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Intrauterine Instillation of Autologous Platelet Rich Plasma to promote the growth and regeneration of the endometrium for patients with recurrent implantation failure, poor endometrium within Assisted Reproductive Technology (ART) or Asherman's syndrome: Investigating the effect on successful pregnancy.
It is anticipated that intra-uterine instillation using autologous platelet-rich plasma (A-PRP) injected into the uterus will improve successful pregnancy outcomes in current IVF cycles and frozen embryo transfer cycles for women either with RIF, an endometrium of <7mm, or an Asherman's Syndrome diagnosis. In the non-randomised prospective trial, around 10mLs of your own blood (autologous) will be collected to produce around 1mL of A-PRP. The A-PRP will be injected into the uterus transvaginally via an embryo transfer catheter either 48 hours prior to trigger for thin endometrium cases or 48 hours prior to ET for RIF cases.
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FEEDBACK trial: Investigating the effect of a personalised feedback intervention on the incidence of road crashes
By 2030, road crashes are predicted to be the fifth leading cause of death globally. Although Australia has made great strides in road injury prevention and safety, road fatality rates have plateaued over the last decade. Of concern is the fact that young drivers are overrepresented in road injury and fatality statistics in Australia - whilst young drivers comprise only 14% of all licence holders, they are involved in about one-fourth of all serious crashes (Australian Transport Council 2011). For young people aged 18-25, driving is a high-risk activity, with the risk of a crash greatest in the first six months of licensure (VicRoads 2005). In-vehicle telematics presents a promising technological means of reducing road trauma. Telematics technology generates real-time motor vehicle data, such as acceleration and braking information, providing drivers with direct feedback on driving performance. Moreover, linking safety-specific feedback with financial incentives may achieve safer driving behaviours. This study aims to assess whether personalised safety feedback linked to financial incentives will improve driving behaviour and reduce road crashes among novice drivers. This study will be the largest trial of personalised transport safety feedback delivered using telematics technology in Australia. Recent aforementioned research highlights that personalised driving feedback and financial incentives shape safer driving behaviours (Mortimer et al. 2006; Stevenson et al. 2018), and this study will extend this important finding by assessing the likely impact that personalised safety feedback and incentives have on reducing the likelihood of road crashes. This study will be a crucial step in advancing scientific knowledge around road safety and enabling large-scale implementation of interventions to reduce road trauma. A unique element of this trial is that it delivers across the entire state(s). Most technology trials have relied on participants and researchers in close proximity to ensure appropriate installation of the technology in-vehicle, and hence have been wholly delivered in urban environments. This trial, on the other hand, will overcome the underrepresentation of regional and rural young drivers in such studies. This is a significant strength as about two-thirds of serious injuries and fatal crashes occur in regional and rural areas. In the past decade, hospitalisations from road crashes in Australia have not declined. As such, the market penetration of technologies like telematics highlights the opportunity to reduce the burden of road traffic injury. Furthermore, this research will provide decision-makers with data in order to guide policymaking. Our research will generate new knowledge that can be directly translated into transport safety policies associated with all newly licensed drivers.
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CheckMyText! Randomised controlled trial to evaluate the SHeLL Health Literacy Editor
Our team created a new online interactive tool, the Sydney Health Literacy Lab (SHeLL) Health Literacy Editor, to help health services staff write health information that is easy to understand. The Editor gives users real-time feedback to help them write more simply and apply health literacy principles. The aim of this study is to see how well the Health Literacy Editor works. To do this, we will ask participants to simplify health texts using either the Health Literacy Editor, or their usual processes. We will then compare findings across the two groups. We hypothesise that when participants use the Health Literacy Editor to help them revise a text, the health information is easier to understand (e.g. lower grade reading score).
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An Online Mindfulness-Based Intervention for Psychological Distress Associated with Inflammatory Bowel Disease: A Feasibility Trial of the Mind4IBD Program
IBD populations experience 2-3 times higher rates of mental health comorbidities in comparison to healthy individuals. Researchers have investigated mental health as contributing to the pathogenies of IBD, finding a significant two-way gut-brain relationship. Mindfulness-based interventions (MBI’s) have been examined as a psychotherapy for IBD. MBI’s aim to foster non-judgmental awareness of emotions, thoughts, and behavior, to support self-regulation. A recent systematic review found MBI’s to be effective in improving IBD biopsychosocial outcomes, including CRP, stress and HRQoL, concluding that MBI’s may be a useful adjuvant therapy in IBD care, with further trials warranted. The review highlighted several limitations providing considerations for the current trial including; trials utilizing unselected participants without psychological distress, no trial utilizing an online intervention, and lack of interventions adapted to IBD. This study aims to evaluate the feasibility and preliminary efficacy of a 6-week online MIND4IBD program, adapted for individuals with IBD, experiencing psychological distress.
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Evaluation of the NaviFUS System in drug resistant epilepsy
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Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
To evaluate the effects of oral care agents on white spots, healthy human participants will wear appliances with tooth slabs containing artificially-created early decay (white spots) attached. During each 14-day treatment period, a slurry of each dentifrice formulation will be prepared by diluting 1 g of the product in 4 mL of distilled de-ionized water in a 15mL tube. Four times a day at 9:30 am, 11:00 am, 1:30 pm and 3:30 pm, participants will rinse with 5 mL of a 10% sucrose solution (supplied) for 60 seconds. They will expectorate the sucrose rinse after 60 seconds. Forty minutes after each sucrose rinse, participants will shake their slurry solution and immediately rinse with all 5 mL of their allocated slurry for 60 seconds (i.e. four times a day at 10:10 am, 11:40 am, 2:10 pm and 4:10 pm). They will then expectorate the slurry. Participants will (gently) remove their appliances only when they brush their teeth and clean their appliances in the morning and at night without touching the wells holding the enamel/dentine pieces. There will be at least a week’s rest between each treatment period with a different slurry allocated for each treatment period. The order of slurries for each participant will be unknown to the participants or researchers. At the end of each treatment period, the slabs from the appliance will be returned and x-rayed outside the mouth to measure repair of decay. Closure of dentine tubules will be analyzed with microscopy. This project will provide valuable information for development of novel toothpastes.
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An online study of an oral supplement combination in knee osteoarthritis.
ATLAS is a 12-week research study sponsored by the University of Sydney, evaluating the efficacy of an oral supplement combination for reducing knee pain compared to a placebo in people with symptomatic knee OA.
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A pilot study measuring Oxygen and Carbon Dioxide in order to assess the impact of Opiate Infusions on young children Undergoing Palatoplasties
Cleft palate is a birth defect that affects the roof of the mouth and requires surgery in the first year of life to close the abnormal opening between the nose and mouth. After surgery, moderate to severe pain is managed using opioid painkillers. However, opioids can cause breathing problems and can be especially risky for children who have had cleft palate surgery. Monitoring a patient's oxygen and carbon dioxide levels can help clinicians understand a patient's respiratory status and detect changes in their breathing and ventilation. This is important in patients who are vulnerable to breathing problems, such as patients recovering after cleft palate surgery. Carbon dioxide monitoring is not currently a routine feature of monitoring for palatoplasty patients. A proposed pilot study aims to monitor both oxygen and carbon dioxide saturations in infants on opioid infusions after palatoplasty to better understand their ventilatory recovery after cleft palate surgery.
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The effect of consumer led teach-back on recall and retention of health information: A mixed methods randomised controlled trial
The primary aim of this study is to determine whether a patient-led communication intervention can improve recall of health information following a healthcare interaction. This study follows a mixed-methods design whereby quantitative and qualitative data will be collected and analysed. A prospective, single centre, two arm RCT will determine the proportion of information recalled at two time points. A qualitative evaluation will be conducted parallel to the RCT, exploring patient perspectives on usability, relevance and value of the intervention through semi-structured interviews. These interviews will only be conducted among participants who have been randomised to the intervention arm of the RCT.
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Co-delivery of tele trial Behavioural Activation in people experiencing depression and financial distress: a feasibility protocol
Poor financial health and wellbeing are known to affect psychological wellbeing in adults. There is good evidence that financial stress can result in a low mood. Behavioral Activation is known to treat depression in adult patients. Potentially, Behavioral Activation (BA) may have a role to play in treating depression in people experiencing financial distress. We are not aware of any studies that have tested the feasibility and acceptability of BA conjunctively delivered with financial support service care for financially stressed adults with depression. This study will examine the feasibility and acceptability of implementing a BA tele-trial delivered collaboratively with the Financial Wellbeing & Capability Programs – Outback SA (FWCP) financial support service offered by Centacare Catholic Country SA, a not-for-profit organization in South Australia. Methods A sample of 60 FWCP clients aged 18 years or above with symptoms of depression as indicated by the PHQ-9 scores of 5-14 (mild to moderate depression) and eight Financial Capability Workers will be recruited from across six sites in regional, rural, and remote South Australia. Study participants will be randomized to receive Behavioral Activation plus FWCP financial support service care or FWCP financial support service care alone. The Behavioral Activation component will involve 6 sessions of 30-minute duration which will be delivered twice weekly over six weeks. Specific BA techniques that will be applied include the identification of depressed behaviors; analysis of the triggers and consequences of depressed behaviors; monitoring of activities; development of alternative goal-orientated behaviors; scheduling of activities; and the development of alternative behavioral responses to rumination. The Financial Capability Workers will complete a 10-week online training program in BA comprising five modules: (a) the evidence base of BA (b) introduction to BA (c) assessment and mood monitoring (d) functional analysis, and (e) activity scheduling before they can deliver the psychotherapy to their clients. Changes in depression symptoms will be assessed at three-time points: (a) at baseline, at 6 weeks, and 3-month follow-ups. Quality of life will be assessed at two-time points: (a) at baseline and (b) immediately at postintervention after six weeks. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability. Discussion The findings from the study will inform the design of a full-scale randomized controlled trial to test the effectiveness preparing FCW to deliver BA to people in financial distress who are depressed.