ANZCTR search results

Aim: To evaluate the feasibility of a randomised controlled trial of critically injured patients with nutrition risk factors where intervention group patients receive a higher dose (equal to 2.2 grams/kg/day) of protein/amino acid administration in ICU and a high protein oral nutrition supplement (ONS) on the ward; control patients receive 1.2 gram/kg/day of protein in the ICU and ONS on the ward as prescribed at the discretion of the treating team. Secondary aim: To contribute ICU data to the EFFORT trial which, is a large, multicenter, pragmatic, registry-based, patient randomised, clinical trial of 4000 nutritionally high-risk critically ill patients. In this study the administration of lower dose of protein/amino acids (equal to 1.2g/kg/day) will be compared with the administration of a higher dose of protein/amino acids (equal to 2.2g/kg/day) to nutritionally high-risk critically ill patients to determine if higher protein administration is associated with greater muscle mass, improved survival and a quicker rate of recovery. Hypothesis: We hypothesise that the trial will be feasible as judged by enrolment rates, intervention fidelity and protocol compliance

The research project aims to evaluate safety and tolerability of a novel method for large volume bone reconstruction that includes a combination of a thin layer of bone with its blood supply kept in tact as well as a 3-D printed scaffold to help bone grow. This method of “growing” new bone uses a 3D printed substance similar to human bone and is already TGA approved for use in reconstruction of the bone of the skull. The novelty to the project stems from a new method of "growing" new bone in the patient by using a small amount of their own bone from another part of the body with its blood supply kept in tact using very fine surgical techniques (microsurgery) to connect the vessels. This approach is known in reconstructive surgery as a "free flap". It is hoped that this trial will provide further evidence to support the use of this method in reconstructing large segment bone loss for a range of conditions where minimal options currently exist – the focus being on “limb salvage” where amputation can be avoided for a better functional and socially acceptable outcome for the patient.

Our research group has developed an individualised model of care for chronic low back pain termed ‘cognitive functional therapy’ (CFT), which showed to be superior to current physiotherapy treatment at one-year (Vibe Fersum et al 2013) and three-years follow up (Vibe Fersum et al 2019). With growing evidence that chronic low back pain and osteoarthritis share similar barriers to recovery, interventions targeting contributing factors at an individual level may offer a promising alternative for people with knee osteoarthritis. However, there are no randomized clinical trial examining the effects of a CFT intervention in people with knee osteoarthritis. The primary aim of this study is to determine the feasibility of conducting a future, efficacy randomized clinical trial of CFT for people with knee osteoarthritis; and evaluate the acceptability of the CFT approach adapted from chronic low back pain to knee osteoarthritis. The secondary aim is to estimate of degree and variability of change, in selected outcomes in people undergoing CFT in comparison to usual care.

Cancer Council Australia recently published evidence-based guidelines which recommend that people aged 50-70 years consider taking aspirin to prevent bowel cancer. The purpose of this study is to determine if a new decision aid is effective in teaching the public about the benefits and risks of taking low dose aspirin and whether there is a change in the use of aspirin. Who is it for? You may be eligible for this study if you are an adult between 50-70 years of age and live in Victoria. Study details Participants in this study will be randomly selected to take part in one of two interventions: 1. The decision aid brochure group, where participants will receive a brochure which explains the benefits and risks of taking low-dose aspirin and 2. The reduce your bowel cancer risk brochure group, where participants will receive a brochure on how to cut your cancer risk and directed to the Cancer Council Victoria and Bowel Cancer Australia modifiable risk factors websites. Participants will then be followed up after 1 and 6 months, at which point they will need to complete a questionnaire on their thoughts, how they feel about numbers and use their of aspirin. It is hoped that this research will help determine if this decisional aid is effective in educating participants in the harms and benefits of the use of low dose aspirin.

This study will pilot a novel model of care integrating face-to-face and online support (Moderated Online Social Therapy) for young people receiving specialist treatment for complex mental health disorders. The primary aims are to assess the feasibility, safety and acceptability of this model of care, with additional aims to assess changes in participants’ psychological and social outcomes and to assess the relationship between these outcomes and usage of eOrygen.MOST.

Previous case studies have shown that intracardiac lead thrombus can cause pulmonary embolism (PE). However, the incidence of new or worsening pulmonary hypertension after cardiovascular implantable electronic devices (CIED) lead placement has not been well investigated. Pulmonary hypertension after CIED implantation will subsequently result in right heart failure and increase morbidity and mortality. This study is aimed to: I. Determine the incidence and factors associated with development of pulmonary hypertension and right ventricular dysfunction in patients with CIEDs. II. Determine the role of anticoagulation in the prevention of pulmonary hypertension in patients with CIEDs.

The aim of this study is to evaluate the effectiveness of microdox bladder rinse in patients with recurrent UTIs. Efficacy will be assessed by the number of symptomatic UTI’s during the 3 month treatment period and 3 months following completion of Microdox. Women must meet criteria for recurrent UTI i.e. > 2 documented symptomatic UTIs in preceding 12 months. We are aiming to exclude catheterised women. This is a multi-centre, double blinded, randomised trial. Intravesical Microdox treatment is superior to intravesical normal saline wash for the prevention of recurrent UTI’s at 6 months. There is currently no human trials using Microdox in the bladder. Most research on Microdox is based on wound care. There is one recent randomized trial using normal saline wash in catheterised patients and the UTI rate decreased markedly. The cost and suffering resulting from Recurrent UTI’s is significant. Hence better treatments of Recurrent UTI’s is desperately needed, particularly treatment that won’t contribute to the growing antibiotic resistance, and we are hoping that Microdox could be the answer.

The study aims to explore the feasibility and acceptability of the younger women’s wellness program for PMS in University students .In Phase one, Feasibility will be determined through composite analysis of eligibility, recruitment, retention, protocol adherence, missing data, and sample size estimates. In phase two, participants in group 1 will be contacted after completing the 12-week study for an in-depth semi-structured interview (30-40 minutes). The aim of Phase two qualitative study is to understand in-depth the interventional components that were helpful for women and those that were not. Further information will also be elicited from informants about the content and delivery methods that are likely to yield maximum likelihood of participant retention.

This is a single-centre, open-label phase 1b study using the P. falciparum induced blood stage malaria (IBSM) model to evaluate the antimalarial activity of a single oral dose of tafenoquine in healthy subjects. The study will be conducted in three parts. Part 1 will be composed of an initial cohort of four subjects followed by up to three cohorts of up to eight subjects per cohort, and will evaluate the potential of different single oral doses of tafenoquine to clear asexual blood stage P. falciparum parasites and inhibit the development of the sexual stage of the parasite (gametocyte) responsible for transmission to mosquitoes. Part 2 will be composed of up to two cohorts of up to eight subjects per cohort, and will evaluate the potential of a single oral dose of tafenoquine administered prior to intravenous inoculation with blood stage P. falciparum to protect against infection. Part 3 will be composed of up to two cohorts of up to eight subjects per cohort and will determine if a single oral dose of tafenoquine is active against mature gametocytes, and is able to block transmission to mosquitoes. Parts 2 and 3 of the study are optional and are dependent on the results obtained in Part 1.

The aim of this program is to reduce the risk of falls in people with Parkinson's disease using non-invasive technology to monitor and improve their walking balance. Falls are a major cause of hospitalisation in people with PD, with 60% of all sufferers experiencing a fall each year. There is strong evidence that fallers walk with greater side to side head movement along with shorter step length and a slower cadence than non-fallers. Improving gait stability by retraining the way these individuals walk may thus have great potential to reduce the risk of falls and consequently reduce fall-related hospitalisations. A cross sectional study involving approximately 30 people with PD with mild to severe disease severity will be conducted. The effect of real-time feedback on walking mechanics will be investigated. Participation in this research will require individuals to visit the school of Exercise Science's Biomechanics Laboratory at the Brisbane campus of the Australian Catholic University on two separate occasions separated by approximately 1 week to complete a series of walking assessments. During these assessments, walking mechanics will be evaluated using a 3-dimensional motion capture system. The protocol will involve each participant receiving real-time biofeedback.