ANZCTR search results

Caffeine is readily available and widely consumed by adults of all ages. We are interested in whether temporarily manipulating caffeine levels (from complete washout to a controlled dose of caffeine) has an effect on ocular dominance in healthy adults. Specifically, we are testing its effect on a vision test that is frequently used to indirectly measure changes in brain function. If caffeine indeed influences our test results, then future studies may need to control caffeine consumption.

Telephone-based behaviour change supports offer a potential avenue for addressing behavioural risks among people with a mental health condition, however, their effectiveness in reducing health risks other than smoking has not yet been explored for this population group. A randomised controlled trial will be conducted to explore the effectiveness of a population-level telephone coaching service (the NSW Get Healthy Information and Coaching Service) in addressing health risk behaviours, including inadequate physical activity and poor nutrition. Compared to a control condition receiving information brochures only, participants exposed to the Get Healthy service are expected to: be engaging in more minutes of physical activity, be consuming more servings of vegetables and fruit, and be more likely to have attempted to change their health risk behaviours.

In this randomised, double-blind, placebo-controlled study, 80 perimenopausal women experiencing climacteric symptoms (e.g., hot flushes, sweating, insomnia, mood changes, muscle pain, joint and back pain, vaginal dryness, urological symptoms, or sexual disorders) will be randomly assigned to receive tablets containing either a saffron extract (affron, 14mg twice daily) or a placebo for 12 weeks. We will assess changes in climacteric symptoms and quality of life through the completion of validated questionnaires.

This study will evaluate the safety and performance of the Instylla Hydrogel Embolic System for patients requiring vascular embolisation for treatment of bleeds. Who is it for? You may be eligible to join this study if you are aged 18 and above and are requiring vascular embolisation for treatment of bleeds. Study details All participants will receive vascular embolisation using the Instylla Hydrogel Embolic System (HES) including Instylla Delivery Kit and Instylla Microcatheter. Safety and performance of the HES will be assessed using using the grading of the NCI Common Terminology Criteria for Adverse Events (CTCAE Version 5.0). Severity of complications will be further classified in accordance with Society of Interventional Radiology (SIR) guidelines. for up to 30 days post-embolisation. This study will also allow a greater understanding of whether HES can be used to embolise vascular bleeds.

Crohn's disease (CD) is a type of inflammatory bowel disease (IBD) - a chronic gastrointestinal disorder - associated with high disease burden and psychological comorbidity. Gut-directed hypnotherapy may be a type of psychological intervention useful for people with CD, as it has been well-researched as a treatment for functional gastrointestinal (GI) disorders (particularly Irritable Bowel Syndrome) with considerable evidence for reduced symptom burden and improved mental health. In the IBD literature however, hypnotherapy has received very little attention, with most research comprising case studies, and no previous trials conducted specifically with CD patients. This pilot trial will investigate the feasibility of conducting a future randomised controlled trial (RCT) of virtual adjunctive gut-directed hypnotherapy for patients with CD. Participants will be randomised to one of two groups: Control group will receive medical treatment as usual (TAU); Intervention group will receive usual medical therapy plus adjunctive gut-directed hypnotherapy delivered via telehealth. Primary outcomes are study feasibility endpoints (e.g. recruitment rates, intervention completion and acceptability, and acceptability of study procedures). Participants will complete assessments at five time-points (in line with pre-treatment, post-treatment, and follow-up three-, six- and 12 months post-treatment) to measure potential changes in disease activity, mental health and quality of life (secondary measures). This research will be a collaborative project between the Central Adelaide Local Health Network and Deakin University, and will contribute to the PhD of the Principal Investigator (PI: TL).

Orthokeratology (OK) lenses are rigid contact lenses that are designed to be worn during sleep. Their purpose is to reshape the front surface of the eye (cornea) in order to temporarily correct short-sightedness, also known as myopia. Although their primary aim is to correct myopia and provide clear unaided vision during the day, studies have shown that they also have an effect on slowing or stopping the progression of short-sightedness in children, termed myopia control. Currently lenses are fit on the eye by optometrists by fitting the lens on the corneal topographic map centred over the vertex normal. However, anecdotal reports suggest improved clinical outcomes are achieved when lenses are fit based on the topographical maps centred over the entrance pupil centre rather than vertex normal. The aim of this project is to compare the clinical outcomes of lenses that were designed based on the entrance pupil centre after 7 nights of overnight wear. We will investigate visual acuity, contrast sensitivity as well as optical aberrations. Our intent is to determine how these measurements can guide best clinical practice in fitting OK lenses.

The purposes of the study are to compare two clinical tests for ambulatory oxygen in patients who do not automatically qualify for oxygen according to the national recommendations (via Arterial Blood Gas results) but who may physiologically benefit ie. show improved functional capacity and/or blood oxygen saturation levels (SpO2). The two tests are six minute walk test (6MWT) protocol published by the American Thoracic Society (2005 and 2014 update), and our locally developed (and clinically utilized) six minute step test. Subjects are required to complete both tests firstly without oxygen and then repeat the tests with oxygen, as is done clinically when assessing if a patient activity capacity will improve with oxygen supplied. The aim is to compare the tests for outcome similarity, end-of-test SpO2 (as defined by the test protocols), determine which tests the patients preferred, and review the frequency of physician-prescribed ambulatory oxygen from the 2 tests..

This is a first-in-human (FIH), single-centre, double blind, randomised, SAD study of XW003 conducted in healthy adult participants. The study is designed to evaluate the safety, tolerability, PK, and PD of XW003 in healthy participants. Oversight for the study will be provided by a Safety Review Committee (SRC) comprised of the Investigator, the Sponsor’s Medical Monitor (MM) and an independent MM. XW003 is an acylated human GLP-1 analogue and is being development for obesity management. Native GLP-1 is a gut-derived incretin hormone that stimulates insulin secretion and suppresses glucagon secretion in a glucose dependent manner. It is also known to delay gastric emptying and reducing appetite and energy intake. These actions improve glucose homeostasis and thereby reduce hyperglycaemia, making GLP 1 an attractive substance in the management of obesity and associated morbidities. There is enough pre-clinical evidence that XW003 to justify the safety and therefore it is now being tested in humans.

This is a preliminary evaluation of the usability of a compact pneumatic compression device (Monterey) currently under development. The study is focused on evaluating comfort and ease of use in a group of non-naive Lymphedema patients

The purpose of this study is to see if a program of manual drainage and use of a compression bra can improve outcomes for breast cancer patients experiencing post-treatment oedema (accumulation of fluid under the skin). Who is it for? You may be eligible for this study if you are aged 18 or over, have completed radiotherapy for breast cancer in the last 3 years and are experiencing oedema in the breast. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive the intervention, which involves two 1 hour sessions of manual drainage per week for 3 weeks, and wearing a compression bra for 12 hours a day for this period. The other group will receive be referred to a lymphoedema clinic for treatment and receive the compression bra after a 3 week waiting period. As part of this study, all participants will have a number of scans (including MRI, mammogram and ultrasound) and answer some questionnaires about their symptoms. It is hoped this research will demonstrate the program being tested can improve outcomes for patients with breast cancer treatment-related oedema.