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Part C - In a randomized, open-label, two-period crossover design, at least 12 healthy participants will be randomly assigned to the FP (fasting-postprandial) group and PF (postprandial-fasting) group in a 1:1 ratio. All participants will take ACT004 capsules. The FP group will be given ACT004 capsules in the first period under fasting condition and in the second period under postprandial condition; the PF group will be given ACT004 capsules in the first period under postprandial condition and in the second period under fasting condition, with two periods of cross-administration and a wash-out period of 5 days. The planned dose regimen for Part C may be adjusted by the SRC according to safety, tolerability, and PK and results of Part A. Participants will be screened within 28 days prior to dosing and admitted to the clinical site on Day -1. Eligible participants will receive ACT004 on Day 1 and Day 6 under fasting or postprandial conditions in the group that they were randomized to. Following completion of all PK sample collection and safety assessments, participants will be discharged on Day 7 and followed up on Day 10 (±1 day).

Inclusion Body Myositis (IBM) is the most common inflammatory muscle disease affecting people aged over 50. Weakness of knee-extensors is characteristic of IBM and knee-extensor strength is frequently used as a key outcome measure to track disease progression and response to interventions in clinical practice and clinical trials. Currently, there exists ambiguity over the best and most practical measurement tool for this purpose. The aim of this study is to assess and compare two methods of portable dynamometry that each measure knee-extensor strength in IBM patients. One of these methods, operator-stabilised handheld dynamometry (OSHD), is the current clinical standard for objective assessment of knee extensor strength in IBM, however this method can be influenced by limb position and operator strength. The second method, strap-stabilised handheld dynamometry (SSHD) addresses the shortcomings of OSHD by utilising a stabilisation strap to hold the handheld dynamometer in place. A crossover design for testing sequence will be used to assess reliability of SSHD as compared to OSHD for knee-extensor testing. Validity of both methods will also be assessed by comparing both OSHD and SSHD to the clinical reference (‘gold’) standard, an isokinetic dynamometer. This design has been chosen to collect data that will enable assessment of both reliability and validity of these methods using the participant as a control. It will enable the comparison of the use of SSHD in this population as compared to OSHD and constitutes a pivotal study in the assessment of this method of dynamometry. All participants will be asked to present for a single testing visit (approximately 3 hours duration), at which eligibility screening will be conducted, written informed consent will be received, and testing will occur. There are no follow-up measures or interventions. Participants are only required to attend the single testing session, which minimises burden on participants and maximises study accessibility. Participants will be randomly allocated to one of two study visit sequences, which differ in the order of testing of OSHD and SSHD.

The demand for alcohol and other drug (AOD) treatment in Australia, greatly outweighs the resources available. Consequently, AOD services tend to prioritize the volume of service delivery over quality. Value-based models of healthcare, which shift the focus away from the volume of service delivery, towards achieving the best possible client outcomes relative to the resources and costs required (value), provide a potential solution to these problems. Outcome measures are at the cornerstone of value-based health care. Over the past 6 years we have worked with our industry partner to (i) identify the core outcome measures (COM) that matter to clients and staff; (ii) identify and address individual, organizational and system barriers to their adoption and (iii) develop a novel online system that collects client self-report COM data and provides automatic feedback to staff and clients at service entry, 1 and 3 months follow up. However, there is still plenty of room for improvement in the uptake of COMs and the delivery of feedback to clients. Based on our previous successful research trial (see First Step ACTRN12621000467831) our industry partner has decided to implement this brief intervention as the first step of treatment to to clients across all of their services. Since outcome measures and feedback are part of Module 1 of First Step, it is an opportune time to determine the impact of our refined outcome measure and feedback training and implementation processes on their level of uptake by staff and clients. The client outcomes of the First Step brief intervention are also yet to be evaluated in a RCT. This study will conduct a stepped-wedge, cluster randomised trial to determine the impact of the outcome measure and feedback training and implementation processes delivered as part of the First Step trial on their level of uptake by staff and clients. The client outcomes of First Step at one and three months follow up will also be evaluated in this trial using the routinely collected de-identified outcome measure data. There are two main objectives of this study. 1. The overall objective of the study is to evaluate the impact of the outcome measure and feedback training and implementation process on the proportion of clients who complete outcome measures and receive feedback at baseline, one month and three months 2. Determine if the First Step brief intervention is more efficacious for improving client substance use, mental health, and quality of life outcomes than standard AOD care at one- and three- months follow up

Malignant Pleural Effusion (MPE) can complicate most cancers and commonly causes disabling breathlessness and impairs quality of life. Patients who develop MPE often have an indwelling pleural catheter (IPC) inserted to drain excess fluid from their lungs, however these catheters can increase patients' risk of infection. This study aims to assess the use of regular preventative antibiotic cream on the incidence of infections for patients with MPE who have been fitted with an IPC. Who is it for? You may be eligible for this study if you are aged 19 years or older, you require insertion of an IPC for the control of malignant pleural effusion and you are willing to comply with the research procedures. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. The first group will be given antibiotic cream to apply around the insertion site for their catheter, together with instructions on how to care for their catheter, how to change the catheter and dressings and how to apply the antibiotic cream. The first group will be asked to apply the antibiotic cream after each catheter drain for up to 6 months. The second group will not be given antibiotic cream but will be given instructions on how to care for their catheter and how to change the catheter and dressings. Both groups will receive standard care from their treating physician throughout the study, including access to support services (e.g. direct phone line). All participants and carers will have the support and care of the respiratory unit. They will have access to the respiratory research staff via a direct phone line should any concerns arise. It is hoped this research will demonstrate whether using preventative antibiotics prior to an infection occurring reduces the number, type and severity of infections that patients with an indwelling pleural catheter may experience. If this study does show a positive impact on the infection rate, it may be expanded to a larger number of patients with indwelling pleural catheters to improve their quality of life.

The study aims to evaluate the engagement with, interest in, and benefits of the use of a mobile app to enhance a virtual Meal Replacement Program conducted through a tertiary weight management clinic from both the patient and clinician point of view. It is hypothesised that using a specifically developed app while participating in a virtual weight loss program will enhance motivation and improve retention in the program that in turn will lead to greater weight loss. It is also hypothesised that the app will free up clinican time and allow for better monitoring of patients during the intensive phase of the program.

This clinical investigation is targeted at collecting clinical effectiveness and safety evidence of HP-OCT+ (Hyperparallel OCT®) instrument in visualising and measuring anterior and posterior ocular structures/parameters. It is hypothesised that the HP-OCT+ is not inferior to, or less safe than the current standard devices utilised to measure anterior and posterior ocular structures/parameters. In this investigation, about 70 subjects (eyes) will be recruited and divided into 6 groups, i.e. cataract, pseudophakic (monofocal or toric IOL), post-refractive surgery (phakic or pseudophakic with monofocal or toric IOL), phakic <30 years with no history of refractive surgery or ocular disease including cataract, corneal cylinder <2 D, phakic <30 years with no history of refractive surgery or ocular disease, corneal cylinder >2 D, and dry eye. The subject will be scanned/measured on HP-OCT+ instrument and the other four comparative instruments (HP-OCT, IOLMaster 700, Keratograph 5M and Innoveyes Sightmap). The measurement data obtained from different HP-OCT+ modalities (biometry, topography, wavefront, tear film test) will be then compared with the corresponding measurement from the comparative instruments, to investigate the agreement of HP-OCT+ with the comparative instruments. The repeatability of these HP-OCT+ measurements will also be determined.

Brief project background & objectives: Running is an important skill that enables children to participate in physical activity. Children with symptomatic joint hypermobility often have difficulty with running due to various factors including difficulty generating lower limb power, fear of movement (kinesiophobia), pain or fatigue. This impacts participation in physical activity and everyday life. A running intervention conducted by this research group has been demonstrated to assist children with cerebral palsy to achieve running goals. Objectives: This pilot study will investigate if a running intervention is a feasible intervention to improve running performance and reduce kinesiophobia for children with symptomatic joint hypermobility. Hypotheses: 1. Children with symptomatic joint hypermobility will achieve their running-related goals following a running intervention programme. 2. Children with symptomatic joint hypermobility will have reduced fear of movement following a running intervention programme. Significance of the project: There is currently no evidence with regards running or running interventions for children with hypermobility. Running is important for children’s participation in physical and social activities. Children with hypermobility can find it difficult to participate in physical activity, yet physical activity is critical for the health of children.

Magnesium is a crucial electrolyte and low serum magnesium concentrations must be treated promptly to avoid adverse effects. In the intensive care unit, critically ill patients are at risk of low magnesium concentrations magnesium ions are frequently administered via the enteral or parenteral (intravenous) route. There is sparse data as to which route to use but there is likely to be at least a tenfold cost differential between the enteral and parental preparations. In addition, there may be more waste and subsequent environmental impact associated with parenteral route. Given the potential but unproven advantages of the enteral route we wish to compare the safety and effectiveness of magnesium replacement via the enteral route and parenteral routes.

An evaluation study of the Arts on Prescription (AoP) in Hospitals program; a service prescribed to people admitted on the palliative care, rehabilitation, and older persons’ mental health wards of the participating hospitals to address health and well-being needs identified during their admission. The primary aim of the study is to assess the impact on psychological well-being from participation in the AoP in Hospitals program for individuals admitted to subacute hospitals, using the Positive Well-being Umbrella - Generic (PWU-G) and the Negative Well-being Umbrella - Generic (NWU-G). Secondary aims are (i) explore the perceived impact of the AoP in Hospitals program in a subacute hospital setting from the perspectives of service users, artists, and hospital staff, (ii) explore the perceived usability of the PWU-G and NWU-G as evaluation tools for the AoP in hospitals program from the perspectives of service users, artists, and hospital staff, and (iii) assess levels of participation in the AoP inhospitals program using the the Pittsburgh Rehabilitation Participation Scale (PRPS). it is hypothesised that participation in the AoP in hospitals program offered in subacute hospitals will contribute to improved psychological well-being among service users.

Individuals with intellectual disability suffer terrible health inequities compared to their healthy peers. This can lead to more dependence on health services and serious diseases in adulthood, which ultimately reduces their lifespan. Physical activity and regular exercise training are important factors that manage the symptoms of and protect against many age-related chronic diseases. Notably, individuals with intellectual disability exhibit much less physical activity compared to the average population, even in childhood. Current exercise prescription guidelines for young people with intellectual disability are vague and effective strategies to engage them in physical activity are sparse. The purpose of this randomised controlled trial is to determine the influence of individualised strength and conditioning (IS&C) versus games-based training (GBT) on health-related components of fitness in young people with intellectual disability. Health-related components of fitness such as cardiorespiratory fitness, muscular strength, body composition, balance, and agility will be assessed. Young people aged 12 to 17 years with an intellectual disability will be recruited from special schools in the local area (Ipswich, Queensland). Participants will be randomly assigned to one of three groups: IS&C; GBT; or a wait-list control group. Participants in the two treatment groups will complete twice-weekly supervised exercise training under the guidance of exercise professionals for 8 weeks. The exercise training will be performed at the University of Southern Queensland in the hours after school. The results from this project will determine effectiveness of IS&C and GBT at improving important health-related components of fitness that are indicative of health status and the risk of age-related diseases in youth with intellectual disability. They will provide evidence to establish if the two different training formats lead to meaningful improvements in health markers in youth with intellectual disability, which will guide exercise prescription recommendations. They will also elucidate whether the exercise training interventions improve long-term adoption and adherence to physical activity participation.