ANZCTR search results

The primary purpose of this study was to test the hypothesis, through a e-health feasibility study (Study 2), that the Prenatal Mindfulness Relationship-Based (PMRB) program could enhance the mental health of pregnant and new mothers as measured by multiple dimensions of psychological health and the relationship with their infants during pregnancy and postpartum, with positive impacts on gestation, birth and infant outcomes as reported by the mothers in a Post-Birth Questionnaire. The study also aimed to provide further information, based on available literature, about the influence of maternal interoception (embodied awareness) on maternal mental health, in particular depression, anxiety, and stress, mindfulness, and mother-infant relationship during pregnancy and post-birth, in particular emotional availability, which can contribute to the development of mind-body approaches to pregnancy healthcare.This study addressed the following research questions (RQ): RQ1: Would participation in the PMRB program lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline? RQ2: Would participation in the PMRB program lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth? RQ3: Open-ended - “How has the PMRB program supported (or not supported) you during pregnancy, labour and birth and the first postpartum trimester?” The specific hypothesis are: 1) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother infant-relationship, and higher interoception during pregnancy (in particular emotional availability), compared to baseline; 2) Participation in the PMRB program would lead to higher levels of mindfulness, better mental health (as indicated by lower levels of anxiety, depression, and stress), more favorable mother- infant relationship (referred to by the Emotional Availability Self-Report -EA-SR; Vliegen et al., 2005 as emotional availability), and higher interoception post-birth; 3) The PMRB program would support women during their pregnancy, labour and birth, and the first postpartum trimester.

The purpose of this study is to evaluate the safety and feasibility of the FloStent implant for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) in adult men. Who is it for? You may be eligible to participate in this trial if you are a male aged 45 years or over with lower urinary tract symptoms due to benign prostatic hyperplasia. Study Details Eligible participants will be scheduled to undergo a minimally invasive procedure to implanted with the FloStent. Participants will be required to attend up to 7 visits over the course of 12 months monitoring the FloStent position and lower urinary tract symptoms. Participants can choose to remain in the study for an additional 4 years after the 12 months for long term follow up. It is hoped that the findings of this trial will establish the benefits of this devices for males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia.

This project aims to test and implement a multicomponent intervention ("No More Shame") comprising a screening tool, online training, and a site champion, for sub-acute health providers, who work with older people in sub-acute care settings and may be in a position to identify and respond to elder abuse. The training and screening tool were both developed using co-design methods. The training comprises modules focused on: identifying elder abuse; drivers and risks factors of elder abuse; screening for elder abuse, and management of elder abuse. The impact of the multicomponent intervention on sub-acute health providers' recognition, response, and referral of elder abuse will be assessed via a cluster randomised controlled trial. Key objectives of this project are to: a) improve health providers' ability to recognise, respond to, and refer cases of elder abuse. b) improve older people's sense of safety and quality of life. c) determine what further refinements the multicomponent intervention requires to support national implementation. d) evaluate the cost-effectiveness of the multicomponent intervention.

Alyra Biotech Pty Ltd is an Australian-owned biopharma company that wishes to develop an optimal intrauterine contraceptive device (IUD) for people with period or pelvic pain. The use of IUDs globally is increasing, however some people experience increased pelvic pain in the 3-6 months following insertion, causing them to have the device removed. They then miss out on the benefits that IUDs can provide, such as; reducing your lifetime exposure to synthetic hormones; decreasing the amount of blood loss at each period; as well as decreasing intense period pain, over time with continual use. Alyra Biotech Pty Ltd has developed and patented a novel IUD designed to reduce the severity of post-insertion pain in those that experience it, giving them access to the benefits of IUD use. The objectives of this study are: 1. To determine how the device performs at releasing the appropriate medicinal drugs (pharmacokinetics). 2. To compare the tolerability of the new Alyra device with the currently approved for use in Australia, the Mirena 'Trademark" device. 3. To determine how much of the medicinal drugs are remaining in the device at study end. 4. To determine the effects of the Alyra Device on the endometrium using endometrial biopsies.

This research study aims to investigate and establish the feasibility, clinical accuracy of remotely-performed, robot-assisted ehocardiographic examination (echo) performed by cardiac sonographers.

SYNERGY -A synergistic research program, incorporating advanced neuroimaging, genetics and liquid biopsy, enabling fetal and newborn diagnosis, prognosis and prediction of treatment responses to prevent, treat and cure CP using precision-medicine interventions. Prevention in this context means a 40% reduction in the rate of CP, and treatment response means a reduction in the size and severity of brain injury, enabling increased function, participation in education, independent living and employment long-term. We propose to do this by bringing together this unique team to: • Accurately identifying the nature/mechanism of the brain injury very early in the fetal or neonatal period, to quantify the location, extent, mechanism and genomics of injury to determine the best prognosis and pathway to precision medicine interventions; • Integrating currently disparate measures of neural injury using cross-cutting research methods across 3 themes involving (1) neuroimaging and EEG, (2) genomics, and (3) liquid biopsy; • Synthesising and converging outputs from themes 1-3 using machine learning (ML) methods to inform theme 4: Translation to precision-medicine trials to prevent, treat and cure CP. • Developing systems to comprehensively monitor how these biomarkers, genomics and precision-medicine interventions impact both the incidence and severity of CP at a population level using our national CP population register (Australian Cerebral Palsy Register, largest country-wide register).

This prospective interventional study will collect data pertaining to demographics, pre-injury factors, injury circumstances and concussion symptomology via online platforms for consenting participants who meet the inclusion and exclusion criteria. These data elements will be correlated with recovery, particularly time to symptom resolution, using machine learning approaches. The output from the machine learning models in the first phase of this project, will be used to revise care recommendations provided through the app. To evaluate the efficacy of the revised care pathway, the time to symptom resolution from the original HeadCheck recovery pathways will be compared to the revised care recommendations in the second phase of the project. Ongoing data collection will form the AUS-mTBI Registry that will enable additional research projects to be undertaken using the collected data to inform clinical decision making, patient care and optimal healthcare for people with mTBI.

Anaemia affects nearly a quarter of the world, and is common in surgical patients with a third of patients presenting with preoperative anaemia and three quarters of patients discharged from hospital with anaemia. The World Health Organisation defines anaemia as an insufficient circulating red cell mass, with a haemoglobin (Hb) concentration of < 130 g.l-1 for men and < 120 g.l-1 for women. Peri-operative anaemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogenic blood transfusions, which is an independent risk for poorer patient outcomes. The most common cause of preoperative anaemia is iron deficiency, which can be caused by reduced or impaired dietary iron absorption, chronic blood loss, or disruption of normal iron metabolism due to co-morbidities or inflammation, aetiologies commonly seen in patients undergoing major abdominal surgery, which causes an increase in hepcidin production resulting in functional iron deficiency, and reduced red cell production. Surgical anaemia can be due to chronic disease, blood loss at operation or secondary to surgical inflammation. Cytokines (particularly IL-6) upregulate hepcidin, the master regulator of iron homeostasis, which prevents iron transport leading to failure of dietary iron absorption, and sequestration of iron within macrophages. This leads to functional iron deficiency and subsequently anaemia of chronic disease. The efficacy of intravenous iron therapy may be impacted by the balance between the inflammatory modulation of iron sequestration and bone marrow suppression with the hypoxic drive for erythrogenesis. Although efficacy of intravenous iron was shown in the IRONMAN trial - performed in patients following ICU admission - and the PREVENTT trial in preoperative patients, the one size all approach may not be precise. Consequently, in the surgical pathway, the optimal timing and modality is unknown. The outcome of this research will provide evidence on the efficacy of post-operative iron administration to treat anaemia in surgical patients. The study will also provide feasibility data to help support a larger future trial.

Memory problems in Alzheimer's disease (AD) are linked to disruptions in the connections between brain regions. In a recent study we demonstrated that Theta Burst Stimulation (TBS), a type of brain stimulation, can alter the connections between brain regions and improve memory in patients with AD. We now propose a randomised controlled trial to examine whether TBS can lead to lasting improvements in 168 individuals with mild to moderate AD. We plan to compare active vs sham (placebo) TBS. Treatment will involve a 6-weeks of daily treatment (Monday – Friday) followed by a 6-weeks of once-weekly treatment. Treatment will be individualised for each participant. This means that stimulation will be based on the individual participant’s brain activity, recorded using electroencephalography (EEG). Additionally, the treatment will be delivered to four areas of the brain, the locations of which will be identified for each participant using a brain scan: a functional magnetic resonance imaging (fMRI) scan. We will examine changes in brain activity, memory and other symptoms of AD before and after treatment, as well as at 3, 6, and 12 month follow ups. If effective, individualised TBS could be used as a new therapy for AD.

This is a 3-arm study using psilocybin-assisted psychotherapy. A randomised controlled, multi-arm design will be used with the same control group all the way through the 57 weeks of the study. Potential participants will be screened to ensure suitability for trial inclusion, and 160 participants will be accepted into the trial upon completion of informed consent. The schedule for all participants will consist of two courses of therapy separated by 4 weeks, each course is comprised of a dosing session plus preparatory and post-integrative psychotherapy sessions with a co-therapist dyad that will generally consist of one female and one male therapist. After the 3-month face to face follow-up session, a third course of therapy (preparatory, dosing, post-integrative) will occur. Participants randomly allocated to the treatment arm will receive an active dose of psilocybin during the first two dosing sessions. Participants in the treatment arm will then be randomly re-allocated to receive either active psilocybin (Arm 1) or an inactive placebo (Arm 2) for the third and final dosing session. Participants allocated to the control group (Arm 3) will receive an in-active placebo at all three dosing sessions. Self-report follow-up assessments will be conducted for all participants every 4 weeks after the first dose-session until 12 months after the second dosing session. Face to face follow-up sessions will occur at 3 months, 6 months and 12 months after the second dosing sessions.