[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adverse-drug-event\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adverse-drug-event":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,74,119,142,169,190,226,249,263],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100560314","phase-4-efficacy-and-safety-of-remimazolam-besylate-for-sedation-in-post-non-cardiac-surgery-patients-requiring-mechanical-ventilation-100560314",false,"NCT06575530","Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation","Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged between 18 and 64 years\n* Scheduled to undergo elective non-cardiac surgery\n* Planned for general anesthesia\n* With or without combined regional nerve blockade\n* Admitted to the ICU with endotracheal intubation post-surgery\n* With an anticipated duration of postoperative mechanical ventilation greater than 24 hours\n* Clinically requiring light sedation( target RASS score 0 to -2)\n\nExclusion Criteria:\n\n* Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases\n* Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease\n* Inability to communicate preoperatively due to coma, severe dementia, or language barriers\n* Preoperative .cardiac insufficiency or severe cardiac arrhythmias\n* Severe hepatic impariment( Child-Pugh class C)\n* Severe renal impariment\n* Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam\n* Pregnancy or lactation\n* Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment\n* Any other conditions deemed by the investigators to render the patient unsuitable for study participation\n* Refusal to provide written informed consent","ALL","18 Years","64 Years",{"count":20,"type":21},306,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China. The objective of this RCT is to evaluate the sedative efficacy and safety profile of remimazolam besylate compared with dexmedetomidine in patients requiring mechanical ventilation following non-cardiac surgery. The study hypothesized that remimazolam besylate is non-inferior to dexmedetomidine regarding the primary efficacy outcome.",[27,28,29,30,31,32],"Effect of Drug","Adverse Drug Event","Mechanical Ventilation Complication","Critical Illness","Surgery","Sedation","RECRUITING","2026-06-13",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2025-01-20",{"date":41,"type":21},"2026-06-30",{"name":43,"class":44},"Beijing Shijitan Hospital, Capital Medical University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100624167","meop---multidimensional-evaluations-in-oncological-psychiatry-100624167","NCT07406113","MEOP - Multidimensional Evaluations in Oncological Psychiatry","MEOP","Inclusion Criteria:\n\n* For cases: any subject affected by cancer with a comorbid psychiatric disorder (further defined as \"cases\") or any first-degree relative of a subject of a \"case\" (i.e., i.e. a fist-degree relative of a subject affected by cancer and a psychiatric disorder). These first-degree relatives will be defined as \"cases-rel\".\n* For controls: a) Subjects with cancer who will undergo a consultation in the Clinical and Emergency Psychiatry Unit of the Fondazione Policlinico Universitario Agostino Gemelli IRCCS but who do not show any psychiatric symptoms (further defined as \"oncology-controls\"); b) subjects without cancer who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and present psychiatric symptoms (further defined as \"psy-controls\"); c) Subjects without cancer and with any suspected psychiatric disorder who will undergo a psychiatric evaluation in the Clinical and Emergency Psychiatry Unit and who are not diagnosed with any relevant psychiatric symptoms after the evaluation (further defined as \"healthy controls\"); d) First-degree relatives of \"oncology-controls\", \"psy-controls\" and \"healthy controls\" (further defined as \"control-rel\").\n* Age between 18 and 75 years.\n* Capability of providing written informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or inability to provide written informed consent.\n* Severe unstable neurological disorders, such as traumatic brain injury, Alzheimer's Disease or dementia.\n* Inability to perform psychiatric or neuropsychological evaluations.",true,"75 Years",{"count":56,"type":21},2000,"OBSERVATIONAL","Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes.\n\nThe pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, the production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss.\n\nMoreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation.\n\nCancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology.\n\nGiven the background presented so far, identifying and managing psychiatric comorbidities in oncological patients and their families is crucial. This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.",[60,61,62,28,63],"Psychiatric Disorder","Cognition Disorder","Treatment Compliance","Family Members","NOT_YET_RECRUITING","2026-02-09",{"date":67,"type":37},"2026-02-12",{"date":69,"type":21},"2026-01-30",{"date":71,"type":21},"2036-01-29",{"name":73,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":17,"enrollmentInfo":83,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":85,"conditions":86,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100478607","pharmacogenomic-association-study-in-indian-children-with-acute-lymphoblastic-leukemia-100478607","NCT05512169","Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia","Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)","MPGx-INDALL","Inclusion Criteria:\n\n* Age \\> 1 year old and ≤18 years old at enrolment\n* Previously untreated\n* ALL diagnosis confirmed by morphology and flow-cytometry\n* Indian origins\n* Fulfilling IciCle treatment protocol inclusion criteria and receiving treatment as per the protocol\n* Written Informed consent to participate in the study has to be signed by the participant\u002Fparent\u002Fguardian\n\nExclusion Criteria:\n\n* Previously tretaed patients\n* Patients with Down's syndrome\n* Patients with mature B-ALL","1 Year",{"count":84,"type":21},556,"A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva.\n\nThe study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.",[87,88,89,28,90,91,92,93],"ALL, Childhood","Pediatric Cancer","Toxicity, Drug","Relapse Leukemia","Drug Toxicity","Drug Effect","Drug Interaction",[95,96,97,98,99,100,101,102,103,104,105,106,107,108],"Pharmacogenetics","Pharmacogenomics","Genetic polymorphism","Sequencing","Genotyping","Indian","Pediatrics","SNP","gene variant","germline genetic variant","somatic variant","biomarker","steroid response","genetic predisposition","2026-01-13",{"date":111,"type":37},"2026-01-15",{"date":113,"type":37},"2022-12-01",{"date":115,"type":21},"2027-03-30",{"name":117,"class":44},"University of Geneva, Switzerland",2,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":118},"100445727","phase-3-melatonin-for-prevention-of-kidney-injury-100445727","NCT05084196","Melatonin for Prevention of Kidney Injury","Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury","Inclusion criteria:\n\n* Aged 18 to 75 years\n* Currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status. Because of the critical nature of starting empiric broad-spectrum antibiotics, we will allow one dose of the antibiotic combination before consent and enrollment. This strategy is necessary for the ethical conduct of the study.\n\nExclusion criteria:\n\n* Estimated creatinine clearance \\\u003C 30 mL\u002Fmin\n* Liver impairment (liver enzymes \\> 3 times upper limit)\n* Any history of allergy or contraindication to melatonin\n* Pregnancy or breastfeeding\n* Autoimmune disease\n* Requiring vasopressors\n* Requiring mechanical ventilation\n* History of acute kidney injury in the past 30 days\n* Inability to take oral medications\n* Clinical evidence of significant unstable or uncontrolled illness which, in the opinion of the research team, could confound the results of the study or put the patient at undue risk.",{"count":127,"type":21},300,[129],"PHASE3","This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.",[132,28],"Acute Kidney Injury","2025-12-16",{"date":135,"type":37},"2025-12-17",{"date":137,"type":37},"2023-06-05",{"date":139,"type":21},"2027-12-31",{"name":141,"class":44},"Rutgers, The State University of New Jersey",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":45},"100605575","comparative-study-of-tranexamic-acid-dosing-in-cardiac-surgery-100605575","NCT07164300","Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery","Comparative Study of Tranexamic Acid Dosage Regimens in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Patients undergoing elective cardiac surgery using cardiopulmonary bypass\n* Patients to have discontinued anticoagulant and antiplatelet therapy preoperatively according to guidelines.\n\nExclusion Criteria:\n\n* Age below 18 years\n* Patient refusal\n* Pregnancy\n* End-stage renal disease\n* History of epilepsy,\n* Cardiac surgery without the use of cardiopulmonary bypass (off-pump)\n* Emergency operations\n* Known allergy to the administered agents.","99 Years",{"count":151,"type":21},150,[153],"NA","Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion. However, there is no consensus regarding the dosage regimen of tranexamic acid that should be administered. The purpose of this study is to compare different dosages of tranexamic acid in cardiac surgery using cardiopulmonary bypass regarding the duration of inhibition of fibrinolysis as measured by the ClotPro test.\n\nBlood samples will be taken from the arterial line placed in the patient at specified time points in order to perform viscoelastic tests (ClotPro, TPA test), to detect successful inhibition of fibrinolysis and to measure tranexamic acid levels in the patient's blood. In case the action of tranexamic acid stops early postoperatively an additional dose of the medication will be administered to the patient.",[156,157,28,158,159],"Blood Coagulation Disorder","Postoperative Blood Loss","Fibrinolysis; Hemorrhage","Tranexamic Acid Adverse Reaction","2025-09-05",{"date":162,"type":37},"2025-09-10",{"date":164,"type":37},"2024-05-14",{"date":166,"type":21},"2027-12-15",{"name":168,"class":44},"University of Ioannina",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":53,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":177,"targetDuration":82,"studyType":57,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":45},"100562767","evaluation-of-the-implementation-of-the-pharmacogenetics-and-personalized-medicine-program-medea-in-the-extremadura-health-service-100562767","NCT06607445","Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program \"MedeA\" in the Extremadura Health Service.","Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program \"MedeA\" in the Extremadura Health Service. Population Cohort [MedeA21].","MedeA","Inclusion Criteria:\n\nPatients with a recent diagnosis and who are to be or are being treated according to usual clinical practice, who meet the criteria to participate in the study, read the corresponding information sheet, sign informed consent and agree to participate, provided they meet the following inclusion criteria:\n\nGeneral criteria for all patients:\n\n* Age ≥ 18 years. In case of minors, they may be included, under the following assumptions:\n* If the minor is under 12 years of age, participation will require the consent and signature of the informed consent document by both parents (or their guardian).\n* If the minor is between 12 and 16 years of age, a proxy informed consent form will be provided and signed by both parents (if both parents are present at the time of the interview) or only one of them (in which case one of the following two conditions must be stated: that the other parent is not present at the time of the interview but does not object to the participation of the minor in the study or that the signatory is the sole legal guardian of the minor).\n* Be registered or potentially\u002Fhave been attended in the Extremadura Health Service.\n* Not have language or communication barrier or present disability being totally dependent on another person.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria described above.\n* Refusal by the patient to be part of the cohort initially, or to continue to be part of the cohort during follow-up.\n* Manifest difficulty for follow-up.",{"count":178,"type":21},6445,"An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant adverse effects. It is a naturalistic study in which no pharmacological or other type of intervention will be carried out, only the information recommended in the drug data sheet (pharmacogenetic biomarkers, relevant interactions and clinical contraindications) will be provided.",[28],"2024-09-18",{"date":183,"type":37},"2024-09-23",{"date":185,"type":37},"2021-05-26",{"date":187,"type":21},"2024-12-31",{"name":189,"class":44},"Complejo Hospitalario Universitario de Badajoz",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":198,"conditions":199,"keywords":205,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":223,"locationsCount":225},"100554367","active-pharmacovigilance-study-of-the-medicine-rinvoq-upadacitinib-100554367","NCT06498167","Active Pharmacovigilance Study of the Medicine Rinvoq™ (Upadacitinib)","LOOK-UP","Inclusion Criteria:\n\n* Prescription of Rinvoq™ from January 1, 2024;\n* 18 years of age or older at the time of recruitment; and\n* Expressed consent to participate in the study.\n\nExclusion Criteria:\n\n* They have any degree of cognitive impairment that prevents them from responding to a questionnaire administered by telephone;\n* They are participating in a phase I, II, or III clinical trial;\n* They have a life expectancy of less than 1 month; or\n* They do not have a valid telephone contact.",{"count":151,"type":21},"The LOOK-UP is an investigator-initiated clinical study with the aim of monitoring the post-marketing safety of the medicine Rinvoq™ (upadacitinib), which is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease. The Marketing Authorisation Holder is AbbVie Deutschland GmbH \\& Co. KG.",[200,201,202,28,203,204],"Inflammatory Disease","Drug Side Effect","Drug Use","Adverse Drug Reaction","Safety Issues",[206,207,208,209,210,211,212,213,214,215,216],"Upadacitinib","Rinvoq","Rheumatoid arthritis","Psoriatic arthritis","Axial spondyloarthritis","Atopic dermatitis","Ulcerative colitis","Crohn's disease","Pharmacovigilance risk","Drug safety monitoring","Patient Safety","2024-07-12",{"date":219,"type":37},"2024-07-15",{"date":221,"type":37},"2024-07-01",{"date":187,"type":21},{"name":224,"class":44},"Universidade do Porto",3,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":17,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":45},"100494401","phase-1-oncolytic-virus-ad-td-nsil12-for-progressive-pediatric-diffuse-intrinsic-pontine-glioma-100494401","NCT05717699","Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n1. Informed consent of the parents or patient.\n2. After surgical resection, biopsy, chemotherapy, or radiation therapy, tumor progression must be confirmed by MRI scan.\n3. Biopsy is performed prior to injection of Ad-TD-nsIL12 to confirm DIPG (frozen section-based).\n4. Pre-enrollment patients LPS (patients aged ≥1 and \\\u003C16 years) and KPS (patients aged ≥16 years) ≥ 50.\n5. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.\n6. Age 1-18 years.\n7. A negative pregnancy test in fertile women (women are considered of childbearing potential (WOCBP) after menarche, unless permanently infertile, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).\n8. Lesion considered by the investigator to be accessible for stereotactic biopsy.\n\nExclusion Criteria:\n\n1. Serious infections or intercurrent conditions, including but not limited to severe renal failure, liver failure, heart failure, or bone marrow failure, which are not permitted for inclusion according to the investigator's criteria. Patients must be afebrile (\\\u003C38℃) at the time of viral therapy.\n2. Other investigational medications within 30 days prior to viral treatment.\n3. Participants with immunodeficiency, autoimmune disease, or active hepatitis.\n4. Any medical or psychological condition that might interfere with the patient's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.\n5. Tumor with multiple location.\n6. Pregnant or breast-feeding females.\n7. Severe bone marrow hypoplasia.\n8. Transaminases (aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT)) or total bilirubin \\> 3 times the upper limit of normal.\n9. Neutrophils \\\u003C 1x10\\^9\u002FL.\n10. Platelets ≤ 100x10\\^9\u002FL.\n11. Hemoglobin \\\u003C 9g\u002Fdl.\n12. Patients with Li-Fraumini syndrome or a known germline defect in the retinoblastoma gene or its associated pathways.\n13. Administer any type of vaccine within 30 days prior to Ad-TD-nsIL12 administration.\n14. Blood transfusions or drugs (such as G-CSF) within 28 days before viral treatment to treat pancytopenia or other hematological disorders.",{"count":233,"type":21},18,[235],"PHASE1","This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in progressive DIPG patients (NCI-CTCAE V5.0).",[238,239,28],"Oncolytic Virus","Diffuse Intrinsic Pontine Glioma","2024-02-25",{"date":242,"type":37},"2024-02-28",{"date":244,"type":37},"2023-01-04",{"date":246,"type":21},"2028-01-04",{"name":248,"class":44},"Capital Medical University",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":17,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":261,"leadSponsor":262,"locationsCount":45},"100494402","phase-1-oncolytic-virus-ad-td-nsil12-for-primary-pediatric-diffuse-intrinsic-pontine-glioma-100494402","NCT05717712","Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n1. Informed consent of the parents or patient.\n2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.\n3. Age 1-18 years.\n4. A negative pregnancy test in fertile women (women are considered of childbearing potential (WOCBP) after menarche, unless permanently infertile, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).\n5. Patient newly diagnosed of DIPG in MRI.\n6. Pre-enrollment patients LPS (patients aged ≥1 and \\\u003C16 years) and KPS (patients aged ≥16 years) ≥ 50.\n7. Lesion considered by the investigator to be accessible for stereotactic biopsy. The location of the lesion allows injection without virus entering the ventricular system.\n8. No previous treatment for DIPG.\n\nExclusion Criteria:\n\n1. Serious infections or intercurrent conditions, including but not limited to severe renal failure, liver failure, heart failure, or bone marrow failure, which are not permitted for inclusion according to the investigator's criteria. Patients must be afebrile at baseline (\\\u003C38℃).\n2. Other investigational medications within 30 days prior to viral treatment.\n3. Participants with immunodeficiency, autoimmune disease, or active hepatitis.\n4. Any medical or psychological condition that might interfere with the patient's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.\n5. Tumor with multiple location.\n6. Pregnant or breast-feeding females.\n7. Severe bone marrow hypoplasia.\n8. Transaminases (aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT)) or total bilirubin \\> 3 times the upper limit of normal.\n9. Neutrophils \\\u003C 1x10\\^9\u002FL.\n10. Platelets ≤ 100x10\\^9\u002FL.\n11. Hemoglobin \\\u003C 9 g\u002Fdl.\n12. Patients with Li-Fraumini syndrome or a known germline defect in the retinoblastoma gene or its associated pathways.\n13. Administer any type of vaccine within 30 days prior to Ad-TD-nsIL12 administration.\n14. Blood transfusions or drugs (such as G-CSF) within 28 days before baseline to treat pancytopenia or other blood disorders.",{"count":233,"type":21},[235],"This is a drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in primary DIPG patients (NCI-CTCAE V5.0).",[238,239,28],{"date":242,"type":37},{"date":244,"type":37},{"date":246,"type":21},{"name":248,"class":44},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":282,"locationsCount":45},"100500730","effect-of-nst-whole-course-nutritional-management-on-nutritional-status-and-adverse-reactions-in-esophageal-cancer-100500730","NCT05800054","Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer","Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy","Inclusion Criteria:\n\n* Sign the informed consent; must have good compliance with the treatment plan and follow-up.\n* No gender restriction, but age between 18 and 75 years old;\n* Cytological or histological is confirmed esophageal squamous cell carcinoma;\n* Non-surgical treatment of stage II-III primary esophageal cancer (except biopsy);\n* The primary tumor can be evaluated;\n* No distant organ metastasis;\n* PG-SGA score B (2\\~8) or C (≥9);\n* KPS score ≥ 70 points, ECOG physical condition score 0-1 points;\n* The function of major organs (bone marrow, liver, kidney function) 7 days before treatment, meet the following criteria: Blood routine examination standards (without blood transfusion within 14 days):\n\n  * Hemoglobin (HB) ≥ 100g\u002FL;\n\n    * White blood cells (WBC) ≥ 4×109\u002FL; Absolute neutrophil count (ANC) ≥1.5×109\u002FL;\n\n      * Platelet (PLT) ≥ 100×109\u002FL.\n* The biochemical examination shall meet the following standards:\n\n  * Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);\n\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 1.5 times ULN;\n\n      * Serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance rate (CCr) ≥ 60ml\u002Fmin.\n* Expected survival ≥ 6 months.\n\nExclusion Criteria:\n\n* No malnutrition or nutritional risk; PG-SGA score of A;\n* Severely impaired intestinal function, or intolerance of enteral nutrition;\n* Severe vomiting, gastrointestinal bleeding, intestinal obstruction;\n* Patients with very severe malnutrition cannot tolerate radiotherapy and chemotherapy;\n* The primary tumor or lymph node has received radiotherapy, chemotherapy or targeted therapy;\n* Suffering from other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or skin basal cell carcinoma);\n* Subjects who have received other drug trials within the past month;\n* Those with severe allergic history or idiosyncratic constitution;\n* Those with a history of severe lung or heart disease;\n* Serious comorbidities, such as uncontrolled hypertension, heart failure, etc.;\n* Pregnant or breastfeeding women;\n* Currently or planning to participate in other clinical trials;\n* Refusal or inability to sign the informed consent form to accept participation in the trial.",{"count":271,"type":21},210,[153],"This study is a randomized, open, parallel controlled clinical trial. The main purpose of this study was to compare the changes in body weight\u002Fbody mass index (BMI) before and after treatment between the two groups of patients with NST full-course nutritional management and without NST full-course nutritional management.\n\nThe secondary objective was to compare the quality of life, nutritional status, immune function and inflammatory response, adverse reactions of radiotherapy and chemotherapy, and short-term\u002Flong-term efficacy between the two groups.\n\nThe treatment plan was: esophageal cancer with routine nutrition guidance as the control group, and the NST whole-process intervention guidance as the experimental group.\n\n1\\. Experimental group: NST whole-course intervention\n\n1. Nutritionists formulate nutritional programs and manage them in a refined manner. On the basis of the patient's natural diet (food and homogenate meal), enteral nutritional preparations or parenteral nutritional supplements are given according to the patient's gastrointestinal obstruction, dietary structure, and food intake. Energy 30-35kcal\u002Fkg\u002Fd, protein 1.2-1.5g\u002Fkg\u002Fd. Enteral nutrition administration route: oral or tube feeding or ostomy, oral feeding is preferred; severe obstruction of eating or oral can not meet the target nutrition, choose tube feeding or ostomy. When it is expected that enteral nutrition cannot meet 60% of the target energy requirement for 3 to 5 days, choose parenteral nutrition. The enteral nutritional preparation adopts the whole protein enteral nutritional preparation Nengquan, and\u002For the tumor nutritional preparation Ruineng, and\u002For whey protein powder.\n2. Radiotherapy\n3. Chemotherapy 2. Control group: routine nutrition guidance for esophageal cancer\n\n(1) Nutritional therapy: The nutritional program was the same as that of the experimental group, and the patients performed it themselves.\n\n(2) Concurrent chemoradiotherapy: the same as the experimental group.\n\nEfficacy evaluation:\n\n1. Body weight and body mass index (BMI)\n2. Quality of life score (EORTCQLQ-C30)\n3. Nutritional status\n4. Immune function and inflammatory response (total lymphocytes, CRP, IL-6)\n\n(4) Intestinal mucosal barrier and intestinal flora (5) Adverse reactions of radiotherapy and chemotherapy (6) Short-term\u002Flong-term efficacy (5) Evaluation of treatment side effects (6) Short-term\u002Flong-term efficacy",[275,28],"Esophageal Neoplasms","2023-03-23",{"date":278,"type":37},"2023-04-05",{"date":280,"type":37},"2021-01-01",{"date":139,"type":21},{"name":283,"class":44},"The First Affiliated Hospital with Nanjing Medical University"]