ANZCTR search results

To test whether image guided radiotherapy for prostate carcinoma has less treatment related side effects and impairment of quality of life when an endorectal balloon is inserted during the radiotherapy compared to image guided radiotherapy alone.

A comparison of two currently used treatments for a stiff painful shoulder (adhesive capsulitis, frozen shoulder). Under x-ray control a radiologist (X-Ray doctor) injects cortisone and local anaesthetic into the patient's shoulder joint. There are two groups of patients. One group then receives an additional injection of normal saline (up to around 50 mls of sterile salty water) to try to stretch the shoulder ligaments (capsule) . The patients are then assessed clinically and by questionnaire at 8 and 12 weeks post procedure to assess increased shoulder movement. Both techniques are curently used. if one is demonstrably better than the other then it may change clinical practice.

The firsrt aim of the study is to identify precisely how long a pudendal nerve block lasts and to find out how the different symptoms of pudendal neuralgia presented by the patient, evolve during the 52 hours following the pudendal nerve block. The second aim is to find out, for patients undergoing afterwards the pudendal nerve release surgery, if there is a correlation between the particular response to pudendal nerve block and the outcome after surgery. This will be a prospective study based on questionnaires. It will include a minimum of 50 women aged 18 or more, who had been referred to the Pudendal nerve Clinic in the Endogynaecology Department at the Royal Hospital for Women, who meet the entry criteria and who already consented to undergo a pudendal nerve block as part of their assessment. The participant will be asked to fill in a questionnaire, always the same, about her symptoms before, just after and then every 6 then 8 hours for 52 hours after the pudendal nerve block. If the patient undergoes a surgery to release the pudendal nerve entrapment, we will ask her to fill in that same questionnaire again 3, 6 and 12 months after the surgery.

This study aims to reduce the emotional, psychosocial and physical needs of women being treated with radiotherapy for gynaecological cancer. We are investigating the benefits of a new program which combines specialist nurse consultations with telephone peer support before, during, and after treatment, compared to current standard care alone. Who is it for? Eligible patients for this trial are 18 years or older, have a confirmed diagnosis of gynaecological cancer, speak and read English, and are scheduled to receive radiotherapy with curative intent to the pelvis. Eligible peer support volunteers are women who are 18 years or older, have received radiotherapy to the pelvis for a gynaecological cancer at least 2years ago, and can speak and read English. Trial details: In this study, patients will be randomly allocated to either standard care currently offered at their hospital, or to standard care PLUS the trial support program involving nurse-led consultations and telephone peer support. The consultations and telephone support will focus on the physical, functional, psychological, sexual, informational and social needs of patients at four time-points: pre-treatment, mid-treatment, at the end of treatment, and post-treatment. Patients randomly allocated to the new program will have a nurse consultation (face-to-face or over the phone) and peer support telephone call at each of these time-points. All participants will complete 5 surveys over 14 months, so we can assess whether the new program improves patient outcomes. The first ACTRN relevant to this study is for the initial development & pilot testing phase: ACTRN12609000312246. A second ACTRN is for the phase III trial for which this study was the initial development & pilot testing phase has also been submitted: ACTRN12611000744954.

Gout is the most common inflammatory disease in the western hemisphere where its incidence seems to be rising. Allopurinol is a widely used and effective treatment for gout. It is used to lower plasma urate concentrations in the body, which in-turn prevents acute gout attacks. It's use, however, has been shown to be sub-optimal. Patients are not reaching target plasma urate concentrations recommended by treatment guidelines due to low dosing of allopurinol. Thus this project aims to understand the dose-response relationship of allopurinol and optimise the dose for patients, such that patients reach target plasma urate concentrations.

Researchers from the Baker IDI Heart & Diabetes Institute in Melbourne, University of Queensland, University of Melbourne and Deakin University are collaborating with Department of Human Services to measure the physical activity levels of office workers and to investigate the relationship between physical activity and health. Research over the last decade has shown that low overall activity patterns throughout the day increase the risk of many chronic conditions such as type 2 diabetes, heart disease, and some cancers. Findings from this project will provide us with valuable information to develop and improve workplace health promotion programs.

Background: In term infants functional closure of the PDA usually occurs in the first 72 hours, but may take longer in preterm infants. The primary rationale for treatment of the duct is that the left to right shunt across the PDA can cause deleterious systemic and pulmonary haemodynamic effects. This potentially leads to excessive pulmonary blood flow that may result in pulmonary haemorrhage or a need for increased respiratory support (oxygen and/or positive pressure) and systemic circulatory compromise causing abnormal organ function and tissue injury. The need to treat a PDA at a later stage when acute complications are less likely is currently controversial. Though the data on the outcome of preterm infants with persistent ductus arteriosus have been scarce, there has been a study addressing this issue which reports eightfold increase in mortality of VLBW neonates with persistent PDA. A recent abstract publication described a case series of 5 infants who appeared to have spontaneous late PDA closure following the use of paracetamol for unrelated indications. Paracetamol is a commonly used medication in infants with a relatively benign side effect profile, so if found to be efficacious, could provide a useful alternative for treatment of PDA. Aim: 1.To study the effect of paracetamol given orally in closure of late PDA in premature neonates; 2. Examine the safety and efficacy profile of paracetamol. Study design: a prospective randomised, blinded, placebo controlled trial. Population: Preterm infants born <33 weeks gestational age with a persistent PDA who are >4 weeks of postnatal age and tolerating at least 50% enteral feeds. Method: A clinician performed ultrasound (CPU) by qualified neonatal medical staff will assess ductal size and haemodynamic significance at 4 weeks of age. Any abnormal liver function will be excluded prior to commencement of study medication using routine blood tests. After randomisation, the study group will receive paracetamol as per Australian guidelines for neonates(25mg/kg loading dose, followed by maintenance dose of 15mg/kg at an interval appropriate for gestational age. The placebo group will receive the same volume of oral placebo solution, most likely sucrose. The study medication course will be for 5 days. A CPU by a clinician blinded to study medication allocation will be performed after 48 hours of medication administration and again after 5 days to document ductal patency and haemodynamic significance. 0.5ml of blood will be collected in a lithium heparin tube for repeat liver function tests and paracetamol serum levels 48 hours after commencement of study medication and again at completion of study medication on day 5. Some of these tests may overlap with required routine blood tests and therefore may not be extra. The primary outcome will be succesful closure of PDA as documented on clinician performed ultrasound.

At present there is debate surrounding the effects of the A1 variant (A1) of the beta-casein protein contained in bovine milk compared to the progenitor A2 variant (A2) in terms of potential health outcomes. However, there is evidence to suggest that the beta-casein composition of milk can have an impact on gastrointestinal symptoms of intolerance which may be due to exposure to A1 beta-casein derived digestion products. Given the Australian Dietary Guidelines recommend the consumption of at least 2-3serves of dairy foods per day, the effects of milk variety on digestive function and exposure to beta-casein digestion products is important and warrants investigation. Most available milk and milk products contain comparable amounts of both A1 and A2, protein variants which are reported to have potential differences in bioactivity upon digestion. This stems from the release of the seven amino acid opioid peptide, termed beta-casomorphin-7 (BCM-7) from the digestion of A1 but not A2 beta-casein. However, further research is required to demonstrate clearly any differential in vivo effects between A1 and A2 beta-casein consumption on biological responses, including those associated with gastrointestinal symptoms of milk intolerance. The general aim of this blinded, cross-over trial is to demonstrate that A2 beta-casein containing milk will have a neutral effect on gastrointestinal symptoms and exposure to BCM-7 relative to A1 beta-casein containing milk.

Current practice at LGH and generally in Tasmania is selective case based antenatal testing for thyroid disease. This is often conducted in a very ad hoc manner and the actual current incidence and prevalence of thyroid disease within the pregnant population is not yet known. Many professional bodies advocate testing for thyroid dysfunction in pregnancy only if symptoms exist, in the setting of prior personal or family history or in the presence of an antecedent or associated medical condition. Iron deficiency has been shown to have a negative impact on maternal thyroid function, which is compounded in areas of borderline iodine deficiency. Serum ferritin, transferrin receptor and body iron stores all significant predictors of TSH. A joint statement by the American Thyroid Association, the American Association of Clinical Endocrinologists and the Endocrine Society in 2005 made firm recommendations for universal screening for thyroid dysfunction in pregnancy as soon as pregnancy is diagnosed.5 Guidelines on management of thyroid disorders during pregnancy published by LeBeau et al in 2006 is in further support of this. The trial will be offered to pregnant women during their attendance at the antenatl clinic at the LGH. The midwives will assist in the study by conducting the questionnaire and organizing blood tests and consenting participants during the booked visits. Obstetric, medical, family, social history along with demographic, and perinatal information would entered into the Obstetrix Database as per routine. A further questionnaire addressing detailed thyroid history will be administered. The questions have been derived and modified from Abalovich et al and their recommended approach for case finding. Recruits will then be referred to the Pathology service at the LGH to have their blood and urine taken. Each recruit should have phlebotomy at the same time each day, i.e 8-10 am to eliminate diurnal variations. Fasting serum/plasma collected would be tested for TSH, FT4, FT3, TPO antibodies, FBC, Fe studies also by the Launceston General Hospital pathology service when usually present for 26 weeks Oral Glucose Tolerance Test (OGTT). TSH, FT3, FT4 & Ferritin (part of Fe studies) to be assayed using Ortho Clinical Diagnostics ECI. The Beckman Coulter LH500 analyzer to be used for the FBC, and iron studies to be performed using an Abbott C8000 analyzer. Remaining serum will be divided into 5 aliquots of 1-2ml each and stored frozen at -70 degree for future reference. Furthermore, we assessed of the utility of HbA1c when used as a screening tool in pregnancy. A direct comparison of HbA1c levels with results of the OGTT test in targeted gravid women, tested concurrently at the 24-28 gestational week and was undertaken in a subset of 480 pregnant women. This amendment was approved the Ethics committee. An informed consent was obtained from all women.

Clubfoot/feet is a common foot deformity seen in newborn infants. While it can occur along side other conditions, most babies with clubfoot are otherwise healthy. Clubfoot affects about one baby in every 1,000 born. Fifty percent of babies with clubfoot are affected in both feet, and males are affected slightly more often than females. The cause is unknown. Treatment for clubfoot aims to correct the deformity that is help the baby’s foot rest flat on the ground and be flexible and pain-free. After correction, bracing and splinting are important in preventing the baby’s foot from reverting back to the curved position. The treatment in total takes can take between 2-4 years. The treatment of the clubfoot deformity is very successful. What is less well understood in children with treated clubfoot/feet is their later ability to perform activities such as running, jumping, kicking a ball and participating in sports i.e. once the deformity corrected i.e the foot now straight- is the child able to do all the typical things a child of a similar age can do? The aim of this study is to look at the functional motor skills (i.e. the way a child can run, move, kick a ball) in children treated for clubfeet compared to children of the same age who were not born with clubfeet. Further, this study hopes to see if there is a relationship between the shape, flexibility and strength of the treated foot and the child’s later motor abilities. Also it hopes to examine how the child’s parents perceive their child’s quality of life related to their treated clubfoot using a quality of life questionnaire specific for clubfeet. Fifteen children who have completed treatment for clubfeet and 15 children without clubfeet will be assessed using a test that identifies and describes children with motor difficulties. The motor abilities of the two groups will be compared. The children with treated clubfeet will have 2 further assessments done. The first assessment looks at the child’s foot shape, flexibility and strength of the foot and the child’s ability to perform simple activities such as hopping, standing on one leg etc. In the second assessment, parents of children with treated clubfeet will also be asked to fill out a questionnaire on how they rate their child’s quality of life. Rating of quality of life will be compared to their score on foot shape, flexibility, muscle strength and motor abilities. All assessments will be completed within a one hour session with assessments conducted by an experienced paediatric physiotherapist. Children aged between five and six years have been chosen, as by this age, treatment is complete. The children are old enough to be able to cooperate in testing and also because at this age difficulties with motor abilities will be becoming more obvious as demands on the child’s motor abilities increase i.e. being able to run and keep up with playmates at school and the beginning of sporting and physical activities at school in a more structured way. There are no identified ethical concerns. No assessment causes pain or discomfort and the assessment in total only takes 1 hour. No interventions are involved