ANZCTR search results

The Early Prevention of Obesity in Children (EPOCH) Collaboration was formed in 2009. The main objective of the EPOCH Collaboration is to determine using a prospective meta-analysis of four randomised trials if early interventions for childhood obesity impact on BMI z scores at age 18-24 months. Additional research questions will focus on whether the interventions have an impact on dietary quality of child, TV viewing time, duration of breastfeeding and parenting styles. The enlarged sample size of the combined dataset (approximately 1800) will allow greater reliability when exploring intervention effects, with respect to pre-specified participant- and intervention- level characteristics. It will also allow for examination of complex interactions that are likely to be of high clinical importance. Individual trial registration numbers are listed below: ACTRN 12607000168459- Healthy Beginnings ACTRN 126080000056392- Nourish ISRCTN 81847050- Infant Feeding Activity and Nutrition Trial (InFANT) NCT 00892983- Prevention of Overweight in Infancy (POI NZ)

This study looks at the role of exercise in managing lymphoedema status and associated symptoms in women with breast cancer related lymphoedema. Who is it for? You can join this study if you are a women who has a clinical diagnosis of lymphoedema secondary to breast cancer. Trial details: Participants will be divided into three groups. Two groups will take part in progressive supervised resistance exercises performed at relatively higher or lower intensities (i.e. upper and lower body resistance based exercise using weight machines and free weights) twice weekly (60 minute sessions) for 12 weeks. The third group will receive usual care for 12 weeks and then will take part in a 12 week exercise program. Lymphoedema status (i.e. the amount of swelling in the upper extremity) will be assessed using standard objective measures including bioimpedance spectroscopy, arm circumference measurements and dual energy x-ray absorptiometry. Lymphoedema associated symptoms will be assessed using a modification of the Brief Pain Inventory. Muscle strength and endurance, shoulder and elbow range of motion, functional ability and quality of life will also be assessed.

Patients who undergo liver transplant surgery have a significant incidence rate of infection by Cytomegalovirus, also known a CMV. This virus is responsible for decreased liver function and transplant failure. In this study, we will monitor CMV infection in liver transplant patients. Monitoring of patients will be performed by laboratory tests and will help determine the best way to prevent and treat CMV infection/disease. Researchers around the world have used various strategies to reduce the incidence of CMV infection/disease in liver transplant patients. These include laboratory tests for detecting CMV as a guide to administering intravenous ganciclovir (pre-emptive therapy) or preventative therapy by giving patients oral valganciclovir from time of transplantation (prophylaxis).

Non-Hodgkin’s lymphoma (NHL) is one of the most common cancers diagnosed in young women, with approximately 105 women under 40 years diagnosed in Australia annually (2005 data), most of whom will have aggressive histology. In aggressive NHL, standard treatment is 6 cycles of R-CHOP-q21. Recently, an accelerated protocol (R-CHOP-q14) has been widely adopted. This regimen has been demonstrated to produce sustained remissions in at least 75% of women aged <40 (J Connors 2010, personal communication). The risk of early ovarian failure with regimens of variable intensity used in NHL (including CHOP) is estimated to be 10-40% (Avishay et al, 2006; Dolmans et al, 2005). Currently, however, there are no specific data available about the short or long-term effects of R-CHOPq14 on fertility, (Pfreundschuh 2008, personal communication) but the more intensive regimen may be expected to induce a higher incidence of ovarian damage than the q21 protocol. It is important, therefore, that the impact of this chemotherapy on fertility be evaluated in this patient population of child-bearing age with a high survival rate (Nicosia et al, 1985), as interventions aiming to protect fertility are worthy of study. There is increasing evidence that fertility protection may be achieved with a GnRH agonist during chemotherapy. Two recent meta-analyses, despite showing benefit from use of GnRH agonists (p<0.05 in one analysis), concluded that because of the lack of randomization in various studies, there was not yet enough evidence to definitively resolve the issue (Beck-Fruchter et al, 2008; Blumenfeld et al, 2008). More recently, results of a randomized controlled trial in patients with breast cancer found a statistically significant reduction in ovarian failure in patients who received concomitant GnRH agonist (Badawy et al, 2009). The lack of data regarding ovarian failure risk with treatment of NHL, and the absence of specific previous trials assessing ovarian protection in this context, both provide the rationale for further evaluation of a GnRH agonist in a rigorous, Australia-wide, clinical trial setting. This randomized, controlled study aims to identify: (1) the underlying risk of temporary and more permanent ovarian failure for patients receiving an accelerated protocol, R-CHOP –q14. (2) whether there is any ovarian protective effect from concurrent administration of a GnRH agonist.

This study aims to test whether a higher intake of vegetables is more beneficial for weight loss than a lower intake of vegetables. We hypothesise that those in the intervention group will have a better anti-loxidant staus, will lose more weight, show greater improvements in risk factors associated with over weight, will demonstrate greater perceptions of satiety and will report a greater acceptability for vegetable consumption.

This research is a prospective study of the CDSMP, with or without a supervised exercise component, in the Royal Hobart Hospital outpatient area for people with chronic obstructive pulmonary diesase. The research will use a mixed methodology of quantitative and qualitative outcome measures: physical activity, shortness of breath, health-related quality of life, stage of change for physical activity, self-efficacy for physical activity in the presence of deterrents and narratives of the lived experience of the participants themselves.

Intubation is one of the most important skills that anaesthetists have. There are currently many different intubating devices available. Anaesthetists have to develop and maintain skills with more than one type of device, so that when faced with difficult tracheal intubation, a safe alternative technique can be used without causing complications. Both the McGrath and the C-MAC videolaryngoscopes are relatively new intubating devices, which have a high-resolution camera and light source embedded at the distal end of the blade. They allow a view of the anterior glottis without the need for a direct line of sight. Both devices claim to provide a comparable or superior glottic view when compared with direct laryngoscopy using the standard curved Macintosh blade. However, the design of the shape of the blades between the two videolarygoscopes are very different. Currently, there are no studies comparing the use of these two devices in patients with potential difficult airways, which are usually the most useful situations. The aim of this prospective randomized controlled trial is to compare the effectiveness of using these two devices in performing endotracheal intubation in adult patients with predicted difficult airways. The research is designed to be conducted in 130 adult patients with Mallampatti 3 or 4 (one of the predictors of difficult airways) and ASA 1-3 having oro-tracheal intubation for elective surgery . After informed consent, the patients will be randomized to having either the McGrath or C-MAC videolarygngoscopes for the intubation. The primary outcome is the timing of intubation. Secondary outcomes include the glottic view, ease of intubation, number of attempts required, haemodynamic changes and also any associated complications.

Currently, patients undergoing hip and knee replacement surgery do not participate in formal exercise classes prior to their operation. It is possible that the introduction of these classes may affect patients’ length of inpatient hospital stay, discharge destination, the speed of post-operative improvement (particularly movement of the affected joint) and the use of healthcare resources. Participation in exercise classes may also improve health-related quality of life following surgery. This pilot project will examine the effect of an exercise group for patients undergoing elective hip and knee replacement surgery provided prior to their surgery (referred to herein as ‘prehabilitation’). Patients attending pre-admission clinic prior to their operation will be invited to participate in the study and included participants will be randomized to either usual care or usual care with the addition of prehabilitation. All participants will undergo baseline testing of health-related quality of life, joint range of movement and functional activity testing in pre-admission clinic and participants will then be re-tested eight weeks following their operation. The differences between groups (usual care and usual care + prehabilitation) will be analysed using appropriate statistical tests.

This study is investigating the utility of a novel technique called 'proteomics' using serial blood samples to see if there are differences in plasma proteins whicn are able to predict toxicity and patient response to chemotherapy for patients with colorectal cancer. The hypothesis is that proteomic techniques are able to (1) identify patients more likely to respond to chemotherapy and predict overall outcome (2) identify patients more likely to expereince side effects and (3) predict the development of cancer cachexia in patients with metastatic colorectal cancer The intervention is the collection of blood samples at 4 time points during chemotherapy or observation. In addition there will be standard care (radiological and nutritional assessment) plus follow up as set out by the trial protocol.

The project will examine whether providing clinicians with feedback regarding depression symptoms, generated automatically following computerised depression screening, will result in higher rates of identification of depression, and treatment initation, and decrease rates of depression at 3 months post-screening.