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临床试验/NL-OMON54221
NL-OMON54221招募中不适用

nderstanding the mechanisms of fatigue and relapse in IBD patients, and the evaluation of an innovative health patch - Fatigue in Inflammatory Bowel Diseases

Amsterdam UMC0 个研究点目标入组 100 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
招募中
发起方
入组人数
100

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

  • All groups:
  • - Aged between 18 and 75 years
  • - Male and female
  • Group 3 and 4:
  • - Willingness to abstain from visiting a sauna, or swimming during the 72h
  • monitoring period
  • - Willingness to wear a shirt at night (to prevent uncontrolled friction on
  • electrodes during sleep)
  • - Willingness to dry area where the electrodes are applied in a dipping fashion
  • after washing
  • - CD in remission (HBI < 4, calprotectin < 250µg/g, CRP < 5mg/l)
  • - Active CD (HBI > 4, calprotectin > 250µg/g, CRP > 5mg/l)
  • - UC in remission (SCCAI <=2, calprotectin < 250µg/g, CRP < 5mg/l)
  • - Active UC (SCCAI > 2, calprotectin > 250µg/g, CRP > 5mg/l)
  • - No CD or UC diagnosis, no intestinal complaints (diarrhea, blood in
  • stool, pain)

排除标准

  • 1. Inability to read, give or sign informed consent
  • 2. Inability to give blood
  • 3. Comorbidity with severe disease
  • 4. Having any cardiac implants
  • 5. Wounded or particular sensitive skin (e.g. skin-rash, discoloration, scars,
  • or open wounds at area of investigation)
  • 6. Pregnant or lactating
  • 7. Known to be allergic to silicone, acrylic chemicals or medical gels
  • 8. Use of medication known to influence the skin at the test area (such as
  • medical creams of lotions)

研究者

发起方
Amsterdam UMC

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