NL-OMON50085已完成不适用
PLEASE5+: Long-term outcomes and quality of life of patients with symptoms attributed to Lyme borreliosis - PLEASE5+
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects who have been randomized into the PLEASE study and not have
- •subsequently withdrawn informed consent for the PLEASE or PLEASE5+ study are
- •eligible. Inclusioncriteria for PLEASE were: persistent symptoms
- •(musculo-skeletal pain, arthritis, arthralgia, neuralgia, sensory disturbances,
- •dysesthesia, neuro-psychological disorders, or cognitive disorders, with or
- •without persistent fatigue) that were attributed to Lyme borreliosis, either
- •temporally related within 4 months to a physician-confirmed episode of erythema
- •migrans or otherwise proven symptomatic Lyme borreliosis manifestation (by
- •positive biopsy, PCR, culture, or intrathecal antibody production); or with a
- •positive B. burgdorferi IgG or IgM immunoblot.
排除标准
- •Subjects who have died, subjects who have withdrawn informed consent to PLEASE
- •participation, have not consented to receive PLEASE5+ study information, and
- •who do not provide written informed consent to PLEASE5+ participation are
研究者
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