ANZCTR search results

The aim of this study is to determine the feasibility and efficacy of an AI-supported intervention that comprises automated phone calls (interactive voice response), and emails or text-message (SMS) delivered according to an algorithm, as well as an educational website. Participants interact with the automated phone calls via voice and the system interprets participant responses using natural language processing (AI component). The intervention incorporates periodic assessments of overall health status, AF symptoms and impact on daily life, General Practice (GP) access, and medication confidence and adherence, along with providing education content related to AF. We hypothesize that a AI supported technology platform for patients with AF can help identify higher-risk patients needing closer follow-up from the healthcare team, provide behaviour support for AF self-management, and identify and address barriers to AF management (attendance at regular GP and specialist appointments), leading to improved outcomes and care experience. We aim to evaluate the effect of the intervention on quality of life, behavioural and self-management outcomes (e.g. medication adherence), patient knowledge, health outcomes (stroke, myocardial infarction, mortality), healthcare service utilisation, feasibility outcomes (acceptability, usability, program engagement) and patient care experience.

Chronic pouchitis is a common complication after a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). Although antibiotics have been the mainstay of treatment for acute pouchitis, a proportion of patients become antibiotic-dependent or develop antibiotic-refractory pouchitis. There are few effective therapeutic options for these patients, and few prospective trials assessing their effectiveness. Tofacitinib was recently approved by Therapeutic Goods Administration (TGA) for treatment of ulcerative colitis (UC). It was found to be effective for induction and maintenance therapy in patients with moderate to severe UC. Chronic pouchitis is associated with similar inflammatory pathway activation as UC, therefore this study aims to investigate whether tofacitinib is effective for the treatment of chronic pouchitis.

Recovery following current treatment for methamphetamine use disorder (MUD) is poor. Only 14% of individuals report continued abstinence at one-year follow-up, which decreases again to 6% after three years. One of the critical limitations of existing treatment approaches is that they do not address the cognitive deficits that result from long-term methamphetamine use, which is critical to recovery from methamphetamine addiction. Goal Management Training (GMT), originally designed for individuals with brain injury, is a well-validated evidence-based intervention for executive dysfunction (i.e. impulsivity, working memory and decision-making deficits). Proof of concept studies conducted in Europe have shown that GMT improves cognition in stimulant (cocaine/amphetamine) users. However, we do not know if GMT is a feasible intervention in the context of methamphetamine treatment in Australia, or if it can improve clinical outcomes such as treatment retention and abstinence rates. We have modified this program (now GMT+) to reduce the content to four weeks (so that it is better aligned with average treatment duration for MUD in Australia) and improve relevance and engagement for consumers with MUD. We intend to conduct a proof of concept trial to test GMT+ within a residential addiction rehabilitation setting for individuals with MUD. Participants will receive follow-up testing immediately after the intervention (cognitive performance, acceptability), 4-weeks after the intervention (treatment retention, quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence), and 12-weeks after the intervention (quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence) to assess the benefit of GMT+ compared to psychoeducation-control.

The ImmunoPET study aims to assess whether it is feasible to use 89Zr-durvalumab (89Zr-durva) as a PET tracer of PD-L1 (a cancer related protein) in patients with cancer. Who is it for? You may be eligible for this study if you are an adult with non-small cell lung cancer. Study details All participants will receive an injection in the arm containing the 89Zr-durva tracer 30 minutes prior to completing a PET scan on Day 0. A further 3 PET scans will be taken 24 hours, 3 days and 5 days after the injection of the 89Zr-durva tracer. Each PET scan will take approximately 30-45 minutes. Blood tests will be taken at each of these PET scans. About 15-20ml of blood will be taken at each PET scan. It is hoped that this study will help determine if 89Zr-durvalumab (89Zr-durva) is a feasible option for use as a tracer of PD-L1.

The purpose of this protocol is to allow for patients on current AP01 studies to continue therapy and for patients with progressive, fibrosing ILD, including IPF without treatment options and who are unable to enroll in an AP01 study to be treated with AP01. The primary objective is to allow patients to continue or start AP01 therapy. A screening visit will be performed if the patient has not previously been on an Avalyn sponsored AP01 study. If a patient has been previously enrolled on an Avalyn sponsored AP01 study, a modified screening visit will occur. If the patient stops treatment for any reason an end of treatment visit will take place. Patients will have an in clinic visit every 12 weeks to collect any safety and lung function tests that are performed as standard care. AP01 treatment within the realm of this study will continue if patient can tolerate the drug or regulatory approval is granted or the study is terminated. Study may be terminated by the sponsor at any time for any reason. The data in this study will be used to assess the safety of patients on AP01 therapy.

The purpose is to determine if it is better (or worse) to include the carpometacarpal joint in total wrist fusion. The carpometacarpal joint (CMC) doesn’t move much in a normal wrist. It is located at the base of the metacarpals which are bones located between the wrist bones and fingers. If the carpometacarpal joint is fused in total wrist fusion, the third carpometacarpal joint (at the base of the long finger metacarpal) is usually fused. Sometimes the second carpometacarpal joint (base of the index finger) is fused if a slightly different position of the wrist is required. We do not yet know if fusing the CMC joint (or not) during wrist fusion leads to better patient outcomes. Currently, some surgeons prefer to fuse this joint as they think it may become painful later and that motion at this joint may cause the metal plates used in wrist fusion to break. Previous research on this question has shown there is no difference in outcome in patients who have or have not have this joint fused during total wrist fusion. However, these studies were small and were not properly designed to answer this question. For this reason, we would like to complete a properly designed study to determine what approach leads to the best outcomes. We seek to compared the two 'gold standards' of wrist arthrodesis in a randomised way - wrist fusion with inclusion of the CMCJ with a plate that goes across this joint to wrist fusion without CMCJ fusion with a plate that does not cross this joint. The results of this study will inform future patients and surgeons of the best option.

Patients with inflammatory bowel disease when commencing on new medical therapy for treatment of their disease will be recruited for participation in this gastrointestinal ultrasound study. The purpose of the study is to determine if gastrointestinal ultrasound can predict who will respond to a particular medical therapy. Gastrointestinal ultrasound findings will also be compared to other routine markers of disease activity such as clinical scores and biochemical markers.

The aim of the study is to determine whether neonatal monitoring of low birth weight babies with the BEMPU TempWatch along with standard neonatal care, as compared with standard neonatal care alone, decreases the need for escalation of care to invasive warming measures such as placement in an incubator or radiant warmer.

This is a prospective trial designed to evaluate the diagnostic performance of the BlueCheck caries detection system in a cohort of adolescent and adult participants pursuing orthodontic treatment with fixed appliances. The study will recruit participants with at least one active carious lesion, identified by visual inspection. After recruitment, participants will undergo caries diagnosis using both visual inspection and BlueCheck detection (primary objective). Each inspection will be performed by separate assessors. Standardized photographs for orthodontic diagnostic purposes (intraoral frontal and buccal views) will document the dentition before and after BlueCheck detection, and again after BlueCheck removal. Photographic records will subsequently be scored by blinded investigators. Data will be recorded as binary (yes/no) for visual inspection of: 1. initial caries, 2. activity status, and 3. BlueCheck detection. All investigators will have training on caries inspection/assessment evaluations. Lay description: This study will show if caries can be detected by BlueCheck. If so, BlueCheck may be a valuable tool allowing correction of early tooth decay using remineralisation products and obviate the need for more invasive procedures.

Brain Boot Camp is funded by the NSW Government Community Project Grant and was voted by members of the public. It is a research initiative which aims to improve awareness of older adults brain health, dementia and its risk factors. We aim to demonstrate how everyday activities can make a difference in supporting older adults’ brain health. Individuals will participate in an online survey to determine their brain health score, receive a box which contains five physical items to promote better brain health and complete a follow-up online survey 3 months later.