ANZCTR search results

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.

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.