ANZCTR search results

The “NEMO” resuscitation monitor has been designed to fill a current gap in respiratory monitoring need during resuscitation of babies at birth. The purpose of the NEMO is to provide immediate feedback on mask seal and technique to clinicians during resuscitation where manual positive pressure ventilation (PPV) is performed. It is hypothesised that this will improve the effectiveness of manual PPV, helping to improve short- and long-term health outcomes for babies who require resuscitation at birth. The NEMO is a new medical device that currently has only been used during training on manikins. This study aims to investigate the safety and acceptability of the NEMO resuscitation monitor for babies who require resuscitation with manual PPV following birth.

PTSD can be a debilitating syndrome of prolonged stress reactions that may develop after either direct or indirect exposure to a traumatic event. It is a significant issue among veterans with up to one in four veterans experiencing PTSD in their lifetime. Treatment usually involves psychotherapy and pharmacotherapy. EMDR and trauma-focused cognitive behavioural therapy (CBT) are both widely used and equally effective therapies. EMDR involves attention to the past, present, and future with a focus on disturbing memories and related events. Targeted memories are identified and the patient attends to those memories while simultaneously focusing on an external lateral stimulation, typically involving eye movements. The COVID-19 pandemic has significantly altered the way in which mental health intervention has been delivered and telehealth has been rapidly implemented throughout Australia. A number of companies have adapted EMDR to telehealth, but the evidence base remains limited. From a clinical perspective, the capacity to deliver EMDR via telehealth provides an opportunity to provide access to rural and remote patients, as well as enabling preparedness for future pandemics. This trial will aim to investigate whether EMDR via telehealth to veterans with PTSD provides similar safety and efficacy outcomes to delivering EMDR in person.

CLIMATE is an observational study which aims to see if additional blood sampling during active surveillance (no additional treatment) following surgery (orchidectomy) in patients with testicular germ cell cancer may help predict the risk of the cancer recurring. Who is it for? You may be eligible for this study if you are a male 18 years or older and you have been diagnosed with a clinical stage 1 testicular germ cell tumour, and are recommended for active surveillance following your recent surgery. Study details All participants will receive active surveillance for 2 years post-enrolment in accordance with the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group’s surveillance recommendations for clinical stage 1 seminoma or non-seminomatous germ cell tumour. Active surveillance requires attendance at face-to-face clinical appointments with an oncologist and involves physical examination, the collection of blood samples within 6 weeks of orchidectomy and at 3, 6, 9, 12, 15, 18, 21 and 24 months post orchidectomy, as well as a CT of abdomen and pelvis at 6, 12, 18 and 24 months post orchidectomy (seminoma) or CT of abdomen and pelvis and chest x-ray at 4, 8, 12, 18 and 24 months post orchidectomy (NSGCT). Blood samples to assess miR-371 will be collected at various time points (within 6 weeks of orchidectomy, at 3, 6, 9, 12, 15, 18, 21 and 24 months post orchidectomy) or until relapse, whichever occurs first. Blood for study purposes will be collected at the same time as standard of care blood is taken for tumour markers. Assessment of miR-371 levels in the blood will be compared to the findings of active surveillance to determine if it is an accurate marker of disease relapse. It is hoped that this study may show that miR-371 levels are able to predict disease relapse, which may help to guide decision-making following surgery in the future.

People with type 2 diabetes have high blood glucose levels largely due to reduced action or section of the main hormone insulin. Larger spikes in glucose levels typically occur following the consumption of carbohydrates. Lowering carbohydrate intake is one way to improve glucose levels. However, it unknown if the distribution of carbohydrate at each meal and snack also influences daily blood glucose averages; specifically in the context of a lower carbohydrate diet. The main objective of this study is to determine if consuming a moderately low-carbohydrate diet of 90g across different distribution patterns will have an impact on blood glucose management. The primary outcome is the change in blood glucose with continuous glucose monitoring over each of the three 3-day periods following different carbohydrate distribution patterns.

Obesity is a relapsing chronic and complex condition with genetic, environmental, physiological, psychological, and behavioural determinants. Obesity is associated with significant comorbidities, particularly type 2 diabetes, cardiovascular disease, osteoarthritis, sleep apnoea and specific cancers. For people living with obesity and type 2 diabetes, the risks of diabetes-related complications adverse cardiovascular and musculoskeletal outcomes are increased. Managing obesity in people with type 2 diabetes through lifestyle modification, screening, and early detection of secondary complications can improve the management of diabetes-related complications. Evidence supports multidisciplinary person-centred approaches to providing obesity and diabetes care where individuals are active decision-makers in their healthcare. Nevertheless, while multidisciplinary management of people living with obesity and type 2 diabetes is the best-evidence practice, barriers to this level of support exist in rural, regional and remote areas. The development of the national guidelines was underpinned by a comprehensive systematic review of the literature (conducted by AI Shaw). This literature review identified important evidence gaps in the management of patients with diabetes mellitus who also have obesity (NHMRC, 2013). A number of these evidence gaps are the focus of this project. Diabetes services routinely focus on managing and treating diabetes, and obesity management are more of an afterthought. Furthermore, there is a greater prevalence of socioeconomically disadvantaged people living in rural, regional and remote areas and less access to services that support behaviour change when needed. This study aims to assess the feasibility and effectiveness of a rural, multidisciplinary model of obesity care personalised for adults living with type 2 diabetes mellitus and obesity. The research design is a randomised controlled clinical trial. The project will recruit 212 patients with diabetes and randomise them to active intervention or usual care. The active intervention group will receive an integrated, multidisciplinary model of care for obesity management devised in partnership with the person receiving the care and including multi-intervention as desired. In so doing, the participant can choose the care model that suits them best considering their circumstances.

Binge drinking is common in residential colleges in Australia and abroad. The objective of this study is to determine what type of AOD harm minimisation intervention is most effective for reducing risky AOD use and related harms among first year residential college students. Six colleges will be randomised to one of three different types AOD interventions: 1) trivia style AOD harm-minimisation workshop; 2) the AOD harm-minimisation workshop + QuikFix brief intervention; and 3) usual AOD / harm minimisation messaging. We expect students at colleges who receive the AOD harm-minimisation workshop + QuikFix brief intervention will have better outcomes.

The PICOBOO study platform is designed to be an adaptive randomised trial to evaluate the safety and effectiveness of COVID-19 booster vaccine strategies in the Australian context. This will enable regulators, researchers and policymakers to flexibly respond to new policy questions as they arise, for example as new vaccine formulations become available and new variants arise in Australia necessitating changes in strategy. This study aims to evaluate, pragmatically and efficiently, the immunogenicity and reactogenicity offered by alternative booster vaccination strategies against SARS-CoV-2. This adaptive trial is designed to allow for perpetual enrolment for as long as is needed to generate high-quality data to inform Australia's national COVID-19 booster vaccination practice and policy.

The objective of this study is to evaluate the effect of multi-domain tailored interventions administered through a POPS (Perioperative care of Older People undergoing Surgery) service among patients with varying degrees of frailty awaiting elective hip or knee arthroplasty on post-operative complications and length of stay. We aim to improve our understanding of how individual characteristics, frailty and comorbidities may have an impact on post-operative outcomes. We hypothesised that a geriatrican-led preoperative comprehensive geriatric assessment (CGA), combined with targeted interventions, along with 6 weeks centre-based exercise program as prehabilitation, would reduce post-operative complications and hence length of stay in older individuals undergoing elective arthroplasty surgery. This was retrospective observational study comparing a post intervention cohort with historic controls. Patients aged 65 years or older with a Clinical Frailty Scale (CFS) of 4 or greater, who were awaiting elective knee or hip replacement surgery were evaluated in our POPS @NALHN service between October 2018 to December 2019. Post-operative outcomes were compared with individuals who underwent joint replacement surgery between July 2017 to September 2018 without any pre-operative interventions.

Pulmonary rehabilitation is a standard of care for patients with chronic obstructive pulmonary disease and other chronic lung diseases, including lung cancer. Language and cultural barriers prevent sufficient uptake of this treatment in particular subgroups. One large population in our region is the Chinese community. This study aims to demonstrate that a tailored Chinese language-specific pulmonary rehabilitation program will provide benefits to a significant population in our local region, and that this may influence funding and policy-making for respiratory interventions. Who is it for? You may be eligible for this study if you are aged 50 years and over, have a pulmonary disorder that may benefit from pulmonary rehabilitation, and have a level of English that is not proficient enough to partake in English-based classes. Study details All participants will take part in weekly 60 minutes classes for 8 weeks, overseen by a physiotherapist and respiratory physician who are fluent in Cantonese and Mandarin. Each class will involve exercises and education to improve lung function, symptoms, and functional status. Before starting the classes and after completion of the 8-week program, participants will have their lung function and physical function tested, as well as completing a questionnaire regarding quality of life relating to their respiratory disease. It is hoped that this research may show that a Chinese language-specific pulmonary rehabilitation class can improve lung function and quality of life for individuals with lung disease from the Chinese community.

This is a multi-site randomised placebo-controlled trial of mirtazapine (30 mg/day for 12 weeks) for methamphetamine dependence. We hypothesise that mirtazapine will reduce methamphetamine use, reduce depression, improve sleep, improve quality of life and reduce HIV risk. We will also examine safety and tolerability of mirtazapine when delivered in routine clinical care in Australia.