ANZCTR search results

The aim of this research study is to characterise the acute physiological and exercise-endurance responses to two divergent passive lower-limb heating modalities (hot-water perfused trousers, and infrared leg heating) compared to knee-down water immersion in individuals with HF with reduced ejection fraction (HFrEF). Participants will be asked to visit Griffith University on up to four separate occasions. During the first visit, participants will be familiarised with the study procedures and equipment, and complete the incremental shuttle walk test. In the subsequent three visits (separated by a minimum of 5 days), conducted in a random order, participants will undergo 45 minutes of one of three different lower-limb heating methods: Placing your lower legs, up to knee height, in a circulating warm water bath (42°C); Wearing a pair of trousers through which warm water is circulated; Sitting with your legs positioned within an infrared heating device; and a control condition where no heating is applied. During all experimental sessions, participants heart rate, blood pressure, oxygen saturation, and cardiac output will be continuously monitored. Every 15 mins throughout heating, we will measure the size and blood flow of the the femoral artery using an ultrasound machine. Immediately after each heating session, participants will complete a walking test (the Endurance Shuttle-Walk Test) that measures how long individuals can exercise at a set pace, It is hypothesised that exercise endurance results will vary dependent on the magnitude of femoral artery blood flow increase at end-heating.

This study aims to assess the safety, practicality and participant experience of a non-invasive DermR® Patch for collecting samples from basal cell carcinoma (non-melanoma skin cancers) before surgical removal. Who is it for? This study is for adults aged 18 years and older with a dermatologist-diagnosed Basal Cell Carcinoma (BCC) in a suitable location and of a suitable size for secure patch placement. This small study will involve 10 adults who have been diagnosed by a dermatologist with Basal Cell Carcinoma, are scheduled to have the affected area surgically removed, are willing to undergo Patch sampling before surgical excision and permit research use of genomic data. Study details Before the participants' planned surgery, trained MoleMap staff will apply the non-invasive DermR® Patch to the affected area and to a nearby area of normal-looking skin. Two Patch applications will be performed on the target dermatologist-diagnosed BCC lesion and two Patch applications will be performed on clinically normal skin in the same body area. Samples will be labelled and shipped to a central laboratory for RNA quality assessment and molecular analysis. Participating in this study's procedures will not delay or alter standard clinical care. Participants will also complete a short experience questionnaire immediately after sampling. The application sites will be checked for any skin reactions. Any reactions or other relevant medical problems occurring within 24–72 hours after Patch application will be recorded. Relevant problems first identified or reported at the participant’s next routine clinical appointment will also be recorded. The laboratory findings will be used only to help develop the DermR® Patch and its associated test. The results will not be provided to participants or their doctors and will not be used to diagnose the skin lesion or change the participant’s usual medical care. It is hoped that the findings of this study will help determine whether the DermR® Patch is comfortable and acceptable to participants, whether it causes any skin reactions, and whether the samples can be safely handled and provide enough good-quality material for laboratory testing.

This study evaluated whether topical gentamicin 0.1% improves wound healing in people with epidermolysis bullosa (EB) caused by nonsense variants in the COL7A1 gene. In this randomised, double-blind, vehicle-controlled phase II pilot study, each participant had two similar wounds, with one treated with gentamicin and the other with an identical placebo for approximately 30 days. The primary aim was to determine whether gentamicin increased the proportion of wounds that achieved complete healing within 30 days and reduced the time to closure. Secondary outcomes included wound size, recurrence, infection, and patient-reported symptoms such as pain and itch. Safety was monitored through clinical assessments, laboratory testing, and hearing evaluations.

The purpose of this study is to find out whether Immersion Therapy can help reduce pain and improve everyday activities for people with chronic non-specific low back pain, the study also aims to assess the feasibility and acceptability of the intervention and the study design. Participants will complete a baseline period, receive Immersion Therapy sessions, and then complete follow-up assessments, including measures of pain, disability, physical activity and daily activity throughout. The findings will help determine whether Immersion Therapy and the study procedures are suitable for a larger future study. Lastly, at the end of the program, participants will be asked to share their thoughts, feelings, and experiences about IT sessions.

This study tested whether listening to a guided meditation audio track after hip or knee replacement surgery reduces pain and anxiety during early recovery. Adults undergoing hip or knee replacement were randomly allocated to one of three groups: a 40-minute guided meditation audio track incorporating neural entrainment technology, an identical-sounding placebo audio track without the entrainment technology, or usual care. Participants in the audio groups listened to their track daily for 14 days, beginning the day after surgery where practicable. Pain and anxiety were measured before treatment and after the 14-day intervention period. We hypothesised that participants in the guided meditation group would report greater reductions in pain severity, pain interference, and anxiety than participants receiving the placebo track or usual care.

Muscle wasting is a major driver of ICU acquired weakness, impacting recovery. Critically ill patients have impaired muscle protein synthesis. Therefore, delivering additional protein does not result in increased muscle mass. This study aims to identify the point at which ICU patients regain the ability to utilise dietary protein for muscle protein synthesis, by measuring changes in whole-body protein synthesis rates using amino acid tracer methodology. It is hypothesised that post-prandial whole-body protein synthesis rates will increase over time, indicating patients are less anabolically resistant post-ICU and therefore have a greater capacity to use dietary protein to stimulate protein synthesis.

Aim: We aim to explore the incorporation of the Biomotum Spark ankle exoskeleton into blocks of goal-directed, participation focused therapy e.g. bike-riding, endurance training, engagement with peers at school lunchtime, and gather the insights and perspectives of the delivery mode from all key stakeholders (people with cerebral palsy, their families, their clinicians, and organisation administrators). Research Question 1: What are the benefits and challenges of incorporating robotic mobility technology into a block of goal-directed therapy? Research Question 2: What are the benefits and challenges of implementation of robotic mobility technology within a large disability organisation? Research Question 3: What is the user experience, for all stakeholders, of implementation of robotic mobility technology? ?

Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat severe aortic stenosis. A common problem after TAVI is disruption of the heart’s electrical system, which can cause the heart rate to slow and may require a permanent pacemaker. Irregular heart rhythms, such as atrial fibrillation can also occur and may require blood-thinning medication to reduce the long-term risk of stroke. In this study, all patients undergoing TAVI at two centres in Sydney, Australia will receive extended heart rhythm monitoring for 28 days before their procedure. After TAVI, they will be randomly assigned to either standard care, with no routine rhythm monitoring after discharge, or a further 28 days of extended heart rhythm monitoring. Patients will be followed up at 1 month and 1 year after TAVI. The study aims to improve our understanding of baseline conduction disease in severe aortic stenosis and the utility of extended ambulatory monitoring for earlier detection of important rhythm disturbances after TAVI. This can help refine periprocedural risk stratification, inform targeted surveillance and support early discharge pathways.

This study is Part 2 of this Phase 1 study. Part 1 is ACTRN12626000320358. Part 2 evaluates the effect of famotidine, on the PK and safety of ATH434 in healthy volunteers. The primary hypothesis is that co-administration of famotidine will not significantly change the systemic exposure of a single 75 mg dose of ATH434. The study also aims to confirm the safety and tolerability of combining these treatments, using a fixed-sequence crossover design to compare ATH434 levels with and without famotidine. The timing of famotidine dosing relative to ATH434 is adaptive and may be altered based on emerging data from Part 1. The proposed famotidine dose timing is either 10 hours before ATH434 dosing or 2 hours after.

This study will evaluate whether providing several rapid sexually transmitted infection (STI) tests together during a single clinic visit can improve timely diagnosis and treatment for people who may experience barriers to accessing conventional sexual health services. Participants attending the Access Health clinic will be offered point-of-care testing for HIV, syphilis, chlamydia and gonorrhoea, with Mycoplasma genitalium testing offered where clinically indicated, alongside routine laboratory testing. The study will assess whether this approach is feasible and acceptable, how well the point-of-care results agree with routine laboratory results, and whether people with a positive chlamydia, gonorrhoea or Mycoplasma genitalium result can start appropriate treatment during the same visit. It will also examine the experiences of participants and service providers, as well as the costs and practical requirements of delivering the service. We expect that integrating multiple point-of-care tests into the clinic will support faster result delivery and same-visit treatment where appropriate, while providing evidence about whether this model could be sustained and expanded in similar services.