ANZCTR search results

The purpose of this study is to assess the feasibility and safety of an exercise program concurrent with immune checkpoint inhibitor (ICI) immunotherapy for people diagnosed with melanoma. Who is it for? You may be eligible for this study if you are a patient aged 18 years or over with a diagnosis of cutaneous melanoma and are scheduled to receive adjuvant immune checkpoint inhibitor immunotherapy treatment. Study details Participants will be randomly allocated to either an exercise intervention, or standard medical care. Participants randomised to the exercise group receive a structured exercise intervention for the duration of their ICI immunotherapy treatment (approximately 12 months). The intervention will involve 3 exercise sessions per week (45-60min per session) involving both supervised and unsupervised exercise sessions. Participants randomised to the control group will receive usual medical care and general exercise advice as per the current exercise oncology guidelines. Participants will be asked to complete a variety of questionnaires, undergo fitness testing, and provide blood samples. It is hoped that findings from this study will inform researchers of the effects of exercise concurrent to ICI immunotherapy, following surgery, for patients with melanoma.

This is a single-arm pilot study, involving 28 individuals with diabetes; aged between 14 and 26 years old, wearing up to four blinded DS5 sensors for a period of 15 days. The DS5 device is a new disposable sensor platform utilising the Enlite 3 sensor technology which provides a longer sensor wear and improved ease of device insertion. The product incorporates an insertion device, a sensor recorder, and sensor flex into a single disposable device. The primary aims of this pilot study will be to assess the feasibility and acceptability of the study protocol, familiarise the team with the study procedures, identify potential logistical difficulties that may arise in the main study, and collect estimates of parameters to inform power calculations for the larger study. Sensor performance will be assessed against the gold standard venous glucose readings generated by the bedside Yellow Springs Instrument (YSI) glucose lactate analyser. Patient visits will be scheduled to ensure observations are equally spread over 10 days for both the hypo- and hyper-glycaemic conditions.

The project aims to continue from a previous exploration. We will implement a feasibility clinical trial/teletrial to 1) determine the impact of having a co-facilitator with lived experience of voice-hearing sharing their experiences as part of the delivery method, on participants’ levels of empathy and 2) explore whether this translates to a change in practice. Workshops will be delivered in regional and remote South Australia and available to health and social care staff and undergraduate health sciences students.

This study aims to investigate if pre-exercise ingestion of whey protein isolate can prevent hypoglycaemia in adults with T1D using automated insulin delivery (AID) during moderate intensity exercise. We will explore this under both 'optimal' conditions (session A) and modified 'sub-optimal' conditions when pre-exercise and exercise conditions are modified (session B and C). We will also investigate in a sub-cohort of individuals the effect whey protein ingestion has on blood glucagon levels during the 'optimal' exercise session and a 'rest' session (session D). We hypothesise that the used of whey protein ingestion will mitigate the risk of hypoglycaemia during moderate intensity exercise in people with T1D.

This research aims to evaluate the real-world feasibility, acceptability and effectiveness of the Stress Autism Mate app for autistic adults in Australia and New Zealand. Participants will include approximately 45 autistic adults who are experiencing stress, can read and type English, have a smartphone and are residents of Australia/New Zealand. Using a single group repeated measures design, participants will complete a baseline survey, use the Stress Autism Mate app for four weeks, complete a post-trial survey, then complete a follow-up survey four weeks after completing the app trial. Expected outcomes are reduced perceived stress, increased coping self-efficacy and improved subjective wellbeing.

Loss of visual clarity during laparoscopic surgery remains a major challenge for surgeons as this can contribute to the safety and outcomes of patients. Typically, a suboptimal display of surgical field can occur due to fogging on the front of the laparoscope lens, smoke generated during tissue cutting, and/or splatter of blood, bodily fluids, fat droplets or tissue etc. When the visual clarity is suboptimal, the surgical procedure will be disrupted or prolonged. Currently there are a number of products for restoring laparoscopic visual clarity. Multiple products are often needed in a surgery to tackle the visual clarity challenge. The frequent practice is still to remove the laparoscope from the abdomen for lens cleaning outside of the body. The F&P Laparoscopic Vision System is designed to remove smoke from the field of view of surgeons, enabling surgeons to continue with their work with better visual clarity and less interruption. Better visual clarity has been demonstrated in bench model and uses in patients. The aim of this prospective randomized study is to evaluate whether laparoscopic visual clarity can be improved by using the F&P Vision System compared to other available visual clarity products. Participants will be recruited and randomized to the intervention (where surgeons will use the F&P Laparoscopic Vision System during the surgery) or control group (where surgeons will use the off-the-shelf smoke filter plus other available visual clarity products during the surgery). All other aspects of the surgery are to be carried out as per standard of care and hospital practice. Study participation ends at the end of surgery.

The aim of this randomised controlled trial is to compare the safety and efficacy of the MAXM Skate Rehabilitation Device and associated digital rehab program to standard rehabilitative care for elective Knee Arthroplasty Patients in a Public Health Setting. Comparisons will be made between several functional, self-reported and performance-based outcomes measures until the completion of their rehab program 3 months post total knee arthroplasty. It is hypothesised that a TKA patient, in a public health care setting, uses MAXM Skate Device and digital rehab program then they will experience equal or greater return of function, clinical performance, and satisfaction in comparison to those receiving standard rehabilitative care.

Burns dressing changes are frequently described as 'excruciating' even with the best current painkillers available to patients. As such, other non-pharmacological options need to be considered to help reduce this pain. Virtual Reality is one such option that works by distracting people from the pain and occupying more of their attention. This experiment will measure patients pain during dressing changes in two groups, one with and one without Virtual Reality (they will play specially designed games during the dressing change). We will also be measuring some psychological factors that may influence patients pain including their coping strategies, locus of control and self-efficacy. We believe that patients will experience a reduction in reported pain from the virtual reality intervention and that externally motivated patients may benefit more from it.

Fear of dental anaesthetic injection can produce anxiety and contribute to dental phobia. Recently, alternative methods for producing effective anaesthesia that reduce the pain experienced during dental procedures have been investigated. One such method is Photobiomodulation (PBM) which uses light to transiently block nerve transmission of pain. Clinical trials have shown that some lasers can generate analgesia using PBM. For example, Sattayut et al in 2014 used a 790nm diode laser (27.69 J/cm2) before palatal injections and found the level of analgesia to be similar to a 20% benzocaine topical gel. Similarly, Khan et al in 2023 found topical anaesthesia produced by a 980nm diode laser (15 J/cm2) to be superior to 2% Lidocaine gel in the administration of inferior alveolar nerve blocks. There are currently no studies that have investigated the efficacy of LED devices utilising PBM for topical anaesthesia before dental injections (inferior alveolar nerve block, palatal infiltration, palatal block and buccal infiltration). Therefore, the purpose of this study is to investigate whether a polychromatic light emitting diode (LED) device (Nuralyte®, Dentroid Canberra, Australia) can lower pain for dental injections when compared with traditional topical anaesthetic gel (5% xylocaine). It is hypothesised that the multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) will lower pain from pain dental injections signifi cantly when compared to topical anaesthetic gel (5% xylocaine). This study is being completed as part of Dr Jessica Zachar's Doctor of Philosophy (PhD) program at The University of Queensland.

Dental local anaesthetic injections cause prolonged numbness of the oral and peri-oral tissues, lasting several hours. This impairs normal functions. Patients can experience self-inflicted injuries such as biting of the cheek and tongue particularly in children. Hence there is interest in methods that can reduce the duration of numbness after dental injections. Three recent studies have shown that visible red diode laser radiation (660 or 810 nm) can give a useful reduction in duration of numbness after dental injections in children, reducing the time of lip numbness by 40-56 minutes. The purpose of this study is to investigate whether a polychromatic light emitting diode device (e (Nuralyte®, Dentroid Canberra, Australia) that emits visible red and near infrared light can likewise reducing the time of numbness, in both adults and children, after dental injections, comparing the active light source to sham irradiation (single blinding for the participants). It is hypothesised that the multiwavelength LED device (Nuralyte®, Dentroid Canberra, Australia) will reduce the numbness time significantly when compared to the sham exposure.