ANZCTR search results

PVX108 is a novel treatment being developed to treat the underlying cause of peanut allergy. It is anticipated that PVX108 administered by intradermal injection every 2 or 4 weeks will produce immune tolerance to peanut proteins in patients with peanut allergy. The product has been designed to have little or no capacity to induce acute allergic reactions, which is a significant risk with most, if not all other forms of allergen immunotherapy. Clinical trial AVX-001 is the first study of PVX108 to be conducted in humans. Its objectives are to determine the maximum dose that can be safely administered as a single injection, and then also to assess the safety of 9 repeat, escalating doses, administered once every 2 weeks. The study will therefore be conducted in 2 stages. In Stage 1, up to 48 peanut-allergic subjects will receive a single dose of PVX108. The first cohort of 6 subjects will receive the lowest dose of PVX108 (or placebo) and be monitored for 24 hours in clinic for adverse events and other clinical effects. A safety review committee will review the results obtained in this cohort. If the committee judges that it is safe to do so, dosing in the next cohort will progress at the next dose level. Dose will be escalated in each cohort until the safety review committee determines that the maximum safe dose of PVX108 has been determined. In Stage 2, up to 18 peanut-allergic subjects will commence the study at the maximum safe starting dose of PVX108. If the dose is well tolerated, an increased dose will be administered 2 weeks later. Subjects will receive a maximum of 6 administrations over a 16 week period. Adverse events and other clinical effects will be monitored periodically during treatment and for 4 weeks after the last dose. A range of blood samples will be collected from subjects prior to, during and after treatment to address an exploratory objective to investigate potential biomarkers of disease and the effects of PVX108 therapy.

The primary purpose of the Managing Your Risk Study is to evaluate the efficacy of personal genetic risk of melanoma information, compared to standard prevention advice, in motivating preventative behaviours in the general population. Who is it for? You may be eligible to enroll in this trial if you are aged between 18 and 69 years, have European ancestry, and have never had a melanoma. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive personalised genetic risk of melanoma information and an educational booklet on melanoma preventive behaviours, or to receive the educational booklet only. Participants allocated to the group receiving their genetic risk information will provide a saliva sample using the kit sent via postal mail. This will be used for genetic testing and 2-3 months later, these participants will receive a booklet in the mail containing information on their personal genetic risk of melanoma. With their genetic risk information, participants will be given an educational booklet on melanoma preventive behaviours including sun exposure, sun protection and skin examinations. Within 2 weeks of receiving the mailed booklets, participants will receive a phone call from a genetic counsellor to answer any questions about the information. The other group of participants will receive the educational booklet only, and no genetic risk information information or phone call. All participants will have be able to contact a study-dedicated genetic counsellor at the time of consent to ask any questions they may have. All participants will be asked to complete questionnaires and to wear a specialised wrist-worn device (similar in appearance to a watch or a fitbit) which measures sun exposure for 10 days. All participants will be asked to complete a questionnaire and wear a UV dosimeter at baseline, complete a questionnaire at 1-month after they are sent their booklet(s) and complete a questionnaire and wear a UV dosimeter at 12 months after baseline. A subgroup of ~240 participants will also be asked to wear a UV dosimeter at 1-month after they are sent their booklet(s). It is hoped that the findings from this trial will provide information on whether providing information on personalised genetic risk of melanoma motivates people to undertake preventative and early detection behaviours.

The Duchenne Registry Australia is an online, patient-report registry for individuals with Duchenne and Becker muscular dystrophy and carrier females. The purpose of The Duchenne Registry Australia is to connect Duchenne and Becker patients with actively recruiting clinical trials and research studies, and to educate patients and families about Duchenne and Becker care and research. At the same time, the registry is a valuable resource for clinicians and researchers in academia and industry, allowing access to a de-identified, aggregate dataset provided by patients and their families—information that is vital to advances in the care and treatment of Duchenne.

A single- and multiple-dose Phase I study of LJPC-401 in healthy adult volunteers. LJPC-401 is being developed to treat conditions characterized by iron overload, such as hemochromatosis and beta thalassemia.

Over 7000 individuals sustain a Traumatic Brain Injury (TBI) each year in Queensland with minimal rehabilitation services available after injury, particularly in regional areas. Individuals with TBI are at increased risk for the development of depression, anxiety, alcohol misuse and suicide. The diagnosis of psychiatric disorders is estimated to occur in approximately 75% of TBI survivors within five years post-injury, with the highest increase of mental illness recorded in the first twelve months. Currently, there are limited resources or services in regional Queensland to address the mental health needs of TBI survivors. This pilot project will use a prospective randomised controlled trial design to compare the efficacy of short psychology treatment interventions after mild to moderate traumatic brain injury. Participants will be recruited at 1-2 weeks post-injury, and complete a short one hour assessment that will consist of a clinical interview and self-report measures of health and wellbeing. They will then be allocated into one of three treatment arms: (1) treatment as usual (TAU): bibliotherapy intervention or (3) brief positive psychology intervention. Follow-up interviews will occur at the end of the one week intervention, and again at 3 months and 6 months post-injury. The findings from this study may assist in the development of short practical interventions that may prevent the onset of novel mental illness in the first 12 months following a TBI.

The objectives of treatment of symptomatic rotator cuff disease are to relieve pain and restore movement and function of the shoulder. Conservative treatments include rest, NSAIDs, glucocorticoid injections and physical therapy. While specific exercise therapy may be beneficial, most of these treatments often only temporarily relieve the patients’ symptoms, and do not address the underlying tendon pathology. A combination of an increased understanding of pathological processes involved in tendinopathy as well as the success of other autologous therapies for tissue repair has highlighted the potential for tendon repair by delivery of tenocytes to the site of injury. Tendon-derived cells, including tendon progenitor cells (TPCs), possess the potential for tendon regeneration as they have the capacity for collagen synthesis, proliferate rapidly and are self-renewable. The efficacy of tenocyte implantation for stimulation of tendon repair has been verified in a number of in vitro and animal studies. Animal studies have revealed that implantation of in vitro expanded autologous tenocytes improved the tendon structure and facilitated the healing process in both an acute tendon tear model and a chronic degenerative tendon disease model . Based on these studies, it was proposed that restoration of functional cells capable of synthesizing extracellular matrix and repairing the damaged tissue within the tendon may be an effective therapeutic strategy for tendon repair. This method is the basis of the Ortho-ATI (Trademark) tenocyte therapy product developed by Orthocell. Imaging studies of rotator cuff tear indicate that injury to the supraspinatus tendon is most likely to be the cause of rotator cuff disease. The majority of supraspinatus tendon tears occur within a zone close to the tendon insertion. This is most likely due to lack of vascularity within that portion of tendon, and/or increased tensile loading. Furthermore, concealed lesions within the substance of the tendon (interstitial or intrasubstance tears) account for approximately one third of rotator cuff tears detected at the tendon insertion. These lesions present an unmet area of clinical need, as they are not suitable for surgical correction, should non-surgical treatments fail. Ortho-ATI (Trademark) is a minimally-invasive treatment which, unlike other conservative treatments, directly addresses the underlying pathology of rotator cuff tendinopathy and tear. This randomised, controlled study has been designed to investigate the feasibility of Ortho-ATI (Trademark) as an alternative treatment for patients with partial, intrasubstance rotator cuff tear and tendinopathy.

Lateral head radiographs are routinely prescribed to every patient who is willing to have braces to correct their abnormal teeth positions (malocclusion). However, the information gathered during a clinical examination of the patient is fundamental to determine the diagnosis of a given malocclusion. The aim of the present investigation is to test the null hypothesis that lateral head radiographs will not alter Australian Orthodontists’ diagnosis and treatment planning decisions. If the results are consistent with our hypothesis and lateral head radiographs are not a ‘must have’ diagnostic record in orthodontics, we can suggest that lateral head radiographs should not be prescribed routinely to all patients. This would alter the conventional prescription of lateral head radiographs required for orthodontic diagnosis. The omission of the lateral head radiograph from a susceptible age group would limit the amount of ionising radiation exposure.

The aim of this three-year project is to evaluate, in the context of a national implementation trial, an evidence-informed intervention to reduce workplace sitting – the BeUpstanding Champion Toolkit. Primary outcomes are: 1) Uptake of the Toolkit overall and within the partner-determined priority sectors 2) Implementation of the Toolkit by workplace teams 3) Effectiveness of the Toolkit in reducing employee workplace sitting time Hypothesis (two-tailed): the Toolkit will elicit significant changes in workplace sitting time following exposure to the program (at 3 months) and in the long term (at 12 months) Target is 20 minute reduction per 8-h workday

To address adolescent PA, Physical Activity 4 Everyone (PA4E1) is a multi-component secondary school PA intervention recently trialled in New South Wales (NSW), Australia in a study involving 10 disadvantaged secondary schools (5 intervention schools, 5 control schools). The program involved schools implementing seven PA strategies, which schools were supported to implement. The intervention delivered over two years resulted in significant improvements in adolescents’ daily minutes of moderate-to-vigorous physical activity (MVPA) and adiposity at 24 months. The program was cost-effective and acceptable to stakeholders. There is currently little evidence to guide the successful scale-up of effective programs, such as PA4E1, to a larger number of secondary schools. Without adequate implementation ‘at scale’ of such programs, their benefits cannot be realised. A larger trial of the PA4E1 intervention will be conducted in secondary schools located in disadvantaged areas in four NSW Local Health Districts. The primary aim of this study is to assess the effectiveness of the intervention in increasing school implementation of seven practices designed to facilitate student PA levels (PA practices). The effectiveness of the intervention in improving adolescent PA and preventing adiposity, and its cost effectiveness in doing so, will also be assessed in a sub-sample of schools (secondary outcome). The study will employ a cluster randomised controlled trial (RCT) design (24 intervention schools and 25 control schools). An implementation support intervention adapted for scale up from the support provided to schools in the PA4E1 effectiveness trial has been designed using the Theoretical Domains Framework (TDF). A nested sample of 30 schools (15 per group) will collect student level measures to assess the secondary outcomes.

This study will be a 3-arm randomised-control trial to examine the efficacy of a combined physical activity and sleep health intervention to improve sleep quality in mid-aged adults, compared with a sleep health only intervention and a wait-list control group. The study will also compare the groups by physical activity, depressive symptoms and health-related quality of life. These outcomes will be assessed after 3 months (primary time point) and 6 months (follow-up). The interventions will be delivered using an internet-enabled app as well as email and text message support, using goal setting, action planning, self-monitoring, and feedback in relation to progress towards goals, as behaviour change strategies. The combined physical activity and sleep health group will use these strategies to change both physical activity and sleep behaviours while the sleep health only group will only change their sleep behaviours. The wait-list control will be asked not to change their behaviours for the duration of the intervention but will be offered the combined physical activity and sleep intervention at the completion of the study. Poor sleep health is associated with an increased risk of non-communicable diseases, decreased work productivity and high health care costs. Approximately 30-50% of adults worldwide report poor sleep quality. Only about half of these people have a diagnosable sleep disorder, yet most interventions to date are targeted at those with a sleep disorder. Additionally, although physical activity has been shown to be effective at improving sleep quality, none of the studies included in a review of sleep health interventions provided participants with specific strategies and behaviour change techniques to foster changes in physical activity. Consequently, sleep health interventions that do not provide participants with targeted strategies to change physical activity may not maximise change in physical activity, nor the resulting flow on effects that physical activity may have on sleep health. The 3-arm design will allow us to determine whether the addition of physical activity enhances the effectiveness of a sleep intervention to improve sleep quality. The combination of a physical activity intervention with a sleep intervention is likely to further reduce the risk of chronic diseases associated with poor sleep such as cardiovascular disease and type 2 diabetes, by synergistically enhancing the effectiveness of the sleep intervention.