ANZCTR search results

This is a double-blind, placebo-controlled study to assess the safety of ZE75-0267 and how this drug acts in the body in healthy volunteers. ZE75-0267 may be indicated for use in patients with Parkinson's disease, but a trial of the drug in healthy volunteers is needed before trials in Parkinson's disease patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive single or multiple doses of ZE75-0267 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. It is hoped this research will determine the maximum dose of ZE75-0267 that can be administered safely without causing severe reactions. Once the dose of ZE75-0267 has been determined in healthy volunteers, a trial investigating the efficacy of ZE75-0267 as a treatment for patients with Parkinson's disease may proceed.

The purpose of this study is to develop a dataset of micro-elastography images co-registered to ex vivo images of breast tissue. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, you have been diagnosed with invasive or in situ carcinoma and you are eligible for breast conserving or mastectomy surgery based on clinical evaluation by the Investigator. Study details The images will be acquired from fresh breast specimens using the ORM-P2 system - a new handheld imaging device being developed for margin assessment using micro-elastography during breast conserving surgery. Participants undergoing breast conserving or mastectomy surgery who consent to the study will have their fresh breast specimens collected from theatre and scanned using the ORM-P2 investigational device, prior to routine pathology testing. It is hoped this research will determine whether use of the ORM-P2 device is effective at developing a dataset of co-registered quantitative micro-elastography ex vivo images of breast tissue.

The Intergenerational Childhood Adversity and Lifetime Morbidity (I-CALM) study extends a previously approved project (MUSP-CALM) that linked a prospective birth cohort recruited at the Mater Hospital in the 1980’s to administrative health data of emergency department (ED) presentations, hospital admissions and contacts with mental health services up to 31 December 2020 (HREC/2022/QMS/83690). MUSP-CALM sought to study the effects of childhood adversity on health outcomes up to 40 years old. With I-CALM, we now seek to anonymously link the same birth cohort to the Perinatal Data Collection (PDC) to a) study their obstetric history and the perinatal history of their children and, b) link children’s perinatal records to their ED presentations and hospital admissions in the same way as we did with their mothers. The new I-CALM dataset will resultantly include two generations of data regarding heath service use, as well data on the 1st generation’s (children of the original mothers) agency reported child maltreatment data, socio-economic information (both already in the CALM dataset). This will enable the study of intergenerational health outcomes in the 2nd generation (grandchildren of the original mothers) relative to the childhood adversity experience by their mothers. The results from this study will provide evidence of intergenerational risk factors for health service use, which could tailor preventative interventions and/or inform risk tools able to identify at-risk individuals in the next generation. We hypothesise that maternal childhood adversity are associated with increased health service use and community mental health service use of their children compared to children with mothers who did not have childhood adversity. We also hypothesise that maternal childhood adversity is associated with higher instances of perinatal complications compared to mothers without previous childhood adversity.

Fifty-one percent of our current Australian population were born with ovaries and 6 million are now aged 40 or over; ie. at or approaching perimenopause and menopause, but very few clinicians have actually received training or education regarding menopause and its care. This study to aims to determine if the simple intervention proposed (combining education, reinforcement and telehealth) is a feasible approach to raise menopausal-awareness & training of your average primary care clinician (& patients too). This is especially important in rural/remote areas where telehealth follow-up may be significantly easier and patients are unlikely to have the option, and/or much longer wait times, to see menopause-specialist GPs who tend to be metropolitan-based.

This study is a multicenter, randomized, single blind (participant and Investigator blinded), placebo-controlled Phase 2 study, with a 2-group, 2-period crossover design. The aim of the study is to evaluate the safety and tolerability of NGM120 in pregnant women with HG, as well as to obtain evidence of relief of HG symptoms, as measured by PRO, including PUQE-24, HELP, nausea numerical rating scale (NRS), daily activities NRS, and well-being NRS. The study aims to show that NGM120 is safe to take and able to relieve HG symptoms (severe nausea and vomiting) in pregnant women by completing patient questionnaires.

This study aims at evaluating effect of LBBAP on clinical outcomes in comparison to RVP which has been a gold standard for six decades. The study hypothesis is that the LBBAP is more effective for pacing in patients with mild LV dysfunction or normal LV function. The study is aimed at evaluating LBBAP's efficacy in patients with LVEF >35%. Primary outcome measure is effect on LVEF. Secondary outcome measures include incidence of heart failure hospitalization, new onset atrial fibrillation and evaluation of structural changes in heart. The minimum follow up in this trial was 1 year.

The current study aimed to investigate the efficacy of two interventions, namely self-compassion (SC) and behavioural activation (BA), for academic worry in undergraduate students. We also examined the maintenance effects of the two interventions at 3- and 6-month follow-ups. Furthermore, we tested potential mechanisms of change in academic worry by focusing on experiential avoidance and intolerance of uncertainty. Undergraduate participants with moderate levels of academic worry were randomly assigned to behavioural activation, self-compassion, or control conditions, which included two in-person sessions targeting academic worry. We expected that (H1) Compared to the control condition, participants in both SC and BA conditions would show lower levels of academic worry, general worry, experiential avoidance, and intolerance of uncertainty at post-interventions, and at 3- and 6-month follow-ups. (H2) Experiential avoidance and intolerance of uncertainty at post-intervention and/or at 3-month follow-up would mediate the effects of BA and SC on academic worry at 3- and 6-month follow-ups.

Tracheal intubation represents considerable risk in critically ill patients. Hypotension following induction has been found to be associated with increased mortality and hospital length of stay. One of the contributors to hypotension may be the type of induction medication used. Ketamine is widely adopted in the emergency department and pre-hospital setting due to its haemodynamic stability. This feasibility trial will aim to allocate 50 patients (25 in each arm) to receive either ketamine-only induction or usual care. The primary outcome is the area under Mean arterial blood pressure (MAP) less than 65mmHg curve. The results will inform design of larger multi-centre trials and the outcomes that will be studied in the future trials.

We have developed VIP to investigate if very early, intensive enrichment-based intervention leads to better infant motor and cognitive outcomes and higher levels of parent responsiveness and parent wellbeing. This single blind randomized controlled trial (RCT) in 128 infants at high risk of cerebral palsy aims to evaluate the effects of 6 months of a Very early Intensive enrichment Program (VIP), versus an evidence-based parent education and monitoring program (usual care).  Assessments will be carried out at baseline (prior to randomisation), 3-4months timepoint (corrected age), 6 months (primary measures) and 12 months (study completion). The expected clinical outcomes of our trial are that infants who received our intervention will have better infant developmental outcomes and their caregivers will have higher levels of parent responsiveness and improved parental wellbeing.

Approximately 15,000 cardiac operations requiring cardiopulmonary bypass are undertaken in Australia each year. Major cardiac surgery necessitates the admission to the Intensive Care Unit for immediate and early post-operative care. Acute kidney injury (AKI) is a common and serious postoperative complication of cardiac surgery with an incidence rate of 5-42%. Cardiac surgery-associated AKI (CSA-AKI) has significant impacts on patients' morbidity, mortality, and healthcare costs. The PROTECTION trial which involved the administration of intravenous amino acids to patients undergoing cardiac surgery, and published in the New England Journal of Medicine (PMID 38865168) should improved renal outcomes for those who received the amino acid therapy compared to those who received the placebo. Crucially, with the publication of the PROTECTION trial, practice change locally, nationally, and international is occurring or likely to occur. In response, evaluating such practice change is a key component of recognising and responding to trends in care and outcomes that are otherwise invisible. We aim to perform a registry-based before and after observational study to evaluate change in the management of cardiac surgical patients admitted to Australian Intensive Care Units. Specifically, we wish to evaluate the change in key practice areas concerning renal injury identification and management. The total evaluable period of time for this before-and-after study is 6 years: 1st January 2022 until 20 – 31st December 2027. Data will be obtained from the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS) registry.