ANZCTR search results

The primary aim of this study is to investigate the benefits of two sessions of behavioural experiments targeting negative beliefs about uncertainty compared to a waitlist control for generalized anxiety disorder. The secondary aim is to investigate the proposed mechanisms of action (i.e., intolerance of uncertainty, metacognitive beliefs, threat appraisals) that underpin generalized anxiety disorder. Participants in the treatment group will begin the intervention immediately, and their results will be compared with a waitlist control condition who will receive the same intervention after a two-week wait period. Outcome measures will be administered at baseline, post treatment and 1-week follow-up. Based on existing studies of behavioural experiments for generalized anxiety disorder it is hypothesised that: 1) behavioural experiment condition will be more effective in reducing symptoms of excessive worry and anxiety than waitlist control; and 2) behavioural experiments will yield greater improvements in intolerance of uncertainty, metacognitive beliefs, and threat appraisals, compared to waitlist control.

The purpose of phase 1 study is to evaluate the Pharmacokinetics, Safety, Tolerability of APC201 in Healthy Adults.

Autophagy is a critical process that helps keep the body’s cells clean and healthy. It is thought to be sensitive to nutrition. Using a test performed on blood that we have developed to measure autophagic activity in humans, This project aims to determine whether a 4-week modification of dietary macronutrient profile (within the context of a balanced diet) in healthy adults will change autophagic activity.

This observational study will investigate injury characteristics and clinical assessments to measure post-concussion symptoms at different time points in the first year post injury and use this information to predict people who are more likely to have a poor outcome after concussion. Participants will be recruited via hospital emergency departments following initial medical practitioner assessment and concussion diagnosis. Once consented into the study, participants will complete a questionnaire about their concussion injury and medical history, in addition to having a blood and saliva sample taken. Other clinical assessments and an MRI scan will also be completed within 4 days of their injury. At 2 weeks, 1-, 3-, 6- and 12- months following injury, participants will be contacted via telephone to complete a follow up questionnaire about their concussion symptoms and quality of life post injury. Having a better understanding of people who are at risk of developing persistent symptoms following a concussion will enable more targeted and timely clinical care to minimise distress and disability that may be experienced as a result of injury.

The Australian population has a large proportion of older adults, and it is known that people of age greater than 65-years-old have a six-fold increased risk of acquiring recurrent urinary tract infections. Recurrent urinary tract infections cause significant burden to quality of life and result in a large number of presentations to general practitioners and hospitals for treatment. They are a significant cost to patients and the healthcare system. Whilst prophylactic use of antibiotics has been shown to be effective in the prevention of recurrent urinary tract infections, due to growing concern regarding antibiotic resistance, alternative treatments are being sought. MV140 is a form of bacterial vaccine, which means it uses de-activated strains of bacteria to improve your immune system’s response to infection. MV140 includes strains from 4 of the most common types of urinary tract infection bacteria (enteroccocus faecalis, escherichia coli, klebsiella pneumoniae, and proteus vulgaris). MV140 is not designed to treat such infections once patients have them, but is designed to help your immune system prevent them from developing in the first instance. Our goal is to determine whether MV140 is effective at preventing recurrent urinary tract infections in people aged greater than 65-years of age.

Dry eye disease is a chronic, multifactorial disorder characterised by instability or poor quality of the tear film. It is associated with a wide variety of signs and symptoms, such as discomfort or visual disturbances (Lemp & Noulks, 2007). Due to the constancy and potential severity of these symptoms, dry eye patients may have their quality of life severely impacted, particularly with activities requiring visual attention like reading, driving or computer work (Uchino et al., 2014). Prevalence of dry eye disease can range from 5–50% depending on the population, with prevalence increasing with age or chronic illnesses (Rouen & White, 2018). Management is targeted towards symptomatic relief and tear film homeostasis, whether by improving tear production or reducing tear evaporation. Previous studies have shown that the Bruder Moist Heat Eye Compress and Optimel Manuka+ Dry Eye Drops have been effective in managing dry eye disease. The former seeks to improve meibum secretions to stabilise the tear film (Tan et al, 2018), whereas the latter has both anti-inflammatory and antibacterial properties to alleviate symptoms of dry eye disease (Tan et al., 2020). However, conventional or standalone treatments may not be effective for everyone; as such, a combination of the Bruder mask and manuka honey eye drops may offer a novel approach to treating dry eye disease. The proposed research aims to assess the effectiveness of this combination and provide evidence for its potential use in clinical practice. It will use both subjective and objective metrics to evaluate changes in tear film properties, eyelid health and comfort, thereby providing valuable information on the potential benefits of adjunctive therapy in comparison to conventional treatments for dry eye. Overall, this study will make an important contribution to the field of dry eye disease treatment by providing information on a novel approach to treating this condition. The results of the study will provide valuable information to both healthcare professionals and patients, and may lead to the development of new and improved treatment options for dry eye disease.

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.