ANZCTR search results

Many patients with Chronic Obstructive Pulmonary Disease (COPD) also have elevated lung blood pressures, or pulmonary hypertension (PH). Having both conditions increases the risk of death. It is difficult to diagnose PH in COPD. We will be using a new Computed Tomography (X-ray imaging) technique to investigate a marker of PH called ‘pulmonary artery pulsatility’. If PH can be diagnosed easily and accurately new treatments can be devised and researched potentially improving outcomes in COPD.

The purpose of this study is to establish the safety and tolerability of orally administered CNSA-001 in healthy subjects follow single and multiple-dose escalation This Phase 1 study will support dose selection for future studies in patients with Segawa Syndrome

The primary purpose of this study is to show that by using ctDNA results, in addition to assessing the risk of tumour recurrence by standard pathology assessments, the number of patients receiving adjuvant (post surgery) chemotherapy will be reduced. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have received chemo-radiation followed by surgery for locally advanced rectal cancer. Study details: All patients enrolled in this study are randomly allocated (by chance) to one of two groups; Standard of care (SOC) group or the ctDNA-informed group. The decision to proceed with chemotherapy for those in the SOC group is based only on the standard risk assessment of the tumour (how likely your tumour is to come back or recur). Their ctDNA result will not be disclosed. Those who are randomised to the ctDNA-informed group will be treated with chemotherapy if they are ctDNA positive OR if they are ctDNA negative AND are considered to have a tumour at high risk of recurring based on the standard risk assessment. Only those in the ctDNA-informed group who have chemotherapy will have monthly ctDNA samples collected; up to four samples collected over 4 months then a final sample after chemotherapy has finished. All participants will be followed up 3 monthly for 2 years, then 6 monthly for 3 years through their hospital for a total of five years for disease recurrence and survival. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision as to who receives adjuvant chemotherapy will result in a reduction in the number of patients having chemotherapy and doing so, without compromising the rate of disease recurrence when compared to standard of care.

Despite pain being the primary reason most patients present to emergency departments (EDs), current methods of pain management in EDs are suboptimal. Patient controlled analgesia (PCA) involves the patient self-administering intravenous analgesia via a pre-set medication administration pump. Although PCAs have being rigorously evaluated and widely used in other clinical areas, they are not routinely used in EDs. This study will determine if PCAs are a feasible mode of analgesic delivery in the ED environment. A feasibility pilot randomised controlled trial (RCT) will be conducted in one private hospital ED to determine the feasibility of using PCAs in EDs. This research will add to a limited body of knowledge in the area of pain management in EDs and potentially enhance pain management in the ED through the use of PCAs. As this is a feasibility pilot RCT, we hypothesise that PCA will be a feasible mode of analgesic delivery in EDs, However a larger-scale, multi-site RCT will be needed to further investigate this topic. .

Scalp dysesthesia is characterised by abnormal cutaneous sensations such as burning, stinging or itching of the scalp in the absence of objective dermatological findings. Scalp dysesthesia has been associated with cervical spine dysfunction, however there is no unified pathogenesis or agreed upon effective treatment. We hypothesise that the unpleasant sensations of scalp dysesthesia are the result of a sensory neuropathy secondary to cervical spine dysfunction. The aim of this pilot study is to evaluate the use of an exercise protocol consisting of cervical spine range of movement exercises, gentle mobilisation and muscle stretches over 4 weeks.

The purpose of this study is to characterize the safety and tolerability of single ascending doses of CSL346 following intravenous (IV) administration in healthy subjects. This is a 3-part first-in-human (FIH) study. Part A is a randomized, double-blind, placebo-controlled, single ascending intravenous (IV) dose protocol to be implemented in healthy Caucasian subjects. Part B is a single ascending IV dose escalation protocol which will test selected doses from Part A in healthy Japanese subjects. Part C is a single ascending dose escalation protocol which will test the subcutaneous (SC) administration of selected doses in Caucasian, and, if needed, Japanese subjects.

In response to the onset of significant inflammatory signalling following severe traumatic brain injury, ascorbate (vitamin C) concentrations rapidly fall to levels associated with severe deficiency. Without replacement, the ascorbate levels remain reduced for the duration of the inflammatory response. There is mounting evidence that replacing ascorbate plasma levels during an inflammatory response may be beneficial, particularly to the brain. Ascorbate is known to be an essential co-factor in several brain metabolic processes. These processes include reducing oxidative stress, maintaining microcirculatory homeostasis and maintaining normalm function of several key enzyme systems, including endothelial nitric oxide synthase (eNOS). In addition, ascorbate is involved in brain energy production, and is required for the production of a significant number of neurotransmitters. It is clear from multiple animal and human studies that deficiency in ascorbate leads to a pro-inflammatory state and worsening organ failure. In response to traumatic brain injury, brain ascorbate levels fall markedly in line with body concentrations. The magnitude of plasma level ascorbate decrease, which often reaches levels associated with scurvy in critical illness, has been shown to correlate with severity of both neurological injury and more general injury severity. Ascorbate supplementation has been shown to reduce the severity of secondary brain injury in multiple animal studies. There is a need to further evaluate the role of intravenous sodium ascorbate in the setting of human brain injury. To this end the authors propose to conduct a small feasibility study in the Australian setting to establish the efficacy of the proposed intervention and to evaluate the effect of intravenous sodium ascorbate on patients suffering from severe traumatic brain injury.

Sleep deprivation / disruption is common across various population cohorts and is linked to poor health, decreased productivity and higher stress. Animal and human studies report a variety of changes to the immune system in response to sleep disruption/deprivation which may underpin the associated adverse health outcomes. Probiotic supplements have a strong evidence base for reducing gastrointestinal and respiratory illness and may be useful in a range of other diseases. These beneficial effects of probiotics are proposed to be via modulation of immune parameters. This study aims to investigate the effects of probiotic supplementation on alterations in indicies of immune and gut health associated with sleep disruption in an adult population. A double-blind placebo-controlled parallel group three-arm study will be undertaken in 90 adults who experience disrupted sleep due to shift work. A range of biological markers (reflecting immune and gut health) will be assessed before and after supplementation in association with sleep disruption.

The impact of parental feeding practices on weight outcomes in young children is unclear. This is an analysis of data from mother-child dyads participating in four childhood obesity prevention trials across Australia and New Zealand were pooled (n=776) to determine whether 1. feeding practices used by mothers when their child was less than 2 years of age were related to overweight status at ages 3.5 and 5 years and 2. investigate whether these associations were moderated by early weight status

This project aims to test the effectiveness of a new online cognitive rehabilitation program known as S.M.A.R.T (Strengthening Mental Abilities with Relational Training) in children with Cerebral Palsy. The study will consist of a randomised controlled trial involving 60 participants, assigned to either the intervention group or a waitlist control. By the end of the study, all participants will have received access to the program. We predict that the S.M.A.R.T. program will be associated with improvements in performance on tests of intellectual functioning, academic achievement, and executive function, as well as measures of emotional and behavioural difficulties. Outcomes will be assessed at baseline, immediately after treatment ends (20 weeks post baseline) and at 40 weeks, to measure retention.