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A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RX108 in Patients with Advanced or Metastatic Solid Tumours.
This study will determine the safety and pharmacokinetics of the investigational drug RX108 in patients with advanced or metastatic solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with an incurable, locally advanced or metastatic solid tumour that has progressed or failed at least one prior systemic therapy or have refused systemic treatment. Study details All participants will receive the investigational drug RX108 through intravenous infusion at a low dose and will be escalated. Each participant will only receive a single dose, depending on the cohort into which they are recruited. The study will use an accelerated dose escalation design using single patient cohorts until a single related toxicity of Grade = 3 or a Dose Limiting Toxicity (DLT) is observed. Safety and tolerability of RX108 will be assessed by such as physical examination, vital signs, ECG, and clinical laboratory testing at 30 days and 7 months post intervention commencement. Maximum tolerated dose will be determined via the safety review committee (SRC) and Investigators review the optimal balance between the dose (pharmacokinetic (PK) parameters), toxicity and biomarker studies confirming target effect. Participants will be followed-up until 7 months post intervention commencement to investigate potential biomarkers for RX108.
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Managing tooth decay of primary teeth in young children
The primary aim is to determine, over a 12 month period, the relative dental caries (tooth decay) arrest and prevention abilities on the primary teeth of children aged one to eight years of a once-only treatment of 38% silver diamine fluoride, compared to three-monthly applications of 5% sodium fluoride varnish in the Tasmanian clinical situation. The secondary aims are to compare: 1/ The dental caries prevention and arrest abilities of once-only treatments of silver diamine fluoride, silver diamine fluoride/potassium iodide, and silver diamine fluoride/potassium iodide/glass ionomer fissure sealant . 2/ The effectiveness as measured by relative cost, patient and clinician acceptability of treating tooth decay on the primary teeth of children of silver diamine fluoride, silver diamine fluoride/potassium iodide, silver diamine fluoride/potassium iodide/glass ionomer fissure sealant, and the standard dental treatment of restorations and extractions as determined by calibrated dentists if it were feasible to do the care under local anaesthetic.
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Restricted Fluid Resuscitation in Sepsis-associated Hypotension (REFRESH) Trial
Sepsis can occur when a person becomes unwell due to an infection. It is caused by inflammation throughout the body and affects the functions of organs such as the heart, lungs and kidneys. Sepsis can cause low blood pressure and impaired blood flow to the body’s tissues. This is sometimes called ‘septic shock’. First line treatment of septic shock is to give intravenous fluid to help restore the circulation. Standard guidelines recommend at least 30ml/kg initially, or approximately 2 litres in an adult. Often up to 5 litres is given in the first 6 hours. However, the volume required varies between individual patients, and calculating the correct amount can be difficult. There is emerging evidence that giving too much fluid can be harmful by leaking into the tissues (such as lungs), impairing organ function, delaying recovery and increasing the risk of complications. Other research suggests that giving excessive fluid affects the body’s immune responses. In particular this can lead to adverse effects on the normal function of small blood vessels within tissues. This may be one mechanism by which too much fluid leads to harm. An alternative means of restoring adequate blood pressure is to use a drug called noradrenaline. This is a chemical produced naturally by the body, which causes blood vessels to constrict, raising blood pressure. Noradrenaline, given by a continuous infusion through a drip, has been routinely used for decades for this purpose and is known to be safe and effective. Normally noradrenaline is commenced in patients whose blood pressure does not improve after 2-3 litres of intravenous fluid. While our current guidelines recommend initial generous fluid administration for septic shock, it has been suggested that using lower volumes of fluid may result in less inflammation and harmful effects, particularly on the cells which line the walls of blood vessels and control their function. This study aims to test this hypothesis. We propose comparing an approach where patients receive a smaller volume of fluid in their initial resuscitation, against the standard guideline-recommended volume. Participants will be randomised to one or other group. We will measure the blood levels of certain chemical markers of inflammation and blood vessel function. We aim to demonstrate that giving a lower amount of fluid in the initial resuscitation phase is feasible clinically, and results in less alteration of blood vessel function and inflammation in the body.
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An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system in people with type 1 and type 2 diabetes.
Until recently, insulin administration has been based upon finger-prick measurements of capillary glucose readings. RT-CGM involves using a subcutaneous sensor to measure interstitial fluid glucose levels continuously and provides the patient with the glucose level in real-time, as well as the rate and direction of change in the glucose. While there is an increasing body of evidence indicating that RT-CGM in combination with an insulin pump results in an improvement in glycaemia and reduces hypoglycaemia, compared with self monitoring of blood glucose (SMBG) and MDI in people with T1D, data is limited regarding the use of RT-CGM in conjunction with MDI. The study aims to evaluate the user acceptance of the RT-CGM device in patients with T1D, and T2D on MDI, as well as to evaluate its' impact on glycaemic control.
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A Phase 1 Investigator Initiated Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of AB-SA01 in Patients with Chronic Rhinosinusitis Associated with Staphylococcus aureus Infection
CRS is a debilitating inflammatory and infection based condition, affecting up to 9% of the Australian population (AIHW, 2010). Currently available therapies to treat this condition include steroids, antibiotics and surgical intervention (Fokkens et al., 2012). Unfortunately there remains a cohort of patients that are resistant to both medical and surgical interventions who experience persistent CRS symptoms, which is termed recalcitrant CRS (rCRS). The presence of bacterial biofilms in the sinonasal tract is one aspect of the condition shown to contribute to this recalcitrance and symptom persistence. Biofilms are 1000-fold more resistant to antibiotics compared to non-biofilm bacterial, making them resistant to the current place antibiotic therapies that are used to treat infections in CRS. There is, therefore, a need to develop novel therapies that are effective against these biofilms if we are to succeed in treating these rCRS patients. Bacteriophage-based treatment, AB-SA01, could be the answer to the problem of biofilms in rCRS. Bacteriophages or phages, identified almost 100 years ago, are bacterial viruses that specifically target bacterial cells, leading to cell death. Given their specific mechanism of action, bacteriophages are not able to infect mammalian cells, and have thus far shown few adverse effects when applied to humans for use as antimicrobial treatments (Chanisvilli, 2012; Brussow, 2005). The Primary endpoint of the study is to: 1. To assess the safety and tolerability of three dosage regimens of AB-SA01 in patients with Chronic Rhinosinusitis associated with Staphylococcus aureus infection. The secondary objectives of the study are: 2. The preliminary assessment of effectiveness of three dosage regimens of AB-SA01 by endoscopic evaluation by the Investigator using the Lund-Kennedy scale. 3. The preliminary assessment of effectiveness of three dosage regimens of AB-SA01 by patient assessment of symptoms.
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Self-compassionate writing for breast cancer survivors: An online intervention
The purpose of the study is to further understand women's experiences, regarding how they feel about themselves, their body, weight and appearance after completing treatment for breast cancer. This study has two parts. The first part is an on-line questionnaire to be filled in upon signing up for the study, with participants then undertaking follow up questionnaires one week, one month and 3 months after completing a writing activity. Participants will be asked about demographic information in the first questionnaire. Participants will also be asked about their current feelings and the impact of breast cancer or lymphoedema upon their body. It is expected that participants will need no more than 30 minutes to complete each on-line questionnaire. The second part of the study involves doing a writing activity. Participants will be allocated to one of two writing groups (structured or unstructured writing formats). Participants will be asked to do an online writing exercise and will be asked to write about their unpleasant feelings and experiences during treatment for their cancer or lymphoedema as well as its impact upon their body. It is expected that this part will take about 30 minutes. This activity is completed anonymously, and participants will have the option to voluntarily submit their writing.
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Evaluating new guidelines based on high-sensitivity troponin for those presenting to the emergency department with suspected acute coronary syndrome (ACS)
The health sciences are replete with innovations promising improvements in health care delivery and outcome. Yet their clinical application based on intuition is often imprecise, conservative and beset with biases leaving these potential gains unrealised. To translate healthcare innovations into real patient and system benefits, clinical decisions and practice must evolve in parallel, supported by objective validated evidence. One such innovation is troponin testing for suspected acute coronary syndrome in the Emergency Department (ED), the most common cardiac test undertaken in Australia. Each new generation troponin assays offer greater diagnostic differentiation, but as yet no discernible improvement in management efficiency or effectiveness has occurred. Translating improved test performance into better patient care will require a more structured approach. In all South Australian (SA) public hospitals, 5th generation troponin assays have been implemented, but reporting of results has remained at previous generation levels (conventional reporting), providing a unique opportunity to robustly evaluate the impact of test reporting on patient outcomes.
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The efficacy of supra-scapular nerve block for the treatment of frozen shoulder: A randomised controlled trial
Frozen shoulder is a condition which involves pain and stiffness of the shoulder joint and is often associated with a significant restriction of arm function and quality of life or well-being. We would like to see whether there are treatments that are better at reducing pain and improving the stiffness than our current treatments. The current treatment approach is called a “glenohumeral joint corticosteroid injection”. The glenohumeral joint is the shoulder joint capsule. It involves an injection of a steroid medication and a local anaesthetic agent into the shoulder joint capsule. Physiotherapy exercises are then given. It is thought that the steroid reduces the inflammation and pain around the shoulder joint which then allows the shoulder to be moved more easily with physiotherapy exercises. The newer approach we want to test is called “supra-scapular nerve block”. This has been shown to be safe and helpful in reducing pain for people with other types of shoulder problems. The treatment involves an injection of a steroid medication and a local anaesthetic agent into the tissues over the shoulder blade. This injection temporarily blocks the supra-scapular nerve which transmits the pain associated with frozen shoulder. Like the current treatment approach, once the pain has been reduced it should be easier to get the shoulder moving again with physiotherapy exercises. It is possible to repeat the suprascapular nerve block up to 4 times, at 3 monthly intervals, if the pain and stiffness remain. We think that the rate of recovery from frozen shoulder might be faster when current treatment and repeated supra-scapular nerve blocks are done together. In order to test this, participants will be randomly placed into one of two groups. One group will receive the supra-scapular nerve block injection and the other group will receive the placebo (saline) injection. These injections may be performed up to 4 times over the course of 1 year. In addition to receiving either the supra-scapular nerve block or the placebo injection, participants will receive the current best treatment available (glenohumeral joint injection and physiotherapy). Baseline information will be collected including age, general medical health, current medications, duration of shoulder symptoms, severity of shoulder symptoms and previous treatment for shoulder symptoms. Measures of shoulder range of motion, participant’s pain scores and levels of satisfaction will be measured at 3, 6, 9, 12, 18 and 24 months in order to compare both treatment approaches.
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Perispinal Etanercept therapy in Australian patients with chronic stroke.
The primary aim of the study is to determine the safety and tolerability of perispinal injection of Etanercept in subjects who have had a stroke and have stable and persistent chronic neurological dysfunction, cognitive impairment, and chronic and intractable pain due to stroke. The effects of the perispinal Etanercept treatment on neurological dysfunction, cognitive impairment, and chronic post-stroke pain will be examined as secondary aims by neurological examination as well as by the use of standarized measures.
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The addition of nitric oxide to cardiopulmonary bypass in children - a randomised controlled trial
We hypothesised that adding nitric oxide to the cardiopulmonary bypass circuit may reduce the occurrence of low cardiac output syndrome on ICU and improve patient outcomes (such as reducing the need for mechanical ventilation and shorten ICU length of stay)