ANZCTR search results

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 Our unpublished consumer data indicate high acceptability and strong maternal demand for this proposed innovative approach,85% of women surveyed indicated they would be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.

Aim: The overall aim of this research is to report on maternal weight status prior to pregnancy and nutrition status (weight gain, oral intake, micronutrient deficiencies) during pregnancy after bariatric surgery and its association with maternal and offspring outcomes.

Children can sometimes have pulsed dye laser procedures for birthmarks and scars without a general anesthetic. Instead of having a general anaesthetic, they instead have pain relief (paracetamol/ibuprofen) before their procedure and have access to additional pain relief during the procedure if required. It is unclear if, in this situation, children might benefit from having a numbing cream (topical anaesthetic) applied to their birthmark or scar before the laser. Any medications have their own risks associated with them, so we want to make sure that if we do start routinely using numbing cream in these situations, that it brings enough of a benefit for children that it would outweigh any associated risks with using numbing cream. We would like to do a study that looks at children's pain scores during and after laser procedures, and whether there is a difference in pain scores of children who have had numbing cream compared to children who receive a placebo (non-active) cream. The first step of doing such a study would be to check that it is feasible to do, and acceptable to everyone who might participate. That is what this feasibility pilot study will aim to do.

To examine the feasibility and acceptability of a 12-week VILPA intervention to increase physical activity (PA) in insufficiently physically active adults who are transitioning to retirement. This study will be a pilot randomised controlled trial with two groups of participants using the adapted Consolidated Standards of Reporting Trials (CONSORT) statement. Eligible participants will be randomised to either a waitlist or intervention group. The intervention group will receive the intervention for 12 weeks. The waitlist group will receive current physical activity recommendation by the World Health Organization until the intervention group has completed their 12-week trial.