ANZCTR search results

Objectives: To determine the feasibility of conducting a future definitive randomised trial to assess the efficacy of specific load-intensity and time-under-tension exercise interventions for reducing pain in mid-portion Achilles tendinopathy. Design: Single-centre, outcome assessor-blind, feasibility factorial randomised pilot trial. Setting: Interventions provided in a university/ gym setting. Participants: Total number of 48 male participants with Achilles tendinopathy, recruited from the community. Interventions: Participants will be randomised into one of the four factorial arms that include high (6 repetitions to failure) or low (18 repetitions to failure) load-intensity calf exercise, and each will be performed with high (6 second per repetition) or low (2 seconds per repetition) time under tension. Exercise will be home-based and performed 3 times per week over 12 weeks. One exercise session per week will be monitored via telerehabilitation (videoconference). Main outcome measure: The primary outcomes will be study processes used to determine feasibility of a future definitive randomised trial. Process outcomes will include recruitment and retention rates, adherence to interventions, response rates to self-reported questionnaire outcomes, adverse events, and participants’ and telerehabilitation observers’ experiences with the interventions. Clinical outcomes including patient rated pain, function, global satisfaction, health-related quality of life, physical activity, kinesiophobia, pain catastrophic thinking as well as measures of plantarflexion motor function will be collected to explore the rate of change over 6 and 12 weeks in patients while completing a loading protocol with varying parameters for mid-portion Achilles tendinopathy. Discussion: This study will determine the feasibility of a future definitive randomised trial examining the efficacy of specific load-intensity and time-under-tension exercise interventions for Achilles tendinopathy.

This study is examining the safety, immunogenicity and efficacy of chemically attenuated P. falciparum 7G8 parasitised red blood cells. Study participants designated for vaccination (n=10/group), will receive three doses of 3 x 10^5 (Group C), 3 x 10^6 (Group B) or 3 x 10^7 (Group A) purified, tafuramycin-A attenuated P. falciparum 7G8 parasitised red blood cells, with the doses administered 28 days apart. Vaccinated study participants (n=10/group) and the unvaccinated infectivity controls (n=2/group) will receive a single inoculum of 1,800 P. falciparum 7G8 parasitised red blood cells 28 days following the final vaccination to assess the efficacy of the vaccine. Samples collected during the study will be evaluated for immunogenicity. Passive and active follow-up will be used to assess safety and tolerability. Determining the safety, immunogenicity and efficacy of the Tafuramycin-A treated malaria parasites is important as they form the basis of a novel malaria vaccine approach.

This pilot study will evaluate a play-based, 12-week, teacher-delivered preschool mindfulness program, compared to teaching-as-usual. The program includes specific mindfulness-based activities, games, props and books. The program is designed to improve young children’s executive functioning and social-emotional wellbeing, using both direct child assessment and parent/teacher report.

Coronary artery disease affects an estimated 1.2 million Australian and over 47,000 stents are inserted in Australia each year. This is a double-blind, randomized, placebo-controlled clinical trial intended to evaluate if photobiomodulation (low level laser applied to the skin) reduces the damage to heart muscle during elective coronary artery stenting Participants will receive either an active laser treatment of an 808nm laser or a placebo laser for a similar length of time Participants will be block randomised and stratified on the basis of lesion description and SYNTAX score Into low and high risk groups. Participants will be excluded if they are under the age of 18 years, pregnant or receiving treatment for haematopoietic malignancy The primary outcome measure is the change in troponin levels between the prior and the 24 hour measures. After discussion with the cardiology working group it was decided that a 30% reduction in troponin rise in this intervention would be considered clinically significant. It was estimated that a sample size of 520 would have sufficient power. An interim analysis will be performed after 260 participants to check if sample size is sufficient The Student’s dependent samples t-test will be used to compare mean values of continuous variables approximating a normal distribution. For non-normally distributed variables ordinal logistical regression will be used.

A Toddler’s Fracture is a fracture of the lower part of the ‘shin’ bone (tibia) in toddler’s or young children aged less than 8 years. The fracture is usually found in the lower 2/3 of the tibia in most cases and is undisplaced and has a spiral pattern. It often occurs after minimal trauma or a twisting injury. Most often, children with these injuries present to an emergency department with refusal to weight bear or walk, but have few other clinical signs. Historically, an above knee plaster of Paris (AK POP) is applied for 4-6 weeks to treat these injuries. An above knee plaster can cause significant disruption to the lives of the child and family as it not only affects bathing and mobility but also requires multiple visits to the hospital. These may be for complications such as broken casts and pressure areas or for routine fracture clinic appointments with the orthopaedic team. A controlled ankle motion walking boot or CAM boot is an orthopaedic device prescribed for the treatment and stabilization of severe sprains, fractures, and tendon or ligament tears and acts like a plaster cast to provide stability to a fractured bone or unstable joint, or to immobilise soft tissue injuries. CAM boot immobilisation would, theoretically, be preferential to parents and children and would allow bathing and regular prams and strollers to be used instead of the required modifications needed for above knee plaster casts. We aim to show that children have improved activities of daily living when immobilised in a CAM boot compared to an AK POP, without any detrimental effect on healing. We will also be looking at the amount of pain children experience in the two groups and parental satisfaction with the immobilisation technique used. Finally, we will assess and compare the cost of the two treatments, including time taken off work or school/day-care, and the number of hospital visits required.

The newer generation TIGRIS GORE nitinol stent observed in this study has been used successfully in many practices in Australia. Given the clinical equipoise surrounding the optimal choice of stent in the treatment of femoropopliteal artery disease, it is routine practice for some surgeons and centres to choose to use this stent for their patients. This study will act as a registry for patients who receive a GORE TIGRIS stent in treatment of their peripheral artery disease, and serve to provide further data for use of this stent in a real-world setting.

Test the safety of a new medication in the treatment of Age Related Macular Degeneration. A Phase Ib, study of safety and tolerability of Intravitreal Fludrocortisone Acetate (FCA) in Patients with Geographic Atrophy (GA) secondary to Age Related Macular Degeneration

This study aims to determine the accuracy of an imaging technique, known as PSMA PET/MRI scanning, in detecting, diagnosing and characterising prostate cancer lesions. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above and have new biopsy diagnosed prostate cancer, for which you are eligible for definitive (surgical) treatment with a radical prostatectomy. Study details All participants in this study will undergo an extra scan in addition to standard clinical care (which includes a multiparametric prostate MRI scan and a Ga68 PSMA PET/CT scan). The additional scan is called PSMA positron emission tomography/magnetic resonance imaging (PET/MRI). It is done immediately after the participant has undergone the standard scans, and does not require any additional radiotracer to be injected. A PET/MRI nuclear medicine technologist will perform the scan, taking around 30 minutes to 1 hour, at a research imaging facility in metropolitan Melbourne. It is hoped that the additional scan will help to detect and characterise prostate cancer lesions and associated metastatic disease.

Cancer screening is one aspect of health care that is perceived as “more equals better”. However, there is uncertainty associated with the benefits and harms of screening for cancer in older adults. More specifically, evidence shows that older men and women are more likely to experience net harm from breast and prostate cancer screening than younger adults. However, it is challenging to communicate effectively and sensitively about these issues to older adults. Qualitative research suggests that life expectancy could be helpful to mention, but the way that it is framed could have importance in how the information is received. The aim of this study is to examine different strategies to communicate with older people about the option of stopping cancer screening, taking into account well-known heuristics and biases that impact on decision making in this group. In particular, we will test the effect of different strategies to communicate about benefits versus harms and life expectancy. Furthermore, we will compare positively and negatively framed statements of life expectancy.

This pilot study aims to determine the feasibility of a randomised controlled clinical trial (RCT) of Supporting Early Play Exploration and Early Development Intervention (SPEEDI) for preterm infants, to inform a larger RCT. SPEEDI focuses on early motor development, environmental enrichment and supporting parent infant interaction. It involves direct physiotherapy/ occupational therapy and parent provided activities, with 5 sessions delivered in the neonatal nursery, and 5 in the home setting, until 3 months’ corrected age. Twenty infants born <30 weeks’ gestation will be recruited from The Royal Women’s Hospital. After baseline assessment at 34-38 weeks’ corrected age, infants will be randomly assigned to SPEEDI or usual care. At 3 and 4 months’ corrected age infants will be assessed using standardised measures of motor function and cognitive skills by assessors blind to infant group allocation. Parents in both groups will be interviewed about their experience of the study. Primary outcome is study feasibility (including enrolment and attrition rates), acceptability (participant experience and willingness to be randomised), and standard deviations of the outcome measures to estimate sample size for a larger RCT