ANZCTR search results

Improvements in medical care and technology have contributed to an overall reduction in ICU mortality over the last 10-15 years. As an increasing number of patients are surviving, the focus of ICU research is gradually shifting from survival to quality of survival. Research has demonstrated that an admission to ICU (especially if prolonged) is associated with an increasing risk of developing delirium, depression, anxiety, distress, hallucinations, cognitive changes, and decreased quality of life and function that can last for years after ICU discharge. Reduced and poor sleep quality is commonly experienced by patients in ICU. Disrupted sleep and sleep deficit have been found to contribute to lingering delirium, hormonal imbalance, mental changes such as memory formation, impaired immune function, and the development of a catabolic state. Neurocognitive disturbances have been reported to persist after discharge from ICU, and alterations to circadian patterns are associated with a decrease in overall well-being and a prolonged recovery from critical illness. Preventing and treating sleep disturbance in ICU may reduce morbidity and mortality. Environmental factors in ICU have been shown to affect the body’s natural production and release of melatonin (a hormone that influences the sleep and wakefulness cycle), thereby disrupting sleep architecture and leading to sleep deficits. This study investigates whether the admission of patients to environmentally improved ICU bedspaces, within the context of the normal ICU operation, impacts on the quality of sleep and, consequently, the speed of recovery and decrease the incidence of post-intensive care syndrome, compare to patients admitted to conventional bedspaces.

Problem: One-third of people with epilepsy continue to experience seizures despite treatment with anti-seizure medications. Dietary therapy, such as the ketogenic diet, is an effective treatment, however, high discontinuation rate remains a significant issue limiting its effectiveness in practice. Our Solution: To utilise digital health interventions to enhance the delivery of dietary therapy for epilepsy, thereby improving treatment adherence and seizure control. Three components will be used: (1) at-home saliva ketone testing, (2) digital seizure and food diaries, underpinned by (3) dynamic dietitian support via telemedicine. Aim: To evaluate the effectiveness of incorporating multi-modality technologies in the delivery of dietary therapy for epilepsy. Study Design and Methods: A randomised controlled trial, enrolling 136 adults newly commencing on dietary therapy for epilepsy. Participants will be randomised to the enhanced technology (ET) or standard care (SC) group and followed up for 12 weeks. The treatment benefit will be measured by a novel consumer co-designed Desirability of Outcome Ranking (DOOR) measure combining seizure frequency, adverse events and quality of life. Secondary outcomes include changes in seizure frequency, quality of life scores and healthcare utilization; retention on dietary treatment; participant and clinician acceptance of the intervention and cost-effectiveness evaluation. Significance: Our enhanced model of providing dietary therapy with medical technologies to support patients and families, has potential to improve adherence to treatment, thereby reducing seizure frequency. Reducing seizures, reduces the risk of hospitalisation, injuries and death, and improved quality of life for people with epilepsy and their families. The virtual delivery and monitoring of dietary therapy will increase access to specialist care in regional areas and could be utilised for other conditions requiring dietary therapy.

Background: Childcare is an opportune setting to influence the early cultivation of healthy, environmentally sustainable food provision practices and feeding behaviours at scale. Aims: To assess adoption, acceptability, feasibility and impact of co-designed strategies to enhance awareness and generate practice change regarding healthy, environmentally sustainable and affordable food provision in childcare settings. These strategies include a self-report 1-day food waste audit, and a whole-of-centre 'toolkit' including a classroom activity to engage the children in a 1-week "Food Waste Awareness Week". Significance: Potential to impact current childcare practices and inform childcare food provision policy and practice guidelines in Australia and internationally with positive health and environmental impacts. Outcomes: Co-designed strategies disseminated via Nutrition Australia, ensuring direct research translation and scalable dissemination.

This study is a cluster randomized, double-blind, crossover trial to develop a school-based HEPA filter intervention program targeting school children aged 6-13 years in Melbourne, Australia, and evaluate its effectiveness to improve school indoor air quality and children’s health. We hypothesized that the intervention would improve school indoor air quality and children's health. The study will fill information gaps for the indoor air quality regulatory framework, providing guidelines and recommendations that support health promotion and disease prevention for children in schools.

Brief description of the study purpose: This study looks at a web based clinical decision support tool, designed to assist clinicians in deciding whether their patient with low risk thyroid cancer is suitable for active surveillance (watch and wait approach). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with Low Risk Thyroid Cancer. Clinicians who are involved in the management of patients with thyroid cancer will also be eligible to participate and provide their feedback on the web-based clinical support tool. Study details Clinicians will be randomly allocated by a randomisation table created by computer software to one of two groups. Clinicians allocated to the first group (intervention) will receive a link to a clinical decision support tool, where they will be able to use this tool to help determine if their patient with thyroid cancer is suitable for active surveillance. They will discuss this result with their patient and then together the patient and clinician will decide between active surveillance or surgery. Clinicians allocated to the second group (control) will receive a link to an online tool that will not generate a result of whether their patient with thyroid cancer is suitable to undergo active surveillance, but will instead provide information about the outcomes of active surveillance and surgery, They will discuss this with their patient and then together the patient and clinician will decide between active surveillance or surgery. Patients will choose either active surveillance or surgery after discussion with their clinician and all patients will be followed over time to see whether they have evidence of cancer progression. Quality of life in all patients will be assessed via a survey. It is hoped this research will determine whether use of web-based clinical support tool has a positive impact on how clinicians discuss the management options for people with low risk thyroid cancer.

TThe OPTMED-D study aims to improve medicine handover and digital communication between hospitals, general practitioners (GPs) and community pharmacists when patients are discharged from hospital to primary care. It also aims to increase uptake of post-discharge medication management reviews by community and credentialed pharmacists. We hypothesise that the multifaceted intervention will reduce 30-day hospital readmissions due to medication related complications, improve patients’ self-reported understanding of their medicines (i.e. how to take them) and quality of life, and lead to a reduction in health care usage. This study will leverage existing transition of care strategies (e.g., discharge summaries) whilst introducing targeted innovations, namely a structured medicine handover process mediated by a digital solution. Stakeholders and end-users will be engaged to co-design a multifaceted intervention that will follow the patient’s transition of care, thus placing the patient at the centre of care. A three-phased, multi-method study design will be followed that is underpinned by the Knowledge-to-Action Framework, with Phase 3 only described in this registration: Phase 1: Co-design of intervention with stakeholders and end-users over nine-month period is underpinned by the Knowledge-to-Action Framework: Phase 2: Development of the intervention over 12-month period Phase 3: Stepped wedge cluster randomised controlled trial (SW-CRT) over 12-month period

This study aims to assess the safety and efficacy of orally administered JBI-802 in subjects with Myeloproliferative Neoplasms (MPN) and Myelodysplastic/ Myeloproliferative Neoplasms (MDS/MPN) with Thrombocytosis. Who is it for? You may be eligible to join this study if you are aged 18 years and over have been diagnosed with Essential Thrombocythemia and either a Morphologically confirmed diagnosis of Myeloproliferative Neoplasms (MPN) or Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN). Study details: Participants in this study will receive JBI-802 administered orally daily for a 28 day treatment cycle for up to 2-years as long as the participant experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease, unacceptable toxicity, or other reasons for study discontinuation. The starting dose of the study drug is 5 mg/day, a total dose of 35 mg. Dose escalation will occur as per the 3+3 design after an internal Safety Review Committee (SRC) review of each dose stage. Dose expansion to other subtypes of MPN and MDS/MPN will occur after Recommended Phase 2 Dose is determined from the dose escalation phase. Eligibility/Screening for this study will occur within 21 days prior to starting treatment. If the study is suitable for you, you will enter the treatment period. The dose level selected for evaluation in Phase 2 will only be selected if it was safe and well tolerated during Phase 1. The treatment cycles will continue until you wish to stop, or you do not tolerate JBI-802 treatment, Some of the study procedures that include during your treatment period are :Medical, surgical, and cancer history, Height and weight, Physical examination, Vital signs, Eastern Cooperative Oncology Group (ECOG) evaluation, Electrocardiogram, Myeloproliferative neoplasm symptom assessment questionnaire,CT/MRI scan, Bone marrow biopsy, medication usage, Side effects assessment, blood and urine Sampling , liver and thyroid function tests, haematology and coagulation tests, Participants will be followed-up at the start and end of each 28-day cycle to assess safety and tolerability Blood samples will be collected to assess safety and tolerability during the study. After the end of study, subjects will be treated in accordance with local practice. Compassionate use of JBI-802 may be allowed in subjects after study completion, based on the Investigator’s judgment in consultation with the Sponsor and on a case-by-case basis. Compassionate use will be controlled by a separate protocol or process as defined by the local regulatory authorities. Continuation of study therapy beyond 2 years may be approved by the Sponsor based on the safety profile and will be contingent on the continued availability of product.

Enhanced Recovery After Surgery (ERAS) has been accepted as a standard of care designed to achieve early recovery and reduce stress response following surgery. While penile prosthesis implantation is a safe and effective treatment for males with erectile dysfunction, it is not without complications including postoperative pain and scrotal hematoma. This study evaluates the concept of ERIC (Enhanced Recovery Implant Care) on clinical outcomes and patient satisfaction rates following inflatable penile prosthesis (IPP) surgery. ERIC pathway appears to improve clinical outcomes and postoperative recovery following IPP surgery in terms of pain score, the analgesic requirement, and time to IPP cycling, as well as the overall patient satisfaction rate.

The primary aim of this research is to investigate how acute exercise affects executive function and whether these effects are modulated by transcranial Direct Current Stimulation (tDCS) of the dorsolateral prefrontal cortex. While we are not directly measuring dopamine levels, we hypothesize that exercise may induce changes in dopamine, which in turn could influence the outcomes of tDCS on executive function. The study will explore the impact of different exercise intensities, ranging from very light to moderate, on these effects.

Depressive symptoms are prevalent among middle-aged women, especially during the menopausal transition. However, the impact of menopause on depression is often overlooked, leading to inadequate treatment and poor outcomes. While current guidelines recommend traditional antidepressants as first-line management, the evidence for hormonal therapy is limited. To address this gap, we propose a new clinical trial comparing the efficacy of Menopause Hormone Therapy and antidepressants in treating menopausal depression. Given that menopausal depression most likely stems from hormonal fluctuations, it is hypothesised that hormonal treatments are more appropriate than antidepressants.