ANZCTR search results

Heart surgery using extracorporeal circulation alters how drugs stay and move within the body, which can lead to sub optimal therapy and adverse effects in patients. Although multiple factors potentially contributing to these changes have been identified, there has been minimal research on the impact of extracorporeal circulation on the function of liver enzymes that have a major role in clearing medications from the body. Extracorporeal circulation is associated with an intense inflammatory response which may alter the extent to which liver enzymes breakdown essential drugs leading to sub optimal dosing and adverse effects. Changes in liver enzyme activities may be associated with unpredictable responses seen in patients during and after treatment with extracorporeal circulation, e.g. increased ventilation times or memory impairment. This pilot study aims to identify factors contributing to the altered breakdown of critical medications and estimate the extent to which changes in the activity of liver enzymes in patients undergoing treatment with short-term (surgeries requiring CPB) or long-term (treatment with ECMO) extracorporeal cuircuits , compared with a control group undergoing a different surgery without extracorporeal circulation (laparoscopic cholecystectomy). Hypothesis Extracorporeal circulation, triggers an inflammatory response in patients altering the capability of liver enzymes to breakdown critical drugs. Outcomes and benefits of the completed pilot study include: 1. Understanding the inflammatory response triggered by extracorporeal circulation and how this affects the ability of liver enzymes to breakdown essential medications. 2 .Utilising new approaches to measure the activities of major enzymes in the clinical setting. 3. Informing the design of a future larger clinical study. 4. Developing guidelines to assist clinicians in delivering optimised drug therapy and personalised health care. 5. Minimising adverse effects associated with altered breakdown of medications in patients thereby reducing length of stay in the ICU and costs associated with complications caused by sub optimal drug therapy.

Low back pain (LBP) is a major health problem affecting approximately 60-80% of the adult population at some stage. LBP is the second most common reason for physician visits, and for work disability and is associated with substantial health care costs. The intervertebral disc (IVD) is the most common source of LBP, being the prime source in about 40% of complex chronic LBP presentations. Non-invasive options, such as pharmacological manipulation, exercise, physical therapy and pain management programs have limited evidence. Further, surgical interventions such as discectomy and fusion for disc degeneration have similarly limited success. Cell based therapies may offer possibilities to regenerate the IVD, restore or improve its function, leading to clinical success. Mesenchymal stem cells (MSCs) are a very attractive cell source for use in restoring the normal cellular constitution of the degenerated disc. A recent pre-clinical animal study showed that implantation of bone marrow derived MSCs to degenerative discs inhibits fibrosis/scarring, preserving mechanical properties and overall spinal function. Furthermore, a study of 10 patients with confirmed disc related LBP and injected with autologous MSCs, described rapid improvement in pain and disability at 3 months, followed by a modest improvement within 6 and 12 months after injection. Importantly, based upon current clinical trial outcomes, MSC therapy is low-risk. A recent meta-analysis of trials involving a total of 1012 participants receiving MSC therapy for various conditions , did not identify any significant adverse events other than transient fever. The primary aim of this prospective case series pilot study is to evaluate the safety, tolerability and dose efficacy of autologous mesenchymal stem cells in the treatment of internal disc disruption (IDD) resulting in LBP. A secondary aim is to determine whether MSC therapy offers disease modifying potential through the examination of structural changes using MRI. Follow-up will be conducted over 12-months.

Mental health problems often have first onset during adolescence and when this happens teenagers frequently turn to their peers, rather than adults, for support. The core aim of this proposal is to test the effectiveness of a new public health intervention, ‘teen Mental Health First Aid’ (teen MHFA), designed to improve the quality of peer guidance and support for adolescents with mental health problems. teen MHFA is a new 3 x 75min training course for adolescents in High School years 10-12. The program is evidence-based and developed from a Delphi expert consensus study with youth mental health consumer advocates and MHFA instructors who work with youth, and from research evidence on barriers to help-seeking. An uncontrolled evaluation has been carried out and showed positive effects on knowledge of how to help a peer, confidence in helping, stigma, help-seeking intentions and participant mental health. The current project aims to carry out a rigorous evaluation with a control group and to investigate the longer-term impacts of the training on student experiences of providing support and guidance to peers. Schools will be randomized to receive either teen MHFA or physical first aid training. Ten schools will receive the interventions over a three-year period. Student questionnaires will be completed at four time points: before training begins, immediately after training, 1 year after training and 18 month after. Questionnaires will assess changes in knowledge, attitudes, intentions and behaviour towards peers with mental health problems, as well as reports of support received from peers, and participant mental health. If found to be effective, this public health intervention can be easily disseminated through the existing MHFA Australia Instructor networks nationally and worldwide.

120 Patients referred with chronic low back pain clinically arising from the facet joints were referred and assessed for suitability for diagnostic medial branch blocks. The patients had 2 blocks performed with either bupivacaine then saline or vice versa or bupivacaine on both occasions in a double blind randomly controlled prospective fashion. Any patient with 50% relief to any block was offered a radio frequency neurotomy and their analgesia and function and distress was measured post procedure for 3 months.

This is the first RCT to evaluate the efficacy of sun-protective clothing in reducing the rate of development of melanocytic naevi (pigmented moles: a major risk factor for melanoma) in early childhood. The proposed prospective cluster randomised intervention trial aims to determine whether reducing sun exposure, primarily through the use of sun-protective clothing can delay the development of a significant proportion of the melanocytic naevi which develop in early childhood, and have been shown in numerous case-control studies to be a major risk factor for lifetime melanoma risk. More specifically, we aim to: 1. determine whether regularly wearing sun-protective clothing can reduce the number of new melanocytic naevi developing on the body during 3 years of follow-up; 2. determine whether regularly wearing sun-protective clothing can reduce the rate of acquisition of melanocytic naevi on those body-sites protected by study clothing (i.e. upper arms, posterior neck, trunk and thighs).

BACKGROUND Myopia is defined as a refractive anomaly of the eye where parallel rays of light from an object at optical infinity are focused in front of the retina when accommodation is at rest. In recent years, the prevalence of myopia has increased dramatically especially in the East Asian population. In the year 2000, the prevalence of myopia was estimated to be 21% in 7 year olds, 61% in 12 year olds and a disturbingly high 81% in 15-year-old Taiwanese school children. While evaluating the causes of visual impairment and blindness in a group of adult Chinese in urban and rural region, it was found that 32.7% was contributed by degenerative myopia. However, the rapid and disturbing increase in the prevalence rates of high myopia over the years’ warrants amending our current knowledge on myopia. The distribution of peripheral refraction profile across different meridians and whether the pattern of distribution of the peripheral refraction can predict the progression of myopia needs to be investigated. The current study is planned to investigate up on a number of optic disc parameters to determine if there is an association between features such as tilt, torsion, RNFL thickness and choroidal thickness and progression of myopia. Analyzing this relationship will help in predicting myopia at an early stage. PURPOSE OF THE STUDY Correlating the peripheral refraction profile and structural variations in the optic disc in different meridians will guide us in identifying potential predictive factors responsible for the progression of myopia. The aim of this study is to determine if risk of progression of myopia can be identified using peripheral refractive error profile, optic disc features and retinal and choroidal thicknesses. STUDY DESIGN A cross sectional and interventional pilot study will be conducted as a first step to derive the required sample size and refine the experimental methods. The sample population aimed for this study is an age group between 18 to 39 years. The study sample will include a minimum of 20 participants to up to 50 participants in individual subgroups of emmetropia, hyperopia and myopia is planned for this pilot study. STUDY METHODS Preliminary examinations will be carried out in order to screen the individuals who fit into the eligibility criteria. The initial examinations included a routine ocular examination comprising detailed history taking, measurement of objective and subjective refraction values, anterior and posterior segment examination and measurement of intra ocular pressures. Participants who meet the inclusion criteria will undergo Shin Nippon auto-refractor and BHVI Eye-Mapper assessments for peripheral refraction profile at different field angles. The order of testing with these 2 instruments will be randomized using http://www.graphpad.com/quickcalcs/index.cfm online software. 3 repeat measurements will be obtained from both the instruments during the assessment by same examiner.

Peripherally Inserted Central Catheters (PICCs) are tubes inserted into the veins of patients to infuse medications, fluids and blood products. The ends of these tubes need to sit near the heart to reduce side effects. Commonly live xray (fluoroscopy) is used to make sure the PICC is at the right place. But this is expensive and difficult to coordinate. ECG tracing represents different parts of the heart working and when the PICC is placed near the heart, this tracing will change. Thus, we can see when the end of the PICC is in the correct place. But, there is limited evidence that this system is accurate compared to fluoroscopy and the cost implications are unknown. This research aims to compare the accuracy of an ECG tip verification system (Nautilus Delta) with fluoroscopy and determine the economic implications of a change in practice. Patients already undergoing PICC insertion will be recruited at Fiona Stanley Hospital. The PICC will be inserted the usual way and when the Nautilus Delta ECG system indicates it’s in the correct area, fluoroscopy will be used to verify where the tip is. Hospital and enterprise bargaining information will be used to determine the costs associated with the different systems. Hypothesis: the Nautilus Delta ECG system will be accurate when compared to fluoroscopy and more cost effective

About half of all stroke survivors experience memory difficulties, which affects their ability to work, carry out daily activities independently, and enjoy a rich quality of life. Memory rehabilitation programs significantly improve everyday memory function. However, barriers to accessing rehabilitation include geographic location, mobility restrictions, and cost. Telehealth service provision could overcome these barriers, however we lack evidence that this mode of delivery results in the same positive outcomes. This project will compare outcomes of a one-on-one telehealth memory skills program with face-to-face one-on-one and group-based programs as well as waitlist control. This innovative study will be the first to establish whether telehealth approaches to memory rehabilitation are feasible, effective, and cost-efficient. If so, this could improve access to effective rehabilitation and represent a significant cost saving to health services, patients and the community.

Background and Significance Evidence supporting the use of tranexamic acid (TXA) in large joint replacements to reduce blood loss and the need for transfusion has been available for many years. To date evidence supports the use of topical or intravenous (IV) TXA, with a recent meta-analysis concluding that the two produced similar effects in the reduction of blood loss due to surgery. Very few studies have investigated the possibility of the use of oral TXA in place of topical/IV. The use of oral TXA has the potential to provide significant financial savings to healthcare facilities, with equivalent quantities of IV TXA ampoules being almost 40-fold more expensive than oral tablets. Aim and method This study aims to identify the non-inferiority of oral TXA in the reduction of peri-operative blood loss when compared to a topical/IV regimen in patients undergoing total knee replacements (TKR). In addition, the effect of pre-operative TXA on surgical blood-loss or total blood loss will be examined, in comparison to post-operative. The study will also investigate safety by incidence of deep vein thrombosis (DVT). The study will comprise of two arms, a study arm which will be treated with and oral TXA regimen and a control arm that will be treated with a currently used topical/IV TXA regimens. The TXA treatment regimens will be as follows: Study: 1g oral TXA 2hr prior to surgery, 1g oral TXA two hours post-surgery and a final 1g oral dose six hours post-surgery. Control: 3g topical TXA perioperatively, 1g IV four hours post-surgery and a final 1g oral dose eight hours post-surgery. Both groups will receive 2.5mg of oral apixaban twice daily for 15 days, commencing 8 hours post-surgery as prophylactic antithrombotic therapy. All procedures will be conducted by the same orthopaedic surgeon and the anaesthetist for the study arm will remain constant throughout. The primary outcome will be blood loss due to surgery. This data will be determined by the amount of blood loss in theatre and the volume collected from the joint drain at ten hours post-surgery. Safety will be measured by the incidence of adverse events attributed to TXA, in particular the incidence of DVT. This will be determined by means of Doppler ultrasound at six weeks post-surgery. Duration and participants The study will be ongoing with an aim of gathering approximately 50 participants in total, i.e. 25 participants per arm. All data will be collected from patients undergoing TKRs at John Flynn Private Hospital, all of which will be conducted by the same orthopaedic surgeon. Patients will be excluded if they require adjustments in the TXA regimen or changes to prophylactic antithrombotic therapy. Patient’s will also be excluded if they are undergoing a TKR revision.

The primary purpose of this trial is to determine effect of enzalutamide dose reduction on fatigue, cognition, and drug trough levels in patients with prostate cancer Who is it for? You may be eligible to join this study if you are a male aged 18 years or above, have prostate cancer who have commenced enzalutamide within 3 months. Study details All patients will be receiving standard dose enzalutamide (160mg daily). If patients experiences a Grade 3 toxicity or an intolerable side effect, enzalutamide will be withheld for one week or until symptoms improve to at least Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg). Dose reduction will be undertaken in 40mg increments, depending on level of cognition and fatigue impairment. Total duration of the intervention period is at the discretion of the investigator. Fatigue and cognition levels will be assessed weekly and blood samples will be collected every four weeks. We hope that this study will improve the individualisation of the enzalutamide treatment by tailoring the doses to each person's needs