ANZCTR search results

This study is a healthy volunteer study assessing anorectal function during defecation. The balloon expulsion study is one of the diagnostic tests used to assess dyssynergic defecation - condition where there is a poor coordination of pelvic floor muscle resulting in impaired defecation. In this study, participants will be asked to undergo anorectal ultrasound, anorectal manometry followed by rectal balloon expulsion tests in three different positions. Balloon expulsion time and the ease and comfort of balloon expulsion will be compared between different positions and environments. Result from this tests will contribute to further refining the interpretation and performing balloon expulsion test.

This study aims to determine whether Barrigel (hyaluronic acid gel) can delineate the tumour bed after breast cancer surgery Who is it for? You may be eligible to join this study if you have been diagnosed with early breast cancer and planned for wide local excision (WLE) and sentinel lymph node biopsy (SLNB) Study details All participants in this study will have both Barrigel and standard surgical clips applied following wide local incision of the breast cancer. Approximately 4-6 weeks after surgery (or after chemotherapy if needed), participants will undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) scans to visualise the gel and clip placements. A group of doctors will then independently contour out where they think the tumour bed is, and the degree of overlap of each contour will help determine its efficacy. Participants will then be assessed annually for up to 2 years using routine surveillance breast mammography and ultrasound to determine gel presence and characteristics over the long-term. It is hoped that this research project will provide us more information about alternative ways to improve the accuracy of post-operative radiotherapy planning and treatment in early breast cancer, especially as MRI guided planning and treatment becomes more prevalent.

This study aims to assess the feasibility and acceptability of an integrated care model focusing on awareness, education, empowerment and behavioural change using a digital health platform for those experiencing the menopause transition. It will assess feasibility and acceptability outcomes for those allocated to one to one coaching ( + digital content), group coaching ( + digital content) or digital content alone using a mixed methods approach.

This project is comparing the pharmacokinetics and pharmacodynamics of single doses of two forms of PRTX007. PRTX007 is being developed for the treatment of patients with acute viral infections (including Covid-19), chronic viral infections and solid tumors. This study will help determine the form of PRTX007 we will take into these future patient studies. You may be eligible for this study if you are a healthy adult male or female aged between 18 and 65 years old. The study is a crossover design study where 18 participants will receive an oral dose of one form of the study drug (regimen A), an oral dose of another form of the study drug (regimen B), and the form of the study drug used in regimen B along with a TGA-approved drug called Probenecid (regimen C). Participants will be dosed on Days 1, 5, and 9 and receive the dosing regimens in the order A-B-C, B-C-A, or C-A-B. Study participation will require 44 calendar days which will include 11 days (10 nights) in the CRU.

Preliminary in vitro data suggests that afterload reduction is independently associated with a reduction in LV filling pressure, with a reduction in mean arterial pressure of 12.5mmHg associated with a 5mmHg reduction in LV filling pressure (Jiang et al; data presented at ISHLT conference, 2023). The aim of this study is to quantify this relationship in humans. This data will allow better optimisation of blood pressure management in VA-ECMO patients, and appropriate selection of those patients who require more invasive and costly techniques to achieve LV unloading. The primary objective of this study is to quantify the extent to which reduction in mean arterial pressure affects left ventricular filling pressure during VA-ECMO support. The study is a single-arm trial with haemodynamic and echocardiographic endpoints. Patients on VA-ECMO who are undergoing a clinically indicated cardiac catheterisation procedure will be administered sodium nitroprusside as a continuous infusion, to achieve a reduction in MAP of 20mmHg but not below 60mmHg. LV end-diastolic pressure will be measured at baseline and at maximal infusion dose. The infusion will then be ceased.

Non-invasive ventilation (NIV) is a medical treatment that delivers pressurised air to the airways, reducing the effort of breathing and improving gas exchange. It is most commonly used in children to treat airway obstruction and respiratory failure. As everyone has a unique facial structure, a one-size-fits-all conventional NIV mask is not suitable for all children, especially those with cranio-facial abnormalities or; different facial sizes, structures and growths. Children often stop wearing their masks due to discomfort, making treatment in these patients challenging. We aim to demonstrate that personalised mask is as safe as the conventional mask, will be more comfortable, resulting in improved compliance, and therefore clinical outcome.

Complex regional pain syndrome (CRPS) is a painful debilitating condition in a limb. This complex disorder is associated with abnormalities in skin, bone, and the autonomic, sensory and motor nerves which significantly impact the quality of life of patients suffering from this condition. Due to the complex and progressive nature of the disorder, the development of specific interventions for CRPS has been challenging. This is a double-blind, randomized, placebo controlled, single ascending dose study in healthy male and female subjects of a dronabinol containing pressurised metered dose inhaler (IRX211). The study will evaluate the safety and tolerability of escalating doses of IRX211 administered as a single inhaled dose in healthy volunteers (Primary Objective). It will also evaluate the systemic exposure of escalating doses of IRX211 administered as a single inhaled dose in healthy volunteers (Secondary Objective). The data collected from this study will be critical to inform the ongoing development of IRX211 as a treatment for CRPS.

This study aims to assess the safety, tolerability and pharmacokinetics of a new cancer treatment, SGR-1505 that may be used for non-Hodgkin's lymphoma patients. Part C will evaluate the effect of food (FE) on the PK profile of SGR-1505 (provisionally at 200 mg, although the dose of SGR-1505 will be determined based on emerging PK data). Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that this study will not be enrolling patients with non-Hodgkin's lymphoma. Study details Part C will consist of 3 phases: a Screening phase (within 28 days of the first dose of SGR;1505), a Treatment phase, and a Follow-up phase. The Follow-up visit will evaluate safety prior to initiating the subsequent cohorts and will occur on Day 34 (± 2 days). It is hoped this research will determine the safest dose of SGR-1505 that can be administered with non-Hodgkin's lymphoma

Gastro-esophageal reflux disease (GERD) is a common gastrointestinal disease. It is a common occurrence after laparoscopic sleeve gastrectomy (LSG) with prevalence of de novo reflux ranging between 9.8 – 30%. GERD after LSG should be considered a serious adverse outcome due to worsening quality of life and increased incidence of Barrett’s esophagus after surgery. Surgical intervention with fundoplication is the usual treatment in those with GERD. However, it is not technically feasible in those who have undergone LSG. Other endoscopic treatments and devices exist however they are technically challenging and difficult to use. Recently, Anti-reflux therapy (ARAT) using Hybrid APC is an efficient and simple way to treat reflux. The first application of Hybrid APC as an anti-reflux procedure in endoscopy was reported in a retrospective study by showing cessation of PPI use of 78.6% at 36 months in a non-bariatric population. Therefore, the aim of this study is to assess the safety, feasibility, and efficacy of ARAT by measuring the reduction in PPI use in patients after LSG.

Aplastic Anaemia (AA) and Bone Marrow Failure Syndromes (BMFS) are rare diseases with significant morbidity and mortality. Currently there is little Australian data on the incidence of both acquired AA and BMFS, the therapies utilised or clinical outcomes. The relative rarity of this disease makes both the accrual of data and material to support scientific studies, and the establishment of high quality randomised prospective trials challenging. Furthermore, the existing literature concerning clinical outcomes of patients with AA may be biased by preferential reporting and publication of only good outcomes and/or serious or unusual events. The national registry for all Australian patients with AA and BMFS provides an important community resource to address these issues.