ANZCTR search results

Finding the balance between the risks and benefits of sun exposure is extremely challenging. The Cancer Council Australia and other organisations now advise daily sunscreen use to reduce UV radiation-induced damage arising from incidental exposure. Sunscreen blocks vitamin D production in experimental settings but there are no data about the effect of frequent application of high SPF sunscreens in community settings. Despite this, there is a widely held perception that using sunscreen will increase the risk of vitamin D deficiency and this is undermining skin cancer prevention messages. We plan a two-arm open-label RCT with a one-year intervention phase. The primary aim is to determine whether participants randomised to provision of a broad-spectrum SPF 50+ sunscreen, and advice to apply it to all body parts uncovered by clothing on all days when the UVI is forecast to reach 3, have a lower mean 25 hydroxyvitamin D (25(OH)D) concentration at the end of either summer or winter than those randomised to usual discretionary sunscreen use. If daily sunscreen use reduces 25(OH)D concentration, we will model the impact on the prevalence of vitamin D deficiency in Australia to assess the public health significance of the change

AIMS OF THIS STUDY To test model PCT-style regimens comprising either hCG or an antiestrogen, framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive function of abstinent androgen abusers. These randomized double-blind placebo-controlled clinical trials are designed to test the efficacy and safety of pharmacological treatment as part of a future rehabilitation program for androgen abusers. To the best of our knowledge, no similar study has been undertaken or reported elsewhere. OBJECTIVES To investigate the efficacy of hCG or letrozole, an aromatase inhibitor, treatment over 4 weeks to accelerate recovery of the male reproductive system of abstinent androgen abusers at 4 and 8 weeks after cessation of trial drug treatment. STUDY POPULATION Androgen abusers who are planning to stop or have recently ceased androgen abuse will be recruited through local advertising, social media postings and word of mouth. STUDY DESIGN Randomized, double-blind, placebo-controlled, parallel group study with 4 weeks of drug (active or placebo) treatment. The primary endpoint is the extent of recovery of the male reproductive system as indicated by a composite measure of serum LH and FSH at 4- and 8- weeks after cessation of study drug treatment.

The project is funded by the NHMRC Medical Research Future Fund to conduct a retrospective and prospective trial of patients with autoimmune encephalitis to gain a better understanding of disease mechanisms, clinical manifestations, identify improved biomarkers for accurate diagnosis, improve treatment options and ultimately enhance patient outcomes/quality of life. Dr Monif believes that the trial and the creation of the Australian Autoimmune Encephalitis Consortium will raise the profile of the disease so that anyone presenting with the symptoms of autoimmune encephalitis are triaged accordingly, and with timely investigations, the disease is diagnosed promptly. The findings from the national research study are hoped to lead to production of clinical guidelines to assist with early diagnosis and improved treatment options. The ultimate aim is to improve patient outcomes.

Gambling-related suicide has been underestimated and few systemic responses are in place to support those experiencing suicidality. The study aims to understand the relationship between gambling and suicide; and, contribute evidence to prevent gambling-related suicide to inform system-wide responses to these preventable deaths. The project will use a descriptive qualitative approach. Adult participants (18 years+) from three key groups located in Australia will be recruited to share their experiences and insights into this problem via a one-to-one semi-structured interview. Participants will be asked to describe their experiences with gambling, suicide or suicidality, their understanding of the relationship between gambling and suicide. Interviews will also seek to document how these participants perceive current gambling arrangements and how this may contribute to stigma and shame.

The distal ischaemic stroke thrombectomy against medical therapy trial is the last FRONTIER in stroke trial and builds on the success of Australian led thrombectomy trial, EXTEND IA. It is an Australian led trial in the Asia-Pacific region (FRONTIER-AP) which seeks to answer an important clinical conundrum on the optimal treatment approach for patients with clot in medium sized vessels (MVO) in the brain. Following the results of multiple randomized clinical trials some states in Australia have structured clinical pathways for treatment of patients with large vessel occlusion (LVO). Such knowledge does not exist for MVO. There is clinical equipoise to proceed with phase II clinical trials given the conflicting data from observations from multiple observational studies and small sample size of data from randomised clinical trial . Our primary hypothesis is that the clinical outcome of ischaemic stroke patients treated with endovascular therapy within 9 hours will be superior compared with that of standard medical therapy. This trial will require moderately large sample (n=240) and thus may not be achievable even in our large network of collaborators in Australia. We will leverage the opportunity provided by the International Clinical Trial Collaborations (ICTC) to recruit 50% of the patients for this trial by our international partners. If the trial shows superiority of thrombectomy for MVO then it may lead to significant restructuring of acute stroke care across multiple states as the current model of care is that hospitals that provide thrombolysis therapy can treat patients with MVO. In anticipation of this change we have built an implementation phase into this grant incorporating statistical analysis, health economics analysis, operational research and geospatial analysis. We will also seek support from Stroke Foundation and engage with their network of consumers to determine their perception of the impact on new model of care and other changes that they would like to see given their experiences These analyses will inform the scalability of our findings as well as design of phase III such that full implementation will be achievable. Within the first 12 months, we would have the trial registration, submit the trial to Australasian Stroke Trial Network, develop educational material for trialists and clinicians to recognise MVO, published protocol paper as well as recruitment of the initial group of patients .

This project examines the feasibility and effects of a 10-week online music therapy program involving songwriting for people with dementia and their family care partners. The project aims to address the following aims: To, 1) examine the feasibility and acceptability of online music therapy for people with dementia and their family care partners; 2) examine the sensitivity of outcomes measuring depression and quality of life with people with dementia and their family care partners who have participated in online music therapy; 3) explore how people with dementia and their family care partners experience an online music therapy program.

The BeCALM study is for people who will be having radiotherapy and may be feeling anxious about it. Who is it for? You may be eligible for this study if you are aged 18 years or over, and will be undergoing 2 or more radiotherapy sessions at Calvary Mater Newcastle. Study details You will be randomly allocated (like drawing your name out of a hat) to receive a form of anxiety monitoring or support. We will also ask you to complete three surveys. These will include questions about how you are feeling about having radiotherapy going forward, and how you have found the experience so far. The questionnaires will take about 10 minutes to complete. You will also be asked to wear a small device on your fingertip to measure your pulse during your first two treatments. It is hoped that this research will show if a certain type of monitoring or support, is a useful way to manage procedural anxiety without medication.

Australian women have high rates of poorly controlled cardiovascular risk factors. In turn, cardiovascular (CV) disease is responsible for the death of 22 women every day in Australia. The ‘Heart Health Check’ is an MBS item number allowing general practitioners to be reimbursed for performing a formal CV risk assessment on a patient. Currently only around 1.1% of eligible NSW women have a formal ‘Heart Health Check’ each year with their GP. This study aims to understand the value of promoting CV risk assessment outside traditional health care settings among female attendees of NSW hairdressing salons. The researchers hypothesise that the intervention will: (i) Increase the proportion of women having a Medicare-rebated Heart Health Check; (ii) Increase the proportion with at-risk levels of cardiovascular risk factors identified; and (iii) Increase the use of medications for cardiovascular risk management

Currently, there is no effective therapy for the management of weight loss/reduction in the post-liver transplant population, who are at a higher risk of obesity and cardiovascular disease as a result of the effect of immunosuppressive medications required in the post-transplant setting. The aim of this study is to investigate the safety and effectiveness of semaglutide, which has documented effectiveness for weight management in the non-transplant setting. The study aims to recruit 100 patients who have undergone liver transplant more than 6 months but less than 5 years ago who are overweight (BMI >27kg/m2) with metabolic risk factors or obese (BMI >30kg/m2) with or without metabolic risk factors to a double-blind placebo-controlled trial for a period of 68 weeks (16 months). Clinical, laboratory and radiology data will be measured throughout the study to assess effectiveness. It is anticipated that semaglutide will be effective in achieving 5% or greater weight loss, and will have beneficial impacts on risk factors for cardiovascular disease.

Cardiovascular disease is the number one killer of Australian women. Yet CVD is preventable with early initiation of the right lifestyle and medical interventions. Current primary prevention relies on 'traditional' risk prediction tools. But almost all women under 65 are categorised as low risk, the vast majority of women who have coronary events are not identified, and novel, female-specific risk factors (e.g pre­ eclampsia, hypertensive disorders of pregnancy, gestational diabetes or premature menopause) are not considered. On top of this, women receive less primary prevention medical therapy, compared to men. These issues are even more pronounced in Aboriginal and Torres Strait Islander women (hereafter respectfully referred to as Aboriginal women). who have a larger burden of female-specific risk factors, and are even less likely to receive appropriate primary prevention. The CAC-Women's Trial aims to use a calcium score, measured via a simple, quick and widely available CT scan, to prompt lifestyle changes and medication use in women who are low-intermediate risk but have female-specific, risk-enhancing factors. in a randomised controlled trial (RCT) will evaluate the overall potential, feasibility and acceptability of a CAC-guided approach to primary prevention of CVD in women, and its impact on cardiovascular risk factor control. The CAC-WOMEN Trial will be a multi-site, randomised controlled trial assessing the effectiveness of a CAC-guided primary prevention intervention on cardiovascular risk factor control and healthy lifestyle adherence compared to usual care. The study aims to recruit 522 patients. Asymptomatic women without CVD aged 40-65 years (35-65 years for Aboriginal and Torres Strait Islander women) will be recruited from the community. Women will undergo blinded CT calcium scoring followed by 1:1 randomisation to intervention (CAC-guided care) or control (standard care). In the intervention group, women undergo a risk factor counselling session. This is performed by the study nurse/coordinator (and/or Aboriginal healthcare worker, where appropriate) with a private, one-on-one, CVD risk factor counselling session. The Study nurse/coordinator will provide printed and electronic information containing standardised recommendations consistent with current guidelines, on how to improve CVD risk profiles. The risk factor counselling session will be aided by the use of the CT-CAC result. Patients will receive a follow up telephone call by the study nurse at 1, 3 months, to monitor risk factor modification. In the control group women remain under the care of their primary care physician and are blinded to the CAC result for the 6month period. The participant is provided with a letter detailing the results of the baseline examination and pathology and are encouraged to see their GP for a discussion of risk factor treatment in accordance with standard care. All participants will be sent electronic survey follow up at 12m.