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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): 14.0-999.0, Cystic Fibrosis Established diagnosis of CF gene mutations identified, or Sweat chloride > 60 mmol/L, and or more typical CF clinical features Age > 14 years Able to perform spirometry and have post-bronchodilator FEV1 > 50% of predicted at screening Oxyhemoglobin saturation (by pulse oximetry) > 92% on room air Able to provide informed consent Unstable lung disease FEV1 > 15% below best clinical measurement within 6 months Requirement for IV antibiotics within 4 weeks of screening Requirement for any change in pulmonary medication within 2 weeks of screening Evidence of reactive airways Clinical diagnosis of asthma -> 15% increase in FEV1 after bronchodilator at screening Hypertonic saline use within 2 weeks of screening Unwilling or unable to either continue or discontinue cyclical therapies (e.g. inhaled tobramycin) for the 2 weeks prior to screening and the entire study period Pregnancy, breast-feeding, or unwillingness to use barrier contraception during the entire study period History of allergy or intolerance to amiloride, hypertonic saline, quinine, albuterol, or related compounds | 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, Chronic Hepatitis B Adult male or female, 18 to 60 years of age chronic hepatitis B patients Patient must have documented positive serum HBsAg for a minimum of 6 months prior to entry into study. Patients must show evidence of HBV replication and hepatitis documented by Positive serum HBV-DNA within 3 months prior to entry (HBV-DNA > 2.5 pg/ml) Positive serum HBeAg within 3 months prior to entry. Documented presence of abnormal alanine aminotransferase (ALT) twice within 3 months prior to entry (2 to 10 fold above the upper normal level) Liver biopsy finding shows chronic hepatitis without liver cirrhosis Compensated liver disease with the following minimum hematological and serum biochemical Hemoglobin values of ≥ 12 gm/dL for both sexes WBC ≥ 3,000/mm3 Neutrophil count ≥ 1,500/ mm3 Platelets ≥ 100,000/ mm3 Total bilirubin ≤ 2 mg/dL Albumin ≥ 3.5 g/dL Uric acid within normal ranges Serum creatinine ≤ 123.76 mmol/L (≤1.4 mg/dL) Fasting blood sugar ≤ 6.38 mmol/L (≤115 mg/dL) for non-diabetic patients Patients older than 60 years of age Any cause for the liver disease based on patient history or biopsy (where applicable) other than chronic hepatitis B, including but not limited to: Co-infection with HCV and/or HIV Hemochromatosis (iron despistion > 2 + in liver parenchyma) Alpha-1 antitrypsin deficiency Wilson's disease Renal or liver transplant patients Autoimmune hepatitis Alcoholic liver disease Obesity related liver disease Drug related liver disease Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices, hepatic encephalopathy. Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the treatment such as: Pre-existing psychiatric condition, especially severe epression, or a history of severe psychiatric disorder CNS trauma or active seizure disorders requiring medication. Patients with any history of cardiovascular dysfunction. Patients with any hemoglobinopathy including but not limited to thalassemia major and minor Poorly controlled diabetes mellitus Chronic pulmonary disease Immunologically mediated disease Clinical gout Sexually active females of childbearing potential must be practicing adequate contraception, Sexually active males must be practicing acceptable methods of contraception (vasectomy, condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 6 months after discontinuation of therapy. Female patients must not breast feed during the treatment period. Patients must agree to limit the drinking of alcohol during the course or the treatment. Patients receiving Chinese herbal medication during the past 3 months prior to study entry. Patient who did not respond to previous interferon therapy or who relapsed after a previous course of Interferon therapy. Patients who have been enrolled in any clinical trial for the treatment of chronic hepatitis B | 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 Hepatitis C Liver Cirrhosis Phase A Subject is 18 to 70 years of age, inclusive Subject has cirrhosis due to chronic HCV infection as documented by Subject has evidence of hepatic encephalopathy as evidenced by Neuro-psychometric Testing (Number Connection Test, Trails Test, etc.) Subject is non-azotemic (creatinine <1.5mg/dL) and ambulatory at screening Subject has cirrhosis due to chronic HCV as documented by: pathologic or clinical and radiographic evidence of cirrhosis with a positive HCV RNA PCR level. Phase A Subject has received active interferon therapy within 2 weeks of enrollment Subject is pregnant or lactating Subject has a life expectancy of less than 100 days Subject has a history of alcohol abuse within 6 months of enrollment Subject has active gastrointestinal bleeding at time of enrollment Subject has used an agent that alters intestinal motility, eg, methadone, cholestyramine, tricyclic antidepressants Subject is unable to take oral medication Subject has used neomycin or other antibiotic within 2 weeks of enrollment or is actively using lactulose at time of enrollment Subject is taking or has hypersensitivity or allergy to rifaximin or rifampin Subject requires long term antibiotic therapy (eg, Lyme Disease, tuberculosis) | 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): 0.0-0.014, Hepatitis B For the primary vaccination phase Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination & written informed consent taken from the parents/guardians of the subject Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy Birth weight >= 2.5 kg and 5 minute Apgar >= 7 Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject For the primary vaccination phase Mother known or suspected to be seropositive for HIV (testing not required for inclusion) Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study Administration of immunoglobulins and/or any blood products to the mother during pregnancy Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed) At risk of pneumococcal disease or planning to receive Prevenar™ during the study period Administration or planned administration of BCG vaccination during the study period Acute disease at the time of vaccination. For the booster vaccination phase Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose, or planned use during the booster phase | 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 Cancer Histological evidence of hepatocellular carcinoma (HCC) No evidence of residual or recurrent disease Received 1 of the following therapies Tumor resection between 4-8 weeks prior to study enrollment Transarterial chemo-embolization between the past 4-8 weeks Radiofrequency ablation and percutaneous ethanol injection (sequential or combinations thereof) between the past 2-8 weeks Meets 1 of the following high-risk features for recurrence History of resection of a single HCC > 5 cm History of multifocal HCC (includes microsatellite disease found at time of resection) History of vascular invasion (macro or micro) | 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, Hepatic Encephalopathy Must sign an Informed Consent Form In remission from past HE Uses appropriate birth control measures More than or equal to 18 years of age Must have potential to benefit from treatment Recent prior HE episodes Capable and willing to comply with all study procedures Participant has personal support available Has a certain Model End Stage Liver Disease (MELD) score Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to Allergies to the study drug or similar drugs Laboratory abnormalities Recent participation in another clinical trial History of non-compliance Pregnant or at risk of pregnancy, or is lactating Recent alcohol consumption Active bacterial or viral Infections Bowel issues Active malignancy | 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, Liver Cirrhosis, Experimental HCV cirrhotics admitted to hospital for a decompensated event, such as ascites, variceal bleeding, and hepatic encephalopathy - rapid deterioration of liver and/or renal function, detection of hepatocarcinoma, infection with HIV or HBV viruses, current alcohol or drug abuse, chronic invalidating disease, bacterial infections, platelets <35,000 cells/μL, neutrophils <1,000 cells/μL, haemoglobin level <10 g/dL, total bilirubin >3 mg/dL, and serum creatinine >2.0 mg/dL. - | 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, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization | 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 Patients with liver cirrhosis with at least one of the followings 1)Major complication of cirrhosis in the past (including variceal bleeding, encephalopathy and SBP) 2)Evidence for portal hypertension 3)Reduced hepatic synthetic function - Patients with alcoholic cirrhosis who still consume alcohol 2. Patients that are chronically treated with antibiotics or lactulose - | 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, Esophageal Varices Portal Hypertension Gastric Varices Esophageal Bleeding Female or male cirrhotic patient aged 18 to 75 years Hematemesis and/or melena (suspected to be caused by portal hypertension) Time interval <=24 hours between onset of initial hemorrhage and initiation of study drug infusion Time interval <=6 hours between admission and initiation of study drug infusion Anticipated time interval<=12 hours between admission and end of therapeutic endoscopy Unequivocal history of cirrhosis, either documented by at least one of classical clinical signs (abdominal collateral venous circulation, firm liver with a sharp lower liver edge, presence of spider naevi, and/or ascites), or by biochemical and/or Doppler-US signs Written informed consent obtained by the patient or his/her relative(s) Patient previously included in this study for a prior bleeding episode Patients treated with a vasoactive drug such as octreotide, vasopressin or its analogue for the current episode of bleeding Hepatic encephalopathy Grade IV Balloon tamponade already positioned at admission Known Child-Pugh score >=13 Pregnant or breast-feeding women Known diffuse hepatocellular carcinoma Known complete portal venous thrombosis Bleeding from esophageal varices within the previous 6 weeks Patient currently enrolled in another therapeutic study, and/or who participated in another clinical study, within the previous 6 weeks | 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, Hepatic Encephalopathy Cirrhosis of any cause 2. History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment 3. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated. 4. Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation. 5. Subject is ≥18 years of age. 6. Subject is capable and willing to comply with all study procedures. 7. If the subject has a history of a portal-systemic shunt, shunt placement or revision must be >6 months from Screening for TIPS or a surgical shunt Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study. 2. Subject has a history of allergy or intolerance to lactulose. 3. Subject has a history of allergy or intolerance to rifampin or rifaximin. 4. Subject has participated in an investigational drug or device study within the 30 days prior to study screening. 5. Subject is pregnant or is lactating. 6. Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator. 7. Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests. 8. Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits. 9. Subject's current, required medications are on prohibited concurrent medication listing. 10. Hemoglobin < 8.0 at time of screening 11. Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening 12. Ongoing gastrointestinal bleeding at time of screening 13. Chronic renal insufficiency with a serum creatinine > 3.0 at time of screening 14. History of tuberculosis infection | 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): 20.0-75.0, Bleeding Acute bleeding from esophageal varices (defined below); 2. the etiology of portal hypertension was cirrhosis; and 3. age was between 20 and 75 years old. The diagnosis of cirrhosis was based on pathology, clinical, biochemical, and sonographic or computed tomographic findings. Acute esophageal variceal bleeding was defined as when blood was directly seen by endoscopy to issue from an esophageal varix, or when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified association with hepatocellular carcinoma or other malignancy, 2. association with cerebral vascular accident, uremia, sepsis or other debilitating disease, 3. had history of gastric variceal bleeding, 4. received beta blocker within one month prior to entry, 5. had history of contraindication to the use of beta blockers, such as asthma, heart failure, atrioventricular block, bradycardia (pulse rate <55/min) or arterial hypotension (systolic blood pressure<90 mmHg). 6. had history of prior shunt operation, TIPS (transjugular intrahepatic portosystemic stent shunt), EIS or EVL, 7. deep jaundice (serum bilirubin >10mg/dl), 8. encephalopathy greater than stage II, 9. failure in control of index variceal bleeding, 10. death within 24 hours of admission, or 11. refused 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): 0.0-999.0, Minimal Hepatic Encephalopathy Hepatic Encephalopathy All the patients diagnosed as having cirrhosis of liver Overt HE or a history of overt HE History of recent (< 6 weeks) alcohol intake Infection, recent (< 6 weeks) antibiotic use or gastrointestinal bleeding History of recent (< 6 weeks) use of drugs affecting psychometric Performances like benzodiazepens, antiepileptics, psychotropic drugs History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension Electrolyte imbalance Renal impairment Presence of hepatocellular carcinoma Severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement | 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, Intracerebral Hemorrhage Hypertension Stroke Age older than 18 years Onset of new neurological signs of a stroke within 12 hours of the time to evaluation AND initiation of treatment with intravenous nicardipine Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and/or gaze, vision, or neglect The total GCS score is greater than 8 at the time of enrollment CT scan demonstrates intraparenchymal hematoma with manual hematoma volume measurement less than 60 cc ICH is supratentorial and is located in lobar, basal ganglionic, or thalamic based on the initial CT scan appearance Admission systolic blood pressure greater than 170 mm Hg on two repeat measurements at least 5 minutes apart Evidence of chronic hypertension Subject is not considered a surgical candidate by the neurosurgery service Time of symptom onset cannot be reliably assessed Previously known neoplasms, arteriovenous malformation, or aneurysms Intracerebral hematoma considered to be related to trauma by the neurologist or neurosurgeon ICH is located in the cortex or infratentorial regions such as pons or cerebellum Blood is visualized in the subarachnoid space Intravenous nicardipine cannot be initiated within 12 hours of symptom onset Use of clonidine hydrochloride and other central alpha-agonist within the last 48 hours that have the potential of withdrawal hypertension Pregnancy, lactation, or parturition within previous 30 days Any history of bleeding diathesis or coagulopathy, including the use of warfarin Use of heparin in the previous 48 hours and a prolonged partial thromboplastin time | 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): 0.0-18.0, Gastreoesophageal Reflux Disease Children > 15 kg Cerebral palsy and mental retardation with swallowing disorders Presence of gastrostomy tube GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks Informed consent Treatment with ciclosporine, tacrolimus, mycofenolate Treatment with anticoagulants Infection Recent start of treatment with known inhibitors of the omeprazole-metabolism Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit) | 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): 14.0-65.0, Hepatic Encephalopathy Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis Patients >14 years, with HE grades 1 to 4 according to West Haven Hyperammonemia (fasting venous blood ammonia level >60 µmol/l), and Patients with a single reversible precipitating factor of HE such as constipation, hypokalemia, urinary tract infection, respiratory tract infection, spontaneous bacterial peritonitis (SBP), dehydration, or none hepatocellular carcinoma severe septicemia active gastrointestinal bleeding hepatorenal syndrome acute superimposed liver injury advanced cardiac or pulmonary disease and end stage renal failure patients with minimal HE patients taking sedatives, antidepressants, or benzodiazepines and patients with chronic HE on metronidazole or lactulose prior to admission | 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, Gastrointestinal Hemorrhage Portal Hypertension Cirrhosis Any Patient with endoscopically assessed Variceal Bleeding (esofagic and gastric) Cirrhosis Patient agreement to be included in the study onsentiment signed Any associated comorbidity with life expectancy lesser than 6 months Patient refusement to be included in the study Pregnancy Failure to control acute bleeding Previous prophylaxis 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): 19.0-999.0, Kidney Transplant Type 2 Diabetes Type 2 Diabetes Mellitus Most recent HbA1C 6.5-10% year post kidney transplant Patients treated primarily with insulin for their diabetes Kidney allograft not functional at entry or estimated creatinine clearance of <30 ml/min Clinical course complicated by persistent nausea severe gastroparesis Severe recurrent hypoglycemia (>1 hypoglycemic episode requiring the help of another person per week) Patients on dialysis therapy Unstable renal function in the preceding 3 months Serum transaminases >2 times normal at study entry Smokers Pregnant or planning to become 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, Sepsis Male or female 18 years of age or older Presenting to the emergency department (ED) for evaluation and who can be enrolled within 6 hours of initial ED evaluation Exhibiting two or more of any diagnostic for sepsis Willing and able to comply with study procedures, including follow-up telephone contact (or in-house assessment) on Study Days 3, 14, and 28 Age < 18 years Participation in any interventional clinical study within the previous 30 days Status-post cardiac arrest (within the past month) Moribund or with active "Do Not Resuscitate" or "Comfort Care Only" status Prisoners or other institutionalized or vulnerable individuals Already a hospital in-patient Unwilling or unlikely to comply with study procedures or to be reachable by telephone (or in person) for Day 3, 14, and 28 status assessments if discharged | 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, Esophageal and Gastric Varices Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy Age greater than or equal to 18 years old Able to give consent Current implantable cardioverter-defibrillators or pacemaker in place Suspected intestinal obstruction Esophageal swallowing disorder Esophageal stenosis Age less than 18 years old Pregnancy Known Zenker's diverticulum Patients with previous endoscopic or surgical esophageal 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): 50.0-999.0, Osteoporosis Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/ apply. All must be answered "yes" for a subject to be enrolled in the trial. 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject female and at or above the age of 50? 3. Has the subject been postmenopausal for more than 5 years in the judgement of the investigator? 4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia? 6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for evaluation? [*] 7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper? [*] Note that no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also and note [**] All must be answered "no" for a subject to be enrolled in the trial. Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: 5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted. 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? according to the investigator's opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**] 17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**] 18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**] 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**] 20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**] 21. have severe impaired liver function ? [**] 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? according to the investigator's opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed. [**] no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available | 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 Disease request of a standard size totally implanted venous port patent superior vena cava normal clotting tests (PT>40% and platelet count >40000/mm3) unable to provide written 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): 18.0-75.0, Cirrhosis Esophageal Varices Large Esophageal varices Treatment with beta-blocking agents Respiratory diseases that contradict endoscopy Gastric-retention Former gastric resection Resent sclerotherapy or former banding | 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): 30.0-80.0, Type 2 Diabetes Newly diagnosed type 2 diabetic patients. 2. Hospitalization due to hyperglycemia hyperosmolality syndrome. 3. Those who age between 30 and 80 years old and can inject insulin by themselves Pregnant women. 2. Impaired liver function (ALT > 120 U/L) 3. Impaired renal function (Serum creatinine >3.0 mg/dL) 4. Recently suffered from MI or CVA. 5. Patients are acute intercurrent illness. 6. 2-hour C-peptide level < 1.8 ng/mL | 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, Viral, Non-A, Non-B, Parenterally-Transmitted Hepatitis B, Chronic Patients with laboratory tests positive for hepatitis B and/or C No laboratory tests available | 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): 18.0-65.0, Hepatic Encephalopathy Age 18-65 years Cirrhosis diagnosed on clinical grounds MHE diagnosed by abnormalities in a psychometric battery (NCT-A, NCT-B, ICT BDT and DST impaired beyond 2 standard deviations of known control values on any of the above 3 tests will be considered to have MHE) Current drivers (valid driving license and driving at least 20 miles/week) All women of child-bearing potential will be required to use effective contraception Current or recent (< 6 month) use of alcohol (AUDIT questionnaire will be used; any cirrhotic with a value of > 0 will be excluded) and a positive blood alcohol level Use of antibiotics within last 6 weeks Allergy to rifaximin, rifabutin, rifampin, or rifapentine Infection or gastrointestinal hemorrhage within the last 6 weeks Renal insufficiency Hepatocellular carcinoma Psychoactive drug use, including interferon concurrently Non-drivers and those who drive less than 20 miles/week Pregnancy and breastfeeding Excluding patients with OHE | 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, Portal Hypertension Cirrhosis Hematemesis Melena All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age Ulcerative esophagitis Mallory Weiss tear Bleeding gastric or duodenal ulcers Bleeding from gastric varices or portal hypertensive gastropathy and Upper GI bleed as a result of thrombocytopenia or bleeding diathesis | 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, Hepatocerebral Encephalopathy Portal-Systemic Encephalopathy Encephalopathy, Hepatic Encephalopathy, Hepatocerebral Age >18 years All acute gastrointestinal bleeding in cirrhotics without hepatic encephalopathy at the time of admission in ER Increased α-fetoprotein level/ Documented hepatoma Portal or hepatic vein thrombosis Large-volume or tense ascites requiring repeated therapeutic paracentesis Serious recurrent or ongoing co morbid illness (e.g., severe renal, cardiac, or respiratory failure; sepsis) Pregnancy Not willing to give consent to participate in the study Patients who are unable to read and write ER arrival time > 12 hrs from index bleed | 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): 18.0-70.0, Hepatic Encephalopathy Patients with End Stage Liver Disease secondary to any cause (patients who have undergone portosystemic shunting (TIPS) procedure > 3 months prior to randomization can be included) Lactulose naïve patients or patients currently on an established dose of lactulose MELD score ≤ 15 (MELD score up to 20 is allowable if it has remained stable for at least 3 months) Meet the for Stage 1-2 hepatic encephalopathy according to the Westhaven Scale Patients must have discontinued rifaximin or other oral antibiotics for at least 48 hours prior to randomization Able and willing to comply with all protocol procedures for the planned duration of the study Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information Have a person (spouse, relative, or friend) willing to accompany the patient to the study visits (patients in this condition are not recommended to drive a vehicle) Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline. Note: Patients already on lactulose and randomized to AST-120 will stop taking lactulose on the day they begin taking AST-120 Patients whose condition necessitates continuous administration of antibiotics (e.g. rifaximin, neomycin, metronidazole) Patients undergoing chemotherapy for treatment of cancer (patients with hepatocellular carcinoma being treated by methods other than chemotherapy may be enrolled) Patients who require continued treatment with narcotics or sedatives Patients who have active GI bleeding Patients who have an active infection Patients who have signs and symptoms of severe dehydration Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling Unable to attend all visits required by the protocol Female patients must be if they are pregnant, breast feeding, planning to become pregnant during the study or using hormonal contraception as their only method of birth control | 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, Esophageal Varices Portal Hypertension Gastric Varices Cirrhosis Recent bleed Previous TIPS Inability to provide consent Renal insufficiency | 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, Hepatic Encephalopathy Male or female between the ages of 18 and 75 years Signed written informed consent by subject's representative Current diagnosis of chronic liver disease with cirrhosis West Haven score of Grade 3 or 4 Hepatic Encephalopathy Weight between 45 and 150 kg Elevated venous ammonia concentration, defined as a value above the normal range at the local laboratory Estimated creatinine clearance of > 30 mL/min/1.73m², calculated using the Cockcroft-Gault formula, or serum creatinine < 2.5 mg/dL [Cockcroft-Gault formula: creatinine clearance = (140 age) x weight in kg divided by (72 x serum creatinine in mg/dL); multiply result by 0.85 for females] Adequate urinary output of ≥ 30 mL/hour for the last 2 hours if estimated creatinine clearance is < 50 mL/min/1.73 m² Negative pregnancy test or documented sterilization procedure (tubal ligation or hysterectomy) or 5 years post-menopausal Major gastrointestinal bleeding (hematemesis, melena, or hematochezia) requiring blood transfusion within the last 24 hours Uncontrolled sepsis, as defined by hemodynamic instability requiring vasopressor agents (renal-dosed dopamine allowed) Current diagnosis of acute hepatic failure Alcohol ingestion during last 24 hours Post liver transplant Serum sodium < 120 mEq/L Serum potassium ≤ 3.5 mEq/L Use of probenecid, valproate, penicillin or its derivatives, or corticosteroids (oral or IV) within the last 24 hours Use of any sedatives, benzodiazepines, or any neuro or psycho-active drugs in the last 6 hours and a positive urinary drug screen | 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): 19.0-120.0, Lung Cancer Current and former smokers with at least a 30 pack-year history of smoking Body weight less than 140 kg (308 pounds) Able to lie flat Able to comply with long-term follow-up Functional capacity and willingness to undergo diagnostic work-up of suspicious nodules and curative therapy if lung cancer is detected Nursing mothers allowed No cognitive impairment that would preclude providing informed consent No other concurrent or prior malignancy within the past five years except superficial basal cell carcinoma or nonmelanoma skin cancer Able to come to clinic for screening No condition that would preclude screening, diagnosis, or surgical 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): 18.0-120.0, Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Histologically or cytologically proven adenocarcinoma of the biliary tree (intra and extra-hepatic biliary ducts or gallbladder) Locally advanced, unresectable, or metastatic disease Patients with pathologically confirmed metastatic adenocarcinoma consistent with biliary primary with clinical documentation of gallbladder or biliary tree involvement and no evidence of another primary adenocarcinoma are eligible Must have evidence of disease but measurable disease is not required Chest x-ray and/or CT scan of the chest, CT scan or MRI of the abdomen, and other radiological examination to document all disease sites have been done within 28 days prior to randomization No repeat scan needed if a negative scan was performed within 35 days prior to randomization Patients who have only one site of disease located inside a previous radiotherapy field are eligible Lesions within a previous radiotherapy field may be considered measurable if documented ≥ 20% increase in size If the lesion size increase has not been documented since the completion of radiotherapy, and the lesion is still present (i.e. not CR), the lesion is considered evaluable for this 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): 16.0-999.0, Hepatitis B Virus Decompensated Cirrhosis over 16 years of age; 2. evidence of active viral replication was documented by a positive test for HBV-DNA in serum; 3. Liver cirrhosis was proven by ultrasound or CT; 4. Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7; 5. patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein) 2. a serum alanine aminotransferase level more than 10 times the upper limit of normal 3. coinfection with hepatitis C or D virus or human immunodeficiency virus 4. other types of cirrhosis 5. a history of anti-viral therapy 6. a total bilirubin level higher than 170 mmol/L 7. a history of malignant tumors | 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): 30.0-80.0, Hepatitis Liver Cirrhosis Hepatocellular Carcinoma Clinical diagnosis of Hepatocellular carcinoma Must be primary Hepatocellular carcinoma and untreament treatment Hepatocellular carcinoma | 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, Hepatic Encephalopathy Must sign an Informed Consent Form In remission from past HE Appropriate birth control measures More than or equal to 18 years of age Must be potential for benefit from treatment Recent HE episodes Capable and willing to comply with all study procedures Participant has support network Significant medical conditions or Investigator decision not to the participant Allergies to the study drug or similar drugs Laboratory abnormalities Recent participation in another clinical trial Problems experienced in a previous HE trial Pregnant or at risk of pregnancy Recent alcohol consumption Active or latent bacterial or viral Infections Bowel issues Recent Active 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): 20.0-70.0, Hepatitis C, Chronic Liver Cirrhosis Adults aged 20-70 years Positive quantitative serum HCV-RNA Participants classified as A in Child-Pugh classification, and who do not have ascites or hepatic encephalopathy Diagnosed with type C compensated liver cirrhosis based on liver biopsy performed within 3 years or latest celioscopy Prolonged prothrombin time by <=3.0 sec Participants and partners of participants willing to use adequate contraception during the course of the study Participants who can be hospitalized for at least 14 days since treatment initiation Weight >40 kg and <=100 kg Hematology laboratory results of hemoglobin >=12 g/dL Participants who did not previously respond virologically to combination therapy with interferon (including polyethylene glycol-modified interferon) and ribavirin Participants who had previously received treatment with interferon for whom at least 90 days have not elapsed since the end of previous treatment Participants who have received treatment within 14 days prior to registration with injectable preparations containing glycyrrhizin/cysteine/glycyron or shosaikoto Participants who have received administration of drugs having antiviral, anti-tumor, or immuno-modulating effect (including glucocorticoids and radiation therapy) within 90 days prior to registration (excluding local administration and topicals) Participants who have received other investigational drugs within 180 days prior to registration Hepatitis B surface (HBs) antigen positive Antinuclear antibody >=320 times Serum creatinine exceeding the upper limit of reference range Participants with fasting blood glucose >=110 mg/dL (participants with fasting blood glucose >=110 mg/dL and <126 mg/dL can be registered if their hemoglobin A1C (HbA1c) is <6.5%) [fasting blood glucose should be measured when participants are not receiving treatment for diabetes mellitus] Participants with any of the following: diabetes mellitus that requires treatment; thyroid function disorder not controlled by treatment; liver disease such as autoimmune, alcoholic and drug-induced liver diseases; hemophilia; arrhythmia requiring treatment; co-existing hypertension not controlled by drug therapy (systolic blood pressure [BP] >=160mmHg or diastolic BP>=100mmHg); chronic pulmonary disease; hemoglobinopathies (thalassemia, sickle cell anemia); malignant tumors or who have a history of malignant tumor within the past 5 years; organ transplants (other than cornea and hair transplant) | 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, Recurrent Thyroid Gland Carcinoma Stage III Thyroid Gland Follicular Carcinoma Stage III Thyroid Gland Papillary Carcinoma Stage IV Thyroid Gland Follicular Carcinoma Stage IV Thyroid Gland Papillary Carcinoma Histopathologically confirmed differentiated thyroid carcinoma of follicular cell origin, including any of the following histologies and their respective variants Papillary Follicular Hürthle cell Must have surgically inoperable and/or recurrent or metastatic disease At least one fludeoxyglucose F 18 (FDG)-PET-avid lesion, defined as any focus of increased FDG uptake > normal mediastinal activity with standard uptake variable (SUV) maximum levels ≥ 3, as documented by baseline PET scan Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan Progressive disease, defined by ≥ 1 of the following occurring during or after prior treatment (e.g., radioactive isotope [RAI] treatment) Presence of new or progressive lesions on CT scan or MRI New lesions on bone scan or PET scan | 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): 18.0-90.0, ERCP Pancreatic Diseases Bile Duct Diseases All patients undergoing ERCP above the age of 18 years Patient with Billroth II gastrectomy Known previous sphincterotomy Active acute pancreatitis before ERCP Ongoing acute cholangitis before ERCP Hypotension (systolic blood pressure < 100 mmHg) Second-degree and third-degree atrioventricular block Heart failure Glaucoma Obstructive uropathy Impaired renal function (serum creatinine > 133μmol/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): 0.0-999.0, Bleeding All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included 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): 18.0-80.0, Hepatic Encephalopathy Cirrhosis Age 18-80 Hepatic encephalopathy grade II-III Serum ammonia > 60 mcg/mL Informed consent Recent GI hemorrhage Severe sepsis Degenerative CNS disease or major psychiatric illness Serum creatinine > 1.5 mg/dl Pregnancy or lactation Poorly controlled DM Insertion of TIPS Received CNS depressants or hypnotics Treatment with metronidazole, kanamycin or branched-chain amino acid Hypersensitivity to L-ornithine-L-aspartate | 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, Liver Cirrhosis Renal Failure cirrhosis of liver of any etiology progressive renal failure stage 0-2 hepatic encephalopathy pregnant 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): 18.0-999.0, Acne Keloidalis Nuchae NdYag Laser AKN Acne Keloidalis AK Dermatitis Papillaris Capillitii Folliculitis Keloidalis Nuchae Sycosis Nuchae Acne Keloid Keloidal Folliculitis Lichen Keloidalis Nuchae Folliculitis Nuchae Scleroticans Sycosis Framboesiformis For the subject must: 1. Be at least 18 years old 2. Be otherwise healthy 3. Have a diagnosis of AKN with at least 10 papules/pustules and/or a non-keloidal plaque > 7 cm2 in area Subject must not: 1. Have AKN with a keloidal plaque >3 cm in length 2. Be using any other medications or undergoing any other procedures for the treatment of AKN 3. Have used any topical medications or undergone any procedures for the treatments of AKN within two weeks of study enrollment 4. Have used any oral medications for AKN within 4 weeks of study enrollment: 5. Have serious, uncontrolled medical conditions 6. Be pregnant at any time during 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): 18.0-70.0, Carcinoma, Hepatocellular Cirrhotic participants, both sexes, Child Pugh A, B, HCV-RNA positive, age < 70 years Participants non-responders to IFN + Ribavirin or PegIFN + Ribavirin or IFN monotherapy Pre-therapy liver biopsy (< 36 months) with PCNA-LI > 2.0 Fibrosis score 5-6 (Ishak) Initial portal hypertension, such as gastroesophageal varices or one of the following US sign Collateral circles Spleen longitudinal diameter > 12 cm Portal vein diameter at hilus > 12 mm Portal flow > 12 cm/sec Participants must have the following minimum hematologic and biochemical Pregnant or breast-feeding women Co-infection with HIV and/or HBV Autoimmune hepatitis or history of autoimmune disease Alcoholic liver disease Metabolic disease HCC Participants with liver and kidney transplants Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices, spontaneous encephalopathy Chronic renal failure or creatinine clearance < 50 mL/min Pre-existing thyroid disease unless it can be controlled with conventional 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): 12.0-80.0, Cirrhosis A clinical, radiological or histologic diagnosis of cirrhosis was made Age was between 18 and 70 years Esophageal varices were small (i.e. ≤5 mm or of grade 1 or 2 according to Conn et al) Presence of previous variceal bleeding Previous medical, surgical or endoscopic treatment for portal hypertension Child-Pugh score >13 Neoplastic disease of any site Splenic or portal vein thrombosis Concurrent illnesses expected to decrease life expectancy to less than one year Pregnancy Contraindication to beta-blockers (atrioventricular block, sinus bradycardia with heart rate <50 beats per minute, arterial hypotension with systolic blood pressure <90 mm Hg, heart failure, asthma, peripheral arterial disease, or diabetes needing insulin treatment) Concurrent anti-viral treatment during the study period Inability to perform follow-up | 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, Liver Cancer Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma Clinical stage T2-4, N0-1, M0 (stage II, IIIA, IIIB, IIIC) OR unresectable T1, N0-1, M0 (stage I) disease M1 disease allowed in phase I if at least 90% of the tumor load (volume) is in the liver Measurable disease (at least one liver lesion that can be measured in at least one dimension as ≥ 10 mm in multislice CT scan/MRI) Volumetry of liver tumor and residual liver tissue: residual liver volume (= total liver volume gross tumor volume) has to be ≥ 800 mL and ≥ 40% of total liver volume No operable disease (with curative intent or planned liver transplantation) No presence of clinical ascites WHO performance status 0-2 Cirrhosis Child-Pugh class A or B (Child-Pugh score of ≤ 9) | 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, Hepatitis C, Chronic Cognition Disorders Fatigue Syndrome, Chronic Major Depressive Disorder Chronic HCV infection with genotype 1, 2, 3 or 4 Age > 18 and <60 Liver biopsy or fibroscan performed within last 5 years Signed informed consent form Liver biopsy showing liver pathology not due to HCV infection Liver cirrhosis or severe liver fibrosis Former antiviral HCV treatment (for included HCV patients) HIV and/or Hepatitis B virus infection Alcohol or drug abuse within the last 2 years Neutropenia, anemia or thrombocytopenia Clinical signs of non-compensated liver pathology Moderate to severe cardiopulmonary disease (NYHA score 1 or above) Creatinine clearance < 80mL/min Pregnancy | 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, Diabetes Mellitus Age 18 years or older Diabetes, defined as either 1) filled a prescription for insulin or an oral hypoglycemic agent; or, 2) had two outpatient or one inpatient or two outpatients encounter claims with an ICD9-CM or CPT code indicating diabetes Gap in a key diabetes management metric as evidenced by no claim for a dilated eye examination in the prior 15 months and no claim for one or more of the following tests: glycated hemoglobin, LDL-cholesterol, or microalbumin. (Individuals with evidence of having received ACE-inhibitors or angiotensin receptor blockers were considered to have had a microalbumin test.) No primary care clinician in the data base Those who had previously asked the health plan to them from research or quality improvement Women whose claim records contained diagnoses suggesting gestational diabetes | 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): 0.0-0.083, Neonatal Hyperbilirubinemia Providers who care for infants in the newborn nursery All newborns in the newborn nursery that are 35 weeks or more weeks of gestation will be study eligible Infants less than 35 weeks gestation | 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 Disease Controls healthy volunteers, male and female, above 18 years NAFLD group patients with histological proven NAFLD, male and female, above 18 years Controls those who will be found to have fatty liver in abdominal ultra sound any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study any participant who had lost more than 10% of baseline body weight during the study period NAFLD group those who will be found to have any concomitant liver disease (i.e., HBV/HCV/HIV/EBV/CMV infection autoimmune hepatitis metabolic liver disease: Wilson's disease, cholestatic liver disease: PBC/PSC, etc.) any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study any participant who had lost more than 10% of baseline body weight during the study period | 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): 20.0-70.0, Hepatitis C, Chronic Liver Cirrhosis Patients with compensated hepatic cirrhosis secondary to chronic hepatitis C who would meet all the below and would not interfere with any of the below Patients (regardless of gender) who can take contraceptive measures from date of informed consent to the end of follow-up Patients who meet all the below in the test/observation/ investigation in 30 days before the beginning of treatment Patients with quantitative HCV-RNA (+) ALT > 40 IU/L Patients who are classified as Child-Pugh Classification A, and who do not have ascites or hepatic encephalopathy Prothrombin Time <=3.0 seconds prolonged, total bilirubin <= 1.5 mg/dL or direct bilirubin <= 0.7 mg/dL, Albumin >= 3.0 g/dL AFP within normal limits, AFP-L3 <= 10%，PIVKA-II <= 100 mAU/mL Serum creatinine <= upper limit of normal, creatinine clearance >= 51 mL/minute Patients with fasting blood glucose < 110 mg/dL | 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, Gastric Bleeding Cirrhosis All patients with upper gastrointestinal bleeding (blood in the upper gastrointestinal tract) of a magnitude that required 2 or more units of blood transfusion and entered the emergency room directly, or were referred from an area hospital, or developed bleeding while in the hospital, and were shown to have cirrhosis of the liver, and were shown by endoscopy to have bleeding gastric varices, absence of bleeding from esophageal varices, and absence of any other lesion that could reasonably account for the bleeding were included ("all comers") 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): 18.0-999.0, Hepatitis C Human Immunodeficiency Virus HIV Infections Newly acquired HCV infection of 6 months or less duration Detectable HCV RNA at study entry HIV infection, any CD4 count Pregnant or intent to become pregnant within 24 weeks of study completion Uncontrolled depression Other serious liver disease Other safety parameters must be met | 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, Gastritis Duodenitis All patients undergo upper endoscopy are included after written informed consent is obtained | 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, Metastatic Colorectal Cancer Liver Metastases Hepatic Lesions Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of liver metastases (new confirmation of metastatic disease is required in case the time interval from last histological diagnosis to enrolment exceeds 3 years) Patient with wild type (WT) KRAS tumor status Patient whose liver metastases are considered to be non resectable with curative intent in medico-surgical staff meeting. In particular patients with at least one of the following which prevent complete local treatment of liver metastasis with surgery alone or surgery plus radiofrequency ablation because less than 30% estimated residual liver after resection disease in contact with liver main vessels documented progressive disease on imaging documents or doubling of serum levels of carcino-embryonic antigen (CEA) or CA19.9 over the past 90 days or less Patient with up to three resectable extrahepatic nodules of <= 10 mm One, two or three prior chemotherapy lines for colorectal cancer Written informed consent Age >=18 years Patient whose primary tumor or metastasis displays mutation of K-Ras (codon 12 and/or 13) Unresectable extrahepatic diseases More than three resectable extrahepatic nodules Size of extra hepatic nodules > 1 cm Prior HAI of the 3 drugs More than 2 prior surgical attempts for metastatic disease Prior radiotherapy for metastatic disease Known documented intolerance or hypersensitivity to any of the drugs used Sensory neuropathy grade 3 (National Cancer Institute-Common Terminology for Adverse Events -NCI-CTCAE, Version 3.0) Past or current history (within the last 2 years prior to treatment start) of malignancy other than colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) | 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, Hepatic Insufficiency Key Male and female subjects aged 18 to 70 years, with hepatic impairment conforming to Child-Pugh class A, B or C Healthy subjects to the extent possible matched to the first four hepatically impaired subject in each Child-Pugh class with regard to age (approximately ± 10 years), body weight (approximately ± 20%) and gender Key History of esophageal and gastric variceal bleeding within past 6 months Primarily cholestatic liver diseases Active alcoholic hepatitis Stable encephalopathy of >= Stage 2 Presence of severe ascites or edema Presence of hepatopulmonary or hepatorenal syndrome Positive for HCV, unless HCV RNA is undetectable | 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): 18.0-65.0, Alcoholic Hepatitis Patient consent Chronic alcohol intake in the last 3 to 6 months Maddrey score ≥ 32 Liver histology compatible Hepato renal syndrome Hepatocarcinoma Recent variceal haemorrhage Recent bacterial infections Other liver diseases associated (HCV, HBV, hemochromatosis, AIH) Cancers or cardiac and respiratory, HIV infection NAC Allergy No patient consent Acetaminophen intoxication | 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, Mild Hepatic Encephalopathy Confirmed cirrhosis of any cause 2. Abnormal RBANS global summary score 3. Grade 0 or 1 hepatic encephalopathy by West-Haven Scale 4. MELD score < or = 25 5. Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control Previous participation in any trial involving AST-120 2. History of TIPS or surgically created portocaval shunt 3. Treatment for overt HE within the past 3 months 4. Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days 5. Active alcohol abuse 6. Psychosis or organic brain syndromes due to alcohol or other causes 7. Use of interferon and sedating or cognition-altering drugs 8. Undergoing chemotherapy or radiotherapy for the treatment of cancer 9. Active GI bleeding within the past 3 months 10. Presence of an active infection 11. Presence of signs and symptoms of severe dehydration 12. Other major physical or major psychiatric illness within the past 6 months 13. Pregnant, breast feeding, or planning to become pregnant during the study 14. Using hormonal contraception as the only method of birth control | 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, Post Liver Transplantation Weight Gain Post Liver Transplantation Obesity Nonalcoholic Steatohepatitis Adult liver transplant recipients Those who have undergone one liver transplantation during 3 months before the time of inclusion Ability to communicate in English (to be able to independently follow directives and record their activities in recall diaries) Patients under 18 years old refusal to give a written consent to participate in the study Those who received liver graft more than 3 months before time of Significant cardiovascular or musculoskeletal health problems interfering with basic physical activity Any manifestations of hepatic failure such as ascites and hepatic encephalopathy Patients will be removed from the study if they develop intolerance to the dietary and physical recommendations (e.g. remarkable fatigue) | 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): 18.0-85.0, Hepatic Encephalopathy Cirrhosis of the liver Hepatic encephalopathy stage>1 Completion of a standardized protocol to investigate precipitating factors Informed consent by next of keen Pregnancy Terminal liver disease (advanced liver disease and performance status 3-4 prior to the episode of acute encephalopathy) Need of advanced life support (mechanical ventilation, ionotropic support, dialysis) Need of albumin administration (e.g. bacterial spontaneous peritonitis) Contraindication for albumin administration (e.g. cardiac 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): 18.0-70.0, Hepatic Encephalopathy Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency Hepatic encephalopathy grade 1 to 4 Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin) Psychoactive substance use within 72 hours | 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, Esophageal Varices patients identified with grade I and grade II esophageal varices by conventional endoscopy who are returning for screening or surveillance patients who have had endoscopic banding of varices in the past patients aged 18 years or older patients able to give consent patients eligible and willing to undergo upper endoscopy and PillCam ESO capsule endoscopy dysphagia Zenker's diverticulum pregnancy esophageal stricture gastric or intestinal obstruction multiple abdominal surgeries cardiac pacemakers implanted electronic medical devices cognitive impairment also, patients found to have bleeding, requiring banding, or other complications on screening EGD the day of the trial will not proceed to capsule endoscopy | 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, Hepatic Encephalopathy Cirrhosis of the liver Recovery from an episode of hepatic encephalopathy within two months prior to inclusion Compliance with a standard diet during two weeks prior to inclusion End-stage cirrhosis (MELD score > 25) Marked cognitive disorder (mini-mental test < 27) Non-treatable hepatocarcinoma in accordance with Milan criteria Comorbid conditions with a life expectancy less than 6 months Neurological conditions that difficult assessment of treatment of hepatic encephalopathy (dementia, encephalitis, severe depression) Diseases requiring administration of a specific diet (malabsorption, chronic diarrhea, chronic pancreatic insufficiency, severe obesity) No acceptation of written 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): 18.0-70.0, Hepatocellular Carcinoma Eligible patients those with HCC based on the diagnostic of European Association for the Study of the Liver (EASL), either confirmed cyto-histologically or confirmed non-invasively (restricted to cirrhotic patients) by radiological (two coincident imaging techniques and focal lesion > 2 cm with arterial hypervascularization) or combined (one imaging technique associated with AFP, focal lesion > 2 cm with arterial hypervascularization, and AFP levels > 400 ng/ml) They have Child-Pugh grade A cirrhosis and are HBsAg-positive for more than 6 months These patients are not feasible for other conventional treatment modalities of treatment including surgery, transarterial embolization, ethanol injection, and radiofrequency ablation No systemic anti-cancer therapy with high priority is available All of the above 3 should be judged by the caring physician All intrahepatic disease must be encompassed within the radiation fields, except intrahepatic diseases outside the radiation field(s) have been controlled by other treatment modalities before radiotherapy Karnofsky Performance Scale ≧ 80 Age > 18 Adequate bone marrow function, defined as follows Absolute neutrophil count (ANC) > 1,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study Prior invasive malignancy, other than HCC, (except nonmelanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields Tumor thrombosis in the main trunk of portal vein, hepatic vein, or inferior vena cava Child-Pugh grade B or C cirrhosis Extrahepatic metastasis Clinical ascites that requires diuretic treatment or paracentesis for symptom relief Serum alanine aminotransferase (ALT) level > 5X normal upper limits or total bilirubin level > 3.0 Active hepatitis (serum ALT level > 5X normal upper limits) or clinically significant liver failure Positivity of anti-HCV, pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this is necessary because the treatment involved in this study may be significantly teratogenic | 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, Hepatic Encephalopathy Consecutive patients aged > 18 years With hepatic encephalopathy Informed consent signed by their families Portal bypass surgery Cancer of any localization Known malignancy and other severe diseases which shorten life expectancy < 6 months Psychiatric illness | 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): 2.0-75.0, Non Cirrhotic Portal Hypertension Patients with Non Cirrhotic Portal Hypertension (NCPH) presenting to our Liver Diseases Follow-up Clinic with history of hemetemesis and/or malena within the past 6 weeks and proven to have esophageal varices as the bleeding source on upper GI endoscopy A history of surgery for portal hypertension Patients already on a EST, EVL, or glue injection program before presenting to our hospital Patients already on beta blockers for primary prophylaxis of variceal bleed Severe cardiopulmonary or renal disease Bradycardia (basal heart rate, <50 beats per minute [bpm]) or complete heart block A history of severe side effects or contraindications to β blockers, like bronchial asthma, diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, or arterial hypotension (systolic blood pressure <90 mm Hg) Refusal to give informed written consent to participate in the trial Patients bleeding from gastric varices or Portal Hypertensive Gastropathy (PHG) Patients who had a failure of primary hemostasis during acute bleed were also 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): 18.0-120.0, Liver Cancer Diagnosis of hepatocellular carcinoma (HCC), as defined by 1 of the following Tissue histology Recurrence of previously resected HCC does not require tissue confirmation if there is clear radiographic recurrence, in the judgment of the investigator AFP > 400 ng/mL with compatible mass on MRI Locally advanced disease Not eligible for surgical resection or immediate liver transplantation OR have refused such procedures All disease must be amenable to embolization in one or two procedures Measurable disease, according to modified HCC Must have radiographically documented measurable disease with at least one site of disease that is unidimensionally measurable as ≥ 10 mm on MRI Lesions previously treated by radiofrequency ablation should not represent the only site of measurable 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, Hepatic Insufficiency Male and female subjects aged 18 to 70, with hepatic impairment conforming to Child-Pugh class A,B or C Each matched control subjects determined to be healthy History of esophageal and gastric bleeding within the past 6 months Primarily cholestatic liver disease Active alcoholic hepatitis Stable encephalopathy of ≥Stage 2 Presence of severe ascites or edema Presence of hepatopulmonary or hepatorenal syndrome Positive for HIV Positive for HCV, unless HCV RNA is undetectable | 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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also 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): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 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 cirrhosis of any etiology, diagnosed by ultrasound,clinical and / or histologic Patients over 18 years and under 75 Patients with hepatic encephalopathy grade 3-4 according to the of West Haven Patients with hyperammonemia >35 µmol/l Evidence of other neurological or psychiatric abnormality Renal failure (serum creatinine greater than 3 mg / dL) Use of drugs affecting the central nervous system Withdrawal Syndrome | 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, Chronic Hepatitis C Infection Chronically infected patients with Hepatitis C virus Genotype 1 (1a or 1b) with detectable viremia (HCV RNA in blood) for more than 6 months and naïve to treatment Patients must have compensated liver disease, with no history of ascites, jaundice, hepatic encephalopathy or bleeding from esophageal or gastric varices requiring beta-blockers No histological evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 24 months prior to baseline; or on a FibroScan® performed within 6 months prior to treatment which indicates the absence of liver cirrhosis, i.e., stage < F4 (METAVIR); in case of no available results, a liver biopsy will be performed prior to treatment All laboratory parameters must be grade 0 or 1 (as per CTCAE criteria) except for alanine amino-transferase (ALT), aspartate amino-transferase (AST), gamma glutamyl transferase (GGT) and alkaline phosphatase (ALP) for which a grade 2 will be allowed if stated non clinically significant No co-infection with Human Immunodeficiency Virus (HIV) or hepatitis B virus (HBsAg positive) No intravenous (IV) drug or alcohol abuse Serum thyroid stimulating hormone (TSH) levels within normal ranges, regardless of treatment with L-thyroxin Normal electrocardiogram (ECG) Normal retinal examination (eye fundus) within last 12 months for diabetic patients or patients suffering from high blood pressure Negative pregnancy test in women of childbearing potential (a woman who is two years post-menopausal or surgically sterile is not considered to be of childbearing potential) Prior treatment for hepatitis C Malignancy within the last 5 years; except for patients with history of squamous cell skin cancer or basal cell skin cancer who will be enrolled, unless patients have a history of skin cancer at the vaccination site Diagnosed or suspected hepatocellular carcinoma History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Patients with mild to moderate depression in the past and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator's opinion, they are suitable for treatment Serious, concomitant medical disorder, including active systemic infection and proven or suspected immunosuppressive disorder History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogenic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia Administration of any vaccine or immunoglobulin within 30 days before the first dose of TG4040 /SOC Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled arterial or ventricular cardiac arrhythmias) Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first TG4040/SOC administration; corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed Any known allergy to interferon (IFN), RBV and/or their excipients | 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 Gastropathy Esophageal Varices Spontaneous Bacterial Peritonitis Hepatic Encephalopathy Ascites Between 18 and 80 years old With liver cirrhosis diagnosed by previous biopsy or by clinical and analytical image No esophageal varices (or with small varices without red signs) in a recent videogastroscophy (<3 months before randomization) Absence of ascites demonstrated by a recent ultrasound (<3 months before the randomization) informed consent previous decompensation of liver cirrhosis associated with portal hypertension GPVH <10 mmHg Portal axis thrombosis affecting the portal trunk or main hepatic branches, or the splenic or mesenteric vein Hepatocellular carcinoma demonstrated by two imaging tests Bilirubin> 3 mg / dl (or> 50 micromol / l), platelets <30 x10E9/lo Quick <30% Presence of renal insufficiency (serum creatinine> 2 mg / dl or> 200 micromol / l) Any comorbidity involving a therapeutic limitation and / or a prognosis of life <12 months Absolute contraindication to treatment with β-blockers (severe bronchospasm, stenosis aortic A-V block, intermittent claudication, severe psychosis, bronchial asthma) Hypersensitivity to β-blockers Pregnancy or lactation | 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): 35.0-70.0, Alcoholic Cirrhosis to 70 years old Compensated cirrhosis or not Caucasian origin of the parents Patient with cirrhosis (histological proof or obvious) HIV, HBV, HCV positive Known Homozygotia (C282Y+/+) Important hepatocytary iron overload for patient with resection HCC non histologically prooved | 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): 18.0-70.0, Hepatitis Main 1. Male and female patients with 18-70 years of age 2. Liver biopsy findings consistent with the diagnosis of NASH with or without compensated cirrhosis within one year before baseline 3. Compensated liver disease 4. Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug 5. All fertile males and females must be using two forms of effective contraception during treatment during the 3 months after treatment. 6. ALT level between 1.3-5 x ULN for 2 occasions during 6 months before screening. 7. HbA1C ≦ 8.0 during screening Main Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months before baseline. 2. History or other evidence of a medical condition associated with chronic liver disease other than NASH (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, > 20 g/day for female or > 40 g/day for male, toxin exposures) 3. hepatocellular carcinoma 4. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease 5. Serum creatinine level >1.5 times the upper limit of normal at screening and calculated creatinine clearance as calculated by Cockcroft and Gault < 60mL/min during screening 6. History of ischemic heart disease during screening 7. New York Heart Association (NYHA) Functional Class 1-4 cardiac status during screening 8. Albumin <3.2g/dL during screening 9. Total bilirubin >1.2 x ULN during screening. Patients with history of asymptomatic indirect hyperbilirubinemia whose total bilirubin < 2 x ULN and direct bilirubin < 20% of total bilirubin could be included. 10. History of prothrombin time > 15 seconds or International normalized ratio (INR) > 1.3 11. Organ, stem cell, or bone marrow transplant 12. History of serious concurrent medical illness that in the investigator's opinion might interfere with therapy this includes significant systemic illnesses (other than liver disease) such as chronic pancreatitis 13. Active systemic autoimmune disorder 14. Pregnancy (or lactation) or, in subjects capable of bearing children, inability / unwillingness to practice adequate contraception 15. Females of child-bearing potential (post-puberty) unwilling or unable to have pregnancy testing at any study visit 16. Therapy with a systemic antiviral agent (with the exception of prophylaxis or treatment of influenza or chronic HSV) within the past 30 days prior to screening. 17. Concurrent participation in another clinical trial in which the subject is or will be exposed to another investigational or a non-investigational drug or device within 6 weeks of the screening visit 18. Current therapy with insulin within 1 week prior to screening. 19. Experienced use with PPARg agonist (e.g., rosiglitazone, pioglitazone) within 6 months prior to screening. 20. Known hypersensitivity to any component of PPARg agonists 21. A history of hepatotoxicity to TZDs and/or a history of severe edema or a medically serious fluid-related event associated with the use of TZDs 22. History of metformin use within 3 months prior to screening. 23. Type Ⅰ diabetes 24. Seropositive of HBsAg, anti-HCV or anti-HIV during screening or 3 month prior to screening | 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, Hepatic Encephalopathy Hypertension, Portal Liver Cirrhosis Hepatic cirrhosis or portal hypertension Hepatic Encephalopathy Acute liver failure Neuropsychiatric diseases Inflammatory bowel diseases Intestinal obstruction Shock Renal insufficiency Alcoholic hepatitis Alcohol abuse Antibiotic premedication | 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, Renal Tumors Ages of 18 to 80 years Urine pregnancy test negative for women of childbearing potential prior to surgery Subject is able to comply with the study procedures A CT or MRI preoperative assessment of renal cortical tumor The renal tumor must be stage T1a-b Written informed consent Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin >1.5 X normal and/or SGOT >2X normal Subject has uremia, serum creatinine >2.0 mg/dl Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure Subject is pregnant or lactating Subjects actively participating in another drug, biologic and/or device protocol The presence of medical conditions contraindicating general anesthesia or standard surgical approaches | 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): 20.0-70.0, Liver Cirrhosis Patients with Primary hepatocellular carcinoma combined liver cirrhosis (Hepatitis B, C, Non-B Non-C) 2. Planned to right hepatectomy or extended right hepatectomy 3. Patients who need right portal vein embolization due to unsufficient expected remnant liver volume (< 40%) or severe hepatic dysfunction (ICG R15 > 10%) 4. Child A classification 5. ICG R15 < 25% 6. Age: 20 years old 7. Expected life period > 3months 8. The patients who agreed to this study Patients who planned liver transplantation 2. Age < 20 or > 70 years old 3. Pregnant women 4. Patients on acute infection 5. Acute hepatic failure 6. Child class B or C 7. Heart failure 8. Existence of bleeding tendency : platelet < 30,000, INR > 2.2, Cr >2.5 9. Patients who did not agree to 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): 18.0-70.0, Hepatic Encephalopathy Patients diagnosed as having cirrhosis of liver at the Inpatient/Outpatient Liver Clinic of Department of Hepatology, Chandigarh, will be candidates for enrollment The diagnosis of cirrhosis of liver will be based on clinical, biochemical, and ultrasonographical or liver histological data Alcohol intake during the past 6 weeks Hepatocellular carcinoma Previous transjugular intrahepatic portosystemic shunt or shunt surgery Significant comorbid illness such as heart, respiratory, or renal failure Any neurologic diseases such as Alzheimer's disease, Parkinson's disease, and nonhepatic metabolic encephalopathies Patients on psychoactive drugs, such as antidepressants or sedatives Those who restart alcohol consumption during follow-up will also be excluded | 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): 12.0-75.0, Cirrhosis Varices, Esophageal Consecutive patients of cirrhosis with portal hypertension who fulfill the following 1. Diagnosed cases of cirrhosis (by clinical, biochemical and radiological with or without liver biopsy) 2. No history of upper GI bleeding in the past 3. Endoscopically documented large esophageal varices history of gastrointestinal bleeding 2. patients who have received beta blockers for portal hypertension in the past 6 weeks. 3. hepatic encephalopathy 4. ongoing bacterial infection, 5. Spontaneous bacterial peritonitis 6. active alcoholism or illicit drug abuse 7. alcoholic hepatitis 8. Treatment with antibiotics in the preceding 2 weeks. 9. presence of hepatocellular carcinoma, 10. portal vein thrombosis 11. serum creatinine>1.5 mg/dL, 12. treatment with vasoactive drugs in the past 6 weeks, 13. history of arterial hypertension, congestive heart failure or arterial occlusive disease, and 14. Refusal to participate. 15. Active smokers | 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, Hepatic Cirrhosis Minimal Hepatic Encephalopathy Hepatic Cirrhosis Minimal hepatic Encephalopathy Personal history of surgery in the last 4 weeks Use of neuropsychiatric drugs Neuropsychiatric disorders (Schizophrenia, bipolar disorder, major depression, dementia and Attention-deficit hyperactivity disorder) Thyroid disorders without replacement therapy Hepatic or renal transplant Alcoholism with active ingest of alcohol in the last 6 months Pregnancy Labour turn-overs Spontaneous bacterial Peritonitis Personal history of 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, Helicobacter Infection patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy pregnant or nursing woman serious concomitant illness and malignant tumor of any kind history of hypersensitivity to test drugs serious bleeding during the course of this ulcer previous gastric surgery receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month | 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, Hepatic Encephalopathy cirrhotic patients(18-70yrs) who never had encephalopathy history of taking lactulose in the past 6 weeks alcohol intake during the past 6 weeks hepatocellular carcinoma previous TIPS or shunt surgery significant co morbid illness such as heart, respiratory, or renal failure neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies patients on psychoactive drugs such as antidepressants or sedatives who restarted alcohol during follow up | 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, Hepatic Encephalopathy Patients with cirrhosis and previous history of recovery from hepatic encephalopathy history of taking lactulose in the past 6 weeks alcohol intake during the past 6 weeks or during follow up patients on secondary prophylaxis for spontaneous bacterial peritonitis previous TIPS or shunt surgery significant comorbid illness such as heart, respiratory, or renal failure any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies | 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): 18.0-99.0, Hepatitis C HIV A subject must satisfy all of the following to be eligible to participate in this study: 1. Latino ethnicity. Latino ethnic background will be defined as a geographic, historical, and cultural heritage shared among persons from Spanish-speaking countries in South and Central America, Mexico, and the Caribbean. Both parents and all grandparents of the participant have to be Latino, with Spanish as the primary language. Participants have to be white; native aboriginal Indians, Asians, and blacks will be excluded. 2. Age greater than or equal to 18 years. 3. Documentation of hepatitis C infection by demonstration of a positive test for hepatitis C antibody and HCV RNA level of greater than or equal to 2,000 IU/mL. 4. Documentation of HIV-1 infection in the second group of co-infected participants by a licensed enzyme-linked immunosorbent assay and confirmed by a Western blot or by HIV polymerase chain reaction positive. 5. Participants with HIV: CD4+ cell counts greater than or equal to 100 cells/mm(3) or CD4+ cell percentage greater than or equal to 14%. 6. Ability to provide informed consent and willingness to comply with the study requirements, storage of blood samples and clinic policies. 7. Participants must have a primary care physician managing medical problems. 8. For HIV infected participants, care provided by a primary physician must be consistent with the current DHHS guidelines. For those on therapy, HAART will be provided by their physician. 9. Willing to undergo genetic testing 10. About to start HCV treatment (with or without direct acting agents DAAs) A subject will be ineligible to participate in this study if any of the following are met: 1. Unable to comply with research study visits 2. Have any condition that the investigator considers a contraindication to study participation. 3. Pregnant or breastfeeding women. 4. Patients with poor venous access | 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, Cirrhosis Portal Hypertension Esophageal Varices Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B. 2. presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment 3. age ≥ 18 years pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control allergic to sandostatin high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs) Child Turcotte Pugh Class C cirrhosis hepatocellular carcinoma evidence of ongoing alcohol or illicit drug abuse within 6 months of the study serum creatinine greater than 2 mg/dL platelet count below 50,000 per microliter prothrombin time 4 seconds or more greater than control human immunodeficiency virus (HIV) positive | 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, Acute Gastritis Gastric Ulcer Age is over 18 years old , men or women 2. Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs; 3. Signed the informed consent forms Patients without 2. Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease 3. Patients with other digestive diseases. 4. Patients with operation on stomach and duodenum. 5. Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids 6. Patients with severity trauma, surgery, infection and shock. 7. Patients with any kind of tumor 8. Women either pregnant or breast feeding | 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, Cirrhosis Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously Any contra-indication to beta-blockers Any EVL or sclerotherapy within last 3 months Child Turcotte Pugh (CTP) score > 12, refractory ascites, hepatorenal syndrome Any past history of surgery for portal hypertension Significant cardio or pulmonary co-morbidity Any malignancy that affects survival Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis Past history of surgery for portal hypertension Uncontrolled diabetes Peripheral vascular 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): 19.0-65.0, Hepatobiliary Diseases Healthy Controls Male or female, age 19-65, no apparent signs of hepatobiliary diseases Levels higher than 50, 56, 78 U/L for ALT, AST, and GGT, respectively. Patient Population Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases MELD score less than 6 | 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, Alcoholic Cirrhosis age ≥ 18 years histologically proven cirrhosis no previous HCC (treated or not ) excessive consumption of alcohol, considered as the main cause of cirrhosis signed informed consent serious associated short-term life threatening disease (except associated HIV viral infection and the liver disease itself) decompensation of cirrhosis (bleeding or ascites) co-infection with HBV or HCV liver focal lesion suggestive of HCC Child Pugh score ≥ 7 (Class B or C) patient under guardianship pregnant women inability to regular monitoring, for whatever reason | 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, Acid Peptic Disorder Adult subjects (18-65 years) suffering from acid peptic disorder (APD), diagnosed endoscopically (reflux esophagitis, gastritis and peptic ulcer) 2. Must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study specific procedures. 3. If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control: 1. Total abstinence from sexual intercourse (minimum one completed menstrual cycle) 2. A vasectomized partner 3. Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration. 4. Intrauterine device (IUD) 5. Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams) Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or bleeding 2. Subjects who have a history of use of any antisecretory drug within past 7 days prior study Day 0 3. Subjects with cardiac, neurological, renal or hepatic dysfunction 4. Past history of significant sensitivity or contraindication to study drug 5. Pregnant or breast-feeding female 6. Any condition that, in the opinion of the Investigator, does not justify the subject's for 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, Hepatic Encephalopathy Cirrhosis Age 18-80 Hepatic encephalopathy grade II-IV Informed consent Degenerative CNS disease or major psychiatric illness 2. Serum creatinine > 1.5 mg/dl 3. Active alcohol intake <4 weeks prior to present episode 4. Others metabolic encephalopathies 5. Hepatocellular Carcinoma 6. Severe comorbidity such as CHF, Pulmonary disease, Neurological & Psychiatric problems impairing quality of life | 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, Chronic Chronic HCV infection ALT >1.5 but <10 times upper limit of normal Decompensated or severe liver disease defined by one or more of the following Prior liver biopsy showing cirrhosis International Normalized Ratio (INR) greater than or equal to 1.5 Total bilirubin greater than or equal to 1.5X ULN, or >2X ULN for unconjugated bilirubin Serum albumin below normal ALT or aspartate aminotransferase (AST) >10 x ULN Evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices Presence of human immunodeficiency virus (HIV) Co-infection with hepatitis B virus (HBV) Co-infection with Epstein Barr Virus (EBV) and/or Cytomegalovirus (CMV) | 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): 12.0-75.0, Acute Bleeding Esophageal Varices Portal Hypertension Cirrhosis Clinical diagnosis of portal hypertension Having hematemesis and/or melena within 24 hour prior to admission Source of bleeding should be esophageal varices Non-cirrhotic cause of portal hypertension Age <12 or >75 years Hepatic encephalopathy grade 3 or 4 Renal failure with serum creatinine >2 mg/dL Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers) Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital Patients with history of surgery for portal hypertension or TIPS Concomitant severe cardio-pulmonary disease Concomitant malignancy | 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, Hepatic Encephalopathy Cirrhosis Portosystemic Encephalopathy PSE Ages 18-80 2. Male and female subjects of all races and ethnicities including Spanish speaking subjects 3. Cirrhosis of any cause 4. Any grade of hepatic encephalopathy (1-4) 5. A legally authorized representative has to be able and willing to comply with all protocol procedures and to understand, sign and date an informed consent document, and authorize access to protected health information on the subjects behalf Acute liver failure 2. Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) 3. Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy) 4. Previous use of rifaximin or neomycin in past 7 days 5. Prisoners 6. Pregnancy 7. <18 years old 8. Serum sodium <125 mEq/L 9. Receiving > 1 dose of lactulose prior to enrollment 10. Uncontrolled infection with hemodynamic instability requiring vasopressors | 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, Hepatitis C Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to: 1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or, 2. liver biopsy consistent with chronic HCV infection. 2. HCV genotype 1 infection confirmed by genotypic testing at screening. 3. Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection. 4. HCV RNA = 1,000 IU/mL at screening 5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months of the screening visit. Note: If cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before enrolment need not be repeated. Biopsies can be waived for patients who would be placed at risk from the procedure. Inability to do a liver biopsy should not patients from a trial. 6. Age 18 to 70 years 7. Female patients: (c) with documented hysterectomy, (d) who have had both ovaries removed, (e) with documented tubal ligation, (f) who are post-menopausal with last menstrual period at least 12 months prior to screening, or (g) of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin. Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance and intra-uterine device. Male patients: 1. who are documented to be sterile, or 2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. 8. Signed informed consent form prior to trial participation HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. 3. HIV co-infection. 4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag. 5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) 6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months 7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient¿s ability to participate in this study. 8. Usage of any investigational drugs within 28 days prior to screening, or planned usage of an investigational drug during the course of this study. 9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 28 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened. 10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to screening and throughout the treatment phase. 11. Known hypersensitivity to any ingredient of the study drugs. 12. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2). 13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following: 1. International normalized ratio (INR) of =1.7 2. Serum Albumin =3.5 g/dL 3. Serum total bilirubin =2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilberts syndrome). 14. Pre-existing psychiatric condition that could interfere with the subject¿s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years | 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): 25.0-89.0, Pneumococcal Infection Able to understand and give informed consent. 2. Immunocompetent community dwelling subjects between the ages of ages of 25-40 and 60-89 years Prior vaccination with pneumococcal vaccine. 2. Receipt of any of the following products: 1. Blood products within 3 months prior to study entry or expected receipt at any time after study entry*. 2. Any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry*. 3. Any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry*. 3. Presence of co-morbidities or immunosuppressive states such as Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, cerebrospinal fluid leaks, severe kidney disease, autoimmune diseases, severe gastrointestinal diseases and grade 4 hypertension per CTCAE criteria** Alcohol, drug abuse or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data Impaired immune function or known chronic infections including, but not limited, to known HIV, hepatitis B or C; organ transplant; immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids*** (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids**** or any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia and congenital immunodeficiency. 4. Conditions that could affect the safety of the volunteers such as: o Severe reactions to prior vaccinations. o An allergy to any component of the study vaccines (phenol, aluminum, CRM197 protein, succinic acid, Polysorbate 80) History of Guillain-Barré syndrome History of bleeding disorders. 5. Volunteers with any acute illness* including, but not limited to fever (> 100.4 F [> 38 C], regardless of the route) within 3 days prior to study entry. 6. Volunteers with social conditions or occupational conditions or any condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation. 7. Pregnant or breast feeding or women expected to conceive within 30 days after vaccination ***** An individual who initially is excluded from study participation based on one or more of the time-limited (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria Grade 4 hypertension per CTCAE is defined as Life threatening consequences(e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis) urgent intervention indicated. ***Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months | 1 |
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