ANZCTR search results

The present study will utilise the new diagnostic criteria for perioperative cognitive disorders. Together with current best practice guidelines of multidomain interventions to test whether, when offered as a packaged intervention, these interventions reduce the incidence of disability occurring as a result of perioperative cognitive decline in older adults undergoing anaesthesia and surgery. This has the capacity to reduce healthcare costs, delay decline, improve outcomes and reduce the loss of quality-adjusted life years as a result of disability from cognitive impairment. Seven key modifiable risk-factors have been identified (diabetes, hypertension, obesity, smoking, depression, cognitive inactivity and physical inactivity) which account for approximately 50% of all Alzheimer's Disease (AD) and a 10-25% reduction in these could prevent 1.3 million cases of AD worldwide. Several proof-of-concept randomised controlled studies have been undertaken to develop population-level interventions with positive results. Five intervention components have been identified (nutrition, physical exercise, cognitive training, management of vascular and metabolic risk factors and stimulation of social engagement) demonstrating a significant effect on overall cognition. The preoperative education package will include these five intervention components: 1. Physical exercise 2. Cognitive training 3. Nutrition 4. Management of Risk Factors 5. Stimulation of Social Engagement Hypothesis: Preoperative implementation of proven risk reduction interventions for cognitive impairment will reduce the incidence of disability as a result of perioperative cognitive disorders and reduce associated social, healthcare and community costs. The current pilot study will assess feasibility of study design and intervention components prior to undertaking the complete study.

The purpose of this study is to further our knowledge on how to manage medication changes and to establish a safe and effective medication management plan for people with type 2 diabetes following the 5:2 diet and using medications like sulphonylureas (i.e. Diamicron) and/or insulin.

The purpose of the study is to measure how well the clear aligner system moves teeth into the desired position over approximately 12 months.

The vascular endothelium plays an important role in the regulation in several important bodily processes, including arterial tone, thrombosis, and inflammation. Dysfunction in the endothelium can lead to the development of atherosclerotic lesions, a pathophysiological link to acute cardiovascular disorders. A common condition associated with endothelial dysfunction is obesity. Current research suggests that the mechanism of obesity-induced endothelial dysfunction may be multifactorial, as excess adipose tissues has been shown to induce several metabolic changes which have the potential to interfere with normal endothelial function. A recent meta-analysis (Joris, P J et al. 2015) of human studies on the effects of weight loss on FMD of the brachial artery reported that weight loss increased FMD vs. control by 3.29%. It also estimated that each 10kg decrease in body weight increased fasting FMD by 1.11%. Researchers highlighted that effects may depend on subject characteristics, type of weight-loss treatment, and dietary composition. Within the studies included in the meta-analysis, increases in FMD were larger in the higher weight-loss group when subjects consumed low-fat diets compared with low-carbohydrate diets. What has not been investigated however, in this meta-analysis or indeed in any RCT to date, is whether the impact of changed dietary composition (and resulting hypocaloric conditions) through intermittent energy restriction results in a change in FMD. Accordingly, the current study is designed to investigate the effect of intermittent energy restriction on endothelial function, relative to habitual intakes. This research will add value to the scientific field by adding to the existing literature targeting intermittent energy restriction and its potential health benefits. primary aim of this study is to investigate the effect of two fasting days compared to two ad libitum eating days on blood vessel function. Secondary aim is to determine changes in, serum lipids, plasma glucose and insulin. We hypothesize that individuals will have similar endothelial function following two fasting days compared to two ad libitum eating days.

Initiating long acting reversible contraception at the time of delivery has several advantages that include high patient motivation, convenience, access to trained professionals, no need for an outpatient insertion (which may be uncomfortable) and immediate contraception prior to the resumption of ovulation(1, 2) . Levonorgestrel releasing intrauterine system (LNGIUS, Mirena, Bayer Healthcare), is an intrauterine long acting reversible contraceptive that provides contraception for 5 years(3). In Australia its use almost always involves insertion through the vagina 6 weeks or more after childbirth (standard insertion). The 2016 Australian contraception guidelines rate immediate insertion of LNGIUS at delivery including caesarean section as category 1 (that is no restrictions placed on use) (4). Mwalwanda and Black (2013) note that, “No studies have specifically examined the uptake rate, long term continuation rates, acceptability or effectiveness” (of LNG-IUS in the immediate postpartum period) (2). Intrauterine device (IUD) insertion has low rates of adverse events such as pain and infection, regardless of timing or route of insertion(1, 5). Expulsion rates following device insertion at the time of caesarean may be higher than following standard insertion but more research is required to quantify the risk. Expulsion of IUDs including LNG-IUS following standard insertion is reported to occur in approximately 1 in 20 women(2). Three studies have been examined expulsion rates of LNG-IUS inserted at caesarean section. Expulsion rates were 0%(6, 7) and 20% (8). IUDs including LNGIUS have nylon strings attached. The strings are useful because they can be seen or felt to check that the device is still present, and they can be pulled to remove the device when this is desired. When devices are inserted through the vagina into the uterus the strings are always visible in the vagina initially, and the chance of strings not being visible in the cervix at follow up visits is 5%(9). When IUDs are inserted at caesarean section the chance of the strings not being in the vagina at followup is 8%(10). Patient satisfaction with LNG-IUS insertion at caesarean section has been found to be high, and not different to standard insertion(7). Continued use of LNGIUS inserted at caesarean for 12 months after delivery has been found to be higher than following standard insertion but this difference was not statistically significant (60.0% vs 40.9%, p=0.35)(8). LNG-IUS contains the hormone levonorgestrel, which is a progestogen. Studies of use of various types of progestogen containing contraceptives early in the neonatal period have not show a consistent adverse effect on breastfeeding initiation or continuation, or on neonatal outcomes such as growth and development(11). LNGIUS insertion at the time of caesarean section is associated with reduced postpartum bleeding compared with insertion of copper-containing IUD at caesarean section or no device insertion at caesarean section(12). There is some evidence that the theoretical advantages of LNGIUS insertion at caesarean encourage higher patient uptake. Two studies of immediate LNGIUS insertion at the time of caesarean section compared to standard insertion showed that more women had the procedure done in the immediate insertion group (19/20 vs 18/22)(8) and 25/25 vs 19/23(7) . This trial aims to offer LNGIUS insertion at elective caesarean section. Uptake rate is the primary endpoint. Device expulsion, string visibility, patient satisfaction, continuing use and bleeding pattern will also be recorded. REFERENCES 1. Lopez LM. Immediate postpartum insertion of intrauterine device for contraception. Cochrane Database of Systematic Reviews [Internet]. 2015; (6). Available from: http://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,athens&db=edschh&AN=edschh.CD003036&site=eds-live. 2. Mwalwanda C, Black K. Immediate post-partum initiation of intrauterine contraception and implants: a review of the safety and guidelines for use. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2013;53(4):331-7. 3. Heinemann K, Reed S, Moehner S, Do Minh T. Original research article: Comparative contraceptive effectiveness of levonorgestrel-releasing and copper intrauterine devices: the European Active Surveillance Study for Intrauterine Devices. Contraception. 2015;91:280-3. 4. Family Planning New South Wales FPV, True Relationships and Reproductive Health. Contraception: An Australian Clinical Practice Handbook. Fourth Edition ed. Australia: Family Planning NSW,Family Planning Victoria and True Relationships and Reproductive Health; 2016. 5. Kapp N, Curtis K. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80(4):327-36. 6. Puzey M. Mirena at caesarean section. The European Journal Of Contraception & Reproductive Health Care: The Official Journal Of The European Society Of Contraception. 2005;10(3):164-7. 7. Braniff K, Gomez E, Muller R. A randomised clinical trial to assess satisfaction with the levonorgestrel- releasing intrauterine system inserted at caesarean section compared to postpartum placement. The Australian & New Zealand Journal Of Obstetrics & Gynaecology. 2015;55(3):279-83. 8. Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception. 2014;89(6):534-9. 9. Marchi N, Castro S, Hidalgo M, Hidalgo C, Monteiro-Dantas C, Villarroeal M, et al. Management of missing strings in users of intrauterine contraceptives. Contraception. 2012;86(4):354-8. 10. Bhutta S, Butt I, Bano K. Insertion of intrauterine contraceptive device at caesarean section. Journal Of The College Of Physicians And Surgeons Pakistan. 2011;21(9):527-30. 11. FSRH. Clinical Effectiveness Unit Guidance Intrauterine Contraception April 2015 2015 [updated October 2015]. Available from: https://www.fsrh.org/documents/ceuguidanceintrauterinecontraception/. 12. Elsedeek M. Puerperal and menstrual bleeding patterns with different types of contraceptive device fitted during elective cesarean delivery. International Journal Of Gynaecology And Obstetrics. 2012;116(1):31-4.

Computerised training for cognitive enhancement is of great public interest, however, there is as yet insufficient data on whether, and how, such training leads to changes in everyday activity that relies on the trained cognitive function. Speed of processing training is a commercial software that has been examined in a number of large trials, particularly in the context of ageing and driving safety. This pilot study aims to examine whether online speed of processing training in healthy older drivers will lead to improvement in other measures known to be associated with driving safety.

The primary purpose of this trial is to evaluate the feasibility of conducting volumetric modulated arc therapy hair sparing whole brain radiotherapy (VMAT HSWBRT) in cancer patients with brain metastases. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have a solid tumour or melanoma with brain metastases, for which you require whole brain radiotherapy (WBRT). The trial will enrol thirteen (13) patients with stable scalp hair of at least 2.5cm in length and two patients who are bald. Study details Standard WBRT involves the scalp receiving the full dose of radiation, damaging hair follicles and often leading to alopecia, which decreases quality of life. VMAT HSWBRT may allow for the radiation to be delivered to the metastases whilst minimising the radiation received by the scalp. For all participants, the treatment will involve attending radiotherapy planning/simulation sessions. Patients are treated with VMAT HSWBRT 30Gy in 15 fractions, one fraction delivered at each daily session. Participants will also undergo follow up visits at 4 weeks and 3 months after treatment. It is hoped that if found to be feasible and effective, the use of VMAT HSWBRT could reduce symptoms of alopecia following WBRT for brain metastases and increase quality of life.

We will test whether a low cost, self-help intervention based on Acceptance and Commitment Therapy (ACT), developed in consultation with consumers, is perceived as acceptable and helpful by Australian farmers, improves their well-being, and leads to effective coping when faced with future challenges such as drought. The website contains five short, interactive modules designed to teach users new tools to equip them to take charge and reduce the negative impact that stressful situations can have as well as better cope with things beyond their control. The website features text message reminders and support messages, audio and video, interactive exercises, farming-related humour, and functionality for use on laptops, desktops, tablets and mobile devices. Interested participants (farmers in Australia over 18, with internet and mobile phone access) will be asked to register online, where they will be asked to complete a short series of questions. Participants will then complete the five modules over several weeks, and at the end, complete the same questions, and repeat them once more six months later. Participants will also be asked to express interest in providing feedback on the intervention in an interview at a later time, or in being re-contacted at a later date (e.g. a period of drought) to complete the questions again. Farming is known to be one of the most physically and psychologically hazardous occupations. For generations Australian farmers have been independent, stoic and skilled at solving practical problems. However, a characteristic of farming that makes it psychologically hazardous, is the fact that farmers' levels of personal and economic success is largely dependent upon factors beyond their control (e.g. weather, disease outbreaks, commodity prices). Periods of drought are expected to become more frequent and prolonged in the future, therefore it is important to conduct research like this to find effective ways for farmers who are interested, to learn how to better cope with things beyond their control.

There is growing evidence that physiotherapy and exercise can improve mobility and balance in people with Parkinson's disease (PD). However, there is limited research on the method of service delivery to provide optimally effective and efficient physiotherapy to people with PD. The primary aim of this pilot randomised controlled trial is to investigate the feasibility of a predominantly home-based physiotherapy program compared to a predominantly group-based program. The secondary aim is to determine the effect of the programs on balance and mobility in people with PD. In addition participants will also provide feedback on their satisfaction of exercising in group environment and at home.

The primary objective of this pilot study is to evaluate the clinical effectiveness of our NEST4E non-invasive method for screening embryo ploidy by determining the number of embryos that can that be successfully screened for aneuploidy using the NEST4E rather than invasive biopsy. Aim 1: For euploid embryos the percentage concordance of media sample screening will be confirmed using non-invasive NIPT based first trimester screening as early as 10 week pregnancy. For aneuploid embryos, we will determine the percentage of embryos with concordance by confirmatory trophectoderm biopsy and PGS screening. Aim 2: To determine clinical pregnancy rates and live birth outcomes of embryos that are transferred once screened as euploid. Fifteen patients will be recruited by informed consent to participate in this pilot study to assess the clinical efficacy of our NEST4E non-invasive PGS test to screen their embryos for aneuploidy. Participants will be made aware that their participation in the study is entirely voluntary and that they can withdraw at any point in time. As per standard protocol, patient confidentially will be strictly maintained and their identity will not be revealed in any reviews and reports of this study which may be published. Patients treatment will not be altered in any way and will proceed as per standard IVF cycle, including medications, oocyte retrieval, insemination and fertilization and embryo culture. Patient embryos will be cultured as per standard protocols; G1/G2 Plus media (Vitrolife) overlayed with oil (Ovoil, Vitrolife) in 6% CO2, 5% O2, 37 degrees. A 4 micro litre drop of the spent culture medium will be sampled using PCR grade filtered tips, under laminar flow, and placed into PCR grade 0.6 ml tubes and assessed for aneuploidy as described below. DNA from the culture media sample will be amplified. If this amplification should fail, the embryo will be removed from the trial and will revert to standard care which involves a biopsy followed by vitrification and sample screening. If the amplification is successful, the embryo will be vitrified and the DNA amplified from the media sample used for screening by NEST4E. If conclusive sequence data is obtained, euploid embryos will be made available for transfer.