Active Studies

Based upon the current state of science, the investigators are proposing to conduct a
randomized clinical trial in which participants are randomized post-surgery to either BIS or
circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS
group have an L-Dex change that is ≥10 units higher than the pre-surgical baseline measure,
and when patients in the tape measurement group have a volume change in the at-risk arm that
is between ≥ 5% and arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.

This screening and multi-sub-study randomized phase II/III trial will establish a method for
genomic screening of similar large cancer populations followed by assigning and accruing
simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker)
will determine to which sub-study, within this protocol, a participant will be assigned to
compare new targeted cancer therapy, designed to block the growth and spread of cancer, or
combinations to standard of care therapy with the ultimate goal of being able to approve new
targeted therapies in this setting. In addition, the protocol includes a "non-match"
sub-study which will include all screened patients not eligible for any of the
biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of
care also with the goal of approval.

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.

RATIONALE: Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking
blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth. Monoclonal antibodies, such as elotuzumab, can
block cancer growth in different ways. Some block the ability of cancer cells to grow and
spread. Others find cancer cells and help kill them or carry cancer-killing substances to
them. Drugs used in chemotherapy, such as lenalidomide and dexamethasone also work in
different ways to kill tumor cells or stop them from growing. Giving elotuzumab together
with chemotherapy may be a better way to block cancer growth.

PURPOSE: This phase I/II trial is studying the side effects and best dose of elotuzumab and
to see how well it works when given with lenalidomide, bortezomib, and dexamethasone in
treating patients with multiple myeloma.

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

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