ANZCTR search results

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

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32850 results sorted by trial registration date.
  • Measuring skin and tissue change before and after compression: a comparative study of people with and without primary lymphoedema

    Primary lymphoedema occurs in people with a genetic predisposition and manifests as long-term swelling of a body part. Current assessments provide little understanding of the composition of the underlying tissues and how they respond to treatments. No information has been available about the difference between those with and without lymphoedema with respect to age and skin properties. This study will use high frequency ultrasound (HFU) to investigate differences in skin composition and thickness in people with and without primary lymphoedema. The measures to be used include clinical tools which measure dermal properties (skin resistance and elasticity, and measures of water content and limb volume). The response of the skin to compression, a standard lymphoedema intervention, will then be assessed with HFU and clinical assessment tools, following the application of intermittent pneumatic compression. Children and adults with and without primary lymphoedema, aged between three and 40 years old, will be included. Analysis of clinical tools for a measure of equivalence with HFU findings will inform the use of clinical tools and enable translation of study findings to the clinical setting. Compression is used in healthy populations to support limbs during travel and sport: inclusion in this study of both the healthy population and the understudied childhood lymphoedema population will add to the understanding of the effect of compression on the skin for all groups and form the basis for targeted treatment guidelines. Most lymphoedema research has investigated secondary lymphoedema, despite there being strong growing evidence of underlying genetic predisposition or covert primary lymphoedema in those who develop secondary lymphoedema. The findings of this study will provide a basis for understanding the progression of primary lymphoedema and inform future primary and secondary lymphoedema research.

  • Comparing two approaches (Cogsmart and CirCuits) to improving the cognitive deficits of people diagnosed with psychosis.

    This clinical trial will look at which of the two therapies works best in improving thinking skills (e.g. memory and attention) which influence real world functioning. The two therapies are Cognitive Symptom Management and Rehabilitation Therapy (Cogsmart) and Computerised Interactive Remediation of Cognition – Training for Schizophrenia (CIRCuiTS). Cogmsart is a group therapy that aims to improve real world thinking skills for functioning. CIRCuiTS is a computerized program with modules including tasks of a wide range of cognitive functions. It also includes “bridging” were participants in the group reflect on how the program relates to thinking skills needed in real world functioning. What are the possible benefits of taking part? We cannot guarantee or promise that you will receive any benefits from this clinical trial; however your participation will help us better understand if Cogsmart and CIRCuiTS are effective in improves thinking skills that help in every day functioning for people who suffer from psychosis. What does participation in the study involve? This clinical trial will randomise participants in a 1:1 design, which means there is an equal chance of being in either the Cogsmart or CIRcuiTS group. Step 1 Screening Process To determine Initial study eligibility you will partake in a screening interview which will take approximately 30 minutes. Step 2 Contact You will be asked to attend group sessions either once a week for 12 weeks, with each session lasting approximately 2 hours, or twice per week for 12 weeks, with each session lasting approximately 1 hour. You will also be asked to attend three sessions as an individual. At each individual session a clinical trial research assistant/psychologist will conduct a series of clinical assessments. This will involve asking questions about your thinking and problem solving skills, thoughts, symptoms, and relationships.

  • Outcomes evaluation of the Victorian Healthy Homes Program: a staggered parallel group cluster randomised controlled trial assessing the thermal comfort and health benefits of home energy efficiency improvements

    The Victorian Healthy Homes Program will focus on better understanding the combined health and energy outcomes of household energy efficiency retrofit programs targeted at vulnerable householders. The evaluation will also include health economics analyses. The two overall aims for the outcomes evaluation of the Victorian Healthy Homes Program are to: (1) measure the health and energy co-benefits of improved thermal comfort among low-income households where at least one person has an existing health need and (2) provide a monetarised estimate of these health and energy co-benefits to inform future government household energy efficiency policy and programs.

  • My Exercise My offspring (MEMO) study: a randomised controlled trial to evaluate the effectiveness of a physical activity program for pregnant women

    The MEMO study is a randomised controlled trial that will evaluate the effects of a physical activity intervention on short-term maternal and neonatal outcomes, as well as maternal physical activity levels at 6 months and 1 year postpartum. Women up to 18+6 weeks of gestation attending the Liverpool Hospital antenatal clinic will be recruited. The primary maternal outcome is the incidence of gestational diabetes mellitus (GDM) and the primary neonatal outcome is the incidence of macrosomia (>4000g). Secondary outcomes include: physical activity level (distance walked and number of steps taken weekly), percentage of participants with GDM requiring pharmacological treatment, gestational weight gain, incidence of labour induction, mode of delivery, incidence of third or fourth degree tears, incidence of pre-eclampsia, incidence of gestational hypertension, incidence of placental abruption, incidence of postpartum haemorrhage, HbA1c at 36/37 weeks in women with GDM. The Edinburgh Postnatal Depression Scale will be administered at 24-26 weeks of gestation and again at 34-36 weeks of gestation. At 24-26 and 34-36 weeks of gestation, as well as 6 months and 1 year postpartum, maternal exercise habits and patterns will be assessed using a survey. Patient satisfaction will be assessed using the MEMO Study Patient Satisfaction Survey to be administered at 8-10 weeks postpartum.

  • Comparing a novel videolaryngoscope with the Macintosh in simulated difficult airway: a manikin study

    Airway or respiratory complication is one of leading causes of morbidity and mortality in anaesthesia. There are different techniques and intubating equipment (laryngoscope) available for anaesthetists to deal with difficult airways. Anaesthetists use their knowledge and previous experience to decide which type of laryngoscope to use in these cases. In this study, we are evaluating, for the first time, this newly available videolaryngoscope. It requires a technique called "indirect laryngoscopy". We are comparing it with the standard direct laryngoscopy by using the Macintosh blade. We hypothesise that In simulated difficult airways, the novel videolaryngoscope achieve a better laryngoscopy view as compared to the Macintosh blade. We will prospectively recruit 30 voluntary anaesthetic residents, registrars or consultants for this study. All participants will be tested on using each of the two intubation devices on a manikin with a simulated difficult airway. Participants will be assigned to one of the two groups – Group 1: novel videolaryngoscope followed by Macintosh laryngoscope, or Group 2: Macintosh laryngoscope followed by novel videolaryngoscope. The primary outcome is the best laryngoscopy view achieved. Secondary outcomes include: • The time taken for successful tracheal intubation. • Number of failed intubation. • Number of intubation attempts. • Number and type of intubating adjuncts used. • The ease of intubation, which will be surveyed using a visual analogue scale from 0-100mm.

  • Music Interventions for Dementia and Depression in Elderly care

    This project is investigating how music impacts levels of depression and symptoms of dementia in older people living in residential aged care facilities. It is part of larger international study involving European investigators. The project will study the impact of music on wellbeing for 500 older Australians living in residential care facilities in Australia over a 12-month period. Each facility participating in the study will be randomized into one of 4 groups (1. small music therapy group, 2. recreational group singing, 3. small music therapy group and recreational group singing, 4 standard care). Over the 12-month period, we will be collecting a range of data that will help us understand whether music has or has an effect on participants' mood, quality of life, and symptoms of dementia. Moreover, we will be asking care staff working with participants on a regular basis to complete questionnaires over the 12-month period, to help us understand the impact of the music intervention on caregivers' wellbeing and burden.

  • The Role of Skeletal Muscle in the development of Insulin Resistance in Women with Polycystic Ovary Syndrome

    Polycystic ovary syndrome (PCOS) is an ill-defined endocrine condition impacting metabolic, reproductive and mental health. The condition affects up to 18% of women of a reproductive age in Australia depending on the diagnostic criteria applied. The condition is associated with a number of morbidities including subfertility, pregnancy complications, insulin resistance, type 2 diabetes mellitus, psychological disorders (depression and anxiety), and increased risk of cardiovascular disease. The aetiology of PCOS remains unknown however there are a number of contributing factors and hypothesis from environmental factors, genetics and in utero developmental programming. Given the complex nature of PCOS attempts have been made to identify biomarkers to determine the severity and improve diagnosis. Women with PCOS are 27% less insulin sensitive than matched controls and insulin resistance is present in ~85% of these women irrespective of obesity. demonstrated that PCOS aetiology is underpinned by insulin resistance and is independent of, but exacerbated by obesity. However, the mechanisms of insulin resistance in PCOS is ill-defined and contributes to its exclusion from diagnostic criteria. insulin resistance in PCOS is currently treated by lifestyle intervention (diet and exercise), and insulin-sensitising medications, but the evidence shows that the efficiency of these therapies in PCOS is ineffective. This study aims to provide novel insights into the mechanisms of insulin resistance that will allow the design of therapies and interventions to treat PCOS. To yield human data to advance understanding of PCOS aetiology. This will be achieved by investigating the role of TGF-beta signalling and tissue fibrosis in insulin resistance in women with PCOS.

  • Effect of 12-weeks supplementation with Superba™ Boost, a novel omega-3 supplement derived from krill oil, on omega-3 index and fatty acid biomarkers in healthy individuals

    The purpose of the present investigation was to examine the effects of a krill oil supplement on omega-3 index and other fatty acids and whether there are any differences according to age, body weight and gender.

  • The Climate Schools Plus Study: Evaluating an online, combined student-parent substance use prevention program

    The aim of this project is to evaluate the efficacy of Climate Schools Plus (CSP), a novel online program for parents and students to prevent adolescent substance use and related harms. CSP combines an effective student program, the Climate Schools: Alcohol and Cannabis course with a new parent program recently developed by our team. The parent program is delivered online and consists of webinars, modules, summaries of student materials, and a rule ranking component. The study will be run in 12 schools across NSW and QLD. The CSP intervention will be compared to standard Personal Development, Health and Physical Education, the control condition. The RCT will be conducted over three years with the delivery of an Alcohol module in Year 8, and an Alcohol and Cannabis module in Year 9. This is the first Australian trial of a combined student-parent program to prevent substance use and related harms, and the first trial, internationally, of a combined program which adopts an online delivery method.

  • What are the individual and combined effects of water drinking and Acarbose (a medication which blocks the breakdown of sugar in the small intestine) on the fall in blood pressure after a sugar drink, in volunteers who are known to have postprandial hypotension (a significant fall in blood pressure that occurs after eating)

    To determine in patients with postprandial hypotension (defined as a fall in systolic blood pressure >20mmHg within 2 hours of a meal) whether the magnitude of the fall in blood pressure and rises in heart rate and blood flow to the stomach in response to a drink of sugar (sucrose) are attenuated by both acarbose (an anti-diabetic drug which blocks the breakdown of sugar in the intestine, preventing its absorption) and gastric distension (by drinking a small volume of water) and if these effects are additive. We hypothesise that both gastric distension and acarbose will attenuate the fall in blood pressure, and these effects will be additive.

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