ANZCTR search results

The study seeks to further understand the role of thinking styles and family factors in children and adolescents suffering from obsessive compulsive disorder (OCD). The study will achieve this by providing Cognitive Behavioural Treatment to a small number of children with OCD while adopting a session by session tracking method. An approved treatment protocol will be applied by an experienced clinician(s), and a variety of measures will be used each session to allow for a thorough investigation into the relationship between thinking styles and family factors and the nature of OCD symptom change.

Alcohol consumption is a foremost determinant for the prognosis of people with chronic viral hepatitis. There are vital benefits in providing assessment and brief intervention for reducing alcohol consumption and associated harms in people attending primary care settings. This randomised controlled trial aims to identify the effectiveness of an evidence based assessment and brief intervention in reducing or stopping harmful alcohol consumption in people with chronic viral hepatitis. Participants will be randomly allocated to three groups: Group1. (assessment and brochure), Group2. (assessment and brief intervention) or Group3. (routine care with no formalised intervention).

Metabolic syndrome is characterised by a cluster of cardiovascular risk factors, including central obesity, elevated blood pressure, dyslipidemia (low HDL cholesterol, high triglyceride levels & LDL cholesterol) and elevated plasma glucose levels. Individuals with metabolic syndrome have central obesity and at least one other risk factor to be clinical diagnosed with the syndrome. Metabolic syndrome is an emerging clinical challenge and imperative public health issue. Subjects with metabolic syndrome have a markedly increased risk of cardiovascular mortality. Prunus salicina, Queen Garnet plum (QGP), is a fruit that was naturally bred to have a high anthocyanin and antioxidant content, in a Queensland Government agriculture initiative. Queen Garnet plums showed anti-obesigenic properties. Studies in laboratory animals have shown that treatment with Queen Garnet plum juice improved the unhealthy blood lipid profile caused by a high-carbohydrate, high-fat diet. The primary object for this study is to monitor blood pressure changes with Queen Garnet plum juice. Blood pressure is measured by using an automatic sphygmomanometer for 12 weeks of duration.

This study will look at the body composition, bone health, quality of life, physical activity and dietary intake of childhood cancer survivors (CCS) and determine whether the use of a nutritional screening tool is indicative of nutritional status and body composition. Who is it for? You may be eligible to join this study if you are aged between 5 and 25 years, were treated at the Royal Children’s Hospital for cancer and are at least 2 years post active treatment. Study details All participants will undergo body composition and bone health examinations using techniques such as total body potassium counting, air displacement plethysmography, and dual x-ray absorptiometry. Participants will also complete questionnaires on quality of life, physical activity and dietary intake. Only one visit of approximately 1.5 hours will be required to undertake the measurement. The proposed research project will ultimately allow childhood cancer survivors to have the best chance of nutritional health, growth, quality of life and optimal health in the long term. This work has immediate clinical relevance, with expected outcomes to guide clinical practice.

The goal of this innovative trial is to test a multidisciplinary home based package of exercise, patient self-management and motivational strategies aimed at improving functional exercise capacity in people with inoperable non-small cell lung cancer (NSCLC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a confirmed diagnosis of inoperable NSCLC, are scheduled to receive treatment other than surgery (radiotherapy, chemotherapy, targeted therapy), and do not regularly partake in exercise. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the intervention package, which comprises 1) a home-based, eight week exercise program including resistance exercises and a walking program and 2) disease self-management education including symptom management and promotion of exercise adherence using behaviour modification strategies with phone follow up. Participants in this group will receive a 1 hour initial home visit from a physiotherapist together with weekly telephone follow-up calls from both the physiotherapist and nurse and up to 2 further physiotherapy home visits if needed. Participants in the second group will receive usual care, which includes 2 booklets: on lung cancer diagnosis and treatment and exercise for people living with cancer produced by Cancer Council Victoria. All participants will undergo assessments of functional exercise capacity, and complete a number of questionnaires at baseline, 9 weeks and 6 months in order to assess quality of life, survival and resource use. This research is clinically based, relevant and aimed at improving the quality of survival of people with NSCLC. The research is designed to be clinically feasible and cost-effective and has the capacity to be widely disseminated and adopted into practice guidelines in this large and vulnerable group.

This study aims to find out if a Decision Aid developed to give women information about neoadjuvant treatment for breast cancer is useful in helping them to make a decision about their treatment. Who is it for? You may be eligible to join this study if you are 18 years or over, have operable invasive breast cancer and are considering whether or not to have neoadjuvant treatment for breast cancer. You will need to have access to the internet and a computer or laptop to read the Decision Aid and complete the questionnaires. Trial Details Most of this study will be carried out online. If you tell your study doctor that you are interested in the study, you will receive an email with a link to further information about the study and to Consent to participate. You can also consent to participate in a telephone interview, which will take place after participants have accessed the Decision Aid. If you consent to the study, you will complete a questionnaire (which will take about 15-20 minutes to do). Once this questionnaire is completed, you will be able to access the Decision Aid; it can be viewed online or can be downloaded and printed. After you see your study doctor and make your decision about your treatment, you will receive another email with a link to another questionnaire (15-20 minutes). This will ask you how useful the Decision Aid is and how you feel about your decision about your treatment. Another email with a link to more questions (15-20 minutes) will be sent to you after you finish the first part of your treatment (surgery for adjuvant treatment or chemotherapy for neoadjuvant treatment). A last email will be sent to you with a link to a questionnaire (15-20 minutes) 12 months after you originally registered for the study.

BioMonitor 2 Pilot Study aims to collect first implantation experience with a new generation of implantable cardiac event recorder.

The primary objective of this study is to demonstrate and prospectively quantify the palliative benefit of external beam radiotherapy to symptomatic mass in malignant pleural mesothelioma (MPM) in terms of patient rated benefits. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with malignant pleural mesothelioma and will undergo palliative radiotherapy. Study details All participants will receive the following scans in addition to their usual care: 2 F18-FDG PET-CT scans, 1 F18-FMISO PET-CT scan and 2 contrast-enhanced thoracic CT scans. The F18-FDG PET scans will require fasting for 6 hrs prior to the scan, a blood glucose level and an oxygen measurement will also be recorded. Prior to each scan a intravenous cannula will be inserted in to your arm and a 10ml blood sample will be collected for analysis of special biomarkers in a lab. The F18-FDG tracer will be injected into the IV cannula and you will be asked to rest for 60 minutes (for tracer uptake) prior to scanning. The scan should take approx 30 minutes to complete. One F18-FDG PET-CT scan will be performed within 2 weeks of the start of radiotherapy and one will be required 6 weeks after radiotherapy. One F18-FMISO PET-CT scan will be performed within 2 weeks prior to the start of radiotherapy (and within 1 week of the pre-radiotherapy FDG PET-CT scan). You will not need to fast for this scan. An IV cannula will be inserted and the tracer will be injected, you will need to wait for 120 minutes before the PET-CT scan is started. The scan should take approx 30 minutes. One contrast enhanced thoracic CT scan will be performed within 2 weeks prior to the start of radiotherapy and another will be performed 6 weeks after completion of radiotherapy to assess the response to the treatment. Participants will be followed up 3 weeks post radiotherapy, 6 weeks post-radiotherapy and then every 8 weeks to determine the symptomatic response to radiotherapy. Follow up will occur as part of your normal outpatient visits and will involve completion of pain scores and quality of life and medication questionnaires. You will attend follow-up appointments every 8 weeks until you require additional treatment (such as increased pain medication or chemotherapy) or until 6 months after the last study participant has been recruited (whichever is earliest). Using an integrated approach (including innovative imaging techniques that target different tumour characteristics (F-MISO PET, FDG PET), biomarkers and plausible and established clinical markers) this study will also examine the role of hypoxia as imaged by F-MISO PET in radio resistance of symptomatic mass lesions in MPM and identify other clinical and biological predictors of response to radiotherapy. We hypothesise that greater lesion hypoxia, anaemia, and systemic hypoxaemia will be associated with lower radiological response rates and both poorer and shorter duration of symptom control

This project is utilising a randomised controlled study to determine whether a novel home-based intervention focusing on altering the home environment results in short-term improvements in dietary, physical activity and sedentary behaviour patterns of children with obesity aged 4 -11 years. Eighty-four children, referred for management of obesity to Flinders Medical Centre (FMC), will be recruited over a two year period. Children will be randomised to receive a home-based lifestyle support intervention in addition to usual care by a paediatrician or to the control group (paediatrician care alone). Outcomes which will be assessed at six months after the intervention will include improvements in physical activity and dietary patterns of children. These outcomes will be assessed using both direct (accelerometer data) and indirect (questionnaire data) methods. The study hypothesis is that obese children enrolled in this study will have better dietary patterns, physical activity and sedentary behaviour patterns at 6 months from initial assessment compared to a control group of obese children receiving standard care

Hypoglycaemia is the commonest metabolic condition of the newborn. It affects up to 15% of babies, and the incidence is increasing as risk factors such as maternal diabetes and preterm birth are becoming more common. Neonatal hypoglycaemia frequently leads to neonatal intensive care unit (NICU) admission and may cause long-term brain damage. There currently are no evidence-based strategies to prevent hypoglycaemia and its adverse consequences. The purpose of this trial is to determine whether prophylactic dextrose gel prevents admission to NICU.