ANZCTR search results

The research project is to test and validate a new system for monitoring focal or generalised epilepsy. The new monitoring system is called Minder and is comprised of an implanted device that communicates to an external device, mobile phone and secure cloud. These components, known as the Minder system, will record each subject's electroencephalogram (EEG) data, also known as brain waves, and export it to a secure cloud via the mobile phone. The subjects will be required to use this Minder system continuously throughout the study for a period of 6 months with an optional long-term follow-up up to 3 years post-implant, during both wake and sleep. The subjects continuous EEG recordings during the study will be downloaded from the secure cloud and reviewed by trained clinical staff to detect seizures.

To implement and evaluate the effectiveness of nutrition and dietetic intervention in improving clinical and patient-centred outcomes in COPD outpatients at nutritional risk. Hypothesis: Dietary modification and oral nutritional support (ONS) is clinically more effective than dietary modification alone in the management of malnutrition in COPD. Study Design: Parallel randomised control trial. Intervention: The intervention involved 4 individual appointments with a dietitian ranging from 30-60minutes in length at initial, 6 and 12 weeks with a follow up at 26 weeks. Over the intervention phase the participants were given individualised dietary advice to improve energy and protein intake using either food modification and fortification (control group) or oral nutritional supplements (intervention group). Outcome measures • Dietary intake will be collected using 24 hour food recall to assess changes in energy and protein intake. • The St George’s Respiratory Questionnaire will provide an assessment of respiratory health status and quality of life. • Body Mass Index (BMI) for assessment of malnutrition status

Despite sleep problems being one of the most common symptoms experienced following concussion in children and adolescents, there is little scientific evidence for its treatment. Therefore, this study aims to determine: 1) the basic characteristics of sleep disturbance in children and adolescents following concussion; 2) the impact of post-concussion clinical insomnia (PCCI) on recovery; and 3) if the addition of melatonin to sleep education can improve patient outcome. Only children and adolescents with sleep disturbance following concussion, aged 8-17 years, will be eligible to participate in the study. Eligible participants will be randomly allocated to either Treatment Group 1 (i.e. sleep hygiene education) or Treatment Group 2 (i.e. sleep hygiene education plus melatonin) for a duration of 4 weeks, and will be monitored throughout this period until they have recovered. The findings from this study will facilitate a better understanding of the nature of sleep problems in children and adolescents following concussion, and will also provide scientific evidence of whether current interventions are effective in their treatment.

This study aims to clinically validate use of the Baker Skin Field Cancerisation Tool (BSFCT) in people attending St Vincent’s Hospital Melbourne dermatology clinic. Who is it for? You may be eligible to join this study if you are aged 18 years or above, are attending St Vincent’s Hospital Melbourne dermatology clinic, and have evidence of actinic damage (i.e. skin damage from ultraviolet exposure). Study details All participants in this study will attend a single [duration of 40 minutes - 1 hour] clinical appointment, administered by dermatologists. The session involves completing two separate questionnaires which will evaluate the quality of your life at the time of the clinic visit, assessment of the area or areas of your body with actinic damage to your skin by the dermatologists and taking photographs of these areas with actinic damage. The skin will be scored during the clinic visit and also later from the photographs using the Baker Skin Field Cancerisation Tool (BSFCT). Additionally, two other tools which have previously been developed by other groups for the assessment of actinic keratoses, the Actinic keratosis field assessment scale (AK-FAS) and the Actinic keratosis area and severity index (AKASI) will be used in both the clinic visits and from the photos. Scores from all of these tools will be correlated in order to determine the clinical validity of the BSFCT. It is hoped that this will be found to be a useful tool to assess skin damage.

Phase 2a trial to evaluate the safety and efficacy of 3 dose groups of CBL-514 on convexity or fullness of abdominal subcutaneous fat.

This research will provide insight into whether post-operative support interventions – other than physical therapy alone – can improve acute and long-term outcomes in spinal surgery patients. In addition to this, the study strives to determine whether an intervention must be behaviorally informed in order to improve patient outcomes. In addition to a CS and BCC arm, a control arm has been included in the study design as previous interventions in this area of research have found minimal variation between the BCC and corresponding intervention (which was not a control intervention), raising the question, are clinician support and BCC effective in comparison to standard treatment?

This research aims to determine whether comprehensive early intervention for injured workers at risk of developing chronic disability and unemployment results in faster return to work than standard care. Secondary aims include determining whether this early intervention is associated with improved emotional well being, quality of life and reduced interference caused by pain than standard care. Participants will be adults who have recently been injured at work and made a workers compensation claim through their insurer. A controlled intervention design will examine comprehensive early intervention versus treatment by a doctor in the community (standard care). We expect to determine whether comprehensive early intervention results in faster return to work, less cost and better treatment outcomes for recently injured workers.

An open-label study in healthy volunteers: To evaluate the safety, tolerability and pharmacokinetics of dapagliflozin (35 mg) extended release capsules (LYN-045) in healthy volunteers To characterize the pharmacokinetics (PK) of dapagliflozin (35 mg) extended release capsules (LYN-045).

The primary purpose of this study is to further compare and analyse dorsal plate vs transarticular screw fixation in Lisfranc injuries through a randomized controlled trial. The primary outcome is improvement of pain post-operatively, as assessed by the Manchester-Oxford Foot Questionnaire (MOxFQ) pain score. Secondary outcomes include, MOxFQ function score, EQ-5D quality of life score, AOFAS midfoot scores and need for further surgery, such as for fixation failure, pain secondary to metalwork and infection. Tertiary outcomes include monitoring for radiological signs of arthrosis/joint fusion. These outcomes have been selected to further examine the factors important to patient satisfaction, as well as the factors to likely require further surgery either acutely or in the future.

Delays in escalation of care (EOC) can have serious consequences for patient safety and patient outcomes. While initiating a Medical Emergency Team (MET) call is a relatively smooth process, there are no defined behaviours surrounding pre-MET conversations. Even with well-established protocols, clinicians are reported to experience factors that inhibit initiation of EOC conversations. Research has identified key barriers to initiating EOC conversations as: fear of hierarchy, respondents explaining away or dismissing concerns, and poor risk awareness or skills. The purpose of this project is to address some of the barriers involved in EOC conversations prior to a MET call. To do this, an intervention that provides clinicians with training on the expectations of the ‘initiator’ and the ‘responder’ during an escalation conversation (in the form of a ‘choose-your-own-adventure’ training video) will be trialled at Austin Health. The training will be evaluated using pre- and post-intervention questionnaires on clinicians’ knowledge, confidence, and reluctance to escalate patient care, and experience sampling will be employed to examine clinicians’ experiences of EOC conversations during the trial period.