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临床试验/NL-OMON42371
NL-OMON42371尚未招募不适用

The effects of preceding human endotoxemia on the Fluenz-induced immune response, a explorative study - LPS-Fluenz

Radboud Universitair Medisch Centrum0 个研究点目标入组 0 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Age >=18 and <=35 years of age

排除标准

  • -Pre-existent lung disease, including asthma
  • -A history of allergic rhinitis
  • -Use of any medication
  • -Use of alcohol > 5/day or >20/wk
  • -Use of any drugs
  • -Current smoker or more than 5 pack-year history
  • -Frequently have nosebleeds
  • -Recent nasal or otologic surgery
  • -Febrile illness or a common cold within four weeks before the LPS challenge
  • -Currently participating in another clinical trial or donation of blood 3 months prior to the LPS challenge.
  • -Previous spontaneous vagal collapse.
  • -History, signs or symptoms of cardiovascular disease.
  • -(Family) history of myocardial infarction or stroke under the age of 65 years.
  • -Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a
  • complex bundle branch block.
  • -Hypertension (defined as RR systolic > 160 or RR diastolic > 90).
  • -Hypotension (defined as RR systolic < 100 or RR diastolic < 50).
  • -Renal impairment (defined as plasma creatinin >120 µmol/l).
  • -Liver enzyme abnormalities or positive hepatitis serology.
  • -Positive HIV serology or medical history of any other obvious disease associated with immune deficiency.
  • -History of allergic reaction to Fluenz®, eggs / gelatin / gentamicin
  • -History of Guillain-Barré Syndrome

研究者

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