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The effect of engaging fathers and daughters on girls' participation in basketball: A preliminary evaluation of the 'Daughters and Dads basketball' program
The Daughters and Dads basketball Program is a sport-specific variant of the highly successful ‘Daughters And Dads Active and Empowered program’. Specifically, the program aims to engage fathers in positive lifestyle role modelling and effective parenting strategies to improve their daughters’ skill proficiency in basketball, basketball enjoyment and participation, and social-emotional wellbeing. The purpose of this pre-post trial is to expand the evidence-base for Daughters and Dads Basketball from intervention testing to intervention replication (i.e., the first phase of translation research) using a quasi-experimental research design. The present study will investigate whether: a) Recruitment targets are achieved and program fidelity, compliance, satisfaction, and attendance is maintained, b) The impact of Daughters & Dads Basketball on daughters’: - Sport-specific skill proficiency (e.g., Basketball skills) - Enjoyment in the sport (e.g., Basketball ) - Intention to continue playing the sport - Long-term engagement in the sport
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An Open-label, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LYN-163 in Healthy Volunteers
Lyndra Therapeutics is currently developing LAO capsules for weekly administration across therapeutic areas with certain medications for which simplified logistics of dosing and/or consistent pharmacokinetics (PK) or enhanced adherence may translate to improved efficacy and possibly better safety. The LYN-163ER capsule is designed to provide steady, extended release of ivermectin into the stomach by gradually eluting the drug from a non-dissolving form that stays in the stomach for approximately 2weeks. Central to this goal is the need for a dosage form capable of safely remaining within the stomach for 2weeks. Equally important are the requirements of safe passage into the stomach after swallowing: opening of the capsule in the stomach to release the formulation (stellate), controlled drug release, and safe exit and passage out of the stomach and through the intestinal tract. This single ascending dose study will evaluate the safety, tolerability, pharmacokinetics (PK) of LYN-163in healthy individuals. The PK of ivermectin will be assessed. Data from this study will be a key indicator of feasibility of the product concept and will inform formulation optimization and dose selection for further development. This study will enroll individuals who are in good health. Healthy volunteers are most suitable for providing the initial characterization of the LYN-163safety and PK profile after a single dose. This is an open-label study that will enroll 3 cohorts, each with 5-10 participants. Cohort 0 had 5 participants and cohort 1 and 2 will have 10 participants in each cohort. Cohort 1 and 2 will include 2 participants in a sentinel group and 8 participants in a main group. In each cohort, safety data through Day 5 post dose for both participants in the sentinel group will be reviewed by the Investigator before enrollment of participants in the main group begins. Enrollment of sentinel participants in Cohort 2 will not begin until review of safety data through Day 5 post dose from both participants in the sentinel group in Cohort 1.
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Feasibility of assessing acceptability, cost-effectiveness and comparative clinical efficacy of the UPLIFT program vs. usual physiotherapy care for people with persistent low back pain: a pilot randomised non-inferiority design controlled trial
This pilot study aims to determine the feasibility of running a larger, multi-centre randomised controlled trial comparing the effectiveness of the UPLIFT program as a treatment for persistent back pain when compared to usual physiotherapy care. Primary outcomes: feasibility (recruitment, retention, intervention delivery) and acceptability (patient satisfaction and semi-structured interviews). Secondary outcomes: Clinical efficacy and cost effectiveness of the UPLIFT program compared to usual care physiotherapy. Participants will include patients aged over 18 years who have been referred to the Gold Coast University Hospital Neurosurgical Screening Clinic (NSC) service with low back pain of >6 months’ duration. 60 participants (30 per group). UPLIFT was developed in response to a need for alternative treatment modalities for people with persistent low back pain at Gold Coast University Hospital. A large cohort study indicated the UPLIFT program to be effective for managing this population. Another advantage is that it is delivered in a group-based format which increases cost effectiveness, by increasing the consumer to clinician ratio. The UPLIFT model of care could become the standard model of care for this cohort of patients state-wide in Queensland and even nationally. The UPLIFT program has been part of standard practice within the Gold Coast University Hospital Neurosurgical Screening Service for the past four years, with no adverse events occurring within this time. The proposed research project involves no changes to standard practice, except participants will be required to complete additional questionnaires imposing an additional but small imposition on their time. The requirement of completing additional questionnaires is also explained in the informed consent procedure. Given the trial involves people experiencing persistent pain, there is a possibility that participants will experience a transient increase in symptoms following exercise, however this possibility is no greater than what occurs with usual care. Experienced clinicians with expertise in managing this population group are leading this project and delivering the UPLIFT program (Experimental group) and physiotherapy care (Control group).
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To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of EQ121 following oral single (Part 1) and multiple (Part 2) ascending dose administration in healthy subjects.
This is a Phase 1 study. This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of EQ121 following oral single (Part 1) and multiple (Part 2) ascending dose administration in healthy subjects. Approximately 104 adult healthy volunteers.
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Telehealth for Falls and Fracture Prevention Implementation Trial (TeleFFIT)
Falls and fragility fractures cause more days of hospitalization than most other diseases and account for over half of all injury-related healthcare costs. Current models of care for osteoporosis and fracture prevention focus on pharmaceuticals which reduce fracture risk by 20-50%, missing 50-60% of fracture cases in those with osteopenia (low bone density), and fail to reduce falls, a key contributor to fractures. Best practice clinical guidelines endorse the use of exercise and nutrition interventions with lifestyle risk factor management to reduce falls/fracture risk, but few evidence-based interventions have been translated into practice and long-term adherence to most effective centre/community exercise-nutrition programs is often poor. This suggests that current delivery models do not meet the needs of many individuals. Digital health technologies such as iPad/tablets and smartphones offer an equitable opportunity to increase the scope, utilization and effectiveness of best practice models of service delivery and care for falls/fracture prevention by delivering personalized programs and information, and supporting timely patient-practitioner communication. Therefore, the aim of this 12-month trial is evaluate the clinical and cost effectiveness of a multifaceted, person-centred, telehealth falls/fracture prevention program in people at increased falls/fracture risk. Key features of TeleFFIT are that it incorporates a home-based exercise program tailored to each individual's needs/preferences and is delivered through an exercise training app with ongoing exercise and nutritional support (health coaching) from qualified exercise professionals and dietitians, tailored health messages and access to evidence-based, online educational material to encourage self-care, and healthy lifestyle behaviour change strategies to optimize musculoskeletal health and mobility for older people with or at risk of osteoporosis, falls or fractures.
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Validation of the Paediatric Appendicitis Risk Calculator in the South Australian Emergency Department Setting
Our objective is to assess the performance of the Paediatric Appendicitis Risk Calculator in an Australian tertiary emergency department and to compare its performance with that of the Paediatric Appendicitis Score (PAS) in predicting risk of appendicitis. This will also be compared to the Alvarado Score for predicting appendicitis. The pARC was developed in 2018 to quantify risk of appendicitis on a continuous scale for patients presenting with acute abdominal pain. Variables that are assessed include duration of pain, fever, nausea or vomiting, pain with walking, hopping or coughing, migration of pain to right lower quadrant, maximal tenderness in right lower quadrant, abdominal guarding, white blood cell count and absolute neutrophil count. The initial study found that the pARC accurately quantified risk for appendicitis, in an American setting, with nearly half of the patients accurately classified as <15% risk or >85% risk for appendicitis. None of the above risk calculators have been investigated in Australian paediatric hospitals. Patients with abdominal pain, where appendicitis is a differential, often require transfer to tertiary centres, imaging and diagnostic surgical intervention, and the utilisation of these calculators could significantly change how patients are managed in the emergency department. This study’s purpose is to determine if the pARC is an appropriate calculator to be utilised to predict the appendicitis in the paediatric population. This may then be utilised as a tool in the emergency department to assist physicians to determine if patients presenting with abdominal pain in the emergency department, where appendicitis is a differential, to help assist in the patient’s clinical journey.
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Does obstructive sleep apnoea treatment improve heart rhythm control in patients after having an Atrial Fibrillation ablation. A randomised controlled trial
AF is a very common heart rhythm disturbance. It is caused by irregular electrical activity in the upper chambers (atria) of the heart. Treatments available for AF are medications and a catheter ablation. Sleep apnoea is a condition in which people stop breathing for periods of time during sleep and is also very common and is often undiagnosed. There are some small studies showing that treatment of sleep apnoea improves heart rhythm control such as AF. However, there are no high quality studies that show this. The aim of this project is to investigate the possible association of these two commonly encountered conditions and in particular whether treating sleep apnoea reduces the risk of AF recurrence after ablation therapy. This study may provide very important information about this link that can help us treat patients in the future. We hypothesise that treatment of sleep apnoea will reduce the recurrence of atrial fibrillation.
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The MEDENI Trial: A microbiome-targeted Mediterranean diet intervention in residential aged care to reduce frailty.
Optimal nutrition is critical in protecting against frailty in later life. A Mediterranean diet has been shown in international trials to reduce frailty in elderly individuals living independently. This benefit is related in part to the impact of diet on gut microbiology. Our study focuses on extending this highly successful nutritional strategy to those living in residential aged care facilities.
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Exploring the impact of caseload midwifery on preterm birth among vulnerable and disadvantaged women: a multi-centre randomised controlled trial
Preterm birth is associated with maternal and neonatal morbidity and mortality. For women who are considered socially disadvantaged, or vulnerable, adverse neonatal outcomes such as preterm birth are substantially poorer than for women who are not from these groups. How perinatal care is provided has the potential to have a major impact on these outcomes. Caseload midwifery, where women receive care from one midwife during pregnancy, labour, birth and postpartum, is associated with improved clinical and psychosocial outcomes among women with low-risk pregnancies. Using a two-arm multi-site randomised controlled trial (RCT) design, this study aims to evaluate the effectiveness of caseload midwifery care for women identified as being socially vulnerable, compared to usual maternity care, on preterm delivery. Secondary aims of the study include low birthweight (< 2,500 grams); admission to the neonatal intensive care unit; caesarean birth; birth experience; maternal satisfaction with perinatal care; breastfeeding initiation and maintenance; maternal psychological wellbeing; health service use; and cost-effectiveness of the model. The views and experiences of care providers and other key stakeholders will also be explored, and a nested sub-study of physiological stress responses will be conducted at one study site to explore the stress response among women in both trial arms.
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Coffee for non-alcoholic fatty liver disease
Non-alcoholic fatty liver disease (NAFLD) is increasing in prevalence worldwide. It can cause advanced fibrosis and lead to complications of cirrhosis and hepatocellular carcinoma (HCC). Current treatments for NAFLD revolve around weight loss and lifestyle modification without any approved drug therapies in Australia. Coffee consumption is thought to be beneficial in patients with NAFLD. It has been associated with reduced prevalence of advanced fibrosis in patients with NAFLD through epidemiological and cross-sectional studies. Our study is a randomized controlled trial aiming to assess the effect of moderate coffee consumption on patients with NAFLD, looking at the percentage change in hepatic steatosis as measured by MRI over 26 weeks. Participants at baseline will need to be non-regular coffee drinkers. Participants will be randomised into 2 groups. The coffee group will be required to consume 2-3 coffees per day. Coffee pods and coffee machines will be supplied for the duration of the trial. All participants will receive standard lifestyle modification advice at commencement. Other parameters will also be assessed during the trial including anthropometric measures, biochemical markers and stool microbiome.