ANZCTR search results

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

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31134 results sorted by trial registration date.
  • An Open Label Study of Participants with Moderate or Severe Cellulite to Evaluate Focal Contouring.

    A prospective study to evaluate the Focal Contouring System to determine whether it is safe and efficacious in reducing the appearance of moderate or severe cellulite on the thighs and buttocks.

  • Does a consumer co-created infographic improve knowledge and self-efficacy about physical activity for women with gestational diabetes mellitus?

    The goal of this research is to explore if a consumer co-created infographic (a visually appealing and easy to read and understand information resource) is effective in improving knowledge and self-efficacy about physical activity for women during a gestational diabetes mellitus (GDM) pregnancy. This is important because although physical activity is known to be beneficial to pregnant women with GDM more than 60% of women with GDM do not exercise as recommended. This study is being undertaken in response to the findings of a previous study reporting that women with GDM needed clear and simple information about physical activity during their GDM pregnancy. This research is designed as a randomised controlled trial with GDM Education classes being randomly allocated to either the intervention or comparator to evaluate the effectiveness, of an evidence based, consumer co-created infographic, on women's knowledge and self-efficacy (confidence) about physical activity during a GDM pregnancy.

  • Ovarian rejuvenation for menopausal or perimenopausal women using autologous platelet rich plasma (A-PRP) injection into the ovaries, for women seeking in vitro fertilisation (IVF) treatment, aiming to improve IVF outcomes.

    It is anticipated that ovarian rejuvenation using autologous platelet-rich plasma (A-PRP) injected into the ovaries will improve IVF outcomes in subsequent IVF cycles using mild ovarian stimulation for perimenopausal and menopausal women. In the non-randomised prospective trial, around 30mLs of your own blood (autologous) will be collected to produce around 4-5mLs of A-PRP. Around 2-2.5mLs of A-PRP will be injected into each ovary using transvaginal ultrasound guidance or laparoscopy, either at the same time as a transvaginal egg collection, or at a separate event. Follicle, egg and embryo numbers, pregnancy rates, and hormones levels (anti-mullerian hormone (AHM) and follicle stimulating hormone (FSH)) will be compared pre and post the injection of A-PRP.

  • Droperidol vs Ondansetron in Nausea Treatment in the Emergency Department (DONuT)

    Ondansetron is an anti-emetic drug that is commonly used in the emergency department to treat nausea and vomiting. Droperidol is an older anti-emetic medication where usage had fallen out of favour until recently, due to unfounded fears concerning QT prolongation. There is anecdotal evidence that IV droperidol is superior to ondansetron for treatment of nausea and vomiting. Although no difference was noted between the two drugs in a recent study, the dose of droperidol that was used was less that what would commonly be used in an emergency department setting. The question is if a higher dose of droperidol will likely demonstrate a difference.

  • Effect of KFibre in heartburn

    K-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.

  • Constipation after elective laparoscopy for benign gyneacological indications – a prospective observational study

    We 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

  • 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

    CSIRO’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.

  • Immunoglobulin use and outcomes in Chronic lymphocytic leukaemia And Non-Hodgkin lymphoma - The ICAN Study

    The 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.

  • 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.

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