ANZCTR search results

This project addresses a significant unmet need: recovery of arm and hand function in people with tetraplegia (loss of use of the arms and legs). This issue is ranked by survivors as being of the highest importance, more important than the ability to walk. A novel non-invasive method of spinal cord stimulation (transcutaneous spinal cord neuromodulation – TESCoN) will be trialled for the first time in Australia, and in both subacute and chronic tetraplegia. Electrodes on the skin at the back of the neck will deliver a unique form of stimulation to the spinal cord without causing discomfort. This will modulate (alter the activity of) spared but non-functional pathways as well as the spinal circuitry below the injury level. When combined with intensive rehabilitation of the arm and hand, TESCoN leads to altered connections within the spinal cord, resulting in improved function. TESCoN enhances the effect of intensive rehabilitation and is not a replacement for it. This study will be an open-label trial using an adaptive design, with a combined efficacy and safety endpoint and clear rules for stopping the trial if the intervention is shown to be ineffective and/or unsafe. TESCoN is expected to lead to improvements in function that are superior to those obtained with current best practice rehabilitation. Such recovery of function may have a substantial impact on independence, potential for employment, and quality of life.

The current study will investigate the potential of a novel treatment approach to AVH in young people with first episode psychosis. This integrative model combines advances in psychological therapy (CBT for psychosis), new technologies (Virtual Reality) and neuroscience (neurofeedback) in an individualised symptom capture treatment approach. The appellation ‘Hybrid’ is used to reflect this integrated approach of treatment. The focus is on the first episode of psychosis rather than on relapsing or chronic samples, as enhancing treatment in the early stages of disorder has been found to have the greatest impact on clinical outcomes. The targets of interest here are both neural (modulating specific neurophysiological activity, see below) and psychological (moving up a symptom-eliciting exposure hierarchy).

Post-acute sequelae of SARS-CoV-2 infection (PASC) or Long COVID is a chronic condition that causes an array of symptoms, affecting multiple body systems. Although Long COVID may affect up to 10% of those who are infection with SARS-CoV-2, there is still poor understanding of disease pathology. Cohort studies of Long COVID patients have observed dysbiosis of the gut microbiota in these patients when compared to healthy subjects. Long COVID patients have reduced abundance of short-chain fatty acid (SCFA) producing bacteria, particularly butyrate producing species that are important for maintenance of gut homeostasis. However, it remains unclear if the reduction in butyrate-producing species may contribute to underlying disease in Long COVID. Increasing butyrate and SCFA concentrations has been observed to have anti-inflammatory effects in other immune-mediated models of disease, and have been proposed as a potential therapeutic to treat Long COVID. It remains unknown if increasing SCFA delivery has any therapeutic benefit in Long COVID. Our study team has extensive experience with supplementing fermentable fiber into the diet to increase SCFA concentrations in people. Therefore, we aim to investigate if fermentable fiber supplementation has therapeutic benefit in Long COVID patients. This will be via a dietary intervention study, to assess if fermentable fiber supplementation improves symptoms of Long COVID.

This study is evaluating the implementation and psychological impacts of an evidence-based booklet designed to assist clinicians with delivering information to individuals diagnosed with HPV-OSCC. Who is it for? You may be eligible for this study if you are a patient with a diagnosis of HPV-OSCC, or the family/friend carer of an individual diagnosed with HPV-OSCC. Healthcare professionals who are involved in a multidisciplinary Head and Neck Cancer team and are overseeing the care of patients diagnosed with HPV-OSCC will also be recruited for this study. Study details Clinicians will supply the booklet to patients in hardcopy and/or digital form, depending on the patient's preference. The booklet will be provided at or shortly after diagnosis, and prior to treatment commencement. This is an exploratory study to understand how clinicians integrate the booklet into their clinical practice, and patients and clinicians will be asked to complete questionnaires and interviews evaluating their experiences. Findings from this study will help researchers understand the effectiveness and implementation outcomes of a patient education material in the context of newly diagnosed HPV-OSCC patients.

In this randomised, double-blind, placebo-controlled study, 90 adults aged 40 to 80 years with self-reported memory problems will be randomly assigned to receive tocotrienols (TheraPrimE rice) or a placebo for 12 weeks. Changes in cognitive performance will be assessed at baseline and week 12 by administering the Test of Memory and Learning (TOMAL-2) and Behavior Rating Inventory of Executive Function–Adult Version (BRIEF-A). Moreover, a self-report questionnaire assessing sleep quality will be administered monthly to assess changes in sleep quality. Changes in blood concentrations of several markers associated with inflammation, neuroplasticity, oxidative stress/ antioxidant activity, and blood lipids will also be measured to help identify the mechanisms of action associated with tocotrienol supplementation.

This is a feasibility and acceptability study of a parent-coaching group, Bloom, which has been co-designed and co-produced between researchers and community organisations. The study aims to recruit parents of 80 autistic children aged 3-8 years through community organisations and social media networks. The primary outcomes will look at how acceptable the group is to parents, and how feasible it is to run a bigger definitive trial of this group in the future.

The prevalence of cancer diagnosis is high and attributable to 30% of all deaths in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness. This pilot intervention study aims to assess the treatment effect and safety of Light-bed-PDT for patients with cancer using Circulating Tumour Cell (CTC) analyses. Who is it for? You may be eligible for this study, if you have been diagnosed with cancer. Study details Cancer patients will undergo 1x session of Light-bed Photodynamic Therapy (LBT) directly after Hyperbaric Oxygen Therapy (HBOT) Step 1 (Day 1 afternoon). Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light 15-20 hours before step 3 Step 2 (Day 2 morning): 1x 60 min of Hyperbaric Oxygen Therapy (at 2 atmospheric pressure), immediately before Step 3. LED Light-Bed whole body therapy, which involves lying in a red-light-bed for 30 min. A blood test measuring the number of Circulating Tumour Cells (CTC) before and after treatment at 1 week and at 3 months will assess treatment effectiveness. Tolerability and safety will be assessed after each treatment session. This study will provide further insight into the safety and efficacy of Lightbed Photodynamic Therapy (LBT) after Hyperbaric Oxygen Therapy (HBOT) in cancer patients.

This study is investigating the activity of an immunotherapy checkpoint called PD-L1 and the activity of the immune T-cells (CD8 T-cells) that kill cancer cells. In this study, we will test proven and new types of cancer imaging, also called scans. We will test if these scans show us new information about non-small cell lung cancer (NSCLC). We will also test if the information shown on the scan matches information shown by pathology. Who is it for? For this study, we need participants aged 18 and over, who have non-small cell lung cancer (NSCLC) who are going to receive radiotherapy treatment. You must have acceptable kidney function and agree to come in for the study follow up assessments. Female participants must either be post-menopausal or have a negative pregnancy test. Study details All participants will be asked to undergo a Positron Emission Tomography (PET)/Computed Tomography (CT) with fluoro-deoxyglucose (FDG), which is a standard scan used to detect lung cancer. PET/CT scanning is achieved by injecting a small amount of radioactive material (called a tracer) into your bloodstream followed by imaging your body by passing you through a PET/CT scanner whilst you lie on your back. This study is using 2 PET tracers: 89Zr-Df-crefmirlimab (CD8 PET), which shows us where the T-cells are in your body and 89Zr-durvalumab, which is made with an immunotherapy drug that targets the protein PD-L1. PD-L1 is a protein that keeps immune cells from attacking non-harmful cells in the body. We think that some cancer cells have high amounts of PD-L1 at the beginning of immunotherapy treatment, but that this may change during treatment, allowing the cancer cells to grow. Alternatively, the cancer cells may remain sensitive to durvalumab, but the tumours do not have enough CD8 T-cells to kill the cancer cells.

We aim to assess the feasibility and acceptability of the BT80 recruitment strategy, intervention (including intervention fidelity), and accompanying outcome evaluation. In addition, we aim to explore how BT80 could be optimised through a mixed methods process evaluation. BT80 will be a 8-week single-arm feasibility study aiming to recruit 20 families from South-Western Sydney. The findings will provide insight into the feasibility and acceptability of BT80, which will be used to inform a future randomised controlled pilot trial.

This study is determining whether a testosterone cream is a feasible treatment for the management of fatigue in patients with advanced cancer. Who is it for? You may be eligible for this study if you are an adult male or female with advanced cancer, solid organ or haematopoietic malignancy. Fatigue questionnaires will also be used to evaluate suitability for this study. Study details Participants will be randomly assigned to apply either testosterone or placebo cream topically daily for 4 weeks. There will also be an optional extension period where all participants will be given testosterone cream for a further 4 weeks. Treatment completion will be analysed, and participants will be asked to provide blood samples and complete questionnaires on their fatigue and quality of life. It is hoped that findings from this study will help inform researchers of the feasibility of conducting a larger study examining the impact of this testosterone treatment for advanced cancer patients.