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.
  • The utility of pedometers in improving mobility outcomes in inpatient rehabilitation - pilot randomised control trial (RCT)

    The proposed project will evaluate the feasibility of using pedometers as a motivational tool to improve mobility outcomes in inpatient rehabilitation. All eligible patients on the rehabilitation ward will be invited once they are able to walk with or without the assistance of one person, with our without a gait aid for a minimum of 3 metres. All participants will be provided with a pedometer for the duration of their stay. Those in the pedometer intervention arm will record daily step counts and be encouraged by staff, family and friends to take more steps each day. Those in the control arm will wear pedometers fixed shut and will be encouraged to walk further each day. Mobility outcomes will be measured at two points, before allocation and discharge from the ward. Pedometer usability by participants will also be evaluated.

  • The effect of low glucose load diet on glycaemic control in patients with cystic fibrosis

    Concentrated carbohydrate loads are often used in CF to help meet increased energy requirements and could have a role in the poor glycaemic control observed in CF. The aim of this project is therefore to establish the feasibility of implementing a low glycaemic load, high calorie dietary management plan for patients with CF and impaired glycaemic status (IGT). A secondary aim is to assess the effect of a low GL diet on clinical outcomes of glycaemic control, lung function and weight. Patients with IGT at the RPA CF clinic will be eligible to participate in this study. Weight, glycaemic control, lung function, diet history and quality of life will be measured at baseline and also at 3 months, following dietary intervention of a low GL diet.

  • Comparison of the incidence and duration of hypoglycaemia assessed by Continuous Glucose Monitoring (CGM) in elderly type 2 Diabetes patients treated with two different insulin regimens (long and short acting insulin VS premixed insulin) .

    Aims of the study: 1-To compare the number of episodes of hypoglycaemia, and time spent in hypoglycaemia between a pre-mixed insulin regimen and a basal-plus 2, Toujeo-based regimen in an elderly population with T2DM using CGM. 2-To compare total insulin requirements, measures of glucose variability and glycaemic control, weight gain and other health-related outcomes between the two insulin regimens. 3-Assess the impact on quality of life in elderly T2DM patients switching from pre mixed insulin to a basal-plus 2 regimen. 4-Assess the incidence and rate of hypoglycemia reported by Self Monitored Blood Glucose (SMBG) during the treatment periods of non CGM recording -Hypothesis: We postulate that hypoglycaemia (interstitial glucose <3.9, or critically <2.5 mmol/l) assessed by (CGM) will remain more prevalent in patients continuing biphasic insulin, compared with those switching to a basal-plus 2 insulin regimen. We hypothesise that subjects switched to a basal-plus 2 regimen will have reduced glycaemic variability and lower insulin requirements. We further postulate that switching to a basal-plus 2 insulin regimen will be not inferior to premixed insulin in term of quality of life (QOL).

  • Case Series Study: Surgical Repair of Peripheral Nerve Injury with CelGro "Registered Trademark" Collagen Scaffold.

    CelGro "Registered Trademark is an acellular type I/III collagen matrix of porcine origin. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens. Treatment of injuries to peripheral nerves is a challenging surgical issue. The primary aim of surgical repair is to guide regenerating axons correctly into place in the distal nerve, with minimal loss of nerve fibres at the site of repair. This results in reinnervation of distal tissues, and restores autonomic, sensory and motor function. Direct, tensionless, end-to-end repair using epineural microsutures (neurorhaphy) provides the most favourable outcomes. Tensionless repair is acknowledged as a major factor in successful recovery of sensorimotor function. However, if a tensionless repair cannot be achieved, autologous nerve grafting is the gold standard treatment for surgical treatment of nerve gaps. However, autologous nerve grafting results in significant donor-site morbidity; is more technically difficult to perform; requires more operative time; and elevates treatment costs. The search for alternatives to nerve grafting has resulted in the development of nerve conduits, which are tubes fashioned of biocompatible materials. The proximal and distal ends of the severed nerve are inserted into the tube and sutured in place. The conduit provides gross alignment for the regenerating nerve, and retains fluids leaking from the nerve ends, enriching the microenvironment with neurotrophic growth factors. Conduits manufactured from bioabsorbable materials are preferred as non-degradable materials such as silicone require additional surgery for removal, and may have detrimental effects on nerve regeneration. Collagen is one of the most commonly used biomaterials for construction of nerve conduits. Key advantages of collagen are that it is biocompatible and has a natural structure that has been shown to support and guide tissue regeneration in vivo. Clinical studies have shown that digital nerve gaps of up to 40mm can be bridged with collagen conduits, resulting in good to excellent sensory outcomes in up to 75% of patients. CelGro"registered trademark" is a next-generation membrane that is manufactured using collagen originating from animals bred and exclusively raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro"registeris mechanically stronger and more elastic than other collagen membrane products of this type. The main complication related to conduit implantation is protrusion or extrusion of the conduit. This is most common when the repair occurs across a joint or where the quality of covering soft tissue is reduced. However, in a systematic review of digital nerve repair using resorbable FDA- and CE-approved nerve conduits, protrusion or extrusion of collagen conduits was not observed

  • A Phase 1, Double-Blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Flecainide Acetate Inhalation Solution to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers

    Part A: A single inhaled dose of flecainide acetate inhalation solution or placebo inhalation solution will be administered per participant in the dose escalation part of the study. Single ascending doses will be administered in a sequential ascending manner from Cohorts 1 through to 4. Part B: The open label crossover part of the study consists of two Periods, Period 1 and Period 2. In Period 1 the administration of flecainide will be via inhalation, whereas in Period 2 the administration of flecainide will be intravenous. The two Periods will be separated by a 10 day washout period. In Part C, six participants will be enrolled, in a cross-over arrangement where two different sources of compressed medical air will be compared using the AeroEclipse XL device to deliver an inhaled flecainide acetate dose of up to 60 mg. Update 2: Part C was not completed.

  • Connecting Rural Children to Therapy Supports: A Trial of Telepractice for Allied Health Service Provision

    Children with disability living in rural and remote communities often do not receive the allied health therapy services they need to live the best life possible. Telepractice, or the delivery of therapy services via videoconferencing, has much potential for spreading therapists’ reach into rural Australia. However, little is known about how telepractice can be used to work effectively with children with disabilities. In this study, we aim to investigate the feasibility, acceptability, and outcomes of telepractice provision of allied health therapy services to children with disability living in rural and remote communities in Australia. Fifteen children and their parents/legal guardians will receive assessment and therapy services from an occupational therapist and/or speech pathologist via videoconferencing, connecting to therapists via web-cam equipped device in their home or other setting. Telepractice models will vary across children as negotiated with parents. e.g., location, number, duration, and frequency of sessions will be tailored to children’s needs. Case study methodology utilizing mixed methods will be used to gain insights into the unique settings and circumstances of each individual child, their family, and community, and how these impact on telepractice. We will collect data about (a) effectiveness of telepractice by examining children’s attainment of therapy goals after completing a telepractice therapy episode; (b) acceptability of telepractice delivery of therapy services to parents/legal guardians, allied health professionals, and other stakeholders, via interviews; (c) feasibility of telepractice by examining assessment and treatment process data routinely collected by allied health professionals throughout the duration of a telepractice therapy episode. This research will reveal the essential components of telepractice models needed to achieve outcomes for children and their families, and will demonstrate the potential of technology for addressing inequalities experienced by rural children in accessing quality allied health therapy services.

  • Women's Wellness Program: An e-Health lifestyle intervention for mid-life women living with type2 diabetes

    Primary purpose of the study is to deliver an e-Health 12 week lifestyle intervention to Women with type 2 diabetes. Primary aim is to improve health related quality of life. secondary aims are to reduce BMI, increase physical activity, and improve diabetes management self efficacy. Hypothesis is that women undertaking this intervention will improve in these aspects of their life through coaching with the registered nurse and access to evidence based information provided in the I-Book and through the interactive website they have access to.

  • A randomised clinical trial to evaluate the effects of continuous positive airway pressure (CPAP) on nocturnal beat to beat blood pressure and vascular function

    In order to better assess the role of CPAP in mitigating cardiovascular risk factors of participants with obstructive sleep apnoea (OSA), this study aims to assess the effect of a night of active and a night of sham CPAP on beat to beat blood pressure and vascular function. To measure vascular function, non-invasive and benign ultrasound based techniques will be used to assess peripheral artery vascular function in the brachial artery, along with intracranial arterial function utilising transcranial Doppler assessments. Finally, we will measure urinary catecholamines from urine collections pre and post sleep. Blood pressure will be monitored continuously throughout the night using a finapress device while participants are simultaneously having their sleep monitored by polysomnography. The results of this study have the ability to further understand the physiological effects of missing one night of CPAP treatment in patients with OSA.

  • A Prospective observational trial to assess if thromboelastography (TEG) can be used to predict blood culture results in clinically septic patients.

    This study will examine if there are changes in coagulation which can be detected by TEG that occur in patients with a bacteraemia before it has been detected in blood cultures. The benefits of being aware of these potential changes may include earlier consideration of non-infective causes of SIRS and altered antibiotic prescribing practices. In contrast, early identification of a potentially life-threatening infective process that is responsible for the SIRS presentation is essential to ensure ‘ideal outcomes’ for patients (1). It is a common and important clinical challenge to distinguish between those patients who have sepsis and those who have SIRS. A hypocoagulable state in sepsis is thought to be associated with increased mortality. Specifically, impaired fibrinolysis may be associated with a diagnosis of sepsis versus SIRS (2). On admission to ICU, patients generally have a set of routine admission bloods sampled; these may include full blood count, electrolytes, renal and hepatic function and a coagulation profile. Routine blood tests may also include blood cultures if the patient is thought to be septic. However, the routine coagulation profile sent to pathology is thought to provide limited clinical information when assessing in vivo hypocoaguable changes (2). Research has demonstrated that TEG parameter changes throughout an episode of sepsis may provide some predictive value for mortality and risk of bleeding (3). Recent research has aimed to identify early TEG parameters that may predict a positive blood culture result (4). The aim of our study is to identify blood changes detected by TEG that may indicate whether a patient has sepsis or a non-infective cause for SIRS. References; 1. Simpson S. New Sepsis Criteria; A change we should not make. Chest. 2016; 149(5). 2. Muller MC, Meijers JCM, Vroom MB, Juffermans NP. Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Critical care (London, England). 2014; 18(1):R30-R. 3. Haase N, Ostrowski SR, Wetterslev J, Lange T, Moller MH, Tousi H, et al. Thromboelastography in patients with severe sepsis: a prospective cohort study. Intensive Care Medicine. 2015; 41(1):77-85. 4. Grant HW, Hadley GP. Prediction of neonatal sepsis by thromboelastography. Pediatric Surgery International. 1997; 12(4):289-92.

  • Improving independence in driving for people with Autism Spectrum Disorder

    Individuals with autism spectrum disorders (ASD) face social and cognitive difficulties that affect their ability to establish relationships, maintain employment and participate in community activities. Difficulties in community mobility act as barriers to their social inclusion. Driving is often difficult for people with ASD, as it requires the individual to make quick decisions and solve problems in response to road conditions and unpredictable traffic. There is currently a lack of understanding on how learner drivers with ASD read and respond to traffic and hazards on the road. The problem is further confounded as there are currently no established standards in Australia for assessing driving behaviours. The aim of the proposed research is to address community mobility challenges experienced by young adults with ASD by designing, pilot testing and evaluating the feasibility, appropriateness and effectiveness of an ASD-specific driver training package in supporting learner drivers with ASD to obtain a driver’s license and maintain on-road safety. The driving project will involve four studies. The Randomised-Controlled Trial study is the last study of this project with the aim to test the effectiveness and appropriateness of the ASD-specific driver training package: - Reducing the number of attempts learner drivers with ASD take to successfully obtain a provisional licence. - Reducing the number of face-to-face practice training sessions learner drivers with ASD require before obtaining a driver’s licence. - Improving driving behaviour, hazard perception skills and attitude to risk taking of learner drivers with ASD. - Improving learner drivers’ reflection on their driving.

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