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Use of novel device in the endoscopic treatment of Zenker's Diverticulum patients
Zenker diverticulum is a herniation of the oesophageal mucosa resulting in pouch formation which can result in dysphagia and spontaneous regurgitation. Treatment with flexible endoscopic myotomy demonstrates lower morbidity compared to previous modalities. However, there is no established standard approach with unknown optimal technique. While the principal is to cut the cricopharyngeal muscle, a careful balance needs to be achieved to not cause perforation, while noting that an incomplete myotomy leads to higher recurrence rates. Intra-procedural measurement of distensibility across the Zenker's using the endoscopic Functional Lumen Imaging Probe (FLIP) could allow real-time determination of whether further incision will be required. Through retrospective review of medical records we hope to determine the feasibility of intra-procedural FLIP measurements in these patients, and assess whether there is a correlation between changes of distensibility following myotomy with symptoms and pouch size. We expect approximately 10 patients and hope to show that intra-procedural measurements will help to guide extent of myotomy to minimise risk of perforation as well as recurrence.
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Prehabilitation for Gastrointestinal Cancer Surgery
The purpose of this study is to determine if a multimodal (exercise, nutrition and nursings support) prehabilitation program for patient undergoing major gastrointestinal cancer surgery for curative intent can be built into routine care. Who is it for? Patients with stage I-III or limited stage IV colorectal or upper gastrointestinal cancer undergoing curative intent surgery at concord repatriation general hospital. Study Details The study will involve both an exercise and diet program 2-4 weeks prior to major gastrointestinal surgery. All participants will receive the intervention. 1.Exercise: The exercise component will involve supervised and tailored 60-minute group-based exercise sessions per week using a combination of resistance and aerobic exercises delivered by an accredited exercise physiologist. In addition, 3 x homebased exercise training. 2. Nutrition: The nutritional component will involve Oral high protein supplements (Fresubin® Protein Energy) containing 20g protein, recommended to be consumed daily within one-hour post exercise to capitalize on muscle synthesis (day one until two days prior to surgery). In addition, nutritional advice will be provided delivered by a dietitian to achieve adequate oral protein intake. 3.Nursing support: One (15-20 minute) nurse-led phone support session per week of intervention Assessment Involvement in the study will involve a variety of body measurements and questionnaires, including questions about quality of life and patient satisfaction. It is hoped this study will further insight into how prehabilitation can decrease length of stay, lead to better surgical outcomes, whilst evaluating the change in functional, nutritional and psychological status.
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Structured exercise prograM to reduce fatigue In patients receiving dialysis: an adaptive Trial (M-FIT)
Fatigue is one of the most common and debilitating symptoms in patients on dialysis. The prevalence of fatigue ranges from 55% to as high as 97% in adult patients on dialysis and is associated with impaired quality of life and increased mortality. Fatigue is also consistently ranked as critically important by patient on dialysis, even higher than death. Our global Standardised Outcomes in Nephrology (SONG) initiative, involving over 2000 patients receiving dialysis, caregivers, and health professionals across 100 countries, established fatigue as a critically important core outcome. Lifestyle (including exercise) interventions was the top priority identified through the research priority setting partnership. Evidence for exercise interventions remains very uncertain due to factors such as the plethora of measurements used to assess fatigue and small sample size. A patient workshop was convened to identify and prioritise exercise interventions for the M-FIT study to ensure acceptability and feasibility. M-FIT is a multi-centre, adaptive randomised comparative effectiveness trial of three structured exercise programs and a control in patients receiving dialysis. The primary outcome of this trial is fatigue as measured by FACIT-Fatigue at 12 weeks. Secondary outcomes include additional measures of fatigue, quality of life, mood, life participation, body composition, exercise capacity, neuromuscular fitness, balance, physical activity, sleep, exercise adherence, SONG core outcomes, hospital admissions, cost-effectiveness, app usability, preference and safety.
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Can an alternative type of intracytoplasmic sperm injection (ICSI) improve fertilisation?
This study is assessing whether or not an alternative intracytoplasmic sperm injection (ICSI) technique (PIEZO ICSI) in patients undergoing assisted reproductive technology treatment results in improved embryo fertilisation and utilisation rates. We hypothesis that as PIEZO ICSI is a gentler insemination method we will see increased fertilisation and embryo utilisation rates following PIEZO ICSI compared with conventional ICSI.
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A Phase Ib, single centre, open label study of a therapeutic Human Papillomavirus (HPV) DNA vaccine co-administered with an anti-PD-L1 immunotherapy, Durvalumab (MEDI4376), for recurrent and/or metastatic HPV-related Head and Neck Cancer
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Internet-Based Professional Learning to Help Teachers Promote Activity in Youth with Intellectual Disability. The iPLAY For Inclusion Project: iPLAY4i
Australia’s children are among the least active in the world. Physical inactivity is a particularly big problem for children with intellectual disabilities. Schools are ideal places to promote physical activity. This school-based intervention, iPLAY4i, will involve two key steps: we will train participating teachers in how to promote physical activity at school; and we will also support a few extra teachers while they try to promote a better culture of physical activity within the school. We hypothesise that this intervention will lead to benefits for children with intellectual disabilities, specifically: higher physical activity, higher physical fitness, better fundamental movement skills, and higher confidence, motivation, and wellbeing.
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Phase 1/2 study of IMC-I109V in non-cirrhotic HBeAg-negative chronic hepatitis B (HBV) infection
Hepatitis B is the most common liver infection in the world and is caused by the hepatitis B virus (HBV). HBV enters the body and travels to the liver via the bloodstream. In the liver, the virus attaches to healthy liver cells and multiplies. The liver is the main site of HBV replication. Hepatitis B infection can lead to cirrhosis (scarring of the liver), liver cancer, or liver failure, if it is not diagnosed and managed appropriately. The purpose of this study is to test IMC-I109V in people with chronic hepatitis B virus (HBV) infection. The main goal of the study is to assess the safety and effectiveness a new treatment, called IMC-I109V. IMC- I109V has been developed to treat HBV by activating the body’s own immune system to fight the virus.
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Is adapted group cognitive behavioural therapy effective in treating anxiety for children and adolescents with intellectual disabilities?
The proposed research aims to evaluate the Fearless Me! program, a CBT program specifically designed for children with ID and anxiety in a clinical group setting. The program was designed to be applied in an individual or group format. Thus far, the program has been evaluated with moderate success in a group format in a school setting, with clinical and non-clinical presentations (Hronis, et al. 2019). Fearless Me! is currently being assessed in an individual format for children with anxiety and ID, however, the program has not been tested in a clinical sample through a group format. It is hypothesised that the intervention will result in better mental health outcomes, including reduced levels of anxiety, improved quality of life and improved emotional development.
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Examining the effectiveness and feasibility of an online Mindfulness program for treatment of insomnia
Insomnia is one of the most prevalent sleep disorders. The symptoms include difficulties getting to sleep, difficulties staying asleep, or early-morning awakenings with an inability to return to sleep. Insomnia may also be associated with problems with memory and attention, and increased feelings of depression, anxiety and stress. Insomnia can be treated effectively without medication. However, there remains a large proportion of individuals who do not seek help possibly due to barriers such as geographical location or time constraints. This project will investigate the efficacy and feasibility of an online mindfulness-based insomnia therapy program for people with difficulties getting to sleep or difficulties staying asleep. The study will also examine whether online mindfulness-based insomnia therapy improves objective sleep measures and reduces insomnia symptoms compared to a waitlist control group.
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Metformin and vitamin B12 deficiency in patients with gestational diabetes mellitus.
Several studies have shown that vitamin B12 status during pregnancy is of major importance to health of mother and her offspring. As vitamin B12 deficiency poses risks to both the expectant mother and foetus it is vital for pregnant women, who are at risk of vitamin B12 deficiency, to undergo appropriate monitoring and to have adequate vitamin B12 supplementation. We hypothesized that the metformin use for treatment of gestational diabetes will increase the risk for the development of vitamin B12 deficiency. Study participants were assigned to their study treatments (diet, insulin, metformin or metformin and insulin) according to the required standard of care during their pregnancies. Pregnant women underwent measurements of total vitamin B12 levels and holotranscobalamin levels, folate, FBC with MCV and MCH. The vitamin B12 levels were measured at the first visit to the gestational diabetes clinic, after 30 weeks of pregnancy and additionally after 4-6 weeks of treatment with metformin. The present study will additionally examine the antenatal and postnatal outcomes of pregnancies in patients with vitamin B12 deficiency, which we will determine based on the information from patients’ medical records.