ANZCTR search results

This project intends to investigate the respiratory effects of a low dose ketamine infusion in patients suffering from obstructive sleep apnoea (OSA). Recent studies have shown that over 25% of patients undergoing surgery may be suffering from Obstructive sleep apnoea (OSA). An estimated 80% of patients with OSA would undergo surgery without a diagnosis. Due to the epidemic of obesity on the rise, the prevalence of OSA, which is common among overweight people, is expected to increase over time. Ketamine is a medication different from the morphine family of medications (opioids), that is used as an adjunct to opioids in pain management following surgery. Low-dose ketamine infusion results in reduced opioid requirements, less sedation, a lower rate of postoperative nausea and vomiting with no change in breathing patterns. Previous trials, both in volunteers and postoperative patients not suffering from OSA, has shown improved oxygen saturation and a lower carbon dioxide level in the blood when ketamine was used with opioid medications. Hypothesis: Based on results from previous trials involving ketamine, we anticipate this medication to have a beneficial effect on breathing during sleep in patients suffering from OSA. The results of this study will enable us to identify whether ketamine is a suitable medication for use in patients suffering from OSA. This will help create accurate guidelines on the management of patients with OSA undergoing surgery. Design: We will administer either low-dose ketamine or a placebo (normal saline) as an infusion to volunteers suffering from severe OSA and conduct a standard in-lab sleep study to assess the blood oxygen level, breathing pattern and sleep pattern. Each patient will receive both a ketamine infusion and the placebo infusion in a random order with a period of one week between the two sleep studies. This will be a single centre, double-blind, randomised, crossover study. Patients with severe OSA will be randomly assigned to receive either ketamine or a placebo in the sequence given below, during an in-lab, overnight polysomnogram (PSG). Sequence A – infusion of ketamine during PSG 1 and a placebo infusion during PSG 2. Sequence B – placebo infusion during PSG 1 and ketamine infusion during PSG 2. Sample size: 22 patients Study duration: 12 months Aim: To identify whether a ketamine infusion significantly affects the ventilation of OSA patients during sleep, when given in doses used for pain relief following surgery. Primary endpoint: ‘Oxygen desaturation index’ of the patients will be compared between the PSG with a ketamine infusion and the PSG with a placebo infusion.

Medlab Clinical is currently sponsoring an early phase clinical study evaluating the safety and efficacy of a new Cannabis formulation containing THC 8.33 mg/ml and CBD 8.33mg/ml in the form of an oro-buccal spray, for the management of severe pain in advanced cancer patients as an adjunct to opioid analgesia. The formulation is a 1:1 mixture of two distinct cannabis oil extracts produced from cultivated Cannabis sativa L. and Cannabis indica L. plants. Who is it for? Males and females aged 18+ diagnosed with advanced cancer who are experiencing intractable pain and are currently administering opioid analgesia. It is a requirement that participants continue to administer the prescribed opioid analgesia while on the study. Participants will not be allowed to drive while administering the study drug. Patients wishing to participate in the study will need a referral from their threating physician. Where? The study is taking place at a major Sydney metro hospital. Recruiting is now open. Study details This study will be conducted in two stages. During the first stage, participants will be enrolled and remain under clinical supervision in hospital for 48 hours. On day 1, a ‘standard dose’ of 2.6 mg delta-9-tetrahydrocannabinol (THC) and 2.4 mg cannabidiol (CBD) in 0.3 mL will be administered using a buccal spray delivery system. On day 2, three ‘standard doses’ will be administered. Participants will be monitored for any adverse events during hospital stay. Stage 2 of study will involve a dose escalation over 7 days commencing with one ‘standard dose’ every 4 hours and three ‘standard doses’ every 4 hours by day 7 which are then maintained until day 15. Several assessments are conducted over administration period and on day 30 post intervention commencement. Participants will be required to self-administer the drug for 15 consecutive days and visit the study site for a total of 8 visits within 30 days. Each visit is approximately 1 hr in duration. There are no overnight stays. In addition, participants will be required to provide a blood sample at each visit and complete daily questionnaires about their pain while on the study. This study may greatly contribute to the research into the pharmacokinetic and medicinal properties of the Cannabis plant, in particular C. sativa L. and C. indica L. strains. The treatment may be beneficial for the treatment of intractable pain in cancer patients in conjunction with the conventional opioid treatment. In the event that the medication is efficacious over the two-week period of the study, Medlab Clinical will make available the medication free of charge after the study to those trial participants that the Principal Investigator deems clinically appropriate to do so in consultation with their treating clinician.

The aim of this research trial is to investigate whether the Mindful Selfcare and Resiliency intervention is effective in reducing burnout, secondary traumatic stress, and symptoms of general psychological distress in General Practitioners working in a rural health service in Queensland, Australia. Secondary aims are to determine whether the intervention increases protective factors for occupational stress, including compassion satisfaction, self-compassion and resilience. Our primary hypothesis is that GPs completing the MSCR intervention will show significant reductions in symptoms of burnout, secondary traumatic stress and general psychological distress from pre to post intervention and from pre intervention to follow-up. A secondary hypothesis is that GPs completing the MSCR intervention would show significant improvements in compassion satisfaction, self-compassion and resilience from pre-post intervention and from pre-intervention to follow-up.

The aim of this project is to investigate the efficacy of N-acetylcysteine (NAC) (1.8g/day) for smoking cessation in a randomised, placebo-controlled trial of current smokers who wish to quit smoking. The primary outcome measure will be 6 months of continuous abstinence from end of treatment (EoT) in tobacco smoking, confirmed by biological measures. Secondary outcome measures include point prevalence abstinence, time to relapse and cigarette consumption. Safety, tolerability and subgroup analyses will also be conducted. Hypotheses: Primary: Treatment with NAC will be superior to placebo for smoking cessation at follow-up (week 42), confirmed by assaying exhaled carbon monoxide and salivary cotinine. Secondary: Treatment with NAC will be superior to placebo for smoking cessation at treatment endpoint (week 16), confirmed by assaying exhaled carbon monoxide and salivary cotinine. NAC is an agent that replenishes the antioxidant glutathione, and also has intrinsic antioxidant actions, as well as modulating glutamatergic, neurotropic and inflammatory pathways.There is evidence that glutamate and in particular the cystine-glutamate exchange system, mediate drug intake, craving and behavioural sensitisation in preclinical models of addiction. Glutamate, which is increased by NAC via cysteine-glutamate exchange, is core to relapse in addiction. NAC can also improve some of the physical harms caused by tobacco smoke exposure, improving mucociliary transport and preventing oxidative damage to lung and other tissues. NAC has several advantages over other pharmacotherapies: a different mechanism of action for smoking cessation, an excellent tolerability profile, low cost and is readily available.

Coping 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.

In 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.

Background: 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.

This 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.

The 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

The 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.