of interstitial lung disease or pneumonitis.\n   4. Patients who have clinically significant pleural effusion or ascites.\n   5. Patients who have neurological condition (e.g., tremor, ataxia, hypotension, confusion), history of seizures or active central nervous system metastases.\n   6. Impairment of gastrointestinal function or gastrointestinal disease (e.g., diarrhea, active ulcer disease, history of gastrointestinal perforation\u002Fhemorrhage, malabsorption or other conditions that under the judgment of the principal investigator (PI) may impair absorption of study drugs).\n   7. Patients who are taking antineoplastic drugs for concomitant cancer or history of malignancy other than CCA 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   8. Any other condition that would, in the Investigator s judgment, contraindicate the patients' participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection, unable to swallow medication, social\u002Fpsychological issues, etc).\n5. Known active viral hepatitis, including HBV and HCV.\n6. Patients with known allergic reaction to quinoline derivatives (e.g., quinine, chloroquine, mefloquine) and\u002For hypersensitivity to study drugs.\n7. Patients who have not recovered for certain AEs due to previous lines of therpay.\n8. Female patients who are pregnant or lactating at the time of enrollment.",{"count":49,"type":50},98,"ESTIMATED","INTERVENTIONAL",[53,54],"PHASE1","PHASE2","This is an open-label, multicenter Phase 1b\u002F2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy",[57],"Cholangiocarcinoma",[59,57,60,61,62],"GNS561","Trametinib","Phase1b\u002F2a","Bile Duct cancer","RECRUITING",{"date":35,"type":36},{"date":66,"type":36},"2023-08-21",{"date":68,"type":50},"2028-06",{"name":70,"class":39},"Genfit",11,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":51,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100053563","phase-2-a-phase-ii-clinical-study-of-multimodal-ablation-combined-with-systemic-drug-therapy-for-advanced-solid-tumors-100053563","NCT06889610","A Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","A Single-center,Multi-cohort,Prospective Phase II Clinical Study of Multimodal Ablation Combined With Systemic Drug Therapy for Advanced Solid Tumors.","Inclusion Criteria i. Common eligibility criteria for all cohorts:\n\n1\\. Age between 18-80 years,gender not limited; 2. Patients with hepatic lesions amenable to ablation, all hepatic lesions \\\u003C5 cm in diameter; 3. Expected survival≥3 months; 4. ECOG performance status score of 0-1; 5. Within 14 days before the first dose,laboratory tests indicate adequate organ function:\n\na) Hematology:WBC≥3.0×10\\^9\u002FL;ANC≥1.5×10\\^9\u002FL;PLT≥75×10\\^9\u002FL;HGB≥90 g\u002FL b) Liver function:Child-Pugh score≤7,AST≤5.0×ULN;ALT≤5.0×ULN;TBIL≤1.5×ULN c) Renal function:Cr≤1.5×ULN or CrCl≥60 mL\u002Fmin d) Coagulation function:INR≤1.5×ULN(for patients on anticoagulant therapy,≤3×ULN,anticoagulants must be discontinued one week before ablation);APTT≤1.5×ULN ii. Additional eligibility criteria for each cohort:\n\n1. Colorectal Cancer：\n\n   a) Clinically or pathologically confirmed colorectal cancer with liver metastases that are unresectable, or the patient is intolerant to or refuses surgery; b) Patients who have failed standard second-line drug therapy.\n2. Triple-negative breast cancer :\n\n   1. Clinically or pathologically confirmed triple-negative breast cancer(triple-negative defined as\\\u003C1% nuclear staining for ER and PR expression and HER2 negative);\n   2. Patients who have failed standard second-line drug therapy(including those who have failed PD-1 monoclonal antibody therapy, with progression within six months of adjuvant or neoadjuvant therapy considered as first-line therapy failure).\n3. Melanoma :\n\n   1. Clinically or pathologically confirmed melanoma liver metastasis, with inoperable or intolerable liver lesions or refusal of surgical resection;\n   2. Patients who have failed standard first-line drug therapy.\n\nExclusion Criteria:\n\ni. Common exclusion criteria for all cohorts:\n\n1. Patients with known allergy or suspected allergy to the study drugs or similar drugs;\n2. Patients who have participated in another clinical study and received at least one treatment within 4 weeks prior to enrollment;\n3. History or concurrent presence of other malignant tumors(except for cured basal cell carcinoma of the skin,superficial bladder cancer,carcinoma in situ of the cervix,and papillary thyroid carcinoma);\n4. Patients with immunodeficiency diseases within 7 days prior to the first dose,or currently receiving systemic corticosteroid therapy(≥10mg\u002Fday prednisone or equivalent dose of other corticosteroids),or other forms of immunosuppressive therapy;\n5. Symptomatic central nervous system(CNS)metastases,or other evidence indicating that the CNS metastases have not been controlled,and deemed unsuitable for enrollment by the investigator;\n6. Patients who have previously undergone organ or bone marrow transplantation;\n7. Uncontrollable pleural effusion,pericardial effusion,or ascites causing respiratory syndrome(≥CTCAE grade 2 dyspnea);\n8. Esophageal(gastric fundus)variceal rupture bleeding within the last month;\n9. Other antitumor treatments outside the combined regimen,such as radiotherapy,systemic chemotherapy,etc.;\n10. Clinically significant electrolyte abnormalities as judged by the investigator;\n11. Insufficiency or failure of major organs;\n12. Patients who have received systemic drug therapy,radiotherapy,or local liver treatment,with a time interval of less than 1 month since the last systemic treatment or local liver treatment;\n13. Patients who have received immunotherapy and experienced grade 3 or higher immune-related adverse events(irAEs)(except for thyroid function abnormalities,blood sugar abnormalities);\n14. Active or uncontrolled severe infections(≥CTCAE grade 2 infections);\n15. Any other disease,clinically significant metabolic abnormalities,physical examination abnormalities,or laboratory test abnormalities that,in the investigator's judgment,may have a disease or condition that makes the patient unsuitable for the study drug,or may affect the interpretation of the study results,or may place the patient at high risk;\n16. Pregnant or breastfeeding women,or women of childbearing age with a positive baseline pregnancy test;\n17. Known human immunodeficiency virus(HIV)infection;known clinically significant liver disease history,including viral hepatitis\\[known carriers of hepatitis B virus(HBV)must exclude active HBV infection,i.e.,HBV DNA positive(\\>1×10\\^4 copies\u002FmL or\\>2000 IU\u002FmL);known hepatitis C virus(HCV)infection and HCV RNA positive(\\>1×10\\^3 copies\u002FmL),or other hepatitis,cirrhosis;\n18. Patients with severe heart,lung,liver,or kidney dysfunction,irreversible coagulation disorders,or other uncontrolled diseases(including hypertension or diabetes,active infections,mental illness,or social conditions that may affect patient compliance);\n19. Other factors that may affect patient safety or trial compliance as judged by the investigator.\n\nii. Additional exclusion criteria for each cohort:\n\n1. Colorectal Cancer :\n\n   a) Patients with uncontrolled hypertension, defined as: patients with hypertension that cannot be well-controlled with a single antihypertensive agent (SBP ≥150 mmHg or DBP ≥100 mmHg); or patients who require two or more antihypertensive medications to control blood pressure.\n\n   b）Patients with urine dipstick proteinuria ≥2+ and a 24-hour urinary protein level \\>1.0 g.\n\n   c）Patients with gastrointestinal diseases such as active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from an unresected tumor; or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation.\n\n   d）Patients with evidence or history of a significant bleeding tendency within 3 months prior to enrollment (e.g., bleeding \\>30 mL, hematemesis, melena, hematochezia), hemoptysis (\\>5 mL of fresh blood within 4 weeks), or a thromboembolic event (including stroke and\u002For transient ischemic attack) within the past 12 months.\n\n   e）Patients with clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment.\n\n   f）Congestive heart failure of New York Heart Association (NYHA) class \\> II; ventricular arrhythmias requiring medication; or an ECG showing a QTc interval ≥480 milliseconds.\n\n   g）Patients who are unable to take fruquintinib orally.\n2. Triple-negative breast cancer :\n\n   a) Patients who have previously received pucotenlimab treatment;\n3. Melanoma :\n\n   1. Patients who have previously received pembrolizumab or toripalimab treatment;\n   2. Patients currently have uncontrolled hypertension,defined as:patients with hypertension that cannot be well controlled with monotherapy(systolic blood pressure≥150 mmHg,or diastolic blood pressure≥100 mmHg);or patients using two or more antihypertensive drugs to control blood pressure;\n   3. Urine routine indicates proteinuria≥2+,and 24-hour urine protein\\>1.0g;\n   4. Significant clinically meaningful cardiovascular diseases,including but not limited to acute myocardial infarction,severe\u002Funstable angina,or coronary artery bypass grafting within 6 months before enrollment;\n   5. Congestive heart failure New York Heart Association(NYHA)classification\\>2;ventricular arrhythmias requiring drug treatment;electrocardiogram(ECG)showing QTc interval≥480 milliseconds.","80 Years",{"count":81,"type":50},95,[54],"This study focuses on the treatment of liver metastases from three common cancers: colorectal cancer, triple-negative breast cancer and melanoma. Currently, there are limitations in the treatment of liver metastases of these cancers. Multimodal thermophysical ablation therapy can reshape the tumor microenvironment, release neoantigens, and act as an in-situ vaccine. On this basis, the combination of multimodal ablation with immunotherapeutic drugs such as pucotenlimab will be explored. The efficacy and safety of this combination therapy in patients with liver metastases of solid tumors will be investigated, with the expectation of breaking through the existing treatment limitations.",[85,86,87],"Triple Negative Breast Cancer Metastatic","Melanoma Metastatic","Colorectal Cancer Metastatic",{"date":35,"type":36},{"date":90,"type":36},"2026-03-30",{"date":92,"type":50},"2028-12-30",{"name":94,"class":95},"Fudan University","OTHER",1,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":96},"100053535","influence-of-hawthorne-effect-and-dual-tasks-on-gait-in-cp-100053535","NCT05417399","Influence of Hawthorne Effect and Dual-tasks on Gait in CP","Ecological Validity of Clinical Gait Analysis in Children With Cerebral Palsy: Influence of the Hawthorne Effect and Dual-tasks. A Pilot Study","Inclusion Criteria:\n\n* Cerebral palsy, bilateral spastic, GMFCS classification I-III\n* Age \\\u003C16 years\n* Use of bilateral AFO's (rigid or ground reaction AFO's) to improve knee extension in stance\n\nExclusion Criteria:\n\n* Behavioural issues or poor instructability which might affect participation in the protocol\n* Significant visual disorders\n* Other diagnoses influencing gait\n* Not willing to sign informed consent before inclusion","4 Years","16 Years",{"count":107,"type":50},15,"OBSERVATIONAL","It is the clinical experience of the authors that some children with cerebral palsy who walk in crouch gait show sufficient knee extension during the clinical gait analysis, but walk in considerable knee flexion when they leave the gait laboratory. Possible differences between walking in a gait lab and walking in daily life may be caused by the effect of observational awareness in the lab (also known as the Hawthorne effect), and the lack of dual-tasks (DT) during the analysis (which are common during daily life walking). Since so far there is no technique to reliably measure gait kinematics in children with CP outside of the laboratory, the researchers aim to objectify the influence of both the Hawthorne effect and dual-tasks by introducing different conditions during a standard clinical 3D gait analysis.",[111,112,113,114,115],"Cerebral Palsy","Gait Disorders, Neurologic","Hawthorne Effect","Dual-tasks","Kinematics",{"date":35,"type":36},{"date":118,"type":36},"2022-09-01",{"date":120,"type":50},"2028-12-01",{"name":122,"class":95},"Roessingh Research and Development",{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":51,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100054308","phase-2-testing-mosunetuzumab-alone-with-zanubrutinib-or-with-polatuzumab-vedotin-for-treating-marginal-zone-lymphoma-that-came-back-or-didnt-get-better-with-treatment-100054308","NCT07638722","Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment","MOZART MZL: A Randomized Phase II Study Evaluating Mosunetuzumab Alone and in Combination With Either Zanubrutinib or Polatuzumab Vedotin for the Treatment of Patients With Relapsed\u002FRefractory Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Participants must have histologically diagnosed CD20+ marginal zone lymphoma (MZL) as per World Health Organization (WHO) criteria including splenic, nodal, and extranodal subtypes, but excluding gastrointestinal-only marginal zone lymphoma (MZL) with disease assessments that can only be evaluated through endoscopic methods and cutaneous-only MZL.\n\n  * NOTE: A repeat biopsy to confirm MZL diagnosis is NOT required at time of relapse unless:\n\n    * The participant has received prior CD3\u002FCD20 bispecific antibody, then a repeat biopsy to document continued CD20+ MZL disease is required after the completion of the prior CD3\u002FCD20 bispecific antibody therapy and prior to study registration.\n    * The participant has splenic MZL in which a bone marrow biopsy pre-registration is required within 42 days prior to registration\n* Participants must have measurable disease by PET-CT (preferred), or CT as defined by extranodal lesion ≥ 1cm or nodal lesion ≥ 1.5cm.\n\n  * Participants with splenic MZL are included in the study if spleen standardized uptake value (SUV) (or any splenic masses) is \\> liver (standardized uptake value) SUV background and\u002For spleen size is \\> 13cm.\n  * Participants must have staging imaging performed within 42 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the neck, chest, abdomen, and pelvis, are acceptable. All disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Participants must have one or more of the following criteria for further systemic therapy as per the discretion of the treating physician:\n\n  * Symptoms due to progressive or bulky nodal disease.\n  * Progressive disease that is currently compromising or may compromise normal organ function if left untreated.\n  * Presence of systemic B symptoms (i.e. fevers, weight loss, night sweats).\n  * Presence of symptomatic extranodal disease.\n  * Cytopenias due to bone marrow infiltration or hypersplenism.\n  * An increase in the tempo of disease progression\n* Participants must not have known or clinically suspected transformation to diffuse large B-cell lymphoma or high-grade B-cell lymphoma. Participants with prior transformed disease but now in relapse with MZL only are allowed on study\n* Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first eight cycles (6 months) of protocol therapy\n* Participants must have relapsed\u002Frefractory MZL after at least one line of prior CD20-directed systemic therapy (either as monotherapy or in combination with chemotherapy or lenalidomide).\n\n  * Prior antibiotic and radiation treatments for localized MZL disease are allowed and do not count as one line of systemic therapy\n* Participants who have been treated with prior Bruton's tyrosine kinase inhibitor (BTKi) or CD3\u002FCD20 targeting bispecific antibodies for their MZL must have completed treatment 180 days prior to registration and must have received a best response of either a partial or complete response\n* Participants being treated with strong and moderate CYP3A4 inducers must be off these therapies within 14 days or 5 half-lives of the drug prior to registration, whichever is shorter\n* Participants must have recovered (\\\u003C grade 2) from any side effects of prior therapy, except for alopecia and lymphopenia\n* Participants must not have been treated with prior polatuzumab vedotin for any condition\n* Participants must not have received chimeric antigen receptor T-cells (CAR-T) within 28 days prior to registration\n* Participants must not have received autologous stem cell transplantation within 100 days prior to registration\n* Participants must not have received allogeneic stem cell transplantation within 180 days prior to registration nor have active graft versus host disease requiring the current use of systemic steroid treatment ≥ 10mg of prednisone (or equivalent)\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (defined as equivalent to ≥ 10mg prednisone) or other immunosuppressive medications within 7 days prior to registration.\n\n  * NOTE: Replacement steroid therapy for adrenal or pituitary insufficiency or short-term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is permitted\n* Participants must not have known clinically active post-transplant lymphoproliferative disorder\n* Participants must not have a known history of severe allergic reaction attributed to compounds of similar chemical or biologic composition to mosunetuzumab SQ, zanubrutinib or polatuzumab vedotin\n* Participants must not have received either primary or booster vaccination with live or attenuated vaccines within 28 days prior to registration\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod Performance Status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count ≥ 1.0 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * Note: Participants with documented MZL bone marrow involvement or a known\u002Fdocumented Fy (A-\u002FB-) immunophenotype by completed duffy antigen phenotyping (i.e. \"Duffy-Null\") must have absolute neutrophil count (ANC) ≥ 0.5 x 10\\^3\u002FuL. Growth factor use is allowed\n* Platelets ≥ 75 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * Note: Participants with documented MZL bone marrow or splenic involvement must have platelets ≥ 50 x 10\\^3\u002FuL\n* Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration)\n\n  * Note: Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration)\n* Participants must have a calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench\n* Participants must have an international normalized ratio (INR) \\\u003C 2 x ULN within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification within 28 days prior to registration. To be eligible for this trial, participants must be class 2B or better, in the opinion of the treating physician\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 180 days prior to registration\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 180 days prior to registration, if indicated. Participants with a positive hepatitis (Hep) B core antibody are at high risk for reactivation and should receive prophylactic antiviral therapy (e.g., entecavir) before initiation of and throughout the duration of protocol treatment\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 180 days prior to registration, if indicated\n* Participants must not have any known uncontrolled intercurrent illness (in the opinion of the treating physician) that would jeopardize the participant's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, peripheral neuropathy, hypertension and gastrointestinal disorders affecting swallowing and\u002For absorption of pills\n* Participants must not require or be receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days prior to registration\n* Participants must not have a history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* Participants must not have a history of stroke or intracranial hemorrhage within 180 days prior to registration\n* Participants must not have a history of progressive multifocal leukoencephalopathy\n* Participants must not have uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura)\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete the PRO-CTCAE questionnaires in English or Spanish must be offered the opportunity to participate in the patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":131,"type":50},138,[54],"This phase II trial compares the effect of mosunetuzumab alone to mosunetuzumab with zanubrutinib or polatuzumab vedotin in patients with marginal zone lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Zanubrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as marginal zone lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug, called monomethyl auristatin E. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79B receptors, and delivers monomethyl auristatin E to kill them. Giving mosunetuzumab alone or with zanubrutinib or polatuzumab vedotin may work well for treating relapsed or refractory marginal zone lymphoma.",[135,136,137,138,139,140],"Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Recurrent Nodal Marginal Zone Lymphoma","Recurrent Splenic Marginal Zone Lymphoma","Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Refractory Nodal Marginal Zone Lymphoma","Refractory Splenic Marginal Zone Lymphoma","NOT_YET_RECRUITING",{"date":35,"type":36},{"date":144,"type":50},"2026-10-03",{"date":146,"type":50},"2035-04-03",{"name":148,"class":149},"SWOG Cancer Research Network","NETWORK",{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100054288","diagnostic-performance-of-4d-dynamic-lafov-fdg-pet-acquisition-for-differentiation-of-residual-disease-and-post-radiation-inflammation-in-head-neck-scc-treated-by-radiotherapy-100054288","NCT07417605","Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.","POLARIS","Inclusion Criteria:\n\n* Adult patient ≥ 18 years of age\n* Presenting with head and neck squamous cell carcinoma\n* Completed curative treatment with external radiation therapy\n* Eligible for dynamic LAFOV FDG-PET scan for therapeutic evaluation at 3 months\n* Having given consent for the end-of-treatment consultation\n\nExclusion Criteria:\n\n* Hypersensitivity to 18F-FDG or other excipients contained in the contrast agent\n* Pregnancy or breastfeeding\n* History of treated upper gastrointestinal tract cancer\n* Other histology\n* Incomplete RTE treatment regimen\n* Refusal to participate",{"count":158,"type":50},180,"This multicenter prospective observational study will evaluate the value of dynamic FDG-PET LAFOV imaging during the initial therapeutic assessment of a head and neck cancer 3 months after completion of curative radiotherapy.",[161],"Head & Neck Squamous Cell Carcinoma",[163,164,165,166],"4D dynamic analysis","post-radical inflammation","squamous cell carcinomas","FDG-PET LAFOV",{"date":35,"type":36},{"date":169,"type":36},"2026-04-13",{"date":171,"type":50},"2029-06-13",{"name":173,"class":95},"University Hospital, Brest",3,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":51,"phases":186,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":40},"100053451","phase-2-acp-211-monotherapy-for-major-depressive-disorder-with-inadequate-antidepressant-response-100053451","NCT07284667","ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response","A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment","NORLIGHT","Inclusion Criteria:\n\n* Adults ≥18 and ≤65 years of age\n* Provides written informed consent\n* Clinical diagnosis of MDD\n* History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode\n* Currently treated with an approved antidepressant at a stable dose prior to Screening\n* MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 at Screening and Baseline\n* Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation\n\nExclusion Criteria:\n\n* Current diagnosis of certain personality disorders or persistent depressive disorder\n* Recent substance use disorders, excluding caffeine or nicotine\n* Active suicidal risk or recent suicidal attempt\n* History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features\n* Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD\n* History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)\n* Documented non-response to ADT, including ketamine or esketamine\n* Allergy or sensitivity to ketamine or esketamine\n* Significant cardiovascular disease\n* Positive history of hepatitis B, hepatitis C, or HIV infection\n* Unstable diabetes or uncontrolled medical conditions\n* Positive urine drug test for an illicit drug or cannabis\n* Received neuromodulation therapies (ECT,TMS, VNS, DBS) in the current depressive episode\n* Recent initiation or change in psychotherapy Additional inclusion\u002Fexclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.","65 Years",{"count":185,"type":50},153,[54],"The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).\n\nThe main questions the study aims to answer are:\n\n* Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?\n* What adverse events do participants have when taking ACP-211?",[189,190],"Major Depressive Disorder (MDD)","Depressive Disorder, Treatment-Resistant",[189,190,192,193,194,195,196,197],"Antidepressive Agents","Randomized Controlled Trial","Double-Blind Method","Clinical Trial, Phase II","Psychiatric Status Rating Scales","Ketamine",{"date":35,"type":36},{"date":200,"type":36},"2025-11-14",{"date":202,"type":50},"2027-09",{"name":204,"class":39},"ACADIA Pharmaceuticals Inc.",{"id":206,"slug":4,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":4,"leadSponsor":226,"locationsCount":96},"100054269","NCT00028080","Evaluation, Treatment, and Follow-up of Patients With Lyme Disease","* INCLUSION CRITERIA:\n* Clinical diagnosis of active Lyme disease at the time of the initial NIH evaluation based on the CDC case definition. Study physician will review history to confirm probable cases.\n* Subjects must maintain a private physician for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders.\n\nEXCLUSION CRITERIA:\n\n* Post treatment Lyme disease syndrome.\n* Unacceptably poor compliance, which, in the opinion of the investigator, would interfere with one's ability to study or provide quality medical care for the patient.\n\nELIGIBILITY CRITERIA TO BE ASKED TO UNDERGO APHERESIS INCLUDE:\n\n* Age 18 years or above\n* Weight greater than 110 pounds\n* No known heart, lung, kidney disease, or bleeding disorders\n* Negative HIV, HCV and HBsAg serologies\n* Female subjects should not be pregnant or nursing\n* Adequate peripheral venous access\n\nPatients will have a CBC performed up to 2 weeks before the procedure. In order to be able to undergo the procedure, patient must fulfill all of the below:\n\n* Hemoglobin greater than 11 g\u002FdL for males and greater than 10 g\u002FdL for females\n* Platelets greater than 150 k\u002Fmm(3)\n* WBC greater than 3.5 x 10(3) uL\n* MCV above 80\n\nWomen who are able to conceive children must have a negative pregnancy test within 2 weeks before the procedure.","2 Years","99 Years",{"count":213,"type":50},500,"This study is designed to establish a population of patients with Lyme disease for evaluation, treatment and follow-up to learn more about the infection.\n\nPatients with active Lyme disease may be eligible for this study.\n\nParticipants will have a medical history and physical examination and diagnostic evaluations as appropriate to their individual condition. Laboratory tests may include routing blood and urine tests, X-rays, or other imaging studies, body fluid or tissue cultures, skin biopsy and tests for allergic or immune responses. Treatment will include only medications approved by the Food and Drug Administration, given according to accepted dose schedules and ways of taking the medicines. All diagnostic tests and treatments will be according to standard medical practice for the disease. No experimental procedures will be offered under this protocol.\n\nPatients will be followed as needed for evaluation and treatment of their condition. In general, they will be asked to return at the end of therapy, then 3, 6 and 12 months later, and then every 6 to 12 months. More frequent visits may be required or less frequent visits may be allowed, depending on the individual s condition.\n\nParticipants may be asked to undergo the following additional procedures for research purposes:\n\n* Extra blood draws to study Lyme disease and other inflammatory conditions. Blood will be drawn from arm veins. The total amount drawn during any 6-week period will not exceed 450 cc (30 tablespoons) for adults and 7 cc (1\u002F2 tablespoon) per kilogram (2.2 pounds) of body weight for children under 18 years of age.\n* Leukapheresis to collect large numbers of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body through the same needle. Only adults 18 years of age and older will be asked to undergo leukapheresis.",[216],"Lyme Disease",[218,216,219,220,221,222],"Borrelia Burgdorferi","Infection","Therapy","Natural History","Lyme",{"date":35,"type":36},{"date":225,"type":36},"2002-01-16",{"name":227,"class":228},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":236,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100053447","a-us-study-that-observes-how-parkinsons-disease-changes-over-time-in-patients-who-still-have-movement-symptoms-despite-taking-parkinsons-medications-100053447","NCT07330258","A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite Taking Parkinson's Medications","A Natural History Study of Treated Parkinson's Disease Patients Experiencing Motor Complications","Inclusion Criteria for Patient:\n\n* Individual of any sex ≥45 to ≤75 years of age at informed consent (at least 30% ≤60 years of age).\n* Diagnosis of clinically established Parkinson's disease (PD) as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD ≥4 and \\\u003C12 years from time of PD diagnosis at informed consent.\n* Modified H\\&Y stage II-III in the practically defined OFF-medication state (≥12 hours from last dose of antiparkinsonian medications).\n* Score of ≥30 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III in the OFF-medication state.\n* Presence of motor fluctuations with ≥1 hour of absolute time in the OFF state per day as assessed by clinician\u002Fpatient at screening.\n* Receiving stable antiparkinsonian medication regimen for ≥4 weeks prior to screening with a levodopa daily dose ≥300 mg or a dosing frequency of ≥3 times per day.\n* Responsiveness to levodopa as determined by change in the following measures from the practically defined OFF state to ON state after taking typical first-daily dose of PD-medications: i. any degree of improvement (≥0.5 point) in modified H\\&Y stage OR. ii. ≥30% improvement in MDS-UPDRS part III score.\n* Montreal Cognitive Assessment (MoCA) score of ≥24.\n* Agree to participate and provide signed informed consent.\n\nExclusion Criteria for Patient:\n\n* Known history or presence of conditions that may provide an alternative to a PD diagnosis including but not limited to: multiple system atrophy, progressive supranuclear palsy, striatonigral degeneration, corticobasal syndrome\u002Fdegeneration, vascular Parkinsonism, drug-induced Parkinsonism, essential tremor, diffuse Lewy body disease, Lewy body dementia, Huntington's disease, Wilson's disease, Fahr's disease, Alzheimer's disease, cerebrovascular disease, brain tumor, trauma, and infection.\n* Known history or presence of significant vascular and\u002For cardiovascular disease limited to: stroke, transient ischemic attacks, poorly controlled hypertension, poorly controlled diabetes, unstable angina pectoris, or unstable myocardial infarction.\n* Known history or presence of significant psychosis or impulse control disorder, or untreated or sub optimally treated depression.\n* Known history or presence of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, syphilis, or tuberculosis.\n* Current or previously active malignant disease within the past 5 years, except definitively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or in situ uterine cervical carcinoma.\n* Currently pregnant, nursing, lactating, breastfeeding, or plan to be during study duration.\n* Known history or current use of percutaneous levodopa\u002Fcarbidopa intestinal gel, subcutaneous levodopa, or apomorphine pump.\n* Prior history of brain surgery, including but not limited to: deep brain stimulation (DBS), pallidotomy, focused ultrasound thalamotomy, or other experimental neurosurgical procedure.\n* Known history or current participation in cell or gene therapy procedures.\n* Current participation in any interventional clinical trial.\n\nInclusion Criteria for Care Partner:\n\n* ≥18 years of age at informed consent.\n* Identified by the PD patient as their primary care partner.\n* Agree to participate and the ability to provide signed informed consent independently, without the need for a legal representative.\n\nExclusion Criteria for Care Partner:\n\n* Not applicable.","45 Years","75 Years",{"count":239,"type":50},300,"This is an observational study in which data are collected and studied from Parkinson's disease patients who have movement symptoms despite taking standard Parkinson's medications. In observational studies, observations are made without any changes to the participant's healthcare or treatment plan. No investigational product will be administered in this study, as participants will be treated with the standard of care that medical experts currently consider most appropriate.\n\nParkinson's disease (PD) is a condition that affects the brain and causes problems with movement and other body functions. The symptoms of Parkinson's disease can worsen over time. People with Parkinson's disease may experience shaking (tremor), slow movements, stiff muscles, trouble walking, and problems with balance. They can also have other symptoms, such as difficulty thinking clearly, changes in mood, or difficulty sleeping. Parkinson's disease mostly affects older adults, but it can happen to younger people too. There is no cure, but treatments can help manage the symptoms and improve quality of life.\n\nWhile doctors and researchers know that Parkinson's disease affects people in different ways and can worsen over time, there are still many things they don't fully understand-especially for people who experience movement symptoms despite taking their usual Parkinson's medicines. Earlier studies did not follow these patients long enough or collect all the important information needed. This study is being done to fill those gaps.\n\nThe main purpose of this study is to better understand how Parkinson's disease changes over time in patients who experience movement symptoms while taking standard oral Parkinson's medications, what challenges patients and their care partners face, and how their treatments are working in real life. To do this, researchers will collect data on:\n\n* Sociodemographics (e.g. age, gender, race\u002Fethnicity, insurance provider).\n* Medical history and vital signs (e.g. comorbidities, family history of Parkinson's, height, weight, blood pressure).\n* Medications and treatments (e.g. Parkinson's and non-Parkinson's medications and other treatments, rehabilitation therapy sessions, use of mobility assistance devices).\n* Movement symptoms (e.g. tremor, slow movement, balance).\n* Non-movement symptoms (e.g. cognition, mood, sleep, activities of daily living).\n* Molecular data (e.g. genetics, α-synuclein).\n* Burden of care (e.g. economic cost).\n\nData will come from questionnaires or rating scales conducted by the doctor with the patient during study visits, diaries and logs completed by the patient, medical records, health insurance claims records, blood samples and skin biopsies, a digital device that records movement\u002Fnon-movement symptoms, and questionnaires completed by the care partner.\n\nData will be collected from December 2025 to December 2032. Each participant may be followed for up to 5 years.",[242],"Parkinson's Disease",[244,245,246,247,248,249,250,251,252],"Natural history study","Parkinson's disease","PD Motor (Hauser) Diary","MDS-UPDRS","Electronic health\u002Fmedical records","Administrative claims data","Biological samples","Digital health technology","Care partner",{"date":35,"type":36},{"date":255,"type":50},"2026-07-22",{"date":257,"type":50},"2033-06-01",{"name":259,"class":39},"Bayer",26,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":51,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100054268","phase-2-testing-the-use-of-neratinib-or-the-combination-of-neratinib-and-palbociclib-targeted-treatment-for-her2-solid-tumors-a-combomatch-treatment-trial-100054268","NCT06126276","Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)","A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4\u002F6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial","Inclusion Criteria:\n\n* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191\n* Patients must have a HER2 amplified solid tumor except breast cancer.\n\n  * If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)\u002FFISH or next generation sequencing (NGS) status\n  * If IHC is 3+, pt IS ELIGIBLE regardless of ISH\u002FFISH or NGS status\n  * If IHC is 2+, ISH\u002FFISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE\n  * If IHC is unknown and…\n\n    * ISH\u002FFISH is positive, independent of NGS results, the patient IS ELIGIBLE\n    * ISH\u002FFISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE\n* Patients must have recurrent or persistent disease\n* No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation\n* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)\n* Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required\n* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic\n* No known leptomeningeal disease\n* Patients may have received up to 5 prior lines of systemic therapy\n* Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed\n* No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib\n* No prior therapy with CDK4\u002F6 inhibition\n* No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g\u002Fdl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and\u002For need for drainage nasogastric or gastrostomy tube\n* No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy\n* No lung disease causing dyspnea at rest\n* No interstitial lung disease with ongoing signs and symptoms at the time of registration\n* No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients",{"count":269,"type":50},70,[54],"This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.",[273,274,275,276],"Malignant Female Reproductive System Neoplasm","Malignant Solid Neoplasm","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm",{"date":35,"type":36},{"date":279,"type":36},"2024-05-07",{"date":281,"type":50},"2027-02-20",{"name":283,"class":228},"National Cancer Institute (NCI)",188,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":51,"phases":294,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":4},"100053444","big-chicago-a-trial-of-basic-income-guarantee-for-young-people-living-with-hiv-100053444","NCT07502365","BIG Chicago: A Trial of Basic Income Guarantee for Young People Living With HIV","Inclusion Criteria:\n\n* Living with HIV for 24 months or longer;\n* Ages 18-35;\n* English-speaking;\n* One or both of the following:\n\n  1. Experienced a gap in HIV provider care of 6 or greater months during the prior 12-month period;\n  2. Had an unsuppressed viral load at any point within the prior 12-month period (unsuppressed meaning a viral load of 200 copies\u002FmL or higher);\n* Household income at or below 250% of the Federal Poverty Level; and\n* Experiencing financial distress, as based on a financial well-being score of 1-4 (high financial distress).\n\nExclusion Criteria:\n\n* Unwilling\u002Funable to provide informed consent\n* Unable to confirm HIV status\n* Unable to conduct the study in English","35 Years",{"count":293,"type":50},304,[295],"NA","The goal of this clinical trial is to compare two interventions - Basic Income Guarantee (BIG) + Treatment as Usual and Treatment as Usual among individuals living with HIV who have experienced financial hardships.\n\nThe main question it aims to answer is:\n\nCompared with the Treatment as Usual group, will participants in the BIG + Treatment as Usual group be more likely to improve care engagement and viral suppression?\n\nParticipants on the study will be:\n\n* Randomly assigned (like the flip of a coin) to participate in either BIG + Treatment as Usual or Treatment as Usual. Participants will have an equal chance of being placed in either group.\n* Complete 9 surveys over a 36 month period.\n* Complete a release of information so electronic medical record data can be accessed for the 18 months prior to treatment engagement and for 36 months from program enrollment.\n* Participants in the Treatment as Usual group will not receive any intervention.\n* HIV viral load testing will be confirmed at 3 timepoints (baseline, 12 months, and 18 months).\n* Participants in the BIG + Treatment as Usual group will receive $500 monthly income for 18 months.\n* Participants in the BIG + Treatment as Usual group will complete 3 social network surveys to assess how receiving BIG impacts their social networks.\n* A subset of participants in the BIG + Treatment as Usual group (30 participants) will complete 5 individual interviews over the course of receiving BIG and the 18 months after.",[298,299],"HIV","Financial Stress",[298,299],{"date":35,"type":36},{"date":303,"type":50},"2026-07",{"date":305,"type":50},"2030-07",{"name":307,"class":95},"University of Chicago",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":96},"100053440","septic-shock-induced-immunosuppression-100053440","NCT04067674","Septic Shock-induced Immunosuppression","Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration","IMMUNOSEPSIS 4","Inclusion Criteria:\n\n* Age over 18 years\n* Patient admitted to ICU\n* Diagnosis of septic shock within less than 48h at time of screening defined by :\n* Presence of a microbiologically diagnosed or suspected infection\n* Initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm Hg initiated during the first 48h after ICU admission\n* Presence of an hyperlactatemia \\> 2 mmol\u002FL (18 mg\u002FdL) during the 24h before or after initiation of vasopressive treatment despite adequate volemic reanimation (30 ml\u002Fkg)\n* Blood sample at D3\u002FD4 available (lab working days)\n* Non opposition to study participation obtained from patient or next of kin\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Patient with no social security insurance, with restricted liberty or under legal protection\n* Language barrier\n* Patient taking part in interventional study about medicin that could interfere with biologic results",{"count":317,"type":50},305,"Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions.\n\nIn this context, the main objectives of IMMUNOSEPSIS 4 study are:\n\n1. to identify the best biomarkers for sepsis-induced immunosuppression\n2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock",[320],"Septic Shock",{"date":35,"type":36},{"date":323,"type":36},"2019-10-21",{"date":325,"type":50},"2026-11-21",{"name":327,"class":95},"Hospices Civils de Lyon",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":335,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":51,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":96},"100053435","culturally-centered-cbt-protocol-for-suicidal-behaviors-among-youth-in-mexico-city-100053435","NCT06885047","Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City","Implementation and Pilot Testing of a Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City","Youth Inclusion Criteria:\n\n* ages 12 to 17,\n* severe SI, defined as a score of 22 or above on the SIQ-JR or having made a SA or having a suicidal crisis (e.g., threats of attempting suicide) within the last 3 months\n* not be engaged in mental health services outside HPIJNN.\n\nExclusion Criteria:\n\n* having a diagnosis of a psychotic disorder\n* having a diagnosis of substance use disorder, rated severe on the DSM-593 (i.e., endorsement of 6 or more symptoms),\n* not having sufficient cognitive ability to enter a psychotherapy service (whether reported by the parents or by data in the clinical record)","12 Years","17 Years",{"count":338,"type":50},60,[295],"This NIMH R34 award application proposes to conduct an adaptation, implementation, and pilot testing of the culturally centered CBT protocol, the Socio-Cognitive Behavioral Therapy for Suicidal Behaviors (SCBTSB), among suicidal youth in Mexico City, Mexico.\n\nThe research plan will (a) culturally adapt and contextualize the SCBT-SB for its implementation in the Mexican public health system, (b) pilot test the protocol through an RCT (SCBT-SB vs TAU; 60 patients and caregivers) and (c) evaluate the implementation process of the SCBT-SB and assess qualitatively possible factors that may promote or hinder its future uptake.",[342],"Suicidal Ideation\u002FBehavior",[193,344,345,346],"Mexico youth","cultural adaptation","cognitive behavioral therapy",{"date":35,"type":36},{"date":349,"type":50},"2026-09",{"date":351,"type":50},"2027-06",{"name":353,"class":95},"Bradley Hospital",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":51,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100053422","phase-2-a-phase-ii-study-evaluating-the-efficacy-and-safety-of-inavolisib-plus-ribociclib-plus-fulvestrant-versus-placebo-plus-ribociclib-plus-fulvestrant-in-participants-with-advanced-breast-cancer-100053422","NCT07405801","A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer","A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent\n* Documented estrogen receptor (ER)-positive and\u002For progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines, defined as \\>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)\n* Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen\n* Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n\nExclusion Criteria:\n\n* Metaplastic breast cancer\n* Radiotherapy within 2 weeks before randomization\n* Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible\n* Any history of leptomeningeal disease or carcinomatous meningitis",{"count":362,"type":50},80,[54],"A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).",[366],"Breast Cancer",{"date":35,"type":36},{"date":369,"type":36},"2026-04-07",{"date":371,"type":50},"2030-02-26",{"name":373,"class":39},"Hoffmann-La Roche",49,{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":385,"conditions":386,"keywords":390,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100053420","to-assess-the-correlation-of-high-resolution-specimen-pet-ct-imaging-using-the-xeos-aura-10-pet-ct-with-the-histopathology-results-and-long-term-outcome-of-patients-undergoing-resective-cancer-surgery-100053420","NCT06970275","To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","PETRiS","Inclusion Criteria :\n\nAll patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT.\n\nPatients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent.\n\nExclusion Criteria:\n\n* Under the age of 18 years at the time of resective surgery.\n* Women who are pregnant or breastfeeding.",{"count":384,"type":50},850,"This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.",[387,366,388,389],"Prostate Cancers","Head and Neck Cancer","Cancer",[391,392,393,394],"PET-CT","Registry","Imaging","cancer",{"date":35,"type":36},{"date":397,"type":36},"2025-11-19",{"date":399,"type":50},"2031-01-15",{"name":401,"class":39},"XEOS Medical",2,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":51,"phases":412,"briefSummary":413,"conditions":414,"keywords":419,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":402},"100054248","phase-1-a-study-of-ln-144-or-ln-145-in-people-with-advanced-uveal-melanoma-undifferentiated-pleomorphic-sarcoma-dedifferentiated-liposarcoma-or-angiosarcoma-100054248","NCT05607095","A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","Inclusion Criteria:\n\n* Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.\n\n  o Patients will be eligible regardless of the number of prior systemic therapies received.\n* Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* Cohort 3: Must have a confirmed diagnosis of unresectable or metastatic angiosarcoma that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).\n* Patients must be ≥ 18 years of age at the time of consent.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.\n* Patients must have the following hematologic parameters:\n\n  * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n  * Hemoglobin (Hb) ≥ 9.0 g\u002FdL\n  * Platelet ≥ 100,000\u002Fmm\\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the ICF and continuing through the Screening Period\n* Patients must have adequate organ function:\n\n  * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 × ULN); patients with liver metastasis ≤ 5 × ULN\n  * Estimated creatinine clearance (eCrCl) ≥ 40 mL\u002Fmin using the Cockcroft-Gault formula at Screening\n  * Total bilirubin ≤ 2 mg\u002FdL\n  * Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg\u002FdL\n* Patients must be seronegative for the following:\n\n  * Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies\n  * Hepatitis B antigen (HBsAg), hepatitis B core antibody (anti- HBc), or hepatitis C antibody (HCV Ab). Patients with acute or chronic hepatitis infections may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment.\n  * Syphilis (Rapid Plasma Reagin \\[RPR\\] test or venereal disease research laboratory \\[VDRL\\] test)\n  * Cytomegalovirus (CMV) IgM antibody titer or PCR assay; and Epstein-Barr virus (EBV) IgM or PCR assay indicating active infection\n  * Herpes simplex virus (HSV)-1 and HSV-2 IgM serology or PCR assay\n* Patients who are HSV immunoglobulin M (IgM) or PCR assay positive will need to receive appropriate treatment and become IgM or PCR assay negative prior to starting the NMA-LD pre-conditioning regimen\n* Anyone with prior COVID-19 infection must be asymptomatic for \\>30 days prior to NMA-LD.\n* Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration, as detailed below prior to the first study treatment (ie, start of NMA-LD):\n\n  * Targeted therapy: prior targeted therapy with an EGFR, MEK, BRAF, ALK, ROS1, or other-targeted agents (eg, erlotinib, afatinib, dacomitinib, osimertinib, crizotinib, ceritinib, lorlatinib) is allowed provided the washout is a minimum of 14 days or 5 half-lives (whichever is longer) prior to the start of treatment\n  * Chemotherapy: minimum of 21 days prior to the start of treatment\n  * Immunotherapy: checkpoint-targeted therapy with an anti PD-1\u002Fanti PD-L1, other monoclonal antibodies, or vaccines are allowed, provided the washout is a minimum of 21 days prior to the start of study treatment\n* Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 5.0.\n* Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0), except for alopecia or vitiligo, prior to enrollment.\n\n  * Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and\u002For had a normal colonoscopy post-immune checkpoint inhibitortreatment, by visual assessment, prior to tumor resection.\n  * Patients with immunotherapy-related endocrinopathies (e.g. hypothyroidism) stable for at least 6 weeks and controlled with hormonal replacement are allowed.\n* Previous surgical procedure(s) is\u002Fare permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.\n* Patients of childbearing potential (or female partners of male participants) must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after their last dose of IL-2. Approved methods of birth control are as follows:\n\n  * Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal\n  * Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner\n  * True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable\n* Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.\n\nExclusion Criteria:\n\n* Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.\n* Patients who have a history of hypersensitivity to any component or excipient of LN-144\u002FLN-145 or other study drugs:\n\n  * NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)\n  * Proleukin®, aldesleukin, IL-2\n  * Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity\n  * Any component of the LN-144\u002FLN-145 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.\n* Patients with symptomatic brain metastases (of any size and any number).\n\n  o Patients with definitively treated brain metastases may be considered for enrollment, if, prior to tumor resection for TIL, the patient is clinically stable for ≥ 14 days, there are no symptomatic brain lesions, and that the patient does not require ongoing corticosteroid treatment.\n* Patients who are on chronic systemic immunosuppressive therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily. Transient use of steroids, e.g. in the perioperative period, is not an exclusion.\n* Patients who are pregnant or breastfeeding.\n* Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.\n* Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immunodeficiency syndrome \\[AIDS\\]).\n* Patients who have a left ventricular ejection fraction (LVEF) \\\u003C45% or New York Heart Association (NYHA) functional classification \\> Class 1.\n\n  * Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and\u002For ventricular arrhythmias must have a cardiac stress test.\n  * Patients with any irreversible wall movement abnormalities are excluded.\n* Patients who have a smoking history or signs or symptoms of obstructive or restrictive pulmonary disease and have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% of predicted normal:\n\n  * If a patient is not able to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary function.\n  * Patients who are unable to walk a distance of at least 80% predicted for age and sex or demonstrates evidence of hypoxia at any point during the test (SpO2 \\\u003C 90%) are excluded.\n* Active, uncontrolled systemic infections, including COVID-19, within 30 days of surgery or NMA-LD. An uncomplicated bacterial UTI treated successfully with symptom resolution is not an exclusion.\n* Participation in another clinical study with an investigational product within 21 days of the initiation of NMA-LD.\n* No other active, concurrent malignancy that requires ongoing systemic treatment (e.g. indolent prostate) or interferes with radiographic assessment of response as determined by the investigator. Exceptions may allow for adjuvant NED cancers undergoing hormone-based therapy assuming the other eligibility criteria are met and the PI affirms the hormonal agent would not change the response.\n\nEligibility Designation for Lymphodepletion\n\nPatients meeting eligibility criteria above between Day -21 and Day -8 prior to the planned initiation of lifileucel will be enrolled to the therapeutic portion of the protocol.\n\nAll patients' eligibility criteria, including repeating cardiopulmonary function tests as necessary, will be reassessed within several days prior to the scheduled lymphodepletion in all cases.\n\nPrior to beginning the NMA-LD preparative regimen the following requirements must be met:\n\n* Patients must meet all eligibility criteria at the time of NMA-LD.\n* Full resolution of any active infection should be documented\n* Critical evaluation of changes in cardiovascular, respiratory, renal, coagulopathy, or immune problems and other major illnesses that may have developed or worsened must be documented\n* Patients with symptomatic, recurrent, pleural effusions that require drainage should not proceed to lymphodepletion without prior placement of a temporary in-dwelling pleural drain\n* All active medical issues must be addressed by Investigator or designee. Re-evaluation with additional imaging or testing may be required\n\nBenefit over risk should be assessed and reassessed throughout the treatment course. Successive lifileucel components (preparative lymphodepleting chemotherapy, LN-144\u002FLN-145 and IL-2 ) should be withheld or discontinued if at any time during the treatment course, at the discretion of the treating physician, benefit may not be justified by risks to the patient\n\nSubsequent delays of lymphodepletion up to 14 days due to logistical issues such as production of lifileucel and\u002For major weather events will not constitute protocol violations and out of window assessments will not need to be repeated unless there is a change in clinical status.",{"count":411,"type":50},40,[53],"This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.",[415,416,417,418],"Uveal Melanoma","Melanoma","Metastatic Uveal Melanoma","Metastatic Melanoma",[415,416,417,418,420,421,422],"LN-144","22-109","Memorial Sloan Kettering Cancer Center",{"date":35,"type":36},{"date":425,"type":36},"2022-11-01",{"date":427,"type":50},"2027-05-01",{"name":422,"class":95},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":436,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":51,"phases":439,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":451},"100054227","phase-3-testing-the-addition-of-an-antiangiogenic-drug-bevacizumab-to-chemotherapy-carboplatin-and-paclitaxel-combined-with-immunotherapy-pembrolizumab-for-pmmr-tp53-mutated-endometrial-cancer-100054227","NCT07198074","Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer","A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* Documentation of disease:\n\n  * Stage III and stage IVA endometrial cancers (with measurable disease),\n  * Stage IVB endometrial cancer (with or without measurable disease), or\n  * Recurrent endometrial cancer (with or without measurable disease)\n* In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI\n* Histologic confirmation of the original primary tumor is required (submission of pathology report\\[s\\] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated\u002Fundifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)\n* Patients must have:\n\n  * Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND\n  * P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted\n* A pathology report demonstrating results of institutional MMR IHC and p53 IHC and\u002For TP53 by next-generation sequencing\n* Patients may have received:\n\n  * NO prior chemotherapy for treatment of endometrial cancer OR\n  * Prior adjuvant chemotherapy (e.g., paclitaxel\u002Fcarboplatin alone or as a component of concurrent chemotherapy and radiation therapy \\[with or without cisplatin\\]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration\n* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara-aortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function\n* Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration\n* NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)\n* Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8 g\u002Fdl\n* Creatinine clearance (CrCl) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and\u002For need for drainage nasogastric or gastrostomy tube\n* No clinically significant bleeding within 28 days prior to registration\n* No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg\n* No major surgery within 28 days of initiation of bevacizumab\n* No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease\n\n  * Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible\n  * Topical or inhaled steroids are allowed\n  * Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis\n* No history of stem cell or solid organ transplant\n* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)","FEMALE",{"count":438,"type":50},255,[440],"PHASE3","This phase III trial compares the effect of bevacizumab in combination with carboplatin, paclitaxel and pembrolizumab to the usual treatments of carboplatin and paclitaxel with or without pembrolizumab in treating patients with stage III, IVA or IVB mismatch repair protein proficient (pMMR) and TP53 mutated endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adding bevacizumab to the combination of carboplatin, paclitaxel and pembrolizumab may be more effective than the usual treatment combinations of carboplatin and paclitaxel with or without pembrolizumab in treating patients with advanced or recurrent pMMR and TP53 mutated endometrial cancer.",[443,444],"Advanced Endometrial Carcinoma","Recurrent Endometrial Carcinoma",{"date":35,"type":36},{"date":447,"type":36},"2026-01-27",{"date":449,"type":50},"2028-07-01",{"name":283,"class":228},232,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":236,"enrollmentInfo":460,"targetDuration":4,"studyType":51,"phases":462,"briefSummary":463,"conditions":464,"keywords":469,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":96},"100054226","effects-of-different-myofascial-release-techniques-on-function-in-chronic-non-specific-neck-pain-100054226","NCT07694882","Effects of Different Myofascial Release Techniques on Function in Chronic Non-Specific Neck Pain","Investigation of the Effects of Different Myofascial Release Techniques on Functional Outcomes in Individuals With Chronic Non-Specific Neck Pain","MFR \u002F CNNP","Inclusion Criteria:\n\n* Neck pain persisting for at least 3 months and diagnosed as chronic non-specific neck pain by a specialist physician\n* Aged between 18 and 45 years\n* Perceived pain affecting daily living activities (VAS at least 3)\n* Presence of myofascial trigger points in the upper-quarter muscles\n\nExclusion Criteria:\n\n* Specific serious cervical spine pathology (radiculopathy, myelopathy, severe nerve root compression, spondylosis, and similar)\n* History of rheumatologic, neurologic, or systemic disease (for example, acute inflammation, multiple sclerosis, Parkinson's disease, rheumatoid arthritis, fibromyalgia, or cancer)\n* History of trauma, fracture, or surgery involving the neck, shoulder, or upper extremity\n* Pregnancy or breastfeeding\n* Any diagnosed psychiatric disorder (for example, major depression or anxiety disorder) or regular use of psychopharmacological medication\n* Use of systemic analgesics, NSAIDs, or muscle relaxants within the last 7 days for pain control\n* Any physiotherapy, manual therapy, or injection treatment to the neck region within the last 3 months",{"count":461,"type":50},84,[295],"This single-center, three-arm randomized controlled trial compares the effects of different myofascial release techniques, combined with a structured exercise program, on functional outcomes in individuals with chronic non-specific neck pain (CNNP).\n\nEligible participants (aged 18 to 45 years, neck pain for at least 3 months, pain intensity VAS at least 3, and myofascial trigger points in the upper-quarter muscles) are allocated by simple randomization into three groups:\n\n* Conventional Therapy Group: hot pack, conventional TENS, and a structured exercise program.\n* Manual Myofascial Release Group: conventional therapy plus therapist-applied manual myofascial release.\n* Self-Myofascial Release Group: conventional therapy plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick\u002Fcane.\n\nAll interventions are delivered 3 days per week for 6 weeks. The primary outcome is pain intensity. Secondary outcomes include pressure pain threshold and tolerance, cervical range of motion, muscle stiffness, craniovertebral angle, cervical proprioception, muscle strength and endurance, disability, neck awareness, multidimensional biopsychosocial status, sleep quality, quality of life, and kinesiophobia. The aim is to determine whether manual or self-applied myofascial release, added to exercise, produces greater functional improvement in people with chronic non-specific neck pain.",[465,466,467,468],"Chronic Neck Pain","Non-specific Neck Pain","Myofascial Trigger Points","Myofascial Pain Syndrome - Neck",[470,471,472,473,474,475],"chronic non-specific neck pain","myofascial release","manual therapy","trigger points","therapeutic exercise","physiotherapy",{"date":35,"type":36},{"date":478,"type":50},"2026-07-15",{"date":480,"type":50},"2026-12-31",{"name":482,"class":95},"Eastern Mediterranean University",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":51,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":517},"100054209","phase-2-a-study-of-zanzalintinib-in-participants-with-recurrent-or-progressive-meningioma-100054209","NCT07428616","A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma","A Phase 2, Single-Arm, Multicenter, Open-Label Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma","STELLAR-201","Key Inclusion Criteria:\n\n* Histologically confirmed World Health Organization (WHO) grade 1, 2, or 3 meningioma.\n* Developed recurrent disease or progressive disease (PD) after receiving standard therapy (for example, surgery and\u002For radiation) or have been deemed ineligible to receive these therapies. At least 1 prior course of meningioma-directed radiotherapy is required, if not contraindicated.\n* Radiologically documented progression of any existing tumor (growth \\> 15% of the bidimensional enhancing tumor within the prior 6 months or appearance of new lesions (including intra and extracranial manifestations).\n* For participants treated with external beam radiation, interstitial brachytherapy, or radiosurgery, an interval ≥ 24 weeks must have elapsed from completion of therapy to initiation of treatment.\n* Measurable disease by RANO meningioma criteria as determined by the investigator, obtained ≤ 14 days prior to initiation of treatment.\n* Karnofsky performance status (KPS) ≥ 60%.\n* Demonstrate adequate organ and marrow function within 14 days of treatment initiation\n\nKey Exclusion Criteria:\n\n* Prior history of hypertensive encephalopathy at any time.\n* Extracranial lesions invading major blood vessels including, but not limited to, inferior vena cava, pulmonary artery, or aorta.\n* Contraindication to magnetic resonance imaging (MRI).\n* Local therapy (surgery and\u002For radiation therapy) is indicated per investigator\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks or 5 half-lives, whichever is shorter, before initiation of treatment. There is no limit on prior systemic therapies\n* Prior Surgery - completed wound healing must occur prior to initiation of treatment; ≥ 8 weeks for major surgery, ≥ 7 days for minor surgery, including stereotactic biopsies.\n* The participant has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders, including uncontrolled hypertension,\n  * Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation,\n  * Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 milliliters \\[mL\\]) of red blood within 12 weeks before initiation of treatment or other history of significant bleeding (eg, intracranial hemorrhage\u002Fbleeding), or\n  * Other clinically significant disorders.\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":492,"type":50},100,[54],"The objective of the study is to evaluate efficacy and safety of zanzalintinib in participants with recurrent or progressive meningioma refractory to standard therapies.",[496],"Meningioma",[496,498,499,500,501,502,503,504,505,506,507,508,509],"Recurrent Meningioma","Progressive Meningioma","Atypical Meningioma","Anaplastic Meningioma","Brain","Zanzalintinib","XL092","Grade 1 Meningioma","Grade 2 Meningioma","Grade 3 Meningioma","Intracranial Neoplasms","Extracranial Meningioma",{"date":35,"type":36},{"date":512,"type":36},"2026-05-21",{"date":514,"type":50},"2029-09-30",{"name":516,"class":39},"Exelixis",12,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":335,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":51,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":96},"100054185","phase-1-pacritinib-a-kinase-inhibitor-of-csf1r-irak1-jak2-and-flt3-in-adults-and-pediatric-participants-12-years-of-age-or-older-with-myelodysplastic-syndromes-or-myelodysplasticmyeloproliferative-neoplasms-100054185","NCT06303193","Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic\u002FMyeloproliferative Neoplasms","Phase I\u002FII Trial of Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic\u002FMyeloproliferative Neoplasms","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed MDS or MDS\u002FMPN, including therapy-related MDS or MDS\u002FMPN, and MDS or MDS\u002FMPN with germline predisposition, by the Department of Laboratory Medicine Hematology Laboratory, CC or by the Laboratory of Pathology, NCI as defined according to the 2016 WHO criteria, 2022 WHO criteria, or 2022 International Consensus Classification\n* Age 12-17 years for phase I and age \\>= 18 years for phase II\n* Participants \\>= 18 years of age with HR-MDS must have resistance to hypomethylating agents as defined as failure to show improvement after at least 4 cycles of treatment (primary resistance) or relapse in participants with initial response to long-term treatment (secondary resistance) OR have intolerance to hypomethylating agents OR have a contraindication to hypomethylating agents\n* Participants \\>= 18 years of age with LR-MDS must be refractory to or ineligible to receive standard of care therapies, i.e. erythropoietin-stimulating agents, lenalidomide, luspatercept, and present with one of the following characteristics:\n\n  * Severe neutropenia defined by absolute neutrophils count \\\u003C=0.5(SqrRoot) 10\\^9\u002FL without the use of granulocyte colony-stimulating factors\n  * Symptomatic anemia defined by hemoglobin 16-week average \\\u003C10 g\u002FdL and symptoms that may include fatigue, weakness, reduced exercise tolerance, dyspnea on exertion, palpitations, (orthostatic) hypotension, near syncope and restless legs\n  * Thrombocytopenia defined as platelets \\\u003C20(SqrRoot) 10\\^9\u002FL or platelets \\\u003C50(SqrRoot) 10\\^9\u002FL and a history of clinically relevant non-major or major bleeding according to the ISTH classification\n* Participants 12-17 years of age with MDS must be relapsed\u002Frefractory OR ineligible to receive immunosuppressive therapy and hematopoietic stem cell transplantation\n\n  --Ineligibility to receive hematopoietic stem cell transplantation will include participants who are not anticipated to be candidates to receive transplantation within the next 3 months due to medical comorbidities, lack of appropriate donor, or logistical barriers to transplant\n* Participants with MDS\u002FMPN must be relapsed\u002Frefractory (failed a minimum of 1 standard of care therapy) OR ineligible to receive standard of care OR without known life-prolonging therapy options OR have a diagnosis for which no known standard of care exists\n* Participants 12-17 years of age must weigh \\>= 35 kg\n* If any of the prior therapies noted below were given to the participant, they must have been completed within the following timeframes:\n\n  * 7 days from last dose of short-acting myeloid growth factors (i.e., filgrastim) and \\>= 14 days for long-acting (i.e., pegfilgrastim)\n  * 14 days from last dose of short-acting thrombopoietic growth factors (i.e.,eltrombopag) and \\>= 28 days for long-acting (i.e., romiplostim)\n  * 14 days or 5 pharmacokinetic half-lives from biological therapy agent\n  * 21 days from myelosuppressive chemotherapy\n  * 28 days from last dose of immunosuppressive therapy (e.g., ATG, cyclosporine, steroids greater than physiologic replacement)\n  * 28 days from last dose of lenalidomide\n  * 28 days from last dose of venetoclax\n  * 28 days from any other investigational agent\n  * 42 days from last dose of erythropoiesis stimulating agents\n  * 56 days from last dose of luspatercept\n  * 100 days from stem cell transplant with no evidence of active graft vs. host disease in participants who relapsed following transplant\n  * 150 days from total body irradiation\n* Performance status:\n\n  * For participants \\>= 16 years of age, ECOG performance status \\\u003C 2 (Karnofsky \\>= 60%)\n  * For participants \\\u003C 16 years of age, Lansky \\>= 60%\n* Participants must have adequate organ function as defined below:\n\n  * Total bilirubin: \\\u003C= 1.5 X institutional upper limit of normal OR \\\u003C= 3 x institutional upper limit of normal in participants with Gilbert s syndrome\n  * AST(SGOT)\u002FALT(SGPT): \\\u003C= 2.5 X institutional upper limit of normal\n  * Creatinine clearance: \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n  * PT and PTT: \\\u003C= 1.5 X institutional upper limit of normal, except in the setting of PTT elevation due to lupus anticoagulant, in which case these participants would be exempt from meeting this inclusion criterion\n* Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant must agree to use one (1) highly effective form of contraception (e.g., intrauterine device \\[IUD\\], surgical) or two (2) effective forms of contraception (e.g., barrier method) while on study drug and for 30 days after the last dose of study drug\n* Nursing participants must discontinue breastfeeding and\u002For not begin breastfeeding until 2 weeks after the last dose of study drug\n* Ability of participant or parent\u002Fguardian (for participants 12-17 only) to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n* Participants with platelet transfusion-refractory thrombocytopenia, with inability to keep platelet threshold above 10 K\u002FmcL with transfusions\n* Participants with evidence of ongoing hemorrhage, active signs\u002Fsymptoms of bleeding, or history of severe (grade \\>= 3) unprovoked bleeding complications in the one year prior to enrollment, or any unprovoked grade 2 bleeding complications in the 3 months prior\n\nto enrollment\n\n* Use of anti-platelet or anticoagulant medication other than low-dose aspirin (100 mg daily or less) in the 14 days prior to enrollment, or any ongoing requirement for these medications\n* Participants who are unwilling to accept blood transfusions\n* Participants with ANC \\\u003C 500 cells\u002FmcL AND hospitalization for a fungal infection in the 12 months prior to enrollment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib\n* Concomitant administration with sensitive substrates\u002Fnarrow therapeutic index drugs of CYP3A4, CYP1A2, P-gp BCRP, and OCT1 should be avoided. Concurrent use of strong inhibitors and inducers of CYP3A4 are not allowed. Prior use is allowed as long as medication is stopped two weeks prior to study drug initiation. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Concomitant administration of medications with significant potential to cause QTc prolongation.\n* Participants with the following cardiac conditions at screening:\n\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Uncontrolled cardiac dysrhythmias\n  * QTc(F) prolongation \\>450 ms, or other factors that increase the risk for QT prolongation (i.e., heart failure, or a history of long QT interval syndrome)\n* Grade \\>= 3 cardiac complication in the 6 months prior to enrollment\n* Left ventricular ejection fraction \\\u003C= 50% by transthoracic echocardiogram (TTE) at screening\n* Participants with any active, uncontrolled viral, bacterial, or fungal infection, including active HIV-1, Hepatitis B (HBV) and\u002For Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody); history of HIV, HBV, or HCV is allowed if there is no uncontrolled viral infection\n* Pregnancy\n* Presence of another known cause of cytopenia or dysplastic marrow that is untreated and may limit interpretation of results\n* Uncontrolled intercurrent illness or any significant disease, evaluated by history, physical exam and chemistries or social situations that may limit interpretation of results, limit compliance with study requirements, or that could increase risk to the participant","120 Years",{"count":527,"type":50},160,[53,54],"Background:\n\nMyelodysplastic syndrome (MDS) and myelodysplastic\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS\u002FMPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed.\n\nObjective:\n\nTo test a study drug (pacritinib) in adults and children with MDS or MDS\u002FMPN.\n\nEligibility:\n\nChildren (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS\u002FMPN.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone.\n\nPacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants.\n\nParticipants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years.\n\nBone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics.",[531],"Myelodysplastic Syndromes",[533,534,535,536,537,538,539,540,541],"Myelodysplastic Syndrome","bone marrow disorder","Myelodysplasia","myeloproliferative disorders","pediatric bone marrow failure","5q deletion","multi-lineage dysplasia","Clonal Hematopoiesis","Aplastic Anemia",{"date":35,"type":36},{"date":544,"type":50},"2026-07-16",{"date":546,"type":50},"2035-01-01",{"name":283,"class":228},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":51,"phases":557,"briefSummary":558,"conditions":559,"keywords":564,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":402},"100054171","aquarius-pilot-study-to-evaluate-the-new-axonics-trial-system-100054171","NCT07335484","Aquarius Pilot Study to Evaluate the New Axonics Trial System","Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)","Inclusion Criteria:\n\n* 18 years or older\n* Provides written informed consent prior to trial procedures\n* Primary indication of OAB (UUI\u002FUF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU\n\nExclusion Criteria:\n\n* Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits\n* Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function\n* Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)\n* Current symptomatic urinary tract infection (UTI)",{"count":556,"type":50},75,[295],"Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and\u002For fecal incontinence (FI).",[560,561,562,563],"Urinary Urge Incontinence (UUI)","Urinary Frequency (UF)","Fecal Incontinence (FI)","Overactive Bladder (OAB)",[565,566,567],"Peripheral nerve evaluation","External trial system","Pilot study",{"date":35,"type":36},{"date":570,"type":36},"2026-04-30",{"date":572,"type":50},"2026-12",{"name":574,"class":39},"Axonics, Inc.",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":582,"enrollmentInfo":583,"targetDuration":4,"studyType":51,"phases":584,"briefSummary":585,"conditions":586,"keywords":589,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":597,"leadSponsor":599,"locationsCount":96},"100054161","phase-2-fast-for-dm---fatty-acid-supplementation-trial-fast-for-dermatomyositis-dm-100054161","NCT07111065","FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)","Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acid (O3FA) Supplementation for Adult and Juvenile Dermatomyositis (DM\u002FJDM)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults 18-60 years of age with probable or definite EULAR-ACR criteria for adult or juvenile dermatomyositis (DM, JDM).\n* Willingness to adhere to the general healthy diet pattern regimen, undergo dietary coaching on weekly to biweekly basis (10 sessions), and to complete online random reporting of dietary intake over a 6-month period.\n* Ability and willingness to comply with taking 4 study pills twice a day for 6 months.\n* Ability and willingness to wear ActiGraph device at home for 7 continuous days, twice in the study.\n* Willingness and ability to complete and consent to study testing, including blood, stool, and urine samples, and imaging studies.\n* Ability and willingness to complete a total of 5 study visits (screening, weeks -6, 0, 12, 24) onsite at NIH Clinical Center in Bethesda, Maryland.\n* Has the ability\u002Ftransportation methods to attend on-site visits. Willing to pay for travel and out-of-pocket expenses.\n* Own or have reliable access to a computer, laptop or smart phone device (iPhone or Android) with internet access, and an active email address, to complete study consent form, online questionnaires, telehealth visits, and review online dietary education materials and videos.\n* Ambulatory\n* Must live within the United States.\n* Must be proficient in the English language and complete questionnaires in English (forms validated in English). Ability and willingness to complete forms online.\n* Moderately active DM\u002FJDM defined by:\n\n  * MD global VAS with a \\>= 2.0 cm on a 10 cm scale and maximum value of 7.0 cm, and\n  * At least 2 of the following criteria:\n\n    * Patient global activity \\>= 2 cm out of 10 cm visual analog scale (VAS).\n    * MMT-8 score of \\\u003C=138 out of 150.\n    * Health Assessment Questionnaire disability index with a minimum value of \\>= 0.50 out of 3.0\n    * Elevation of at least one of the muscle enzymes (which includes creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), ALT and AST) at a minimum level of 1.3X the upper limit of normal.\n    * Global Extramuscular disease activity score with a minimum value of \\>= 1.0 cm on a 10 cm VAS scale (this measure is the physician s composite evaluation and is based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary and cardiac scales of the Myositis Disease Activity Assessment Tool (MDAAT).\n* Physician global damage and muscle damage both \\\u003C= 5.0 cm\u002F10 cm VAS\n* If receiving prednisone and methotrexate, the dose must be stable for at least 4 weeks prior to the Week 6 visit, and daily prednisone \\\u003C= 20 mg\u002Fday.\n* Background therapy with other non-corticosteroid immunosuppressive agent, if required, must be at a stable dose for at least 6 weeks prior to the Week 6 visit, except with IVIG regimen should be stable 90 days prior to the Week 6 visit and for rituximab, stable regimen for 4 months prior to Week 6.\n* If an immunosuppressive agent was discontinued prior to the screening visit, then there must be a washout period before week -6 visit:\n\n  * 4-week washout for prednisone, methotrexate, and IV methylprednisolone (IV pulse therapy)\n  * 8-week washout for other immunosuppressive drugs, including azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, cyclophosphamide, colchicine, and hydroxychloroquine\n  * 8-week washout for IVIG\n  * For discontinuation of biologic or targeted drug therapies or dietary supplements, a washout prior to visit 1 (week 6) is required of 4 terminal half-lives.\n\n    * Half-lives of most common biologics and targeted drug therapies used in the treatment of DM\u002FJDM:\n\n      * Etanercept Half-life 70 hours, Waiting period before enrollment (4 Half-lives) 12 days\n      * Adalimumab, Half-life, 14 days, Waiting period before enrollment (4 Half-lives) 60 days\n      * Rituximab, Half-life 32 days, Waiting period before enrollment (4 Half-lives) 130 days\n      * Infliximab, Half-life 9 days, Waiting period before enrollment (4 Half-lives) 36 days\n      * Abatacept, Half-life 17 days, Waiting period before enrollment (4 Half-lives) 68 days\n      * Anakinra, Half-life 6 hours, Waiting period before enrollment (4 Half-lives) 1 day\n      * Tofacitinib, Half-life 3 hours, Waiting period before enrollment (4 Half-lives) 1 day\n      * Baricitinib, Half-life 12hours, Waiting period before enrollment (4 Half-lives) 2 days\n* Negative pregnancy test (urine or blood sample) if born female.\n* Body Mass Index (BMI) \\> 18 and \\\u003C= 35 kg\u002Fm\\^2\n* Fish intake of less than 2 servings per week on average for the past 3 months.\n* Intake of meat products (beef, lamb, pork, venison, rabbit, cow s milk or dairy products) within 2 months of screening visit and of week 0 and have no reaction (no shortness of breath, hives, rash, or diarrhea) within 6 hours of ingestion of these meat products.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Polymyositis; inclusion body myositis; cancer-associated myositis, defined as the diagnosis of myositis within 3 years of the diagnosis of cancer, except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision.\n* Myositis in overlap with another autoimmune disease will be excluded under the following conditions:\n\n  i. Myositis overlapping with another autoimmune disease that precludes accurate assessment of treatment response (e.g., difficulty assessing muscle strength in a patient with scleroderma and associated myositis).\n\nii. Myositis overlapping with inflammatory bowel disease, including Crohn s disease, ulcerative colitis, or celiac disease.\n\niii. Myositis overlapping with autoimmune thyroid disease (e.g., Hashimoto s disease or Graves disease), unless the thyroid disease is\n\nstable and well controlled with no changes in thyroid-related medications for at least 3 months prior to enrollment, in which case the\n\npatient may be included.\n\n* Drug- or toxin-induced myositis, including known HMG-CoA reductase autoantibody-positive necrotizing myopathy following statin use.\n* Moderate to severely active myositis that would require initiation of another immunosuppressive treatment.\n* Joint disease, severe calcinosis, or other musculoskeletal condition, which precludes the ability to assess\u002Fquantitate muscle strength and function.\n* Concomitant illness that would prevent adequate patient assessment or in the investigators opinion pose an added risk for study participants. The investigator may consider further evaluation or consultation if clinically indicated prior to study enrollment:\n\n  * Recurrent or chronic infections, including HIV, hepatitis B and C, Epstein Barr virus, active coronavirus infection, active or recurrent gastrointestinal infection (including Helicobacter pylori), active or recurrent skin infections with calcinosis.\n  * Disorders that would preclude accurate assessment of neuromuscular function.\n  * Severe swallowing dysfunction with inability to swallow pills.\n  * Patients with generalized lipodystrophy.\n  * Severe cardiomyopathy or arrhythmias, including atrial fibrillation or atrial flutter, New York Heart Association Classification III or IV for congestive heart failure, severe interstitial lung requiring oxygen therapy, gastrointestinal vasculopathy\u002Fulceration or gastroparesis, renal failure requiring dialysis, that in the investigators opinion poses an additional risk for study participants.\n  * Subjects with any acute and life-threatening condition unrelated to myositis, such as prior sudden cardiac arrest, acute myocardial infarction, stroke, embolism in last 3 months.\n  * History of malignancy, except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision.\n  * Uncontrolled hypertension with average blood pressure \\>= 140\u002F90, requiring a new anti-hypertensive medication in the past 8 weeks.\n  * Psychiatric illness that precludes compliance or neuromuscular assessment, including major psychiatric illness requiring hospitalization within the past year and\u002For has had a change in depression or anxiety prescription medications within the past 3 months (by discretion of study physician).\n  * Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, irritable bowel syndrome, symptomatic gallstones, or other conditions that could affect intestinal fat absorption.\n  * Subjects with clinically diagnosed hepatic disease, including but not limited to hepatitis, steatosis, cirrhosis.\n  * Osteoporotic fracture under therapy for pain control or impacting ambulation.\n  * Serum creatinine \\> 2.0mg\u002Fdl or eGFR less than 50 mL\u002Fmin per 1.73 m\\^2.\n  * Subjects with coagulation or bleeding disorders (such as hemophilia) or receiving anti-platelet or anti-coagulant medications, including daily aspirin, warfarin, or Plavix.\n  * Life-threatening non-myositis illness that would interfere with the patient s ability to complete the study.\n* Known contraindications to O3FAs, excipients or placebo contents (e.g., allergy or known hypersensitivity to that drug or its excipients, including porcine gelatin, allergies to fish or shellfish, tocopherols, glycerin, or corn). Religious or ethical reasons to not consume fish, corn and\u002For porcine (pork) products.\n* Participants with any of the following:\n\n  * Idiopathic anaphylaxis\n  * Alpha-gal reaction\n  * Known food allergies to beef, pork, lamb or other meat products, including cow s milk and dairy products, with a history of shortness of breath, rash, or hives within 6 hours of eating these foods.\n* Currently using O3FAs or consuming EPA\u002FDHA in any form for the past 6 months.\n* Currently taking supplements or medications that affect lipoproteins for the past 6 months, including fish oil supplements, bile-acid sequestrants, plant sterol supplements, PCSK9 inhibitors, fibrates, statins, or niacin.\n* Use of medications or dietary supplements that interact with O3FA per pharmacy evaluation. A PharmD will evaluate the patient's current medication list for medications\u002Fsupplements with the potential for significant interactions with O3FA.\n* No antibiotic usage in past 3 months, as well as no usage of anti-virals, antifungals, anti-parasitics in past 3 months (except antimalarials and Paxlovid or other COVID-19 anti-viral therapy allowed).\n* Subjects being treated with tamoxifen, estrogens or progestins that have not been stable for \\> 4 weeks.\n* Uncontrolled diabetes with HgbA1C \\> 8 or hospitalization in past 6 months for diabetes.\n* Uncontrolled hyperlipidemia with TC \\> 400 mg\u002FdL, TG \\>150mg\u002FdL.\n* Currently on a weight-loss program\n* Has experienced a weight change (gain or loss) of greater than 15 pounds or greater than 20 percent in the past 3 months\n* Currently taking a GLP-1 receptor agonist medication\n* No restrictive dietary habits per discretion of the study team.\n* Current use of medications or dietary supplements for weight or appetite control, including laxatives or diarrheal inhibitors within the past 4 weeks.\n* History of eating disorder.\n* Initiation of an exercise program within 4 weeks of screening visit.\n* Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview.\n* Blood donation in the last 6 weeks or planned blood donation during study or requiring regular blood transfusion.\n* Pregnant females or nursing mothers within past 3 months, or those planning to get pregnant during the next 9 months.\n* Low total WBC \\\u003C 2000, platelets \\\u003C 100,000\u002Fmm\\^3; hemoglobin \\\u003C 9.5 gm\u002Fdl.\n* Vitamin D level \\\u003C 20 ng\u002Fml (at screening visit - necessitates addition of supplement and re-screen after minimum of 8 weeks).\n* Subjects with TSH levels greater than 1.5X upper limit of normal or clinical evidence of hypothyroidism (at screening visit- necessitates addition of supplement and re-screen after minimum of 8 weeks).\n* Participants with severe claustrophobia.\n* History of or anticipated poor non-cooperation with study requirements.\n* Participation in another clinical experimental therapeutic study within 30 days of screening visit or during the study.\n* Hospitalization within past 30 days (other than for routine infusions).\n* Prisoners or subjects who are involuntarily incarcerated.\n* Resident of a nursing home, ward of the state, or institutionalized during any part of the study period.\n* Persons with decisional incapacity\u002Fcognitive impairment.\n* Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator, unsuitable for the study.\n* Participants who do not complete the ASA24 within 4 calendar days of screening will be excluded from the protocol. Additionally, participants will be excluded if their energy intake from the ASA24 is above or below established cut-off values for age and gender based on the 5th and 95th percentile of energy intakes from National Health and Nutrition Examination Survey (NHANES) data. Cut-off values for exclusion are \\\u003C600 kcal or \\>4400 kcal for women and \\\u003C650 kcal and \\>5700 kcal for men.","60 Years",{"count":239,"type":50},[54],"Dermatomyositis (DM) is a rare autoimmune disease that causes muscle weakness, skin rashes, and other symptoms. Researchers think both genetic and environmental factors play a role in this disease. They want to find out more about how diet and lifestyle choices affect people with DM\u002FJDM.\n\nObjective:\n\nTo see if omega-3 fatty acid supplements from fish oil, combined with a healthy diet, can help people with DM\u002FJDM.\n\nEligibility:\n\nAdults 18-60 years old, who live in the United States, can read English, and access Internet to complete questionnaires can participate.\n\nDesign:\n\nParticipants will have 5 or 6 inpatient visits. For 5 visits they may need to stay in the Clinical Center for up to 5 days. Participants will be screened. They will have a physical exam with blood, urine and stool tests. They will have tests of their heart and lung function. Their muscle strength will be measured. They may have an imaging scan of their thighs and pelvis. They will complete online questionnaires about their health and lifestyle. They may complete two optional skin biopsies. Participants will take 4 small capsules by mouth twice a day for up to 6 months. The capsules will contain omega-3 fatty acids from fish oil or a placebo. The placebo looks just like the regular capsule but contains no active ingredients. Participants will not know which capsules they are taking. They will follow a healthy diet based on the General Healthy Eating Pattern.\n\nParticipants will receive dietary coaching and will have virtual check-ins throughout the study. For two 7-day periods, they will wear a watch-like device to track their daily activity and sleep patterns. Participants may opt to remain in the study for an additional 12 weeks. All will receive the fish oil supplements during this stage.",[587,588],"Dermatomyositis (DM)","Juvenile Dermatomyositis (JDM)",[590,591,592,593,594],"Fish oil supplements","Omega-3 Fatty Acid","Clinical Trial","Online questionnaires","Diet Study",{"date":35,"type":36},{"date":544,"type":50},{"date":598,"type":50},"2031-11-03",{"name":600,"class":228},"National Institute of Environmental Health Sciences (NIEHS)",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":608,"sex":17,"minAge":609,"maxAge":610,"enrollmentInfo":611,"targetDuration":4,"studyType":51,"phases":613,"briefSummary":614,"conditions":615,"keywords":620,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":96},"100053402","technology-assisted-methods-to-advance-suicide-prevention-among-youth-in-colombia-100053402","NCT06651554","Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombia","Harnessing Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombian School Settings","Inclusion Criteria for youth:\n\n* aged 14-19\n* attending a secondary school in Bogota\n* willing to try the digital platform\n\nExclusion Criteria for youth:\n\n* not meeting inclusion criteria",true,"14 Years","19 Years",{"count":612,"type":50},228,[295],"This study will investigate a multi-level approach that applies technology-assisted methods to reduce suicidal thoughts and behaviors (SIB) and promote mental health among Colombian youth: (a) digital platform for youth; (b) digital platform for teachers; and (c) hybrid mental health training diploma program for teachers. This approach will evaluate an open-access digital platform for suicide prevention among Colombian youth. Key features of the digital platform include mental health self-help tools, a customizable safety plan, links to online counseling services, and gamification elements. The digital platform's teacher interface will incorporate psychoeducation, brief suicide-risk screening and decision support tools to enhance teacher capacity to assess risk for suicide and refer youth to the appropriate level of services.\n\nStudy investigators will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial design to evaluate the digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota, Colombia. Study aims are to:\n\nAim 1. An initial needs assessment will be conducted with key stakeholders (youth, teachers, caregivers, school administrators) to identify barriers and facilitators to successful implementation of the multi-level approach. User-centered design methods will be used to refine the digital platform and incorporate end-user feedback into the final prototype.\n\nAim 2. Investigators will evaluate: (a) feasibility, acceptability, and usability of the digital platform across three schools in Colombia; and (b) the preliminary effects of the digital platform in reducing SIB and improving mood (e.g., anxiety\u002Fdepression) among Colombian youth aged 14-19 attending the three schools. Safety planning skills acquisition (youth-level) and linkages to mental health services (service-level) will be assessed as potential mechanisms of change.\n\nAim 3. The study will apply a multi-disciplinary capacity building model to strengthen behavioral health and implementation science research, healthcare delivery capacity, and mental health policy. In partnership with Pontificia Javeriana University, experts in suicide prevention, data science, and implementation science will be engaged to build in-country research capacity at the individual and institutional level.",[616,617,618,619],"Suicidal Ideations","Suicidal Behaviors","Depression, Anxiety","Well-being",[621,622,623,624,625],"suicide prevention","adolescent health","mHealth","Colombia","Implementation Science",{"date":35,"type":36},{"date":628,"type":36},"2025-05-12",{"date":630,"type":50},"2027-01-31",{"name":632,"class":95},"Brown University",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":51,"phases":642,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":655},"100053397","phase-2-testing-the-addition-of-cemiplimab-regn2810-to-chemotherapy-treatment-given-prior-to-surgery-in-patients-with-sinonasal-squamous-cell-carcinoma-100053397","NCT07281417","Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma","Neoadjuvant Chemotherapy With or Without Cemiplimab (REGN2810) in Sinonasal Squamous Cell Carcinoma: A Randomized Phase 2 Study","Inclusion Criteria:\n\n* Patients must have histologically confirmed squamous cell carcinoma of sinonasal origin\n* Patients must have a T stage (T3, T4a, and select T4b) primary tumor according to American Joint Committee on Cancer (AJCC) 8th edition. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* No evidence of metastatic disease determined by pre-treatment imaging. Metastatic disease to neck nodes is considered locally advanced and therefore allowable. Patients with N0 and N1-3 disease will be eligible\n* Known HPV status (i.e., HPV negative, p16 immunohistochemistry \\[IHC\\] positive, high risk \\[HR\\]-HPV in situ hybridization \\[ISH\\] positive) from testing performed prior to referral. HPV status data (e.g., date of test, type of test \\[p16 IHC or HR-HPV ISH\\] and testing result) must be collected during enrollment. Patients who do not have this information available for collection will not be enrolled on this study\n* Age ≥ 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of cemiplimab (REGN2810) in combination with carboplatin and paclitaxel in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin ≥ 8 g\u002FdL (acceptable to reach via transfusion)\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Creatinine clearance ≥ 40 mL\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1\u002FPD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. For this reason and because paclitaxel is a class D agent with the potential for teratogenic or abortifacient effects, women of childbearing potential (WCBP) and men should use highly effective contraception during treatment and for 6 months after the last dose of the study drugs. WCBP and men should avoid donating eggs\u002Fsperm during treatment and for 6 months after the last dose of the study drugs. Women should discontinue nursing during treatment and for 6 months after the last dose of the study drugs\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Prior to enrollment, verification of payment coverage by insurance (or other payment) for neoadjuvant paclitaxel and carboplatin chemotherapy must be obtained\n\nExclusion Criteria:\n\n* Patients with unresectable disease\n* Patients presenting with T3 disease without the need for maxillectomy and\u002For orbital invasion requiring orbital dissection\u002Fresection\n* Patients who have had any previous systemic therapy to the index lesion in the past 12 months. This includes cemiplimab (REGN2810) and\u002For other immune modulating agents. Previous systemic therapy may alter or affect response\n* Patients who had palliative RT (\\\u003C 20 Gy) within 1 week prior to entering the study\n* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)\n* History of pneumonitis within the last 5 years\n* Patients who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab (REGN2810) or carboplatin and paclitaxel\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Men and WCBP who are not prepared to use highly effective contraception during and for 6 months after completion of treatment are excluded from this study",{"count":641,"type":50},108,[54],"This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.",[645,646,647,648],"Sinonasal Squamous Cell Carcinoma","Stage III Sinonasal Cancer AJCC v8","Stage IVA Sinonasal Cancer AJCC v8","Stage IVB Sinonasal Cancer AJCC v8",{"date":35,"type":36},{"date":651,"type":50},"2026-11-24",{"date":653,"type":50},"2030-12-16",{"name":283,"class":228},5,{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":51,"phases":665,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":677},"100054138","phase-4-a-post-marketing-clinical-trial-of-pemafibrate-in-patients-ith-hypercholesterolemia-and-inadequate-response-to-statins-100054138","NCT07634484","A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequate Response to Statins","A Post-Marketing Clinical Trial of Pemafibrate in Patients With Hypercholesterolemia and Inadequate Response to Statins-Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial","Inclusion Criteria:Patients who meet all the following criteria shall be eligible for the clinical trial.\n\n1. Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent\n2. Patients who have taken statins at a fixed dose and regimen within the approved dose range for at least four weeks prior to the first screening assessment.\n3. Patients who have received stable dietary and\u002For exercise therapy for at least 12 weeks prior to the first screening assessment.\n4. Patients with the fasting serum TG \\\u003C 150 mg\u002FdL on two consecutive occasions at screening\n5. Patients who apply any of the following risk category with LDL-C level (direct) based on JAS2022 on two consecutive occasions at screening\n\n   * Low risk for primary prevention: LDL-C \\>=160 mg\u002FdL\n   * Intermediate risk for primary prevention: LDL-C \\>=140 mg\u002FdL\n   * High risk for primary prevention: LDL-C\\>=120 mg\u002FdL or 100 mg\u002FdL\\*\n   * Secondary prevention: LDL-C\\>=100 mg\u002FdL\n   * Familial hypercholesterolemia (heterozygous): LDL-C\\>=100 mg\u002FdL\n\n     * For patients with diabetes, those with peripheral artery disease (PAD), microvascular complications (retinopathy, nephropathy, neuropathy), or current smoking are included if LDL-C\\>=100 mg\u002FdL.\n\nExclusion Criteria:Patients who meet any of the following criteria will be excluded from the clinical trial.\n\n1. Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent\n2. Patients with type 1 diabetes and uncontrolled type 2 diabetes \\[HbA1c(NGSP) \\>= 10.0 % at Screening\\]\n3. Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.\n4. Patients with uncontrolled thyroid disease\n5. Patients who are undergoing or are scheduled to undergo LDL apheresis\n6. Patients with cirrhosis or those with biliary obstruction\n7. Patients with gallstones\n8. Patients with familial hypercholesterolemia (homozygotes)\n9. Patients with impaired renal function (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 at screening)\n10. Patients with uncontrolled hypertension (SBP \\>= 160 mmHg or DBP \\>= 100 mmHg) at screening\n11. Patients with AST and ALT levels three times or greater than the upper limit of normal at screening\n12. Patients with CK levels at least three times the upper limit of normal at screening\n13. Patients with any of the following experiences within 3 months prior to informed consent: myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass surgery, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, abdominal aortic aneurysm, uncontrolled severe arrhythmia and decompensated heart failure\n14. Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization\n15. Patients with heart failure class III or higher according to NYHA cardiac function classification\n16. Patients with malignant tumor or those who are judged to have a high risk of recurrence\n17. Patients with a history of myopathy or rhabdomyolysis due to pemafibrate\n18. Patients with a history of hypersensitivity due to pemafibrate\n19. Patients with a history of serious drug allergies (anaphylactic shock, etc.)\n20. Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women of childbearing potential\\*2 who do not use specific contraceptive methods\\*1\n21. Patients who have undergone whole blood donation of 400 mL or more within 16 weeks, or 200 mL or more within 4 weeks, or component donation (plasma or platelet donation) within 2 weeks prior to screening.\n22. Patients with alcoholics or drug addicts\n23. Patients who participated in other clinical trials of a drug with new active ingredients within 16 weeks or a drug with an approved active ingredients within 12 weeks prior to administration and received an investigational drug other than placebo,or those who will participate in other clinical trials at the same time as the clinical trial\n24. Patients who are considered inappropriate for participation in this study by the investigator, etc\n\n    * 1 Acceptable contraceptive methods: Oral hormonal contraceptives (combination pills containing progestin and estrogen), intrauterine devices, intrauterine hormonal delivery systems, abstinence\n    * 2 Woman of childbearing potential refers to a woman who is physiologically capable of becoming pregnant with a male partner who has not undergone contraception. However, it does not apply if the investigator confirms that any of the following criteria is met.\n\n      * Patients with hysterectomy or tubal ligation before informed consent\n      * Post-menopausal women (those who have passed more than 1 year since their last menstrual period without other medical reasons).",{"count":664,"type":50},120,[666],"PHASE4","To investigate the efficacy and safety of Pemafibrate 0.2 mg\u002Fday or 0.4 mg\u002Fday for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.",[669],"Hypercholesterolemia",{"date":35,"type":36},{"date":672,"type":50},"2026-07-01",{"date":674,"type":50},"2027-07-31",{"name":676,"class":39},"Kowa Company, Ltd.",10,""]