ANZCTR search results

This study looks at the efficacy of an early and frequent nutrition intervention model, compared to usual care, for improving the quality of life in people with oesophageal or stomach cancer Who is it for? You can join this study if you have cancer of the oesophagus or stomach and will have surgery and/or chemotherapy at Southern Health in Victoria. Trial details Participants will be i n two groups. One group will receive the usual dietetic consultation at the time of surgery or chemotherapy which involves a completing a malnutrition screening questionnaire and referral to hospital dietician services if appropriate. The other group will receive early (at the time of diagnosis) and frequent dietetic assessment. This will involve an initial telephone or face-to-face interview lasting at least 30 minutes and weekly follow-up telephone calls lasting 15 minutes for 18 weeks and then at week 26. Oral nutritional supplement samples will be given to participants at the discretion of the treating dietician. The aim of the study is to compare the quality of life, nutritional status and patient satisfaction with dietetic intervention in the two groups.

Sydney Children's Hospital is doing a study to see whether haemangiomas of infancy (strawberry marks) which are no longer flat or which have continued to grow in spite of oral corticosteroids (cortisone), or present when the baby is too old for steroid treatment, will stop growing and /or shrink when treated with propranolol. A recent report of 11 cases suggests that propranolol may be helpful in shrinking haemangiomas of infancy.

It is well understood that parenting a child with a disability, such as CP, brings additional challenges e.g. increased burden of care and grief. Mothers of children with CP experience greater parental stress and anxious/depressive symptoms. In addition, children with CP are more likely to face behavioural and emotional problems which is in turn associated with further increases in parental stress. Parental stress and child behavioural problems are likely to impact on the optimising of physical, behavioural and educational outcomes in children with CP over and above the impact of the initial brain lesion on disability. Behavioural Family Interventions aim to improve child behaviour and adjustment through changes in the family environment and are well established for improving child behavioural outcomes in typically developing children. The behavioural family intervention Triple P (Positive Parenting Program) has been developed and evaluated extensively over the past 30 years and is implemented in Australia and 19 other countries. The results of three independent meta-analyses using 55 evaluation studies confirm that Triple P has significant positive effects on child behaviour and parenting style. The effect size of Triple P with high-risk groups such as parents of children with ADHD is large (mean d = 0.88). Stepping Stones Triple P (SSTP) is a new variant of Triple P that targets families of children with disabilities. SSTP has a meaningful treatment effect with families of children with developmental disabilities and is efficacious for families of children with Autism Spectrum Disorder (ASD). SSTP has not yet been validated specifically with parents of children with CP. In addition, we will specifically target parenting stress with a parental stress intervention based on Acceptance and Commitment Therapy. ACT is a new cognitive behavioural intervention model that incorporates mindfulness (psychological contact with the present moment) and acceptance (of emotional and cognitive responses). The goal is to increase psychological flexibility- the ability to persist or change in the service of chosen values. ACT has the ability to contribute to parenting interventions by addressing the emotional context of parenting including increasing the parent’s ability to foster their child’s emotional regulation skills and to improve the parent child relationship. Mindfulness and acceptance have been found to decrease distress in parents of children with disabilities however, research has yet to focus on the additive benefit of ACT to Behavioural Family Interventions. This study aims to assess the efficacy of the Behavioural Family Intervention Stepping Stones Triple P with families of children with Cerebral Palsy. In addition, we aim to test the additive effects of an ACT-based parental stress management intervention. It is predicted that Stepping Stones Triple P will be associated with reductions in child behavioural problems. It is predicted that the addition of an ACT-based parental stress management intervention will lead to additive effects on parental adjustment.

The use of Methylnaltrexone Bromide is approved to treat adults with opioid-induced constipation, but it has not yet been test in children with opioid-induced constipation. This study will see how safe and effective Methylnaltrexone Bromide is in children with opioid-induced constipation.

When we ingest a meal a number of hormones are released from the small intestine. These hormones play an important role in regulating the motor function of the gut, the levels of sugar and fat in the blood, and the rate at which the body uses energy. The effects of these hormones on these factors may, however, be limited by the fact that they undergo rapid degradation by an enzyme in the blood. There is a new class of drugs that act by inhibiting this enzyme, and as a result, these drugs improve blood glucose levels in type 2 diabetic patients by increasing active concentrations of these hormones following glucose ingestion. It is currently unclear how these drugs will influence concentrations of these gastrointestinal peptides following fat intake, and that is what this study is designed to investigate.

The first aim of the current project is to assess the utility of two methods of implementing an anxiety prevention program in schools. This will assist in identifying the most effective dissemination method to increase the implementation of mental health prevention programs in schools. The two methods that will be evaluated have been named the e-GAD school method and e-GAD health service method. The e-GAD school method will involve the delivery of an Internet-based anxiety prevention program in schools by classroom teachers, while the e-GAD health service method will involve the delivery of the same program in schools by classroom teachers who are aditionally assisted and supported by headspace education officers. The second aim of the current project is to evaluate the acceptability and effectiveness of the implemented Internet-based program (e-couch Anxiety and Worry program) in reducing and preventing symptoms of anxiety in an adolescent school-based population relative to usual classes (wait-list control). The trial will delimit the likely range of the benefit of using the e-couch Anxiety and Worry program as a universal, active school-based prevention program. Secondary aims of the trial are to evaluate the program's efect on participants' depressive symptoms, mental well-being, anxiety literacy, anxiety stigma, and help-seeking behaviour, attitudes and intentions.

There is growing concern about and awareness of the failure to recognise and appropriately manage deteriorating patients on the wards in hospitals. The consequence of not managing these deteriorating patients is evidenced by unplanned ICU admissions and in-hospital deaths. In April 2010, the Australian Commission on Safety and Quality in Health Care released a National Consensus statement on the essential elements to recognising and responding to clinical deterioration. Royal Darwin Hospital (RDH) is preparing to implement a multifaceted intervention to comply with these national recommendations. New ward observation charts will be introduced to two wards at RDH which will allow the recording of a modified early warning score (MEWS). High scores will automatically trigger the nurse at the bedside to call an appropriately qualified medical practitioner for a timely review of the patient and initiate earlier management. The roll out of this system will be preceded by a period of education for nursing and medical staff using the COMPASS program. I will review the use of MEWS observation charts and the morbidity and mortality of patients before and after this intervention on two wards at RDH.

This is a randomized, openlabel, national, multicenter, three arm, pilot, investigator initiated study evaluating the efficacy and safety of Tenofovir 300 mg PO in combination with peginterferon alpha2a sc 180 µg in patients with HBeAg positive CHB. The patients will be randomized into three treatment arms at a ratio of 1:1:1 Arm 1: Full course combination therapy: 48 weeks of both peginterferon alpha2a plus Tenofovir disoproxil fumarate Arm 2: Peginterferon alpha2a lead-in therapy: 24 weeks of a ‘lead in’ course of peginterferon monotherapy, followed by 24 weeks of combination peginterferon Arm 3: Peginterferon alpha2a 180mcg weekly for 48 weeks The study consists of four periods: Screening (= 8 weeks prior to Baseline visit), Baseline Visit (Day 1), Treatment Phase (48 weeks) Posttreatment Followup (24 weeks) Study purpose: The primary purpose of this study is to evaluate whether the combination of Peginterferon and Tenofovir therapy may lead to improved antiviral outcomes compared to that typically seen with Peginterferon monotherapy. Objectives: The primary objective of this study is to demonstrate the efficacy of the combination of peginterferon alpha-2a with Tenofovir in achieving sustained HBV suppression as measured by HBsAg loss in adult patients with HBeAg positive CHB Secondary objectives include 1. Evaluating the effect of on HBsAg clearance rates by a lead in phase of Peginterferon monotherapy for 24 weeks prior to combination therapy 2. Evaluating the effect of peginterferon and Tenofovir combination therapy on other parameters of viral suppression including 3. HBV DNA non-detectability, reduction from baseline, and sustained reduction in HBV DNA over the course of the study. 4. HBeAg loss, Anti-HBe seroconversion and reduction in HBeAg titres from baseline 5. HBsAg loss, HBsAb seroconversion and reduction in HBsAg titres from baseline 6. ALT normalization 7. To determine which baseline and ‘on therapy’ markers may be used to predict clinical and virological outcomes including quantitative HBeAg and HBsAg titres, HBV viral load, ALT and HBV genotype In addition a sub Immunological Study will be conducted at 2 of the study sites (Monash Medical Centre and St Vincent’s Hospital Melbourne). Patients recruited at both sites will be invited to participate in smaller subcohort study evaluating innate immune during the treatment and follow up periods to determine whether innate immune function can be used as a predictive marker of treatment induced HBsAg and HBeAg seroconversion.

Each participant will receive physiotherapy treatment involving one-on-one education about physical activity for heart failure, including guidelines for walking and exercise while an inpatient at The Prince Charles Hospital. A walking and exercise program for home will also be provided before discharge. In addition, those in the walking group will receive twice daily walking supervised by a physiotherapist. Treatment will take up to 40 minutes each day to complete and will be carried out each day until discharge. All participants will undergo an assessment prior to discharge involving a walking test to measure walking capacity in 6 minutes and activity levels. Soon after discharge activity levels will again be monitored and all participants will receive surveys looking at quality of life and return to everyday activity in the community.

In treatment naïve HIV infected subjects, combination antiretroviral therapy including efavirenz combined with tenofovir and emtricitabine will offer non-inferior antiretroviral efficacy over 48 weeks, compared to either atazanavir boosted with ritonavir combined with tenofovir and emtricitabine or tenofovir and emtricitabine combined with zidovudine and abacavir, as assessed by change from baseline plasma HIV-1 RNA viral load.