ANZCTR search results

SARS CoV-2 (COVID-19) is highly infectious, with each case transmitting infection to between 2 to 3 other people. Approximately 15% of COVID-19 infected individuals are hospitalised and 1 in 3 require artificial ventilatory support. Up to a third have a poor prognosis with the main cause of death being overwhelming respiratory failure and/or cardiac failure and cardiac arrest associated with a cytokine storm. Approximately 30% of hospitalised individuals will ultimately require artificial ventilatory support for deteriorating respiratory status while under clinical observation. Conservatively, at least one third of intubated people will succumb to the infection with the most common causes of death being overwhelming respiratory failure associated with acute respiratory distress syndrome (ARDS) and/or cardiac failure and cardiac arrest, both associated with cytokine storm. Over 1.9 million individuals of the 46 million infected individuals globally have died from COVID-19 infection (as of January 2021), with many more deaths projected over the next 6-12 months. Fatal outcomes are thought to be driven by inflammatory responses to the virus resulting in host-mediated tissue damage to the lung, heart, and kidney and a prothrombotic milieu. Approximately 10% of patients with COVID-19 suffer from symptoms beyond 3-4 weeks, labelled as ‘long COVID-19.’ A variety of symptoms are experienced including cough, breathlessness, fever, sore throat, chest pain and cognitive deficits. Oral colchicine has demonstrated striking anti-inflammatory properties in patients with vascular disease and a “single shot” of colchicine markedly suppresses monocyte inflammasome activation, which is pivotal in the cascade leading to the cytokine storm. Troublesome side effects with colchicine appears to be rare. Thus, this treatment may reduce the serious complications associated with COVID-19 and non-COVID-19 ARDS.

Medications to treat rheumatoid arthritis and psoriatic arthritis have possible side effects. People may be unwilling to take them if they are unaware of the benefits. Educational tools using pictures may improve people’s understanding of arthritis and medications. Musculoskeletal ultrasound (US) is useful in assessment of joint inflammation and damage. It is portable, non-invasive, and allows joint structures to be seen in "real-time". It may be rapidly done by a trained user. There is strong evidence that US is of value in monitoring the severity of rheumatoid arthritis and psoriatic arthritis. Recent work by our research group has shown that patients found real-time US more useful than written leaflets or online information for understanding rheumatoid arthritis and medications used to treat it. The aim of this study is to determine if showing people with rheumatoid or psoriatic arthritis “real-time” US of their inflamed joints: i) improves their willingness to take an extra medication which turns off inflammation (Disease Modifying Anti-Rheumatic Drug, or DMARD) and ii) increases their willingness to keep taking this medication (medication adherence) This research has been initiated by the study doctor, A/Prof Peter Wong. This research has been funded by investigator-initiated grants from Pfizer. The funding bodies have no input into conduct of the research.

Takotsubo syndrome, also known as the broken heart syndrome, is an acute and commonly reversible heart dysfunction characterised by changes in the structure of the heart. The condition is frequently triggered by a sudden physical or emotionally stressful event. It has long been postulated that an excess of the “fight or flight” hormones adrenaline and noradrenaline (collectively called catecholamines) caused by substantial activation of the sympathetic nervous system in the heart might play a key role in the development of this syndrome. However, this has not yet been proven, and the exact mechanism of Takotsubo syndrome remains subject to debate. The research project aims to better understand the biological mechanisms that cause this syndrome. In this study, we will, for the first time, directly measure the amount of catecholamines released from the heart in affected patients and explore its association with impaired heart function characteristic of the condition. Understanding the relevant mechanisms will allow more tailored therapies to further improve the management and outcomes of patients suffering from broken heart syndrome.

This trial aims to determine the effect of cognitive bias modification on fear of cancer recurrence or progression in patients with breast and ovarian cancer. Who is it for? You may be eligible for this study if you are aged 18 or above, have been diagnosed with a breast or ovarian cancer (unless you are receiving palliative care), and are currently struggling with a fear of cancer recurrence or progression. Study details Participants will be randomly allocated (by chance) to receive cognitive bias modification training (CBM) or a placebo. . CBM is an intervention that is administered online and trains people not to interpret ambiguous situations in a threatening way. Participants will receive four cognitive bias modification sessions over the duration of 14 days and will be required to answer a number of questionnaires before the trial, and both 14 and 28 days after the trial has commenced. It is hoped that this study may demonstrate that cognitive bias modification is effective in reducing fear of cancer recurrence and progression in patients with breast and ovarian cancer, and may help to reduce pain, anxiety, and depression, and improve quality of life.

Prostate cancer is the most common cancer in men, and the second leading cause of cancer deaths (25%) in Australia. There is a need for better treatment combined with reliable assessments of treatment effectiveness. The purpose of this study is to determine whether Photodynamic Therapy (PDT) is an effective and safe treatment option for patients with prostate cancer. Who is it for? You may be eligible for this study if you are an adult male with prostate cancer. Study details Participants in this study will receive one of two treatments, with the treatment decided by chance. The two treatments participants may receive are: 1. Photodynamic Therapy, which involves participants being given a chlorophyll-derived liquid food product which will help absorb light along with 25 min light therapy using a red-light laser that is delivered through a rectal probe. 2. The Photodynamic Therapy described above plus additional whole body red-light therapy, which involves lying in a red-light-bed for 25 min 4 hours after the PDT rectal laser therapy. These treatments will be provided to participants 6 times over a 9 week period. Participants will complete an assessment at baseline and at 12 weeks where they will provide a blood and urine sample, and have their prostate measured. It is hoped that this research will help determine whether Photodynamic Therapy is an effective and safe option for the treatment of prostate cancer.

The purpose of this trial is to assess the efficacy of cannabidiol (98% CBD) for sleep disturbances in healthy adults. This study will compare the botanical CBD with a placebo and evaluate its efficacy via the PROMIS sleep disturbance instrument. The study will take place in 4 sites; Brisbane, Sydney, Lismore and Melbourne. In total, the study will successfully enrol 438 participants. Eligible participants will be between 18 to 65 years old, considered to be generally healthy and self-reports sleep difficulty and quality. The trial will be 10 weeks, with an initial two-week titration period and a phone call one month after stopping medication. The study will involve a 15mg CBD per soft gelatin capsule or placebo capsule that is similar in appearance, smell and taste. The active product will contain hemp seed oil as the carrier and 0.5 mL of liquid encapsulted into a gelatin/ glycerin soft capsule. CBD will make up >98% of the total cannabinoids in the capsule. Participants will take 1 capsule after breakfast and 1 capsule 30 minutes before bed and build up to a tolerance/ maximum dose during the titration period with the maximum morning dose being 2 capsules and the maximum night dose being 8 capsules. After the titration period, the participants will stay on their maximum dose for 8 weeks or until they withdraw from the study. In total, the study should be 10 weeks in total with a one month follow up phone call after the ceasing the medication. The expected outcome is that a botanical CBD (98%) will significantly improve people's sleep who suffer from sleep disturbance more than the placebo.

Improving perinatal bereavement care after the loss of a baby is an urgent priority in Australia, and accessible perinatal bereavement care approaches that include early psychological support are required, Internet-based programs offer one solution to address this gap, particularly for primary care settings and those parents in rural Australian communities. The primary purpose of this trial is to evaluate the acceptability and efficacy of a new internet-delivered cognitive behaviour therapy (iCBT) support program in reducing emotional distress for parents who have experienced a stillbirth or neonatal death, compared with usual care. We hypothesise that participants who complete the online program “Living with Loss” will experience greater improvements in psychological distress and psychosocial health and wellbeing outcomes (e.g. anxiety, depression, decisional regret etc) than those in the usual care control group. It is also hypothesised that the Living with Loss” will be acceptable to participants with high rates of program satisfaction reported, and will be more cost-effective in improving psychosocial health and wellbeing outcomes than usual care alone.

The X-ACTA Cemented Short Stem is a highly polished, double tapered cemented stem that has been manufactured in wrought iron stainless steel, with a Polymethyl methacrylate (PMMA) distal centraliser. This unique design is suggested to correct stem positioning and provide uniform cement distribution. The aim of this investigation is to evaluate the radiological performance of the X-ACTA Short Cemented Stem device in patients following Total Hip Arthroplasty. The hypothesis for this study is that the X-ACTA cemented short stem is non-inferior to other commercially available cemented stems in terms of stability and degree of migration.

The problem: The high burden of asthma and chronic obstructive pulmonary disease (COPD) on individuals, the health care system and the community. The solution: The identification of high risk asthma/COPD and reduction in subsequent avoidable hospitalisations, through a focused approach on the prevention of frequent disease flare ups (exacerbations) and improved management of chronic and complex health conditions, associated with preventable factors. The strategy: 1.To improve the quality of primary health care delivered, reduce frequent flare ups (exacerbations) and avoidable hospitalisations. 2.To implement an electronic clinical audit process utilising electronic medical record data and patient reported outcomes, which is multidisciplinary, structured, evidence-based and embedded in practice. 3. To apply new technologies to enhance current technological capabilities, increase efficiency, maximise capacity and optimise current infrastructure. 4. To harness strategic, stakeholder partnerships to support long-term change

Up to 80% of people discharged from the ICU experience various physical, cognitive, and/or psychological complications and enduring impairment, termed ‘post intensive care syndrome’ (PICS). The prevalence and burden of PICS remains uncertain, and current interventions are not effective longer-term; further research into prevention, early diagnosis and intervention of this syndrome is considered internationally is a priority. The interlinked aims of this study are 1. To describe the predictors, correlates and prevalence of PICS, and 2. To use this information to develop screening, diagnostic and outcome measures for use in research and clinical practice.