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60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Hepatic Encephalopathy Adult Patients from 18 to 65 years Patients with grade II-III Hepatic Encephalopathy Patients with active GIT bleeding Patients with major psychiatric illness Patients receiving benzodiazepines, narcotics, alcohol and marijuana Patients with compromised renal or biliary functions Patients known to have AIDS Patients receiving medications highly bound to plasma proteins eg. Warfarin Patients with known hypersensitivity to nitazoxanide Pregnant or lactating women | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Liver Cirrhosis Portal Vein Venous Thrombosis Varicose Veins Hemorrhage A diagnosis of liver cirrhosis. 2. Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding. 3. Patients agreed to undergo endoscopy to evaluate the presence and severity of varices. 4. Patients agreed to undergo contrast-enhanced CT scans to evaluate the portal vein patency. But if an abdominal contrast-enhanced CT scans was performed within 3 months after admission, it was not necessarily repeated Non-cirrhotic patients. 2. Malignancy. 3. Contrast-enhanced CT scans were neither feasible nor available. 4. Severe cardiopulmonary diseases. 5. Severe infectious diseases. 6. Pregnant or breastfeeding. 7. Allergic to contrast agents. 8. Poor adherence | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 19.0-999.0, Gastritis Age is over 19 years old, men or women Patients diagnosed with acute or chronic gastritis by gastroscopy Patients with one or more erosions found by gastroscopy Signed the informed consent forms Patients who is impossible to receive gastroscopy Patients with peptic ulcer and gastroesophageal reflux disease Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy) Patients with esophageal varix Patients with malignant neoplasm of gastrointestinal tract Patients with thrombosis or administered with anti-thrombotic drugs Patients with consumption coagulopathy Patients administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks Patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment Allergic or hypersensitive to any of the ingredients in the test products | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Portal Hypertension Cirrhosis > 18 years old (Male/Female) and not more than 75 years old 2. Diagnosis of cirrhosis: i. By liver biopsy ii. Or strong suspicion of cirrhosis by accepted for the clinical diagnosis of cirrhosis (e.g. peripheral edema or varices, palpable hard left lobe of the liver, small right lobe span or palpable splenomegaly), and/or radiological evidence of cirrhosis (by abdominal US, CT, or MRI, showing a nodular liver and/or portosystemic collaterals with portal vein patency and/or ascites and/or splenomegaly, and/or colloid shift on a colloid-isotope liver-spleen scan), and/or laboratory variables (platelets <100,000/mm3, albumin< 3.5g/dL, or INR >1.3) and/or presence of esophageal varices (without previous variceal bleeding episode) or HVPG≥12mmHg from previous testing, or by FIbroscan or Fibrotest results showing fibrosis stage c. Has been scheduled for hemodynamic study testing. d. Patients should have a Child Pugh score A or higher Patients already receiving beta blockers 2. Hepatocellular carcinoma 3. Portal vein thrombosis 4. Cholestatic liver disease 5. Severe heart, pulmonary or renal disease. 6. Patients with Ischemic heart disease 7. Patients with diabetes mellitus 8. Any major surgery in the past 3 months. 9. Patient is a recipient of any organ transplant 10. Patient, based on the opinion of the investigator, should not be enrolled into this study. 11. Patients unable or unwilling to sign informed consent 12. Patients that are participating in other clinical trials evaluating experimental treatments or procedures or have participated in a clinical trial in the past 3 months. 13. Active smoking 14. Uncontrolled hypertension Withdrawal 1. Patient that based on the opinion of the investigator should be withdrawl from the study due to no compliance 2. Patient wish to stop participate in study | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 19.0-999.0, Acute Gastritis Chronic Gastritis Age is 19 years old and over, men or women 2. Patients diagnosed with acute or chronic gastritis by gastroscopy and need a treatment for gastritis symptoms 3. Patients with one or more erosions found by gastroscopy 4. Patients who voluntarily signed written informed consent may participate in the study Patients with peptic ulcer and gastroesophageal reflux disease 2. Patients with Gastrointestinal malignant tumor or surgery related to stomach resection 3. Patients with thromboembolism and coagulation disorder 4. Patients with significant cardiovascular, pulmonary, heptic, renal primary disease 5. Patients with abnormal laboratory result at screening Aspartate aminotransferase(AST), Alanine aminotransferase(ALT), Creatinine > upper limit of normal range x 2 White blood cell(WBC) < 4,000/mm3 Platelet < 50,000/mm3 6. Patients administered with H2 receptor antagonists, proton pump inhibitors, muscarine receptor antagonists, other gastiritis treatment drug, protective factor builder, non-steroid anti-inflammatory drugs prior to study in 2 weeks 7. History of allergic reaction to the investigational product 8. Women either pregnant, breast feeding or possible to pregnant without contraceptive method 9. Use of other investigational drugs within 3 months prior to the study 10. Patients that investigators consider ineligible for this study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-76.0, Esophageal Varices Patients presented to our hospital with esophageal varices diagnosed by gastroscopy, with or without gastric varices The age of the patients range from 18 to 80 years old Patients who have contraindications for lauromacrogol therapy or transparent cap Patients who have no previous upper gastrointestinal bleeding history Patients who have fecal disease that could greatly impact survival, such as uremia, advanced cancer or respiratory failure, et al | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Chronic Hepatitis C Males or females, ≥ 18 years & ≤ 65 years of age. 2. HCV antibody positive, with serum HCV RNA ≥ 10,000 IU/mL, with clinical history compatible with chronic hepatitis C. 3. HCV genotype-4 infection, confirmed at the central study laboratory 4. Body mass index (BMI) between 18 and 35 kg/m2, inclusive. 5. Both male and female patients who have childbearing potential must agree to practice an acceptable method of birth control during the study and for at least 6 months after the cessation of treatment; such contraceptive methods must at least one barrier method. 6. Patients for Group 1 must be treatment-naïve i.e., they have never received any antiviral treatment for their HCV infection, including interferon, pegylated interferon, ribavirin, or other regulatory-approved or investigational HCV antiviral therapies. 7. Patients for Groups 2 and 3 must have previously failed treatment with an interferon-based therapy i.e., interferon or pegylated interferon, with or without ribavirin, with no other previous HCV antiviral therapies. Patients for Group 2 must be non-cirrhotic diagnosed on screening visit by both Fibroscan™ liver stiffness measurement < 12.5 kPa and FIB-4 score < 3.25 if the results of Fibroscan and FIB-4 score are not matching; liver biopsy will be used for detection of cirrhosis. In case that the liver biopsy is not applicable, hepatic imaging or ultrasound reports could be used for determination of cirrhosis. Patients for Group 3 must have underlying cirrhosis diagnosed on screening visit by both Fibroscan liver stiffness measurement > 12.5 kPa and FIB-4 score > 3.25, if the results of Fibroscan and FIB-4 score are not matching liver biopsy will be used for detection of cirrhosis. In case that the liver biopsy is not applicable, hepatic imaging or ultrasound reports could be used for determination of cirrhosis. 8. Willing and able to give informed consent 9. Willing and able to complete all study visits and procedures, including compliance with the requirements and restrictions listed in the consent form Mixed genotype or non-typable HCV genotype infection, 2. Positive test for HBsAg or HIV antibody, or IgM antibody to HAV or HEV 3. History of schistosomiasis or positive test for schistosoma surface antigen at Screen. 4. Serum alpha-fetoprotein (AFP) >100ng/ml. Patients with an AFP between 50 and 100ng/ml may be included as long as a liver ultrasound within 3 months of Screening, or at Screening, shows no evidence of potential hepatocellular cancer. 5. History of treatment with any investigational or regulatory-approved direct-acting antiviral (DAA) agent for HCV infection nucleos(t)ide or non-nucleosidic HCV polymerase inhibitor, HCV protease inhibitor, NS5A inhibitor, or other antiviral agent for HCV infection other than pegylated -interferon and/or ribavirin Previous pegylated interferon and/or ribavirin treatment is allowed for Groups 2 and 3 but prohibited for group 1, as noted above in criterion 6) 6. Evidence of a medical condition other than HCV that is contributing to liver disease 7. History of, or clinical signs of, hepatic decompensation or portal hypertension: Variceal bleeding, or documented esophageal or GI varices (at investigator discretion, patients suspected of having esophageal varices should be evaluated by endoscopy, and varices excluded) Ascites by history or on physical examination Documented or suspected hepatic encephalopathy Physical signs of portal hypertension: Clinically significant splenomegaly Spider angiomata History of porto-systemic shunt procedure(s) 8. Uncontrolled diabetes mellitus as evidenced by HgbA1C ≥ 8.5% at Screening. 9. Hemoglobin < 11g/dL for females and < 12 g/dL for males 10. WBC count < 3,500/mm3 OR absolute neutrophil count (ANC) < 1800/mm 11. Platelet count < 75,000/mm3 12. Serum creatinine > 1.3 x ULN OR creatinine clearance (GFR) < 50 mL/minute 13. Serum ALT or AST >10x ULN 14. Serum albumin ≤ 3.2 g/dl 15. Direct serum bilirubin > 2xULN 16. INR > 1.7. 17. History of poorly controlled asthma, with one or more hospitalizations or emergency room visits in the previous 6 months 18. History of any malignancy within the last 5 years (except prostate cancer still within Glisson's capsule or basal cell carcinoma of the skin). 19. History of alcohol abuse as assessed by the investigator within the past 2 years, or an alcohol use pattern that may interfere with the patient's study compliance. Patients must have abstained from alcohol for at least 6 months prior to study start. 20. History of drug abuse as assessed by the investigator within the last 2 years. 21. Pregnancy, including current lactation in female patients, male patients with partners who are pregnant, or female patients intending to become pregnant. 22. Major surgery requiring overnight hospitalization within 3 months prior to Screening 23. Participation in another clinical trial of an investigational drug or device within 6 months prior to Screening 24. Current use or history of use within the preceding 6 months of immunosuppressive or immune-modulating agents, including: azathioprine, systemic corticosteroids (prednisone or prednisone equivalent of more than 10mg/day for more than 10 days), or other immunosuppressive agents. Use of inhaled steroids for mild/moderate asthma and topical steroids for minor skin conditions is allowed. 25. History of solid organ or bone marrow transplantation. 26. History of use of medications associated with QT prolongation concurrently or within the 30 days prior to Screening Visit, including: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants. 27. correction, or a personal or family history of Torsades de Pointe. 28. Cardiac ischemia with history of recurrent angina, clinically symptomatic cardiac abnormalities, or requirement for cardiac pacemaker 29. History of a known allergy to ribavirin (RBV), or any excipient in the investigational product, or history of drug or other allergy that, in the opinion of the investigator, mitigates against study participation | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, We Will Focus on Assessing the Clinical Performance of the BiliCare Device Parental informed consent Male and female newborns with a GA ≥ 35 wks Enrollment at age > 6 hrs until neonatal discharge Pre-phototherapy Infants requiring respiratory assistance (such as mechanical ventilation) Severe or life-threatening congenital anomalies Hematomas at the point of measurement on both ears Neonates undergone blood transfusion | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, We Will Focus on Assessing the Clinical Performance of the BiliCare Device Signed parental informed consent 2. Gestational Age >=24 weeks Less than 24 weeks of pregnancy at delivery 2. Bruising at the point of measurement on both ears 3. Birthmarks at the point of measurement on both ears 4. Hematomas at the point of measurement on both ears 5. Excessive Hairiness at the point of measurement on both ears 6. Neonate is during Phototherapy or has been exposed to phototherapy treatment during the last six hours | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cirrhosis Variceal Haemorrhage An acute oesophageal variceal bleed with haemostasis following initial endoscopy A diagnosis of liver cirrhosis Childs-Pugh score ≥8 Inability to control bleeding at index endoscopy (this is a "rescue TIPSS") Previous portosystemic shunt or TIPSS Bleeding from isolated gastric or ectopic varices Known portal vein thrombosis precluding TIPSS Active cancer including hepatocellular carcinoma Age less than 18 or more than 75 Clinically significant encephalopathy causing recurrent hospital admissions Pregnant at time of index endoscopy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Hepatic Encephalopathy Patients aged between 18 and 65 years of either gender Patients admitted to the hospital with liver cirrhosis and grade 3 or grade 4 (West Haven Criteria) HE Patients treated with lactulose retention enema within 48 hours of onset of grade 3 or 4 (West Haven Criteria) HE Patients treated with agents other than lactulose retention enema for grade 3 or 4 (West Haven Criteria) HE Patients who had significant concomitant diseases that could impair or contribute to the impairment of consciousness Patients who had a major neuropsychiatric illness Patients who had a contraindication to lactulose, including Hypersensitivity to the active substance or to any of the ingredients; Galactosaemia; Gastrointestinal obstruction, digestive perforation or risk of digestive perforation | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-75.0, Acute and Chronic Gastric Inflammation Patients Adult males/females aged 20~75 years Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents Subjects who voluntarily agree to participate in this clinical test with written consent Patients impossible gastroscopy In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded) Patients with malignant tumor on digestive organ Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Liver Cirrhosis Diagnosis of cirrhosis of any etiology Men and women between 18 and 70 years Right-holders of the Mexican Social Security Institute Patients who agree to participate in the study and signed the informed consent Recent history of alcohol abuse and/or drugs (less than 6 weeks) Illiterate Alcoholic cirrhosis History and/or diagnosis of overt hepatic encephalopathy Consumption of psychotropic medications (benzodiazepines, antiepileptics) Patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements History of chronic renal disease or heart failure Patients with gastrointestinal bleeding History of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests Diagnosis of bacterial overgrowth | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Cirrhosis Adults (18-60 years) of both sexes Signing the free and informed consent Show interest, conditions and availability to participate in all procedures included in the study protocol liver cirrhosis Carrier Refusal to participate Patients who have made liver transplantation Physical Amputation Swelling in the lower limb | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Tuberculosis for Patients with Hepatic Impairment (Groups 1-3): 1. Subject is able to give voluntary written informed consent before any study related procedure is performed. 2. 18-70 years of age, inclusive. 3. Acceptable laboratory values* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit Chemistry, complete blood count, AST, ALT, total bilirubin, alkaline phosphatase, albumin, and urinalysis deemed not clinically significant by the investigator. 4. Hepatic impairment classified as Child-Pugh class A (mild), B (moderate), or C (severe) at screening for Groups 1, 2, or 3, respectively, and documented evidence of hepatic cirrhosis*. *by biopsy, nuclear scan, CT, MRI, ultrasound, or other clinically acceptable methods 5. If female, not of childbearing potential* or agrees to avoid becoming pregnant by using acceptable contraception** during the duration of the study. *Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men. 6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control* In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #5, and abstinence from sexual intercourse with women. 7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit. 8. Willingness to comply with all protocol requirements. for Non-Hepatically Impaired Controls (Group 4): 1. Subject is able to give voluntary written informed consent before any study related procedure is performed. 2. 18-70 years of age, inclusive. 3. Subject is a healthy volunteer as determined by no clinically significant findings from medical history, physical examination, vital signs, and 12-lead ECG as determined by the Site Investigator. 4. Acceptable laboratory values* obtained at screening (within 21 days prior to admission to the confinement/hospital unit) and either at or within 72 hours of admission to the confinement/hospital unit. *Chemistry, complete blood count, AST, ALT, total bilirubin, alkaline phosphatase, albumin, and urinalysis within the reference range for the test laboratory, unless deemed not clinically significant by the investigator. 5. If female, not of childbearing potential* or agrees to avoid becoming pregnant by using acceptable contraception** during the duration of the study. *Non-childbearing potential is defined as being post-menopausal for at least 2 years, status after bilateral oophorectomy or status after hysterectomy. **Females of childbearing potential must agree to use two acceptable methods of contraceptives: bilateral tubal ligation; barrier method (condom) by the male partner (even if vasectomized); hormonal contraceptives; intrauterine contraceptive devices; diaphragm in combination with contraceptive jelly, cream, foam, or spermicide; and abstinence from sexual intercourse with men. 6. If subject is male and capable of reproduction, agrees to avoid fathering a child for three months after dosing by using an acceptable method of birth control*. *In addition to the use of a barrier method (condom) even if vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #5, and abstinence from sexual intercourse with women. 7. If the subject is female, a negative serum pregnancy test at screening and a negative urine pregnancy test at admission to the confinement/hospital unit. 8. Willingness to comply with all protocol requirements for Patients with Hepatic Impairment (Groups 1-3): 1. Hypokalemia (< 3.5mEq/L), severe hypomagnesemia (< 1.1 mg/dL) or severe hypocalcemia (< 7.5 mg/dL). 2. AST or ALT > 10 times the upper limit of normal. 3. Creatinine clearance < 60 ml/min. 4. Inability to swallow tablets. 5. Presence of any condition or finding* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments**. *in the opinion of the site investigator **e.g., inability to draw PK samples 6. History of fever or documented fever (oral temperature > / = 100.4 degrees F or > / = 38.0 degrees C) in the 48 hours prior to admission to the the confinement/hospital unit. 7. Currently breastfeeding. 8. History of chronic tobacco/nicotine use (> 10 cigarettes per day for 3 months minimum prior to admission). 9. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors). 10. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening. 11. Use of any over the counter (OTC) medication* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *including vitamins and herbal supplements, cough and cold medications. **in the opinion of the site investigator 12. Treatment with CYP450 enzyme altering drugs* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *except hormonal contraceptives **in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section. 13. Treatment with any drugs* known to prolong the electrocardiographic QT interval within 15 days prior to admission to the confinement/hospital unit.. *Including excessive chronic caffeine (> six 8 oz cups of brewed coffee daily or > 3 energy drinks daily), theophylline (> 600 mg/day), or ephedrine (> 300 mg/day) use. 14. A positive blood screen for HIV. 15. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse* at screening and at admission to the confinement/hospital unit Amphetamines, barbiturates, cocaine metabolites, marijuana, opiates, phencyclidine (PCP). NOTE: Results of the urine screen test can be ignored if in the opinion of the PI the results can be explained by the concomitant medications history. 16. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weight lifting, competitive sports) during the course of the study. 17. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12. 18. A QTcF interval > 440 msec (males) or > 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval. 19. A family history* of Long QT Syndrome, premature cardiac death**, or sudden death without a preceding diagnosis of a condition*** that could be causative of sudden death. *parents **due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women) ***such as known coronary artery disease, congestive heart failure, or terminal cancer 20. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit. 21. Donation of > 500 mL blood within the 30 days prior to admission to the confinement/hospital unit. 22. Plans to donate blood during the study or up to 14 days after dosing. 23. Persons with a transjugular intrahepatic portosystemic shunt for Non-Hepatically Impaired Controls (Group 4): 1. Inability to swallow tablets. 2. Presence of any condition or finding* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments**. *in the opinion of the site investigator **e.g., inability to collect PK samples 3. History of fever or documented fever (oral temperature > / = 100.4 degrees F or > / = 38.0 degrees C) in the 48 hours prior to admission to the confinement/hospital unit. 4. Currently breastfeeding. 5. History of chronic tobacco/nicotine use (> 10 cigarettes per day for 3 months minimum prior to admission to the confinement/hospital unit). 6. History of seizures (other than febrile seizures during childhood) or known or suspected CNS disorders that may predispose to seizures. 7. History of clinically significant allergy or severe side effects with nitroimidazoles (e.g., Metronidazole and related substances and azole antifungals or aromatase inhibitors). 8. Receipt of an investigational drug, vaccine or biologic in a clinical trial within 30 days prior to screening. 9. Use of any over the counter (OTC) medication* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *including vitamins and herbal supplements, antacids, cough and cold medications. **in the opinion of the site investigator 10. Use of prescription medication except hormonal contraceptives within 30 days prior to admission to the confinement/hospital unit, unless* the substance would not likely impact study result validity. *in the opinion of the site investigator 11. Treatment with CYP450 enzyme altering drugs* within 7 days prior to admission to the confinement/hospital unit, unless** the substance would not likely impact the validity of the study results. *except hormonal contraceptives **in the opinion of the site investigator NOTE: See list of CYP450 enzyme altering drugs under the concomitant medications section. 12. Treatment with any drugs* known to prolong the electrocardiographic QT interval within 15 days prior to admission to the confinement/hospital unit. *Including excessive chronic caffeine (> six 8 oz cups of brewed coffee daily or > 3 energy drinks daily), theophylline (> 600 mg/day), or ephedrine (> 300 mg/day) use. 13. A positive blood screen for HIV. 14. A positive blood screen for hepatitis B surface antigen (HBsAg), or hepatitis C antibody. 15. A positive alcohol breath test (or other suitable test for alcohol) or a urine screen test for drugs of abuse* at screening and at admission to the confinement/hospital unit. *Amphetamines, barbiturates, benzodiazepines, cocaine metabolites, marijuana, opiates, phencyclidine (PCP). 16. A history of alcohol abuse or dependence within the past 1 month prior to admission to the confinement/hospital unit. 17. Unwillingness to abstain from engaging in strenuous physical activity (e.g. running, bicycling, weight lifting, competitive sports) during the course of the study. 18. Consumption of grapefruit juice in the 48 hours before admission to the confinement/hospital unit, or the inability to abstain from these until completion of Day 12. 19. A QTcF interval > 440 msec (males) or > 450 msec (females) at screening (Visit 00A) or admission to the confinement/hospital unit (Visit 00B) or a history of prolonged QTc interval. 20. A family history* of Long QT Syndrome, premature cardiac death**, or sudden death without a preceding diagnosis of a condition*** that could be causative of sudden death. *parents **due to ischemic heart disease or sudden cardiac death before 55 years of age (men) or 65 years of age (women) ***such as known coronary artery disease, congestive heart failure, or terminal cancer 21. Any clinically significant ECG abnormality, in the opinion of the site investigator, at screening and at admission to the confinement/hospital unit. 22. Donation of > 500 mL of blood within the 30 days prior to admission to the confinement/hospital unit. 23. Plans to donate blood during the study or up to 14 days after dosing. 24. Persons with a transjugular intrahepatic portosystemic shunt | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-90.0, Chronic Hepatitis C Cirrhosis Portal Hypertension Age 18 to 90 years History of chronic hepatitis C infection Compensated advanced chronic liver disease (Baveno VI definition) Baseline liver stiffness ≥15 kPa or Baseline liver stiffness 10-15 kPa and one of the following: platelet count <150x10e9/L, spleen size ≥13 cm, nodular liver or collateral circulation in abdominal ultrasound, HVPG >5 mmHg, upper gastrointestinal endoscopy showing gastroesophageal varices or previous liver biopsy showing bridging fibrosis or cirrhosis Indication to start antiviral treatment with new oral drugs Willingness to enter the study Sign the informed consent Chronic liver disease due to other etiology than HCV Terminal illness Treatment with interferon Liver stiffness measurement < 10 kPa at baseline | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-999.0, Cerebrovascular Diseases Stroke Cardiovascular Diseases CVD Risk Factors At high risk of stroke Already suffered a stroke or Transient Ischemic Attack (TIA) or At least two risk factors for stroke High blood pressure Overweight Low physical activity Smoking Unhealthy diet Inability to fill out or to understand the informed consent No signed informed consent Dementia | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.673-999.0, Transcutaneous Bilirubinometry Parental informed consent 2. Male and female newborns with a GA ≥ 35 wks 3. Enrollment at age > 6 hrs until neonatal discharge 4. Pre-phototherapy Infants requiring respiratory assistance (such as mechanical ventilation) 2. Severe or life-threatening congenital anomalies 3. Hematomas at the point of measurement on both ears 4. Neonates undergone blood transfusion | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Upper Gastrointestinal Bleeding Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy UGIB with fresh hematemesis requiring urgent endoscopy dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery presence of an electromedical device (pacemaker or internal cardiac defibrillator) altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent Allergy to Maxolon Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 15.0-79.0, Liver Failure, Acute on Chronic inpatient (hospitalization >1 days)(including patient in emergency observation wards) chronic liver disease patients including non-alcoholic fatty liver disease patients,chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients and decompensated cirrhosis patients having acute liver injury [ALT(alanine aminotransferase)>3NL(normal level),AST(aspartate aminotransferase)>3NL or TB(total bilirubin)>2NL within 1 week before enrollment] or acute decompensation[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB>5NL)within 1 month] pregnancy hepatocellular carcinoma or other liver malignancies malignancy of other organs severe chronic extrahepatic disease including chronic obstructive pulmonary disease combined with respiratory failure, coronary heart disease with cardiac function level 3 (NYHA), myocardial infarction in the 3 months before admission, diabetes with severe complications and chronic kidney disease with end-stage renal failure receiving immunosuppressive drugs for reasons other than chronic liver disease | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Encephalopathy, Hepatic Age 18-70 years Cirrhosis, defined by a combination of any of the following Laboratory findings Endoscopic results Ultrasound Histology Overt hepatic encephalopathy • Creatinine>1.5 mg/dl Alcohol use within prior 4 weeks Non-hepatic metabolic encephalopathy Hepatocellular carcinoma Degenerative CNS disease Any significant psychiatric illness or other medical comorbidity | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Cirrhosis With Esophageal Varices All patients of chronic liver disease with esophageal varices. 2. Age more than and equal to 18 years Patients of chronic liver disease with history of upper Gastro Intestinal bleed. 2. Patients of acute on chronic liver failure 3. Thrombosis of splenoportal axis 4. Hepatocellular carcinoma 5. Patients who were on primary variceal ligation sessions as prophylaxis 6. Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia). 7. Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial Peritonitis) , HRS(Hepato Renal Syndrome)}. 8. Failure to give consent for in the study | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Bleeding Esophageal Varices Cirrhosis Cirrhotic patients requiring β blocker in primary prophylaxis of bleeding esophageal varices Patients under 18 year's old life expectancy of less than one month Patient already has a vasoactive treatment patient with CHC or portal vein thrombosis patient without social security or deprived of freedom contraindication to MRI contraindication to beta-blockers mental state does not allow the signing of an informed consent | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 25.0-75.0, Esophageal Diseases Men only who are referred for upper endoscopy for the first time.Or who have had normal upper endoscopy in the last 10 years 2. Age 25-75 years in age 3. Patients undergoing EGD and willing to also consent to tissue biopsy, blood work and CT scan. 4. ECOG PFS 0-1 Unstable medical condition, such as uncontrolled diabetes mellitus or hypertension or active infections requiring systemic therapy 2. Clinical evidence of cardiac or pulmonary dysfunction including, but not limited to, unstable congestive heart failure, uncontrolled arrhythmias, unstable coagulation disorders, or recent myocardial infarction (within 6 months) 3. Documented history of erosive esophagitis or non-erosive esophageal luminal. No prior history of Barrett's esophagus | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatitis C For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Patients chronically infected with HCV Genotype 1b No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent HCV RNA viral load ≥ 10,000 IU/mL at screening Seronegative for HIV and HBsAg BMI of 18-35 kg/m2, inclusive Patients with compensated cirrhosis are permitted Infection with HCV other than genotype (GT) -1b Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy Evidence of a medical condition contributing to chronic liver disease other than HCV Diagnosed or suspected hepatocellular carcinoma or other malignancies Uncontrolled diabetes or hypertension History of moderate to severe depression. Well-controlled mild depression is allowed Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN) Confirmed platelet count < 50,000 cells/mm3 Confirmed hemoglobin < 8.5 g/dL | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 65.0-999.0, Orthostatic Hypotension years or older For postural hypotension group: >20mmHg systolic BP drop or >10mmHg diastolic BP drop on standing, and syncopal symptoms on standing For control group: no fall in BP or <20mmHg systolic BP drop and <10mmHg diastolic BP drop on standing, and no syncopal symptoms on standing. No previous diagnosis of orthostatic hypotension On warfarin Unable to consent Unable to stand unaided | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cirrhosis Portal Hypertension Diagnosis of liver cirrhosis (based on clinical, biochemical and radiological with or without liver biopsy) Presence of esophageal varices at high risk of bleeding Hepatic Venous Pressure Gradient > 12 mmHg age ≤75 Informed Consent Patients already treated with beta blockers Treatment with systemic antibiotics and/or non-absorbable intestinal antibiotics in the previous two weeks Bacterial infection, spontaneous bacterial peritonitis overt hepatic encephalopathy in the last week active gastrointestinal bleeding, or in the last week active alcoholism or drug abuse in last 3 weeks Acute Alcoholic Hepatitis Hepatocellular carcinoma or other neoplasm significant coronary artery disease (angina NYHA III/IV), congestive heart failure (NYHA III/IV), relevant cardiomyopathy, history of myocardial infarct within the last 12 months Contraindications to the administration of beta blockers; allergy to Rifaximin | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-60.0, Minimal Hepatic Encephalopathy Truck drivers with liver cirrhosis and minimal hepatic encephalopathy Overt hepatic encephalopathy Sensory or motor deficits; neurological causes of impaired cognition Electrolyte imbalances (serum sodium level <125 mmol/L; serum calcium level >10 mg per /DL and potassium level <2.5 mmol/L) Ongoing systemic illnesses, intercurrent infection or active spontaneous bacterial peritonitis Recent history (< 6 weeks) of alcohol intake Patients on drugs affecting psychometric performances Recent (<6 weeks) intake of antibiotics for gastrointestinal bleeding, history of shunt operation or trans jugular intrahepatic portosystemic shunt for portal hypertension Chronic renal impairment (creatinine level >2.0 mg per/ DL Patients with color blindness, mature cataract and diabetic retinopathy Hepatocellular carcinoma, or other comorbidities such as congestive heart failure and pulmonary disease | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Gastritis, Atrophic Helicobacter-associated chronic gastritis Hypochlorhydria Hypergastrinemia Hypopepsinogenemia Active peptic ulcer disease Other inflammatory gastrointestinal disease Gastrointestinal bleeding Gastrointestinal surgery Neurological disease Alcohol abuse Mental disorder Not able to sign informed consent | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Chronic Delta Hepatitis Key 1. Male or female, 18 to 65 years of age, inclusive 2. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6 months duration and detectable HDV RNA by qPCR at study entry 3. Liver biopsy demonstrating evidence of chronic hepatitis 4. Willingness to practice appropriate contraception Key Previous use of lonafarnib 2. Co-infected with HIV or HCV 3. Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have Gilbert's disease 4. Decompensated liver disease or cirrhosis, history of bleeding esophageal varices, ascites, or hepatic encephalopathy 5. Serum creatinine concentration ≥1.5 times upper limit of normal (ULN) 6. Evidence of another form of viral hepatitis or another form of liver disease 7. Evidence of hepatocellular carcinoma 8. Use of alpha interferon, either interferon alfa-2a or interferon alfa-2b, or pegylated interferon alfa-2a within 2 months before the start of screening 9. Concomitant use of any of the following: 1. Medications or foods that are known moderate or strong inducers or inhibitors of CYP3A4 or CYP2C19 2. Drugs known to prolong the PR or QT interval 3. Receipt of systemic immunosuppressive therapy within the 3 months before start of screening 4. Statins, due to inhibition of mevalonate synthesis, which reduces protein prenylation 5. Medications contraindicated in the prescribing information for ritonavir | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-99.0, Chronic Hepatitis C chronic hepatitis C Genotype 1-4 acute hepatitis C | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, End Stage Liver Disease NASH - Nonalcoholic Steatohepatitis NAFLD - Nonalcoholic Fatty Liver Disease Age 18 years of above, male or female ESLD patients with clinically diagnosed NAFLD or NASH Absence of any other possible cause for liver dysfunction Stable MELD score of at least 8, but no greater than 15 over the past 6 months (+/ month) prior to enrollment Able to speak and understand English Willing and able to provide informed consent Willing and able to return for regularly scheduled research study visits & comply with study requirements Rapid deterioration of liver function, over the past 6 months (+/ month) prior to enrollment per study physician determination Hepatocellular carcinoma Positive HIV/ AIDS, or other chronic immunodeficiency Concurrent hepatitis A or B infection Current drug and/or alcohol abuse (per treating physician) Bacterial infection at time of enrollment Daily use of dedicated vitamin E supplementation within the 12 months prior to study participation Platelets <25,000 cells/µL, neutrophils <1000 cells/µL, hemoglobin <8g/dL, total bilirubin >3mg/dL, serum creatinine >2.0mg/dL Women who are pregnant, breastfeeding, or plan to become pregnant during course of study participation (36 months) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Liver Cirrhosis Esophageal and Gastric Varices A diagnosis of liver cirrhosis. 2. Age and sex are not limited. 3. Etiology of liver cirrhosis is not limited. 4. Routine laboratory data. 5. Upper gastrointestinal endoscopy Non-cirrhotic portal hypertension. 2. Malignancy. 3. Absent laboratory data. 4. A previous diagnosis of esophageal varices. 5. A previous history of variceal bleeding | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Hepatitis C, Chronic Cirrhosis, Decompensated Treatment-naïve and treatment-experienced patients with CHC genotype 1 infection and decompensated cirrhosis as defined by one of the following history of variceal bleeding presence or history of ascites history of grade III-IV hepatic encephalopathy Coagulopathy with an INR>1.7 Jaundice with a serum bilirubin of >85µmol/L Cirrhosis is defined as any one of the following A liver biopsy performed prior to the study showing cirrhosis (F4) Fibroscan performed within 12 calendar months of the start of this study with a result of > 12.5 kPa A Fibrotest ® score of >0.75 Patients older than 75 years Presence of hepatoma at entry Patients awaiting living-related liver transplantation MELD score of >30 Significant co-morbid condition(s) with a life expectancy of <6 months HIV co-infection HBV co-infection | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-1.0, Hemorrhage Premature Infants Newborn Hydrocephalus GM-IVH group: for GM-IVH group: born at gestational age (GA) 24-32 weeks; < 3 months old corrected-GA (cGA) at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade I-III IVH diagnosed by clinical cranial ultrasound or magnetic resonance imaging (MRI) for GM-IVH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than GMH-IVH; central nervous system (CNS) infection. 2. PHH group: for PHH group: born at gestational age (GA) 24-37 weeks < 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial ultrasound or MRI for PHH group: chromosomal abnormalities known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; congenital hydrocephalus; brain lesions that affect cerebral brain metabolism, other than IVH-PHH; CNS infection. Implanted devices or other devices that preclude the use of MRI. 3. HC group: for HC group: born at gestational age (GA) 24-32 weeks; < 3 months old cGA at first measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks age (PMA); Apgar >7 at 5 min for HC group: any clinical indication of brain injury or congenital brain malformation; chromosomal abnormality known at the time of enrollment; known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. 4. VC group: for VC group: < 12 months old cGA at first measure or eligible for measurement within 1 year after the infant reaches 40 weeks age (PMA). Symptomatic hydrocephalus of any etiology or at high risk of developing hydrocephalus of any etiology, except post-hemorrhagic etiology; characterized by abnormal rate of head growth and full anterior fontanelle. Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH for VC group: known or suspected metabolic disorder or neoplasm; critical congenital heart disease; CNS infection. Implanted devices or other devices that preclude the use of MRI | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Liver Dysfunction Subjects with hepatic impairment 1. male or female aged 18 to 70 years； 2. has a body mass index of 17 to 30 kg/m2； 3. eGRF>50ml/min/1.73m2； 4. Patients in stable condition with moderate impaired hepatic function, due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis or other causes, and determined to be level B according to Child-Pugh classification； 5. B-ultrasonography, CT or MRI shows or biopsy confirm that have a positive diagnosis of cirrhosis ； 6. Has stable regimen of treatment of hepatic function impaired for 3 months prior to enrollment; 7. Female volunteers must meet: 1. Has sterilization operation, or who are postmenopausal must have been postmenopausal for >1 year, or 2. Has childbearing potential, but meet the requirement as following: Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding; 8. Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (7) above) during the study and through 1month after the end of study； 9. Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea, chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine； 10. Can sign informed consent form on his own accord； 11. Can comply with study procedures Healthy subjects without hepatic impairment 1. Male or female volunteers (matched to a subject with hepatic impairment in gender）； 2. Aged 18 to 70 years (matched to a subject with hepatic impairment±5 years, matched range cannot exceed±5 years)； 3. Has a body mass index of 17 to 30 kg/m2（matched to a subject with hepatic impairment±15%，matched range cannot exceed±15%）； 4. Must be in good health as determined by screening medical history, physical examination, vital signs, laboratory test, B ultrasonography and chest X ray； 5. Female volunteers must meet: 1. Has sterilization operation, or who are postmenopausal must have been postmenopausal for >1 year, or 2. Has childbearing potential, but meet the requirement as following: Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1month after the end of the study, and Non-breastfeeding； 6. Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (7) above) during the study and through 1month after the end of study； 7. Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea, chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine； 8. Can sign informed consent form on his own accord； 9. Can comply with study procedures Subjects with hepatic impairment 1. Has known or suspected allergies to quinolones, fluoroquinolones, Nemonoxacin or excipients or allergic constitution； 2. Has acute disease or chronic disease which may affect PK profile of drug in vivo except the disease caused hepatic function impaired； 3. Has abnormal result of laboratory tests with clinical significance except which caused by the disease of hepatic function impaired； 4. Has history of clinically significant cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, renal, endocrine disease prior to study within 1 year； 5. Has disease seriously affect the immune system such as hematological disease, malignant tumor, or taking immunosuppressant； 6. Has acute or sub-acute hepatic function failure； 7. Has experienced esophageal variceal bleeding within the past 6 months； 8. Has advanced ascites or spontaneous bacterial peritonitis； 9. Has a history of Gilbert's disease； 10. Has resistance or liver function abnormal after orally taking nucleoside analogue, an antiviral drug； 11. Stop taking nucleoside analogue, an antiviral drug within 1 year； 12. Has total bilirubin>3×upper limit of normal (ULN) and without cholestasis; alkaline phosphatase (ALP)>2×ULN； 13. Alanine Aminotransferase (ALT)or Aspartate Aminotransferase（AST）>5×ULN； 14. ALT or AST>3×ULN with total bilirubin>2×ULN； 15. international senstibity index，INR≥1.5 or prothrombin time activity≤40%； 16. Child-Pugh assessed as C level； 17. Has a history of alcoholism within 2 years prior to dosing; drink≥12 times within 3 months prior dosing; alcohol test positive as screening； 18. Has history of drug misuse within 2 years prior to dosing; urine drug screen positive； 19. Has history of taking products of tobacco or nicotine more than 5 cigarettes/day within 1 month prior to dosing, or cannot stop smoking during the study; 20. Use of another investigational drug or drug which can damage hepatic function within 3 months prior to dosing； 21. Use of drugs affect function of liver metabolism enzyme (e.g. benzene, isopropyl amine, the barbiturates benzodiazepines, marijuana, cocaine, opiates and phencyclidine) within 30 days prior to dosing ； 22. Has to take the drug which may affect the PK profile of investigate drug (e.g. antacids, sucralfate, metal cation, calcium supplements, warfarin, non-steroidal anti-inflammatory drugs, theophylline, cyclosporine, probenecid and cimetidine) ； 23. Has gastrointestinal disease or malabsorption syndrome affecting drug Absorb； 24. Has history of seizures or central nervous system disease which the investigator considers to interfere with compliancy of protocol; or has risk of suicide； 25. Clinical significant abnormal 12-lead electrocardiograms (ECGs) at screening (eg. atrioventricular block, torsades de pointes ventricular tachycardia (TdT), and other types of ventricular tachycardia, ventricular fibrillation, ventricular flutter, T wave change with clinical significance or any abnormal results of 12-lead ECG which affect QTc interphase) ； 26. HIV or syphilis RPR test positive； 27. Conditions investigator consider not suitable to be enrolled in the study. Healthy subjects without hepatic impairment 1. Has known or suspected allergies to quinolones, fluoroquinolones, nemonoxacin or excipients or allergic constitution； 2. Has a history of alcoholism within 2 years prior to dosing; drink≥12 times within 3 months prior dosing; alcohol test positive as screening； 3. Has history of drug misuse within 2 years prior to dosing; urine drug screen positive； 4. Has history of taking products of tobacco or nicotine more than 5 cigarettes/day within 1 month prior to dosing, or cannot stop smoking during the study； 5. Donated blood or use of another investigational drug within 3 months prior to dosing； 6. Has history of chronic liver, renal, cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, urinary, endocrine disease cannot controlled by drugs； 7. Use of drugs affect function of liver metabolism enzyme within 30 days prior to dosing; or need to take medications which may affect the PK profile of investigational drug (including: products containing Calcium, aluminum, magnesium, iron and zinc, sucralfate, antacid, nutrition supplements, Vitamins and metal supplements) during the study； 8. Is taking any antibacterial agents or prophylaxis or treatment drugs； 9. HIV-Ab, HBsAg ,HCV-Ab or syphilis RPR positive； 10. Clinical significant abnormal 12-lead electrocardiograms (ECGs) at screening (eg. atrioventricular block, torsades de pointes ventricular tachycardia (TdT), and other types of ventricular tachycardia, ventricular fibrillation, ventricular flutter, T wave change with clinical significance or QTc>450ms) ； 11. Has abnormal result of laboratory test with clinical significance assessed by investigator at screening； 12. Has gastrointestinal disease or malabsorption syndrome affecting drug Absorb； 13. Has history of seizures or central nervous system disease which the investigator considers to interfere with compliancy of protocol; or has risk of suicide； 14. Has any antibacterials, glucocorticoids, immunosuppressive agents or drug may damage organs within 14 days prior to dosing； 15. Cannot orally take drug； 16. Has history of or currently has disease and condition may affect the safety and efficancy assessment of investigational drug judged by investigator； 17. Is a member of the clinical site personnel directly affiliated with this study； 18. Conditions investigator consider not suitable to be enrolled in the study | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Hepatic Encephalopathy Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of Health Related Quality of Life (HRQOL) Patients willing to provide written authorization to provide data for the study Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Portal Hypertension Diagnosis of cirrhosis based on history, physical examination, laboratory tests, ultrasound scans and liver biopsy in some occasion Hepatocellular carcinoma Portal vein thrombosis Parenteral drug addiction | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatitis C HIV Male and females ≥18 years Documented HIV infection Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA Absence of advanced liver disease or clinical signs of extra-hepatic disease F0-F2 (< 9,5 kPa) established by transient elastography, and No clinical signs of extra-hepatic disease Not on HCV antiviral treatment Currently on/or history of hepatitis C treatment Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography) Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in this study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 21.0-75.0, Hepatic Encephalopathy Cirrhosis Cirrhosis diagnosed by either of the following in a patient with chronic liver disease Liver Biopsy Radiologic evidence of varices, cirrhosis or portal hypertension Laboratory evidence of platelet count <100,000 or AST/ALT ratio>1 Endoscopic evidence of varices or portal gastropathy At least two episodes of hepatic encephalopathy, one within the last year but not within the last month (patient can be on lactulose and rifaximin) Age between 21 and 75 Able to give written, informed consent (demonstrated by mini-mental status exam>25 at the time of consenting) MELD score >17 WBC count <1000 cells/mm3 Platelet count<50,000/mm3 On the liver transplant list TIPS in place No HE episode within a month prior to the study Patients allergic to ciprofloxacin, penicillins or metronidazole Currently on absorbable antibiotics Infection at the time of the FMT (diagnosed by blood culture positivity, urinalysis, paracentesis as needed) Hospitalization for any non-elective cause within the last 3 months | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Gastroesophageal Varices Cirrhosis Patients with cirrhosis diagnosed by histology, radiological evidence of cirrhosis, and endoscopic evidence of varices Patients with a previous history of variceal hemorrhage Patients admitted to Zhongshan Hospital and other 6 tertiary centers in Shanghai from Dec 1, 2015 to Sep 31,2018 Patients already taken secondary prophylactic treatment including endoscopic, pharmacological, surgical and interventional therapies Patients with severe systemic diseases such as chronic heart failure or chronic renal failure that will have impact on survival Patients in pregnancy and lactation Patients already diagnosed with hepatic cellular carcinoma or other malignant tumors Patients with contraindication to treatment of endoscopy, surgery and TIPS: severe coagulation defects, allergic to contrast medium used in TIPS, hepatic encephalopathy, spontaneous bacterial peritonitis Patients with conditions that will influence the accuracy of HVPG measurement: Cavernous transformation of portal vein, diffused portal vein thrombosis, severe shunt Patients refuse to give consent to the study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Cirrhosis Aged between 18 and 75 years of both sexes Clinical and / or laboratory ultrasound and / or liver biopsy compatible with the diagnosis of viral cirrhosis (If hepatitis B virus: hepatitis B virus-DNA must be negative; if hepatitis C virus: sustained virologic response should be at least for 6 months prior to enrollment); alcohol (in the last 6 months: in men less than 60 g daily intake in women less than 40 g); nonalcoholic steatohepatitis and cryptogenic Presence of clinically significant portal hypertension defined by clinical (presence of esophageal varices or ascites), elastography (liver Fibroscan® ? 21 kPa) or hemodynamic (Hepatic venous pressure gradient > 10 mmHg) Mild to moderate hepatic impairment defined by Child-Pugh of 7-10 points Written informed consent to participate in the study Any previous or current thrombosis in splenoportal axis (must be ruled out by US-Doppler earlier than one month after randomization; if doubts: computed tomography angiography or magnetic resonance angiography if required) Background of hepatic encephalopathy grade II or higher Ascites that required prior practice of paracentesis in the last year d. Indication for use of anticoagulant and / or antiplatelet therapy for any reason Hypersensitivity to the active ingredient or to excipients Active bleeding, clinically significant, or risk of major bleeding Pregnancy and lactation Hepatocellular carcinoma or malignant neoplasia at the time of inclusion Any comorbidity involving a therapeutic limitation and/or a life expectancy <12 months Existence of risk bleeding esophageal varices or prior variceal bleeding. They may not be included until full treatment (stable beta blockers dosage or eradication trough varices ligation) Pregnancy or lactation | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Ascites Cirrhosis of any etiology with grade 2 ascites including refractory patients and varices/variceal hemorrhage requiring prophylaxis 2. Cirrhosis diagnosed by clinical, analytical, and ultrasonographic findings or available histological findings 3. Both inpatient and outpatient 4. Child B or C status 1. Active infection or recent infection < 2 weeks 2. Hepatic encephalopathy grade 2 or higher 3. Renal dysfunction at the time of 4. Presence of hepatocellular carcinoma or portal vein thrombosis 5. Active alcoholism 6. Pregnancy 7. HIV infection 8. Severe heart, respiratory or contraindications for beta blockers(severe chronic obstructive pulmonary disease, severe asthma, severe insulin-dependent diabetes mellitus, bradyarrhythmia) 9. Not giving consent | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 4.0-99.0, Methicillin-Resistant Staphylococcus Aureus Cystic Fibrosis Male or female with a confirmed diagnosis of CF (clinical features and positive sweat test and/or identification of 2 CF disease causing mutations). 2. At least 4 years of age or older. 3. Chronic infection with MRSA defined as having had MRSA positive respiratory cultures for > 1 year with ≥ 50% of cultures being MRSA positive e.g. 2/4 of the most recent cultures grew MRSA. 4. Being able to expectorate sputum on a consistent basis, i.e. also at the end of IV therapy. 5. Having a pulmonary exacerbation defined for this protocol as the decision of the treating physician to start IV therapy in hospital or at home. Typically this occurs when there has been a >5% drop in FEV1 % predicted compared to the patient's baseline and increased respiratory symptoms. NOTE: Patients who had oral or inhaled antibiotics with or without MRSA activity but failed this outpatient therapy i.e. are changed to IV anti-MRSA antibiotics are allowed to participate.(Example: was on oral doxycycline and on admission changed to ceftaroline = eligible. On oral doxycycline that is continued on admission = not eligible) Patient enrollment should be prioritized to those receiving IV vancomycin or ceftaroline, with secondary consideration of patients who receive oral anti-MRSA therapy (TMP-SMX or a tetracycline derivative) that was initiated on hospital admission Patients on linezolid will not be included as this medication is given orally and IV and may confound analyses Presence / infection with B. cepacia genomovar III (=B. cenocepacia). Subjects who have undergone lung or liver transplant in the past (NOTE: patients listed for transplant are eligible) 2. Concomitant participation and/or use of an investigational drug within 30 days of this study. 3. Concomitant observational studies are allowed with TRI-STAR, if approved by the other study investigator or their proxy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Multiple Myeloma Subjects must satisfy the following to be enrolled into the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF) 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements 4. Subject must have documented diagnosis with previously untreated (for cohort C, the induction and consolidation treatment along with the first autologous stem cell transplantation (ASCT) are allowed), symptomatic multiple myeloma (MM) as defined by the below: MM diagnostic (all 3 required) Monoclonal protein present in the serum and/or urine Clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma Any one or more of the following myeloma defining events: 1. one or more of the following Myeloma-related organ dysfunction (at least one of the following) (C) Calcium elevation (serum calcium >11.5 mg/dl )(>2.65 mmol/L) (R) Renal insufficiency (serum creatinine >2 mg/dl)(177 µmol/L or more) or creatinine clearance < 40 ml/min (A) Anemia (hemoglobin <10 g/dL or >2 g/dL below the lower limit of laboratory normal) (B) Bone lesions (lytic or osteopenic) one or more bone lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-computed tomography (PET-CT) 2. one or more of the following biomarkers of malignancy Clonal bone marrow plasma cell percentage ≥60% Abnormal serum free light-chain ratio ≥100 (involved kappa) or < 0.01 (involved lambda) The presence of any of the following will a subject from enrollment: 1. Previous treatment with anti-myeloma therapy (does not radiotherapy, bisphosphonates, or a single short course of steroid (ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1), for Cohort C, the induction and consolidation treatment along with the first Autologous stem cell transplantation (ASCT) are allowed) 2. Any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) < 1,000/μL 2. Untransfused platelet count < 75,000 cells/μL 3. Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) > 2.5*upper limit of normal (ULN) 4. Serum total bilirubin > 1.5*ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome 5. Corrected serum calcium >13.5 mg/dL (> 3.4 mmol/L) 3. Renal failure requiring hemodialysis or peritoneal dialysis 4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, subject with unstable cardiac disease as defined by: cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment 5. Peripheral neuropathy ≥ Grade 2 6. Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis 7. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years with the exception of the following non-invasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative 8. Subjects is positive for human immunodeficiency virus (HIV); chronic or active hepatitis B or active hepatitis A, or C 9. Subject had prior exposure to immunotherapy, including, but not limited to, other anti CTLA-4,anti-PD-1, anti-PD-L1 monoclonal antibody or inhibitor, cell-based therapies, or cancer vaccines 10. Subjects has history of organ or allogeneic stem cell transplantation 11. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma, or plasma cell leukemia 12. Known or suspected hypersensitivity to the excipients contained in the formulation of durvalumab, lenalidomide, or dexamethasone 13. Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment 14. Received prior treatment (for any reason)with a monoclonal antibody within 5 half-lives of initiating study treatment 15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment 16. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection); 2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent; 3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography (CT) scan premedication); 17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis); myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: 1. Subjects with vitiligo or alopecia; 2. Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or 3. Subjects with psoriasis not requiring systemic treatment; 18. History of primary immunodeficiency 19. Subject has incidence of gastrointestinal disease that may significantly alter the absorption of LEN 20. Receipt of live, attenuated vaccine within 30 days prior to the first dose of durvalumab 21. Unable or unwilling to undergo protocol required thromboembolism prophylaxis(for Cohort C, this will be only for the subjects who have a history of VTE) 22. Females who are pregnant, nursing or breastfeeding, or intend to become pregnant during the participation to the study 23. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 24. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 25. Any condition that confounds the ability to interpret data from the study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Gastrointestinal Diseases Patients aged 18 years and over Patients presenting with haematemesis (fresh blood or coffee grounds) and/or malaena within the previous 48 hours, who require a gastroscopy as part of their diagnostic investigations Patients under the age of 18 years or over the age of 80 years Patients who have a suspected UGIB and haemodynamic instability, i.e. hypotension (systolic blood pressure <100mmHg) and tachycardia (>100 bpm), requiring urgent resuscitation Pre-endoscopy Rockall score >4 (patients with a lower pre-endoscopy Rockall score but haemodynamically unstable will still be excluded) Active vomiting or haematemesis Patients with a permanent pacemaker, implantable cardioverter-defibrillator or device Patients with any electronic/magnetic/mechanically controlled devices e.g. sacral nerve stimulators, bladder stimulators Patients with dysphagia, odynophagia or known swallowing disorder Patients with known Zenker's diverticulum Patients with suspected bowel obstruction or bowel perforation Patients with prior bowel obstruction | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Liver Cirrhosis Esophageal and Gastric Varices the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation age greater than 80 years old or younger than 18 years old non-cirrhotic portal hypertension contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on ABPsys less than 95 mmHg or HR less than 50 bpm prior treatment for prevention of bleeding from EGV presence of spontaneous bacterial peritonitis or other severe infections presence of hepatorenal syndrome uncontrolled hepatic encephalopathy presence of refractory ascites pregnancy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Esophageal and Gastric Varices acute or recent bleeding from esophageal varices; 2. portal hypertension caused by cirrhosis; 3. age between 18 and 80 yr history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices; 2. presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL; 3. presence of hepatocellular carcinoma or other malignancy; 4. an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness; 5. history of gastric variceal bleeding; 6. encephalopathy of stage II or worse; 7. failure to control initial variceal bleeding; 8. death within 48 h of admission; 9. refusal to participate in the trial | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 2.0-999.0, Chronic Gastritis Caused by Helicobacter Pylori Patients with gastritis or gastric ulcer who are positive to H. pylori People allergic to egg proteins | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-80.0, Esophageal Varices Age of 20 to 80 years Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy Stable hemodynamic condition for at least 3 days after banding ligation Hepatocellular carcinoma or other malignancy Stroke or active sepsis Chronic kidney disease under renal replacement therapy Contraindications to non-selective beta-blockers A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery Serum total bilirubin >10 mg/dL Grade III/IV hepatic encephalopathy Refractory ascites Hepato-renal syndrome Pregnancy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatitis B Hepatitis B, Chronic Age at least 18yrs CBCHB employee or spouse of an employee Able to provide written informed consent Willing to comply with follow-up visits None | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 21.0-999.0, Chronic Atrophic Gastritis PRE-REGISTRATION Ability to understand and the willingness to sign a written informed consent document Willingness to undergo screening tests and procedures Willingness to provide blood and tissue samples for safety/toxicity monitoring and biomarker analyses Willingness to avoid the use of curcumin or any over-the-counter or prescription medications containing curcumin or curcuminoids Histologically-confirmed chronic multifocal atrophic gastritis (MAG) and/or gastric intestinal metaplasia (GIM) Helicobacter pylori negative, defined as negative stool antigen testing and negative histological examination Eastern Cooperative Oncology Group (ECOG) performance status =< 1 Aspartate transaminase (AST), alanine transferase (ALT) within institutional limits of normal or judged to be not clinically significant by the investigator Alkaline phosphatase within institutional limits of normal or judged to be not clinically significant by the investigator PRE-REGISTRATION History of other malignancy =< 2 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancer History of colorectal cancer; exception: individuals with stage I or II colorectal cancer who have not received any chemotherapy Known diagnosis of human immunodeficiency virus (HIV); Note: An HIV screening test does not have to be performed to evaluate this criterion History of gastric surgery Receiving any other investigational agents Use of any anticoagulation medications, such as warfarin or Coumadin Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or breast feeding; Note: Pregnant women are excluded from this study; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Meriva, breastfeeding should be discontinued if the mother is treated with Meriva Receiving any other investigational, anticoagulation, and/or chemotherapy agents | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Decompensated Cirrhosis Participants must meet all of the following 1. Subjects who are decompensated cirrhosis of any cause. 2. Subjects are repeated exacerbations despite treatment and hospitalized more than once within one year because of complications of cirrhosis, (e.g., massive ascites, spontaneous bacterial peritonitis, gastrointestinal bleeding or hepatic encephalopathy). 3. Need intermittent plasma albumin and oral diuretics supplement. 4. Serum albumin <35 g/L, total bilirubin<170 μmol/L, prothrombin activity >30% (prothrombin time <20 s), moderate or mild ascites, spontaneous bacterial peritonitis and hepatic encephalopathy have been cured, Child-pugh score ≥7. 5. Peripheral blood hemoglobin concentration> 70g/L，platelet count > 3 × 10^9/L, hematocrit (HCT) level>0.25. 6. No gastrointestinal bleeding during the last one month before enrolment. 7. Patient has no conditional to undergo orthotopic liver transplantation (OLT). 8. Willing to sign informed consent Participants meet any of the following 1. The presence of hepatocellular carcinoma (HCC) or other malignant tumors. 2. Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection. 3. Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease). 4. Pregnant or lactating women. 5. Allergy to G-CSF, contrast agents and anticoagulants. 6. Alcoholism or drug abuse | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Cirrhosis, Alcoholic Adult, i.e. age 18 years or above. 2. Is attending the liver cirrhosis rehabilitation clinic at Bispebjerg hospital; i.e., has alcohol-induced liver cirrhosis or hepatorenal syndrome and has at least once experienced severe decompensation in the form of hepatic encephalopathy or variceal haemorrhage. 3. Has attended at least 50% of the scheduled sessions in the 12 week run-in physical exercise program 4. Is the owner of a mobile phone capable of receiving SMS-messages 5. Has signed informed consent 6. Reads and speaks Danish Any condition that in the opinion of the investigator puts an otherwise eligible participant at increased risk by participation or otherwise make the person unfit for participation | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Triage Category 3 (Urgent) Aged 18 years or above who are triage category 3 in emergency department Presenting to emergency department between 9am and 4pm, Monday to Friday Aged below 18 years Pregnant | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Fatal Outcome Age more than or equal to 18 years Written informed consent provided by the patient High-risk for death the first 24 hours post admission i.e. moribund patients unlikely to thrive as defined by the attending physicians | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Hepatitis C Cryoglobulinemia Subjects must meet all of 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 ≥ 15 IU/mL at Screening 4. HCV genotype 1 5. Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy 6. Classification as treatment naïve or treatment experienced: 1. Treatment naïve is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon or ribavirin or DAAs (except for SOF-containing regimens). 2. Treatment experienced is defined as prior treatment failure or relapse to a regimen containing interferon either with or without RBV or DAAs (except for SOF-containing regimens) that was completed at least 8 weeks prior to Baseline/Day 1. The subject's medical records must sufficient detail of prior virologic failure to allow for categorization of prior response, as either: 1. Non-Responder: Subject did not achieve undetectable HCV RNA levels while on treatment, or 2. Relapse/Breakthrough: Subject achieved undetectable HCV RNA levels during treatment or within 4 weeks of the end of treatment but did not achieve SVR. 7. Cirrhosis determination (approximately 20% of subjects may have cirrhosis) a. Cirrhosis is defined as any one of the following: i) Any previous liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score ≥5) ii) FibroMeter® score >0.442 or an AST:platelet ratio index (APRI) >2 during Screening iii) Fibroscan with a result of >12.5 kPa at any time prior to or during screening. b. Absence of cirrhosis is defined as any one of the following: i) Liver biopsy within 2 years of Screening showing absence of cirrhosis ii) FibroMeter® score <0.442 or APRI ≤ 1 performed during Screening iii) Fibroscan with a result of ≤12.5 kPa within 6 months of Baseline/Day 1 Fibroscan results will supersede FibroMeter® /APRI; liver biopsy results will supersede Fibrotest® /APRI or Fibroscan results and be considered definitive. 8. Liver imaging (ultrasound, CT scan or MRI) within 6 months of screening is required in patients with cirrhosis to hepatocellular carcinoma (HCC) 9. Presence of MC vasculitis (please see on the note below). 10. Null or partial response to previous therapies for MC, including corticosteroids, cytotoxic agents (cyclophosphamide, azathioprine), hydroxychloroquine, methotrexate, mono or combination therapy with IFNα/PEG-IFN and ribavirin, and/or CD20 depletion with Rituximab. a. Patients can be on ongoing treatment with one of the drugs described above at unless there is significant DDI. 11. Subjects has the following laboratory parameters at screening: 1. ALT <10 x the upper limit of normal (ULN) 2. AST <10 x ULN 3. Adequate bone marrow function as indicated hematologic parameters listed below and/or bone marrow cellularity >60-70% average for age. i. WBC >1500 /uL ii.Platelets > 50,000/uL d) Direct bilirubin >2 x ULN e) INR >1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 12. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Baseline/Day 1 prior to treatment. 13. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. 14. Lactating females must agree to discontinue nursing before the study drug is administered. 15. Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator. 16. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments. Note: Definition of Mixed Cryoglobulinemia (patients must meet one of the five overlapping syndromes listed below and the presence of cold-precipitable immune complexes in blood on two different occasions Clinical evidence of cryoglobulinemia, overlapping syndromes: 1. Cutaneous vasculitis (Raynaud's phenomenon, purpura, skin ulcers, livedo, acrocyanosis) 2. Glomerulonephritis (hypertension, hematuria, nephrotic syndrome) 3. Arthropathy (arthralgias, arthritis) 4. Neuropathy (peripheral and/or central nervous system, distal sensorimotor, mononeuritis multiplex) 5. Sicca syndrome (xerostomia, xerophthalmia) Other factors that will be assessed / recorded in patients with MC will be: 1. Associated laboratory abnormalities including Positive HCV serology (recombinant immunoblot assay), viral nucleic acid quantitation diagnostic for HCV infection, and reflex genotyping Evidence of glomerulonephritis, including an active urinary sediment, hypoalbuminemia (albumin <3gm/dL) and/or significant proteinuria (>300mg/day) Abnormal nerve conduction testing. 2. Pathologic evidence of cryoglobulinemia including Leukocytoclastic vasculitis Membranoproliferative glomerulonephritis Vasculopathy and/or mononuclear cell infiltrates on sural nerve biopsy Lip biopsy suggestive for Sjogren's syndrome. 3. Laboratory evidence of cryoglobulinemia including | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Fibrosis patients with chronic liver disease or cirrhotic or with diagnoses HCC with HCV, HBV, NAFLD, Alcohol background patients with chronic liver disease or cirrhotic or with diagnoses HCC with autoimmune background or other background than HCV, HBV, NAFLD and Alcohol | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hepatocellular Carcinoma Biliary Tract Cancer Cirrhosis Liver Diseases Lab results from within the previous 90 days Diagnosis of HCC or biliary tract cancer Diagnosis of cirrhosis based on histology, imaging, or ultrasound Diagnosis of a chronic liver disease without cirrhosis for the HCC/biliary tract cancer group Prior solid organ transplant Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC for the cirrhosis and chronic liver disease groups Prior solid organ transplant Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer) | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-110.0, Encephalitis Meningitis Exclusions Patients on a 5150 or 5250 psychiatric hold Prisoners University of California employees / students or close associates of any of the key personnel on the study Outpatients and/or patients with chronic illness Demographic 1. Age: any (no age limit) 2. Language: any (with the use of interpreting services for obtaining consent) For the following, the infectious syndromes meningitis, encephalitis, fever, sepsis, and pneumonia: Clinical 1. Hospital admission or transfer with diagnosis of an presumed infectious syndrome or clinical presentation consisting with an infectious syndrome, as defined below Meningitis: fever >38°C and abnormal imaging or CSF pleocytosis (CSF white blood cell count (WBC) > 5 /mm^3) +/ stiff neck, +/ headache, +/ seizure Encephalitis: pleocytosis and at least one of the following: altered mental status, seizures, new onset of focal neurologic findings, abnormal EEG, acute brain abnormalities on neuroimaging 2. No known diagnosis of non-infectious etiology responsible for symptoms 3. Time of enrollment: within 7 days of onset of symptoms, either initial presentation or acute exacerbation of presumed infectious syndrome. Specimen 1. cerebrospinal fluid available within 7 days of symptom onset AND within 3 days of hospital admission or transfer unless evidence for acute exacerbation as defined by abrupt decline in clinical status, worsening pleocytosis or other laboratory parameters 2. Minimum of 600 microliters (uL) of clinical sample, stored at 4 degrees Celsius (C) no more than 5 days (ideally frozen in -70 degrees Celsius within 24 hours of collection) 3. No more than 3 freeze-thaw cycles | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Cholangitis Liver Cirrhosis, Biliary Cholestasis Liver Diseases Liver Cirrhosis Bile Duct Diseases Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016 Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cirrhosis Cachexia Malnutrition Diagnosis of cirrhosis No restriction of etiology 75 years Child-Pugh stage A/B/C Signed informed consent Pregnancy Extremity amputation Malignancy different from hepatocellular carcinoma | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Hepatitis C Infection Refractory Liver Carcinoma Stage III Hepatocellular Carcinoma AJCC v7 Stage IIIA Hepatocellular Carcinoma AJCC v7 Stage IIIB Hepatocellular Carcinoma AJCC v7 Stage IIIC Hepatocellular Carcinoma AJCC v7 Stage IV Hepatocellular Carcinoma AJCC v7 Stage IVA Hepatocellular Carcinoma AJCC v7 Stage IVB Hepatocellular Carcinoma AJCC v7 FOR ARM 1 AND 2: Subjects with advanced hepatocellular carcinoma (HCC) with no curative option; for Arm 2 subjects that are HCV-positive with genotype 1 or 4 virus infection will be enrolled Be willing and able to provide written informed consent for the trial; the subject may also provide consent for Future Biomedical Research (FBR); however, the subject may participate in the main trial without participating in FBR Have histologically or cytologically documented HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) in cirrhotic subjects is required; for subjects without cirrhosis histological confirmation is mandatory FOR ARM A AND B: Have Barcelona Clinic Liver Cancer (BCLC) stage C disease or BCLC stage B disease not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach Have a Child-Pugh A liver score at screening or within 14 days of first dose of study drug Have a predicted life expectancy of greater than 3 months Have measurable disease based on 1.1 as confirmed by the blinded MD Anderson radiology; target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions; Note: the same image acquisition and processing parameters should be used throughout the study for a given subject Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) performance scale within 7 days of first dose of study drug Have documented objective radiographic progression after stopping treatment with sorafenib or else intolerance to sorafenib; intolerance to sorafenib is defined as: Common Terminology for Adverse Events (CTCAE) grade >= 2 drug-related adverse event(s) which both a) persisted in spite of comprehensive supportive therapy according to institutional standards and b) persisted or recurred after sorafenib treatment interruption of at least 7 days and dose reduction by one dose level; patients treated on sorafenib as the last treatment may start pembrolizumab at least 14 days after the last dose of sorafenib FOR ARM B: Subjects with chronic infection by HCV who are treated or untreated are allowed on study; subjects with a past or resolved hepatitis B virus (HBV) infection, defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV deoxyribonucleic acid (DNA) test at screening, are eligible for the study Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy, herbal/complementary oral or IV medicine, or used an investigation device within 4 weeks of the first dose of treatment; subjects must also have recovered from associated therapy (i.e., to grade =< 1 or baseline) and from adverse events due to any prior therapy Has had esophageal or gastric variceal bleeding within the last 6 months; all subjects will be screened for esophageal varices, unless such screening has been performed in the past 12 months before first dose of treatment; if varices are present, they should be treated according to institutional standards before starting study treatment Subjects with ALT > 5 x ULN at day 1 are not eligible for enrollment Subjects with total bilirubin > 2.0 mg/dL at day 1 are not eligible for enrollment Subjects with clinically apparent ascites or encephalopathy, or untreated varices are not eligible for enrollment Portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging Has had encephalopathy in the last 6 months; subjects on rifaximin or lactulose to control their encephalopathy are not allowed Had a solid organ or hematologic transplant Had prior systemic therapy for HCC other than sorafenib, or intercurrent local therapy to the liver tumor between sorafenib and study drug Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 21.0-80.0, Cirrhosis Patients 1. Cirrhosis proven by radiology, endoscopy (esophageal varices present) or biopsy 2. Able to give informed consent as determined by the study staff 3. Have a family member or caregiver who lives with them that is willing to participate Unable to give consent 2. Active psychosis 3. Acute suicidal ideation 4. No identified family member or caregiver Caregivers/Family members: 1. Sharing living space with cirrhotic patient for at least 3 years 2. Able and willing to participate in the groups Unfamiliar with patient's routines and does not live in the same space 2. Unwilling to consent or participate | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 60.0-999.0, Common Variable Immune Deficiency Specific Antibody Deficiency X-linked Agammaglobulinemia Inclusion/ for Antibody Deficient Patients Adults 60 years of age and older Diagnosis of common variable immunodeficiency (CVID), Specific Antibody Deficiency (SAD), or X-linked agammaglobulinemia (XLA) Receiving replacement gammaglobulin Willing and able to sign consent and follow study schedule History of varicella or long-term (greater than or equal to 30 years) residence in the USA Allergy to Zostavax® or any of its components (i.e gelatin, neomycin) Absolute CD3, CD4, or CD8 lymphopenia as determined by age specific reference ranges Poor T cell function as indicated by a < 30 % increase in T cell response to mitogens or antigens as compared to the age matched normal reference range (in CVID) subjects Evidence of acute systemic illness or infection at within four weeks of screening or enrollment | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-69.0, Hepatitis C Evidence of chronic HCV infection, defined as: Positive anti-HCV antibody or detectable HCV RNA or HCV genotype at least 6 months before screening and HCV viral load ≥10^4 IU/mL at the time of screening / In subjects without documented HCV test results 6 months before screening, chronic hepatitis C infection can be assumed if risk exposures occurred > 6 months prior to screening and HCV viral load ≥10^4 IU/mL at the time of screening Willing and able to provide written informed consent Men and women age ≥ 18 years and < 70 years Body Mass Index (BMI) of 18 to 35 kg/m2 Intention to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments Women with a negative pregnancy test at screening and baseline Women of child bearing potential who accept a highly effective contraceptive method from at least 2 weeks prior to study day 1 until 1-month post-treatment. A woman is of non-child bearing potential if she (a) reached natural menopause determined retrospectively after 12 months of amenorrhea without any other obvious medical cause or (b) had procedures like bilateral tubal ligation or hysterectomy or bilateral oophorectomy Subjects who are compliant in an opioid substitution maintenance program (e.g. with methadone or buprenorphine) may be included as long as there is no concern about study medications adherence and interaction or compliance to study schedules related to HIV/HCV co-infected patients HIV/HCV co-infected patients receiving cART fulfilling the below are eligible for the study: Antiretroviral therapy (ART) should have been initiated at least 6 months prior to screening / Patient has to have been on the same protocol-approved ARV regimen for ≥ 8 weeks prior to screening and is expected to continue the current ARV regimen through the end of study / HIV ARVs: agents allowed in this study should be administered per the prescribing information in the package insert / Screening HIV RNA < 50 copies/mL / Screening CD4 cell count ≥ 100 cells/uL Decompensated cirrhosis defined as: Evidence of advanced stage liver cirrhosis and Child-Turcotte-Pugh (CTP) Class B or C or CTP score >6) or current/past history of decompensation including ascites, variceal bleeding, spontaneous bacterial peritonitis, or hepatic encephalopathy Hepatocellular carcinoma: for all patients with cirrhosis, hepatocellular carcinoma (HCC), should be excluded by liver imaging within 6 months prior to screening, and this must continue periodically as in routine HCC surveillance Laboratory cirrhotic subjects with albumin < 2.8 g/dL direct bilirubin > 3xULN AST, ALT > 10xULN Low neutrophil count (≤599 cells/mm3), hemoglobin (<9.0 g/dL for male, <8.5 g/dL for female), platelets (<50000 cells/mm3 ) classified as ≥ Grade 3 Patients with serum creatinine > 1.5 ULN or end stage renal disease Hepatitis B co-infection (HBsAg positive) Pregnancy, as documented by positive pregnancy tests at screening or baseline | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Cirrhosis Esophageal and Gastric Varices Gastrointestinal Hemorrhage y.o. ≤age≤75 y.o Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N-butyl-cyanoacrylate injection) age <18 y.o. or age > 75 y.o Never had the variceal bleeding episode before Do not have endoscopic treatment combined with other malignant tumor (not patients with hepatocellular carcinoma who don't not need treatment at the moment) Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.) Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics Acute variceal bleeding within 5 days Use of other antibiotics in the past 2 weeks Refuse to participate | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Alcoholic Hepatitis Alcoholic hepatitis patients: 1. More than 10 years of heavy alcohol consumption (mean intake ≈ 100 g/day). 2. Elevated aspartate aminotransferase level (but <500 IU per millilitre) and Ratio ofAST/ALT≥2 times 3. Elevated serum total bilirubin level ≥ 5 mgdL (86 μmol/L) 4. Elevated INR(≥1.5) and 5. Neutrophilia. Patient with Maddrey's DF of≥ 32 will be included in the study, with or without biopsy Age < 18 and > 75 years 2. Hepatocellular carcinoma or portal vein thrombosis 3. Refusal to participate in the study 4. Serum creatinine >1.0 mg% 5. Hepatic encephalopathy grade 3 or 4 6. Upper gastrointestinal bleed in last ten days 7. Uncontrolled bacterial infection 8. Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus seropositivity, Autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency 9. Pregnancy 10. Glucocorticoid treatment 11. Significant co-morbidity 12. Previous known hypersensitivity to G-CSF/NAC | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, GERD for Healthy Persons: -Patients 18 years of age or older with no symptoms of GERD for Patients Patients 18 years of age or older with symptoms of GERD Upper gastrointestinal endoscopy within the past 6 months and a prior diagnostic pH impedance study showing predominantly upright reflux for Patients; Items indicated with an asterisk (*) are also for healthy persons Patient who fulfil ROME IV for rumination disorder20 Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological (e.g., spinal cord injuries, dementia, multiple sclerosis, Parkinson's disease), psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.* Any prior gastric or esophageal surgery and significant intestinal or colonic resection* Hiatal hernia measuring 3 cm or larger as assessed by endoscopic or radiological studies Prior history of Los Angeles Grade C or D esophagitis, or esophageal stricture Current use opioid analgesics or anticholinergic drugs.* We will permit low doses of tricyclic antidepressants, nortriptyline (up to 50 mg/day) or amitriptyline (up to 25 mg/day) provided they were commenced 3 months prior to the screening period, calcium channel or adrenergic1 antagonists Current use of proton pump inhibitors Known significant esophageal motor disorder (ie achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)* Inability to read due to: blindness, cognitive dysfunction, or English language illiteracy * | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Cirrhosis Esophageal and Gastric Varices Gastrointestinal Hemorrhage y.o. ≤age≤75 y.o Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection) age <18 y.o. or age > 75 y.o Never had the variceal bleeding episode before Do not have endoscopic treatment Combined with other malignant tumors (not patients with hepatocellular carcinoma who don't need treatment at the moment) Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.) Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics Acute variceal bleeding within 5 days Refuse to participate | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Portal Hypertension Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins) Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II) Pregnancy Hepatic encephalopathy grade III-IV Hepatocellular carcinoma Treatment with statins in the previous 3 months Hypersensitivity to statins Previous surgical shunt or TIPS Treatment with calcium channel blockers | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cirrhosis All must be met at the time of screening Signed informed consent Male or female patients with an age of 18 to 75 years Liver cirrhosis History of variceal bleeding > 5 days Presence of ascites Successful TIPS Use of Viatorr stent Child-Pugh score within B7-C13 Bilirubin level of 3 mg/dL or less (51.3 umol/L) Patients who meet the following at the time of screening will be excluded | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Acute Decompensation in Liver Cirrhosis Cirrhosis with decompensation in a period of 3 months in form of ascites, jaundice, Hepatic Encephalopathy, Acute Variceal bleed irrespective of prior decompensation. 2. Age 18-70 years 3. Valid consent HepatoCellular Carcinoma 2. Admitted and survival less than 48 hrs 3. Pregnant 4. Acute Liver Failure 5. Post transplant | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Crohn Disease Ulcerative Colitis Intestinal Helminthiasis The included volunteer is a researcher within parasitology with main focus on Trichuris trichiura and Trichiura suis. He planned to infect himself and contacted our department with the purpose of being monitored during this infection for safety (medical supervision) and research reasons. The only clinical criterion for his in the study was that he was healthy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hematologic Disorders Recipient Ages 18-80 years inclusive Diagnosed with high risk hematologic disorders warranting stem cell transplant per institutional standard of care Lack HLA-identical related donor Availability of at least one HLA haploidentical (i.e. => 5/10 and <= 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP). The cord blood unit must contain a minimum TNC (prior to thawing) of at least 2x107 cells per kilogram of recipient body weight Ability to comprehend the nature of the treatment 6.2 Recipient (any of the following) HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation Any patient not meeting institutional standard guidelines for transplant | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Hepatic Encephalopathy Adult Patients with Overt Hepatic Encephalopathy Patients with active GIT bleeding. 2. Patients with history of bowel obstruction, perforation. 3. Patients with history of allergy to PEG. 4. Treatment with rifaximin or neomycin in the previous 7 days. 5. Patients with major psychiatric illness. 6. Patients receiving benzodiazepines and narcotics. 7. Patients with compromised renal. 8. Patients receiving medications highly bound to plasma proteins eg. Warfarin. 9. Pregnant or lactating women. 10. Fulminant hepatic failure | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Hepatitis C Patients that treated with Zepatier after SVR results | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 21.0-75.0, Hepatic Encephalopathy Cirrhosis, Liver 75 years of age Cirrhosis diagnosed by either of the following in a patient with chronic liver disease (a) Liver Biopsy (b) Radiologic evidence of varices, cirrhosis or portal hypertension (c) Laboratory evidence of platelet count <100,000 or AST/ALT ratio>1 (d) Endoscopic evidence of varices or portal gastropathy At least two HE episodes, one within the last year but not within the last month (patient can be on lactulose and rifaximin) Able to give written, informed consent (mini-mental status exam>25 at the time of consenting) Disease-related: (1) MELD score>17 (2) WBC count<1000 (3) TIPS, non-elective hospitalization or HE within last month (4) on dialysis (5) known untreated, in-situ luminal GI cancers (6) chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease) Endoscopy-related: (1) Platelet count<50,000 (2) adverse reactions to sedation (3) lack of driver or other contra-indications Safety-related: (1) Dysphagia (2) History of aspiration, gastroparesis, intestinal obstruction (3) Ongoing absorbable antibiotic use (4) Severe anaphylactic food allergy (5) allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil) (6) Adverse event attributable to prior FMT (7) ASA Class IV or V (8) Pregnant or nursing patients (9) acute illness or fever on the day of planned FMT | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Portal Hypertension Patients aged between 18 years old Who agree to participate in the study Compensated liver cirrhotic patients (alcohol, virus, autoimmune, NASH, primary sclerosing cholangitis and primary biliary cirrhosis) Moderate or severe perihepatic or perisplenic ascites. The presence of ascites limits the stiffness measurement Acute and acute on chronic hepatitis. It aims to decrease the influence of inflammation in the elastography evaluation Multiple focal liver lesions Cholestatic liver disease and biliary obstruction Failure to carry out liver TE by Fibroscan. Patients with an interquartile range (IQR) >30% of the median value and a success rate <60% will be excluded from the analysis but included in the intention to treat Portal vein thrombosis Esophageal, gastric, liver, spleen or pancreatic tumors that may impede to perform a correct EUS-E Cirrhotic patients with a recent episode of gastrointestinal bleeding or infection that may affect the hemodynamic flow Splenectomy or history of partial splenic embolization Pregnancy | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 16.0-999.0, Sepsis Suspected source of infection Presence of any of the following organ dysfunction Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg or fall in systolic blood pressure> 40 mmHg Creatinine> 2.0 mg / dl or diuresis less than 0.5 ml/kg/h in the last 2 hours OR Bilirubin> 2mg/dl Platelet count<100,000 Lactate> 2 mmol/dl (or above the reference value) Coagulopathy (RNI> 1.5 or APTT>60 sec) PaO2/FiO2 ratio <300 or recent or increased O2 need to maintain SpO2> 90 End of life care Previous sepsis episode in the same hospital admission | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | 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) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-60.0, Liver Cirrhosis Liver cirrhosis (Child B or Child C class) 2. Age between 18-60 years 3. History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months Evidence of overt hepatic encephalopathy at the time of enrollment 2. History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days 3. Alcohol intake during past 6 weeks 4. Receiving secondary prophylaxis for spontaneous bacterial peritonitis 5. Previous transjugular intrahepatic portosystemic shunts or shunt surgery 6. Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies 7. Receiving psychoactive drugs, promotility and hypomotility drugs 8. Hepatocellular carcinoma 9. Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L) 10. Intercurrent infection such as spontaneous bacterial peritonitis 11. Patients of acute on chronic liver failure (ACLF) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | 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) | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cancer Hepatic Carcinoma Written informed consent must be obtained prior to any screening procedures Cytohistological confirmation is required for diagnosis of HCC Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy At least one tumor lesion meeting measurable disease as determined by v1.1. Lesions previously treated with local therapy, such as radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy should not be selected unless progression is noted at baseline, in which case, these lesions would be considered as non-target lesions Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2 Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure Hemoglobin > 100g/L Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1 Any contraindications for hepatic arterial infusion procedure Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%) Renal failure / insufficiency requiring hemo-or peritoneal dialysis Known severe atheromatosis Known uncontrolled blood hypertension (> 160/100 mm/Hg) Patients with any other malignancies within the last 3 years before study start History of HCC tumor rupture Patients with severe encephalopathy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Cirrhosis Hypertension, Portal Clinical diagnosis of cirrhosis GEVs was diagnosed by endoscopy Acute gastrointestinal bleeding need emergency surgery Acid-related disease, such as peptic ulcer disease or gastroesophageal reflux diseases (GERD) Hepatocellular carcinoma (HCC) or other malignant tumor History of esophagus, stomach or liver surgery Child-Pugh C and can't be improved to Child-Pugh A or B Preparing to be pregnant, pregnant or breast feeding Allergic to PPIs(proton pump inhibitors) or intolerable Cannot provide informed consent | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 19.0-999.0, Gastritis Male of female of at least 19 years old Patients diagnosed with acute or chronic gastritis by gastroscopy Patients with one or more erosions found by gastroscopy Patients with peptic ulcer and gastroesophageal reflux disease Patients with previous gastrointestinal surgery Patients with history of gastrointestinal cancer | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-70.0, Portal Vein Thrombosis Acute non-neoplastic portal vein thrombosis Compensated cirrhosis (Child class A-B) The onset of PVT is within 1 week Decompensated liver disease Bleeding tendency or recent bleeding event as bleeding peptic ulcer or oesophageal varices Neoplastic invasion of the portal vein Renal impairment with the creatinine clearance ≤ 30 ml/min Pregnancy and breastfeeding Hypersensitivity to rivaroxaban Concomitant treatment with another anticoagulant Concomitant use of clopidogrel | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Chronic Liver Disease Esophageal Varices patients with chronic liver disease Patient in hepatic encephalopathy or coma Patient in active bleeding or with history of bleeding within the two weeks prior to entry in the study Patients with heart failure Patients with renal failure Patient with hepatocellular carcinoma and portal vein thrombosis Patient taking Beta blockers | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-85.0, Parkinson Disease Neurogenic Orthostatic Hypotension Idiopathic Parkinson's disease patients with orthostatic hypotension (Systolic Blood Pressure drop of > 20 mm hg or Diastolic Blood Pressure drop of >10 mm hg measured at some point) within a month of inclusion Age >85 Concurrent use of Midodrine Medical conditions that in the opinion of the investigator, might not allow for same completion of the study i.e. unstable angina, neoplasm, etc | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Transplant Liver transplanted patients older than 18, transplanted in Lille University Hospital Written consent by the patient or his/her legal representative (especially patient with hepatic encephalopathy) Patients with health insurance Minor patients Pregnant women or during lactation Patient under curatorship | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Obesity Bariatric Surgery Candidate A BMI greater than or equal to 40 Kg/m² A BMI greater or equal 35 Kg/m² associated with comorbidity (e.g., arterial hypertension, diabetes, dyslipidemia, sleep apnea) Surgery, fractures or nasal malformations History of epistaxis Allergy to components of the topical anesthetic used prior to the examination Coagulation disorders or use of anticoagulants Pregnancy Psychiatric disorder important | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-105.0, Bacterial Infection Intensive Care • Suspected or proven bacterial infection at emergency department triage Imminent death Pregnancy Breast-feeding For patients managed by a medicalized pre-hospital emergency team before ED admission : administration of a first dose of antimicrobial agent before ED admission Lack of coverage by the public health insurance system Patient's refusal for study enrollment Lack of confirmed bacterial infection (i.e., documented either clinically, microbiologically or by imaging procedures) in patients with a suspected bacterial infection at emergency departement triage | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-99.0, Acute Heart Failure ED physician clinical diagnosis of AHF; 2. Planned admission for AHF 3. Systolic blood pressure > 100mmHg, heart rate < 115bpm* 4. Previous history of HF *Patients with atrial fibrillation but controlled HR are eligible For Caregiver Burden assessments. The for a caregiver: 1) person either self-identifies, or when asked identifies themselves, as the primary caregiver for the patient. If there are multiple caregivers, the person who self-identifies as providing the most care will be asked to provide verbal informed consent. 1. Transplanted organ of any kind or ventricular assist device patient; 2. End stage renal disease, on dialysis, or eGFR < 20 mL/min; 3. Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin elevation secondary to ACS); 4. Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are unlikely to be treated within a SSU stay; 5. Patients who require ventilatory support of any kind or intravenous vasodilators/vasopressor/inotropic support. Patients who receive a one-time dose of an intravenious vasodiolator, but are no longer on this medication, are eligible. 6. Pregnant patients or any patient who has been pregnant in the last 3 months 7. < 18 years of age 8. Any patient who in the opinion of the clinician or investigator requires hospitalization or ICU level care or will require rehabilitation or skilled nursing after discharge from the ED or hospital 9. Planned discharge from the emergency department 10. Patients hospitalized within the last 30 days ONLY if the institution mandates these patients are observed. Otherwise these patients are eligible. 11. De Novo (new Onset) AHF | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Hepatic Encephalopathy Patient has decompensated liver cirrhosis Patient has overt hepatic encephalopathy Protein losing enteropathy. 2. Neurological conditions that make the assessment of hepatic encephalopathy difficult 1. Parkinson's disease 2. Alzheimer's disease 3. Concomitant stroke 3. Gastrointestinal Bleeding requiring blood transfusion - | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Cirrhosis Patients with liver cirrhosis of any etiology, diagnosed using imaging and/or histological and observed in the Liver Unit of the "A. Gemelli" University will be included in this study. All patients will sign an informed consent. The severity of liver function failure will be assessed using the Child-Pugh score [11]. Upper gastrointestinal endoscopy will be performed in all patients; the size of esophageal varices will be recorded as well as the presence of previous episodes of gastrointestinal bleeding. All the subjects will be outpatients and the time interval between the follow up visits will be approximately 120 days. The ultrasound for the diagnosis of PVT will be the detection of echogenic material within one or more of the following vessels: portal trunk, right portal branch, left portal branch, splenic vein and superior mesenteric vein. Color and pulsed Doppler analysis will allow to confirm the diagnosis and to distinguish partial from complete obstructive thrombosis and in all cases the Doppler ultrasound diagnosis of PVT will be confirmed by contrast enhanced abdomen computed tomography. The presence and/or extension of the thrombosis to the other major vessels of the portal venous system (mesenteric or splenic vein) will registered in all patients. PVT will be classified according to the extension of thrombosis, as previously reported: grade I is referred to as portal thrombosis confined to the portal vein beyond the confluence of the splenic vein; grade II was a PVT extended to the superior mesenteric vein, but with patent mesenteric vessels; grade III is a PVT extended to the whole splanchnic venous system, but with large collaterals; grade IV is a thrombosis extended to the whole splanchnic venous system with only fine collaterals [12]. All the biochemical and coagulation parameters described below, including and VWF levels, will be measured at each follow up visit All patients should not have hepatocellular carcinoma or other malignant tumors, they should not be treated with anticoagulant / antiplatelet agents, not affected by PVT already diagnosed and not suffering from congenital coagulation disorders (haemophilia A / B, von disease Willebrand, another congenital deficiency of coagulation factors) or severe thrombocytopenia (<30,000/µl) | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Portal Vein Pressure Patients who receives liver resection. 2. PVP is more than 12mmHg in 5 minutes after liver resection Age: <18, >75; 2. Portal vein tumor thrombus is confirmed by preoperative assays; 3. Obstruction of biliary tract; 4. Active hepatitis; 5. Previous history of myocardial infarction; 6. Previous history of chronic kidney disease; 7. Severe arrhythmia; 8. Any other contraindications of the Terlipressinum | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Hepatic Encephalopathy patients with decompensated liver cirrhosis regardless of the etiology acute variceal bleeding or with history of variceal bleeding evidenced by endoscopy an age between 18 and 75 years old a total bilirubin level more than 3mg/dL (51.3mmol/L) a creatinine level greater than 3 mg/dL(265umol/L) severe dysfunction of heart and respiratory system pregnancy uncontrolled neoplasm active systemic infection history of any kind of encephalopathy, mental disease, alcohol dependence, or any other status that influence brain function diabetes or any other metabolic diseases | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Esophageal Varices in Cirrhosis of the Liver 75 years HBsAg positive confirmed cirrhosis based on results of histologic examination of liver tissue or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver on ultrasonography, CT, or MR imaging active alcohol abuse (less than 6 months of alcohol abstinence); portal thrombosis history of treatments for portal hypertension (drug therapy, such as β-blocker, vasopressin) within 2 weeks prior surgeries (such as splenectomy, partial splenic embolization/devascularization, transjugular intrahepatic portosystemic shunt) prior endoscopic therapies (such as endoscopic variceal ligation) previous variceal hemorrhage acute-on-chronic (sub-acute) liver failure malignant tumor (such as hepatocellular carcinoma) cirrhotic portal hypertension with isolated gastric varices or ectopic varices inability to adhere to study procedures (such as heart failure, renal failure) pregnancy or unknown pregnancy status | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Bleeding Esophageal Varices cirrhotic patients presented with actively bleeding other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 21.0-75.0, Cirrhosis Alcohol Abuse A. Cirrhosis diagnosed by any of the following in a patient with chronic liver disease: 1. Liver Biopsy 2. Radiologic evidence of varices, cirrhosis or portal hypertension 3. Laboratory evidence of platelet count <100,000 or AST/ALT ratio>1 4. Endoscopic evidence of varices or portal gastropathy 5. Fibroscan B. Age between 21 and 75 C. Able to give written, informed consent (demonstrated by mini-mental status exam>25 at the time of consenting) D. Subject must have alcohol as a cause of cirrhosis i. Continued sustained drinking pattern with AUDIT score ≥8 in the last month and fulfilling DSM-V for alcohol misuse ii. Unable or unwilling to get mental health attention to quit alcohol (at least 3-months period of referrals to Substance abuse programs or other alcohol treatment approaches) iii. Adult companion who can accompany patient and provide insight into alcohol drinking patterns A. MELD score >17 B. Child Class C C. WBC count <1000 cells/mm3 D. Platelet count<50,000/mm3 E. TIPS in place for less than a month F. HE episode within a month prior to the study G. Currently on absorbable antibiotics H. Infection at the time of the FMT (diagnosed by blood culture positivity, urinalysis, paracentesis as needed) I. Patients who are aged >75 years J. Patients who are pregnant or nursing (will be checked using a urine pregnancy test) K. Patients who are incarcerated L. Patients who are incapable of giving their own informed consent M. Patients who are immuno-compromised due to the following reasons: 1. HIV infection (any CD4 count) 2. Inherited/primary immune disorders 3. Current or recent (<3 months) treatment with anti-neoplastic agent 4. Current or recent (<3 months) treatment with any immunosuppressant medications [including but not limited to monoclonal antibodies to B and T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil]. Subjects who are otherwise immunocompetent and have discontinued any immunosuppressant medications 3 or more months prior to enrollment may be eligible to enroll. N. Patients with a history of severe (anaphylactic) food allergy O. Patients who have previously undergone FMT P. Patients on renal replacement therapy Q. Patients who are unwilling or unable to hold the enemas R. Patients with untreated, in-situ colorectal cancer S. Patients with a history of chronic intrinsic GI diseases such as inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis), eosinophilic gastroenteritis, celiac disease or irritable bowel syndrome T. Major gastro-intestinal or intra-abdominal surgery in the last three months U. Unable to comply with protocol requirements V. Patients who are American Society of Anesthesiologists (ASA) Physical Status classification IV and V W. Patients with acute illness or fever on the day of planned FMT will be excluded with the option of including that subject at a future date X. Any conditions for which, in opinion of MD, the treatment may pose a health risk Y. Grade 2-4 or complicated hemorrhoids | 0 |
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