ANZCTR search results

This is a prospective observational multi-centre registry in which clinical data on consecutive patients with prostate cancer who undergo irreversible electroporation (IRE) procedure is collected. Who is it for? You may be eligible to join this study if you have been diagnosed with histologically confirmed prostate cancer and are scheduled for IRE Nanoknife procedure. Study details Patients with prostate cancer who undergo IRE procedure at participating clinics will have their medical data collected and collated into this clinical registry. Patients’ data to include baseline visit (pre-IRE) and peri-operative data. Participants will then be followed-up at 1, 3, 5, and 10 years after IRE to determine oncological and functional outcomes. Follow up data at each participating treatment site is collected according to the guidelines for focal therapy in prostate cancer and/or by discretion of each treating Urologist. Amendments to the standard of care are not required nor desirable. Deviation from current practices will be by the discretion of the treating urologist only and outcomes will be included in this registry as it is purely observational in nature. It is hoped that this research project will provide a better understanding of patient outcomes undergoing IRE procedure. .

Pregnancy and birth provide a critical window for intervening to improve short- and long-term health and wellbeing for women and their children, yet there is a lack of evidence to guide preventative interventions. Group pregnancy care (where women have care and education in a group of 8-10 women) is very popular among women and midwives but needs further testing for safety. This small pilot study will explore whether we can successfully do a larger study in Victoria, Australia that will provide evidence for the safety of this pregnancy model of care.

Post-operative ice block consumption offers potential to reduce adverse symptoms of post-operative nausea and vomiting (PONV) and thus optimise patient recovery, patient experience, as well as decrease costs to healthcare systems through decreased antiemetic use and hospital length of stay. Therefore, in people who have undergone surgery requiring general anaesthesia, the objectives of this study are to examine the effect of post-operative consumption of a lemonade ice block compared to 1). unflavoured ice chips or 2). standard care (no ice block or ice chips) on postoperative recovery; specifically, PONV incidence and severity, rescue antiemetic use, and PONV-related outcomes (blood glucose level, quality of recovery, gastrointestinal recovery, post-anaesthesia recovery unit length of stay, patient experience). Outcome data will be collected at four time points: T0 (pre-surgery, within 24-hours of scheduled surgery), T1 (post-surgery, on waking in recovery unit; medical records only), T2 (post-surgery, on discharge from recovery unit), and T3 (24 hours post-surgery).

Asthma is the most common chronic illness in children. Yet, identifying wheeze is challenging for parents (disagreement rate between doctors and parents are >50%) and indeed many cultures (including Indigenous Aus) do not have a word for wheeze. Our multicentre study addresses the need to define wheeze accurately using digital technology. We will use WheezeScan (WzS) digital technology during face-to-face clinics as well as remotely (child’s home) in Queensland (including outreach clinics), Darwin and Sydney. In 125 children aged <12 years with asthma, we aim to evaluate the impact of using WzS impacts upon asthma control assessment, PROs, self-efficacy scale and health cost. WzS’s dependable accuracy will provide parents/caregivers and doctors the ability to discern if a child is wheezing-subsequently providing the confidence and clarity over the next steps that need actioning. Our study will lead to more accurate assessment of asthma control, thus resulting in improved management. Asthma guidelines identify that the primary goal of management is achieving good asthma control, thus reducing the risk of exacerbations.

This is a multi-centre, prospective, cohort study to evaluate epileptic encephalogram abnormalities and seizures in relation to sleep measures using polysomnography in patients diagnosed with an epileptic encephalopathy (Dravet syndrome and LGS) during video-EEG monitoring admission and are undergoing treatment with cannabidiol (EPIDYOLEX) as part of their routine clinical care. A total of 26 patients will be recruited from The Alfred and The Austin hospitals who are newly prescribed with EPIDYOLEX but have not yet commenced. The study will consist of a 4-week baseline period prior to drug initiation, during which time participants will keep a seizure diary and undergo actigraphy (GENEActiv accelerometer wristwatch) measurements. Participants will subsequently undergo two hospital admissions consisting of 24-hour EEG and polysomnography assessments at baseline, and the end of the study (16-weeks following drug initiation), respectively; actigraphy will be measured throughout the study period. All medications or interventions for epilepsy will remain unchanged the 4-weeks during the screening period and throughout the study period.

Adult community participants with a diagnosis of either bipolar disorder, schizophrenia, or schizoaffective disorder will be randomized to a dietary intervention alongside their treatment as usual. Participants will be assessed for their metabolic health, and social and mental functioning and supported with education and assistance in ensuring adherence to the allocated dietary protocol.

This study aims to identify biological markers in tumour and blood samples which may predict clinical outcomes and responses to treatment for people with a variety of cancer types, including but not limited to melanoma, lung cancer, breast cancer, colorectal cancer and genitourinary cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a solid organ cancer, including but not limited to melanoma, lung cancer, breast cancer, colorectal/bowel cancer, cervical cancer, ovarian cancer, or liver cancer. Study details All participants who choose to enrol in this study will be asked to consent to having their health information (collected as part of their diagnosis and treatment) accessed by the research team. Participants who have already had tumour samples taken will be asked to consent to having some of these samples used for additional testing to determine if their tissue expresses any cancer-related genes or other biological markers. They will also be asked to provide blood samples prior to starting their cancer treatment, and again at 1 month, 3 months, 6 months, and 12 months after starting their cancer treatment. Participants may also choose to continue to provide additional blood samples every 3 months for another 3 years after starting their cancer treatment, if they wish. All samples collected for this study will undergo a range of different assessments to identify any cancer-related genes or other biological markers. Tumour and blood samples will be collected from participants as part of their routine treatment and follow-up. This means no additional blood tests or biopsy procedures will be required for this research project. It is hoped this research will identify new biological markers that can be used to determine how cancer patients may respond to different treatments, or their risk of cancer relapse post-treatment.

The pandemic has significantly impacted the day-to-day lives of many children, their families, and schools, which has resulted in increased levels of anxiety, depression, social isolation, and loneliness among young people. An integrated public health model of interventions is needed to address the problem and to safeguard the mental health and wellbeing of children. The Triple P – Positive Parenting Program is a system of evidence-based parenting with a strong evidence-base and wide international reach. When implemented as a public health approach, this program has demonstrated positive effects on child wellbeing at a population level. The current study is the first large-scale, multi-site randomised controlled trial of a newly developed, low-intensity variant of Triple P, a schools-based seminar series, as a response to the impacts of the pandemic. The evaluation will employ an Incomplete Batched Stepped Wedge Cluster Randomised Trial Design. At least 300 Australian primary schools, from South Australia, Queensland, and Victoria will be recruited and randomised in three batches. Within each batch, schools will be randomly assigned to either start the intervention immediately or start in six weeks. Parents will be recruited from participating schools. The Triple P seminar series includes three seminars titled: “The Power of Positive Parenting”, “Helping Your Child to Manage Anxiety”, and “Keeping your child safe from Bullying”. Parents will complete measures about child wellbeing, parenting, parenting self-regulation and other key intervention targets at baseline, six weeks after baseline, and 12 weeks after baseline. Intervention effectiveness will be evaluated with a Multilevel Piecewise Latent Growth Curve Modelling approach. Based on the strong evidence for the more intensive versions of each of the seminars, we anticipate finding improvements in primary intervention targets, including child social, emotional, and behavioural wellbeing, general parenting practices, and parenting self-efficacy/self-regulation. We also expect to find improvements in secondary outcomes such as child anxiety, depression, family adjustment, and specific parenting practices that facilitate child anxiety. The findings from this study will extend the current knowledge of the effects of evidence-based parenting support delivered through brief, universally offered, low intensity school-based parenting seminars in a post pandemic world.

This platform trial aims to provide an overarching research framework that will enable research questions to be addressed prospectively and systematically for AML patients receiving VEN-AZA. Domain 1 of the AMLM28 ADAPT platform trial aims to determine the utility of adding navitoclax to VEN-AZA for patients with suboptimal response to VEN-AZA by offering therapeutic interventions for patients with TP53 aberrations or MRD persistence.. Who is it for? You may be eligible for this study if you are aged 18 and above and have been diagnosed with AML. Study details Domain 1 (ADAPT-Rx) consists of two different strata: - TP53 stratum - Patients who are found to have TP53 aberrations during or after cycle 1 may be eligible - Measurable Residual Disease (MRD) persistence stratum Participants who are eligible to commence Domain 1 ADAPT-Rx therapy for either strata will receive an oral dose of navitoclax once daily for 7 days prior to commencing the VEN-AZA and Navitoclax (from day 6) treatment cycle, All patients will initially be enrolled into the AMLM28 Master Protocol. If during or after cycle 1 VEN-AZA, the patient is found to have one or more TP53 aberrations, the patients may be assessed for eligibility to commence Domain 1 ADAPT-Rx therapy (TP53 stratum). If after cycle 4, the patient is found to have persistent MRD by flow cytometry, the patient may be assessed for eligibility to commence Domain 1 ADAPT-Rx therapy (MRD persistence stratum). If more than 1 treatment arm is open to recruitment in domain 1, and if the patient is eligible for more than 1 treatment arm, the patient will be randomised to one of the available treatment arms. The patient will then be given the consent form for that treatment arm and screened. If the patient passes screening, they will be registered to that treatment arm. If the patient fails screening, they will be randomised to another treatment arm and screened accordingly. It is hoped this research will deliver adaptive interventions to improve clinical outcomes in patients receiving frontline VEN-AZA for newly diagnosed AML.

The aim of the study is to evaluate the efficacy and feasibility of a conversational artificial intelligence (AI) intervention comprising automated phone calls and text messages to improve quality of life and self-management of patients with atrial fibrillation (AF). The hypothesis is that this program will better support patients with AF, improving their quality of life and overall health management and risk factors.