ANZCTR search results

This study will investigate the association between left atrial compliance on AF type (paroxysmal versus persistent), patient symptoms, exercise tolerance, left ventricular function and long-term prognosis. The hypothesis is that left atrial compliance will be increased in patients with persistent AF compared with those with paroxysmal AF and may be correlated with patient symptoms, exercise tolerance and long-term outcomes of AF ablation. This will be the first study to assess left atrial compliance using direct measurements of the left atrial dimensions and pressure and direct infusion of saline into the left atrium.

"Approach bias modification" (ABM) is a computer-based, behavioural "brain-training" intervention that has been shown to help prevent relapse in people receiving residential treatment for alcohol use disorder (AUD). However, very few studies have tested whether ABM can be delivered as a smartphone app, and whether an ABM app can benefit heavy drinkers in the community who are not engaged in residential treatment. There have also been no studies examining whether it is useful to "personalise" ABM by allowing participants to select the stimuli used in the training task. We have developed "SWIPE", an ABM smartphone app, in which participants are trained to avoid alcohol-related images by "pushing them away" (which causes the image to shrink and then disappear), and approach positive images by "pulling" them, causing them to enlarge, Unlike previous alcohol ABM tasks, which use a standard set of images for all participants, SWIPE is personalised. Participants are prompted to select alcohol-related and positive images that are most relevant to them to use as training stimuli before commencing training. Additionally, SWIPE is "gamified", awarding points to participants for the speed and accuracy of their response, and encouraging them to try to improve their score on subsequent training sessions. We aim to test the feasibility and acceptability of SWIPE in people reporting hazardous alcohol use, recruited from the general community. In addition, we aim to gather data on drinking, alcohol craving, and alcohol dependence outcomes following training to assess whether these decrease after using SWIPE, since that would help determine if it is worth proceeding to a controlled trial testing its efficacy. We hypothesise that: 1. We will recruit 500 participants within 3 months of launching the app, supporting the feasibility of this programme. 2. At least 60% of participants will complete 8 sessions of ABM, supporting its feasibility and acceptability. 3. Mean ratings of the app will be greater than 3 on each subscale of the Mobile Acceptability Rating Scale, demonstrating adequate acceptability. 4. There will be statistically significant decreases in number of standard drinks per week, number of days on which alcohol was used in the past 7 days, alcohol craving, and Severity of Dependence Scale scores at the end of the 4-week intervention, relative to pre-training scores, suggesting its potential effectiveness. 5. The more sessions of ABM that participants complete, the larger will be the reductions in alcohol drinking, craving, and dependence symptoms. 6. The reduction of drinking over the intervention period will be larger in those with more severe baseline alcohol use/problems, and also larger in those with greater motivation and confidence to reduce alcohol use. We also intend to explore participants’ reaction time and error rate data from their ABM sessions as this will inform further refinement of the app after this study is completed.

Children frequently present to the emergency department with forearm injuries and often have an x-ray to assess if there is a fracture. Due to the soft and plastic nature of the bones in young children, injuries can cause their bones to bend, known as a buckle fracture. Bedside ultrasound is a test that emergency practitioners can use to rapidly diagnose a fracture at the time of examination, without exposing children to ionising radiation. Ultrasound in this setting is well tolerated, only requiring light touch and gentle manipulation of the forearm and has similar accuracy when compared with x-rays for diagnosing children’s forearm fractures. This is the first trial to assess whether an x-ray is unnecessary when there is either a buckle fracture or no fracture seen on a portable ultrasound machine. This is important as they can be treated at the time of review without any further delay and will avoid these children being exposed to ionising radiation. Children will be randomised to receive either an ultrasound or x-ray for their forearm injury. Both groups will be followed up to see whether there are any differences in their recovery and to determine any complications. We will also determine the time and cost implications of this new approach, which could enable families to go home earlier and could be more cost-effective, with less x-rays being ordered. It is hypothesised that ultrasound is non-inferior to x-ray imaging for the diagnosis of paediatric distal forearm fractures and that it is cost-effective.

Over the last decade there has been increasing recognition of psychological distress experienced by doctors (Mata, Ramos et al. 2015, Zhou, Carder et al. 2017). Emerging evidence suggests that increasing numbers of doctors find it difficult to manage the demands of their roles alongside their personal lives, which can potentially negatively impact on the quality of patient care they provide (Blue 2013, Dawson 2014). At a time where the world is facing the unprecedented global challenge of the COVID-19 pandemic, the issue of psychological distress among our medical staff is of great importance. Research surveying healthcare workers from areas most affected by the COVID-19 pandemic, such as China, show results suggesting that around 50% report some symptoms of poor mental health, including depression and anxiety (Lai, Ma et al. 2020). Doctors play a leadership role in system responses, supporting teams, and adapting ways of providing care for patients. A recent review in JAMA highlighted the importance of supporting medical staff with 5 simple requests: “hear me, protect me, prepare me, support me, and care for me” (Shanafelt, Ripp et al. 2020). A critical part of this support is to provide a safe space for staff to reflect, learn, and find solutions to their issues. This can be achieved using the positive psychology approach of professional coaching. One study has evaluated an individualised coaching program in a sample of physicians, demonstrating significant improvements in emotional exhaustion, burnout, quality of life, and resilience (Dyrbye, Shanafelt et al. 2019). The aim of this study is to reduce psychological distress and improve positive psychological outcomes in Senior Doctors at Liverpool Hospital during the COVID-19 pandemic.

People confirmed positive with COVID-19 are often managed at home in home isolation and receive regular contact from the hospital team to manage their care. This study is to assess the feasibility and suitability of the Everion armband device on top of this management for COVID-19 high risk patients under home isolation period.

Nightmares and nighttime worries are substantial contributors to decreases in child sleep duration and quality, and have been shown to have a myriad of adverse effects on child development and well-being. As these phenomena are pervasive, there is a critical need to provide parents with simple parenting practices that will help their children cope with nightmares and promote better sleep. This project aims to determine whether parents who provide their children with an imagination-based technique (specifically, a ‘Dream-Changer’ remote) subsequently report fewer child nightmares and improved sleep, compared to parents who do not use this technique. The value of identifying such accessible, straightforward, low-cost interventions to promote child sleep and well-being is of vast value and significance.

Endovascular aneurysm repair (EVAR) is a widely used surgical technique for the treatment of abdominal aortic aneurysm, an increasingly common pathology. The Achilles heel of EVAR is endoleak, which is the persistence of blood flow into the aneurysm sac following stent deployment. Vascular surgeons are keen for a preventative and non-invasive option to reduce the incidence of type II endoleak, which is the most frequent type and the most common indication for re-intervention after EVAR. Two international studies have suggested that there is a relationship between reduction in peri-operative blood-pressure and the likelihood of developing endoleak. The BOLD study aims to assess this relationship in a more realistic, achievable and scientifically robust fashion. We will recruit patients who are booked for EVAR electively into two groups, an INTERVENTIONAL group and a CONTROL group. Both groups will self-monitor and record their blood-pressures twice-daily and attend weekly in-person/phone/telehealth appointments. In the former group, we intend to target a systemic blood-pressure of <120mmHg by actively adapting the patient's blood-pressure medications on a weekly basis for the 3-weeks before, and 6-weeks after surgery. We will then compare the outcomes between the groups, with respect to (1) the incidence of type II endoleak at 6-weeks post-operatively, (2) the rate of aortic re-intervention at 6-weeks post-operatively and (3) the rate of aortic rupture at 6-weeks, 6-months and 12-months post-operatively. We hypothesise that the INTERVENTIONAL group will see a significant reduction in these 3 outcomes.

In this research project we will investigate the feasibility of conducting a study on how an instrument (Activator IV) used by Chiropractors to deliver spinal manipulation affects pain sensitivity in healthy adults. The Activator IV is a spring- loaded device that delivers a rapid short thrust instead of hand-delivered spinal manipulation. The study aimed at comparing the effect of two interventions (real and sham) and no intervention (control group) on pain sensitivity, among healthy participants. The sham intervention replicates the experience of the actual instrument (Activator IV) while producing no force to the targeted spinal area. Mechanical pain sensitivity also referred to as pressure pain threshold will be recorded using a device called a digital algometer. Recordings will be taken before and after the respective interventions, as stated above. We hypothesize that significant changes in mechanical pain sensitivity will occur after the real instrument compared to the sham and control. We also hypothesize that recruitment rates will be achieved in the timeframe outlined.

The purpose of this study is to assess the safety, tolerability of the drug INCB106385 and assess how this drug acts in the body with and without food in increasing doses and assess how this drug interacts with esomeprazole, a PPI. You may be eligible for this study if you are a male or female, aged 18 to 55, and you are in good health with no existing conditions. All participants will provide blood and urine samples. Participants in this study will be randomized (by chance) in each of the 7 cohort. In Cohorts 1-5, all participants will either receive a single dose of the drug or placebo (orally in a fasted condition (no food). In Cohort 6 all participants will be randomly assigned to treatment A or treatment B groups and then crossed over to the other treatment group (A or B) after a washout of 7 days. Participants in treatment A group will be dosed after fasting of 8 hrs. Participants in treatment B group will be fed a high-fat calorie meal before 30 min of dose administration. In Cohort 7 all participants will be dosed with drug on day 1 and dosed with esomeprazole on day 5-9 and on day 10 participants will be dosed with drug and esomeprazole. It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions and the impact of changes in gut pH. Results from the study will affect how patients with cancer take the drug in regards to their meals.

This is a multi-centre prospective cohort study to collect data related to the management of metastatic triple negative breast cancer (TNBC) in a routine clinical practice patient population, Who is it for? Patients of any age, gender and ECOG performance status diagnosed with metastatic, or inoperable TNBC (either relapsed or newly diagnosed metastatic disease), after 1st July 2018. Study details It is intended to collect real world data on the duration of therapy, the rationale for any change in treatment and uptake of targeted therapies or immunotherapy. This study will also collect comprehensive data on any treatment received in the (neo) adjuvant setting given that the type of chemotherapy regimen selected often impacts on treatment decisions in the metastatic setting. Where applicable, data on trimodality treatment of primary breast cancer and metastatic disease will also be recorded. Patients will not be required to do anything extra, we will just be collecting, demographics (age, any other diseases you have, how well you feel) whether you have had a test to check any gene mutations, like BRCA, where your cancer has spread to and any treatment information (chemotherapy, surgery, radiotherapy). This study will give us real life information about how various chemotherapy and other treatments are used in patients with advanced TNBC in routine practice in terms of when and in what combination, and how these variations in practice might influence patient outcomes.