ANZCTR search results

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.

The primary purpose of this study is to determine if plasmapheresis, a medical intervention undertaken in hospital and used for treatment of some autoimmune conditions, may reduce symptoms in people who are living with Postural Orthostatic Tachycardia Syndrome (POTS), that has not improved with standard lifestyle and pharmacological measures. Plasmapheresis involves separating out plasma from other parts of the blood and replacing this with a different fluid. The hypothesis of this study is that plasmapheresis will be superior to intravenous fluids in reducing autonomic symptom burden.

The research project conducted a randomised controlled trial in March-April 2023 to assess the feasibility and acceptability of EMI survey delivery and a small prototype of the Daily Growth program. This pilot evaluated ten prototype parenting resources (5 x Emotion Coaching; 5 x Active Play) offered to parents over two weeks delivered via a web platform. Specifically, the project aimed to test: 1. The feasibility of the prototype version of Daily Growth in terms of parent recruitment rates, retention, and flow through the stages of the study, as well as parent engagement via completion rates of the baseline survey, post-study survey, and daily prompts. 2. The acceptability of the ten prototype video resources and the program delivery method via twice-daily pre- and post-EMI prompts. 3. The feasibility of the prototype version of the Daily Growth program and the evaluation process in improving parent/child emotion regulation, mental health, and emotion coaching parenting behaviours in-the-moment and post-intervention compared to the control condition.

The PROMPT-RC study will assess whether the use of the AusTAPER App/Pathway by pharmacists improves medication management for residents in aged care facilities compared to usual care. This intervention helps pharmacists identify and reduce potentially inappropriate medicines (PIMs) to optimise medication regimens. The study hypothesises that the AusTAPER tool will lead to safer and simpler medication use, resulting in optimised medications and improved quality of life over 12 months.

Healthy eating advice is recommended by guidelines as a mainstay therapy for women at high risk or those who have developed gestational diabetes mellitus (GDM), prior to pharmacotherapy. GDM is a condition characterised by higher-than-normal blood sugar levels during pregnancy with immediate and long-term health consequences. 'Food is Medicine' programs aim to integrate nutrition interventions into the health care system to help improve the clinical population's diets and complement pharmacologic treatment of diseases. 'Produce prescription' is one such approach whereby clinicians and other health professionals prescribe free or subsidised healthy foods to people who experience food insecurity as part of their treatment. We will assess the effect of produce prescription on gestational weight gain for women with food insecurity and at high risk of GDM compared to usual care. We will conduct a randomised control trial of a produce prescription intervention in pregnancy women at high risk of GDM, who have difficulty buying or eating nutritious food. Intervention participants will be prescribed produce boxes from 14-18 weeks gestation to 34-38 weeks gestation. In addition, intervention participants will also receive three consultations with a dietitian. Predefined, composite secondary maternal (GDM, pregnancy related hypertension, excess gestational weight gain, caesarean section) and neonatal (large for gestational age, preterm birth, mortality) outcomes will be assessed. Diet quality, cardiometabolic outcomes, food and nutrition security, patient-reported outcome measures, and the feasibility and acceptability of the produce prescription program will also be assessed. Finally, a sub-sample of participants will be interviewed to explore how the program worked (or did not work) for them, and ways the program can be improved and scaled up. We hypothesise that the intervention group will have improved diet quality and reduced gestational weight gain during pregnancy which will prevent a range of pregnancy complications. We anticipate that the program will be highly acceptable to pregnant women and suitable for scale up as part of healthcare.