ANZCTR search results

This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with locally advanced or metastatic epithelial cancers, including ovarian cancer, breast cancer, bladder cancer and pancreatic cancer. Who is it for? You may be eligible for this study if you are an adult with locally advanced or metastatic (cancer that has spread to other organs) ovarian, breast, bladder or pancreatic cancer with a visible tumour on diagnostic imaging. You may also be asked to provide a tumour sample for testing to ensure that you are eligible for this study as it is targeting tumours that express a specific cell surface receptor (CUB domain-containing protein 1). Study Details All participants who meet the eligibility criteria in this study will receive a single dose of 89Zr-hu/mo-10D7 as an intravenous infusion over 30 minutes to deliver a maximum dose of 37 MBq of 89Zr-labelled antibody. During and after completion of the treatment participants will be assessed for safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 via vital signs, blood tests, ECG, urinalysis and PET/CT scans. Participants will be asked to attend a minimum of 5 study visits, with the imaging and tests described above to be completed at each visit. It is hoped that this research project will demonstrate 89Zr-hu/mo-10D7 targets locally advanced and metastatic ovarian, breast, bladder or pancreatic cancers in humans and therefore prove its potential utility as a theranostic in these cancers.

This research study aims to examine the effects of a multi-level school-based sleep health intervention: ‘Sleep Ninja for Schools’, designed to improve sleep knowledge and behaviours among students in Years 5 to 8. Implementation factors including the acceptability, appropriateness and feasibility of delivering the stepped support model in schools will also be explored. The intervention includes three main components: (1) Delivery of a universal sleep health education program to students in Years 5 to 8 by their regular class teacher, with accompanying educational resources provided to parents. (2) Training of school wellbeing staff in assessment, support, and referral options for students with significant sleep disturbances. (3) Screening for sleep disturbances in students, with stepped support provided for students who report subthreshold or significant sleep disturbances. Hypotheses: (1) Students who participate in the sleep education program will demonstrate improvements in sleep knowledge relative to a control group; (2) The classroom program will be rated as acceptable by students and teachers. All other outcomes are exploratory and no specific hypotheses are proposed.

CIRCA DIEM KIDS is a prospective observational follow-up at 5-8 years of children born before 32 weeks of gestation who were enrolled in the CIRCA DIEM Study (ACTRN12618000371291) during their initial hospitalisation after birth. The CIRCA DIEM study (ACTRN12618000371291) aimed to determine whether cycling light and noise during initial hospital care improve brain development and overall well-being compared with routine care with constant levels of light and noise during both daytime and nighttime. This follow-up study aims to establish if exposure to this cycled environmental care in the neonatal period has longer term benefits including improved intellectual performance at 5-7 years, and improved vision, hearing, breathing, sleep, school performance and general quality of life.

This study aims to evaluate a new, accessible treatment approach for children with obsessive–compulsive disorder (OCD). The program, called FAST-ERP, supports parents to learn practical skills through online modules and telehealth sessions so they can help their child manage OCD symptoms at home. FAST-ERP will be compared to the current gold-standard treatment, where children receive individual cognitive behavioural therapy (CBT) with a clinician via telehealth. The study will assess whether FAST-ERP is as effective (non-inferior) as standard CBT in reducing OCD symptoms and improving children’s daily functioning.

To characterise current ventilatory practices and adherence to low tidal volume ventilation (LTVV) in the management of patients with acute hypoxaemic respiratory failure (AHRF) receiving invasive ventilation in intensive care units in Australia and New Zealand.

The purpose of this study is to assess how safe and effective elranatamab is in treating newly diagnosed systemic AL amyloidosis. You may be eligible to participate if you are 18 years of age or older, have been recently diagnosed with this condition, and have not yet received any treatment. If you join the study, you will be given elranatamab as an injection under the skin for up to 6 treatment cycles, with each cycle lasting approximately 28 days. Throughout the study, your health will be carefully monitored to assess how you respond to the treatment and to identify any potential side effects. Following completion of treatment, you will attend follow-up visits every three months for up to five years. The purpose of this study is to determine whether elranatamab can slow or stop the progression of the disease, and whether it's safe to have it.

This is a cluster randomised trial of a novel skin preparation, OPAL X Wound Healing Cream, It is based in multiple aged care facilities within a statewide, church-based Aged Care provider. The comparator will be the standard moisturising cream currently in use at each facility. Randomisation will be by facility to minimise disruption to the routines of each facility by the research process. This is a pilot trial prior to a full trial. The hypotheses of the full trial will be: That OPAL X cream used as the moisturiser in best practice wound management regimes, vs standard moisturising creams will: 1. have reduced time to full healing.for acute wounds (like skin tears); 2 have reduced time to full healing.for chronic wounds (like skin ulcers); 3. Reduce the incidence rate of new skin tears on the affected limb 3. Generate improved quality of the undamaged skin of the affected limb. All people will be approached to participate, but only people with existing chronic wounds at enrolment, or who develop an acute skin injury in the first 2 months or until the target number of wounds is reached.

This study aims to determine whether using clinical and genetic calorie-to-satiation scores can help select the most effective weight loss medication for people with obesity. Participants will undergo detailed assessments and be randomly assigned to receive either phentermine–topiramate or a GLP-1–based medication (semaglutide or tirzepatide). The study will compare how much weight participants lose after reaching a stable treatment dose. We hypothesise that individuals with different calorie-to-satiation scores will respond better to specific medications, allowing more personalised treatment. The findings may help improve weight loss outcomes and reduce trial-and-error prescribing in obesity care.

This study aimed to explore any correlation between salivary and serum ferritin in 150 women undergoing elective surgery, to evaluate the feasibility of using salivary ferritin as a non-invasive biomarker for iron deficiency. Participants provided a fasted morning saliva sample and blood sample prior to their surgery. It was hypothesised that ferritin levels in saliva would accurately reflect serum ferritin levels.

This study is evaluating a new GP-integrated model of care for children with developmental and behavioural concerns in rural Western Australia. In this model, specially trained rural general practitioners work collaboratively with paediatricians to provide earlier developmental assessment and management for children while they are awaiting specialist review. The study will assess whether this model improves access to care, reduces wait times, and is acceptable to children, families and healthcare providers. The study hypothesis is that a GP-integrated developmental clinic model will improve timely access to paediatric developmental assessment and provide an acceptable and feasible model of care for rural communities.