ANZCTR search results

This project aims to generate experimental evidence from one online randomised controlled trial to determine the relative effect of simultaneously displaying multiple added sugar labels to facilitate healthier choices by consumers. We hypothesise that displaying multiple added sugar labelling on food and beverage items will reduce the proportion of intended purchases of products that are high sugar, compared to no added sugar labels or only one added sugar label. Further we hypothesise participant characteristics including age, gender, education, income, and usual levels of sugar consumption alter the effect of added sugar labelling on intended purchasing. This new evidence will be critical to the development of effective labelling policies to reduce added sugar consumption for all Australians and New Zealanders.

The purpose of this study is to investigate the use of the medication combination Bazedoxifene and conjugated estrogen, a hormone replacement therapy, in the treatment of depression with a first onset or relapse during the peri-menopausal phase that is still persisting. The study will employ a 12-week, double-blind, randomised, two-arm parallel-group design. Participants will be randomised to one of two groups: (1) Daily oral Bazedoxifene and conjugated estrogen (20mg/0.30mg), (2) Placebo (sugar pill). The aim is to compare, in a twelve-week double-blind randomised controlled trial, the psychological and physical outcomes of women experiencing a first-onset, relapse or persistent depressive symptoms that commenced during the peri-menopause in four groups: i) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day) in adjunct to standard antidepressant treatment, ii) women taking placebo in adjunct to standard antidepressant treatment, iii) women taking Bazedoxifene and conjugated estrogen (20mg/0.30mg oral/day), iv) women taking placebo alone (i.e. women not using any psychotropic / hormone treatment). It is hypothesized that women receiving Bazedoxifene plus conjugated estrogen alone, and Bazedoxifene plus conjugated estrogen in adjunct to standard antidepressant medication will have the same as or significantly greater improvement in depressive symptoms compared with women receiving placebo in adjunct to standard SSRI and women not using any psychotropic/hormone treatment.

The aim of the proposed study is to determine the proportion of patients who are administered oxygen therapy in accordance with the current World Health Organisation (WHO) guidelines by anaesthetists in Australia and New Zealand. The primary outcome of this study will be to determine the proportion of cases where time-weighted average intra and postoperative inspired oxygen concentration (FiO2) was at least 0.8 in accordance with WHO guidelines. We hypothesise that among the population group studied, fewer than 5% of patients will be administer intraoperative oxygen therapy as recommended in the WHO guidelines.

The primary purpose of this study is to provide long-term patient follow-up, and review of clinical and correlative data outside of clinical trials. Who is it for? The registry will collect information on patients age 18 years or older, with a new diagnosis of Myelodysplastic syndrome (MDS). Study details Treating clinicians at sites will identify patients at the time of referral and enrol them to the study. The following categories of data items will be collected to the Myelodysplastic syndrome database using a web portal: • Health at diagnosis • Demographic details • Laboratory and bone marrow biopsy results at diagnosis including cytogenetics and molecular studies if available • Therapy decisions including pharmacological agents, transfusion practice and supportive therapy, and side effects of treatment • Outcomes (overall and progression free survival, duration of response and time to next treatment and quality of life measures – EORTC QLQ-C30, QUALMS) • Long-term outcomes (through linkage with Cancer and Death Registries) Patients are asked to completed both questionnaires 6 monthly up to 3 years either at their hospital appointment or send to them via email. It is hoped that the data collected for this registry will identify patterns of treatment and variation in outcomes, for survival and quality of life. Findings will be valuable in informing optimal treatment strategies for Myelodysplastic syndrome and will assist with monitoring patient access to care, as well as monitoring trends in Myelodysplastic syndrome incidence and survival in Australia.

The participant is invited to take part in this research project. This is because the participant has had a stroke within the last 15 years and has ongoing disability and impairments. The research project is testing a new treatment for stroke called Etanercept. Stroke survivors often have lifelong, disabling effects as a result of their stroke which impact daily life. Because current treatment options for post-stroke impairments are limited, stroke survivors sometimes try out therapies that may not be scientifically proven. The use of Etanercept injected at the base of the neck, is one treatment that has received a lot of attention in the media as it has been linked with improvement of stroke symptoms. It is unclear whether these improvements are due to the drug or other factors, as many of the effects have been seen in small observational case studies. Etanercept is approved in Australia to treat joint conditions (such as rheumatoid arthritis) or skin conditions (such as psoriasis). However, it is not approved to treat stroke. Therefore, it is an experimental treatment for stroke. This means that it must be tested to see if it is an effective treatment for stroke. This trial is aiming to properly test to see whether this medication is an effective treatment. The participant will be randomly assigned to receive an injection of Etanercept or an injection of a placebo at two timepoints in the study. The study will be double-blinded. This means that neither you, the participant nor their study doctor will know which treatment they are receiving. However, the study doctor can find out which treatment they are receiving if necessary, for safety reasons.

Post exercise blood flow restriction (PE-BFR) appears to offer a novel, ecologically viable, and practical method of enhancing recovery that is becoming increasingly common in athletic settings. In brief, PE-BFR consists of repeated brief alternating periods of blood flow restriction and reperfusion on targeted limbs, most commonly applied via an inflatable pneumatic cuff placed on the proximal most portion of the limb. However, the effect of PE-BFR on recovery have been conflicting. In certain settings, PE-BFR has been shown to attenuate decrements in physical performance, measures of muscle damage, and perceptual measures of recovery between 24 and 72 hours after exercise. Conversely, in others, no positive effects on recovery have been observed. Irrespective of outcomes, it is important to highlight that methodological differences exist between previous studies regarding the implementation of BFR. For example, all previous methods of application used either standardised arbitrary pressures, pressures based on thigh girth, or pressures based on a percentage of systolic blood pressure – none of which align with the current recommendations of restricting blood flow using a percentage of limb occlusion pressure (LOP) As such, this study aims to explore the effects of individualised post exercise blood flow restriction, based upon a percentage of LOP, on measures of physical performance and perceived recovery following heavy resistance training exercise.

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.