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Difference in Patterns of Liver Diseases Related Admissions After the Era of DAAS

10 maart 2022 bijgewerkt door: Momena Hassan Ahmed, Sohag University

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

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

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

Studietype

Observationeel

Inschrijving (Verwacht)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

This study will include all patients admitted at Tropical Medicine and Gastroenterology Department, Sohag University Hospital diagnosed with liver diseases

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The different patterns of liver disease in patients admitted to Sohag University Hospital after the era of direct acting antiviral drugs
Tijdsspanne: from 15 March 2022 to 15 September 2022
from 15 March 2022 to 15 September 2022

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: momena H Ahmed, master, Sohag University
  • Studie directeur: Mona M Abdelrahman, MD, Sohag University
  • Studie stoel: Asmaa N Mohammed, MD, Sohag University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

15 maart 2022

Primaire voltooiing (Verwacht)

15 september 2022

Studie voltooiing (Verwacht)

31 december 2022

Studieregistratiedata

Eerst ingediend

10 maart 2022

Eerst ingediend dat voldeed aan de QC-criteria

10 maart 2022

Eerst geplaatst (Werkelijk)

17 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

10 maart 2022

Laatst geverifieerd

1 maart 2022

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Soh-Med-22-03-09

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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