ANZCTR search results

This study aims to determine the safety and feasibility of a combination of ketamine and cognitive behavioural therapy (ketamine-assisted therapy) for people with methamphetamine use disorder in an outpatient drug and alcohol treatment setting. There are currently no approved medications in Australia to help people manage, reduce, or stop their methamphetamine use; and psychotherapy is moderately effective. It is hoped that this study will help find out if ketamine-assisted psychotherapy (four sessions of cognitive behavioural therapy with three doses of ketamine, over a four-week period) is a safe and feasible treatment approach for methamphetamine use disorder.

The Commonwealth of Australia (Department of Health and Aged Care) published updated Guiding Principles for Medication Management in Residential Aged Care Facilities (Guiding Principles) that set out recommendations for medication management to support aged care provider organisations, residential aged care facilities (RACFs) and aged care staff to improve medication safety. The intervention will involve a multifaceted implementation strategy including knowledge brokers, supported by a national quality improvement collaborative called the MEGA-MAC collaborative. The knowledge brokers will work in pairs at each RACF to form a ‘knowledge broker dyad’. The knowledge broker dyad (a pharmacist and a Medication Advisory Committee [MAC] chair/member) will develop, evaluate and monitor quality improvement strategies to implement the Guiding Principles into practice at their RACF. The MEGA-MAC collaborative will support the knowledge broker dyads to deliver the intervention. It is hypothesised that knowledge broker dyads supported by the MEGA-MAC collaborative will lead to improvements in Guiding Principles concordance in RACFs post-intervention compared to pre-intervention.

In 2014, Australia declared intimate partner violence (IPV) a national emergency reported to affect one in six women. Unfortunately, the prevalence, severity, and frequency of IPV have been exacerbated since the outbreak of COVID-19, with more recent estimates of IPV reported to affect up to 1 in 4 Australian women and is the leading cause of preventable death, disability, and illness among women aged 15-44. Of the many challenges faced by IPV survivors, post-traumatic stress disorder (PTSD) is notable, with an estimated prevalence of up to almost 64% of survivors, irrespective of the type of IPV experienced. Also, 60-92% of women facing physical IPV experience facial/head injuries, including mild traumatic brain injury or non-fatal strangulation events, which can lead to persistent post-concussion symptoms (PPCS). The primary aim of this study is to determine whether aerobic exercise intervention can improve outcomes in IPV survivors with post-traumatic stress disorder (PTSD). Secondary to this is whether this intervention is effective in women who have experienced intimate partner violence brain injury (IPV-BI) experiencing persistent post-concussion symptoms (PPCS). In addition, we hope to identify objective markers in the blood to supplement our knowledge of improvement. Exercise intervention holds promise as a readily available, easy-to-apply, non-pharmacological treatment for PTSD and PPCS and offers a highly accessible option for healthcare providers. This project hopes to address the urgent need for an effective intervention in this underserved population.

In 2014, Australia declared intimate partner violence (IPV) a national emergency reported to affect one in six women. Unfortunately, the prevalence, severity, and frequency of IPV have been exacerbated since the outbreak of COVID-19, with more recent estimates of IPV reported to affect up to 1 in 4 Australian women and is the leading cause of preventable death, disability, and illness among women aged 15-44. Shockingly, 60-92% of women facing physical IPV experience facial/head injuries, including mild traumatic brain injury or non-fatal strangulation events, which can lead to persistent post-concussion symptoms (PPCS). The primary aim of this study is to determine whether aerobic exercise intervention can improve outcomes in IPV survivors with persistent post-concussion symptoms (PPCS). In addition, we hope to identify objective markers in the blood to supplement our knowledge of improvement. Exercise intervention holds promise as a readily available, easy-to-apply, non-pharmacological treatment for PPCS and offers a highly accessible option for healthcare providers. This project hopes to address the urgent need for an effective intervention in this underserved population.

This is a double-blind, placebo-controlled study to assess the safety of TRX-100 and how this drug acts in the body in healthy volunteers. TRX-100 may be indicated for use in patients with influenza, but a trial of the drug in healthy volunteers is needed before trials in influenza patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 64 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive a single dose of TRX-100 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of TRX-100 that can be administered safely without causing severe reactions. Once the dose of TRX-100 has been determined in healthy volunteers, a trial investigating the efficacy of TRX-100 as a treatment for patients with TRX-100 may proceed.

Contraint Induced Movement Therapy (CIMT) is an evidence-based therapy that improves the functioning of the more-affected hand in children with unilateral cerebral palsy (CP), also known as hemiplegia. Children with hemiplegia also have difficulty with gross motor skills as the movement of the leg on the same side of the body as the more-affected hand is also impacted by the brain injury. We have developed a therapy called CIMT-Leg, based on the principles of CIMT, that aims to improve the functioning of the more-affected leg. This could improve the child's ability to walk, move, climb, play, and participate in things that are important to them such as sports. CIMT-Leg is delivered by trained physiotherapists. We will test the feasibility of 6 weeks of CIMT-Leg treatment, including how safe it is and how much it works to improve gross motor and mobility function in children with unilateral CP between 4-8 years of age.

Brain waves (also known as neural oscillations) in the brain’s default mode network (DMN) and visual cortex (VC) appear to be functionally and clinically relevant targets for the treatment of post-traumatic stress disorder (PTSD). Novel non-invasive brain stimulation techniques can directly target neural oscillations, potentially providing a safe and effective means to treat this complex disorder. Using transcranial alternating current stimulation (tACS), this research project will directly investigate for the first time whether stimulating alpha oscillations (8-12 Hz) to treat pathophysiological DMN activity results in improved clinical outcomes in patients with PTSD. This essential research is a crucial first step in demonstrating the potential of tACS as a novel therapeutic treatment option for those with PTSD. The aim of the proposed research is to conduct an exploratory study demonstrating the behavioural and electrophysiological impact of personalised tACS in participants with PTSD. Specifically, we will aim to confirm whether we can successfully use personalised tACS to enhance alpha oscillations in the prefrontal cortex and visual cortex to reduce clinical symptoms in participants with PTSD.

The BEYOND Study is a multi-centre, open-label pilot study that utilises a participant-centric clinical trial protocol for epilepsy. It aims to assess the effectiveness, safety, and tolerability of Epidyolex as an adjunctive therapy for beyond seizure outcomes in individuals aged 2 to 65 years with DEE. The study will enrol 20 participants from metropolitan and regional areas in New South Wales, including rural and remote locations. The acceptability of this model will help guide health economists and medical affairs teams in collecting cost-effective data that can be used to optimise Pharmaceutical Benefits Advisory Committee (PBAC) submissions with regulators.

Type 1 and 2 Diabetes Mellitus is a major cause of severe and irreversible vision loss in children and adolescents globally, with Australia having one of the highest rates of T1DM in the world. The most important cause of vision loss due to diabetes is the development of diabetic retinopathy; nearly 100% of children with Type 1 Diabetes Mellitus will eventually develop the condition. Currently, there are only a limited number of strategies to manage diabetic retinopathy until sight-threatening complications arise and current treatments are costly, associated with discomfort, risk and may not be able to reverse any loss of vision that has already occurred. Previous experimental studies in animals have shown that the earliest stages of diabetic retinopathy involve abnormalities in retinal capillaries and retinal perfusion. Optical Coherence Tomography Angiography (OCTA) is a fast and non-invasive clinical technique that allows high-resolution imaging of retinal capillaries. OCTA provides an imaging technique able to detect the earliest blood vessel changes due to diabetic retinopathy, prior to the occurrence of sight threatening complications. We have developed a novel method to quantify retinal perfusion in human eyes using OCTA and therefore propose a new method for detecting the very earliest changes to retinal capillaries in eyes with diabetic retinopathy. Furthermore, as there is an intricate link between diabetic eye disease and diabetic kidney disease we propose that it may be possible to use OCTA to detect early kidney disease using the same ocular biomarkers. This project will investigate if retinal vessel perfusion abnormalities captured on OCTA are an early and leading factor in the development of diabetic retinopathy that occur prior to structural changes detected using conventional screening techniques such as colour photography. The project will compare children with Type 1 and 2 diabetes with no retinal pathology against healthy controls to see if retinal vessel changes are present in diabetic vs healthy children. These children will also have blood and urine markers of kidney function compared to investigate if retinal vessel changes are associated with renal dysfunction makers. The study will investigate if changes in retinal vessel abnormalities over time are associated with clinical changes in children with Type 1 and 2 diabetes. To collect this data, the project will follow Type 1 and 2 diabetic children and a matched number of healthy children over 5 years at annual visits.

The study was approved via the Low or Negligible Risk review pathway. It is recommended practice when introducing a new model of care or a new element into a model of care, that it be evaluated properly. In this study, we will observe the effect of the new addition to the clinical pathway - a hospital in the home or HITH program. HITH programs have been included as part of management pathways after low-trauma (osteoporotic) hip fracture since the late 1970s in the United Kingdom. HITH programs are a priority for NSW Health, but their uptake appears to be limited by available resources and published documentation of their effect. In trialling a HITH program here, we aim to establish whether such a program is feasible/practical in our patients. We are not testing a hypothesis, but we will specifically monitor program uptake/acceptance by patients/carers and safety. If the program is feasible, it is hoped its continuation (plus or minus any refinements) are supported by the organization.