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This proposal aims to answer a critical question in the Diabetic Macular Oedema management, and by testing regularly with conventional and novel ophthalmic imaging to predict early response to anti-vascular endothelial growth factor (VEGF) therapy. This anti-vascular endothelial growth factor (VEGF) therapy, is standard of care approved by the Therapeutic Goods Administration for Diabetic Macular Oedema treatment. Diabetes is a common condition that can result in severe vision loss. The structure of the eye can be considered very similar to a camera and diabetes causes damage to the retina which is analogous to the film in the camera. More specifically, diabetes causes injury to blood vessels in the retina causing them to bleed and leak fluid. A spectrum of these retinal changes can occur in diabetes and is referred to as diabetic retinopathy. Currently, fluorescein angiography (FA) is considered the gold-standard technique for visualising the blood vessels in the retina. It is a more precise technique for detecting retinal vascular changes than clinical examination. FA is a technique that was described over 50 years ago and is still widely used. FA is an invasive technique that involves the injection of fluorescein dye into the human vein with images captured by a camera as the dye circulates through the retina. FA is associated with adverse effects including nausea, dizziness and rarely, death due to anaphylaxis. FA is also an expensive procedure and cannot be repeated frequently. Over the past 3 years, a new technique known as optical coherence tomography angiography (OCTA), has come into widespread use for the clinical management of diabetic retinopathy. OCTA is a non-invasive technique that allows rapid image acquisition (3-5 seconds) of the retinal circulation. It is a commercial technique that is widely used by ophthalmologists today. Most importantly, our own research has shown that OCTA provides greater detail of the order and organisation of retinal capillaries and large vessels than FA. The intervention to be administered is intravitreal aflibercept. This study will help develop ways to detect diabetic changes in the eye at an earlier stage than what is possible with current technology. OCTA data acquired from this study may aid the evaluation and treatment of diabetic retinopathy for the individual diabetic participants.

Shoulder pain affects 7-26% of people at any given time[1] and is the third most common musculoskeletal condition seen in primary care[2]. Rotator cuff disease is an umbrella diagnosis that captures 85% of shoulder pain cases[3]. Diagnostic labels influence management preferences for rotator cuff disease. Our online randomised controlled trial (n=1,308) found that people who were told they had a rotator cuff tear had higher perceived need for shoulder surgery and imaging compared to those told they had bursitis[4]. However, we only investigated the isolated effect of labels. In clinical practice, some health professionals could give patients a diagnostic label followed by positive prognostic information and simple management advice (e.g. temporarily avoid activities that aggravate the pain, continue to move the arm). Others could give patients a diagnostic label followed by advice (e.g. take prolonged rest, stop going to work) that increase patients’ fear and perceived need for unnecessary care (e.g. surgery). The primary aim of this online randomised controlled trial is to examine the effects of diagnostic labels and advice on people with rotator cuff disease, and interactions between labels and advice, on perceived need for shoulder surgery. Secondary outcomes include perceived need for imaging, perceived need for an injection, perceived need for a second opinion, perceived need to see a specialist, perceived seriousness of the condition, recovery expectations, and perceived impact on attendance and performance at work. We hypothesise that both the bursitis label (compared to rotator cuff tear) and evidence-based advice (compared to standard advice) will reduce perceived need for surgery. We also hypothesise that there will be a supra-additive effect of providing both evidence-based advice and the bursitis label. References 1. Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, et al. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. 2. Rekola KE, Keinanen-Kiukaanniemi S, Takala J. Use of primary health services in sparsely populated country districts by patients with musculoskeletal symptoms: consultations with a physician. J Epidemiol Community Health. 1993;47(2):153-7. 3. Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005;44(6):800-5. 4. Zadro JR, O’Keeffe M, Ferreira GE, Haas R, Harris IA, Buchbinder R, et al. Diagnostic Labels for Rotator Cuff Disease Can Increase People’s Perceived Need for Shoulder Surgery: An Online Randomized Controlled Experiment. Journal of Orthopaedic & Sports Physical Therapy.0(0):1-45.

The Bionics Institute Rigidity Device (BiRD) is a palm-worn device intended to be used to measure the severity of movement problems seen in people with Parkinson's disease, including uncontrollable shaking (tremor), slowness of movement (bradykinesia) and joint stiffness (rigidity). The aim of the study is to evaluate its performance through a clinical feasibility study. This will involve 20 healthy adults and 60 people with Parkinson's disease, where half the participants with Parkinson's disease are treated with medication and the other half are primarily treated with deep brain stimulation (DBS). Participants will be asked to make a series of postures and movements as guided by standard clinical tests while wearing the device. Testing will occur under different treatment scenarios to ensure it works in each situation. Some tests will last about half an hour, whereas other tests will take approximately three hours. The data from the device will be compared to regular clinical assessments completed by a health professional to ensure they tell us similar information about the movement problems. A previous pilot study has suggested that information extracted from the device will relate to clinical assessments and is safe to use.

Stage 2 is a follow up study which implements a pilot Model of Care developed from Stage 1 (ACTRN12621000739819) where participants (n=80) are recruited, and will complete a study period of 24 weeks, with study follow-ups at weeks 2, 4, 8, 12 and 24. Approximately 10-20 psychiatrists, who are involved in the care of patient participants, will be enrolled in the study, to complete online questionnaires. Stage 3 involves economic evaluation of the pilot Model of Care. Approximately 80 GPs, who are involved in the care of patient participants, will be enrolled in the study, to complete online questionnaires. This Model of Care is hypothesised to enhance the feasibility and clinical utility of pharmacogenomics testing to guided pharmacotherapy into routine clinical care of patients with mental illness.

The aim of this study is to compare the opportunistic use of chest computed tomography (CT) scans obtained as part of the International Lung Screening Trial (ILST) and clinical fracture risk prediction tools, against the reference standard dual-energy X-ray absorptiometry (DXA) scan to detect osteoporosis in lung cancer screenees. Who is it for? You may be eligible for this study if you are a lung cancer screening participant currently enrolled in the Queensland site (based at The Prince Charles Hospital) of the Osteoporosis Sub-study of the International Lung Screening Trial (ILST), and you are either due to have your second CT scan soon or have had your second CT scan within the past 6 months. Study details In addition to the CT scan received as part of the ILST trial and the osteoporosis questionnaires completed as part of the Osteoporosis sub-study of the ILST, all participants enrolled in this study will be requested to have a single DXA scan, This DXA scan will be performed either on the same day or different day to your CT scan, but should be within 6 months of the CT scan. The DXA study should only take up to 20 minutes and will be performed at The Prince Charles Hospital. It is hoped that this study will demonstrate that CT-based methods will be highly accurate, and have higher discriminative ability compared to clinical risk tools, in classifying DXA-defined osteoporosis, and therefore may validate their use in diagnosing osteoporosis in lung cancer screenees. This, in turn, may help to facilitate early diagnosis and treatment in this high-risk group of lung cancer screening participants.

The primary purpose of this study is to assess the feasibility, safety, and activity of vaginal oestriol in preventing vaginal stenosis in women receiving radiotherapy for gynecological, rectal and anal malignancies. Who is it for? You may be eligible for this study if you are a woman aged 18 years or above, who has received external beam radiotherapy, with curative intent to the pelvis, for treatment of a confirmed diagnosis of gynaecological, rectal or anal cancer. Study details Participants will be asked to regularly apply vaginal oestriol cream following completion of pelvic radiotherapy, and will be followed up for safety and effectiveness. It is hoped that information from this study will help improve health-related quality of life for women after cancer treatment for gynecological, rectal and anal malignancies.

The study will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of RLS103 in healthy adult volunteers. Safety oversight will be provided by a Safety Review Committee comprised of the Principal Investigator (PI), Sponsor’s medical representative, and an Independent Medical Monitor. The study consist of 3 cohorts and each cohort includes 4 treatment period with a washout period of 7 days between each treatment in each cohort. The total duration of study participation will be up to 38 days.

The study aims to investigate the potential therapeutic benefits of cannabidiol (CBD) as a treatment for brain changes and depression in individuals living with early-stage dementia. Accumulating evidence suggests that CBD is a novel, well tolerated medicine with beneficial neurorepair, hormone and symptom regulating effects and it may therefore be a promising candidate to address multiple facets of dementia. However, no trial to date has investigated the effects of pure CBD in people with early-stage dementia. The trial design includes 60 participants randomised to one of two treatment arms (30 CBD, 30 placebo), who will take a daily 300mg dose of their respective capsules for 12 weeks. A comprehensive range of outcome measures will be assessed at baseline, mid- point and post-treatment. It is anticipated that treatment with CBD will lead to improvements in neural structure, cognitive function, psychological symptoms and hormone profiles.

There is international evidence supporting the effect of intensive family preservation and reunification services in preventing out-of-home care (OOHC) placement among vulnerable families. However, such evidence in Australia is scant. This paper describes the protocol for a hybrid effectiveness-implementation evaluation of the Victorian Family Preservation and Reunification (FPR) Response implemented by MacKillop Family Services. Participants will include families who engage in the FPR and MacKillop Family Services staff involved in program delivery. A pre-post study design will be used to assess the effectiveness of the FPR in facilitating changes in family outcomes from intake to closure, including: i) parenting capability; (ii) family safety and home environment; (iii) child development; and (iv) prevention of children from entering or re-entering OOHC. Interviews will be conducted with staff to evaluate the program’s implementation (i.e., fidelity, reach, feasibility, acceptability, enablers and barriers to implementation). Quantitative data will be analysed using descriptive statistics and a series of paired-samples t-tests to examine changes in outcomes over time; thematic analysis will be used for qualitative data. If the FPR is well-implemented and yields significant improvements in families’ outcomes, this would provide strong support for its scale-up across Australia, to improve outcomes for vulnerable families.

Health service often requires healthcare workers (typically doctors and nurses) to place a thin plastic tube into patients' veins called an intravenous cannula (IVC). Placing an IVC is one the most commonly performed medical procedures. It is estimated that every year 2 billion IVCs are sold around the world and over 7 million Australians have an IVC placed. Despite the huge numbers of IVCs placed each year, inexperienced clinicians often take many attempts to successfully place one. This causes pain for patients and, in an emergency, failure to rapidly place an IVC can cause serious patient harm including death. There are some recent realisations about how the shape of the IVC tip influences the proper approach to placing the IVC. If these realisations are effective at improving IVC success rates then this will impact on millions of people. This study will test this by randomly allocating students to watch different videos. Each video will contain helpful tips for the students to place IVCs but only some students will be shown novel details about the recent realisations. A subset of students will also learn a novel method of practicing a critical step of placing the IVC. Students will then report back the outcome of their first 20 IVC attempts. This will enable us to test if the realisations and the novel practice method lead to less failed IVC placement attempts. The research team will monitor the results using predefined stopping rules. We hypothesise that teaching the theory of lifting of needle tip will increase cannulation success rates. We further hypothesise that the using the hands-on alcohol wipe teaching model will have an additional benefit beyond purely theoretical instruction.