Oral cavity, esophageal, gastric, and duodenal microbiota samples, as well as saliva for the NRA analysis.

Functional Dyspepsia

Gastro Esophageal Reflux

Peptic Ulcer

Normal Control

Hamilton Health Science Centre

Digestive Disease Research Institute, Tehran University of Medical Sciences

Tohoku University Hospital

Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting for Endoscopy. Correlation of Symptoms With Upper GI Microbiome: The JUICE Study

The primary outcomes is the bacterial microbiome in patients with FD compared to control patients without upper GI symptoms and a normal endoscopy. The investigators will do a planned subgroup analysis according to country of recruitment as well as sex and age based subgroups (<or =50 years versus >50 years). Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

The microbiome in esophagitis patients compared to patients without esophagitis. To assess the oral nitrate reducing bacteria on the dorsum of the tongue of erosive GERD patients, patients with non-erosive GERD and comparing them with those of the normal controls enrolled in the JUICE study. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

Microbiome between H. pylori +ve and -ve peptic ulcer disease. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

The microbiome in those with anxiety patients versus controls without anxiety in the FD. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

The microbiome in those with depression versus controls without depression in the FD, Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

microbiome in those with and without anxiety in those with normal EGD and no symptoms. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

microbiome in those with and without depression in those with normal EGD and no symptoms. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

Comparison of upper GI pathology (inflammation, dysplasia, malignancy) and the microbiome in the Canadian versus the Japanese and the Iranian populations. Bacterial community profiling of the 16S rRNA gene will be carried out using paired end reads of the V3 region. Triplicate amplifications will be pooled for 150 or 250 nt paired-end Illumina sequencing in the McMaster Genome Center.

Paul Moayyedi

Professor

Hamilton Health Sciences Corporation

Tohoku University

Tehran University of Medical Sciences

All patients who enroll will receive C134 inoculation into their tumor (one time procedure with 1-5 inoculation sites)

Glioblastoma Multiforme of Brain

Anaplastic Astrocytoma of Brain

Gliosarcoma of Brain

C134 is a virus that was created from an oncolytic Herpes Simplex Virus (oHSV) known to infect and kill tumor cells. The Investigators have made changes to the original virus to make C134. It efficiently infects tumor cells (not normal healthy cells) and induces an immune response to fight the cancer as well.

C134

University of Alabama at Birmingham

Trial of C134 in Patients With Recurrent GBM

A Phase I Trial of IRS-1 HSV C134 Administered Intratumorally in Patients With Recurrent Malignant Glioma

Adverse events will be monitored and any changes in status will be recorded for each patient as outlined in CTCAE v4.0 reporting requirements.

Patients will receive contrast-enhanced MRI to monitor progression (changes in tumor volume or tumor enhancement assessed by the iRANO criteria). As indicated in the criteria, biopsy and/or resection may be performed in instances of uncertainty. Determination of time to progression (in months) will be recorded for each patient and median progression-free survival will be calculated for the entire cohort (Kaplan-Meier).

Patients survival will be recorded (Kaplan-Meier).

Detection and quantification of HSV antibody titer via ELISA, pfu/mL.

White blood cell subset analysis by FACS, as a percent of total white blood cell number.

Intracellular lymphocyte interferon levels will be assessed by FACS analysis ng/mL

James Markert, MD

Principal Investigator

Gateway for Cancer Research

National Cancer Institute (NCI)

Modified continuous reassessment model (mCRM). Using this statistical method, dose changes occur based upon toxicities (or lack thereof) observed after a 24 day observation period for the initial dose level. If toxicities occurring at any dose were acceptable, doses for subsequent cohorts can be increased by up to 1 log until a maximum tolerated dose is reached. If toxicities are unacceptable then dose de-escalation occurs until a safe acceptable maximum tolerated dosage is defined. However, it should be noted that the dose alterations are not predictable and cannot be predefined, they are statistically determined after each patient using mCRM software.

TRUS and TRUS-Robot will be used during PVP

Benign Prostatic Hyperplasia

The TRUS and TRUS-Robot will be used to record ultrasound images during PVP. The PVP procedure will be conducted as usual, without using the ultrasound for guiding the intervention.

Transrectal Ultrasound

Johns Hopkins Hospital

Ultrasound-Guided Photoselective Vaporization of the Prostate

Prostate volume will be measured before (Set I, initial: 3 min) and after (Set F, final: 3 min) the PVP.

reductase/karijes

Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting

Trial of C134 in Patients With Recurrent GBM

Ultrasound-Guided Photoselective Vaporization of the Prostate

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