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Forearm skin flap for monitoring of acute transplant rejection in children and adolescents
In this study, patients receiving a liver or bowel transplant will also receive a transplant of skin. The study will assess whether it is safe to transplant skin with a liver or bowel transplant by recording all adverse outcomes and assessing the survival of the skin transplant at regular intervals. It is hypothesised that it is safe to transplant skin. Future studies will assess whether the skin transplant can alert doctors to rejection occurring in the liver or bowel transplant.
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Adaptation of the My Food and Mood app for adults at risk of Posttraumatic Stress Disorder (PTSD): Lived experience feedback, engagement and prototype design ideas
Post-Traumatic Stress Disorder (PTSD) is a debilitating and costly condition. Conventional treatments are insufficient and fail to adequately address comorbid conditions such as coronary heart disease and diabetes. Dietary intervention is a well-established approach in treatment of physical conditions whereas building evidence suggests improving diet quality may address factors that are maintaining and exacerbating PTSD. However, current research in dietary improvement programs for those at risk of PTSD is limited in quantity and quality. We aim to adapt the My Food and Mood app for adults with PTSD symptoms, using a co-design approach with those with lived experience of PTSD. 24 adults at risk of current PTSD (i.e. with an elevated score on a PTSD symptoms measure) will undertake a consumer survey, trial the My Food and Mood app and provide feedback in an online group meeting. This information will be used to develop the Healthy Eating Lifestyle Program (HELP) app to pilot. This project will provide a solid foundation for the co-development and optimisation of a digital program targeting diet quality improvement for those at risk of PTSD. Given the relatively high prevalence of PTSD and its enormous individual and societal costs, an online self-help approach could provide a pragmatic and effective adjunct treatment strategy. Outcomes of the project will inform funding applications for a large online RCT to establish the comparative efficacy of dietary interventions for PTSD populations.
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FLASH-CGM – investigating the effect of flash glucose monitoring on glycaemic profile in patients with insulin-treated type 2 diabetes in the post-discharge setting; a randomized pragmatic trial
Flash glucose monitoring is a form of continuous glucose monitoring (CGM) that continuously measures interstitial glucose while the sensor is implanted into a patient. Flash CGM use the same basic technology, but require the patient to ‘flash’ the sensor with a reading device every 8 hours to read the data that is gathered in the continuous monitoring. While there has been a relatively large amount of research looking at traditional CGM and flash CGM in patients with especially type 1 diabetes, there is currently little evidence around the utility of flash CGM for patients with type 2 diabetes Therefore, this paper presents the protocol for a randomized pragmatic trial comparing flash glucose monitoring to care as usual in a group of acutely unwell people with type 2 diabetes requiring insulin. This will provide important information about the potential benefits of the technique to clinical metrics, as well as answering key questions about the feasibility of use in this target group. A non-technical explanation is that this study will compare a continuous glucose monitoring technology, which measures people's blood sugars over time rather than them having to prick their fingers, to the usual care people are given after being discharged from hospital. The hypothesis is that this may improve people's management of their blood sugars and help the specialist and patient to get their sugars on track more effectively.
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Development and Evaluation of an Novel Treatment Adapting a Cognitive Behaviour Therapy Approach for Sexuality Problems After Traumatic Brain Injury
You don’t have to be having sex or be able to function sexually from a biological perspective as prerequisites for sexuality. Sexuality is very multi-dimensional. Beyond sexual function, it includes sexual orientation, preferences, motivation, pleasure, body image, self-esteem, intimacy, relationships and communication. Sexuality is a fundamental part of being human and following traumatic brain injury (TBI), sexuality doesn’t end, but it can change. Up to 50% of people who have had a traumatic brain injury experience a significant change. The majority report a global reduction in sexuality, including reduced frequency of sexual encounters and lower quality when they do occur, as well as reduced libido, arousal, and orgasm. There have been only two single case study intervention studies that have explored remediation of sexuality disturbance after TBI. Indeed, the lack of evidence-based treatments for sexuality problems after TBI is a significant barrier to addressing this topic in rehabilitation settings. The aim of this study is to evaluate the preliminary efficacy of an individualised intervention using a cognitive behavioural therapy (CBT) framework to treat sexuality problems after TBI. Treatment consists of eight weekly, individual therapy sessions, combining behavioural, cognitive, and educational strategies to address a diverse range of sexuality problems. Clinical psychologists adopt a patient-centred and goal-oriented approach whilst following a treatment guide and accommodating TBI-related impairments. This research will assist clinicians and services providers improve their knowledge and skills and further inform the development of guidelines to support the management of sexuality across the continuum of care.
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A pilot randomised controlled trial testing the efficacy of cannabidiol for anxiety in Tourette Syndrome
This trial will identify the efficacy of CBD for the treatment of anxiety in children and adolescents with Tourette Syndrome. Forty children and adolescents aged 6 to 17 years will be recruited to a 32-week randomised, double-blind, placebo controlled cross-over trial. Participants will be randomised on a 1:1 basis to either the active group (CBD) or control group (placebo). Following 14 weeks of the trial participants will then cross-over to the alternative group for comparison. It is proposed that while participants are in the active group their levels of anxiety will be significantly lower than when they are in the placebo group. Similarly, it is proposed that participants in the active group will also have significantly less tics, lower levels of depression, decreased obsessive-compulsive behaviours and improved quality of life, sleep and global symptomology.
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Testing safety and efficacy of a live bacterial therapy for the treatment of active Rheumatoid Arthritis.
The aim of this study is to evaluate the efficacy and safety of SVT-6A4710 as a treatment for active Rheumatoid Arthritis. The treatment consists of a combination of carefully selected bacteria. Bacteria are naturally found in the digestive tract and are a research focus for their important role in many health conditions. 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 Arthritic symptoms. This study will help determine how safe and effective SVT-6A4710 is as an adjunct therapy to synthetic disease-modifying anti-rhuematic drugs (DMARDs) in treating symptoms of Rheumatoid Arthritis.
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Exploring the Impact of Sex Hormones and Obesity on Asthma Outcomes in Women with Asthma
Purpose of Study In Australia, asthma affects >10% of adults and costs $28 billion per year. The highest burden occurs in obese, older women, with non-Type 2 (T2), non-eosinophilic severe asthma, which is resistant to corticosteroids. Severe, steroid-resistant disease is the biggest unmet need in asthma therapy, as patients have greatly reduced quality of life, with poor asthma control, frequent exacerbations and side effects from high-dose steroids. Severe asthma also disproportionately contributes to the economic burden of the disease, accounting for >50% of asthma costs. There are no effective therapies for non-T2 obesity-associated asthma, as the underlying mechanisms are largely unknown. We have pilot data showing that the oral contraceptive pill (OCP) may be more effective than corticosteroids in controlling asthma in women, via effects on inflammation and metabolism (immunometabolism). We will extend upon these findings by examining the relationships between sex hormones, immunometabolism and asthma control in a well-defined clinical population of women with and without obesity. Hypothesis Female sex hormones play a major role in asthma control and asthma severity in women with comorbid asthma and obesity. Aims Aim 1 – Observational cross-sectional study: To characterise the association between female sex hormone levels, inflammatory and metabolic markers, and asthma control in women with and without obesity. Aim 2 – Observational longitudinal study: To examine the effect of hormonal fluctuations on asthma control in pre-menopausal women with and without obesity.
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Topical Antibiotics in Ankle Fracture Surgery (TAAFS) pilot study
The proposed pilot study is a multi-center, prospective, double-blinded, randomized controlled trial comparing standard surgical fixation of ankle fractures with and without local topical antibiotics at the time of wound closure. The null hypothesis is that there will be no difference in post-operative rates of infection despite the addition of local topical antibiotics to the surgical wound at the time of closure. We will test our hypothesis by randomizing one group of patients to receive topical vancomycin and gentamicin solution to the wound at the time of closure and the other group to not receive additional topical antibiotics. Routine follow-up of patients will be completed under the standard of care, to assess whether or not the addition of topical antibiotics at the time of wound closure will reduce the rate of post-operative wound infection in ankle fracture surgery.
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Eating in Context Study: understanding the ways through which individual and everyday factors affect food choices at different eating occasions, and how this impacts health in adults aged 18 to 64 years.
The overall aim of this project is to characterise pathways through which individual and everyday contextual factors affect food choices at eating occasions and their role in cardiometabolic health. Participants aged 18 to 64 years will be asked to complete an online survey, and attend a research clinic where blood pressure and anthropometry will be measured. They will also be instructed to complete seven days of data collection including fasting blood sampling, online dietary recalls using ASA24-Australia, and the use of a wearable camera and SenseWear armband. This study will help us understand the pathways through which everyday contexts influence eating behaviours and health. Understanding these complex pathways will help inform the development of realistic and practical intervention strategies that tailor to everyday eating situations and promote heart healthy eating patterns.
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Optimising Exercise Preparation using Closed-loop Insulin Delivery for Exercise in People With Type 1 Diabetes
Regular physical activity has been clearly demonstrated to have a range of beneficial effects in people with and without diabetes, although in those people with type 1 diabetes this may come at the expense of increased risk of low blood sugar (or a hypo). This increased risk during exercise in individuals with type 1 diabetes occurs as insulin concentration cannot be decreased rapidly at the start of exercise, generally causing blood glucose levels to fall. On the other hand, very hard or intense exercise may cause blood glucose levels to rise. These differing responses to exercise of varying intensities makes generalizing recommendations for exercise difficult in people with type 1 diabetes. A number of strategies are currently recommended to reduce the risk of exercise-induced low blood sugar (hypo), including reducing the meal-time insulin dose for meals close in timing to the beginning of exercise, or eating carbohydrates prior to and during exercise. However, these strategies often require the person with diabetes to actively plan in advance their exercise, and predict its intensity and duration, which is not always possible. Current guidelines for insulin delivery via an artificial pancreas suggest reducing insulin delivery by setting a temporary increased glucose target 60-120min prior to exercise (ie. Increasing the target on the pump from 5.5mmol to 8.3mmol). However, it is important to consider the optimal timing for setting a temporary elevated glucose target using artificial pancreas systems. If good glucose control with very little high or low blood sugar can be achieved when the temporary glucose target is initiated closer to, or at the beginning of exercise, then this would make planning and undertaking exercise easier in people with type 1 diabetes. The purpose of this research study is to collect data that can help to answer questions about the performance of the Medtronic 780G artificial pancreas system during and post-exercise when a temporary glucose target is set at different time points pre-exercise. The study will compare glucose control in adults with type 1 diabetes in response to short-duration (40min) moderate intensity exercise, short-duration (40min) high-intensity exercise and long-duration (90min) moderate intensity exercise, when a temporary glucose target is set 60min pre-exercise, 20min pre-exercise, 0min pre-exercise, or when no temporary target is set.