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临床试验/NCT04888923
NCT04888923招募中不适用

Natural History of The Human Biological Response to Environmental Exposure and Injury

National Institute of Environmental Health Sciences (NIEHS)2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
2
主要终点
To identify the interaction of host and environmental factors in the response to injury and the development of disease.

研究概览

简要总结

Background:

Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.

Objective:

To identify and understand how environmental exposures contribute to human disease.

Eligibility:

Healthy adults ages 18 and older

Design:

Participants will be screened with questions about their health history, demographics, and medicines they take.

Participants may give blood, hair, stool, saliva, and/or urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath.

Participants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup.

Participants may have their nasal passages brushed, scraped, or washed.

Participants may give cheek cell samples. They will swish mouthwash and spit it into a cup.

Participants who produce sperm may give samples.

Participants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung.

Participants may have a pelvic or transvaginal ultrasound. They may have lung function tests.

Participants may collect household dust, urine, or stool at home.

Participants will complete surveys about their health, diet, and exposures.

Participation will last for one or more study visits.

Participants may be contacted in the future to take part in other studies.

详细描述

Study Description:

Environmental exposures such as pollution, diet, stress, etc. contribute to the development and exacerbation of human disease. Understanding the mechanisms of environmentally induced injury and inflammation will allow us to devise better prophylaxis and treatment measures.

Subjects may undergo sampling of (including but not limited to:) blood, urine, saliva, household dust, cheek cells, hair, nasal cells, stool, nail clippings, exhaled breath condensate, sperm samples, skin cells, and/or sputum etc., and may answer predefined questionnaires regarding health and exposures.

Studies which may be performed on collected material includes establishment of cell cultures and immunologic studies.

Objectives:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Ability to provide informed consent.
  • Able to read and speak English
  • Male or female, aged >=18
  • Able to travel to the NIEHS CRU for study visits or travel to an offsite event or conference.

排除标准

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Not willing to have samples stored for future use.
  • Current pregnancy or lactation, by participant verbal confirmation.
  • Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.
  • Participants will be enrolled according to pre-defined host (e.g. disease, genetic, or demographic) or environmental (exposure) characteristics.

研究组 & 干预措施

Healthy Controls

General public population, including females and males, who are over the age of 18, with a mixture of races and ethnicities representative of North Carolina.

结局指标

主要结局

To identify the interaction of host and environmental factors in the response to injury and the development of disease.

时间窗: On-going

To identify the interaction of host and environmental factors in the response to injury and the development of disease.

次要结局

未报告次要终点

研究者

发起方
National Institute of Environmental Health Sciences (NIEHS)
申办方类型
Nih
责任方
Sponsor

研究点 (2)

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