ANZCTR search results

Remote monitoring (RM) has been established as advantageous in the follow-up of patients with implantable cardiac devices as a safe alternative to standard clinic follow-up. While RM is associated with various benefits, compliance is often sub optimal suggesting a more intensive model of RM is required. The aim of the current trial is to determine the clinical utility, feasibility and workflow of implementing an intensive RM program compared to standard RM in patients with implantable cardiac devices. We hypothesize that time from event to action will be shorter for patients in the intensive remote monitoring program compared to participants in the standard remote monitoring program.

This study is being conducted to determine the feasibility, acceptability, and effectiveness of online singing groups as an intervention for wellbeing and symptom management in participants with COPD and interstitial lung disease (ILD) in Australia. Online delivery is important to determine feasibility and acceptability of alternative delivery models to improve accessibility and equity. Previous studies have shown some benefits to singing groups for COPD patients, but no randomized, controlled trials have been conducted in Australia or in participants with ILD. Singing is not anticipated to present risks or adverse effects based on previous cilnical trials and widespread implementation in the UK.

This project will investigate the impact of a professional development training program, (herein called the Training) for early childhood educators that has a focus on improving the communication interactions with children in their care. The Training is a modified version of Learning Language and Loving It [Trademark] Online program developed by the Hanen Centre [Registered Trademark] and modified by the current research team to suit the needs of the local community. The modification has been approved by the Hanen Centre [Registered Trademark]. Previous research by the current team established that educators reported increased confidence using trained interaction strategies following the Training. The current study will evaluate the direct change in child and educator language use during communication interactions before and after the Training. We hypothesise that participation in the Training leads to positive child and educator communication outcomes including an increase in the number of interaction skills used by educators following Training, and the number and complexity of words used by children during these interactions. Eligible educators and children will be paired by centre of attendance and language background. Children will be aged 24-42 months and have typically-developing communication skills. Twenty-four educator-child pairs will be recruited in two groups: Group A and Group B. Each group of educators will receive the 8-week Training in two separate stages; Group A in Stage 1 and Group B in Stage 2. This will allow for control and follow-up comparisons to be completed. Demographic information will be collected from educator and child participants before any training commences. In addition, 15-minute educator-child interactions will be video recorded at four time-points within their early childhood education centre. Measures will examine the extent to which educators use target interaction strategies and the way children use language in these interactions. This project will help to address a critical gap in knowledge about whether this modification of the Learning Language and Loving it [Trademark] Program has a direct impact on children’s communication outcomes.

HepTemp is a prospective observational study of heparin pharmacokinetics whereby the effect of therapeutic hypothermia on heparin clearance will be observed at different temperatures in individual patients and compared with the equivalent rate of clearance when the same patient is returned to normothermia at the end of cardiopulmonary bypass, prior to separation. Mathematical modelling to demonstrate the changes in elimination time constant with differing temperatures will be derived to allow correction of existing mathematical models of heparin elimination.

(S)-S-adenosylmethionine (SAMe) is a physiological co-substrate, involved in cellular metabolism. SAMe is available as an over-the-counter complimentary medicine with an emerging role in the treatment of depression. Pre-menstrual spectrum disorders, including pre-menstrual syndrome (PMS) and pre-menstrual dysphoric disorder (PMDD), are highly prevalent and often treatment elusive. This study proposes a pilot open label clinical trial of SAMe in women with PMS/PMDD. 30 women will be recruited between the ages of 18-45 years old who experience regular menstrual cycles. Participants must have a diagnosis of a PMS or PMDD, or meet the criteria for diagnosis as determined at recruitment. Data will be collected over a 16-week period, involving the completion of questionnaires, including at baseline, and on day one of menstruation for a total of four menstrual cycles, alongside a daily pre-menstrual symptom questionnaire. Participants will receive SAMe 1200mg oral / day (400mg tablet taken three times per day) for 14-days prior to menstruation for two consecutive menstrual cycles. It is expected that SAMe will reduce pre-menstrual symptoms, and reduce symptoms of depression, anxiety and stress in treatment cycles compared to control cycles (no SAMe treatment). This novel study may provide preliminary evidence to support a future placebo-controlled double blinded randomised control trial.

The AIROPLANE trial aims to evaluate the effect of commencing respiratory support at birth, in preterm infants born 32 to 35 completed weeks’ gestation, with either 30% or 21% oxygen. The primary outcome is the need for ongoing respiratory support upon leaving the delivery room. This study will be conducted as an unblinded, multi-centre, cluster randomised crossover trial, with recruitment occurring over a 2 year period, overlapping with GenV recruitment. We hypothesise that if respiratory support is required during transition at birth, commencing with 30% oxygen will be superior to commencing with 21% oxygen, resulting in improved transition and less need for ongoing respiratory support.

Pain is multifactorial and involves both biological and psychological components. Multi-disciplinary treatment approaches incorporating drugs, cognitive-behavioural therapy and exercise interventions are the most efficacious for managing chronic pain. Single sessions of exercise and pain education are both demonstrated to have positive effects on pain in people with chronic pain such as osteoarthritis, however it is not known whether pain education delivered immediately prior to exercise can enhance the efficacy of exercise in relieving pain. Recent studies from our group have identified that the pain relieving effects of exercise involve a psychological component that influences the appraisal of pain; this would likely be augmented by a combination of exercise and education. The current project will examine the effect of explicit pain education about the pain relieving effect of exercise, compared to more general exercise and pain education, on pain responses to exercise in people with chronic osteoarthritis). The results will provide insight into the impact of pain education on the pain response to exercise and may have implications for how exercise and pain education are combined in clinical practice in the management of chronic pain

This is an investigational agent within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. This investigational agent (MBG453 - a new treatment) will be evaluated for its activity alone and in combination with azacitidine in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your minimal residual disease (very small amounts of disease) is rising. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details Participants who choose to enrol in this study may be randomly allocated by chance (similar to flipping a coin), to receive either MBG453 alone or MBG453 with azacitidine or another available treatment option within the Intercept platform which the TMC has indicated are your best treatment options. MBG453 is given intravenously by itself (treatment A) or in combination with azacitidine therapy administered either intravenously or subcutaneously (injections under the skin, Treatment B). Participants who receive Treatment A will have MBG453 administered as a single 800mg intravenous dose on day 1 of a 28 day treatment cycle for 12 cycles. Participants who receive Treatment B will have daily 75mg doses of azacitidine during the first week of a 28 day treatment cycle and 800mg of MBG453 on day 8. This treatment will also continue for 12 cycles. After 100 days on therapy, participants in Treatment A who are not responding to the single therapy may be re-allocated to Treatment B for another 12 cycles (after rescreening for eligibility). Participants will undergo a disease assessment at screening after cycle 1, cycle 3, cycle 6 and then 3 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that MBG453 will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

The purpose of this trial is to compare the visual performance of various spectacle films (test) against films without optical features (control). Visual performance will be assessed with vision testing and questionnaires completed by the participant. The films are made of polycarbonate material and have been designed to provide optical features for the use by people with short-sightedness. It is hypothesized the visual performance of test films will be no different to the control film.

Cardiogenic shock (CS) is a clinical syndrome which is characterised by cellular and tissue hypoxia due to either inadequate oxygen delivery, increased oxygen demand, or a combination of these processes. It may present on a clinical spectrum ranging from occult hypoperfusion (with preserved blood pressure) to fulminant circulatory collapse. For patients presenting with CS, approximately 80% of cases can be attributed to an underlying cause of acute coronary syndrome (ACS). In patients with refractory CS that is not responsive to conventional measures such as fluid resuscitation, inotropic or vasopressor supports and revascularisation, mechanical circulatory support (MCS) can represent a reasonable salvage therapy. To date there is no data assessing the impact of various support modalitites on coronary physiology. We aim to characterise coronary perfusion in the shocked state, comparing and contrasting the impact of various support strategies.