ANZCTR search results

This is a phase 2b, multi-centre, double-blind randomised controlled trial evaluating psilocybin-assisted psychotherapy (PAT) for methamphetamine use disorder (MAUD). One hundred and twenty treatment-seeking adults with MAUD will be randomised 1:1 to receive either PAT with a single 25 mg oral dose of psilocybin or PAT with a single 5 mg oral dose of psilocybin, with both groups receiving the same structured preparatory and integration psychotherapy. The primary outcome is the number of days of methamphetamine use in the 28 days prior to week 12 post-randomisation, assessed using Timeline Follow Back methodology and supported by urine drug testing. Secondary outcomes include methamphetamine abstinence and remission, other substance use, craving, mental health, sleep, quality of life, functional impairment, safety, acceptability, feasibility and cost-effectiveness. Participants will be followed to 52 weeks, with an optional open-label 25 mg psilocybin-assisted psychotherapy treatment offered after the week 16 assessment.

This randomised controlled trial aims to compare the effectiveness of three types of fixed orthodontic retainers in maintaining lower front tooth alignment after orthodontic treatment. Participants will receive either a CAD/CAM 0.026-inch stainless steel retainer, a CAD/CAM 0.018-inch stainless steel retainer, or a conventional multi-stranded stainless steel retainer. All participants will also receive a standard lower removable vacuum-formed retainer. The study will assess post-treatment tooth stability as the primary outcome, as well as retainer failure, periodontal health, and patient satisfaction. We expect to determine whether the CAD/CAM retainers provide similar or improved stability and clinical outcomes compared with the conventional fixed retainer.

This pilot study will compare three pain-treatment approaches in children aged 2–16 years with burn injuries: standard care with paracetamol, paracetamol plus celecoxib, and paracetamol plus ibuprofen. The study will assess whether celecoxib and ibuprofen can be used safely in these children and whether they reduce inflammation, pain and the time required for burn wounds to heal. It will also examine whether the treatments affect the need for skin grafting, scar outcomes and post-traumatic stress symptoms. We hypothesise that children receiving celecoxib or ibuprofen will have less inflammation and improved healing outcomes compared with children receiving paracetamol alone, without an unacceptable increase in adverse effects.

This study aims to find out whether listening to artificial intelligence (AI)-generated ambient music or AI)-generated binaural beats can reduce stress in adults undergoing cataract surgery while awake under a sub-tenon eye anaesthetic block. The researchers expect that participants who listen to AI-generated ambient music or binaural beats will experience lower levels of stress than participants who do not receive an audio intervention. The study also aims to determine whether these interventions can improve recovery, reduce the need for anxiety-relieving or pain-relieving medications, and shorten the amount of time spent in hospital after the procedure. Participants will be randomly assigned to one of three groups: AI-generated ambient music, AI-generated binaural beats, or a comparison group that wears headphones without any audio. Stress will be measured using brain activity monitoring, blood pressure, heart rate, breathing rate, and questionnaires completed before and after surgery. Hospital stay and medication use will also be reviewed from clinical records. The results of this study may help identify safe, low-cost, non-drug approaches to reducing stress and improving the surgical experience for people undergoing cataract surgery.

Insulin therapy is recommended in gestational diabetes when dietary changes have not adequately controlled blood glucose levels. The purpose of this study is to compare the effectiveness of two different types of insulin that we use in treating gestational diabetes, Optisulin® and Novomix30®, in managing fasting blood glucose levels.

This study will compare two exercise programs for adults aged 40 to 64 years to determine whether multi-planar functional training is more effective than machine-based strength training for improving balance performance and physical function during midlife. Participants will be randomly allocated to either a machine-based strength training program or a multi-planar functional training program, completed twice per week for 12 weeks at HSCfit, Hunter Sports Centre. Balance performance will be assessed using force plate technology, and lower limb muscle strength and power will be assessed using a countermovement jump test performed on force plate technology. The findings will help inform exercise approaches that may support early prevention of age-related balance decline and future falls risk before older age.

The goal of this study is to assess the safety and performance of the ProstaCath System for the treatment of lower urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH) The ProstaCath System is a minimally invasive prostate therapy device with the intention to administer direct current energy to the body for use by healthcare professionals (urologist). Participants will be enrolled in the study over a 6 month period. Each participant will be treated with the ProstaCath System and assessed at 1 and 6 weeks, and 3, 6, and 12 months post treatment to assess symptoms, urine flow, sexual function and adverse events. A subgroup of participants will have an MRI at 1 week to assess the volume and location of ablated tissue. The duration of the study is expected to be 18 months.

This co-designed single-arm feasibility study explored whether or not a tailored exercise program was feasible, safe and acceptable to implement, in people living with a stoma and without a parastomal hernia, It was delivered by skilled physiotherapists, with individual personally tailored sessions, face to face over a 3-month period, with 12 people completing the program. It had no major adverse events and those living with a stoma, without a parastomal hernia, reported positive experiences.

The purpose of this study is to find out whether the number of heart operations performed on people aged 90 years and older in Australia and New Zealand has changed over the past 15 years, and whether patients treated in public hospitals have different outcomes from those treated in private hospitals. To do this, we will look back at existing de-identified records held in a national intensive care registry for every patient aged 90 or older who was admitted to intensive care after open heart surgery, a heart valve operation, a coronary artery bypass, or both together, between 1 January 2010 and 31 December 2024. This is an observational study: we will only study information that has already been collected as part of routine care, so there is no new treatment, no randomisation into groups, and no contact with patients; the two groups being compared are simply patients treated in public hospitals and patients treated in private hospitals. We expect to find that the share of these operations taking place in public hospitals has fallen over time, and this is our main hypothesis; we also want to learn whether the sector of the hospital is linked to a patient's chance of going straight home after surgery, being transferred to another hospital, dying in intensive care or in hospital, or surviving over the following years. Because the two groups of patients may differ from the outset, we will take account of measured differences such as age, sex, type of operation, whether the surgery was planned or urgent, the year of surgery, and the level of social advantage in the area where the patient lives. Finally, we will check how well an existing risk score used in Australian and New Zealand intensive care units predicts death in hospital for patients of this age, so that in future patients and their families can be given more accurate information when deciding whether to proceed with surgery.

This study is aiming to evaluate the feasibility of a novel shared care model involving general practitioners (GPs) and genetic counsellors (GCs) who will deliver multifactorial breast and ovarian cancer risk assessment to people aged 20-39 years-old Who is it for? You may be eligible to join this study if you are aged between 20 to 39 years old, recorded female at birth and registered as a patient at one of the ten general practices involved in the trial, in metropolitan or regional areas of Victoria. Participating clinics will advertise directly to their eligible clients. Note: this is a trial for people without a diagnosed cancer. Study details This is a 2x2 factorial cluster allocation and randomised feasibility study. All eligible participants will be contacted, informed of the trial and provided with access to a breast and ovarian cancer risk assessment. The mode of the access to the cancer risk assessment will be determined by the how the GP clinic is allocated: either through a GP (GP-facilitated access) or through participant self-access (consumer led-access). After accessing the risk assessment, participants will be asked to provide DNA for testing (saliva test kit) and enter data about their health history and family cancer history into a secure online portal. Study genetic counsellors will then collate the genetic and health history data to generate a breast and ovarian cancer risk assessment result. Consumer participants will then be randomised to receive these results through their GP or by a genetic counsellor. Participants will complete surveys at 2 weeks and 3 months post-results delivery to assess whether they thought the intervention was acceptable and determine effect on psychosocial outcomes such as cancer worry. This feasibility trial will provide important information on how to improve access to multifactorial breast and ovarian cancer risk assessments to the general population. It is hoped that this research will define appropriate access and results-delivery pathways for young people seeking breast and ovarian cancer risk assessments via primary care. By providing access to these breast and ovarian cancer risk assessments at a younger age, it is hoped that young people identified at higher risk of developing cancer will have access to earlier screening and better treatment options.