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Sponsored by: |
National Institute of Environmental Health Sciences (NIEHS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00017914 |
This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.
Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results.
All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:
All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.
Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.
Condition |
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Dermatomyositis Polymyositis Idiopathic Inflammatory Myopathy Healthy |
Study Type: | Observational |
Official Title: | Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies |
Estimated Enrollment: | 600 |
Study Start Date: | June 1994 |
This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.
Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results.
All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:
All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.
Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
All patients admitted to the study must satisfy the following criteria:
EXCLUSION CRITERIA:
1. Severe medical diseases requiring intensive care or any other conditions in which drawing the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 940165, 94-E-0165 |
Study First Received: | June 19, 2001 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00017914 |
Health Authority: | United States: Federal Government |
Juvenile Dermatomyositis Juvenile Polymyositis Autoimmune Diseases Disease Activity Assessment |
Myositis-Specific Autoantibodies Dermatomyositis Polymyositis Idiopathic Inflammatory Myopathy |
Juvenile dermatomyositis Autoimmune Diseases Skin Diseases Healthy Myositis Dermatomyositis Muscular Diseases |
Musculoskeletal Diseases Neuromuscular Diseases Autoantibodies Polymyositis Connective Tissue Diseases Idiopathic myopathy |
Nervous System Diseases |