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There is increasing awareness that adaption of existing PSTD treatment approaches for CTSD has had mixed results for individuals who have experienced interpersonal traumas and childhood adversity; often there is a demonstrated attenuation of PTSD symptoms, yet the challenges related to difficulties with DSO remain. There is an internationally recognised need to develop evidence-based clinical interventions that focus on the emotional-, interpersonal-, and self-, dysregulations involved in DSO, and are purpose-built to improve functioning. To date, treatments for the symptoms of DSO have leveraged those more commonly used for personality disorder, such as Dialectical Behaviour Therapy (DBT). DBT is resource intensive, often delivered through extensive one to one therapy over an extended period (up to 2 years) and is not ‘purpose built’ for DSO arising from trauma experiences. It is thus less efficient and less effective than the proposed INTEGRATE program. INTEGRATE is a novel 12-week group-based therapeutic intervention that has been developed in response to this identified need. Importantly, INTEGRATE has been carefully designed to situate as complementary to existing best-practice approaches for treatment of PTSD. The purpose of this study is to evaluate implementation feasibility of INTEGRATE with a community-based sample in collaboration with a Northern Territory (NT) government supported local community service for people who have experienced sexual assault, the Sexual Assault Recovery Centre (SARC). The project has the following aims: 1) to evaluate recruitment capability and gather information about the characteristics of the sample, 2) to evaluate the data collection procedures and outcomes, 3) to evaluate how well the INTEGRATE program is received by participants and suitability of the intervention and data collection procedure for future trials, 4) to gather preliminary evaluation data regarding participants response to the INTEGRATE program, and 5) to gather insights from facilitators and service providers about their perceptions of participants response to INTEGRATE, their evaluations of the benefits, challenges, and impacts of the INTEGRATE program at a client and service level, and identified areas for improvement. Longer-term, the success of INTEGRATE will have both social and economic value to the Australian, and international, community. As a complementary program to those dealing with the symptomology of conventional PTSD reactions, INTEGRTATE will enhance client recovery and act to reduce waitlists of traditional services. INTEGRATE will also reduce treatment costs associated with more lengthy and less efficacious approaches to DSO symptomology. Importantly, INTEGRATE will support holistic client recovery and therefore client function, attenuating the social and economic costs of long-term disability.

Medicine related harms are a national problem, contributing to 250,000 annual hospital admissions and increased health care costs. Medication harms are an even larger issue for residential aged care, with a report showing over 95% of residents experiencing one or more medicine related problems. The ADEPT project is a joint project between the University of South Australia, University of New South Wales, and Flinders University. Our aim is to develop and implement a digitally enabled, evidence-based, pharmacist service to actively detect medicine harms in residential aged care, and to determine the extent to which this model of care reduces medicine induced deterioration.

Bacteria in biofilm contributes to the persistence and recurrence of infection within the middle ear. Our preliminary data shows that as well as biofilm being present on the surface of the middle ear mucosa, bacterial biofilms are also present within extensive DNA scaffolding in the viscous middle ear effusion (MEE). We have demonstrated otopathogenic bacteria both in biofilm microcolonies and singularly throughout DNA strands within 92% of MEEs tested. The DNA appears to be mainly neutrophil derived and is largely produced via an active immune mechanism known as neutrophil extracellular traps (NETs). The extensive DNA stranding and the involvement of biofilm microcolonies is similar to what is observed in broncho-alveolar lavage fluids from children with cystic fibrosis (CF). This DNA increases the viscosity of the sputum in the lung and it is within this viscous fluid that bacterial biofilm aggregates exist. Sputum viscosity is targeted in CF through the use of a recombinant human deoxyribonuclease I (Dornase alfa or Pulmozyme®). Dornase alfa acts to selectively cleave DNA which reduces fluid viscosity and allows bacterial clearance from the lung. We propose that administration of Dornase alfa to the middle ear at time of VTI may help to reduce the viscosity of the MEE and thereby permit clearance of the bacteria that are the cause of recurring ear infections. Our preliminary in vitro studies have demonstrated that Dornase alfa successfully dissociates the DNA scaffolding in MEE from children with OM. Dornase alfa is used extensively in the treatment of CF in adults and in children and has been proven both safe and efficacious in humans when administered by inhalation via a nebuliser. These patients are often administered with 2.5ml of a 1mg/ml solution of the enzyme twice daily. Furthermore, Dornase alfa has been tested in a chinchilla model, testing for toxicity to cochlear outer hair cells and any changes in the auditory brain response following application to the round window. These studies determined that Dornase alfa is non-ototoxic when administered into the middle ear of chinchillas. This group has subsequently gone on to conduct a clinical trial investigating the use of Dornase alfa to unblock clogged ventilation tubes (VTs) in children (ClinicalTrials.gov identifier: NCT00419380). The aim of this study is to evaluate whether Dornase alfa treatment at the time of ventilation tube insertion (VTI) will break down the DNA scaffold and the associated biofilms in the MEE improving bacterial clearance from the middle ear. We believe this will reduce the recurrence of infection and reduce the number of repeat VTIs.

The purpose of this pilot comparative effectiveness trial is to estimate the standard deviation of the primary outcome (% grams wastage of oral nutrition supplements (ONS) among hospital patients) for a larger definitive trial.

Problem: In the last 10 years, rates of induction of labour amongst first-time (nulliparous) mothers have increased by 43%, from 32% to 46%. Situated in the context of soaring medical costs, few significant improvements in perinatal outcomes have been realised in the last decade. Despite escalated investment and medical intervention, rates of stillbirths, neonatal deaths and maternal mortality remain largely unchanged. Conversely, rates of maternal and neonatal morbidity have increased, with rising rates of induction of labour, caesarean section, epidural, episiotomy, postpartum haemorrhage, maternal and neonatal birth trauma and sepsis. Evidence indicates that induction of labour in the absence of medical compromise may increase the risk for iatrogenic harm to the mother and baby. Solution: Melatonin, a hormone released by the pineal gland, is essential for healthy spontaneous labour. Whilst it is naturally produced in the body at night, contemporary environmental impacts such as increased exposure to blue light and shorter sleep periods compete with melatonin production and release. This proposed clinical trial (randomised, double-blind, placebo-controlled trial) will test what would be a high-impact, high-value, low-cost solution aimed at potentiating spontaneous labour and reducing the rates of labour induction. This meets both the requirements for reducing unnecessary interventions while addressing some of the safety concerns about the risks associated with pregnancy extending beyond 41 weeks as outlined below. The aim is to determine if oral supplementation with 3mg melatonin from 39 weeks gestation in nulliparous women will reduce the induction of labour rates. Our unpublished consumer data indicate high acceptability and strong maternal demand for this proposed innovative approach,85% of women surveyed indicated they would be interested in participating if this exact trial were available to them.

Deep brain stimulation (DBS) involves the surgical implantation of two electrodes (one for each hemisphere of the brain) within the subcortex (the region of the brain below the cortical surface). These are connected by wires that run underneath the skin to a pulse generator (a brain pacemaker) that is implanted in the chest wall. A small (millimeters in diameter) electrical field is generated around the tip of the electrode and this changes local brain activity and activity in brain regions connected to the site of stimulation. We recently published the first Australian, randomised, double-blind, sham-controlled trial of DBS for treatment-refractory obsessive-compulsive disorder (OCD). All cases were completed at St Andrew’s War Memorial Hospital in Brisbane, Australia. Amongst 9 participants, the average reduction in OCD symptoms after 12-months of stimulation was 50%, with 7 of those 9 showing a clinically-significant response resulting in an improved quality of life. In this new trial funded by the National Health and Medical Research Council, we will implant a DBS device in a further 5 participants with treatment-refractory OCD. We will use a device that can record local neuronal activity as well as stimulate, and that is also approved for postoperative magnetic resonance (MR) neuroimaging. Therefore, this research will not only provide further evidence of the effectiveness of DBS for OCD, but it will also measure local and global changes in brain activity. These advances will help close a significant knowledge gap: how DBS changes brain network activity to reduce OCD symptoms. In turn, this will help us develop more effective stimulation paradigms for OCD.

In an Australian context, there is a paucity of information regarding the uptake, safety and outcomes of veno-venous bypass during liver transplantation. We seek to characterise contemporary practice at a major Australian center and will conduct an observational study, describing the baseline characteristics, intra-operative course and postoperative outcomes for patients receiving VVB. Through this case series, we aim to explore the persisting indications and practicalities of veno-venous bypass in a modern era of selective use. Who is it for? You may be eligible for this study if you are an adult patient over 18 years of age who underwent liver transplantation at Austin Health and required veno-venous bypass as part of your standard of care. Study details This study will be conducted using a review of medical records, and no patient contact will be required. The study will review the medical records of adult patients who underwent liver transplantation at the above Hospital between March 2008 and March 2022. It is hoped that this research will help to provide a better understanding of outcomes associated with venous venous bypass during surgery in this unique patient cohort.

This study is testing a new radiation therapy device, a rotating chair, as an alternative to the normal treatment position (lying down) for patients with either head and neck or lung cancer. The main purpose of this research is to find out if the images we take of patients seated in the radiation therapy chair are suitable for positioning a patient during radiation therapy, which is essential to ensure that the therapy can be delivered to the target area. Who is it for? You may be eligible for this study if you are aged 50 years or older, you have been scheduled to receive radiation therapy for either lung cancer or head and neck cancer, you are able to move into a sitting or a lying position independently and you are willing to have routine radiotherapy in the afternoon. Study details All patients who choose to enrol in this study will be asked to participate in three main sessions, a seated simulation session (30 minutes), a seated imaging session and questionnaire (approximately 60 minutes), and a follow up questionnaire (approximately 15 minutes). These sessions are in addition to a radiation simulation session and multiple radiation treatment sessions which are a part of usual care. During the seated sessions, participants will be asked to sit in the rotating radiation therapy chair. The chair is rotated by a small electric motor, in a similar motion to how an office chair rotates. Study participants will be rotated very slowly – it will take 1-2 minutes to do two full rotations. There will be no extra visits to the hospital if you choose to take part in this study, all additional sessions will be scheduled on days you would be attending hospital for usual care. In the seated simulation session, we will introduce participants to the rotating radiation therapy chair. Our therapists will adjust the chair to a comfortable position and setup equipment to help keep participants still. In the seated imaging session, we will take an image similar to a CT image (CAT scan) by rotating participants in the chair whilst taking a series of x-ray images. This image will be assessed to see if it is suitable for positioning patients for radiation therapy in the future. We will also take x-rays to test if a patient’s body position changes while sitting in the chair, and if we would be able to set a patient up in the same body for multiple treatments in the future. Participants will be interviewed about their experience of both lying down for routine treatment and sitting in the rotating chair. Patients will be interviewed with a follow-up questionnaire, after one of their routine radiation treatments near the end of their treatment course. It is hoped this research will determine whether use of a rotating chair for radiation therapy is possible and whether this method of delivery is comfortable for participants. If this study demonstrates that is possible, a larger study to test treatment with the chair may occur in the future.

This study is a randomised controlled trial (RCT) utilising a single virtual site, the virtual Nurse on Call (NOC) platform. Participants will be recruited by contacting NOC and following the ascertainment of their eligibility by the nurse from NOC, eligible patients will be randomised to either receive advice to attend a physical emergency department or to contact the VVED. 1,142 participants will be included with 571 in each trial arm. Follow-up will continue for one week to observe participants’ health service use but the trial itself will take place over the course of several months until the last patients have been recruited and follow-up is completed. The outcome is patient’s use of either the VVED, physical ED, or admission to hospital and will be used to reflect the acceptability of NOC advice by patients.

PMDD is a common condition that causes significant distress and disruption to daily life. The treatment options for PMDD are limited, however, newer forms of COCPs are becoming available and investigation of its efficacy is urgently needed. Moreover, no study to date has directly compared the efficacy of the first-line treatment options for PMDD. The proposed study aims to investigate whether nomegestrol acetate/17-beta estradiol (Zoely) or sertraline (Zoloft) is more effective in reducing symptoms of PMDD.