ANZCTR search results

First human use clinical trial of an investigational (not-approved) study device used to facilitate the biopsy of pulmonary nodules with unknown etiology. The purpose of this study is to evaluate the safety and feasibility/performance of the investigational device - up to 30 subjects will be enrolled, and will be followed-up for up to 6 months post-procedure. For non-malignant subjects, data may be collected from a standard of care follow-up visit at 12 months post-procedure

Knee osteoarthritis (OA) is a leading cause of pain and disability around the world. OA involves the breakdown of joint cartilage, but it also appears to include the proliferation of blood vessels and nerves about the joint. It is suggested that these blood vessels and nerves contribute to the experience of pain. One pilot study found that embolising abnormal vessels about the knee substantially improved individual's pain. The primary aim of the current study is to determine whether transcatheter arterial embolisation of abnormal neovasculature about the knee improves pain. Secondary aims include whether embolisation improves physical function, quality of life, joint stiffness, and medication usage. The study is a randomised controlled trial. People are eligible if they have knee OA that is not yet ready for knee replacement surgery and have tried other forms of traditional management such as medications and physiotherapy. Participants will be randomly allocated to one of two groups: intervention or placebo. Participants in the intervention group will receive embolisation of abnormal vessels about the knee. Participants in the control group will receive a placebo intervention that looks and feels like the real intervention but does not include embolisation of abnormal blood vessels. All participants will be assessed shortly before the intervention (real or placebo) and then 1, 6 and 12 months after the intervention. Participants in the intervention group will also be assessed 24 months following the intervention. Assessment includes a variety of questionnaires and physical tests.

This is a single-blinded study. The ultrasound and x-ray images will be stored as a study number only. They will be analysed later after completion of enrolment. The x- rays will be evaluated by paediatric radiologist (AL) blinded to the ultrasound measurements and clinical management. The x-rays will be reported as the distance from ET tip to carina and Position of ET tip in relation to vertebral body. The ultrasound images will be analysed by investigators separately, blinded to the x-ray results and clinical management. The results will be used to compare correlation and reliability of two methods. The distance between ET tip and carina on x-ray will be correlated with ultrasound measurements of - 1. Distance between aortic arch and ETT 2. Distance between RPA and ETT

This study aims to investigate the diagnostic test accuracy of Cxbladder for diagnosis of bladder cancer in patients presenting with macroscopic or microscopic haematuria. Who is it for? You may be eligible to join this study if you are aged between 18 years or over and are to undergo an investigative cystoscopy for recent macroscopic or microscopic haematuria (presence of red blood cells in the urine) and do not have a prior history of urothelial carcinoma of the bladder. Study details All participants of this study will provide urine samples just prior to undergoing cystoscopy. These samples will be analysed using Cxbladder diagnostic test and results compared with pathology results from samples collected during cystoscopy. These findings will not be used in treatment decisions but will help establish if Cxbladder test can be used in diagnosis of bladder cancer.

The aim is to determine whether Cxbladder is as accurate as cystoscopy current technologies in determining freedom from, or recurrence of cancer in the group of patients having undergone Bacillus Calmette-Guerin (BCG) immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder. This study aims to investigate the diagnostic test accuracy of Cxbladder for predicting recurrence of cancer in the group of patients having undergone Bacillus Calmette-Guerin immunotherapy or Mitomycin C intravesical chemotherapy for transitional cell carcinoma of the bladder.. Who is it for? You may be eligible to join this study if you are aged between 18 and 85 years undergoing Bacillus Calmette-Guerin therapy or Mitomycin C therapy for bladder cancer or DMSO/heparin therapy for painful bladder syndrome at Concord Hospital. Study details All participants of this study will provide urine samples before they commence treatment and then at 1, 2, 3 and 6 months and one additional timepoint 1-3 years following completion of treatment. These samples will be analysed using Cxbladder diagnostic test and results then compared with currently used cystoscopy exam results. These findings will not be used in treatment decisions but will help establish if Cxbladder test can be used to predict cancer recurrence in patients undergoing this type of treatment.

Ageing Australians represent a growing proportion of the total population and retirement villages are becoming an increasingly popular residential option for older adults. Although initiatives designed to increase activity among residents are widely available in these settings, their uptake is limited and their sustainability unknown. There is an urgent need to identify effective, sustainable strategies that can serve to increase physical activity, reduce sitting, and improve mental health. We will examine whether a 16-week programme using well-established motivational techniques, will result in sustainable increases in walking, reduced sitting time and improved mental health in older adults (minimum 60 years old) residing in retirement villages in Western Australia. The program will use motivational strategies for which the research team is particularly expert and has successfully used in previously funded research. To make the intervention relevant to the target population, we have also conducted extensive interviews with residents and managers in retirement villages in preparation for this proposal. The results of these interviews have been used to adapt the program to the needs of the target group. It is expected that participants who are allocated to the treatment with trained walk ambassadors and who have received motivation training will show greater (sustained) increases in walking, reductions in sitting and larger improvements in mental health than the other conditions Residents allocated to the experimental with ambassadors group to one group will take part in a combination of 16 weeks of group-led and individual walks facilitated by motivationally trained resident ambassadors. Residents will also be taught motivation skills they can use to help them change and sustain a physically active lifestyle in the longer-term without the help of the resident ambassadors. The experimental walkers only group will also be taught motivation skills but will not have resident ambassadors. Participants in the control with ambassadors group will also be encouraged to engage in group and individual walks, but their resident ambassadors will not be trained in motivational techniques. The final group will not have ambassadors assigned to them. Changes in walking and sitting behaviour, and as a consequence, changes in mental health, will be examined. The effects of the surrounding physical environment (e.g., perceived safety, safety from traffic and proximity to amenities) will also be explored. This is a motivation-enhancing programme which has the potential to eventually be rolled out across various types of accommodation for older adults.

This study aims to identify the prevalence of hypoglycaemia during extended OGTTs and associations with biochemical parameters relevant to glucose metabolism. In particular, this study will explore the role of glucagon and the incretins GLP-1 and GIP in reactive hypoglycaemia during OGTTs.

Patients in the intensive care unit (ICU) are known to be at higher risk of developing pressure injuries than other patient populations due to their illnesses and the types of therapies (medications, devices and technologies) used to treat their life-threatening event. More medical devices are used in critically ill patients because of the life-saving treatments needed and, thus, there are often high rates of medical device-related pressure injuries. Medical device-related pressure injuries are suspected when an injury has the same shape or outline as the device. Stomach tubes for feeding patients, and breathing tubes for mechanically assisted breathing, are the two most common devices used in ICUs. Together they cause the most medical device-related pressure injuries in the intensive care. Critically ill patients in the ICU with medical devices are nearly four times more likely to develop a pressure injury of any kind. There has been some research into ways to reduce medical device-related pressure injuries but none of these suggested methods have been tested in large patient groups. Hence, the aim of this project is to test the effectiveness of different ways of securing these devices, the use of a thin dressing under the device, regular assessment of your skin beneath the device, and regular repositioning of the device. The combination of these preventative methods in an intensive care environment has not been tested. This study will examine whether ICU patients with NGT or ETT who receive the intervention demonstrate less medical device related PI compared with patients who receive standard care practices.

This is a study of decision making and bias, as it relates to care in the intensive care unit. Participants are ICU staff, they will be recruited at handover after a night shift to give a fatigued group (end of night shift) and a non-fatigued group (start of day shift). Participants will be allocated to one of two questionnaires (A&B) which are identical in terms of the hypothetical clinical scenarios, but differ in terms of the social status of the hypothetical patient. For example, a case might describe a patient who has been involved in an MVA with severe injuries necessitating ICU support, but in Questionnaire A the patient would be a policeman chasing a violent criminal and in B the patient IS the violent criminal. Participants will be asked to rate the "risk" of the scenario on a 10 point likert scale, then rate their degree of agreement with an aggressive treatment strategy and a limited treatment strategy We hypothesize that participants risk assessment and treatment strategies will significantly differ between the groups. We also hypothesize that these differences will be exaggerated when participants are fatigued.

Exercise training leads to clinical improvements in blood glucose control in individuals with T2DM. This improvement in blood glucose control occurs because of improvements in post-meal glucose spikes (reducing time spent in hyperglycaemia by 129 min per day) and not in improvements in fasting glucose. Acute (single observation) studies reveal that exercise performed during the post-meal period (>30 min after meal ingestion) results in significant improvements in the post-meal glucose response compared to exercise performed fasted (or pre-meal consumption), at the same time as minimising the risk of hypoglycaemia. Moreover, exercise has consistently been shown to alter circadian rhythms in humans and within this body of research, the evidence shows that morning and evening exercise differentially regulate the autonomic nervous system. What is currently not known is (i) the impact of exercise-timing (morning versus evening) on daily glucose control and longer-term glucose control in individuals with T2DM; (ii) the potential mechanisms which may explain the improvements observed in glucose control with exercise training. Therefore, the overarching aim of this proposed research is to determine the impact of exercise-timing (morning versus evening) on blood glucose control in individuals enrolled into a 12-week evidence-based combined exercise training program. The secondary aim of this study is to explore the underlying mechanisms associated with the improvements in blood glucose control control. This research builds on previous work from which demonstrates: (i) reduced post-meal glucose and insulin responses when exercise is performed after meal ingestion; (ii) increased glucose responses when exercise is performed in the fasted state before breakfast; (iii) exercise training improves autonomic function in individuals with T2DM. We hypothesise that: 1. Both morning and evening training programs will lead to significant improvements in blood glucose control which will be attributable to improvements in post-meal glucose levels; 2. Morning exercise will improve blood glucose control and post-meal glucose responses to a greater extent than evening exercise, and this will be associated with improvements in autonomic function. The International Diabetes Federation has stated that, "Postmeal hyperglycaemia is harmful and should be addressed". The project proposed herein will directly address this issue by furthering our understanding of the role of exercise training in improving the post-meal glucose responses and longer-term blood glucose control control.