ANZCTR search results

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

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31373 results sorted by trial registration date.
  • Increasing rates of eating disorder detection and treatment in adolescence

    This research has the overall aim of identifying strategies to facilitate the detection and early treatment of eating disorders and related mental health problems in adolescence. It is being implemented in two phases. Phase 1 aims to identify barriers to the detection and treatment of eating disorders and related mental health difficulties in adolescence, with reference to data from adolescents, parents and teachers. This phase involves online questionnaire completion. Phase 2 aims to evaluate the effectiveness of a school-based intervention designed to facilitate the early detection and treatment of eating disorders and related mental health difficulties. This second phase takes the form of a randomised controlled trial comparing a 5 month school-based intervention to a waitlist control group. The waitlits control group will receive the intervention after a 5 month waiting period.

  • Study of increasing doses of genetically modified GD2-specific T cells in patients with metastatic melanoma and refractory solid tumours

    The main aim of this Phase I study is to assess the safety and immune effects of using autologous peripheral blood T cells in GD2 positive patients with metastatic melanoma or refractory solid tumours. Patients who are BRAF positive will be given being treated with dabrafenib and trametinib. These inhibitors are proving to be effective in the up to 60% of malignant melanomas that are found to have a BRAF mutation. However, drug resistance is emerging and many patients relapse affirming the need for further treatment development. Who is this study for and who is it open to? This study is for patients with metastatic melanoma who are BRAF V600E/K/R/D positive or negative, or other GD2-positive malignancies. Those who are BRAF positive must be eligible to receive dabafenib and trametinib Patients who consent to the study will be asked permission to test their archived tissue for GD2 expression. If this test returns a positive result, the patient may then continue with the trial. What will the patients receive? BRAF positive patients will receive dabrafenib 150mg bd and trametinib 2mg od during the 3 week period in which the T-cell product is being prepared. Once produced, the T-cell product will be given as a single intravenous infusion at a dose relevant to the cohort that the patient has been assigned to. The patient will then be monitored as per the follow up schedule specified by the study protocol. For patients who are BRAF negative and not receiving dabrafenib or trametinib, they may potentially receive two further doses of the T-cell product.

  • A Longitudinal Study into Physical Activity and Cardiovascular Risk in People with Stroke

    Stroke is a major cause of disability in Australia, it affects over 50,000 people annually. Stroke survivors are at increased risk of health problems, particularly a second stroke. Many of the risk factors for a second stroke, such as smoking, poor diet and lack of physical activity could be reduced with increased awareness, education and support. We plan to conduct a longitudinal study to investigate physical activity levels and cardiovascular risk factors in the 2 years following discharge from therapy after first ever stroke. Participants will be reviewed at baseline and at 6, 12 and 24 months following this. They will answer questions around their medical history and health status, complete questionnaires, have physical measurements taken (for example, blood pressure and walking tests) and be given activity monitors to wear for 5 days. At the baseline, 12 and 24 month assessments they will also be asked to have a blood sample taken within the following week. We hope to identify relationships between physical activity, cardiovascular risk, physical function and fatigue levels. This study has not previously been undertaken and will provide essential information for clinicians, allowing them to target their interventions to specific risk factors and reduce risk of further stroke. If a link between physical activity and cardiovascular risk is demonstrated, a strong rationale will be provided for therapies that improve physical activity participation.

  • New diagnostic techniques in liver cancer

    Cancer of the liver is becoming more common in Australia. A PET scan is used to diagnose many forms of cancer, but it is not commonly used in cancer of the liver. This study aims to determine whether a PET scan is an accurate way of diagnosing cancers of the liver by performing this scan on someone who we know already has a cancer of the liver. We will also see if a PET scan can provide other pieces of information about the liver cancer that we do not already have. Finally, we will investigate whether a second PET scan done after a certain type of treatment for the liver cancer will tell us whether that cancer has responded to the treatment. If the results from the research project are encouraging, we will begin larger trials. Hopefully in the future, PET scans in liver cancer will become an important part of management and will improve the outcomes for patients with this disease. Who is it for? You may be eligible to join this study if you are aged 18 to 90 years old, with newly diagnosed Hepatocellular Carcinoma (HCC), Barcelona-Clinic Liver Cancer Stage O, A or B, and considered for transarterial chemoembolisation, radiofrequency ablation or resection Trial details In this study, you will receive an 18F Fluorodeoxygluose (FDG) Positron Emission Tomography (PET) scan, as well as an 18F Fluorocholine (FCH) Positron Emission Tomography (PET). One group of participants will receive both scans performed at the time of diagnosis, and a second group will receive both scans performed at the time of diagnosis followed by a second set of scans performed after standard care transarterial chemoembolisation

  • The effects of Mindfulness training people recovering from alcohol dependence.

    While effective treatments are available for mild levels of alcohol and drug dependence the repeated and persistent, long lasting nature of the disorder often involves people attending groups to prevent relapse. One type of approach considers whether by learning to accept and just notice the cravings for substances, instead of trying to suppress or fight off the cravings, makes it easier for people to use different or opposing behaviours to prevent relapse. This study examines the effect of an eight session programme designed to disrupt thoughts, feelings, and bodily functions implicated in stress-initiated relapse to alcohol consumption.

  • Evaluating web-based pelvic floor muscle education for pregnant women

    In 2008 in Western Australia (WA) there were 30,234 babies born. Pregnancy is a period when the pelvic floor muscles (PFM) are stretched and weakened which may lead to PFM dysfunction causing urinary incontinence. During pregnancy PFM exercises are the recommended treatment to strengthen the PFM and reduce the risk of developing urinary incontinence. Accordingly, pregnant women are encouraged to attend antenatal education which typically includes information on the function and facilitation of the PFM. This study will examine the effect of providing web-based education on pelvic PFM function and PFM exercises for pregnant women in WA. The pregnant women will be evaluated on the knowledge, awareness, intention, self-efficacy and adherence to the PFM exercises. If pregnant women can successfully use web-based PFM education during pregnancy then people with PFM dysfunction and incontinence can be guided to an appropriate evidence-based website. This may improve quality of life for women. Hypotheses: H0: There will be no difference in awareness and knowledge gained on the function of PFM in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care in WA H1: There will be an increase in awareness and knowledge gained on the function of PFM in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care in WA H0: There will be no difference in confidence and motivation to engage in PFM exercises in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care H1: There will be an increase in confidence and motivation to engage in PFM exercises in pregnant women who undertake a web-based PFM intervention programme compared to pregnant women who only receive usual care H0: There will be no difference in adherence with PFM exercises by pregnant women who undertake a web-based, PFM exercises intervention programme and pregnant women who only receive usual care in rural WA H1: There will be an increase in adherence with PFM exercises by pregnant women who undertake a web-based, PFM exercises intervention programme and pregnant women who only receive usual care in rural WA

  • Sleep, Lifestyle, Energy, Eating, Exercise Program for the management of sleep apnea patients indicated for weight loss treatment: A randomised, controlled pilot study.

    This trial will investigate the effect of two different diets for patients with obstructive sleep apnea who are trying to lose weight. This study will look at changes in sympathetic activity (which controls your fight or flight response) as well as assessing your cardiometabolic health and disease risk factors. All participants who choose to enrol in the study will follow a very low energy diet for three months followed by nine months of free health coaching and weight loss therapy delivered by an accredited exercise physiologist and nutritionist. Those who proceed with the trial will be randomised to a low glycemic index/high protein diet or a standard low calorie diet based on the Australian guide to healthy eating after following a very low energy diet for three months.

  • Does statin use have a disease modifying effect in symptomatic knee osteoarthritis? A multicentre randomised, double-blind, placebo-controlled trial

    The aim of this randomised controlled trial is to determine whether statins slow the progression of knee osteoarthritis. The hypothesis is that atorvastatin use will reduce the rate of knee cartilage volume loss over 2 years compared with placebo in people with symptomatic knee osteoarthritis.

  • The association between Neuropeptide Y (NPY) peptide/ Gut Hormones and skeletal health

    This study will directly compare changes in bone mass caused by intense medical treatment for obesity and by three different types of weight loss surgery (gastric banding, gastric sleeve and gastric bypass). The aim is to determine the future risk of bone loss and osteoporosis in patients who lose a large amount of weight after the weight loss surgery and through intense dieting. As surgery has been increasingly used for treatment of obesity, there is growing evidence that these procedures may result in bone abnormalities. This project will examine if hormonal changes related to surgery have an effect on the human skeleton, particularly on thickness or strength of bones. In addition, it may explain whether changes hormones (peptide YY, ghrelin and glucagon-like peptide1) are responsible for the bone mass loss, which is experienced after these procedures, independently of weight loss. This study will also investigate if the weight loss and rapid improvement in diabetes control observed after gastric bypass surgery are driven by the changes in hormones such as leptin and peptide YY. Importantly, our study will pave the way for development of diagnostic test, which will predict if the prospective patient will benefit (or not) from the different forms of weight loss surgery.

  • Telehealth Remote Monitoring for People with Multiple Chronic Conditions

    The study is a randomised controlled trial of telehealth remote monitoring for people with multiple chronic illnesses. The patient is provided with equipment and trained to measure their vital signs daily which are then reviewed remotely through a secure website by a nurse. The aim is to promote early intervention to detect deterioration in the client’s condition before they require hospitalisation. It also aims to empower older individuals to take a more active role in managing their chronic illness.

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