This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of emricasan in improving event-free survival based on a composite
clinical endpoint (where all-cause mortality, new decompensation events, and MELD score
progression are events) in subjects with decompensated NASH cirrhosis.

The primary purpose of this project is to determine if acute monitoring of shunt patency via
ultrasound elastography measurements of splenic stiffness before and after TIPS placement
results in reduced morbidity and mortality from shunt failure.

The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea
will be effective and safe for kidney transplant patients, allowing them to continue with
MPA medication.

This observational study will collect blood and urine and clinical information from
individuals with early-stages of polycystic kidney disease (PKD), their unaffected siblings
and normal volunteers to create a biobank, also called a biorepository. The long-term goal
is to develop new knowledge on biological markers or biomarkers that indicate changes in the
disease progression. An understanding of biomarkers for early renal cyst growth will benefit
PKD patients as new therapies are being developed and tested.

The purpose of this research is to determine if an investigational new drug solution called
Prismocitrate 18 lengthens extracorporeal circuit life in acute kidney injury (AKI) patients
treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT
treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who
receive CRRT treatment with no anticoagulation.

The primary objectives of this study are to evaluate the effect of Obeticholic Acid
treatment compared to placebo on 1) histological improvement and 2) liver-related clinical
outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver
fibrosis.

The ALF-MBT protocol is for a multicenter, open label, non-randomized study to determine the
value of Breath Identification® (BreathID®) Acute Liver Failure 13C-Methacetin Breath Test
System in predicting the outcome of patients diagnosed with acute liver failure who meet
inclusion/exclusion criteria.

Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed
one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin
solution (test substrate).

The Breath Test will be performed on all patients upon admission into the study (Day 1) and
repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test
continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the
improvement or deterioration in liver metabolic function about improvement or deterioration
in liver metabolic function.

Patients will be contacted for the Day 21 follow up (21 days after enrollment into the
trial) to determine spontaneous survival, transplantation and occurrence of serious adverse
events since the patient's last study treatment.

The purpose of this study is to collect clinical and epidemiological data as well as serum,
plasma, urine, tissue and DNA samples on individuals who have acute liver failure and on
individuals who have acute liver injury, a less severe group of patients who have
coagulopathy but do not reach the threshold of encephalopathy.

This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute
liver failure/acute liver injury (ALF/ALI) in regard to:

- safety and tolerability;

- metabolism of the compound to glutamine and phenylacetylglutamine (PAGN);

- its effect on circulating ammonia levels and neurological function in patients with and
without impaired renal function after continuous infusion at different infusion rates.

Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day
follow-up visit post infusion. It is anticipated that this early safety and tolerability
study, with appropriate PK/PD data, will lead to a development program for the use of
OCR-002 in the treatment of hyperammonemia either due to ALF or possibly other liver
conditions. The hypotheses are:

- Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute
liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune
hepatitis, viral hepatitis or indeterminate etiologies.

- A dose of 10g/24h (0.42g/h) will achieve steady state plasma concentrations within
6-12h with little additional accumulation in the ALI/ALF setting.

- Treatment with OCR-002 will improve neurological function in patients with acute liver
failure/severe acute liver injury due to acetaminophen overdose.

Purpose:
The purpose of this study is to understand cognitive impairment in end stage renal disease before and after a kidney transplant.