ANZCTR search results

A major source of sleep disruption in older adults is obstructive sleep apnoea (OSA), a disorder characterised by frequent pauses in breathing due to partial or complete airway closure during sleep. These events result in sleep disturbance and oxygen deprivation, which previous studies have shown to be associated with an increased risk of dementia. Therefore, there is an imperative to establish definitively whether treatment of sleep apnoea can prevent dementia. This multi-site feasibility randomised-controlled trial aims to determine whether it is feasible to deploy a targeted intervention to treat sleep apnoea in participants with subjective memory complaints and determine the magnitude of effect on memory decline. Participants will be randomised to the intervention or control group for 2 years. Participants in the intervention group will receive treatment for their OSA following an algorithm and incorporating key principles of goal setting and behavioural sleep management. Participants in the control group will have their screening results sent to their referring medical practitioner, with recommendations for further investigation. Further, 90 participants will undergo a 25 min MRI at the study center during their standard visit at baseline and 24 months. For the MRI scan, participants will be selected based on participant choice and willingness to participate, as well as, if they pass the MRI safety questionnaire and consent. The primary outcome is the feasibility of the trial. The stop-go criteria to determine feasibility will depend on meeting the acceptability, hypoxic burden, and tolerability criteria. The secondary outcomes listed are primary being collected for the propose of showing feasibility of collection rather than serious intension of showing efficacy.

TDAY is a pilot open-label randomised control study comparing two different forms of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment for Major Depressive Disorder (MDD) in adolescents and young adults. Participants with MDD will be randomised to one of two rTMS treatment groups. In both groups a magnetic coil will be applied to L) side of the scalp, in which the coil generates an electrical impulse to the stimulate the underlying brain tissue, No anaesthetic is required. Group 1 will receive what is considered a standard 10Hz treatment protocol while Group 2 will receive a more novel, intensive intermittent thetaburst (iTBS) treatment protocol. Treatments will be administered Monday - Friday for 4 weeks. All participants will be engaged with their treating doctor for the duration of the trial, and will continue their current treatment regimen (i.e., either maintain a stable dose of antidepressant medication, or continue without antidepressant treatment). The primary outcome measures of safety and tolerability will be assessed continually across the study by monitoring adverse events and dropout rates. The secondary outcome measure (change in depression score) will be assessed at the end of week 2 and week 4, with a further assessment at week 8 to ascertain if any improvements have been maintained, and if some participants have a delayed response to treatment. The study hypothesis is that the acceptability and safety/tolerability of the more novel intensive iTBS treatment protocol (Group 2) will similar or greater than that of the standard rTMS treatment protocol (Group 1).

The primary purpose of this trial is to evaluate whether FDG PET is helpful for clinicians treating men with newly diagnosed aggressive prostate cancer (according to tissue histology) and staged with PSMA PET. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with aggressive prostate cancer (high risk features) and have not had treatment to date, but you may be planning to undergo surgery, radiotherapy or other treatments. Study details: All participants enrolled in this trial will undergo a FDG PET/CT scan. The results of the scan will be made available to your doctors to help them to plan the most suitable treatment course. The accuracy of the PET scans will be determined according to follow-up information available up to 12 months after entering the study. The findings of the scans will be investigated for their ability to predict future cancer outcomes. Patient reported outcomes (PROs) as to how the scans and subsequent treatment affect enrolled participants will also be assessed.

This study aims to determine if increasing nutrient intake of men who are obese can improve sperm function without the need for weight loss. Men who are obese will be allocated to either control (given current South Australian guidelines for health eating) or intervention (prescribed the CSIRO Total Well-being Diet for Men with four Dietician appointments) for a period of 12 weeks. Sperm function will be measured both pre and post intervention.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12515000908437. This substudy will evaluate the activity of pamiparib in participants with acute myloid leukaemia or myelodysplastic syndrome with DNA repair pathway mutation (e.g. BRCA1/2), and/or BRCA mutational signature. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with acute myeloid leukaemia or myelodysplastic syndrome. Your cancer will need to harbour DNA repair pathway mutations (e.g. BRCA1/2), and/or BRCA mutational signature. Study details: Participants will receive pamiparib, to be taken orally at a dose of 60 mg twice daily. Pamiparib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo clinical assessments at 4 weekly intervals from first treatment until end of treatment.. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who have limited treatment options available to them. It is hoped that pamiparib will be well tolerated and will improve outcomes for future patients, however there may be no clear benefit from participation in this study.

Cannabidiol is a phytocannabinoid found naturally in the Cannabis sativa plant. Despite CBD’s long history of use, its medicinal properties have been somewhat anecdotal. There are very few pharmaceutically approved products on market, and these are limited to rare clinical indications (i.e. Epidiolex® for rare childhood epilepsy). Cannabidiol is being developed for a range of medicinal applications. These applications typically require CBD at high purity, which can be extracted and purified from Cannabis sativa, or synthetically manufactured. High purity CBD is a white to pale yellow crystalline solid that is insoluble in water. Consequently, CBD is usually administered in an oil vehicle. The limited aqueous solubility of CBD leads to poor oral bioavailability, which has been reported as between 3-8%. CBD has been selected for clinical development in a formulation containing TPM. It is believed that CBD TPM formulations may have improved bioavailability when compared to CBD alone, which would allow for lower doses administered to patients, or the targeting of therapeutic indications that would ordinarily need CBD doses that are so large as to be prohibitive. The proposed Phase I clinical study will evaluate the PK, safety and tolerability of an oral CBD soft-gel capsule. The PK profile of the capsule will be compared at two separate doses. Results from this study will support further clinical development of the CBD soft-gel product, with a focus on indications that can be treated with low-dose CBD.

We aim to identify complexities in the scale-up, spread and sustainability of convers-ABI-lity, an online conversation skills training program to provide scalable communication training to adults with acquired brain injury (ABI) and familiar communication partners such as family, partners and friends. We therefore seek to identify; 1. Who uses convers-ABI-lity and what are their characteristics? 2. In what geographical locations and healthcare and social contexts is convers-ABI-lity used? 3. Do users complete convers-ABI-lity as intended? Why/not? 4. How usable is the technology for those completing convers-ABI-lity? 5. What barriers, facilitators and workarounds do users experience when completing convers-ABI-lity? 6. How satisfied with convers-ABI-lity are the users? 7. What is the cost of delivering convers-ABI-lity? The direct evaluation of the implementation of convers-ABI-lity by end-users aims to ensure the intervention reaches and meets their needs in a feasible, scalable, sustainable and acceptable manner.

The feasibility pilot trial will recruit and randomly allocate approximately 48 adults with lower back pain to an exercise program with or without breathing cues. The 12 x 1-hour exercise sessions will be weekly for 12 weeks at University of South Australia East Campus. Some individual tailoring (progression/regression) for individual capacity will be undertaken and recorded by the physiotherapist. The intervention and control groups will experience the same standardised floor exercises, length of session, location and class numbers. The aim is to determine if the addition of specific cues to a 12-week exercise program alters participant tolerance and compliance, including dropout rate and satisfaction. The aim is not to establish evidence reliant on sample size, rather determining which measures demonstrate most relevance for future research.

We aim to identify complexities in the scale-up, spread and sustainability of social-ABI-lity, an online social media training course to provide scalable communication training to people with acquired brain injury (ABI). We therefore seek to identify; 1. Who uses social-ABI-lity and what are their characteristics? 2. In what geographical locations and healthcare and social contexts is social-ABI-lity used? 3. Do users complete social-ABI-lity as intended? Why/not? 4. How usable is the technology for those completing social-ABI-lity? 5. What barriers, facilitators and workarounds do users experience when completing social-ABI-lity? 6. How satisfied with social-ABI-lity are the users? 7. What is the cost of delivering social-ABI-lity? The direct evaluation of the implementation of social-ABI-lity by end-users aims to ensure the course reaches and meets their needs in a feasible, scalable, sustainable and acceptable manner.

Twenty percent of adults meet criteria for food addiction, with 70% reporting greater than four symptoms of food addiction. Food ‘addicted’ individuals have significantly lower diet quality, higher intakes of junk foods and higher weight status. The personality characteristic of impulsivity is a common risk factor for substance use and food addiction. There are currently no evidence-based interventions run by clinicians for food addiction. Current treatment options largely stem from online self-help groups such as Food Addicts Anonymous and Overeaters Anonymous which have 10 000+ members, demonstrating the clear need for services and evidence-based programs. Interventions targeting personality risk factors and motivational interviewing for other addictions, such as alcohol use, are effective. This project builds on an existing pilot study utilising a personality-based intervention for the targeted treatment of addictive overeating in individuals with food addiction and is a subgroup study of our parent study ‘Examining the efficacy of a personality-based intervention targeting addictive overeating in Australian adults: a randomised controlled trial’. The current study will determine if the personality-based intervention targeting addictive overeating has an effect on cardio-metabolic profiles and neural reward responses in individuals with food addiction at 3 months follow up. Cardio-metabolic will be assessed via a fasting blood test, and neural reward responses will be assessed via a brain scan through clinical fMRI imaging. Additionally, this subgroup study will determine if individuals with food addiction are different from those without food addiction, in terms of their cardio-metabolic profiles, genetic profiles and structural brain function. It is hypothesised, individuals with food addiction will have improved cardio-metabolic profiles and altered neural reward responses at 3 months post-intervention compared to baseline, and individuals with food addiction will have different cardio-metabolic and genetic profiles (assessed via a fasting blood test), and heightened neural reward responses, compared to individuals without food addiction at baseline. If successful, this project will provide an evidence-based treatment for those individuals with food addiction and addictive overeating behaviours in the community and clinical services.