ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Blood stage challenge study to assess Tafenoquine prophlyaxis against Plasmodium falciparum in healthy volunteers.

    Previous studies suggest that tafenoquine is an effective antimalarial, acting against both Plasmodium liver stages and subsequent asexual blood stages, although it is difficult to determine the contribution of each activity to the overall prophylatic effect of tafenoquine. Both activites would be important as any parasites that escape killing in the liver would need to be killed at the subsequent asexual blood stage. Furthermore, there was a paucity of observed P. falciparumin fections in non-immune participants during Study 033 (Nasveld 2010). Therefore, confirmation of blood parasite activity separate to any liver activity is warranted in a non-immune population to confirm the findings of the activity tafenoquine demonstrated in semi-immune participants in Africa (Dow 2015). This Phase Ib study will evaluate the prophylatic activity of a multiple dose regime of tafenoquine against challenge with P. falciparum asexual blood stage parasites in nonimmune participants. The Induced Blood Stage Malaria (IBSM) challenge model in which healthy non-immune participants are administered ~2,800 viable P. falciparum parasites within red blood cells is well suited to test this hypothesis. This study will help identify if a single dose of tafenoquine following three loading doses can prevent symptomatic blood stage infection following P. falciparum exposure. This study will also enable characterisation of the exposure-response relationship for tafenoquine and will also provide data regarding the safety and tolerability of tafenoquine in a controlled disease-like setting.

  • Use of Surgicel in Parotid Surgery

    The aim of this study is to evaluate the effect of Surgicel use in parotid surgery on the incidence of post-operative sialocele formation. Who is it for? You may be eligible to join this study if you are aged 18-90 years and are scheduled to undergo a parotidectomy. Study details Patients will be randomized (allocated by chance) to use of Surgicel (a type of oxidised regenerated cellulose) or no use of Surgicel in the control arm. Surgicel is used after parotidectomy in the wound bed to aid in haemostasis and to protect the facial nerve. Surgicel Original Haemostat (Ethicon) 0.5x2inch will be placed in the wound bed after parotidectomy by the treating surgeon prior to closing. The primary outcome will be formation of a sialocele post-operatively, quantified on ultrasound if a sialocele is clinically detected at the one week follow up. Secondary outcomes examined will include drain output, length of hospital stay and other post-operative complications.

  • The Tape Locking Screw Technique: A new Anterior Cruciate Ligament (ACL) reconstruction technique

    A comparison of the Tape Locking Screw (TLS) in Anterior Cruciate Ligament (ACL) reconstruction technique and conventional Anterior Cruciate Ligament reconstruction surgical technique. Hypothesis: The TLS ACL reconstruction technique has superior post-operative outcomes compared to conventional ACL reconstruction techniques. a) The single (semitendinosus) tendon harvest has less functional detriment compared with the double (semitendinosus/ gracillus) tendon harvest b) Retrograde tunnelling has superior post-operative outcomes compared to traditional anterograde tunnelling c) TLS fixation with 500N of pre-loading has better functional outcomes compared to a non-tensioned hamstring tendon graft

  • Carbon dioxide (CO2) Surgical Laser for Treatment of Stress Urinary Incontinence in Women – a RCT study

    Stress urinary incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Management of stress urinary incontinence includes both conservative therapy and more invasive surgical intervention. The current main conservative approach to treatment of stress urinary incontinence is pelvic floor muscle therapy (PMFT). PFMT improves stress incontinence symptoms by 56 %. However, pelvic floor muscle therapy has poor long term compliance and women then choose more invasive surgical treatment. Fractionated CO2 laser has been established for use in dermatological and dental applications to stimulate collagen neogenesis and skin and tissue remodeling. Recently, use of fractionated CO2 laser has been introduced and has been successfully used for vulvovaginal atrophy. The rationale for the use of CO2 laser for treatment of SUI is to trigger tissue remodeling and regeneration to improve urethral support. Women may prefer to vaginal CO2 laser treatment as a conservative option to treat SUI over surgical intervention due to the morbidity of surgical intervention. The aim of this study is to evaluate the use of fractionated CO2 laser treatment in combination with physiotherapy as a potential treatment for women with stress urinary incontinence over physiotherapy alone.

  • HELLEN: A robot to assist patients with acquired brain injury to stand and exercise

    For those with severe acquired brain injury, weight-bearing exercise can pose many challenges for both patients and their therapists. Due to physical demands and safety issues, those with severe mobility impairment are often denied the opportunity for weight bearing, task specific training. This type of training is essential if the recovery of functional abilities such as independent transfers and mobility are to be achieved. Advances in robotic technologies have led to the development of wearable lower body exoskeletons. These can be used to assist sit to stand, weight bearing activities and gait. This research team is in the fortunate position to be provided access to an exoskeleton (HELLEN) to research its applicability in people with acquired brain injuries. This device has the potential to assist therapists to increase patient opportunities for weight bearing training at higher intensity and dosage to maximise their potential for recovery. This is ground breaking research with no previously published literature on this topic. Our aim is to examine the potential health benefits and feasibility of using a lower limb exoskeleton as an adjunct tool for neurorehabilitation in those with severe mobility impairment due to acquired brain injury. This is a Phase I, wait-list controlled trial with 20 participants. Baseline measurements will be taken on enrolment into the study followed by a 12week waitlist period. They will then receive 12 weeks of intervention, provided by a physiotherapist (Nicola Postol). This will involve two 1 hour sessions of individualised upright weight-bearing exercise facilitated by HELLEN, per week. Participants will be provided with a home exercise program, updated throughout the trial as required. Reassessment will occur after 6 and 12 weeks of intervention and after 12 weeks follow-up and will comprise of a battery of impairment, function and quality of life measures.

  • Investigating the impact of a web-based melanoma awareness video on intentions to engage in sun protection among a sample of young Australians.

    This was the first study to investigate empirically the impact of the online melanoma awareness video, ‘Dear 16-year-old me’, on sun protection intentions and related cognitive processes in young adults aged 17-30. We examined changes in perceived threat, skin cancer fear, and intention to participate in a variety of sun protection behaviors after exposure to ‘Dear 16-year-old me’, the personal risk for melanoma questionnaire (PRMQ), or an informational control condition. It was anticipated that: (1) participants exposed to ‘Dear 16-year-old me’ or the PRMQ would demonstrate significant improvements in perceived threat, skin cancer fear, and sun protection intentions post-intervention, (2) participants in the control condition would not demonstrate any significant changes in perceived threat, skin cancer fear, or sun protection intentions post-intervention, (3) all significant effects would be maintained two weeks later at follow-up. A mixed within-between subjects design was used. Participants were randomly allocated to one of three experimental conditions: ‘Dear 16-year-old me’, PRMQ, control) and completed an online questionnaire at three time points (baseline, post-intervention, two-week follow-up).Data were obtained from 222 participants (158 female) at baseline and 187 at follow-up. There was a significant interaction between group and time for intended sun protection behaviors and perceived threat, with participants exposed to ‘Dear-16-year-old me’ reporting the greatest improvements. Heightened perceptions of threat among participants exposed to ‘Dear 16-year-old me’ were maintained at follow-up, although increased levels of skin cancer fear were not. Sun protection intentions increased across all groups over time, but this increase was significantly greater in the intervention groups than the control group. The results suggest that ‘Dear 16-year-old me’ is a promising intervention for reducing skin cancer risk among young adults. The study findings support the assertion that providing people with narrative evidence from other “real” people can be an effective strategy to increase perceptions of personal health risk and encourage health protective behavior.

  • Validation of the 2-minute step test in healthy middle-aged adults.

    Evidence suggests that poor cardiorespiratory (CR) fitness is associated with increased risk of morbidity and mortality, and is therefore used as a measure of health. Submaximal exercise testing is commonly used in practice to assess CR fitness due to time constraints, lack of equipment and safety. Submaximal step tests have been shown to be valid method of assessing CR fitness (Bennett et al 2016), although the majority of these tests require a step and are externally paced. The 2-minute step test (2MST) requires minimal equipment (no step) and is self-paced. It has been shown to be reliable and valid in an older population (60+ years old) (Rikli and Jones 1999). If the 2MST is found to be valid in a wider age range, it may be a simpler method of assessing CR fitness that can be used in a variety of settings, potentially preventing a decline in health and physical fitness in the population. Here we will compare the number of steps completed in the 2MST in middle-aged adults to a direct measure of peak oxygen consumption (cardiorespiratory fitness) using an incremental cycle test.

  • Reducing inappropriate catheterisation to prevent catheter-associated urinary tract infection (CAUTI) through a hospital-wide, bundled catheter care (BCC) approach: a non-randomised, controlled intervention study

    Catheter-associated urinary tract infection (CAUTI) is possibly the most preventable healthcare associated infection. This study will implement a care bundle to reduce urinary catheter use and CAUTI in four acute care facilities in NSW, Australia. The care bundle includes evidence-based recommendations of: appropriate indications for catheter insertion, patient consent, clinician competency, asepsis, unobstructed flow, timely catheter removal, daily periurethral hygiene, and collecting urine specimen only when indicated. Implementation strategies used will include education, audit and feedback, and champions. Point prevalence will be used to evaluate changes to rates of catheterisation and CAUTI. A phased non-randomised pre-post design will be used, providing a contemporaneous control.

  • Integrated versus nOn-integrated Peripheral inTravenous catheter in adult hospitalised patients. Which Is the most clinical and cost-effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM randomised controlled trial)

    Introduction: Peripheral Venous Catheters (PVCs) are frequently used to provide treatment for hospitalised patients. However, the failure rate of these devices is extremely high. Recent evidence suggests that integrated PVC systems may improve patient outcomes compared to the traditional non-integrated PVC systems. However, more evidence is needed to inform clinical practice and guidelines. Objectives: 1. To compare the clinical and cost-effectiveness of two PIVC systems: (i) integrated, and (ii) non-integrated (current practice) to prevent PIVC failure, insertion pain, microbial colonisation, functional dwell time, and adverse events. 2. To assess the acceptability and implementation challenges of integrated systems via quantitative and qualitative feedback from inserters, patients, clinicians and policy-makers. Methods: Two-arm randomised controlled trial including 2200 adult (greater than or equal to 18yrs) patients. · Integrated system: BD Nexiva integrated intravenous catheter system with two SmartSite connectors to close the Y-connector completely (n=1100). · Non-integrated system: B Braun Introcan Safety 3 or BD Insyte Autoguard catheter, Connecta extension set 15cm, with SmartSite connector/s (n=1100). The primary outcome is PIVC failure: Composite endpoint of occlusion, infiltration, phlebitis/pain, dislodgement, haematoma, localised or bloodstream catheter-related infections. Results: Results could improve millions of patients' health outcomes by reducing PIVC complications and failure as well as clinicians' workloads and health-care costs. Conclusion: Results of this study could assist policy-maker decision-making about the best PIVC system choice, and inform clinical guidelines, which could benefit patients and health care systems worldwide.

  • Listening to preferred music to reduce risky wandering: A feasibility study

    In the absence of effective alternatives, residential aged care (RAC) still resort to using pharmacological interventions, such as antipsychotic and sedating medications, to manage behaviours of dementia despite there being strong evidence that these are ineffective and are associated with severe adverse outcomes for the person with dementia. Non-pharmacological interventions are recommended as best practice to mitigate adverse outcomes associated with behaviours of dementia. There is considerable evidence that listening to preferred music reduces agitation in dementia. However, there is also robust evidence that dementia-related wandering and agitation are distinct phenomenon. Therefore we cannot assume that an intervention effective in reducing agitation will also reduce aspects of wandering that incur risk or result in negative outcomes for the person with dementia. There have been no known trials of music based interventions for people with dementia who wander, despite the pressing need for non-pharmacological interventions in this area. The goal of this applied research is to test the feasibility of using an intervention protocol, previously found to be effective in reducing agitation for people with dementia, to determine if it can be used with people who wander. Therefore the aims of this feasibility study are: 1) For people with dementia who wander and exhibit boundary transgression (BT) (entry into out of bounds and hazardous areas) in residential aged care (RAC): a. Is listening to music for a period of 20 minutes five times per week for 3 weeks tolerated? b. Is listening to the music via ear bud head phones tolerated? c. Do participants enjoy listening to the music? 2) Does listening to preferred music daily for 20 minutes under two conditions: a) Reduce risky aspects of wandering including frequent ambulation and boundary transgression (BT)? b) Reduce participant agitation? c) Provide immediate pleasure to the participant? 3) Are facility care staff able to reliably identify residents with dementia who wander and exhibit BT at an intensity that is observable? 4) Do care staff and family members perceive the music intervention to be beneficial for resident with dementia who wander? This feasibility study will use cluster randomisation (Facility 1 and Facility 2) to trial two intervention conditions: Condition 1: Daily (Mon-Fri) session of listening to preferred music for 20 minutes, 30 minutes before unique peak activity period Condition 2: Daily (Mon-Fri) session of listening to preferred music for 20 minutes at a randomly selected time between 10 am-7pm not including 30 mins prior to individual peak activity periods. Pre, during and post intervention measures of wandering characterisitics (frequency, boundary transgression, pattern), mood and agitation will be collected.

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