ANZCTR search results

This multi-site randomised controlled trial will test whether adding an online stoma-specific core-strengthening exercise program, Convatec Me+Recovery®, to standard stoma support garment use helps prevent parastomal hernia or delays the time to parastomal hernia after stoma formation. The study will recruit 450 adults with a new stoma across Australian hospitals/services. Participants will be randomly allocated 1:1 to either stoma support garment alone or stoma support garment plus the Convatec Me+Recovery® program. Participants will complete monthly online surveys and attend routine Stomal Therapy Nurse reviews for up to 24 months. The main outcome is time to diagnosis of parastomal hernia.

Depression is one of the leading causes of disability worldwide. Intermittent theta burst stimulation (iTBS) is a safe and effective neuromodulation therapy for depression, but its effects can vary between individuals. This study aims to investigate whether combining iTBS with transcranial alternating current stimulation (tACS) using a personalised, phase-synchronised approach improves brain responses compared with fixed-frequency and sham stimulation. The main hypothesis is that individualising stimulation frequencies based on brain activity will enhance the effects on brain function, compared with fixed-frequency and sham conditions. The findings will help inform the development of more effective, personalised brain stimulation treatments for depression in future research.

The aim of this study is to evaluate the impact and feasibility of using domiciliary humidified nasal high flow therapy as an adjunct to standard care in reducing exacerbation burden and healthcare utilisation in patients with chronic lung disease, using respiratory rate as an early physiological marker of clinical deterioration. This study is a randomised, 2-period, open-label crossover trial evaluating domiciliary humidified nasal high flow (NHF) therapy in adults with chronic lung disease (CLD) who experience recurrent exacerbations.

This trial evaluates the feasibility and preliminary effectiveness of delivering iCBT for insomnia prior to Reboot Online. It will assess whether targeting sleep first leads to greater improvements in pain, psychological wellbeing, and functioning compared with Reboot alone. We hypothesis that iCBT insomnia + Reboot Online will be a feasible model of care for participants reporting chronic pain and sleep disturbance and will result in significant reductions in pain interference and pain disability.

GRWD5769 is a first-in-class, orally bioavailable small molecule inhibitor of ERAP1, developed for immune-oncology applications, particularly for solid malignancies. Thid study aims to compare the bioavailability of a new tablet formulation versus the existing capsule formulation and to assess the effect of food on drug absorption in healthy adults. The rationale for developing a tablet is to reduce pill burden and improve participant convenience. This is a Phase 1, open-label, randomized, cross-over study in healthy adults (18–65 years) consisting of 2 and up to 3 parts: Part A1: Compares 800 mg tablet (2 x 400 mg) vs. 800 mg capsule (4 x 200 mg) in fasted state. Optional Part A2: If needed, compares 400 mg tablet vs. 400 mg capsule. Part B: Assesses food effect on the selected formulation/dose (fed vs. fasted).

A prospective, blinded, randomised split-face trial was performed, evaluating the effect of topical Arnica cream on postoperative periorbital ecchymosis and oedema following open septorhinoplasty. Each participant served as their own control, with Arnica applied to one hemiface and no treatment applied to the contralateral side This study tested whether arnica cream reduces bruising and swelling around the eyes after a nose job. To make it a fair test, it was planned ahead of time and ensured neither the patients nor the evaluating doctors knew which side of the face received the treatment. Each patient actually served as their own comparison; they applied the cream to one half of their face and left the opposite side completely untreated. By tracking the healing process on both sides, the study could directly measure if arnica cream truly speeds up recovery and lessens standard post-surgery black eyes and puffiness.

This study will be a pilot randomized clinical trial to assess whether magnetic acupuncture reduces pain prior to painful procedures (heel prick) in neonates. Neonates born at greater or equal to 29 weeks gestational age and/or greater or equal to 1,000 grams will receive either auricular magnetic acupuncture or placebo 30 minutes prior to a painful procedure (heel prick). Changes in cortisol levels and pain scores pre and post procedure will be evaluated both in the intervention and placebo groups. The purpose is to investigate non-pharmacological ways to reduce pain in neonates.

This study will compare a simple bladder test called single-channel cystometry with the standard multi-channel cystometry test used in urodynamic testing. Urodynamic testing is performed in women with bladder symptoms such as urgency, urinary leakage, difficulty emptying the bladder, or before some prolapse or continence operations. The standard multi-channel test measures pressures in both the bladder and abdomen. Single-channel cystometry is a simpler test that uses a single bladder catheter and sterile fluid to observe bladder filling, bladder sensations, bladder overactivity, and leakage with coughing. Women who are already having clinically indicated urodynamic testing will be invited to participate. All participants will have their usual multi-channel cystometry first as part of standard care. They will then have the additional single-channel cystometry test during the same appointment. The single-channel test is performed for research purposes only and will not be used to determine diagnosis or treatment. The main purpose of the study is to assess how accurately single-channel cystometry identifies detrusor overactivity, or bladder overactivity, and urodynamic stress incontinence, or leakage with increased abdominal pressure, compared with standard multi-channel cystometry. The study hypothesis is that single-channel cystometry will show acceptable diagnostic accuracy and agreement with multi-channel cystometry for detecting detrusor overactivity and urodynamic stress incontinence.

During Personalised External Aortic Root Support (PEARS) surgery, blood pressure is deliberately lowered for a prolonged period to allow safe placement of the external aortic support. This study will investigate how the brain regulates its blood flow during these periods of low blood pressure using non-invasive monitoring techniques. Researchers will determine whether each patient has an individual blood pressure threshold below which blood flow regulation becomes impaired. The study will examine whether time spent below this threshold is associated with postoperative complications, including delirium, kidney injury, heart injury, and changes on brain imaging. The findings will help determine whether personalised blood pressure targets may improve patient outcomes during future surgery.

This study aims to understand how genetic differences affect how Aboriginal and Torres Strait Islander people respond to commonly prescribed medications for chronic health conditions. Participants will undergo a simple blood test to identify genetic factors that may influence how their body processes medicines. The results will be provided to their doctor to help guide medication selection and dosing. The study will assess whether using this genetic information can improve medication safety and effectiveness by reducing adverse drug reactions and supporting better treatment decisions. We expect that pharmacogenomic-guided(PGx) care will lead to more personalised and safer medication use for participants.