Clinical Trials

Clinical Trial – Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude

During ascent to high altitude there is a physiologic response to hypoxia that results in an
elevated pulmonary arterial pressure associated with decreased exercise performance,
altitude-induced pulmonary hypertension, and high altitude pulmonary edema (HAPE). Riociguat
is a novel agent from Bayer Pharmaceuticals that has already demonstrated effectiveness in
the treatment of pulmonary hypertension, and it may prove to be beneficial in cases of
altitude-induced pulmonary hypertension or HAPE. This research study, composed of 20 healthy
volunteers ages 18-40 years, will attempt to mimic the decreased oxygen supply and elevated
pulmonary artery pressures found in conditions of high altitude, allowing observation of the
effects of riociguat and exercise on pulmonary arterial pressure, arterial oxygenation, and
exercise performance. Prior to entering the hypobaric chamber, subjects will have radial
arterial lines and pulmonary artery catheters placed to obtain arterial and pulmonary artery
pressure measurements. Subjects will then enter the hypobaric chamber and perform exercise
tolerance tests at a simulated altitude of 15,000 feet on an electrically braked ergometer
(exercise bike) before and after administration of riociguat. If, after administration of
riociguat and exposure to a simulated altitude of 15,000 feet, the exercise performance is
improved and observed pulmonary artery pressures are lower than those measurements seen prior
to administration of riociguat, this could lead to development of a prophylactic and/or
treatment strategy for HAPE and high-altitude pulmonary hypertension. Statistical analysis
will compare the variables of pulmonary artery pressure, radial arterial pressure,
ventilation rate, cardiac output, PaO2, and work rate at exhaustion before and after
administration of the drug riociguat. The investigator’s hypothesis is that riociguat will
decrease pulmonary artery pressure and improve gas exchange and exercise performance at
altitude.

Clinical Trial – Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S

Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with
hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for
analgesics in patients undergoing elective cesarean section. Our hypothesis is that
hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic
conditions compared to hyperbaric bupivacaine.

Clinical Trial – Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) – Effect of One HBO Session.

Obesity is an epidemic in Western society and is the biggest risk factor for insulin
resistance and type 2 diabetes. The investigators have recently shown that exposure to
hyperbaric oxygen (HBO) leads to an increase insulin sensitivity in males ubjects and that
this improvement can be measured in all men, not just those with diabetes. The aim of this
study is to investigate the time course of this effect and explore the mechanisms involved.
The investigators suspect that insulin sensitivity as measured by
hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour
hyperbaric oxygen exposure, and that the improvement will be measurable in females as well as
males.

Clinical Trial – Hyperbaric Oxygen Therapy Attenuates Central Sensitization Induced by a Thermal Injury in Human Volunteers (HBO)

The hypothesis of this investigation is to observe if HBO have an anti-inflammatory effect in
humans induced by tonic heat stimulation. It has been shown in animal studies with rats that
HBO could reduce the paw edema induced by carrageenan as an inflammatory agent. The authors
are not aware of similar studies in human subjects investigating this effect of HBO. Aim: To
investigate the anti-inflammatory effect of HBO by reducing the hyperalgesia induced by heat
stimulation in healthy subjects and promote future research and understanding of the
anti-inflammatory processes in humans. The primary endpoint is a reduced area of secondary
hyperalgesia after HBO.

Clinical Trial – Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on
long-term symptoms after brain injury. This study will enroll 90 individuals with persistent
problems 6 months to 10 years after a brain injury. These individuals will be randomized to
receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive
40 daily hyperbaric chamber sessions.

Participants will have a series of tests and questionnaires before they begin their chamber
sessions, after they complete 40 sessions, and 6 months after they joined the study. These
tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain
imaging, a neurological examination, and an eye exam. Participants will also be asked to
provide blood for future research.

After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen
sessions, then undergo the same tests at 9 months and 12 months.

Clinical Trial – Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)

Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy
for cancers, and may have a devastating effect on the patient’s quality of life (QOL).
However,CRN was once regarded as a progressive and irreversible disease, no standard therapy
has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF)
to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been
published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective
study to test the efficacy of NGF for CRN.

Clinical Trial – Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section

We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central
venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a
higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of
hypotension, and compare pain control and maternal satisfaction during and after cesarean
section.

We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia
for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster
recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by
self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to
interact with baby in the OR.

Clinical Trial – Hyperbaric Levobupivacaine for Spinal Anaesthesia

Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of
regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space,
generally through a fine needle.

There is no generic hyperbaric form of levobupivacaine currently available so we aimed in
this study that to find the appropriate concentration of the levobupivacaine which achieves
unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less
motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be
suitable for outpatient anesthesia.

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