ANZCTR search results

The objective of the study is to evaluate the performance of the MyCellHealth (MCH) Test Kit in detecting abnormal cell metabolism in urine samples from known cancer patients, compared to samples from non-cancer patients. Who is it for? You may be eligible for this study if you are a male or female aged between 40 to 80 years old, attending one of the specialist clinics involved in this study. You will be recruited into cohort one if you are otherwise healthy and not known to have malignancy or following appropriate testing to have benign disease as adjudicated by the participant’s doctor. You will be recruited into cohort 2 if you have any known malignancy determined by the participant’s study doctor by way of routine diagnosis including, but not limited to physical examination, biopsy, pathology and/or imaging. Eligible participants were provided a urine collection pot with a label detailing their unique study ID at the end of their clinic visit to provide a sample of first void urine. Women of childbearing potential were asked to complete a urine pregnancy test and if positive, were deemed a screen fail and exited from the study. Participants were encouraged to provide a first void, midstream sample of 40 to 50ml of urine into the pot the following morning. After the participant had collected a sample of their urine, a pathology courier collected the sample on the same day to take to the lab for testing. The Core Lab analysed the results using the MCH Test Kit according to the Instructions for use, using the Pantone colour chart provided. A positive or negative result was recorded in the Electronic Data Caption system. It is hoped that findings from this study will help detect potential cancer early and improve cancer outcomes.

When your knee gets a tear in the meniscus (a part of your knee), it can really hurt and make it hard to do things you enjoy or even work. At Bendigo Health, people with these knee problems often have to wait a long time to see a doctor. This can be up to 5 years. Recent studies and guidelines suggest that surgery is not the only option for most cases of knee meniscus pain. Experts say that one of the best things for knee meniscus pain is learning about your condition, doing specific exercises, and getting advice on changing your lifestyle. At the moment, patients don't always get this kind of help. So, we're trying something new. We want to see if an online program that teaches you about your knee and gives you exercises can help. We're checking if this can make your knee hurt less, make it easier to move around, and make your life better.

K-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).

Hypoglycaemia (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.

The 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.

MTS-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).

Concomitant 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.

Previous 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.

This 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 project's primary aim is to assess the impact of the NY initiative on enhancing metabolic health outcomes and promoting dietary compliance. The secondary aim is to assess the feasibility of NY with the intent to upscale it for wider uptake. Adopting a stepped-wedge study design, consenting participants will be assigned to a cluster (group) as NY is rolled incrementally across two sites.

We 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.