ANZCTR search results

This is a first in human study for MAP 315 designed to investigate the safety, tolerability and pharmacokinetics of multiple doses of MAP 315 in healthy adult volunteers. The pharmacodynamic effects of MAP315 will also be explored. The active ingredient of MAP 315 is a live bacterium that is a common member of the gut microbiome of healthy adults. MAP315 is being developed for the treatment of Ulcerative colitis. It is a randomised, double-blind and placebo-controlled study conducted at a single clinical trial centre with a satellite site as an alternate location for screening and outpatient assessments. The study will enroll 2 cohorts of 16 participants each, who will be randomised 3:1 to receive MAP 315 (4 x 10^7 CFU of MAP 315 per capsule) or its matching placebo for 14 consecutive days (2 weeks). The first Cohort will receive one capsule of MAP 315 (4 x 10^7 CFU of MAP 315 per capsule) or matching placebo daily administered orally for 14 consecutive days, (total daily dose of 4 x 10^7 CFU of MAP 315). Cohort 2 will receive four (4) MAP 315 capsules, twice daily for a total of 8 MAP 315 capsules per day for 14 consecutive days, (a total daily dose of 3.2 x 10^8 CFU of MAP 315). The capsules are administered orally with water and regardless of food. Participants in the study will be confined in the clinical research unit (CRU) from Day -1 until Day 3, when they will be discharged after completion of all CRU-based assessments scheduled for that day, in the absence of clinically significant signals, at the discretion of the Principal Investigator. Both dose level cohorts (Cohort 1 and Cohort 2) will include at least 2 sentinel participants: 1 to receive MAP 315 and 1 to receive placebo. If dosing of the sentinel participants proceeds without clinically significant safety signals up to at least 72 hours (h) following the administration of the initial study drug dose, as determined by the Principal Investigator in consultation with the local Medical Monitor and Sponsor if required), the remaining 14 participants in the cohort can be dosed according to the randomisation schedule. The decision to proceed to Cohort 2 of the study will be dependent upon review of data from all participants in Cohort 1 up to at least 6 days after the beginning of dosing (ie, the Day 7 visit) by a safety monitoring committee (SMC). This will include the review of all safety data and available PK data for at least 12 participants in Cohort 1.

Polymyalgia rheumatica (PMR) is a common condition that causes severe pain and stiffness at the shoulders and hips in patients over the age of 50 years. Up until now, its diagnosis has been based on the patient’s symptoms and high levels of inflammation detected in their blood. However, this approach is not always accurate. A special CT scan (whole body positron emission tomography/computed tomography [PET/CT]) capable of detecting areas of inflammation throughout the body has recently been recognised as a new test to help diagnose PMR. In research studies, it appears to be better than the current approach to diagnosis. The easiest way to analyse these scans is not yet known though. In 2020, a simplified way to diagnose PMR on whole body PET/CT was developed. In this study, this simplified method will be investigated to determine its accuracy in a group of patients with a suspected new diagnosis of PMR.

Pulmonary rehabilitation (PR) is effective in reducing exacerbations and hospital admissions, improving health-related quality of life, exercise tolerance, and symptoms of breathlessness and fatigue in people with chronic obstructive pulmonary disease (COPD) and other chronic lung diseases such as interstitial lung disease, Bronchiectasis. However, despite the robust evidence for the benefits of PR, uptake is low, with 8-50% of those referred to PR never attend and 10-32% of those who commence not completing the program. Studies from the United Kingdom report that low PR program uptake, high non-attendance and non-completion rate are particularly evident in people who have physical frailty or high levels of anxiety and/or depression. In the elderly population with chronic lung disease, frailty is characterised by multisystem decline encompassing physical, cognitive, social and psychological aspects. Frailty is prevalent in people with COPD when compared to healthy age-matched community living individuals as young as 50 years old and is strongly associated with a higher risk of mortality. One in five people who are frail and living with COPD suffer from adverse outcomes such as increased risk of acute exacerbations and hospitalisations. A recent systematic review reported that frailty is associated with respiratory impairment and poorer health-related quality of life in people with COPD, idiopathic pulmonary fibrosis (IPF) (a subcategory of ILD) and asthma. There are no studies in people with other chronic lung diseases, such as ILD other than IPF or bronchiectasis, who are commonly referred to PR. Thus, frailty is now highlighted as an important condition that needs to be recognised and managed to improve patient outcomes and reduce healthcare costs. However, in Australia, there are no data on the proportion of people with chronic respiratory diseases referred to PR who have physical frailty, anxiety and/or depression, and the relationship between physical frailty, anxiety and/or depression and the uptake, attendance and completion of PR in people with chronic lung disease is unknown. The hypothesis of the study is people who have chronic lung disease and is physically frail, anxious and/or depressed have poor uptake, attendance and completion of a PR program.

To determine if supervised home spirometry can replace in-lab spirometry when needed, this study will evaluate Australian Register of Therapeutic Goods (ARTG) approved home spirometry quantitative and qualitative performance compared with in-lab spirometry supervised by a respiratory scientist. Older spirometers (> 1 year of use) will have a calibration check to assess ongoing validity of results. Hypothesis: a) Supervised outpatient spirometry indices (FEV1, FVC) and grade performed on a personal portable spirometer via Telehealth and standard in-lab spirometry 15 minutes apart in patients with chronic lung disease will be comparable b) Home spirometers will remain reliable after > 1 year of use

This will be a blinded, placebo-controlled clinical trial conducted within natural medicine clinics. Initial screening and consenting of participants will be conducted by the Co-Investigator and participants allocated to individual naturopathic clinicians for assessment interviews. The study includes two active treatment options and a placebo control. Participants will be allocated into Treatment Arm #1 or Treatment Arm #2 based on their initial clinical presentation, categorised into either an ‘anxiety-driven’ stress type (Treatment Arm #1) or a ‘non-anxiety driven’ stress type (Treatment Arm #2). Participants will be tested for stress, depression and anxiety indices at baseline and at day 21 for changes in these areas.

The study will assess a potential new method for the early detection of changes in brain function, referred to as Brain Function Fingerprinting or BFF. BFF involves the recording of brain waves (electroencephalogram or EEG) in response to sequences of simple visual or auditory stimuli and analysing the variability of their response. Changes in the variability of the response are hypothesised to indicate changes in brain function. We wish to test the hypothesis that BFF can detect differences between cognitively normal participants and participants suffering from mild dementia due to possible or probable Alzheimer’s Disease. The study will aim to recruit, over 12 months, a maximum of 24 participants suffering from mild dementia due to possible or probable Alzheimer’s Disease, and 24 of their cognitively normal partners, from the St George’s Hospital. The partners' cognitively normal status will be confirmed by comprehensive clinical evaluation.

This research will further understanding of the characteristics of immersive virtual reality physical activity programs that support or impede their utility for people without cognitive impairment in residential aged care from the perspectives of residents and staff. People without cognitive impairment are in the minority in Australian residential aged care settings. This research aims to provide insight into how VR programs can be developed and implemented as a group activity to be a useful and enjoyable experience that advances physical and psychosocial health and wellbeing for residents who may be disengaged from health promotion programs tailored for the majority of residents.

The purpose of the ICAROS study is to observe the experiences of patients and health care workers involved in implementing Cabotagravir-Rilpivirine long acting injectable treatment in the Australian setting at both GP clinics and tertiary Institutions. CAB-RPV LA ( Cabeneva) was approved and re-imbursed by the PBS on 1 April 2022 and presents a new HIV treatment paradigm and new challenges in its implementation. Hypothesis: The successful implementation of Cabenuva can be achieved by using a mix of different strategies in both primary & tertiary settings.To achieve this objective.: Patients will complete quality of life and patient satisfaction questionnaires before commencing Cabenuva, after their first injection and at month 12. Health care workers will complete questionnaires at implementation and at month 12. Participants will receive a card with a QR code to enter the study, to consent electronically and will be provided with a unique study number. The data will be stored in RedCap built by the Burnet Institute.To ensure personal information is kept confidential, name, contact details and any other information that allows the participant to be identified directly will be kept separately from all other information collected. Identifying information will not be entered on any study records. Instead, can only be identified by a unique study number. Information will be stored in a secure password protected database at the Burnet Institute where only the research team has access. All data sent to our servers is encrypted and cannot be tempered with or inspected along the way. It is hoped to represent under served groups e g women, ageing, culturally and linguistically diverse community, Aboriginal and Torres Strait Islander communities across Australia.

This study aims to determine safety and gastrointestinal tolerance of a novel ingredient for internal use up to a period of 14 days. This project is testing the safety of a traditional Australian Indigenous ingredient in a modern context. The sap resin produced by several species of eucalypts (gum trees) has an extensive history of oral use, however, the safety aspects have never been investigated. The purpose of this study is to demonstrate safety of a selection of sap resins taken from a range of different Eucalypt species (both Eucalyptus and Corymbia), in a modern context, at a standardised dose. The dosage form (in capsules) is not in accordance with traditional use (dissolved in water) and the ingredient has not been tested in this form before. The evidence of therapeutic internal use of this ingredient details a primary use of sap resin for digestive complaints. The potent astringent properties and ability to stem the secretion of body fluids have been detailed as the primary action for its effectiveness as a remedy for upset stomachs, diarrhoea and dysentery. The duration of use in the historical literature is not described, and it is expected, due to the primary use of this ingredient, to have been limited to short-term use, perhaps a few days to a week. Given the potential modern-day use of a mucilaginous astringent may extend to conditions such as diarrhoea predominant irritable bowel syndrome, the safe use of the ingredient for a period up to two weeks was chosen to be evaluated. The potential benefit of this research is to demonstrate the safe use of this ingredient internally at a standardised dose over a two-week period.

A randomised control trial investigating the surgical management of carbuncles, with the goal to identify whether incision and drainage with conservative debridement of carbuncles is superior to the current standard of full-thickness excision (saucerisation). The hypotheses tested involves comparing the two surgeries in their wound healing time, likeliness to require skin graft, and overall length of hospital stay and patient travel episodes.