ANZCTR search results

The purpose of the research is to evaluate the design of the ‘dyspnea challenge’, a two-minute treadmill protocol which has been developed to measure exertional dyspnea (ED) (“breathlessness”). ED is the feeling of discomfort in breathing during exercise/physical activity and it is the most common symptom of chronic heart and lung disease. It is important that a test is designed to precisely measure changes in ED over time as this will allow for the mechanisms behind ED to be better understood and for treatment pathways to be evaluated with greater accuracy. This study is looking at the impact that Pulmonary and Heart Failure Rehabilitation has on ED and whether the dyspnea challenge is able to detect any changes in ED. A minimally important difference for the dyspnea challenge will be established.

Dizziness is a common presentation to the ED. There are a wide range of differential diagnoses to consider, some of which are time sensitive and life threatening and others which are benign, of which benign paroxysmal positional vertigo (BPPV) is the most common. The gold-standard tests to diagnose BPPV are provocative manoeuvres performed during the clinical examination. From the literature we know these manoeuvres are poorly performed and interpreted in clinical practice. There is overuse of neuroimaging and medications, leading to increased health care costs, misdiagnosis, and morbidity. There exists opportunity for quality improvement in the assessment and management of the dizzy patient in the ED. This study aims to determine if educational interventions improve the performance rates of provocative manoeuvres to diagnose BPPV in a tertiary ED. We will be conducting a pre- and post-intervention retrospective chart review to determine effects of the interventions. The primary objective is to determine if the intervention impacts the performance rate of the Dix-Hallpike (DHP) manoeuvre. The secondary objectives are to determine if the intervention impacts performance rate of the supine head turn (SHT), compliance to BPPV guidelines, hospital admission rates, hospital length of stay, cost of presentations, representation rates and stroke rates. Long-term aims include acquisition of funding for translational research and implementation of education programs in collaboration with other LHDs. Future research direction may involve improved access to vestibular physiotherapy, mobile application development or incorporation of video-oculography and telemedicine for rural/remote areas. Our hypothesis is that the interventions will increase the performance rate of provocative manoeuvres for BPPV, improve compliance to BPPV guidelines, decrease use of neuroimaging, reduce hospital admission rates, and reduce cost of presentations without increased hospital representations or increased rate of strokes.

Aims: This study will assess whether pregnant women at risk for mental health concerns benefit from a model of care offering continuity-of-care throughout the perinatal period. Research question: Is an enhanced model of midwife care effective and acceptable for reducing mental health symptoms in a cohort of pregnant women at low to moderate psychosocial risk in an ethnically diverse, socio-economically disadvantaged area? Objective: Implement a maternity care intervention offering continuity-of-care to pregnant women of low to moderate psychosocial and mental health risk and assess whether parental distress was lower in the group allocated to continuity-of-care.

Many patients who have bariatric surgery already have micronutrient (vitamin and mineral) deficiencies before their surgery. However, there is no standard approach to how deficiencies are corrected. This pilot study is conducted to test the feasibility of our methods before conducting a larger study. Participants will be randomised (will not be given a choice) to one of two groups. The intervention group will be referred to a medical practitioner to have their deficiencies treated via infusions and/or injections, alongside multivitamin and calcium tablets for two weeks. The comparator group will receive relevant vitamin and mineral tablets to correct their deficiencies. They will take these tablets, as well as multivitamin and calcium tablets for two weeks. We hypothesise in this pilot study, that a larger study will be feasible to be conducted in a private clinic setting.

This will be a single-centre, randomised, double-blind, placebo-controlled, and sequential cohort study to evaluate the safety, tolerability, PK and PD of single and multiple ascending doses of SIR9900 after oral administrations in healthy adult volunteers. Male and female healthy adult volunteers aged 18 to 64 years inclusive at the time of screening are eligible for recruitment. Part 1 SAD participants (except cohort 3) will have a screening period of up to 28 days and be required on-study for approximately 2 weeks post-dose. Part 1 SAD cohort 3 (FE) and Part 2 MAD participants will have a screening period of up to 28 days and be required on-study for approximately 3 weeks post-dose. SIR9900 is a potent and selective allosteric RIPK1 inhibitor being developed for the potential treatment of inflammatory, autoimmune, and degenerative diseases, particularly in the central nervous system.

The current study aims to investigate the outcomes, benefits and feasibility of a brief evidence-based eating disorder prevention program within an Australian youth mental health service (at headspace Camperdown). This program is the Body Project program, which is a well-established eating disorder (ED) prevention program. The study aims to investigate the feasibility of this program in a sample of young Australians (between ages 12-25). Specifically, this study aims to compare outcomes (including body image concerns/outcomes, eating disorder symptomatology and general psychological distress) between the those who complete the Body Project program at headspace (our Treatment Group) and those who do not complete the Body Project program but who do continue to access their standard care at headspace (Treatment-as-usual Control group), and compare outcomes pre-treatment, post-treatment and at one month follow-up. By conducting this study we hope to assess the potential utility of such a brief and low-cost program within the headspace centre setting which, if found to be effective, could be rolled out nationally (to the 150+ headspace centres around Australia) as an early intervention approach to preventing the development of eating disorders amongst Australian youth. We hypothesise that our study results will demonstrate that attending the Body Project group program embedded into the headspace youth mental health service model will effectively reduce symptoms of eating disorders, body image concerns and psychological distress for young Australians at risk of developing an eating disorder.

In this study, we are trying to find out if a novel, inexpensive, non-invasive medical device might reduce pain associated with blood test. We are aiming to recruit participants who are undergoing regular blood tests in the setting of a fertility clinic. Given this is a pilot trial, we plan to recruit up to 40 participants and randomise them into the medical device group, or the control group. We hypothesise that our non-invasive device will reduce or eliminate pain associated with venepuncture, whilst not compromising the success probability of obtaining adequate blood sample.

The Australian Mepolizumab Registry for Chronic Rhinosinusitis with Nasal Polyps (AMR-CRSwNP) will be an electronic registry of well characterised patients with severe eosinophilic CRSwNP who receive mepolizumb treatment. It will be a national, multi-centre, observational post-marketing surveillance registry. Patients will receive mepolizumab via the Australian Commonwealth Government Pharmaceutical Benefits Scheme (PBS) or outside of the PBS restrictions. Patients will be identified for participation across multiple clinics in Australia. The central registry team will manage participant recruitment and data collection via a central telehealth model. Participants will be characterised at baseline (before starting mepolizumab) and have 12 months follow-up. The registry will provide insight into CRSwNP patient characteristics , report on mepolizumab use (effectiveness, safety) and be a databank for future research.

Sublocade (buprenorphine) is currently approved only for intra-abdominal subcutaneous injection for the treatment of opioid treatment disorder. However, intra-abdominal subcutaneous injection is sometimes poorly tolerated by patients because of certain discomfort. Using the same product in different sites may actually have a similar rate and extent of buprenorphine release. However, the rate and release profile of alternative injection sites (e.g., deltoid (shoulder) or thigh or buttock) compared to abdominal (stomach) injection is unknown. This study aims to evaluate the rate and extent of buprenorphine release and its tolerability from different injection sites in 50 patients who are on treatment for opioid use disorder. Eligible participants will be randomized to receive first injection sites and baseline samples will collected. Subsequent doses will be given in order abdomen, thigh, buttock, and deltoid. Serial blood samples will be collected after the injection for each subsequent injection.

The current evidence suggests that the optimal length of a sequence of night shifts may depend on the intensity of light that shiftworkers are exposed to during the night. If so, then OHS guidelines that recommend a blanket limit on night shifts of a maximum of 2-4 in a row may inadvertently expose shiftworkers to a higher level of fatigue-related risk than is necessary in some workplaces. In this project, we will test the proposition that shorter sequences of night shifts may be suited to workplaces where shiftworkers operate in dim light and are less likely to adapt to a nocturnal schedule, whereas longer sequences of night shift may be suited to workplaces where shiftworkers operate in normal indoor light and may be more likely to adapt to a nocturnal schedule. The project will include a multiple-day night work simulation study with three conditions. The only difference between conditions will be in the light intensity during night shifts – dim (10 lux), moderate (100 lux), and normal (350 lux) – as experienced by truck drivers, hospital-based healthcare practitioners, and control room operators, respectively. The data will be used to test three hypotheses: 1. Body clock time will get progressively later, i.e., delay, with each successive night shift, and the daily rate of delay will be smallest (or absent) in the dim light condition and greatest in the normal light condition. 2. The quantity/quality of daytime sleep will progressively increase with each successive night shift, and the daily increases will be smallest (or absent) in the dim light condition and greatest in the normal light condition. 3. Night-time alertness will decline with each successive night shift in the dim light condition, remain stable in the moderate light condition, and increase with each successive night shift in the normal light condition.