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Open-label placebo for insomnia (OPIN)
Expand descriptionThere has been growing interest in whether open-label placebo (i.e. placebos given honestly) can improve health outcomes. Some studies have shown that open-label placebo is effective for conditions such as depression and chronic pain. This study aims to test whether open-label placebos can improve insomnia symptoms, compared to conventional placebos and a no-treatment control condition. We are using an innovative trial design, called a multiple cohort randomized controlled trial, to overcome some of the issues with current research into open-label placebos. Using this design, we will also be able to find out how many people with insomnia would accept open-label or conventional (deceptive) placebo treatment.
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Open vs ultrasound guided insertion of central venous lines in children
Expand descriptionThe study is about comparing two techniques of inserting central venous lines and ports. These are special catheters inserted into a large vein in the neck for the purpose of administration of parenteral nutrition, chemotherapy or administration of other medications. Traditionally, this is performed by open surgery through a cut in the neck to expose the vein. The catheter is tunnelled from the chest up into the neck and inserted into the vein. This will be compared with ultrasound guided insertion. Using ultrasound the vein is identified and a needle inserted into the vein and then a wire threaded through. The tract will be dilated and the catheter passed through a sheath. This is an established technique of central vein access and we have used this at this Hospital for over 3 years now. Safety of this technique is now well established at our Hospital and internationally. There are no prospective studies comparing these two techniques. In children requiring long term treatment, infection and clotting of the vein may happen necessitating change of line and at times there is difficulty with access. We are comparing the two techniques to identify which of these is associated with lesser complications and loss of vein in the long term.
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The Probiotics for Hayfever Trial: Effect of the NutritionCare (NC) probiotic formulation on seasonal allergic rhinitis in adults
Expand descriptionIn 2017-18, seasonal allergic rhinitis or hayfever affected about 4.6 million (19%) of Australians. Hayfever manifests in runny and/or blocked nose, and often itchy/sore/swollen eyes, with symptoms greatly impacting the quality of life. Rescue medication such as anti-histamines are often needed to restore function, but may trigger some other unwanted side effects. Probiotics have been shown to reduce hayfever symptoms in a number of RCTs. In this randomised double-blind placebo-controlled 12-week trial we aim to assess the tolerability and efficacy of the Nutrition-Care Probiotic Formula ‘Seasonal Biotic’ on symptoms, quality of life, and immunological and microbial factors.
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Testing safety of a live bacterial therapy for the treatment of Chronic Constipation
Expand descriptionThe aim of this study is to evaluate safety and tolerability of SVT-1B149 as a treatment for chronic functional constipation together with preliminary efficacy. The treatment consists of carefully selected bacterial species. Bacteria are naturally found in the digestive tract and are a research focus for their important role in many conditions related to gut health. Bacteria play an important role in the function of the immune system, digestive health, inflammation and have anti-microbial properties. Several research studies have found treatment with beneficial bacteria to relieve constipation and related symptoms. This study will help determine how safe and effective SVT-1B149 is as a stand-alone therapy in treating constipation and reducing symptoms.
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Empagliflozin in Cirrhosis (EmC) Safety Study
Expand descriptionEmpagliflozin is a sodium glucose transporter-2 (SGLT2) inhibitor drug, a class of diabetic medication. Interestingly, there is survival benefit in patients with heart failure. There are similarities between heart failure and the complications of severe liver disease, termed cirrhosis. As a result, it has been suggested that the SGLT2 inhibitors, may be of benefit in managing cirrhosis. While safe in liver disease in single dose studies, there is no long-term safety data in patients with cirrhosis. The aim of the study is to assess the safety of empagliflozin in three different groups (n=5) of increasing degrees of severity of cirrhosis and healthy controls (n=8). If this small pilot study demonstrates empagliflozin to be safe, then we will be able to do a larger study to assess the benefit of this medication in cirrhosis. This would be a significant advance in the treatment of cirrhosis.
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A pragmatic trial seeking to implement an improved model of care for people with either insomnia or obstructive sleep apnoea (OSA) within an Australian primary care setting, in order to increase access to evidence-based therapies
Expand descriptionThis novel implementation study represents a major step towards improving management of sleep disorders in primary care (PC). The two most common sleep disorders, chronic insomnia and obstructive sleep apnea (OSA), affect >4 million Australians, and are associated with broad ranging negative physical and mental health outcomes, as well as reduced safety and productivity, costing over $66 billion annually. People with sleep disorders commonly receive care that is far from best practice and potentially dangerous. A lack of sleep-specific training for GPs contributes to widespread under recognition of sleep disorders, and an over-reliance on specialist care. Long waiting periods for specialist OSA care have led to a rise in vertically integrated business models from pharmacy/corporate treatment device suppliers, without adequate medical input to manage these disorders, and often complete separation from a person’s usual medical care. Our research group and others, have demonstrated in randomised trials that GPs and PNs can manage OSA, producing equivalent patient outcomes to those in specialist centres at significantly lower cost. Similarly, for insomnia, despite clinical guidelines recommending cognitive behavioural therapy (CBTi) as the first line treatment, the majority of patients receive sedative/hypnotic drugs with potentially dangerous side effects, and do not get access to the CBTi that would address the underlying cause of their insomnia. To address this, our study will utilise a simplified Model of Care for screening, diagnosis and treatment of OSA and chronic insomnia in PC, and a suite of practice change support tools. These tools are currently being developed and will be translated through our NHMRC CRE (GNT1134954) – National Centre for Sleep Health Services Research, and include simple clinical guidelines, education modules, eHealth decision support tools, and referral pathways. This will facilitate and demonstrate the uptake, efficacy and cost-effectiveness of the new sleep health services model. We hypothesise that our implementation strategy for improving sleep disorder management in PC settings will result in management that is: a) better aligned with recommendations of evidence based clinical guidelines; b) more cost-effective in terms of patient outcomes/waiting times and cost when compared with usual care; c) feasible and acceptable from the perspective of GPs, PNs and patients, indicating viability for up-scaling the project.
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Effect of an exercise intervention on the sleep of sedentary Australian pregnant women
Expand descriptionThe present project is a feasibility study which aims to examine the effect of an 11-week exercise intervention on the sleep of sedentary Australian pregnant women.
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Sensory innervation of the forearm detected by ultrasound-guided local anaesthetic block
Expand descriptionThe primary aim of this study is to map the sensory distribution pattern and area of sensory overlap of the posterior antebrachial, medial antebrachial and lateral antebrachial cutaneous nerves (PABCN, MABCN, LABCN) of the forearm following an ultrasound-guided local anaesthetic block. The secondary aim is to map any sensory block that occurs in the hand. Results from the study will enhance our current understanding of the variability of cutaneous sensory innervation. It may clarify why some local anaesthetic nerve blocks do not produce the expected area of cutaneous sensory anaesthesia. It will benefit pain physicians when investigating and managing the cause of symptoms of injury to the cutaneous nerves of the forearm. Forearm flaps are often used by plastic surgeons to repair soft tissue defects. Sensory deficits often occur over the skin at the donor site. The results of this study will help with sensory matching when designing forearm flaps for reconstructive surgery
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Evaluation of scar outcomes after treatment of burn scars with fractionated CO2 ablative laser
Expand descriptionFor quality assurance and research, this project aims to evaluate burn scar outcomes following treatment with the Lumenis® UltraPulse® Fractionated CO2 ablative laser at the Royal Adelaide Hospital (RAH). Similar laser therapy is currently available for the paediatric population in SA, however, until recently, there was no access to this treatment for adults in SA. As comparison burn units around Australia and internationally have been successfully using this therapy for over 4 years to improve patient outcomes without negative long-term effects, the RAH Adult Burn Service decided to investigate offering this modality as a scar management option for our patient population. As part of introducing this new procedure, we are interested in evaluating the outcomes to ensure there are meaningful clinical benefits for patients that complement our current scar management. We also aim to add to the research knowledge base by comparing subjective and objective scar properties and outcomes. And finally, we would like to also evaluate patient-reported outcomes and the effect on psycho-social well-being of both laser treated and non-laser treated scars.
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Evaluating the effect of ultrasound guided pacemaker or defibrillator lead implantation on tricuspid regurgitation.
Expand descriptionWe will conduct a two-centre randomised control study designed to assess the impact of transesophageal (TOE)- guided lead placement on the development of new or worsening tricuspid regurgitation (TR). All eligible patients will have a TOE at the time of randomisation, as an exclusion criteria is inadequate TOE images. In the treatment arm, the implanter will be guided by the images obtained on the TOE in order to place the lead in a favourable commissural position so as to minimise tricuspid regurgitation. In the control arm, the implanter will be blinded to the findings on TOE and use fluoroscopy to guide lead placement as is standard practice. The projected duration of the study is 2 years and it is expected that we will enrol 125 patients during this period who require the implantation of a pacemaker (PPM) or automated implantable cardioverter-defibrillator (AICD) as deemed clinically appropriate by their treating cardiologist. The follow-up to assess the primary and secondary endpoints after lead implantation will be at 6-months during a routine clinical follow-up with the treating specialist