ANZCTR search results

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

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33638 results sorted by trial registration date.
  • A randomised clinical trial comparing post-operative pain scores in patients with suspected prostate cancer undergoing transperineal prostate biopsy with and without a periprostatic nerve block under general anaesthesia.

    This study aims to determine if local anaesthetic injected around the prostate reduces pain after prostate biopsies under general anaesthesia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are undergoing planned transperineal prostate biopsy for suspected prostate cancer. Study Details All participants in this study will undergo a transperineal prostate biopsy under general anaesthesia. This study will be completed in two parts: In part one, 10 participants will be recruited, and they will be placed into two groups by chance to receive a local anaesthetic periprostatic nerve block of 1% lignocaine with adrenaline or to receive no injection while under general anaesthetic. Depending on the results of this part of the study, we will determine whether a placebo is required for part 2 of this study. In part two, if results of part 1 show that a placebo is necessary for the study to continue, the trial will recruit 50 participants to receive the same injection as part 1 (1% lignocaine with adrenaline) or receive a placebo (non-active injection of normal saline). If results of part 1 show a placebo is not necessary, the trial will continue the same way and recruit 40 more participants. After the procedure, the participants will be asked to rate their worst level of pain and be monitored for additional analgesia and complications (if any). All participants will be recruited via clinics of and by the two treating surgeons with biopsies performed in the adjoining hospitals. It is hoped that this trial will provide information on patient reported outcomes to improve transperineal prostate biopsy techniques making them more tolerable, as patients may be expected to undergo more than one such procedures in the course of prostate cancer diagnosis and treatment.

  • A randomised controlled trial of SOLAR-m: A low-intensity, brief, psychosocial intervention for firefighters delivered via smartphone

    In recent years, evidence has turned to how to best meet the psychosocial needs of individuals exposed to traumatic or stressful events who are experiencing adjustment and subclinical problems, but have not transitioned to a psychiatric disorder. First-responders, such as firefighters, who have high rates of trauma exposure are particularly vulnerable to these psychosocial difficulties. The Skills For Life Adjustment and Resilience (SOLAR) program is a brief, psychosocial, skills-based intervention designed to promote recovery and maintain wellbeing following stress and trauma. SOLAR is typically delivered face-to-face by non-mental health professionals. The SOLAR-m app, however, has been culturally adapted for firefighters, and participants in this RCT will be firefighters experiencing distress. The aim of this project is to conduct a randomised controlled trial to assess whether a smartphone-based version of the SOLAR intervention, known as SOLAR-m, is more effective than a control app comparator. We expect the SOLAR-m app to be better at reducing symptoms of anxiety, depression and posttraumatic stress disorder than the comparator app, both immediately after using the app and three months later. We also hypothesise that people using the SOLAR-m app will have better performance at work, less conflict between their work and family lives, and incur fewer costs related to psychiatric care and sick leave.

  • A Good Start in Life for Young Children: Investigating the impact of place-based interventions for young children at risk of developmental vulnerability

    The proposed trial will evaluate a multi-sector, multi-component program of interventions for improving the health and wellbeing of children who are at the highest risk of developmental vulnerability and disadvantage in the Australian Capital Territory. This study will apply quasi-experimental methods to assess the effectiveness of an integrated service model to address early childhood developmental disadvantage. We propose that a model of better integration for child-focused development and support services will reduce developmental delay for children aged 0 – 5 in the ACT. This study will evaluate whether providing place-based programs and activities that support young children’s development will reduce the proportion of children with one or more developmental vulnerabilities living in identified suburbs in the Belconnen District Area. The study design is a quasi-experimental study, comparing suburbs in the Belconnen District Area (the intervention site) with the highest levels of developmental vulnerability with matched suburbs in Tuggeranong (control site). Findings will inform practice and policy, leading to benefits for young children aged between 0 and 5 living in the ACT.

  • A comparison between two silver fluoride materials on dental caries management in an adult special needs population

    The purpose of this split mouth clinical study will explore differences in the clinical outcomes of Silver fluoride followed by potassium iodide (AgF/KI) and silver fluoride followed by stannous fluoride (AgF/SnF2). The outcomes will assess for how clinical performance is influenced by patient factors, such as their salivary profile, systemic conditions, medications, and diet. It is hypothesised that both materials will have similarities in its effects on clinical outcomes of dental caries management.

  • The impact of an exercise program on social cognition, psychosocial wellbeing, and physical health in people with traumatic brain injury

    People with traumatic brain injury (TBI) face social isolation and reduced quality of life because of the difficulties they have in recognising and responding to the emotions of others. People with TBI also face substantial health risks because of their low activity levels, which further impacts social engagement and quality of life. Increasing physical activity for people with TBI through a structured exercise program has been shown to improve aspects of cognition (e.g., recall of information) and mood and to decrease symptoms of depression. Given this, it is reasonable to suspect that increased physical activity may also positively impact social cognition for people with TBI. Social cognition is a construct that encompasses a wide array of skills that help people to recognise, accurately interpret, respond to the emotions of others. Some key skills associated with social cognition are facial and vocal emotion recognition, empathy, and social behaviour. The primary aim of the proposed study is to evaluate the impact of increased physical activity on social cognition for people with TBI. Our hypothesis is that the increase in exercise, will have a positive impact on the participants' life, hence increasing their social cognition. The study will include 30 people with moderate to severe TBI who will complete a 12-week supervised exercise program. The exercise program will be individually tailored to accommodate any physical needs participants have and to ensure safe progress throughout. Baseline and post-program measurements will assess social cognition, cognition, community participation, depression and anxiety, and health outcomes which will allow us to explore associations between these various factors. This is a novel study that will inform future, external funding applications.

  • Feasibility of a Musculoskeletal-targeted Exercise and nutrition TElehealth program for Older women following bariatRIC surgery (METEORIC Trial)

    Despite its overwhelming benefits, a negative outcome of bariatric surgery is severe loss of bone and muscle mass. Postmenopausal women experience over two-fold greater bone microarchitecture deterioration than premenopausal women and men following bariatric surgery, and as such are at greatest risk for incident fractures. We have previously identified that supervised 30 minute, twice weekly functional impact training (FIT) in postmenopausal women with low bone mass resulted in significant improvements in lumbar spine and femoral neck bone mineral density (BMD) compared to control. No study has investigated the role of FIT in postmenopausal women following bariatric surgery using telehealth applications. We hypothesise that an 8-month functional and impact training (FIT) program combined with nutritional education, delivered via a mobile application, will be acceptable, safe, and well-adhered to in postmenopausal women following bariatric surgery. It is anticipated that the outcomes of the bariatric trial will inform the design of innovative future randomised controlled trials exploring this program as a potentially effective, safe, and feasible treatment strategy for maintaining musculoskeletal health after bariatric surgery.

  • KPJ (kidney protective jacket) Feasibility Study

    This is a feasilibility study to determine if use of KPJ™ (Kidney Protective Jacket) during renal transplantation is feasible and implementable in the Australian kidney transplant setting. In addition, it shall also assess whether the KPJ™ improves transplantation outcomes from ‘marginal’ or higher risk grafts currently used for transplantation.

  • The impact of endovascular therapy on clinical, physiological and imaging parameters in patients with ilio-caval occlusive disease

    The aim of this research is to establish how well stent treatment works at improving the condition of legs affected by narrowing of the veins that drain blood from the leg. It also aims to identify which diagnostic tests are best at determining which veins should be treated. Although we know that stenting can improve the condition of legs by improving the drainage of blood in legs affected by vein disease it is not clear when stenting should be offered as a treatment. In particular there are few studies that have looked at a wide range of ways of assessing the condition of the legs. There are a range of ways of assessing how severe an area of vein narrowing is, but it is not clear which method is best for guiding the surgeon when deciding whether or not to treat with a stent. In this research project we will be assessing the condition of the legs using a wide range of methods. We will also assess the narrowing in the vein with a range of different diagnostic tests prior to treatment at the time of the venogram. We will also follow up participants for one year after the treatment to check on the success of the treatment. From this information we hope to clarify some of the uncertainties around treatment of vein disease by identifying which assessment methods are best for identifying which patients will benefit the most from treatment.

  • ACTIVE STRIDES-CP: Effect of Intensive rehabilitation for children with moderate to severe cerebral palsy on gross motor skills and physical activity participation

    ACTIVE STRIDES-CP: Effect of Intensive rehabilitation for children with moderate to severe cerebral palsy on gross motor skills and physical activity participation. In Australia, 420 infants are born annually with cerebral palsy (CP), making it the most common physical disability in childhood. Of these infants, 40% will have moderate to severe motor disability which is associated with reduced general health, greater pain and discomfort, reduced independence in daily life skills and participation in physical activity, and poorer vocational outcomes. We have promising data about a new intervention, called Active Strides-CP, which we will test in 150 children with bilateral cerebral palsy and compare results to usual care. Researchers from The University of Queensland, led by A/Professor Leanne Sakzewski in partnership with researchers in Sydney, Melbourne and Perth are testing a new rehabilitation approach for children with moderate to severe cerebral palsy to help improve gross motor abilities, and participation in physically active leisure in the community. This novel approach combines a package of gait training using treadmills, overground walking using assistive devices, cycling and targeted training of gross motor goals with a total of 32 hours of training provided over an eight week period.

  • State-wide dissemination of the Internet-based Professional Learning to help teachers to support Activity in Youth (iPLAY) intervention

    Whole-of-school programs are considered one of eight investments that work for physical activity promotion by the International Society for Physical Activity and Health. However, very few whole-of-school interventions progress beyond efficacy testing to implementation at-scale. The ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY) program ) is a whole-of-school physical activity intervention, that includes three curricular and three non-curricular components: (i) quality physical education, (ii) classroom energisers, (iii) active homework, (iv) active playgrounds, (v) parental engagement, and (vi) community links. The iPLAY program was designed to improve cardiorespiratory fitness by providing children with opportunities to participate in moderate-to-vigorous physical activity within and beyond the school setting. The iPLAY program was evaluated via a cluster randomised controlled trial (RCT) in 22 New South Wales (NSW) primary schools (ACTRN12616000731493). At 12- and 24-months, students in the iPLAY group had greater increases in cardiorespiratory fitness than students in the control group. The aim of this study was to examine the dissemination of the iPLAY program in NSW primary schools using the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework.

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