- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01628497
Exhaled NO Testing in Filariasis
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Region 4
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Georgetown, Region 4, Guayana
- Georgetown Public Hospital Corporation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Study subjects:
- recruited from patients with a chief complaint of wheezing, asthma or cough.
- assessed by a physician prior to consideration for enrollment into the study
- screened by the study investigator after evaluation by the physician
Control subjects:
Controls will be matched with cases by gender, age and region of residence. They will have non-emergent complaints without respiratory symptoms.
Descripción
Inclusion Criteria:
- Age 6 years or older of either gender
- Patients presenting with pulmonary symptoms a. Confirmed or suspected asthma patients: i. Patients presenting with symptoms consistent with an acute exacerbation of asthma, including:
1. Wheezing 2. Shortness of breath 3. Chest tightness 4. Cough ii. Disposition to the asthma room after triage and physician evaluation (disposition to other areas of the A&E allowed if due to no available space in the asthma room) iii. Patients are potentially eligible with or without a past history of health care provider diagnosed asthma iv. Patients are potentially eligible regardless of the number of previous episodes of wheezing (i.e. patients with a first episode of bronchospasm are potentially eligible) v. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if:
- They have a dry cough (no production of purulent sputum)
- They have bronchospasm as manifested by wheezing or need for salbutamol (albuterol) breathing treatments vi. Patients with wheezing are not eligible if they:
1. Have purulent sputum production 2. Have known or suspected:
a. Tuberculosis b. Immunodeficiency c. Congestive heart failure d. Foreign body aspiration b. Patients presenting with a chief complaint of cough: i. Potentially eligible patients will have a cough of greater than one week (seven days) duration ii. Asthma room disposition is not required for these subjects iii. If suspected or documented to have pneumonia or a pulmonary infiltrate, patients are potentially eligible if:
1. They have a dry cough (no production of purulent sputum) iv. Patients with cough are not eligible if:
- Have purulent sputum production
Have known or suspected:
- Tuberculosis
- Immunodeficiency
- Congestive heart failure
- Foreign body aspiration
- Patients will be medically stable at the time of the consent process (see exclusion criteria below)
- A minimum of 2 years of continuous residence in Guyana at the time of enrollment, exclusive of short trips out of the country (at least 21 of previous 24 months physically in Guyana)
- English speaking
Exclusion Criteria:
- Patients less than 6 years of age
- Patients who do not consent to the study
- Children (<18 years) without a parent/guardian present
- Prisoners
Patients who appear to be medically or psychologically unstable or felt to be otherwise inappropriate for study enrollment, in the opinion of the investigator or any treating health care provider. This determination will be made on an individual basis, but some of the general criteria to be used in making this determination will be:
i. The patient appears to be in significant pain ii. The patient appears acutely ill - severe respiratory distress, diaphoretic, altered mental status, active bleeding, actively vomiting, etc.
iii. Those with respiratory difficulty to the point they cannot speak in complete sentences iv. Chief complaint of sexual assault v. The patient appears acutely intoxicated vi. The patient displays agitated, nervous, restless, or other behavior suggestive of an uncontrolled psychiatric emergency
- Patients with pulmonary findings felt to be secondary to congestive heart failure, foreign body, bacterial pneumonia, tuberculosis or other clearly defined cause
- Non-English speaking patients
- Patients without at least 2 years of residence (exclusive of short trips abroad, total of 21 of 24 previous months physically in Guyana) in Guyana at the time of enrollment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Positive filariasis test
Those testing positive for filariasis
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Filariasis negative
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Fil-01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Filariasis
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University Hospitals Cleveland Medical CenterWashington University School of Medicine; Case Western Reserve University; Papua... y otros colaboradoresReclutamientoEliminación de la filariasis linfática por la administración masiva de medicamentos | Monitoreo y evaluación de la administración masiva de medicamentos para la filariasis linfática | Aceptabilidad de la administración masiva de medicamentos para la filariasis linfáticaPapúa Nueva Guinea
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Washington University School of MedicineIndonesia University; Case Western Reserve University; Ministere de la Sante Publique... y otros colaboradoresTerminadoFilariasis LinfáticasFiyi, Haití, India, Indonesia, Papúa Nueva Guinea
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Washington University School of MedicineCase Western Reserve University; Regional Hospital of Agboville, Southern Cote...Activo, no reclutando
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University Hospitals Cleveland Medical CenterWashington University School of MedicineTerminado
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National Institute of Allergy and Infectious Diseases...TerminadoFilariasis linfaticaIndia
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Noguchi Memorial Institute for Medical ResearchGhana Health Service, Neglected Tropical Diseases ProgramTerminadoOncocercosis | Filariasis LinfáticasGhana
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The Task Force for Global HealthUnited States Agency for International Development (USAID)TerminadoLinfedema | Filariasis linfatica | FilariasisMalí
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National Institute of Allergy and Infectious Diseases...TerminadoFilariasis linfaticaMalí
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Washington University School of MedicineNational Institute of Allergy and Infectious Diseases (NIAID)Terminado
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Washington University School of MedicineIndian Council of Medical Research; Case Western Reserve UniversityTerminadoFilariasis linfaticaHaití, India, Indonesia, Papúa Nueva Guinea