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Eligibility Screening for National Institute of Dental and Craniofacial Research Studies

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Dental and Craniofacial Research (NIDCR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Fibromyalgia focused on measuring Questionnaires, Eligibility, History, Physical Examination, Tests, Fibromyalgia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: All patients who may be eligible for other currently approved protocols. Inclusion and exclusion criteria will vary according to the protocol(s) for which the patient is being screened. Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis.

Sites / Locations

  • National Institute of Dental And Craniofacial Research (NIDCR)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 26, 2000
Last Updated
March 3, 2008
Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT00001983
Brief Title
Eligibility Screening for National Institute of Dental and Craniofacial Research Studies
Official Title
Screening Protocol to Evaluate Patients for Approved Studies
Study Type
Observational

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Questionnaires, Eligibility, History, Physical Examination, Tests, Fibromyalgia

7. Study Design

Enrollment
300 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: All patients who may be eligible for other currently approved protocols. Inclusion and exclusion criteria will vary according to the protocol(s) for which the patient is being screened. Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis.
Facility Information:
Facility Name
National Institute of Dental And Craniofacial Research (NIDCR)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Eligibility Screening for National Institute of Dental and Craniofacial Research Studies

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