10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.

10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.

Subarachnoid Hemorrhage, Aneurysmal

Delayed Cerebral Ischemia

Vasospasm, Cerebral

Endothelial Dysfunction

GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.

GSK2256294

Placebo will be administered in a single dose once daily enteral for a duration of 10 days.

Placebo

Oregon Health & Science University

Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial

Summary tables and listings will be provided for all reported adverse events, defined as adverse events that start on or after the first administration of study drug. The reported adverse event term will be assigned a standardized preferred term.
Adverse events will be summarized based on the number and percentage of patients experiencing the event. In the event a patient experiences repeat episodes of the same adverse event, then the event with the highest severity grade and strongest causal relationship to study treatment will be used for purposes of incidence tabulations. Tabular summaries will be provided for all adverse events, the relationship to study drug treatment the maximum severity grade, action taken, and whether the event qualified serious adverse event or not.
All deaths will be reported in a patient listing, which will include the primary cause of death and the number of days between the date of the last dose of study drug and death.

Day 7 and day 10 serum EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected blood samples.
Day 7 and day 10 CSF EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected CSF samples.

Study day 7 and study day 10 serum epoxyoctadecenoic acid (EPOME) to dihydroxyoctadec-12-enoic acid (DPOME) ratio, will be measure by mass spectroscopic analysis of collected blood samples.

The following serum biomarkers will be obtained from collected blood samples by Luminex assay: e-selectin (pg/mL), p-selectin (pg/mL), Vascular cell adhesion marker (VCAM-1) (pg/mL), Platelet endothelial cell adhesion marker (PECAM-1, CD31) (pg/mL), intercellular adhesion molecule (ICAM-1) (pg/mL)

The following CSF biomarker will be obtained from collected CSF samples by Luminex assay: Tumor necrosis factor alpha (TNF-α) (pg/mL), Interleukin 1β (IL-1β) (pg/mL), Interferon gamma (IFN-γ) (pg/mL), Interleukin 6 (IL-6) (pg/mL), Interleukin 8 (IL-8) (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL)

The hospital length of stay will be recorded in days, at the time of hospital discharge.

The disposition from the hospital in one of the following categories: home, home with services, rehab, long term acute care facility, skilled nursing facility, hospice, death

The last head CT or other brain imaging to detect the presence of a new area of cerebral infarction will be reviewed at the time of hospital discharge. A cerebral infarction will be defined as a one identified on hospital discharge that was not present on imaging between 24-48 hours after aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities resulting from extraventricular drains or residual intraparencyhmal hematomas will not be considered new strokes.

The mRS score will be determined by patient or surrogate interview, at both hospital discharge and 90 day follow up. Scores will be assigned based on the following: 0 - no symptoms, 1 - no significant disability, able to carry out all usual activities despite some symptoms, 2 - slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 - moderate disability, requires some help, but able to walk unassisted, 4 - moderately severe disability, unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 - severe disability, requires constant nursing care and attention, bedridden, incontinent, 6 - deceased.

At 90 day follow up, the GOSE will be determined by patient or surrogate telephone interview, based on a structured interview of 19 questions. The GOSE will be recorded on an a scale of 1-8 where 1 - deceased, 2 - vegetative state, 3 - low severe disability, 4 - upper severe disability, 5 - low moderate disability, 6 -upper moderate disability, 7 - low good recovery, 8 - upper good recovery.

Ross Martini, MD

Principal Investigator

Oregon Health and Science University

Subjects will be randomized to one of the two treatment arms based on an unrestricted or "fair-coin" randomization procedure.

Investigational pharmacy staff will maintain the randomization list and study/drug placebo assignment. Participants, care providers, the investigators and outcomes assessors will be blinded to the grouping.

Non-stroke participants. Blood drawn for analysis of biomarkers.

Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, and MRI infarct size assessed in hospital. 3 month modified Rankin scale score collected by phone interview.

Participants presenting at the University of Florida Shands Emergency Department with signs and symptoms resembling a stroke, but which are determined to be from another cause. Blood drawn during initial emergency room evaluation.

Stroke

Blood drawn for comparison with other groups

Blood draw

Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, blood pressure, MRI infarct volumes, and hospital length of stay taken from the medical records. 3 month modified Rankin scale score collected by phone interview.

Stroke blood draw

University of Florida

Neuronal and Glial Biomarkers in Stroke

Serum and whole blood will be analyzed for levels of ACE2 activity. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.

Serum and whole blood will be analyzed for levels of ACE2 Activity.

Serum and whole blood will be analyzed for levels of ACE2 Activity. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.

NIH stroke scale scores will obtained as part of the normal care and are scored with points being assigned for neurological deficits (0 = best possible, highest number = best possible) in areas of motor control of the arm (0-4), leg (0-4) sensory perception (0-2), language (0-3), limb ataxia (0-2), gaze (0-2), level of consciousness (0-3), orientation (0-2), response to commands (0-2), facial palsy (0-3), visual (0-3), dysarthria (0-2), and extinction (0-2), and is used to assess the level of neurological deficit from the stroke.

Infarct size will be measured as part of the normal care by MRI volumetric analysis in cm cubed and may range from less than a cm cubed to 20 cm cubed or greater depending on the extent of the stroke. This is meant to assess the size of the stroke.

Initial modified Rankin scale scores will be acquired in hospital as a part of the normal care and by a follow-up phone interview at 3 months. This is scored as follows:
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.

Serum and whole blood will be analyzed for levels of GFAP. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.

Serum and whole blood will be analyzed for levels of GFAP. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.

Serum and whole blood will be analyzed for levels of UCH-L1. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome.

Serum and whole blood will be analyzed for levels of UCH-L1. These markers will be assessed for their value as biomarkers of stroke subtype and long-term outcome. This last time point will be assessed after discharge from the hospital at the time that the patient returns to the UF Neurology Clinic for their follow-up visit.

Hepatocellular Carcinoma

All enrolled patients will receive 3.5 Gy per fraction (five fractions per week) at the following levels;
Dose escalation by 7 Gy in 2 fractions to maximum of 63 Gy, as follows:
Dose Level I: 3.5 Gy for 12 fractions (42 Gy total) Dose Level II: 3.5 Gy for 14 fractions (49 Gy total) Dose Level III: 3.5 Gy for 16 fractions (56 Gy total) Dose Level VI: 3.5 Gy for 18 fractions (63 Gy total)

3DCRT or IMRT

National Taiwan University Hospital

A Dose Escalation Trial of Radiation Therapy (RT) for Hepatocellular Carcinoma (HCC)

A Phase I Dose Escalation Trial of Conformal Hypofractionated Radiation Therapy for Patients With Hepatitis B Virus-Related Child A Cirrhosis and Hepatocellular Carcinoma

hydrolase/hemorrhage

Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial

Neuronal and Glial Biomarkers in Stroke

A Dose Escalation Trial of Radiation Therapy (RT) for Hepatocellular Carcinoma (HCC)

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