ANZCTR search results

The primary aim of this study is the evaluate the impact of a coach development program for improving coaching practices and player outcomes with a cohort of community level netball coaches (using a randomised controlled trial) Based on previous findings with football coaches (pilot study), it is anticipated that coaches participating in the program will demonstrate significant improvements in: 1. The coaching environment (with reference to the MASTER framework) 2. The quality of their training sessions (use of playing-form activities within training sessions and learning opportunities) 3. The quality of coach feedback during training sessions

Comparing safety outcomes of patients treated based on Cardiac MR/ imaging screening of acute rejection compared to endomyocardial biopsy guided screening. The imaging technniques used will be a combination of tissue characterisation, strain and ventricular function on CMR and TTE. Objectives: Primary Safety Outcomes Endpoints 1) Frequency and severity of cardiac rejection 2) Frequency and severity of serious infections 3) Cardiovascular morbidity 4) Cardiovascular hospitilisation 5) All cause for hospitilization 6) Death 7) Biopsy - related complications 8) Frequency and severity of cardiac allograft vasculopathy as determined by CTCA or Invasive angiography at 1 year 9) Total immunosuppression required 10) Measures of tissue characterisation and myocardial performance by CMR and TTE utilising in addition CMR strain and TTE global longitudinal strain

Orthokeratology (OK) lenses are specialised rigid contact lenses that are worn overnight during sleep in order to reshape the front surface of the eye to temporarily correct short-sightedness or myopia. The traditional approach to improve centration of conventional rigid contact lenses on the eye involves increasing total lens diameter. Similarly, it has been proposed that increasing the diameter of an OK lens will improve lens centration. However, this has not yet been comprehensively investigated. Therefore this research study aims to explore the influence of OK lens diameter on lens centration. This study is significant, as it will provide insight into methods to improve the fitting and efficacy of orthokeratology lenses for myopia correction.

The current study aims to conduct a primary investigation of the feasibility and effectiveness of an online-based ‘Compassion based mindfulness course’ that is self-directed (low interaction) compared to a highly interactive (collaboratively based) online course on psychological well-being outcomes. The present study aims to address prior methodological issues by evaluating the impact of the online course using an adequately powered parallel randomised controlled trial design to increase well-being in a student sample. Whilst monitoring levels of engagement to determine the effectiveness of the delivery and use of the online space. In addition, assessing the levels of engagement against course completions.

Foot ulcers are a frequent complication of diabetes. These wounds can be serious, and may result in amputation or even death, if left untreated. A frequent cause of these wounds is high pressure under the foot. Prevention of such wounds is of great importance. This is especially the case in people who cannot feel touch or pressure on their foot, which is called peripheral neuropathy, or an insensate foot. Reduced foot sensation can prevent people from noticing when high pressure develops and this places them at high risk of developing foot ulceration. Clinical guidelines recommend the provision of protective footwear and pressure relieving insoles in the prevention of ulceration in the insensate foot. This needs to be guided by measuring pressure under the foot and subsequent modification of footwear or orthoses to provide optimal conditions for the prevention of ulceration. Many systems exist to measure pressure beneath the foot to determine how effective pressure relieving strategies are. Current validated systems consist of high numbers of sensors but are expensive, which limits implementation into routine clinical practice, and can be difficult to use for untrained clinicians. In this study, we will test how well an affordable portable multi-point pressure sensor module measures pressure at key sites during normal, overground, walking and whilst changing from sitting to standing and back. We will compare this to a validated gold-standard reference pressure measurement system. Clients of the Metro North Hospital and Health Services (MNHHS) community-based High-Risk Foot Clinic (HRFC) with peripheral neuropathy and no current foot ulcers will have pressure measurements taken prior to routine follow-up care. The results obtained from portable multi-point pressure sensor module will be compared to results from a laboratory insole testing system, which is considered to be “gold standard” for the measurements. Fifteen participants with diabetes mellitus type 1 or 2 and peripheral neuropathy will be included in the study. People with severe peripheral artery disease, a foot wound, severe foot deformities or unsteadiness in normal walking will be excluded from the study. When the study is finished, we will know if the portable multi-point pressure sensor module gives similar results as “gold standard” measurement system.

This research project is called "Personalised advice and instructions for pain relief following discharge from ED". This research project is aiming to study the ways doctors and nurses to give pain relief instructions to patients who are being discharged from the emergency department. We are particularly interested in whether personalising the pain relief instructions and making them print outs and accessible on mobile phone is useful for patients. We aim to use the information from this research to improve the ways we provide pain relief instructions to patients leaving the emergency department.

Malnutrition is a common problem in patients waiting for a liver transplant and can impact their health both before and after transplantation. Malnutrition prior to transplant can be caused by poor dietary intake due to the symptoms of chronic liver disease, altered metabolism of nutrients, or malabsorption. Poor nutritional status can be identified by weight loss, muscle wasting, poor appetite, and/or blood tests. Patients with malnutrition who are waiting for liver transplant are encouraged to eat a high calorie and protein diet with additional supplement drinks, to help meet their extra nutritional needs. However, most patients are not able to consume enough of their usual meals and extra supplements to meet these needs, which can worsen malnutrition and influence recovery after surgery. Many studies have shown that malnourished patients undergoing liver transplant have a longer hospital length of stay, have an increased number of infections, increased incidence of rejection, and are more likely to be readmitted to hospital in the early months after transplant. Patients with malnutrition awaiting liver transplant who aren’t able to eat or drink enough may therefore need a different way to meet their nutrition needs. Enteral nutrition (nutrition fed by a ‘nasogastric’ tube (NGT) directly into the stomach) is the preferred way for these patients to receive all the energy, protein and nutrition they need, and can be undertaken in both hospital and at home. The aim of this study is to determine if NGT feeding before liver transplant helps improve outcomes for patients with malnutrition. Patients will be randomised to either NGT feeding while awaiting transplant, or standard high energy and protein diet (current practice). Patients in the NGT group will have a NG feeding tube inserted and receive feeds overnight to meet 75% of their nutrition needs. They will also be allowed to eat and drink throughout the day (to meet the other 25%). Patients in the diet group will be advised by the dietitian to eat high energy and protein foods and fluids (target 100%), which is the current standard practice for patients before liver transplant. If NG feeding is effective, it may minimise the loss of weight and muscle strength that commonly occurs before transplant; and has the potential to reduce patient length of stay, and reduce episodes of infection and rejection after transplant.

The purpose of this study is to determine if the radio-tracer 18F-PSMA-1007 has similar diagnostic accuracy to the radio-tracer 68Ga-PSMA-11 in patients with prostate cancer metastasis. Who is it for? You may be eligible for this study if you are aged 60 and above and currently have prostate cancer. Study details. Participants will receive a PET scan using the radio-tracer 68Ga-PSMA-11 as normal standard-of-care. Participants will be asked to return for a second PET scan within two weeks of the first PET scan. This second PET scan will be performed using the radio-tracer 18F-PSMA-1007. The only tests involved with this study will be PET scans. By comparing the two radio-tracers (68Ga-PSMA and 18F-PSMA) we hope to validate the use of 18F-PSMA for diagnostic use in screening and staging prostate cancers. 18F-PSMA has slightly different properties to 68Ga-PSMA that will make it a more versatile tool for diagnosing prostate cancer. Its longer half-life means that 18F-PSMA will be able to be shipped to regional centres to be used instead of cancer patients having to travel to a large metropolitan hospital.

The aims of this pilot study are three-fold: the practicality of conducting a formal trial and information needed including recruitment rates, to determine whether using a peanut ball for pregnant women who have an epidural during labour makes clinically significant different outcomes and inform whether to conduct a larger randomised controlled trial (RCT) to establish clinical and statistical significance. The assessment of endpoints is to determine if the peanut ball makes clinically significant different outcomes by comparing the intervention group that uses the peanut ball and the control group that does not use the peanut ball. Specifically it asks: Is there a difference between women using the peanut ball and those who do not in the rate of vaginal births? Is there a difference between women using the peanut ball and those who do not in the length of labour? Is there a difference in health service usage between arms, regarding staff time, medications, procedures and length of stay in hospital. Is there a difference in experience in labour, including health related quality of life? We hypothesise that placing the peanut ball between the labouring woman’s legs who has an epidural may facilitate the progress of labour (Tussey et al., 2015) and would be more likely to have a vaginal birth as opposed to a caesarean birth. We also hypothesise that women’s views about their own experience and health related quality of life will be more positive. Evidence of these outcomes will be evaluated more closely in the larger randomised control trial.

This is a phase I study investigating the mean circulation time, biodistribution and safety of an infusion of cultured red cells (CRC) in patients with MDS or patients in remission from haematologic malignancies CRCs are enucleated red cells (reticulocytes) that are grown in culture from donor human haematopoietic stem cells. The collection, manufacturing and administration process used for CRC reduces the risks of infection and immune mediated transfusion reactions associated with traditional blood product administration. This trial will be conducted in patients with very low and low-risk MDS or previous haematologic malignancy in remission and not on active treatment and who are able to undergo infusion of CRC and who fulfil all of the other protocol-defined eligibility criteria. This is a single centre, Peter MacCallum Cancer Centre (PMCC) Study outline: The study will recruit four patients in the initial treatment phase. These patients will have a single infusion labelled cultured red cells at a dose of 0.7-1.5 x10^10 cells. They will be labelled with chromium and a cell surface marker called biotin. Following infusion the patients will undergo blood sampling, surface scanning, clinical review and physical examination at predefined intervals to determine mean circulation time of the red cells and evidence of distribution throughout the body. The Data Safety Monitoring Board will review the safety data, circulation times and biodistribution after the fourth patient’s day 27 post infusion assessment has been completed and make a recommendation on safety to proceed to expansion phase. The Principal Investigator and the Clinical Study Oversight Group will determine need to pursue the expansion phase in which up to six additional patients may be recruited. Patients in the expansion phase will be treated and evaluated in the same way as those in the initial phase. Up to 10 patients in total may be treated on this protocol. Mean CRC circulation time (mCCT) and biodistribution will be determined from data collected in the first 27 days post infusion using the 51Cr label. Patients will be monitored until 120 post infusion to monitor for mCCT, alloantibody development and delayed transfusion associated reactions. This Phase 1 study aims to determine the mean circulation time, biodistribution, safety and tolerability of CRCs in these patient groups. It is anticipated that the technology in this study will be used in the development of Red-Cell Therapeutics that will act as a protein/drug delivery mechanism in the treatment of a wide range of diseases.