ANZCTR search results

Differentiation between bilateral and unilateral (aldosterone-producing adenoma, APA) causes of primary aldosteronism (PA) relies on CT imaging of the adrenal glands and adrenal vein sampling (AVS), the latter of which is the current gold standard. CT imaging is limited by a high rate of adrenal incidentalomas, which can lead to dilemmas in management and pursuance of extensive investigations. AVS is operator dependent, labour intensive, expensive and invasive, also posing the risk of a failed or inconclusive study. We conduct this pilot prospective study in adults with confirmed PA with the objective of evaluating the efficacy of 68Ga-PentixaFor PET-CT in determining if an adrenal adenoma is the cause for primary aldosteronism, compared to AVS as the gold standard.

This trial will compare high-intensity exercise delivered in short bursts (intervals) against the typical moderate intensity exercise that is used during cardiac rehabilitation. The study will be a randomised controlled trial. Endpoints that will be examined include aerobic fitness, blood pressure and body fat percentage.

The aim of this study is to evaluate the the PET imaging agent, O-(2-[18F]-fluoroethyl)L-tyrosine (FET) to definitively establish the role of FET-PET in the management of brain cancer (Glioblastoma). Glioblastoma (GBM) is the most common primary brain cancer in adults representing approx. 50% of brain tumours. Standard treatment entails surgery followed by chemoradiation and then adjuvant chemotherapy. Imaging plays a key role in diagnosis, radiotherapy planning, and monitoring of treatment response in GBM. The current standard of care with respect to imaging is MRI. A alternate form of imaging has been developed using Positron Emission Tomography (PET), where tumours can be imaged by utilising a newer radiotracer (FET) which detects whether tumour cells are active. You may be eligible for this study if you are 18 years or older with a newly diagnosed brain cancer, specifically a histologically confirmed GBM IDH1 wild type or IDH1 mutant via IHC (2016 WHO grade IV glioma) following surgery. All participants in this study will continue with their usual care, and undergo additional FET-PET scans following chemo-radiation treatment, and at the time of subsequent suspected progression of disease. Group 1 patients will undergo an additional FET-PET prior to their radiation therapy at the time of their routine MRI scan for planning, Biomarkers obtained from participants tumour and blood will also be analysed. Participants will be asked to complete QOL questionnaires in their clinical assessment follow ups at 4 weeks, 3 months, 6 months and 12 months after the completion of chemo-radiation and at the time that the FET-PET3 scan is done. It is hoped that this new imaging approach with FET-PET scans will lead to more accurate assessment, and improve both treatment decisions and outcomes for patients with Glioblastoma. Currently FET-PET scans are not part of routine care for patients diagnosed with Gliobastoma. The use of FET-PET is experimental.

Hidracare, a topical solution, is a proposed treatment for mild to moderate hidradenitis suppurativa (HS), and this proof of concept study is designed to assess the safety and efficacy of Hidracare. It is expected this topical solution will be beneficial in reducing the number of lesions in participants with mild HS. As Hidracare is not yet approved for marketing or evaluated through human clinical trials, no clinical experience of this specific investigational product is available. However, a literature review provides data demonstrating the safety and efficacy of the four active ingredients in Hidracare (magnesium sulfate heptahydrate, magnesium chloride hexahydrate, alpha lipoic acid and dimethyl sulfone). This is an open-label study in which a total of up to 20 participants will be enrolled in the study and will receive active treatment, applied to all HS lesions twice daily for 8-weeks.

Study Aim The primary aim of this project is to evaluate the feasibility, acceptability and appropriateness of implementing a comprehensive adherence protocol into the Queensland Children's Hospital Cystic Fibrosis clinic. Study Design This is a mixed method, implementation study design. The four-phase Replicating Effective Programs (REP) framework developed to translate effective health services interventions into community-based settings, will inform implementation. Focus groups and interviews will form the needs assessment (pre-conditions), Descriptive data will be collected throughout implementation and interviews will be conducted post implementation to evaluate the change process. Pre-Conditions Phase: The researchers will review literature, existing adherence promotion interventions, clinic processes and resources. From this, the team will determine the core components of the iCARE intervention and create an implementation strategy that will support translation into the existing LCCH clinic structure and resourcing. Pre- Implementation Phase: The iCARE protocol, business case and draft implementation plan will be presented to the Cystic Fibrosis care team. Focus groups and consumer interviews will be used to gather qualitative data on adherence assessment and intervention and inform the implementation plan. Implementation Phase: All children and family’s accessing the clinic will receive the adherence promotion protocol as part of their routine clinic attendance. The research team will continue to collaborate with consumers and staff to troubleshoot, provide feedback and booster training as indicated. The implementation plan will continue to be modified and refined according to staff and consumer input. The researchers will record all facilitator input via technical assistance and training logs. Retrospective chart audit and a protocol checklist will be utilised to monitor fidelity and uptake of each aspect of the protocol into routine care. Maintenance and Evolution: Following three months of clinic implementation, the implementation process will be evaluated by the research team. Participants (staff and consumers) will be recruited to complete qualitative evaluation of the protocol and its components. Following the completion of the project, it is anticipated that the protocol will continue to be used in the clinic as standard care, if deemed acceptable to staff and consumers and sustainable within the existing resourcing of the clinic.

The purpose of this study was to create a nutrition education website to improve accessibility and immediacy of trustworthy nutrition information targeted at young people with T1D and their families. The website also aims to improve engagement of patients with longer diabetes duration, thereby improving their nutritional management of T1D. The primary aim of this study was to determine the effect of this online nutrition education website on nutrition knowledge (primary outcome), clinical outcomes, and treatment satisfaction, compared to standard care, on patients with T1D and their carers attending the WCH diabetes clinic. It was hypothesised that those who had access to the pilot website would have a higher nutrition knowledge score than those receiving standard care alone.

This is a proof of concept trial to deliver an early pharmacological intervention to enhance sleep spindle EEG features to optimise sleep quality and improve memory in those presenting with subjective memory complaints. Participants will receive a short-acting, non-benzodiazepine zolpidem or a placebo immediately prior to an overnight 8 hour sleep opportunity in a randomised order with a 5 to 10 day washout at the Woolcock Institute’s sleep and chronobiology laboratory using high-density electroencephalography (EEG). It will be hypothesized that memory consolidation will be significantly better with active drug compared to placebo.

In this study we aim to collect dental, saliva, blood and stool samples to characterise the gut microbiome profile of individuals with cardiovascular disease, specifically acute coronary syndrome and chronic stable angina and compare their microbiome profile to that of healthy individuals. Individuals with cardiovascular disease will have an alteration in the composition and functionality of their gut microbiome compared to healthy individuals.

Researchers have begun delivering mindfulness and aerobic exercise training concurrently on the premise that a combination intervention will yield salutary outcomes over and above each intervention alone. An estimate of the effect of combination training on chronic psychosocial stress in a nonclinical population has not been established. The objective of this trial was therefore to assess the preliminary efficacy of combination training for reducing chronic psychosocial stress in a healthy sample, and to establish assurance of protocol feasibility in preparation of a definitive RCT. This trial was designed as a prevention-focused (i.e., primary) intervention to be used by all individuals and not just those presenting with mental health risk factors.

This Phase 1b study is designed to assess the safety and tolerability of repeated topical ocular administration of CMB-012, 2 times per day , in participants with chemical burns of the cornea and/or persistent corneal epithelial defect, to allow a preliminary assessment of a safe and efficacious dose to be studied in further clinical studies.