ANZCTR search results

This is a study of safety and tolerability of a drug called IMG-7289; also known as bomedemstat. The study will compare the amount of IMG-7289 that is in the blood after taking a single dose of 2 different formulations of IMG-7289, both with food and without food. IMG-7289 is being developed to inhibit an enzyme (LSD1) known to contribute to tumour growth, and may be used as a future treatment for cancers including myeloid leukemia and myelofibrosis. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 65 years, have a non-smoker status and have no prior history of relevant drug hypersensitivity. People who have been diagnosed with cancer will not be eligible for this study. Study details In this study participants will test two formulations of IMG-7289 with and without food. In each study period, participants will spend 4 nights in clinic followed by 4 follow-up visits. There will be 4 study periods, with one End of Study outpatient visit. There will be a 14-day washout period between doses to ensure there is no IMG-7289 in their body before the next dose. All participants will be asked to undergo blood tests and answer questions regarding their health. It is hoped that information from this study informs researchers of how the body metabolises IMG-7289 and thus how it may be used to treat bone marrow malignancies, such as myeloid leukemia and myelofibrosis.

This study will assess the anti-cancer activity of sulfasalazine in patients with advanced or metastatic pancreatic ductal adenocarcinoma. Who is it for? You may be eligible for this study if you are participating in the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437) and have SLC7A11-positive pancreatic ductal adenocarcinoma that has progressed following therapy with current standard of care. Study details All participants will be treated with oral sulfasalazine. It is usual to start taking sulfasalazine at a lower dose and gradually increase. Participants will start treatment by taking one 500mg tablet, three times a day. If the sulfasalazine is tolerated, the dose will be increased during the first cycle of treatment up to a maximum dose of four 500mg tablets, three times a day. To prevent low levels of folic acid that can occur with sulfasalazine treatment, participants will also take 1mg of oral folic acid tablets daily. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. Participants will have weekly clinic visits during Cycle 1 dose escalation. The frequency of visits declines to monthly later in the study. It is hoped that this study will help increase treatment options for patients with advanced pancreatic cancer.

For better educating patients and sustaining their self-management, we have developed, based on digital health principles, an innovative Mobile-based Diabetes Management System (MDMS). The MDMS consists of a clinician portal, as well as a consumer-facing smartphone application. The proof-of-concept, feasibility and pilot trials of the Mobile Diabetes Management System (MDMS) that we have completed have demonstrated a significant improvement in blood glucose levels, a high degree of consumer satisfaction and a good proportion of conventional in-person visits being substituted in a tertiary diabetes service at the Princess Alexandra Hospital, Brisbane. In this project we have added an insulin titration feature to the MDMS, which will be trialled with people living in regional, rural and remote Queensland. Participants will be recruited from the PA’s telehealth service. The aim of the project is to trial the updated MDMS for efficacy and safety. We anticipate that this project will lead to improved glycaemic outcomes.

Frozen shoulder is a type of shoulder disorder that affects an individual's physical and mental health in daily life. It could cause economic burden to individuals, families, health system, and the society. It is essential to find the best treatment plan to promote frozen shoulder patients' wellness and fasten the recovery time. Laser acupuncture has been used in a few health conditions with positive outcomes. However, the evidence in use laser acupuncture for frozen shoulder is still limited and inconclusive. This study will investigate the feasibility and therapeutic effect of using low-level laser acupuncture to manage frozen shoulder, and provide preliminary evidence in this field.

This study aims to assess whether a test called coronary artery calcium (CAC) score, can help predict the risk of a heart attack in cancer patients who are undergoing radiation therapy. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with any type of cancer, and you will be undergoing a thoracic computed tomography (CT) scan to plan for radiotherapy as part of your cancer treatment. Study details All participants who choose to enrol in this study will undergo their thoracic (chest) CT scan as planned, but the scan images will be used to calculate the CAC score will be completed after the scan. There are no changes to your normal scan for us to measure CAC. The duration of scan will be as per normal and you will not need any additional procedures. The CAC score will be used to identify patients who are at high risk of a heart attack in the future, and we will provide these patients with a referral to see the cardiologist (heart doctor) for management to help reduce this risk. After the scan you will have your radiotherapy treatment as planned. Throughout the study, you will be asked to complete a a series of questionnaires about your overall quality of life and your anxiety levels. You will be asked to complete these at the beginning of the study (Baseline), when you receive your CAC score from your doctor and about 3 months after you finish your radiotherapy treatment. It is hoped this research will demonstrate that the CAC score is able to identify patients who are at high risk of a heart attack in the future and help plan additional care to reduce this risk. We believe that this will have a positive effect on quality of life and reduce anxiety for future cancer patients undergoing radiotherapy.

This study aims to determine the safety, tolerability and pharmacokinetics (drug interactions within the body) of CCX559, a new chemotherapy drug that has not been previously tested in humans. Who is it for? You may be eligible for this study if you are aged 18 or older, you have a solid tumour of any cancer that is considered to be refractory (not responding to treatment), or you are intolerant of other approved treatments including standard chemotherapy, radiotherapy, and/or immunotherapy. Study details All participants who choose to enrol in this study will be given the study drug (CCX559) in either a powder form or as a capsule to be taken each day for 21 day treatment cycles. During each treatment cycle, participants will also be asked to report any side effects they have experienced and will undergo CT imaging at the beginning of every other treatment cycle (Cycles 3,5,7, 9 etc.), and again at the end of the study (7 days after the last dose) and after the safety follow up visit (30 days after the last dose). After taking the first dose, participants will also be asked to provide several [blood] samples over the first 24 hours, on Days 2, 5, 8, 15, 21 of the first treatment cycle and then again at the start and midpoint of each 21-day treatment cycle for the duration of the study. Overall study participation will take up to 2 years. It is hoped this research will determine whether CCX559 is safe and can be tolerated by adult cancer patients. If CCX559 is safe, future studies may be conducted to determine the drug's effect on cancer progression, which may improve health outcomes for future cancer patients

The overall aim of this study is to assess the effects of cognitively demanding resistance training breaks in secondary school classrooms. More specifically, this study will assess the effect of cognitively demanding classroom resistance training breaks on adolescents' executive function, on task behaviour and muscular fitness. The majority of research in physical activity and cognition has investigated the quantitative aspects of physical activity, such as duration and intensity. Alternatively, the qualitative characteristics of physical activity, such as task complexity, novelty and activity context, have received less attention. Emerging research on cognitively demanding physical activity, using the qualitative characteristics of physical activity, seems to promote changes in executive functions. The outcomes from this research will benefit current and future generations of young Australians as physical activity levels decline dramatically during adolescence, and only 15% of Australian adolescents are sufficiently active. Finding ways to promote physical activity in adolescents is particularly important considering that physical inactivity is linked with a range of diseases such as obesity, Type II diabetes, and a range of mental health disorders. Of note, stress and anxiety among youth are increasing in recent decades, particularly among older adolescents. Schools are ideal settings for the promotion of physical activity because they have the necessary facilities, equipment, personnel and are accessible to young people. Our proposed study, focusing on the promotion of physical activity for adolescents has the potential to create new knowledge and reduce the burden of physical inactivity. This project will offer a significant contribution to the field by emphasising the impact of cognitive demanding physical activity.

An open label, cluster randomised controlled trial to determine the comparative efficacy of 2 different insulin regimens for management for dexamethasone induced hyperglycaemia amongst diabetes patients with COVID-19. Patients with COVID-19, with hyperglycaemia when treated with dexamethasone will be eligible. The 2 regimens being compared are morning isophane insulin combined with standard basal bolus insulin therapy versus basal bolus insulin therapy alone. The hypothesis is that the addition of morning isophane insulin will result in superior glucose control, compared to basal bolus insulin therapy alone. The primary outcome is the mean of pre and post meal glucose levels following commencement of the protocol.

This is a bone mineral density (BMD) study using a dedicated analysis protocol to compare bone density around the surgical knee implant. in total knee arthroplasty (TKA). Patients with osteoarthritis will be recruited prior to their TKA operation by their treating surgeon. Patients who participate have an equal chance of being allocated to the Triathlon cemented baseplate or the Triathlon cementless baseplate (Tritanium). Clinical information, such as age, height, weight, ethnicity, general health, medications and medical conditions will be collected. Patient reported outcomes, functional activity, pain and adverse events will also be recorded. The study involves four visits to Monash Medical Centre in Clayton which are additional to routine clinical appointments: before the operation, 6-weeks after, 12 months after and finally 24 months after the operation.

This school trial investigates how family-school partnerships can improve education and mental health outcomes for children in primary school. The project will investigate the effect of family-school partnerships, and how best to increase parent recruitment into evidence-based programs and research studies. Families with children in Grades 2 and 4 in primary schools across Geelong and surrounding municipalities will be asked to participate by completing surveys. We will also gather school-wide (not individual) outcomes related to student academic achievement and readiness using school administrative data. We plan to analyse how family and school influences can improve education and mental health outcomes for primary-school aged children, and how parent engagement can impact these outcomes. The hypotheses are that schools randomised to receive a family-school partnership intervention will show improvements in parent-reports of child academic achievement and parent school engagement (primary outcomes), and in school-wide indicators of student academic achievement, school readiness, and parent-reports of child behaviour problems and child adherence to nutrition and physical activity guidelines (secondary outcomes). We may also conduct further analyses that are aligned to these outcomes in the future using this data.