ANZCTR search results

This study aims to investigate whether 3D printed patient-matched intranasal splints are effective in improving outcomes of full-thickness skin grafts on nasal oncological defects. Who is it for? You may be eligible for this study if you are an adult patient presenting to the Princess Alexandra Hospital via the Skin Lesion Assessment and Management clinic with a skin cancer localised to the nasal alar requiring surgical excision and reconstruction with a full thickness skin graft. Study details Participants will be randomly allocated to either receive 3D printed splints in their nostrils immediately post-operatively which will be changed daily for 10 days, or an intranasal merocel pack which will be inserted post-operatively and remain in place for 7 days, or no intranasal dressing. Participants will be asked to complete questionnaires on aesthetic and functional outcomes of surgery for up to 45 days post-operatively. It is hoped that findings from this study will contribute to new methods of improving rates of graft take on the nasal alar in patients with skin cancer causing nasal defects.

Delirium is a transient and fluctuating cause of cerebral dysfunction and manifests with a wide range of cognitive and behavioural abnormalities. Delirium is associated with both increased morbidity and mortality and is a medical emergency. The sequelae of delirium are multiple and significant and extend well beyond the acute hospital stay. Delirium is associated with higher rates of death, medical complications, longer hospital stays, functional and cognitive decline and admission to residential aged care facilities. There are no registered pharmacological agents for the prevention or management of delirium. Pharmacological management is currently focused on symptomatic control with antipsychotics, as thus far, the cerebral abnormalities causing delirium have been poorly elucidated. We hypothesise that intranasal insulin, via its neuromodulatory effects, will reduce the rate of delirium leading to improved outcomes for patients and decreased costs of patient care in hospital. This RCT aims to evaluate the use of short-acting intranasal insulin in the prevention of delirium in patients undergoing orthopaedic surgery for femoral fractures. We will also assess the effect of intranasal insulin on duration and severity of delirium, acute and total hospital length of stay, complications, new residential aged care facility placement, cognitive decline, new onset of dementia, mortality, function, cost of care, quality of life (QoL) and emotional/mental impact on patients and caregivers.

Systane Hydration is a lubricating eye drop with unique features and ingredients that may support corneal healing and reduce ocular surface inflammation. This project aims to investigate whether eye drops containing hyaluronic acid and hydroxypropyl guar improve the rate of corneal healing following transepithelial photorefractive keratectomy (tPRK) laser eye surgery, compared to standard carboxymethylcellulose drops. Secondary aims include evaluating the impact of the eye drops on vision and patient-reported comfort levels using a modified dry eye symptom scale. tPRK is an ideal model for assessing corneal healing, as a standard-sized epithelial defect is created in each eye during laser ablation. This controlled setting enables consistent comparison of healing outcomes between treatment groups.

The GLOW Trial is a randomised, double-blind, placebo-controlled feasibility trial of enema-delivered faecal microbiome transplant for Long COVID. This trial aims to test the feasibility of a clinical trial protocol of enema-delivered faecal microbiome transplantation (FMT) in adults living with Long COVID.

Eating disorders are highly disabling and have a high mortality rate (Treasure et al., 2020). Clients referred to community mental health services with an eating disorder can wait for 6-12 months to access specialist treatment. Long waitlists have been linked to poorer treatment outcomes, such as increased dropout rates (Carter et al., 2012). The aim is to evaluate the feasibility of using online self-help modules developed by the eating disorders team at the Centre for Clinical Interventions (CCI) to support people with eating disorders who are currently not receiving treatment. CCI provides free online evidence-informed self-help modules for eating disorders – Break Free from ED (BFED) - which have been accessed over 350,000 times since July 2022. The present research study will evaluate the feasibility of using the BFED modules in a self-help format with minimal guidance in reducing eating disorder and related symptoms.

PrEP STAT is an open-label-two-arm RCT designed to evaluate the uptake of PrEP where Medicare-ineligible MSM receive the intervention—the free PrEP STAT pack (Tenofovir disoproxil fumarate 300 mg and Emtricitabine 200 mg)— compared to those who receive the control —a prescription for PrEP with a PrEP initiation infosheet. Clients will receive either the intervention or control within their consultation at MSHC. This trial will be carried out between June and September 2025. The trial will be integrated into routine care, in which clinicians will be digitally notified (via a message on the client file) when eligible clients visit the centre. Participating clinicians will assess eligibility and invite eligible clients to participate in the PrEP STAT trial.

The Kids Connect Integrated Program aims to increase the engagement of parents and families with the health services by optimising the uptake of child developmental checks through the WMG-E platform. Secondly, this program will include screeners for parental mental health and unmet family psychosocial needs. Intervention in this study is tiered care and support provided to families based on the survey responses. While both both groups receive universal resources (Tier 1), intervention group will receive targeted support for tiers 2, 3 and 4. Tier 2 will include general information of local support services via automated REDCap email. Tier 3 will include digital contact with Service navigator and recommendations of targeted support services, follow-up with email/SMS check-in in the next month. Tier 4 will include direct contact with service navigator over phone, with assistance to access services (warm hand-over), with regular follow-up calls over the next few months, as appropriate. Outcomes include the uptake of child developmental checks, utilisation of resources and services for child development, parental mental health, breastfeeding practices, and family psychosocial needs. We hypothesise that the provision of extra resources and service navigator support will increase the uptake of developmental checks and mental health screeners, will increase the utilisation of health services and improve outcomes of parental mental health, breastfeeding practices and family psychosocial needs.

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