| Solmedx Clinical Studies
As we develop data on our clinical studies, we would be happy to share our results with you. If you would like to receive new data as it is generated, please Contact Us and give us your email address. We promise to send only data and no promotional material.
Current ongoing clinical study:
Rutgers IRB Protocol No: 2011001111
Title: ROX analysis to create norms for patients suffering from pain associated with
chronic disease.
Principal Investigator: John Bach, MD, Rutgers NJMS, Department of Physical
Medicine and Rehabilitation
Co-investigators: Zamir Brelvi, MD, PhD, Michael Demyen, MD, Rutgers New Jersey
Medical School, Gastroenterology and Hepatology; Samyadev Datta, MD, Center for
Pain Management; Andrew Kaufman, MD, Rutgers Comprehensive Pain Center
Study Coordinator: Sam Sofer, PhD, PE, Solmedx
Study Performance Sites: Apollo Medical Center, Parsippany, NJ; Center for Pain
Management, Hackensack, NJ; Immedicenters, Bloomfield, Clifton, and Totowa, NJ;
Rutgers University Hospital, Newark, NJ
We are currently seeking volunteers and patients for our clinical study on the
relationship of pain and ROX levels. We need volunteers with essentially no pain (0-2
on a scale of 0 to 10); volunteers with pain that is largely controlled with medication (3-6
on a scale of 0 to 10); and volunteers with pain that largely cannot be controlled with
medication (7-10 on a scale of 0 to 10). You may also volunteer if you have a chronic
disease, such as diabetes, neuromuscular disease, asthma, cardiovascular disease,
COPD, schizophrenia, bi-polar disease, etc.
The purpose of this multi-center study is to create norms for people suffering from pain
associated with chronic disease. If you are interested in volunteering for this study:
(1) Please read the Study Abstract below;
(2) Please download and read the Consent to Take Part in a Research Study;
(3) Once you have read and understood the Abstract and Consent form, please call Dr.
Sam Sofer, Project Coordinator, at 201-953-1719 with any questions you may have
regarding the study and/or to discuss your participation in the study.
(4) You must then follow up with an appointment at one of the following participating
clinics:
Dr. John Bach
Doctors Office Center
90 Bergen St.
Newark, NJ
973-972-2809
Dr. Zamir Brelvi
Apollo Medical Center
148 Parsippany Rd.
Parsippany, NJ
973-884-3355
Dr. Samyadev Datta; Monique Sweeney
Center for Pain Management
294 State St., Suite 1
Hackensack, NJ
201-488-7246
Dr. Michael Demyen; Dr. Zamir Brelvi
Rutgers Doctors Office Center
90 Bergen St., Suite 2100
Newark, NJ
973-972-2343
Dr. Andrew Kaufman
Rutgers Comprehensive Pain Center
90 Bergen St., Suite 3400
Newark, NJ
973-972-2085
Dr. Zamir Brelvi
Immedicenters
557 Broad St., Bloomfield, NJ
1355 Broad St., Clifton, NJ
500 Union Blvd., Totowa, NJ
973-778-5566
(5) The Consent form and a Study Questionnaire must be signed and completed by a
participating member of the study team above. Downloadable Questionnaire
(6) Please note that the Questionnaire is confidential and does not include any
identification information, such as name, address, or social security number.
Abstract of Current Study:
The ROX™ Analyzer is a new tool, which is of potential use to quantify pain levels in
individuals. Pain is very difficult to quantify, and a major obstacle in the treatment of
pain is its subjective nature. No tools generating hard data have been available for
aiding physicians to monitor the progress of treatments for pain1,2. We propose to use a
ROX Analyzer to create norms for subjects with no reported pain, chronic treated pain,
and treated but unstable pain. ROX Analyzers allow us to measure the viability of the
oxygen delivery and concentration system, and are therefore of obvious importance in
immune oxidative attack, oxidative liver detoxification, and mitochondrial energy
generation. Our hypothesis is that the firing of nerves and generation of impulses also
critically require an adequate and balanced oxygen delivery system. Thus, ROX
analysis may be very useful in quantifying pain.
Abstract of Final Report of Completed Clinical Study
When blood is subjected to a protocol of increasing stress, hidden reservoirs of
oxygen (O2) and nitric oxide (NO) are revealed. As stress applied to a blood
sample increases, at first O2 vanishes suddenly and later re-appears, also
suddenly. NO appears the same way, indicating a reservoir mechanism, into and
from which these molecules are rapidly transported.
O2 and NO are key molecules involved in immune system function, and their
transport characteristics in blood are key to the investigation and monitoring of
any disease. The purpose of this paper is to present an immunography
technique, which exploits blood stress profiles and is useful for evaluating
disease level and progress in any patient.
Immunography is the use of an Immunogram Analyzer (IA) to generate blood
stress profiles, called immunograms, to measure O2 and NO profiles.
In this paper we demonstrate how to use immunography to evaluate Hepatitis C
(Hep C) patients. On the basis of four known Hep C patient samples and 19
controls, we have found higher NO levels, along with higher oxidative activity, in
the Hep C samples. Information about blood reservoirs of oxygen (ROX) and
cellular boosting of oxygen (BOX) is also presented and discussed.
Planned Clinical Studies
Additional clinical studies are planned for ALS; Alzheimer’s, Huntington’s, MS, and other
neurodegenerative diseases; Cancer; Complex Regional Pain Syndrome; Diabetes;
HIV/AIDs; Parkinson’s Disease; and Rheumatoid Arthritis and other auto-immune
diseases.
If you are interested in taking part in a clinical study, please Contact Us.
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