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临床试验/EUCTR2020-002433-15-SE
EUCTR2020-002433-15-SE进行中(未招募)1 期

Positron emission tomography (PET) of patients with brain injury and athletes with concussion symptoms - Descriptive study of the tau tracer 18F-RO6958948

Region Skåne0 个研究点目标入组 80 人开始时间: 2020年12月29日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Region Skåne
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - The subject/patient has given his written consent to participate in the study.
  • Study population A-C (patients with TBI, ICH or SAH):
  • - Cared for in the intensive care unit NIVA with one of the diagnoses traumatic brain injury (TBI), intracerebral haemorrhage (ICH) or subarachnoid haemorrhage (SAH). During the care period, relatives have been informed and did not object to participation.
  • - Age 18-60 years.
  • -The patient is judged by the investigator to be clinically stable enough to pass the examination with PET, and understand the study information
  • Study population D (athletes):
  • - Athletes age 18-40 years
  • - The athlete has suffered from at least one previous concussion in sports and has persistent symptoms.
  • - The athlete must have had symptoms (post-emotional syndrome) for at least 6 months after the last concussion.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 80
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Claustrophobia
  • - Pregnancy, breast-feeding or planned pregnancy.
  • -- Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.
  • -- Treatment or illness which, according to the examiner, may affect the treatment or the study result.
  • -- Participates in or has recently participated in a clinical trial in the last 6 months.
  • - Pregnancy, breast-feeding or planned pregnancy.
  • - Mental inability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study.
  • - Treatment or illness which, according to the examiner, may affect the treatment or the study result.

研究者

发起方
Region Skåne

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