ANZCTR search results

The current study is investigating the effects of supplementation with a herbal complex called LZ Complex3 on sleep quality, daytime functioning, mood and brain function. The complex contains a combination of herbal ingredients that have individually been used to improve aspects such as sleep quality, mood, and calmness. The complex also contains dietary supplements that may provide nutritional support for sleep. However, there has not been any studies to date that has looked at the combination of these ingredients together and their effect on sleep quality.

Provision of allied health services over 7 days per week as opposed to 5 days per week for medical and surgical hospital inpatients is a practice inconsistently applied across health services in Australia. Presently, no evidence from randomised trials is available to guide service delivery for this population. These services have developed incrementally and in an ad hoc process at Monash, Western and Melbourne Health, in a similar experience to other health services around the state. It is possible that this is wasting resources that could be used for other purposes within these organisations. This study aims to examine whether removal and provision of weekend allied health services on general medical and surgical wards has an impact on length of stay on those wards, other indicators of quality and safety of service provision, and staff satisfaction. A novel research methodology will be applied using a stepped wedge cluster randomised controlled trial design to both incrementally remove existing services, then reintroduce services in a structured, stakeholder driven process (the 1st phase has been registered as a separate trial ID: ACTRN12613001231730). At Monash, Western and Melbourne Health, new, stakeholder driven weekend allied health services will be incrementally rolled out across 6 wards over a 7 month period. Outcomes will be collected predominantly through existing data collection processes, although additional data will be collected through staff group and key informant interviews, and random sampling of patients.

Twenty patients undergoing kidney transplant will be included in the study. Data regarding preoperative variables, intraoperative and postoperative variables are prospectively collected. A non-invasive device (called Sidestream Dark Field imaging), that allow for clinical observation of the microcirculation will be used. It is hand-held probe with a sterile extension for direct contact with renal parenchyma. kidney biopsies are performed to assess Immunohystochemical intensity of ET-1 and other markers. The tissue to be acquired in this study will be obtained from surgical specimens taken from consented participants having kidney transplant.

Women who misuse alcohol and other drugs have low rates of contraceptive use and higher rates of pregnancies (including unplanned pregnancies) compared to the general population. Once pregnant, these women and their babies experience higher rates of adverse health outcomes such as preterm birth, low birth weight and adverse developmental and social outcomes. Our research aims to explore whether women in drug and alcohol treatment who do not wish to conceive will have better rates of contraceptive use when contraceptive services are integrated into drug treatment clinics, compared to standard care where women are referred to primary health care services for their contraceptive needs. With this model we seek to increase use of all contraceptive methods but particularly methods that do not require daily adherence such as injections, implants and intrauterine devices that are reversible but extremely reliable. These methods are known collectively as the long acting reversible contraceptive (LARC) methods. A pilot integrated contraceptive medical service will be introduced within a drug and alcohol clinical setting. We propose to evaluate this pilot, to determine whether integrated care is feasible, and if it is more effective in increasing the use of contraceptive methods and reducing unplanned pregnancy than the standard of care.

Type 1 diabetes (T1D) incidence is rising globally at a rate of 3–5% per year with patients having increased susceptibility to macrovascular complications and diabetic retinopathy a major microvascular complication of diabetes. Cardiovascular disease is the major cause of disability and death, with diabetic retinopathy the leading cause of blindness and significant burden to the individual and society. Current treatments target elevated blood glucose, high blood lipids and blood pressure, however diabetic patients continue to have 2- to 4-fold greater risk of a heart attack (MI), hence the optimum treatment for minimising this complication during diabetes has not yet been established, and additional treatment strategies are urgently needed. Hormones of the renin-angiotensin-system (RAS) are key mediators of adverse complications in diabetes, with blockade of this system by medications known as angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are routinely used as therapy for diabetes; although there are mixed reports for their efficacy in diabetic retinopathy. We propose this variability is due to the action of aldosterone, another steroid hormone in the renin-angiotensin-aldosterone system (RAAS). Aldosterone exerts adverse actions via activation of mineralocorticoid receptors (MR), often referred to as “aldosterone receptors”. Our hypothesis is that adding a medication known as “aldosterone receptor” antagonist to standard treatment for T1D will delay or prevent progression of complications of diabetes. Although this medication is used treat patients with heart failure and MI, there are no clinical trials investigating this medication in T1D. The design is open label, 9 week duration, proof-of-concept study to assess the efficacy of the selective "aldosterone receptor" antagonist, eplerenone in T1D. Twenty patients with T1D will be recruited from the Diabetes clinic. They will have baseline measures within the first week and then receive eplerenone for 12 weeks in addition to standard treatment. The same measures are repeated in each patient at the end of the treatment period; hence the proof-of-concept is baseline versus treatment for each person. The patients will return 7 days after completing the study for routine clinical visit. A separate group of 20 age matched, healthy volunteers will be recruited for comparing the same measures to establish prognostic markers. Our specific objectives are: 1. Prevent and arrest the complications of diabetes on cardiac structure and function, including platelet activation and reactivity and endothelial dysfunction; 2. Prevent progression to diabetic retinopathy; 3. Improve metabolic control; 4. Provide prognostic and predictive biomarkers for clinical management.

Long-chain omega-3 polyunsaturated fatty acids (PUFAs) play an important role in a range of physiological processes in all living organisms. Supplementation with omega-3 PUFAs has been shown to have range of beneficial effects on both physical and mental health, while results of previous trials in child and adult populations suggest that omega-3 PUFAs may offer a safe and effective treatment for depression. However, conclusions from these trials have been limited by their relatively small sample sizes. This study aims to test the therapeutic effects of a 12-week randomised, placebo controlled trial of approximately 1.4 grams/day omega-3 fatty acids in 300 help-seeking 15 to 25 year olds presenting with moderate to severe major depressive disorder (MDD). The primary hypothesis is that young people with moderate-to-severe MDD will show greater improvement after 12 weeks of treatment with omega-3 PUFAs plus cognitive behavioural case management (CBCM) compared to treatment with placebo plus CBCM. The primary outcome measure is change in the Quick Inventory of Depression Symptomatology (QIDS-A17-C) score. The secondary hypotheses include the rate of remission (defined as patients not meeting the criteria for MDD at 12 weeks and 6 months) will be greater for young people treated with omega-3 PUFAs plus CBCM compared to treatment with placebo plus CBCM.

This project will compare the effects of Skype (Trademark) and regular telephone conversations with a family member on the levels of agitation, mood and engagement shown by aged care residents with dementia and an agitated behaviour. Conversations with a family member will be held in random order via Skype (Trademark) computer software and regular audio-only telephones on four occasions each. Conversations will last for a maximum of 20 minutes. A researcher will conduct observations before, during and after the conversations to record the presence or absence of the target behaviour and residents’ engagement and affect.

The inflammatory bowel diseases (IBD), Crohn’s disease and ulcerative colitis, are immune system related conditions where an overactive immune response from the body’s white blood cells causes inflammation and damage to the intestines and in turn the typical symptoms of diarrhoea, abdominal pain and weight loss. Immune-modifying drugs (immunomodulators) like azathioprine (AZA) and 6-mercaptopurine (6MP) dampen down the overactive white blood cells that are the cause of the inflammation. Over 50% of patients who attend an IBD clinic at Eastern Health are on one of these medications. In IBD like other immune related conditions, AZA and 6MP have been shown to both get patients well (induce remission), and keep patients well (maintain remission). Importantly, they also reduce the need for cortisone-based medicines such as prednisolone that are associated with many side effects and no long-term benefits. We know that AZA and 6MP to produce two chemical end-products (metabolites) that are responsible for the benefits and also side effects of these drugs. These metabolites are known as 6-thioguanine nucleotides (6-TGN) and 6-methylmercaptopurine (6-MMP). 6-TGN is the good metabolite that makes these drugs work, while 6-MMP instead can cause side-effects, especially affecting the liver. Therefore it is desirable to have high levels of 6-TGN and low levels of 6-MMP to get the best out of these drugs. Recent research has shown that by adding another drug called allopurinol to AZA/6MP in almost all cases the 6TGN levels improve and the 6MMP levels greatly reduce. Also, we generally use a much lower dose of the AZA/6MP combined with the allopurinol and thus most patients end up getting a greater benefit but with fewer tablets, with no increase in side effects. It should be noted that the use of allopurinol in combination with azathioprine or 6-mercaptopurine remains experimental, and is not currently approved by the TGA. In this study we are comparing patients who are commencing on treatment with azathioprine with those who will be started on a combination of azathioprine and allopurinol to see if this combination of drugs is more effective and quicker to work, yet similarly safe, to those taking the standard AZA alone. If we are able to show that the combination is better in this study, then this will have major consequences to how azathioprine is used in the treatment of IBD in the future.

The purpose of this study is to conduct a prospective double blind placebo randomized control trial to evaluate the effect of colchicine in preventing postoperative atrial fibrillation after cardiac surgery.

INTRODUCTION Dependency of the lower limb following free flap reconstruction needs to be gradually introduced due to the risk of edema and consequent effects on flap microcirculation. It is well established that these flaps must undergo graduated periods of wrapping and dangling before progressing to full dependency. Objective evidence for initiation of post-operative dangling following lower limb free flap reconstruction is limited and there is significant variability in the protocols of individual centres and surgeons. OBJECTIVE The goal of this study is to determine the physiological effect of dangling on lower limb free flap perfusion in order to determine an evidence-based protocol. METHODS Randomised controlled trial of patients from Royal Adelaide Hospital who have undergone lower limb free flap reconstruction. Group 1 will begin dangling on day 3, whilst group 2 will begin dangling on day 7. All patients will have their flap monitored by clinical assessment, implantable venous doppler and transcutaneous oxygen saturation (St02%). CONCLUSION The results of this study will be statistically analysed and summarised, will be presented at a plastic surgery conference, and will be submitted for publication in a peer-reviewed journal.