- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: momena H Ahmed, master
- Telefonní číslo: 01060178232
- E-mail: moamenahassn@med.sohag.edu.eg
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
The different patterns of liver disease in patients admitted to Sohag University Hospital after the era of direct acting antiviral drugs
Časové okno: from 15 March 2022 to 15 September 2022
|
from 15 March 2022 to 15 September 2022
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: momena H Ahmed, master, Sohag University
- Ředitel studie: Mona M Abdelrahman, MD, Sohag University
- Studijní židle: Asmaa N Mohammed, MD, Sohag University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Soh-Med-22-03-09
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .