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NCT00017914 · ClinicalTrials.gov registry record
Adult and Juvenile Myositis
A clinical trial of Dermatomyositis and Inclusion Body Myositis, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Recruiting
- Registry status
- 1,200
- Enrollment target
- 4
- Study locations
NCT00017914 is a study of Dermatomyositis and Inclusion Body Myositis that is actively recruiting participants, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 1,200 participants, above the 422-participant average among 19 other Dermatomyositis trials with a reported enrollment target (184% higher). The trial reports 4 study locations across 4 states.
The verdict
NCT00017914, a study of Dermatomyositis and Inclusion Body Myositis, is actively recruiting participants, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- RECRUITING
- Registry status
- 1,200 participants
- Enrollment target
- 4
- Study locations
Study Summary
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: 1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks 2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic) 3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles 4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow 5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function 6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray 7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imag
Conditions Studied
Study Locations (4)
Georgia
- Emory University - Atlanta
Maryland
- National Institutes of Health Clinical Center - Bethesda
North Carolina
- NIEHS Clinical Research Unit (CRU) - Research Triangle Park
Texas
- Texas Scottish Rite Hospital - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 1995-06-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00017914
The ClinicalTrials.gov registry entry for NCT00017914 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 422-participant average among 19 other Dermatomyositis trials with a reported enrollment target (184% higher). The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 0 interventions.
NCT00017914 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Georgia, Maryland, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00017914 about?
NCT00017914 is a clinical study titled "Adult and Juvenile Myositis". 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...
What is the current status of trial NCT00017914?
This trial is currently recruiting. The enrollment target is 1,200 participants. The study started on 1995-06-07.
What conditions does trial NCT00017914 study?
This clinical trial studies the following conditions: Dermatomyositis, Inclusion Body Myositis, Polymyositis.
Who is sponsoring clinical trial NCT00017914?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00017914 being conducted?
This trial has 4 study locations across Georgia, Maryland, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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