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Salivary Evaluation in Healthy Volunteers

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Qué se está recopilando

Recolección de datos

Quiénes están siendo reclutados

Healthy

+ Salivary Gland Disease
De 18 a 70 años
Cómo está diseñado el estudio

Other

Observacional
Inicio del estudio: octubre de 1993

Resumen

Patrocinador PrincipalNational Institute of Dental and Craniofacial Research (NIDCR)
Última actualización: 24 de septiembre de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 26 de octubre de 1993Fecha en la que se inscribió al primer participante.

Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated several disorders of salivary glands. The purpose of this protocol is to obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation. Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary glands. * Objective: To obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction. * Study population: Healthy volunteers aged 18-70 years old * Design: Observational * Outcome measures: Clinical and basic science data to serve as controls for comparisons with subjects presenting with salivary gland dysfunction Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated several disorders of salivary glands. The purpose of this protocol is to obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation. Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary glands. The outcome measurement for this study is to determine those healthy subjects whose data and specimens can be used as control comparison for our patient subjects in our Sj(SqrRoot)(Delta)gren s syndrome studies (15-D-0051, 99-D-0070, 11-D-0094 and/or 11-D-0172).

Título OficialSalivary Evaluation in Healthy Volunteers 
Patrocinador PrincipalNational Institute of Dental and Craniofacial Research (NIDCR)
Última actualización: 24 de septiembre de 2018
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 173 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
De 18 a 70 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Healthy
Salivary Gland Disease
Criterios

* INCLUSION CRITERIA: * Healthy male or female volunteers from 18 to 70 years old. * Ability to understand and sign an informed consent document. EXCLUSION CRITERIA: * Known pregnancy. * Chronic medical illness, other than well-controlled hypertension or hyperlipidemia. * Chronic use of medications, with the exception of oral contraceptives, hormone replacement therapy, antihypertensives and antilipemics. * Have problems with dry mouth and/or dry eyes. * NIH employees who are subordinates/relatives/co-workers of investigators.



Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
Este estudio tiene una ubicación
Suspendido
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United StatesVer ubicación

Completado1 Centros de Estudio