- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05284916
Difference in Patterns of Liver Diseases Related Admissions After the Era of DAAS
Difference in Patterns of Liver Diseases Related Admissions in Sohag University Hospital After the Era of Direct Acting Antiviral Drugs
Liver disease accounts for approximately 2 million deaths per year worldwide, 1 million due to complications of cirrhosis and 1 million due to viral hepatitis and hepatocellular carcinoma Hepatitis is defined as inflammation of the liver that can result from a variety of causes such as heavy alcohol use, autoimmune, drugs, or toxins In the United States, the most common types of viral hepatitis are Hepatitis A, Hepatitis B, and Hepatitis C The other types of viral hepatitis are hepatitis D and E and are less frequently encountered Cirrhosis results from chronic liver disease, and is characterized by advanced fibrosis, scarring, and formation of regenerative nodules leading to architectural distortion.In the past cirrhosis was generally thought to be irreversible but recent studies have shown that treatments aimed at the underlying cause especially in earlier stages of the disease can improve or even reverse fibrosis Since its discovery, hepatitis C virus (HCV) has been a constant burden for global health, with 3 to 4 million new infections each year and an overall number of 130-170 million infected people in the world New direct acting antiviral regimens (DAA) have changed the landscape of treatment of chronic hepatitis C DAA provide important advantages, including higher efficacy, shorter duration of treatment and an optimal safety profile Place of the study in patient admitted to Tropical Medicine and Gastroenterology Department, Sohag University Hospital Type of the study The study will be conducted in two stages The first one is a retrospective collection of the data from patients records during the period from Feburary 2017 to January 2018 and the second stage will include agroup of patients that will be admitted to Tropical Medicine and Gastroenterology Department within 6months after protocol acceptance Study period duration of study will be 6months after protocol acceptance Inclusion criteria:
Patients diagnosed with liver diseases(acute hepatitis, chronic hepatitis, liver cirrhosis, HCC and others) depending on clinical evidence of stigmata of liver disease (e.g. jaundice ,ascites ,palmar erythema , spider navi , etc),laboratory data and ultra sonographic features Methods Complete History Taking Clinical ExaminationLaboratory Investigations Abdominal Ultrasonography
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Liver disease accounts for approximately 2 million deaths per year worldwide, 1 million due to complications of cirrhosis and 1 million due to viral hepatitis and hepatocellular carcinoma Hepatitis is defined as inflammation of the liver that can result from a variety of causes such as heavy alcohol use, autoimmune, drugs, or toxins In the United States, the most common types of viral hepatitis are Hepatitis A, Hepatitis B, and Hepatitis C The other types of viral hepatitis are hepatitis D and E and are less frequently encountered Cirrhosis results from chronic liver disease, and is characterized by advanced fibrosis, scarring, and formation of regenerative nodules leading to architectural distortion.In the past cirrhosis was generally thought to be irreversible but recent studies have shown that treatments aimed at the underlying cause especially in earlier stages of the disease can improve or even reverse fibrosis Since its discovery, hepatitis C virus (HCV) has been a constant burden for global health, with 3 to 4 million new infections each year and an overall number of 130-170 million infected people in the world New direct acting antiviral regimens (DAA) have changed the landscape of treatment of chronic hepatitis C DAA provide important advantages, including higher efficacy, shorter duration of treatment and an optimal safety profile Place of the study in patient admitted to Tropical Medicine and Gastroenterology Department, Sohag University Hospital Type of the study The study will be conducted in two stages The first one is a retrospective collection of the data from patients records during the period from Feburary 2017 to January 2018 and the second stage will include agroup of patients that will be admitted to Tropical Medicine and Gastroenterology Department within 6months after protocol acceptance Study period duration of study will be 6months after protocol acceptance Inclusion criteria:
Patients diagnosed with liver diseases(acute hepatitis, chronic hepatitis, liver cirrhosis, HCC and others) depending on clinical evidence of stigmata of liver disease,laboratory data and ultra sonographic features Methods Complete History Taking Clinical ExaminationLaboratory Investigations Abdominal Ultrasonography
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: momena H Ahmed, master
- Número de teléfono: 01060178232
- Correo electrónico: moamenahassn@med.sohag.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients diagnosed with liver diseases depending on clinical evidence of stigmata of liver disease laboratory data and ultra sonographic features
Exclusion Criteria:
- Any patient without liver disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
patients admitted at Sohag University Hospital diagnosed with liver diseases
The study will be conducted in two stages.
The first one is a retrospective collection of the data from patients records during the period from Feburary 2017 to January 2018 and the second stage will include agroup of patients that will be admitted to Tropical Medicine and Gastroenterology Department within 6months after protocol acceptance
|
The different patterns of liver disease related admissions after the era of DAAS
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The different patterns of liver disease in patients admitted to Sohag University Hospital after the era of direct acting antiviral drugs
Periodo de tiempo: from 15 March 2022 to 15 September 2022
|
from 15 March 2022 to 15 September 2022
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: momena H Ahmed, master, Sohag University
- Director de estudio: Mona M Abdelrahman, MD, Sohag University
- Silla de estudio: Asmaa N Mohammed, MD, Sohag University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- Soh-Med-22-03-09
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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