ANZCTR search results

Chronic obstructive pulmonary disease (COPD) is a complex chronic disease that is characterised by a progressive deterioration of pulmonary function punctuated with exacerbations that frequently require hospitalisation. COPD affects approximately 2.1 million Australians and it is the 4th leading cause of death in this country. Evidence-based guidelines for clinical management of COPD are widely available, however concordance with treatment guidelines is relatively low in the primary care setting. Numerous barriers to guideline adherence have been identified, and there are evidence-based approaches that could be used to address these barriers. Currently, there is no formal, systematic process for specialists to provide personalised, guideline-based recommendations to GPs beyond the traditional referral letter. This prospective randomised controlled trial will test the effect of an electronic checklist, the “COPD Snapshot”, on the management of outpatients with COPD. We aim to determine whether this checklist will improve GP uptake of specialist treatment recommendations. Patients attending the outpatient clinic at The Prince Charles Hospital will be invited to participate in the study. After obtaining written informed consent, participants will be randomly allocated to either a control group or an intervention group. The control group will receive usual best practice care from their thoracic physician. The intervention group will receive a COPD Snapshot in addition to usual best practice care form their thoracic physician. The COPD Snapshot is a communication tool that is contained on a credit card-sized USB stick. It is a checklist-format adaptation of the Lung Foundation Stepwise Management of Stable COPD Guidelines. This Snapshot will contain key management points that have been identified by each patient’s thoracic physician as requiring ongoing review by the patient’s GP. The electronic Snapshot will be completed during the clinic appointment and given to the participant at the end with instructions to give it to their GP to review when they next attend for ongoing care, within the next 2 months. After reviewing the Snapshot, GPs will return it to their patient and complete a brief, 3-question survey. After attending follow up with their GP, participants will return the COPD Snapshot to the investigators by mail in a pre-addressed envelope. In addition, participants will complete a brief follow up survey regarding their experience with the Snapshot and the clinical care they received. We will assess whether the COPD Snapshot has an effect on GP implementation of specialist treatment recommendations. In addition, we will assess the feasibility of the Snapshot, clinician uptake, and clinician and patient satisfaction.

The primary purpose of this research is to determine whether targeting perfectionism directly in treatment, using an evidenced based transdiagnostic CBT, is an effective intervention for obsessive-compulsive disorder (OCD) and elevated perfectionism; and to compare the outcomes of this with a waitlist control condition. It is hypothesized that individuals who receive the intervention will demonstrate superior outcomes as indexed by reliable change and clinically significant change, compared to wait listed participants. Data obtained whilst the ERP arm of the study was still in operation will be reported if and where appropriate for comparison purposes.

The Paragon hip stem and the Global acetabular cup non-cemented prostheses will be evaluated following primary total hip replacement surgery.

We propose a randomised double-blind multicentre placebo-controlled clinical trial to determine the clinical effectiveness of aspirin in addition to compression in healing venous leg ulcers. All eligible patients who are treated in participating wound clinics and who fulfil selection criteria will be offered study participation. All participants will be treated with best practice compression therapy. In addition to compression the Aspirin Group: will receive 300 mg of aspirin daily (one tablet each morning) and the Placebo Group: will receive placebo (one tablet in the morning). We will assess wound size/depth, serum samples for inflammatory markers, pain, score, compression adherence, medication adherence, Quality of Life scores, target ulcer recurrence, adverse events and blinding success

Surgery and anaesthesia in infants is associated with a small but definite increased risk of brain injury. The reasons for this are very unclear. One reason may be that the infant does not receive enough oxygen to the brain during the operation. This in turn may be because the blood pressure is not optimal – the blood pressure often falls during anaesthesia in infants. This study hopes to use a new technology known as NIRS (near infrared spectroscopy) to try and see which infants are at risk and why. NIRS consists of a device that shines a red light through the infant’s skull into their brain. The amount of light reflected back gives an indication of how much oxygen is in the brain tissue. In this study we shall attach the NIRS to infants having routine surgery to see if the brain oxygen levels fall and what tends to make the levels fall. We also hope to be able to compute how blood pressure is related to levels of brain oxygen in infants during surgery. Eventually we hope this technology will help develop techniques to ensure brain oxygen levels are kept optimal and hopefully the risk of brain injury reduced.

Stillbirth directly affects over 2,700 families in Australia and New Zealand each year and is associated with devastating and long-lasting psychosocial impact. Some late-pregnancy stillbirths may be preventable with early detection of a baby's ill-health, which may be indicated by Decreased Fetal Movements (DFM). Maternal reporting of (DFM) has therefore been proposed as a simple, inexpensive stillbirth screening tool. This trial will evaluate ‘My Baby’s Movements’ (MBM): a package of interventions to raise awareness and promote early reporting and optimal clinical management of DFM. MBM will be evaluated as part of a large multi-centre clinical trial across participating hospitals in Australia and New Zealand. Over three years, women attending for antenatal care with a singleton pregnancy will be included in measurement of stillbirth rates and other birth outcomes using routinely collected data. Maternal psychosocial outcomes, health service use, acceptability of MBM, and cost will also be assessed.

Purpose This study is evaluating the safety of haploidentical stem cell transplantation using high dose chemotherapy and radiotherapy, with the infusion of donor stem cells followed by the infusion of genetically modified donor T cells. The genetic modification involves the insertion of a safety switch, called iCasp9, into the donor T cells, which allows the cells to be removed with a drug, AP1903, if the patient develops graft-versus-host disease, which is a life-threatening complication of stem cell transplantation. Who is it for? You may be eligible to join this study if you have a poor risk haematological malignancy (leukaemia or myelodysplastic syndrome) that requires treatment with an allogeneic stem cell transplant but do not have a suitable conventional donor, meaning you do not have a fully-matched or single-antigen mismatched (9/10 matched) related or unrelated donor. You should be aged 18 to 59years old and have adequate organ function to undergo an allogeneic stem cell transplant. You should have a suitable first, second or third degree relative who can be your donor. Trial details Participants in this study will undergo myeloablative conditioning which involves high dose chemotherapy and radiotherapy. This consists of total body irradiation, thiotepa, fludarabine and rabbit antithymocyte globulin (Thymoglobuline). Donor mobilised peripheral blood stem cells are CD34+-selected and infused fresh on day 0 without post-transplant immunosuppression. On day +21 or later, patients are given a single infusion of iCasp9-transduced T cells, which are generated from unmobilised donor peripheral blood using a clinical grade retroviral vector. The iCasp9 T cell dose is increased in cohort size of two: 5x10e5/kg, 1x10e6/kg, 5x10e6/kg and 1x10e7/kg. Each patient will receive only a single dose. Patients who develop grade II or above acute Graft Versus Host Disease (GVHD) are treated with an infusion of AP1903. AP1903 is a chemical dimeriser that triggers the apoptotic death of iCasp9-transduced T cells. Participants will be required to undergo regular assessment to evaluate the safety of this study treatment.

Research shows women are struggling to eat well and exercise during pregnancy with up to 50% exceeding the weight gain guidelines for pregnancy. This excess gestational weight gain (GWG) puts the mother and infant at risk of negative health consequences (eg gestational diabetes, difficult deliveries and future obesity). Novel ways to extend our reach to all women is required. This project aims to test a mobile phone (m-health) and internet delivered intervention promoting healthy eating, physical activity and pregnancy and GWG in pregnant women. This study will trial the intervention with 50 pregnant women from MHW from recruitment to 36 weeks gestation and compare with 50 pregnant women in standard care. It will include: tailored text messages, video messages from health professionals and peers, weight and goal self-monitoring, detailed information on a website and a chat forum. Findings will inform the development of larger-scale digitally based programs to improve the delivery of healthy pregnancy nutrition, physical activity and healthy GWG.

The aim is to evaluate the effectiveness of mindfulness for anxiety and depression in a sample of people with Parkinson's disease. The aim is to establish whether mindfulness is successful in reducing the impact of the depressive and anxiety symptoms while improving quality of life. It is expected that, compared to a wait-list control group, mindfulness participants will demonstrate significant improvements in depression, anxiety, mindfulness, and quality of life at post-intervention and at 3 month follow-up.

The aim of this project is to validate a sham dry needling protocol in the cervical spine for healthy adults, for future applications to headache. To build on results to be established from a small pilot study investigating the efficacy of a sham protocol in healthy needling-naive subjects, two randomised controlled trials are proposed to strengthen the methodology of the future research. This will be achieved through determining whether a toothpick is an effective sham to use as a placebo treatment for dry needling in healthy subjects, and to investigate the influence, if any, of previous exposure to needling therapy. There is no consensus in the existing literature regarding an appropriate sham to acupuncture or dry needling. Historically, needles have been inserted either away from the area of pain or acupuncture point or inserted superficially (a shorter distance than that hypothesised to be required for therapeutic benefit). More recent studies suggest that both of these approaches trigger a physiological response that may confound the treatment effect of the dry needling itself. Other studies investigating more conservative sham approaches for acupuncture have focused on areas away from the neck, which, due to variation in tactile acuity may not be transferable, and no studies have investigated sham protocols specifically for dry needling (as compared to acupuncture).