ANZCTR search results

This study aims to assess the diagnostic and predictive powers of host/bacteria-derived EVs, Ti ions, and inflammatory cytokines in saliva and PICF across peri-implant health, peri-mucositis, and peri-implantitis patients following nonsurgical treatments at 0, 3, 6, and 12 months. This study has two main aims: Aim 1: Assess the diagnostic power of host/bacteria EVs, Ti ions, and cytokine profiles as biomarkers in saliva and PICF to diagnose peri-implant health, peri-mucositis, and peri-implantitis patients. Aim 2: Assess the predictive power of host/microbial EVs, Ti ions, and cytokines as biomarkers in saliva and PICF for monitoring the treatment response of peri-implantitis patients following treatment for up to 12 months.

This study is testing two new products to diagnose and treat patients with advanced solid tumours. One product (called 68Ga-3BP-3940) helps to see the tumours using a PET/CT scan, and the other (called 177Lu-FO-004) is used for treatment. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with an advanced/metastatic solid tumour. Study details: All participants will undergo a PET/CT scan at the beginning of this study using 68Ga-3BP-3940 as a tracer. Once this has been completed satisfactorily participants will take part in one of two parts in this study: - Part 1 (Dose Escalation): Up to 30 patients will be divided into 4 groups. Each group will receive up to 6 doses of 177Lu-FO-004 treatment every 6 weeks to find the best dose for the next phase. - Part 2 (Dose Expansion): Up to 26 patients will receive the optimal dose of 177Lu-FO-004 found in Part 1 to confirm its safety and effectiveness. Some of these patients will have extra tests to check how the drug moves through the body and its effect on the heart. All participants in this study will have SPECT/CT scans at 4 times in Cycle 1 and two scans for each additional cycle. All participants will also have CT scans every 12 weeks for up to 2 years to monitor the disease. Participants will also be followed up throughout the study to assess side effects. It is hoped that this study will determine how safe and tolerable 177Lu-FO-004 is for patients with advanced solid tumours and to find the best dose to use.

The Endobronchial VAlves for Pneumothorax On Reducing Admission Time (EVAPORATe) study is a pilot feasibility multi-centre randomized controlled trial (RCT) to investigate if an early referral of patients with PAL from SSP for EBV can help shorten total length of hospital stay. The pilot data will inform in protocol feasibility and power calculation for the next stage (full-scale) RCT

This study seeks to establish a safe, one-step oral provocation challenge pathway for children with penicillin allergies. To be eligible, children must have experienced a low-risk initial reaction, such as a mild rash or a delayed urticarial rash. The goal of this approach is to inform primary shared care pathways for conducting penicillin testing in children within the community.

This study will conduct a hybrid type II implementation trial of a co-designed school and community support program to address food insecurity among Aboriginal families. Utilising culturally appropriate mixed methods and community-based participatory research approaches, the study will: • adapt and tailor a pilot program for relevance in other communities; • test the effectiveness of the program in shifting food insecurity among Aboriginal families (primary outcome) and in enhancing food and nutrition literacy (secondary outcomes); and • determine the barriers and enablers for scale up at other sites.

Exclusive enteral nutrition (EEN) is a dietary therapy for the treatment of Crohn's disease (CD) well established in reducing inflammation, particularly in paediatric CD. Gaps in knowledge relating to EEN remain, particularly relating to mechanism of action, impact on body composition, quality of life and adherence, particularly in adult cohorts. This study aims to address many of these gaps in knowledge through prospectively evaluating adult patients commenced on EEN, including objective measures of disease activity (biochemical, sonographic), body composition measures, novel biomarkers, adherence and quality of life over 6 weeks. It is hypothesised that EEN will lead to sonographic response, improvements in body composition and muscle strength as well as clinical symptoms and quality of life

This study will be a randomized controlled trial including children aged 2-16 years and adults >16 years of age, with newly diagnosis type 1 diabetes (< 7 days). Participants will be randomized 2:1 to Omnipod®5 automated insulin delivery device OR standard care (multiple daily insulin injections and continuous glucose monitoring [CGM]). Participants will receive the treatment for 12 weeks. Over this time their CGM data will be analysed, along with HbA1c and psychosocial outcomes from questionnaires and cost to the health system and the participant. We think the participants using Omnipod®5 from diagnosis of type 1 diabetes will have better glycaemic and psychosocial outcomes (such as less distress, more confidence and improved sleep) compared to those using standard care.

Stroke remains a leading cause of disability. Rural Australia has higher prevalence of stroke and reduced access to services. The purpose of this study is to evaluate an intensive stroke recovery program, delivered as a hub-spoke model, targeting areas of need in rural South Australia. The intensive burst of training will target arm recovery after stroke.

The purpose of this study is to investigate the safety and tolerability of 3D printed intranasal splints in healthy participants. Who is it for? You may be eligible for this study if you are a healthy adult, without a history of surgeries to the nose. Study details All participants in this study will be asked to wear a splint in the nose continuously for 10 days and will be followed up for 30 days to see if there have been any side effects It is hoped this study will help determine if these splints are safe to use for a future randomised trial looking at whether these devices can be helpful in nasal skin cancers

Shoulder pain affects 15-27% of adults and is the 3rd most common musculoskeletal complaint seen by general practitioners in Australia. Rotator cuff (RC) tendinopathy is the most common cause of shoulder pain and people affected have impairments in work and self-care activities, with 40% having ongoing disability beyond 12 months. Clinical practice guidelines and consensus statements suggest 12 weeks of first line management (activity modification, medication advice, clinician guided exercise) for RC tendinopathy prior to considering imaging or surgical referral. In contrast, our team and others have shown high rates of non-guideline indicated (‘low-value’) imaging (up to 80%) and surgical referral (about 20%). Video conferencing-delivered care is cost effective, convenient, and able to reach people in rural and remote regions. However, video conferencing rely on synchronous contact with a health professional, which is both time and labour intensive, and costly. Providing first line care directly to patients in their homes is now possible via digital voice assistant (DVA) or voice-controlled intelligent personal assistants (VIPAs) like Amazon Alexa (“Alexa”). Our group pioneered this technology for delivering exercise interventions for elderly people. We have now developed an Alexa program that delivers high-quality first-line exercise and education to people with RC tendinopathy. Our program includes behaviour change strategies as well as asynchronous interaction with a health professional via the user’s voice responses. The proposed study aims to test the feasibility of a randomized trial comparing DVA care (via Alexa) to telehealth (via Zoom video conferencing) and active control. If successful, this will lead to a full-scale randomized trial in Australian primary care that has the potential to develop evidence for a high quality and efficient internet-delivered intervention that could benefit millions of Australians who suffer with shoulder pain.