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The Central Australian Heart Protection Study: A Randomised Trial of Nurse-Led, Family Based Secondary Prevention of Acute Coronary Syndromes.
Despite the high burden of cardiovascular diseases among Indigenous Australians, few intervention trials have sought to evaluate novel approaches to reducing differential outcomes in this vulnerable group. The Central Australian Heart Protection Study seeks to test the effectiveness of a nurse-led, family based education and assessment program in reducing the incidence of poor outcomes in indigenous and non-indigenous patient’s following an Acute Coronary Syndrome (ACS).
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Exercise positron emission technology (PET) imaging of the heart to predict cardiac complications after major cancer surgery
This study is evaluating the feasibility of exercise cardiac positron emission technology (PET) imaging to determine cardiac risk for patients undergoing major cancer surgery. Who is it for? You may be eligible to join this study if you greater than or equal to 18 years of age and are scheduled to attend pre-admission clinic review and cardiopulmonary exercise testing prior to major thoracic or abdominal surgery at Peter MacCallum Cancer Centre. Study details: All participants in this study will undergo cardiopulmonary exercise testing at the preadmission clinic to assess heart and lung function. You will be required to fast for 8 hours prior to arriving at the clinic, and you will be asked to consume a high fat and low carbohydrate meal 12 hours prior to the testing. Radiolabelled glucose will then be intravenously injected, i.e. administered directly into your vein. A positron emission technology (PET) scan of the heart will be performed 1-2 hours after the radiolabelled glucose injection. The diagnostic tests used in this study may have the potential to rapidly provide more specific information regarding myocardial metabolic function than CPET, and also enable anatomic localisation of areas of the myocardium which are susceptible to ischaemia under conditions of metabolic stress. We therefore hope to improve on the current tests available to identify patients at high risks of heart complications after surgery.
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Moving 4 Mood: a trial of a physical activity intervention as an adjunct to regular care for young people with depression
This project aims to train allied health professionals working with young people with depression to integrate a brief physical activity intervention into the clinical care they would usually offer young people who access their service. The project also aims to evaluate the effectiveness of the physical activity intervention in reducing depression and increasing engagement in physical activity in young people. Physical activity has an emerging evidence base for the treatment of depression in young people. This project has the potential to provide early intervention to encourage the establishment and maintenance of positive health behaviours. All allied health professionals at headspace Collingwood (an enhanced primary care youth mental health service) will be invited to take part in the project and those who participate will be offered training in the delivery of the intervention and a treatment manual. All help-seeking young people aged 12-25 years who present to headspace Collingwood will be screened for eligibility to participate in a randomised controlled trial. Those who consent to take part will be randomised to receive either the physical activity intervention (active intervention) or psycho-education on physical activity (control condition) in addition to treatment as usual. Participation will involve the completion of questionnaires designed to measure symptoms, physical activity levels, social and vocational functioning, coping skills, and changes associated with therapy. These measures will be collected at baseline and at the end of treatment. Participants will also be invited to take part in an optional qualitative component of the project to obtain feedback on their experiences of treatment, using a semi-structured interview format. Given the high prevalence of depression and the associated negative consequences, there is an urgent need for a ‘real-world’ effectiveness trial to examine the additional benefits of integrating physical activity, a low-stigma intervention with few side effects, into routine clinical care
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Acupuncture Transcutaneous Electrical Nerve Stimulation (Acu-TENS) for acute exacerbations of Chronic Obstructive Pulmonary Disease(COPD)
This study will investigate if Acu-TENS is able to reduce symptoms of breathlessness in people with COPD presenting to the Emergency Department (ED) of the Gold Coast University Hospital (GCUH) and if it is enough to reduce the need for hospital admission. We will also try to clarify the brain and nerve system (neurochemical) pathways whereby Acu-TENS relieves breathlessness - this will be assessed by blood samples.
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The dressing and securement of tunnelled, cuffed Central Venous Access Devices (CVADs), in acute care paediatrics: a pilot, randomised controlled trial.
Children admitted to an acute care facility frequently require the insertion of a CVAD for the administration of medication and fluids. When treatment is required for an extended duration, clinicians often elect to insert a tunnelled, cuffed CVAD. These CVADs are associated with a high rate of failure, including CVAD-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU), are used to protect the CVAD insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), sutureless securement devices (SSD), and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for CVAD. It is not known whether these new products are effective at reducing CVAD failure, in comparison to standard care (BPU and suture). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on CVAD failure due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with tunnelled, cuffed CVAD in acute care.
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Abnormal fibre utilisation in ulcerative colitis in remission
Already known about fibre and ulcerative colitis is that a) Fibre intake goals not achieved by patients with ulcerative colitis b) Gut microbiota differ in patients with ulcerative colitis from healthy people c) Dietary management of ulcerative colitis is not well established New Findings are that a) Patients with inactive ulcerative colitis often have reduced ability to ferment fibre b) Supplementation with fibre as a combination of resistant starch and wheat bran-associated non-starch polysaccharide is well tolerated in patients with ulcerative colitis in remission c) Supplementation with this fibre combination tends to normalise gut transit, but does not increase the proportion of dietary fibre fermented d) Diminished fermentation is not related to rapid gut transit, but more likely resides in the abnormal microbiota Impact on future clinical practice a) The effects of dietary manipulation directed at changing colonic physiology and/or gut microbiota in healthy subjects cannot be extrapolated to patients with ulcerative colitis b) Supplementation with a combination of resistant starch and wheat bran in patients with ulcerative colitis may have some benefits to colonic physiology and health
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Self-paced walking for chronic low back pain
The individual and community cost of chronic low back pain (CLBP) is staggering. Guidelines recommend physical activity (PA) as a management for CLBP. Adults with CLBP report unique barriers to PA which need to be overcome to facilitate long term PA behaviour change. Walking, regulated by an internal sense of emotion (affect-regulated), may provide an effective approach to increase PA in people with CLBP. The primary hypothesis is that affect-regulated walking (ARW) will lead to improved disability status and increased PA levels compared with usual advice walking (UAW).
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Intravenous APG-1387 administered to patients with advanced solid tumors and lymphomas to test for safety, tolerability and effect of APG-1387 on the body and how APG-1387 is processed by the human body
This study aims to establish the safety and best tolerated dose of a new investigational drug called APG-1387 in participants with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with an advanced solid tumour or lymphoma. Study details All participants in this study will be treated with a new investigational drug called APG-1387. This drug blocks tumour growth by promoting cell death (a process called apoptosis) in cancer cells and attempts to stop the cancer cells from spreading further throughout the body. This drug has not previously been tested in humans. APG-1387 has undergone extensive testing in various animal models (including rats and monkeys) and human cancer cell models in the laboratory. APG-1387 will be administered via intravenous (IV) infusion (i.e. directly into the vein) on Days 1, 8 and 15 of study participation. The first group of participants will receive a dose of 0.3 mg of APG-1387, and if tolerated the dose will be increased for subsequent patient groups. Participants will be regularly monitored until they reach their endpoint (disease progression, intolerable toxicity or withdrawal of consent) in order to determine safety, tolerability and preliminary efficacy of treatment. The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.
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Use of Tocilizumab (TCZ) to prevent acute graft versus host disease (GVHD) randomized trial
This study aims to determine whether adding the drug, Tocilizumab, to standard transplant immunosuppression is safe and effective at preventing acute graft versus host disease (GVHD). Who is it for? You may be eligible to join this study if you are aged between 18 and 70 years of age and are undertaking HLA-matched allogeneic haematopoietic cell transplantation (HPCT). Trial details: Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will receive a single dose of 8mg/kg Tocilizumab by a 60 minute intravenous infusion (administered via the vein). This will occur one day before your HPCT. Participants in the second study group will receive a placebo treatment. Participants will be assessed for up to 2 years to determine the incidence of GVHD.
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Boiled peanut oral immunotherapy for the treatment of peanut allergy
Peanut allergy is increasingly common, especially in countries such as Australia and to date no safe and effective therapy exists to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted or raw peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects. It is possible that boiled peanut is less immunogenic than roasted peanut and it may provide a safer way to desensitise patients who are allergic to roasted peanut by desensitising them first to boiled peanut.