ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Magnetic Resonance Spectroscopy of Post Traumatic Stress Disorder.

    Post-Traumatic Stress Disorder (PTSD) is a complex condition where sufferers are affected by a varying range of symptoms following an exposure to a traumatic situation or event. Sufferers may experience symptoms such as recurrent and intrusive thoughts, nightmares, flashbacks, or distress and avoidance of situations that are similar to the event that first occurred. It is not yet known why some people experience PTSD following a traumatic event and others do not. This research study aims to try to determine if the chemicals that allow the brain to carry out its normal functions are different in a person who suffers from PTSD when compared to a person who does not. In this study researchers will use a technique called Magnetic Resonance Spectroscopy (MRS) to look for any changes in the normal chemistry of the brain. The researchers will then compare the images obtained from participants who have PTSD with those who do not. The researchers conducting this study hope that by using MRS to look for and isolate any abnormalities in the brain chemicals of those with PTSD this may lead to improvements in the diagnosis and treatment for PTSD suffers in the future. MRS is a non-invasive medical test. It is conducted on the same machine as conventional Magnetic Resonance Imaging (MRI) scans. The MRI scan uses a powerful magnet, radio waves, and a computer to create detailed images. MRS is a series of tests that are added to an MRI scan to measure the chemical properties of molecules in cells and tissues. In this study MRI will be used to take anatomical images of your brain and MRS will be used to provide detailed information about the nature and chemical environment of the molecules in your brain.

  • Compassion at the heart of well-being: an inter-disciplinary study to evaluate the effect of a meditation intervention and a positive psychology intervention on well-being and compassionate care among healthcare employees

    This RCT compares two interventions designed to enhance nurse well-being and compassion with a control group. Nursing teams will be randomized into one of three conditions: a) a meditation training program, b) a positive psychology training program and c) a wait list control group. Pre-, post- and 4-month follow-up self-report measures of nurse well-being, compassionate care and related measures will be administered along with physiological measures of nurse heart-rate variability. In addition, ethnographic interviews and ethnographic observations will be undertaken along with semi-structured interviews with nurses regarding their experiences of compassionate care, Lastly, the study will explore the effects of the interventions on compassionate care among nurse-patient dyads and among nurses' broader social networks.

  • The relationship between changes in the neural mechanisms associated with pain and the improvement in clinical symptoms of Achilles tendon pain.

    The proposed research aims to provide insight into the mechanism(s) behind the improvement patients with Achilles tendon pain experience from rehabilitation. Specifically is there an association between the neural mechanisms associated with pain. Therefore this body of work may enable clinicians to more effectively understand the mechanisms which drive improvement in pain and function in people with Achilles tendon pain. Investigating these mechanisms of action may serve to refine and optimise rehabilitation strategies to improve outcomes.

  • What are the effects on carbohydrate digestion and absorption of variations in the salivary amylase gene in healthy adults?

    The aim of this study is to identify the variation of the salivary amylase (AMY1) gene copy number in the Australian population and to investigate the effect of AMY1 copy number on carbohydrate digestion, acute metabolic and satiety responses, and potential associations with obesity and diabetes risk. This project will screen Australian adults for their number of copies of the AMY1 gene. This gene produces a protein, salivary amylase, which is secreted in the mouth and begins starch breakdown. Individuals with varying AMY1 copy numbers will be asked to perform a series of starch challenge tests during which they will consume different high carbohydrate foods. Fingerprick blood samples will be taken at regular intervals over 2 hours to measure their metabolic responses to starchy foods. To assess the efficiency of starch digestion, salivary amylase activity, breath hydrogen and methane responses, and postprandial glucose and insulin responses will also be assessed over an 8 hour period following the consumption of different high carbohydrate meals. Information on how AMY1 copy number influences carbohydrate metabolism and usual dietary intake may have important implications for the dietary management of diabetes and obesity and/or identify those at greater risk of developing these conditions.

  • Primary school Physical Education and Physical Literacy (PEPL) support system: a quasi randomised controlled trial

    The Physical Education Physical Literacy (PEPL) project evaluates a support system designed to assist primary schools to create a physically active culture, increase student opportunities for physical activity, and to enhance the content and delivery of physical education. This study continues on from a previous research project conducted in Victoria (ACTRN12615000066583) The system is guided by a PEPL coach - an expert physical educator working in a network of 8 schools who tailors the support system to meet individual school needs. The objectives of the PEPL coach include: 1) Develop a school climate that understands the benefits of PEPL for student learning and development 2) Provide in-class lesson modelling and professional development for the generalist classroom teacher 3) Increase opportunities for students to take part in physical education and physical literacy activities outside of physical education time 4) To develop relationships between schools, community organisations and sporting clubs

  • The effect of high carbohydrate and low carbohydrate suppers on fasting blood glucose levels (BGLs) in gestational diabetes mellitus (GDM): GDM Supper Study

    Diabetes in pregnancy is the most common metabolic dysfunction in pregnancy. Many women are managed with diet control alone. It is therefore essential that women are receiving accurate nutritional advice. Current practice at our hospital is to advise women to have a bedtime snack to help meet the caloric requirements of pregnancy, and with the expectation that it may suppress hepatic gluconeogenesis thus achieving lower fasting blood glucose levels (BGLs). Recommending supper in GDM is widely practiced across Australia and is contained in the Dietitians Association of Australia resources, and supported by the Canadian and American Diabetes Associations’ Guidelines; however, there is no strong or recent evidence to support this. This study aims to recruit 66 women and measure the effect of two different snacks: a higher carbohydrate snack (apple and yoghurt) and a lower carbohydrate snack (nuts and dark chocolate) as compared to no snack, to see what influence each of these has on fasting BGLs. Each snack will be consumed for five consecutive days. Women will be randomly allocated an order in which to consume each snack. Women will also be required to record their activity levels each day, in order to monitor the effect that this has on fasting BGLs It is expected that women will have lower fasting BGLs when consuming either snack than when they are not having a snack. It is also expected that those women with higher physical activity levels will have lower fasting BGLs.

  • Measuring the effects of the Silence is Deadly program on mental help-seeking attitudes in young men

    The largest mortality risk facing young men is suicide, and their unwillingness to seek help for their mental health troubles greatly exacerbates this problem. Rather than blame men for their poor attitudes, some organisations are changing the nature of the public health message directed at young men to make it more male friendly. It is not known whether these interventions are having a positive effect on mens help-seeking attitudes and intentions, particularly among young men with indicated mental health problems, those with more stigmatising attitudes, or those who conform more strongly to gender norms. The current research project seeks to evaluate one such existing intervention, the Silence is Deadly Program, which has been delivered in ACT schools since 2014. This intervention is delivered by not-for-profit organisation Menslink in partnership with the state representative rugby league team (the Canberra Raiders) and uses role-modelling and social norming, as well as male-tailored vocabulary, to influence young mens help-seeking attitudes and intentions. The proposed research project will be conducted in 2017-2018, and will comprise a cluster randomised wait-list control trial that involves 8 ACT schools, totalling 800 male students who will be surveyed pre, post and three months after the intervention. The primary aim of the study is to determine the effectiveness of this tailored approach to suicide prevention and identify if it is differentially effective for participants with different levels of mental health symptoms, suicidal thoughts, stigmatizing attitudes towards seeking help and adherence to gender role norms. This analysis will be complemented by a qualitative investigation into the interventions effect on the culture of helping seeking in the school through semi-structured interviews with staff members. The research team has a strong track record of research in schools, service evaluation, stigma and help-seeking for mental health issues and suicide.

  • Lisdexamfetamine for the treatment of methamphetamine addiction

    Australia has one of the highest rates of methamphetamine dependence in the world. While counselling is effective for many people with less severe dependence, there is no proven medication treatment for severe dependence. Lisdexamfetamine is a stimulant of the brain and is approved in Australia for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is a once-daily oral medication converted to dexamphetamine in the blood. The aim of the LiMA study is to test if lisdexamfetamine is effective in reducing methamphetamine use, cravings and withdrawal symptoms in people who are dependent on methamphetamine. This will be a randomised double-blind placebo-controlled study which means that one group will receive lisdexamfetamine and another will receive a placebo (a medication with no active ingredients), in addition to counselling. Participants, clinicians and researchers involved in the study will not know to which group they have been allocated. The two groups will be compared and the findings will contribute to evidence for the future use of lisdexamfetamine in the treatment of methamphetamine dependence. 180 people will be recruited to the LiMA study which will be conducted in specialist treatment centres in Sydney, Newcastle and Adelaide. It is anticipated that recruitment will start in early 2017.

  • Validation of Whole Blood Point of Care B-hCG Testing for Pregnancy Using Urine Pregnancy Assay in Women of Reproductive Age Presenting to the Emergency Department

    Anecdotally, whole blood can be used on point of care cartridges for rapid determination of a patient's pregnancy status. Early identification of pregnancy status is important in the case of females of reproductive age with abdominal pain, as the possibility of a pregnancy (including an ectopic pregnancy) can be quickly included or excluded. The manufacturers of the point of care testing cartridges, however, state that these can only be used with urine or serum, both of which there is often a delay in obtaining. This study aims to validate the use of whole blood for rapid point of care investigation for pregnancy. The hypothesis is that the whole blood point of care testing will have similar sensitivity and specificity to lab serum testing for detection of pregnancy.

  • Dynamic and static functional imaging and morphological imaging in Neuroendocrine Tumour (NET) with known liver metastases.

    The aim of this study is to compare the accuracy of novel, dynamic and static functional imaging, and also morphological imaging, with standard of care imaging for the detection of liver metastases in patients with neuroendocrine tumour (NET). Who is it for? You may be eligible to join this study if you aged 18 years or above and have been diagnosed with histologically proven WHO Grade I or Grade II NET with known liver metastases. Study details All participants in this study will receive three scans on a single day: an initial PET-MRI Scan, followed by a PET-CT Scan, and then a final PET-MRI Scan. For the initial PET-MRI scan a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast. The scan involves lying flat with knees supported and arms resting by your side. You will be scanned from the top of your head to the middle of your thighs. The scan time for the PET-MRI will be approximately 45 minutes. The PET-CT scan involves lying flat and takes approximately 30 minutes to scan you from the top of your head to the middle of your thighs. The final PET-MRI scan will not require any further injections. This scan will go from the top of your head to the middle of your thighs and should take approximately 30 minutes. This scan is performed to directly compare the PET-CT images to the PET-MRI images. The images generated will be independently reviewed by trained Nuclear Medicine physicians partaking in the study to count the number of liver metastases. It is hoped that additional dynamic PET may further increase the sensitivity of detecting liver metastases. This may potentially influence treatment options in individual patients, including possibly avoiding futile surgery in patients with more extensive disease burden than detected on current standard imaging

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