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60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Cirrhosis, Liver Decompensated Cirrhosis of liver irrespective of etiology Acute on chronic liver failure (fulfilling either APASL or of ACLF) Splenic diameter of more than 18 cm Concomitant HCC or other active malignancy Upper gastrointestinal bleeding in the previous 7 days Portal vein thrombosis Severe renal dysfunction as defined by creatnine > 1.5mg/dl Severe cardiac dysfunction Uncontrolled diabetes (Hb A 1c ≥ 9) or diabetic retinopathy Acute infection or disseminate intravascular coagulation Active alcohol abuse in last 3 months | 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, Portal Hypertension Clinically Significant Portal Hypertension Chronic liver disease (including all etiologies of liver disease) Patient is able to give informed consent for this study Patients preferably (but not necessarily) underwent/will undergo: 1. Liver biopsy (percutaneous or transjugular or surgical) performed within 6 months, as part of routine clinical care and/or HVPG measurement as part of their clinical care (within 6 months) and/or clinically indicated upper gastrointestinal endoscopy. and/or 2. Liver transplant or liver resection performed as part of routine clinical care and/or 3. Medical therapy for portal hypertension or TIPS placement as part of routine clinical care. Control group Healthy volunteers without history of liver disease (will be used for the purpose of image optimization). These subjects will NOT undergo HVPG measurement Age less than 18 years Unable or unwilling to give informed consent Contra-indications to MRI 1. Electrical implants such as cardiac pacemakers or perfusion pumps 2. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants 3. Ferromagnetic objects such as jewelry or metal clips in clothing 4. Pregnant subjects 5. Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions | 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, Hepatic Encephalopathy Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis Abnormal ICT (>5 lures) or abnormal Stroop test (>200 seconds) Baseline Conn score 0 or 1 Infectious etiology of HE has been ruled out those with tense ascites those who do not provide assent life expectancy <3 months TIPS within the past 3 months neurologic disease such as dementia, Parkinson's, structural brain lesions pregnancy intestinal obstruction alcoholic hepatitis active alcohol or substance abuse those without stable social support | 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, Aortopathies Thoracic Aortic Aneurysm Aortic Valve Disease Thoracic Aortic Disease Thoracic Aortic Dissection Thoracic Aortic Rupture Ascending Aortic Disease Descending Aortic Disease Ascending Aortic Aneurysm Descending Aortic Aneurysm Marfan Syndrome Loeys-Dietz Syndrome Ehlers-Danlos Syndrome Shprintzen-Goldberg Syndrome Turner Syndrome PHACE Syndrome Autosomal Recessive Cutis Laxa Congenital Contractural Arachnodactyly Arterial Tortuosity Syndrome Open to external enrollment Subjects with a genetic diagnosis of Marfan Syndrome (MDS), Loeys-Dietz Syndrome (LDS), or Vascular Ehlers-Danlos Syndrome (EDS); (Positive genetic testing or a previous cardiac study required to be eligible) Family members of eligible subjects (Only family members of subjects with syndromic diagnoses are eligible for external enrollment at this time) Closed to external enrollment Subjects with aortic disease including TAA* or dissection, aortic tortuosity, or aortic hypoplasia/stenosis (based on any cardiac imaging modality including echocardiography, CT, MRI, or angiography) Subjects with aortic valve disease (bicuspid, unicuspid, or tricuspid disease) Control subjects having tissue removed during a surgical procedure (e.g. coronary artery bypass graft surgery (CABG), cardiac transplant, etc.) • Inability or unwillingness to provide consent (assent when indicated) | 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, Trans-femoral Amputated Patients Age >18 and <75 years Patients with Trans-femoral Amputations since at least 2 years and suffering from pain and discomfort with the current standard socket prosthesis, i.e., with a baseline VAS score for pain between 3 and 10 or a health-related quality of life (Eq-5D) score < 60 or an SF-36 result below the 50th percentile Amputation due to: 1. Trauma 2. Oncologic disease Written informed consent Trans-femoral amputation due to infection Patients affected by 1. metabolic disease 2. neurologic degenerative disease 3. vascular disease proximal to the amputation 4. body weight >100 kg 5. Hip arthritis of the amputated limb | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-65.0, Cirrhosis Documented cirrhosis with any underlying etiology 2. Hepatic encephalopathy of grade II and above 3. 18 to 65 years of age Acute change in mental status due to a diagnosis other than hepatic encephalopathy 2. Patients who have received lactulose as an anticoma measure before enrollment 3. Patient who have developed encephalopathy post bleed 4. Patients with gut paralysis 5. Patients with tense ascites 6. Patients with altered sensorium due to organic brain disease. 7. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy 8. Hemodynamic instability obviating vasopressors for resuscitation 9. Acute liver failure defined as severe acute liver injury with encephalopathy and international normalized ratio (INR)≥1.5 in a patient without pre-existing liver disease 10. Refusal of 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): 12.0-999.0, Cystic Fibrosis ≥ 12 years of age at the time Informed Consent/ Assent is signed. 2. Weight ≥ 40 kg. 3. FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months. 4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX Severe or unstable CF at screening or Visit 1. 2. Any of the following values for laboratory tests at screening: 1. A positive pregnancy test. 2. Hemoglobin < 10 g/dL in males and < 9 g/dL in females. 3. Neutrophils < 1.0 x 10^9 /L. 4. Platelets < 75 x 10^9/L. 5. Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation. 6. Serum transaminases > 2.5 x upper limit of normal. 3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments | 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 Hepatitis C Virus Infection, Response to Therapy of aged between 18 and 65 years (inclusive) and of either sex with a body mass index (BMI) between 18 and 30 kg/m^2 chronically infected with genotype 2 HCV, and the diagnosis of chronic hepatitis C consistent with the Chinese Guideline for Prevention and Management of Hepatitis C HCV RNA equaling to or above 10^4 IU/mL and anti-HCV positivity naive to anti-HCV treatment, defined as being not previously treated with any interferon (including interferon alfa or beta or peginterferon), ribavirin, or other approved, investigational or any other not approved anti-HCV regimens of any source with or without cirrhosis, presence or absence of which must be documented as at lease one item of the following: 1) liver biopsy confirming presence (e.g., Metavir score = 4 or Ishak score >=5) or absence of cirrhosis within twelve (12) months before screening; 2) FibroScan showing cirrhosis (liver stiffness modulus [LSM]>=12.5 kPa) or no cirrhosis (LSM=<9.6 kPa); 3) a subject with a LSM of 9.6-12.5 kPa (exclusive) could only be enrolled when the liver biopsy confirmed or excluded presence of cirrhosis women of childbearing potential without a history of menopause and with a negative blood pregnancy test; subjects of childbearing potential (including male subjects and their female partners) had no childbearing plan from screening, initiation of treatment until six (6) months after the end of treatment and consented to use effective contraceptive measures voluntary participation in the study and being able to understand and sign the informed consent form being infected with mixed-genotype HCV having previously used any investigational or experimental direct antiviral agents against HCV, including protease, nonstructural (NS) protein 5B polymerase or NS5A inhibitors, before screening having received any interferon-based anti-HCV regimens before screening having been exposed to any systemic potent immunomodulators , such as steroids or thymosin alfa (excluding use of nasal, inhalational, topical steroids and/or others) for more than two (2) weeks within six (6) months before screening, or anticipated to be exposed to these agents during the study period being coinfected with hepatitis B virus (HBV) or human immunodeficient virus (HIV) with evidence of decompensatory liver function, including but not limited to total serum bilirubin (TBIL) above twice (2) of the upper limit of normal (ULN), serum albumin (ALB) below 35 g/L, or prothrombin activity (PTA) below 60%; emergence of ascites, upper gastrointestinal bleeding and/or hepatic encephalopathy; with liver function reserve Child-Pugh class B or C with primary liver cancer confirmed or evidenced by serum alfa-fetoprotein above 100 ng/ml or liver imaging study showing suspected nodules with a previous history of liver disease of other causes, including alcoholic liver disease, nonalcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (anti-nuclear antibody[ANA] titer above 1:100), Wilson disease or hemochromatosis with serum alaine aminotransferase (ALT) or asparate aminotransferase (AST) above ten (10) times of ULN with white blood cell (WBC) count below 3x10^9 per liter, neutrophil count below 1.5x10^9 per liter, platelet count below 50x10^9 per liter, or hemoglobin below the lower limit of the normal | 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, CT Portography Grading of Liver Cirrhosis Patients with cirrhosis and\or portal hypertension diagnosed by; laboratory or radiological parameters Patients with ligation, disconnection or shunting of esophageal varices. Patients with combined hepatic malignant tumor Patients with splenectomy. Patients with renal dysfunction or iodine allergy | 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, Upper Gastrointestinal Bleeding Individuals aged 18 years or older presenting to the Emergency Department with acute overt UGIB, defined as bloody emesis and/or coffee ground vomiting and/or melena within the previous 48 hours Stable for discharge without further testing (Glasgow Blatchford Score of 0 Upper GI bleed with hemodynamic shock (BP <90mmHg and pulse > 120 beats per minute) Active hematemesis High Risk Upper GI Bleed (Glasgow Blatchford Score greater than or equal to 6) Known history of gastric cancer Known history of gastric or esophageal varices GI surgery within the last 6 months Dysphagia, swallowing disorder, Zencker' s diverticulum, suspected bowel obstruction or perforation Gastroparesis, Gastric outlet obstruction, Crohn's disease, past UGI tract surgery | 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 Clinically diagnosed as decompensated liver cirrhosis. 2. Hepatitis B/C Liver Cirrhosis After Viral Treatment, HBV/HCV Viral Loads Below Detection Level over six mouths, and the liver function remained below Child-pugh A grade or MELD score >10. 3. Other causes of cirrhosis, liver function compensatory incomplete. In the past year, despite active medical treatment taken, the condition has continued to increase, at least because of cirrhosis complications such as ascites, spontaneous peritonitis, gastrointestinal bleeding, and hepatic encephalopathy in hospital over one time. 4. Need to intermittently supplement albumin and apply diuretic therapy. 5. Albumin <35 g/L, total bilirubin <170 umol/L, prothrombin activity> 30%; (Prothrombin time <20 s, moderate or lower mass ascites, spontaneous peritonitis and hepatic encephalopathy (grade II or lower), Child-pugh score> 5 points). 6. There was no history of gastrointestinal hemorrhage within the last month and population with no high-risk portal hypertension and gastrointestinal bleeding was evaluated recently. 7. Unconditional acceptance of orthotopic liver transplantation. 8. Aged from 18 to 65 years. 9. Voluntarily signed informed consent form A malignant tumor with liver or other organs or a history of previous cancer. 2. Complications gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes. 3. Patients with severe heart, lung, kidney or blood system diseases and failure status. 4. Pregnant or lactating women. 5. Allergic constitution. 6. There is a history of alcohol abuse, drug abuse, and failure to effectively quit. 7. Patients did not participate in other clinical trials within 4 weeks. 8. Any condition, investigator believe that patients should not participate in this study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 6.0-999.0, Crohn Disease Group 1 Males or females 6-18 years of age Current weight >10 kg (or 22 lb) Ability to swallow pills Normal kidney function Normal Aspartate transaminase (AST), Alanine transaminase (ALT), and alkaline phosphatase Active CD or IBDU defined as PCDAI ≥ 30 C-Reactive Protein (CRP) ≥ 15mg/L (or 1.5mg/dL) or fecal calprotectin (FCP)>350mcg/g (within one month of enrollment) Have been treated with one of the following therapies for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages Known allergy or intolerance to aminoglycosides or any of the medications used in this study Current use of one or more of the following medications: 5-fluorouracil, digoxin, anticoagulants, theophylline, phenytoin, probenecid, duloxetine, clozapine, sildenafil, hydrochlorothiazide, cyclosporine, hypoglycemics, terfenadine, tacrolimus, rifabutin, midazolam, and voriconazole Known diagnosis of diabetes mellitus Known or suspected structuring disease producing obstructive symptoms Active Clostridium difficile infection Prolonged QTc interval as seen on enrollment EKG Current use of antibiotics Starting or increasing the dose of an IBD related medication within 4 weeks of screening Group 2 Males or females 10 years of age and older Patients undergoing a clinical GI endoscopy due to suspicion for active intestinal inflammation determined by physician global assessment (PGA) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Hepatitis E • Patients have clinical diagnosis of acute viral hepatitis as (recent onset of nausea, fever, fatigue, abdominal pain , hepatomegaly and abnormal transaminases (at least 2 fold higher than the upper normal level)) Post-transplant acute hepatitis hepatitis A, B and C patients autoimmune hepatitis Alcoholism Treatment with hepatotoxic drugs Biliary disease Infection with CMV or EBV Taken ribavirin therapy | 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 Ascites Liver Diseases Cirrhosis Adult 18 years or older of age Clinical diagnosis of cirrhosis with ascites. Diagnosis of cirrhosis will be based upon: 1. liver biopsy, OR 2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR 3. 2 of the following 4 i. Ultrasound (US), computerized axial tomography (CT) or Magnetic Resonance Imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites) ii. Fibroscan liver stiffness score >13 kPa iii. Laboratory testing: Aspartate Aminotransferase (AST)/platelet ratio index (APRI) >2.0 iv. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices At least one of the following: Any cause hospitalization within 90 days OR outpatient therapeutic paracentesis within 30 days Language barriers that cannot be surmounted with in-person interpreters Estimated life expectancy < 3 months Pregnancy (self-reported) Unable or unwilling to provide consent History of liver transplant Planned discharge to nursing facility Anuria or serum creatinine > 2.0 mg/dL Uncontrolled hepatic encephalopathy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Cirrhosis Aged 18 years old; 2. Diagnosis of liver cirrhosis (Cirrhosis is diagnosed using standard laboratory, radiological, and physical examination findings, or by liver histology in equivocal cases); 3. Paired noninvasive tests (blood tests, TE, abdominal CT, and/or ultrasound) and endoscopy within 3 months A body mass index > 35; 2. Severe cardiopulmonary diseases, renal failure，acute illness; infectious diseases; 3. Pregnant or breast-feeding subjects; 4. Previous splenectomy or liver transplantation;(文献55) 5. Previous β-blocker therapy; 6. Endoscopic treatments (band ligation or sclerotherapy); 7. Previous surgery for portal hypertension or transjugular intrahepatic portosystemic stent shunt placement; 8. Portal vein or splenic vein thrombosis; 9. Current or past history of hepatocellular carcinoma; 10. Presence of severe ascites that might significantly hamper the accurate assessment of LSM; 11. Unreliable LSM with an interquartile range (IQR) to median value ratio (IQR/M) of > 0.3, a success rate of < 60% , or validated measurements of < 10 | 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, Cirrhosis aged 18-80 years old. 2. confirmed patients with cirrhosis : Cirrhosis is diagnosed using standard laboratory, radiological, and physical examination findings, or by liver histology in equivocal cases 3. paired noninvasive tests (blood tests, TE, and CT/enhanced CT) and gastroscopy within 3 months; 4. The nature of the present study was explained to all patients and informed consent was obtained from each case the presence of severe ascites that might significantly hamper the accurate assessment of LSM , obesity (body mass index>35kg/m2) or intercostal space was too narrow; 2. severe cardiopulmonary diseases, renal failure, acute illness, infectious diseases, acute liver failure or cholestasis or hepatic congestion; 3. malignant tumors or other serious medical diseases (such as hepatocellular carcinoma, gastric cancer, pancreatic cancer and colon cancer) that may reduce expected survival time; 4. non-cirrhotic portal hypertension and those with portal vein thrombosis; 5. previous or ongoing treatment for portal hypertension, spleen diameter<4cm or splenectomy; 6. pregnant women and patients with implanted pacemakers; 7. patients can not cooperate with the endoscopy, CT/enhanced CT, FibroTouch /FibroScan and other related examination | 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): 18.0-55.0, Polycystic Kidney, Autosomal Dominant Male or female adult with Autosomal Dominant Polycystic Kidney Disease (ADPKD) with age at the time the consent is signed: 1. between 18 to 50 years (both inclusive) for patients from Stage 1 2. between 18 to 50 years (both inclusive) for patients from Stage 2 with eGFR between 45 and 89.9 mL/min/1.73 m2 during screening period* 3. between 18 to 55 years (both inclusive) for patients from Stage 2 with eGFR between 30 and 44.9 mL/min/1.73 m2 during screening period.* Diagnosis of AKPKD in patients with a family history will be based on unified Pei criteria. In the absence of a family history, the diagnosis will be based on the presence of renal cysts bilaterally, totaling at least 20, in the absence of findings suggestive of other cystic renal diseases Mayo Imaging Classification of ADPKD Class 1C, 1D or 1E** **Total kidney volume (TKV) must be confirmed by a central reader prior to Visit 3 Estimated glomerular filtration rate between 45 to 89.9 mL/min/1.73 m2 during screening period* (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) for Stage 1 Estimated glomerular filtration rate between 30 to 89.9 mL/min/1.73 m2 during screening period* (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) for Stage 2. *Eligibility will be confirmed by eGFR value from one of the two first pre-randomization eGFR measurements Stable treatment regimen of antihypertensive therapy for at least 30 days prior to the screening visit for hypertensive patient Able to read, comprehend, and respond to the study questionnaires Patient has given voluntary written informed consent before performance of any study related procedures not part of standard medical care Patient does not have access to tolvaptan at the time of study start or tolvaptan is not indicated for treatment of patient according to treating physician (patient does not meet recommended for treatment, refuses to initiate or does not tolerate treatment with tolvaptan) The patient, if female of childbearing potential, must have a negative blood pregnancy test (β-human chorionic gonadotropin [β-hCG]) at the screening visit and a negative urine pregnancy test at the baseline visit Systolic blood pressure >160 mm Hg at Run-in and Baseline visits Administration within 3 months prior to the screening visit of tolvaptan or other Polycystic Kidney Disease-modifying agents (somatostatin analogues) Current participation in another investigational interventional study or use of investigational medicinal product (IMP), within 3 months or 5 half lives, whichever is longer, before randomization The patient has a positive result of any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti HIV1 and anti HIV2 Ab). Patients with a positive hepatitis B surface antibody (HBsAb) test are eligible if other are met (ie, negative tests for: HBsAg, hepatitis B core antibody [HBcAb]). Patients immune due to natural infection (positive hepatitis B surface antigen (HBsAb), negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody [HBcAb]) are eligible if they have negative HBV DNA test A history of drug and/or alcohol abuse within the past year prior to the screening visit. A history of alcohol dependence within the 5 years prior to the screening visit The patient is scheduled for in-patient hospitalization including elective surgery, during the study The patient has a clinically significant, uncontrolled medical condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the condition exacerbated during the study, or that may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities The patient, in the opinion of the investigator, is unable to adhere to the requirements of the study or unable to undergo study assessments (eg, has contraindications to pupillary dilation or unable to undergo magnetic resonance imaging (MRI) [For example: patient's weight exceeds weight capacity of the MRI, ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, large abdominal/back tattoos, etc]) Any country-related specific regulation that would prevent the patient from entering the study The patients did not adhere to treatment (<70% compliance rate) in the run-in | 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, Decompensated Cirrhosis chronic active HCV proved by the positivity of HCV RNA, elevated transaminases CTP score was >9, MELD score was <29 Decompensated cirrhosis with frequent hepatic encephalopathy (HE) or difficult to treat ascites exposure to previous antiviral therapy hepatocellular carcinoma other causes of liver diseases or mixed causes (excessive alcohol consumption, autoimmune liver disease) previous liver transplantation | 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, Systemic Sclerosis Scleroderma Age 18 years old at the time of pre-transplant evaluation 2. An established diagnosis of systemic sclerosis 3. Diffuse cutaneous systemic sclerosis with involvement proximal to the elbow or knee and a modified Rodnan Skin Score of ≥ 14 (see Appendix A) AND Any one of the following: 1. DLCO < 80% of predicted or decrease in lung function (DLCO, DLCO/VA or FVC) of 10% or more over 12 months. 2. Pulmonary fibrosis or alveolitis on CT scan or chest x-ray (ground glass appearance of alveolitis). 3. Abnormal EKG (non-specific ST-T wave abnormalities, low QRS voltage, or ventricular hypertrophy), or pericardial effusion or pericardial enhancement without constriction on MRI 4. Gastrointestinal tract involvement confirmed on radiological study. Radiologic findings of scleroderma are small bowel radiographs showing thickened folds with dilated loops, segmentation, and flocculation +/ diverticula, or pseudodiverticula. A hide-bound appearance may be present (e.g. dilated and crowded circular folds). GI involvement may also be confirmed by D-xylose malabsorption, patulous esophagus on high-resolution computed tomography (HRCT), or esophageal manometry. OR Limited cutaneous systemic sclerosis (SSc) (modified Rodnan Skin Score <14) with lung involvement defined as active alveolitis on bronchoalveolar lavage (BAL), ground-glass opacity on CT scan, a DLCO < 80% predicted, or decrease in lung function (DLCO/VA, DLCO, FVC) of 10% or more in last 12 months. Other for "CAST" Conditioning Regimen (presence of any of the following): 1. Septal flattening or D-sign on MRI (without deep breathing) 2. PASP >40 mm Hg or >45 mm Hg with fluid challenge* 3. mPAP >25 mm Hg or >30 mm Hg with fluid challenge* 4. Non-ischemia diffuse ventricular hypokinesis or non-ischemia wall hypokinesis Fluid challenge is 1000 ml normal saline over 10 minutes. Fluid challenge will not be done if right atrial pressure is >13 mm Hg at rest or pulmonary capillary wedge pressure is >20 mm Hg at rest Active ischemic heart disease or untreated coronary artery disease 2. Untreated life-threatening cardiac arrhythmia on EKG or 24-hour holter 3. Pericardial effusion > 1 cm on cardiac MRI unless successful pericardiocentesis has been performed 4. LVEF <35% 5. End-stage lung disease characterized by TLC<45% of predicted value, or DLCO hemoglobin corrected < 30 % predicted. 6. Creatinine clearance <40 by 24-hour urine 7. History of breast implants that have not been removed (unless they cannot be surgically removed due to risks of surgery) 8. Liver cirrhosis, transaminases >2x of normal limits, or bilirubin > 2.0 unless due to Gilbert's disease 9. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment 10. Prior history of malignancy 11. Positive pregnancy test, inability or unable to pursue effective means of birth control, or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy 12. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible 13. Major hematological abnormalities such as platelet count < 100,000/ul or absolute neutrophil count (ANC) < 1000/ul 14. HIV positive 15. Hepatitis B or C positive 16. PASP >50 mmHg without fluid challenge 17. mPAP >34 mmHg without fluid challenge 18. Coronary artery disease not reversed by cardiology and interventional radiology | 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): 0.0-0.583, Jaundice, Neonatal Neonatal Hyperbilirubinemia Neonatal Disorder Provision of at least one parent/legal guardian's signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Infants born after 35 weeks and 0 days of gestation 4. Infants who developed significant hyperbilirubinemia Infants who developed significant hyperbilirubinemia per BiliToolTM plot requiring phototherapy as determined by the attending neonatologist utilizing the American Academy of Pediatrics' 1. Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation (Bhutani Nomogram) 2. Guidelines for Phototherapy in Hospitalized Infants of 35 or More Weeks Gestation Participants will be screened on the following at the time of enrollment Perinatal asphyxia (Apgar score <4 at 1 minute or <7 at 5 minutes) Respiratory distress Exchange transfusion Major congenital malformations As identified throughout the course of the investigation, additional Direct-reacting component of bilirubin >2 mg/dL Glucose-6-phosphate deficiency ABO incompatibility Evidence of hemolysis | 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 Hepatitis D Age 18 years or above, male or female Presence of anti-HDV in serum Presence of quantifiable HDV RNA in serum at three time pre-treatment points with a mean HDV RNA level >2 log10 above the lower limit of quantification (LLOQ) of the HDV RNA assay Demonstration of chronicity as evidenced by the presence of HDV RNA in serum for >/= 6 months, or presence of Anti-HDV antibody >/= 6months Decompensated liver disease, defined by bilirubin >4mg/dL, albumin <3.0 gm/dL, prothrombin time >2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. Patients with ALT levels greater than 1000 U/L (>25 times ULN) will not be enrolled but may be followed until three determinations are below this level. Patients with an absolute neutrophil count <1000/dL and platelets <75,000/dL will be excluded from the study as well Pregnancy, active breast-feeding, or inability to practice adequate contraception, in women of childbearing potential or in partners of such women. Adequate contraception is defined as vasectomy in male sexual partners of female participants, tubal ligation in women, or use of two contraceptive methods such as condoms and spermicide combination with an intrauterine device or Depo-Provera, or Norplant Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR <50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the NIH psychiatric consultation service), or active coronary artery disease Systemic immunosuppressive therapy within the previous 2 months before enrollment Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, alcoholic liver disease, ongoing drug induced liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency) Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year | 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): 12.0-60.0, Autism Spectrum Disorder Autism Males or females age 12 to 60 years Documented autism spectrum disorder (ASD) diagnosis Verbal IQ >/= 75 (verbal and non-verbal) Informed consent (if adult) or parental/guardian permission (if child or adult with diminished capacity) and, if applicable, assent Participation in pilot virtual reality (VR) study at the Children's Hospital of Philadelphia (CHOP) Personal or family history of seizures or a seizure disorder Primary sensory impairment (e.g., blindness, deafness) Personal or family history of migraines History of vertigo History of strabismus, other eye muscle problems, or eye surgery History of concussion with hospitalization Diagnosis of a known genetic syndrome (e.g., Down syndrome, Fragile X syndrome) History of a medical condition which has affected/affects cognitive, sensory, or motor functioning (e.g., Fetal Alcohol Syndrome, brain injury, stroke, brain tumor) Non-English speaking | 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): 45.0-60.0, Non-alcoholic Fatty Liver Disease Liver Fibrosis Subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily. 2. Subjects without known liver disease. 3. Subjects agree to sign a consent form. - History of right-sided heart failure 2. History of liver disease including positive infectious serology for hepatitis B or C 3. Pregnant women 4. People incapable of judgment - | 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, Cancer Survivor Dysphagia Fibrosis Head and Neck Carcinoma Late Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade >= 2 dysphagia on Modified Barium Swallow (MBS) >= 2 years after curative-intent radiotherapy for head and neck cancer Grade >= 2 Common Terminology for Adverse Events (CTCAE) fibrosis Willing and able to return for 10 sessions over 6 weeks of therapy Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment History of subtotal or total glossectomy or total laryngectomy Functionally limiting cardiac, pulmonary, or neuromuscular disease Current tracheostomy | 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 Varices Liver Cirrhoses Bleeding Esophageal Varices Upper Gastrointestinal Bleeding Adult males and females who are 18 years of age or older. 2. Evidence or suspicion of upper gastrointestinal bleed (GIB) 3. Patient with known or suspected cirrhosis 4. Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation 5. Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so Known upper gastrointestinal malignancy 2. Bleeding from gastric varices, with or without esophageal varices 3. Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation 4. Variceal bleeding in the last 90 days 5. History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery 6. Pregnant females 7. Incarcerated individuals 8. Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks 9. Non-cirrhotic portal hypertension causing esophageal varices 10. Known or suspected allergy to octreotide | 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): 20.0-999.0, Glioblastoma Multiforme Brain Tumor Glioblastoma Glioma Neoplasms Neoplasms, Nerve Tissue Patients diagnosed with recurrent GBM and will undergo surgery Able to give written informed consent for the participation in the trial Adult male/female patients > 20 years of age Patients if already on radiotherapy, a gap of 7 days shall be maintained between the last day of radiotherapy and the day of screening Patients if already on the steroids treatment, then should be on a stable dose of steroids for at least 7 days prior to screening Body mass index (BMI) ≥17 kg / m2 Patients with life expectancy ≥ 3 months Able to comply with study requirements in the opinion of the investigator Adequate hepatic, renal, coagulation, and hematopoietic function Hemoglobin ≥ 10 g/dL Patients at screening visit have arteriovenous malformation (AVM) or cerebral aneurysm Use of any recreational drugs or history of drug addiction Pregnant or breast-feeding women The receipt of an investigational drug, or participation in a drug research study within a period of one month prior to the first FUS exposure Known sensitivity/allergy to MRI contrast agents, CT contrast agents, SonoVue®, or any of its components Any other condition that, in the investigator's judgment, might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints Patients who have hemorrhage or cyst within the ROI Severe hypertension at screening (diastolic blood pressure > 100 mmHg on medication) Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week prior to study treatment or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month prior to study 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): 20.0-65.0, End Stage Liver Disease Acute Kidney Injury living donor liver transplantation recipients previous history of acute kidney injury previous liver transplantation history Fulminant hepatic failure history of TIPS, transjugular intrahepatic porto-systemic shunt | 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): 15.0-79.0, Liver Failure, Acute on Chronic Liver Dysfunction inpatient (hospitalization >1 days)(including patient in emergency observation wards)chronic liver disease patients including non-alcoholic fatty liver disease patients,chronic liver hepatitis patients without cirrhosis, compensated cirrhosis patients and decompensated cirrhosis patients having acute liver injury [ALT(alanine aminotransferase)>3ULN,AST(aspartate aminotransferase)>3ULN or TB(total bilirubin)>2 ULN within 1 week before enrollment] or acute decompensation[having ascites, hepatic encephalopathy, bacterial infection ,gastrointestinal bleeding or jaundice(TB>5NL)within 1 month before enrollment] pregnancy hepatocellular carcinoma or other liver malignancies malignancy of other organs severe chronic extrahepatic disease including chronic obstructive pulmonary disease combined with respiratory failure, coronary heart disease with cardiac function level 3 (NYHA), myocardial infarction in the 3 months before admission, diabetes with severe complications and chronic kidney disease with end-stage renal failure receiving immunosuppressive drugs for reasons other than chronic liver disease | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 40.0-75.0, Diabetes Mellitus, Type 2 Hyperuricemia Men and women ages 40-75 years at randomization BMI between 25.1 and 50 kg/m2 Type 2 diabetes diagnosed > 3 months ago. Patients with T2D will be classified based on physician diagnosis serum uric acid < 5.5 mg/dL (for medication/allopurinol and isocaloric low-fructose diet arm) habitual diet containing low amount of sugars < 5% of total energy intake recent CVD event (stroke, heart failure hospitalization, revascularization or acute coronary event in the last 12 months) abnormal thyroid tests or chronic liver disease stage IV renal disease (GFR <30) hyperparathyroidism use of azathioprine active cancer autoimmune diseases excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for 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, Liver Failure Male or female Age 18 and older Active on the transplant list Donor organ with Antibody and nucleic acid test (NAT) positive for HCV Graft with F2 fibrosis or less at time of explant HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject Participants co-infected with HIV Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known) Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV) Pregnancy and/or actively breastfeeding | 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, Esophageal Varices Bleeding Signed informed consent 2. All cases met the diagnostic for cirrhosis 3. All patients were confirmed to be combined with esophageal and gastric varices through endoscopy or portal vein CTA or abdominal CT, and had at least one history of esophageal and gastric varices rupture and bleeding. Child-pugh was graded as A/B. 4. All patients had basal heart rate greater than 60 beats/min and systolic pressure greater than 90mmhg Patients with liver cancer or other gastrointestinal tumors 2. Patients with splenomegaly due to extrahepatic portal hypertension and noncirrhosis 3. Patients with basal heart rate less than 55 beats/min or systolic pressure less than 90mmhg 4. There are patients with NSBB contraindications such as severe cardiac insufficiency, cardiogenic shock, sinus bradycardia and morbid sinus syndrome, severe ventricular conduction block, bronchial asthma, etc. 5. Patients with other diseases other than liver cirrhosis should take beta blockers (such as coronary heart disease, arrhythmia, etc.). 6. Patient data is incomplete, data cannot be collected and counted 7. Patients who do not agree with secondary prevention after informing them about the adverse reactions associated with medication | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Esophageal Varices in Cirrhosis of the Liver Liver cirrhosis diagnosed by clinical examination, imaging or biopsy A previous history of variceal hemorrhage Written informed consent Previous history of secondary prophylactic treatment Contraindications to treatment of endoscopy, surgery and TIPS Severe cardiac, pulmonary or renal dysfunction Lactating or pregnant Malignancies | 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, HIV Infections Hepatitis B Hepatitis C Hepatocellular Carcinoma HIV-infected individuals with and without HBV or HCV co-infection Positive HIV antibody At least one visit in one of the HIV clinics Subjects with positive HBsAg and/or anti-HBc will be regarded as having HBV co-infection Subjects with positive HCV antibody will be regarded as having HCV co-infection -nil 2. HBV/HCV mono-infected individuals Documented diagnosis of hepatitis B or hepatitis C infection, or Positive HBsAg and/or anti-HBc, or Positive HCV antibody, and Negative HIV antibody result, or no record of HIV diagnosis or anti-retroviral therapy prescription nil | 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, Smoking Cessation Weight, Body Eligible subjects will be males and females: 1. 18 years of age or older who self-report smoking cigarettes (menthol and non-menthol) at least 10 times per day, on average, for the past 6 months. 2. Interested in quitting smoking (defined as "intend to quit within one month"). 3. Body mass index (BMI) greater than or equal to 27 kg/m2 with one weight-related comorbidity (e.g. high blood pressure, high cholesterol, dyslipidemia) or greater than or equal to 30 kg/m2 per the manufacturer label for weight management. 4. Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, intrauterine device (IUD), tubal ligation) or agree to abstain from sexual intercourse during the time they are in the study. 5. Able to communicate (speak, read, and write) fluently in English. 6. Capable of giving written informed consent before any study-related activities, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form. 7. If current or past diagnosis of bipolar disorder, eligible if: 1. No psychotic features 2. MADRS: total score less than 8 (past 4 weeks); suicidal item score less than 1 (past 4 weeks) 3. Y-MRS: total score less than 8 (past 4 weeks); irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks) 4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months 5. No aggressive or violent acts or behavior in the past 6 months Subjects who present with and/or self-report the following will not be eligible to participate in the study. Smoking Behavior: 1. Current enrollment in a smoking cessation program, or use of other smoking cessation medications (e.g. Chantix/varenicline, Zyban/bupropion, nicotine replacement therapy/gum/patch, etc.) in the last month or plans to do either in the next 2 months. 2. Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes. Alcohol/Drug Use: 1. Self-report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months. 2. Current untreated and unstable diagnosis of severe substance use disorder (eligible if past use and/or if receiving treatment and stable for at least 30 days). Current untreated and unstable moderate substance use disorder requires Study Physician approval. 3. A positive urine drug screen for cocaine, methamphetamines, PCP, barbiturates, and/or ecstasy (MDMA). 1. Participants believed to have a false-positive result on the drug screen may continue with the study with investigator approval. Medical: 1. Females who self-report current pregnancy, planning a pregnancy during the study, currently breastfeeding/lactating, or not using adequate contraceptive measures. All female participants will undergo a urine pregnancy test at Intake and at every in-person study visit. 2. Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for at least 30 days). 3. Current or past diagnosis of psychotic disorder, as determined by self-report or MINI. Mood Disorder with Psychotic Features determined by MINI requires PI approval for eligibility. 4. Suicide risk on the C-SSRS indicated by active suicidal ideation (within past 30 days), any suicidal attempt within the past 2 years, or 2 or more lifetime suicidal attempts. 5. Self-reported kidney and/or liver disease or transplant. 6. Heart/Cardiovascular disease (e.g., angina, coronary heart disease, stroke, etc.) in the past 6 months. 7. Type-1 or type-2 diabetes (previously diagnosed or indicated by HbA1c level of 6.5% or higher). 8. Uncontrolled hypertension (BP systolic greater than 159 and/or diastolic greater than 99)*. 9. Personal or family history of medullary thyroid carcinoma (MTC). 10. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 11. History of pancreatitis. 12. History of gallbladder disease. 13. A blood glucose level less than 70 mg/dl at the Intake Visit. 14. Prior history, or plans, of surgical intervention for weight loss. 15. Hypersensitivity to liraglutide or any product components. 16. Current diagnosis of hyperthyroidism or hypothyroidism (requires thyroid function test review by SP to determine eligibility) 17. Recent weight loss (more than or equal to 5% body weight) in the past 3 months Participants presenting with SBP greater than 159 mmHg and/or DBP greater than 99 mmHg at the Intake visit will be instructed to sit quietly for 10 minutes. Then the participant will have a second blood pressure reading taken after a 10 minute period. If, after the second reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be instructed to sit comfortably for 10 minutes and then have a third blood pressure reading. If, after the third reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be ineligible to participate. Medications: 1. Current or recent use (last 14 days) of weight loss medication, and/or use of medications known to impact weight (e.g. corticosteroids, excluding inhaled). General 1. Current, anticipated, or pending enrollment in another research program over the next 2-3 months that could potentially affect subject safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician. 2. Not planning to live in the area for the next 9 months. 3. Previous participation in this trial (i.e., previously randomized and started study medication). 4. Any impairment (physical and/or neurological) including visual or other impairment preventing ability to complete study tasks. 5. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator | 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, Gastroesophageal Varices Liver Cirrhosis Patients over 18 years of age；Past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination Patients who are not suitable for endoscopic treatment judged by the clinician; Patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; Patients with acute hemorrhage | 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, Cirrhosis, Liver Portal Hypertension Esophageal Varices Gastric Varix Gender is not limited. 2. Patients aged 18 years or older. 3. Both inpatients and outpatients. 4. Clinically evident or biopsy-proven liver cirrhosis, without previous diagnosis of gastroesophageal varices but with clinical indication for screening endoscopy for the detection of varices, or with prior endoscopic diagnosis of gastroesophageal varices and indication for surveillance endoscopy. 5. Able to provide informed consent Patients aged less than 18 years. 2. Patients with active upper gastrointestinal bleeding. 3. Patients who have participated in or are participating in other clinical trials within three months. 4. Patients with cancer on active treatment with chemotherapy and/or radiation therapy. 5. Pregnancy or suspected pregnancy. 6. Suspected or known intestinal stenosis or other known risk factors for capsule retention. 7. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance. 8. Patients with dysphagia. 9. Life-threatening conditions. 10. Patients who refuse to undergo or can't tolerate EGD. 11. Patients whose consents for removal of remained ds-MCE are unable to be 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): 18.0-65.0, Liver Cirrhosis Adult patients between 18 and 65 years NASH (Non Alcoholic SteatoHepatitis) cirrhosis BMI > 30 and failure to control weight despite full dietary and life style modifications Compensated : CTP 6 & 7 without any evidence of decompensation in form of Hepatic encephalopathy, ascites, GI bleed or prolonged jaundice Small varices: Grade I varices Alcoholic liver disease Advanced liver disease with ascites, hepatic encephalopathy Other liver diseases such as chronic hepatitis B, chronic hepatitis C, Wilsons' disease, Hemochromatosis, glycogen storage diseases etc Pregnancy Unwilling patients Large varices Past h/o GI bleed Hiatus hernia Gastric ulcer Severe esophagitis (Grade B and above) | 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, Cirrhoses, Liver Oesophageal Varices Age >18 years 2. Cirrhosis and portal hypertension, defined by any 2 of the following: A) Characteristic clinical examination findings; one or more of i) liver function tests ii) haematological panel iii) coagulation profile abnormalities B) Characteristic radiological findings; one or more of i) heterogeneous, small liver with irregular contour ii) splenomegaly iii) ascites iv) varices v) recanalized umbilical vein C) Fibrosis score > stage 4 on liver biopsy D) FibroScan liver stiffness measurement >15 kilo Pascal without other explanation 3. Small oesophageal varices diagnosed within the last 3 months defined as <5 mm in diameter or varices which completely disappear on moderate insufflation at gastroscopy. 4. Not received a beta-blocker in the last week 5. Capacity to provide informed consent Non-cirrhotic portal hypertension 2. Medium/large oesophageal varices (current or history of), defined as >5 mm in diameter 3. Isolated gastric, duodenal, rectal varices with or without evidence of recent bleeding 4. Previous variceal haemorrhage 5. Red signs accompanying varices at endoscopy 6. Known intolerance to beta blockers 7. Contraindication to beta blocker use i) Heart rate <50 bpm ii) Known 2nd degree or higher heart block iii) Sick sinus syndrome iv) Systolic blood pressure <85 mm Hg v) Chronic airways obstruction (asthma/COPD) vi) Floppy Iris Syndrome vii) CYP2D6 Poor Metaboliser viii) History of cardiogenic shock ix) History of severe hypersensitivity reaction to beta-blockers x) Untreated phaeochromocytoma xi) Severe peripheral vascular disease xii) Prinzmetal angina xiii) New York Heart Association IV heart failure 8. Unable to provide informed consent 9. Child Pugh C cirrhosis 10. Already receiving a beta-blocker for another reason that cannot be discontinued 11. Graft cirrhosis post liver transplantation 12. Evidence of active malignancy without curative therapy planned 13. Pregnant or lactating women 14. Women of child bearing potential not willing to use adequate contraception during the protocol of IMP dosing 15. Patients who have been on a CTIMP within the previous 3 months | 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, Chronic Hepatitis b Group 1: Patients with history of HBV-related clinical endpoint events No age limit Male or female Patients with liver biopsy performed after 1 to 3 years of antiviral therapy; patients with history of clinical endpoint events (decompensated cirrhosis, hepatocellular carcinoma, liver transplantation or liver-related death) after liver biopsy Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases Patients with malignant lesion on liver image Patients with other uncured malignant tumors Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases Pregnant or lactating women Patients with any other reasons not suitable for the study. Group 2: Patients without history of clinical endpoint events No age limit Male or female Patients with liver biopsy performed after 1 to 3 years of antiviral therapy; or Chronic hepatitis B (CHB) patients with antiviral therapy for 1 to 3 years content to be performed liver biopsy at enrollment | 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, Advanced Chronic Liver Disease, NASH Adults aged 18 years or older 2. Ability to provide informed consent 3. Previous Fibroscan with LSM ≥10 kilopascals (kPa) Inability or refusal to provide informed consent 2. Fasting for less than three hours prior to the scan 3. Subject is a pregnant or lactating female 4. Subject with current, significant alcohol consumption 5. Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment 6. Patients with a pacemaker or defibrillator 7. Acute hepatitis defined as AST/ALT > 500 U/L | 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): 21.0-75.0, Cirrhosis Hepatic Encephalopathy Cirrhosis diagnosed by either of the following in a patient with chronic liver disease Liver Biopsy Radiologic evidence of varices, cirrhosis or portal hypertension Laboratory evidence of platelet count <100,000 or AST/ALT ratio>1 Endoscopic evidence of varices or portal gastropathy Fibroscan values suggestive of cirrhosis On treatment for hepatic encephalopathy (patient can be on lactulose and rifaximin) Able to give written, informed consent (demonstrated by mini-mental status exam>25 at the time of consenting) Women of child bearing potential must agree to use effective contraception for the duration of the study and for 10 days prior and 30 days after the study Negative pregnancy test in women of childbearing age MELD score >22 WBC count <1000 cells/mm3 Platelet count<25,000/mm3 TIPS in place for less than a month Currently on antibiotics apart from rifaximin Infection at the time of the FMT (diagnosed by blood culture positivity, urinalysis, paracentesis as needed) Hospitalization for any non-elective cause within the last 1 month Patients who are aged >75 years Patients who are pregnant or nursing (will be checked using a urine pregnancy test) Patients who are incarcerated | 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, Irritable Bowel Syndrome Interested in taking part Ability to give informed consent Men and women aged 18-65 years with diarrhoea-predominant IBS (IBS-D), constipation-dominant IBS (IBS-C), or mixed (IBS-M), based on fulfilment of the Rome IV for irritable bowel syndrome who do not have a major medical condition (e.g. diabetes, psychiatric or current eating disorders), severe oesophagitis, gastritis or duodenitis, gastrointestinal disease (inflammatory bowel disease, coeliac disease, active diverticulitis), or history of previous GI surgery (excluding appendicectomy, cholecystectomy and haemorrhoidectomy), severe renal, cardiac, pulmonary, or other chronic diseases likely to affect motility, history of gastric bezoars Females who report to be pregnant or lactating Body Mass Index (BMI) >40 kg/m2 Use of unpermitted medications in the last 4 weeks prior to, or during the study including: Antibiotics within the last 4weeks, dietary fibre food supplements within the last 4 weeks (e.g. Fybogel, Lactulose), prebiotics or probiotics (in food products or as supplements) within the last 4 weeks, other dietary supplements that may affect the luminal microenvironment of the intestine (e.g. Orlistat) Use of drugs known to alter GI motility, transit or gastric pH (e.g. mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines) in the last 1 week Full bowel preparation for a diagnostic procedure within the last 4 weeks Changes to IBS medications or dose in the 4 weeks prior to the study Changes to anti-depressant medications or dose in the 12 weeks prior to the study Swallowing disorders (physical or psychological) Use of implantable and/or medical devices such as pacemakers Individuals following extreme diets e.g. 8 or more caffeinated serves per day, 4 or more bottles of wine (40 or more units of alcohol per week) or equivalent per week as assessed by diet questionnaires or changes to smoking habits | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Portal Hypertension Hepatic Encephalopathy The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old; 2. Clinically diagnosed post-hepatitis B cirrhosis; 3. History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment; 4. Liver function Child A or B; 5. Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic portal can construct a shunt; 6. Platelet count ≥ 50 × 109 / L; 7. Prothrombin time (PT) does not exceed the upper limit of the normal control for 3 seconds; 8. Serum creatinine concentration ≤115umol/L; 9. Patients and their families agree to join the clinical trial and sign an informed consent form Imaging confirms portal vein thrombosis; 2. Patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt); 3. Combine any malignant tumor; 4. History of previous hepatic encephalopathy; 5. Consolidation of intractable ascites; 6. Pulmonary artery pressure > 40 mmHg, left ventricular ejection fraction < 50%, congestive heart failure or severe valvular insufficiency; 7. Others: persistent active bleeding, vital signs can not be maintained, blood ammonia ≥ 100, total bilirubin > 51umol / L failed to improve after symptomatic treatment; combined active infection, especially biliary system inflammation; female patients are pregnant Or lactation; severe contrast allergy | 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, Cirrhosis Age between 18 and 90 years Child-Pugh B or Child-Pugh C cirrhosis diagnosed on the basis of one or several of the following elements Liver Biopsy Liver stiffness>15kPa measured by Fibroscan Combination of clinical, laboratory and imaging characteristic of cirrhosis (association of signs of portal hypertension, liver failure and abnormal liver morphology in a patient with at least one cause of cirrhosis) Acute renal failure (increase in serum creatinin level by more than 1.5 times the baseline value or by more than 26 μmol/l from the baseline value) within 15 days before Bacterial infection proven or highly suspected on the basis of clinical-laboratory features within 15 days of Digestive bleeding within 15 days before Alcoholic hepatitis in the previous month History of porto-systemic shunt or liver transplant Primary sclerosing cholangitis Primary biliary cirrhosis Budd-Chiari Syndrome Hepatocellular carcinoma outside the Milan contraindicating transplantation Active extrahepatic neoplasia | 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, Microbiota Hepatocellular Carcinoma Cirrhosis signed Informed Consent (CI), obtained before carrying out any specific procedure of the study Clinical or histological diagnosis of cirrhosis Child Pugh A or B Presence of clinical signs of portal hypertension: esophagogastric varices or hypertensive gastropathy or edematous ascitic syndrome or encephalopathy History of hepatocellular carcinoma prior to randomization Solid organ transplant Immunosuppressive treatment Previous treatment (during the last 6 months prior to the of the study) or current with pre or probiotics Current antibiotic treatment for any reason Active alcoholism: alcohol consumption in the last 3 months prior to randomization History or current history of other neoplasms Major surgical intervention or serious traumatic injury in the 28 days prior to randomization Unstable angina (angina symptoms at rest, recently started angina, or within the last 3 months of randomization) or myocardial infarction in the 6 months prior to randomization Uncontrolled cardiac arrhythmia, valvular heart disease | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Antibiotic Resistant Infection Liver Cirrhoses Patients with ESLD at Liver ICU. All patients have the diagnostic for liver cirrhosis by clinical, biochemical, and ultrasonography findings. The severity of liver cirrhosis will be assessed according to the Child-Pugh classification and model for end-stage liver disease (MELD) score These patients are diagnosed as having infection at admission or acquire infection during hospitalization Age ≤ 18 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): 18.0-999.0, Sepsis Any patient to which paramedics apply the Hamilton Early Warning Score or patients who arrive to the Emergency Department (ED) by ambulance without a pre-alert and meet the definition of sepsis in the ED will also be included, and patient is ≥ 18 years Patient is an inter-facility transfer, or patients with absent vital signs are absent, or death before blood can be drawn in the Emergency Department, or the patient fits the for another prehospital alert (ST-elevation myocardial infarction, cerebrovascular vascular accident, or trauma) | 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): 19.0-60.0, Kidney Failure, Chronic Hepatitis C Participants with hepatitis C virus infection with detectable HCV RNA in blood naïve to direct acting antiviral drugs based anti-HCV treatment Hepatitis B virus co-infection Human immunodeficiency virus co-infection Clinical evidence of cirrhosis or portal hypertension such as ascites, esophageal or gastric varices on esophago-gastro-duodenoscopy, liver stiffness more than 15 KPa as measured with transient elastography or history of hepatic encephalopathy | 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, Renal Impairment Tuberculosis Subject for Patients with Renal Impairment (Groups 2-5) 1. Have the ability to understand the requirements of the study and have provided written informed consent* before any study related procedure is performed. *As evidence by signature on an informed consent document approved by the IRB 2. Agree to abide by the study restrictions. 3. Are between the ages of 18 and 70, inclusive, at the time of enrollment. 4. Must have mild, moderate, severe or end stage renal disease but are not on dialysis. 5. Are free from tobacco/nicotine usage (30-day minimum from screening visit). 6. Have QTc interval on electrocardiogram (ECG) < 500 msec. 7. Have a body mass index of 18 to 35 kg/m^2. 8. Women of childbearing potential** must use an acceptable contraception method*** for the duration of the study. **Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, implanted contraceptive device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or < 1 year has passed since the last menses if menopausal. ***Includes, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 9. If subject is male and capable of reproduction, agrees to avoid fathering a child for the duration of the study by using an acceptable method of birth control****. ****In addition to the use of a barrier method (condom) unless vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #8, and/or abstinence from sexual intercourse with women. 10. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receipt of study product Subject for Healthy Subjects (Groups 1A-1D) 1. Have the ability to understand the requirements of the study and have provided written informed consent* before any study related procedure is performed. *As evidence by signature on an informed consent document approved by the IRB. 2. Agree to abide by the study restrictions. 3. Are healthy male or non-pregnant female, between the ages of 18 and 70, inclusive, with normal GFR > / = 90 at screening. 4. Are free from tobacco/nicotine usage (30-day minimum from screening visit). 5. Have a normal QTc interval < 500 msecs on electrocardiogram (ECG). 6. Have a body mass index of 18 to 35 kg/m^2. 7. Women of childbearing potential** must use an acceptable contraception method*** for the duration of the study Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, implanted contraceptive device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal Includes, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving study product, barrier methods such as condoms or diaphragms/cervical caps with spermicide, effective intrauterine devices, NuvaRing(R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 8. If subject is male and capable of reproduction, agrees to avoid fathering a child for the duration of the study by using an acceptable method of birth control****. ****In addition to the use of a barrier method (condom) unless vasectomized, acceptable methods of birth control are restricted to a monogamous relationship with a woman who agrees to use acceptable contraception as outlined in criterion #7, and/or abstinence from sexual intercourse with women. 9. Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to receipt of study product Subject for Patients with Renal Impairment (Groups 2-5) 1. History of known active TB. 2. History of peptic ulcer disease 3. Have known hypersensitivity to pretomanid or any of the excipients 4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI)). 5. Any clinically significant ECG abnormality at screening* *Note: the following can be considered not clinically significant Heart rate < / = 50 beats per minute (bpm) (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic subjects) Mild first degree A-V block (P-R interval > 0.23 seconds) Right or left axis deviation Incomplete right bundle branch block Isolated left anterior fascicular block (left anterior hemiblock) in younger athletic subjects 6. History of or screening results show a QTc interval > / = 500 msecs. 7. Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition*** that could be causative of sudden death ***such as known coronary artery disease or congestive heart failure (CHF) or terminal cancer. 8. Inability to swallow tablets. 9. History of fever or documented fever (oral temperature > 100.4 degrees Fahrenheit) in the 48 hours prior to admission to the hospital. 10. Resting pulse rate <50 or > 100 bpm at Screening. 11. At Screening blood pressure > / = 20 mm Hg systolic or 10 mm Hg diastolic above baseline**** (sitting). ****Baseline is most recent blood pressure in the last 3 months if not similar to control group. 12. Current hypokalemia or hypomagnesemia. 13. Positive result of urine drug screen or blood alcohol screen prior to hospital admission. 14. Significant history of drug and/or food allergies (as deemed by the PI). 15. For women, subject is pregnant (positive test for urine HCG at Screening or Check-in), breastfeeding or planning to conceive for the duration of the study. 16. Women who are breastfeeding or lactating. 17. Any contraindication to the use of nitromidazoles, or prior treatment with pretomanid or delamanid. 18. Treatment with strong CYP450 enzyme inducers or inhibitors***** within 7 days prior to admission or during the study, unless****** the substance would not likely impact the validity of the study results. *****except hormonal contraceptives ******in the opinion of the site investigator 19. Use of any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine, etc.) within 30 days prior to dosing and during the entire study. 20. Use of St. John's Wort within 7 days prior to admission and during the entire study. 21. Consumption of products containing grapefruit within 5 days prior to dosing until discharged from the hospital. 22. Donation of whole blood or blood products > 500 mL within 30 days and plans to donate during the study or up to 14 days after dosing. 23. Participation in another interventional clinical trial within 30 days prior to dosing until after the last study visit. 24. Hemoglobin < 9.0 g/dL in both men and women at the screening visit. 25. Positive Screening test for HCV, HBV, or HIV. 26. Renal transplant. 27. Scheduled for hemodialysis or peritoneal dialysis 28. Presence of any condition or finding******* which would jeopardize subject safety, impact study result validity, or diminish the subject's ability to undergo all study procedures and assessments. *******In the opinion of the investigator 29. Semen donation for the duration of the study. 30. AST and ALT > 2.0 x ULN. 31. Hyperbilirubinemia > 1.5 x ULN. Subject for Healthy Subjects (Groups 1A-1D) 1. History of known active TB. 2. History of peptic ulcer disease 3. Have known hypersensitivity to pretomanid or any of the excipients 4. History of any clinically significant uncontrolled cardiac abnormality (as deemed by the Principal Investigator (PI). 5. Any clinically significant ECG abnormality at screening*. *Note: the following can be considered not clinically significant Heart rate > / = 50 beats per minute (bpm) (sinus bradycardia with heart rate between 45 and 49, inclusive, is acceptable only in younger athletic subjects) Mild first degree A-V block (P-R interval > 0.23 seconds) | 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): 0.0-75.0, NASH - Nonalcoholic Steatohepatitis Fatty liver disease diagnosed by sonography (steatosis hepatis grade II and III) and CAP measurement (> 280dB) compliance Allergy to oats Alcohol intake of more than 30 g/d (men) or 20 g/d (women) Treatment with ursodeoxycholic acid (UDCA), vitamin E or other NASH drugs 3 months prior to randomization Hepatocellular carcinoma or non-hepatic malignancy within the last 5 years Evidence of cirrhosis of the liver (Child A, B, C) or a history of decompensation Liver diseases not related to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinically manifest iron overload (heterozygous HFE is permitted), cholestatic liver disease (PBC/PSC) Adiposity surgery in the last 5 years BMI <18.5 kg / m2 Liver transplantation Fibroscan> 12 kPa (patients with liver cirrhosis) | 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): 20.0-999.0, Helicobacter Pylori Infection participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received first-line eradication therapy pregnant or nursing woman; 2. serious concomitant illness and malignant tumor of any kind; 3. history of hypersensitivity to test drugs； 4. serious bleeding during the course of this ulcer; 5. previous gastric surgery; 6. receiving bismuth salts, proton pump inhibitors (PPIs), 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): 18.0-999.0, Gastroesophageal Varices Adult patients with cirrhosis presenting to UAB Endoscopy for surveillance endoscopy to detect and grade gastroesophageal varices Inability to provide written informed consent History of bleeding gastroesophageal varices, variceal intervention or portosystemic shunt Prior liver transplant History of malignancy Severe chronic kidney disease with estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 Presence of acute kidney injury Prior iodinated contrast allergy Patient weight >300 lbs Multiphasic liver CT within 3 months of upper endoscopy Pregnancy | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Decompensated Cirrhosis of Liver • Decompensated Cirrhosis of liver irrespective of etiology Acute on chronic liver failure (fulfilling either APASL or of ACLF) Splenic diameter of more than 18 cm Concomitant HCC or other active malignancy Upper gastrointestinal bleeding in the previous 7 days Portal vein thrombosis Severe renal dysfunction as defined by creatnine > 1.5mg/dl Severe cardiac dysfunction Uncontrolled diabetes (HbA1c ≥ 9) or diabetic retinopathy Acute infection or disseminate intravascular coagulation Active alcohol abuse in last 3 months | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 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, Upper Gastrointestinal Bleeding Age, more than 17 years old Patients diagnosed with UGIB Any etiology of the UGIB Patients with UGIB previously treated in other hospitals Patients with UGIB with Blatchford scale less than 2 points Pregnant women Refusal to participate in the protocol | 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): 18.0-69.0, Decompensated Liver Cirrhosis Age 18-69 years; 2. Decompensated liver cirrhosis (manifestations including gastrointestinal bleeding, hepatic encephalopathy, and ascites, based on previously stable cirrhosis); 3. Positive testing for serum hepatitis B surface antigen (HBsAg) for more than 6 months (chronic hepatitis B patients); 4. Written consent Hepatocellular carcinoma or other malignancies; 2. Liver cirrhosis caused by other reasons, such as autoimmune diseases, alcocal, drugs and so on; 3. Pregnant women; 4. The presence of other vital organ severe dysfunction; 5. Participate in other studies; 6. Lack of a supportive family; 7. Refusal to sign the informed consent form | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Chronic Subdural Hematoma Age greater than or equal to 18 years old; 2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT); 3. Patients are joining the trial voluntarily with consent form signed Allergy to atorvastatin or other statins; 2. Deranged liver function; 3. Patients who are already on long term steroid for other condition(s); 4. Patients who are already on statin for other condition(s); 5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt); 6. Pregnant or on breast feeding; 7. Hematoma is secondary to tumour or haematological disorders; 8. Patients taking angiotensin converting enzyme (ACE) inhibitor | 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 Acute-On-Chronic Liver Failure Age 18-75 years Patients with ACLF with presence of hepatic encephalopathy > grade 2 as per WHC Pregnant women or those who are suspected to be having acute fatty liver of pregnancy Malarial hepatopathy, enteric hepatitis, or ischemic hepatitis Serum Na <125 mEq/litre Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy Uncontrolled infection with hemodynamic instability requiring vasopressors | 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): 16.0-80.0, Liver Cirrhosis Esophageal Varices Liver Stiffness Cirrhosis were diagnosed by liver biopsy, CT and ultrasound before enrolled Age was 16-80 With bleeding history With EVL history, BRTO or TIPS history With NSBB history With ascites With splenectomy or splenic embolism, history With liver 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): 18.0-69.0, Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis Ages 18 to 69 years NAFLD, defined by confirmed hepatic steatosis by imaging or by liver biopsy, in the absence of other causes of hepatic steatosis or significant alcohol consumption. If liver imaging or biopsy has not been performed clinically, liver ultrasound assessment will be performed as part of the screening visit Early-stage liver fibrosis, defined as fibrosis less than or equal to Fibrosis Stage 2 (F2), confirmed by either (1) a recent liver biopsy or (2) a recent elastography / Fibroscan study. If no recent biopsy or elastography/Fibroscan have been performed, a Fibroscan will be performed as part of the screening visit Liver fibrosis stage > 2 Current aspirin use Contraindications to aspirin use Contraindications to magnetic resonance imaging (MRI) Pregnancy or desire to become pregnant Breastfeeding | 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, Cirrhosis, Liver Hypertension, Portal Esophageal and Gastric Varices Bleeding Gastric Encephalopathy Aged ≥ 18 years Ability to provide written consent Endoscopically proven acute or recurrent VH from GVs, or high risk GVs Prior indwelling TIPS Prior endovascular obliteration procedure Elevated heart pressures (left or right) Heart failure or severe valvular insufficiency Severe pulmonary hypertension Rapidly progressive liver failure Severe or uncontrolled hepatic encephalopathy Uncontrolled systemic infection or sepsis Unrelieved biliary obstruction Polycystic liver disease | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-49.0, Influenza Provide written informed consent prior to initiation of any study procedure. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Agree to remain an inpatient for at least seven days after challenge, and until they have no virus shedding,* determined by qualitative RT-PCR for a minimum of two consecutive days post-challenge For a minimum of seven days post-challenge (Study Day 8). 4. Healthy* males and non-pregnant, non-breastfeeding females**, aged >/= 18 and </=49 years of age, inclusive, at enrollment. *Good health is defined in 10 Females subjects of childbearing potential must agree to have a serum pregnancy test at screening, a urine pregnancy test before Chest X-Ray (CXR) performed (if more than 7 days have passed between CXR and serum pregnancy test), and a urine pregnancy test upon admission to the inpatient unit prior to CHI, and results must be negative. 5. Women of childbearing potential* must agree to use or have practiced true abstinence** or use at least 1 acceptable primary form of contraception***,****. These are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the do not apply to subjects in a same sex relationship). *Not of child bearing potential post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement with history of documented radiological confirmation test at least 90 days after the procedure). **True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). ***Acceptable forms of primary contraception monogamous relationship with a vasectomized partner who has been vasectomized for180 days or more prior to the subject receiving the influenza challenge virus, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products. ****Must use at least one acceptable primary form of contraception for at least 30 days prior to admission and at least one acceptable primary form of contraception during the remainder of the study. 6. Non-habitual smoker* of tobacco, e-cigarettes or marijuana. *Non-habitual smokers are those who smoke no more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months and agree not to smoke cigarettes, other tobacco products, e-cigarettes and/or marijuana products during participation in the study. 7. No self-reported or known history of alcoholism or drug use within the last 30 days and agrees to abstain from alcohol and drugs* for at least one week before admission and throughout the inpatient period. *Including forms of marijuana not included in criterion 6. 8. Negative drug urine toxicology result on screening (i.e., amphetamines, cocaine, and opiates) and on admission to the challenge unit (i.e., amphetamines, cocaine, opiates, and cannabinoids). 9. Agree not to use the listed* prescription or over-the-counter medications within 7 days prior to inpatient stay and through inpatient stay, unless approved by the investigator. *Oseltamivir, zanamivir, peramivir, baloxavir marboxil, amantadine (generic) and rimantadine (Flumadine and generic), aspirin, intranasal steroids, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs (NSAIDs). 10. In good health* and not have clinically significant medical, psychiatric, chronic or intermittent health conditions including those listed in the Subject Criteria. *Good health, as determined by medical history, medication use and physical examination to evaluate ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would not affect the assessment of the safety of subjects or the immunogenicity of challenge. These medical diagnoses or conditions should be stable for the last 90 days (no hospitalizations, emergency room (ER) or urgent care for condition (excluding musculoskeletal conditions) and not listed in the Subject Subjects may be on medications only if the condition or disease is stable and not deteriorating, if the medical intervention (such as device or medication) was not available during the maximal inpatient period of time, medications are not listed in the Subject and pose no additional risk to subject safety or assessment of adverse events. This also includes no change in prescription medication, dose or frequency as a result of new symptoms or deterioration of the medical diagnosis or condition in the 90 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this criterion. Any change in prescription medication due to improvement of a disease outcome (e.g., lowering of the dosage or frequency), as determined by the site principal investigator (PI) or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572, will not be considered a deviation of this criterion. 11. Does not have an ongoing symptomatic condition* for which subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan. *e.g., ongoing fatigue without a diagnosis for symptom. 12. Vital signs as follows: pulse is 47 to 99 beats per minute, inclusive; systolic blood pressure is 85 to 139 mmHg, inclusive; diastolic blood pressure is 55 to 89 mmHg, inclusive; SpO2 >95%; RR<18; oral temperature is less than 100.0 Degrees Fahrenheit. 13. laboratory values (White Blood Cell (WBC), Absolute Lymphocyte Count, Hemoglobin (Hgb), Platelets (PLTs), Alanine Transaminase (ALT) and Creatinine (Cr)) are within acceptable parameters. 14. Body mass index (BMI) >18.5 and <35 kg/m^2 at screening. 15. Other screening tests (ECG and CXR) are within normal reference range or not deemed clinically significant by the PI or appropriate sub-investigator*. *Designated clinician licensed to make medical diagnoses and listed on the Form FDA 1572. 16. Negative test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) at screening blood draw. 17. Negative respiratory virus panel by respiratory panel by bioMérieux or by Luminex xTAG (R) on Day (-2), and Day (-1) Female subject who has a positive pregnancy test on screening or admission, is breastfeeding or planning to become pregnant from 30 days prior to challenge through the end of the study. 2. Presence of self-reported or medically documented significant medical or psychiatric condition(s)*. *Significant medical or psychiatric conditions but are not limited to Respiratory disease (e.g., chronic obstructive pulmonary disease (COPD), asthma) requiring daily medications (Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics) currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years Presence of any febrile illness or symptoms suggestive of a respiratory infection within two weeks prior to Controlled Human Infection (CHI) Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis) Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell carcinoma of the skin, which is allowed An autoimmune disease An immunodeficiency of any cause | 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 Liver Diseases Minimal Hepatic Encephalopathy Cirrhosis, Liver Acute-On-Chronic Liver Failure >18 years old cirrhosis acute on chronic liver failure severe liver diseases liver cancer other malignancy poor eyesight uncooperative | 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, Acute Gastritis Chronic Gastritis Age is over 20 years old, under 75 years old, men or women Patients diagnosed with acute or chronic gastritis by gastroscopy Patients who is impossible to receive gastroscopy Patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit | 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, Gastritis Helicobacter Pylori Infection Patients who Report dyspeptic symptoms (nausea, heartburn, epigastric pain, aggravated / relieved abdominal discomfort, and early satiety); Confirmação Have gastritis and H pylori confirmed by upper digestive endoscopy and pathological examination are between 18 and 80 years old Understand and sign the Informed Consent Form Patients who Are being treated with proton pump inhibitor, non-steroidal anti-inflammatory drugs and / or H2 receptor blockers in the month prior to enrollment for clinical study Are pregnant or lactating Have intestinal obstruction, gastrointestinal surgery in the last thirty days, *Barrett's esophagus. * Make use of reflux stimulating drugs With Zollinger-Ellison Syndrome, * Have active bleeding Are currently in use or have recently used oral / venous antibiotics (within the last six weeks). Patients whose biopsy from upper digestive endoscopy is negative for H. pylori will also be excluded | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-70.0, Chronic Hepatitis C Chronic hepatitis C patients treated with interferon plus ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct antiviral drugs (DAAs) Co-infected with hepatitis B virus or human immunodeficiency virus Had an autoimmune disease, liver tumour, or severe cardiac disease | 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, Hepatic Encephalopathy Cirrhosis, Liver Portal Hypertension Liver Diseases Pathological Processes Elective TIPS placement for refractory ascites or recurrent variceal bleeding: Recurrent tense ascites and one or more of the following i. Not responding to the maximal dose of diuretics (400 milligram spironolactone and 160 milligram furosemide). ii. Kidney insufficiency (Creatinine > 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium < 125 mmol/L, Potassium > 5.5 mmol/L) induced by diuretics. iv. Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps). Recurrent variceal bleeding, not responsive to treatment with endoscopic band ligation and beta-blockers, with a high risk of failure of endoscopic treatment: i. Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis or ii. Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy 2. Age ≥18 years 3. Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria. 4. Signed informed consent Any absolute contraindications for TIPS placement 2. Use of ciclosporin 3. Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours 4. Age > 80 years 5. Non-cirrhotic portal hypertension 6. Portal vein thrombosis (main trunk) 7. HIV 8. Current or recent (<3 months) use of rifaximin 9. Overt neurologic diseases such as Alzheimer's disease, Parkinson's disease 10. Pregnant or breastfeeding women 11. Patients refusing or unable to sign informed consent | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 20.0-85.0, Acute Kidney Injury Cirrhosis Esophageal Varices Age of 20 to 85 years Cirrhotic patients with esophageal varices regardless of bleeding event or not will be enrolled in this study Terminal stage HCC/ other malignancy/ Stroke or active sepsis/ Chronic kidney disease stage 4 under renal replacement therapy/ Contraindications to non-selective beta-blockers/ A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery/ Serum total bilirubin >10 mg/dL/ Refractory ascites/ Hepato-renal syndrome/ Pregnancy/ Severe heart failure (NYHA Fc III/IV)/ Bronchial asthma or chronic obstructive pulmonary disease/ Second or third degree atrioventricular block/ Severe hypotension/ Refusal to participate | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Bleeding Procedural Complication Cirrhosis, Liver Coagulation Disorder, Blood Adult patients with cirrhosis admitted to a hospital ward or ICU for greater than 24 hours Patient must undergo 1 or more invasive non-surgical procedures at admission or during the hospitalization Age < 18 years old Prisoner Pregnant Unable to provide consent Previously enrolled in this study | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Hepatic Encephalopathy Cirrhosis, Liver Age 18-75 years 2. Cirrhosis defined by any one of the following 1. Cirrhosis on liver biopsy or transient elastography 2. Nodular liver on imaging 3. Endoscopic or radiological evidence of varices in a patient with chronic liver disease 4. Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease 3. Women of childbearing age will need to be on accepted birth control for 10 days prior to entering study and 30 days after the end of the last dose of the study drug. 4. Cognitive impairment on PHES aggregate score [more than or greater than] -4SD based on norms published in Allampati et al located at the website www.encephalapp.com17 (This is the accepted diagnosis of minimal HE.) 5. Willing and able to participate, provide samples and complete follow-up 6. Stable Liver function tests between 2-12 weeks prior to enrollment (can the screening laboratory values details in Unclear diagnosis of cirrhosis (does not meet the outlined above) 2. Child score >8 3. Increasing trend of ALT and AST in the 2-12 weeks prior to study (Baseline values established by at least two samples obtained at least 2 weeks and no more than 8-12 weeks apart) to account for disease related changes in liver enzymes and bilirubin while on study that may otherwise be inappropriately attributed to study drug. >20% increase in baseline serum AST, ALT, ALP and total bilirubin (TBL) will be considered an criterion. 4. Unable to consent, follow for the study duration 5. Normal performance on PHES 6. Mini-mental status exam<2518 7. Recent alcohol abuse (within 3 months) 8. Recent illicit drug abuse (within 3 months) except marijuana 9. Current use of psychoactive drugs apart from long-standing opioids or stable anti-depressant use. 10. Prior overt HE episodes defined as West-Haven grade 2 or higher in the past that required hospitalization or initiation of lactulose or rifaximin therapy 11. Currently on lactulose or rifaximin 12. Current or recent invasive bacterial or fungal infections (<1 month) 13. Allergic reactions to rifamycin, rifampin or rifaximin 14. MELD >20 15. TIPS placement 16. Serum sodium<125 17. On SBP prophylaxis 18. Post-transplant cirrhosis 19. Infections within 4 weeks 20. End-stage organ failures: CHF with EF<25%, End-stage renal disease on dialysis, COPD on home oxygen 21. Pregnancy (positive urine pregnancy test at screening) 22. Current on statin therapy 23. In the opinion of the PI, those who are unlikely to survive or remain without liver transplant for 6 weeks, or cannot adhere to the trial activities | 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, Involuntary Movements Patients with movement disorders attending Assiut University neurology outpatient clinic and internal department, from Sep 15th 2019 to March15th 2020 involuntary movements epileptic in origin 2) refusal of patient to give consent to join 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): 21.0-65.0, Alcoholic Hepatitis of Subjects with Alcoholic Hepatitis (AH): *diagnosis of AH either by imaging, biochemical values or liver biopsy as well as drinking history Heavy Drinking Controls: *heavy alcohol drinking will be defined as >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men for a minimum of 6 months [6] and within the 4 weeks prior to study enrollment for all groups inability or unwillingness to sign informed consent cancer autoimmune disease that in the opinion of the PI will confound study data Control subjects (drinking and non drinking) must meet the following INR < 1.4 total bilirubin levels must <3 no prior history of known alcoholic liver disease absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-999.0, Emergencies All patients presenting to Mount Hagen Provincial Hospital during the study period. The for the primary outcome is any patient presenting to Mount Hagen Provincial Hospital diagnosed by the treating clinician with any of severe trauma, major burns, severe head injury, ruptured ectopic pregnancy, septic shock, myocardial infarction, severe asthma/COPD, severe pneumonia, meningitis or appendicitis 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, DISTAL MALIGNANT BILIARY OBSTRUCTION Age ≥18 years Patients with distal malignant biliary obstruction Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct > 15 mm diameter Agree to receive follow up phone calls Able to provide written informed consent Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000 Use of anticoagulants that cannot be discontinued Pregnant women Inability to sign the 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): 18.0-999.0, Gastro-intestinal Tolerance Subject has voluntarily signed and dated an ICF approved by an IRB/IEC, and provided applicable privacy authorization prior to any participation in the study Subject is diagnosed with dysphagia Subject is under the care of a Speech and Language Therapist and is currently using a thickener Subject currently has normal GI function Subject is interested in participating in the study, willing to comply with the study protocol and product Subject who is able to consent and is able to evaluate the product Subject has a normal swallow Subject at high risk of aspiration with oral fluids requiring nil by mouth and enteral tube feeding Subject has impaired renal function Subject has liver failure, decompensated chronic liver disease, active hepatitis B or C receiving treatment, or hepatic encephalopathy Subject has severe dementia or unable to communicate or consent or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures Participant is known to be allergic or intolerant to any ingredient found in the study product Participation in another study that has not been approved as a concomitant study Subject has a clinical condition that is contraindicated with this product such as hepatic and renal disease Subject has a clinical condition which may interfere with gastrointestinal tolerance Subject is 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): 18.0-75.0, Gastroesophageal Varices Portal Hypertension The age ranged from 18 to 75 years. 2. Clinical or pathological diagnosis of cirrhosis; 3. Electronic gastroscopy is planned; 4. To agree and sign the informed consent Hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed; 2. Orthotopic liver transplantation patients; 3. Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt; 4. Pregnant women; 5. Neurological or psychiatric disorders | 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, Esophageal Varices in Cirrhosis of the Liver Patients over 18 years old with cirrhosis of esophageal varices who underwent endoscopic ligation Signed informed consent Hemorrhage in the digestive tract, unstable vital signs Hepatic encephalopathy Unwilling to cooperate with the examiner Skin allergies | 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 B, Chronic Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment for at least 24 months prior to screening Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening Body mass index (BMI) between 18.0 and 35 kilogram per meter square (kg/m^2), extremes included Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 9 Kilopascal (kPa) at screening Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol Evidence of liver disease of non-HBV etiology History or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellular carcinoma (HCC) Significant laboratory abnormalities as defined in the protocol at screening Participants with a history of malignancy within 5 years before screening Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant History of or current clinically significant skin disease or drug rash | 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, Liver Cirrhoses Hepatic Encephalopathy Known liver disease/cirrhosis Pregnancy, non compatible material with MRI | 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): 20.0-85.0, Liver Cirrhosis Peptic Ulcer Between 20 and 85 years old Liver cirrhosis associated with esophageal varices or gastric varices Gastric ulcer or duodenal ulcer ,size bigger or egual than 0.5 cm Acute bleeding Steroid or NSAID user Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...) Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial 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): 18.0-999.0, Cirrhosis, Liver Adults (great than 18 years of age) with a clinical diagnosis of cirrhosis (confirmed by compatible radiology, histology or fibroscan) Admitted to a study hospital site o Adult patients who do not have cirrhosis | 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 Cirrhosis, Liver Individuals who are male or female and are between the ages of 18 and 70 years. 2. Individuals with a current diagnosis of liver cirrhosis as evidenced by one or more of the following: a. Liver Biopsy OR a clinical suspicion of cirrhosis based on the presence of one or more of the following 1. Radiologic evidence of varices, cirrhosis or portal hypertension 2. Laboratory evidence of platelet count <100,000 or AST/ALT ratio >1 3. Endoscopic evidence of varices or portal gastropathy 4. Elastography (i.e. Fibroscan) 3. Individuals must have at least one previously documented episode of HE. 4. Individuals must be able to read and write in the English language. 5. Individuals must be able and willing to utilize the electronic device necessary to measure cognitive function without assistance from outside individuals once the training phase has been completed. 6. Individuals must be able to provide valid informed consent prior to any study related procedures Individuals who are color-blind. 2. Individuals actively using psychotropic substances including alcohol. 3. Individuals who are pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Study individuals are expected to attest to this fact during their participation time. Females who are not surgically sterile or having undergone greater than one year of menopause will receive urine pregnancy tests at screening and initial drug dosing. 4. Presence of TIPS (transjugular intrahepatic portosystemic shunt). 5. Individuals with an active bacterial infection and are taking antibiotics for those infections at time of consent. 6. Individuals with ANC <800 (neutropenia). 7. Individuals with MELD >17. 8. Individuals with platelet count <35,000/mm3. 9. Individuals who are immunocompromised due any of the following reasons: 1. HIV infection (CD4 count <200/mm3) or AIDS diagnosis 2. Inherited/primary immunodeficiency disorders 3. Treatment with any anti-neoplastic agent within the last 3 months (excluding locoregional therapy for hepatocellular carcinoma) 4. Treatment with any immunosuppressant medications [including but not limited to monoclonal antibodies to B cells or T cells, anti-TNF agents, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine), calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate mofetil] within the last 3 months 10. Individuals who have previously undergone FMT. 11. Individuals with a history of colorectal cancer (all stages). 12. Individuals with a history of chronic intrinsic GI diseases such as inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis), eosinophilic gastroenteritis, celiac disease or irritable bowel syndrome as determined by Rome III criteria. 13. Individuals with a history of colectomy, major gastro-intestinal surgery, or intra-abdominal surgery. 14. Individuals with a history of Clostridium difficile infection six months prior to study enrollment. 15. Individuals with a history of chronic diarrhea. 16. Individuals currently participating in a research trial that involves drug or device intervention. 17. Individuals who are unable to fulfill all study criteria. 18. Individuals that the PI determines are not capable of participating in the research study | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Fibroses Patients with radiologic features suggestive of cirrhosis on abdominal imaging studies such as transabdominal ultrasound, CT or MRI and indication for variceal screening Patients with suspected advanced liver fibrosis as detected by Fibroscan Patients with clinical evidence of hypersplenism Age > 18 years Written informed consent available Patients with features of decompensated cirrhosis, such as history of ascites, prior variceal bleeding, hepatic encephalopathy, hepatorenal syndrome Patients with history of hepatocellular carcinoma Patients with history of liver transplant or TIPS or shunting surgery Patients with portal and/or mesenteric vein thrombosis Moribund patients from terminal illnesses Patients with terminal malignancy Contraindications for endoscopy Unable to provide written informed consent Pregnancy | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Liver Cirrhosis Patients diagnosed with liver cirrhosis and one or more complications hereto during admission to the Gastro Unit, AHH. Complications but are not limited to: hepatic encephalopathy, infection, ascites, edema, kidney failure, upper or lower GI bleeding Patients must read and understand Danish Adults >18 years When the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging Patients with comorbidity as the primary diagnosis and where an independent rehabilitation or post-discharge program is offered, for example hip fracture, chronic obstructive pulmonary disease etc Patients diagnosed with an active and invasive malignant disease Residency outside the catchment area of Amager Hvidovre Hospital | 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, Renal Insufficiency Hepatic Insufficiency Immunosuppression The study will enroll participants in whom treatment with ceftobiprole has been completed (including both on-label and off-label use) plus at least one of the following (more than one criterion may apply) Participants with severe renal impairment / ESRD (end-stage renal disease, defined as calculated CLCr ( creatinine clearance) < 30 mL/minute or oliguria < 20 mL/hour unresponsive to fluid challenge or any form of dialysis) Impaired baseline hepatic function (patients with liver failure/cirrhosis Child Pugh Grade A, B, C or existing non-cirrhotic liver disease associated with total bilirubin > 2 mg/dL or alanine aminotransferase [ALT], or aspartate aminotransferase [AST] ≥ 3 times upper limit of the normal range [ULN]) Participants with immunosuppression, i.e HIV-positive with CD4 (cluster of differentiation 4) counts of ≤ 0.2 × 10E9/L (≤ 200 cells/mm3) Immunocompromised as determined by the investigator (any type or aetiology) Baseline neutropenia or baseline myelosuppression, defined as presence of myelosuppression or neutropenia (absolute neutrophil count [ANC] ≤ 0.5 × 10E9/L [< 500 polymorphonuclear neutrophils (PMNs)/mm3]), severe anaemia (haemoglobin < 6.5 g/dL), or severe thrombocytopenia (< 49.9 × 10E9/mm3) In addition, the study will enroll a control group of patients in whom treatment has been completed without any of the listed above | 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): 19.0-74.0, Acute Gastritis Chronic Gastritis Adult males and females aged ≥19 and <75 years Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP) Patients ineligible for gastroscopy Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP Patients who have to continue taking drugs that may induce gastritis Other clinically significant medical or psychiatric findings that the investigator considers inappropriate 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): 18.0-99.0, Liver Diseases Hepatitis C Age ≥ 18 years Presence of advanced fibrosis or cirrhosis (stage F≥3 based on liver stiffness by transient elastography (≥ 9,5 kPa) or liver biopsy Gastrointestinal endoscopy at least 24 months before start of direct-acting agents for HCV treatment Liver stiffness measurement at least 18 months after SVR Autoimmune hepatitis, hepatosplenic schistosomiasis or cholestasis diseases Liver transplantation Presence of high volume ascites or hepatocellular carcinoma Participation in programs of esophageal band ligation for eradication of esophageal varices Presence of signs of acute decompensated liver disease | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Liver Cirrhoses Portal Hypertension Above 18 years old Willingness to participate in the study Compensated liver cirrhosis based on clinical and imaging findings Written informed consent provided Decompensated liver cirrhosis: ascitis, encephalopathy, gastrointestinal bleeding, infection Hemodynamic instability Pregant or nursing patients Patients with history of esophageal, gastric, liver, pancreas and spleen tumors Severe uncontrolled coagulopathy Any contraindication for portal pressure gradient meassurement via radiological evaluation | 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, Gastric Varices Bleeding Liver Cirrhoses Liver cirrhosis diagnosed by clinical examination, imaging or biopsy Patients with a previous history of variceal hemorrhage Gastric variceal confirmed by an endoscopic examination, including IGV1 or IGV2 Aged 18 to 75 years Adequate liver and kidney function, including Child-Turcotte-Pugh score < 12, MELD score <19, and serum creatinine less than 2 times the upper limit of normal Active variceal bleeding Esophageal variceal, including GOV1 or GOV2 type, mainly esophageal varices Refractory ascites Patients with contraindication to treatment of TIPS, including congestive heart failure, NYHA III and IV, pulmonary arterial hypertension(>50mmHg), polycystic liver, intrahepatic duct dilatation, spontaneous bacterial peritonitis, hepatic encephalopathy Patients with contraindication to treatment of Carvedilol, including asthma, insulin-dependent diabetes, peripheral vascular diseases Child-Turcotte-Pugh score >=12, or MELD score >=19 Budd-Chiari syndrome The main portal vein thrombosis is greater than 50% Malignancies An uncontrolled infection | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Autoimmune Hepatitis for de novo AIH Age 18 or older Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and a different pre-transplant etiology of liver disease will be eligible Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible Ability to provide signed and dated IRB approved written consent in accordance with regulatory and institutional guidelines prior to any protocol-related procedure Women of child bearing potential agree to have pregnancy test at screening Males agree use of appropriate contraceptives during the active Orenia dosing period for recurrent AIH Age 18 or older Patients who have biopsy evidence of autoimmune liver disease following liver transplantation and whose original etiology of liver disease was AIH will be eligible Patients who have been treated with steroids or other immunosuppressive agents for at least a month and who have not responded either with respect to normalization of liver function tests or biopsy evidence of hepatitis will be eligible Active systemic infection Allergy to abatacept Known malignancy in the previous 2 years except for non-melanoma skin cancer Pregnancy or breast feeding Inability to commit to complete treatment protocol at Duke, as all procedures must be completed at Duke Prisoners or those who are compulsory detained Inability to read and understand English EBV seronegative (if not tested within 2 years prior to study enrollment, then testing will be done prior to study enrollment, results must be positive for study participation) | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-80.0, Esophageal and Gastric Varices The 1. patients who were diagnosed with liver cirrhosis. 2. patients who underwent the abdominal contrast-enhanced CT examination. 3. patients who received endoscopic screening. 4. patients with written informed consent. The patients who previously underwent endoscopic therapy, transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, partial splenic embolization (PSE), hepatectomy, balloon-occluded retrograde transvenous obliteration, or liver transplantation. 2. patients with liver cancer. 3. patients with severe ascites or hepatic encephalopathy. 4. lacks abdominal contrast-enhanced CT within 1 month of 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): 18.0-999.0, SCLC, Extensive Stage Written informed consent including participation in translational research obtained from the subject prior to performing any protocol-related procedures, including screening evaluations that are not SOC ECOG 2 At least one measurable tumor lesion (according to Histologically confirmed small cell lung cancer (SCLC) Stage IV disease (according to UICC8) No active autoimmune disease Adequate organ function defined as neutrophil count > 1.5 x 109/L thrombocytes ≥ 100 x 109/L hemoglobin ≥ 9 g/dL Any preceding systemic anticancer therapy for stage IV SCLC. [Up to one full-cycle-dosing of carboplatin+etoposide chemotherapy within the context of SOC is permitted prior to study treatment.] (Note: Prior treatment for limited stage disease allowed) Participation in another clinical study with an investigational product during the last 30 days before or 7 half-lives of previously used trial medication, whichever is longer Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed cell death-ligand 1 (anti-PD-L1), anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) Previous treatment in the present study (does not screening failure) Symptomatic CNS metastases. [Patients with asymptomatic brain metastases may be included.] Major surgery ≤ 28 days before first dose of study treatment Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to: 1. known active HBV, HCV or HIV infection [Patients who are HIV-positive are allowed in the trial, so long as they are stable on anti-retroviral therapy, have a CD4 count ≥ 200 cells/μL, and have an undetectable viral load at the time of screening.] 2. active tuberculosis 3. any other active infection requiring systemic therapy 4. history of allogeneic tissue/solid organ transplant 5. diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of IMP 6. other active malignancy requiring treatment 7. clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrolment Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year) Known hypersensitivity to carboplatin, etoposide or atezolizumab or any of the constituents of the product Medication that is known to interfere with any of the agents applied 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): 18.0-70.0, Helminthiasis Helminth Infection The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his in the study was that he was healthy N/A | 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): 18.0-89.0, Sepsis Encephalopathy sepsis 3.0 diagnostic criteria; 2. Estimated length of hospital stay> 24h; 3. ages 18-89; 4. Acute brain dysfunction: delirium, coma, epilepsy, focal neurological deficit; 5. Patients who meet the non-infectious SIRS diagnostic Diagnosis of patients with brain injury before admission, including Alzheimer's disease, craniocerebral injury, etc .; 2. Primary brain injury (cerebral hemorrhage, cerebral infarction, etc.), secondary brain injury (liver brain, lung brain, uremia encephalopathy, pancreatic encephalopathy, metabolic encephalopathy, Wake encephalopathy, etc.); 3. pregnant and lactating women; 4. Those who have undergone bypass surgery in the past 3 months; 5. Hearing and vision impairment; 6. mental illness and melanoma; 7. Abnormal coagulation, active bleeding 8. Patients with infection at lumbar puncture site 9. Meningeal leukemia patients 10. Patients with other types of encephalopathy | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-999.0, Hematologic Diseases Key Patient has a hematological malignancy and is eligible to receive CHOP or R-CHOP regimen Patient must have adequate hematological, renal, and hepatic function as specified below within 30 days prior to the first dose of study treatment Patient has a left ventricular ejection fraction ≥50% by multigated acquisition scan or echocardiogram within 30 days prior to the first dose of study treatment. Key Patient has severe neurologic disorders (Grade 3 and above) including peripheral motor and sensory, central and autonomic neuropathy Patient has a history of persistent active neurologic disorders including the demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other demyelinating conditions Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study Patient has bowel obstruction, paralytic ileus, or uncontrolled chronic constipation Patient has severe, active and uncontrolled hepatic disease or dysfunction | 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, Cirrhosis, Liver Minimal Hepatic Encephalopathy Small Intestinal Bacterial Overgrowth Gastrointestinal Motility Disorder Cirrhosis patients between 18-70years of age, without prior transjugular intrahepatic portosystemic shunt (TIPS) placement or prior overt hepatic encephalopathy. 2. Cirrhosis diagnosed on the basis of liver biopsy, liver stiffness measurement (Fibroscan) or radiological study. 3. CHE diagnosis using pre-defined [two of the following should be abnormal as compared to healthy controls: number connection test A/B (NCT-A/B), Digit Symbol Test (DST), or Block Design Test (BDT)] at least 2 months prior to the start of the study (beyond 2 standard deviation of normal). Testing will be carried out by a trained psychologist. 4. No prior episode of overt HE, not on therapy for overt HE, not on any psycho-active medications apart from stable doses of selective serotonin re-uptake inhibitors Known allergy to rifaximin / rifabutin / rifampin. 2. Current or recent (<6 months) abuse of alcohol or illicit drugs 3. Use of antibiotics within last 6 weeks 4. Use of lactulose / lactitol, probiotics, L-ornithine L -aspartate, zinc, metronidazole, or neomycin, within last 6 weeks 5. Use of any drug known to affect gastro-intestinal motility within the previous 2 to 4 weeks (such as, Reglan, erythromycin, or domperidone) 6. Use of drugs such as opiates and antidepressants (except stable doses of selective serotonin re-uptake inhibitors) 7. Diarrhea or abdominal distention 8. Patients deemed higher risk for capsule retention including a history of esophageal stricture or Zenker's diverticulum, partial or complete bowel obstruction, known fistula, known large or numerous diverticula and dementia 9. Diseases associated with poor gastrointestinal motility such as cardiac and pulmonary dysfunction, renal insufficiency, diabetes, rheumatological disorders (such as scleroderma and mixed connective tissue disorders) 10. History of gastrointestinal tract or abdominal surgery 11. Spontaneous peritonitis or other severe infections 12. Colonoscopy or enema treatment within 4 weeks 13. Hepatic encephalopathy with clinical signs 14. Inability to complete neuropsychiatric testing due to hearing loss, poor vision, etc. 15. Poorly compliant patients 16. Rifaximin Pregnancy Category C There are no adequate and well controlled studies in pregnant women. Rifaximin has been shown to be teratogenic in rats and rabbits at doses that caused maternal toxicity. Female study subjects of childbearing potential must have a negative pregnancy test and agree to use an acceptable method of contraception throughout the study | 2 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive The study cohort will all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period The following will then be applied to generate the unmatched cohort Aged <40 years on cohort entry Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration >30 days, or any prescription within the 30 days prior to cohort entry Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period No prior diagnosis of COPD [International Classification of Diseases (ICD)-10: J41*, J43*, J44* and doubt (UTAGAIFLG) = 0 (no)] Patients without a second prescription claim of their index medication within 60 days after the cohort entry date Diagnosis of asthma [ICD-10: J45* and doubt (UTAGAIFLG) = 0 (no)] during the baseline period Diagnosis of lung cancer [ICD-10: C34*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-75.0, Liver Cirrhoses Variceal Hemorrhage Esophageal Varices Confirmed diagnosis of liver cirrhosis History of esophageal variceal bleeding confirmed by endoscopy Time interval between index bleeding and randomization > 5 days Child-Pugh score < 12，MELD score<19 Clinical manifestation of active bleeding Gastric variceal bleeding: GOV2，IGV1 or IGV2 Degree of main portal vein thrombosis > 50% Refractory ascites Contraindications of TIPS Contraindications of NSBB Budd-Chiari Syndrome Malignancy tumor Uncontrolled infections History of portal-systemic shunt surgery | 0 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 18.0-99.0, COVID-19 COVID-19 Immunisation A subject must meet all of the following to be eligible to participate in this study: 1. Provides written informed consent prior to initiation of any study procedures. 2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Male or non-pregnant female, >/= to 18 years of age at time of enrollment. 5. Body Mass Index (BMI) 18.0-35.0 kg/m^2, inclusive (< 56 years of age), at screening; BMI 18.0-30.0 kg/m^2, inclusive (>/= 56 years of age), at screening. 6. Women of childbearing potential* must agree to use or have practiced true abstinence** or use at least one acceptable primary form of contraception.***, **** Note: These are applicable to females in a heterosexual relationship and child-bearing potential (i.e., the do not apply to subjects in a same sex relationship) Not of childbearing potential post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement) True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) Acceptable forms of primary contraception monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products Must use at least one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination. 7. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination. 8. Male subjects of childbearing potential*: use of condoms to ensure effective contraception with a female partner of childbearing potential from first vaccination until 60 days after the last vaccination. *Biological males who are post-pubertal and considered fertile until permanently sterile by bilateral orchiectomy or vasectomy. 9. Male subjects agree to refrain from sperm donation from the time of first vaccination until 60 days after the last vaccination. 10. In good health.* *As determined by medical history and physical examination to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of subjects. Chronic medical diagnoses/conditions should be stable for the last 60 days (no hospitalizations, emergency room (ER), or urgent care for condition or need for supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 60 days before enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the participating site principal investigator (PI) or appropriate sub-investigator, will not be considered a deviation of this criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening of medical diagnosis/condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided the change was not precipitated by deterioration in the chronic medical condition, and there is no anticipated additional risk to the subject or interference with the evaluation of responses to study vaccination. 11. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius). 12. Pulse no greater than 100 beats per minute. 13. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive. 14. Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), Lipase, prothrombin time (PT), and partial thromboplastin time (PTT)) are within acceptable normal reference ranges at the clinical laboratory being used. 15. Must agree to have samples stored for secondary research. 16. Agrees to adhere to Lifestyle Considerations throughout study duration. 17. Must agree to refrain from donating blood or plasma during the study (outside of this study). Leukapheresis A subject must meet all of the following to be eligible for leukapheresis: 1. Written informed consent for leukapheresis is provided. 2. Weight >/= 110 pounds. 3. Screening laboratory evaluations are within acceptable ranges at the site where the leukapheresis procedure will be performed. 4. Negative urine or serum pregnancy test within 48 hours of the leukapheresis procedure for women of childbearing potential. 5. Adequate bilateral antecubital venous access. 6. No use of blood thinners, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the leukapheresis procedure. 7. Enrolled in cohorts 2, 3, 5, 10, or 11, and possibly cohort 6, if enrolled, and completed the two-dose vaccination series. Optional Substudy 1. Enrolled in the main study and received both the first and second mRNA-1273 vaccinations. 2. Provides written informed consent for the third mRNA-1273 vaccination. 3. Agrees to the collection of venous blood per substudy. 4. Must agree to have samples stored for secondary research. 5. Women of childbearing potential have had a negative urine pregnancy test within 24 hours before the third mRNA-1273 vaccination. 6. Women of childbearing potential* must agree to use or have practiced true abstinence** or use at least one acceptable primary form of contraception.***/**** Not of childbearing potential post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure® placement) True abstinence is 100% of time no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) Acceptable forms of primary contraception monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products. ****Must use at least one acceptable primary form of contraception for at least 30 days prior to the third mRNA-1273 vaccination and for at least 30 days after the third mRNA-1273 vaccination A subject who meets any of the following will be excluded from participation in this study: 1. Positive pregnancy test either at screening or just prior to each vaccine administration. 2. Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination. 3. Has any medical disease or condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation.* *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. 4. Presence of self-reported or medically documented significant medical or psychiatric condition(s).* *Significant medical or psychiatric conditions but are not limited to: Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics. Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), history of myocarditis or pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia. Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease). Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed. An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis. An immunodeficiency of any cause. Chronic kidney disease, estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2. 5. Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 6. Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening. 7. Has participated in another investigational study involving any investigational product* within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration. *study drug, biologic or device 8. Currently enrolled in or plans to participate in another clinical trial with an investigational agent* that will be received during the study-reporting period.** *Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. **13 months after the first vaccination. 9. Has previously participated in an investigational study involving lipid nanoparticles (LNPs) (a component of the investigational vaccine assessed in this trial). 10. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. 11. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.* *Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted. 12. Anticipating the need for immunosuppressive treatment within the next 6 months. 13. Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study. 14. Has any blood dyscrasias or significant disorder of coagulation. 15. Has any chronic liver disease, including fatty liver. 16. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration. 17. Has a positive test result for drugs of abuse at screening or before the first vaccine administration. If cannabis is the only detected drug, is permitted. 18. Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region). 19. Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. 20. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination. 21. Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study. 22. Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration. 23. History of COVID-19 diagnosis. 24. On current treatment with investigational agents for prophylaxis of COVID-19. 25. Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the investigator or necessary to manage a chronic condition. 26. Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska) from enrollment through 28 days after the last vaccination. 27. Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. 28. Non-ambulatory. 29. For subjects >/= 56 years of age, history of chronic smoking within the prior year. 30. For subjects >/= 56 years of age, current smoking or vaping. 31. For subjects >/= 56 years of age, individuals currently working with high risk of exposure to SARS-CoV-2 (e.g., active health care workers with direct patient contact, emergency response personnel). Optional Substudy Anaphylaxis or other systemic hypersensitivity reaction following a mRNA-1273 or any other vaccination. 2. Immediate allergic reaction of any severity after mRNA-1273 or any of its components.* *Including polyethylene glycol (PEG) 3. Immediate allergic reaction of any severity to polysorbate.* *Due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG 4. History of an SAE judged related to mRNA-1273 vaccine. 5. Female subject who is breastfeeding or plans to breastfeed from the time of the third mRNA-1273 vaccination through 30 days after the third mRNA-1273 vaccination. 6. Has an acute illness*, as determined by the participating site PI or appropriate sub-investigator, with or without fever [oral temperature >/=38.0°C (100.4°F)], within 72 hours prior to the third mRNA-1273 vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the substudy. 7. Has received any approved, authorized or investigational COVID-19 vaccine outside of this trial. 8. Any clinically significant medical condition that, in the opinion of the investigator, poses an additional risk to the subject from vaccination. 9. History of documented COVID-19 infection. 10. Has any medical disease or condition that, in the opinion of the participating site PI or appropriate sub-investigator, precludes substudy participation. 11. Received or plans to receive a licensed vaccine, other than a COVID-19 vaccine, within 2 weeks before or after the third mRNA-1273 vaccination | 1 |
60 yo M with Hep C cirrhosis, grade II esophageal varices, recent admission for UGIB [**2-9**] NSAID gastritis, referred for admission throught the ED by hepatology clinic for new slurred speech and tangential thought process. Patient also describes new imbalance leading to a fall during which he may have hit his head on. Per last liver clinic note has been off ETOH for a year (corroborated with pt), utox was negative for alocohol. CT was within normal limits, and neuro evaluation determined this was not ischemic infart. Patient was given a presumptive diagnosis of hepatic encephalopathy and started on lactulose. Liver function tests showed a striking increase in his total and direct bilirubin since last visit. Another worrisome feature was the increase in the patient's AFP. This could be progression of cirrhosis as he failed interferon twice. He is to follow-up as an outpatient to work this up. Past Medical History: HCV Cirrhosis (tx with interferon x2 with no response) Portal Gastropathy Grade II Esophageal varices HTN Recent admission [**4-/2150**]: UGIB [**2-9**] non-steroidal induced gastritis | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
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