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TransformUs All Abilities – School-based physical activity and sedentary behaviour interventions for children and adolescents with disability (implementation trial).
TransformUs All Abilities is a hybrid effectiveness-implementation trial and the outcomes of both trials will contribute to evaluating the roll-out of TransformUs All Abilities. This registration describes the the Implementation component of our hybrid trial. The Effectiveness Trial is registered separately (ACTRN12622001050741). TransformUs All Abilities is a behavioural school-based intervention targeting reducing sedentary behaviour and increasing physical activity in students with additional needs. This is an adaption of a previously registered successful trial "Scalability of the Transform-Us! program to promote children’s physical activity and reduce prolonged sitting in Victorian primary schools" (ACTRN12617000204347). The adapted TransformUs components and supporting resources will be made available in an “All Abilities” section on our website and adaptations to existing activities will be embedded in other sections as well (i.e., Primary, Secondary, Higher Education). Teachers who agree to take part in the Implementation trial will be able to access all the training material via the TransformUs website and will also provide data either online, via text or over the phone interviews. As the program will be available to all Australian primary and secondary schools (mainstream or specialist), an online delivery mode has been deemed the most feasible and sustainable. The focus of this trial will be on investigating the implementation-level outcomes (e.g., acceptability, adoption, feasibility, fidelity, penetration, sustainability, satisfaction) of the TransformUs All Abilities, to understand whether the program is feasible, practical, and sustainable in a real-world environment. School staff involved in the implementation trial will be asked to complete an online survey on two occasions, ecological momentary assessments 3 times per term for up to 6 terms, and a sub-sample will be invited to participate in an interview. In this study, the total number of potential combined primary/secondary schools is 3,440. Based on the uptake of the TransformUs Primary program, we anticipate that approximately 5% of eligible schools and staff may register for the program (i.e., 172 schools).
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Evaluation of the effects of sugar free chewing gums containing oral care agent on early tooth decay.
The study is to compare the remineralisation (repair) of early decay-like lesions in tooth treated with sugar free chewing gums containing 0, 5mg and 10mg CPP-ACP (Recaldent) in a randomized, double-blind trial. All participants will wear palatal appliances with attached enamel slabs during each 14 -day treatment period. This study hypothesis is that there is no significant difference between treatments.
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Stereotactic Body Radiotherapy for Ventricular Tachycardia (CARDIAC SBRT)
This study aims to investigate whether the use of Cardiac Stereotactic Body Radiotherapy (SBRT) reduces the number of Ventricular Tachycardia (VT) events in patients who are not candidates for, or have failed standard of care therapies The study will use patient reported quality of life assessments, toxicity assessments and compare the use of anti-arrhythmic medications prior to and post treatment to assess effectiveness of the treatment.
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Food, Move, Sleep (FOMOS) for Postnatal Mental Health
Background: Home-based health interventions have shown promise in improving some health behaviours (e.g. physical activity) amongst postnatal women, yet little is known regarding the efficacy of home-based interventions that target multiple health behaviours (physical activity, sedentary behaviour, nutrition and sleep) for improving PND symptoms in postnatal women. Intervention description: Food, Move, Sleep (FOMOS) for Postnatal Mental Health is an evidence-based, multi-component and multi-behaviour program which offers a potentially convenient and low-burden solution to improving health behaviours among women at-risk of PND. Study aims: 1) to test the impact of a 6-month home-based program for reducing depressive symptoms by targeting risk factors such as physical activity, nutrition, sleep, and sedentary behaviour in women at-risk of PND; 2) to assess whether the program is efficacious and appealing (e.g., adoption, acceptability, appropriateness, costs, feasibility) at 6 months; and 3) to assess maintenance of behaviour change sustained intervention effects at 12-months follow-up (6-months post-intervention completion). Hypothesis: The FOMOS program will improve depressive symptoms at 6-months, compared to those in the control group.
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Effect of two probiotic formulations on mental health and mood biomarkers in adults with depressive symptoms
In this randomised, double-blind, placebo-controlled study, 60 adults presenting with depressive symptoms will be randomly assigned to receive probiotic capsules containing (1) Bifidobacterium adolescentis (5 billion colony-forming units a day), or (2) Lacticaseibacillus rhamnosus LGG and Bifidobacterium BB-12 (1 billion colony-forming units a day), or (3) a placebo for 12 weeks. We will assess changes in mood and sleep using self-report questionnaires. Changes in blood markers associated with inflammation (tumour necrosis factor-alpha, interleukin -1beta, interleukin-6, interferon-gamma, and high-sensitivity C-reactive protein), intestinal barrier integrity (lipopolysaccharide-binding protein and intestinal fatty acid-binding protein), and brain-derived neurotrophic factor (important for the survival of brain cells) will be assessed over time. We will also assess changes in cortisol (blood and hair), heart rate variability, and the gut microbiome over time.
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A Pharmacokinetic and Safety Comparison of Oxytocin Administered as a Dry Powder by Inhalation and by Intravenous and Intramuscular Injection in Healthy Female Participants
To evaluate the pharmacokinetics, safety and tolerability of a novel dry powder oxytocin inhaler in comparison to oxytocin intravenous and intramuscular injections. To assess and quantify how effectively oxytocin can be delivered into the human blood stream as a powder from an inhalation device compared with delivery via an intravenous or intramuscular injection. In addition to assess if oxytocin can be delivered as a powder from an inhalation device without causing adverse effects to the recipient
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Assessment of Magnesium administration effect on Atrial Fibrillation duration in patients admitted to the Intensive Care Unit.
Atrial Fibrillation (AF) is a type of heart rhythm disturbance which is relatively common in patients admitted to the Intensive Care Units (ICU) especially in people on breathing machines and/or who need drugs to support their blood pressure. Onset of fast AF (>130 beats/minute) in ICU is a clinical problem and usually associated with worsening clinical condition, low blood pressure, and poor outcome. The treatment of fast AF is variable and ranges from giving potassium or magnesium replacement or medications that slow down the heart's rate all the way up to providing an electric shock to "reset" the heart into a normal rhythm. Such invasive treatments are usually associated with significant side effects, and recognising ways to prevent fast AF could improve patient outcomes. Magnesium is also frequent in patients who are admitted to intensive care and I sbeleived to contribute to fast AF. Magnesium replacement via intermittent delivery via a drip in the patient’s vein is common practice in intensive care units. However, an optimal approach to replacing magnesium may be via continuous adminsotration via drip and may decrease the risk of fast AF. This study will aim to establish which of these two methods of administration of magnesium replacement in patients at risk of developing fast atrial fibrillation (AF) is better at preventing early AF in high risk patients.
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Comparing the effects of almond and walnut butters on glucose and insulin levels after eating white bread, in a population at increased risk of diabetes.
Diabetes is a progressive, chronic disease characterised by elevated blood glucose levels. Approximately two million Australians are currently at high risk of developing Type 2 Diabetes. There has been increased attention to the effects of individual food items and nutrients on the outcome of Type 2 Diabetes in recent times, including nuts. Regular nut consumption has been shown to improve glucose control and reduce the overall risk of Type 2 Diabetes. The glycaemic response varies for different carbohydrates. In addition to the level of available carbohydrate in foods, the remaining composition of a food item can also influence the glycaemic response. Almonds have been shown to decrease blood glucose levels and increase satiety after eating. Walnuts contribute numerous positive health benefits including lowering cholesterol and reducing inflammation. Both walnuts and almonds contain high amounts of polyphenols. The form in which nuts are consumed (butter vs whole nuts) may lead to differing metabolic responses. Whilst there are several acute feeding studies which have looked at the postprandial glucose and insulin responses of whole walnuts and almonds, very few have looked at almond or walnut butters, (despite widespread commercial availability of such products). The current study design hopes to provide answers to this research gap. Significant outcomes of the research may include: - Understanding the effects of almond and walnut butters on blood glucose and insulin levels - Understanding the subjective satiety measures of almond and walnut butters We hypothesise that consuming almond butter or walnut butter with white bread will lower the resulting glucose and insulin response, as compared to white bread alone.
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A prospective observational study assessing the impact of positive airway pressure therapy in patients with chronic obstructive pulmonary disease and obstructive sleep apnoea (overlap syndrome).
COPD and OSA are the most prevalent respiratory diseases. Patients with both conditions termed overlap syndrome are at increased risk of dying from cardiac related problems. Positive airway pressure therapy are devices that stabilise the airway and assist with breathing. The aims of this study is to assess whether positive airway pressure therapy can reverse the negative consequences that occur in the heart of people with overlap syndrome and whether it can reduce their cardiovascular risk.
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Rehabilitation after bone marrow transplant- what is the impact on patient outcomes? The REBOOT trial
This research will be conducted at four Australian hospitals. This study aims to investigate the effectiveness of an eight-week multidisciplinary rehabilitation intervention (including exercise and nutrition) i in patients 30 days following bone marrow transplant (either from a donor or from yourself), compared to usual care. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have received a bone marrow transplant within the last 30 days and you are able to walk independently. or using a gait aid Study details All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention program or usual care. Participants who are allocated to the intervention program will firstly undergo a one-on-one session with a dietitian to review their current diet and discuss options to optimise their intake to meet their needs and have their function measured by a Physiotherapist. They will then undertake an 8- week exercise program that will be delivered via telehealth as 2 x 1 hour sessions each week with a face to face session in week 4 replacing one telehealth session. At the end of the program, all participants will be asked to attend a follow-up session to measure their fitness, nutrition, healthcare utilisation and and quality of life. Participants will also be asked to provide these details again at 6 and 12 months after completion of the program/usual care to determine any long term effects. It is hoped this research will demonstrate that delivery of an individualised nutrition and exercise program to patients who have undergone a bone marrow transplant will lead to improvements in their physical function and quality of life.