ANZCTR search results

The primary purpose of this trial is to evaluate the efficacy of using parent donors for bone marrow transplants in children, using a particular processing method of the donor blood cells (TCR a+ß+/CD19+ cell depletion) compared to those receiving a standard bone marrow transplant from another donor, We also want to compare cost to the health system of TCR a+ß+/CD19+ cell depletion with that of standard bone marrow transplant procedures, Who is it for? Patients may be eligible to enrol in this trial if they are aged 3 months to 18 years of age, have been diagnosed with haematological malignancies or non malignant disorders requiring a bone marrow transplant, and have an eligible parent donor. Study details Patients who have no fully matched brothers or sisters, and no well matched volunteer donors or umbilical cord blood units available will receive a TCR a+ß+/CD19+ cell depleted graft from a parent donor. Control patients will receive a standard bone marrow transplant from another donor (e.g., volunteer donor) as per institutional practice. Patients will undergo clinical assessments at regular intervals for two years following the transplant to evaluate the efficacy of the treatment. Further information, such as quality of life and carer burden, will be collected for up to 5 years following the transplant. It is hoped that the findings from this trial will provide information on whether parent donor cells undergoing specialised cell processing can be effectively used for bone marrow transplants in children with haematological malignancies or non malignant disorders.

We know that patients with serious illness undergoing surgery are at risk of major complications after surgery and benefit from treatment by specialists in Intensive Care and High Dependency Units. It is more recently recognised that patients with less serious medical illnesses (such as diabetes, obesity, and hypertension) undergoing certain surgery also have a high risk of life-threatening complications in general postoperative wards in the early hours after elective surgery. Recent evidence suggests that providing these patients with advanced treatment in the early hours after surgery may benefit their recovery from surgery in terms of the risk of serious complications and time to return to home and that overall health care costs may fall. It is also possible that there is a positive impact on post-discharge return to normal living, which may also positively impact on health care costs. We already have skilled medical and nursing teams in place in recovery rooms to provide very short-term advanced care for these patients, but often there is no option to continue this beyond a few hours. We propose that an anaesthesia led advanced care service based in operating suite recovery rooms can care for both the sicker patients currently being sent to the wards after surgery and the less sick of the higher risk patients currently being admitted the high dependency beds. We call this combined group of patients “medium risk” for early and late complications. To fully test this proposal we will need to conduct a large multi-million dollar randomized trial at over 20 hospitals. Before we can do that trial we need to conduct a study of the feasibility of elements of the trial. This feasibility study will examine the impact on patients and the health care system of providing advanced post-anaesthesia care with the skilled staff and facilities in recovery rooms. Formal screening of patients preoperatively, including using computer risk-assessment tools to assist clinical judgment will be tested to identify the patient group at risk. A group of these patients will receive advanced postanaesthesia care in a small number of hospitals around Australia, with careful measurement of the effect on their recovery from surgery. If the results of this feasibility study show a potential benefit to patient and the health care system, and that we can expect to complete the large randomised trial.

The purpose of the proposed study is to evaluate whether a self-compassion-focused writing exercise, (“My Changed Body”), can decrease levels of distress among women with lymphoedema Who is it for? You may be eligible to join this study if you are a woman aged 18 years or over and have cancer related lymphoedema. Study details Study participants will be allocated by chance to one of the two groups. One group will receive general lymphoedema information as per usual care. This contains information about lymphoedema prevalence, reducing the risk, and self management strategies . The second group will receive a writing exercise. The writing exercise consists of 6 steps (total 30 minutes) with structured prompts that will encourage the writer to be kind; to consider how they would support a friend in the same circumstances; and to look at their feelings from a broader perspective Study questionnaires will be completed up to six months past intervention completion to assess self-compassion and sexual functioning. This is a significant project because lymphoedema is a prevalent side-effect of cancer treatment, is incurable and leads to concerning levels of psychological morbidity, which may be alleviated by a simple, low-cost writing exercise.

The “Successful Oral Feeding Teat Trial (SOFTT)” will investigate infant feeding performance on two brands of teats (Sepal vs Medela) to evaluate if infants have better feeding performance, suck-swallow-breathe coordination and quality of feeding (including infant cues of tolerance and intolerance) on a specific brand of teat. This study will determine if a new range of teats ‘Sepal Infant Feeding System” designed by speech pathologists and dietitians at Royal Children’s Hospital in Melbourne improves infant feeding performance and quality of feeds compared to the teats currently used in the Newborn Care Nursery. This study incorporates a randomised crossover design, where infants suitable to commence oral bottle feeds will be randomised initially to either the Sepal or Medella teat and have their oral feeding performance observed on two consecutive bottle feeds (BF1 - Teat 1; BF2 - Teat 2) by their treating nurse. This information will provide novel data for the international literature about the effects of Sepal teats in fragile infants admitted to a Newborn Care Unit for issues including prematurity and inform future purchasing and supply of teats for Gold Coast University Hospital. Additionally, we will investigate whether participation in education sessions on cue-based feeding practices and feeding infants in the SOFTT trial will increase nursing staff awareness and reporting of feeding quality and infant cues in the electronic medical record. This will facilitate research translation and uptake about the benefits of cue-based care to practice in the Newborn Care Unit.

This is an off-label, randomized, open blinded end-point study to determine the safety and tolerability of Metformin XR administration starting at 500mg daily to a maximum total daily dose of 1500mg XR daily on discharge in patients with pre-diabetes (defined as an HbA1c of 5.7-6.4%) admitted with a stroke. During an acute stroke admission or following a recent stroke admission, patients who are recruited into the trial will be randomized (in a 1:1 ratio) to either the active arm, receiving Metformin or usual care for a total of 4 months. Usual care for pre-diabetes includes advice on dietary and lifestyle improvements, advice of regular physical exercise and weight loss as well as advice on smoking cessation or avoidance. At baseline, we will record clinical and biochemical characteristics, cardiovascular risk factors and medication use. One month into the study, a phone call follow up will occur and participants in both groups will be asked to complete a side effect questionnaire and compliance determined. A second follow up phone call will occur at 2.5 months and participants will again be asked to complete the questionnaire and asked about compliance. Finally a physical study visit will be scheduled at four months following randomization. At this last visit, patients will complete the same questionnaire to determine their compliance and nature of any of the side-effects of the treatment. At both physical study visits, the fasting glucose levels, HbA1c, C-peptide, fasting lipid profile, blood pressure, urine albumin to creatinine ratio, body mass index (BMI), waist circumference, blood pressure, and lipid profile will be assessed. Questions regarding side effects and completion of the side effect questionnaire during both follow up phone calls and second physical visit will be performed with a blinded investigator.

Diabetic foot bone infection (osteomyelitis) is among the most common causes of leg amputation and prolonged hospitalization among Australians. Early and prompt diagnosis and treatment of osteomyelitis is crucial to reducing hospital admissions and limb amputations. Currently the tests that are used to confirm osteomyelitis are either costly (MRI, bone scan), not readily available at the time of immediate need (MRI) or ineffective (x-ray) in differentiating foot osteomyelitis from soft tissue foot infections (cellulitis). To date no simple laboratory test shown to reliably differentiate the 2 common form of diabetic foot infections –cellulitis and osteomyelitis. Procalcitonin, a cheap, simple blood test for detecting and monitoring infections in other conditions is thought to be a useful test for diabetic foot infections. Blood level of procalcitonin has been reported to be markedly elevated in bone infections and lower levels in cellulitis. This study is designed to determine the role of procalcitonin in correctly distinguishing diabetic foot cellulitis from osteomyelitis and to assess levels that will be used to monitor response to treatment of both conditions.

The primary purpose of this trial is to evaluate whether providing reminder letters or phone calls in women's preferred languages improves breast cancer screening rates in North-West Melbourne, Australia. Who is it for? You may be eligible to participate in this trial if you are in the BreastScreen Victoria region of North-West Melbourne and are eligible for breast cancer screening, who has previously identified your preferred language as Italian or Arabic, and who are due to receive their 2-yearly routine reminder letter, or have not re-screened following a reminder letter at least 3 months previously. Study details The study comprises two trials in separate participant groups. In trial one, participants will be randomly allocated (by chance) to receive either the usual reminder letter only (in English), or to receive the reminder letter in their preferred language (as well as English on the reverse side). In trial two, participants will be randomly allocated to receive a reminder phone call at 3 months following their last reminder letter if no appointment has been made, or to receive no phone call. It is hoped that the findings of this trial will provide information on whether providing reminders for breast cancer screening in women's preferred language can improve the rates of rebooking in these populations

This project aims to determine the clinical effect of intra-articular multiple PRP injections compared to single PRP injection into the symptomatic early arthritic knee. The objective is to determine the effectiveness of PRP injections for early knee arthritis and if multiple injections give a better clinical response at up to 12 months following treatment. This study is designed as a double blinded, randomised placebo-controlled trial with three groups. All groups receive 3 injections 1 week apart. • Group 1 receives 3 placebo injections (Normal Saline). • Group 2 receives one PRP injection followed by two placebo injections. Group 3 receives 3 PRP injections

To collect patient outcome data into a database that allows research to be generated. This occurs by identifying trends, systematically recognising unexpected outcomes from surgical techniques and allowing hypothesis generation to be tested in a retrospective manner.

The main evidence-practice gaps in emergency departments for patients presenting with acute low back pain include overuse of imaging, liberal use of opioids, and inappropriate admission to hospital. These practices are wasteful of scarce health resources and lead to worse patient outcomes. The Sydney Health Partners Emergency Department (SHaPED) trial will address these problems by improving clinical pathways through implementation of the ACI model of care for acute low back pain. The ACI model of care promotes best practice and collaboration across the care continuum. The SHaPED trial uses routinely collected measures of healthcare to judge success of the implementation of the model of care. We will use these same measures to monitor whether the improved outcomes are sustained at the SHaPED trial sites and also at other sites when we scale up the project. The SHaPED trial will implement the ACI model of care for acute low back pain at three urban and one rural emergency department in NSW: Royal Prince Alfred Hospital, Concord Repatriation General Hospital, Canterbury Hospital, and Dubbo Base Hospital. After a retrospective control period of 12 months, where the emergency departments are not exposed to the intervention, each emergency department will randomly and sequentially crossover from control to intervention periods, until all emergency departments are exposed to the intervention. This study design, known as a stepped wedge cluster randomised controlled trial, is particularly suited for the evaluation of policy interventions and healthcare service delivery. Participants are emergency department clinicians (such as medical doctors, nurses, and physiotherapists). The 4-week initial intervention period, targeting emergency clinicians, comprises of printed and electronic educational materials, weekly educational meetings, and an audit and feedback approach focussed on the outcomes of the study. Outcomes are routinely collected measures of imaging referrals (primary outcome), opioid prescription, and inpatient admission. Data will be extracted directly from participating hospitals’ electronic record systems, such as the Sydney Local Health District Targeted Activity and Reporting System (STARS).