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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | July 7, 2001 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | July 2001 | ||||||||
| Estimated Primary Completion Date | March 2004 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
HIV disease progression (new or recurrent AIDS defining illness) or death as a first event. | ||||||||
| Change History | Complete list of historical versions of study NCT00018889 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
CD4+ cell count changes, Plasma HIV RNA load changes, HIV disease progression alone, Survival, Treatment discontinuations, HIV risk behavior, Productivity analysis, Health care utilization. Quality of life, Nutritional status. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Phenotype/Genotype Correlations in Movement Disorders | ||||||||
| Official Title ICMJE | Phenotype/Genotype Correlations in Movement Disorders | ||||||||
| Brief Summary | The goal of this protocol is to identify families with inherited movement disorders and evaluate disease manifestations to establish an accurate clinical diagnosis by using newest technological advances and investigate the underlying molecular mechanisms. Studies of inherited movement disorders in large families with good genealogical records are especially valuable. Patients with diseases of known molecular basis will be genotyped in order to investigate phenotype/genotype correlation. Patients with disease of unknown or incomplete genetic characterization will be studied with a hope of contributing to the identification of specific disease-causing genes and genetic mechanisms responsible for a specific disorder. |
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| Detailed Description | The goal of this protocol is to identify families with inherited movement disorders and evaluate disease manifestations to establish an accurate clinical diagnosis by using newest technological advances and investigate the underlying molecular mechanisms. Studies of inherited movement disorders in large families with good genealogical records are especially valuable. Patients with diseases of known molecular basis will be genotyped in order to investigate phenotype/genotype correlation. Patients with disease of unknown or incomplete genetic characterization will be studied with a hope of contributing to the identification of specific disease-causing genes and genetic mechanisms responsible for a specific disorder. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Movement Disorder | ||||||||
| 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 | Recruiting | ||||||||
| Enrollment ICMJE | 500 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | March 2004 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Individuals with known or suspected inherited movement disorders. Families where multiple family members that are affected with a movement disorder. EXCLUSION CRITERIA: Pregnant women will be excluded from any tests involving radiation treatment. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00018889 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 010206, 01-N-0206 | ||||||||
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | July 2009 | ||||||||
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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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