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Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. Edible seaweeds (macroalgae) have the potential to provide a rich and sustainable source of macronutrients and micronutrients to the human diet. The recent surge of interest in seaweed is fueled by attention on the bioactive components of seaweed, which have potential applications in the food and nutraceutical industries, with impetus toward the reducing cholesterol and improving blood sugar levels. One candidate bioactive compound of interest is the polysaccharide, Fucoidan. Fucoidans are found in brown seaweeds and the health benefits of Fucoidans have been demonstrated in both human and animal studies where the multiple effects include anti-inflammatory, anti-oxidant, anti-tumour, and immune-modulating properties. Our research group in collaboration with industry leading Fucoidan producers (Marinova Pty Ltd) have shown in a pre-clinical study in mice that a novel Fucoidan blend increased muscle mass. While the animal study evidence does exist for Fucoidan imfluencing muscle health, more human evidence (including mechanistic evidence) is needed to evaluate both the nutritional benefit conferred and the efficacy of Fucoidan on muscle health. Therefore, the aim of this pilot clinical trial is to evaluate the effect of oral supplementation of a Fucoidan blend on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that fucoidan could be a supplement that increases muscle strength with greater adaptations when consumed in addition to resistance training. Here we propose a study designed to establish whether a novel fucoidan blend can potentiate the adaptation of muscle to a resistance training protocol.

This is a longitudinal observational study that will monitor the health of Western Australians who have been exposed to asbestos through an annual clinical review. Who is it for? You may be eligible for this study if you are a resident of Western Australia aged 16 years or older, you are an asbestos exposed ex-worker and/or ex-resident of Wittenoom (the asbestos mine), or if you are an individual with more than 3 months cumulative asbestos exposure and/or radiological evidence of asbestos related disease. Study details All participants who choose to enrol in this study will be asked to undergo a general and lung health assessment, lung function tests and an ultra-low dose CT scan of the chest to look for lung disease from asbestos. The Western Australian Asbestos Review Program (ARP) also performs blood tests to see if we can find markers of lung disease to help diagnose problems earlier. Each of these investigations will be completed annually, the appointment usually takes about two hours. The ARP has no limit on age or how long it is since first exposure to asbestos – the study aims to follow as many people exposed to asbestos for as long as possible. It is hoped this research will provide important information that will allow clinicians to further characterise, diagnose and understand asbestos-related diseases. This information may then be used to improve health outcomes of future patients who have been affected by asbestos exposure.

Itch is a common and disabling symptom for people living with advanced kidney disease (termed Uraemic Pruritus (UP)). It causes skin irritation and bleeding, disrupts sleep, is associated with mood changes (depression) and often indicates a shortened survival. As many as 75% of patients, who are not receiving dialysis, suffer from UP. The cause of UP currently remains poorly understood. Pregabalin is a medication which acts by desensitizing peripheral nerve fibers, which leads to a reduction of the itch sensation. It is an emerging drug that is becoming more commonly used in clinical practice to treat UP. However, current evidence is weak, and further research is required to definitely confirm the benefit of this medication. This proposed Phase 2 Feasibility Study is an open-label, single arm, dose up-titration study that is looking at Pregabalin efficacy and tolerability in treating patients with moderate to severe UP who are being conservatively treated for End Stage Renal Failure (ESRF) (eGFR<30, CKD 4 and 5). The primary outcome measure is to recruit at least 24 patients over a 12 month period at both Liverpool and St George Hospitals. It is a 12 week study with the primary outcome measure at Week 4 which specifically looks at a Retention rate of >60. It is important to note that both hospitals contain large culturally and linguistically diverse (CALD) populations. The results of this Phase 2 study will be used to design a subsequent Phase 3 study that will specifically look at the effectiveness of Pregabalin for the treatment of UP and may facilitate access to the medication through subsidised means, if found to be effective.

This research project is investigating if the amount of caffeine and the time that it is consumed during the day changes the quantity and quality of night-time sleep. The project will involve a low (100mg) and high (400mg) dose of caffeine administered in the morning, afternoon and evening to find out if the effect on sleep changes. Given caffeine is a stimulant, it is expected that sleep will be influenced when more caffeine is consumed closer to bedtime. By investigating different dose and timing combinations, we are aiming to determine if there is a cut-off time for consuming caffeine to avoid poor sleep. This is important as poor sleep is associated with an increased risk of illness, accidents and injuries.

PICU related complications can affect up to 66% of critically ill children. They not only impact duration of hospital length of stay and cost of care (short-term impacts), but can also cause morbidity with significant ongoing negative consequences on the child’s quality of life, including psychological, behavioural and neurocognitive problems (long-term impacts). There is a lack of paediatric specific bundles to help in the recognition and prevention of PICU-related complications. It is essential to have more studies shifting from a mortality focus to quality of survivorship. The focus of the PICU Liberation study is improvement in quality of care through interdisciplinary team collaboration and best methods for sustainable quality inititative implementation. There is strong clinical evidence in the adult ICU context that the ICU Liberation program leads to significant, and dose-related, improvements in patient outcomes. This study is a single-centre prospective cohort trial evaluating the PICU Liberation program that adapts the A2F bundle in adult ICU to the PICU of a large children’s hospital in Queensland (Australia). The study aims to establish the feasibility of adapting the A2F bundle from the adult to the child context, assess the implementation success of the PICU Liberation trial through measuring the capacity to achieve A2F bundle objectives, improve patient quality of care, and optimise children’s recovery as well as reducing PICU length of stay.

This study aims to address gaps in the current literature and Australian treatment guidelines for knee osteoarthritis by conducting a high quality randomised control trial to compare the impact of intra-articular botulinum toxin A injections with intra-articular corticosteroid injections on knee pain and function. It is hypothesised that the intra-articular botulinum toxin A injection will significantly reduce knee pain and improve function compared with the intra-articular corticosteroid injection. It is also hypothesised that the intra-articular botulinum toxin A injection group will require less analgesia for knee pain post-injection than the intra-articular corticosteroid injection group. Finally it is hypothesised that there will be no difference in adverse event rate between groups.

SIR2446M is a Receptor-Interacting Protein 1 (RIP1) inhibitor that is under development as a new investigational drug for the treatment of degenerative and inflammatory diseases. SIR2446M will be supplied as API-in-capsule in this study. The primary objectives are to evaluate the safety and tolerability of SIR2446M after single escalating doses, and multiple escalating doses for 10 days, administered orally in healthy participants. In part 1 the secondary objectives are to characterize the PK profile and preliminary food effect of SIR2446M after single escalating oral doses in healthy participants; to compare the PK profile of SIR2446M in capsule and tablet after single dose; and to explore the metabolite identification of SIR2446M in urine after a single dose. In part 2 the secondary objectives are to characterize the PK profile of SIR2446M after escalating multiple oral doses in healthy participants; to characterize the PD profile of SIR2446M after escalating multiple oral doses in healthy participants; and to explore the metabolite identification of SIR2446M in plasma after multiple doses.

This project lays the foundations for an Australian trial to test the usefulness and safety of drug therapies to prevent the development of long-term diabetes among women who develop diabetes in pregnancy, gestational diabetes mellitus (GDM). GDM, previously considered a transient condition, is now an established risk factor for long-term diabetes. Women whose blood sugar levels do not return to normal soon after giving birth are at particularly high risk of developing established diabetes and consequent heart and blood vessel disease. Lifestyle interventions may help, but they are hard for busy mothers to adopt and sustain. Even with lifestyle interventions, these women still have substantial “residual risk”, warranting investigation of preventive drug therapies. Currently, clinical guidelines do not recommend routine use of medications because of the lack of adequate research. Our proposed research will provide critical information that will form the basis of a substantial Australian contribution to global research efforts in diabetes. Our research will: - Identify all women who were diagnosed with GDM from three (3) Sydney hospitals in the past 3 years and invite them to complete an online questionnaire and, if long-term diabetes has not already developed, to undergo a blood test to evaluate their glucose status. - Invite a sample of women to participate in interviews to understand their perspectives of GDM, long-term risks and willingness to take preventive medications (including willingness to participate in trials of preventive medicines). - Conduct interviews with healthcare providers to understand their views of long-term diabetes risk, screening and preventive strategies for women with GDM. Collectively, this study will provide a contemporary snapshot of post-GDM care and outcomes from a diverse Australian population who receive obstetric care at large urban hospitals. These data will critically inform the design and conduct of a large-scale trial of preventive medications in this and similar populations.

The primary aim of this project is to determine whether a single session intervention is no less effective (i.e., non-inferior) in reducing anxiety and depressive symptoms compared to a multi-session intervention, the Wellbeing Course. The secondary aim of this project is to determine whether the single session intervention is more effective than a waitlist control group. Participants in the SSI will receive access to a single online lesson and will be invited to contact the clinician within the 1-week following the release of the lesson. Participants in the MSI will receive access to the 8-week intervention and contact with the clinician. Participants in the Waitlist Control Group will receive access to the MSI following the 8-week waitlist period. All participants will complete questionnaires at assessment, pre-treatment, and then 4-weeks, 8-weeks, and 17-weeks later. The primary endpoint will be 8-weeks after pre-treatment (i.e., Week 9).

This study is a randomised, double-blinded parallel group controlled study to evaluate the safety and efficacy of eptinezumab against lignocaine in the inpatient treatment of status migrainosus. Subjects who fulfil the International Classification of Headache Disorders, third edition criteria of migraine and status migrainosus and who have failed or are inappropriate to receive triptan and chlorpromazine therapy will be enrolled into this trial. Upon randomisation, forty subjects will be allocated in a 1:1 ratio to receive either eptinezumab 300mg or placebo infusion, and admitted to hospital to receive intravenous lignocaine as standard medical therapy (if they received a placebo infusion on randomisation), or a placebo infusion for up to five days, or until their migraine is successfully treated.