ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32707 results sorted by trial registration date.
  • Early detection of autism in toddlers within General Practice in Australia

    This 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.

  • Frailty-stratified, randomised controlled Bayesian adaptive trial of bortezomib versus lenalidomide in transplant-ineligible myeloma (TI-NDMM) – the FRAIL-M study

    The 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.

  • Influence of a behavioural incentive and intensive education on the quality of bowel preparation prior to diagnostic colonoscopies

    Research 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).

  • 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

    The 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.

  • Magnetic brain stimulation for multiple sclerosis trial

    Transcranial 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

  • Neuropsychological Outcomes Following Acute Ischaemic Stroke

    The 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.

  • Anticoagulant (Apixaban Vs Warfarin) in prevention of nephrotic syndrome associated thromboembolism

    Incidence of venous thromboembolism (VTE) in adult nephrotic syndorme is 25-30% and this risk is inversely related to serum albumin (protein) level. This study will investigate whether apixaban (new oral anticoagulant) is as effective as warfarin which is prescribed routinely when patients serum albumin level is very low. Measurement of apixaban in this study will give a good insight into pharmacokinetic of the drug in nephrotic syndrome.

  • Narrow versus broad antibiotic treatment for diabetic foot infections (NvB-DFI)

    We plan to determine if narrow (targeted) spectrum antibiotics have the same outcomes as broad spectrum antibiotics when treating mild or moderate diabetic foot infections. We know through research that often diabetic foot infections have two main bacteria present, and more often than not, these infections can be treated with a narrow targeted spectrum antibiotic.

  • Effect of individualized injury prevention pograms on risk of athletic knee injuries

    An emerging body of research has shown promising effects of exercise-based injury prevention programs (IPPs) in reducing knee injury risk. However, the efficacy of IPPs as reflected in clinical trials have not been replicated in real-world practice largely due to lack of compliance and implementation support. Individualized IPPs targeted to specific biomechanical components may provide the most prudent and effectual implementation strategy by specifically targeting high risk groups. However, the individualization process is hampered by the absence of field-based objective screening methods to stratify risk according to trunk dominance deficits, and a lack of consensus on the ‘best’ combination of IPP components. Thus, the objectives of this study are 1) to identify the best combination of field-based tests to screen for trunk dominance deficits, and 2) to explore the effects of an injury prevention program individualized according to trunk dominance screening results in reducing knee injury risk in athletes. Study hypotheses: 1) that field-based tests for trunk dominance deficits are a valid and reliable alternative compared to three-dimensional biomechanical motion analysis; 2) that individualization of IPPs are more effective in decreasing trunk dominance deficits than generic IPPs

  • A randomised trial of a Carer End of Life Planning Intervention (CELPI) in people dying with dementia.

    Whist palliative care is highly effective for patients with dementia and their carers it is rarely accessed. We hypothesize that the provision of education, advance care planning and better referral to palliative care for carers will reduce the number of people with dementia that die in hospital and result in improvements in systems and patients centered outcomes. Therefore, this research is about increasing access to palliative care for a group of patients that are currently underrepresented.

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