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Prospective Longitudinal Evaluation of Coagulation with Novel Thromboelastography Technology in Patients after Subarachnoid Hemorrhage - A Pilot Study
When patients suffer from bleeding into the subarachnoid space surrounding the brain it is known as a “Subarachnoid Haemorrhage” (SAH). When a SAH is suffered the patient is exposed to very high risk of death and long-term illness and disability. This is due to development of multiple complications following the start of the bleeding. The cause of these complications can be attributed directly to the cause of the bleeding in the first place. Examples include thinning of the blood, trauma or aneurysms (a weakness in the wall of the brain arteries that become enlarged and rupture). However, one of the most serious complications of subarachnoid bleeding occurring 3 to 7 days after bleeding is a phenomenon called vasospasm. This phenomenon in which the blood vessels narrow and decrease the blood flow, reducing the blood supply and oxygen delivery to the brain tissue, potentially causing permanent brain damage ( stroke) . It can be fatal if severe. The causes of vasospasm and subsequent brain damage are not fully understood. Understanding the causes of vasospasm and the way it causes brain damage could help in starting new treatment lines that eventually might lead to a better outcome. We believe that increased blood clotting could be a contributing factor in reducing blood flow to the brain causing permanent blockage of brain blood vessels and brain damage. Therefore, our study seeks to determine whether patients who develop symptoms of delayed brain damage have an increased blood clotting tendency. The study involves a simple, point of care test of blood clotting - thromboelastogram (TEG) that measures increased clotting susceptibility far better than other conventional blood tests. These blood test results will be correlated against longer term progress of patients neurological recovery. The outcome test will use standard CT scan, serial Doppler Ultrasound for brain blood vessels and neurological information obtained during routine followup by neurosurgeons and neurologists. The blood for the TEG will be taken together with other routine blood tests and should not usually require separate blood samples. The neurological assessments will be part of routine care. Some blood plasma may be stored for additional coagulation tests depending on the primary result of the study. All information gathered will be aggregated and no individual patient would be identified in any publication. This study is prospective cross sectional cohort study and use thromboelastogram in patients with subarachnoid bleeding excluding trauma related causes. We suspect that there will be association between brain damage symptoms and increasing coagulation of the blood. That will facilitate, in future studies, introducing medical intervention earlier to assist in treating such morbid complication.
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Effects of oxytocin on body perception in healthy volunteers
This study will test whether a single dose of oxytocin influences body perception. Body perception will be examined using a multi-sensory illusion, in which individuals experience a sense of ownership for a prosthetic limb, involving integration of visual, tactile and proprioceptive sensory information. Perceptual and kinematic effects of this illusion will be assessed. Oxytocin will be delivered via nasal spray, and compared to a placebo spray in a repeated measures design. Participants will be healthy adult males. The effects of oxytocin on body perception will be examined with respect to autism spectrum traits (in the sample of healthy volunteers). It is hypothesised that oxytocin will facilitate the effects of the illusion.
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OPAL: The first placebo-controlled trial of opioid analgesia for acute spinal pain
Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease both in Australia and globally. Strong analgesics, such as opioid analgesics, are recommended by clinical practice guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. The latest Australian data suggest that opioid analgesics are now the most widely prescribed medicine for low back pain and neck pain in general practice. Despite the widespread use, there are no randomised, placebo-controlled trials evaluating opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened due to the risks of adverse events, some of which can be serious such as opioid misuse, poisoning, and deaths. Given the lack of evidence on efficacy and concerns regarding safety, there is an urgent need to understand whether opioid analgesics are beneficial for patients with acute low back pain and/or neck pain. OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (modified-release oxycodone up to 20 mg per day) or placebo in addition to guideline care for up to 6 weeks. The primary outcome will be pain severity measured up to 12 months with treatment efficacy over the 6-week treatment period being the primary time point for analysis. Medication-related adverse events will be assessed and a cost-effectiveness analysis will be conducted. We will additionally assess long-term use and risk of misuse of opioid analgesics for up to 12 months. The results of this study will be critical in providing robust evidence to inform the quality use of opioid analgesia in acute low back pain and neck pain. The results will also influence international clinical practice guidelines and most importantly, improve care for patients suffering acute spinal pain.
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Mobile sequential pneumatic calf compression for leg swelling study.
The purpose of the research is to investigate the effects of a sequential calf compressor device, which is somewhat similar to a blood pressure cuff, on lower leg swelling when it is a result of poor vein function. The study also wishes to evaluate if there are any safety concerns with this device. It is hypothesized that there will be improvement on lower leg swelling, as well as being a safe intervention.
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Adaptive Radiotherapy for Head and Neck Cancer: Feasibility and Clinical Implications
This project aims to evaluate whether a protocol of adaptive radiotherapy (ART) for Head and Neck cancer patients can provide significant reduction in radiotherapy dose to critical structures, particularly the parotid salivary glands, aiming to potentially reduce the long term side effects of radiotherapy (particularly dry mouth). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with locally advanced head and neck cancer for which you plan to undergo curative-intent definitive radiotherapy. Study details All participants in this study will receive standard radiotherapy treatment (5 days a week for 7 weeks) as prescribed by the treating Radiation Oncologist. At 3 weeks and 5 weeks participants will have a repeat non-contrast planning CT scan plus repeat PET scan. We then overlay the initial radiotherapy plan on to the new CT dataset to determine if there are significant shape changes, whether the critical structures are receiving too much dose, or if the target volume (the tumour) is receiving too little dose. The participant’s radiotherapy plan will only be altered if there are unacceptable areas of radiotherapy over or under-dosage according to the discretion of the treating radiation oncologist. All participants will have a new radiotherapy plan created using their repeat scans. These plans will be run through our treatment planning computers to model the dose distribution on the new CT datasets. We will then compare the dose received by the normal structures and the tumour using this "adaptive approach" with the expected doses if no changes are made to the initial plan. This will give us a measure of the benefit of ART. We will also record how much time each re-planning takes to evaluate whether an adaptive approach is feasible in a real world clinical setting.
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Evaluation of RAS mutations in cell free deoxyribonucleic acid (cfDNA) in response to cetuximab anti-epidermal growth factor receptor (EGFR) therapy in patients with metastatic colorectal cancer.
This aim of this study is to explore the emergence of RAS mutations as an escape mechanism in patients receiving first-line cetuximab anti-EGFR therapy in combination with FOLFOX or FOLFIRI as well as to demonstrate the general utility of cfDNA RAS mutation monitoring as compared to standard care measurements of treatment resistance and disease progression using CEA and imaging. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic colorectal cancer. Study details All participants in this study will receive first line anti-EGFR antibody (cetuximab) therapy in combination with either irinotecan-based (FOLFIRI) or oxaliplatin-based (FOLFOX) chemotherapy, as chosen by their treating medical oncologist. To examine the emergence of RAS mutations during anti-EGFR therapy, serial blood samples (30mls) will be collected from patients. The timing of emergence and genotype analysis of RAS mutations from cfDNA in patients undergoing 1st line treatment with cetuximab in combination with FOLFOX or FOLFIRI will then be examined. For all patients, disease progression will be examined by comparing RAS mutation levels to routine CEA assessment and imaging. Patients having RAS WT tumours and receiving first-line cetuximab therapy in combination with FOLFOX or FOLFIRI will be monitored until documented tumour progression.
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A study comparing the efficacy of current products utilizing participant’s adipose tissue (Lipogems technique), and blood extracts (Orthokine or Platelet-Rich-Plasma (PRP)) in combination with peptide injections for the treatment of moderate to severe knee osteoarthritis.
Osteoarthritis is a major cause of pain and disability worldwide. Recent research and clinical evidence indicates that Human adipose-derived stem cells are safe for use in Humans. Researchers suggest that the treatment may alter the operation of the immune system to ameliorate degenerative activity. In a conducive environment supported by a combination of growth factors and certain other peptides, stem cells can also be stimulated to differentiate into a range of different cell types facilitating tissue regeneration. In addition, clinical practice using adipose tissue implants indicates that site stability and health is improved with less processed, tissue fractions. In the regulation of therapeutic goods, controversy has arisen concerning the lack of regulation on treatments that involve a high degree of cellular manipulation. The Lipogems product is extracted from the patient’s adipose tissue using a minimal and subtle, physical process without need for enzymatic digestion or cell culturing. This trial is investigating to what extent moderate to severe Osteoarthritis of the knee is modified by an injection of an adipose tissue fraction (Lipogems) obtained from the participants own fat tissue and two different blood extracts : (1) Platelet-Rich-Plasma which contains growth factors released from platelets and endogenous fibrin scaffold which is used to stimulate the natural healing cascade and tissue regeneration directly at the site of treatment; (2) Orthokine, a conditioned blood serum rich in the anti-inflammatory cytokines particularly IL-1Ra which is thought to alter the progression of OA by neutralizing pro-inflammatory cytokines. These treatments are applied in combination with proprietary peptides which are derived from those that are naturally present throughout the body and are critical to cellular processes particularly growth and regeneration. Age and disease conditions can reduce the levels and effectiveness of these peptides which normally promote healing.
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The use of injectable treatments in the management of acute muscle strains
Muscle tears are a common injury in athletic populations. This exploratory study will involve a randomised trial comparing the effects of Traumeel with placebo in the treatment of acute muscle strains, specifically those of the hamstring muscles. This substance is used extensively in Europe for treatment of muscle injuries, however, there is no available evidence base for the use of these treatments. Due to this lack of evidence these treatments are not offered as standard practice to Australian athletes. Investigating these treatments that may provide additional options for injured athletes is a priority in reducing training days lost to injury.
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The Predicting Glaucoma Development Project: Examining the utility of an Ibopamine challenge test to predict glaucoma development in glaucoma suspects.
It’s a clinical trial of a drug called Ibopamine, to be used in a challenge test in much the same way as a water drinking test. Ibopamine is an alpha, beta and dopamine receptor agonist, which causes a brief increase in aqueous production for about 4 hours after a single drop. Among normal patients, this causes no change in intraocular pressure, but in glaucoma patients, IOP will increase. My suspicion is that the degree of IOP rise might be related to the patient’s likelihood of further progression in the future. I have recently completed a pilot case-control study which has successfully shown that an ibopamine challenge can differentiate between glaucoma suspects, stable glaucoma patients and patients whose glaucoma is rapidly worsening. Now, I would like to commence a longitudinal study investigating the predictive value of a positive ibopamine challenge among glaucoma suspects and early glaucoma patients.
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A pilot study of hypertonic saline in children with chest infections and disabilities
At The Royal Children's Hospital (RCH) Melbourne, there has been a change in clinical practice with the increased prescription of nebulised Hypertonic Saline (HTS) (3% or 6%) compared to Normal Saline (NS) (0.9%) prior to chest physiotherapy in children with severe neurological impairment and acute lower respiratory tract infection (LRTI). Historically NS (0.9%) has been administered when secretions are thick and difficult to expectorate (Hull et al., 2012; McCrea et al., 2013). This pilot study aims to address the questions, “Is a trial comparing nebulised HTS (6%) compared to NS (0.9%) before chest physiotherapy in children with severe neurological impairment and acute LRTI feasible in Paediatric Intesive Care Unit (PICU)” and “Is there any indication of a difference in short-term respiratory outcomes when participants are given nebulized HTS (6%) compared to NS (0.9%) before chest physiotherapy in children with severe neurological impairment and acute LRTI that warrants a larger, definitive study?”