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Efficacy of cognitive behavioural therapy and/or simulation-based learning resources on the mental health of chronic obstructive pulmonary disease patients.
Expand descriptionChronic obstructive pulmonary disease (COPD) is an irreversible lung disease characterised by airflow obstruction. Symptoms of COPD include breathlessness, a chronic cough and sputum production. COPD is complicated by the number of other diseases experienced by patients, particularly anxiety disorders and depression. Psychological distress is experienced by a large number of people with COPD, with international evidence estimating 37% of COPD patients suffer from anxiety and 40% from depression. Furthermore, COPD patients with anxiety disorders have a poorer quality of life, higher death rates, more hospitalisations and emergency visits, and are a greater economic burden. An effective approach to reduce anxiety disorders is cognitive behavioural therapy (CBT). There are currently no data in Australia on the effect of CBT for COPD patients for anxiety disorders and depression. Furthermore, with the recent advances in technology, there is potential for electronic communication to become a complementary self-management tool with CBT or as a stand-alone resource which can provide COPD patients with coping skills for anxiety and depression. Therefore, a randomised control trial will be conducted to determine the efficacy of CBT and/or simulation-based learning resources on COPD patients on anxiety disorders, depression, health outcomes and healthcare costs. The aims of the project are: Aim 1: To determine the impact on healthcare utilisation of treating anxiety disorders in COPD patients. It is expected that treating anxiety disorders amongst COPD patients will reduce WA hospital bed days and emergency department visits in COPD patients. Aim 2: To demonstrate the use of CBT and/or a simulation-based learning resource improves health outcomes amongst COPD patients It is expected that individually CBT and simulation-based learning resources will reduce anxiety disorders and depression among COPD patients. However, compared to CBT or simulation-based learning resources, combining both methods will reduce anxiety disorders to a greater extent amongst COPD patients.
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The relationship between cortical activity and cognitive function after traumatic brain injury
Expand descriptionTraumatic brain injuries are common, estimated to affect 107 in 100,000 Australians per year. Of these 80% sustain a mild-moderate traumatic brain injury (mTBI). A wide range of cognitive, behavioural and affective symptoms occur as a result of the biomechanical forces to the brain. The acute and long lasting impact of mTBI on brain activity is not well characterised. Combined transcranial magnetic stimulation (TMS) with electroencephalography (EEG) can be used as a tool to identify the neurophysiological mechanisms associated with mTBI symptoms. Furthermore, it allows the association between cognitive impairments and the functional integrity of the neural areas underlying these symptoms to be investigated. Thirty mTBI participants and 30 age and gender matched controls will attend three testing sessions across a 6 month period to capture acute, sub-acute and chronic symptoms post injury. A neuropsychological assessment and TMS/EEG recording will be conducted at each time point. Analyses will be conducted between groups to assess for differences in brain activity and within groups to investigate recovery in mTBI and test-retest reliability in controls. By improving our understanding of how changes in brain activity relate to impairments and recovery of function, targeted therapeutic strategies to modulate these may be developed. In summary, the aim of this study is to investigate changes in cortical activity, and the relationship with cognition, during recovery post mTBI using TMS-EEG.
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Coenzyme Q10 Blood Level Absorption Study in Healthy Adult Volunteers
Expand descriptionTo Evaluate the Absorption Efficacy Characteristics and Further Safety Over a 6-hour period of Coenzyme Q10 [100 mg administered as ONE dose orally] from SIX study Preparations to Healthy Participants. The study aims to find out whether; 1) Different Over The Counter (OTC) Coenzyme Q10 products absorb differently as assessed by blood serum levels 2) Different modes of Coenzyme Q10 oral preparations [i.e. as a liquid or capsule] can provide the best delivery vechile 3) and what forms of Coenzyme Q10 such as liquids, capsules or other forms are acceptable to participants
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CannabisCINV: A placebo-controlled trial evaluating an oral THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting in patients of any known malignancy receiving chemotherapy.
Expand descriptionThe primary purpose of this trial is to evaluate the efficacy of an oral capsule containing plant-derived tetrahydrocannbinol (THC) and cannabidiol (CBD) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with any cancer for which you are scheduled to receive at least three further chemotherapy cycles using intravenous chemotherapy of high or moderate emetic risk. Study details We will first enrol 80 participants in a pilot trial and if the data from these participants shows the medicine works and is well tolerated, a further 170 participants will be enrolled, this is called the definitive trial. Participants enrolled in the pilot trial will be randomly allocated (by chance) to receive the study drug for the first five days of their first chemotherapy cycle following enrolment, followed by a placebo capsule for the first five days of the next chemotherapy cycle, or to receive the placebo first followed by the study treatment. All participants will then choose which treatment they would prefer to take for the first five days of the third chemotherapy cycle. Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. Participants enrolled in the definitive trial will be randomly allocated (by chance) to receive the study drug or the placebo for the first five days of their next three chemotherapy cycles following enrolment, Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. It is hoped that this trial will provide preliminary information on the efficacy of THC and CBD capsules for the prevention of CINV, which will inform further clinical trials.
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Implementation and evaluation of peripheral intravenous catheter (PIVC) flushing guidelines: A Stepped Wedge Cluster Randomised Trial
Expand descriptionIntroduction and Background: Intravenous access via peripheral intravenous catheters (PIVC) in the hand or arm is frequently required during hospital care to administer hydration fluids, medicines, blood transfusions and nutrition, and to withdraw blood for testing, It is estimated up to 85% of hospital patients require infusion therapy with up to 70% of patients requiring a PIVC. Historically, research and practice has focused (understandably) reducing blood stream infection rates, particularly in central venous catheters (CVCs). Catheter related blood stream infection (CRBSI) rates in PIVCs are extremely low (0.01)6, whereas PIVC failure rates due to dislodgement, occlusion, infiltration or phlebitis sit at 26% in Australia, 38% in Spain and 53% in the USA. Occlusion and infiltration account for 35% of failure. Australian and US Standards of Practice on PIVC maintenance include statements pertaining to securement, monitoring and flushing to maintain patency and function. A range of strategies to prevent or reduce PIVC complications exist. These include preventing failure through continuous or intermittent flushes of saline or heparin saline solution, and use of heparin, antibiotic and/or ethanol locks left inside the PIVC in between uses, continuous infusion and intermittent flushing. The Infusion Nurses Society's Infusion Nursing Standards of Practice clearly define three purposes of catheter flushing; to assess catheter function, to maintain catheter patency, and to prevent contact between incompatible medications or fluids that could produce a precipitate. For effective catheter flushing, the nurse must have an understanding of technique and the equipment used within his/her institution as well as the type of catheter in use. Specific to flushing current practice recommendations included aspiration of blood prior to flush administration to ascertain patency, flushing pre and post drug administration, use of 0.9% sodium chloride solution, amount of flush to at last equal that of device, use of single dose prefilled device, administration via syringe no smaller than 10mL to minimise applied pressure. There were varied recommendations for frequency of flushing. However, clinical trials and practice surveys have identified little if any adherence to these recommendations. Translation and evaluation of current evidence for flushing of PIVCs is urgently required to reduce the unacceptably high failure rate of PIVCs. Aims and Hypothesis. The aim of this implementation study is to evaluate the impact, feasibility and acceptability of a multifaceted intervention tailored to improve post insertion PIVC maintenance - specifically, patency and flushing. Primary hypothesis: the rate of PIVC failure (as measured by a composite of occlusion , infiltration, dislodgement, phlebitis and infection) in patients who receive recommended flushing practice will be lower than those patients who receive standard care.
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Evaluation of Partnered Pharmacist Charting at Admission and Discharge
Expand descriptionObjectives - The aim of this study was to evaluate the effectiveness of pharmacists completing the medication management plan in the medical discharge summary for preventing medication errors. Design - We conducted a cluster randomised controlled trial comparing pharmacist completed medication management plans in the discharge summary to standard medical discharge summaries among patients discharged following an inpatient stay under a general medical unit. Setting - This trial was conducted at an adult major referral hospital in metropolitan Melbourne, Australia with an annual Emergency Department (ED) attendance of approximately 60,000 patients Participants The evaluation included patients’ discharge summaries written in the period of 16th March 2015 to 27th July 2015. Interventions - Patients randomised to the intervention had their medication management plan completed by a pharmacist. Main outcome measures - The primary outcome variable was an erroneous discharge summary related to a medication error as identified by an independent assessor, who was not part of the patient’s admission process.
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Are viruses associated with disc degeneration or disc herniation? An evidence of concept study.
Expand descriptionDiscs in the spine are shock absorbers and are the subject of wear and tear, and on occasions collapse and pinch nerves that deliver severe pain into the leg or arm. This research is designed to look for "germs" that may be present in disc fragments that are removed at surgery. If a connection is found between "germs" and disc wear then a larger study will be planned to verify the finding. Ultimately a therapy may be used to counter the infiltration.
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PROxIMO: Efficacy of proactive therapeutic drug monitoring and dose adjustment of infliximab based on point of care testing for inflammatory bowel disease
Expand descriptionPatients with inflammatory bowel disease (IBD) are prescribed medications used to treat inflammation. Infliximab is an effective intravenous therapy that is used in the treatment of Crohn’s disease and ulcerative colitis. Conventionally, infliximab is given as an infusion every 8 weeks. The dose of infliximab is calculated according to weight and may differ between patients. Despite initially responding to infliximab, some patients will lose response over time, such that the drug no longer continues to work as well as it once did. Studies have demonstrated that patients on a maintenance treatment are more likely to continue to show positive responses to infliximab therapy when the blood level of infliximab, measured just prior to the next scheduled infusion (referred to as a ‘trough level’), is within an optimal range (referred to as ‘therapeutic range’). Infliximab levels are measured from a blood sample. In the past we measured infliximab levels only occasionally. This is partly because the results took time to be processed and were not available on the same day. In this project a blood test will be taken to measure the infliximab level every time patients are due for your infliximab infusion. The test to be used is able to measure the drug level within an hour at the point of care. We will then be able to modify the infliximab dose immediately, in small increments, according to the infliximab level with the aim of ensuring that infliximab levels remain within the ideal therapeutic range. The infliximab blood test and dose modification, if needed, will occur at each visit for the duration of the study (for 12 months, or 6-7 infusions). At each visit, 10mL (about 2 teaspoons) of blood will be taken from your peripheral access line to measure the level of infliximab in your blood along with other blood tests normally conducted when you have your infusion. The information from the blood tests will be used by the researchers to adjust the infliximab dose and to validate the dosing guide. Participants will be asked to provide faecal samples to measure faecal calprotectin, a protein that is secreted in the intestine of patients with inflammation of the gastrointestinal tract (this is a test we currently perform periodically; during this study we will do this test at the second visit and at the end of the study). Participants will be asked to complete a brief survey that assesses quality of life at the beginning and the end of the study, and to answer some short questions about their Crohn’s disease or ulcerative colitis
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A Multicentre Phase 3 Trial Comparing Elotuzumab-Cyclophosphamide-Thalidomide-Dexamethasone (E-CTD) with Cyclophosphamide-Thalidomide-Dexamethasone (CTD) for the Treatment of Relapsed and/or Refractory Multiple Myeloma (RRMM)
Expand descriptionPURPOSE The primary purpose of this study is to determine the efficacy and safety of elotuzumab when combined with cyclophosphamide, thalidomide and dexamethasone (E-CTD) when compared to a standard cyclophosphamide, thalidomide and dexamethasone (CTD) triplet for the treatment of relapsed and/or refractory multiple myeloma (RRMM) WHO IS IT FOR? You may be eligible to join this study if you are over 18 years, have been diagnosed with RRMM, have had between 1-3 prior lines of therapy (may include autologous or allogeneic stem cell transplant (induction followed by ASCT and maintenance is one line of therapy), and do not have central nervous system involvement with the disease. STUDY DETAILS Enrolled participants who meet the eligibility criteria at registration will be randomised in a 2:1 ratio with 2 patients randomised to the E-CTD arm for every 1 patient randomised to the CTD arm. Treatment in both arms will include a combination of weekly intravenous infusions, and daily and weekly oral tablets. Patients will receive treatment in 28 day cycles until disease progression, unacceptable toxicity, or withdrawal or consent. Patients will be followed up every 4 weeks for MM response until disease progression, and then every 12 weeks for survival. The trial duration is estimated at approximately 4.75 years. OUTCOMES It is hoped that the findings of this trial will determine whether the addition of elotuzumab to a standard cyclophosphamide, thalidomide and dexamethasone triplet will improve progression free survival in relapsed and/or refractory multiple myeloma patients
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The effects of yo-yo dieting on whole-body and fat tissue metabolism in pre-menopausal obese women undergoing bariatric surgery
Expand descriptionWeight cycling (yo-yo dieting) is an ongoing battle for many obese individuals and is commonly believed to impair energy metabolism and promote future weight gain. However, scientific evidence for this idea remains scarce and mechanisms of how this occurs has not been examined in humans. The aim of this study is to investigate whether weight-cyclers have impaired energy metabolism, greater fat deposition and greater circulating and fat tissue inflammation compared to non-cyclers. 100 overweight/obese women undergoing bariatric surgery will be recruited into this study. 60 women (30/group) will be classified as weight-cyclers or non-cyclers using a validated questionnaire. Blood and fat tissue samples will be collected at the time of surgery and markers of inflammation measured in the laboratory. Clinic visits will be performed at baseline prior to surgery and at 6, 12 and 24 months after surgery. Measurements include anthropometry, body composition, resting metabolic rate and circulating markers of cardiometabolic disease (glucose, insulin, HbA1c, lipids, inflammation). Using a rigorous scientific approach and comprehensive clinical phenotyping we will address whether individuals who weight cycle have reduced energy expenditure and greater fat deposition. These results will assist in tailoring personalised weight loss treatment strategies for the over 70% of Australians affected by overweight and obesity.