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Tracking Information | |||||
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First Received Date † | April 20, 2001 | ||||
Last Updated Date | September 1, 2006 | ||||
Start Date † | September 1996 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00015561 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Pesticides--Health Fertility and Reproductive Risk | ||||
Official Title † | |||||
Brief Summary | This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Natural History, Cross-Sectional, Defined Population, Retrospective/Prospective Study | ||||
Condition † |
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Intervention † | |||||
Study Arms / Comparison Groups | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 1803 | ||||
Completion Date | August 2001 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Pesticide applicators and their spouses |
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Gender | Both | ||||
Ages | 18 Years to 70 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00015561 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | National Institute of Environmental Health Sciences (NIEHS) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Institute of Environmental Health Sciences (NIEHS) | ||||
Verification Date | September 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |