ANZCTR search results

This project will evaluate the implementation and delivery of a new model of care for people with diabetes in the Yarra Ranges,including a multidisciplinary, integrated team within the local community health provider INSPIRO (Lilydale). Research will include collection of data from medical records, specifically designed questionnaires, interviews and focus groups with key stakeholders including clients,staff, management and the local community. The results of the evaluation will inform improvements to the service and the development and implementation of similar models in other locations within the Yarra Ranges

This is a Phase 1, open-label, non-randomized single-ascending dose study of DMTS in healthy subjects to study the maximum tolerated dose (MTD) as primary objective. The study consists of up to 8 cohorts, which will be evaluated sequentially. Subjects in each cohort will receive a 4-day application of DMTS followed by a 48-hour washout period. Subjects in Cohort 1 will receive 1 DMTS (0.49 mg dexmedetomidine). If this dose is well tolerated, the dose will be increased in each subsequent cohort up to a maximum of 4 DMTS (1.96 mg dexmedetomidine). Dose escalation will occur only after review by a safety monitoring committee of safety data collected during the immediately preceding cohort, with the data indicating that the dose had been tolerated.

Obstructive sleep apnoea syndrome (OSAS) is a chronic disorder characterised by recurrent episodes of complete or partial upper airway obstruction during sleep contributing to repetitive arousals and subsequent symptoms of non-restorative sleep. In a subset of patients with OSA, obstructive events occur much more frequently during supine sleep. In such patients, considered to have positional OSA (pOSA), vibrotactile positional therapy has been shown to restrict supine sleep thereby reducing the severity of OSA, improving sleep architecture and depression scores. These devices can also be used to accurately monitor adherence and other treatment outcomes. This study will undertake a prospective crossover trial of positional and CPAP therapy in eligible patients (see Inclusion and Exclusion Criteria) with mild-to-moderate positional OSA. In a prospective, randomized crossover trial, patients with pOSA will undergo an 8 week trial of both positional therapy (NightShift) and CPAP. The primary end-point for comparison will be change in subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS).

The research project will investigate the effects of medicinal cannabis oil among those living within a residential aged care facility and have received a medical diagnosis of dementia. Using a cross-over N-of-1, randomised double blind trial, participants will receive either an oil-based placebo or medical cannabis oil in the form of purified THC/CBD. In safety and efficacy trials, medicinal cannabis oil has shown to improve symptoms such as agitation and aggressive, disruptive sleeping patterns and increase appetite. Medicinal cannabis oil has also shown a number of benefits to other neurodegenerative diseases such as Multiple sclerosis, Parkinson’s disease and Epilepsy. However we do not know the extent to which medicinal cannabis oil may influence the symptoms associated with dementia at an individual level. Therefore this project aims to monitor the effects of administering medicinal cannabis oil to those with dementia and to determine if there are any changes in behaviour, quality of life, discomfort or pain levels or weight. The results from this study will be important in helping us understand the benefits to medicinal cannabis oil within residential aged care facilities and may lead to the continuation of medicinal cannabis oil to be used among this population. The primary question for this study is: Does medicinal cannabis affect the behavioural symptoms of care recipients with dementia? Secondary research questions include: 1. Does medicinal cannabis affect care recipients with dementia quality of life? 2. Does medicinal cannabis affect care recipients with dementia discomfort and pain?

This study aims to determine how well flash glucose monitoring performs in patients during the periods before, during and after surgery, in patient who are undergoing major general surgery with a focus on pancreatic surgery, surgery on the bile duct system and surgery on the liver and liver transplantation. It will compare the results of the flash glucose monitoring with arterial blood glucose and capillary blood glucose levels

An advanced hybrid closed-loop (A-HCL) insulin delivery system has shown safety and high time-in-range in a previous study. The use of a faster acting insulin aspart (FiASP) with a more rapid onset and shorter duration of insulin action compared to standard insulin aspart could improve the responsiveness of a HCL system. Limited data is available regarding the use of FiASP in HCL systems. The aim is to compare glucose control using A-HCL delivering FiASP vs. insulin aspart. All participants will undertake the study over a 17 week period, completing 2 study stages in random order, each of 6 week duration 1) A-HCL with FiASP, 2) A-HCL with insulin aspart. Stage 3 will be a 1 week period, reverting back to the insulin formulation used in Stage 1 without a washout period. Outcome measures include CGM time-in-range and time in hyperglycaemic and hypoglycaemic ranges; safety and system performance outcomes.

The overall aim of this research is to explore alternative treatment options for OSA in people with psychotic disorders. Specifically, the aim is to test the efficacy and tolerability of three previously unexplored treatment options for Obstructive Sleep Apnoea (OSA) and previously tested Continuous Positive Airway pressure (CPAP) in people with psychosis. The non-CPAP treatment arms include: oropharyngeal exercises, positional therapy and dental appliances. The outcome measures in this study will look at 1) OSA severity, 2) Quality of life, 3) Cognitive Functioning and 4) Severity of Psychosis Symptoms.

This is a double-blind pharmacokinetic study designed to assess bioequivalence between a test, BP001, and reference formulation, Xolair®, of 150 mg omalizumab. The study will consist of 84 healthy male participants, each receiving a single 150 mg subcutaneous dose of BP001 or Xolair® in a randomized parallel-group design.

The purpose of this study is to assess how the accommodative system (the focusing mechanism) of the eye extracts the directional information from the visual experience, We will be assessing the accommodative system function using a non-contact instrument where you are asked to look at a target provided on a computer screen.

Long-term cannabis use is associated with deficits in areas of cognitive functioning. It is important to intervene at the cognitive level as cognitive deficits impede everyday functioning (i.e., driving) and health outcomes for individuals who have engaged in prolonged substance use (Aharonovich, Brooks, Nunes, & Hasin, 2008; Cousijn & Filbey, 2015; Sofuoglu, DeVito, Waters, & Carroll, 2013). For example, poor inhibitory control can reduce the ability to refrain from drug use and hence increase the risk of relapse (Goldstein & Volkow, 2002). There is a need to provide cognitive intervention to cannabis users to 1) improve everyday functioning, and 2) alleviate cognitive problems to hopefully empower individuals to cease cannabis. Pharmacological interventions are being investigated for assisting drug abstinence, however, such treatment often has unwanted side effects (e.g., headaches, suicidality) and typically does not result in long-term abstinence (Le Foll, Gorelick, & Goldberg, 2009; Levin et al., 2011; McRae-Clark et al., 2015; Schoedel et al., 2011). Pharmacological interventions at the cognitive level has received less attention and existing studies provide mixed results across populations (Boggs et al., 2018; Hindocha et al., 2018; McGuire et al., 2017; Solowij et al., 2018). Moreover, novel pharmacotherapies can be exorbitantly priced and some have restricted access in Australia. In various reviews, researchers emphasise that effective cognitive-enhancing interventions need to be identified as there are few successful pharmacotherapy options for assisting cognitive problems among people who use substances, such as cannabis (Coles, Kozak, & George, 2018; Cousijn, 2015; Flöel, 2014). Cognitive training has received some attention but with mixed results and researchers are now investigating brain stimulation techniques to target cognitive-related brain regions, such as the dorsolateral prefrontal cortex. The aim of this pilot study is to determine the feasibility of using transcranial Direct Current Stimulation (tDCS; HDCStim, Newronika s.r.l. Italy) to enhance cognitive functioning in individuals who have engaged in long-term, regular cannabis use. We will provide a single session of tDCS (20 minutes, 1.5mA, DLPFC) and measure decision making and inhibitory control before and after tDCS. Urine will also be collected before and after tDCS in order to investigate potential urinary biomarkers (specifically, a panel of amino acids such as glutamine and GABA) of cognition in relation to cannabis use. Our hypothesis is that cognitive functioning, as measured by objective cognitive tests, will increase from pre- to post-tDCS and that changes in urinary biomarkers will be associated with changes in cognitive functioning as a result of tDCS. The group of individuals who use cannabis are expected to show greatest improvements in cognition compared to the control group.