Clinical Trials

Clinical Trial – Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment

By doing this study, researchers hope to learn the following:

– If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC)
transplant will help to improve the homing process

– The safety of HBO administration in the setting of the UBC transplant

– The effects of HBO therapy on the engraftment process

Clinical Trial – Comparison Between Two Different Parameters of Argon Plasma Coagulation in the Treatment of Chronic Radiation Proctitis: Historical Control Trial.

There is a wide variability of options for treatment of chronic radiation proctitis. However,
studies are still limited, usually case reports from a single center and few are comparative
studies between methods. Therefore, the choice of treatment is determined by availability and
local expertise for each method. The variability of treatment options range from
anti-inflammatory medical treatment, sucralfate, short chain fatty acids, antioxidants and
hyperbaric oxygen to such endoscopic and surgical treatments. Surgery is usually the last
therapeutic option due to the high morbidity and mortalityassociated. Various endoscopic
treatment modalities have been reported. Formalin topic is effective in up to 48% of patients
with chronic radiation proctitis.

The endoscopic treatment with argon plasma (APC) is low cost, easy to apply and
transportation, safe and effective in the treatment of rectal bleeding in patients with
chronic radiation proctitis. Currently, the APC is the preferred endoscopic modality.

Most studies on the use of APC in radiation proctitis showed benefit. The APC controls the
mild to moderate rectal bleeding in 80% to 90% of cases and improves symptoms of urgency,
diarrhea and tenesmus in 60% to 75% of cases.

Clinical Trial – Hyperbaric Oxygen Therapy for Mild Cognitive Impairment

Dementia is a very frequent cognitive disorder among elderly individuals. Its prevalence is
about 15-20% of the population over the age of 65. The most common forms of dementia among
the elderly demented patients are Alzheimer’s disease (AD) (prevalence of 70%) and Vascular
dementia (VD) (prevalence of about 30-40%).There is also a high rate (about 40%) of
coexisting of AD and VD among the dementia patients, defined as mixed dementia.

Mild Cognitive Impairment (MCI) is a pre-dementia phase of cognitive decline. It is also
considered as a prodromal phase of both VD and AD. Its basic clinical features include:
cognitive concern, reflecting a change in cognition, reported by the patient or informant
(i.e., historical or observed evidence of decline over time), with objective evidence of
impairment in one or more cognitive domains (i.e., by formal cognitive testing), as well as
preservation of independence in functional abilities and not being demented (i.e., no
significant impairment social or occupational functioning).

Hyperbaric oxygen therapy (HBOT) has been investigated for treatment of numerous diseases for
more than 300 years. The principal effect of HBOT is increasing the solubility of oxygen in
plasma to a level sufficient to support tissues with minimal oxygen supply carried on by
hemoglobin. Clinical studies published this year present convincing evidence that hyperbaric
oxygen therapy (HBOT) can be the coveted neurotherapeutic method for brain repair. Thus, it
seems that HBOT might be an efficient and clinically feasible method capable of increasing
tissue/cellular oxygenation and effectively evoking neuroplasticity in the chronically
vascular-lesioned areas during the post microvascular lesion phase.

This is a prospective, randomized, control crossed over, study evaluating the effect of HBOT
in patients suffering from Mild Cognitive Impairment and Vascular Subcortical Ischemia.

Clinical Trial – Hyperbaric Oxygenation in Diabetic Ulcer

Hyperbaric oxygenation (HBO) involves breathing of 100% oxygen under elevated ambient
pressure. In correlation to the pressure level oxygen dissolves in the plasma resulting in an
increase of total oxygen in the body. The elevated tissue levels of oxygen may persist for
hours, instigating healing processes in wounds caused by disturbances in of perfusion in
small vessels, a condition often found in patient with diabetes.

We plan a prospective, double-blind randomized clinical study in 80 patients with chronic
diabetic ulcer. All will have optimum treatment of diabetes. The HBO group will be given HBO
at 2.4 bar, 90 min., 30 sessions, controls will have sham HBO. Routine wound care will be
identical in both groups. Before, during and after treatment (3, 6 and 12 months), a number
of monitoring and imaging procedures will be done, cells in the bloodstream indicating
improved healing will be determined.

Hypothesis: HBO will instigate the healing process in the majority of patients with chronic
diabetic leg ulcer, provided the patency of the large vessels is given.

Clinical Trial – Urinary Retention in Orthopedic Patients

The participants were hospitalized in Orthopedic and Traumatology Departments in Military
Institute of Medicine, Warsaw, Poland.

The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and
(3) surgery under spinal anesthesia. All the patients where (1) opioids were administered
during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder
catheterization was perform during the surgery were excluded from the study.

The participants were randomly divided into the study and control groups. No oral
premedication was administered. All the patients were asked to empty their urinary bladders
before arrival to the operating theatre. When the standard monitoring (continuous
electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous
premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric
0.5% solution of bupivacaine hydrochloride was performed.

In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride
was administered intramuscularly. The decresed intravascular volume was corrected with
cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay
scale, level of sedationt was obtained with midazolam and/or propofol. All the participants
received a questionaire in which we asked the questions about (1) the duration of anesthesia,
(2) the time of micturition, (3) the time when discomfort or pain appeared in the lower
abdomen, (4) the incidence of the urinary bladder catheterization and time to
catheterization. On the next day after the surgery the questionaires were collected. In
cases, when the patient’s dischaged from the hospital was planned during the weekend, he or
she was asked to pass on the questionaire to the nurses.

Clinical Trial – Tranexamic Acid and Thromboelastography During Cesarean Delivery

The aim of this study is to characterize the coagulation changes, using thromboelastography
(TEG), after prophylactic tranexamic administration during cesarean delivery. Specifically,
TEG values will be compared in patients who receive prophylactic tranexamic acid or placebo
before surgery, during elective cesarean delivery, and 2 hours postpartum.

Postpartum hemorrhage (PPH) is increasing in incidence in the United States, renewing
interest in multimodal approaches to blood conservation during cesarean delivery.
Pharmacologic therapy with the antifibrinolytic agent, tranexamic acid (TA), has been shown
to reduce estimated blood loss (EBL) during cesarean delivery, but its effect on global
coagulation as assessed by TEG, and how this correlates with lowering blood loss, has not
been elucidated.

This study will be conducted as a randomized, double-blind, controlled trial with two study
arms: control (60 patients); and treatment (60 patients).

Subjects will be pre-medicated with routine pre-cesarean delivery medications including oral
sodium citrate 30 mL and intravenous (IV) metoclopramide 10 mg. A peripheral IV and
noninvasive hemoglobin monitor will be placed, and baseline labs sent: type and screen, serum
hemoglobin, platelet count, fibrinogen, activated partial thromboplastin time (aPTT),
prothrombin time (PT), and baseline TEG values (r time, k time, alpha angle, and maximum
amplitude). Patients will have blood pressure, heart rate, and pulse oximetry measured
throughout surgery as per standard of care. Patients will all receive IV lactated Ringers’
(LR) solution prior to surgery and throughout surgery, with volume recorded and a goal of
less than 2 L unless more IV fluid is clinically indicated. All patients will have a spinal
anesthetic as per standard of care, with hyperbaric bupivacaine 12 mg, fentanyl 10 μg, and
hydromorphone 100 μg. If the anesthetic plan is altered (combined spinal-epidural, general
anesthesia conversion, general anesthesia planned), indications and medication doses used
will be noted for analysis.

Immediately following induction of anesthesia and prior to skin incision, infusion of study
solution will be initiated.

Study solutions will consist of:

1. Control group: 100 mL 0.9% normal saline (NS).

2. Treatment group: 100 mL 0.9% NS containing 1g tranexamic acid (TA). Study solution will
be infused via an infusion pump over 10 minutes. Blood loss will be measured by visual
estimate and weight of surgical sponges. Noninvasive hemoglobin will be measured
throughout the study. All routine care lab values will be noted. At minimum, one lab
panel will be sent one hour after study solution initiation (hemoglobin, fibrinogen,
platelet count, aPTT, PT, and TEG).

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