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Randomised clinical trial to assess the feasibility for a larger study comparing the use of three Veno-Thrombo-Embolic prophylaxis treatments in patients undergoing major abdominal surgery.
Expand descriptionOne of the risks of having surgery is the formation of a blood clot in a vein in the body. These may form in the deep veins in the legs especially, this kind of clot is called a “thrombus” and if it moves to another part of the body it is then called an “embolus”. Developing a blood clot is a major complication of surgery and at its worst may be life-threatening, and at its best in some cases you may not even know you have a clot as there are no signs and symptoms. Part of the usual care of a person having a surgical procedure is to try and stop these clots forming by using 3 treatments or a combination of these 3 treatments: • Compression stockings (commonly known as TED stockings) • Intermittent pneumatic compression devices (IPCDs). These are disposable and inflatable “sleeves” and are applied to your legs at the time of operation by wrapping around your lower legs and are connected to a pump to inflate and deflate continuously to help move blood from your lower legs back to your heart. • Injection of an anti-blood clotting drug called Clexane® under the skin daily, up to 28 days from surgery (extended Clexane® injections is not for all patients). For this “pilot” the research team are wanting to know if they are able to get sufficient patients to a 30 day ultrasound of both legs.
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Randomised, controlled trial evaluating the effectiveness of probiotic and egg oral immunotherapy at inducing desensitisation or tolerance in participants with egg allergy compared with placebo (Probiotic Egg Allergen Oral Immunotherapy for Treatment of Egg Allergy: PEAT study).
Expand descriptionThe primary purpose of the study is to evaluate the efficacy of probiotic and egg oral immunotherapy compared to placebo in achieving sustained unresponsiveness in participants with egg allergy 8 weeks after end-of-treatment. The trial will include proven egg allergic people from 5 to 30 years of age. They will be randomised 1:1 into active and placebo groups. This study is expected to run for 6 years from the start of participant screening to the last participant finishing the study. The length of the treatment period for each participant is 18 months and the follow up period is 3 years. The discovery of a safe and tolerable treatment for food allergy will have great public health benefit.
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Emergency department clinicians’ perceptions on the use of patient controlled analgesia in emergency departments
Expand descriptionDespite pain being the primary reason most patients present to emergency departments (EDs), current methods of pain management in EDs are suboptimal. Patient controlled analgesia (PCA) involves the patient self-administering intravenous analgesia via a pre-set medication administration pump. Although PCAs have being rigorously evaluated and widely used in other clinical areas, they are not routinely used in EDs. This study will identify and describe ED clinicians’ perceptions of the use of PCA in EDs. In phase one, semi-structured interviews will be conducted in a private and a public ED in Western Australia (WA) to identify the perceptions of ED clinicians of using PCAs in EDs. In phase two, a survey will be developed based on findings in the previous phase. This survey will be distributed to ED doctors and nurses across Australia and New Zealand in phase three. This research will add to a limited body of knowledge in the area of pain management in EDs and potentially enhance pain management in the ED through the use of PCAs.
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A Comparison of Two Different Models of Care for People with Diabetes in the Yarra Ranges.
Expand descriptionThis 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
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An Ascending Dose Study of the Dexmedetomidine Transdermal System in Healthy Subjects
Expand descriptionThis 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.
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A comparison between positional therapy and continuous positive airway pressure therapy for positional obstructive sleep apnoea..
Expand descriptionObstructive 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).
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Medicinal cannabis use among dementia patients
Expand descriptionThe 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?
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FLASH.V: Flash Glucose Monitoring and Surgery in the Hepatopancreaticobiliary (HPB) Surgery and Liver Transplant Population - Verification Study
Expand descriptionThis 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
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FiASP vs. aspart using an advanced closed-loop system
Expand descriptionAn 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.
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Exploring Treatment Options for Obstructive Sleep Apnoea in People with Psychosis
Expand descriptionThe 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.