Clinical Trials

Clinical Trial – Saliva, Hyperbaric Oxygen Therapy, & Gland Function: A Prospective Study

The purpose of this study is to determine if Hyperbaric Oxygen (HBO) therapy improves
salivary gland function in previously head-and-neck irradiated patients. The following will
be evaluated: salivary a-amylase, IGF-1, Thrombospondin-1, and VEGF-A concentrations, resting
and stimulated salivary flow rate and pH, and salivary buffering capacity. Demographic data,
past medical/surgical histories, social history and habits, risk factors, medication list,
nutritional status, stage and location of tumor treated, dose/duration of radiation, and time
elapsed since radiation treatment will be reviewed and recorded. Subjects will complete a
quality of life questionnaire, describe (presence/absence) dry mouth symptoms prior to HBO
therapy, and provide current A1c level, or submit to a finger stick. The following groups
will be evaluated: 1. Head-and-neck irradiated subjects with ORN (indicating HBO therapy) 2.
Subjects with other conditions indicating HBO therapy (positive control), and 3.
Head-and-neck irradiated subjects without ORN (negative control). Subjects will include 78
males or females, 18 years old and over. In total, participation will last 22 weeks.

Clinical Trial – Motor Sparing Block vs. Peri-Articular Catheters

This study is designed to determine if one anaesthetic modality, either motor sparing nerve
block or peri-articular local infiltration anaesthesia with infusion, is superior in
providing postoperative analgesia following total knee joint arthroplasty and if the efficacy
of analgesia affects TKA outcomes. These outcomes include pain and function for a period of
up to 3 months, narcotic consumption, and specific non-pain complications, including cardiac,
respiratory, central nervous system, thromboembolism, infection, nausea and vomiting and
urinary retention.

Economic outcomes will also be examined, including length of hospital stay, direct health
care costs and patient satisfaction.

Clinical Trial – Effects of Levocetirizine and Hydroxyzine on Cognitive and Psychomotor Functioning During Simulated Diving

Antihistamines are commonly used and currently levocetirizine is most frequently prescribed
in the Netherlands. They are commonly used by divers, to solve ear, nose and throat problems,
especially to open tubal passage. However, the effects of these drugs on cognitive
performance have not been investigated during diving.The objective of this study is to
investigate the effects of levocetirizine, hydroxyzine and placebo on cognitive and
psychomotor functioning during controlled simulated diving in a hyperbaric chamber in
professional navy divers at 10 mt (2 bar) and 30 mt (4 bar).It is hypothesized that
hydroxyzine will produce significant impairment, and that the magnitude of impairment is
related to hyperbaric pressure.

Clinical Trial – Effects of Hyperbaric Oxygen Therapy on Surgical Wound Healing

The aim of this study is to test the effect of Hyperbaric Oxygen Therapy) HBOT (100% oxygen;
2.0 ATA; 90 minute total exposure) and compare against a hyperbaric sham treatment (HBST)
(patient’s breathing room air; 2.0 ATA; 90 minute exposure) in reducing edema and ecchymosis.
HBOT will be applied as a single pre-operative and a single post-operative treatment for
patients undergoing eyelid surgery. Briefly, patients will be exposed to HBOT 2-4 hours prior
to undergoing surgery, 2-4 hours post-surgery and healing will be assessed at day 3, 10, 21,
30 & 90 days after surgery. Edema and ecchymosis will be assessed in a time series to
determine the extent that HBOT reduces these clinical signs. The primary null hypothesis to
test will be that no differences in scores will exist between treatment and control at day 3,
10 & 21 post-surgery. A secondary null hypothesis to test is the time required to change a
score will be no different between the two groups.

HBOT=hyperbaric oxygen therapy; HBST=hyperbaric sham treatment

Clinical Trial – Hyperbaric Oxygen Therapy in Distal Radius Fractures: Can it Shorten Recovery Time and Increase Fracture Healing?

This project is meant to show wether the HBOT can fasten the recovery process after surgical
treatment of distal Radius fractures. For this propose the microcirculation is measured,
together with the level of pain on a visual analog scale (VAS) and the remaining force of the
hand after surgery is examined. Furthermore the sonography with contrast medium which is long
established for examination of organs of the parenchyma, is meant to be verified at the
muscular-skeletal system in this project.

Archives

Categories