ANZCTR search results

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.

The overall aim of this project is to investigate the feasibility of implementing facial taping via a hybrid model of care (in-person and telehealth) to inform the design of a larger randomized control effectiveness trial. This is a nonrandomised pilot and feasibility study which will consist of two study arms; a treatment arm consisting of participants recruited from GCUH and PAH sites, and a control arm recruited from ACH. Several validated assessment tools will be used to define facial palsy. Recruitment to the treatment arm will be of adults with central facial palsy resulting from stroke who reside within 50km from either tertiary hospital site and meet inclusion criteria; 6-8 speech pathologists working either PAH or GCUH. Following recruitment and consent, baseline assessment will be performed with all participants (treatment arm and control arm). Participants in the treatment arm (and significant others where applicable) will then receive training in the application of facial taping. The facial taping will be applied daily for three weeks with guidance provided by an experienced speech pathologist via a combined telehealth model. The assessment battery will be repeated at the conclusion of the intervention period and at a month following this timepoint. In addition, participants will be interviewed at both post-intervention timepoints. Significant others will also be interviewed at the conclusion of the intervention period. Speech pathologists involved in the care of participants will be invited to participate in a focus group at the end of recruitment. Data collection for the research questions addressed in each study will be undertaken concurrently across a range of focus areas including: - Appropriateness of recruitment methods; - Suitability of assessment tools, data collection procedures, and outcome measures; - Acceptability of assessment and intervention protocols; - Adherence to intervention protocol; - Measurement of health resource utilization and service impact (e.g., cost benefit analysis); - Preliminary impact of intervention on participants. Feasibility outcome measures have been developed from relevant literature. Data will be analysed using a combination of descriptive statistics and qualitative content analysis.

In patients with diseased aortic valves, catheter-based replacement of the sick valve (TAVI) is a less invasive alternative for surgical valve replacement. TAVI has become the procedure of first choice in patients with increased operative risk. Because the valve is implanted through a catheter from the groin, there is no need for open heart surgery and recovery is much quicker. However, there remains a risk of major or life-threatening bleeding from the access site, especially because patients require blood-thinners (heparin) during the valve implantation. At the end of the procedure, when blood-thinners are no longer required, the effect of heparin can be reversed by protamine injection, but routine use of protamine has not been tested in TAVI patients in a randomised trial. In this study we will evaluate if routine use of protamine reduces the risk of major bleeding and improves outcomes for patients who underwent TAVI. We will compare safety and effectiveness of routine use of protamine in a randomised controlled trial and will compare outcomes after 30 days. The results of this study will help to improve the safety of the TAVI procedure and its outcomes for patient (reduced morbidity and mortality) and society (reduced demand on constrained economic resources).

We are hoping to develop an accurate and reliable fetal ECG device. In this application we will examine our fetal ECG device against current technology used, the CTG. We will also examine the accuracy of our device to detect a fetal heart rate over 24 hours. We will compare the accuracy of our device against the Monica device, a fetal ECG available for research purposes.