ANZCTR search results

Prosthetic joint infection (PJI) is a catastrophic complication of orthopaedic joint replacement surgery that is increasing in incidence despite current best-practice. The success rate of treating Prosthetic Joint Infections (PJI) ranges from 0 to 89%, and the median cost per patient in Australia is $34,800, with a 156% increase in treatment cost when the treatment fails. Emerging evidence suggests that Gut dysbiosis i.e altered gut microflora is associated with absence or reduced abundance of beneficial microorganisms, increased abundance of pathogens and could predispose patients to a higher risk of PJI post orthopaedic procedures. Supplementaion with suitable prebiotics (non-digestable carbohydrates) results in production of short chain fatty acids that alters gut microbiome favourable. Hence, in this study, we will be investigating the effect of modifying gut microbiome with an in-market prebiotic supplement on surgical outcomes and recovery in PJI patients.

Currently, specialised early interventions are not accessible for a majority of youth with Bipolar Disorder (BD) who seek care. To address this gap, we have developed a bipolar-specific model of care for those with early-stage BD (BLEND) integrating: (i) evidence-based psychological strategies delivered through digital and face-to-face sessions; (ii) psychopharmacological interventions; (iii) relapse prevention strategies, and (iv) online peer support networking. We will conduct a randomised trial to evaluate the effectiviness of BLEND, compared with an enhanced form of standard care (ESC). We will include young people aged between 15 and 25 years, seeking specialised help for Bipolar Disorder types I or II. After informed consent, we will randomise 125 such young people (1:1) to BLEND or ESC. Interventions will be delivered over 4 months and assessments will be conducted at Baseline, 2, 4, 6 and 8 months from Baseline.

People with severe asthma experience high symptom burden and frequent severe asthma attacks (termed exacerbations). In the last decade new biologic (antibody) treatments, including mepolizumab, have become available for severe asthma. Clinicians now recognise that mepolizumab treatment results in almost complete suppression of symptoms and exacerbations, termed remission, in around a quarter of patients. Remission of severe asthma is a relatively new concept, and further understanding of numerous aspects of remission is now required to promote remission as a clinical target and to further raise remission rates on treatment. To address this, in this study we aim to understand the clinical, immunological, economic and health literacy characteristics of long-term remission of severe asthma treated with mepolizumab.

This study aims to continue the pursuit of therapy approaches that view the client holistically, and do not just focus on their overt stuttering. ImpACT Therapy uses group improv to support clients to positively participate and continuously engage in the activities and social situations that are important to them. Focusing on increasing the awareness of one’s own communication abilities in a risk-free supported environment guided by experts in the field of stuttering has the potential to improve long term outcomes for participants. Currently, relapse following treatment is estimated to occur in 30% to 60% of stuttering clients. This research will contribute to identifying specific factors that lead to favourable and less favourable outcomes among this group.

This is a multisite, pragmatic cluster randomised trial. We will compare the (1) Ageing Well Tool that incorporates a personalised report (provided to GPs and patients) that outlines the presence/absence of personalised risk factors coupled with clinical treatment recommendations and management plans, to (2) a treatment-as-usual with a self-help control condition. N = 384 patients (n = 192 for each condition) will be enrolled in the study. We expect the The Ageing Well Tool will result in significantly greater reductions in the number of risk factors present from baseline to 12-month screening compared to the control condition. The Ageing Well Tool will also result in increased healthcare costs and improved health outcomes based on activities undertaken by participants to change dementia risk factors, significantly reduced cognitive decline on neuropsychological measures, and older adult and GP satisfaction with the Ageing Well Tool treatment condition will be high with few significant barriers, at 12-month measurement.

Patients who are admitted to the Intensive Care Unit (ICU) are at high risk of developing delirium, a form of acute brain failure which can manifest with agitation and confusion, and/or withdrawal from interaction. When delirium occurs, the overall prognosis for the hospital stay is adversely affected, and there is a risk of future cognitive decline and dementia. There is no gold standard treatment for delirium. Its presentation in people admitted to the Intensive Care Unit (ICU) is complex and it complicates treatment of other conditions requiring ICU admission. ICU patients with acute delirium can be a danger to themselves and others. Presence of delirium confers an adverse prognosis for ICU patients, and management of delirium when it occurs is largely supportive. There is an urgent need for the exploration of new treatment modalities to manage acute delirium in critically ill patients. This exploratory study assesses the application of a helmet (twice daily from Monday to Friday, for up to 4 weeks) that delivers pulses of near-infrared light to the brain in patients admitted to the Mater Adult Intensive Care Service who are diagnosed with acute delirium. Four slightly different protocols (with variations of application parameters) will be used. Patients enrolled in the study will have assessment of brainwaves using Quantitative Electroencephalography (QEEG) before and after treatment. Other behavioural and physiological observations that are routinely collected and recorded in the medical record in ICU patients will also be assessed.

The Longitudinal Head Injury Outcome Project is a long-standing research project investigating the functional, cognitive, behavioural and physical and emotional outcomes of patients who have sustained a TBI from the time of injury up to 30 years after their injury. This study aims to provide comprehensive information regarding the difficulties experienced by these individuals and their families over long periods of time after injury. This information can be used to establish the needs of individuals with TBI, identify predictors of outcome, develop rehabilitation programs to improve outcome, inform TAC policy and provide ongoing service to TBI patients.

This project aims to gain insight into the effect of a digital physical activity intervention (tailored walking program and physical activity coaching) and an online psychological program (Pain Course) in people 50 years and over living with chronic low back pain (CLBP). Does a tailored walking intervention combined with an online psychological program improve physical activity levels measured by daily walk time in people 50 years and older with chronic low back pain (CLBP)? We hypothesise that our intervention will lead to an increase in physical activity levels (daily walk time) over 6-months. This project is a two-arm, single-blinded, interventional, randomised control trial with a 14-week intervention period and a 6-month follow up.

The purpose of this study is to assess the safety, tolerability (how well an individual can tolerate a drug), pharmacokinetics (how a drug moves into, through and out of the body) and pharmacodynamics (the effect of a drug on the body) of single and multiple ascending doses of PLX-4545 in healthy volunteers. PLX-4545 may be indicated for use in patients with cancer that present as solid tumours, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details This trial will be conducted across three parts. In the first study (Part 1), healthy volunteer participants will be assigned by chance to receive either a single dose of PLX-4545 or placebo, to be taken after a fasting period. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of PLX-4545 or placebo, followed by blood testing. This will continue until a maximum safe dose is determined. In the second study (Part 2), healthy volunteer participants will be assigned by chance to receive either multiple doses of PLX-4545 or placebo to be taken once per day for 14 days. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger daily dose of PLX-4545 or placebo for 14 days, followed by blood testing. This will continue until a maximum safe dose is determined. In the third study (Part 3), healthy volunteer participants will be assigned by chance to receive either a single dose of PLX-4545 after fasting conditions or immediately after a high fat meal. All participants will have their vital signs checked and will provide blood samples for testing to determine the effect of food on PLX-4545. Once participants have completed their first dose, they will be asked to take another dose either after fasting or a meal, whichever they did not do for the first dose round. It is hoped this research will determine the maximum dose of PLX-4545 that can be administered safely without causing severe reactions. The healthy volunteer study will help define the starting doses of PLX-4545 to be evaluated in a subsequent Phase 1 clinical trial in cancer patients for determining the recommended dose to support a Phase 2 clinical study.

Major depressive disorder (MDD) is a severe and common illness. It has been well established that approximately 30% of patients with MDD have an inadequate response to standard medication and psychological therapies. These patients remain disabled for long time as treatment options are limited. Current brain stimulation treatment options for MDD are costly and can be inconvenient as they may require daily trips to clinics for long treatment sessions that happen over the course of 6 weeks or more. Additionally, we are technically constrained in what we can achieve and current technologies and approach to treat MDD have generally used a ‘one size fits all’ method. Transcranial alternating current stimulation (tACS) is a novel, non-invasive brain stimulation method that delivers a weak electrical current to the brain and is able to modulate brain oscillatory activity. tACS has potential to change the lives of patients with MDD by specifically targeting brain circuits and oscillations relevant to MDD. Our approach aims to change the ‘one size fits all’ method by conducting a proof-of-concept study demonstrating the feasibility, clinical and electrophysiological impact of closed-loop theta tACS. The study will specifically aim to confirm whether theta oscillations and mood in patients with MDD can be successfully modulated by tACS. We hypothesize that a series of personalized theta tACS sessions applied to the dorsolateral prefrontal cortex (DLPFC) in patients with depression can modulate the following to a greater degree in participants who are receiving active treatment compared to sham stimulation: 1. Modulate theta activity at rest and during cognitive tasks (measured using EEG) on and emotional Stroop task and a working memory task 2. Modulate behavioral performance on both the emotional Stroop and working memory tasks. 3. Modulate depression symptoms (clinician rated and self-reported).