ANZCTR search results

Effect of topical and oral Resveratrol on skin health, condition and visible signs of ageing, in healthy ageing females. This study aims to assess the effectiveness of Resveratrol for skin health parameters and visible signs of ageing compared to a placebo in otherwise healthy females aged over 40 years old. This study hypothesises that oral supplementation and topical application of Resveratrol will improve skin health parameters and ageing, including fine lines, wrinkles, uneven pigmentation, skin elasticity, hydration, visible pores and oxidative stress markers compared to the placebo products.

This study involves using a new imaging processor (TXI) while performing a colonoscopy looking for colon polyps (pre-cancerous growths). The aim is to assess whether TXI is able to detect more polyps than usual colonoscopic imaging. In order to determine if there is any significant difference, we will randomise patients either to a routine colonoscopy or to colonoscopy using TXI. We will then document the number of polyps found with each imaging type if they are confirmed as pre-cancerous when examined by a pathologist under the microscopy, then compare the two methods statistically.

This is a Phase I/IIa, double-blind, placebo-controlled study which is subdivided into 4 parts. Parts A-C will be conducted in healthy adult participants and Part D will be conducted in hospitalised COVID-19 patients with moderate illness. Part A (Cohorts 1-4) will be conducted as a single ascending dose (SAD) study, whereby healthy volunteers will be enrolled to receive a single dose of inhaled enoxaparin (or placebo). Three dose levels of inhaled enoxaparin will be explored in Part A (0.25, 0.5, 1 or 2 mg/kg/dose). Sentinel dosing will be employed for all dose level cohorts for Part A. Part B (Cohorts 5-6) will be conducted as a multiple ascending dose (MAD) study, whereby healthy volunteers will be enrolled to receive multiple doses of inhaled enoxaparin (or placebo). Two dose levels of inhaled enoxaparin will be explored in Part B (0.5 or 1 mg/kg/dose). In Part C (Cohorts 7-8), healthy volunteers will be enrolled to receive MADs of inhaled enoxaparin (or placebo) in combination with fixed doses of inhaled N-acetylcysteine . Two dose levels of inhaled enoxaparin will be explored in Part C (0.5 or 1 mg/kg/dose). Each dose of inhaled N-acetylcysteine will be 600 mg.Sentinel dosing will be employed for all dose level cohorts for Part C. In Part D (Cohort 9), COVID-19 patients will be enrolled to receive inhaled enoxaparin (or placebo) in combination with inhaled N-acetylcysteine (multiple dosing schedule), plus best supportive care treatment for COVID-19. The dose level of inhaled enoxaparin to be evaluated in Part D will be based on safety and tolerability data obtained in Part C, or placebo. Each dose of inhaled N-acetylcysteine will be 600 mg. Dosing in each cohort Part A-C will occur in a sequential manner. The decision to escalate between dose levels and proceed to the next cohort will be based on a review of the available safety and PK data by the Safety Review Committee (SRC). The SRC will consist of (at a minimum), the PI, an independent Medical Monitor and a Sponsor’s medical representative. Other individuals (e.g. medical experts) may be invited to participate at the discretion of the SRC.

Young people accessing community mental health services often have a history of complex trauma in addition to a wide array of mental health issues including anxiety, depression, borderline personality traits and poor interpersonal skills. Commonly this group of individuals suffer from social anxiety and report difficulties in connecting with peers. Standard treatment approaches vary, but tend to encompass both individual and group therapy with elements of cognitive behavioural therapy (CBT) and/or dialectical behavioural therapy (DBT). Dropout rates tend to be high however, with meta-analyses estimating dropout rates of 25-30% for both group and individual therapy. The current project aims to assess the efficacy of using a table-top role-playing game in a group setting as a means of improving both treatment adherence and treatment outcomes. Clients will play the popular table-top game “Dungeons and Dragons” in groups of eight, which requires them to take on the role of a character and work collaboratively with other characters to solve problems and achieve goals. The aim of this project is to investigate whether treatment principles embedded in a table-top role-playing game can improve both treatment adherence and treatment outcomes in a community mental-health setting. The primary research questions that this study seeks to address are: 1. Whether, relative to a wait-list group who receive treatment as usual, participating in the specialised group intervention significantly reduces self-reported social anxiety and daily-life interference from past trauma/stressful life events. 2. Whether, relative to a wait-list group who receive treatment as usual, participating in the specialised group intervention significantly improves self-reported self-esteem and reduces self-reported depressive symptoms.

The purpose of this study is to understand the feasibility and effects of adding 30 grams/day of nut butter to a usual diet compared to no nut butter of older adults living in the community for 12-weeks. The outcomes of this study include dietary intake, various health markers, and wellbeing indicators.

The purpose of this study is to determine whether high intensity interval training can improve health outcomes and influence the gut micro biome in breast, prostate and colorectal cancer survivors. Who is it for? You may be eligible for this study if you are an adult with confirmed breast, prostate or colorectal cancer, and are at least one month post-treatment completion for cancer. Study details: All participants will undertake an initial 4-week supervised training phase, with 3 sessions per week of exercise with an Accredited Exercise Physiologist or equivalent. Following the supervised phase, participants will enter a 6-month maintenance period where they will be asked to maintain 150 minutes of moderate intensity or 75 minutes of vigorous intensity or a combination, therefore meeting the Australian exercise oncology guidelines. It is hoped that this research will help determine if exercise, and especially high intensity exercise, is effective in positively influencing the gut microbiome and other health outcomes in cancer survivors.

Coronary calcification complicates the delivery and expansion of stents and is a risk factor for major adverse cardiovascular events such as cardiac death or myocardial infarction. Intravascular lithotripsy (IVL) provides a variation to currently available percutaneous coronary interventions by delivering an acoustic pressure wave within the balloon to modify calcium, and in doing so enhancing vessel accessibility and providing a better environment for stent deployment. IVL has shown safety and effectiveness in multicentre studies, and our study will confirm the benefits of IVL in the context of our local facility for optimising stent implantation in calcified coronary lesions.

This study aims to assess if the administration of a clot busting medication (tenecteplase) administered at the site of the clot in the brain following intravenous administration of the clot busting medication is safe and feasible in patients with acute ischaemic stroke within 4.5 hours of symptom onset. The approach in our study is to carefully select the patients with disabling strokes within hours of their symptoms commencing. If the clot can be dissolved at this point the damage to the brain can be prevented. Patients will receive the treatment with a clot busting medication (tenecteplase) shown in multiple trials to be likely more effective and at least as safe in opening up brain vessels compared to the standard medication used. This is followed by an angiography and if the clot is still present and visualised in a medium sized vessel, which is deemed too small to be treated with mechanical removal, a small dose of the same clot busting medication will be administered directly into the clot. (These patients are still at risk of having disabling stroke deficits if the vessel cannot be reopened.) The administration of a clot busting medication directly at the site of the clot in the brain has been safely tested in multiple trials, but not targeting the specific patient group as in our study. The participants will be monitored for their immediate stroke symptom outcomes and followed up until three months after their stroke for any disabling effects. We will assess if the participants are able to return to their pre-stroke function and lifestyle. This is a pilot study including 18 patients with the expectation that it will be followed by a larger trial involving multiple centres comparing this intervention with a group receiving the current standard treatment. We hypothesise that the administration of a clot busting medication directly into the clot is safe will lead to better outcomes in stroke patients who are not suitable for the standard therapy.

This is a study for patients diagnosed with ductal carcinoma in situ (DCIS) of the breast. The primary objective of the study is to create a de-identified database of patients, test results, treatment decisions and outcomes that can be queried to determine the clinical utility of the DCISionRT™ test in the diagnosis and treatment of ductal carcinoma in situ of the breast. Who is it for? You may be eligible for this study if you are over the age of 25 and have been diagnosed with ductal carcinoma in situ of the breast. Study details All participants will have had a tumour sample taken and agreed to have that sample tested using the DCISionRT test. Physicians will be asked to provide information on their treatment decisions before and after they receive the results of the DCISIonRT test. Participants will not be required to have additional tests or procedures as a result of participating in the study. The registry is designed to be hypothesis-generating, rather than focusing on a specific hypothesis. The main objective is to accumulate a sample size (1,500) that could accommodate future hypotheses based on subsets of the general population of DCIS patients across the country.

Effect of Ageratum conyzoides on osteoarthritis in an ageing adult population: A double-blind randomized placebo-controlled parallel study. The aim of this study is to assess the effectiveness of a pyrrolizidine alkaloid-free A. conyzoides extract on alleviating osteoarthritis symptoms and measures of quality of life in a healthy, ageing adult population. It is hypothesised that A.conyzoides will improve symptoms of osteoarthritis such as pain, joint function and inflammation while also improving quality of life.