ANZCTR search results

The COVID-19 pandemic presents significant risks to the health of people living with chronic conditions. Inflammatory bowel disease (IBD) is a chronic and life-limiting illness affecting 85,000 Australians and up to 7 million people worldwide, with symptoms involving chronic diarrhea (up to 20-30 times a day), pain, and fatigue. A large proportion of patients with IBD receive immunosuppressive medication and are at a particular risk of COVID-19. Further, given the recent COVID-19 related product shortages, toilet paper, heavily used by patients, has become difficult to purchase. This has resulted in significant distress expressed by the members of the IBD community. This project will provide timely information on the effectiveness of a simple, brief, evidence-based, online, group-based expressive writing intervention targeting COVID-19-related distress in people with IBD.

To date, COVID-19 has resulted in nearly 721,000 infections and almost 33,000 deaths globally, with no proven effective therapeutic options to reduce mortality. Hydroxychloroquine (HCQ) is a widely used anti-malarial drug showing great promise in treating COVID-19 in preclinical studies. The intensive care physicians at the Royal Brisbane and Women's Hospital (RBWH) have chosen to treat all COVID-19 patients admitted to the ICU with HCQ. The dose of HCQ used in virtually every other hospital is the same as used for malaria. However, critically ill patients with renal failure and other problems commonly require different doses of many drugs. The aim of this study is to investigate whether the dosing of HCQ for critically ill COVID-19 patients requires adjustment, in order to ensure the safety of practice at RBWH, Inclusion criteria is suspected or proven severe COVID-19 infections admitted to the RBWH ICU. Data will be routinely collected as part of standard ICU practice. The outcome of this study will potentially be of critical importance in the interpretation of results of the large randomised comparative trials of HCT using fixed dosing currently underway.

To establish and follow up a Victorian cohort of children who had a prenatal diagnosis of a genomic copy number variant from 2013-2019. Children aged 12 months to 7 years will be assessed for developmental, social-emotional and health outcomes using validated, age-appropriate measures. Objectives: 1. To compare the developmental, social-emotional and health status of children with prenatal CNVs to children with normal prenatal CMA results. 2. To measure the impact of a prenatal diagnosis of a VUS on parental perceptions of their child. 3. To determine the proportion of prenatally-ascertained VUS that are reclassified as benign or pathogenic after 2 or more years.

ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled Bayesian adaptive platform trial. The aim of the trial is to identify the best regimen (combination of interventions) to treat adults hospitalised with COVID-19.

- This clinical trial aims at describing the clinical features of COVID-19, the response to treatment, as well as pathogen replication, excretion and evolution within the host, determinants of severity and transmission using high-throughput sequencing of pathogen genomes obtained from respiratory tract, blood and stool. - Characterise the host responses to infection and therapy over time, including innate and acquired immune responses, circulating levels of immune signalling molecules and gene expression profiling in peripheral blood - Identify host genetic variants associated with disease progression or severity - Understand transmissibility and probabilities of different clinical outcomes following exposure and infection

The aim of this study is to evaluate the efficacy and efficiency of two telerehabilitation interventions: 1) traditional model which is predominantly focuses on improving physical function and is currently offered as usual care by the home rehabilitation service: 2) a rehabilitation intervention which focuses more on participation in usual activities and is offered via a coaching model to a virtual group of people. Both interventions are provided in a telehealth format as a response to the global pandemic, COVID-19. The purpose is to determine whether the novel intervention is more effective as well as if it is more efficient (as it is offered in a virtual group format). We plan to recruit 58 participants who have been confirmed with COVID-19 and referred to home rehabilitation services at Flinders Medical Centre Division of Rehabilitation Aged and Palliative care. At the completion of the study, we expect to be able to describe the functional and social impacts of a telerehabilitation interventions for individuals confirmed with COVID-19 receiving home rehabilitation services.

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status. Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening, stem fractures and reduced functional movement, which lead to poorer patient outcomes. Recently, a new range of hip replacement devices have been engineered to address some of the shortcomings of existing stems. In particular, the Quadra-P stem has specifically been designed as a straight, triple tapered stem with a rectangular cross-section and manufactured with Ti-6Al-7Nb alloy material to increase osseointegration and reduce wear. The newly designed Quadra-P stem device was recently introduced into the Australian market, however, its clinical performance is yet to be evaluated. Thus, the purpose of this study is to investigate the Quadra-P stem efficacy (survival) at 2, 5 and 10 years post-surgery and ensure that it performs just as well as other commercially available stems. The hypothesis for this investigation is that the 2, 5 and 10 year percent revision rate (need to re-implant) is not inferior (comparable) to the average performance of all other cementless femoral stems currently in use in the Australian Market.

The purpose of this study is to test the safety of a new medication (called ALMB-0168) in people with malignant bone cancer lesions either from bone cancer or from migration of other cancers. Who is it for? You may be eligible for this study if you are aged 16 or older, and have confirmed bone cancer (osteosarcoma) or cancer cells in the bone originated from other cancers which has been deemed untreatable. Study details All participants in this study will receive the active medication ALMB-0168. The dose will depend on when the participant enrolls in the study. The medication is administered through a needle in the arm, and will continue for up to 6 months. As part of this study, all participants will have additional blood tests, imaging scans and answer questions regarding to your health. It is hoped this research will demonstrate the safety of ALMB-0168 and find the ideal dose for larger-scale studies.

The purpose of this study is to trial a new program, led by nurses, for management of heart (cardiovascular) disease in people being treated for breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or over and have been diagnosed with breast cancer in the last 6 months. Study details All participants in this study will receive the intervention, which is a clinical pathway lead by nurses. As part of this pathway, participant will be assessed by a nurse for their level of heart disease risk. Depending on their level of risk, they will then receive either information resources (if low risk) or a care plan including referrals to appropriate health professionals to manage their risk factors (if intermediate or high risk). The nurse will then follow up every six weeks (if possible, by telephone) to monitor how each participant is going managing/reducing their level of heart disease risk and make any adjustments to their care plan, including additional referrals, as needed. Finally, the nurse will provide each participant with a plan for ongoing management of heart disease risk at the end of participation in the study. As part of this trial, participants will complete some questionnaires, surveys and have some additional routine health tests like weighing and blood pressure. If required, the nurse may recommend for additional tests such as blood tests to be performed, so that information such as cholesterol levels can be used to calculate participant's risk of heart disease. It is hoped this research will demonstrate that this program is feasible to maintain, and acceptable to patients.

COVID-19 patients in intensive care will have their ongoing respiratory & ventilator management decided in one of two ways either 1. Using Lung Ultrasound imaging 2 The traditional method of using auscultation, arterial blood gases and ventilator settings such as static compliance Number of patients ventilated, length of stay (intensive care, hospital (time on ventilator , ventilator free days, mortality (in intensive care and at 28 day ) will be recorded and compared between the two groups. Both methods of management are standard in the intensive care units.