Veterans Special Report
Clinical Trials

Clinical Trial – Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus

Feb 5, 2013 | , ,

A prospective, open labeled, randomized controlled clinical trial comparing the benefit of
both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical
treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical
treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be
randomized into either the intervention group or the control group:

Clinical Trial – Hypercapnia: Cognitive Effects and Monitoring

Jan 31, 2013 | , ,

The investigators will simulate the conditions of a working, helmeted diver by using
exercising, "head out" immersed subjects to test the following hypotheses:

1. An algorithm can be developed which predicts cognitive performance in immersed
exercising divers, based on the exhaled carbon dioxide (PETCO2) and the diver’s inspired
partial pressures of oxygen and nitrogen (PIO2 and PIN2).

2. PETCO2 using mass spectrometry is an accurate estimate of arterial carbon dioxide
(PaCO2) at rest and during immersed exercise and can be used as a PaCO2 surrogate at
levels exceeding 50 mmHg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165
fsw density of 6.8 g/l).

Clinical Trial – Efficacy of Peripheral Nerve Stimulator in Assessing Sensory Nerve Block Level of Spinal Anesthesia

Jan 8, 2013 | , ,

Various methods are used to assess the level of anesthesia block after spinal anesthesia.
Among them, ice cubes, alcohol swabs, and needles are commonly used in the clinical setting,
but ice is limited by difficulties with management and transportation, and needle assessment
has problems owing to the risk of pain, infection, and injury to the patient.

Hence, the alcohol swab is commonly used in practice. However, the absence of pain is more
important in the surgical process, and assessing the pain block level is more feasible in
practice than assessing the sensory nerve block level using the alcohol swab.

Therefore, it seems to be better to use the peripheral nerve stimulator for the accurate
assessment of the pain block level. This has the advantage of continuous measurement of the
block level, which can be used in a practical manner in conjunction with the surgical
incision.

Hence, the author compared the conventional method using the alcohol swab with the use of the
peripheral nerve stimulator to determine which method is more practical in the measurement of
spinal anesthesia block level.

Clinical Trial – Stem Cell Quantification In Peripheral Blood After Hyperbaric Oxygen Therapy Treatments

Nov 30, 2012 | , ,

This is an observational research study whose purposes are to see the effects of repeated
hyperbaric oxygen therapy treatments on the levels of stem/progenitor cells in peripheral
circulating blood following five days of treatment, 90 minutes per day at 2.0 atmospheres
absolute in 100% USP Grade Oxygen. Hyperbaric oxygen has a greater oxygen concentration than
air at sea level. In this research, the concentration of oxygen will be twice the level of
oxygen at sea level.

Clinical Trial – The Using of NEurocryostimulation in Military Ankle Sprains

Oct 16, 2012 | , ,

Introduction: The military population is at high-risk for injury with by painful sprains,
especially of the ankle. The referenced treatment method for pain is the cryotherapy,
consisting in applying cold-packs to the injured ankle several times a day. However, another
pain treatment has been developed and is commonly used by high-level sports teams and
rheumatologists but its efficacy has never been assessed within a military population, i.e.
the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.

Research design: This study was carried out on a French multicenter basis, the study
consisting in a randomized controlled superiority trial and open-label prospective analysis
in the treatment of 40-year-old military patients or younger suffering from acute ankle
sprains. Two groups were made: patients were treated either by neurocryostimulation or by the
referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six
supervised 30 minute-sessions within a period of three consecutive days.

Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity
resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we
theorized that the total consumption of paracetamol and the number of days of temporary
inaptitude and of work exemption were lower in patients treated by neurocryostimulation.

Outcomes:

For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning
and at the end of session 20 minutes later after a four-step walk.

Clinical Trial – Optical Coherence Tomography for Monitoring Late Oral Radiation Toxicity After Radiotherapy of Head and Neck Cancer Patients

Aug 30, 2012 | , , ,

Radiation therapy of the head and neck cancer patients causes late oral radiation
complications such as xerostomia (dry mouth) or mucosal atrophy. Currently, methods such as
hyperbaric oxygen are used to treat these complications; however, there are no quantifiable
means of assessing the outcome of these methods. At present, subjective methods such as
superficial examination of the oral cavity are used, yet complications are known to mostly
start in the subsurface layers. In this feasibility study, we apply an imaging technique
called optical coherence tomography (OCT) as a means of providing objective and quantifiable
images of the subsurface micro-structural and micro-vascular changes of oral tissue.
Depth-resolved, micrometer-resolution OCT images provide information on changes associated
with late radiation complications.

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