ANZCTR search results

Rationale: Ureteric injury is a known risk associated with complex gynecological surgery given its variable anatomical course through the pelvis. Ureteric injury is associated with significant morbidity thus methods to reduce surgical complications are important. Objectives: The primary objective is to determine the feasibility of undertaking a four-arm randomized trial to determine the most effective method of introducing cystoscopic-guided intraurethral indocyanine green (ICG) solution for ureteric identification during laparoscopic gynecological surgery. The intended primary outcome of the final study will be surgeon opinion of ease of ureteric identification laparoscopically. Secondary objectives include assessing if improved ureteric visualisation reduces surgical time, reduces additional procedures such as repeat cystoscopy or additional radiological investigations such as CT-IVP and reduces ureteric injury.

Cardiac catheterisation is an invasive cardiac procedure performed for diagnostic (angiography) and/or therapeutic (percutaneous coronary intervention [PCI]) purposes. Transradial approach to catheterisation is common, Current protocols for TR Band® deflation have been noted by staff as challenging to meet, with a recent audit identifying inconsistencies in practice and delayed deflations. Prolonged inflation times can increase the risk of radial artery occlusion (RAO). Evidence suggests that accelerated deflation protocols are safe and feasible and may reduce patient discomfort and length of stay. Various protocols have been developed and tested however, few assessed bleeding outcomes, efficiency of deflation and patient comfort. This study aims to assess the feasibility of accelerated protocols for TR Band® deflation. Outcome measures will be bleeding complications, deflation time/steps and patient comfort.

The current study aims to evaluate the efficacy of Goodnight Poor Sleep, a brief sleep intervention, by examining the long term improvements in sleep and mental health. It is hypothesised that the intervention (GPS) group will have significantly better sleep and mental health at post-treatment compared to the active control group.

This trial will explore the role of exogenous cannabinoids in people with endometriosis and look at the effects of ingested cannabinoids on a number of outcomes including (a) pelvic pain symptoms, and (b) gastrointestinal inflammation. The project utilises a placebo controlled, double blind, three arm parallel group trial, including two active arms of medicinal cannabis products (1:1 THC/CBD, CBD isolate). Eligible participants (people with endometriosis) will be randomly allocated in a 1:1:1 ratio to THC:CBD, CBD-isolate, or placebo oil products. The intervention phase is 3 months/menstrual cycles and follow-up phase is 2 months/menstrual cycles. The primary outcome is mean severity of endometriosis symptoms (pelvic pain, fatigue, nausea and gastrointestinal symptoms) and explore any in association between changes in symptoms and gut microbiota, endocannabinoids and vaginal microflora. Adverse event data will be collected during the trial and follow-up phase.

This study is evaluating the adaptations required to implement on-site pharmacists into residential aged care facilities (RACHs) in urban, regional, rural and remote areas. The study is seeking to understand what are the barriers and enablers that assist rural, regional and remote aged care homes to employ a pharmacist as part of the aged care home operations. The study will also assess the impact that having an on-site pharmacist with an aged care home has on aged care quality indicators.

It is well documented that rates of drop out from youth digital mental health programs are high, with on average only half of modules being completed. Greater adherence and engagement with programs has been found to be associated with better outcomes. Finding ways to encourage greater program completion may enhance the benefits that users derive. The current study aims to assess the effectiveness of an imagery-based motivation enhancement component embedded within an online program for youth anxiety. The study examines whether the motivational component improves young people’s engagement with the platform, and the subsequent effect on outcomes following treatment.

This is a placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of multiple dose levels of AP02 (Nintedanib Solution for Inhalation) administered using the eFlow Nebulizer in healthy volunteers, The purpose of this study is to learn about the study drug properties and determine what doses of AP02 are safe and well-tolerated in humans. AP02 is a liquid solution that is inhaled into the lungs with a device known as a nebuliser (the eFlow Nebulizer). The nebuliser releases the liquid as tiny particles a person can breathe in through their mouth to directly target the lung tissue, which is the primary disease site.

This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with metastatic bladder cancer. Who is it for? You may be eligible for this study if you are an adult with recurrent, histologically proven bladder cancer with a macroscopically visible tumour on diagnostic imaging. 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 delivery maximum dose of 4.5 mg protein and 37 MBq radiation. 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 scan. It is hoped that this research project will demonstrate hu/mo-10D7 targets bladder cancer metastases in humans and therefore prove its potential utility as a theranostic in ovarian cancer.

Physical activity (PA) improves motor skills, fitness, social functioning, muscular strength, and endurance in children with autism. However, the benefits of PA depend on the type of PA. In this study, we will co-design a PA program with parents and children to tailor benefits of PA to individual goals and determine the impact the PA has on everyday life. We expect to find that parents and children share some common goals for PA; that fun-based individual activities will be preferred PA; and that positive physical and mental health outcomes will result from adherence to the PA program.

This study investigates the characteristic electrical activity of the stomach conduit in patients with delayed gastric conduit emptying (DGCE), a clinical condition characterised by persistent nausea and difficulty swallowing after oesophageal cancer surgery. Who is it for? You may be eligible for this study if you are an adult male or female who has previous has had oesophageal cancer surgery at Peter MacCallum Cancer Centre atleast 12 months ago. Study details All participants will undergo a series of patient questionnaires regarding their symptoms, followed by a 4-hour gastric motility assessment using the device known as 'Gastric Alimetry', which works similarly to an ECG for the stomach. This will facilitate the identification of electrical activity characteristics for DGCE and validate the role of Alimetry in diagnosing DGCE.