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A synthetic haemostatic agent (PuraStat) for endonasal surgery
Expand descriptionBleeding is among the most common complications following endoscopic sinus and turbinate surgery and has historically been managed through the use of nasal packing. Haemostatic gels are seeing as use as an alternative method that is more comfortable for patients and reduces complications due to excessive tamponade by packs. This study evaluates the effect of RADA16, a nanopeptide based haemostatic hydrogel with a proposed role in reducing post-operative bleeding as well as reducing the incidence of other common complications including crusting/adhesion formation and chronic nasal infection, in the setting of endoscopic nasal surgery.
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Novel Delivery of Chemotherapy for Treatment of Patients with Mesothelioma: A Feasibility Study
Expand descriptionMalignant pleural mesothelioma (MPM) is a rare cancer of the lung lining caused by exposure to asbestos. MPM is regarded as one of the most aggressive solid tumours, with limited treatment options and poor prognosis. Emerging MPM treatment options are of particular interest in Australia where the incidence of MPM is among the highest in the world. One such emerging treatment involves the injection of chemotherapeutic agents into the aorta, where they perfuse directly into the vessels which supply the pleural lining. This approach, termed transarterial chemoperfusion, allows a high concentration of chemotherapy to be delivered directly to the cancer. This study is investigating the safety and effectiveness of transarterial chemoperfusion for the treatment of patients with MPM. We will evaluate tumour response, symptoms, quality of life, progression free survival and overall survival. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been diagnosed with malignant pleural mesothelioma that is not being treated with surgery and you have not had recent chemotherapy (within the last 4 weeks). Study details Participants enrolled in this study will undergo an angiogram (imaging of the heart and blood vessels), which involves having a catheter inserted into a vein. The chemotherapy agents will then be directly infused into the aorta and surrounding blood vessels over a period of 60 minutes. All participants will be receive this treatment for at least 2 sessions scheduled every 3-6 weeks, before undergoing a CT scan to assess treatment response. Participants who show a reduction in their tumour burden will continue to receive therapy every 3-6 weeks until they no longer respond to treatment. Participants who do not show a response to treatment after the first 2 procedures will not undergo further infusion therapy. It is hoped this research will determine whether this specific method of chemotherapy infusion is a safe and effective treatment for patients with malignant pleural mesothelioma, and can improve outcomes for future patients.
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The effect of maintenance macrolide antibiotic de-escalation during the Australian summer season on exacerbations of respiratory diseases such as asthma, COPD and bronchiectasis
Expand descriptionThis study is a new initiative to promote appropriate use of long-term macrolide antibiotics such as azithromycin, clarithromycin, roxithromycin and erythromycin in the management of respiratory diseases such as asthma, COPD and non-cystic fibrosis bronchiectasis. Although these drugs are effective, it is not clear for how long the treatment should be continued. Guidelines recommend a treatment duration of 6-12 months. They also recommend a drug break each year. In this study, we are investigating whether it is possible to stop these drugs permanently or at least temporarily after undergoing a certain period of treatment. We are looking for participants who are currently taking azithromycin, clarithromycin, roxithromycin or erythromycin for the treatment of asthma, COPD or bronchiectasis for at least 6 months. Participants will be randomised to one of the two study groups. Participants in both groups will stop the current macrolide during the Australian summer season as we anticipate that the summer season would be the best time to try medication withdrawal in respiratory diseases. After stopping the current macrolide, group 1 will start an equivalent macrolide which will be azithromycin, and group 2 will start an identical placebo. Participants will continue the study medication for a period of nine months with scheduled follow-ups at 3-, 6- and 9-months.
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Pyridostigmine to reduce the duration of postoperative Ileus in patients undergoing colorectal surgery
Expand descriptionPost-operative ileus (POI) is characterized by impairment of bowel motility and is a common complication after major abdominal surgery in general, and after colorectal surgery in particular. The principal features of POI include nausea and vomiting, inability to tolerate diet, significant abdominal distension and delayed passage of flatus and stool. POI as a complication has the largest overall effect on length of postoperative hospitalization. The purpose of this phase II trial is to determine the safety and effectiveness of oral pyridostigmine after elective colorectal surgery. We hypothesise that, within an optimised Enhanced Recovery Protocols (ERPs) setting, giving oral pyridostigmine to patients post-operatively will result in a reduction in the duration of postoperative Ileus.
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A First-in-Human Study of a Controlled Release Formulation of Lanreotide acetate in healthy male volunteers
Expand descriptionThis study will determine the pharmacokinetics and safety of the controlled released formulation of Lanreotide acetate in healthy male volunteers Who is it for? You may be eligible to join this study if you are male, aged 18-50, and in good general health. Study details After a screening period beginning up to 28 days before admission to the Clinical Research Unit (CRU), 8 participants in this study will receive one injection of Lanreotide acetate at a dose of 60mg. In the absence of safety issues, the remaining 8 participants will receive one injection of Lanreotide acetate at a dose of 120mg. As part of the study, participants will undergo safety assessments, Plasma/serum pharmacokinetic and global local tolerance assessment. Participants will be admitted to the CRU until day 2. Compared to the product already available on the market, this new lanreotide formulation [Lanreotide CRF] allows for a more convenient administration for both the patients and caregivers. The Lanreotide CRF is provided in a shorter and standard pre-filled syringe and a smaller needle is used for the injection (21G needle). In terms of PK profile, an equivalent performance is expected for the new Lanreotide CRF formulation when compared to the marketed product. It is hoped this research will determine whether this new lanreotide formulation can be administered safely without causing severe reactions. Once the PK profiles and safety have been determined in healthy volunteers, additional trials investigating the efficacy of Lanreotide CRF as a treatment for patients with neuroendocrine cancer or acromegaly may proceed.
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Aussie Fans in Training (Aussie-FIT): Feasibility trial of a health improvement program for men with cardiovascular disease
Expand descriptionIn this feasibility trial, we will create a version of Aussie-FIT, a men’s health program that uses the appeal of sport to engage men, adapted for cardiac patients’ needs. We aim to recruit 72 participants; 36 men will complete “Aussie-FIT” and 36 will receive “usual care”. The Aussie-FIT program will consist of workshops on healthy eating and building physical activity habits, and will offer a range of exercises, ball skills and circuit training. We will take pre- and post- assessments of weight, diet, physical activity, well-being and biomedical markers of cardiovascular risk. The project will provide pioneering evidence of the feasibility and acceptability of this program among cardiac populations and will set the stage for a future, fully powered trial to assess the potential role such programs to complement existing cardiac rehabilitation options.
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Safety and tolerability trial of an eye drop treatment for short sightedness (myopia)
Expand descriptionThis will be a first-in-human safety and tolerability trial of a novel ophthalmic solution for the treatment of the visual disorder myopia (short-sightedness). Myopia has been hypothesised to be driven by a reduction in dopamine levels within the eye. Over the past five decades, levodopa (the precursor to dopamine) has been the primary treatment for neurological disorders involving the dysregulation of the dopaminergic system, such as Parkinson’s disease. Before we can examine the efficacy of this compound at inhibiting myopia, this study will assess the safety and tolerability of levodopa as a reformulated eye drop solution.
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Evaluating the outcomes of a group parenting program for parents experiencing difficulties with affect, identity and relationships
Expand descriptionParents with Borderline Personality Disorder (BPD) appear to experience additional burden in their parenting role than those with other mental illnesses (Eliot et al., 2014; Newman et al., 2007). Additionally, individuals with BPD frequently report their own history of childhood maltreatment, which they may find activated in their role as parents. Parenting stress has been shown to mediate the relationship between maternal history of maltreatment and parenting sensitivity (Pererire et al., 20120), and can influence a parent’s capacity to mentalise, that is, the capacity to be attuned to the mental states in self and others (Nolte et al., 2013). Parenting behaviours are, however, amenable to change, and these changes may have positive effects on children’s outcomes, especially when parenting skills deficits are targeted during early development (Stepp et al., 2011). Given the body of research outlining difficulties and impairments faced by parents with BPD, there is a significant dearth in literature on the efficacy of parenting interventions for personality disorders, with even less exploring parenting interventions specifically tailored for individuals with personality disorder. The current trial was therefore aims to compare, in parents with BPD, a brief parenting intervention versus treatment as usual, in terms of parenting stress and parental mental health functioning.
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Chronic Myocardial Injury-Evaluating The Possible Role Of Sodium Glucose Co-Transporter 2 Inhibition (CHIRON)
Expand descriptionWhile a significant volume of research and resources are devoted to the diagnosis and management of myocardial infarction, chronic myocardial injury represents a far greater proportion of patients with high-sensitivity troponin T threshold above the upper reference limit of >14ng/L. In South Australia almost a third of patients presenting to emergency services have elevated troponin levels, of which approximately 40% are eventually diagnosed with chronic myocardial injury and are associated with greater rates of late cardiovascular deaths and events. Despite the overwhelming burden of chronic cardiac injury, currently no evidence-based recommendations exist for the management of these patients. SGLT-2 inhibitors such as dapagliflozin have shown to reduce heart failure related rehospitalisations and cardiovascular-related mortality among both patients with established diabetes and heart failure as well as patients with heart failure in the absence of diabetes, representing an exciting opportunity to improve the outcomes of patients with cardio-metabolic disease. This study will evaluate the impact of dapagliflozin on the cardiac biomarkers of myocardial injury among patients with chronic cardiac injury.
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Use of text messaging support to aid smoking cessation in patients presenting for surgery (TextPOP)
Expand descriptionSmoking in the perioperative setting leads to increased surgical and anaesthetic complications. It has been demonstrated that by reducing perioperative smoking rates it can lead to a reduction in these complications, resulting in better outcomes for both patients and health care systems. Undergoing an operation creates a unique encounter between the patient and a variety of health-care professionals. It occurs at a time when patients maybe more receptive to lifestyle changes and provides an opportunity for a “teachable moment” when the patient may be willing to adopt and sustain a positive behavioural change. This project will utilise deliver a m-Health smoking cessation intervention opportunistically targeted to a time point at which patients have been shown to be particularly receptive to behaviour change (before a surgical procedure). Inclusion criteria will be patients booked for surgical procedures in a large metropolitan hospital who have a self-reported history of smoking. Inclusion criteria include access to an active mobile phone and ability to understand written English. Participants will be randomised 1:1 in a single blinded randomised control trial to either usual care, or usual care plus a 12 week smoking cessation intervention delivered via 4 SMS messages per week. SMS messages will include 24 smoking cessation messages and 24 general message which include 1) healthy lifestyle (i.e. diet and physical activity) and 2) information specific to Westmead Hospital pre-admission and surgical services (eg. Parking locations, typical clinic duration, items to bring etc.)