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This study is planned to investigate the effect of food on the absorption of EMA401 when EMA401 Sodium Salt is administered orally in healthy adult males (18-55 years of age inclusive) at a dose level of 50mg.

The purpose of this research project is to evaluate a plan of action designed for general practitioners and practice nurses to safely and efficiently start patients with Type 2 diabetes on insulin injections who have high sugar (glucose) levels despite taking tablets. To be eligible to take part in this study subjects must have Type 2 diabetes; be aged between 18-80 years old; are on at least two diabetes tablets at the highest doses that they are able to tolerate and that these doses have been unchanged over the last 3 months, or based on the opinion of the general practitioner who normally cares for the patient insulin, is required to ensure ensure their health health. The subject must have a HbA1c (a simple laboratory measurement on blood that reflects average glucose levels in a person's blood over the previous three months) between 7.5-10.5% which indicates less than satisfactory diabetic control; and must have never taken insulin before. Women of childbearing age must not get pregnant during the study. There will be up to 142 subjects recruited for this study across 16 sites in Victoria Australia only. Participating subjects will be commenced on insulin initially with a single injection of an insulin (Glargine) which lasts for 24 hours. The dose will then be adjusted to match the subject’s needs. If necessary, because sugar levels rise after meals despite providing an appropriate dose of the long acting insulin, a second injection of a short acting insulin (Glulisine) will be added in to coincide with the subject’s biggest meal for the day. A second purpose of this study is to determine if a new device that provides information regarding a patient’s glucose levels continuously is helpful in guiding treatment that results in better control of diabetes when compared to current methods for monitoring glucose levels by finger-prick readings. The study will be looking to see if the protocol used improves sugar levels as measured by a fall in HbA1c which will be measured at the start of a subject's involvement in the study, at 12 weeks and at 24 weeks.

There is compelling evidence to support a study of aromatase inhibitors in selected patients with potentially hormone sensitive recurrent or metastatic gynecological cancers. Hormonal therapy is an attractive option in patients with recurrent gynecological cancers where the objective of treatment is palliation and prolongation of survival rather than cure. Aromatase inhibitors are generally well tolerated and in contrast to chemotherapy can be administered for prolonged periods with relatively little cumulative toxicity. The degree of activity and response rates reported in previous studies has varied considerably. This variability almost certainly reflects the heterogeneous populations treated, which have included women with advanced chemotherapy and hormone resistant tumours and those with a poor performance status where response rates are generally low. There is a clear need to investigate the role of hormonal therapies, particularly AIs, in women with potentially hormone responsive recurrent gynaecological cancers. Studies are required to establish the response rates, clinical benefit and quality of life as well as to identify predictors of response.

Oral diseases are among the most common health problems experienced by Australians, affecting almost 11 million people annually. Pregnant women are particularly at risk of poor oral health due to hormonal variations related to pregnancy. The government has commenced addressing these issues through the Australia’s National Oral Health Plan (2004-2013) which emphasises the need for health promotion, prevention and early identification of oral diseases as well improving access to appropriate and affordable services. However, research conducted by the investigators in this study has indicated that women are poorly informed about the implications of poor oral health during pregnancy and experience barriers to accessing dental services during pregnancy. Through a series of research activities, the study investigators have developed a unique oral health service (MIOH-DS), bringing together midwives and dentists, to improve maternal oral health. This innovative, high impact and internationally important intervention for pregnant women has the potential to offer an intervention relevant to all Australian child-bearing women and their antenatal care providers. This study will provide a pathway for national policy on oral health assessment and services for Australian women during the perinatal period. Aim The aim of this study is to determine the effectiveness of a Midwife Initiated Oral Health-Dental Service (MIOH-DS). The MIOH-DS will provide pregnant women with oral assessments by midwives, and referral to dental clinics, which we anticipate will improve women’s oral health status, uptake of dental services, oral health knowledge, and quality of oral health. We propose to pilot test the MIOH-DS service at a large metropolitan hospital in Sydney Southwest using a true randomised control trial. Intervention groups will receive either the MIOH-DS service which will include: a midwifery intervention involving oral health education, brief oral assessment and referrals and a dental intervention involving prompt treatment at dental clinics (through a voucher) or the MIOH service involving midwifery intervention and referral to current dental services. The control group will not receive any midwifery or dental intervention (current practice) but will be provided (if required), dental referrals after pregnancy. All participants will receive oral health promotional material at the time of recruitment

The effect of cumulative stress and trauma on children and families has been demonstrated to lead to compromised outcomes in health and well-being for the child. Cumulative stress or trauma can arise from multiple co-existing or recurrent experiences such as poverty, inappropriate housing, unemployment, ill-health or injury, family breakdown, family violence, parental substance misuse, abuse or neglect. Acute paediatric health services play a unique role in contributing to the maintenance and improvement of child’s health and well-being and support of their families. They have been identified as playing a crucial role in the identifying children as risk of suffering deleterious effects of the cumulative stress and trauma. This study aims: 1) To describe the health and well-being of children admitted to The Royal Children’s Hospital (RCH) and identified by clinical staff as being vulnerable to the effects of cumulative stress or trauma 2) To compare the health and well-being of participants in this study to Australian reference data (using data from Growing Up in Australia: The Longitudinal Study of Australian Children) 3) To trial and evaluate an enhanced assessment and intervention program in an acute paediatric setting for children identified as being vulnerable to the effects of cumulative stress and trauma 4) To identify the interdisciplinary professional decision making processes of RCH health professionals working with clinical presentations of cumulative stress and trauma. This study will use a sequential comparison group design, collecting both quantitative and qualitative data, to address the above aims. Data will be collected by questionnaire, interview and hospital Unit Record audit at two time points: entry to study (T1); discharge from hospital (T2) and six months post-discharge (T3). Participating families will be recruited from children admitted to select Medical Units in The Royal Children’s Hospital Melbourne.

This is a pilot study to investigate a new scanning technique called respiratory gated (4D) PET scanning in patients with solitary pulmonary nodules. Who is it for? You can be part of this trial is you have a single round lesion in your lung that needs investigation with a PET scan. Trial details The participants will recieve their whole body PET scan as per normal but they will have an additional 4D PET scan that will take an extra 10 minutes. The 4D PET scan is a scan that will create a movie of the lung breathing. This movie can reduce blurring of lesions caused by movement due to normal breathing. The study aims to see the proportion of patients who have a change in the way the cancer is classified as a result of the additional 4D PET scan

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.