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临床试验/NCT02561260
NCT02561260Unknown不适用

Multicenter and Prospective Clinical Registry Study of Autoimmune Encephalitis in China

Beijing Tongren Hospital0 个研究点目标入组 400 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
主要终点
death

研究概览

简要总结

In recent years, more and more previously thought to be unknown encephalitis was found to be a specific antigen associated encephalitis,but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to establish a database of autoimmune encephalitis in Chinese population. The prospective clinical trial of atutoimmune encephalitis in China, by screening the autoimmune encephalitis associated antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of autoimmune encephalitis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 6 months.
  • Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
  • At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;
  • Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear.
  • Signed the informed consent.

排除标准

  • Infants less than 6 months;
  • The metabolic encephalopathy;
  • Infectious encephalitis with clear pathogen clinically, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
  • Non-infectious encephalitis with clear diagnosis clinically, including: multiple sclerosis, neuromyelitis optic, acute disseminated encephalomyelitis and so on.

结局指标

主要结局

death

时间窗: 30days

次要结局

未报告次要终点

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jia Wei Wang,MD

Chairman and Full Professor of Department of Neurology and Medical Research Center

Beijing Tongren Hospital

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