[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"toxicity-drug\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:toxicity-drug":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,62,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100478607","pharmacogenomic-association-study-in-indian-children-with-acute-lymphoblastic-leukemia-100478607",false,"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","ALL","1 Year","18 Years",{"count":21,"type":22},556,"ESTIMATED","OBSERVATIONAL","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.",[26,27,28,29,30,31,32,33],"ALL, Childhood","Pediatric Cancer","Toxicity, Drug","Adverse Drug Event","Relapse Leukemia","Drug Toxicity","Drug Effect","Drug Interaction",[35,36,37,38,39,40,41,42,43,44,45,46,47,48],"Pharmacogenetics","Pharmacogenomics","Genetic polymorphism","Sequencing","Genotyping","Indian","Pediatrics","SNP","gene variant","germline genetic variant","somatic variant","biomarker","steroid response","genetic predisposition","RECRUITING","2026-01-13",{"date":52,"type":53},"2026-01-15","ACTUAL",{"date":55,"type":53},"2022-12-01",{"date":57,"type":22},"2027-03-30",{"name":59,"class":60},"University of Geneva, Switzerland","OTHER",2,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100489404","safe-stop-ipilimumab-nivolumab-ipi-nivo-trial-100489404","NCT05652673","Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial","Safe Stop IPI-NIVO Trial: Early Discontinuation of Nivolumab Upon Achieving a (confirmed) Complete or Partial Response in Patients with Irresectable Stage III or Metastatic Melanoma Treated with First-line Ipilimumab-nivolumab","Inclusion Criteria:\n\n* 18 years of age or older\n* Irresectable stage III or metastatic melanoma\n* Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:\n\n  * previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed\n  * in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.\n* Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2\u002F+6) weeks from the start of ipilimumab-nivolumab:\n\n  * for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET\u002FCT) is allowed at baseline\n  * for patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET\u002FCT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria 30\n  * in case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI for response evaluation prior to inclusion in this study.\n* Patients should be included after first CR\u002FPR or first confirmed CR\u002FPR according to RECIST v1.1 30:\n\n  * inclusion should take place no later than 5 weeks after first confirmed CR\u002FPR\n  * in case of SD at first response evaluation, confirmed CR\u002FPR is required for inclusion\n  * planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR\u002FPR or first confirmed CR\u002FPR\n  * no later than 9 months after start of treatment with ipilimumab-nivolumab\n* Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab)\n* Participants with previously locally treated brain metastases may participate in case they meet the following criteria:\n\n  * completely asymptomatic brain metastases at inclusion\n  * MRI of brain at baseline and for response evaluation during treatment\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* Patients with SD\u002FPD according to RECIST v1.1\n* Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.\n* Presence of symptomatic brain metastases:\n\n  * prior to first-line treatment with ipilimumab-nivolumab, or;\n  * when defined as new or progressive brain metastases at the time of study entry;\n  * brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion.\n\n(provided that the other in- and exclusion criteria are met);\n\n* Presence of leptomeningeal metastases;\n* Systemic chronic steroid therapy (\\>10mg\u002Fday prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the treatment of immune related adverse events (irAEs). Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial",{"count":70,"type":22},80,"INTERVENTIONAL",[73],"NA","Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab",[76,77,78,28],"Melanoma Stage IV","Melanoma Stage III","Immunotherapy","2025-02-26",{"date":81,"type":53},"2025-02-28",{"date":83,"type":53},"2023-02-01",{"date":85,"type":22},"2029-12-01",{"name":87,"class":60},"Erasmus Medical Center",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":71,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":88},"100400872","potential-role-of-gastric-lavage-by-paraffin-oil-in-acute-aluminum-phosphide-poisoning-100400872","NCT04499885","Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning","Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* • Patients with symptomatic acute aluminum phosphide poisoning\n\nExclusion Criteria:\n\n* • Pregnant and lactating women\n\n  * Asymptomatic patients with history of acute aluminum phosphide exposure.\n  * Patients with ingestion or exposure to other substances in addition to aluminum phosphide.\n  * Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).\n  * Patients with previous medical intervention (had gastric lavage in any medical center before admission).\n  * Patients with disturbed consciousness level\n  * Patients with post cardiac arrest cases",{"count":97,"type":22},62,[73],"Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.",[28],"2020-08-01",{"date":103,"type":53},"2020-08-05",{"date":105,"type":53},"2020-06-01",{"date":107,"type":22},"2030-12-10",{"name":109,"class":60},"Sherief Abd-Elsalam"]