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While traditional surgical procedures for heart valve replacement generally require a large incision in the middle of the chest and use of a heart-lung machine, the GATE tricuspid valve is delivered through a comparatively small incision in the chest or neck in a beating heart. This approach can be referred to as being “minimally invasive.” The procedure includes use of a catheter delivery system, through which the replacement valve is delivered to the heart. By replacing the diseased native valve, the purpose of the study is to demonstrate that the GATE system provides a safe and effective means of restoring valve function and improving quality of life for patients at high risk for traditional cardiac surgery. The study hypothesizes that replacing the diseased tricuspid valve in a minimally invasive manner will restore valve function, minimize regurgitation (leaking) and lead to improved quality of life.

The greatest risk factor for glaucoma is pressure within the eye. Management of glaucoma aims to reduce eye pressure and glaucoma surgery involves increasing the outflow of fluid from the eye to achieve this. XEN gelatin stent surgery delivers a consistent non-inflammatory and flexible stent to form a drainage connection between the space at the front of the eye and the outside of the eye, just beneath the surface of the clear skin (conjunctiva). The fluid from the eye drains out along the tube to form a blister (bleb) in the surrounding tissue, which is vital for long term success. This project will allow the long term collection and analysis of data to help improve patient outcomes. Multiple surgical variables may influence post-operative outcomes and success rates of the surgery. These include the entry position, dimensions of the stent within different parts of the eye and the final position of the stent. Other non-surgical factors which are likely to play a role in terms of surgical success include age, sex, racial sub-type and disease (glaucoma) sub-type. We would like to answer questions surrounding which of these parameters are important in determining XEN stent function, eye health after surgery and pressure reduction. The three major endpoints in terms of judging surgical success rates are eye pressure reduction, number of pressure lowering medications (eye drops) used and drainage (bleb bister) area shape and appearance. This will be a prospective observational study over a 12 month period after surgery. Patients who have already undergone surgery will be asked to participate as well as patients about to undergo surgery. We will collect clinical data over a 12 month period following patients' XEN surgery during their routine post-operatively clinical reviews.

The aim of this randomised control trial is to determine if improvements in the nutrition quality of lunchboxes following an app based intervention can be maintained with or without additional support. Schools who have received the app based intervention will be randomised to either receive two additional booster messages via the school communication app, over a one month period or to the control group.

Pathways and Resources for Engagement and Participation (PREP) is a 20-week innovative strengths-based intervention which aims to increase the participation of adolescents with reduced mobility in leisure/recreational pursuits. Occupational therapists collaborate with adolescents to identify 3 goals and use coaching to support adolescents, and if appropriate, their parents, to identify aspects of the environment which either support or create barriers to participation and implement strategies to remove barriers. The program addresses one goal at a time in a staged fashion and progress and outcome measurement is embedded in the program. PREP has been evaluated in Canada with adolescents with moderate physical disabilities and shown to be feasible and effective for increasing participation. We plan to evaluate the implementation of PREP in i) an Australian cultural context, ii) a hospital clinic environment and iii) with an older group, that is, youth aged 18 to 30 (approximately) who are part of the Young Adult Complex Disability Services clinic (YACDS) at St Vincent’s Hospital in Melbourne. Our hypothesis is that PREP, following any modifications required for the Australian context, can improve the participation outcomes of young adults with complex disability.

This proposal aims to evaluate whether liquid melatonin can be used to improve sleep in children aged 5-8 years with or at risk of FASD as per the Australian Guidelines for the Diagnosis of FASD. In addition we will investigate how any changes in child sleep behaviour owing to the intervention will lead to effects on parent wellbeing, child behavioural functioning, and child neuropsychological functioning.

A recent Australia-wide survey found that many general practitioners recommend unnecessary imaging and surgical referrals for a common type of shoulder pain (rotator cuff tendinopathy). We hypothesise that educating patients with rotator cuff tendinopathy directly about their condition and recommended care has the potential to reduce nappropriate imaging and surgery, increase adherence to recommended care and ultimately improve healthcare outcomes. The proposed study is a three-arm, parallel group, pilot and feasibility randomised controlled trial. Participants will be randomised to one of three trial arms; Group (i) standard advice and exercise via online pamphlet; group (ii) pamphlet in (i) + video delivery; group (iii) pamphlet in (i) & videos in (ii) and individualised daily feedback.

Prevention and early diagnosis of diabetes is key to avoid diabetes-related complications. In 2018, 2 million Australians are estimated to have pre-diabetes and are at high-risk of developing type 2 diabetes. The Nutrition-Care Gluco-Metabolism Formula contains a mixture of herbs and nutrients, which have been shown to be beneficial for balancing blood glucose levels in the blood. In this randomised double-blind placebo-controlled 12-week trial we aim to assess the tolerability and efficacy of the Gluco-Metabolism Formula for glucose control in pre-diabetics.

Mobile health technology may assist children with disabilities in completing school therapy programs prescribed by their physiotherapist, occupational therapist, or speech pathologist. We have developed an iOS (iPad/ iPhone) app, designed specifically for children with disabilities, that employs electronic gaming elements and other features to maximise children’s motivation to practice therapy activities at school. The feasibility of using this app, with 6-12 years old children with disabilities, for completing individualised therapy programs in a classroom environment will be investigated in this study.

Acute Kidney Injury (AKI) following cardiac surgery is a significant cause of morbidity and mortality, affecting up to 30% of patients. It is unclear if 20% albumin infusion is useful in reducing the incidence of AKI in these patients. We hypothesise that an infusion of 20% albumin will reduce the incidence of perioperative AKI after high-risk cardiac surgery, compared with standard care.

The primary objective of this study is to determine if nutritional supplementation improves exercise capacity in patients with Chronic Obstructive Pulmonary Disease (COPD) attending pulmonary rehabilitation. Secondary aims of this study are to evaluate if nutritional supplementation results in greater improvements in hand grip strength, body weight, body mass index (BMI), nutritional status (MNA), health related quality of life and lower limb strength in people with COPD participating in pulmonary rehabilitation. Participants will attend an 8 week (16 session) pulmonary exercise rehabilitation program which consists of two 1.5 hour exercise sessions per week. Participants that consent to take the nutritional supplement will be assigned to the intervention group and will be asked to take a nutritional supplement daily for the period of their 8-week exercise rehabilitation program. Participants who decline to take the nutritional supplement will be invited to also take part in the study and will be assigned to the Control Group (non-randomised) and asked to complete baseline and follow up outcome measures only. Overseas studies have shown that nutritonal supplements improve exercise outcomes for patients with COPD attending pulmonary rehabilitation and we aim to see if this can be replicated in the Australian population.