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Effect of KFibre in heartburn
Expand descriptionK-fibreTM is produced in Australia by KFSU Ltd from sugar cane as a whole cane product. Informal observations of KFSU customers indicated that of K-fibreTM was effective in controlling of symptoms in heartburn or gastroesophageal reflux disease (GERD). Gastroesophageal reflux disease (GERD) is a condition that affects around 20% Australians and causes drastic reduction in quality of life.This preliminary human clinical study is proposed with a hypothesis that KFibre will reduce/control gastroesophageal reflux disease and associated heartburn or indigestion symptoms.
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Constipation after elective laparoscopy for benign gyneacological indications – a prospective observational study
Expand descriptionWe aim to investigate the prevalence of constipation in patients undergoing elective laparoscopy for benign gynaecological indications. We also aim to investigate the negative impact that this has as well as factors that may predispose to this This will be a prospective observation study. The participants will perform three surveys. Prior to surgery to assess baseline bowel function. One week post surgery to assess the immediate effect of surgery on bowel function. Three months after surgery to determine if symptoms are persistent or resolve
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Improving the diet quality: "My Nutrition Score" of Australian adults using a brief, online, tailored, nutrition messaging intervention: A Randomised Controlled Trial with a nested Cross-Over Trial study design
Expand descriptionCSIRO’s Nutrition and Health program conducts research to understand how we can do better to motivate and support people to improve their eating habits. Advances in technology means we are starting to move towards delivering online interventions which can reach more people and be tailored more easily for different people. For this project, we are testing tailored and standard nutrition messages delivered online, in a short 5-week intervention. We expect that a tailored intervention approach will be more effective in improving eating habits, compared to a standard 'one size fits all' approach. The findings from this project will help to guide the development of larger, digital programs which aim to improve the health and well-being of Australians.
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Immunoglobulin use and outcomes in Chronic lymphocytic leukaemia And Non-Hodgkin lymphoma - The ICAN Study
Expand descriptionThe purpose of this study is to evaluate the outcomes of immunoglobulin (Ig) therapy in people who have non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukaemia (CLL). In Australia, Ig therapy is commonly used to prevent infection in patients with CLL and NHL, but there is limited evidence from clinical studies to guide doctors on which patients are most likely to benefit, when treatment should start, and for how long it should continue. Whos it for? Individuals 18 years or older with newly diagnosed B-cell Non-Hodgkin lymphoma or Chronic Lymphocytic Leukaemia. Study Details Participants will attend their medical appointments at the discretion of their treating clinician. Data will be collected for the ICAN database at six-monthly intervals (6, 12,18 and 24 months) starting from the date of diagnosis. Additional assessments involve questionnaires about the participants quality of life. Participants of the biobank sub-study will be asked to provide non-fasting blood samples (30mL) at baseline (before treatment), 6-months, 12-months and 24-months. Once collected the blood samples will be stored for future testing and analysis. Results from this study will be valuable in assisting research that improves the prevention, diagnosis and treatment of infections in people with these illnesses.
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Early detection of autism in toddlers within General Practice in Australia
Expand descriptionThis project will synergise and build on existing State and Federal programs to identify barriers and develop mechanisms for accurate early detection of developmental problems including autism spectrum disorders (ASD) in Australia. The project will also evaluate an integrated model of care for ASD surveillance within the primary care setting of General Practice followed by standardised assessment and care pathways incorporating the national guideline for the assessment and diagnosis of ASD in Australia (National Guideline) for further assessment and early intervention. Developed and published by Autism CRC with the support of the National Disability Insurance Agency, the National Guideline aims to create greater consistency in diagnostic practices across Australia. Aims of the project 1. To work with key stakeholders to: (a) develop a method for ‘universal’ surveillance of ASD in 18- to 24-month-olds across Australia, and (b) carry out a “real life” evaluation of a care pathway for children at ‘high likelihood’ for ASD using the National Guideline. 2. To examine the Autism Surveillance Pathway (ASP) with regard to uptake and completion of the surveillance program and the accurate diagnosis of ASD against the current program (Surveillance as Usual [SaU]). 3. To determine acceptability, feasibility, and effectiveness of this surveillance protocol. A major outcome of this project will be the cooperation of various agencies and organisations, which will enable the embedding of the surveillance program within the existing health system and facilitate the long-term sustainability of the program. In addition, this project will allow the evaluation of the National Guideline. Currently, many children are missing early intervention opportunities. In this regard, it is noteworthy that the mean age of diagnosis for ASD in Australia is 49 months which urgently requires addressing. This is in part due to the extremely low uptake of the existing surveillance programs contributing to lack of access and opportunity for early detection with flow on effect on delay in intervention and consequent long-term effects. The significance of the project is highlighted by the fact that there is escalating economic impact of ASD both from health care and from a socio-economic perspective. Early identification and early intervention can provide significant buffers to assist children with ASD to reach their optimum potential and enhance school readiness in addition to preventing the cascade of a negative developmental trajectory and these difficulties becoming entrenched with secondary consequences such as academic failure, school absence, social dysfunction and forensic involvement. Long term, this work will undoubtedly be of enormous benefit to not only children with ASD and their families, but also to the wider society in terms of increasing human capital and reducing health, social and economic impacts.
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Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM) – the FRAIL-M study
Expand descriptionThe study utilises the infrastructure of a national clinical registry (Australian and New Zealand Myeloma and Related Diseases Registry) to enable identification of patients, efficient data collection, long-term follow-up beyond the trial and comparison with non-trial patients to assess study generalisability. The primary purpose of this trial is to assess appropriate treatment approach newly diagnosed with multiple myeloma with respect to frailty assessment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, have been newly diagnosed with multiple myeloma and are a candidate for chemotherapy but not for autologous stem cell transplant. Study details Eligible participants will be treated with their allocated treatment regimen (bortezomib or lenalidomide) through randmonisation. All patients will continue on treatment until the either the development of progressive disease (PD), unacceptable toxicity or withdrawal of consent. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the most appropriate treatment approach in the context of the Australian re-imbursement environment.
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Influence of a behavioural incentive and intensive education on the quality of bowel preparation prior to diagnostic colonoscopies
Expand descriptionResearch Aims: To test the effect of a patient reward system (Instant scratchie lottery ticket) or augmented education improves: a) quality of bowel preparations b) and the polyp detection rate To test whether the total SAGIS score correlates with the number of polyps found Research Design & Methods to Achieve Aims: During one calendar year 300 outpatients referred for a colonoscopy will be recruited who have consented to the study. The quality of bowel preparation will be scored via the Boston bowel preparation scale, which is the most extensively validated scoring system. Block randomisation will be used to allocate all patients consented on a given day into one of three treatment groups (Scratchie ticket lottery ticket reward vs. no reward vs. intensified education).
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A Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-729 Administered by Subcutaneous Injection to Subjects with Chronic Hepatitis B Infection
Expand descriptionThe study drug AB-729 is being developed as a potential new treatment for Chronic Hepatitis B (CHB). The main goal of the study is to determine whether AB-729 is safe and well tolerated when given at different doses. We will also measure the levels of the drug in the blood at different times. The study will be conducted in 3 parts. Part 2 will be an open-label, non-randomized, SAD design and will be conducted in up to 30 subjects with CHB infection.
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Magnetic brain stimulation for multiple sclerosis trial
Expand descriptionTranscranial magnetic stimulation is a safe and well proven technique used to treat a number of psychiatric and neurological disorders. It has never been trialled in MS. We have demonstrated that TMS may have an effect on the ability of brain cells to replenish the myelin sheath (the insulation surrounding nerve cells) which may thus help multiple sclerosis lesions to heal. This data is from animals and cell culture and has not been shown in humans. This study is a safety/tolerability study of TMS in humans to determine whether wee can give TMS to people with MS with acceptable tolerability and safety. We will also collect preliminary data on the effects of TMS on people with MS and their MRI scans
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Neuropsychological Outcomes Following Acute Ischaemic Stroke
Expand descriptionThe aim of the current study is to conduct a non-randomised three-arm parallel controlled clinical trial comparing the cognitive, emotional, and functional outcomes of acute ischaemic stroke patients treated with ECR and t-PA, as well as those who receive no treatment (neither ECR nor t-PA) in the acute phase.