ANZCTR search results

The primary purpose of this trial is to evaluate the efficacy and tolerability of a 'slow tempo' chemotherapy regimen for the treatment of acute myeloid leukaemia (AML). Who is it for? You may be eligible to take part in this trial if you have newly diagnosed AML and are aged 65 or over, or are unable to undergo standard care chemotherapy; if you have untreated secondary AML or transformed AML and are aged 18yrs or over; or if you have relapsed or refractory AML are you are aged 18 or over. Study details All participants enrolled in this trial will undergo the slow tempo chemotherapy treatment regimen, which will involve 35-day cycles of induction chemotherapy until remission is achieved, followed by three 35-day cycles of consolidation chemotherapy, lastly followed by 42-day chemotherapy cycles for two years. Participants will be assessed for disease progression and for treatment side effects throughout the treatment. It is hoped that the findings from this trial will provide information on whether slow tempo chemotherapy with low dose cytarabine and thioguanine is safe, tolerable and effective in the treatment of newly diagnosed and refractory/relapsed AML.

This study is being undertaken to test the hypothesis that the pH of the media used to hold human eggs during IVF treatment can impact fertilisation rates We propose that pH has a profound effect on the assembly and functioning of a component of the egg called the spindle. We have already demonstrated this in mice. We believe that incorrect spindle function can cause lower than expected fertilisation rates, and should fertilisation occur the resulting embryo is of poorer quality. Therefore if pH can effect the spindle, it could have an effect on overall fertilisation. This has significant relevance for the culture systems utilised in IVF clinics worldwide. pH is the term used to describe the balance of acidity (+) and alkalinity (-) of a liquid. The pH scale is from 1-14. If a liquid produces more hydrogen (H+) it is an acid, if it produces more hydroxide (OH-) it is an alkaline. A liquid with a low pH value (less than 7) has lots of hydrogen and is described as acidic, an example of an acidic liquid is lemon juice. A liquid with a high pH value (more than 7) has lots of hydroxide and is described as alkaline, an example of an alkaline substance is bleach or most cleaning products. A liquid which has an equal amount of hydrogen and hydroxide is described as neutral, with a pH of 7. Pure water is usually neutral. The pH inside the human body varies, however the pH of the environment in the ovaries and reproductive tract is slightly alkaline. This is the usual pH of the liquid in which we keep eggs in when they are outside the body. In our laboratory we use media and products from a company called Vitrolife. We will be investigating 2 of their solutions which have been specially manufactured by Vitrolife to be at 2 distinctly different pHs – one at pH 7.2 (the normal pH used in our laboratory), the other will be pH 7.4 (this level is used by some other clinics around the world). We intend to determine which is the optimum pH level to give us the highest rates of fertilisation so that we can try and achieve better results for our patients in the future.

The fetal heart rate device (HEARD) is a novel device developed by BIORITHM, a medical technology company, to assess fetal heart rate. For the following study, the current phase entails a proof of concept in women antenatally to assess the quality of signals obtained on HEARD. Aims 1. Examine the signal quality of fetal electrocardiogram signals obtained on various electrodes 2. Elicit patient opinion about utilising HEARD ( i.e. What do patients think?) Research design The following study is a cross sectional survey with a cohort design. Methods Primary outcomes: 1. Quantifying signal quality across various electrodes utilising HEARD 2. Correlation between signal quality and placental location, fetal back position and amniotic fluid index Secondary Outcomes 1. Patient views on HEARD (i.e pros, cons, will they recommend it)

The proposed trial involves using a social robot to help facilitate a healthcare program that focuses on decreasing unregulated high sugar snack episodes for adolescents aged 11-17 with type 1 diabetes.

The aim of this study is to analyse cumulative exposure, pharmacokinetics and pharmacogenomics of daily intravenous busulfan in paediatric haematopoietic stem cell transplantation. Who is it for? You may be eligible to join this study if you are aged 18 years or below, with underlying disease with recognised HSCT indication and are receiving once daily IV busulfan as a component of HSCT conditioning regimen and have adequate central venous access for blood sampling. Study details This study will involve a prospective nonrandomised trial where patients who consent be asked to provide small volumes (7 ml per day, in total 28mL from 28 samples over four days) of blood which will be sent to a central laboratory for analysis. These sample results will be used for study purposes only and will be taken in conjunction with those taken for standard of care per the institutions current practice. Transplant outcome data will be attained at day +30, +100 and +365 post transplant. The blood sample results will not interfere and will not be available to guide clinical treatment of participating patients, however will improve dose optimisation of busulfan in future patients. This study will help guide optimal dosing regimens and reduce toxicity for paediatric patients who require intravenous busulfan as part of a HSCT regime.

Preeclampsia is a common, serious complication of pregnancy and leading cause of maternal, fetal and neonatal death and disability. Currently there is no medical treatment and the only way to stop disease progression is to deliver the pregnancy. At early gestations this inflicts the serious risks of prematurity on the newborn whilst the mother is exposed to the risk of disease progression during the delivery process. A treatment that stabilises the disease to allow the safe prolongation of pregnancy would be a major advance. Excitingly we have discovered that a medication safe in pregnancy, sulfasalazine, can reverse key features of preeclampsia disease pathophysiology in laboratory studies using primary human pregnancy tissues. Firstly we showed that sulfasalazine reduces the placental secretion of antiangiogenic factors sFlt-1 and soluble endoglin that cause preeclampsia. Secondly we demonstrated sulfasalazine reduced features of vascular dysfunction specific to preeclampsia. Given these promising findings and that sulfasalazine is safe in pregnancy (category B) we hope to progress this concept and translate these findings from the laboratory to the clinic with a proof of concept early phase clinical trial. We propose to recruit 20 women with preterm preeclampsia (30+0 weeks to 36+0 weeks gestation) at The Mercy Hospital for Women and treat them with 2-3 grams of sulfasalazine per day. We will assess the pharmacokinetics of sulfasalazine in women with preeclampsia and monitor key clinical and biochemical features of the disease. If successful, at the completion of this study, we will have evidence to progress the study of sulfasalazine as a treatment for preeclampsia to randomized clinical trial. It may form the basis for a medical treatment for preeclampsia and reduce the devastating burden of this common obstetric disease.

Study Purpose: Previous ED-based antiemetic research has failed to show a benefit of antiemetic drugs over placebo, with the possible exception of droperidol 1.25 mg IV. This has led to doubts about the value of ED antiemetic drug use, or further ED-based antiemetic research. Recent literature has suggested that the primary outcome measure in the ED-based placebo controlled RCTs to date (comparison of mean VAS change between groups) may not have been sensitive enough to detect true differences. Hence, for this study, an alternate primary outcome measure of VAS reduction in excess of 5 mm is being used, as this cut-off level has been shown to equate with symptom improvement. Study findings should then clarify whether or not antiemetic drugs do have value for ED patients, and may guide future research directions regarding antiemetic drug use in the ED.

We aimed at examining the association between vitamin B12 status and sleep quality of healthy people in Melbourne between age of 18-65 years with diverse dietary plans and life style at a community-based setting. Based on the known roles of B12 on proper neuronal functions and the fact that one of the symptoms of its deficiency is tiredness, we hypothesis that B12 plays crucial role in maintaining good sleep quality in humans.

Anthocyanins are compounds found naturally in fruits and vegetables that provide the rich colour such as blue and deep red. These compounds possess strong antioxidant abilities which may protect the cells of the body from damage. Over recent years, there has been considerable interest in the health effects of diets that are high in plant foods, and particularly the role of anthocyanin content of foods. There is some research that has shown that intake of foods and beverages that are rich in anthocyanins may protect against age-related diseases, such as cancer, cardiovascular disease and neurodegeneration. The purpose of this study is to determine the effect of consumption of fruit juice for 8 weeks on blood pressure and memory and cognition in generally healthy older adults. The study will also determine if the fruit juice affects inflammatory markers in the blood (these are produced as the body's response to injury or infection) and change in gut microbiota population.

This study will investigate 2 natural responses that our nervous system uses to relieve pain called conditioned pain modulation (CPM) and manual therapy-induced pain modulation (MIPM). CPM refers to the capability of our body to inhibit the painfulness of one stimulus when another stimulus is also felt. For example, if you have a headache but then you stub your toe, the headache is forgotten. MIPM is the pain relieving effect you get following a manual therapy treatment. In this study, we are comparing CPM and MIPM responses in people with tennis elbow. If we find that both CPM and MIPM responses behave in the same way, then this may potentially indicate that they share similar pain processes in the nervous system. This will broaden our knowledge about the way in which physiotherapy influences natural pain relieving effects in the body, which will allow us to enhance the effect of manual therapy in clinical practice, Eligible participants attend the Physiotherapy Clinic at the School of Physiotherapy and Exercise Science at the Bentley campus of Curtin University for 2 test sessions, with a rest period of 3 days in between. Each test session will each take approximately one and half hours. They will be required to avoid taking pain medications 24 hours before each test occasion although they can continue to take them during the course of the experiment. We will also ask them to avoid any additional physiotherapy treatment and other physical treatments. Eligible participants will be randomly allocated to 15mins session of low intensity or moderate intensity aerobic cycling group by the Physiotherapy Clinic supervisor. Participants in each group will be initially tested for PPT at both elbow and wrist measurement sites. They will then be randomized to undergo a precondition CPM assessment protocol and an MIPM assessment protocol, in two separate test sessions (i.e. two study days) separated by three days. All CPM and MIPM protocols will be performed by the same assessor who will remain blinded to the level of aerobic exercise subjects are completing. Following completion of the aerobic exercise, all subjects will be reassessed for CPM and MIPM by the blinded assessor. The PPT value will then be analysed to determine if there is an association and/or a difference in the CPM and MIPM following the physiotherapy intervention. If both forms of pain modulation demonstrate a similar pattern of response, this would suggest a common underlying mechanism of action. This may provide a base from which to investigate the possibility of enhancing manipulation-induced pain modulation effects . It will therefore extend our knowledge of manipulation-induced analgesia (MIA).