ANZCTR search results

This project focuses on investigating the implementation of a set of new clinical tools, for intended in-office use by optometrists, to support best-practice care provision to people with AMD. We are also aiming to support and engage optometrists to audit their own clinical practices, using the Macular Degeneration Clinical Care Audit Tool (MaD-CCAT), which we previously developed with funding support from the Macular Disease Foundation of Australia. We expect these tools will result in an improvement in accurate classification of AMD severity and management advice provided to patients with AMD to ensure consistency in optometric practice, and in the longer-term may have the capacity to be disseminated both nationally and internationally.

The purpose of this study is the measure the effect of continuous positive airway pressure (CPAP) on the movement of thoracic and abdominal tumours. Who is it for? You may be eligible for this study if you are an adult who is receiving stereotactic ablative radiotherapy for any cancer in the abdominal or thoracic region. Study details All participants in this study will be asked to complete a radiotherapy simulation session where you will have a CT taken with and without CPAP. We will then measure your tumour motion from the imaging. If your tumour motion with CPAP is reduced, you will have this for your treatment sessions. We hope that CPAP will be a well-tolerated, effective method of reducing respiratory tumour motion. This will reduce the volume of healthy organs around the tumour receiving radiation.

Intramuscular epinephrine injection is the most commonly used epinephrine injection indicated for the treatment of anaphylaxis. An epinephrine nasal spray is being developed for patients who experience anaphylaxis to provide an alternative more convenient and acceptable route of epinephrine administration. The purpose of this pilot study is to determine the optimal dose of ARS-1 to be used in Part 2 and Part 3 to compare the bioavailability of epinephrine after intranasal administration as ARS-1 and the intramuscular administration as IM epinephrine injection as well as evaluate the safety and tolerability of ARS-1 in healthy volunteers.

This study will investigate the effect of personalised surveillance colonoscopy of people at increased risk of colorectal cancer on the health system. All participants invited into this study will be individuals who are enrolled in the 'Southern Co-operative Program for the Prevention of Colorectal Cancer', SCOOP (a colonoscopy surveillance program in Adelaide). Eligibility will be for those 18 years or older, who have either had a previous colonoscopy finding of adenoma or who have a significant family history of colorectal cancer (CRC) and with a colonoscopy surveillance interval of at least three years. Those who have done a 'faecal immunochemical test' (FIT) and had a zero result for the prior three years will be eligible for Group 1. This group will be asked to complete a series of 6 questionnaires over a 3 - 5 year period, before and after colonoscopy. These questionnaires, will ask participants about their quality of life, general health and well-being, satisfaction with their current surveillance program and their personal preferences for surveillance strategies. There will also be questions about how much it costs individuals to have a colonoscopy, including out-of-pocket expenses and time spent. The costing information will be linked to the Medicare costs of colonoscopy procedure. There will also be a follow-up questionnaire at the end. Half of this group will have their surveillance colonoscopy as scheduled by the SCOOP team of doctors and the other half will have their colonoscopy extended by one-third. To ensure safety, this group will have extra FIT kits sent out annually and will be booked for an urgent colonoscopy if returning a positive result. A negative result will mean it is safe to continue the extended colonoscopy interval. People who are not due for colonoscopy during the 5 year study period, will be invited to join Group 2 and asked to complete a single survey about perceptions of their surveillance tests and test frequency as part of the routine SCOOP surveillance management. This study will determine if surveillance colonoscopy intervals can be safely extended based on FIT results for individuals at increased risk of CRC within an established CRC surveillance program. This will become the world’s first study to determine the safety, cost effectiveness & patient acceptance of extending colonoscopy surveillance intervals based on interval FIT results.

Parkinson’s Disease (PD) is a progressive condition that affects at least 1% of people over 65 with 10% of PD cases younger than 50. Drooling occurs in up to 74% of people with PD and leads to debilitating effects on social interaction, confidence, speech and eating. Despite its high prevalence, treatments for drooling are limited because the cause is unclear. It is assumed that people with PD swallow their saliva less frequently than the general population, and that this leads to an accumulation of saliva in the mouth. However, a reduction in swallowing rates has not been definitively established in research. This study aims to measure the rate of spontaneous saliva swallowing in people with and without PD. A non-invasive, validated method will be used to count swallows in participants recruited from the Parkinson’s Program at Cabrini rehabilitation. Swallowing rates will be compared between groups and results will show whether swallowing rates differ in PD. This information is vital for developing treatments for this degrading symptom of Parkinson’s. Lower swallowing rates in Parkinson’s will support treatments to encourage swallowing more regularly, whereas no difference in rates will call these approaches into question.

The research project is testing a potential new treatment for acute and chronic pain called HSK21542. Before a new medicine can be approved for use for humans, it is necessary to confirm that it is safe and effective. This is done by carrying out clinical research studies such as this one. The purpose of this study is to evaluate the safety and tolerability of a single dose of HSK21542. The pharmacokinetics (PK) of HSK21542 in humans will also be determined. PK testing involves taking blood, urine and faeces to measure how much of the drug get into the bloodstream and how long the body takes to get rid of it. When testing for PK the sample will also be tested for metabolites (breakdown products)of HSK21542.

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.