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A randomised controlled trial evaluating the effectiveness of coping planning in reducing distress in university students
Expand descriptionCoping planning is an approach to working with people who are distressed. The aim of this study is to evaluate the effectiveness of this approach in reducing distress in university students and improving coping, coping self-efficacy.
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The effect of intermittent energy restriction (5:2 diet) on weight loss and risk of type 2 diabetes in women who have had gestational diabetes.
Expand descriptionIn 2015 at least 10.9% of pregnant women in Australia were diagnosed with gestational diabetes (GDM) (1, 2). GDM creates risk of complications to both mother and baby during pregnancy, labour and delivery, and although GDM usually disappears shortly after birth, the mother remains at high risk for developing Type 2 Diabetes (T2DM) in the future (3). The health risks and complications associated with T2DM are well known and include development of other chronic diseases including cardiovascular disease (CVD), heart attack, stroke and kidney disease making diabetes a major health concern in Australia and globally (4). Lifestyle interventions involving diet and/or exercise that result in weight loss can reduce the risk of developing T2DM (5), however research has shown weight loss is not easily achieved or maintained (6-8). Keeping women engaged in a weight loss program can be difficult when they have a baby or young children to care for given the time constraints and lifestyle adjustments associated with looking after their children (9). Intermittent Energy Restriction (IER) is a form of calorie restriction which requires periods of severe calorie restriction or fasting) followed by periods of non-restricted eating each week. Previous research shows IER can result in weight loss at a comparable rate to daily energy restriction (10, 11). This study will test if the IER diet strategy commonly known as ‘the 5:2 diet’ provides a suitable regime for women with a history of GDM who have a young family at home by creating less burden and interruption to daily life by restricting energy intake for short periods and advising usual but not excessive eating the rest of the week. This will be the first study that examines an IER pattern for weight loss and T2DM prevention following GDM. Results from this PhD have the potential to benefit Australian women and families by improving their health and potentially reducing the financial burden associated with diabetes to individuals and the community. References 1. National Diabetes Services Scheme. NDSS Data Snapshots December 2015 2015 [20/06/2017]. Available from: https://static.diabetesaustralia.com.au/s/fileassets/diabetes-australia/2fdff38c-078e-4e76-8dee-8a5bdcf07ae8.pdf. 2. Australian Bureau of Statistics. 3301.0 - Births, Australia, 2015, Summary of Statistics for Australia 2016 [Available from: http://www.abs.gov.au/ausstats/abs@.nsf/mf/3301.0. 3. Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet (London, England). 2009;373(9677):1773-9. 4. Baker IDI Heart & Diabetes Institute, Diabetes Australia, Juvenile Diabetes Research Foundation. Diabetes: the silent pandemic and its impact on Australia. 2012:27. 5. Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, et al. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. The Journal of clinical endocrinology and metabolism. 2008;93(12):4774-9. 6. Morton S, Kirkwood S, Thangaratinam S. Interventions to modify the progression to type 2 diabetes mellitus in women with gestational diabetes: a systematic review of literature. Current opinion in obstetrics & gynecology. 2014;26(6):476-86. 7. Guo J, Chen J-L, Whittemore R, Whitaker E. Postpartum lifestyle interventions to prevent type 2 diabetes among women with history of gestational diabetes: A systematic review of randomized clinical trials. J Women's Health. 2016;25(1):38-49. 8. Peacock AS, Bogossian F, McIntyre HD, Wilkinson S. A review of interventions to prevent type 2 diabetes after gestational diabetes. Journal of the Australian College of Midwives. 2014;27(4):e7-e15. 9. Amorim AR, Linne YM, Lourenco PM. Diet or exercise, or both, for weight reduction in women after childbirth. Cochrane Database Syst Rev. 2007(3):Cd005627. 10. Davis CS, Clarke RE, Coulter SN, Rounsefell KN, Walker RE, Rauch CE, et al. Intermittent energy restriction and weight loss: a systematic review. Eur J Clin Nutr. 2016;70(3):292-9. 11. Headland M, Clifton PM, Carter S, Keogh JB. Weight-loss outcomes: A systematic review and meta-analysis of intermittent energy restriction trials lasting a minimum of 6 months. Nutrients. 2016;8(6):08.
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SurgicalPleth Index for the prediction of acute postoperative pain
Expand descriptionBackground: The surgical pleth index (SPI, GE Healthcare, Helsinki, Finland) is a 0-100 score derived from the intraoperative non-invasive monitoring of oxygen saturation. Simply speaking, SPI is a software using existing data. The SPI score claims to reflect states of intraoperative pain. A previous investigation by us published in the British Journal of Anaesthesia (Br J Anaesth. 2016 Sep;117(3):371-4) found that a SPI > 30 at the end of surgery (prior to awakening) predicted moderate-severe postoperative pain. Objectives: As such prediction would provide a significant benefit for the pre-emptive treatment of pain, the proposed project aims to prospectively validate the SPI cut-off published by us in a larger cohort. In addition, we would like to evaluate the influence of age on the SPI cut-off value predicting moderate-severe pain, as well as the influence of a different anaesthetic technique (total intravenous anaesthesia) on the predictive value of SPI. The latter sub-group will be investigated by our collaborators in Kiel, Germany. Within WA Health 200 patients scheduled for non-emergency surgery under sevoflurane/opioid anaesthesia will be included in the study. Patients will receive a completely standard anaesthetic. At the end of surgery, SPI will be recorded minutely for 5 minutes. As outlined above, this simply requires recording of displayed SPI values. As SPI uses available data derived from standard monitoring, no discomfort or risk is associated with study inclusion. After awakening, 3 pain scores (numeric rating scales 0-10) will be recorded in the recovery room. The 5-minutely recording of pain scores is standard protocol in the involved hospitals and does hence not at all inconvenience patients. Apart from SPI and pain readings, only very limited data are recorded.
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Pancreatic cancer: Understanding Routine Practice and Lifting End Results (PURPLE). A Prospective Pancreatic Cancer Clinical Registry
Expand descriptionThis project is non-interventional registry of the treatment and outcomes of patients with pancreatic cancer managed at hospitals enrolled to participate in Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been newly diagnosed with pancreatic cancer (with or without metastatic disease) , with any ECOG performance status and are yet to receive treatment. Study details This registry will capture data on presentation and the disease course of pancreatic cancer, surgical interventions for primary and metastatic disease, prescription of systemic therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting. This project will collect clinical data using the already established data collection and analysis resources built up over the last 15 years in the Systems Biology & Personalised Medicine Division of the Walter & Eliza Hall Institute of medical research (WEHI). This protocol aims to enrol at least 800 eligible patients over 10 years. Findings from analyses that occur as part of this project are anticipated to improve our understanding of the presentation, clinical course and management of pancreatic cancer in Australia and other participating countries.
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Treating hypoglycaemia in newborns with Glucagon And Diazoxide: The Glad Study
Expand descriptionThe aim of this research project is to compare Glucagon with Diazoxide for the maintenance of normal blood sugar levels in babies of mothers with diabetes who have low blood sugar levels. The routine nursery treatment differs with each baby but includes use of high concentration sugar infusion (drip) given through an IV line placed in a large vein, intravenous Glucagon and oral Diazoxide. We aim to determine which of these medications, Glucagon or Diazoxide, is better at maintaining blood sugar and which is easier to use
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An Integrated Family Intervention for Child Conduct Problems: How a parenting intervention for childhood behavioural problems influences and is influenced by epigenetic variation in children aged 3 to 8 years.
Expand descriptionThe REAL Treatment project will investigate the inter-play between evidenced-based interventions that improve the child caregiving context, childhood behavioural outcomes, and, changes in DNA methylation of the major neurodevelopmental genes. 400 Children aged 2 to 8 years and their families will be recruited through the Sydney Child Behaviour Research Clinic over a 4 year period to participate in the REAL Treatment Study: A parenting Intervention for Child Conduct Problems. Families and the research team will form a supportive partnership to assess and monitor a child’s behavioural, emotional and neurodevelopmental progress, as well as parenting progress and family environment over the course of a 6 to 10 week tailored, evidenced-based parenting intervention to address child conduct problems. Assessments will be taken prior to and directly after receipt of the intervention as well as at a three month follow-up review assessment. Assessment will cover areas including: Child adjustment and diagnostic status, caregiver/parent adjustment, family environment, engagement with and dose of intervention received, epigenetic assessment (buccal cell collection for methylation assessment) and neurodevelopmental assessment (examining processes of emotional attention and responsiveness to stimuli). Preliminary assessments will also be conducted with a sub-sample of participants who are expected to be on the wait-list for 3 months or more before commencing treatment. A multi-informant assessment method will be applied throughout the research protocol that includes gathering data from: parents/caregivers; clinical interviews; the use of standardized questionnaire and psychometric assessments; coding of observational data of child and family interaction activities; and, teacher/educator reports and completion of questionnaires. We aim to a) confirm an emerging model of how epigenetic regulation of the major neurodevelopmental systems maps onto individual differences in comorbid symptom profiles before and after intervention; b) to examine how this regulation and mapping predicts individual differences in responsiveness of children to intervention that produces standardised and measurable improvements in the child caregiving environment; c) to examine how early intervention alters epigenetic regulation of the major neurodevelopmental systems and REAL (responsiveness, emotional attention and learning) phenomena, thus modifying risk versus protection for future development.
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A trial comparing ACP-011 administered as a single dose via a syringe and needle versus an auto-injector
Expand descriptionThis study aims to investigate an alternative method of administration, an auto-injector device containing ACP-011 compared to the usual needle and syringe. This research project is testing and comparing the safety, tolerability, pharmacokinetics (the amount of study drug and it’s breakdown products in your blood), pharmacodynamics (how your body is affected by the study drug) and immunogenicity (how your immune system is affected by the study drug) of ACP-011. Approximately 26 healthy male participants will be enrolled across 2 cohorts (groups). Each cohort will consist of 13 participants. The study medication will be administered through two methods over two periods, Particpants will receive both treatment methods in a particular sequence. The dose of study drug will be the same for each method. Participants will not have a choice as to which method or treatment sequence assigned, this will random (like flipping a coin). After the first treatment period, there will be a 14 day period where there will not be any study medication given. This period is known as a wash-out period. Treatment A: consists of a single subcutaneous (SC) (just under the skin) injection to the abdomen administered via syringe and needle. Treatment B: consists of a single SC injection administered via the auto-injector to the same quadrant of the abdomen as the previous injection (depending on sequence). Total participation in the study consists of 45 days which is broken up into 3 phases: - Screening Phase: During which participants will undergo suitability assessments - Treatment Phase: During which participants will be required to stay overnight in the unit for 8 consecutive nights on two separate occasions. Following this participants will be required to attend the study centre on 3 separate occasions - Washout Phase: in between the inpatient stays, where no study visits are required.
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A clinical study to investigate the safety of multiple doses of DEN-181 in rheumatoid arthritis patients
Expand descriptionCurrent treatments to control damaging immune responses during autoimmunity use broad immunosuppressive drugs associated with undesirable side effects. Alternative strategies to control damaging immune responses are desirable. DEN-181 offers a novel liposomal therapy that does not broadly suppress the immune system, with the associated increased risk of infectious complications, but rather is designed to specifically address the underlying pathology of Rheumatoid arthritis by re-programming the immune system towards tolerance for improved patient outcomes and minimal side effects. This trial will examine the safety, tolerability and preliminary efficacy of DEN-181 in Rheumatoid arthritis patients.
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Durvalumab and Tremelimumab +/- Platinum-Based Chemotherapy in Patients With Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Expand descriptionThe purpose of this study is to compare the effects of an immunotherapy combination of both durvalumab plus tremelimumab with or without chemotherapy on you and your lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have histologically and/or cytologically confirmed diagnosis of metastatic squamous or non-squamous, non-small cell carcinoma of the lung. Study details Participants will be allocated by chance to one of two treatment groups. Participant in both groups will receive durvalumab and tremelimumab every 28 days for 4 cycles followed by durvalumab every 28 days until disease progression. Participants in one group only will also receive additional chemotherapy during the first stage which will be dependent on Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC). Squamous Cell treatment will include gemcitabine and cisplatin or carboplatin while Non-Squamous Cell treatment will include pemetrexed and cisplatin or carboplatin. Immunotherapy with immune checkpoint inhibitors has demonstrated superior efficacy compared to chemotherapy and has a favourable side effect profile in the treatment of a subset of patients with NSCLC. Combining immunotherapies in the second-line setting has resulted in higher anti-cancer activity, but increases risk of immune-related side effects. Combining immunotherapy with chemotherapy is a promising new approach, with early results indicating much higher anti-cancer activity then would be expected with either treatment alone with no additional toxicity. The combination of two immunotherapy agents, with or without chemotherapy may be the best way to balance the chances of prolonged anticancer responses seen with immunotherapy against the risk of side-effects associated with treatment.
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Joint Mobilisation in Chronic Ankle Instability
Expand descriptionThe purpose of this study is to, 1. Assess the effect of MWM on fibular positional fault in CAI 2. Evaluate the effectiveness of MWM on clinically relevant outcomes (dorsiflexion range, pressure pain threshold, pain intensity, function, static and dynamic balance) Participants aged over 18 years will be recruited from the general community in the Newcastle area of New South Wales, Australia and volunteers with CAI will be accepted into the study if they satisfy the inclusion and exclusion criteria as endorsed by the International Ankle Consortium. They will also be excluded if they have conditions for which manual therapy, taping or radiographs are contraindicated. All physiotherapy undergraduates, except first year students also be excluded. The initial screening will be performed over the telephone after the potential participant contacts the research team. The screening questions are based on injury history. If a potential participant appears eligible following the telephone interview, further screening will be performed using Qualtrics survey tool. Survey link with two questionnaires: the Foot and Ankle Ability Measure (FAAM) and the Cumberland Ankle Instability Tool (CAIT), will be sent, along with the participant information statement and the consent form, through an email. Once the eligibility decided, (CAIT less than or equal to 24, FAAM: ADL < 90%, FAAM: Sports <80 %), the participant will be contacted to schedule an appointment for data collection. Consenting participants will be randomised into two groups: an experimental group (MWM), and a placebo group (detuned laser). All of the participants will be assessed for general joint hypermobility using the Beighton score. Mechanical ankle instability will be tested using two X-rays taken while performing an anterior drawer stress test. The clinically important outcome measures will include; radiological imaging of fibular position, dorsiflexion range of motion, pressure pain threshold, pain intensity, function, static balance and dynamic balance. Researcher who collect the measurements, and the radiographer will be blinded to the treatment allocation. Due to the nature of the intervention, treating physiotherapist cannot be blinded. Further, the participant does not know which treatment is the active intervention. Then according to the random allocation; the participant will receive a MWM or a placebo intervention. Participants will receive between 2- 8 intervention sessions over 4 weeks, depend on the clinical judgement of the treating therapist on individual response. The same measures will be repeated at the fourth week after enrolment. Follow up data collection will be carried out after twelfth week, and after twelfth month of the intervention. Telephone interviews will be conducted in every 4 weeks after enrolment up to one year. These will be made to record new injuries, any treatment co-interventions and the level of engagements in sports and other activities