ANZCTR search results

A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). A clinical trial to test a new drug, NVG-2089, in patients with CIDP

This project aims to identify the prevalence of POTS in patients who attend the emergency department with symptoms consistent with this condition, using a novel diagnostic pathway. A validated patient reported survey will be used to predict the likelihood of POTS in patients whose symptoms are consistent with POTS based on their hospital presentation. Participants who progress to the next stage of the study will complete objective autonomic testing to quantify the presence of POTS. As there is limited prevalence data on POTS available, and given that testing for POTS in a general symptomatic population has not been tested before, we have elected not to hypothesize a prevalence in this population.

This study aims to compare two ways of performing skin biopsies, using a full sterile dressing pack versus a simplified method without it, to determine whether the simpler approach is just as safe and effective. Skin punch and shave biopsies are minor procedures used to diagnose skin conditions, including skin cancer. The current standard uses a sterile pack, which generates more waste and cost. However, clinician experience suggests that for small 2mm biopsies, using fewer materials may still lead to excellent patient outcomes. This research will test whether avoiding the sterile pack increases the risk of infection. The study’s hypothesis is that performing 2-4 mm skin biopsies without a sterile dressing pack is just as safe as doing them with full sterile materials. If proven, this could reduce healthcare waste, lower costs, and support environmentally sustainable practices, without compromising patient care.

Non-invasive brain stimulation offers new hope to individuals suffering from depression who do not respond to standard therapy. Recent work demonstrates brain stimulation clinical outcomes might be substantially improved by adjusting the exact position, at which brain stimulation is applied, to directly modulate a brain circuit involved in depression. We aim to test this in a large clinical trial comparing this new targeted brain stimulation approach with a conventional brain stimulation therapy.

We hypothesise that an Allied Health Assistant supporting people who have a mild to moderate diagnosis of dementia to complete six sessions of a personalised, goal-directed intervention will result in them maintaining or improving their overall wellbeing, improve their quality of life and have an impact on their likelihood to have falls, require hospitalisation or enter residential aged care. SPICE at Home draws on elements of a multicomponent, multidisciplinary personalised and goal-directed intervention, SPICE, which has demonstrated promising results in improving and maintaining wellbeing in people with mild to moderate dementia when delivered in a group setting. The SPICE at Home intervention will be a pilot trial to test the feasibility and effectiveness of a fully powered trial. We will explore the perceived benefits of the intervention through both quantitative and qualitative data collection and analysis of participants who received the intervention.

This randomised feasibility trial aims to assess the potential and feasibility of an individualised 12-week exercise program supervised by an Accredited Exercise Physiologist, embedded within an existing healthcare service.

This study will investigate the feasibility of a High Fibre Dietary Intervention in patients with Melanoma receiving Neoadjuvant Immune Checkpoint Inhibitors Who is it for? You may be eligible to join this study if you are aged 18 years or above with a histologically or cytologically confirmed diagnosis of Stage III or IV melanoma, naïve to immune checkpoint therapy and planned for neoadjuvant pembrolizumab. Study details All participants in this study will receive a dietician-led dietary counselling intervention over 9 weeks to escalate daily fibre intake to >30g per day. The intervention will be undertaken face to face or via telehealth and will involve provision of resources including recipes and meal plans, fibre-counting tables, and individualised advice. Adherence will be assessed via 3-day food records while safety and tolerance to the dietary intervention will be assessed via questionnaires. This intervention will help establish whether a dietician-led counselling intervention can successfully help escalate fibre intake in an area where a high-fibre diet may be important in improving responses to immune checkpoint therapy.

Artificial Intelligence (AI) has grown in popularity over the last few years, being used by more people for more purposes. The characteristics and communication styles of generative AI systems (like ChatGPT) impact user perceptions and interactions with the systems. In fact, some evidence suggests that we evaluate our interactions with AI systems in a similar way to our human-to-human interactions (e.g. their warmth/friendliness and competence/intelligence). As general acceptance of generative AI systems is low in the general population, we are seeking how to create trustworthy generative AI systems that might be used by health consumers for easily accessible health information. This is important as AI tools become more advanced, with greater ability to provide accurate information from curated sources. We believe that elevated perceived competence and high warmth in the agents conversational style will elevate the trust and intention to use the agent in participants.

This is a first in human, prospective, multicentre, single arm feasibility study of the B3 gel. Tendons connect muscles to bones, helping transmit forces needed for body movement. In the hand, flexor tendons help fingers bend, and extensor tendons help fingers to straighten. Scar tissue forming around tendons can cause pain/discomfort and difficulty with movement. The B3 Gel acts like a casing for hand tendons after tenolysis surgery (done to free up tendons in the hand). The gel will be applied between hand tendons and other tissues. After standard surgery to separate tendons from scar tissue, B3 Gel will be applied along the tendons. The gel will be applied using an applicator, which mixes proteins and a salt solution to create the gel and then applies it precisely. In this study, participants will have tenolysis surgery as per standard practice and will have the B3 Gel applied as part of this procedure. After the procedure, participants will be followed for up to 169 days.

There is an ongoing shortage of suitable organs for transplantation, and as a result we are using more marginal/suboptimal donor kidneys, which tend to have inferior short and longer term outcomes. Technologies exist that can potentially improve the outcomes of such kidneys by reducing the injury that occurs to these kidneys during transportation/storage prior to transplantation. One such technology is oxygenated hypothermic machine perfusion (HMP). This technology is very commonly utilised overseas, and is also currently being used in Australia (in Brisbane and Melbourne). However, the evidence for HMP efficacy in Australasia is currently lacking, and overseas results are not necessarily translatable given we tend to have shorter preservation times in Australia compared to overseas. We aim to investigate the impacts of this technology in our local setting, comparing short duration of HMP to a more prolonged duration of HMP in kidney transplantation. We will initially perform a pilot study with 20 patients, but hope to expand this into a larger scale clinical trial at the conclusion of the current study.