ANZCTR search results

Paracetamol poisoning can cause liver injury; the mainstay of treatment is administration of the antidote acetylcysteine. There is a subgroup of paracetamol poisoned patients who develop liver injury despite standard treatment. Fomepizole has been proposed as an antidote due to its ability to inhibit production of paracetamol’s toxic metabolite. However, the clinical evidence for its use is limited. Hence in this study we will utilise a healthy human volunteer simulated overdose crossover model. Each volunteer will serve as their own control. We will examine both immediate and modified release paracetamol formulations at a dose of 80mg/kg. We will investigate the efficacy of fomepizole at 2 hours post ingestion. If there is a significant effect we will then examine fomepizole at 4h. This study aims to provide valuable information on the potential use of fomepizole as an antidote for paracetamol poisoning.

Endometriosis is a chronic, inflammatory condition which can lead to chronic pelvic pain and infertility. There is no cure for this condition and the gold standard for diagnosis is laparoscopy (keyhole surgery) which is costly, has long wait times and is associated with risks. This study (Imagendo) will use artificial intelligence to create a diagnostic algorithm by analysing ultrasound and MRI endometriosis scans, providing general practitioners with an earlier, easily accessed, non-invasive, diagnosis of endometriosis.

The aim of the study is to determine the feasibility of a 12-week lifestyle program on type 2 diabetes in the Indigenous community in Australia. Feasibility is defined as achieving an attendance rate over 70%. It is hypothesised that the Too Deadly program can lead to an improvement in HbA1c and/or a reduction in glucose lowering medications for Indigenous Australians with type 2 diabetes and can be achieved safely. Secondary hypotheses include: 1. Efficacy: The Too Deadly program is superior to standard care after 12 weeks in assisting participants to: (a) increase in percentage (%) of time in range (target) for blood glucose levels (3.9–10 mmol/L), (b) reduce percentage (%) of below range for blood glucose levels, defined as <3.9 mmol/L. (c) reduce percentage (%) of time below range for blood glucose levels, defined as <3.0 mmol/L. (d) reduce percentage(%) of time above range for blood glucose levels, defined by >10.0 mmol/L (e) reduce percentage(%) of time above range for blood glucose levels, defined by >13.9 mmol/L. 2. Safety: Too Deadly program will not lead to increased number of severe hypoglycaemia (ADA, 2019), defined as a severe event characterised by altered mental and/or physical status requiring third-party assistance (ADA, 2019), ambulance call out or hospital presentations from baseline to 3 months. 3. The Too Deadly program will lead to improvements in glucose time in range as determined by the Flash Libre Pro. 4. The Too Deadly program will lead to a reduction in medication dose for some individuals. 5. The Too Deadly program will lead to improvements in quality of life as measured by the EQ-5D-5L questionnaire.

Heart failure is a major burden in Australia in terms of morbidity, mortality and healthcare expenditure. While multiple guideline-based therapies are recommended for heart failure with reduced ejection fraction (HFrEF), they are underutilised and thus ineffective. Barriers to guideline adherence for HF management exist at the patient, healthcare provider, and healthcare system level. This study will develop and deploy a heart failure education program, delivered by SMS as "e-TIPs" to patients after a discharge from hospital for heart failure every week for 6 months. We aim to assess the impact and patient-acceptance of the tailored electronic message-driven patient education program in recently admitted HFrEF patients. The study hypothesises that the patient driven education program "e-TIPs" will be acceptable to patients and ehance their self-education and self-management.

A model of neonatal nurse-controlled analgesia (NNCA) to manage neonatal surgical pain has been developed. This model was informed through the literature, the results of a systematic review, a survey of current Australasian neonatal pain practices and an expert panel of neonatal clinicians/researchers with knowledge/expertise of pain assessment and management practice across Australia and New Zealand. The final model of this NNCA will be tested in the Cardiac/surgical neonatal intensive care unit (C/S:NCCU) of the Mater Mothers’ Hospital South Brisbane. This pilot trial will be a randomised controlled trial to test the feasibility of study methodology. Infants will be randomised into either the control arm and receive current standard postoperative pain management or the intervention arm in which infants will receive postoperative pain management as per the model of NNCA.

This study aims to evaluate the uptake, engagement, and short-term effects of Partners in Parenting (PiP), an online parenting program, for adult carers of adolescents (aged 12-18) to support their adolescent’s mental health. The program aims to build carers’ parenting skills and confidence by equipping them with evidence-based parenting strategies that are associated with reduced risk and impact of depression and anxiety disorders in adolescents. The program is being delivered online, to adult carers of a young person (aged 12 to 18), who have an online account on the headspace National Youth Mental Health Foundation website (https://headspace.org.au/). The PiP program comprises up to 10 self-guided, online modules covering different topics related to parenting and adolescent mental health. Carers can also choose to complete a self-assessment survey to receive tailored feedback about their parenting, as well as feedback about their adolescent’s symptoms of anxiety and depression. In this trial, we aim to evaluate: 1) changes in parenting practices and parenting confidence, from pre- to post-program; 2) changes in adolescent symptoms of depression and anxiety, from pre- to post-program; 3) uptake of the program by adult carers via their headspace account, including factors that improve or reduce uptake; 4) engagement with the program (e.g. how much of the program is completed), including factors that may improve or reduce engagement; and 5) satisfaction and acceptability of the program by carers. We hypothesise that carers who complete the PiP program will report improved parenting skills and confidence 3-months after starting the program, as well as improved (reduced) symptoms of depression and anxiety in their adolescent child. Because the analysis of program uptake, engagement and acceptability is exploratory, no hypotheses have been specified.

The purpose of this study is to evaluate the efficacy of retreatment with Venetoclax and Rituximab in relapse and refractory CLL patients. Who is it for? You may be eligible for this study if you are aged 18 and above and have relapsed/refractory chronic lymphocytic leukaemia (CLL) with disease progression following two years of VenR therapy. Study details This study design involves two phases of study treatment: 1) VENETOCLAX RAMP UP: this phase will have two parallel cohorts that will receive the same treatment. -Cohort A: for patients with 12-24 months since last dose of Ven -Cohort B: for patients with greater than or equal to 24 months since last dose of Ven An initial dose of 20mg venetoclax is administered orally for all patients on day 1 - If a patient demonstrates one or more electrolyte abnormalities suggestive of laboratory TLS during the 24 hour period after the first dose: • Electrolyte abnormalities will be treated according to the Electrolyte Management Guidelines • Following resolution of electrolyte abnormalities, patients may be instructed to resume self-administration of venetoclax at 20mg daily for an additional 6 days. • Patients will then increase the venetoclax dose to 50mg daily and be monitored as described above. If the 50mg dose is tolerated without any abnormalities, daily dosing of venetoclax will continue at 50mg daily for a total of 7 days. • The venetoclax dose is then increased to 100mg daily for 1 week (week 3), followed by 200mg daily for 1 week (week 4) and then increased to 400mg daily (week 5). For patients who do not show any evidence of electrolyte abnormalities suggestive of laboratory TLS during the 24 hours after the initial 20mg dose: • Venetoclax will be escalated to 50mg on day 2 and patients will be monitored for TLS over 24 hours. • If the 50mg dose is tolerated, daily dosing of 50mg venetoclax will continue for a total of 6 days. • The venetoclax dose is then increased to 100mg daily for 1 week (week 2), followed by 200mg daily for 1 week (week 3) and then increased to 400mg daily (week 4). 2) VENETOCLAX IN COMBINATION WITH RITUXIMAB - After the patient has completed the venetoclax ramp-up period and received the target dose of 400 mg of venetoclax for 1 week with no evidence of laboratory or clinical TLS, the patient will begin combination therapy consisting of 6 cycles of rituximab (infusions occurring on Day 1 of each 28-day cycle) in combination with the 400mg daily dose of venetoclax. -Rituximab will be administered to patients in both treatment arms at 375 mg/m2 IV on Day 1 of Cycle 1 followed by 500 mg/m2 on Day 1 of Cycles 2 through 6 (total of six infusions of rituximab). It is hoped this research will determine if patients with relapsed/refractory CLL can further clinically benefit from VenR re-treatment.

Continuous Electroencephalography (cEEG) monitoring in neonates provides information on evolving neurological conditions in neonates in the neonatal intensive care unit (NICU). The aim of this study is to clinically validate an automated seizure detection algorithm by comparing EEG interpretations with the gold standard reading by a Paediatric Neurologist. A second aim of the study is to validate the algorithm when housed within a custom built wireless EEG machine and compare that to a commercially available cEEG machine

The main purpose of this study is to help determine whether recommending the use of paracetamol or ibuprofen makes any difference to the risk of another febrile convulsion (fit) within the same illness in children aged 6 months- 6 years old who have presented to the ED with a febrile convulsion. The study will also help determine whether paracetamol or ibuprofen given regularly reduces hospital re-attendance with febrile convulsion, health care use and costs. We are also interested in long-term outcomes of children who have had a febrile convulsion. Information will be collected for the study by parent/guardian surveys on days 3,7 and at 12 months, and medical chart review (and optional data linkage) at 12 months post ED attendance. Febrile convulsions are the most common paediatric neurological presentation to the emergency department. Depending on our study findings, we will either confirm current practice, or provide definitive evidence to change practice to update clinical guidelines in AUS & NZ to recommend this simple, low-cost intervention to improve management of febrile convulsions.

This research study will evaluate the feasibility and preliminary efficacy of the TEG hand therapy model of care for people post CTR surgery within a public hospital-based (STARS), hand therapy service. It is expected that the outcomes of this study will determine the feasibility and acceptability of the new model of care and determine the feasibility of a future fully powered randomised controlled trial (RCT) that will determine the clinical and cost-effectiveness of the model of care. The TEG model aims to increase efficiency and outcomes, use telehealth delivery to improve patient access and app-based video-guided exercise and monitoring to improve self-management, adherence, and outcomes. Our hypotheses are that the TEG intervention will be acceptable and feasible for patients, and a future, larger randomised trial will be feasible to conduct. We will describe and explore the clinical and cost outcomes from this pilot RCT with due caution to not extrapolate results beyond the feasibility and pilot nature of the study.