ANZCTR search results

Aim: This randomised controlled trial will assess the feasibility and acceptability of EndoOptions, a new co-designed online resource which aims to support people with endometriosis to make decisions about their symptom management. The mixed-methods trial will also assess whether EndoOptions (i) reduces decisional conflict, and (ii) improves emotional wellbeing, and will also explore whether decisional self-efficacy mediates these effects. Participants: N=150 (aged 18 or over, living in Australia, with a diagnosis of endometriosis or suspected of having endometriosis) will be recruited via the offices of obstetrician-gynaecologists and specialist Endometriosis and Pelvic Pain Clinics, then randomly assigned to the Intervention group or the Control group. Design: The Intervention group will receive access to EndoOptions immediately, while the Control group will receive access after three months. Individual links will enable researchers to examine back-end user statistics on site access and navigation, and participants will also be asked to fill out online questionnaires at baseline, 1 month, 3 months and 6 months. Participants who have completed the six-month survey will also be offered the chance to take part in a 30-minute interview to give more detailed feedback on EndoOptions. In recognition of their time, we will be offering all participants who complete the six-month trial a $50 honorarium. Outcome: It is hoped that participants report EndoOptions to be acceptable and feasible, and that EndoOptions reduces psychological conflict in relation to making decisions about endometriosis symptom management.

The BREATHE FAST study (Breathlessness Rapid Evaluation And THErapy – Fast Assessment Spirometry Testing) aims to improve the early and accurate diagnosis of chronic obstructive pulmonary disease (COPD) in rural and regional general practice. It will use a self-administered digital screening questionnaire for breathlessness and a point-of-care micro-spirometry test (FAST) performed within the practice to support general practitioners (GPs) in identifying and managing patients with chronic breathlessness. Each practice will participate for 3-6 months. The study will assess the benefits for patients and GPs in terms of case detection of COPD. The BREATHE FAST system will • Identify patients with chronic breathlessness through a short digital questionnaire completed on their phone or tablet and provide results directly into the GP software ahead of the consultation. • Enable practice nurses or GPs to perform a Fast Assessment Spirometry Test (FAST) using a simple handheld device to detect a lung condition called chronic obstructive lung disease (COPD). We hypothesise that this approach will provide clinicians with timely, objective information prior to and during the consultation, improving the case detection of COPD.

This is a double-blind, placebo-controlled, dose-escalating study conducted in healthy adult volunteers. The study will be conducted in 2 parts, with each part having a double-blind period and an open-label period. Phase 1a will evaluate the safety and immunogenicity of Centi-Flu 01 in healthy adults aged 18 to 64 (Cohorts 1 and 2), and healthy adults aged equal to or greater than 65 (Cohorts 3 and 4). In this part of the study, 6 different dosing regimens of Centi-Flu 01 will be evaluated in a double-blind manner. Sentinel dosing will also be utilised in each cohort. Dose and age escalation will be based on the principle that to proceed with the lowest doses in older adults and to proceed with higher doses in the younger adults, preliminary safety of the lowest doses in younger adults will first be established. This phase also incorporates an open-label evaluation of the safety and immunogenicity of Centi-Flu 01 against an age-appropriate seasonal influenza vaccination. Adaptive design elements will be used to determine whether a booster vaccination dose will be given 1 year after the initial immunisation.

Our study aim is to determine the promise of a Communication Enhanced environment for improving aphasia recovery and patient goal attainment. Our Communication Enhanced Environment intervention incorporates individual activities and resources, staff and volunteers training, and enhancing the ward's physical environment. It is hypothesised that i) the Communication Enhanced Environment will be successfully implemented defined by 75% of the intervention implemented during our fidelity monitoring checks and, ii) the Communication Enhanced Environment will have sufficient promise for one or both participant strata (mild-moderate aphasia; severe aphasia) to progress the intervention to a Phase IIb-III clinical trial.

The primary aim of this study is to determine the feasibility of undertaking a large randomised clinical trial investigating the effect of MHT on pain and function in postmenopausal women with SAPS. This aim will be addressed by an evaluation of key parameters including i) ease of recruitment (rate and number as well as suitability of the assessment algorithm), ii) adherence to the hormone and exercise interventions with a standardised diary, iii) drop-out number and rate, and iv) adverse events (nature and number) will be undertaken and used to inform the implementation of a large-scale RCT. The study is a triple blinded pilot randomised clinical trial and will be known as the EMPOWER (Exercise and MenoPausal hOrmones for postmenopausal WomEn with shouldeR pain) Trial. Participants will be randomised into one of two intervention groups: menopausal hormone therapy (MHT) plus exercise and education or placebo plus exercise and education. This pilot study aims to screen 150 participants over a 12-month period with a recruitment rate of greater than or equal to 30%, resulting in 50 participants (25 each group) entering the pilot trial, with an additional five per group to allow for attrition. We therefore aim to recruit a total of 60 participants over a 12-month period

Functional Neurological Disorder (or ‘FND’ for short) is a common condition in which patients develop neurological symptoms such as paralysis, tremor or seizures. However, FND is different to other neurological conditions such as stroke or multiple sclerosis because standard neurological investigations do not show abnormalities within the brain or nervous system that can explain the patient’s symptoms. FND symptoms often persist for many years and have a major impact on patients' quality of life. There is no effective treatment for FND at present. Recently, it has been shown that a drug called psilocybin, which belongs to a class of drugs known as psychedelics, may be effective in the treatment of some health conditions. There is reason to believe that psychedelic drugs could be particularly effective in the management of FND. These drugs have a unique mechanism of action that may enable the brain to re-learn how to process signals received from the body. In this study we will test if psilocybin (15mg or 1mg), combined with a course of specialised physiotherapy (8 sessions completed in an outpatient setting at the Austin Hospital in Heidelberg, VIC within a 2-week period), is effective in relieving FND motor and related symptoms.

The purpose of this study is to compare a new treatment called electrochemotherapy (ECT) with standard surgical treatment for keratinocyte skin cancers, which are the most common type of skin cancer in Australia. The research team would like to see which approach is more acceptable to patients and easier to deliver in Australian hospitals. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have at least one primary keratinocyte cancer, either basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), and your skin cancer is able to be surgically removed (determined by the study doctor). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive either ECT or surgical removal of their skin cancer. Participants who are allocated to the ECT group will receive up to two doses of bleomycin chemotherapy, delivered with localised electric pulses to their skin cancer. Participants who are allocated to the surgical group will have their skin cancer removed and a skin graft added. Both groups will receive treatment under local or general anaesthesia, depending on the number and size of your lesions. Being allocated to either group will not impact the level of care you receive. It is hoped that this research will show that electrochemotherapy is a feasible and acceptable alternative to surgery for treating keratinocyte cancers that require complex reconstruction. If this small study shows that electrochemotherapy is safe and easy to deliver, it may be expanded to enable a larger number of skin cancer patients to access this treatment.

The purpose of this study is to evaluate the short term effects of selective light filters incorporated into single vision prescription spectacle lenses on short sightedness outcomes. The aim is also to investigate the effect of selective light filter spectacles on vision, colour perception, and comfort and impact on activities of daily living. The resulted will be compared to standard (non-filtering) single vision spectacle lenses in young adults with short-sightedness through a cross-over RCT. We hypothesise that four week exposure will show short term changes to myopia outcomes and have no adverse effects on vision with good safety and minimal interference with activities of daily living.

The research comprises a randomized, placebo-controlled, double-blind trial to evaluate the safety, tolerability, and physiological effects of a hydrogel-encapsulated sodium bicarbonate formulation co-delivered with caffeine and carbohydrates. The study seeks to establish whether this intervention improves exercise tolerance, with minimal adverse effects, in healthy volunteers. Phase 1 will involve 16 healthy adults (8 per group). Participants will complete two test visits. During the first visit participants will undertake a cycling based exercise test (INSCYD lactate test) to define baseline exercise tolerance. During the second visit, 96 hours later, they will ingest either the active hydrogel formulation or a placebo hydrogel before undertaking the same INSCYD lactate test. Physiological responses will be assessed using capillary lactate sampling, venous blood gas (VBG) analysis, and subjective effort ratings. Tolerability will be evaluated using GI symptom questionnaires, palatability scores, and protocol adherence. Performance outcomes will include maximal 4-minute power output, and detailed metabolic profiling via INSCYD software. Statistical analyses will include repeated-measures ANOVA and chi-square tests for tolerability. Both intention-to-treat and per-protocol analyses will be conducted.

Mindfulness training and psilocybin interventions are both promising approaches for supporting mental health and wellbeing, and may have complementary or synergistic effects when used together. The Psil-oMM study aims to examine the combined and independent effects of mindfulness training and psilocybin by comparing three conditions in 45 healthy volunteers: a 4-week mindfulness intervention, a single high-dose psilocybin session with psychological support, and a combined mindfulness plus psilocybin intervention. The primary outcome is wellbeing, assessed using the Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS).