ANZCTR search results

Compared to participants who are randomised to the normal care group participants randomised to the intensive telenutrition phosphate control strategy will have lower serum phosphate and reduced intake of high phosphate dietary sources.

SIR1-365 is a potent and selective allosteric kinase inhibitor of RIP1 with favorable drug-like properties in vitro and in vivo. RIP1 inhibitors may be beneficial for the treatments of degenerative diseases including neurodegenerative and systemic inflammatory diseases. The primary objective is to assess the overall safety and tolerability of SIR1-365 administered orally at 200 mg, two times per day (BID) for 28 days relative to the placebo group. The secondary objectives are to assess the effects of SIR1-365 on clinical efficacy endpoints, and the biomarkers indicative of inflammation, and target engagement as well as the plasma SIR1-365 levels.

Peripheral artery disease (PAD) is a disease that leads to a reduction in blood flow to the legs. This study looks at the feasibility of using heart rehabilitation, which is well established in Australia, to help patients with PAD. We will conduct an 8-week supervised exercise program for patients with PAD and provide a medical risk assessment, education and counselling, and address lifestyle factors (diet, exercise, medication use), and how you’re feeling. After 8 weeks of supervised exercise, you will be prescribed a home exercise program. After 6 months, we will re-assess your ability to walk, as well as your symptoms, strength, and overall state of health and well-being. The exercise program will be tailored to your ability. We believe using the heart model for exercise, education and counselling will help to improve physical activity, symptoms, and quality of life in patients with PAD, similar to those with heart problems.

The switch to plant-based diets (PBD) is not only an emerging societal trend but a global movement. Diets with an emphasis on higher intakes of plant foods and lower intakes of animal foods (i.e. plant-based) have been associated with a lower risk of cardiovascular morbidity and mortality as well reduced risk of major risk factors such as obesity, type 2 diabetes mellitus and hypertension. This cross-sectional cohort study aims to investigate the dietary profile and nutritional adequacy of current plant-based dietary patterns followed by middle-aged Australians and compare the risk of cardiovascular disease across plant-based dietary patterns and omnivorous diet (regular meat eaters). It is hypothesised that individuals following a PBD will have significantly different food group and nutrient intakes to individuals who regularly eat animal flesh. Moreover, the cardio-metabolic risk profile will differ between individuals following a PBD and individuals who are regular meat eaters. It is also hypothesised that the dietary profile and indicators of cardio-metabolic disease will differ across various types of PBDs and some PBDs may even be nutritionally inadequate when compared against the Australian Dietary Guidelines and/or Nutrient Reference Values. Unlike other studies where PBD are often categorised under the same category (e.g vegetarian) findings from this study will provide more specific information across the difference PBD categories and therefore more comprehensive evidence to potentially support future dietary guidelines around PBD.

The DREAM study aims to compare a single dose of temazepam to a placebo, to investigate whether this will improve sleep in patients in the intensive care unit (ICU) of a tertiary hospital. Currently, there is no evidence on whether temazepam, a commonly prescribed sleep aid in the ICU, is effective in promoting sleep for critically ill patients. Patients will be given a weight adjusted dose of temazepam, or a blinded placebo, on a single night during their stay in the ICU. Both subjective measures of sleep (bedside nurse assessment), and objective measures (polysomnography) where available will be collected.

This study seeks to evaluate the safety and effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of Painful Diabetic Neuropathy. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength that other traditional spinal cord stimulators and it may help to alleviate pain.

Reflective groups for doctors to reduce burnout. The hypothesis is that sharing difficult work-related experiences in a safe and supportive group environment will develop psychological preparedness for similar experiences in the future, via imaginal exposure and and enhance the ability to regulate associated stress by and normalise appropriate communicate about stressful experiences, which will encourage ongoing use of reflection and communication after the intervention ends. The primary aim to is reduce burnout and secondary aim is for participants to experience the treatment as helpful and supportive.

Background: Genetic factors play an important role in contributing to the variability in response to pharmacological agents. For example, genetic variants can affect the activity of enzymes involved in drug metabolism, either reducing or enhancing drug exposure and thus altering drug response and toxicity profiles. Despite the evidence, Australia has been slow in adopting PG testing to guide therapy. A recent Australian Parliamentary Inquiry into the Management of Healthcare Delivery in NSW, in its published report 8/56 in September 2018, expressed concerns that PG testing is not being adequately utilised in the public mental health system. It further identified PG testing as one of the key mental health priorities and made recommendations that NSW Health actively pursues and funds the increased use of PG testing as a means of improving treatment for patients with mental illness. Primary purpose: To develop a model of care which will be informed by the attitudes and acceptability of PG, as well as the support and resource requirements, amongst potential ends users which includes clinicians and patients. Study objectives: The primary objective of this project is to assess patient and clinician experiences, opinions and reported outcomes when utilising PG testing results, as well as barriers encountered in using PG. The secondary objective is to investigate potential impact of PG, by retrospectively auditing PG testing results, and determining the average number of major versus moderate DGI per patient, the incidence of actionable DGI (defined as one that would trigger a change in prescription), as well as the proportion of patients having at least one actionable DGI for a medication they were taking at the time of PG testing or have taken in the past. The proportion of patients whose experience of medication side effects and/or ADR may be explained by their PG results will also be determined.

This is a first-in-human (FIH) study to evaluate the safety and immunogenicity of IVX-411 in 84 healthy SARS-CoV-2-seronegative adults 18 to 69 years of age. The study will also investigate whether an adjuvant is required in the formulation to enhance immune responses to IVX-411. The selected adjuvant, MF59®, is an oil-in-water emulsion that has shown to increase immunogenicity and is associated with a good safety and tolerability profile. The stopping rules and safety will be monitored by an internal safety review committee (iSRC) and a Safety Monitoring Committee.

International and local research indicates that Intensive Care Unit (ICU) survivors (patients and families) experience adverse outcomes. In Australia, ICU survivors return home with little or no follow-up. Peer support, which brings survivors together to share experiences, holds potential to improve post-ICU outcomes although this warrants exploration. We have recently developed an in-person peer support model, where we engaged both ICU survivors and staff using a new and innovative method called experience-based co-design (EBCD). We recently tested the feasibility of this co-designed peer support model for ICU survivors via a pilot RCT (ACTRN12618000615280 manuscript in progress). Despite multiple strategies, there were barriers to participants attending in-person. Further, the global pandemic necessitated the need to find ways of supporting ICU survivors in their recovery and in a format that did not require return to hospital. This study aims to test via a pilot RCT, our previously developed peer support model, delivered via a virtual format. Feasibility of the virtual format will be assessed via attendance rates, participant satisfaction, and participant recruitment, as well as any impact on disability, psychological and quality of life outcomes. This is a small pilot study and the results of this study will inform a larger, multi-site randomized study.