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Does inflating a balloon in the aorta (to reduce blood flow) stop severely injured adults from bleeding to death at a Level 1 Australian Trauma Centre (The ACE Study)?
Expand descriptionNon-compressible torso haemorrhage is a leading cause of preventable trauma death. Although Trauma Systems have optimised access to surgery and interventional radiology for definitive haemorrhage control, a significant proportion of deaths occur before this can be achieved. Resuscitative thoracotomy with aortic compression is a means of temporary haemorrhage control. This procedure is effective in patients with a thoracic source of haemorrhage that can be directly controlled, but is invasive and has poor outcomes in those with sub-diaphragmatic haemorrhage. Temporary occlusion of the aorta with an endovascular balloon is a technique used to control haemorrhage in shocked patients with ruptured aortic aneurysms. This technique has also been described in other forms of non-compressible haemorrhage such as gastro-intestinal bleeding and post-partum haemorrhage. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock has recently been promoted. REBOA provides a means of temporary haemorrhage control in patients with severe non compressible haemorrhage - potentially enabling these patients to access means of definitive haemorrhage control and survive. However, the procedure requires specific technical expertise as well as integration into current models of trauma reception and resuscitation - and there are conflicting reports about whether REBOA contributes to survival. This pilot study involved the introduction of Balloon Occlusion for Aortic Control of Exsanguinating Trauma Related Haemorrhage (The ACE Study) at an Australian Adult Major Trauma Centre, to determine whether REBOA would be a feasible and effective strategy to provide temporary circulatory support to trauma patients with critical, refractory, hypovolaemic shock and hypovolaemic cardiac arrest - allowing transfer to an operating theatre for definitive haemorrhage control surgery. The primary purpose was to determine if the introduction of REBOA outcome was feasible and, if so, it would improve survival of blunt or penetrating trauma patients aged 18-60 years with exsanguinating sub-diaphragmatic haemorrhage.
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The Dementia Lifestyle Coach: a pilot study of a support and coaching program for people recently diagnosed with early dementia
Expand descriptionThe Dementia Lifestyle Coach aims to test the feasibility of delivering and evaluating the Dementia Lifestyle Coach program for people newly diagnosed with early dementia The Dementia Lifestyle Coach fills a gap in dementia care in Australia and internationally by supporting people with early dementia to adjust psychologically to having the condition, stay active and involved in their community. If shown to be efficacious in a fully-powered trial, the availability of an early support program for people with dementia may increase the motivation of general practitioners to make earlier diagnoses of dementia. The Dementia Lifestyle Coach program is a 14 session psychoeducation, counselling and coaching program for people recently diagnosed with dementia. Sessions are hour-long and held weekly for the first 2 months, then fortnightly for 2 months, then monthly for the last 2 months (14 sessions in total). Sessions are delivered by a registered psychologist or rehabilitation counsellor. In addition, participants receive support (monthly conversations) from a trained peer who lives with dementia. This parallel group design will have an intervention group and a wait-list control group. The wait-list control group will receive the intervention after 6 months. A wait-list control group was selected rather than no-treatment control group because the study investigators considered it unethical to offer no support to participants, further offering the intervention to the control group would allow a greater sample with which to test acceptability of and fidelity to the intervention.
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A Randomised, Double Blind, Placebo-Controlled Trial of Medicinal Cannabis in Adults with Tourette's Syndrome
Expand descriptionTourette’s syndrome (TS) is a neurological disorder that develops in childhood and often continues into adulthood. Individuals with TS make involuntary movements and vocalisations (known as tics), which may be painful, embarrassing and functionally impairing. There is no cure for TS, but certain medications (particularly antipsychotics) are effective at suppressing tics when taken continuously. Unfortunately, these medications have significant and independently-disabling side effects, which limit their acceptability for many sufferers. The human body has its own (‘endogenous’) cannabinoid neurotransmitter system, which facilitates communication between nerve cells in the brain. This system is implicated in the control of normal movement and the development of movement disorders such as TS. The ‘endocannabinoid’ system could therefore be a new therapeutic target for tic suppression. There is some early evidence to support the effectiveness of cannabinoids in TS, but well-designed clinical trials have yet to be conducted. We plan to use an oral formulation of medicinal cannabis containing two cannabinoids: tetrahydrocannabinol and cannabidiol. This formulation does not intoxicate or cause the unpleasant psychiatric effects of ‘street’ cannabis. We predict that treatment with tetrahydrocannabinol and cannabidiol will significantly reduce tics, when compared to placebo, as well as improving psychiatric and cognitive symptoms associated with TS. We also predict that this formulation will be well tolerated, without psychiatric side effects, and will not lead to craving or intoxication. Therefore, this study may support the development of a new, safe and effective treatment for TS, with potential applications to other neurological disorders.
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Stoma closure using bio-absorbable reinforcement (SCUBAR).
Expand descriptionThe rate of incisional hernia formation following closure of a temporary intestinal stoma is approximately 30%. Hernias following abdominal surgery are a significant cause of morbidity and may adversely affect a patient's quality of life and may require emergent repair. Currently closure of the abdominal fascia is accomplished with sutures however, newer surgical materials are now available to reinforce fascial closure which have shown promise in their abilities to reduce IH formation and tolerate bacterial contamination that is present in these contaminated wounds. We propose a randomised clinical trial in patients undergoing reversal or resiting of an intestinal stoma to have placement of a new synthetic tissue reinforcement material or standard repair to determine if this material can reduce incisional hernia formation with low morbidity, specifically surgical site infection which has prohibited the use of existing materials.
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A Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of PBT434 in healthy volunteers.
Expand descriptionThis is a Phase 1 Single and Multiple Ascending Dose Study of PBT434 in Healthy Volunteers. The first in human study consists of two parts, both of which are randomised, double-blind, and placebo-controlled: The single ascending dose (SAD) and the multiple ascending dose (MAD) parts of the study will be conducted in sequential stages. Key safety and PK data from the SAD portion will be reviewed before progressing to the MAD part of the study.
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Meaningful Engagement in Nutritional Understanding (MENU): Best choices for aged care
Expand descriptionResearch suggests that the majority of Australians with dementia in residential aged care are malnourished or at risk of malnourishment. This project seeks to change this unacceptable situation by trialling a practical multi-component nutrition support intervention (MENU: Meaningful Engagement in Nutritional Understanding) that arose from suggestions from staff in a Tasmanian aged care home on how to improve care and support of people with dementia. The project will trial MENU in two Wicking-partner aged care facilities. The impact of MENU on raising staff awareness of best nutrition care and support for residents with dementia and reducing malnutrition prevalence will be evaluated. There are two specific objectives: 1. raise awareness (knowledge and practice change) among care facility staff/care volunteers/family of best nutrition care for residents with dementia; 2. reduce residents’ malnutrition risk. The project findings, outputs and the MENU approach will be disseminated across Tasmania.
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Does very early therapy reduce the time spent hospital and improve the recovery of people with serious illness?
Expand descriptionThe aim of the study was to determine whether early, structured rehabilitation is effective in critically ill patients in aiding physical and psychological recovery. The study was conducted as a trial and compared patients receiving early rehabilitation versus usual care. Patients were assessed on commencement on the study, on discharge from hospital, and at 6 and 12 months. The study was conducted at St. Vincent’s Hospital Sydney. Patients were eligible for the study if they were critically ill patients and were in intensive care (ICU) for at least 5 days. The early rehabilitation group received early routine screening by a rehabilitation physician, routine multidisciplinary assessment and provision of individualised, structured rehabilitation programme (up to two 30-minute therapy sessions per day) with formal coordination through case conferencing. This was be provided through the Mobile Rehabilitation Team (MRT). The participants were followed-up by the rehabilitation clinic The key components were daily team communication, higher intensity of therapy than usual care, and weekly case conferencing. In the usual care group, therapy could be provided by usual therapists in the ICU or acute ward. A rehabilitation physician was still able to review the patient at the request of the treating team and the MRT may have been involved if deemed necessary. The 2 groups were followed at hospital discharge and at 6 and 12 months. Outcomes assessed at discharge included their length of hospital day; muscle strength; mobility/endurance; functional independence/ability to carry out activities of daily living; and symptoms of depression, anxiety and stress. The outcomes assessed at 6 and 12 months included: ability to carry out activities of daily living; symptoms of depression, anxiety and stress; and quality of life.
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PLENVU vs Prepkit-C Bowel Preparation for Colonoscopy
Expand descriptionThe study aim is to compare the efficacy and patient tolerability of PLENVU®, a new low volume bowel preparation which has demonstrated safety and overall bowel cleansing success in three European and American trials, with the current standard bowel preparation at Alfred for patients undergoing colonoscopy for clinically accepted reasons, which uses Prepkit-C®. PLENVU is a registered trademark of the Norgine Group of companies. Who is it for? You may be eligible for this study if you are aged 18 or over and undergoing an outpatient colonoscopy. Study details Participants in this study will be randomly assigned (by chance) to receive one of two bowel preparation methods, either PLENVU or Prepkit-C. Participants will use the kits before their procedure according to the instructions provided by Alfred Hospital. The effectiveness of the two kits in preparing the bowels for colonoscopy will be compared using two validated scoring methods to assess quality of bowel preparation for colonoscopy. Participants will be asked to complete a brief (10 minute) questionnaire on the day of the colonoscopy, in the waiting area, ahead of going through for their procedure. The questionnaire will ask about their experience in taking the bowel preparation they received. The study will aim to determine whether PLENVU leads to a similar quality of bowel cleanliness as Prepkit-C and also whether patients' tolerance, acceptance and compliance is similar between the two bowel preparations.
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Study to Assess the Efficacy and Safety of Tecfidera in Patients with Amyotrophic Lateral Sclerosis - TEALS Study
Expand descriptionThe primary purpose of this study is to assess whether dimethyl fumarate will slow down disease progression in sporadic ALS. The study hypothesis is based on findings that the regulatory T cells, which form an important component of the immune system, slow down disease progression in ALS. increasing the levels and function of regulatory T cells could slow down disease progression in ALS. Dimethyl fumarate effectively increases the function of regulatory T cells and it is hoped that this increase in T cell function will significantly slow disease progression in ALS when compared to conventional treatment.
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Intraosseous Administration of Prophylactic Cefazolin in Total Shoulder Arthoplasty
Expand descriptionAim: To determine whether intraosseous (IO) administration of prophylactic cefazolin achieves higher tissue concentrations than IV administration in total shoulder arthroplasty. Relevance: Propionibacterium Acnes has been shown to be responsible for up to 56% of shoulder infections after orthopaedic implant. Recently papers came out revealing that higher cefazolin and vancomycin concentrations were found in tissue after IO administration rather than IV. This was associated with less colony forming units in a murine model and thus theoretically more effective at reducing infection rates. This was also the case in revision TKA where the tourniquet is down for significant periods. As such, we aim to determine whether this is the case in TSA where no tourniquet is used. Design: Randomised Control Trial Method: Patients undergoing TSA will be randomly allocated to either IV or IO prophylactic antibiotic administration groups using computer generated random allocations placed in numbered, opaque, sealed envelopes. Patients will be randomised in the pre-operative area to allow appropriate setup in the operative room. Upon signing consent, the patients will be asked to complete a demographics survey. The data collected from this survey will be filed electronically using numbers for patients, the number each patient is assigned will be filed safely. Both IV and IO groups will receive 600mg of Lincomycin as per usual TSA prophylaxis. The IV group will receive 1g Cefazolin at this time (60-30mins prior to incision). The IO group will receive 1g Cefazolin as a bolus in 50mL through in intraosseous cannula, placed in the greater tuberosity of the humerus, after draping and before skin incision. The cannula will be removed and skin incision will follow immediately (<1min). TSA will proceed as usual and cancellous bone and subcutaneous fat samples will be taken at the following four steps. First subcutaneous fat sample immediately after skin incision, then cancellous bone and subcutaneous fat samples at the time of humeral head removal and glenoid reaming, and the final subcutaneous fat sample immediately before closure. It should be noted that 0.5-1cm2 of each sample will be placed into sterile 15mL tubes kept in ice and water within a biochemical container. The bone samples will come from bone that is removed usually during TSA. A total of two bone samples and four fat samples will be taken from each patient. Patients will be monitored and followed up as per normal TSA protocol. The biochemical container will be kept in -80-90 degrees Celsius to ensure degradation of cefazolin does not occur prior to analysis. The biochemical container will be transported to Griffith University Gold Coast where analysis via high performance liquid chromatography will be used to determine the cefazolin concentrations of the samples. The laboratory staff will only know the number that the samples belong to and no patient information or the group they belong to will be known.