ANZCTR search results

This project is testing the safety and pharmacokinetics (PK, the amount of study drug in your blood) of single intravenous doses of a new drug called VGT-309. VGT-309 is a tumour targeted imaging molecule that has the potential to assist in cancer surgery. Who is it for? You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 65 years old. Study details Participants will be randomised (assigned randomly, like flipping a coin) to receive a single dose of either the active study drug or placebo which will be given to you as in intravenous infusion over a period of 15 to 20 minutes. Total participation will last about 7 weeks which will include 3 days (2 nights) in the clinic during which we will need to collect blood and urine samples. It is hoped that this research will help determine the safety of VGT-309 when given to healthy men or women so that it can be tested in cancer surgery patients.

Type 1 diabetes (T1D) is classically regarded as a metabolic disorder diagnosed when the symptoms of persistently high blood glucose levels appear. The clinical presentation, however, follows an extended period of months to years when the immune system attacks the insulin producing cells in the pancreas. Prospective longitudinal studies of older children at genetic risk of T1D have shown that impaired glucose homeostasis starts much earlier than symptomatic diabetes. A gradual decline in insulin secretion and beta cell sensitivity can be detected at least 2 years before the onset of clinical symptoms, and these changes become more rapid in the last few months prior to diagnosis. Higher glucose levels and increased glycaemic variability are also detectable prior to the onset of clinical T1D. This recent recognition that T1D progresses in these three distinct stages has led to a paradigm shift that re-defines T1D as an autoimmune beta cell disorder with clear characteristics associated with Stage 1, Stage 2, and Stage 3 (symptomatic) disease. The purpose of this sub-study is to undertake serial measurements of continuous glucose monitoring data in the ENDIA protocol that will provide the longitudinal data required to define the transition in islet autoantibody-positive children from normoglycaemia (Stage 1 T1D) to dysglycaemia (Stage 2 T1D). Moreover, it will enable characterisation of asymptomatic hyper- or hypo-glycaemia and inform clinical care for such children prior to onset of symptomatic clinical T1D (State 3 T1D).

The modern diet is nutrient poor and high in processed sugary food promoting inflammation and metabolic dysregulation. Nutrition can play a crucial role in the modulation of inflammatory processes and may be a useful pain management tool. The aim of this research is to determine if a well-formulated ketogenic diet (WFKD) will alter reported pain in patients with chronic pain. The primary hypothesis is that a WFKD will result in a reduction in reported pain for patients with chronic pain. This study will implement a run-in period of 3 weeks where all participants will undertake a whole-food diet (WFD) that focuses on improving diet quality based on the NOVA classifications of unprocessed or minimally processed foods/ingredients (removal of NOVA category 4 foods from diet). Participants will be randomised from the start of week 4 into either a WFKD (intervention) or to continue the WFD. The WFKD will adjust carbohydrate level for the individual participant to achieve average blood ketone levels of between 0.5 and 3.0 mmol/L. The intervention will run for 9 weeks (total trial intervention 12 weeks). Participants will meet with the study researcher fortnightly via telehealth for education and monitoring. Participants will be followed up 12 weeks after completing the intervention.

Currently, there is a high unmet medical need for patients with ALS and effective treatment modalities are desperately needed. About half of all patients with ALS experience a change in their energy use that causes their body to consume more energy, which accelerates the spreading of ALS throughout the body. We showed previously that this change in energy use, called hypermetabolism, is clinically important as it is linked to an increased risk of death and faster rate of progression in people with ALS. In this project, we aim to reduce hypermetabolism in patients with ALS and counter its detrimental consequences. Trimetazidine, a partial fatty acid oxidation inhibitor, has been shown to reduce hypermetabolism in patients with chronic heart failure and is licensed as treatment for angina. Trimetazidine has a favourable safety profile and, more importantly, reduces the expression of oxidative stress markers that are also increased in patients with ALS. With growing evidence linking oxidative stress, metabolism and ALS, Trimetazidine may lower the occurrence of hypermetabolism and, potentially, slow disease progression in patients. The aim of this study is to verify target-engagement, and to study a unique composition of proteins/compounds in the blood that can be used as markers of disease progression. We will study the safety and tolerability of Trimetazidine in patients with ALS. This study will provide significant insight into the biological response when targeting metabolic parameters in patients with ALS. In addition, this trial will set up an international infrastructure to evaluate potential targets for ALS and mediate the adoption of early-stage clinical studies to drive pivotal future rials.

A Placebo controlled Phase I study to demonstrate the safety of a therapy using nano vesicles purified from human donor platelets and administered to healthy adult volunteers.

The purpose of this study is to compare the effects of two internet-delivered interventions on mental health. Who is it for? Eligible participants include adult cancer survivors who have finished their primary treatment for cancer within the last two years. Study details Participants will be randomly selected to take part in one of two interventions: 1. The CanCope Mind intervention, which focuses on helping individuals understand, recognise and respond to uncomfortable emotions, or 2. The CanCope Lifestyle intervention, which focuses on health eating, physical activity, relaxation, and sleep. Both interventions are delivered online over an 8-week period. All participants will need to complete questionnaires during the 8-week period and at 3-months after they have completed the intervention. The findings from this study will inform how to best support the mental health needs of individuals affected by cancer. If effective, the CanCope programs will be one of the few online and easily accessible interventions developed for cancer survivors.

This study is a randomised, crossover, double-blinded, single-dose experimental trial investigating the effects of purified, oral cannabidiol (CBD) on exercise physiology and bioenergetics in healthy individuals. Participants will complete two experimental sessions involving either (1) CBD (300mg) or (2) Placebo (0mg). Trials will be conducted at the Charles Perkins Centre Research. We hypothesise CBD will decrease submaximal oxygen consumption during moderate intensity exercise (~75% HRmax).

Although 5-10% of women with endometriosis will have bowel involvement, currently it is very difficult to predict this group preoperatively. This group of women require both gynaecological and colorectal input at surgery. Preoperative imaging is being increasingly utilised to predict the level of complexity of laparoscopic surgery for endometriosis. It has the potential to facilitate the triage of women with suspected bowel deep endometriosis (DE) to the most appropriate surgical expertise required for laparoscopic intervention for endometriosis. Transvaginal ultrasound (TVUS) (Guerriero S, et al. UOG, 2016) and magnetic resonance imaging (MRI) (Medeiros, et al. Arch Gyn Obs, 2015) have been shown to accurately diagnose the presence of rectosigmoid DE. Recently, positron emission tomography-computed tomography (PET-CT) with 16a-[18F]fluoro-17ß-estradiol ([18F]FES) has had promising results when compared with MRI. The study would be a prospective observational pilot study on women who present with suspected bowel DE diagnosed on TVUS and a plan for laparoscopic endometriosis surgery. Women would undergo a detailed history and clinical examination including a specialized TVUS, MRI and PET-CT with [18F]FES in a tertiary referral unit prior to laparoscopy.

This study seeks to evaluate the safety and the effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of lower back pain with or without leg pain. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength than other traditional spinal cord stimulators and it may help to alleviate pain.

This research aims to determine the feasibility and acceptability of inspiratory muscle training in people with Parkinson’s disease who currently attend an exercise clinic. We hope to see if this type of training is accepted by people in this population, if this training modality if feasible for this population, and feasible via telehealth if administered this way.