ANZCTR search results

This is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD, Part 1) and multiple-ascending dose study (MAD, Part 2) of KER-012 in healthy postmenopausal women. The study will evaluate the safety, tolerability and PK of KER-012. In addition, this study will explore the effects of KER-012 on muscle, bone, and adipose tissues, and determine the pharmacokinetic/pharmacodynamic (PD) relationship of those effects.

Bronchial Thermoplasty (BT) is an approved radiofrequency treatment for patients with severe asthma. In this study we evaluate whether the treatment is likely to be useful in patients with moderately severe COPD. We explore whether BT leads to airway dilatation after treatment in the same way as it does in asthma, and whether this is accompanied by an improvement in patient symptoms.

Hypothesis: The use of HOFA on patients with facial medical devices will decrease the incidence of facial pressure injuries in the adult ICU population. One in four patients admitted to the ICU will sustain a pressure injury from a medical device (Barakat-Johnson et al., 2017). Pressure injuries (PI) are painful and when sustained to the face can result in permanent disfigurement. Pressure injuries are also very expensive in economic terms representing approximately 1.9% of all public hospital expenditure (Nguyen et al., 2015). This diverts resources from other areas within health care (Slawomirski et al., 2018). Research has established that the cost of prevention for PI in patients at risk is dwarfed by the costs to treat them (Demarré et al., 2015). And, as PI are largely preventable (Slawomirski et al., 2018), medical device-related pressure injuries (MDRPIs) have become a key indicator of patient safety and nursing quality in acute care settings (Jackson et al., 2019). Medical devices pose an increased risk for PI development because the pressure of the device on the skin may cause friction, excessive moisture and increase temperature, which impairs the microclimate. The increased pressure and shearing load are accepted as the causal pathway to the development of pressure injuries (Otero et al., 2017). This project has two primary aims: (1) To assess the effectiveness of HOFAs to prevent facial pressure injuries (FPI) from medical devices in the adult ICU setting; and (2) Assess the implementation and dissemination of the intervention, in particular the acceptability, feasibility, and sustainability among clinical nursing staff.

In Australia, approximately one third of community-dwelling older people aged 65 years and older fall each year and the risk of falling increases with age. The consequences of falling can be fatal including fractures, institutionalising and loss of independence. The sport of judo includes a number of techniques and strategies that can be amended to teach older adults aged 65 years and older how to prevent falls, how to fall safely, and how to stand up once on the ground. The aims of this project are to (a) examine the safety and feasibility of an 8-week judo-based exercise program designed for community-dwelling older people aged 65 years and older, and to (b) determine the impact of the judo-based exercise program on fear of falling, quality of life, balance and physical performance. The hypothesis is that a suitably designed and delivered judo-based exercise program is feasible and safe in older community-dwelling adults and that it has the potential to reduce fear of falling, improve balance and physical performance, minimize harm from a fall, thus improving older adults’ quality of life.

Background Stroke is a cardiovascular disease that is estimated to affect 1.7% of all Australians. Due to stroke-related disabilities, 40% of patients experience limitations with walking, upper limb function and other activities, causing reduced participation in society. High intensity rehabilitation is required to optimise recovery however, this is not being achieved using current approaches to therapy. There are limited strategies for maximising intensity of stroke rehabilitation that have proven benefit and do not involve additional resources. Counting and recording repetitions is a possible solution, however, this strategy is yet to be evaluated. This study will quantify the effect of counting and recording repetitions and discussing target numbers of repetitions on the intensity of practice achieved in stroke rehabilitation. During therapy sessions for the intervention group exercise repetitions will be counted and recorded and participants will be encouraged to reach target numbers based on their previous performance. The control group will continue with usual therapy. Significance of Research If this study demonstrates that counting and recording repetitions increases the intensity of practice done in rehabilitation, it could lead to changes within stroke rehabilitation that will make therapy more efficient and effective. It will provide a strategy that incrases the intensity of stroke rehabilitation with no additional resources, time or cost for the therapist or the patient. Aim Therefore, the aim of this study is to determine the impact of counting and recording repetitions on the intensity of rehabilitation (rate of repetitions) completed. It is hypothesised that this intervention will lead to a statistically and clinically relevant increase in the intensity of stroke rehabilitation. Objectives • To determine the percentage difference in the rate of repetitions between the start and end of study for both the intervention and control group. • To compare the percentage difference between the intervention and control group • To determine if counting and recording repetitions has any statistical or clinical significance in increasing the intensity of stroke rehabilitation

Project Summary In the majority of cases coronavirus disease (COVID-19) people present with signs and symptoms of respiratory tract infection including fever, cough, fatigue, dyspnoea, and sputum production. Although the majority of COVID-19 cases have mild to moderate disease, approximately 15% will develop severe or critical disease that requires intensive medical management or admission to an intensive care unit (ICU). Medical management in ICU often includes use of sedation, neuromuscular blocking agents and prolonged mechanical ventilation. Given the nature of the disease process and the treatment required, those affected by severe COVID-19 infection are at risk of long-term sequelae that can potential to affect long-term health and wellbeing. These sequelae include symptoms such as fatigue and shortness of breath, ongoing weakness and reduced physical function due to ICU-acquired weakness (ICUAW) and impaired psychological function. It is essential to provide an in-depth multidimensional description of recovery trajectories during and following the acute phase of the disease from a symptom, physical and psychological perspective. The main aim of this study will be to provide a multidimensional analysis of recovery in people with severe (or critical) COVID-19 during the first 12 months following diagnosis. Specific objectives are to: (i) document recovery trajectories during and following the acute phase of the disease from a symptom, physical and psychological perspective; and (ii) identify factors associated with prolonged recovery.

Anaemia is defined as having reduced haemoglobin (an oxygen carrying substance) concentrations in the blood. There are many causes but it is often due to iron deficiency which is common in women, especially during pregnancy. Currently in Australia about one in three pregnant women are anaemic and approximately one in four women undergo birth of their baby by caesarean section surgery – an abdominal surgical operation. This means that some women will undergo both caesarean section surgery and be anaemic. In non-pregnant adults pre-existing anaemia before surgery is associated with an increased risk of postoperative complications such as requiring a blood transfusion, increased risk of blood clots, infection and heart and lung complications. Anaemia is defined differently in men and non-pregnant women, and different again in pregnant people. However, investigators have recently questioned this and have challenged the dogma and traditional view that men, women and pregnant people should have different haemoglobin concentrations. They instead propose that the threshold value for defining anaemia should be the same in all adults and argue this strongly in the context of adults having major surgery. As caesarean section surgery is major surgery, then this would apply to pregnant women. There is only limited information about how anaemia, including the new thresholds proposed for pre-operative anaemia, affects the care of women having caesarean section surgery and the outcomes for their babies. In the future we aim to conduct a large multicentre study to examine the relationship between a pregnant woman’s haemoglobin concentration and her haemoglobin concentration on discharge from hospital to see if anaemia before surgery is associated with low haemoglobin concentrations after birth, and complications for the woman or her baby after caesarean section surgery. Before conducting a large study in this area we need to collect information about the feasibility of such a study including data that can inform sample size calculations regarding these associations. This is the purpose of this feasibility study.

This study will aim to evaluate, pragmatically and efficiently, the safety (reactogenicity) of seasonal influenza vaccines co-administered with licenced COVID-19 vaccines in Australia. Simultaneous administration of vaccines is common practice within vaccine programs for children and adults worldwide. Co-administration of COVID-19 vaccines with seasonal influenza vaccines could offer significant advantages for health systems planning (including cost, administrative practicalities and effective use of resources) and for increasing the uptake of both vaccines. These benefits may be substantial given the likely need for booster doses of COVID-19 vaccines. It is envisioned that this study will be extended to assess the safety and immunogenicity of other potentially co-administered vaccines.

Mitochondria are compartments within our cells that facilitate various important processes, including that of energy generation. Mitochondria rapidly adapt to changing needs within the cell through a process called mitochondrial biogenesis, by which, new components are added to the network of mitochondria. Mitochondrial biogenesis is stimulated in skeletal muscle by exercise, however, the signalling that allows this to occur is poorly understood. This project aims to uncover the different signalling pathways activated by exercise in skeletal muscle using novel techniques combined with advanced statistical analysis. Analysis will be performed on quadriceps muscle biopsies collected from forty untrained men and women (equal numbers of each). Using samples both prior, in the middle, and at multiple time points after exercise, we will capture all changes in gene expression and protein localisation. This data will be combined with measurements of participants' fitness before and after training to generate a timeline and predictive model of mitochondrial biognesis signalling. Expanding the knowledge of mitochondrial biology will have many ramifications for both athletic and biomedical disciplines. Recently, links between the function of mitochondria and life expectancy have been discovered, with numerous diseases characterised by mitochondrial dysfunction, such as diabetes, cardiomyopathy and various neurological disorders on the rise globally. We hope by understanding how exercise triggers mitochondrial biogenesis, exercise can be used to a greater effect as therapy for these diseases. By applying this methodology to different exercise intensities and durations, better exercise prescription for athletes can also be determined. Additionally, the identification of novel mitochondrial biogenesis regulators may enable new targeted drugs that aid treatment of mitochondrial dysfunction or mimic exercise in those who cannot do exercise.

Patients with specific antibody deficiency (SAD) have impaired immune function and suffer from recurrent infections. Some patients are treated with immunoglobulin replacement which involves receiving monthly infusions of pooled protective antibodies from healthy blood donors. This multi-centre study will be the first to investigate vaccine responses to a commonly used typhoid vaccine (Vi-polysaccharide; Vi-PS) in adult patients with SAD on immunoglobulin replacement. We hypothesise that Vi-PS vaccine responses will differ between SAD patients, in particular those who require long-term immunoglobulin replacement and those with less severe disease. This study will describe Vi-PS vaccine responses in SAD patients both on and off immunoglobulin replacement as well as healthy adults and patients with known antibody deficiency (common variable immunodeficiency). These groups will help us to understand normal and abnormal Vi-PS vaccine responses. Having more information on how to assess SAD patients on immunoglobulin replacement will help clinicians to better manage patients with SAD in the future.