Clinical Trials

Clinical Trial – Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation

Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct
therapy for diabetic wounds. However, some patients have insufficient increase or even
paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was
to investigate the pathophysiology responsible for the different consequences of HBOT and to
evaluate the effect of N-acetylcysteine (NAC) on these changes.

Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with
non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the
second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and
plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide
(NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete
HBOT protocol.

Clinical Trial – Randomized Controlled Trial of Hyperbaric Oxygen in Patients Who Have Taken Bisphosphonates

Osteonecrosis of the jaw (ONJ) has recently been recognized as associated with bisphosphonate
therapy, however there is little information on the natural history, treatment or prevention
strategies for this condition. The purpose of this study is to determine the effectiveness of
hyperbaric oxygen as a treatment. We will randomize 35 out of 70 ONJ patients to receive HBO
in addition to their routine oral surgery care and follow both groups over a 2-year period.

Clinical Trial – Effect of Repeated Exposures to Compressed Air on Patients With AIDS

The exposure of human beings to markedly altered environments (ambient pressure and inhaled
gas mixtures) has profound effects on their innate immune capacity to effectively combat
viral illnesses. This Phase IIA clinical trial examines the effects of an exposure to a 4
atmospheric environment has on HIV-infected humans whose clinical condition has progressed to
formal AIDS status.

Clinical Trial – Effects of Hyperbaric Oxygen Therapy on Children With Autism

PURPOSE

The purpose of this investigation is to evaluate the cognitive and behavioral effects of
Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum
disorder.

HYPOTHESIS

1. Hyperbaric Oxygenation Therapy will be safe to use with children with autism.

2. Hyperbaric Oxygenation Therapy will have a statistically significant effect on the
symptoms of autism.

3. Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on
the overt symptoms of autism.

4. The decreases in the symptoms of autism will correlate positively with the number of
Hyperbaric Oxygenation Therapy sessions.

5. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at
follow-up, post 40 treatment sessions.

SPECIFIC AIMS

1. Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children
with autism.

2. To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and
cognitive symptoms of autism before, during, and after treatment.

3. Identify number of treatments required to reach therapeutic effects.

4. Identify the length and durability of treatment effect and maintenance.

Clinical Trial – Effect of Body Mass Index on the Dose of Intrathecal Hyperbaric Bupivacaine for Elective Cesarean Section

Combined spinal – epidural (CSE) anesthesia is a well established technique used for elective
Cesarean section. As its name suggests, it combines two anesthesia techniques – spinal and
epidural. Adjusting the dose of freezing medication for body size is not as simple as giving
a larger dose to a larger person. This study asks a simple, yet important question: does your
body mass index (BMI) influence the amount of freezing medication needed for adequate CSE
anesthesia for Cesarean section? BMI is a number calculated from your height and weight. In
patients with a higher BMI, freezing medication appears to spread farther (to a higher level)
in the spinal fluid. When freezing is too high, it can cause unwanted side effects.
Therefore, in order to provide optimal spinal anesthesia to patients with a higher BMI, it
may be advisable to administer less freezing medication. In this study, we want to find the
ideal dose of freezing medication for patients with a higher body mass index, and compare it
to the dose found to be ideal for patients with normal body mass index.

Clinical Trial – Is it Possible to Treat Cyanide Poisoning With HBO?

People who has been in a fire accident have been shown often to be cyanide poisoned as well
as poisoned with carbon monoxide(CO). According to recommendations from the Danish Health
Agency people who are CO poisoned must be treated with hyperbaric oxygen (HBO). We want to
see if HBO treatment can also treat cyanide poisoning.

The hypothesis is that as cyanide binds the same place in the mitochondria as CO cyanide will
be detached from the mitochondria like CO and diffuse back to the blood.This way it will be
easier to treat with hydroxycobalamin.

Clinical Trial – A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children

Autism is a neurodevelopmental disorder currently affecting as many as 1 out of 166 children
in the United States. Autism is considered by many to be a permanent condition with little
hope for improvement. Treatment for autism is centered on special schooling and behavioral
therapy; medical science currently has little to offer. Recent research has discovered that
some autistic individuals have decreased blood flow to the brain, evidence of
gastrointestinal and brain inflammation, increased markers of oxidative stress, and a
relative mitochondrial dysfunction. Hyperbaric oxygen therapy (HBOT) can compensate for
decreased blood flow by increasing the oxygen content of plasma and body tissues and can even
normalize oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT
has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent
evidence demonstrates that HBOT increases the production of mitochondria and mobilizes stem
cells from human bone marrow, which may aid recovery in neurodegenerative diseases. Based
upon these findings, it is hypothesized that HBOT will improve symptoms in autistic
individuals.

Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic
children. We recently completed a prospective pilot trial using HBOT in 18 children which
demonstrated significant clinical improvements in autistic children on several standardized
scales. Most of the scales were parent-rated, although some were rated by teachers. However,
parents were not blinded to the fact that their children received HBOT and evaluation of the
children was through parent-rated scales, either of which could lead to bias. There was no
placebo or control group. Therefore, the improvements found in this prospective study could
have been due merely to chance or the natural development of the children. To determine if
HBOT improves symptoms in autistic children, a double-blind controlled study is needed.

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