Subject who have previously had MI Profiling performed prior to 11/11/2016 are eligible for this study. No drug intervention is required for this study.

Oncology

Solid Tumor, Adult

Caris Molecular Intelligence Profile

Highlands Oncology Group

Nebraska Cancer Specialists

The University of Texas Health Science Center at San Antonio

POA Retrospective Repository

Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database

Documentation of the frequency of specific clinical events in relation to diagnosis, treatments and outcomes provided

Caris Science, Inc.

Subjects must have undergone Caris MI Profiling in order to be eligible for the study. No required intervention is dictated by the protocol.

Customized comprehensive biomarker testing

Caris MI Profiling

HonorHealth

University of Arizona

St. Joseph Heritage Healthcare

John Wayne Cancer Institute

MedStar Health Research Institute, Inc.

AdventHealth Orlando Cancer Institute

University of Cincinnati Health, LLC

The Institute for Cancer Research dba The Research Institute of Fox Chase Cancer Center

The West Clinic

POA Prospective Repository

Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository

Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment.

Performing retrospective research including clinical presentation, treatment and outcomes. This eligible cohort includes select subjects who have already undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management.

Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed.

Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms.

Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.

The placebo is olive oil, stripped of polyphenols, 70% oleic acid, and will be administered at two 1 gram capsules per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.

POA Dose 1 is a 1 gram capsule containing 500 mg POA and one placebo capsule containing 500 mg olive oil per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.

POA Dose 2 is two, 1 gram capsules containing 500 mg POA, totaling 1,000 mg POA per day for twelve weeks.The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast.

Chronic Inflammation

Overweight

The placebo is olive oil, stripped of polyphenols, 70% oleic acid, administered as two 1-gram capsules per day. Packaged as single-serve packets containing 2 capsules for each daily dose.

Placebo

Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA

Palmitoleic acid, 500 mg (Dose 1)

Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA

Palmitoleic acid, 1,000 mg (Dose 2)

University of North Carolina Nutrition Research Institute

Effect of Palmitoleic Acid on C-reactive Protein

Effects of Palmitoleic Acid on Circulating C-reactive Protein Levels in Humans

Fasting blood draws will be used to evaluate circulating CRP level by high-sensitivity c-reactive protein laboratory blood analysis.

Fasting blood draws will be used to evaluate circulating cytokine IL-6 level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating cytokine TNF alpha level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating ghrelin level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating peptide YY level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating leptin level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate circulating adiponectin level by ELISA (enzyme-linked immunosorbent assay).

Fasting blood draws will be used to evaluate glucose/insulin ratio level.

Fasting blood draws will be used to evaluate HbA1c level.

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.

University of North Carolina, Chapel Hill

Organic Technologies

12-week randomized, double blinded study in volunteers consuming either the test agent, 500 mg or 1,000 mg POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study and 41 individuals per arm, thus, a total of 123 subjects.

Administration of the POA supplements and placebo (olive oil capsules) will be via a simple randomized double-blinded allocation. The study sponsor will provide the Principal Investigator with bags, or boxes, of single serve packets containing two capsules for each daily dose per participant in accordance with the proper dosage for each of the three arms of the study. The study sponsor will hold the code for the subjects and will randomize the capsules. No site personnel will have access to the randomization allocation; only the study sponsor will have the code. The identity of the capsules will be revealed once all analyses are complete.

IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen

Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.

Infection

The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation.
Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation.

IrriSept System

Institution will provide routine Standard of Care (SoC) only surgical preparation for subjects with abdominal trauma or acute surgical abdomen.

No Intervention - Standard of Care (SoC) only

University of Arizona/Banner Health Medical Center

LA County/USC Medical Center

Denver Health

Tampa General Hospital

University of Iowa Hospitals

University of Kentucky

University of Maryland Medical Center

Baystate Medical Center

University of Michigan

Saint Louis University

University of Cincinnati

MetroHealth

Wright State/Miami Valley Hospital

Elvis Presley Trauma Center

University of Texas SW-Parkland Hospital

Memorial Hermann Hospital

University of TX Health Science Center San Antonio

University of Washington Harborview Medical Center

Medical College of Wisconsin

IrrSept vs. Standard of Care in Prevention of Surgical Site Infections

A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the IrriSept System Versus Standard of Care on the Prevalence of Surgical Site Infection in Patients With Abdominal Trauma or Acute Surgical Abdomen

Compare the rate of SSI in the IrriSept system randomization group to the rate of SSI in Standard of Care randomization group.

Compare the hospital readmission rate of subjects receiving the IrriSept system to the hospital readmission rate of subjects receiving Standard of Care treatment.

Compare the estimated hospital cost to charge ratio between the IrriSept system and Standard of Care.

Compare the length of hospital stay between IrriSept system and Standard of Care.

Irrimax Corporation

Adult patients undergoing elective surgery
Having a CPET as part of routine care
Patients with a Hb value of < 130 g/L who are iron deficient, iron restricted/deplete or have functional iron deficiency.
Able to provide written informed consent.

Plasma stored in freezers at University Hospital Southampton

Anemia

Anemia, Iron Deficiency

Anaemic patients undergoing major surgery who would routinely be receiving intravenous iron 'MonoFer' will get this as part of routine care. They will then have a CPET repeated at least 10 days afterwards.

MonoFer

University Hospital Southampton NHS Foundation trust

CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

Cardiopulmonary Exercise Testing Before and After Intravenous Iron: a Prospective Clinical Study

Using cardiopulmonary exercise testing (CPET) to assess the oxygen consumption at anaerobic threshold before and then after intravenous iron therapy.

Using cardiopulmonary exercise testing (CPET) to assess the oxygen consumption at peak exercise before and then after intravenous iron therapy therapy

Laboratory measured haemoglobin concentration

By using the optimised carbon monoxide rebreathing technique (oCOR) total haemoglobin mass will be measured before intravenous iron therapy and then again after intravenous iron therapy

Hepcidin is iron regulatory hormone produced in the liver that affects iron transport. This will be measured twice.

Ferritin is an acute phase protein but it is also the body major storage protein for iron.

Plasma marker of iron storage and availability.

Hospital length of stay after to include entire perioperative stay. (This is routinely collected already as part of the preoperative optimisation of anaemia before surgery (POAS) service.)

poa/saratani

POA Retrospective Repository

POA Prospective Repository

Effect of Palmitoleic Acid on C-reactive Protein

IrrSept vs. Standard of Care in Prevention of Surgical Site Infections

CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

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