ANZCTR search results

This study is aiming to create an adverse event database to document any negative side effects that people with cancer who are taking specific immunotherapy drugs (immune checkpoint inhibitors) may experience. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with any type of cancer that features solid tumours and you are about to start an immune checkpoint inhibitor therapy alone or in combination with chemotherapy. Study details All participants who choose to enrol in this study will be asked to provide a blood sample once before they start the immunotherapy and then before the second and third cycle of treatment. Participants will also be asked to provide stool and tissue samples before starting treatment and before the second cycle, for biomarker analysis. All participants will be asked to list any side effects/adverse events that they experience while taking the immunotherapy drugs to their usual treating oncologist. It is hoped this research will identify potential biomarkers and clinical features that may predict adverse events related to treatment with immune checkpoint inhibiting drugs that are increasingly being used to treat cancer patients. This information may then be used to improve health outcomes for future cancer patients.

People with cerebral palsy (CP) have significant health issues. We will access National Prescribing Service MedicineWise (NPS) data to provide baseline information about the use of primary care (general practitioner, GP) services by people with CP compared to an age and sex-matched control group without CP. NPS MedicineWise holds deidentified data from 8.6% of GPs in Australia and is considered to be representative of all GPs in this country. We will be able to determine the frequency and reasons for GP visits, medications prescribed and investigations ordered. From this data, we will gather information the health care for this vulnerable population and whether there are barriers that can be addressed.

Ultrasound-guided nerve blocks require integration of motor skills, visuo-spatial orientation, and cognitive processing. This complex medical procedure is usually taught through intensive one-on-one teaching with an expert tutor. VR is a computer-generated, artificial environment designed to replace real-world sensory inputs. Participants can interact within this world, using hand controllers to manipulate objects, while user head movements are replicated by shifting fields of view. Training using VR also engages muscle memory, allowing users to practice the same motor movements that they would have to reproduce in real-life situations. This trial seeks to investigate if a virtual reality teaching program be just as effective in teaching ultrasound-guided nerve blocks as a human tutor, with great potential for future medical education. It is a prospective, double-blinded, RCT, single-site study comparing the effectiveness of VR training against standard training (a face-to-face, didactic training). Participants will be medical students with no anaesthetic training at Liverpool Hospital. The VR software is a bespoke trainer programmed by the research group. Data collected will be the difference in the Global Rating Scale and composite error scores between VR and standard training groups, measured by two independent assessors. If shown to be useful, VR training has several advantages: 1. The opportunity to pre-train skills prior to attendance at hands-on workshops to reinforce teachings 2. Pre-training prior to clinical exposure, potentially reducing errors and improving safety 3. Enable remote learning, and not constrained by access to expert teaching faculty, particularly useful in COVID lockdowns 4. Computer-based learning calculates errors accurately, giving audible and visual cues which is more precise and consistent than a human teacher.

This study aims to determine if local anaesthetic injected around the prostate reduces pain after prostate biopsies under general anaesthesia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are undergoing planned transperineal prostate biopsy for suspected prostate cancer. Study Details All participants in this study will undergo a transperineal prostate biopsy under general anaesthesia. This study will be completed in two parts: In part one, 10 participants will be recruited, and they will be placed into two groups by chance to receive a local anaesthetic periprostatic nerve block of 1% lignocaine with adrenaline or to receive no injection while under general anaesthetic. Depending on the results of this part of the study, we will determine whether a placebo is required for part 2 of this study. In part two, if results of part 1 show that a placebo is necessary for the study to continue, the trial will recruit 50 participants to receive the same injection as part 1 (1% lignocaine with adrenaline) or receive a placebo (non-active injection of normal saline). If results of part 1 show a placebo is not necessary, the trial will continue the same way and recruit 40 more participants. After the procedure, the participants will be asked to rate their worst level of pain and be monitored for additional analgesia and complications (if any). All participants will be recruited via clinics of and by the two treating surgeons with biopsies performed in the adjoining hospitals. It is hoped that this trial will provide information on patient reported outcomes to improve transperineal prostate biopsy techniques making them more tolerable, as patients may be expected to undergo more than one such procedures in the course of prostate cancer diagnosis and treatment.

In recent years, evidence has turned to how to best meet the psychosocial needs of individuals exposed to traumatic or stressful events who are experiencing adjustment and subclinical problems, but have not transitioned to a psychiatric disorder. First-responders, such as firefighters, who have high rates of trauma exposure are particularly vulnerable to these psychosocial difficulties. The Skills For Life Adjustment and Resilience (SOLAR) program is a brief, psychosocial, skills-based intervention designed to promote recovery and maintain wellbeing following stress and trauma. SOLAR is typically delivered face-to-face by non-mental health professionals. The SOLAR-m app, however, has been culturally adapted for firefighters, and participants in this RCT will be firefighters experiencing distress. The aim of this project is to conduct a randomised controlled trial to assess whether a smartphone-based version of the SOLAR intervention, known as SOLAR-m, is more effective than a control app comparator. We expect the SOLAR-m app to be better at reducing symptoms of anxiety, depression and posttraumatic stress disorder than the comparator app, both immediately after using the app and three months later. We also hypothesise that people using the SOLAR-m app will have better performance at work, less conflict between their work and family lives, and incur fewer costs related to psychiatric care and sick leave.

The proposed trial will evaluate a multi-sector, multi-component program of interventions for improving the health and wellbeing of children who are at the highest risk of developmental vulnerability and disadvantage in the Australian Capital Territory. This study will apply quasi-experimental methods to assess the effectiveness of an integrated service model to address early childhood developmental disadvantage. We propose that a model of better integration for child-focused development and support services will reduce developmental delay for children aged 0 – 5 in the ACT. This study will evaluate whether providing place-based programs and activities that support young children’s development will reduce the proportion of children with one or more developmental vulnerabilities living in identified suburbs in the Belconnen District Area. The study design is a quasi-experimental study, comparing suburbs in the Belconnen District Area (the intervention site) with the highest levels of developmental vulnerability with matched suburbs in Tuggeranong (control site). Findings will inform practice and policy, leading to benefits for young children aged between 0 and 5 living in the ACT.

The purpose of this split mouth clinical study will explore differences in the clinical outcomes of Silver fluoride followed by potassium iodide (AgF/KI) and silver fluoride followed by stannous fluoride (AgF/SnF2). The outcomes will assess for how clinical performance is influenced by patient factors, such as their salivary profile, systemic conditions, medications, and diet. It is hypothesised that both materials will have similarities in its effects on clinical outcomes of dental caries management.

People with traumatic brain injury (TBI) face social isolation and reduced quality of life because of the difficulties they have in recognising and responding to the emotions of others. People with TBI also face substantial health risks because of their low activity levels, which further impacts social engagement and quality of life. Increasing physical activity for people with TBI through a structured exercise program has been shown to improve aspects of cognition (e.g., recall of information) and mood and to decrease symptoms of depression. Given this, it is reasonable to suspect that increased physical activity may also positively impact social cognition for people with TBI. Social cognition is a construct that encompasses a wide array of skills that help people to recognise, accurately interpret, respond to the emotions of others. Some key skills associated with social cognition are facial and vocal emotion recognition, empathy, and social behaviour. The primary aim of the proposed study is to evaluate the impact of increased physical activity on social cognition for people with TBI. Our hypothesis is that the increase in exercise, will have a positive impact on the participants' life, hence increasing their social cognition. The study will include 30 people with moderate to severe TBI who will complete a 12-week supervised exercise program. The exercise program will be individually tailored to accommodate any physical needs participants have and to ensure safe progress throughout. Baseline and post-program measurements will assess social cognition, cognition, community participation, depression and anxiety, and health outcomes which will allow us to explore associations between these various factors. This is a novel study that will inform future, external funding applications.

Despite its overwhelming benefits, a negative outcome of bariatric surgery is severe loss of bone and muscle mass. Postmenopausal women experience over two-fold greater bone microarchitecture deterioration than premenopausal women and men following bariatric surgery, and as such are at greatest risk for incident fractures. We have previously identified that supervised 30 minute, twice weekly functional impact training (FIT) in postmenopausal women with low bone mass resulted in significant improvements in lumbar spine and femoral neck bone mineral density (BMD) compared to control. No study has investigated the role of FIT in postmenopausal women following bariatric surgery using telehealth applications. We hypothesise that an 8-month functional and impact training (FIT) program combined with nutritional education, delivered via a mobile application, will be acceptable, safe, and well-adhered to in postmenopausal women following bariatric surgery. It is anticipated that the outcomes of the bariatric trial will inform the design of innovative future randomised controlled trials exploring this program as a potentially effective, safe, and feasible treatment strategy for maintaining musculoskeletal health after bariatric surgery.

This is a feasilibility study to determine if use of KPJ™ (Kidney Protective Jacket) during renal transplantation is feasible and implementable in the Australian kidney transplant setting. In addition, it shall also assess whether the KPJ™ improves transplantation outcomes from ‘marginal’ or higher risk grafts currently used for transplantation.