ANZCTR search results

This project involves evaluating the effectiveness of a new teacher-delivered body image program for early primary school children, 'Achieving Body Confidence for Young Children' (ABC-4-YC). The aim is to assess improvements in 5- to 8-year-old children's body image, weight stigma, and appearance-based teasing by comparing children who receive ABC-4-YC with children who receive their usual classroom curriculum. School classes will be assigned to receive ABC-4-YC or their usual curriculum. Children will be interviewed to assess changes in body image weight stigma, and appearance-based teasing at baseline, post-test, and 6 week follow-up.

This Phase 1b study entails administration of GS-9688 in CHB subjects for the first time with the objective of evaluating its safety, tolerability, PK and PD, and thereby understand the clinical pharmacology profile of GS-9688 to determine if it is suitable for clinical development as a treatment for CHB. The results from this study will form the basis for further evaluation of GS 9688 and dose selection for a Phase 2 study in subjects with CHB. This study will proceed in two parts, governed within and between parts by reviews of safety data and application of stopping rules, as applicable. Based on safety and available PK and PD data, and at the discretion of the sponsor in consultation with the investigators, any cohort may be repeated at the same dose level, be held until further safety, PK or PD data are available, or not be initiated.

The aim of this study is to evaluate whether Chinese herbal topical wash (Huo Xue Tong Luo Decoction) can relieve and/or prevent Oxaliplatin-induced peripheral neuropathy in gastrointestinal cancer patients. Who is it for? You may be eligible to join this study if you aged 18 years or above and are going to receive XELOX chemotherapy for gastrointestinal cancer. Study details Study participants will be allocated by chance (allocation ratio of 2:1) to one of the two intervention groups. One group will receive Huo Xue Tong Luo Decoction solution while the second group receives a placebo solution. Participants will use provided solutions to separately soak hands and feet for 20 minutes once a day for five consecutive days during each chemotherapy cycle (8 cycles). Participants will be required to complete a quantitative thermal testing from baseline, midway through each chemotherapy cycle and at the end of 3 months follow-up along with pain and QoL questionnaires in order for researchers to monitor whether the intervention is safe and whether it is effectively treating Oxaliplatin-induced peripheral neuropathy. It is hoped that the findings of this trial will establish the benefits of Huo Xue Tong Luo Decoction as topical wash for the prevention and treatment of Oxaliplatin-induced peripheral neuropathy in gastrointestinal cancer patients.

Our pilot study will establish baseline carriage prevalence in approximately 500 first year university students. The findings will assist in a more refined estimation of sample size required for a cross sectional study of first year university students to be conducted in 2018 and 2019. It will also be used to validate study processes including delayed freezing of samples.

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.