ANZCTR search results

This study is designed to assess the impact of a six month high- and low-intensity cycle-based exercise intervention on cognitive function, measures of brain volume and connectivity and Alzheimer’s disease (AD)-related blood biomarkers in a cohort of older adults aged 60 - 80 years. Furthermore, we will assess the impact of genetic predisposition on responses to exercise within this population. The effect of the exercise regimen will be assessed using a comprehensive battery of neuropsychological tests to assess cognitive function. To assess the impact of the intervention on AD risk, MRI scans and measurements of blood biomarkers will also be evaluated across the intervention groups.

Purpose The purpose of this study is to investigate how safe and tolerable single and repeat doses of BTX1503 solution are in healthy volunteers. The study will look at whether the body adsorbs cannabidiol (CBD). by analysing the levels of CBD in blood at various times after drug administration. The application site will also be monitored for reactions and irritation. Study participants Healthy adults, aged between 18 and 65 years, inclusive, will participate. Experimental Treatment The study will investigate single and multiple doses of BTX1503 solution applied to the face. The components of BTX1503 have all been used in products that are applied to the skin. There will be four (4) different treatment cohorts with up to six (6) participants in each cohort. Cohort 1: 1 mL of BTX1503 5% Solution will be applied as a single dose in the first part of the study and then, after washout period, a single application will occur each day in the clinic for 14 days during the second part of the study. Cohort 2: 1 mL of BTX1503 5% Solution will be applied twice on Day 1 (12 hours apart) in the first part of the study and then, after washout period, twice daily applications will occur (one in the clinic and one self-applied) for 14 days during the second part of the study. Cohort 3: 3 mL of BTX1503 5% Solution will be applied as a single dose in the first part of the study and then after washout period, a single application will occur each day in the clinic for 14 days during the second part of the study. Cohort 4: 3 mL of BTX1503 5% Solution will be applied twice on Day 1 (12 hours apart) in the first part of the study and then after washout period twice daily applications will occur (one in the clinic and one self-applied) for 14 days during the second part of the study. The study consists of a Screening Visit (up to 14 days before receiving the study treatment), a confinement visit starting on the morning of Day 1 and lasting approximately 24 hours, daily applications at the clinic on Day 8 through Day 20, a second confinement on Day 21 lasting 24 hours and 1 follow up visit on Day 23. The maximum study duration for any participant from screening visit to last clinic visit is 37 days. Tests and procedures which are conducted at some, or all visits during the study include: a brief review of your body systems, vital signs measured, blood and urine sampling.

The aim of this 15-year follow-up study was to determine the influence of environmental, anatomical, metabolic, physiological and genetic determinants on health outcomes in older women. This was a follow-up study of 1500 women aged 70 years and over, recruited from the general population of Perth, Western Australia.

The purpose of this study is to formally follow up and record the effectiveness of autologous (your own) stem cell injections in the treatment of arthritis. A secondary objective is to determine whether stem cell therapy offers disease modifying potential and therefore whether it can limit, prevent or possibly reverse progression of arthritis.

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.