ANZCTR search results

Acute respiratory distress syndrome (ARDS) is a condition where the lungs have become injured and do not work as they normally should to provide oxygen and remove carbon dioxide from the body. Patients may need higher levels of respiratory support and perhaps the use of a ventilator (breathing machine). Despite advances in the understanding and recognition of ARDS; novel therapies being developed and employed, ARDS can cause damage to other organs, causes a longer stay in the intensive care unit (ICU) and the hospital and significantly increases ICU costs. There is also a high risk of death at 40-50%. Previous studies have provided great insight and helped shape our understanding of the disease, however there remains limited information about the recognition, management and outcomes of patients with ARDS. Currently limited evidence exists regarding the management and outcomes of patients with moderate-severe ARDS in Australia and New Zealand to inform future trial design. This will be the first study to report this data in Australia and New Zealand. We plan to undertake study for 6 months in 25 ICUs in Australia and New Zealand to assess the management of moderate-severe ARDS. Trained research nurses in each ICU will collect data to describe management practises, use of ventilator strategies and additional therapies and describe outcomes in patients with moderate-severe ARDS; determine factors in early moderate-severe ARDS associated with survival; and determine the impact of artificial external heart lung machine use in these patients. We hypothesise that this data will give an accurate description of the characteristics and management of adult patients admitted to the ICU in Australia and New Zealand with moderate-severe ARDs. This data will be used to inform future trial design to test interventions to reduce further deterioration and death in these patients. We have a unique opportunity to prospectively collect high quality data regarding the management and outcomes of patients with moderate-severe ARDS admitted to ICUs in Australia and New Zealand. We will then compare this data to the data generated by our US colleagues to report and compare regional trends. Study findings will be presented at national and international meetings and published in high-quality peer reviewed journals.

The Tackling Tobacco in Community Mental Health Organisations trial aims to enhance the capability of community managed mental health organisations to address tobacco use by consumers and staff in a holistic, routine, consistent and comprehensive manner. Tackling Tobacco is a program that offers an organisational change based framework through which organisations can change or introduce new policies, procedures, and systems to address tobacco. The program aims to generate cultural change to ensure tobacco is viewed as a priority across the organisation. In the trial, community mental health services will be offered differing levels of the Tackling Tobacco program. We hypothesise that consumers from services receiving the more intense version of Tackling Tobacco will be more likely to report being offered support to quit (in the form of nicotine replacement therapy) than those consumers in the low intensity services. Addressing tobacco in communities that experience severe mental illness is important because it helps reduce the disproportionate health and economic affects of smoking.

This study seeks to detect chemotherapy-associated neurocognitive impairment in patients with Acute Myeloid Leukemia, using Neurocogntive Assessment and Magnetic Resonance Imaging. Who is it for? You may be eligible to join this study if you are aged 18 and above and are commencing induction chemotherapy for Acute Myeloid Leukaemia (AML). Study details This prospective longitudinal pilot study seeks to determine the prevalence and severity of chemotherapy-associated neurocognitive impairment (CANI) in patients undergoing treatment for AML, and to evaluate the feasibility of using magnetic resonance imaging as a biomarker of CANI in this population. Each participant will undergo Neurocognitive Assessment (NCA) and Magnetic Resonance Imaging Quantitative Susceptibility Mapping of brain iron (MRI-QSM) before and after their treatment for AML It is hoped that the findings from this trial will provide information regarding the incidence of chemotherapy associated neurocognitive impairment during AML treatment, and the feasibility of using MRI-QSM as a diagnostic tool in these patients.

A two-stage tissue expander–to-implant procedure is the most common implant-based reconstructive method, and accounted for 2868 procedures in Australia in 2016. The saline implant with self-sealing port was patented in 1980 by Radovan and requires serial bolus injections of saline to be administered by a clinician every few weeks after surgery. This process can be uncomfortable, lengthy, and logistically challenging for patients and clinics due to the need for ongoing recurrent appointments. The AeroForm® tissue expander (AirXpanders® Inc., Palo Alto, California) is a remote-controlled, carbon dioxide–filled breast tissue expander. It was designed to provide women with a gradual, needle-free, controlled, and faster method of completing the expansion process. This system is composed of an implantable tissue expander containing a reservoir of compressed carbon dioxide, and an external hand-held remote control. The patient uses the controller to activate a valve within the reservoir to release carbon dioxide into the expander, eliminating the necessity for repeated injections and the associated clinic visits. The device is programmed to allow patient dosing in increments of 10 cm3. Multiple safety mechanisms are incorporated into the device design; only one 10cm3 dose of carbon dioxide may be administered during a 3-hour period, and no more than three doses (30 cm3) of carbon dioxide may be given per day. The AeroForm® expander demonstrated successful expansion within 2 weeks with no adverse effects in a sheep model, and the first human trials, conducted in Australia, demonstrated 100 percent success rates in the Patient-Activated Controlled Expansion I and II (pilot and extended pilot) trials. These were single-surgeon trials. These early trials, supported with additional data from the Australian Aspirin to Prevent Recurrent Venous Thromboembolism trial, provided the basis for successful Therapeutic Goods Administration approval of the device in Australia. The only randomised, controlled trial, AeroForm® Patient Activated controlled tissue expander (XPAND) has been performed in the United States, showing statistically significant shorter expansion and reconstruction times compared to saline implant, non-inferiority for safety with a 10 percent margin, and high rates of patient-rated ease, convenience, and satisfaction. The purpose of this study is to undertake the first multi-surgeon case series in Australia. AeroForm® is already standard supply in Gold Coast Health, with very positive patient feedback about the convenience and comfort of patient-controlled inflation. However, it is very important to the surgeons of the unit that clinical outcomes are also satisfactory.

The purpose of this study is to investigate the impact of an Artificial Intelligence (AI) algorithm - Deep Ensemble for Recognition of Malignancy (DERM) - on skin cancer diagnosis services in primary care. Who is it for? You may be eligible for this study if you are over the age of 40 and are visiting your GP with at least one suspicious skin lesion that is suitable for photographing. Study details All participants in this study will have a photograph taken of their suspicious lesion(s) during their regular GP consult, which DERM will analyse. The GP will decide whether to biopsy the lesion before DERM provides a recommendation on whether the lesion should be tested further. Where DERM recommends a lesion is biopsied that the GP otherwise would not have done, the GP may choose to follow DERMs recommendation or their own assessment. It is hoped that this research will help determine if DERM can help identify cancerous skin lesions and reduce the number of unnecessary biopsies.

Endoscopic retrograde cholangiopancreatography (ERCP) is a common intervention in the treatment of biliary and pancreatic diseases, and the demand for ERCP is increasing. There are several difficulties for the anaesthetist to deal with. It is generally performed in a prone or lateral position under moderate to deep sedation or general anaesthesia. The rate of oxygen desaturation could be as high as 11-50%. Both low flow and high flow nasal cannulas are now established ways of delivering oxygen during sedation. It is unclear whether one technique is better than the other. We hypothesis that high flow nasal cannula may provide better oxygen administration and compare these two techniques

In NSW, one in five children are overweight or obese (Hardy et al 2016). Poor diet, inadequate physical activity, excessive screen time and inadequate sleep are the key behavioural risk factors for unhealthy weight gain in childhood (Bauman et al 2016). As key role models and decision makers and decision makers regarding their child’s food intake, physical activity, screen time and sleep patterns, parents have a critical role to play in childhood obesity prevention. Despite the important role parents have, there are recognised barriers to parental participation in child obesity prevention or weight management programs such as scheduling of sessions (Young et al 2007), finding childcare for other siblings (Kelleher et al 2017), travel (Warren et al 2007). Also, existing services that provide information for parents with young children are often not evidence based, and lack a population-wide infrastructure, thereby making it difficult for some parents to access and benefit from them. Online and telephone-based obesity prevention programs offer advantages in convenience and accessibility compared with conventional face-to-face programs currently available in NSW and have the potential to be delivered population wide at relatively low cost (Eakin et al 2010). This study aims to evaluate the effectiveness and cost-effectiveness of two health promotion programs (‘Healthy Habits’ – telephone based program and ‘Time2bHealthy – online program) designed to support parents of 2-6 year old children to promote healthy eating, physical activity and adequate sleep in children. It also aims to determine the most optimal approaches to maximising recruitment to and retention of parents in such programs. The study will employ a three-arm parallel-group randomised preference trial design. Participants may choose to participate in a telephone-based program (Healthy Habits), an online program (Time2bHealthy) or receive written educational materials which will serve as the comparison group. Participants who do not have a particular preference will be randomly allocated to one of the three arms. It is expected that this research will identify one or more programs for parents of children aged 2-6 years that are effective in improving their child’s behaviours (nutrition, physical activity, sedentary time and sleep). The programs will be implemented in New South Wales, Australia and contribute to the Premier’s Priority target of reducing childhood overweight and obesity.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple subcutaneous (SC) doses of CBP-201 in patients with moderate to severe Atopic Dermatitis. Thirty patients will be randomized at approximately 10 study sites. This research study is made up of the following parts: Screening Period, Baseline, Treatment Period and Follow-Up Period. Patients will be randomized to receive either CBP-201 or placebo once a week for 4 doses. Each dose group will consist of 10 participants, with 8 participants receiving active study drug and 2 receiving matching placebo (8 active: 2 placebo). Three ascending dose levels are planned (75, 150 and 300 mg CBP-201). Patients will be followed for an additional 8 weeks for safety, efficacy and to further characterize the profile of CBP-201.

Brief Summary Cranial reconstruction using mesenchymal stromal cells and resorbable biomaterials, will result in the patient producing their own bone to fill the void which will reduce the risk of infection and resorption, lead to a better cosmetic result and obviate any long term consequence of having a synthetic material in vivo. Introduction: There are several reasons that parts of the skull may need to be removed: - After trauma to relieve brain swelling - During brain surgery (for brain cancer) - After trauma where the bone is so badly fractured/fragmented it needs to be removed. In all but the last case the bone flap is temporarily stored in a freezer and once the brain swelling has subsided it is reinserted. This procedure is called "autologous cranioplasty"; autologous, because it originally came from the patient and cranioplasty, referring to the repair. Although this is a straightforward procedure, there are a number of complications including infection and bone resorption that can occur. This study: Stromal cells have a proven ability to aid in bony healing. Furthermore stromal cells on a ceramic framework encased in a plastic scaffold have been shown in a small clinical trial to lead to healing of skull defects. In the present study, it is proposed to add stromal cells, either autologous or allogeneic, to a resorbable ceramic material and insert into the skull. The ceramic is designed to dissolve away over time as the body's own blood vessels and cells populate the construct and create the patient's new bone. It has been proven that without the encouragement of the cells and temporary scaffold materials, a hole in the skull will not heal. Given the incidence of bone resorption/infection and metal plate infection using traditional methods, it would seem prudent to provide a construct that will allow controlled replacement with the patient's own bone, thus negating any adverse long-term complications with synthetic materials that remain for life.

This study aims to evaluate the feasibility and safety of normal saline, compared to heparinised saline, for the prevention of occlusions (blockages) in central venous access devices (CVADs) in a paediatric oncology population. Who is it for? You or your child may be eligible to join this study if you/they are aged 0-18 years, have been diagnosed with an oncological or malignant haematological condition, and have a central venous access device (CVAD) in situ. CVADs are flexible tubes inserted in the chest, neck or upper arm veins, which enable the administration of anti-cancer drugs, collection of blood tests, and delivery of supportive therapies. Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will have their CVAD locked with 0.9% Sodium Chloride, whilst participants in the other group will have theirs locked with heparinised saline. Duration of study enrollment will be capped at six weeks. All participants will be monitored throughout their enrolment in the study to determine any CVAD blockages (known as occlusions), or other adverse events such as venous thrombosis and infection. We hope to determine whether a larger efficacy trial of these CVAD locking techniques is feasible and safe.