ANZCTR search results

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).

Despite the high burden of cardiovascular diseases among Indigenous Australians, few intervention trials have sought to evaluate novel approaches to reducing differential outcomes in this vulnerable group. The Central Australian Heart Protection Study seeks to test the effectiveness of a nurse-led, family based education and assessment program in reducing the incidence of poor outcomes in indigenous and non-indigenous patient’s following an Acute Coronary Syndrome (ACS).

This study is evaluating the feasibility of exercise cardiac positron emission technology (PET) imaging to determine cardiac risk for patients undergoing major cancer surgery. Who is it for? You may be eligible to join this study if you greater than or equal to 18 years of age and are scheduled to attend pre-admission clinic review and cardiopulmonary exercise testing prior to major thoracic or abdominal surgery at Peter MacCallum Cancer Centre. Study details: All participants in this study will undergo cardiopulmonary exercise testing at the preadmission clinic to assess heart and lung function. You will be required to fast for 8 hours prior to arriving at the clinic, and you will be asked to consume a high fat and low carbohydrate meal 12 hours prior to the testing. Radiolabelled glucose will then be intravenously injected, i.e. administered directly into your vein. A positron emission technology (PET) scan of the heart will be performed 1-2 hours after the radiolabelled glucose injection. The diagnostic tests used in this study may have the potential to rapidly provide more specific information regarding myocardial metabolic function than CPET, and also enable anatomic localisation of areas of the myocardium which are susceptible to ischaemia under conditions of metabolic stress. We therefore hope to improve on the current tests available to identify patients at high risks of heart complications after surgery.

This project aims to train allied health professionals working with young people with depression to integrate a brief physical activity intervention into the clinical care they would usually offer young people who access their service. The project also aims to evaluate the effectiveness of the physical activity intervention in reducing depression and increasing engagement in physical activity in young people. Physical activity has an emerging evidence base for the treatment of depression in young people. This project has the potential to provide early intervention to encourage the establishment and maintenance of positive health behaviours. All allied health professionals at headspace Collingwood (an enhanced primary care youth mental health service) will be invited to take part in the project and those who participate will be offered training in the delivery of the intervention and a treatment manual. All help-seeking young people aged 12-25 years who present to headspace Collingwood will be screened for eligibility to participate in a randomised controlled trial. Those who consent to take part will be randomised to receive either the physical activity intervention (active intervention) or psycho-education on physical activity (control condition) in addition to treatment as usual. Participation will involve the completion of questionnaires designed to measure symptoms, physical activity levels, social and vocational functioning, coping skills, and changes associated with therapy. These measures will be collected at baseline and at the end of treatment. Participants will also be invited to take part in an optional qualitative component of the project to obtain feedback on their experiences of treatment, using a semi-structured interview format. Given the high prevalence of depression and the associated negative consequences, there is an urgent need for a ‘real-world’ effectiveness trial to examine the additional benefits of integrating physical activity, a low-stigma intervention with few side effects, into routine clinical care