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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Age > 18 years, male or female 2. Willing and able to comply with program assessment, including routine tests, attendance for follow up and compliance with medicine taking. 3. Able to provide written agreement (or witnessed in the case of patients who cannot read and write) 4. Have a diagnosis of hepatitis C (based on a hepatitis C point-of-care test and then confirmed by PCR) with or without HIV Additional for PK sub-study 1. HIV well-controlled on current therapy (co-infected patients only) 2. Willing and able to comply with the additional blood sampling in the PK-PD sub-study protocol for the duration of the study Current pregnancy (pregnancy test to be performed in women of child-bearing age) 2. Previous HCV therapy. 3. HCV PCR negative 4. Patients with significant renal impairment with Cr Cl < 50 ml/min. 5. Known hypersensitivity to any part of the drug regime. 6. Presence of significant comorbidity with life expectancy of less than 12 months. 7. Clinical evidence of decompensated cirrhosis with current or previous episode of ascites, variceal bleed, encephalopathy, and treated hepatocellular cancer (HCC) [Child-Pugh score B or C]. 8. Presence of concomitant medical or social situation that would make it difficult for the patient to comply with program protocol or put the patient at additional risk 9. Concomitant medications that cause unacceptable drug-drug interactions. Additional for PK sub-study 1. Anaemia (Hb <100 mg/L)
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Chronic Hepatitis c Our study proposed for all consented patients complaining from chronic Hepatitis C virus infection undergoing treatment with antiviral drugs is possible through certain indications or as follow Patients with chronic Hepatitis C virus who are candidates for Direct Acting Antiviral Therapy Age is from 18 to 65 years Those patients with chronic Hepatitis C virus infection are impossible or contraindicated to be treated with antiviral drugs as follow Geriatrics (> 65 years of age) Pediatrics (< 18 years of age) patients with known hypersensitivity to any of the components of the antiviral drug Post-Liver Transplant Patients. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection Experienced patients (previously failed treatment)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C, Chronic Patients with HCV infection eligible for treatment with new (DAADs) and having: A Normal Complete Blood Count ( hemoglobin not less than 10 gm/dl ). B Mild to moderate impairment of Liver function test and kidney function test. C Positive polymerase chain reaction for HCV virus. D Controlled Blood sugar . 2. Patients > 18 years Patients on treatment for skin disease. 2. Pregnancy and lactation. 3. Patients <18 years. 4. Patients not eligible for oral anti hepatitis C drugs
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C for Part A Subjects must meet the following to be eligible for participation in this study. 1. Willing and able to provide written informed consent. 2. Male or female, age ≥ 18 years. 3. HCV RNA ≥ 104 IU/mL at screening. 4. Confirmed chronic HCV infection as documented by either: a. A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit. 5. HCV genotype 4 at screening as determined by the Central Laboratory. Any non definitive results will the subject from study participation. a Presence of cirrhosis is defined as any one of the following Liver biopsy within 2 years of Screening showing cirrhosis Fibroscan with a result of ≥ 12.5 kPa within 6 months of Baseline/Day1 6. Body mass index (BMI) ≥ 18 kg/m2. 7. Screening ECG without clinically significant abnormalities. 8. Subjects must have the following laboratory parameters at screening ALT ≤ 10 x the upper limit of normal (ULN) AST ≤ 10 x ULN Hemoglobin ≥ 12 g/dL for male, ≥ 11 g/dL for female subjects Platelets > 50,000 cells/mm3 INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR Albumin ≥ 3 g/dL Total Bilirubin ≤ 1.5 ULN 2.1 for Part A Subjects who meet any of the following are not to be enrolled in this study. 1. Prior exposure to IFN, Ribavirin, or other approved or experimental direct-acting antiviral targeting the HCV. 2. Current or prior history of any of the following: a Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) b Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol, or, current evaluation for a potentially clinically significant illness (other than HCV) c Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug d Solid organ transplantation e Significant pulmonary disease, significant cardiac disease or porphyria f Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 6 months prior to Baseline/Day 1 or that has not required medication in the last 12 months may be enrolled. g Any malignancy within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.), or current evaluation for possible malignancy h Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy i 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV). 5. Contraindication to Ribavirin therapy e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia). 6. History of malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible. 7. Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day). 8. Clinically-relevant drug or alcohol abuse within 12 months of screening. A positive drug screen will subjects unless it can be explained by a prescribed medication; the diagnosis and prescription should be approved by the investigator. 9. History of solid organ transplantation. 10. Current or prior history of clinical hepatic decompensation (eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome). 11. History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 12. History of a gastrointestinal disorder (or post-operative condition) that could interfere with the absorption of the study drug. 13. History of significant pulmonary disease, significant cardiac disease or porphyria. 14. Excessive alcohol ingestion, defined as 3 glasses/day (1 glass is equivalent to 284 mL beer, 125 mL wine, or 25 mL distilled spirits) for females and 4 glasses/day for males. 16. Known hypersensitivity to Ribavirin, the study investigational medicinal product, the metabolites, or formulation excipients. 1.2.2 for Part B Subjects who meet any of the following are not to be enrolled in this study. 1. Prior exposure to IFN, Ribavirin, or other approved or experimental direct-acting antiviral targeting the HCV. 2. Current or prior history of any of the following: a Clinically hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) b Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol, or, current evaluation for a potentially clinically significant illness (other than HCV) c Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug d Solid organ transplantation e Significant pulmonary disease, significant cardiac disease or porphyria f Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 6 months prior to Baseline/Day 1 or that has not required medication in the last 12 months may be enrolled. i Significant drug allergy (such as anaphylaxis or hepatotoxicity) 3. Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis) 4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 5. Use of any prohibited concomitant medications 6. Contraindication to Ribavirin therapy, including significant history of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia) 7. In the judgment of the investigatory, any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with subject treatment, assessment of compliance with the protocol 8. Pregnant or nursing females or male with pregnant female partner 9. Known hypersensitivity to Sofosbuvir, or formulation excipients
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Carcinoma, Hepatocellular Hepatitis C Patients with HCV related Hepatocellular carcinoma (HCC); all patients with confirmed diagnosis of HCC according to EASL-EORTC guidelines who attend HCC outpatient clinics in the study centers will be enrolled after signing informed consent. Patients will be then assigned into two main comparison groups Group I: HCC patients who received DAAs for chronic HCV previously (either responders or not) Group II: HCC patients who are naive to DAAs Patients who refuse to be enrolled in the study Patients with hepatitis B virus or any other causes of cirrhosis Other prior malignancy without complete remission in the last five years, with the exception of adequately treated basal cell carcinoma or in situ cervical cancer; in case of other prior malignancy, the diagnosis of HCC has to be histologically proven HCC developed on transplanted liver
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Virus (HCV) Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening Does not have current active hepatitis B virus infection defined as positive hepatitis B surface antigen (HBsAg), OR hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs]) Platelets ≥ 150,000 cells/mm³ Albumin ≥ lower limit of normal (LLN) Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening No past history/evidence of cirrhosis No history of hepatocellular carcinoma
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 21.0-75.0, ALD - Alcoholic Liver Disease Alcoholic Steatosis Patients Fat accumulation (Steatosis) without signs of fibrosis/ inflammation in patients with alcohol abuse (alcohol intake >60 g/day in men and >40 g/day in women) Abnormal liver serum tests indicative of liver disease (elevated AST>ALT, y-glutamyl transpeptidase and bilirubin) . Alcoholic Hepatitis with Mild Fibrosis Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning) Polymorphonuclear infiltrate Fibrosis stage 1-2 Alcoholic Hepatitis with Advanced Fibrosis Steatosis plus hepatocellular damage (presence of Mallory bodies and hepatocellular ballooning) Polymorphonuclear infiltrate Fibrosis stage 3-4. Alcoholic Cirrhosis Fibrosis stage 4
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-60.0, Hepatitis C Antiviral patients with arthropathy concomitant HCV (proved by PCR testing) patients with child-pugh B and child-pugh C decompensated cirrhosis patients more that 60 years patients with chronic infection e.g.(pulmonary T.B) patients with organ failure e.g.( heart failure, respiratory failure) patients with CKD with GFR lead that 60 ml/ ministry/1.73m2 patients on immunosuppressive agents patients with HBV coinfection
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Liver Transplant Disorder Vitamin D Deficiency All recipients of liver transplantation at Ismett, aged 18 or more Lack of informed consent for the treatment of personal data. otherwise all the patients will be included if the accept to sign the informed consent
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Liver Cirrhosis Age: ≥ 18 years. 2. Disease status: patients with hepatitis C Virus related liver cirrhosis child A& B (scores 5-9). 3. Previous treatment: treatment naïve and treatment experienced. 4. HCV RNA: Negative at any point between 12-24 weeks post treatment to confirm successful eradication of the virus. 5. Negative HBsAg and HIV antibody. 6. Normal kidney function test Child C liver cirrhosis (Child score ≥ 10). 2. HCV coinfection with HBV or HIV. 3. Patients with high risk of infection (I.V drug users, patients with blood disease requiring blood transfusion)
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-999.0, Hepatitis C Virus Infection, Response to Therapy of Human Immunodeficiency Virus Age > or = 20 years Chronic HCV infection, defined as detectable HCV antibody (anti-HCV; Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) and quantifiable serum HCV RNA (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, lower limit of quantification [LLOQ]: 25 IU/mL) for ≥ 6 months Chronic kidney disease (CKD) stage ≥ 4 Organ transplantation Prior DAA exposure Refusal to provide written informed consent
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-80.0, Alcoholic Liver Disease alcoholic liver disease able to consent without alcoholic liver disease unable to consent
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Hepatitis C Patients with chronic hepatitis C only will be included Patients who are eligible for treatment by DAAs only Cirrhotic patients will be excluded based on USS, APRI score index and FIB4 index Hepatitis B infected patients will also be excluded Patients with current or previous history of neuropsychiatric disorders will be excluded Failure to obtain consent
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis E Hepatitis Chronic Viral Willing and able to provide written informed consent 2. Male or female, age ≥ 18 years 3. Confirmation of chronic HEV infection documented by: Positive HEV RNA at least 3 months before Screening, and positive for HEV RNA at the time of Screening 4. Documented previous ribavirin therapy or documented contraindication for full dose (≥ 600mg qd) ribavirin monotherapy for at least 3 months 5. Body mass index (BMI) ≥ 18 kg/m2 6. Screening ECG without clinically significant abnormalities 7. Subjects must have the following laboratory parameters at screening Platelets ≥ 60,000/μL INR ≤2.0 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR HbA1c ≤ 10% Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight) 8. Subject has not been treated with any investigational drug or device within 42 days of the Screening visit 9. A negative serum pregnancy test is required for female subjects (unless surgically sterile or women ≥ 54 years of age with cessation for 24 ≥ months of previously occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted. Or Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until 30 days after last dose of study drug intrauterine device (IUD) with a failure rate of < 1% per year female barrier method: cervical cap or diaphragm with spermicidal agent tubal sterilization vasectomy in male partner hormone-containing contraceptive Clinically-significant illness (other than HEV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol. 2. Ribavirin administration within the last 28 days. 3. Infection with the hepatitis C virus (defined as HCV RNA positive) 4. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis). 5. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. 6. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is wellcontrolled on a stable treatment regimen for at least 12 months prior to screening or has not required medication in the last 12 months may be included. 7. Significant drug allergy (such as anaphylaxis or hepatotoxicity). 8. Pregnant or nursing female 9. Clinically-relevant drug or alcohol abuse within 12 months of screening including any uncontrolled drug use within 6 months of screening. A positive drug screen will subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study. 10. Use of any prohibited concomitant medications within 21 days of the Baseline/Day 1 visit. Use of Amiodaron as concomitant medication is prohibited within 60 days of Baseline/Day1 visit. 11. Known hypersensitivity to SOF or formulation excipients
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Liver Cirrhoses Chronic Hepatitis c Directly Acting Antivirals Patients known to have HCV-related liver cirrhosis and candidate for therapy with Sofosbuvir and Daclatasvir with or without Ribavirin Chronic hepatitis due causes other than chronic HCV infection Coinfection with HIV or HBV infection Hepatocellular carcinoma Decompensated cirrhosis
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Antiviral Drug Adverse Reaction Both male and female patients with age above 18 years presented with chronic HCV infection (diagnosed by HCV RNA positive) with normal kidney functions, i.e Normal S.creatinine Normal urine analysis (without proteinuria, haematuria or abnormal casts) Normal renal sonography and candidate for direct acting antiviral drugs Any chronic HCV patient with known renal disease Patients with abnormal kidney functions, i.e Abnormal S.creatinine Abnormal urine analysis (with proteinuria, haematuria or abnormal casts) Abnormal renal US Any other known renal disease (lupus nephritis, diabetic nephropathy) Severe co-morbidity as severe heart failure or malignancy Other liver disease (autoimmune hepatitis, HBV, Wilson, ……) Decompansated liver disease (ascites, hepatic encephalopathy, …)
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis b Liver Inflammation Hepatitis B surface antigen [HBsAg]-positive Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody (HBeAb)-positive disease were eligible Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum total bilirubin(TBIL)levels<2×ULN Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus Other forms of liver disease More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against HBV, and therapy with any anti-HBV drug within 24 weeks prior to randomization More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC) During the study patients were not allowed to use other medicines
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 19.0-45.0, Healthy Male Volunteers Age between 19 to 45, healthy male subjects(at screening) Body weight between 55kg g, BMI between 18.0 FPG 70-125mg/dL glucose level(at screening) Subjects who are appropriate to conduct study procedure in the decision of investigator Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, meurology, immunology, pulmonary, endocrine, hematooncology,cardiology,mental disorder.) Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included) Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics) Subject who already participated in other trials in 3months Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, End Stage Liver Disease Infection Decompensation of liver cirrhosis: 1. ALB <35 g / L; A / G <1.0 2. TBIL> 35μmol / L; 3. ALT> 1 × ULN and / or AST> 1 × ULN 4. PTA <60% 5. Ascites or hepatic encephalopathy or esophageal variceal bleeding Acute-on-chronic liver failure: 1. Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis 2. onset time: <4 weeks 3. Hepatic encephalopathy: with or without 4. Coagulation: PTA ≤ 40% or INR ≥ 1.5 5. Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L Chronic liver failure: 1. The basis of chronic liver disease: decompensated cirrhosis 2. onset time: - 3. Hepatic encephalopathy: with or without 4. Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, HCV Patients with SOF/VEL treatment for the treatment of chronic HCV genotype 1 through 6. 2. Patient is at least 18 at the day of screening. 3. Patient is able and willing to sign the Informed Consent Form. 4. Patient is able and willing to follow protocol requirements Pregnant female (as confirmed by an hCG urine test performed at screening) or breast-feeding female. 2. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 3. Inability to understand the nature and extent of the study and the procedures required. 4. Clinically relevant low hemoglobin concentration at screening judged by the patient's own hepatologist
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Chronic Stroke more than 3 months post-stroke ischemic or hemorrhagic stroke a person who understands the experiment and has a willingness to participate and signs the agreement User of artificial heartbeat Patients with claustrophobia Patients with metal implants Patients who are contraindicated for other common MRI
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Normal Physiology FOR ALL A subject can be included in this study if he/she is in good general health is between 18 and 65 years old is capable of understanding the procedures and requirements of this study is willing and able to provide his/her own informed consent; FOR IN-LAB has visual acuity of 20/40 in at least one eye (corrected with contact lenses is okay) has no hearing impairment requiring a hearing aid. FOR IN-LAB A participant is not eligible for participation in the in-lab portion of this study if any of the following are present, as self-reported by the prospective participant or determined during clinical testing following consent Participant has serious vision or hearing problems; for some sub-studies focused on color vision, subjects who are colorblind will also be excluded Participants without consent capacity will not be enrolled Participant has a neurological disorder (examples but are not limited to: epilepsy, schizophrenia, Alzheimer s Disease, Parkinson s Disease, multiple sclerosis) or a psychiatric disorder (examples but are not limited to: clinical anxiety, depression, attention deficit hyperactivity disorder (ADHD), schizophrenia) Participant has had a serious head injury or has a history of brain surgery. Head injury is defined as an injury to the brain from some external force resulting in loss of consciousness of 30 minutes or more Participant has psychoactive drug or alcohol abuse or dependence in the past three months, as determined by the Drug Abuse Screening Test (DAST), except nicotine and caffeine. A score of 6 or greater on the DAST will be considered exclusionary. The effects of nicotine and caffeine in neuroimaging are attenuated if participants do not smoke or consume caffeine 2-3 hours before the scan session; Over-the-counter medication/herbals will not be a criterion for exclusion Participant is an NEI employee within the Sensation, Cognition and Action section FOR MRI SUB-STUDIES: Contraindication to MR scanning the following: pregnancy; metallic tattoos or metallic eyeliner; claustrophobia; inability to lie still on their back for ~2 hours; implanted cardiac pacemaker or auto-defibrillator; surgical aneurysm clips; implanted neural stimulator; artificial heart valves or pumps; metal fragments in cranial cavity, body or eyes (e.g., history as a metal worker); nitroglycerin patch (foil backer); cochlear implants (tubes are okay); weight > 450 lbs; metal rods, plates, screws in body; shrapnel or bullet wound; intrauterine device (IUD) not approved on mrisafety.com (most IUDs are okay); vestibular or inner ear abnormality such as Meniere s disease; metallic braces; hair extensions attached with metallic wires; transdermal patches; movement disorders; dental implants; consumed of nicotine or caffeine in the two hours prior to the experimental session. Subjects may participate in this study, but will not be allowed to have a 7.0 T MRI scan if they have metallic dental crowns or a bridge FOR ON-LINE Subjects may not participate in the on-line portion of the study if they Do not have access to compatible equipment. For example, smartphone screens are too small to be used. Amazon MTurk will outline which devices may be used
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 12.0-999.0, Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village All village inhabitants starting from 12 years old inhabitants less than 12 years old
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-80.0, Cirrhosis, Liver Decompensated Cirrhosis of liver irrespective of etiology Acute on chronic liver failure (fulfilling either APASL or of ACLF) Splenic diameter of more than 18 cm Concomitant HCC or other active malignancy Upper gastrointestinal bleeding in the previous 7 days Portal vein thrombosis Severe renal dysfunction as defined by creatnine > 1.5mg/dl Severe cardiac dysfunction Uncontrolled diabetes (Hb A 1c ≥ 9) or diabetic retinopathy Acute infection or disseminate intravascular coagulation Active alcohol abuse in last 3 months
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-999.0, Hepatitis C yeas or more Male or female Body mass index (BMI) 18.5-35.0 kg/m2 Chronic HCV infection, defined as patients who meet as least one of the two following 1. Anti-HCV antibody (Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) or HCV RNA > 1,000 IU/mL for at least 6 months before screening 2. Positive HCV RNA > 1,0000 IU/mL (Cobas TaqMan HCV Test v2.0, Roche Diagnostics GmbH, Mannheim, Germany, low limit of quantification (LLOQ): 25 IU/mL) at the time of screening with a liver biopsy consistent with chronic HCV infection HCV genotype 1 (HCV GT-1b) infection (Abbott RealTime HCV genotype II, Abbott Molecular Inc. Illinois, USA) Treatment-naïve or treatment-experienced (including patients who relapsed, who had virological breakthrough, or who were null-responsive to IFN-based therapies) HCV RNA > 10,000 IU/mL at screening Estimated glomerular filtration (eGFR) rate < 15 mL/min/1.73m2 as assessed by modified of diet in renal disease (MDRD) equation, and receiving regular hemodialysis HCV infection other than HCV GT-1b HBV or HIV coinfection Presence of decompensated cirrhosis (Child-Pugh class B or C) Any primary cause of liver disease other than chronic HCV infection, including but not limited to the following 1. Hemochromatosis 2. Alfa-1 antitrypsin deficiency 3. Wilson's disease 4. Autoimmune hepatitis 5. Alcoholic liver disease 6. Drug-induced hepatitis 7. Screening laboratory analyses showing any of the following results Hemoglobin (Hb) level < 10 g/dL Absolute neutrophil count (ANC) < 1,500 cells/μL Platelet count < 70,000 cells/mm3 International normalized ratio (INR) > 2.0 Albumin (Alb)< 3.0 g/dL Bilirubin (Bil) > 2.0 mg/dL
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Virus Infection Diagnosed with HCV HCV RNA positive Approved for HCV treatment Excessive alcohol use Pregnancy information of other cause of chronic liver disease (autoimmune hepatitis (AIH), primary sclerosing cholangitis (PSC), primary biliary cholangitis (PBC), Alpha-1-antitrypsin deficiency)
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-80.0, HCV Infection Age: > 18 years Receive chronic hemodialysis (for at least 6 consecutive months) at the NRHC. EsSalud Inability to provide informed consent
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Arthroplasty Osteoarthritis Patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis WOMAC functional subscale less than 66.5/100 Patients under 18 years of age Patients undergoing joint revision on the affected side patients under the same day discharge protocol Patients undergoing bilateral arthroplasty Patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program Patients having surgery in less than 16 weeks after verbal consent Patients unable or unwilling to commit to required study follow-ups Patients with no fixed address Patients with a cognitive impairment that may preclude questionnaire completion Pregnant or suspected pregnant women as dual-energy x-ray (DXA) used in this study may be harmful to a fetus
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Liver Fibrosis Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN classification, as assessed by the central reader Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the Screening Period. Vitamin E treatment (>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus [HCV] infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study may be eligible Current or past history of hepatocellular carcinoma (HCC) Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation Other protocol defined inclusion/ could apply
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Hepatic Cirrhosis Liver Fibrosis Nonalcoholic Fatty Liver Disease (NAFLD) Nonalcoholic Steatohepatitis For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH and cirrhosis according to the NASH CRN classification, as assessed by the central reader Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the screening period. Vitamin E treatment (>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus infection [HCV], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study may be eligible Current or past history of hepatocellular carcinoma (HCC) Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation Medical history of gastroesophageal varices, except if esophagogastroduodenoscopy [EGD] performed within 12 months prior to the Screening Period has shown <= Grade 1 varices Other protocol defined inclusion/ could apply
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Hepatitis E • Patients have clinical diagnosis of acute viral hepatitis as (recent onset of nausea, fever, fatigue, abdominal pain , hepatomegaly and abnormal transaminases (at least 2 fold higher than the upper normal level)) Post-transplant acute hepatitis hepatitis A, B and C patients autoimmune hepatitis Alcoholism Treatment with hepatotoxic drugs Biliary disease Infection with CMV or EBV Taken ribavirin therapy
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-90.0, Diabetes Mellitus Hepatitis C, Chronic Cardiovascular Diseases Phase I for Subjects Who Have Not Achieved a SVR (Phase I) Subjects must meet all of the following to be eligible for participation in this study: 1. Male or female, age greater than or equal to 18 years. 2. Either treatment na(SqrRoot) ve or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only (except for NS5a failures). 3. Confirmation of chronic HCV infection documented by either: 1. A positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or 2. A liver biopsy performed prior to screening visit showing evidence of chronic hepatitis. 4. Subjects must have the following laboratory parameters at screening ALT less than or equal to 10 (SqrRoot) the upper limit of normal (ULN) AST less than or equal 10 (SqrRoot) ULN Total bilirubin <2.5 mg/dL, Direct bilirubin less than or equal 1.5 ULN Platelets more than or equal 50,000 K/mm3 HbA1c less than or equal 8.5% eGFR more than or equal 60 mL /min, as calculated by the CKD-EPI equation Hemoglobin more than or equal 10g/dL Albumin more than or equal 3g/dL INR less than or equal 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR for Subjects Who Have Not Achieved a SVR Subjects who meet any of the following will not to be enrolled in this arm of the study: 1. Pregnancy, active breast-feeding, or inability to practice adequate contraception, in women of childbearing potential. Adequate contraception is defined as vasectomy in men, tubal ligation in women, or use of one method such as condoms and spermicide combination, birth control pills, an intrauterine device, Depo-Provera, or Norplant until 12 weeks post therapy. 2. Current or prior history of any of the following Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug Decompensated liver disease as defined by serum bilirubin more than or equal to 2.5 mg/dL (with direct bilirubin more than or equal to 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding or hepatic encephalopathy Solid organ transplantation Significant pulmonary disease, significant cardiac disease or porphyria. 3. History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin). 4. Chronic liver disease of a non-HCV etiology with the exception of steatosis (e.g., chronic hepatitis B, NASH, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis). 5. Evidence of harmful or hazardous drinking as defined as a score more than or equal to 8 on the AUDIT questionnaire. 6. Co-infection with HIV defined as the presence of anti-HIV in serum. 7. Clinically-relevant drug abuse based on patient history within 12 months of screening. 8. Use of any prohibited concomitant medications as described in concomitant medications and Table 1 within 21 days of the Baseline/Day 1 visit; this washout period does not apply to PPIs, which can be taken up to 7 days before baseline Day 1. 9. Use of antiviral medications within the last 30 days. 10. Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent more than or equal to 10 mg/day). 11. Known hypersensitivity to sofosbuvir and velpatasvir, or formulation excipients. 12. Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alphafetoprotein level of greater than 500 ng/mL. 13. Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study. 14. Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study for at least 1 year. 15. Inability to provide consent. Phase II for Phase II (follow-up after SVR24): 1. Age greater than or equal to 18 years and older, male or female 2. SVR following therapy with a direct acting antiviral agent regimen and available liver biopsy performed prior to treatment 3. Subject must be of generally good health as determined by the Investigator for Phase II (follow-up after SVR24): 1. Current or prior history of any of the following Clinically-significant illness (other than resolved HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded Decompensated liver disease as defined by serum bilirubin greater than or equal to 2.5 mg/dL (with direct bilirubin greater than or equal to 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding or hepatic encephalopathy
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 21.0-999.0, Hepatitis C Former Drug Users residing in Halfway Houses Age below 21 years Residents of Halfway Houses who have never used drugs
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Hepatitis B HIV Infections Ability and willingness of participant to provide informed consent. 2. Men and women age 18 years. 3. Active HCV infection as defined by detectable serum or plasma HCV RNA at any time prior to study entry. Documentation may be obtained from medical records if available. NOTE: If no medical records on HCV infection are available, active HCV infection must be confirmed by a detectable HCV RNA PCR prior to project entry. 4. Allowed HCV treatment history: 1. HCV treatment naïve defined as not having been previously treated for Hepatitis C infection with any medications approved for the treatment of HCV in any country. 2. HCV treatment experienced with interferon with or without ribavirin only (no prior DAA treatment). 5. Chronic Hepatitis B status must be documented by hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), and hepatitis B core antibody (HBcAb) testing. Participants with positive HBsAg must be already on an active HBV regimen at study entry. 6. HIV-1 infection status must be documented as either absent or present, as defined below: 1. Absence of HIV-1 infection, as documented by rapid HIV test or HIV-1 enzyme immunoassay (ELISA) test kit, within 60 days prior to entry. OR 2. Presence of HIV-1 infection, documented by rapid HIV test or HIV-1 ELISA test kit at any time prior to entry. OR 3. HIV-1 infection confirmed by medical documentation as participant is registered in care at AIDS Center and receiving or preparing to initiate ARV treatment. 7. HIV co-infected participants taking ART or planning to initiate ART, should be: 1. Tolerating ART for at least 2 weeks without signs of needing to modify or discontinue the ART regimen before initiating HCV treatment. AND 2. The ART regimen must be a regimen that can be co-administered with SOF/VEL. 8. Participants who are assigned to receive ribavirin as part of the treatment protocol must have hemoglobin ≥11.0 g/dL 9. For females of reproductive potential who will receive ribavirin, a negative urine pregnancy test (urine -HCG with a sensitivity of <25 mIU/mL) within 48 hours prior to project entry (HCV treatment initiation) must be documented. 10. Male and female participants who are able to impregnate or become pregnant (ie, of reproductive potential) and are participating in sexual activity that could lead to pregnancy must agree to practice contraception/birth control as indicated below or agree to not participate in a conception process while on treatment with ribavirin through at least 12 weeks post-treatment. 11. Life expectancy >12 months, in the opinion of the site investigator Child-Pugh Score corresponding to Class B or C (decompensated cirrhosis). This requires assessment for encephalopathy and ascites, as well as measurement of serum bilirubin, albumin, and international normalized ratio (prothrombin time). 2. Breastfeeding or pregnancy if patient will be receiving ribavirin. 3. Known allergy/sensitivity or any hypersensitivity to components of drug(s) or their formulation. 4. Acute tuberculosis (TB) infection. They will be followed and offered enrolment when they complete TB treatment. 5. Renal impairment defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or end-stage renal disease receiving dialysis as treatment with SOF/VEL is contraindicated (https://www.mdcalc.com/mdrd-gfr-equation). 6. Unwilling to provide informed consent for participation in the project. 7. Prior treatment with any HCV Direct Acting Agents (DAA). 8. Unable or unwilling to adhere to the HCV treatment course and monitoring in the opinion of the investigator
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-80.0, Hepatitis C Consecutive patients with different rheumatologic diseases from seven geographically different rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection pregnancy and end organ failure
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Liver Disease Hepatitis D Age 18 years or above, male or female Presence of anti-HDV in serum Presence of quantifiable HDV RNA in serum at three time pre-treatment points with a mean HDV RNA level >2 log10 above the lower limit of quantification (LLOQ) of the HDV RNA assay Demonstration of chronicity as evidenced by the presence of HDV RNA in serum for >/= 6 months, or presence of Anti-HDV antibody >/= 6months Decompensated liver disease, defined by bilirubin >4mg/dL, albumin <3.0 gm/dL, prothrombin time >2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. Patients with ALT levels greater than 1000 U/L (>25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Patients with an absolute neutrophil count <1000/dL and platelets <75,000/dL will be excluded from the study as well Pregnancy, active breast-feeding, or inability to practice adequate contraception, in women of childbearing potential or in partners of such women. Adequate contraception is defined as vasectomy in male sexual partners of female participants, tubal ligation in women, or use of two contraceptive methods such as condoms and spermicide combination with an intrauterine device or Depo-Provera, or Norplant Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), or active coronary artery disease Systemic immunosuppressive therapy within the previous 2 months before enrollment Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic liver disease, ongoing drug induced liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency) Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-85.0, Hepatitis C Signed informed consent 2. Clalit insured patients 3. Female and male over the age of 18 4. Capacity to provide written informed consent 5. HCV RNA Viral Load (VL) larger than 105 IU/mL at screening and on at least one other occasion 6 months or more prior to the most recent HCV RNA test result. 6. HCV genotypes 1a, 1b, 2, 3 or 4 7. Liver fibrosis stage 0-4 as determined by one of the following methods performed within 2 years prior to the screening visit: 1. Fibrotest 2. Transient elastography 3. Liver biopsy using the scoring system. 8. Patients must have the following laboratory parameters within 3 months of screening 1. ALT and AST ≤ x10 the upper limit of normal (ULN) 2. Direct bilirubin ≤ 1.5 the ULN 3. Platelet count ≥70,000 4. Hemoglobin ≥10 mg/dL 5. Albumin ≥3 mg/dL 6. INR ≤ 1.5 x ULN 7. eGFR ≥ 60 mL/min as calculated by the Cockroft-Gault equation. 9. Abdominal ultrasound, C.T or MRI scan showing no evidence of a focal lesion suspicious of hepatocellular carcinoma within 6 months of enrollment. 10. A female patient will be eligible to enter the study if it is confirmed that she is: 1. Not pregnant or nursing 2. Of non-childbearing potential (following hysterectomy, bilateral oophorectomy or post-menopausal) 3. Women of childbearing potential must have a negative urine pregnancy test at baseline and willing to use an accepted mechanical, medical or surgical birth control method from the day of screening until 90 days from the last dose of study drug. 11. All male participants in the study must agree to consistently and correctly use a condom, while their female partner agrees to use one of the above-mentioned birth control methods from the day of screening until 90 days after the last dose of study drug. 12. Patient must be able to comply with the dosing instructions for the study drug administration and able to complete the study schedule of assessments including all required post-treatment visits Clinical, serologic or histopathological evidence supporting the presence of chronic liver disease other than HCV (Including but not limited to: HBV, HDV or HIV coinfection, non-alcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, A1AT deficiency and Celiac disease). Workup performed within 6 months of recruitment will be considered sufficient to the above-mentioned conditions (except for A1AT deficiency and Wilson's disease for which at any time point qualifies). 2. Current or past history of any of the following: 1. Clinically significant illness (other than HCV) or any other medical disorder that may interfere with patient's assessment, treatment or compliance with the protocol. Examples congestive heart disease with moderate to severe left ventricular function and chronic obstructive pulmonary disease requiring chronic corticosteroid therapy. 2. Clinical evidence of decompensated liver disease (e.g. ascites, bleeding esophageal varices, spontaneous bacterial peritonitis, encephalopathy or hepatorenal syndrome.) 3. Child Pugh score higher than 6 4. Gastrointestinal disorder or post-operative condition that may interfere with the absorption of the study drug. 5. Solid organ transplantation 6. Malignancy within 5 years prior to screening with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer etc.) Patients under the evaluation for possible malignancy are not eligible. 3. Any prior treatment with a DAA (protease inhibitors, NS5A inhibitors, NS5B polymerase inhibitors/non-nucleoside polymerase inhibitors) 4. Use of anti-viral medications within 30 days of screening. 5. Chronic use of systemically administered immunosuppressive/immune modulating medications 6. Clinically relevant substance abuse within 6 months of enrollment. Patient with prior history of drug addiction who are currently maintained on a stable dose of opiate substitutes (naloxone) will be allowed to participate in the study if they can provide documentation of repeated negative toxicology screens from the 6 months prior to screening. 7. Participating in clinical trial 30 days before screening
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis c Age > 18 ys Disease status: patients with chronic hepatitis C infection, based on the presence of anti-HCV and detectable serum HCV-RNA for 6 months or more who had different grades of fibrosis (F) as estimated by fibroscan Treatment: treatment naïve patients who will receive direct acting antiviral drugs (Sofosbuvir and Daclatasvir ± ribavirin) for 12 weeks Negative hepatitis B virus surface Ag and HIV antibodies No history of hepatocellular carcinoma or development of hepatocellular carcinoma during the treatment period No other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease) Diabetic patients Patients using lipid lowering agents HCV co-infection with hepatitis B virus(HBV) or human immunodeficiency virus(HIV) Presence of other causes of chronic liver disease (alcohol consumption more than 80 g/day, hepatotoxic drugs, autoimmune hepatitis, primary biliary cholangitis, hemochromatosis and Wilson's disease) Patients with hepatocellular carcinoma
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-100.0, Hepatitis C Virus Subject At least 18 years of age Chronic HCV VGT-1 infection Completed treatment with ledipasvir/sofosbuvir (with or without ribavirin) for either 8, 12 or 24 weeks at a participating KP-NC clinical site Data available to determine virological relapse and SVR12 Subject Otherwise eligible subjects who have left KPNC will not be included in the study Otherwise eligible subjects who cannot provide informed consent in English will not be included in the study
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis B, HBeAg Negative Male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg. 2. Age > 18 years 3. Ongoing antiviral therapy with Entecavir or Tenofovir (TDF) 4. At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml) 5. HBeAg negative 6. Willingness to give written informed consent and willingness to participate and to comply with the protocol HIV infection, persistent HDV-infection, persistent HCV infection 2. History or other evidence of a medical condition associated with chronic liver disease other than HBV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures). 3. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease 4. Patients with advanced liver fibrosis and liver cirrhosis (fibroscan >10.0 kPa) 5. Patients with hepatocellular carcinoma 6. History of major organ transplantation or other immunosuppressive conditions 7. History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study 8. History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 12 months prior to cessation of antiviral therapy or the expectation that such treatment will be needed at any time during the study -
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Dried Blood Spot ≥18 years of age Known HCV infection Willing to participate to the study by giving his/her consent None
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Viral Patients 18 years or older. 2. Non-smokers Patients who took any antibiotic or probiotics in the past month. 2. Patients having known active bacterial, fungal or other viral disease. 3. Patients having clinically apparent oral disease. 4. Patients undergoing radiotherapy
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Chronic Hepatitis c Chronic HCV patients eligible for treatment with Direct Acting Antivirals Chronic HCV patients 3 months after starting of treatment Cirrhosis Diabetes Mellitus Hemochromatosis HBV HIV Hepatocellular carcinoma (HCC) Chemotherapy Organ transplantation
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Metastatic Hepatocellular Carcinoma Stage III Hepatocellular Carcinoma AJCC v8 Stage IIIA Hepatocellular Carcinoma AJCC v8 Stage IIIB Hepatocellular Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Stage IVA Hepatocellular Carcinoma AJCC v8 Stage IVB Hepatocellular Carcinoma AJCC v8 Unresectable Hepatocellular Carcinoma Willing and able to provide written informed consent for the trial Life expectancy > 12 weeks Histologically or imaging confirmed hepatocellular carcinoma (mixed hepatocellular/cholangiocarcinoma or fibrolamellar subtypes are excluded) Have disease that is not amenable for curative treatment approach Have measurable disease based on v1.1 >= 1 liver lesions accessible for core biopsy that was either not previously treated by liver-directed therapy or progressed following liver-directed therapy Child-Pugh score of A Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Absolute neutrophil count (ANC) >= 1000 cell/mm^3 Platelet count >= 50,000/mm^3 Received more than 1 prior systemic HCC-related therapy or currently receiving HCC-related systemic treatment or participating in a clinical trial and receiving study therapy Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Known diagnosis of immunodeficiency or active autoimmune disease or requiring systemic steroid equivalent of prednisone >= 10 mg/day or any immunosuppressive therapies =< 7 days of before the first dose of the study Active bacterial, viral (except hepatitis B and C), or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, anti-viral therapy, anti-fungal therapy, and/or other treatment Active pneumonitis or history of interstitial lung disease (ILD) / pneumonitis requiring steroids Clinically significant ascites Hepatic encephalopathy Any significant medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that would prevent the subject from participating and adhering to study related procedures Live attenuated vaccine =< 30 days before the first dose of study treatment. Examples of live vaccines but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed Use of strong inhibitor / inducer of CYP3A4 or CYP1A2
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Hepatitis C Patients undergoing solid organ transplantation, including liver, kidney, and simultaneous liver-kidney who are not chronically infected with HCV No evident contraindication for organ transplantation HCV RNA negative (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV) Age 18-75 years at the time of transplantation Signed Informed Consent Form No identified living organ donor Able to travel to the University of Maryland for routine post-transplant and HCV follow-up visits Men and women must agree to use at least one barrier method to prevent any secretion exchange No active illicit drug use DONOR • Qualitative HCV nucleic acid test (NAT) positive and/or Hepatitis C antibody positive HCV donors offered to the University of Maryland History of prior solid organ transplantation HIV infection HBV surface antigen or DNA positive. Organs from HCV positive donors who are also Hepatitis B core antibody positive (hepatitis B surface antigen negative) can be used. These patients will however need to undergo prophylaxis for HBV according to their respective organ specific and during treatment for hepatitis C due to the increased risk of reactivation of hepatitis B with DAA therapy Waitlisted for a multi-organ transplant (with the exception of simultaneous liver-kidney transplant) HCV RNA positive (can be isolated HCV antibody positive provided the patient will have no history of previously treated HCV) Prior direct-acting antiviral (DAA) treatment for HCV. Patients previously treated with interferon-based regimens may be included. DONOR Every donor that is considered unsuitable by the transplant surgeon for any reason Hepatocellular carcinoma HIV infection Use of HCV positive livers to be determined according to current existing
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, HIV Infections Hepatitis B Hepatitis C Hepatocellular Carcinoma HIV-infected individuals with and without HBV or HCV co-infection Positive HIV antibody At least one visit in one of the HIV clinics Subjects with positive HBsAg and/or anti-HBc will be regarded as having HBV co-infection Subjects with positive HCV antibody will be regarded as having HCV co-infection -nil 2. HBV/HCV mono-infected individuals Documented diagnosis of hepatitis B or hepatitis C infection, or Positive HBsAg and/or anti-HBc, or Positive HCV antibody, and Negative HIV antibody result, or no record of HIV diagnosis or anti-retroviral therapy prescription nil
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 6.0-18.0, Gaucher Disease HCV Aged 6 to <18 years Parent or legal guardian must provide written informed consent Treatment naïve or experienced children with chronic HCV infection Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy Screening laboratory values within defined thresholds No History of solid organ or bone marrow transplantation No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) Patients with other sever comorbidities of chronic medical illness (e.g. decompensated heart disease, chronic kidney insufficiency) Concomitant hepatitis B virus (HBV) or Human immunodeficiency virus (HIV) infection Medications (systemic steroids, immunosuppressives) Patients or guardians who are unwilling to participate or sign informed consent
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-999.0, Chronic Hepatitis c Liver Transplant Infection Kidney Transplant Infection At least 20 years of age 2. Chronically infected with genotypes 1b HCV 3. Underwent liver and/ or kidney transplantation 4. Without clinical or pathologic evidence of moderate or severe rejection HCV genotype other than 1b 2. Liver decompensation (Child-Pugh score > 6) 3. Co-infected with human immunodeficiency virus: Positive HIV1/2 or hepatitis B virus : Positive HBsAg and detected HBV DNA 4. Prior exposure to an NS5A inhibitor 5. Any active malignancies 6. Hemoglobin level less than 10 g/dl 7. Platelet level of 75,000/mm3 or less 8. Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase level 10 times or more the upper limit of normal 9. Total bilirubin level greater than 3 times or more the upper limit of normal 10. Albumin less than 3 g/dL 11. Using medication that is not considered safe to co-administer with , such as cyclosporine 12. Pregnant or breast-feeding women 13. Known allergy to grazoprevir or elbasvir (Unregistered liver or kidney transplant in other countries is illegal in Taiwan)
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis b ALT Criteria:All of below 1. Patients with chronic HBV infection,defined as those in whom presence of serum hepatitis B surface(HBsAg) for more than 6 months; 2. All patients had underwent a liver biopsy; 3. All patients signed the informed consent before liver biopsy; 4. No history use of interferon or Nucleoside analogue treatment Any of below 1. Co-infection with hepatitis A virus(HAV),hepatitis C virus(HCV),hepatitis D virus(HDV) hepatitis E virus(HEV) and/or human immunodeficiency virus(HIV); 2. Decompensated cirrhosis; 3. History of hepatocellular carcinoma(HCC); 4. History of liver transplantation; 5. Patient with a history of antiviral treatment; 6. Patient has medical condition that requires concurrent use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent) 7. Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis,alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.) 8. Patient who interrupted antiviral therapy; 9. Patient with incomplete data; 10. Follow up less than 1 year
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-70.0, Inguinal Hernia patients male, and age between 20 to 70 years Reducible inguinal hernia Irreducible, obstructed or strangulated hernia uncontrolled diabetes
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Chronic Hepatitis b Group 1: Patients with history of HBV-related clinical endpoint events No age limit Male or female Patients with liver biopsy performed after 1 to 3 years of antiviral therapy; patients with history of clinical endpoint events (decompensated cirrhosis, hepatocellular carcinoma, liver transplantation or liver-related death) after liver biopsy Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases Patients with malignant lesion on liver image Patients with other uncured malignant tumors Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases Pregnant or lactating women Patients with any other reasons not suitable for the study. Group 2: Patients without history of clinical endpoint events No age limit Male or female Patients with liver biopsy performed after 1 to 3 years of antiviral therapy; or Chronic hepatitis B (CHB) patients with antiviral therapy for 1 to 3 years content to be performed liver biopsy at enrollment
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Chronic Hepatitis B HBsAg positive, HBeAg negative, antibody to HBeAg-positive; 2. Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year; 3. Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule; 4. Patients read, understand the consent form, and signed the study consent Patient with other liver diseases; 2. Patient with concurrent hepatitis viruses or HIV infection; 3. Patients are reluctant to stop their anti-HBV treatment
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 35.0-75.0, Renal Transplantation Aging are group specific. HBV, HCV and HIV testing are not necessary in the RT groups as all RT recipients are tested prior to transplant. The investigators will not restrict volunteers with respect to gender, ethnic or racial group. Groups 1 (65-75 yrs) and 2 (35-45 yrs) Renal Transplant populations End stage renal disease cause either DM2 and/or hypertension (HTN) Renal transplant >12 months ago Group 3: Diabetic/hypertensive 65-75 year old controls With DM2 and/or HTN Previous immunization with PPV23 >1 year prior Willingness to be tested for HIV, HBV and HCV "normal kidney function" defined as glomerular filtration rate (GFR) of 60% or above Group 4: Healthy Control 65-75 yr old Without DM2 May have high blood pressure (systolic>140 and/or diastolic>90) as long as it is well controlled (systolic<140 and/or diastolic <90) and has not affected kidney function Previous receipt of PPV23 > 1 year prior are either applicable to all groups or group specific. Therefore we have listed the applicable to ALL groups first. Group specific are listed under each group common to all groups Previous immunization with PCV13 Pregnancy, no contraceptive practice in women of childbearing age, or breastfeeding Known anaphylaxis, hypersensitivity or "bad allergic reaction" to the pneumonia vaccine. This does not egg allergy or previous Guillan Barre syndrome Those who received blood products or gamma globulin within 3 months Inability to comprehend or sign the informed consent form Previous/present illness that may affect immune response to the vaccine previous pneumococcal disease
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-69.0, Hepatitis C Permanent residents in the province Ages 18-69 (inclusive) Both blood anti-HCV test and HCV-RNA test is positive Familiar with the use of mobile phones and WeChat Informed consent and voluntary participation in the study Temporary staff who come to the city to work, travel or visit relatives, or those who will be living in other cities for a long time Suffering from other serious diseases Patients with mental disorder or memory disorder Pregnant women or those who have a plan to prepare for pregnancy within one year Refuse to participate in the investigation
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Outcome, Fatal All patients, regardless of race, gender, age and co-morbids, who were treated with proximal femur fracture with any of the following variables: Poor bone quality Bone loss Severe communition Multiple comorbids Failed hip surgery Pathological fractures The patient who weren't treated with proximal femoral replacemnt, those lost to follow up, those with missing record
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Hepatitis C, Chronic Age from 18 to 70 years HCV RNA positivity Any Body Mass Index(BMI) Treatment-naive or treatment experienced all fibrosis stages Direct serum bilirubin greater than 2 mg/dl Serum albumin less than 2.8 g/dl International normalization ratio (INR) greater than or equal to 1.7 Platelet count less than 50 000/mm3 Ascites or history of ascites Hepatic encephalopathy or history of hepatic encephalopathy Hepatocellular carcinoma Serum creatinine greater than 2.5 mg/dl Pregnancy
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Patients diagnosed with Chronic Hepatitis C confirmed by quantitative HCV RNA test Patient affiliated to the contributory system of one Health Promoting Enterprise from Colombia Patients with prescription of pharmacological treatment for Hepatitis C Patients with incomplete information in at least one of the following variables: fibrosis, cirrhosis (if applicable), antiviral drug
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-999.0, Hepatitis B Viral Hepatitis Patients more than 20 years old 2. Chronic hepatitis B patients 3. Patients who were indicated for hepatitis B virus antiviral therapy Decompensated liver disease (Child-Pugh B &C) 2. End stage renal disease (eGRF < 15 ml/min/1.73m2) 3. Prior use of nucleot(s)ide analogues for chronic hepatitis B 4. Prior use of interferon for chronic hepatitis B within six months 5. Known history of human immunodeficiency virus or hepatitis C virus co-infection 6. Concurrent other uncontrolled malignancy 7. Women in pregnancy or lactation 8. Cannot conform to the study protocol of this study
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Over 18 years of age Previous or current injecting drug user Stable OST dose for greater than 12 weeks prior to study enrolment Glecaprevir/pibrentasvir treatment naïve Able to voluntarily sign and date an informed consent form prior to initiation of any screening or study specific procedures Able to understand and adhere to study visit schedule and all other protocol requirements Female who is pregnant, planning to become pregnant or breastfeeding or unwilling/unable to take appropriate birth control Known current HIV infection Known current HBV infection. Serological: patients with a positive HBsAg or isolated positive anti-HBC will be excluded from the study and followed up in secondary care Previous treatment with glecaprevir/pibrentasvir Currently taking any concomitant medication that has a warning of'do not co-administer' with glecaprevir and/or pibrentasvir as defined by the Liverpool Hep drug interactions website and product SmPC Clinically significant abnormalities that make candidate unsuitable for this study in the opinion of the investigator including but not limited to Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric or other medical disease or disorder, which is unrelated to existing HCV infection History of either current or previous decompensated liver disease or symptoms/signs of decompensation e.g. ascites noted on physical exam, use of beta-blockers for portal hypertension, hepatic encephalopathy or oesophageal variceal bleeding Candidate is deemed unsuitable to receive study drugs by the study investigator, for any reason according to clinical judgement Unable or unwilling to provide informed consent
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Aged ≥18 years Attendance at study site Willing and able to provide written informed consent Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment Treatment experienced (either DAA or pegylated interferon) Hepatitis B virus (HBV) infected Human Immunodeficiency Virus (HIV) infected estimated glomerular filtration rate (eGFR) <30 Active tuberculosis (if known active tuberculosis or as per symptom screening assessment) Pregnant women Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking
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1
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Primary Biliary Cholangitis over 18 years old of either sex Anti-mitochondrial antibody +ve or liver histology compatible with PBC stable UDCA dose of 13-15 mg/kg for > 12 months or intolerant to UDCA ALP at least 1.67 x ULN or abnormal bilirubin less than 2x ULN able to read and sign informed consent form subjects with baseline total bilirubin > 2 x ULN use of non-standard or experimental therapy within the last 6 months advanced liver disease: INR > 1.2 ULN, Albumin < 35 g/L lower limit of normal, platelets < 120,000, Childs Pugh class B or C cirrhosis, presence of grade 2 varices or previous variceal hemorrhage, encephalopathy, ascites or need for liver transplantation within the next two years secondary diagnosis such as HIV, viral hepatitis, drug induced liver injury, extrahepatic biliary obstruction, primary sclerosing cholangitis, metabolic liver - regular use of > 30g alcohol/day in the last year a predicted survival of less than 3 years from malignant or other life threatening disease hepatic mass consistent with hepatocellular carcinoma previous allergic reaction to study medications Glomerular Filtration Rate less than < 30 mL/min as measured Cockcroft-Gault formula pregnancy, breast-feeding or pre-menopausal patients not using contraception
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Vascular Diseases Patient ≥ 18 years old Patient hospitalized in the vascular medicine department of the GHPSJ or attending a general medical consultation at the CMT Patient with at least one vascular pathology: pulmonary embolism, venous thrombosis or phlebitis, cardiac arrhythmia by atrial fibrillation, obliterating arteriopathy of the lower limbs or myocardial infarction Patient on antithrombotic treatment[anticoagulants : AVK or Anticoagulants Oraux Directs (AOD), or antiplatelet agents] Patient affiliated to a health insurance plan Patient able to read and understand the French language Patient capable of giving free, informed and express consent Patient not residing in Ile de France Patient whose investigator considers that he/she is not able to use a digital tablet Patient deprived of liberty Patient under guardianship or curatorship Refusal to participate in the study Patient judged not to be included by the investigator on the basis of the questionnaire
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-64.0, Hepatitis C, Chronic ≥18 years of age anti-HCV and HCV RNA positive interested in starting HCV treatment at the time of diagnosis Women of childbearing potential engaged in sexual activity that could lead to pregnancy must consent to use contraception and agree to pregnancy testing during treatment If currently not enrolled in insurance, agree to assistance to enroll in insurance HBsAg positive from pre-screening visit and no medically controlled hepatitis B virus (HBV) condition History of hepatic decompensation (ascites, hepatic encephalopathy, or variceal hemorrhage) Current use of medications that is not compatible with SOF/VEL use, according to current prescribing guidelines, including amiodarone or a proton pump inhibitor exceeding 20 mg of omeprazole equivalent Prior treatment with an NS5a based HCV treatment regimen with subsequent viral rebound. Participants who have clear HCV reinfection as defined by an HCV GT that is different from the original genotype may enroll. If genotype results are not available from the initial and subsequent HCV infection, the individual will not be enrolled unless participant can provide SVR-12 record confirming HCV cure Pregnancy or breastfeeding Life expectancy of < 12 months as assessed by study clinical health provider Late Participants with the following lab values at week 0 will be evaluated on a case by case basis for continuation of SOF/VEL at the week 2 visit Albumin < 3.0 Hemoglobin < 8.0 (women) and < 9.0 g/dl ( men)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Chronic Hepatitis c Intravenous Drug Usage People who inject drugs (PWID) who are receiving substance abuse counselling or rehabilitation treatment programs in halfway house and rehabilitation centres run by Non-governmental organisations (NGOs) in Hong Kong Already on antiviral therapy for known HCV
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 60.0-85.0, Male Osteoporosis DXA BMD T-score < or = -2.0 at either lumbar spine (LS), femoral neck (FN) or total hip (TH) sites; or DXA BMD T-score < or = -1.5 with at least one additional important clinical risk factor for osteoporotic fracture [e.g., fragility fracture after age 50 years; parental history of hip fracture; history of hypogonadism, prior glucocorticoid therapy (>3 months prior), current smoking, prevalent vertebral fracture(s), or prior hyperthyroidism on stable treatment] At least 2 LS vertebral levels with reliable BMD values (i.e., at least 2 without compression or hardware) Metabolic bone disease other than osteoporosis (e.g., Paget's disease, hyperparathyroidism) Any osteoporosis drug therapy within 12 months; any prior course of TPTD for > or = 3 months; any history of IV bisphosphonate therapy; oral bisphosphonate therapy exceeding 3 months in past 2 years; oral bisphosphonate treatment exceeding 2 years ever; or use of denosumab (within the past 3 years or > 3 or = injections ever) Oral glucocorticoid use (> or = 5 mg prednisone) taken within 3 months prior to enrollment Hypercalcemia (albumin-corrected serum [Ca] >10.2 mg/dL), hypocalcemia (albumin-corrected serum [Ca] <8.8 mg/dL), elevated intact PTH level, or hypercalciuria (urinary Ca >300 mg/24 hours) at screening OH vitamin D levels <20 ng/ml or >80 ng/ml at screening Estimated glomerular filtration rate < 30 ml/min (chronic kidney disease (CKD) stage 4 or 5) Cancer within past 5 years except for non-melanomatous skin cancers History of skeletal radiation, prior history of osteosarcoma or bone metastases Substance abuse (>3 drinks/day), liver disease or impaired liver function (abnormal liver function tests defined as greater than 3 times the upper limit of normal), known cirrhosis, malabsorption Poorly controlled diabetes (A1c >9.0%) or current thiazolidinedione therapy
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Shoulder Arthoscopy Beach Chair Position Cerebral Desaturation Events Obese • All patient over age 18 BMI > 30 Undergoing shoulder arthroscopy in beach chair position • Age < 18 years BMI < 30 Known and documented >90% occlusion of carotid artery Prior neck surgery Women who are pregnant
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Hepatitis, Chronic Informed consent of patients. 2. Evidence of persistent virus infection for greater than six months [hepatitis C virus(HCV) RNA positive, hepatitis B surface antigen(HBsAg) or hepatitis B virus(HBV) DNA positive] Serious psychiatric history, especially depression Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness. 2. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs. 3. Patients with malignant tumors (excluding those cured)
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-69.0, HCC HBV Coinfection older than 18 years and less than 69 years old; 2. HBsAg positive HCV antibody negative and HIV antibody negative; 3. HBV-DNA>200 IU/mL; 4. BCLC（Barcelona Clinic Liver Cancer） staging O and A stage; 5. Platelet100×10^9/L; 6. Liver function Child-Pugh A,with no invasion in portal vein, hepatic vein and two large branches, no extrahepatic metastasis; 7. Creatinine clearance rate≥ 70 mL/min; 8. Antiviral treatment was not performed before surgery or antiviral treatment was accepted in a short term (<3 months); 9. No treatment was performed before the operation. The results of postoperatively histopathological biopsy were HCC; 10. The patients agree to participate in the clinical trial The image found extrahepatic lymph nodes or visceral metastasis, the existence of large vascular invasion, the existence of bile duct embolus in the first operation; 2. The patient combined with a malignant tumor of other organs or had a history of other malignant tumors in other organs; 3. Liver function decompensation, such as: upper gastrointestinal bleeding, refractory ascites, coagulation dysfunction and so on; 4. contraindications to surgery; 5. Patients with poor compliance and not adhered to the follow-ups; 6. Patients refused to participate in the clinical trial
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C of archived samples Non-hemolytic plasma samples with EDTA used as anticoagulant Sample were frozen at -20°C or lower on the day of processing and stored at -20°C or lower until they are used in this study Samples pre-characterized for, HCV, HIV serology status using assays routinely used at the sites and approved for diagnostic use by a local health authority. If available, samples should also be characterized for HBV status Samples taken from subjects aged ≥18 years Availability of informed consent to use the sample in future research Samples not stored correctly
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, End Stage Liver DIsease Complication Informed consent of patients. 2. Diagnosis of any of the following diseases: acute decompensation of cirrhosis, chronic and acute liver failure, chronic liver failure and hepatocellular carcinoma (stage III-IV) HIV antibody positive and AIDS patients 2. Serious psychiatric history, especially depression. Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness. 3. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs. 4. Patients with other malignant tumors (excluding those cured). 5. Pregnant, lactating women or women of childbearing age who are ready to conceive
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatocellular Carcinoma Patients who meet all of the following in screening tests and observations within 14 days before enrollment will be included in the study. 1. Signed Informed Consent Form 2. Males and Females, 18 years or older at time of signing Informed Consent Form 3. Ability to comply with the study protocol, in the investigator's judgment 4. HCC with diagnosis confirmed by histology/cytology by AASLD 5. Barcelona clinic liver cancer (BCLC) C stage. 6. No prior systemic therapy for HCC 7. Patients must not be appropriate for surgery or loco-regional therapy. Patients can receive no previous anti-cancer therapy or have progressed or have intolerable adverse events after surgery or loco-regional therapy. Surgery or locoregional therapy hepatic resection, ablation, transcatheter arterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiotherapy, and must have been completed at least 4 weeks (washout period) prior to the baseline scan. In addition, all acute toxic effects of the locoregional procedure must have resolved to National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.03 Grade<=1. 8. At least one tumor lesion that can be accurately measured according to the 1.1 9. ECOG Performance Status of 0 or 1 10. No cirrhosis or cirrhotic status of Child-Pugh class A only. Documented virology status of HBV, as confirmed by screening HBV serology test, as evidenced by detectable HBV surface antigen. (there is no lower and upper limit of HBV DNA, but patients must be on effective antiviral therapy if HBV DNA is positive [greater than zero]). 11. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior torandomization, unless otherwise specified: 1. white blood cell count ≥ 3.0×10⁹ per L 2. absolute neutrophil count ≥ 1.5×10⁹ per L 3. platelet count ≥ 75×10⁹ per L 4. Hemoglobin ≥ 8.5 g/dL 5. Prothrombin time (PT)-international normalized ratio (INR) ≤ 2.3 or Prothrombin time (PT) ≤ 6 seconds above control 6. total bilirubin ≤ 30mmol/L 7. serum albumin ≥ 30 g/L 8. aspartate transaminase and alanine transaminase ≤ 5×upper limit of the normal 9. creatinine clearance of ≤1.5×upper limit of the normal or a creatinine clearance > 50 mL/min (Cockcroft-Gault formula) 10. left ventricular ejection fraction (LEVF) ≥45% as measured by echocardiography 12. Reproductive status: Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within one day prior to the start of study drug. Women must not be breastfeeding Patients who meet one of the following in screening tests and observations before enrollment will be excluded from the study: 1. Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC was excluded. 2. Any history of hepatic encephalopathy 3. Any prior (within 30 days) or current clinically significant gastrointestinal bleeding or clinically significant ascites as measured by physical examination and that requires active paracentesis for control 4. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) 5. Known history of hepatitis C virus (HCV) or hepatitis D virus (HDV) infection 6. Active bacterial or fungal infections requiring systemic treatment within 7 days prior to study drug dosing 7. Prior organ allograft such as liver transplant, etc. or allogeneic bone marrow transplantation 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial 9. Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement. psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll 10. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 30 days of study administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease 11. Treatment with anti-platelet therapy (aspirin at dose>=300 mg/day, clopidogrel at dose>=75 mg/day) or current anticoagulation therapy 12. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) 13. All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 4.03) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae are permitted to enroll. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 4.03). 14. Known central nervous system tumors including metastatic brain disease 15. Patients who are pregnant or breastfeeding. Women with a positive pregnancy test at enrollment or prior to administration of study medication 16. Other invasive malignant diseases 17. Prisoners, or subjects who are compulsory detained 18. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Substance Use Disorders HCV RNA positive Attending the low-threshold HCV clinic in Oslo
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Patients with active rheumatoid arthritis based on DAS28 score. Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months Known hypersensitivity to metformin Patients who have a prior diagnosis with diabetes mellitus Patients receive metformin for any other indications Patients with congestive heart failure Patients with a history of myocardial infarction Patients with severe anemia Patients with active infections or other inflammatory diseases Patients receiving biological therapy Pregnancy or lactation Patients with impaired liver functions
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 20.0-70.0, Chronic Hepatitis C Chronic hepatitis C patients treated with interferon plus ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct antiviral drugs (DAAs) Co-infected with hepatitis B virus or human immunodeficiency virus Had an autoimmune disease, liver tumour, or severe cardiac disease
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 1 Albuminuria Male or female patients ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset <40 years; permanent insulin treatment initiated within 1 year of diagnosis) 2. Albuminuria: UACR > 30 mg/g documented in medical history 3. Calprotectin quick-test result ≥ 50 μg/g (CalDetect 50/200, Preventis) between visit 1 and visit 2. 4. Able to understand the written patient information and give informed consent Known inflammatory bowel disease 2. IBD symptoms due to investigators opinion 3. Known celiac disease 4. Existing ostomy 5. Known rheumatic disorders treated with anti-inflammatory agents 6. Known hyperthyroidism or hypothyroidism Butyful Protocol page 12 Version 3, 25.02.2019 7. Active immunosuppressant therapy with systemic effect due to investigator's opinion 8. Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer) 9. eGFR<15, dialysis or kidney transplantation 10. Diagnosis of non-diabetic CKD 11. Active antibiotic therapy until 30 days ahead of screening 12. Unable to participate in study procedures 13. Not able to assess calprotectin by quick test in two attempts 14. Any clinically significant disorder, except for conditions associated with type 1 DM history, which in the Investigators opinion could interfere with the results of the trial 15. Pregnancy or lactation 16. Participation in another intervention study
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 15.0-999.0, HIV Infections Immune Activation Comorbidities Consenting pregnant woman of Bantu origin of ≥15 years of age, at least 20 weeks of gestation at enrolment and planning to deliver at any of the 4 study sites, Kuwadzana, Rujeko, Glenview or Budiriro. Mothers should be willing to be followed together with their babies from delivery, and willing to provide the required data and biological specimens in follow-up visits for two years Presence of severe maternal mental disorders
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Idiopathic Thrombocytopenic Purpura Normal healthy Egyptians on the age range from 18-85 Egyptian patients with ITP in age range from 18 on high dose dexamethasone together with cyclosporin and rituximab Egyptian patients with ITP in age range from 18 on parenteral or oral steriods Age less than 18 years old Pregnancy Thrombocytopenia other than ITP Patients with ITP but on other modalities of treatment Patients with blood born viral hepatitis infection before treatment with high dose dexamethasone together with cyclosporin and rituximab
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-80.0, Hernia, Inguinal Hernia Direct Hernias Indirect Quality of Life Patients, 18 years and above, presenting with primary reducible inguinal hernias Patients, 18 years and above, with irreducible inguinal hernias which is neither obstructed nor strangulated Patients who do not consent to participate in the study Patients presenting with recurrent, obstructed or strangulated hernias Patients with bilateral hernias Patients with immunosuppression (uncontrolled diabetes mellitus, malnutrition, patients on long-term steroids, known AIDS patients) Patients with chronic debilitating illnesses (chronic renal or liver failure, congestive cardiac failure) and urinary bladder outlet obstruction Concomitant repair of another abdominal hernia e.g. umbilical hernia Hernia repair combined with another surgical procedure Patients under the age of 18 years and over 80 years Pregnant women ASA score 4 or more
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-100.0, Hepatitis C Johns Hopkins Hospital ED patient years or older HCV positive without HCV RNA information Younger than 18 years of age Unable to provide informed consent Altered mental status Incarcerated Critically ill
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Solid Tumor Lung Cancer HCC Written and signed informed consent. 2. Aged over 18 and less than 75 years at the time of signing the informed consent form, both female and male. 3. ECOG PS is 0-1. 4. The expected survival time is ≥ 3months 5. Histologically or cytologically confirmed selected advanced solid tumor. 6. Subject must have at least one measurable lesion according to Version1.1. 7. Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy. 8. Adequate organ function. 9. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product. 10. Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product. 11. Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other requirements for the study Had received experimental drug or used experimental device in the past within 4 weeks prior to the first dose of study drug. 2. Receipt of last radiotherapy or any anti-tumor treatment [chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization] within 4 weeks prior to the first dose of study drug. 3. Had received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, etc.), or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways (such as ICOS, CD40, CD137, GITR, OX40 antibody or drug), immunocytotherapy, therapeutic antibody, etc.). 4. Toxicity from previous anti-cancer therapy has not been alleviated or resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/ 5. Patients with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors. 6. Active or previously recorded inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea). 7. Patients with a condition requiring systemic treatment with either corticosteroid (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. 8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 9. Large surgical procedures (defined by researchers as open biopsy, severe trauma, etc.) were performed within 28 days prior to the first dose of study drug. 10. Known history of interstitial lung disease. 11. Patients with untreated chronic hepatitis B or HBV DNA exceeding 1000IU/mL or active hepatitis C. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative. 12. Patients with active tuberculosis (TB). 13. History of known primary immunodeficiency virus infection or positive HIV testing. 14. Severe infections within 4 weeks prior to the first dose of study drug, including but not limited to complications, sepsis or severe pulmonary infections requiring hospitalization. 15. Patients with meningeal metastasis, spinal cord compression, pia mater disease or active brain metastasis. Patients who meet one of the following requirements may be enrolled: a). No central nervous system metastasis symptoms and signs, such as neurological dysfunction, epilepsy or other central nervous system metastasis before admission. No edema around the lesion found by imaging examination, and no brain metastasis more than 1.5 cm in length. b). Patients with central nervous system metastasis had received treatment and achieved asymptomatic status (e.g. without neurological dysfunction, epilepsy or other typical central nervous system metastasis symptoms and signs) 16. Patients with pleural effusion, pericardial effusion or ascites that could not be controlled stably by repeated drainage or other methods as judged by the investigator. 17. Receipt of live, attenuated vaccination within 30 days prior to the first dose of study treatment, or plan to receive live, attenuated vaccine during the study. 18. Known history of sever hypersensitivity reaction to other monoclonal antibodies. 19. Known history of allergy or hypersensitivity to AK105 or any of its components 20. Any conditions that, in the investigator's opinion, may put subjects treated with the study drug at risks, or interfere with the evaluation of study drug or subject safety, or the interpretation of results
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-90.0, Liver Regeneration Liver Metastases • Patients with liver lesions, who are eligible for liver resection Pregnant women Liver resection is not performed
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-65.0, Healthy Chronic Pain Opioid Use Pain, Chronic Age 18 (to maximize participation). 2. Does not have a history of and is currently not experiencing chronic pain. 3. Able to read and understand questionnaires and informed consent. 4. Lives within 50 miles of the study site. 5. Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold). 6. Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage Any psychoactive illicit substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels. 2. Meets DSM-V for moderate substance dependence, current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder. 3. Has current suicidal ideation or homicidal ideation. 4. Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD. 5. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control. 6. Has current charges pending for a violent crime (not including DUI related offenses). 7. Suffers from chronic migraines
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Autoimmune Hepatitis for de novo AIH Age 18 or older Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and a different pre-transplant etiology of liver disease will be eligible Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure Women of child bearing potential agree to have pregnancy test at screening Males agree use of appropriate contraceptives during the active Orenia dosing period for recurrent AIH Age 18 or older Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and whose original etiology of liver disease was AIH will be eligible Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible Active systemic infection Allergy to abatacept Known malignancy in the previous 2 years except for non-melanoma skin cancer Pregnancy or breast feeding Inability to commit to complete treatment protocol at Duke, as all procedures must be completed at Duke Prisoners or those who are compulsory detained Inability to read and understand English EBV seronegative (if not tested within 2 years prior to study enrollment, then testing will be done prior to study enrollment, results must be positive for study participation)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-85.0, Hernia, Inguinal primary inguinal hernia unilateral hernia bilateral hernia recurrent hernia incarcerated hernia large scrotal hernia known femoral hernia need for associated procedures not able to understand the questionaire immunosuppression (including corticosteroids, radiotherapy, chemotherapy) chronic renal failure (hemodialysis) active infection
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Helminthiasis Helminth Infection The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his in the study was that he was healthy N/A
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Hepatitis C Chronic hepatitis C virus patients Patients do not start treatment protocol Pregnant women Hepato-cellular carcinoma patients Autoimmune disease patients Patients with liver cirrhosis Patients who refuse to participate in the study
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Psoriatic Arthritis Patients eligible for in this study have to fulfil all of the following 1. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed. 2. Male or non-pregnant, non-nursing female patients at least 18 years of age. Before randomization, a woman of childbearing potential must be on a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: eg, established use of oral, injected or implanted hormonal methods of contraception associated with inhibition of ovulation; placement of an intrauterine device (IUD) or intrauterine system (IUS); male partner sterilization (the vasectomized partner should be the sole partner for that subject); true abstinence (when this is in line with the preferred and usual lifestyle of the subject). A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) at baseline before randomization. A woman must agree not to donate ovocytes for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study agent. Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) that woman must begin a highly effective method of birth control, as described above. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study agent The method of birth control will be clearly documented in patient file. 3. Patients with active PsA according to for ≥6 months, despite ≥3 months of csDMARD therapy, and ≥4 weeks of non-steroidal anti inflammatory drugs (NSAIDs) therapy. 4. At least 1 swollen joint at screening or baseline (despite csDMARD therapy) with ability to perform a synovial biopsy at W0. 5. Patients with newly documented latent TB are eligible provided initiation of appropriate treatment. 6. Concomitant MTX or SSZ is permitted if started ≥3 months prior to study start and at a stable dose (≤25 mg/week for MTX and ≤ 3 g/day for SSZ) for ≥4 weeks. 7. Patients on MTX must be on stable folic acid supplementation before randomization. 8. Concomitant NSAIDs and oral corticosteroids (≤10 mg prednisone/day) are permitted if stable for at least 2 weeks. 9. Allowed concomitant medications are to remain stable through week 24. 10. Patients cannot have previously received any biologic agent 11. DMARDs other than MTX or sulfasalazine (SSZ) must be interrupted. DMARDs other than MTX are not allowed within 4 weeks prior to or during trial participation. A washout period needs to be considered. (8 weeks for leflunomide). 12. At least one joint (small or large) to biopsy in order to get synovial tissue. Small joints must have an US grey-scale score > 2 on Doppler Patients fulfilling any of the following are not eligible for in this study. 1. Contraindications for needle-arthroscopy such as joint replacement (in the affected knee or ankle joint) or anticoagulation. 2. Use of any investigational drug and/or devices within 4 weeks of baseline, or a period of 5 half-lives of the investigational drug, whichever is longer. 3. Conditions/situations such as: 1. Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint 2. Impossibility to meet specific protocol requirements (e.g. blood sampling) 3. Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 4. Uncooperative or any condition that could make the patient potentially noncompliant to the study procedures 4. Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline. 5. Any intramuscular corticosteroid injection within 2 weeks before baseline. 6. Prior treatment with a biologic agent. 7. A history of active tuberculosis (TB)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-80.0, General Surgery Inguinal Hernia Ventral Hernia ages must be upper 18 Morbit obesity (BMI>40)
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-75.0, Chronic Hepatitis C Ages 18 to 75 Unlimited gender Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015) No hormones and / or immunosuppressants and other hepatoprotective drugs Sign a written informed consent Combined with other hepatitis virus (HBV, HDV) infections Immune liver disease HIV infection long-term alcohol and / or other liver damage drugs mental illness Evidence of liver tumor (liver cancer or AFP> 100 ng / ml) Decompensated cirrhosis Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up There are hormones and / or immunosuppressants and other hepatoprotective drugs
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-80.0, Hepatitis C Virus Infection HCV infection 2. HCV RNA > 1,000 IU/mL 3. Aged 18 to 80 4. Willingness and capacity to provide informed consent Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings. 2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5 3. History of current or past hepatocellular carcinoma 4. Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection 5. Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin 6. Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV 7. Significant co-morbid illness that precludes in the opinion of the investigator 8. Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted. 9. Pregnancy/breast-feeding/inability to use contraception 10. Use of concomitant contraindicated drugs
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Hantavirus Infections Hemorrhagic Fever With Renal Syndrome Nephropathia Epidemica Hantavirus Cardiopulmonary Syndrome Serological or molecular evidence of hantavirus infection and clinical evidence of nephropathia epidemica or hemorrhagic fever with renal syndrome (HFRS) Serological or molecular evidence of hantavirus infection and clinical evidence of hantavirus cardiopulmonary syndrome (HCPS) Serological or molecular evidence of hantavirus infection without clinical signs of nephropathia epidemica, HFRS or HCPS
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Inguinal Hernia Chronic Pain Elective inguinal hernia repair in a portuguese hospital Willing and able to consent and comply with the follow up protocol Urgent/emergent inguinal hernia repair
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-80.0, COVID19 Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O)) Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions: 1. Hypercholesterolemia 2. Hypertriglyceridemia 3. Liver disease 4. Renal disease 5. Sjögren syndrome 6. Pregnancy 7. Lactation 8. Depressive disorder 9. Body mass index less than 18 points or higher than 25 points 10. Contraindications for hormonal contraception or intrauterine device. 11. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation 12. Patients receiving anti-hcv treatment 13. Permanent blindness in one eye 14. History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery 16-The competent physician considered it inappropriate to participate in the study ------------------------------------------------------------------------------------------- ------------------------------------------------------------------------------------------- ---------------------------------------------------------- Safety and promising features of isotretinoin in tne era of COVID 2019 according Principal Investigator Protocol: 1. This medication have the feature of Aerosolized Drug Delivery to increase its efficacy beside Oral administration, Which makes it distinct from other medication in which should dose be only given orally. A study demonstrated that treating with 13 cis retinoic acid aerosolized via inhalation rout did not cause any damage in lung cells. 2. Repeated high doses of 13 cis retinoic by inhalation resulted in moderate loss of body weight, but microscopic investigation of ten tissues including lung and oesophagus did not detect any significant aerosol-induced damage. The results suggest that administration of isotretinoin via powder aerosol inhalation is probably superior to its application via the oral route in terms of achieving efficacious drug concentrations in the lung. 3. Inhaled isotretinoin might provide sufficient drug to the target cells for efficacy while avoiding systemic toxicity. 4. A study demonstrated that 13 cis retinoic is used in treating Emphysema (emphysema is a lung condition that causes shortness of breath) 5. RA has been reported to induce formation of new alveoli and returns elastic recoil in the lung to approximately normal values in animal models of emphysema. 6. Strong expectation of complete COVID -19 blockade from cell entry and infection depending on strong ethics, researches and references. 7. Availability of our compounds. 8. Ease of application. 9. Expectation of COVID -19 treating by isotretinoin via more than one distinct mechanism. 10. Expectation of High induction of anti inflammatory T cells and significant inhibition of IL-6 at low concentrations of isotretinoin. 11. Controlling Accompanying cytokine storm. 12. No interactions with Egyptian protocol drugs were found. 13. (13 cis -Retinoic acid ) can be given in the form of aerosol to avoid these systemic side effects. A clinical trial conducted on 148 subject from 5 university hospitals to evaluate the possibility of retinoids in the treatment of emphysema. The patients, were randomized to receive 13-cis retinoic acid (1 mg/kg/day, daily or ATRA at either low dose (1 mg/kg/day for 4 days/wk) or high dose (2 mg/kg/day for 4 days/wk), placebo for six months, followed by a three-month crossover phase. then, they were observed for an additional nine months before the final evaluation. In the trial, retinoids(13 cis retinoic acid ) were proven to be safe as the drug-related AEs were generally mild[188]. A study reported that the application of aerosolized RA system led to a rise of RA levels in lung, but not plasma. or liver. In lung concentration and levels of retinol, retinyl palmitate and retinyl stearate also showed to be unchanged [189] A study on rabbits demonstrated that 13 cis retinoic acid can be given in the form of aerosol without serious side effects In this study repeated elevated doses of 13 cis retinoic acid by inhalation caused moderate loss of body weight, but microscopic examination of ten tissues including oesophagus and lung did not found any significant inhalation-induced injury or damage therefore aerosolized 13 cis retinoic acid might provide sufficient therapy to the target cells in lung for efficacy while avoiding systemic toxicity © 2000 Cancer Research Campaign[190]
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-999.0, Occult Hepatitis B Biological Substance; Adverse Effect Immunosuppression Age ≥ 18 years old at the time of starting biological modifier therapies or at the time of recruitment Positive for anti-HBc OR Positive for anti-HBs and born before year 1988 Known HBV carrier with HBsAg positive Concomitant HCV and/ or HIV infection Already on HBV anti-viral Refuse to consent Baseline ALT > 80 IU/ml
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 0.0-999.0, Viral Hepatitis residents normally living in Hong Kong living in domestic households randomly selected from Building Groups Any age, while subjects below the age of 18 would require informed consent of their guardians for participation Any gender unable to understand written Chinese or English failure to give consent for participation living in institution or non-domestic housing foreign domestic helpers normally living in Hong Kong
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0
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, Chronic Hepatitis C Virus Infection Non-cirrhotic treatment-naïve participants FIB-4 < 3.25 albumin > 3.5 total bilirubin < 1.2 mg/dl international normalized ratio (INR) < 1.2 platelet count > 150,000 mm3 experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis liver disease of non-HCV etiology hepatitis B or human immune-deficiency virus (HIV) infection poorly controlled diabetic (HbA1C > 9) participants hepatocellular carcinoma a history of extra-hepatic malignancy within 5 years prior to the study pregnant or breast feeding renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3) major severe illnesses such as congestive heart failure and respiratory failure
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2
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A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
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eligible ages (years): 18.0-70.0, COVID-19 Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O)) Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions: 1. Hypercholesterolemia 2. Hypertriglyceridemia 3. Liver disease 4. Renal disease 5. Sjögren syndrome 6. Pregnancy 7. Lactation 8. Depressive disorder 9. Body mass index less than 18 points or higher than 25 points 10. Contraindications for hormonal contraception or intrauterine device. 11. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation 12. Patients receiving anti-hcv treatment 13. Permanent blindness in one eye 14. History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery 15. The competent physician considered it inappropriate to participate in the study 16. HIV infection or other immunodeficiency or with an absolute neutrophil count ≤1.0 × 109/L 17. Abnormal liver biochemistry (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase) >1.5 × upper limit of normal or total bilirubin > upper limit of normal (unless Gilbert's disease with normal conjugated bilirubin) 18. Any of the following laboratory abnormalities are present at baseline Platelet count <150×109/L Serum albumin ≤ 3.5 g/dL INR ≥1.2 CPK ≥ ULN. 19. Significant liver fibrosis as evidenced by Fibrosis-4 (FIB-4) score >3.25 20. History of hypersensitivity to retinoic acid or any of its excipients or the class of neutrophil elastase inhibitors Known hypersensitivity to medications used in the study procedures (e.g. midazolam, fentanyl, and lidocaine for bronchoscopy)
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