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Cessation Of Pharmacotherapy In Recovered Chemotherapy induced cardioToxicity (COP-RCT) – a pilot study
The purpose of this research is to explore the effect of stopping heart medication in cancer patients whose hearts have recovered from chemotherapy-related cardiac dysfunction (CTRCD). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been previously diagnosed with asymptomatic CTRCD and you are currently taking CTRCD medications including Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB). Study details All participants who choose to enrol in this study will be randomly divided into one of two groups by chance (similar to flipping a coin). One group will continue their heart medications as prescribed. The second group will cease their heart medications (Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB)) under medical supervision, this will occur over a staged period. All participants regardless of their group allocation will undergo monthly clincial review. An echocardiogram (heart ultrasound, approximately one hour), Electrocardiogram (ECG), blood tests and cardiac magnetic resonance imaging (CMR) will be taken at the start and end of study involvement. It is hoped this research will determine whether completely stopping cardiac medications including ACE inhibitors and beta blockers is safe and whether this has any negative impacts on patients with previous chemotherapy related cardiac dysfunction. If this treatment cessation is safe it may be used to improve health outcomes for future cancer patients who are affected by chemotherapy related cardiac dysfunction.
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Activity Counselling Early post-Percutaneous Coronary Intervention: the ACE-PCI trial.
Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart. After a PCI, it is recommended in medical guidelines that everyone should receive physical activity advice and referral to a cardiac rehabilitation program prior to discharge. However, physical activity levels have been found to be low in people following a PCI. The aim of this research is to investigate whether a 30-minute physiotherapist-led physical activity counselling session prior to discharge improves physical activity levels early in individuals recovery (first 3-weeks) compared to brief physical activity advice provided by nursing staff. Findings from this study will inform further investigation of physical activity advice after a PCI, to determine how we should deliver this information, and whether this has an impact on physical activity levels early in people's recovery.
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AustraLIan trial of GeNotype-guided pharmacothErapy for Depression (ALIGNED Study)
Depression is a common form of mental distress that affects 1 in 7 Australians in their lifetime. People who are depressed not only feel depressed and sad, but often find they sleep poorly, experience a change in appetite, have low energy, poor concentration and have lowered self-esteem. Sometimes, they might think of harming themselves. Often, they find it hard to enjoy life or be productive. Recovery from depression is possible and treatment for depression includes psychotherapy (talking therapy), cognitive behavioural therapy and medication. In fact, almost 10% of Australians use antidepressants each year. Finding the right medication and the right dose can be challenging, often requiring several trial-and-error attempts. Approximately two thirds of people do not get better with the first medication they’re prescribed and one third of people do not recover even after four different medications are tried. Pharmacogenomics is a new, simple genetic test which can determine the way a person’s body will respond to medication. The ALIGNED Study (AustraLIan trial of GeNotype-guided pharmacothErapy for Depression) is looking at how pharmacogenomics can help to find the right antidepressant medication for people with depression. This may improve the likelihood of recovery from depression.
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Fussy Eating Rescue: Evaluating the feasibility and acceptability of a mobile-web app for responsive feeding practises among parents of toddlers
This project aims to evaluate the feasibility and acceptability of an intervention to improve the feeding practices of parents concerned for the fussy eating behaviours of their toddlers. The program will be delivered via a mobile web-based application with text-message prompts.
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Safety, efficacy and tolerability of the Novoglan foreskin tissue expander product as a conservative treatment for adult phimosis.
The aim of the Novoglan-01 clinical trial is to conduct a scientific study in compliance with good clinical practice in order to confirm the safety, efficacy and tolerability of the Novoglan product as a conservative treatment for adult phimosis. This study is expected to provide evidence for the use of the Novoglan product as an alternative to steroid creams in the conservative treatment of adult phimosis. The study is an investigator-initiated running in two sites at Macquarie University Hospital in NSW and Princess Alexandra Hospital in QLD. The Novoglan-01 study is a single arm, non-randomised, observational, prospective study that plans to recruit 24 participants starting in September 2019 and concluding in February 2022.
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Routine cardiorespiratory and sleep monitoring in an epilepsy monitoring unit
The primary objective of this study is to use machine learning methods to examine autonomic, cardiorespiratory and sleep function in patients with epilepsy to determine whether this data can be used to detect seizures. We will also examine seizure classification and prediction as secondary objectives using the same approach. We will examine whether autonomic, cardiorespiratory and sleep function can be used to differentiate between epileptic seizures and non-epileptic events. Further, we will also examine the prevalence and risk-factors for sleep-disordered breathing in patients who undergo video-EEG monitoring.
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Evaluating the implementation of a new approach to preventive care provided by community mental health services to people with a mental health condition
People with mental health conditions die up to 20 years earlier than the general population, largely due to a higher prevalence of risk factors: nutrition, physical inactivity, alcohol overconsumption, tobacco smoking and weight. ‘Preventive care’ to address risk factors is infrequently provided in community mental health services. A new approach to providing preventive care will be co-developed with mental health clinicians; incorporating a ‘dedicated provider’ within community mental health services and strategies to facilitate the integration of preventive care into usual practice. The research team will evaluate this new approach in a cluster randomised controlled trial across three local health districts (Hunter New England, Mid North Coast, and Central Coast). Community mental health services will be randomly allocated to an intervention or control group. Primary outcomes will be client-reported receipt of assessment, advice and referral for relevant risk behaviours (nutrition, smoking, alcohol, physical activity) from their mental health service.
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Prevalence, severity, and outcomes of sepsis in Australian and New Zealand children
Background: Sepsis is the leading cause of early childhood death worldwide, with an estimated 4 million children dying from this final common pathway for severe infections every year. The burden of disease in Australia and New Zealand is unknown, including mortality, duration of hospitalisation, requirement for intensive care and organ support therapies, and long-term functional outcome in sepsis survivors. Early markers of severe disease and predictors of poor outcome in childhood sepsis are unknown. Sepsis-related hospital costs are estimated at $4 billion per annum for children and $12 billion per annum for adults in the United States. The cost of hospitalisation for children with sepsis in Australia and New Zealand is unknown. Variation in guidelines for sepsis treatment in Australia and New Zealand, and adherence to such guidelines, is unknown. The microbiology and resistance patterns of bacterial pathogens in children treated for sepsis in Australia and New Zealand are unknown. Whether current empiric antibiotic recommendations are appropriate to cover bacterial pathogens causing sepsis in Australia and New Zealand is unknown. The prevalence and outcomes in subgroups of vulnerable, high risk children, including those receiving cancer chemotherapy, those self identifying as of Aboriginal or Torres Strait Islander or Maori ethnicity, those with chronic medical conditions, and infants or neonates who are treated for sepsis are unknown. Rationale: Baseline observational data is required to answer fundamental aspects of sepsis care for children in Australia and New Zealand, and to plan future interventional studies. Defining characteristics, prevalence, severity, resource utilisation, cost, variation in care, and antimicrobial stewardship are all important and unexplored components of the paediatric sepsis research landscape that will be addressed by this study. Aim: To describe the epidemiology of hospitalised children treated for sepsis in Australia and New Zealand.
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Responsible opioid use before hip and knee replacement surgery
Although we like to think that morphine-type (opioid) drugs are strong painkillers that work for all types of pain, the story turns out to be more complicated. Opioids are commonly prescribed for the pain of hip and knee osteoarthritis where there is little evidence to support their effectiveness, yet there is evidence that they increase harms. Despite this risk, an estimated 24 to 39% of patients undergoing knee or hip arthroplasty use opioids regularly while waiting for surgery. Not only is pre-surgery opioid use not very effective for the pain of severe arthritis, but research has shown that regular use is related to worse pain at the time of the operation, more side effects, longer hospital stays and more complications after discharge from hospital compared to patients who don’t use opioids regularly before surgery. Hip and knee replacements are among the most common elective surgeries performed in Australia, with approximately 100,000 hip or knee replacements performed in 2019. This means approximately 30,000 people annually potentially have their joint replacement outcomes undermined by opioid use. The proposed pilot study aims to reduce these opioid-related harms by measuring whether patients are willing and able to reduce their opioid medication by at least 50% while they are on the waiting list for elective hip or knee replacement. Those patients who agree to participate will be randomised to either a usual waiting list experience or to having a pharmacist work with their General Practitioner to reduce their opioid dose very slowly. Most patients find that their pain does not increase as the doses reduce if tapering is slow and performed in partnership with the patient. Further, individualised tapering that supports the patient, provides them with information relevant to their circumstances and allows their control of the weaning phases. After the patient and pharmacist come to an agreed opioid tapering plan, an Anaesthetist will review this plan to ensure its safety and effectiveness. Whilst the aim is to measure the feasibility of a 50% taper, the patient will decide the point at which they cease to taper. Patients will receive follow-up appointments with the pharmacist one week after each opioid dose reduction. Patients already seeing a pain specialist or undergoing opioid tapering will be invited to join an observational group. This research will be performed at both metropolitan and regional teaching hospitals in NSW, in recognition of the increased community use of, and harms from, opioids in regional areas. Patients who present for surgery while taking regular opioids not only have poorer outcomes but also pose a challenge for anaesthetists and pain management teams. Thus, the proposed research has the potential to improve the perioperative experience for both the patients and their medical teams.
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Light Therapy for the treatment of post-stroke fatigue
Individuals following a stroke experience an array of clinical problems, including post stroke fatigue (PSF). PSF has been articulated as a feeling of a lack of energy, weariness and aversion to effort. It is considered one of the most detrimental consequences of a stroke and is estimated to affect between 40% and 70% of individuals at six months post-stroke. These values significantly exceed those in the general population, where fatigue is estimated to affect between 10% and 23% of individuals. These figures are alarming, particularly considering the well-documented associations between greater PSF and shorter survival, institutionalisation, poorer functional outcomes and reduced functional independence and quality of life. Treatment strategies aimed at combating post-stroke fatigue are therefore crucial. To date, evaluation of non-pharmaceutical treatment options for PSF have largely focused on the utility of exercise training and psychotherapy. A recent Cochrane report indicated no positive effect of psychotherapy on PSF. The effects of exercise training on PSF are also equivocal with limited high-quality evidence. While not demonstrated in individuals with stroke, light therapy has been demonstrated to positively impact on fatigue in individuals with Parkinson’s disease, traumatic brain injury, seasonal affective disorder and cancer-related fatigue. Considering its positive effect on fatigue in these populations, particularly individuals with Parkinson’s disease and traumatic brain injury who both display neurological damage, it is conceivable that light therapy will have a positive effect on post-stroke fatigue. The purpose of this study is to evaluate the feasibility and therapeutic effects of light therapy in combination with sleep health, compared to sleep health alone, in individuals experiencing post-stroke fatigue at least three months following a stroke. It is hypothesised that both therapies will be feasible and positively impact on fatigue, however, light therapy plus sleep health guidance will prove to be more therapeutically effective than sleep health guidance alone.