ANZCTR search results

AT-01 is a novel peptide radiotracer which binds to a constant region of the insoluble amyloid protein; the agent which results in end-organ damage in AL amyloidosis. It is able to demonstrate on molecular imaging scans the presence of amyloid within all vital organs of the body, namely the heart, kidneys, liver and spleen. No other imaging modality has been able to capture this in a single scan. By accurately detecting amyloid in organs of the body and assessing for response to therapy, AT-01 PET/CT scans have the potential to revolutionise the way AL amyloidosis is diagnosed, monitored, and help to guide treatment decisions in the future.

The proposed study will aim to address existing gaps in literature by conducting a feasibility study of a group schema therapy intervention for comorbid anxiety and mood disorders in adults. This will involve conducting an empirical investigation of a manualised group schema therapy intervention to understand feasibility and assess effectiveness of the group. The manualised group intervention will be based on the group protocol established by Farrell, Reiss & Shaw (2014) and further adopted by Younan, Farrell, & May (2017). The group treatment will be conducted in an outpatient clinic by involving two co-therapists and ten patients per treatment group. Participants will complete quantitative measures of symptoms at pre, mid and post-test intervals to investigate preliminary feasibility of the program and qualitative analyses will be conducted to analyse patient experiences.

The purpose of this study was to assess the feasibility of implementing the Optimal Health Program for Inflammatory Bowel Disease (OHP-IBD) as an intervention to provide support for young adults with paediatric onset IBD, after they transfer to adult health services. The OHP-IBD is a psychosocial intervention, comprising 5x one-hour sessions and 1x one-hour booster session 3 months later. It aims to enhance self-empowerment and quality of life in IBD patients, despite the limitations that their chronic illness may impose upon them. Qualitative assessments will be conducted to explore patients’ perspectives on the impact off the program. Participants will also be required to complete quantitative assessments before and after the intervention, as well as 3 months later, to assess the potential effectiveness of the program. Participants aged between 18-25 years, with paediatric-onset IBD, who attend the an IBD Clinic for adults will be eligible for participation.

This trial will evaluate the efficacy of an ultra-brief online psychological treatment for women with perinatal depression or anxiety. The treatment involves online materials and optional support from a psychologist. We will evaluate efficacy against a waitlist control group 2-months after starting (i.e., 9-weeks later). Questionnaires will be administered Week 1, Week 5, Week 9, Week 13, and Week 17. We expect that the treatment will be more effective in reducing depression and anxiety symptoms.

This is a Phase 2, randomised, double-blind, placebo-controlled study assessing the safety, tolerability, and efficacy of KNX100 in out-patients participants with clinically significant agitation/aggression associated with dementia. The primary objective is to evaluate the effect of twice daily oral dosing of KNX100 for 4 weeks, compared to placebo, on symptoms of agitation in subjects with dementia as measured by Cohen-Mansfield Agitation Inventory. The secondary objectives of the study include evaluation of the effects of KNX100 on NPI-12 and CGI(S/I) as well as evaluation of caregiver burden by CSI. Safety and tolerability of KNX100 will be also assessed. Upon meeting eligibility criteria participants will receive blinded treatment twice daily for 4 weeks followed up by 2 weeks of follow up.

This phase 2 study is a randomized, placebo-controlled, double-blind trial of an oral drug called AT-5214 vs placebo in participants with moderate to severe facial acne vulgaris. The study will assess the efficacy and safety of AT-5214.

This study aims to develop, implement, and evaluate an allied health led mHealth assisted opioid tapering intervention for people with chronic pain on long-term opioid therapy. A pilot Randomised Controlled Trial (RCT) will be used to investigate the acceptability, feasibility and potential efficacy of this novel approach to supportive opioid tapering. Potential efficacy will be established by comparing the mHealth assisted intervention to usual care (i.e. GP correspondence) to determine potential clinically meaningful differences in health outcomes at 6 months follow up pertaining to opioid use, pain severity and pain interference (i.e. the impact of pain on one’s life). Our progression criteria for a more robust and full scale RCT for this trial are: i) adequate recruitment (equal to or greater than 6 participants/month), ii) retention (equal to or less than 25% drop out) and iii) intervention acceptability (equal to or greater than 80% of mHealth intervention participants recording a positive response on the 7-point Likert scale (i.e. score equal to or greater than 5)).

(O-acyl)-hydroxy fatty acids (OAHFA) and Wax esters (WE) are part of the natural lipid layer of the tear film, which helps to stabilize tears, and is believed to maintain comfort. During contact lens wear, the tear film rapidly breaks up, and this may be a reason for people complaining of discomfort during lens wear. The aim of this study is to investigate changes in the ocular surface (corneal and conjunctival staining, non-invasive tear break-up time, and tear lipid layer thickness) of experience contact lens wearers wearing OAHFAs-loaded contact lens, Wax esters (WE) loaded contact lens and commercially available contact lens. The findings from this study will explore the use of OAHFAs and WE to improve the comfort of daily disposable contact lenses. We hypothesize that wearing contact lenses containing OAHFAs or WEs will result in a more stable tear film and increase wearer comfort.

Given the burden of chronic pain to society and individuals and the potential to improve outcomes through adjunctive treatment, a randomised controlled trial comparing the effectiveness of multi-disciplinary pain management (PM) on its own versus multi-disciplinary pain management plus an additional treatment is planned for people with nociceptive or neuropathic dominant low back pain. We hypothesise that the additional treatment added to a pain management program will lead to some additional benefits for people with low back pain compared to a pain management program alone.

The research study is looking at what are the effects of orthodontic treatment of a small lower jaw in children. The treatment being investigated in this study is composed of an appliance (known as invisible functional appliance) that will help the lower jaw posture forward. The invisible functional appliance will be used for 9-12 months and will be compared with two other commonly used appliances to correct the small lower jaw.