Fibromyalgia Clinical Trial
Official title:
Screening Protocol to Evaluate Patients for Approved Studies
This screening protocol is designed to evaluate patients for participation in clinical
studies in the Gene Therapy and Therapeutics Branch (GTTB) of the National Institute of
Dental and Craniofacial Research. To participate, patients must meet the specific
requirements of at least one of the available research studies; this protocol serves as a
first step for admitting patients to an appropriate program.
People with diagnosed or undiagnosed conditions may participate in this screening protocol.
They will undergo procedures that may include questionnaires, a physical examination,
routine laboratory tests, and diagnostic imaging or radiological studies. Eligibility
screening will be limited to three visits within 12 months of entry into the protocol. If an
appropriate study is not found by the end of this time, the candidate's participation in the
screening program will terminate. No experimental treatments are offered under the screening
protocol.
Patients who are found eligible for a current GTTB study will be notified of their options
and invited to enroll.
This protocol is designed to screen patients with either diagnosed or undiagnosed
conditions, and provides for determining eligibility for approved protocols within the Gene
Therapy and Therapeutics Branch (GTTB), National Institute of Dental and Craniofacial
Research. The purpose of the protocol is to allow evaluation of patients who do not meet the
requirements for other screening protocols, such as the screening protocol for Sjogren's
syndrome patients.
Each subject will be evaluated to determine whether they are suitable candidates for
inclusion in any protocols in the GTTB. The screening evaluation will include past and
current medical history, and an appropriate physical examination. Further routine diagnostic
tests may also be performed to determine eligibility for approved studies. The tests and
procedures are of minimal risk. When the screening has been completed, subjects will be
informed of the options available at the time for participation in available, approved
research protocols.
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