{"id":"nse-dosage-hypothermia-arm","safety":{"commonSideEffects":[{"rate":null,"effect":"Shivering and discomfort during cooling"},{"rate":null,"effect":"Coagulopathy and bleeding risk"},{"rate":null,"effect":"Infection risk"},{"rate":null,"effect":"Arrhythmias during rewarming"}]},"_chembl":{"chemblId":"CHEMBL3896316","moleculeType":"Small molecule","molecularWeight":"654.59"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Therapeutic hypothermia reduces cerebral metabolic rate and inflammation, potentially limiting ischemic or hypoxic brain damage. The 'hypothermia arm' designation suggests this is a comparative study arm testing NSE (neuron-specific enolase) dosing or monitoring in patients undergoing controlled temperature management. NSE itself is a biomarker of neuronal injury rather than a therapeutic agent.","oneSentence":"NSE dosage in the hypothermia arm likely refers to a neuroprotective strategy using mild hypothermia to reduce neuronal injury during acute neurological events.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T01:23:32.327Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Neuroprotection in acute neurological injury (likely cardiac arrest, stroke, or traumatic brain injury) with therapeutic hypothermia"}]},"trialDetails":[{"nctId":"NCT02722473","phase":"PHASE3","title":"NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.","status":"COMPLETED","sponsor":"Centre Hospitalier Departemental Vendee","startDate":"2016-03","conditions":"Cardiac Arrest, Hypothermia, Critical Care","enrollment":106}],"_emaApprovals":[],"_faersSignals":[{"count":9751,"reaction":"HYPOTHERMIA"},{"count":3090,"reaction":"HYPOTENSION"},{"count":2423,"reaction":"OFF LABEL USE"},{"count":2378,"reaction":"NAUSEA"},{"count":2318,"reaction":"ACUTE KIDNEY INJURY"},{"count":2272,"reaction":"DRUG INEFFECTIVE"},{"count":2213,"reaction":"DIARRHOEA"},{"count":2001,"reaction":"VOMITING"},{"count":1988,"reaction":"COMPLICATION ASSOCIATED WITH DEVICE"},{"count":1876,"reaction":"FATIGUE"}],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"NSE dosage \"hypothermia arm\"","genericName":"NSE dosage \"hypothermia arm\"","companyName":"Centre Hospitalier Departemental Vendee","companyId":"centre-hospitalier-departemental-vendee","modality":"Biologic","firstApprovalDate":"","aiSummary":"NSE dosage in the hypothermia arm likely refers to a neuroprotective strategy using mild hypothermia to reduce neuronal injury during acute neurological events. Used for Neuroprotection in acute neurological injury (likely cardiac arrest, stroke, or traumatic brain injury) with therapeutic hypothermia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}