ANZCTR search results

This trial will assess the clinical and cost effectiveness of two in pharmacy screening interventions to detect and enable early intervention with regards to Cardiovascular disease and prevent its complications or detect existing and related disease (eg type 2 diabetes).

Clinicians and researchers agree that neonates (infants between 0 and 27 days old following birth) admitted to the neonatal intensive care unit (NICU) experience pain. In addition to being a source of immediate distress and agitation for neonates, pain may also have consequences for neonates during their admission and also extending beyond discharge from the NICU. Researchers have hypothesised that early-life exposure to pain may alter the development of the brain, and thus hinder an infant’s ability to reach age-appropriate developmental milestones. Indeed, acute pain, or procedure-related pain, has been shown to result in long-lasting impacts on developmental outcomes such as brain development (neurodevelopment), growth, and psychosocial functioning. Specifically, researchers have suggested a dose-response relationship between pain in the NICU and poor long-term outcomes. Studies have shown that a greater frequency of painful procedures in the NICU may result in poor cognitive and motor development at eight and 18 months of age, poor cognitive outcomes at school age, increased sensitivity to pain in early childhood, higher rate of internalising behaviours at school age such as fearfulness and social withdrawal, and low weight and head circumference. Furthermore, the impact of painful experiences on the infant’s social wellbeing is unknown. In particular, the role of ongoing pain on the infant-to-parent relationship at such a critical period of relationship formation has not been investigated. Depending on their underlying medical condition, neonates and infants in the NICU undergo a wide range of interventions, some of which may contribute to ongoing pain and distress. It has been difficult to establish whether pain has a direct impact on the developmental trajectory of infants. In order to elucidate whether there is a dose-response relationship between pain experience and developmental outcomes, it is important to determine if there is an impact of the duration of treated pain on the developing infant. The primary objective of this study is to determine whether the persisting need for analgesia, operationalised as the duration of treated pain, during NICU admission has an impact on gross motor skills after discharge. Secondary objectives of this study are to determine whether the duration of treated pain during NICU admission has an impact on 1) other neurodevelopmental outcomes including cognition/problem-solving, fine motor skills, receptive and expressive language, and personal-social skills, 2) complications following surgery, 3) growth, and 4) psychosocial functioning, of the infant.

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.