ANZCTR search results

The purpose of this trial is to assess the visual performance of a monthly, centre-near multifocal contact lens available in two near additions against two commercially-available equivalents. Participants will each lens for one month on a daily wear basis.

Making a decision about elective egg freezing can be difficult and requires weighing up a number of different factors including costs, side-effects and the uncertainty of outcomes. This study aims to understand how different information resources help women making a decision about egg freezing. Participation will involve completing three online surveys over a 12 month period which take about 10-25 minutes each to complete. You will also be randomly allocated into one of two groups. Each group will be emailed different online information to look at, and you can spend as much or as little time as you like using this information. The surveys will cover topics including: personal details about yourself; how you are feeling; your decision-making, understanding, experience and attitudes towards egg freezing; and questions relating to information resources.

Pulmonary and cardiac rehabilitation programs are part of standard care for people with chronic respiratory conditions and cardiac disease. As part of these programs, a mix of endurance and resistance exercise training is undertaken, with the benefits of improving exercise tolerance, reducing symptoms, improving quality of life and reducing the risk of future cardiac events. However, some individuals undertaking a pulmonary or cardiac rehabilitation program achieve minimal benefit. For some individuals in pulmonary rehabilitation, this has been attributed to symptoms of breathlessness or fatigue which may reduce the adherence to an exercise program. In cardiac rehabilitation, compliance may be dependent on the degree of pleasure experienced during the program as well as motivation and family support. In healthy people, listening to music during exercise can reduce the perception of fatigue or breathlessness and this has been linked to achievement in greater exercise intensity, due to the distraction of the music listening. To maximise the benefits of music listening, the tempo of the music and type of music are both important. It is thought that music listening during cardiac and pulmonary rehabilitation programs may optimise the benefits of these exercise sessions, as it may desensitise individuals to their symptoms of breathlessness and fatigue and may enhance motivation for attending these programs. Anecdotally, background music is often played during cardiac or pulmonary rehabilitation programs as part of clinical practice. However, the use of background music in these program, the actual choice of music and the reasons for these choices have not been examined. In addition, while individuals attending these programs may choose to listen to their own music choices, but the frequency to which this occurs, the interface used for self-selected music listening and the reasons for self-selected music choices have not been examined.

Functional dyspepsia (FD), characterised by symptoms of epigastric pain or early satiety and post prandial distress, has been associated with duodenal eosinophilia, raising the possibility that it is driven by an environmental allergen. Non-coeliac gluten or wheat sensitivity (NCG/WS) has also been associated with both dyspeptic symptoms and duodenal eosinophilia, suggesting an overlap between these two conditions. The aim of this study is to evaluate the role of wheat (specifically gluten and fructans) in symptom reduction in participants with FD in a pilot randomized double-blind, placebo controlled, dietary crossover trial.

During the COVID-19 pandemic of 2020, a large number of patients attending Australian Emergency Departments (EDs) require viral screening to allow appropriate disposition and treatment decision making. Over 1000 tests were performed in Box Hill ED during July 2020. This process is currently hampered by the long turnaround times of laboratory PCR testing, which currently takes up to 8 hours to be available in this setting. This prolonged COVID-19 time-to-result(s) leads to poor patient flow as COVID-19 suspected patients are held in assessment cohort areas until their results are available. Prolonged ED length of stay has been associated with adverse patient outcomes in general. In addition, lack of single occupancy rooms means that COVID-19 negative patients cohorted in these assessment areas are at risk of acquiring infection from positive patients before test results are available. Rapid, accurate diagnostic or screening tests are therefore urgently required. Current ED testing for COVID-19 involves obtaining nasopharyngeal swabs from three sites (oropharynx and both nostrils) and performing viral PCR testing. FebriDx (Lumos diagnostics, Sarasota, Florida, US) is a TGA registered single use point of care testing (POCT) device that detects two host response proteins, Myxovirus resistance protein A (MxA) and C reactive protein (CRP), in finger prick blood samples, and is designed to distinguish viral from bacterial respiratory infection. Results are available after 10 minutes. A recent UK study performed by Clark et al during the pandemic, found the FebriDX test had a high accuracy for the identification of COVID-19 in hospitalised adults and suggested FebriDx could be deployed as a patient triage tool. In this study of 248 patients, the FebriDx test was shown to have a sensitivity of 93% and specificity of 86% for COVID-19 when compared to reference PCR testing. In their population this translated to a negative predictive value for COVID-19 of 93%. Due to different testing criteria and lower population COVID-19 infection rates, Australian data is required to assess applicability of FebriDx test as a first line screening test for suspected COVID-19 patients within Australian hospitals.

Chest pressure during direct current cardioversion reduces transthoracic resistance and increases cardiac energy delivery. This may decrease energy requirements, potentially increasing cardioversion success and reducing procedure time. The purpose of this study is to examine the efficacy of an initial strategy of chest pressure for direct current cardioversion for atrial fibrillation. Those enrolled will be randomised in a 1 to 1 ratio to the control or intervention arm. The intervention strategy will consist of up to three attempts of direct current cardioversion with chest pressure with increasing energy administered as follows: - 1 shock – 150 Joules with chest pressure - 1 shock – 200 Joules with chest pressure - 2 shocks – 360 Joules with chest pressure Manual chest pressure will be applied with gloves and a towel by the proceduralist (cardiologist/cardiology trainee) over the anterior pad. A maximum of four shocks will be provided until cardioversion success or failure, with a maximum energy of 360 Joules. The control strategy will consist of up to three attempts of direct current cardioversion with increasing energy administered as follows: - 1 shock – 150 Joules without chest pressure - 1 shock – 200 Joules without chest pressure - 1 shock - 360 Joules without chest pressure - 1 shock – 360 Joules with chest pressure A maximum of four shocks will be provided until cardioversion success or failure, with a maximum energy of 360 Joules.

The purpose of this research study is to observe any changes in sexual health that patients may have following the diagnosis and treatment of a head and neck cancer called oropharyngeal cancer (which includes tonsil and base of tongue cancers). Who is it for? You may be eligible for this study if you are aged 18 years or older, and you have started chemoradiotherapy or radiotherapy for human papillomavirus (HPV)-associated oropharyngeal cancer in the last week, or are about to start chemoradiotherapy or radiotherapy for HPV-associated oropharyngeal cancer soon. Participants enrolled in this study will be asked to attend up to five study visits at the Peter MacCallum Cancer Centre, starting from enrolment and continuing each year up until 2 years after they have completed chemoradiotherapy or radiotherapy treatments. Each study visit will take approximately 40 minutes and participants will be asked to complete a series of questionnaires about their sexual health, quality of life, head and neck symptom burden, emotional distress, body image, resilience and levels of optimism. Participants will also be asked to list in order how important sexual function is compared to other functions such as swallowing and eating. These questionnaires will be administered in either a paper or electronic format and patients will be able to answer the majority of the questionnaires at home, except for the exercise where patients will be asked to order their priorities (sexual function, swallowing, eating) which will be done in the hospital face to face with a member of the study team. It is hoped this research may be used to improve health outcomes for future patients with human papillomavirus-associated oropharyngeal cancer by determining how chemoradiotherapy and radiotherapy treatments impacts sexual health and function

The aim of this project is to develop and evaluate whether a digital monitoring and support tool, called Workplace Wellbeing Assist (WWA), is effective in promoting a workplace climate that enhances the mental wellbeing of direct-care staff working at Residential Aged Care facilities in Victoria, Australia (Western Division). Direct-care workers and managers will be invited to participate in a 24-week evaluation of WWA. The study is a non-randomised, pre-mid-post study design, including validated questionnaires and interviews. Specifically, this project seeks to: 1. Determine whether WWA increases perceptions of psychosocial safety in the workplace among consenting residential aged care staff as measured by differences on the Psychosocial Safety Climate questionnaire from Baseline (week 0), to mid (week 12), to post-intervention (week 24). 2. Determine whether WWA can successfully promote staff mental wellbeing and quality of life, and reduce psychological distress and workplace psychosocial risk factors as measured by differences in a pre-mid-post trial. 3. Use quantitative and qualitative evaluation trial data, to further explore the acceptability, usability and usefulness of WWA and allow for future optimisation of WWA for the residential aged care sector. The results of this research will be used to determine whether a digital intervention can effectively promote a mentally healthy workplace that enhances staff mental wellbeing within Residential Aged Care facilities and how it could potentially be optimised for other workplaces.

The aim of the study is to assess nutrition provision and practice over the duration of hospitalisation in critically ill adults in Australia and New Zealand (ANZ) to inform nutrition practice and future reserach. SItes will also use this study as a quality procedure being able to review their individual data compare to other sites in Australia and New Zealand. All data collected is observational. Participating sites will enrol eligible patients into the study over a 1 week study period and collect observational nutrition and hospital care data during their ICU admission and ward stay up to day 28, discharge or death (whichever comes first). Data will be collected daily for the first 7 days while the patient remians in ICU and then weekly where on the ward or still in ICU.

Erectile Dysfunction (ED) affects the quality of life of more than 50% of men aged over 40 years. Diagnosis is complex and requires a multidisciplinary approach. Treatment begins with lowering cardiovascular risks followed by oral medication. Third line is treatment with invasive procedures for example, intracavernosal injections, surgical ligations and implants. Venogenic involvement is one of the causes of ED and is diagnosed by cavernosography. Venogenic ED (vED) may be treated surgically or by the endovascular technique Pelvic Vein Embolisation (PVE). A 2019 review (8 studies, 212 pts) found that PVE was safer than surgical management and the success rate was cited as 60%. However, well-designed trials are lacking in the literature. Published data is limited by small patient numbers, study design and short follow up. Based on the positive findings in the 2019 review and because of our increasing referral rate, we aim to conduct a Level 1, randomised, single blinded, sham controlled study to assess the safety, efficacy and durability of PVE for the treatment of vED. As per standard of care, patients with suspected vED will be referred to Interventional Radiology (IR) by urologists. They will be seen in the IR clinic, counselled and if suitable, booked for cavernosography +/- PVE. 80 patients will be randomised 1:1 to PVE or sham after the cavernosography. Safety will be assessed by determining the composite number of procedural and post procedural complications. Efficacy and durability will be assessed quantitatively with pelvic vein Doppler ultrasound (End Diastolic Velocity (EDV) <5 cm/s) and qualitatively with the validated Quality of Life - International Index of Erectile Function (IIEF) patient questionnaire. Assessments will be made prior to the procedure, at 6 months and annually to 5 years. At the 12 month time point, patients in the sham arm will be able to have the procedure.