ANZCTR search results

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients with Advanced Solid Tumors. You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. Trial details Participants in this trial will be allocated to take Volitinib (HMPL-504) tablets once daily for a period of [a cohort /21 days] at one of six dose levels (100, 200, 400, 600, 800 or 1000 mg/day). Patients will be assigned to dose levels sequentially as they are enrolled. Participants will be assessed for up to 20 months in order to determine safety and tolerability of the treatment. They will also be asked to give blood samples to assess the pharmacokinetics (i.e. action of the drug in the body) over a 21 day period.

Advanced glycation endproducts (AGEs) are formed within the human body as a normal consequence of metabolism, but their formation is accelerated in people with elevated blood glucose levels such as those with diabetes. Excessive AGEs are known to have negative effects within the body including contributing to kidney damage, stimulating inflammation and promoting changes in blood vessels which lead to heart disease. AGEs have been shown to contribute to the development of the complications of diabetes and more recently it has been hypothesised that AGEs may play a major role in the development of type 2 diabetes. Simple therapies aimed at reducing the progression of inflammation and insulin resistance are urgently needed to prevent or slow type 2 diabetes development in susceptible individuals. Dietary supplements (called prebiotics) which promote the growth of beneficial bacteria in the human bowel have been shown to reduce inflammation and improve insulin resistance, but their effect on AGEs is unknown. Taking a daily prebiotic dietary supplement which stimulates the growth of beneficial bacteria in the human bowel might offer protection against AGE-related pathology in people at risk of developing type 2 diabetes. This study aims to determine the effect of 24-week consumption of a prebiotic dietary supplement on tissue AGE (advanced glycation endproduct) levels, insulin resistance and inflammatory biomarkers in adults with pre-diabetes in comparison to those receiving a placebo supplement.

The current standard of practice for the treatment of CRS includes antibiotics either given by mouth or through an injection in your arm, nasal sprays and rinses, oral and nasal corticosteroids and/or anti-allergy medicines. Despite these treatments some patients are still unable to get relief from their sinus symptoms. When the above treatments fail and the disease continues then some patients will move forward to surgery. This type of surgery is called “Functional Endoscopic Sinus Surgery (FESS)”. The surgery is quite difficult and requires great surgical skill. One of the problems associated with FESS surgery is making sure that the area being treated is clear of blood so the surgeon can see the area he is treating. There are a number of complications associated with bleeding with this type of surgery which your doctor will explain to you. A potential solution to try and improve the visibility when performing FESS surgery is to use laser throughout the procedure. Laser is used in many types of surgery, including surgery for ears, nose and the throat (otolaryngology). The laser being tested during this study is a new laser. It has been designed so that it delivers the laser through a much smaller fibre (a tube that delivers the light to the tissue) and also uses very low power to avoid unwanted damage to nearby healthy tissue, which will hopefully help achieve better results from surgery and also fewer complications with this type of surgery. This study is being done to look at the safety and the performance of this new laser when it is used during FESS procedures. It is important to remember that you would have undergone the surgery regardless of this new laser – the new laser is an additional treatment being used during the procedure.

A high salt diet is associated with an increased risk of hypertension. By contrast, in patients with type 2 diabetes, a low salt diet is associated with an increased risk for cardiovascular and total mortality. As a low salt intake may increase sympathetic nervous system (SNS) activity, we aim to determine baseline SNS activity and endothelial function in patients with diabetes consuming a habitual low salt diet and determine whether salt loading reduces SNS activity and enhances endothelial function.

Prior to general anaesthesia the standard of care is to pre-oxygenation all patients. This involves the patient breathing 100% oxygen via a face mask. The 3 most common methods of pre oxygenation involve 4 deep breaths over 30 seconds, 8 deep breaths over 60 seconds or 3 minutes of tidal volume breathing (normal breathing) using high flow 100% oxygen (15L per minute via the anaesthesia machine with a face mask). The most common reasons for poor preoxygenation is an inadequate face mask seal resulting in the patient breathing room air (low oxygen content) through the leak. Nasal oxygen and the anaesthesia machine oxygen flush delivery higher flow rates than the standard method by the the anaesthesia machine so may reduce the amount of inspired air from the leak. Study Hypothesis - High flow oxygen with nasal oxygen or anaesthesia machine oxygen flush produces higher end tidal oxygen levels (better pre oxygenation) in the simulated mask leak scenario.

Gestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing. A randomised controlled trial (RCT) will be conducted involving pregnant women who are overweight (BMI >25 to 29.9 kg/m^2) or obese (BMI >30kg/m^2), less than 14 weeks gestation and recruited from the Barwon South West region of Victoria, Australia. From recruitment until birth, women in the intervention group will receive a program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief (less than 5 minute) phone contact will alternate each week with a text message/email and will involve goal setting, behaviour change reinforcement with weekly weighing and charting, and the provision of health information. Those in the control group will receive usual care. Data for primary and secondary outcomes will be collected from medical record review and a questionnaire at 36 weeks gestation. Evidence based strategies that reduce the incidence of GDM are a priority for contemporary maternity care. Changing health behaviours is a complex undertaking and trialling a composite intervention that can be adopted in various primary health settings is required so women can be accessed as early in pregnancy as possible. Using a sound theoretical base to inform such an intervention will add depth to our understanding of this approach and to the interpretation of results, contributing to the evidence base for practice and policy.

Apnoea of prematurity (AOP), where an infant stops breathing for more than 20seconds, is found in over half of babies born very prematurely. AOP may be accompanied by slowing of the heart rate as well as drop in the blood oxygen levels. Another form of breathing disorder called periodic breathing, is found primarily in premature infants where there is a repetitive pattern of breathing efforts alternating with pauses. Most preterm infants exhibit periodic breathing and it can continue until the infant reaches 4-6 months of age. Apart from breathing control disorderm preterm babies are also at risk of developing bronchopulmonary dysplasia (BPD) or chronic lung disease of prematurity, where there the injured premature lung develops in an abnormal way. There is still some debate about the best way of classifying this disease with the NICHD in the United States dividing this into three levels (mild, moderate and severe) based on the need for oxygen or respiratory support. Infants with BPD experience periods of low blood oxygen that may be severe, especially during sleep and these infants are thought to be at risk of sudden infant death syndrome (SIDS) or cot death. The major cause of oxygenation problems in BPD is due to the severity of the lung disease. The level of the lung disease will determine how much oxygen gets absorbed into the blood of the baby with every breath. A reliable way of determing the severity is by measuring how much the blood gets "oxygenated", i.e. the less severe the lung disease the better the oxygenation and vice versa. This measure is also called the right-to-left shunting and the ventilation: perfusion (V:Q )ratio. A nonivasive way of measuring the shunt will involve making stepwise reductions in oxygen that the baby breathes while ensuring that the oxygen level (that is constantly monitored) remains within intended range. The aim of this study is to investigate 1) firstly breathing patterns (or disorders) and develop tools for classifying breathing patterns and 2) secondly lung disease severity (right-left shunts) and develop quantitative measures of these in preterm infants with bronchopulmonary dysplasia or chronic lung disease.

The main aim of this study is to assess the ability of a new test to detect endometrial cancer in post-menopausal women. The diagnostic test being evaluated involves performing a wash of the uterus and collecting this wash fluid for analysis of markers that are shed from cancer cells. Two different laboratory testing methods will be used to obtain information that will enable us to develop a more cost-effective, sensitive and specific test for detecting early stages of endometrial cancer. Who is it for? This studyis open to peri- and post-menopausal women aged 45-80 years with endometrial cancer and who are currently undergoing a hystrectomy procedure. Trial details In this study you will undergo a uterine wash procedure while under general anesthetic prior to hysterectomy procedure. The wash sample is then tested for specific MMPs.

This study aims to determine whether ginger can reduce chemotherapy-induced nausea and vomiting. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and you are scheduled to undergo chemotherapy for the first time. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take 4 ginger capsules per day, commencing 1 hour before chemotherapy and then every 3-5 hours for 4 days directly after. This will be repeated for 3 chemotherapy cycles. Participants in the other group will take an identical-looking sham tablet, i.e. one that has no active ingredients. Participants will not know whether they are taking the ginger or sham tablets until the end of the trial. All participants will be assessed over the 4 days post each chemotherapy session in order to determine: 1) the effect of ginger on chemotherapy-induced nausea; 2) the tolerability of ginger to chemotherapy patients when used alongside standard anti-nausea medication; and 3) the feasibility of introducing it in our clinical setting.

This study is comparing the treatment response to pre-operative chemotherapy with nab-paclitaxel versus paclitaxel in women with breast cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. Trial details Participants in this trial will be randomly (by chance) allocated to receive either 4 cycles of nab-paclitaxel (abraxane) or 4 cycles of paclitaxel, followed by 4 cycles of chemotherapy containing anthracyclines. Approximately 2-4 weeks following chemotherapy the patients will undergo breast surgery as part of local regional treatment. All patients will be followed for 10 years after the date of randomisation in order to evaluate treatment response and safety.