ANZCTR search results

A Phase 1b Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple Dose Safety and Tolerability Study of Daily Dosing of BL-001 for 12 Weeks in Adults with Obesity. The study is being conducted to test the safety and tolerability of BL-001 in adult participants living with obesity and to determine the effect of BL-001 on the body by measuring changes in body weight. Adult participants will be randomised into 1 of 3 treatment arms at a ratio of 3:3:2. Eligible participants will complete a 14 day Screening period, undergo a 12-week Treatment period and a follow-up visit at Week 16.

This trial aims to determine how best to deliver polygenic risk assessment, at scale to all Australians in a one-off risk assessment in general practice, for our four most common cancers - breast, colorectal, prostate cancer, and melanoma. Who is it for? People aged 40-59 years old who are able to read and write in English and currently do not have any alarm symptoms or diagnosis of breast, colorectal, prostate cancer, or melanoma. All participants must be under the care of a General Practitioner who is participating in the trial. Study details Potential particpants who are patients of consented general practice clinics, in the age range of the trial, and are not known to be ineligible by clinic staff will be randomised to an invitation method, arm A or arm B. Potential participants in both arms will be invited to the trial by their general practice and receive information about the trial and risk assessment. Additional to the invitation, those in arm A will be sent a DNA saliva collection kit at first contact to compare to Arm B who will receive the DNA saliva collection kit after consent to the trial. Opportunistic recruitment at their GP clinic may also occur. Interested potential participants will then complete the enrolment steps outlined in the invitation to take part in the trial. All participants will receive an individualised cancer risk report and tailored advice for risk-appropriate screening. It is hoped that this study will determine whether delivery of a polygenic risk assessment via immediate DNA collection or delayed DNA collection for risk testing. The results of this study may then be applied to future risk screening policies.

This study aims to improve recovery for stroke survivors with arm and hand movement difficulties. Currently, therapists lack clear guidance on the best treatment approach, and what to do when an initial treatment isn't working. This research addresses this gap by using a new strategy that personalises treatment based on a patient's progress. Participants will be screened for eligibility and then randomly assigned to one of three therapies: robotics training, electrical stimulation, or task-specific exercises. A key part of the study involves reassessing participants after three weeks. If they haven't shown improvement, they will be reassigned to a different therapy for another three weeks. To track progress and identify who benefits most, upper limb function will be measured at the start, at three weeks, and at the end of the six-week trial. Additionally, biological markers, such as brain scans and saliva samples, will be analysed to help predict which patients are most likely to respond to a particular treatment.

The purpose of this study is to assess the outcomes of early intervention from cardio-oncology service for testicular cancer patients with heart risks and compare this data to testicular cancer patients who receive cares from their oncologist. Who is it for? You may be eligible for this study if you are an man with a diagnosis of testicular cancer within the last 5 years that either: 1. is receiving cisplatin-based chemotherapy; or 2. is planned to receive cisplatin-based chemotherapy within 1 month of enrolment; or 3. completed treatment of testicular cancer with cisplatin-based chemotherapy Study details All participants will also be asked to complete an interview at baseline and be followed up for 3 months(phone call), 6 months, 12 months, and optional 18 months (phone call) and optional 24 months which includes vital signs, blood tests, echocardiongram,and questonnaires. Intervention group will receive text message for education and support and may be prescribed medication for LDL and blood pressure if clinically indicated. Intervention group may see the cardiologist based on an as-needed basis as determined by the cardiologist. The control arm will be initially assessed within the cardio-oncology service and then a letter will be provided to their treating physician detailing ongoing care and receive usual clinical care, according to the treating physician’s standard practice. It is hoped that this study help mitigate longterm cardiovascular morbidity and improve qulaity of life in poeple diagnosed with testicular cancer.

AURA is a single-centre, outcome-blind pilot randomised controlled trial (RCT) designed to evaluate the effectiveness of autofluorescence-guided antimicrobial dressings in managing diabetic foot ulcers (DFUs). Conducted at Fiona Stanley Hospital (FSH), the trial will recruit adult patients from podiatry outpatient and Multidisciplinary Diabetic Foot Ulcer (MDFU) clinics. Eligible participants will be those with a DFU with <50% reduction in area in 4 weeks (“hard to heal ulcers”). Baseline data will be collected in accordance with international standards for DFU management. All participants will have their wounds cleansed and imaged using the MolecuLight i:X device to detect autofluorescence (AF), which indicates bacterial presence. Participants with negative AF (AF-) will receive standard care, including offloading, infection management, glucose control, and sharp debridement, along with inert dressings selected for exudate control, comfort, and cost. Participants with positive AF (AF+) will be randomised into two groups: one receiving antimicrobial dressings (AF+AD) and the other receiving inert dressings (AF+C), both alongside standard care. Dressing changes between clinic visits will be managed by carers or community nurses. All participants will attend follow-up appointments every two weeks over a 12-week period for ongoing podiatric treatment and wound evaluation. The study aims to recruit 60 AF+ patients, with 30 allocated to each treatment arm. The trial’s goal is to assess whether autofluorescence-guided antimicrobial dressing use improves DFU outcomes compared to inert dressings, potentially informing future clinical practice and larger-scale studies.

In this project we will implement a CYP2C19 genetic testing service in patients who are undergoing percutaneous coronary intervention, to guide antiplatelet therapy and reduce the risk of recurrent ischaemic events. The aim of the project is to investigate the feasibility of this service using the RE-AIM framework. DNA samples of participants will be collected via a blood sample and sent to NSW Health Pathology for testing and a pharmacogenomic report. The report will be reviewed by the treating cardiologist who will interpret and make recommendations regarding antiplatelet therapy. Recommendations will be communicated to the participant, their general practitioner and referring cardiologist. Barriers and facilitators to implement this service will be identified using semi-structured interviews with stakeholders. We expect to understand the feasibility and clinical utility of implementing a CYP2C19-guided antiplatelet service for secondary prevention of recurrent ischaemic events.

The study is a large, multi-site national clinical trial led by Deakin University in collaboration with major hospitals and research institutions across Australia. The study focuses on individuals who have experienced an assault-related TBI and aims to improve assessment, recovery support, and long-term care outcomes. Participants undergo a series of assessments, including cognitive testing, questionnaires, neuroimaging, and ecological momentary assessments. A key component of the study is the development and delivery of a personalised Survivorship Care Plan (SCP), which summarises results from participants’ assessments, provides tailored recommendations for follow-up care, and is designed to enhance communication between patients and their treating health practitioners. Findings from this study will inform the design of future Phase II and III trials and contribute to improved models of care for TBI patients.

The PROSPECT-OA study is a national registry that will track patients with osteoarthritis who receive radiotherapy as part of their standard clinical care. Osteoarthritis is a common condition that causes joint pain and stiffness, and radiotherapy is sometimes used to help manage symptoms. This registry aims to collect real-world information about treatment patterns, pain levels, and patient outcomes across GenesisCare sites in Australia. We hypothesise that radiotherapy can provide meaningful pain relief and improve quality of life for patients with osteoarthritis. By collecting data on pain scores and pain response, the study will help clinicians better understand how radiotherapy is used in practice and its impact on patients over time. Participants will be followed for up to 24 weeks after each course of radiotherapy, with pain response assessed at 12 weekly regular intervals.

This study aims to track adult and child (aged 5-17 years) participants who are using Medigrowth medicinal cannabis products for any chronic medical condition over a 12-month period. Who is it for? You may be eligible if you are an adult who is 18 years or older, seeking treatment for a refractory chronic medical condition at Azure Health, and considered suitable for medicinal cannabis by an Azure Health clinician. You must consent to being prescribed products supplied by Medigrowth Australia as per standard clinical practice (via the SAS or AP pathways), be able to read and understand English to complete study questionnaires, and provide informed consent. Alternatively, you may be eligible if you are a parent or guardian of a child aged 5–17 years who is seeking treatment for a refractory chronic medical condition at Azure Health and is considered suitable for medicinal cannabis by an Azure Health clinician. You must consent to your child being prescribed products supplied by Medigrowth Australia as per standard clinical practice (via the SAS or AP pathways), be able to read and understand English and assist your child to complete study questionnaires, and provide informed consent on behalf of your child. Study details Study participants will complete online questionnaires prior to starting their Medigrowth medicinal cannabis products (baseline), and then at 1 month, 3 months, 6 months, 9 months, and 12 months after entering the study. Questionnaires will assess patient-reported changes in mental health, pain, sleep, quality of life, global impression of change, and work performance using validated questionnaires. The study will also collect information on demographics, medical history, other therapies, and track how Medigrowth products are being used over time, including an estimate of CBD/THC dosages. The findings of this study are expected to inform clinicians about the safety and efficacy of Medigrowth medicinal cannabis products, and the outcomes may be used to inform future randomised controlled trials for specific indications.

This study aims to find out whether 3D-printed soft foods can improve the eating experience and nutritional intake of older adults living in aged care homes. Many residents require texture-modified foods because of swallowing difficulties, but these meals often look unappealing and may lead to poor appetite. We will compare a 3D-printed, easy-to-eat appetizer with the standard pureed appetizer currently used in aged care. Each participant will receive both types of foods at different times during the study. We hypothesise that older adults will enjoy the 3D-printed foods more, eat a greater amount of the meal, and have a more positive mealtime experience compared with standard pureed foods.