ANZCTR search results

People living with rheumatic heart disease are often recommended to have antibiotic injections at least every 28-days over five years to reduce their risk of permanent heart damage. Our team has developed a new, less painful, way to provide these antibiotics, called ‘SCIP’, which provides 10-weeks of protection. By partnering with the Mala'la Aboriginal Health Service Corporation we will offer SCIP to people in need of regular BPG in Maningrida, Northern Territory, Australia and evaluate how well it works for them, with the ultimate goal of using SCIP to lengthen life, reduce illness and disability from rheumatic heart disease. We hypothesize that SCIP will provide an acceptable alternative way for people to get their regular BPG.

The aim of the study is to explore the efficacy of the 7-week online Mindovergut.com optimal health and resilience program for individuals living with a gastrointestinal condition and low to moderate psychological distress. The Mindovergut.com resilience program is based on 7 modules (1 module per week). Each module (consisting of videos, text, handouts, and audio files e.g. relaxation tracks) is designed to be completed once a week, taking approximately 30 minutes, with associated homework-based activities taking a further 20-40 minutes per day. It is hypothesised that participants will report increased quality of life post intervention.

Bronchiectasis is a commonly seen chronic lung disease in our inpatient and outpatient services. The unmet needs of people with bronchiectasis are huge, with relatively few randomised controlled trials (RCTs) and evidence-based interventions. This pilot RCT aims to improve the outcomes of children and young adults with bronchiectasis. It will examine the benefits (or otherwise) of a novel medication, erdosteine. Erdosteine’s effects include (a) mucolytic action, modulation of mucus production and increasing muco-ciliary transport; with (b) antioxidant; (c) airway anti-inflammatory and; (d) bacterial anti-adhesion properties. This pilot RCT will answer: In children (aged 2-18 years) with bronchiectasis, does 2 weeks of treatment with erdosteine as an add-on therapy, compared to placebo, (i) reduce the duration of the acute respiratory exacerbation, (ii) improve quality of life (QoL) and/or (iii) increase the time to next respiratory exacerbation.

This project aims to test and implement the MindCare education program, an intervention designed to improve self-efficacy, health literacy, and dementia risk reduction knowledge among community members from Arabic-, Vietnamese-, Greek-, and Hindi-speaking backgrounds aged 40 and over. The program was developed using co-design methods with input from CALD communities and service providers, and is delivered by bilingual peer educators through community-based workshops. The trial will assess the impact of the MindCare program through a randomised controlled trial, comparing outcomes between the intervention group and a control group that receives basic healthy ageing advice. Key objectives include improving participants' confidence in managing their health, increasing knowledge of dementia prevention, and evaluating the program’s acceptability and effectiveness within community settings. The trial will also examine the influence of cultural and linguistic factors on the program’s success in promoting healthier lifestyles for dementia prevention. The study hypothesis is that participants who receive the MindCare intervention will show improvements in several key areas compared to those in the control group. Specifically, it is expected that the intervention group will demonstrate increased knowledge of dementia risk reduction, improved health literacy, enhanced self-efficacy, and greater changes in health-related behaviours and lifestyle for dementia prevention. These improvements will be compared to the outcomes of the control group, which will only receive basic healthy ageing advice.

The purpose of this study is to assess the safety and feasibility of the BiVACOR Total Artificial Heart (TAH) to support support adult, end-stage heart failure patient who are awaiting heart transplantation. Patients that may be eligible patients for this study will be adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. survival on the original BiVACOR pump at six months post implant or survival to cardiac transplantation if occurring prior to six months post pump implant. This study will be conducted in up to 5 patients in up to two hospital sites in Australia.

The purpose of this study is to investigate the preliminary effectiveness and safety of a topical cannabidiol salve for rheumatoid arthritis. We hypothesise that using the salve for 4 weeks will have a clinically significant effect on functional status. This is an open label trial with all participants receiving the intervention for 4 weeks. Participants will apply the salve to affected joints twice daily for 28 days. The primary outcome is change in functional status. Secondary outcomes include health-related quality of life, pain, swollen and tender joint count, side effects, and change in inflammation.

This study aims to assess the safety, tolerability, tumour uptake, biodistribution and dosimetry of a new tumour imaging agent, [68Ga]Ga-A9-5209, in patients with advanced or metastatic cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above with advanced or metastatic breast cancer, prostate cancer, non-small cell lung cancer, small cell lung cancer or mesothelioma. Study details All participants who choose to consent in this study will undergo a screening visit to assess their eligibility. Participants will receive a single administration of [68Ga]Ga-A9-5209 via intravenous injection on Day 1. Participants will receive up to four PET/CT scans, and four blood draws (one for each scan) on Day 1. Participants will complete a safety follow up visit/end of study visit on Day 2. Patients with advanced or metastatic breast cancer, prostate cancer, NSCLC, SCLC, or mesothelioma can participate in either Part 1 or Part 2 of this study. There will be no differences in the assessments conducted for participants in Parts 1 and 2, the analysis however will differ. Part 1 participants will be evaluated for tumour uptake, biodistribution and dosimetry of [68Ga]Ga-A9-5209. Part 2 participants will be evaluated for tumour uptake. A minimum of 4 participants per indication will be included in the study. Target indications are advanced or metastatic breast cancer, prostate cancer, non small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), or mesothelioma. If successful, this potential new product could provide more accurate tumour staging and treatment response evaluation.

Medicinal cannabis has recently become available under prescription for the treatment of a range of intractable diseases. The efficacy of medicinal cannabis has not been tested in the general practice setting. We will test the hypothesis that specific formulations of medicinal cannabis will provide partial or complete symptom relief of at least one intractable disease..

The aim of this study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations Who is it for? You may be eligible for this study if you are male or female over 18 years of age, histologically confirmed stage IIB to IIIB non-small cell lung cancer with an absence of EGFR mutation or ALK translocation, and fit enough to receive at least one of the platinum-based chemotherapy regimens. Study details Participants will receive 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). Durvalumab is given at a fixed dose of 1500 mg intravenous infusion every 4 weeks (±1 week) until relapse or unacceptable toxicity, for a maximum of 12 cycles after surgery. Disease-free survival, time to treatment, time to recurrence, overall survival and Toxicity will be assess every 12 weeks in year 1, every 6 months in year 2 and 3, until relapse.

This study investigates disease behaviour of PSC-UC and treatment resistant aypical UC presenting similar features to PSC-UC yet without confirmed PSC, before and after therapy with OVT, We compared pre-post OVT clinical presentation and endoscopic findings, and corraleted them to pre-post OVT gut and saliva microbiota composition and function. The gut and saliva microbiota will also be compared to healthy controls. We plan for at least 12 months of follow-up, and will observe crucial time points such as relapses and remissions in more details. In our hypothesis, OVT would induce changes in gut microbiota composition and function, leading to different treatment responses in different patinet, based on these changes.