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| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 26, 2000 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | January 2000 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001983 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Eligibility Screening for National Institute of Dental and Craniofacial Research Studies |
| Official Title ICMJE | Screening Protocol to Evaluate Patients for Approved Studies |
| 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | Fibromyalgia |
| Intervention ICMJE | |
| 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 ICMJE | Completed |
| Enrollment ICMJE | 300 |
| Completion Date | December 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001983 |
| Responsible Party | |
| Study ID Numbers ICMJE | 000066, 00-D-0066 |
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | December 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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