ANZCTR search results

This is a single-centre, randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized to receive fenofibrate (145mg daily for 6 months) or placebo in a parallel group, double blind design. Participants will undergo a cardiac MRI, Adenosine stress MRI perfusion, echocardiography and ECG at baseline and 6 months.

Diabetes mellitus is a National Health Priority Area in Australia because of its impact on the Australian community. The MILES Study of Australian community found that 28% of people with T1DM had severe diabetes-related distress, slightly less for T2DM participants (17.22%). For participants with insulin treated T2DM, 35% reported moderate to severe depressive symptoms compared to 22% in T1DM and 23% of noninsulin treatment T2DM participants. Preliminary findings from our pilot studies at St. Vincent’s support this data highlighting the presence of mental health concerns in this population. Government reports have also highlighted the nationwide burden with The Australian Institute of Health and Welfare Report (2011) found 31.0-41.6% of people with diabetes had either medium, high, or very high levels of psychological distress. Underrecognition and undertreatment of mental health disorders, in particular depression, is common in this field however and there is need for further mental health data specific to diabetes. Individuals and their families can experience difficulties and adjustments following a diagnosis of diabetes. Not only is there shock and adjustment to the diagnosis itself, but also challenges adapting to daily self-management regimens. A person’s sense of identity can be affected as they process what it means to be ‘diabetic’ and any associated social, legal and medical implications. A focus on diabetes is especially needed given increased rates of depression and anxiety as well as a near two fold increase of eating disorders in adolescent females with T1DM compared to the general population. There is strong overlap between mental health and diabetes, yet gaps remain in service provision. A recent report by Marrero et al. highlighted the importance of behavioural medicine in diabetes given the significant impact of behaviour on the disease process and management of diabetes. The authors emphasise that developing behavioural change interventions will be as important as medical advances, as people are living longer and will need to adopt regimens for chronic conditions with ways to manage new information and sophisticated treatments. There is some evidence that psychological/behavioural treatments can assist, and these have been shown to improve metabolic control, selfmanagement, quality of life, and blood glucose awareness. Mental Health in Diabetes Optimal Health Program (MINDS OHP) The MINDS OHP is a multidisciplinary collaborative therapy and self-efficacy intervention supporting people with mental or physical illness. The program promotes hope, growth and partnership by providing a comprehensive therapeutic approach for consumers, clinicians, services and other to work systematically towards the achievement of optimal health outcomes. The concept of self-efficacy and care coordination are integral components of OHP. The OHP model is focused on wellbeing with a capacity to include additional components addressing particular mental or physical health problems. OHP is delivered in nine sequential sessions comprising: i) interagency collaboration; ii) care coordination ; and iii) support information and identifying community supports. The MINDS OHP incorporates diabetes-specific information to support the self-efficacy and wellbeing of people living with diabetes. This purpose of this research study is to compare the benefits of an 8week (plus booster session) MINDS OHP targeting wellbeing versus the current standard treatment that is provided. This program aims to teach coping and planning skills that may reduce anxiety and depression in people with diabetes. This study is part of a wider program of research designed to inform the OHP adaptation to chronic illness settings including carers of people with stroke and dialysis. The self-management foundations of OHP are particularly relevant for adults with diabetes, who are faced daily with managing aspects of diabetes including insulin delivery (for some), carbohydrate counting, monitoring blood sugar levels, and of course coping with the emotional impact of this. The collaborative focus of OHP also provides a growth facilitative environment for patients to develop confidence, learn strategies for self-care, and know where to seek further assistance if required. References available upon request

Pregnancy may be complicated by threatened pre-term delivery, which is associated with neonatal respiratory distress syndrome. Antenatal corticosteroids reduce the incidence of neonatal respiratory distress syndrome in preterm delivery but cause acute severe maternal hyperglycaemia in pregnancies complicated by diabetes. Data is limited on the blood glucose profile following corticosteroid administration and guidelines to control hyperglycaemia are lacking. Intravenous (IV) insulin infusions may be utilised but are labour intensive and require significant expertise. This prospective interventional study seeks to prospectively validate in-patient management principles utilising a supplementary subcutaneous (SC) insulin regimen in comparison to IV insulin infusion titrated to predicted maternal hyperglycaemia to reduce hyperglycaemia in diabetic pregnancies.

The pulmonary artery catheter (PAC), also known as Swan-Ganz catheter, is a catheter that is inserted into the heart through a large vein in the neck or groin. It is used routinely in all patients undergoing cardiac surgery at Austin Hospital and allows direct, simultaneous measurement of pressures in the right atrium and right ventricle of the heart and pulmonary artery. In addition, it allows the calculation of important cardiac and respiratory physiological information. The PAC is also used to evaluate the effects of drugs on the cardiovascular system, assess and optimise fluid requirements, and manage complications of cardiac surgery such as myocardial infarction and heart failure. Complications from PAC insertion, although infrequent can be harmful. Mal-positioning can lead to arrhythmias, trauma to the pulmonary artery causing bleeding or thrombosis (clotting), infection and pneumothorax (puntured lung). The “standard” anaesthetic technique used to insert the PAC involves slow advancement of the catheter through the heart chambers. The catheter cannot be visualised as it is inserted, however as the catheter traverses the chambers of the heart (right atrium, right ventricle, and pulmonary artery), a characteristic change in cardiac pressure waveforms is seen in each chamber. This change in waveform allows the clinician to advance the catheter through the heart chambers until is its final positioning in the pulmonary artery. Because the catheter is inserted “blindly”, malposition of the catheter commonly occurs. Prolonged and repeated attempts at placing the PAC increase the risks of complications, particularly arrythmias (irregular heart beats), coiling and incorrect position. A technique commonly used by radiologists to guide catheter placement is the use of an X-ray image intensifier, or video flouroscopy. This allows the catheter to be visualised as it is being inserted through the heart chambers into its final position in the pulmonary artery. This technique is also commonly employed by anaesthetists to insert the PAC if it insertion by the standard "blind" method fails. The use of this technique to insert the PAC has never been studied any any scientific way, therefore we propose to study this X-ray technique on patients who are at increased risk from having a complication from PAC insertion. High-risk patients will include those with poor heart function, high pre-existing pulmonary artery pressures, or severe valvular heart disease. The use of the X-ray image intensifier involves X-ray exposure to the patient, but studies have shown that the risk is very minimal. We hypothesize that the use of the X-ray image intensifier to guide positioning of the PAC in high-risk patients undergoing cardiac surgery results in a shorter insertion time, with fewer attempts at insertion, and precise final positioning of the catheter in the pulmonary artery when compared to standard "blind" insertion. Primary end point: time taken in seconds to insert the PAC and final positioning of the PAC. Secondary end points: number of attempts at insertion and complications from insertion Final correct PAC positioning will be checked in theatre by trans-oesophageal echocardiography.

The purpose of this study is to evaluate the effects of nab-paclitaxel compared to paclitaxel in patients with advanced urothelial cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic or locally advanced transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter, renal, pelvis), which has progressed on or after a platinum containing regimen. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive intravenous infusions of the chemotherapy drug Paclitaxel every 21 days. Participants in the other group will receive intravenous infusions of the chemotherapy drug Nab-Paclitaxel every 21 days. Treatment will continue indefinitely as long as you are responding and able to tolerate the drug well. All participants will be followed-up for up to 42 months in order to evaluate disease response, survival, toxicity, and quality of life. This research is being done because currently there is no effective treatment for advanced urothelial cancer that has progressed after prior chemotherapy.

Approximately 220-250 mg of iron is lost with each 470 mL whole blood donation. This may result in progressive iron deficiency, ultimately leading to iron deficiency anaemia and deferral at a subsequent attendance. This study will investigate the use of oral iron supplments after whole blood donation in women aged 18-45 years who make two or more whole blood donations in a year. Participants will be followed for a period of 13 months and asked to take iron supplements after each whole blood donation during that time (up to a maximum of three occasions during the study period). Donors will be provided with the following options to assist with access to a suitable iron supplement: - having the iron supplied by a pharmacy (at no cost to the donor) or -if preferred by the donor purchasing a supplement at their own cost from any pharmacy from a list of suitable supplements provided by the Blood Service. Participants are not required to donate at certain timepoints. Participants will have ferritin samples collected at baseline and again 8-13 months (if applicable) after their recruitment visit. Participants will be asked to complete up to two surveys. The study will evaluate donor acceptance, efficacy and operational feasiblity.

An imbalance in gut microorganisms (referred to as gut dysbiosis) has been shown to be related to illness and some ME/CFS symptoms. More research is needed to understand the relationship between the gut and the brain to help with understanding possible causes and treatment options for individuals with ME/CFS. This project will examine how treatment to reduce high levels of Streptococcus bacteria (determined by Bioscreen stool analysis and indicative of abnormal gut functioning) is related to improvements in sleep, mood and cognitive symptoms in individuals with ME/CFS. There is also preliminary evidence to suggest sex differences in response to gut bacteria, thus, this research will examine if there is a sex-differential response to treatment. This is an open-label pilot study that will follow a baseline, treatment and follow-up protocol across 6 weeks. The baseline and follow-up phases are one week each. Possible improvement in sleep, mood and cognition will be measured by using a wrist device (Actiwatch), pen and pencil sleep and day diary, questionnaires and an individual cognitive testing session conducted at Victoria University. A second Bioscreen stool analysis will provide information about changes to gut flora.

Trial to test difference in efficacy between an expensive moisturiser (Eulactol Heel Balm) & inexpensive moisturiser (Walker's Sorbolene) in the treatment of foot xerosis over a 4 weeks period. A secondary cost / benefit analysis will also be conducted to help determine 'value for money' of the interventions

The study aims to assess the effectiveness of Ageratum conyzoides on day-time and night time urinary frequency, symptoms of BPH, sleep quality and on SHBG and serum testosterone levels. Due to the ant-inflammatory and analgesic actions of Ageratum conyzoides, it has a long history of use traditionally in Caribbean folk medicine for a number of men’s health issues including prostate and urinary problems. The investigational product is a tablet - form herbal medicine, containing 250mg of Ageratum conyzoides extract. The daily dose will be 1 capsule per day taken with the evening meal, taken over 3 consecutive months.

This is an observational study of patients who have previously been diagnosed and treated for Microangiopathic Thrombocytopenia (MAT). The study will collect clinical and laboratory data to assess the disease characteristics, laboratory features, treatments, and clinical outcome.