ANZCTR search results

The TraumaFocused Cognitive Behavioural Therapy (TF-CBT) manualized protocol is a component of the QLD Health child and adolescent mental health stepped care response to the 2011 flood and cyclone disasters. This intervention is only being offered to children identified through a two stage screening process as experiencing a posttraumatic mental health problem following the 2011 QLD disasters. The protocol consists of 2 parent sessions and 8 sessions of individual therapy with children. Sessions are conducted in children’s schools during school hours in order to minimize the inconvenience experienced by families. The followup assessments (to be conducted posttreatment, 6 and 12 months following completion of treatment) consist of the same tools used to identify children in the first instance through screening. These consist of the Spence Children's Anxiety Scale, the UCLA PTSDReaction Index, the Children's Depression Inventory, and the Anxiety Disorders Interview Schedule for Children (parent and child versions). The broad aims of the intervention are to improve parents’ confidence and competence in managing their children’s posttraumatic mental health problems; and to reduce children’s symptomatology. TF-CBT has the strongest evidence base of any psychological therapy with children experiencing posttraumatic mental health problems.

Background: Endoscopic ultrasound fine needle aspiration (EUS FNA) allows cytologic and/or histologic diagnosis of lesions within or adjacent to the gastrointestinal tract (GIT). Currently there are multiple different needle types, including the recent development of fine needle biopsy (FNB) needles, which aim to increase the amount of tissue acquired. These needles are designed with an opening on the side and a reverse bevel. Needles also vary in diameter, which range from the largest at 19 gauge (19G) to the smallest at 25 gauge (25G). Studies comparing needles have mainly focused on diagnostic yield and the results between needles has been similar given that only a few cells are needed for diagnoses. However any differences, if found, have frequently been non-significant. The quantity and quality of diagnostic tissue obtained is becoming increasingly important in the diagnosis and treatment of patients who are suspicious of having a malignant lesion. Equally importantly, a larger specimen would improve specificity of the diagnosis of non-neoplastic conditions, which has been poor with cytological specimens from FNA. Most importantly, the advances in oncological treatment based on histological subtypes, molecular biomarkers and more recently, genomic profile, have demanded the need for larger but good quality specimens for these ancillary tests. This concept has been observed in the management of pancreatico-biliary cancers, and thus, has resulted in development of EUS FNB to acquire larger specimens for these purposes. To our knowledge, there has been no method or criteria to objectively quantify the tissue obtained from different needles. This may explain the indifferences in trials comparing needles thus far. The NanoZoomer Digital Pathology System (NDP) allows scanning of histology slides with high definition (0.5 µm per pixel). It was developed to allow the digital sharing of slides between pathologists over a network. The associated software (NDP viewer) has the advantage of being able to objectively assess the slides by measuring the width, length and surface area of the tissue. This is a proof of concept trial to assess the use of the NDP viewer in assessing tissue specimen quality. This can then allow for further trials using this system to directly assess different specimens from different needles on a head to head basis. Hypothesis: The differences in the tissue quantity depend on the size and type of needles used in EUS guided biopsies. It is anticipated that the study will provide valuable insights into which needle size is able to obtain the most and highest quality tissue. Aim: To objectively quantify and qualify the amount of tissue acquired by different sizes and types of EUS-guided biopsy needles, using a digital scanning system.

The primary purpose of this trial is to compare the effect of simvastatin with placebo on the effectiveness and side effects of pre-operative chemoradiotherapy treatment prior to rectal cancer surgery, and on the body's inflammatory response to cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with rectal adenocarcinoma or high grade dysplasia with radiological evidence of invasive tumour, for which pre-operative chemoradiotherapy treatment is planned. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either the active simvastatin treatment in addition to their planned chemoradiotherapy treatment, or to receive an inactive placebo in addition to their planned chemoradiotherapy treatment. Participants will take the allocated treatment capsule once daily for 90 days starting one week before chemoradiotherapy. The study will last 3 years and participants will be asked to visit the clinic on nine occasions for clinical examinations and they will also have blood tests and magnetic resonance imaging (MRI) scans. Tumour tissue removed at the time of surgery will be assessed in the laboratory. It is hoped that if the study showed a positive outcome, then it may ultimately lead to patients in the future benefiting from adding simvastatin to chemoradiotherapy.

Influenza is a highly infectious respiratory virus that can affect people of all ages. Every year, influenza causes 35 million cases of severe disease worldwide including more than 250,000 deaths. The most effective method of protection from influenza infection is by vaccination. However vaccination is often not 100% effective, and various factors can influence the immune response achieved following vaccination. One such factor that may play an important role in altering the immune responses to influenza vaccination is obesity. Studies among adults have shown that significant obesity puts individuals at increased risk of more severe disease and a more prolonged disease course from influenza. In addition, the effectiveness of influenza vaccination may differ between obese and non-obese individuals. Studies among adults vaccinated with influenza vaccination showed that obese individuals developed significantly higher rates of influenza as compared to non-obese individuals suggesting that influenza vaccination may be less effective in obese than in non-obese adults. Other studies have shown that obese individuals had a reduced cell-mediated immune response to influenza vaccination as compared to non-obese individuals. Most of the studies exploring vaccine effectiveness in obese individuals have been conducted in adults and there are currently no published studies examining differences in immune responses between obese and non-obese children or adolescents in response to influenza vaccine. It is important to further explore and understand how the obese state alters immune function and response to influenza vaccination, and the impact that young age may have on these changes. Understanding mediators of lowered immune responses following vaccination is important for public health policy and programs, and will provide evidence which could be highly translatable to immunization policy and inform vaccination strategies for obese populations. This study will enrol 25 non-obese (BMI 5-<95th percentile) and 25 obese (BMI >=95th percentile) children aged 9-17 years of age (N=50) and include 3 study visits. Participants will receive a single dose of licensed quadrivalent influenza vaccine at visit 1. Blood samples will be collected at all 3 visits (visit 2 and 3 will occur 1 and 6 months post-vaccination). Influenza specific antibody concentrations and haemaggluttination inhibition assay (HIA) titres will be measured on blood samples from all three time-points. A HIA titre of 1:40 is the established level of protection for influenza vaccination. Serum antibody concentrations will be log transformed to provide geometric mean concentrations (GMC). The protective HIA titres and GMC will be compared between obese and non-obese cohorts using linear regression models with effects expressed as mean differences and 95% confidence intervals. Both unadjusted and adjusted analyses will be performed, with adjustment for biologically plausible potential confounders.

Feeling informed about research seems to correlate with positive attitudes towards researchers and greater trust in researchers. However, many people feel they are not informed enough about ongoing research. 86% of the Australian population seems to be somewhat or very interested in health and medical research suggesting that the population would be rather receptive if we present the information in an acceptable way. Formal peer reviewed publications are lacking in this topic. Recruitment of participants to research projects depends on a reasonable interest for research among the general population. The interest for research among the general population in north Queensland is not yet elucidated. Furthermore, any activity that may increase the general population's interest in health care related research might have a positive influence on recruitment to future research projects. This project aim to estimate: 1) What proportion of patients in an ED waiting room in North Queensland express an interest in knowing about current health and medical research in their surroundings? 2) Do patients express any appreciation of being informed about current health and medical research in the surroundings by an automated information presentation? 3) What is the potential effect on interest in health related research by actively presenting information to the general public using large TV screens?

Chronic Kidney Disease (CKD) is increasingly being recognised as a global public health problem with increasing incidence and prevalence, contributing to significant morbidity and mortality. Dietary intervention is a pivotal aspect of care for people with all stages of CKD and can significantly improve the morbidity and mortality of these patients. However, it is a complex diet that is frequently met with resistance from patients. Improving patient engagement and education regarding diet and lifestyle is vital to improve patient outcomes and reduce the burden on the healthcare system. Using mobile phone technology, such as text messaging, offers a novel way of engaging with patients on dialysis. This randomised controlled trial aims to determine the feasibility and clinical impact of using text messages to improve nutrition-related behaviours in the haemodialysis population. The primary aim of this study is to assess of the feasibility of using a mobile phone text message intervention to improve dietary adherence in a haemodialysis population.

This project will involve a FMS program that will be implemented at the UNSW Early Years Childcare Centres. PLAYFUN will be a cluster randomised controlled trial in preschool aged children to be conducted over a 12-week period with fundamental motor skill testing to be completed at the beginning and end of the 12 weeks, with follow-up testing to be completed 12-weeks after the program has finished. If the program is shown to be beneficial, children in the control group will be offered the exercise program free of charge at the end of the study. Therefore, initially the control groups will be allocated as wait list for the program. The primary outcome measure will be FMS measured using the Test of Gross Motor Development 2 (TGMD-2). Secondary outcome measures include both perceived and actual physical activity (PA) levels and anthropometric data (BMI).

Retrospective descriptive analysis of the safety of maternal vaccination utilising 4 datasets: ‘FluMum’, ‘PneuMum’, ‘1+1HS’ and a population based de-identified NT birth cohort. Combined datasets ~85,000 mother-infant pairs, of which ~30% identify as Aboriginal and/or Torres Strait Islander. There is no active participant recruitment, no blood tests or specimen collections and no direct contact with any participants. Results will be presented as large aggregate data with no potential for identifying information. Results will contribute novel information on adverse maternal and infant perinatal outcomes over a 21 year period (1994-2015) .We will calculate ‘Observed-to-Expected’ ratios to describe the risk of an adverse outcome occurring following maternal vaccination in pregnancy with influenza, pertussis or pneumococcal vaccines.

Background: Endoscopic ultrasound fine needle aspiration (EUS FNA) allows cytologic and/or histologic diagnosis of lesions within or adjacent to the gastrointestinal tract (GIT). Several studies have shown this approach to be cost-effective and safe with complication rates less than 2%. EUS FNA also carries a high-diagnostic yield with accuracy ranging from approximately 80-95%. Currently there are multiple different needle types, including the recent development of fine needle biopsy (FNB) needles, which aim to increase the amount of tissue acquired. Studies comparing needles have mainly focused on diagnostic yield as well as complication rates. However any differences, if found, have frequently been non-significant. The quantity of diagnostic tissue obtained is becoming increasingly important in the work up of cancer patients, where personalised therapy is a goal. Treatment can now be influenced not only by histological subtype, but also based on the presence of molecular markers. In order to sub classify tumours further, adequate tissue samples are needed for both diagnosis and molecular testing. Therefore, when comparing different needle types or sizes, studies should also look at the amount of tissue obtained. The Echo Tip ProCore is a FNB device with a side-bevel designed to obtain histological cores of tissue. It is well-established, has been extensively studied and shown to be safe and highly accurate. The 19G EZ Shot 3 Plus needle is a newer needle that is also designed to obtain a histological core, with the addition of the flexibility one would expect from a smaller gauge needle. It has been approved by the Australian Register of Therapeutic Goods. Hypothesis: The 19G EZ shot 3 Plus needle will obtain equal diagnostic tissue quantity to the ProCore needle in solid pancreatic lesions. Aim: To compare the diagnostic accuracy and obtained tissue quantity of 19G EZ shot 3 Plus needle versus the ProCore needle in the investigation of solid pancreatic masses. Design: This is a non-inferior paired, prospective, single-centre study involving patients undergoing EUS evaluation of solid pancreatic masses. It will involve 66 patients who will each have a single pass using the EZ shot 3 Plus and ProCore needles (2 passes total).

Temper outbursts are a leading cause of morbidity for individuals with Prader-Willi syndrome (PWS). Despite this, there is currently no known treatment. Meditation on the Soles of the Feet (SoF) is a mindfulness-based intervention designed to help individuals with intellectual disability (ID) regulate their emotions during times of distress. Three single-case experimental studies suggest SoF can reduce physical and verbal aggression in adolescents with PWS. The present study aims to evaluate the feasibility and acceptability of the SoF intervention and data collection. Information collected in this study will be used to direct a wait-list randomised controlled trial.