ANZCTR search results

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.

Type 1 Diabetes (T1D) is a chronic lifelong illness that requires a complex treatment regime. T1D is a condition that is often difficult for parents to manage and can cause significant stress in parents who have trouble dealing with their child’s condition. Parental stress is compounded as the child transitions to adolescence. An Acceptance and Commitment Therapy (ACT) intervention has been developed that may have the potential in reducing parental stress in parents of adolescents with T1D. The content of the workshop sessions will focus on the six core processes of Acceptance and Commitment Therapy (ACT): cognitive defusion, acceptance, self as context (self-compassion), contact with the present moment, values, and committed action. The aim of this study is to assess feasibility, acceptability and efficacy of Acceptance and Commitment Therapy (ACT) in managing the parental stress in parents of adolescents with T1D..

This is a first-in-human, single-centre, randomised, double blind, three-part multiple dose study to assess the safety and tolerability of OXT-328 and how this drug acts in the body in patients with chemotherapy induced peripheral neuropathy (CIPN). Who is it for? You may be eligible for this study if you are over 18 years of age and have moderate-to-severe CIPN. Study details: All patients with CIPN who choose to enrol in this study will be assigned by chance to receive multiple doses of OXT-328 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with CIPN.