ANZCTR search results

This study aims to investigate the effect of a combined exercise training program, compared to a sham-placebo control group on skeletal muscle microvascular blood flow and exercise intolerance in adults living with atrial fibrillation. Secondary to this, the study aims to determine the effect of combined exercise training on quality of life, symptom severity and traditional cardiovascular risk factors. It is hypothesised that participants in the combined exercise training group will have an increase in skeletal muscle microvascular blood flow and exercise tolerance when compared to the sham-placebo control. Additionally, those randomised to the combined exercise training group will have an improvement in quality of life, lower symptom severity and improved cardiovascular risk factors.

Most ICU patients who need a breathing machine (ventilator) to help them breathe require sedation and pain relief with one or more sedative (calming) and analgesic (pain reliever) drugs given as continuous drip into a vein. Combinations of sedative and analgesic drugs are usually used in the ICU to make patients on ventilators comfortable. The focus of this study is on the analgesic component of this management. Analgesic drugs will treat a patient’s pain, but may also provide some sedation. The type and the manner in which analgesic agents are used will vary. The type of analgesic drug and the way they are given may determine whether or not a patient is deeply or lightly sedated (more or less responsive to voice or physical stimulation). Currently, there is no agreement amongst doctors around the world about the best choice of analgesic drug or the best way to manage pain in patients receiving mechanical ventilation. Many of the commonly used analgesic drugs have side effects and may be associated with longer time on the ventilator, longer stay in the ICU, leading to delirium (a confused state often including hallucinations) and decreased mental awareness after recovery from critical illness. Clinical guidelines recommend a multi-modal approach to pain relief in patients who are being treated with a breathing machine (mechanical ventilation). This approach is to try and minimise the amount of pure analgesic agents used and theoretically minimise side effects of these agents. The purpose of this study is to evaluate a drug which has both analgesic and sedative properties, ketamine (Ketalar®), that might decrease the need for other analgesic agents and improve survival and recovery (reduce delirium, time on a ventilator and time in ICU) for patients who are receiving mechanical ventilation in the ICU.

Aortic stenosis(AS) is the most common valvular condition with an increasing prevalence in an ever-ageing population. Historically, the only treatment was surgical valve replacement, but transcatheter aortic valve replacement(TAVR) has emerged as the treatment of choice for those patients at high or intermediate surgical risk. Coronary artery disease(CAD) is common in patients with AS. But the assessment of CAD severity is challenging as our usual physiological tools are not reliable in this group. One of their problems is that they do not assess coronary microcirculation, which is altered in severe AS. A potential solution would be to measure absolute coronary flow to better understand the microcirculation and lead to more reliable estimates. This project seeks to validate absolute flow in patients with severe AS using a novel catheter, Rayflow(Hexacath, France), that measures coronary flow using thermodilution. Once validated, we would then ascertain if this can translate into routine practice with serial measurements pre and post TAVR.

Uterus transplantation involves taking the uterus (womb) from one woman and transplanting it into another with the sole purpose of allowing the second woman to have a baby. Up until recently women with no womb (called absolute uterine factor infertility or AUFI) could only use surrogacy, adoption or fostering if they wanted to become mothers. The prevalence of AUFI among women of childbearing age is not exactly known. Women can either be born without a womb called congenital AUFI (affecting 1:4500 women) or have it removed (hysterectomy) called acquired AUFI. A woman’s womb might be removed due to cancer, large growths in the womb or severe bleeding after a previous childbirth. The most common form or AUFI is called Mayer–Rokitansky–Küster–Hauser syndrome (MRKH), these women are born without a womb but have otherwise normal ovaries. This means they can create embryos but without a womb, can’t carry the baby. Currently the only options for women with AUFI in Australia are surrogacy, adoption and fostering but these options can sometimes be difficult to achieve. Therefore, uterus transplant could give women with AUFI a third option should they wish to become biological parents. Internationally more than 10 countries have now commenced clinical trials to see if uterus transplantation could give these women the opportunity to carry their own babies. The procedure has proven to be successful with more than 30 babies having already been born after a uterus transplant in countries such as Sweden, USA, Brazil and Germany. An International Society for Uterus transplantation (ISUTx) has been established to help countries collaborate and share clinical de-identified data through a secure data registry. However, deciding to put a woman (and her living donor) through a long surgery and short-term immunosuppression (medication to support the womb transplant) needs to be thoroughly explored prior to it becoming a mainstream option in the Australian setting.

During the COVID-19 pandemic there was a rapid move to telehealth use (either via phone or video) in the delivery of pregnancy care. There have been mixed findings from research conducted during the COVID-19 pandemic in Australia and elsewhere. One local study found the use of telehealth at Monash Health showed no compromise to pregnancy outcomes, however women didn’t receive telehealth for all of their pregnancy as some care was provided prior to the start of the COVID-19 pandemic. Another multi-centre cohort study including all public maternity services in metropolitan Melbourne found an increase in preterm stillbirths during lockdown periods and a decrease in medically required preterm births, which could be related to there being fewer episodes of in-person pregnancy care during lockdowns. This two-arm pilot randomised controlled trial (RCT) aims to develop and implement an agreed pregnancy care schedule that combines video-based telehealth care (referred to as telehealth hereafter) with face-to-face visits, and test it against a schedule of all face-to-face visits, with the ultimate aim of testing these in an adequately powered RCT. This study will be conducted at the Women’s and Mercy Hospital for Women. We will recruit 200 pregnant women who are obstetrically low-risk, with approximately 100 women randomised to receive all face-to-face pregnancy care, and 100 to receive combined telehealth and face-to-face care. Participants will complete a survey at recruitment and at two months post birth. Clinical data for each participant will be collected from their medical record. A second component of this pilot study is to evaluate obstetric and midwifery staff views and experiences of providing pregnancy care via telehealth. An online survey will be sent to all obstetric and midwifery staff to explore their views. Findings from this study will help to inform the development of a larger trial investigating the use of telehealth in providing pregnancy care.

Cancer immunotherapy with immune checkpoint inhibitors (ICI) have revolutionised the treatment and outcomes for multiple cancers in the past 10 years leading to sustained remission and cure in some patients even when diagnosed with advanced disease. However, immune mediated side effects are common including diarrhoea and colitis which can affect up to 40% of patients who take ICI's. This study aims to assess whether a short course (7 days) of oral treatment with faecal microbiota transplantation (FMT) therapy has any impact upon ICI colitis symptoms in patients who are affected by this. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have experienced diarrhoea from your ICI and your last dose was within 4 months of symptom onset. Participants who are steroid intolerant, have had no response to oral glucocorticoids, have had recurrence of symptoms during or following corticosteroid wean or have had recurrent episodes of immune checkpoint inhibitor colitis will be considered for inclusion. Study details All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the FMT group or a placebo group. Both groups will be asked to take FMT capsules each day for 7 days, and to keep a diary of their bowel movements for up to 12 weeks after enrolling in the study. Participants will also be asked to provide stool and blood samples throughout the study and may also require a colonoscopy. The overall participation will be 12 weeks. It is hoped this research will demonstrate that it is safe and effective to use orally administered FMT to treat ICI colitis in cancer patients who have been taking immune checkpoint inhibitors. If FMT is successful, this may lead to a reduction in overall corticosteroid use, hospitalisation and an early resumption of their cancer immunotherapy for affected patients.

Cancer therapies are associated with significant adverse events, particularly cognitive impairment, where over 75% of breast cancer patients report cognitive impairment. As breast cancer occurs primarily in mid-life, this has created a large population of survivors who are at a unique intersection of both cancer and age-related effects on the brain, specifically declined brain blood vessel function and cognition. The aim of this study is to investigate the effects of a supervised 8-week multimodal exercise intervention on brain blood vessel and cognitive function in female breast cancer patients. Who is it for? You may be eligible for this study if you are a female breast cancer patient aged 40-80 years and you meet specific health requirements (blood pressure, heart health and cognitive/mental function). Study details Participants who choose to enrol in this study who are willing to undertake the exercise intervention program will be asked to complete a series of baseline measurements, before being invited to attend 2-3 x 1 hour exercise sessions each week for 8 weeks. Each sessions will include both aerobic exercises (e.g. stationary cycling, rowing) and muscle strength training (e.g. chest press and lat pulldown) and will be supervised by an Accredited Exercise Physiologist. One week after the completion of the exercise program, participants will be asked to complete the baseline measurements again for comparison. A second group of participants who are not wishing to participate in exercise at this point in time will also be invited to complete both the baseline and 9 week measurements for comparison. These participants will form the control group. Once the study has concluded, the control group will be provided with the exercise regime used in this study It is hoped this research will provide some evidence as to the effects of exercise therapy on cardiovascular, cerebrovascular and cognitive function in breast cancer patients. If this study is found to have a positive impact on the cardiovascular health and cerebrovascular and cognitive functions of these patients it may evolve into a larger randomised controlled trial to further examine the exercise effects in this population.

This is the first pragmatic randomised trial to comparatively investigate Ethanol ablation and Radiofrequency ablation for the treatment of chronic Morton’s neuroma. This study was deemed necessary as no prospective studies compare Ethanol ablation with Radiofrequency ablation or focus on patient recorded outcome measures, specifically measuring pain, foot health, function and ability.

Decline in cognition and physical function often occurs simultaneously and increase falls risk in older people. Previous research has shown that step training reduces falls risk as well as improving cognition. Previous research has also shown that combining motor and cognitive training would induce greater cognitive improvements than individual motor or cognitive training. Therefore, we have created ReacStep, a novel step training program with an added cognitive component. it requires minimal equipment and can be individually tailored to older adults with a range of physical functional levels. This trial will examine the effects of the ReacStep program on fall risk and cognitive function in older adults. We hypothesise the the ReacStep program will improve fall risk and cognition in healthy older adults. If this study is successful at improving fall risk and cognition, it will provide a basis for a larger clinical trial and a feasible solution for preventing falls and dementia in older adults, and can be a new training program that health professionals can use in their practice.

This study aims to build on existing local research to trial a linguistically and culturally tailored asthma education strategy that builds on our recently established early intervention asthma nurse lead education program. Shortly following a hospital admission, patients with asthma including those from culturally and linguistically diverse communities will be seen by a Nurse educator and a Bilingual health care worker if required for a detailed asthma education session. They will be supported by phone and in person over the next few months. Their asthma control will be assessed with a validated questionnaire at the end of the study. We hope to demonstrate that such a tailor-made programme of asthma education will improve asthma outcomes. for all patients with asthma