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临床试验/NCT04653558
NCT04653558已完成不适用

Clinical Manifestations and Long-Term Outcome in Early Lyme Neuroborreliosis According to Diagnostic Certainty

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 311 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
311
试验地点
1
主要终点
composite clinical score

研究概览

简要总结

In this retrospective cohort study of patients with early Lyme neuroborreliosis (LNB), clinical and microbiologic characteristics and long-term outcome of definite vs. possible LNB were evaluated at a single university medical center in Slovenia. Severity of acute disease and long-term outcome during a 12-month follow-up were assessed using a composite clinical score based on objective clinical findings and subjective complaints.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • early Lyme neuroborreliosis

排除标准

  • Not fulfilling study criteria for definite or possible Lyme neuroborreliosis
  • Alternative diagnosis during follow-up
  • Concomitant tick-borne encephalitis
  • Clinical symptoms/signs present for >6 months
  • Data not available

结局指标

主要结局

composite clinical score

时间窗: follow-up for 12 months-post-treatment

Composite clinical score based on objective clinical findings and subjective complaints. The sum of subjective complaints and objective findings scored as 0=absent or 1=present represent severity of disease on admission or clinical outcome at follow-up, respectively. Maximum total score=31

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daša Stupica

Principal Investigator

University Medical Centre Ljubljana

研究点 (1)

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