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临床试验/jRCT1032230545
jRCT1032230545已完成不适用

Validation of the Clinical Value of Interstitial Fluid Biomarkers in Skin

TOPPAN Holdings Inc.0 个研究点目标入组 60 人开始时间: 2024年5月16日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
skin interstitial fluid BMs difference

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Diagnostic Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 70age old not(—)
性别
All

入选标准

  • (1)Thyroid, circulatory, or respiratory disease such as who expected to show abnormal BM values specific to each of the disease mentioned or healthy adults.
  • (2)Patients who are at least 18 years old and less than 70 years old at the time of consent.
  • (3)(Healthy adult group only) Body Mass Index between 18.5 and 25.
  • (4)Patients who can obtain document consent with their own will before any study related procedure.

排除标准

  • (1) Those who are unable to undergo blood tests.
  • (2) Persons with obvious skin abnormalities (abnormal pigmentation, swelling, wounds, etc.) at the site of interstitial fluid collection
  • (3) Patients who have received an injectable medication or vaccination within 1 week.
  • (4) (Healthy adult group only) Those who are allergic to inhaled allergens (pollen, house dust, etc.)
  • (5) (Healthy adult group only) Those with allergies to food, drugs, metals, etc., and have confirmed exposure to the relevant allergens within 1 week.
  • (6) (Healthy adult group only) Those who have suffered a traumatic injury or received invasive treatment within 1 week.
  • (7) (Healthy adult group only) Persons who have contracted an infectious disease within 3 weeks
  • (8) Persons with hypersensitivity to raw materials (aluminum alloy and polypropylene) used in the research equipment.
  • (9) Other persons who are judged to be ineligible by the principal investigators or research assistants.

结局指标

主要结局

skin interstitial fluid BMs difference

The difference between the skin interstitial fluid BMs collected from patients with each disease with the skin interstitial fluid BMs collected from healthy adults.

次要结局

未报告次要终点

研究者

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