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A Study Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-3505 in Healthy Volunteers (PART II)
Expand descriptionK-3505 P001 (Part II) is a Phase 1 study with a primary purpose of assessing the safety and tolerability of single doses of an intravenously (i.v) administered drug called K-3505 when K-3505 is administered alone (Day 1) and when K-3505 is administered after prior oral administration of another drug called Fezolinetant (Day 2).
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Redefining Glucose thresholds for Hypo Treatment in Children with Type 1 Diabetes on Closed loop Therapy
Expand descriptionHypoglycaemia (hypo) education is provided at the time of type 1 diabetes diagnosis and knowledge reviewed in the clinic as required. The current threshold for initiating hypo treatment at glucose level < 3.9 mmol/L is on expert opinion, rather than evidence based, which was chosen to avoid glucose levels from dropping even further (<3.0 mmol/L), considered as significant hypoglycaemia below which neurocognitive decline occurs. However, it needs to be appreciated that levels between 3.0 and 3.9 mmol/L are considered as normal in healthy individuals with no diabetes. With the availability of continuous glucose monitoring (CGM) and closed loop therapy as standard care in management of T1D, there is ability to support lower glucose thresholds for treatment as basal insulin delivery is suspended with prediction of a hypo. This will avoid overtreatment of hypos and resultant high glucose levels. The study aims to determine if reducing the cut-off of initiating treatment will be an acceptable hypo threshold and will not be associated with an increase in time spent in hypos <3.0 mmol/L with worsening of glycaemic outcomes.
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A non-randomised trial comparing personalised versus non-personalised versions of the Daily Growth parenting app for emotion regulation in parents/carers and their children aged 2-5 years
Expand descriptionThe research project will involve a non-randomised trial of Daily Growth, a smartphone parenting app for parents and carers of children aged 2-5 years. The trial aims to: 1. Develop a machine learning algorithm for personalising interventions to determine the type of program most likely to be acceptable and beneficial to a parent in a given moment. 2. Evaluate the real-world effectiveness of a 6-week, in-the-moment and personalised Daily Growth app for parents of children 2-5 years. The research team hypothesises that the final personalised version of the Daily Growth app will be more acceptable and beneficial in improving parent and child emotion regulation and mental health compared to (a) no support, or (b) non-personalised parenting support from a single program.
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A Randomised, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MTS-201 in Healthy Volunteers and MTS-201 and Multiple Ascending Doses of MTS-201 in Combination with Sitagliptin in Obese, Otherwise Healthy Volunteers,
Expand descriptionMTS-201 is being developed by METis Pharmaceuticals for the potential treatment of metabolic diseases such as obesity and type 2 diabetes mellitus. This is a randomised, double-blind, placebo-controlled study conducted in healthy adult volunteers. The study will be conducted in 3 parts: Part A: Single Ascending dose of MTS-201 or placebo Part B: Multiple Ascending dose MTS-201 or placebo Part C: MTS-201 in combination with sitagliptin or placebo (Combination) Decisions about how and when to move between cohorts will be based on reviews of the available blinded safety data and available pharmacokinetic (PK) data: this data will be reviewed by a prespecified Safety Review Committee (SRC).
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Do cannabidiol and diazepam interact? A proof-of-concept clinical trial.
Expand descriptionConcomitant use of the anxiolytic drugs diazepam and cannabidiol (CBD) is expected to increase in the community. However, findings from a recent investigation by Lambert Initiative scientists suggest that CBD, via inhibition of the CYP2C19 and CYP3A4 enzymes, could reduce the rate at which diazepam is metabolised. Higher plasma diazepam concentrations (or concentrations that remain elevated for an extended period of time) have the potential to increase the risk of unwanted side effects and to exacerbate or prolong diazepam-induced sedation and impairment. This could have significant implications for individuals performing safety sensitive tasks such as driving. Thus, the overall objective of this study is to determine whether CBD alters the pharmacokinetics and pharmacodynamics of diazepam. Participants will complete two 7-day treatment periods: one involving the administration of a placebo, and the other, CBD (600 mg per day). Individuals will receive a single dose of diazepam (10 mg) along with their existing treatment at a test session on the morning of Day 7. Blood will be drawn, and simulated driving and cognitive performance measured, at regular intervals over the following 24 hours. We hypothesise that CBD will: (1) increase diazepam exposure; that is, the area under the plasma diazepam concentration–time curve; and (2) exacerbate diazepam-induced sedation and impairment.
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Investigating Acceptability and Usage of Voice Banking for People Living with Motor Neurone Disease (MND)
Expand descriptionPrevious studies with plwMND indicate that using a banked voice on a device has benefits in maintaining identity and preserving social networks (Cave & Bloch, 2021). However, in a recent study, 26% of plwMND who had banked their voices were not satisfied with their output voice (unpublished; Krikheli & Jackson, 2023). This novel study aims to investigate the factors relating to: - the acceptability of undertaking the voice banking process at disease onset, and - downloading and using banked voice output on speech generating devices This project will contribute to our understanding of how clinicians and voice banking services can improve acceptability of voice banking technology for plwMND and their carers, leading to more informed informational counselling approaches, improved therapeutic interventions and increased uptake.
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Type 2 diabetes and metabolic syndrome remission program, a co-designed pilot with Aboriginal people living on Ngarrindjeri Country – ‘Nra:gi Ya:yun’ (healthy foods)
Expand descriptionThis project is an Aboriginal led, non-randomised pilot to evaluate a co-designed initiative entitled 'Nra:gi Ya:yun' (NY), developed during the formative phase of the wider Coorong Diabetes Collaborative (CDC) study. NY is a healthy eating initiative with the objective of reducing the prevalence of type 2 diabetes and metabolic syndrome in Aboriginal people living on Ngarrindjeri Country. The aims of this pilot study are two-fold. Firstly, to assess the feasibility of the Nra:gi Ya:yun initiative with Aboriginal people living on Ngarrindjeri Ruwe, to inform the implementation of a large-scale trial. Secondly, to determine the preliminary effects of the initiative on participant metabolic health. Adopting a stepped-wedge study design, consenting participants will be assigned to a cluster (group) as NY is rolled incrementally across two sites.
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Determining whether access to a co-designed website and an online self-management facilitation session improves self-efficacy in survivors of stroke
Expand descriptionWe have co-designed a website to help improve self-efficacy (feeling of confidence in your abilities) after stroke. Survivors of stroke will be invited to take part in one online "take Charge" session (60 minutes) to discuss what matters most to them, After this session, they will have access to the co-designed website for 4 weeks. We will measure self-efficacy, health-related quality of life and participation before and after the 4 weeks. We would like to test the Take Charge session and access to the website on different groups of survivors to see who the solution looks likely to help. This will guide future research.
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Feasibility of a tailored weekly meal box delivery service addressing quality of life and nutritional intake for people with Acquired Brain Injury in Western Australia
Expand descriptionNutritional challenges due to motor, cognitive and behavioural issues can occur after an Acquired Brain Injury, leading to poor nutritional intake and reduced quality of life (QoL). We aim to evaluate a co-designed meal-box solution for improving nutrition and QoL in ABI. Fifteen ABI families will receive the meal-box comprising recipes and ingredients for five meals. Feasibility, acceptability, QoL and nutritional intake will be assessed pre and post, using qualitative and quantitative measures. Positive results could lead to rapid implementation within the ABI community through our industry partner, with potential to extend the novel approach to other neurological conditions, thereby addressing a critical need.
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Ambulatory fetal movement monitoring device - Fetal Kicks
Expand descriptionThis trial will evaluate a novel device, namely the Fetal Kicks device, for the detection of fetal movement in the third trimester of pregnancy. The study participants will be healthy women with uncomplicated pregnancies. The primary aim of the study is to determine that the Fetal Kicks Device is able to detect fetal movements and differentiate fetal movement from maternal activities. The secondary aim is to determine that the Fetal Kicks device is able to perform over an extended period of up to 12 hours.