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The purpose of Part 3 of the study is to determine what the highest dose of DSM265 (study drug) is that can be safely given to people. This will be determined by how it makes people feel, how the body absorbs, processes and gets rid of DSM265 when receiving DSM265 every day for 3 days in increasing doses for the treatment of malaria. This trial is to be conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification Scheme (CTN).

Escherichia coli (“E. coli”) and Klebsiella are bacteria which are common causes of infections in your blood stream. Patients with bloodstream infections due to either E. coli or Klebsiella, can commonly be treated with antibiotics called third generation cephalosporins, such as the antibiotic ceftriaxone. When the blood stream infection is resistant to these antibiotics, the antibiotics meropenem and piperacillin/tazobactam have been shown to be effective alternatives for treatment. The purpose of this study is to work out whether these two other antibiotics, meropenem and piperacillin/tazobactam, are equally effective in the treatment of these antibiotic resistant bloodstream infections. These antibiotics have never been compared “head to head” in order to establish the best available treatment for these serious infections. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.

During shoulder surgery patients are positioned into an upright sitting position for optimal access to the shoulder joint. In some patients blood pressure may decrease and a concern of the anaesthetist is whether sufficient blood reaches the brain during such surgery. Even though this can be routinely treated with cardiac drugs, the exact effect of this treatment on the brain is unknown. This study plans to investigate the changes in flow to the brain when patients are anaesthetised and placed upright. The surgery will be performed using the anaesthetic technique that we use for the majority of the surgeon’s cases. Special monitoring of the oxygen level within the brain, using reflected light waves, will be used. This technique is non-invasive and presents no harm to the patient. The study will investigate whether the administration of medication to gently increase blood pressure has an effect on blood flow to the brain, and on recovery following surgery. A number of commonly used drugs will be studied by infusing them into a large vein within the arm. By agreeing to the study patients will give us permission to make these extra measurements during anaesthesia. This will help us understand whether we are protecting the brain during surgery.

Patients with sciatica experience low back pain, with pain radiating into the leg and possible neurological deficits. Sciatica is associated with substantial pain and chronic disability. The lack of evidence supporting effective treatments for sciatica makes clinical management difficult. The aim of the study is to determine the efficacy and cost effectiveness of adding pregabalin to usual care for reducing leg pain intensity in patients with sciatica. PRECISE is a prospectively registered, double blind, randomized placebo controlled trial of pregabalin, in addition to usual care in people with sciatica. Participants will be recruited from patients in the community who consult a study general practitioner (GP) or medical specialist (e.g. orthopaedic surgeon, neurosurgeon, neurologist or rheumatologist) with moderate to severe sciatica. GPs and specialists will be recruited from the Sydney metropolitan area (Australia). Other referral sources include physiotherapists and chiropractors that may identify potential participants and then refer the patient to a study GP. Participant inclusion criteria include low back pain that radiates below the knee, neurological compromise, interference with normal daily activities and pain duration of 1 week to 1 year. Participants will not be eligible if they are scheduled for spinal surgery, have known serious pathology, are pregnant, have contraindications to pregabalin or taking certain prescribed medicines. Participants will be randomised to receive either pregabalin with usual care (n=102) or the placebo with usual care (n=102) for 8 weeks. The medicine dosage will be titrated up to the participant’s optimal dose, to a maximum 600 mg per day. Usual care, if deemed appropriate by the study doctor may include analgesic medication or physical and manual therapy. Participants, doctors and researchers collecting participant data will be blinded. The primary outcome is leg pain. Secondary outcomes include back pain, disability and quality of life. Treatment effectiveness analysis will be blinded and by intention-to-treat. A p-value of < 0.05 will be considered statistically significant. A parallel economic evaluation will be conducted from the societal perspective.

The aim of this project is to compare two different total knee arthroplasty (TKA) approaches with regards to alignment. Traditionally TKA aimed to achieve a neutral or straight (mechanical) alignment of the knee with a perpendicular joint line. However studies have shown that rarely does this arrangement echo normal anatomy. In most individuals the mechanical axis of the limb is not neutral and the joint line is often slightly oblique. Given that up to 20-25% of patients are dissatisfied with their TKA outcomes due to pain and poor function with activities of daily living, there is much room for improvement. Kinematic alignment aims to restore the knee to its normal pre-diseased alignment, in doing so match the prosthesis more closely to the ligamentous envelope which it must function and therfore may improve post-operative kinematics and function. The gold standard for accuracy in TKA is computer assisted surgery and although mechanical versus kinematic alignment has been studied in a single randomised control trial, the surgery was performed without computer assistance. This study will compare outcomes of navigated kinematically aligned TKA versus navigated mechanically aligned TKA which uses computer assistance to ensure accurate positioning of the prosthesis. 250 patients will be chosen for the study. These patients will be selected by three surgeons involved with ORIQL as needing total knee arthroplasty and as indicated by clinical guidlines. There will be two study groups. Group A (200 patients) will be patients undergoing unilateral total knee replacement and group B will be those undergoing bilateral TKR. The participants in group A will be randomized to either mechanical or kinematic alignment. Group B (50 patients) will have one knee replaced kinematically and the other mechanically. Randomisation will apply to which knee is done first. The first replacement will be done kinematically and the second mechanically provided that any alignment difference between the two does not produced visual asymmetry. In this instance, the second knee will be done kinematically and the patient withdrawn from the trial. All patients will undergo the same protocol process for total knee arthroplasty. All other intra-operative and post-operative protocols will be the same for all patients. They will be followed up post-operatively at 2 weeks, 6 weeks, 6 months, and then yearly. Post-operative radiologic assessment will be that normally required following TKA. Outcome measures will include validated clinical pain and function scores such as the WOMAC score, EQ5D, Knee Society Score, the Oxford Knee Score, and the Forgotten Joint Score. Data collected will be analysed using statistical methods in order to find any statistically significant difference in results between the two alignment strategies

IMPROVING OUTCOME OF SEPSIS Greater numbers of patients are surviving intensive care but have poor quality of life due to immobility, poor cognition, post traumatic stress disorder, depression and frequent readmissions to hospital. Patients with a severe infection “sepsis” are particularly affected. This study aims to improve the overall outcome of critically ill patients with sepsis, through a follow up outpatient service. The intervention group will be screened by several instruments and appropriate referrals made. This trial will investigate whether these interventions can prevent readmission to hospital; improve health related quality of life, decrease mortality, and decrease utilization of health resources thereby decreasing the burden on the Australian health system.

This purpose of Part 2 of the study is to determine the activity of DSM265 (study drug) against malaria parasites in healthy subjects who have been inoculated with a low dose of malaria-infected red blood cells. This trial is to be conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification Scheme (CTN).

Aim: The aim of this pilot study is to examine the interactive effects of psychological stress and malnutrition on DNA damage and epigenome biomarkers in a long term chronically-stressed cohort. Hypotheses: (i) Stress hormones induce specific types of DNA damage at the gene sequence, epigenome and chromosome level, including compromised telomere length and integrity; (ii) Susceptibility to DNA damage by the stress hormone cortisol is increased when dietary B vitamin methyl donors (folate, vitamin B12, choline) are deficient; (iii) Telomere length is inversely associated with perceived and actual stress, and this relationship is strengthened with increased chronicity of stress exposure.

The purpose of Part 1 of the study is determine if DSM265 is safe, how it makes people feel and how the body absorbs, processes and gets rid of DSM265 (study drug), in single, increasing oral doses of DSM265 in healthy subjects for the treatment of malaria. This trial is to be conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification Scheme (CTN).

When you receive a general anaesthetic for your operation, you will be asleep also unable to breath for yourself. Therefore, a breathing tube is inserted in your windpipe to allow the anaesthetist to assist your breathing while the surgeon operates. This study aims to determine the rate at which your lungs ‘suck in’ (or inspire) air while you are asleep and not breathing.This is possible with a continuous opening from your lungs to oxygen source. We believe that if the composition of the air being sucked into your lungs is all oxygen than it will continue to flow at a constant rate but if the composition of air is the same as in the room (20% oxygen) then the flow rate will tail off (like slowly turning off a tap). Computer programs and our understanding of the biology of people suggest this would be the case. However, we have no proof of this at present.