ANZCTR search results

This study aims to investigate the effectiveness and safety of a single intraarticular injection of Articul One in comparison with Synvisc-One Registered Trademark or placebo for the treatment of symptomatic primary knee osteoarthritis. 30 subjects will be randomized to receive either Articul one , the experimental arm (20 subjects), Synvisc-One Registered Trademark, the active comparator arm (5 subjects), or Placebo (5 subjects). This will be done by analysing questionnaires to understand the severity of the disease status, pain and rescue medication diary, and side effects. Safety will be monitored during the treatment visits using standard measures, including physical exams, vital signs (including oral temperature), and side effect monitoring. Subjects may be eligible to join this study if they are aged over 40 years, have knee pain due to osteoarthritis of the knee and are in otherwise general good health. This study will investigate a single dose of Articul One in comparison with Synvisc-One Registered Trademark or placebo (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means the subject and the assessing doctor, together with the study staff will not know whether the subject is receiving Articul One, Synvisc-One Registered Trademark or placebo. The person who administers the injection will be unblinded (they will know what treatment the subject will receive) however, they will not allow the subject or the assessing team know which treatment is being received. The study includes a screening visit (visit 1) to check eligibility and to explain the study.. There will be 1 treatment visit (visit 2) which will occur within 21 days of visit 1. There will also be 4 further visits to assess the safety and effectiveness of the treatment. These visits will occur at weeks 4, 12, 20 and 26. During the follow up period, four clinic visits are required for: review of diary, medications, AEs;. Participants will record rescue pain medication in a daily diary.

The aim of this study is to evaluate the effect of two separate interventions via a randomised controlled trial on the dextrous performance of novice podiatry students in order to identify an evidence-based strategy to help target students struggling with manual clinical skills. One of the interventions will target afferent input (sensory system) via sensory awareness training whilst the other will target efferent output (motor system) via additional motor practice.

This study will be an open-label, 12 week, clinical trial in males aged 18 to 45 with the aim: To compare genetic expression patterns after 12 weeks treatment of temulawak extract in male adults. To evaluate safety parameters of the active compound. A total of 32 participants will be enrolled into the study in order to allow for 24 participants to complete the study. Participants will be asked to attend the clinic at Screening, Day 1 (Visit 1), Day 7 (Visit 2), Day 40 (visit 3) and Day 81 (visit 4) the end of study visit. The study will last approximately 4 months in total for each participant from screening to last visit. Participants will need to attend the clinical unit 5 times for around three hours at each visit.

Alfred Health has implemented a partnered pharmacist medication charting (PPMC) model which has been in place since November 2012. A randomised trial conducted in 2015 demonstrated that PPMC significantly reduced medication errors on admission compared to a standard medical model. As part of a Department of Health Workforce Innovation Grant, the PPMC model is being extended as a standard of care to patients on admission to residential aged care following discharge from an inpatient admission. The specific aim of this project is to evaluate whether a pharmacist generated interim medication chart facilitates the transfer of medication information when patients are transferred from an inpatient hospital admission to a residential care facility. Aiming to reduce the proportion of missed medication doses and the number of locum medical officer visits in the first 7 days postadmission to the residential care facility. And improving the communication and continuation of hospital medication plans onto long term residential care medication charts. A pre and post methodology will involve visiting the 10 most utilised residential care facilities (RCF) in the Alfred Health catchment to collect data.

External fixation is commonly used as a means of definitive fixation of pelvic fractures. Pin site infection is common, with some cases of osteomyelitis and inpatient nursing can be challenging. The aim of this study is to report the outcomes and complications of an alternative minimally invasive technique, known as INFIX, utilising spinal pedicle screws inserted into the supra-acetabular bone and connected by a subcutaneous rod. A single centre prospective case series was performed. The primary outcome measures were fracture stability and displacement at time of implant removal and intra and post-operative complications.

Early mobilisation of intensive care patients has been shown to improve functional outcomes, attenuate-ICU acquired weakness, reduced ICU and hospital length of stay and reduce mortality rates at 12 months discharge (Morris et al., 2008, Schweickert et al., 2009). Despite these benefits, there are many barriers (femoral vascular lines, staffing logistics and sedation management), which still prevent adequate mobilisation of ICU patients (Leditschke et al., 2012). An ICU mobility scale has been generated to qualitatively describe on a continuum the level of mobilisation from nil to independent locomotion of ICU patients. (Hodgson et al., 2014a). A second strongly correlated measure of physical function, the Acute Care Index of Function (ACIF) has also been used to measure ICU patient function, and is advantageous in that it incorporates a neurological assessment and has been shown to predict patient physical function post-ICU discharge (Bissett et al., 2016). In addition, a multinational consensus statement was also published in 2014 (Hodgson et al., 2014b) outlining the safety criteria for the mobilisation of critically ill patients. The statement described which intensive care patient could be safely mobilised and how they could be mobilised. However, it is still possible that these criteria are somewhat conservative compared to existing practices at Canberra Hospital. This study will determine the current barriers to mobilisation at Canberra Hospital ICU and ascertain whether these have changed compared to data collected in 2008 (Leditschke et al 2012). This study will also describe the safety of patient mobilisation at Canberra Hospital in the context of the consensus statement (Hodgson et al 2014b) and describe the IMS and ACIF scores of patients mobilised in Canberra Hospital ICU as part of routine practice.

The primary purpose of this study is to develop and validate a brief questionnaire (up to 5 questions) to identify those children and young people with cerebral palsy who may have feeding difficulties are may be undernourished. The primary hypothesis is that "risk" of feeding difficulties and undernutrition for children and young people with cerebral palsy can be determined using a brief, parent completed questionnaire.

Impairments in memory, attention, and social/psychosocial functioning are common consequences of acquired brain injury (ABI) sustained in childhood and adolescence. However, there exists a dearth of evidence-based interventions that target these difficulties, while only a few studies have evaluated the feasibility of these interventions in an ABI population. This study aims to pilot the feasibility and efficacy of the English version of the Amsterdam Memory and Attention Test for Children (Amat-c), with an online clinician support component, in children and adolescents presenting with difficulties in these functional domains post-ABI. The Amat-c is to enhance children’s attention, memory and executive functioning (EF) skills. The child is trained using specific exercises focusing on deficient cognitive abilities, in an attempt to improve these skills, as well as to impact more generally on cognitive functions. Parents of participating children will have to engage their children in a daily 30 minutes session for 18 weeks. During these sessions families in the treatment group will complete the Amat-c activities. Those in the control group will complete some psycho-education models, and will be invited to receive the Amat-c intervention after it is found to be efficacious. Feasibility of this intervention will be assessed immediately and at 6 months post-intervention using neuropsychological and ecologically sensitive measures. Relative to baseline scores, we expect significant improvements in attention, memory, and functional everyday outcomes both immediately and at 6 months post-intervention. We anticipate that preliminary support for the feasibility and efficacy of this online clinician-supported program will inform current evidence-based practices and optimize childhood/adolescent outcomes post-ABI. Potentially, this will inspire larger future studies and provide an evidence base for the incorporation of the Amat-c into standard clinical care for children and adolescents with ABI.

Symptoms of low mood and depression are common in later life and can include; feeling sad, empty or down, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, poor concentration and thoughts about death. There is now evidence that depression is 23% more frequent among people living in regional Australia than in the city, possibly because of difficulty accessing relevant health services. When feeling low, a person’s motivation to do things can decrease. Some may find that they give up hobbies or activities previously enjoyed, and over time might end up doing very little. This can lead to a further decline in mood and start a vicious cycle that can be difficult to break. One of the ways of overcoming depression and low mood is by changing behaviour, such as gradually increasing activity levels. The results of several studies show that the more activities people engage in the better they feel. Behavioural Activation (BA) interventions encourage participants to meaningfully increase their engagement in activities with the aim of improving mood and sense of achievement. The current pilot study is seeking to test out (pilot) whether a supported self-help behavioural activation intervention designed for older Western Australians living in regional and remote areas is effective at decreasing the severity of depression amongst those who are depressed. The results will be used to improve the program and make it ready for a full clinical trial so that definitive evidence of the effectiveness of the intervention can be obtained. Specific aim of definitive trial: To determine if a greater proportion of older adults with Major Depression living in regional Western Australia randomly assigned to the BA intervention, compared to Standard Care, experience remission of symptoms after 12 weeks.

One of the most common reasons for presentation to a gynaecologist is for abnormal uterine bleeding (AUB). Women suspected for leiomyomas clinically or on ultrasound evidence are likely to be recommended to have surgical treatment for their condition, since medical treatment is ineffective for this presentation. Monopolar electrosurgical resection is frequently used in hysteroscopic removal of fibroids. Main complications include electrolyte disturbances and potential fatal outcomes due to use of hypotonic, non-conductive media (glycine) for uterine distension; and need for removal of the hysteroscope mid-procedure in order to clear the intrauterine cavity of debris, increasing operating time and potentiates cervical trauma. The hysteroscopic morcellator (Myosure (registered trademark)) has become an increasingly used tool to remove submucosal leiomyomas, as well as other intra-uterine pathology such as retained placental remnants. This instrument operates in a normal saline medium, removing the risk of hyponatraemia second to excessive absorption, during mechanical resection and concurrent removal of the fibroid from the intra-uterine cavity. Risk to the patient of fluid overload due to intra-vascular or intra-peritoneal absorption of large quantities of saline may occur. This study will compare the use of a mechanical hysteroscopic morcellator to monopolar electrosurgical hysteroscopic resection to remove submucosal leiomyomas in symptomatic women with AUB-L. We hypothesise that the hysteroscopic morcellator will allow for significantly faster resection of fibroids independent of surgical skill. The primary outcome of the study will investigate cost minimisation of the two different devices in an operating room setting, and determine opportunities for direct and indirect savings in a public health setting. Secondary outcomes will include determining: (1) ease of use of device; (2) completeness of resection, in terms of cessation of operation due to fluid deficit point being reached; and (3) the number of adverse events. This study is a prospective, randomised, single-blinded multi-centre clinical study. Women will be randomised to one of two study groups: 1. Intervention group: Resection of the leiomyoma with the hysteroscopic morcellator (Myosure (registered trademark)) and a normal saline distension medium. 2. Control group: Resection of the leiomyoma with a monopolar electrosurgical hysteroscopic resector with a glycine distension medium. Randomisation will occur via a third-party randomisation service, and study participants only will be blinded with regards to group allocation. A minimum of 162 participants to be enrolled over a 1-year recruitment period. All cases must satisfy the inclusion/exclusion criteria and will be followed for a minimum of 6 months after surgery.