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Type 2 diabetes is linked with many complications such as heart disease, eye disease and kidney disease. People with Type 2 diabetes also have higher rates of diseases of the nervous system in the body including dementia and may have poorer memory and thinking ability compared to people without Type 2 Diabetes. Older people with Type 2 Diabetes are at higher risk for poorer brain function. Diet plays an important role in mental well-being and brain function as the brain needs nutrients found in foods to function well. Omega 3 fatty acids such as those found in fish oils, are found in the brain tissue in large amounts. Increasing dietary intake of fish oils can increase the amount of fish oils in the brain. The aim of this study is to determine if an increase in dietary fish oils can improve the function of the brain in older people with Type 2 diabetes. This pilot study will fill a gap as it is not known if an increase in dietary Omega 3 fatty acids can improve brain function in older people with type 2 diabetes. This is important as the number of older people with diabetes is increasing and currently there are no effective treatments for poor brain function. Eligible volunteers who participate in the study will be given a 6 month supply of fish oil or placebo capsules to take daily. Mental function will be measure by a verbal and computerized tests at the beginning, middle and end of the trial. A blood test, height, weight, and waist circumference will also be collected as well as information about the food you eat and drink at the beginning middle and end of the study. Neither you or the clinician conducting the research will know if you receive the fish oil or the placebo treatment, but a confidential record of which treatment you received will be kept by the chief investigator in the unlikely event you have an adverse reaction.

Building Bridges Triple P is a parenting program designed to help parents who have an adolescent with a developmental disability. The program aims to assist parents in their caring role and equip them with skills to address their adolescent’s emotional and behavioural problems. Building Bridges consists of four group and four individual telephone sessions, held over eight weeks. The program is open to all carers in the adolescent’s life. The program addresses a number of areas of concern for parents and an accredited Triple P facilitator will run the sessions. The groups will use a mix of discussion, practice and home based activities to address parenting practices, adolescent emotional and behavioural problems and symptoms associated with depression, anxiety and stress. Topics of discussion in the parenting group will include, understanding adolescents’ behaviour, encouraging independence in your adolescent, promoting positive family interactions, managing problematic behaviours, helping adolescents to manage their emotions and self care for carers. We are looking for carers of adolescents between the ages of 12 and 16, diagnosed with autism spectrum disorder. It is important that you are not participating in any parenting interventions at the same time. If you express interest in the program, you will be required to complete a short screening questionnaire over the phone. If you are eligible for the program, you will asked to attend the Curtin University Health and Wellness Clinic to complete a 90 minute interview. During the interview you will complete a booklet of questionnaires and you will be asked to complete the booklet of questionnaires again at two predetermined times following the Building Bridges program. The final booklet of questionnaires will be given to you three months after the parenting group has finished. Each booklet of questionnaires is estimated to take you approximately 60-90 minutes to complete. If you agree to participate, you will be required to attend four parenting group sessions at the Health and Wellness Centre at Curtin University. You will also be asked to complete four telephone sessions with the therapist at the same time as attending the parenting group. Other Triple P programs have demonstrated a variety of benefits for parents of teenagers and children with a disability, including improvements in child behaviours, positive parenting skills, parenting confidence, child relationships, and reduced parental stress. It is anticipated that Building Bridges will result in similar improvements. Results from the study are likely to improve the accessibility of the program to a wide range of parents that require positive parenting assistance.

Over the past 15 years a number of new treatments have proved successful in the treatment of multiple sclerosis. There a remains though a small group of patients who do not respond and who continue to have attacks despite treatment causing further permanent neurological disability in a cumulative fashion. This disability can take the form of muscle weakness, impairing walking ability, visual loss, impaired balance, bladder and bowel dysfunction and loss of higher intellectual faculties. Patients with aggressive forms of MS also have a shortened life span as a result of their disease. Haematopoietic stem cell transplantation (HSCT) is a procedure originally used to treat patients with blood cancers. A high dose of chemotherapy is given which not only kills the malignant cells but also normal healthy bone marrow and blood cells. In order for the patient to survive these cells must be replaced by giving the patient a stem cell infusion following the chemotherapy . The stem cells replenish the bone marrow and a new blood and immune system then grows from it. Over the last 15 years, HSCT has become much safer. At the same time, numerous lines of evidence have emerged suggesting that a small number of patients with severe autoimmune diseases such as MS not controlled by other treatments could also respond to treatment with HSCT. This evidence came initially from patients with a co-existent auto-immune disease (AID) including multiple sclerosis (MS) who had chemotherapy for blood tumours. It was observed that not only did their cancers remain in prolonged remission after HSCT but so did the manifestations of their autoimmune disease. The procedure requires an initial dose of chemotherapy with a drug called cyclophosphamide to help stem cells to be collected via a vein in the arm. Subsequently the patient is admitted into hospital tohave high doses of chemotherapy that intensely suppresses the immune system. At this point the stem cells collected at the earlier time point are reinfused through the vein so they can re-grow a new immune system and protect the patient from the toxic effects of the chemotherapy. It takes about 14 days for the new stem cells to grow and then follow up is conducted carefully over several years to see if this method of immunosuppression and immune reconstitution prevents the reemergence of multiple sclerosis. The procedure is not without risk with the major complications of infection and death. Overall the risk of death where the procedure is done for an autoimmune disease is quoted at between 1-5 %. The Neurology Unit at Austin Health has conducted trials in MS since 1996 and the Haematology Unit performs HSCT on a regular basis for patients with blood malignancies. The unit’s morbidity and mortality results for HSCT are on par with the world’s leading hospitals. We intend to explore therapy in patients with an aggressive form of MS and then follow them in a rigorous fashion over 5 years to gauge its effectiveness.

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.