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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | December 1997 | ||||||||
| Estimated Primary Completion Date | October 1998 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
To assess cardiopulmonary function in patients with sickle cell disease and thalassemia with and without pulmonary hypertension. | ||||||||
| Change History | Complete list of historical versions of study NCT00001778 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
To determine the relative acute vasodilatory effects of sildenafil, and inhaled NO in patients with hemolysis-associated pulmonary hypertension. | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Patients With HAM/TSP | ||||||||
| Official Title ICMJE | Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP) | ||||||||
| Brief Summary | Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP with emphasis on defining its virological and immunological changes with respect to clinical progression. Study Population: Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate. Design and Outcome Measures: A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with serodeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes will be obtained from participants. Lumbar punctures may be performed on individuals with HAM/TSP. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response and the genetic makeup. |
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| Detailed Description | Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP with emphasis on defining its virological and immunological changes with respect to clinical progression. Study Population: Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate. Design and Outcome Measures: A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with serodeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes will be obtained from participants. Lumbar punctures may be performed on individuals with HAM/TSP. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response and the genetic makeup. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| 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 | 200 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | October 1998 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
EXCLUSION CRITERIA:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001778 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 980047, 98-N-0047 | ||||||||
| 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 | December 2008 | ||||||||
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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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