ANZCTR search results

AIMS: This study aims to clarify factors impacting upon outcomes in women presenting with persistent pelvic pain (PPP). The study team are keen to understand whether there are specific features of the woman, including the type and severity of the pain, the duration of these symptoms, or her response to her pain, that might influence or predict her outcome and thus potentially allow selection of the most appropriate therapeutic approach for specific patient characteristics. METHODS: Pelvic pain is the most common indication for referral to the outpatient gynaecology clinic. Information regarding this study, including study information, consent, and questionnaires regarding symptoms, quality of life(QoL), pain catastrophisation scale(PCS), will be sent to patients at the same time as their appointment information. On arrival at their first appointment, the research assistant will approach the prospective participants to ensure that initial paperwork and questionnaires were received, and offer the opportunity for questions. If the patient agrees to participate and has not completed the questionnaires they will be encouraged to do so whilst waiting. Consent to access patient data from medical records will also be sought. All clinical decisions regarding management will be independent of study questionnaires. Clinicians, who with the patient, decide that surgery for the PPP is warranted, will be asked to complete a brief survey regarding the factors influencing this decision. Follow-up questionnaires at 6 monthly intervals will be sent (either electronic, utilising survey monkey, or in paper format with reply paid envelopes, depending on patient preference). The pilot study will conclude at a minimum of 36 months. Patient questionnaires will take 15-30minutes.

Patients with new onset chest pain, suggestive of angina pectoris, are at high risk of acute cardiac events including myocardial infarction and death. Chest pain remains one of the most common reasons for presentation to the emergency department and hospital admission. In 2013-14, 653,572 presentations to emergency departments within Australia were attributed to ‘circulatory system illness’, 9.4% of all emergency presentations. The majority of patients presenting to hospital with recent onset chest pain are ultimately found to have a non-cardiac cause for their symptoms, or no definite diagnosis is made. Others may have an acute coronary syndrome (ACS) and require urgent admission and treatment. Appropriate risk stratification and triaging of all patients with chest pain is therefore crucial. New onset chest pain remains a common clinical presentation. Establishing efficient clinical care pathways, such as a rapid access chest pain clinic (RACPC), may help to reduce unnecessary and costly presentations to emergency departments and hospital admissions. However, among patients with an intermediate pre-test likelihood it remains unclear as to which test is best to perform. This project aims to assess the impact of a RACPC and to better understand the role of currently recommended investigations, such as exercise treadmill tests, CT coronary angiography and myocardial perfusion scans, among patients who attend the clinic with an intermediate pre-test likelihood of significant coronary artery disease.

Apnoeic oxygenation is the delivery of oxygen to the lungs without causing the lungs to inflate. Whereas, low tidal volume ventilation is the delivery of oxygen to the lungs that causes the lungs to partially inflate and deflate. Both are established anaesthetic techniques that have been used for over fifty years and are used routinely in many surgical procedures to allow easier access to different structures in the chest. During cardiac artery bypass graft surgery (open heart surgery to bypass blocked arteries of the heart), the most common artery used to bypass blocked arteries is the left internal mammary artery (LIMA). This artery is has been proven to be the best option for short and long term survival after cardiac surgery. This artery is 15-26cm long and runs straight down the left side of the breastbone. The use of apnoeic oxygenation and low tidal volume ventilation are used as routine techniques to allow safe surgical access of the LIMA. Currently, there are no studies comparing apnoeic oxygenation to a low tidal volume strategy in a cardiac setting. It is unknown what the effects of these techniques are on levels of oxygenation and carbon dioxide on the vessels in the lungs, or on the function of the heart. In this study, we aim to compare the usefulness and safety of apnoeic oxygenation to a low tidal volume ventilation technique during dissection of the left internal mammary artery. There will be no additional requirements of the participant or deviation from standard surgical and anaesthesia care except for the additional sampling of 8mL (approximately two teaspoons) of blood from an artery in the wrist. This will allow for the additional measurements of oxygen and carbon dioxide. This study will help us determine if one technique (apnoeic oxygenation or low tidal volume ventilation) is better than the other. If so, that technique could be adopted as standard of care in this setting for all patients. A total of 24 subjects will be included at the Austin Hospital.

This study is a Phase I single site randomized, and double blinded comparison of the safety pharmacokinetics, pharmacodynamics and immunogenicity of one dose of SYN008 to one dose of omalizumab (Xolair) control. The primary objective is to compare the safety of SYN008 to Omalizumab. Omalizumab is an effective therapy for both moderate to severe asthma as well as chronic idiopathic urticaria. SYN008 is intended to be a biosimilar agent (generic) to omalizumab. The availability of a highly similar alternative will help to provide a more robust marketplace and provide this treatment to more patients who might need it. The current study is performed in normal adults to reduce the background of adverse events. The dosage (single dose of 150mg) and administration (by injection under the skin) of the study drugs SYN008 and omalizumab are identical providing a comparison of the adverse reactions to the agents. The bioavailability and immunogenicity of the study drugs will be evaluated with pharmacokinetics and anti-drug antibody determinations. The effect of SYN008 and omalizumab on free IgE concentrations will be measured as a pharmacodynamic effect. A single dose will be used to reduce any long term adverse effects from the agents and to mimic the way that the antibodies will be used clinically. This initial study will enroll healthy volunteers. This latter selection is made to facilitate the safety evaluation. This study is a double blinded comparison of SYN008 and omalizumab. A total of 80 subjects will be randomized in a parallel 1:1 ratio to either SYN008 or omalizumab resulting in 40 subjects in each group. The study will be conducted at a dedicated Phase I Unit in Melbourne, Australia. The dose will be 150 mg for both study drugs. This dose is the minimum dose in the omalizumab product information. The study duration is 84 days and the screening interval is 14 days for a total duration of 98 days for an individual. The major outcomes measured in the trial will be solicited adverse events, adverse events and serious adverse events that will be collected according during the trial. The follow-up for comparison of safety (adverse events) will continue through the day 84 Study Visit. Standard assessments of serum chemistry including liver function tests, renal function tests, complete blood count, and blood clotting studies, urinalysis findings, vital signs and ECG evaluations will be performed. Baseline values for pulse oximetry and blood tryptase will be recorded to assist in adverse event evaluation. The pharmacodynamic parameter being measured is the change in free IgE serum concentrations. The development of anti-SYN008 antibodies will also be evaluated. There are 11 scheduled clinical visits after the screening visit(s).

Protein intake has remained relatively stable through the development of the obesity epidemic, yet total energy intake has risen. The protein leverage hypothesis (PLH) proposes that a separate and dominant appetite for protein drives excess energy intake when dietary protein is diluted by fat and carbohydrate. The PLH has been shown in various other species, including non-human primates where excess total energy intake occurs when the percent protein of the diet decreases. Experimental and population-level data also suggest the same may be true in humans (meta-analysis included in the current manuscript). Experimental verification of the protein leverage hypothesis is lacking because it is difficult to separate the role of protein from confounding influences on intake associated with concurrent changes in dietary fat and carbohydrate. The unequivocal test for the PLH is to develop protocols that disguise macronutrient composition of foods offered to subjects under ad libitum feeding conditions. We have recently developed these protocols and in the current study report experiments in which they were applied to confirm the PLH in humans. Here we show that reducing dietary protein by 5% whilst controlling palatability, availability, variety and sensory aspects of the diet resulted in subjects increasing total energy intake by 12%, and this increase was mainly due to increased intake of foods available between meals. We therefore confirm the PLH in humans and show that any change in the nutritional environment that dilutes dietary protein with carbohydrate and fat will promote increased energy intake. Our findings provide a new understanding of a major global health problem, and have considerable implications for the management of obesity.

Adolescents with a combination of anxiety and depression have especially severe symptoms that can cause major impact on their lives. While we already have good treatments for teenagers with either anxiety or depression alone, there are no good treatments currently available for adolescents with both problems. This trial will evaluate the effects of a new treatment for adolescents with mixed anxiety and depression that teaches them new ways of thinking, acting, and feeling. It is delivered over the internet and is assisted by 8 sessions with a therapist over the telephone. Adolescents will be randomly allocated to either receive the new treatment (called Chilled Plus) or to wait for 8 weeks (after which these adolescents will also get the program). We expect that those adolescents who immediately enter the program will show large reductions in anxiety and depression and improvements in quality of life.

What is this study about? Biocon Research Limited (India) is developing itolizumab, a humanised monoclonal antibody which is aimed at modifying disease course of various auto-immune diseases. The aim of this study is to study the safety and pharmacokinetics of single ascending doses of Itolizumab (Bmab 600) given subcutaneously and also compare the PK of two formulations of itolizumab given intravenously and subcutaneously and determine the absolute bioavailability of Bmab 600 given subcutaneously.. Who is this study for? This study is for healthy volunteers aged between 18 and 50 years and Body Mass Index between 18-30 kg/m2. What is involved? The study has 2 Stages. Stage 1 will investigate the safety and tolerability of Bmab-600, when administered to healthy volunteers as a subcutaneous injection. That is to find out how it makes people feel and whether there are any side effects or changes to laboratory results. The pharmacokinetics (PK) of single, ascending doses of Bmab-600 will also be investigated. Pharmacokinetics is a science that looks at how the body absorbs, distributes, breaks down and then removes the study product from the body. This will be done by analysing the levels of Bmab-600 that are present in blood at various times following each dose. It will also evaluate whether there are any effects on immune system. Stage two will compare the two formulations of itolizumab – It will investigate if these formulations are processed by the body in the same way, and if they have the same effect. There will be a screening visit which could be up to 28 days before the dosing day and a 3 day confinement period at the study centre. After that, there will be approximately 9 out patient clinic visits. Individual participation in the study will be up to 16 weeks.

The aim of this project is to develop a clinically safe and effective treatment against bacterial infections in patients with chronic rhinosinustis (CRS). Current standard antibiotic therapy often fails to treat sinonasal infections, and we therefore need to develop novel, effective therapeutics. Previous in vitro and in vivo work have found manuka honey augmented with additional active ingredient methylglyoxal (MGO) to be effective against a bacterial infections. We hypothesis that manuka honey with augmented MGO will effectively treat infections in the sinonasal region of patients with CRS.

Older Australians are high consumers of complementary medicines (CMs) such as nutritional supplements (minerals and vitamins) and herbal medicines. CM may offer a way for older people to cope with their ill health, to engage in maintaining their health, and to improve their quality of life. National policy states consumers are responsible for: asking for and utilising information, to make decisions and take actions that enable medicines to be chosen and used wisely, being aware of the risks and benefits of medicines, developing skills and confidence to use medicines appropriately, and seeking help to solve problems when they arise. Our study identified older Australians had difficulties navigating the health care system to discuss and use CM; finding good CM information, and appraising this information. Our findings highlight the potential for older vulnerable people to be misinformed and to make inappropriate self-care decisions. To facilitate older Australians to take an active role in their health, we will develop and evaluate a novel educational intervention based on our preliminary research to support self-advice, good decision making, and improve health literacy skills. One hundred and sixty residents in Western Sydney, NSW will be invited to participate in a randomised controlled trial to evaluate the effect of an education intervention to increase their decision making regarding CM and self-care, health literacy and their ability to actively engage and navigate the health care systems.

We propose a comprehensive investigation of the effects of a standardised, intensive refeeding regime on GI function in adolescent patients with restrictive AN, which will form the fundamental basis for subsequent acute investigative and longer-term intervention studies. The study aims to examine whether gastrointestinal (GI) hormone and appetite responses to, and gastric emptying of, a mixed-nutrient oral test meal in anorexia nervosa (AN) patients are modified in response to changes in nutrient exposure and energy expenditure occurring during the refeeding period. Thirty adolescent participants with AN (age 12-19 years) will be recruited during their inpatient admission at the Children’s Hospital at Westmead and Westmead Hospital. They will be studied on 3 separate occasions during their nutritional rehabilitation, and their results compared to thirty age-matched healthy-weight adolescent control participants assessed on one occasion. On each study day, participants in both the AN and control groups will undergo indirect calorimetry to assess energy expenditure. After this, they will receive an oral test meal, following which, GI hormones and appetite perceptions will be measured. Gastric emptying will also be measured on all study days. Specific hypotheses: (1) In comparison with healthy, age-matched controls, adolescents with AN will have exaggerated ‘anorexigenic’ gut hormone secretion and delayed gastric emptying in response to an intragastric mixed-nutrient test meal. (2) With increased GI nutrient exposure during refeeding over 2 weeks, gut hormone concentrations, blood glucose and gastric emptying will return towards healthy levels. Outcome measures: Gut hormone concentrations, gastric emptying, appetite perceptions, blood glucose, GI symptoms. Study implications: GI hormone, blood glucose and gastric emptying disturbances in AN will be comprehensively characterised before, during and after treatment, identifying possible GI mechanisms underlying the starvation condition and potential treatment interventions.