Clinical Trials

Clinical Trial – Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares

Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent
mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal
pain, and constitutional symptoms such as fever and weight loss. Treatment strategies vary
based on disease activity and target various aspects of the inflammatory cascade. Options
include: anti-inflammatory drugs (mesalamine), immunosuppressive or modulatory medications
(corticosteroids, thiopurines, cyclosporine) and biologic agents (Anti-TNF). Disease severity
can be wide ranging, and nearly 25% of UC patients are hospitalized for acute severe disease.
Of these patients, 30% will undergo colectomy after the acute episode, a quarter of which
will experience post-operative complications. Although there has been great progress in
treatment of UC over the past decade, even with the anti-TNF agent infliximab, the one-year
remission rate for patients not responding to conservative management is barely 20%.
Furthermore, corticosteroids have significant long-term consequences and immune suppressive
drugs such as 6-mercaptopurine, azathioprine and infliximab have been associated with serious
adverse events including life-threatening infections and lymphomas. With growing evidence
that the pathogenesis of UC is multi-factorial and involves a complex interaction of genetic
and environmental factors, newer treatment modalities are being evaluated to target the
mucosal immune response and mucosal inflammatory regulatory system.

Hyperbaric oxygen offers a promising new treatment option since it targets both tissue
hypoxia and inflammation. Recent small scales studies evaluating the impact of hyperbaric
oxygen treatment in acute ulcerative colitis flares demonstrated improved outcomes. The
mechanisms underlying the improvement are not known. In this study, we will treat ulcerative
colitis flares with hyperbaric oxygen and measure changes in both markers of tissue hypoxia
and inflammation. We hypothesize that hyperbaric oxygen will (a) improve outcomes, and (b)
show reductions in markers of both tissue hypoxia and inflammation.

Clinical Trial – Effect of Different Types of Anesthesia on Perioperative Brain Natriuretic Peptide Levels in Parturient Cardiac Patient Undergoing Elective Cesarean Section

comparing the effect of general anesthesia versus spinal anesthesia on brain natruretic
peptide hormone levels preoperatively and postoperatively in parturient cardiac patient
undergoing cesarean section

Clinical Trial – Hyperbaric Oxygen Therapy for Adult Onset Post Traumatic Stress Disorder

Posttraumatic stress disorder (PTSD) is the long term effect of severely distressing
traumatic event characterized by intrusive thoughts, nightmares, and avoidance. Brain imaging
of PTSD patients demonstrate alterations in regional brain perfusion, with stunned,
hypoperfused regions. Those brain-biological pathologies may be responsible for the limited
success rate of currently available interventions.

During the last years data regarding Hyperbaric Oxygen Therapy (HBOT) induced neuroplasticity
accumulated. A number of studies in traumatic brain injury, cerebrovascular attacks, and
fibromyalgia have presented evidence of improved perfusion and recovery of metabolic brain
tissues, accompanied by clinical improvement under HBOT even years after the acute insults.

Considerable evidence supports potential benefit of HBOT on PTSD, however, no clinical trial
was done on this pure PTSD population. The aim of the proposed study is to examine hyperbaric
oxygen therapy as a treatment for PTSD. Advanced brain imaging and functional analysis tools
will be used to evaluate treatment’s effect.

Clinical Trial – SOFT Block Versus Spinal Anesthesia in Patientsusing Ilizarov External Fixator

Peripheral nerve block is an ideal choice for lower limb surgery because of the peripheral
site of the surgical procedure and the ability to block pain pathways at multiple levels. On
the contrary to other anesthetic techniques, as spinal or general anesthesia, properly
performed peripheral nerve blocks bypass adverse events as hemodynamic instability and
respiratory complications, properly treat post-operative pain leading to early hospital
discharge. Additional advantages of peripheral nerve blocks are that they can be used in
patients receiving anti-coagulants or lumbosacral disease in addition to avoidance of airway
instrumentation.

Recently, there has been a significant interest in regional anesthesia and peripheral nerve
blockade. This is facilitated by a significant advance of the research in this field and
availability of better equipment facilitating regional anesthesia.The aim of this study was
to assess the efficacy and safety of SOFT block (sciatic-obturator-femoral nerve block
technique) in comparison with spinal anesthesia in patients undergoing surgery for fixation
of open tibial fractures using Ilizarov external fixator.

Clinical Trial – Effect of Intrathecal Morphine on Chronic Pain After Elective Caesarean Section

The incidence of chronic post-surgical pain (CPSP) after caesarean section (CS) is reported
to be as high as 18%, reflecting it to be a significant clinical problem. Studies related to
prevention of progression of acute post-CS pain to its chronicity are sparse. Current
guidelines on post-CS analgesia recommend the use of intrathecal (IT) opioids to spinal
anaesthesia for improved post-CS pain relief. Despite its frequent use, studies related to
the IT morphine use and its association with post-CS chronic pain are lacking.

A recent prospective observation study revealed a significant reduction in persistent pain
after CS when IT morphine was used as an adjuvant to spinal anaesthesia. However, there is no
any randomized controlled trial (RCT) that has explored this association to date. We
hypothesized that spinal morphine would reduce the incidence of persistent pain after CS.

Clinical Trial – Analgesic Efficacy of Two Adjuvants During Spinal Anaesthesia.

: Pain modulation is very important after operation, particularly for women who undergo
caesarean section. A pain-free postoperative period is essential following a caesarean
section so new mothers may care for and bond with their neonates. The consequences of the
improper pain management which raise the healthcare costs and prolong the recovery process.
Intrathecal adjuvants are often administered during this procedure to provide significant
analgesia, but they may also have bothersome side effects. Intrathecal midazolam and
magnesium sulfate produces effective postoperative analgesia with no significant side
effects.

Objectives: This prospective, randomized, double-blind study was designed to compare the
analgesic efficacy and safety of intrathecal midazolam vs. Magnesium sulfate vs plain
bupivacaine as an adjunct to bupivacaine in pregnancy patients scheduled for elective
caesarean section.

Clinical Trial – Continuous Spinal Anesthesia in Renal Transplantation

Renal transplantation is now recognized as a treatment of choice for patients with end-stage
renal disease. An adequate anesthetic technique should achieve hemodynamic stability and
enhance perfusion of the transplanted kidney. The aim of this study is to assess the use &
effects of continuous spinal anesthesia for kidney transplantation recipients, compared with
balanced general anesthesia.

Clinical Trial – Effect of Diabetes Mellitus on Spinal Block Criteria During Cesarean Section

The current study aimed at studying the effect of DM during pregnancy on the spinal block
criteria during C.S.

The primary end point of the trial is the incidence of complete failure of spinal block.

Secondary endpoint is to determine the effect of DM on the other spinal block criteria as
onset and duration of block, level of spinal block, rate of regression, hemodynamic changes,
doses of inotropes and incidence of complications

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