ANZCTR search results

This is a Phase I, single dose escalation clinical trial conducted in healthy volunteers. The safety, tolerability, and PK of AI-071 following a single intravenous administration in healthy volunteers will be evaluated using a randomised, double-blind, placebo-controlled trial design. A total of up to 40 healthy participants are planned to be enrolled into 5 cohorts (8 participants per cohort). Eligible participants will be randomised to receive single ascending doses of AI-071 or placebo. Dose escalation will be conducted in a total of 5 dose levels. At each dose level, participants will be randomised to receive a single dose of AI-071 (6 participants) or placebo (2 participants). The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. AI-071 dose levels in the range of 60 to 960 mg will be investigated. Dosing in each cohort will start with 2 sentinel participants with one of the 2 sentinels randomised to receive AI-071 and the other randomised to receive placebo. The safety and tolerability of each sentinel participant will be monitored in the clinic until Day 2 and will be reviewed prior to dosing the remainder of participants in each cohort. Participants will be confined at the clinical facility from Day -1 through to Day 2. Participants will be discharged following completion of all safety and PK assessments on Day 2.

Clinical guidelines commonly recommend exercise as management for chronic neck pain. Several studies, however, demonstrate that exercise for chronic neck pain is effective for some, but ineffective for others. This project aims to investigate (1) the ability of clinical measures of central sensitisation to predict the effectiveness of exercise, and (2) relationship of lactate and pain sensitivity post-exercise in people with chronic neck pain. We hypothesize that higher intensity exercise, which results in higher production of lactate, will have a greater positive outcome on central sensitisation. Better understanding of these mechanisms would provide valuable insight to clinicians of the effects of exercise and lay the foundation for improved exercise prescription for chronic neck pain.

People experiencing mental illness experience poor physical health at disproportionate rates when compared with the general population. The research goal is to improve the cardiometabolic health of young people living with severe mental illness. The study objectives are to determine whether a specialist-delivered intervention improves cardiometabolic outcomes of people living with severe mental illness and to determine whether a specialist-delivered intervention improves global functioning, dietary intake, physical activity level, neuromuscular and cardiorespiratory fitness, eating behaviours and nutrition knowledge of people living with severe mental illness.

Non-insulin-dependent diabetes mellitus (NIDDM) is a leading cause of mortality in the adult population and its prevalence is known to rise steadily with increasing age. The presence of obesity and low levels of physical activity are the major lifestyle determinants of NIDDM. Given that both are potentially modifiable, there is universal agreement that lifestyle strategies emphasising improved diet and increased physical activity play important roles not only in the primary prevention of diabetes, but also the secondary prevention of diabetic complications arising from poor glycaemic control. Unfortunately, traditional approaches combining endurance-type exercise with dietary modifications, may be compromised in elderly NIDDM patients because of age-associated declines in muscle strength and functional capacity. Resistance (weight) training may be a plausible exercise alternative for elderly NIDDM patients because of its known effects on muscle strength, size and function. However, the efficacy and feasibility of dynamic resistance training in elderly NIDDM patients is not known. We postulate that the combination of resistance exercise training with moderate energy restriction will counterbalance fat-free mass loss often seen with energy restriction alone and may have additive or synergistic benefits in the non-pharmaceutical management of glycaemic control, cardiovascular risk factors and general well-being of elderly NIDDM patients. The aim of this randomised controlled trial is to therefore examine the safety, feasibility and effects of high-intensity PRT combined with healthy eating to elicit moderate weight loss in glycaemic control and body composition in those with type 2 diabetes.

Women with polycystic ovary syndrome (PCOS) are at an increased risk of developing cardiometabolic complications which can include insulin resistance, damaged blood vessels, type 2 diabetes, and heart disease. Some studies have shown that regular exercise can help to reduce tissue fat levels, improve glucose control, blood flow and fitness. However, the optimal type and dose of exercise for health improvement in women with polycystic ovary syndrome is unclear. Recently, high-intensity functional training (HIFT) has become increasingly popular, particularly among younger women. This form of training focuses on performing repeated functional, multi-joint movements which can incorporate aerobic and/or muscle-strengthening components. Consequently, we aim to determine whether this form of training can improve fitness and health outcomes in women with PCOS. We’ll be comparing the effectiveness of HIFT on physical fitness and cardiometabolic outcomes to an exercise program matching the current physical activity guidelines, as well as to usual-care in women with PCOS. The results produced from this study will provide a greater evidence base for future physical activity guidelines for PCOS.

Laparoscopic Fundoplication (LF) is the gold standard surgical procedure for the treatment of Gastro-Oesophageal Reflux Disease (GORD). Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is commonly performed to achieve weight loss in obese patients, but it also has anti-reflux properties. Hence, in the obese population suffering from GORD, LRYGB is an attractive alternative to LF and indeed is recommended in some national and international guidelines despite there being no randomised trials comparing the two procedures to provide efficacy data (subjective or objective), either in normal, overweight or obese patients. The aim of this trial is to compare LF and LRYGB in an obese population presenting for consideration of surgical correction of GORD.

The aim of this research is to determine if the established effectiveness of a real-time continuous glucose monitoring system (RT-CGM) combined with a prescriptive low carbohydrate eating plan for optimising glycaemic control for T2D management, can be maintained when delivered by Community GP practices. The research also investigates the real-world pragmatics of translating such research for an innovative, public health and clinical service delivery model of care that can be delivered in a cost effective and sustainable manner.

Background: Approximately half of all spinal cord injury patients develop chronic pain. Current treatments for this pain have proven to be largely ineffective and many have significant side-effects. We will examine whether a novel non-intoxicating component of cannabis, cannabidiol (CBD), can reduce pain. Using modern brain imaging techniques, we aim to determine if pain reductions result from normalisation of brain, immune, psychological and sleep function. In addition, we aim to identify a biomarker that will predict whether an individual will respond to CBD treatment, easing suffering, saving time and reducing costs. Study Aim: To determine the impact of CBD treatment on chronic pain following SCI and to investigate biological changes associated with reduced pain. Hypothesis: We hypothesise that CBD treatment will reduce ongoing pain to a significantly greater degree than placebo. Furthermore, we hypothesize that pain relief during CBD treatment will be associated with reduced diffusivity markers of astrogliosis, reduced resting infra-slow oscillations in the ascending pain pathway, restored thalamic blood flow to control levels and reduced thalamocortical rhythm power. We also hypothesize that CBD treatment will reduce ongoing peripheral inflammatory markers, improve sleep and psychological state and that this will correlate with a reduction in ongoing pain. Finally, we hypothesize that pain relief during CBD treatment will be associated with pre-trial levels of endogenous pain modulatory ability and endocannabinoid levels.

This study examines opioid prescriptions that are given to patients following a wide variety of common surgery types. One week following going home, patients will be asked to fill out an online survey via their smart phone or via phone with a research nurse. The amount of opioid used will be examined and pain crises explored. This data will be used to create a prediction model to predict patients' requirements so that unused opioids in the community can be minimised while protecting patients from pain crises.

This study will be a pilot examination of the effectiveness of a multi-strain probiotic intervention to improve cognitive symptoms (primary outcome variables), and cognition-related fatigue, everyday functioning and health-related quality of life (secondary outcome variables) in people living with Relapsing Remitting MS. The study will also examine the potentially important relationship between gut microbial imbalance, kynurenine pathway biomarkers, and cognitive symptoms in this population. The study will broaden our understanding of the role of the gut-brain connection in MS pathogenesis. It is a requisite step in exploring the innovative application of probiotics to improve cognitive symptomology and associated clinical and psychosocial outcomes in people living with MS.