ANZCTR search results

The application of music as an intervention has a long history. Music intervention had rapidly developed and was introduced to healthcare settings in mid twentieth century. In clinical settings, music can be applied to alter mood and stress level, as well as to enhance immunity. Five-phase music therapy (FMT) is a modality of traditional Chinese medicine (TCM), which is a form of music intervention. For FMT, it was proven to have the potential of benefiting mental issues, such as depression, perinatal mental health, and improving the quality of life and symptoms of cancer patients. In addition, cultural background of the participants could affect the impact of music intervention. Cultural background of the participants is important to consider when conducting music intervention as it plays a crucial role in forming ones’ life perceptions, contributing to their presenting problems, and their responses towards music intervention. This study aims at evaluating whether TCM FMT can bring the same influence to people who are familiar with Chinese culture and those who are not. It is hypothesised that cultural background does not influence the impact of TCM FMT on mood and stress level. This can support the application of FMT in diverse cultural contexts. As this is a pilot study, this can also set as a foundation for future full-scale study with similar topics.

Venous thromboembolism (VTE) (blood clotting) is a recognised risk after major surgery. Current methods to reduce this risk include chemical prophylaxis (low molecular weight heparin medication), graduated compression stockings, and intermittent pneumatic compression devices. Australian guidelines currently recommend the use of heparin along with stockings and/or compression devices after surgery, with most Australian surgeons routinely adopting all three methods. Compression devices introduce new clinical risks, increase care burden, are not well tolerated by patients, and are expensive, single-use, disposable plastic items. Further, they may prolong recovery as patients lie immobilised while wearing them. The potential to use just heparin and stockings without compression devices, as occurs in the UK, without impeding patient outcomes would therefore be more practicable and acceptable for patients and health services, as well as having added financial and environmental benefits. Our primary hypothesis: Treatment with heparin and stockings alone results in a proportion of patients with VTE by 30 days that is no greater than 2% higher than the patients randomised to receive heparin, stockings, and compression devices. This study is a clinical trial for patients undergoing major surgery at John Hunter Hospital, Calvary Mater Hospital, Gosford Hospital, Tamworth Hospital and Port Macquarie Hospital. Participants are randomly allocated using a computer to one of two groups: Group A: Participants are treated with low molecular weight heparin (LMWH) plus GCS for standard procedural timeframe plus intermittent pneumatic compression devices (IPCDs) for 5 days. Group B: Participants are treated with low molecular weight heparin (LMWH) as per standard clinical recommendations (dosing regimen depending on participant characteristics). These patients are also given below graduated compression stockings (GCS) to wear. The research nurse will contact each participant by telephone on days 30 and 90 post-surgery to collect outcome data. If participants report that they had symptoms, they will be followed up with GPs and get the ultrasound images and final diagnosis. Outcome data will be recorded for each participant, including the presence of DVT or PE (confirmed by ultrasound), clinical symptoms of DVT or PE, surgical complications, all-cause mortality at Day 30 and Day 90, length of stay in the hospital, days alive and out of the hospital, ED presentations, and any hospital readmissions due to VTE, patient-reported measures including compliance with interventions while an in-patient, sleep disturbance measures (PROMIS-SF), health professional service utilisation, QoL (EQ5D) and WHODAS-12. Removal of compression devices will have benefits for patients, staff and health services, including reduced nursing workload, early patient mobilisation, improved patient experience, reduced needless cost and reduced plastic waste.

The main purpose of this study was to analyse the test-retest reliability of the 30 second sit to stand squat test as a measure of lower body muscular fitness. Secondary outcomes were to assess the validity of the 30 second sit to stand test compared to the highly reliable standing long jump test. Only a few field based tests are available to assess muscular fitness in youth and the 30 second sit to stand test may be a useful addition to the field. Participants aged 14-17 years completed the assessments on two occasions separated by 1 week. On each occasion students completed the 30 second sit to stand test and the standing long jump test as well as anthropometric tests of height and weight.

There is increasing evidence that new interventional pharmacotherapies such as psychedelic therapy may be helpful for the treatment of a number of mental health conditions. The purpose of this study is to explore the potential for psychedelic therapy using psilocybin and MDMA to improve symptoms of treatment resistant OCD, and to determine whether there is any pre-post change in electroencephalography (EEG) measurements following psychedelic exposure. To do so, we will carry out a double blind (participant and rater) clinical trial of psilocybin and MDMA assisted psychotherapy in 40 participants (20:20 drug allocation) with treatment resistant OCD. Participants will undergo a series of preparation and integration therapy sessions and 3 drug administration sessions. The results of this study will provide us information about the effectiveness, acceptability, and tolerability of this treatment for this disorder, as well as whether there are any brain activity changes associated with having been exposed to MDMA and psilocybin.

This study aims to determine whether there is measurement equivalence between traditional paper-and-pen and electronic delivery of disease-specific patient-reported outcome measures (PROMs) in paediatric burn scar patients and their caregivers. Determining the equivalence of these delivery methods will provide evidence regarding the ability to transition from paper-based administration to electronic based administration of patient-reported outcome measures involving children and caregivers in research and clinical practice based on the comparability of psychometric properties and conceptual base of the measures. We hypothesise that there will be acceptable equivalence between pen-and-paper and electronic completion methods.

The objective of this study is to provide supporting clinical evidence in particular with regard to the efficacy and safety of the ElePulse electroporation ablation system. It might reveal indicators for hidden risks and trigger further dedicated investigations or tests.

The availability and accessibility of post-diagnostic support for people living with dementia and their carers are of central importance in dementia care. People with dementia and their carers benefit from timely access to emotional and practical support, lifestyle advice, and meaningful activities to maximise their quality of life and potentially delay cognitive decline. Allied health professionals at Canberra Health Services at the University of Canberra Hospital and the University of Canberra have designed an evidence-based 12-week multi-component program, tailored to people with dementia and their carers, which includes: physical activity, social engagement, nutrition assessment, education and capacity building. The team has engaged with Dementia Australia advocates to refine the program and set priorities for research. The research study will assess the value of a pilot version of this multi-component dementia support program, measure impact and effectiveness for people with dementia and their carers. If shown to be successful, the multi-component program could become part of standard care in the ACT region and provide a replicable model of comprehensive post-diagnostic services for dementia care Australia-wide.

Patients with Ischaemia and No Obstructive Coronary Artery Disease (INOCA) are under-diagnosed and under-treated in current clinical practice. There is a growing body of evidence that pathological abnormalities in coronary vessels characterise these conditions, leading to increased morbidity and mortality. These patients continue to experience recurrent angina, a poor quality of life and adverse cardiovascular outcomes. Although there is growing recognition of the impact of this entity amongst the cardiology community, methods and criteria pertaining to the diagnosis remain poorly defined. The MAD-NOCA trial (Multivessel compared to Single-vessel Functional Angiography to Diagnose Patients with No Obstructive Coronary Artery Disease) aims to develop a novel diagnostic algorithm for patients with INOCA. This randomised controlled trial will evaluate whether comprehensive three-vessel coronary physiology and vasoreactivity testing, compared to standard single vessel testing, in patients with INOCA, will: 1) Increase the proportion of patients diagnosed with a ‘disorder of coronary vasomotion’, 2) Influence clinical management, 3) Lead to improved clinical outcomes

This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of tinlarebant when administered as an oral dose to healthy volunteers aged 50-85. Tinlarebant (previously called LBS-008) is being developed as an oral treatment to slow or halt the progression of dry age-related macular degeneration (AMD) and juvenile onset macular degeneration, known as Stargardt disease (STGD). Accumulation of lipofuscin bisretinoids in the retina is associated with several retinal degenerative diseases including dry AMD and STGD. A total of up to 16 healthy volunteers aged 50-85 are planned to be enrolled into 2 cohorts (8 participants per cohort). Participants will receive a single oral dose of tinlarebant, either 5 mg (Cohort 1) or 10 mg (Cohort 2). The total maximum study duration for participants in this study is 45 days, inclusive of visit windows. This includes a screening period of up to 27 days (Day -28 to Day -2), confinement to the clinical facility over 2 nights (Day -1 to Day 2) and 5 outpatient visits including the EOS visit or Day 15. Tinlarebant will be administered in tablet form; a single tinlarebant tablet will contain 5 mg of IP. Participants in Cohort 1 will receive 1 tinlarebant tablet (5 mg dose) and participants in Cohort 2 will receive 2 tinlarebant tablets (10 mg dose). Enrolment and dosing of participants in Cohorts 1 and 2 may occur concurrently. Healthy volunteers aged 50-85, will be screened between Day -28 and Day -2, inclusive. Participants will be admitted to the clinical facility on Day -1 with tinlarebant dosing to occur on the following day (Day 1). All participants will be dosed under fasted conditions. Participants will be confined at the clinical facility from Day -1 through to Day 2 with discharge following completion of all PK and PD blood sample collections and other scheduled assessments on Day 2. If participants experience any clinically significant (CS) AEs during the confinement period, they may remain in the clinical facility for further observation at the discretion of the Principal Investigator (PI). Blood samples for PK and PD analysis will be collected pre-dose and at timepoints up to 24 hours (Day 2) post-dose during the confinement period. Participants will be required to attend the clinic as outpatients on Days 3, 4, 6 and 8 for further safety assessments, PK and PD blood sampling. Participants will then return to the clinical facility for final safety assessments, In the event of early study termination prior to the EOS visit (Day 15), participants will be requested to attend the clinic for an early termination (ET) visit.

This is a two-part, double-blind, placebo-controlled, Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MVD1 in healthy volunteers. The decision to escalate between dose levels and proceed from Part A to Part B will be based on review of the safety and available PK data by the study safety review committee (SRC) from a minimum of 5 active treated participants per cohort. The SRC may recommend repeat of a cohort, or a change in the dose levels of subsequent cohorts, or that no further dose escalation cohorts occur and recommend the final sample size of the MAD cohorts based upon consensus and emerging data from safety, PK and PD biomarkers. In Part A, screening for study eligibility will occur between Day -28 and Day -2 inclusive. Following confirmation of eligibility on Day -1, participants will be randomised to be enrolled in Cohorts S1, S2 or S3 and to receive either MVD1 or placebo. Participants will then be admitted to the clinical facility. The confinement period will commence on Day -1, followed by dosing on Day 1 with placebo or active drug in a double-blind manner. Participants will receive a single oral dose of MVD1 or placebo on Day 1. Participants will be discharged from the clinical facility on Day 4 following completion of study assessments and will be required to attend the clinic for a final follow-up visit on Day 8 ± 1 Day. In Part B, screening for study eligibility will occur between Day -35 and Day -2 inclusive. Following confirmation of eligibility on Day -1, participants will be randomised to be enrolled in Cohorts M1, M2, or M3 and to receive either MVD1 or placebo. Participants will then be admitted to the clinical facility. In Part B, the confinement period will commence on Day -1, followed by dosing on Day 1 with placebo or active drug in a double-blind manner. Participants will receive twice daily oral doses of MVD1 or placebo (administered 12 hours apart) on Days 1-14 and a single dose on the morning of Day 15 (total of 29 doses). Participants will be discharged from the clinical facility on Day 18 following completion of study assessments and will be required to attend the clinic for a final follow-up visit on Day 22 ± 1 Day.