ANZCTR search results

This study aims to find out whether treatment with alpelisib plus fulvestrant increases progression-free survival compared to capecitabine in women and men with eostrogen receptor positive (ER+), HER2-negative advanced breast cancer who have a PIKC3A mutation identified in circulating tumour DNA (ctDNA). Who is it for? This study may be suitable for you if you are 18 years or older, have advanced ER+, HER2-negative breast cancer, and have already had treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Potential participants will consent to a blood test to find out if the cancer has a PIK3CA mutation. This mutation occur in 35-40% of ER+ breast cancers and may make tumours more sensitive to treatments, such as alpelisib, that target the PI3K pathway (which is important for cell growth and survival). The PIKC3A gene mutation can be detected through a blood test for circulating tumour DNA. As a cancer grows, cancer cells die and are replaced by new ones. The dead cells get broken down and their contents, including DNA, go into the bloodstream. These very small pieces of DNA are called circulating tumour DNA (ctDNA). Trial Details If a PIK3CA mutation is identified, before being randomised, participants will have their health checked, medical history recorded, standard blood tests, and provide a tumour biopsy (either a new biopsy or provide material collected earlier). Participants will be randomised 1:1 to either: Arm A: alpelisib plus fulvestrant (clinic visits every 28 days) Arm B: capecitabine (clinic visits every 21 days) Participants on Arm A will take 1 alpelisib tablet per day with fulvestrant injected intramuscularly once every 28 days. Women who are pre- or perimenopausal will also have a goserelin implant inserted under their skin to stop their ovaries producing oestrogen. Participants on Arm B will take 1 capecitabine tablet twice per day on Days 1 to 14 of a 21 day cycle. All participants will be regularly monitored throughout treatment to evaluate their health. Tumours will be assessed by imaging (CT scan, Bone Scan, MRI or PET scan if clinically indicated) and as per RECIST 1.1 every 8 weeks during treatment. Treatment will continue until documented disease progression . The following biological samples will be collected: * Tumour samples of archived tissue or a new biopsy at screening (before first dose of study treatment); * Blood samples for ctDNA testing at pre-screening (to confirm eligibility), Cycle 1 Day 1, Cycle 1 Day 15 (Arm A only), at every cycle during treatment and the End of Treatment Visit. In the event of DNA extraction failure, a replacement blood sample may be requested from the participant. * Tissue collection at disease progression is suggested (optional). Participants will have their final visit 28 days after their last dose of study treatment. It is hoped this research will provide a new treatment option for people with incurable breast cancer.

Collective evidence supports the salutary benefits of exercise training for health and fitness among healthy adults, working populations, and adults with cardiovascular diseases (Andrews et al., 2019). However, there are several limitations of previous research into training health evaluations of firefighters including pooled measurement and lack of objective precision, lack of applicability to firefighter performance outcomes and limited holistic evaluation of the perceptions of key stakeholders within the process (Andrews et al., 2019). Thus, the aim of this research is to evaluate the effectiveness of the Fire and Rescue NSW (FRNSW) Tactical Athlete Resilience Program (TARP). The TARP is a holistic training intervention for metropolitan firefighters conducted on site with South Sydney Football Club (SSFC) with SSFC performance staff. Effectiveness outcomes include cost effectiveness, program adherence and satisfaction, objective health, physiological and psychosocial outcomes,

This study seeks to investigate the efficacy and mechanisms of change of group behavioral activation therapy (BA) for depression in adults in comparison with standard group cognitive behavior therapy (CBT). It is hypothesized that severely depressed adults receiving group BA will show a significantly greater reduction in self-reported depression scores over 10 weeks of therapy than severely depressed adults receiving group CBT over the same period, and that improvement in depression scores in the BA group will be mediated by changes in participants use of behavioural coping skills, while improvement in the CBT group will be mediated by changes in participants use of cognitive coping skills.

Stroke survivors fall often with fall rates of more than twice that of the general older population, placing an enormous economic burden on the national health system and society in general. The aim of Falls After Stroke Trial (FAST) is to test the effect of home-based, tailored intervention to reduce falls. A sample of community-dwelling stroke (n=370) survivors who have completed formal rehabilitation will be randomly assigned to an experimental group (habit-forming exercise and safety training), or a control group (usual care). The primary outcome measures will be falls recorded daily by the participants and monitored monthly by a researcher blinded to group allocation. Secondary outcomes will be community participation, balance, self-efficacy, mobility, physical activity, health-related quality of life healthcare utilisation and costs.

People with severe mental illnesses like schizophrenia or bipolar disorder do not often receive the best care for heart disease. This contributes to a 20-year reduction in life expectancy. In this study we will work alongside General Practitioners to check the heart health of 504 people aged between 35 and 74 diagnosed with a severe mental illness. People randomly allocated to the intervention group will work with a research nurse to set pharmacological and non-pharmacological treatment goals tailored to their individual risk factors with general practitioner involvement. This will be followed by 12 months of focused support. People allocated to the active control group will receive general heart health information, a recommendation follow up with their general practitioner and monthly contact from a research team member. We hope the intervention leads to a reduction in the 5-year absolute cardiovascular disease risk compared to the active control group.

This project aims to test the appeal, feasibility and effects on eating behaviours of a scalable, evidence-based, web- and phone-delivered healthy eating program for socioeconomically disadvantaged adults with Type 2 diabetes. The project also aims to test the effects of the program on food-related skills and attitudes, including self-efficacy and perceived barriers to selecting and preparing a balanced healthy diet. Sixty adults with Type 2 diabetes, and who hold a health care card or pension (indicators of socioeconomic disadvantage), will be recruited, with 40 expected to complete the program and evaluations (conservatively assuming up to 33% drop-out). Participants will receive a 12-week, skills-based behaviour change program, aimed at increasing healthy eating skills, attitudes and behaviours. It is based on an evidence-based behaviour change program developed by the investigators, and delivered using 6 website modules and 36 SMS text messages. Effects on eating behaviours and attitudes will be assessed at baseline, immediately after the intervention (week 12), and six months (26 weeks) later (ie, at 12 and 38 weeks post-baseline). We will also assess participants' perceptions of the program (process evaluation) at weeks 12 and 38.

Potential participants will be identified from an existing database of knee surgery with ethical approval. If the sport of injury is undocumented then the participants medical record will be reviewed, which is within the parameters of the approved database. Participants will be contacted via email where possible and invited to complete the questionnaire online, using RedCap questionnaire which is hosted on a secure medical server at St Vincent’s Hospital. The questionnaire should take less than 5 minutes to complete. Participants who are unable or unwilling to complete the questionnaire online will be invited to complete a paper copy of the questionnaire, which can be posted to them and include a reply paid envelope. The questionnaire will consist of the ACL RSI scale, which is a disease specific, reliable and validated questionnaire for ACL injuries. Participants will also be asked if they have made a return to sport, whether any of their direct family members have had ACL injuries, and if they have sustained any further injuries to their knees. Results will be grouped according to sport of primary injury to determine the incidence of reinjury and return to sport across sporting populations.

Intraocular lens technology has significantly developed over time to include multifocal and trifocal options. The motivated patient can now readily achieve optical independence for most circumstances. Previously, Alcon have provided the Panoptix Presbyopia Correcting IOL in spherical form only. Residual astigmatism has been shown to decrease unaided visual acuity. As approximately 40% of patients will have corneal astigmatism of 0.75D or greater, this represents a significant cohort of patients that may not adequately benefit from the Panoptix IOL in its current format. (Teresa JCRS 2009) The introduction of a toric option presents a positive opportunity for these patients to optimize their unaided vision at all distances. The objective of this study is to describe the visual outcomes and safety at minimum 6 months (180 days) post bilateral implantation of the Panoptix Toric IOL. Subject information will be drawn from a single study visit however preoperative and prior surgical information will be collated also.

Sales of wearable technology have grown exponentially over the last few years. The latest generation devices promise the ability to diagnose a common abnormal rhythm, atrial fibrillation (AF) which is a leading cause of stroke. However, data on the accuracy of these diagnoses has not been validated in clinical trials. Our study aims to assess the accuracy of 2 commercially available smart watches for diagnosing AF compared to the gold standard 12 lead ECG. 200 participants will be recruited from the cardiology outpatient clinic. Those over 65 years of age will be included. Exclusion criteria will be: Participants <65 years, unable to provide consent, presence of pacemaker, non-ambulatory participants and those unable to record an ECG on the smart watch (eg. tremor, arthritis). Recordings will be taken from each watch and a 12 lead ECG acquired during the same session. The accuracy of each watch for diagnosing AF and sinus rhythm will be compared to the 12 lead ECG. A brief survey will also be given to each participant. Baseline characteristics including cardiovascular risk factors, history of arrhythmia's and medication use will be noted.

This study is designed to measure the risk factors that are important in the development of muscle relaxant anaphylaxis. It does this by comparing risk factors between two similar groups of patients that have had anaphylaxis, the only difference being that one group suffered anaphylaxis to a muscle relaxant, the other to cephazolin.