ANZCTR search results

This Phase 1, randomised, placebo-controlled, double-blind clinical trial will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MZE782 when administered at increasing dose levels in healthy adult participants in Australia. Participants will receive MZE782 or matching placebo as multiple doses.

The study aims to evaluate the toxicity and quality of life outcomes associated with urethra-sparing prostate stereotactic ablative radiotherapy (SABR) for intermediate risk prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have intermediate risk prostate cancer. Study details: Traditional radiotherapy for intermediate risk prostate cancer typically involves four weeks of daily treatment. Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment SABR, is just as effective and safe, and this has now become one of the standard radiation schedule option for men with intermediate risk prostate cancer. The question then is whether we can further reduce treatment-related toxicities while maintaining cancer control. In this Australian phase 2 trial of urethra-sparing prostate SABR, we aim to evaluate the efficacy, toxicity, quality of life outcomes of this treatment

This project will address the significant impact of antipsychotic-induced weight gain among people with serious mental illness (SMI) by co-designing an evidence-based, easily understandable, and low-cost, educational resource on diet and physical activity. This study will use a co-production methodology to co-design the lifestyle resource with individuals with SMI and their treating clinicians. We will identify the key components required for this educational resource, and then develop, and refine this resource by running three focus groups (N = 5 per group) with Metro South Addiction and Mental Health Service (MSAMHS) case-managed out-patients (18-65 years) with lived experience of SMI. We will then pilot this lifestyle self-management intervention with MSAMHS consumers (N=20). We expect that this resource will lead to positive changes in consumer intentions, attitudes, perceived behavior control, motivation and health literacy in relation to their physical activity and nutrition. We also expect that this will lead to a change in consumer health behavior (i.e., increased physical activity and healthy eating).

This study aims to evaluate the feasibility and impact of incorporating a stereotactic ablative radiotherapy (SABR) boost before definitive radiotherapy in the treatment of muscle-invasive bladder cancer (MIBC). Who is it for? You may be eligible for this study if you are a male or female, aged 18 or over, and diagnosed with muscle-invasive urothelial carcinoma of the bladder (T2-4a) of any grade. You need to be suitable for radical radiotherapy and medically inoperable or refused to undergo radical cystectomy. Study details Participants will be given SABR dose escalation of 8-10Gy in 1 single session prior to standard course of radiotherapy with or without chemotherapy. During and after the intervention, participants will be assessed for disease free survival of bladder cancer using Computer Tomography imaging of pelvis and cystoscopy examinations. Acute and late toxicities will be assessed using the grading of the National Cancer Institute Common Toxicity Criteria for Adverse Events v5.0 It is hoped that this research will improve local disease control in patients with muscle-invasive bladder cancer by evaluating the feasibility and effectiveness of incorporating a stereotactic ablative radiotherapy (SABR) boost prior to standard definitive radiotherapy.

RespectED is a universal school-based prevention program designed to reduce harmful attitudes and behaviors related to intimate partner violence (IPV) among adolescents. Delivered through five 40-minute cartoon-based lessons during Year 9/10 health education classes, the program aims to challenge attitudes condoning violence and build skills for healthy relationships. We hypothesise that students who participate in respectED will have lower rates of harmful attitudes condoning dating violence, as well as reduced IPV victimisation and perpetration, compared to students in the control condition at 6-month follow-up.

The SMART-AF study will enroll patients with atrial fibrillation, half randomly assigned access to a digital tracking platform to help participants engage and track their progress with optimal RFM for atrial fibrillation, half randomised to control. The aim of this study is to investigate the effiacy of a digital tracking platform to help participants engage, track and meet their progress towards optimal RFM, and it's relationship with AF outcomes.

DALE is a prospective, multi-site registry and biorepository, established to facilitate the collection of clinical data and biospecimens with the aim of furthering drug allergy research. Research questions which may be addressed relate to the epidemiology of drug allergy, our mechanistic understanding of the immune response to drugs in allergic patients, predictors of true or false drug allergy, diagnostic methods to identify causative drugs and quality of care in the management of drug allergy and delabelling.

This will be a double-blind, multicenter, parallel arms study of low and high dose levels of BRP-180 evaluated for improving wakefulness and reducing cataplexy in patients with Type 1 Narcolepsy. This trial will consist of 3 study periods: 1. Screening and Observation Period: Day -42 to Day 0. Sleepiness and cataplexy diary recording daily. 2. Treatment Period: Weeks 1-8. Parallel arms treatment period. During the treatment period, patients self-administer the allocated treatment (low doses of BRP-180, high doses of BRP-180, or placebo) once a day for 8 consecutive weeks.Sleepiness and cataplexy diary recording. 3. Follow-up Period: Week 9-12. Continued sleepiness and cataplexy diary recording daily and bi-weekly telehealth check-ins

It is hypothesised that there will be a correlation between the overall exposure to vancomycin of the whole blood (as represented by drawn serum samples) and subdermal tissue (as represented by ISF concentrations measured by the Nutromics device). This study is to assess the validity of this hypothesis in healthy human subjects, as a precursor to studies in the Device’s intended use population. It is designed to be able to deconvolute within participant effects from between participant effects, by giving multiple different doses to the same participants and repeating over multiple participants.

Online symptom checkers are digital health tools allowing health consumers to input symptoms to receive triage or diagnosis advice. If appropriate, another important feature is to provide consumers with self-care advice for managing their symptoms at home. Integrating Generative Artificial Intelligence (AI) into symptom checkers may help address unmet needs of diverse users, including those with lower health literacy. A retrieval-augmented generation (RAG) framework may be particularly useful by addressing concerns around accuracy via greater control of the quality of information informing the AI output. However, it is unknown how to best communicate the use of RAG generative AI in symptom checkers, nor how to present the advice. This project aims to 1) evaluate the effects of different presentations of generative AI symptom checker self-care advice on intentions, trustworthiness and understanding of the advice, and 2) explore in-depth user responses and perspectives on AI generated triage and self-care advice in an online symptom checker.