ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Progesterone for transgender women

    Transgender individuals seeking feminisation (transfeminine individuals) are treated with estrogen and anti-androgen (testosterone blocker) to align their physical appearance with their gender identity. There has been increasing interest in the potential use of progesterone for transfeminine individuals, given anecdotal reports of improved mood and breast development. This project is a trial of micronised progesterone in transfeminine individuals treated with estradiol therapy. We aim to establish the influence of progesterone on sleep, psychological distress and breast development.

  • Structured Weight Management Program for Diabetes REmission Clinical Trial-Australia – (DiRECT-Aus Study)

    Primary objective To determine whether a program, designed to achieve remission of Type 2 Diabetes Mellitus to normal glucose tolerance by substantial weight loss using a very low energy diet (VLED), can be effectively delivered within the routine primary care setting where most people with Type 2 Diabetes Mellitus are managed. Secondary objective: To evaluate the attitudes of participants to the very low energy diet (VLED) program including acceptability, ease of use and perceived value.

  • Effect of enoxaparin (a low molecular weight heparin) given in a single or split dose, on stroke occurrence after unruptured brain aneurysm treatment utilising coils or stents

    Thromboembolic events are frequent adverse events in neurointerventional procedures such as cerebral aneurysm coiling and stenting. Ischaemic lesions are visible on MRI diffusion weighted imaging (DWI). These can be further characterised as clinically evident or clinically silent. They are clinically evident ischaemic lesions(CEIL) if a neurological deficit is present, or clinically silent ischaemic lesions (CSIL) if not. Most ischaemic strokes occur 4-12 hours post procedure. The overall incidence of DWI lesions post endovascular cerebral aneurysm treatment has been reported as 49-60% and the literature suggests that they can increase the risk of dementia and cognitive decline. To assess the efficacy of enoxaparin (a low molecular weight heparin) in prevention of thromboembolic events, patients will be randomised to receive one of two enoxaparin dose regimens post elective endovascular aneurysm treatment: (A) subcutaneous enoxaparin 1mg/kg at T=0 and T=12hrs (split dose); or (B) subcutaneous enoxaparin 1.5mg/kg (single dose) at T=0. T=0 refers to the end of the endovascular procedure. Each patient will have pre and post-procedure MRIs. The primary outcome of interest is the proportion of patients who have thromboembolic events assessed by neurological examination at 24 hours and MRI at 48hrs. Secondary outcomes include the frequency of puncture site complications and haemorrhage assessed through clinical monitoring. We hope to learn which enoxaparin dose regimen should be recommended to neurointerventionists.

  • A three-dose study of N-Acetyl-D-Mannosamine Monohydrate (ManNAc) in fasting conditions to determine the difference in absorption when dosed differently in healthy male participants

    N-Acetyl-D-Mannosamine Monohydrate (ManNAc). ManNAc is a sugar (monosaccharide) which is found in humans where it plays a role in the synthesis and maintenance of muscle. In particular, it facilitates a process called ‘sialylation’. It is being studied as a supplement to treat a condition known as GNE myopathy, a rare genetic disease which is characterised by progressive skeletal muscle wasting (atrophy) caused by lack of sialylation. In other words, the disease causes the wasting and weakness of muscle which affects movement and other bodily functions resulting in disability, wheelchair use and/or incapacitation. While supplementation with ManNAc is a promising treatment for patients with GNE myopathy, we need to know more about how this sugar-like compound is absorbed after oral ingestion. We are now investigating whether we can improve the absorption of ManNAc by administering it as small amounts over a longer period of time, rather than all at once (i.e. multiple small doses of ManNAc vs one large dose of ManNAc). We are also evaluating the influence of dietary salt on the absorption of ManNAc with the aim of understanding how it is absorbed and further improving absorption.

  • Promoting Teacher Mental Health: A School-based Risk Management and Health Promotion Intervention for Teachers

    This application is for the purpose of registering a pragmatic cluster-randomised controlled trial that aims to evaluate the efficacy and implementation of a school-based risk management and health promotion intervention for school teachers. Various components of this intervention have been implemented in other non-education industries; this is the first attempt at evaluating the intervention effects and implementation outcomes in the education sector. Participating schools will be randomised into the intervention or wait-list control condition. The intervention consists of a workshop and consultations with school personnel, access to a eLearning program on an app and support from coaches to develop a mental well-being action plan for school staff. Key outcomes include improvements in psychological distress, psychosocial safety climate, as well as reductions in functional impairment, absenteeism, intention to quit and mental health related WorkCover claims.

  • Can 'strength snacking' offset losses of muscle mass and strength with physical inactivity in older adults?

    Ageing is associated with reductions in muscle mass, muscle strength, and the ability to perform daily tasks (e.g., climbing the stairs), which can be accelerated during periods of short-term physical inactivity such as those imposed by periods of hospitalization, illness, or disease pandemics. There is a need, therefore, to identify effective strategies to counteract the negative effects of imposed physical inactivity on muscle mass and muscle strength. Resistance (strength) exercise can improve muscle mass and muscle strength in both younger and older adults, but participation rates are low, mainly due to barriers including a lack of time, the need for expensive equipment or a gym membership, and a high perception of difficulty. Recent evidence has shown that very brief (5-10 min) and frequent (twice per day) resistance exercise, requiring no equipment to perform, can improve muscle strength in older adults. This novel resistance exercise approach, termed "strength snacking", is therefore time-efficient, cost-effective, and simple – thereby avoiding the common barriers associated with traditional resistance exercise. "Strength snacking” may therefore be a feasible strategy for improving muscle function and health in older adults. It may also be a strategy to counteract the negative effects of short-term physical inactivity that occurs with by hospitalisation or illness, however, this has not yet been examined. The proposed study will be the first to determine whether "strength snacking” can offset the negative effects of short-term inactivity in older adults. It is hypothesised that "strength snacks” will be effective for offsetting anticipated muscle losses when performed during two weeks of imposed physical inactivity in older adults. We also expect that 4 weeks of "strength snacking" will be effective to improve muscle health and function.

  • A Facebook delivered physical activity focused group lifestyle intervention for the families of children with genetic epilepsy

    This study will recruit sedentary parents/primary carers of children with epilepsy and their chosen support partner to a 4 week, group based physical activity promotion intervention delivered online through a private Facebook group. The group will allow members to receive information and contribute to weekly conversations on pre-specified topics related to physical activity, e.g goal setting, reducing sedentary behaviour and overcoming barriers. The purpose of the Facebook group is to facilitate social support and provide participants with a platform to exchange personal experiences including barriers and facilitators to commencing and maintaining a PA program. All participants will also be provided with a Fitbit and encouraged to set goals and track their PA levels as a way to support self-monitoring.

  • Implementing a patient-centred care model to diagnosis of Maturity Onset Diabetes of the Young (MODY)

    Currently, genetic testing is recommended to be undertaken by genetics professionals (e.g. clinical geneticists, genetic counsellors) following appropriate counselling. This approach requires an additional referral to a genetics clinic which often has a long waiting list. This research explores the feasibility of “mainstreaming” genetic testing for MODY by allowing genetic testing to be arranged by non-genetics professionals and in this case to be arranged by Endocrinologists in their usual routine clinical setting. The advantage of mainstreaming is that it can be done at point of care, as a one-stop shop, for the patients, rather than having them referred to a genetics unit. A genetic mainstreaming model has been successfully trialled in oncology care to guide breast/ovarian cancer management. Leveraging Next Generation Sequencing technology, MODY represents an ideal non-cancer disease model for genomic mainstreaming, as its point-of-care diagnosis will guide tailored management in those newly diagnosed with diabetes.

  • Optimising treatment outcomes for children and adults through rapid genome sequencing of sepsis pathogens. A study protocol for a prospective, multi-centre trial (DIRECT)

    The primary purpose of the study is to estimate the impact on time to effective therapy of real-time pathogen sequencing direct from clinical samples when integrated with personalised antimicrobial dosing in children and adults on ICU with sepsis. It is hypothesised that real-time pathogen sequencing combined with dosing software to identify optimised personalised antimicrobial therapy will reduce the time to effective antimicrobial concentrations in critically ill patients with sepsis leading to improved patient outcomes. This novel approach to rapid pathogen sequencing coupled with antimicrobial dosing software has great potential to overcome the limitations of conventional sepsis diagnostics which often result in prolonged inappropriate antimicrobial therapy. This pilot study will yield key feasibility data to inform future studies which are urgently needed in the era of increasing antimicrobial resistance. Reduced time to optimal antimicrobial therapy may reduce sepsis mortality and ICU length of stay.

  • How accurately do pre-admission surgical patients report the ability to climb a flight of stairs?

    This project aims to identify whether patient self reported ability to climb a flight of stairs (FOS) correlates with objective measures, and whether self-reported or objective measures correlate with near infra-red spectroscopy (NIRS) measures of leg muscle oxygen saturation. Patients from an anaesthetic pre-admission clinic will be asked to self report their ability to climb a FOS before having a NIRS device (non invasive way to measure muscle oxygen saturation) attached to their leg, and then climbing a flight of stairs. Additional parameters will be measured including Borg scale, heart rate and duration of exercise.

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