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The objective of Study IPX203-B13-02 is to characterize the pharmacokinetics of IPX203 and levodopa formulations in healthy subjects.

Type 1 diabetes is associated with significant fluctuations in blood glucose levels in patients on multiple daily insulin injections or insulin pump therapy. This glycaemic variability limits patients ability to adequately control blood glucose due to its association with hypoglycaemia and subsequent high readings or 'rebounds'. The medication vildagliptin is currently used in the treatment of type 2 diabetes and in this setting has the ability to lower glucose and reduce hypoglycaemia. Its action is both on insulin producing cells, beta cells, and glucagon producing cells, alpha cells. Patients with type 1 diabetes have traditionally been thought to have no insulin production, however recent studies using a more sensitive assay have shown residual beta cell function in many type 1 patients after 10 years. This study is designed to assess the effects of vildagliptin in patients with type 1 diabetes and aspects of blood glucose control including glycaemic variablity. The hypothesis is that vildagliptin may reduce variability due to its action on both alpha and beta cell activity in a glucose dependent manner.

This study is designed to test if feedback of patient satisfaction score after consultation sessions improves clinical consultation performance among medical students. We hypothesise that 1) additional feedback of patient satisfaction scores to students improves student performance over usual feedback; and 2) the teaching model increases patient satisfaction scores in student consultation over time.

Patients will be assessed for suitability for this study and then invited to participate. All participants will then undergo an initial face-to-face session by the investigators on matters related to methodology and technical requirements on conducting home-based internet programmes on exercise and stress management techniques. Following this initial session, supervised home based training sessions will be conducted over 4-6 weeks. This will be followed by assessment at end of the training period and then at 3, 6, and 12 months after the training sessions. .

Advanced airway management is an accepted core skill of Emergency Physicians in Australasia. Rapid Sequence INtubation (RSI) is, however, a high-risk procedure that has been shown to have an increased rate of severe complications – such as failed intubation, hypoxia, hypotension or surgical airway – when it takes place in the Emergency Department (ED) in comparison to the operating theatre. The recently published Fourth National Audit of Major Complications of Airway Management in the UK reviewed severe complications associated with airway management in the ED. The authors found that a large proportion of events occurred out of hours, without consultant supervision, or without the operators following standard airway management algorithms and “failing to plan for failure.” Several studies have been published that describe the performance of intubation in the EDs of North America, UK, Korea and Japan, but to date, only a single centre study has been published from an Australian ED. This study, carried out at the Royal North Shore Hospital, prompted significant changes in the practice of intubation in that ED, along with an increased educational focus on the subject, in order to improve clinical management. This current project is being led by Dr. Toby Fogg and Dr. John Vassiliadis from the Royal North Shore Hospital ED, as a collaborative research venture with other EDs across Australasia and the Emergency Care Institute in NSW. It is a surveillance study to acquire data on the practice of intubation in the ED in order to improve the quality of care associated with this procedure.

Objective: To compare reduction of pain following laparoscopy after ablation or excision of endometriosis. Design: A prospective, randomized, double-blind study. Setting: Endometriosis and pelvic pain clinic at a university teaching hospital. Patients: Women of reproductive age presenting with pelvic pain and visually proven endometriosis. Interventions: Subjects completed a questionnaire rating their various pains using visual analogue scales (VAS). Following visual identification subjects were randomised to treatment with ablation or excision by supervised training gynecologists as primary surgeon. Follow-up questionnaires documented pain levels every 3 months for 1 year then 6 monthly until 5 years. Main Outcome Measure: Change in pain VAS scores during 5 years post-operation and rates of pregnancy, repeat surgery and use of hormonal medication Results: There was a reduction in all pain scores over the five year follow up in both treatment groups. A significantly greater reduction in sex pain VAS scores was seen in the excision group at 3 years 6 months (p=0.015); 4 years 6 months (p=0.047) and at 5 years (p=0.031). More women went on to use medical treatments for endometriosis amongst the ablation group (p=0.004) by 5 years. Conclusions: Surgical treatment of endometriosis provides symptom reduction for up to 5 years. There are some limited areas, such as deep dyspareunia, where excision is more effective than ablation.

The objective of this study is to determine wether local endometrium trauma (LET), applied once during the mid-luteal phase of the cycle preceding in vitro fertilization (IVF) treatment, can improve the chance of pregnancy for women with recurrent implantation failure. The primary aim of this study will be the prescence of fetal heart activity seen on transvaginal ultrasound approximately four weeks after embryo trasnfer. The secondary outcome will be the effect of the LET procedure on positive pregnancy test two weeks after embryo transfer, ongoing pregnancy, pregnancy outcome and complications up to delivery. Endometrail tissue collected during the LET will be analysed for putative markers of successful implantation.

Our primary objective is to determine the effect of 5 days of dietary energy restriction (i.e. ~30 vs. the normal energy balance of ~45kcal/kg FFM/day) on muscle myofibrillar fractional synthetic rate (FSR; directly measured muscle protein synthesis) at rest as measured by primed constant infusion of ring-[13C6]phenylalanine. Our secondary objectives involve examining whether the anabolic stimulus of protein ingestion and resistance exercise will significantly increase FSR (post-exercise FSR). If an exercise plus nutrition intervention rescues the deleterious effect of a hypocaloric diet on muscle FSR this will provide novel and practical information for effective weight management in which fat mass can be reduced without loss of muscle mass.

Major joint surgery is associated with significant blood loss which often requires transfusion. Tranexamic acid is a recommended medication to assist with limiting blood loss. It acts by preventing the breakdown of blood clot. The usual dosage is multiple intravenous injections. The optimal dose is unknown. This study will examine the effects of direct injection of tranexamic acid into the site of surgery and compare this to the intravenous route. The hypothesis is that this will be as effective if not more effective than intravenous use and is easier to administer.

The administration of intravenous crystalloid fluid (also known as fluid therapy) is a ubiquitous intervention in patients undergoing surgery. Worldwide, the most commonly used crystalloid fluids available for patients undergoing major surgery include Saline (0.9%) or the balanced fluid solutions - Hartmann’s and Plasmalyte. Choice of fluid therapy is based frequently dependent on geography, and choice of fluid amongst anaesthetists at Austin Hospital is similar to worldwide practices. Saline has been used in clinical practice for fluid therapy since the late 1800s. While it is the most commonly used IV fluid in the world recent data raise the possibility that it might increase the risk of developing kidney damage in acutely unwell patients compared to fluids with lower concentrations of chloride such as Plasmalyte. While this increased risk of kidney damage with the use of saline is plausible, current data are insufficient to recommend clinical practice change and data from an interventional trial are urgently needed. However, the design of such a Trial requires sufficient pilot data to establish feasibility, safety power calculations and define an optimal study protocol. This study aims are to provide high quality pilot data in a rapid time frame to address this important question and to help decide whether a pivotal randomized controlled trial is justified. Thus, all patients undergoing surgery at Austin Hospital will be assigned to receive either Saline (0.9%) or the balanced crystalloid solution Plasmalyte as the primary crystalloid fluid in a blinded fashion during two study periods. The study will be conducted over a 4-month period allowing including two periods of 6 weeks each where all patients will receive the intervention, with a three week wash-in and a three week wash-out period for each group. Blinded study fluid will be used for all crystalloid therapy in all participants. Austin Hospital staff specialists in anaesthesia agree that on the basis of current evidence, Saline (0.9%) and Plasmalyte are equally acceptable for crystalloid fluid therapy in every situation requiring major surgery with the exclusion of surgery for liver transplantation, renal transplantation and patients with raised intracranial pressure, where specific hospital perioperative fluid protocols are used in these settings. Both Saline (0.9%) and Plasmalyte will be available for open-label administration in the rare situations, where, in the opinion of the treating anaesthetist or clinician, there is a clinical indication for one fluid or the other. This may occur, for example, in the setting of severe acidosis where the higher chloride content of saline may make this fluid problematic because it may increase the severity of such acidosis. All adult patients who receive blinded or open-label fluid during one of the two-month study blocks will be analysed. The primary outcome will be the proportion of patients with kidney injury or failure based on established criteria. Secondary outcomes will include delta creatinine (the difference between baseline and peak creatinine), serum electrolyte levels, bicarbonate level, requirement for renal replacement therapy, complications and in-hospital mortality. All of the data required for this study are collected routinely as part of standard clinical care and/or quality assurance activities. The study will establish the pilot feasibility, safety and preliminary efficacy evidence base for the design of a large interventional trial to inform clinicians looking after major surgery patients as to whether Saline (0.9%) or Plasmalyte or solution is the preferred crystalloid fluid in this setting. Hospitals involved: Austin Hospital Number of participants: Given the current theatre workload at Austin Hospital, approximately 1000 participants will be recruited in each group. A total of 2000 participants are expected.