ANZCTR search results

Knee osteoarthritis (OA) is a major public health problem with significant personal, social and economic burden. Being overweight is a known risk factor for the development and progression of symptomatic knee OA. One potential reason may be due to the increased forces placed on the knee joint during weight bearing activities in people that are overweight. The development of targeted treatments for people at high risk of disease progression, such as those who are overweight, is a research priority. Our primary aim will therefore be to evaluate whether people with knee OA and obesity respond differently to two different types of exercise; 1) weight bearing functional exercise and ii) non-weight bearing quadriceps strengthening exercise. Participants will be randomly allocated to one of the two exercise groups. Over 12 weeks participants will attend 5 in clinic physiotherapist appointments. The physiotherapist will prescribe a home based exercise program following the exercise protocol assigned to the participant. The home based exercise program will be completed 4 times a week, in addition to the physiotherapy sessions. Primary outcomes are overall knee pain and physical function measured at 12 weeks. As body mass index is easily measured our findings will potentially provide clinicians with a simple and effective means to tailor their exercise prescription and optimise outcomes for their patients with knee osteoarthritis.

There is an increasing number of people developing end-stage kidney disease in Australia every year. Peritoneal dialysis (PD) is the most cost-effective and user friendly form of dialysis, yet the rate of PD utilisation in Australia has been steadily falling since 2003. A major contributor to low referral rates by physicians to PD and relatively high rates of PD technique failure is PD related peritonitis. Studies in a number of countries have shown that peritonitis rates vary greatly between PD units (between 5 to 20 fold variation). With PD critically dependent on patient self-management, research is required into potentially modifiable peritonitis risk factors, including patient training. The primary objective of the TEACH-PD (Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes) pilot study is to refine the TEACH-PD training modules for PD patients and trainers. TEACH-PD pilot study is an investigator-initiated, single-armed, non-randomised, pilot trial assessing the use of training modules for both PD nurse trainers and incident PD patients undertaking PD training. A total of 10 PD trainers will be enrolled and at least 1 PD patient per trainer and at least 10 English speaking patients (between 10 and 20 patients in total) from PD units at John Hunter Hospital, New South Wales and Logan Hospital in Queensland. PD trainers will complete “train the trainer” modules during the study which have a focus on adult learning principals and be provided with Patient Training Manuals. Once the PD trainers are assessed for competency with the modules, the trainers will then instruct the incident PD patient using the Patient Training Manuals and practical demonstrations. The primary objective of this pilot study is to further refine the TEACH-PD training modules designed for PD trainers and patients. The TEACH-PD training modules were developed by the Home Network, a group of health professionals focused on identifying and addressing barriers to home dialysis. The study is being coordinated by the Australasian Kidney Trial Network (AKTN).

Background: Endoscopic ultrasound guided fine needle aspiration (EUS FNA) is a key component for the investigation and diagnosis of solid pancreatic masse. It has a proven track record for being safe with complications and tumour seeding being a rare occurrence. The sensitivity, specificity and diagnostic accuracy for pancreatic lesions in many studies is high and exceeds 85%. Studies aiming to optimize EUS FNA have compared several factors including needle size, the number of needles passes and suction versus slow-pull. Initial studies showed that the use of rapid on-site evaluation (ROSE) had the biggest impact with increased diagnostic accuracy and reduced needle passes. However more recent reports show conflicting results on whether ROSE actually does influence outcome in EUS FNA. ROSE has historically been performed using FNA needles with cytological assessment. The act of smearing specimens (a necessary step for ROSE) to prepare cytology slides using cell aspirates obtained from FNA needles can be done without difficulty after necessary training and experience. The fine needle biopsy (FNB) needle (the ProCore needle) was introduced to further improve upon EUS guided tissue sampling. It is designed to collect a larger amount of core sample tissue by having a reverse bevel near the tip. Several studies favour the EUS FNB needle over the classic FNA needle for obtaining more adequate histological specimens with a high diagnostic yield. Data comparing the performance of EUS FNB without ROSE versus EUS FNA with ROSE is currently lacking. With this in mind, needles that provide histological specimens with an excellent (>95%) diagnostic yield (thus negating the need for ROSE) are the ideal devices for obtaining EUS guided diagnostic tissue. We therefore aim to compare the diagnostic yield of solid pancreatic masses using EUS FNA with ROSE versus EUS FNB without ROSE. Hypothesis: EUS FNB without ROSE will have equal diagnostic accuracy to EUS FNA with ROSE, hence negating the need for ROSE when EUS guided tissue acquisition is performed with FNB needle for solid pancreatic masses. Aim: To compare the outcomes of EUS FNA with ROSE versus EUS FNB without ROSE for solid pancreatic masses. Design: This will be a prospective, multi-centre, randomized control trial involving 600 patients with pancreatic solid mass of more than 1cm. There will be 10 centres participate in the trial, each recruiting 60 patients per hospital. Patients at each site will be randomized to either: Group A, (n=30, total = 300) which will undergo EUS FNA with the standard 22G EchoTip needle with ROSE. Group B (n=30; total=300), which will undergo EUS FNB with the 22G ProCore needle without ROSE.

The aim of this project is to test the effectiveness of a seaweed dietary fibre extract on gut and metabolic health and, consequential effects on inflammatory related Palmoplantar / psoriatic Keratoderma symptoms. This study will follow the initial Bio-Belly Study 1, where we have already found significant outcomes in an overweight population. Improvements were seen in plasma cholesterol, inflammation and insulin, as well as a case study, anecdotal improvement to a psoriatic skin disorder. Therefore, we aim to demonstrate repeated efficacy of the seaweed extract in an independent sample population, and to increase the power by restricting it to overweight participants only, and not obese, as there was a larger effect size in the overweight population. In addition, we would like to recruit to test the anecdotal effect of improvement to psoriatic skin disorders found in the initial trial. We propose to undertake a randomised placebo controlled crossover trial, with two six week treatment arms. Therefore the trial in its entirety will last 12 weeks.

Cystic Fibrosis (CF) is a complex, progressive, life-limiting disease that predominantly affects children and young adults. ‘Flare-ups’ of CF lung disease are common in people with this condition and often lead to admission to hospital and decline in lung capacity, imposing considerable burden on patients, their families and the healthcare system. Physical activity (PA) participation is a low-cost, easily accessible treatment option that has the potential to reduce the impact and progression of chronic lung disease in CF and may help reduce ‘flare ups’ of lung disease. However uptake and adherence to PA and exercise rehabilitation programs by young people with CF is poor. Advances in Internet technology and accessibility have made it possible for people to receive specialist medical care and rehabilitation therapy without attending the hospital. By using a secure website, readily accessible on any smartphone, tablet, laptop or computer it is possible for young people with CF to track their PA participation and receive feedback – at any time and place of their choosing. The aim of this project is to determine whether use of an online program to track PA participation and provide feedback, is more effective than usual care at improving PA participation, exercise capacity and quality of life, and prolonging the time to next hospital admission. People who agree to take part in the study will be randomly allocated to use the online program via the Internet, or to usual post-hospital care. At the beginning and end of the 12 weeks of the intervention phase, and at 3-months post completion of the intervention period, all participants will undergo measurements of PA participation, exercise capacity and health status. At 12 months- post completion of the intervention, hospital medical records will be reviewed to determine the frequency of hospital admission and number of hospital days. It is hypothesized that: 1. The web-based intervention will improve uptake and participation in PA by young people with CF. 2. The web-based intervention to increase PA will lead to improvements in exercise capacity, lung function, quality of life, anxiety and depression and sleep quality in young people with CF and reduced health care utilisation for this group in the 12 months post intervention.

This study aims to assess whether subcutaneous immunoglobulin (SCIg) replacement therapy is an acceptable alternative to intravenously immunoglobulin (IVIg) replacement therapy in terms of safety and efficacy in chronic lymphocytic leukaemia (CLL) patients with acquired hypogammaglobulinaemia. Who is it for? You may be eligible to join this study if you are aged 18 years, have a diagnosis of chronic lymphocytic leukaemia (CLL) and are currently receiving IVIg. Study details Study participants will be allocated by chance to one of the three groups. One group will continue receiving IVIg monthly for at least 12 months (their usual care). Second group will receive SCIg (Hizentra®) weekly for at least 12 months and third group will receive SCIg (Hizentra®) fortnightly for at least 12 months. Safety and efficacy measures including evaluations of blood samples and completion of questionnaires will be collected over a 12 month period. This study will address whether SCIg is an acceptable alternative to IVIg in terms of safety and efficacy in patients with acquired hypogammaglobulinaemia in the setting of CLL.

This is a stage 1b placebo controlled clinical trial investigating the safety and tolerability of an attenuated live hookworm vaccine. The study will be performed in two parts. Stage 1. The degree to which attenuation will impede the larvae’s ability to penetrate the skin in vivo is unknown. This is a dose escalation stage performed to de ne the optimal dose to be used in stage 2. The dose in cohort 1 will be 50 attenuated larvae dermaly applied to the volar aspect of the forearm, approximately 4 inches proximal to the thumb. Dose escalation will occur after safety review following completion of cohort 1. Cohort 2 will consist of 100 attenuated hookworm larvae applied in the same way. The optimal dose is defined as the number of larvae required to produce a grade 2 -3 dermal reaction. Cohorts of two participants will be enrolled and inoculated sequentially with attenuated hookworm. Safety and tolerability data will be collected and used to guide the escalation of dose for use in the next cohort. STAGE 2 Pilot randomised control trial 15 participants will be randomly assigned 1:2 to receive either 2 doses of placebo or attenuated larvae via dermal application 6 weeks apart. Albendazole will be administered 4 weeks following each inoculation. 6 weeks following the second dose all participants will receive a challenge dose of 30 normal hookworm larvae (15 larvae dermaly applied to each forearm). Albendazole 400mg (200mg tablets, Zentel – Glaxo-Smith-Kline) will be administered at the termination of the studyat week 11. Outcomes measured will include adverse events, faecal hookworm egg content and immune response

Gangliosides are compounds of fat and carbohydrate (glycolipids) that are an important component in cell membranes of most animals and humans. They are found particularly abundant in the plasma membrane of the brain and central nervous system and are recognised as having an important role in their development. Gangliosides occur naturally in our diet and are high in foods from animal origin such as dairy products, meats and eggs. Gangliosides are particularly high in human breast milk. Enhanced cognitive development in infants is seen as an area of particular interest with previous research demonstrating that feeding infants from age 2-8 weeks until 24 weeks of age with an infant formula enriched in gangliosides was associated with improved cognitive development and increased blood levels of gangliosides at the 24 week time point, relative to normal formula fed controls. The ultimate long-term goal is to optimise infant formula to replicate breast milk as closely as possible in both composition and impact on development. However, key information gaps exist regarding the bioavailability and absorption of bovine milk derived gangliosides from the gut and their impact on circulating levels of gangliosides. Addressing these gaps is the primary aim of this study. Furthermore, the validation of a finger prick dried blood spot method may provide a long lived viable alternative to venepuncture-derived blood as a vehicle for quantifying total ganglioside levels in blood samples. In parallel with finger prick blood sampling, saliva samples will be collected from participants to identify if gangliosides are a measurable entity in this fluid, derived in a minimally invasive manner. This study aims to: 1. Understand normal diurnal and day-to-day variation in ganglioside levels in healthy women of child bearing age 2. Describe the kinetics of uptake of bovine gangliosides after consuming a ganglioside-rich meal 3. Validate a finger prick dried blood spot method for measuring blood gangliosides (minimally invasive technique compared to venepuncture derived blood). Collect saliva samples in parallel with finger prick blood samples as a further minimally invasive measure of gangliosides.

A small number of patients who are brought to the emergency department need a general anaesthetic. This lets us help them by keeping their airway open, improve their oxygen levels and breathe for them on a mechanical ventilator. Some of these patients have injured or severely diseased lungs. In these patients, a protective ventilator setting (small volumes of breath at lower pressures) reduces rates of death and time on a ventilator. Other patients have normal lungs initially, but are at risk of developing lung disease whilst on a ventilator. The use of the same protective ventilator settings on these patients can reduce the development of severe lung disease, including infections and lung collapse. Currently, the ventilator settings in our emergency department are set by the bedside, treating clinician. These may not always be with protective settings. We aim to improve the quality of our care of our ventilated patients by optimising ventilator settings and increasing the frequency by which protective settings are used. This will be done by implementing a guideline (called ELVIS) designed to prompt clinicians and bed-side nursing staff to set the ventilator to patient-specific, protective values whilst promoting frequent reassessment of these targets and adjusting settings on a regular basis to meet the patients needs. This guideline has been developed by both Intensive Care and Emergency Medicine specialists. The ELVIS guideline will be used on all ventilated patients in the emergency department, unless the clinician believes an alternate method is safer based on their underlying lung disease. For example, asthmatic patients do not need a protective strategy and will not have the guideline used. Most ventilated patients are transferred from the emergency department to the intensive care unit. These protective ventilator settings will be continued in intensive care. This study aims to compare clinical data, ventilation settings and outcomes of patients ventilated according to the ELVIS guideline to those who were ventilated during the subsequent two years (2015-2016).

The aim of this study is to determine the effectiveness of an online self-management program on cancer-related fatigue in cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with a haematological malignancy, completed cancer treatment, and experience cancer-related fatigue. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive a 12-week web-based interactive self-management program, whilst participants in the other group will receive usual care. The self-management program provides comprehensive information and multimodal fatigue management strategies based on best evidence reflecting the recommendations of the recent American Society of Clinical Oncology guidelines for the non-pharmacological management of cancer-related fatigue. Participants will be followed-up at the end of the 12 week period to assess the impact of the program on fatigue. After waiting for a period of 12 weeks, the group who received usual care will be invited to participate in the online program for a total of 12 weeks.