ANZCTR search results

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

The primary objective of this study is to establish if exogenous glucose-dependent insulinotropic polypeptide in combination with glucagon-like peptide-1 (both hormones released from the gastrointestinal tract) has a glucose lowering effect in critically ill patients

Sleep disturbance occurs in a significant proportion of the Acquired Brain Injury (ABI) population. Traumatic Brain Injury, a type of ABI, has been associated with reduced sleep quality, more night-time awakenings and longer sleep onset latency's. Recent research has shown that TBI patients have significantly lower endogenous concentrations of melatonin in the evening as compared to healthy controls. Melatonin is a naturally occurring hormone in the body which is intricately involved in the regulation of sleep and more importantly with the timing of sleep. Specifically, recent work has shown that this reduced concentration of melatonin was related to reduced rapid eye movement sleep and that these patients had more arousals during the evening. In light of recent work which provides evidence that a prolonged release melatonin formula is efficacious in treating age-related insomnia in individuals who also have decreased bodily concentrations of melatonin, it is hypothesized that melatonin will reduce the time taken to sleep and will improve sleep quality in ABI patients. The current study will implement a randomized, placebo-controlled crossover study with the aim of recruiting 80 participants. ABI patients who report sleep disturbance post injury will be eligible to participate. As this is a crossover design every participant will receive both the placebo and active melatonin treatments. If melatonin therapy is successful in reducing latency to sleep and improved sleep quality this could substantially improve the quality of life of individuals with ABI. As melatonin is a naturally occurring hormone relatively devoid of side-effects, its use to treat sleep disturbance could be implemented into clinical practice.

Some patients are admitted to the intensive care unit (ICU) either with renal failure or develop renal failure during their stay. Renal failure in ICU is often treated with continuous renal replacement therapy, usually continuous veno-venous haemofiltration (CVVH) or continuous veno-venous haemodiafiltration (CVVHDF). The nature of continuous renal replacement therapy is that it is run over consecutive 24 hour periods (as long as the circuit remains patent). However, there is wide variability in the mobility restrictions imposed on patients undergoing CVVH or CVVHDF therapy in ICUs and patients may often remain immobilised and bed-bound whilst on renal replacement therapy. These mobility restrictions may contribute to the adverse effects of immobilisation in ICUs and there is some evidence to suggest that immobilisation secondary to a vascular catheter (vascath) increases risk of blood clots. Although there is no empirical evidence to suggest that mobilisation of patients with a vascath is detrimental, vascath manufacturers provide no guidance around the specifications of vascaths with movement. In some settings, patients undergoing CVVHDF or CVVH do mobilise out of bed and there is no evidence with which to guide practice around this. Empirical data is required to demonstrate the effects of patient movement on renal replacement therapy flows via vascath and treatment cessation in ICU. However, prior to determining the effect of movement on CVVHDF flows, the safety and feasibility of moving patients on renal replacement therapy must be established. This pilot study will look at patients who have been admitted to an ICU and are requiring continuous renal replacement therapy via a vascath. The aim is to see if it is safe to move and mobilise patients who are having continuous renal replacement therapy via the vascath. Possible adverse events may involve the vascath being pulled out, clotting at the catheter site or in the blood vessels, bleeding or bruising at the catheter site. The settings and parameters on the dialysis machine will be measured to establish a baseline standard of renal replacement therapy flows and performance for comparison in future studies. The collected data will be analysed for safety and assessed for the feasibility of moving the hip or mobilising patients on CVVH or CVVHDF. The project will be written up for publication in an Australian Journal. Depending on the result of this pilot study, a study powered to examine the effects of mobilisation on haemofiltration circuit life may follow.

This study will evaluate the efficacy of three feeding intervention programs for children recovering from cancer with feeding difficulties and/or restricted oral intake. Who is it for? Children can join this study if they are aged between 1 and 6 years, are stable and/or in their maintenance phase of treatment for cancer, and have a feeding difficulty and/or restricted range of oral intake (e.g. limited range of foods, prolonged mealtime duration, problematic behaviour at mealtimes, parent stress related to mealtimes). Trial details: Participants of this trial will be offered a comprehensive assessment of feeding, general development and nutrition in the first instance. Children identified as eligible, based on these assessments, will be randomly (by chance) divided into one of three groups. Group 1 will undergo an individual child-directed behaviour modification program, Group 2 will undergo small group child-directed sensory desensitisation program, and Group 3 will involve group parent education sessions on general nutrition and behaviour management for children with feeding difficulties. Treatment will be offered in weekly sessions for a 10 week block (10 sessions). Participants who are unable to commit for weekly intervention for 10 weeks will be offered the opportunity to be placed on a wait list for intensive intervention (10 sessions in 1 week). Assessments will be conducted at baseline, immediately post treatment, and 3 months post treatment to determine the impact of the programs on dietary variety, overall nutrition, maladaptive behaviours and parent stress.

The objective of this study is to assess to what extent cathodal transcranial Direct Current Stimulation (tDCS) of the temporal cortex, in conjunction with anodal tDCS of the prefrontal cortex, may reduce auditory hallucinations, and induce improvements in cognition, and negative symptoms in people with schizophrenia who are concurrently maintained on antipsychotic treatment. The central hypothesis is that cognitive deficits and negative symptoms, having been linked to prefrontal cortex dysfunction, will be reduced by anodal stimulation of the prefrontal cortex via facilitation of neural function, and that cathodal stimulation of the temporal cortex will reduce auditory hallucinations through disruption of pathological over-activity.

This study will be a randomised controlled trial to evaluate the clinical benefits and cost-effectiveness of two child-directed feeding intervention programs for children from complex medical backgrounds (cardiac, respiratory, gastrointestinal) with feeding difficulties and restricted range of oral intake (<30 foods across the food groups). Baseline assessments will include parent-completed questionnaires on-site (Herston) and feeding and growth evaluations. There are two arms of intervention. Arm One is an individual behaviour modification program. Arm Two involves small group sensory desensitization therapy. Intervention will be provided over three phases. In Phase One, interventions will be provided weekly, over a 10-week period. Phase Two will involve offering a further block of therapy, (Arm One or Arm Two), where appropriate, over a 10 week period. Phase Three will involve providing either arm one or arm two on an intensive basis.

Lung cancer is the most common cause of cancer-related deaths. Although some improvements in the treatment of early stage lung cancer have occurred, the majority of participants still present with advanced (non-operable) disease. The treatments for participants with advanced lung cancer are mostly palliative using various treatments, including chemotherapy, targeted therapies and radiotherapy. This study looks at whether response rates to an assay-directed chemotherapy regime - adenosine triphosphate tumour cell assay (ATP-TCA) - may be greater than in patients who are receiving current, standard chemotherapy for lung cancer. Who is it for? You may be eligible for this study if you have had a confirmed diagnosis of inoperable non small cell lung cancer or mesothelioma, are 18 years and above in age, have an ECOG performance status of 0, 1 or 2, and adequate bone marrow, hepatic and renal function as determined by clinical assessments. Trial details In this trial, you will be treated with either an assay-directed chemotherapy regime, ATP-TCA, or your physician’s choice of standard therapy for your condition. Which treatment you will receive will be determined by randomisation. If you are randomised to the ATP-TCA arm, you will be offered therapy based on your chemo-sensitivity profiles, from which a list of drugs that were positive on the ATP-TCA assay will be provided to your treating oncologist to decide the best first-line chemotherapy agents for you, provided in standard doses based on current clinical practice. The chemotherapy drugs that will be tested in the ATP-TCA assays include: Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane). If you are randomised to the standard chemotherapy treatment, you will receive carboplatin and docetaxel administered every 3 weeks in standard doses. For both treatments, a total of 6 cycles will be administered providing there is evidence of stable disease or partial or complete response by the RECIST criteria. CT scans will be performed after the 3rd and 6th cycles of chemotherapy treatment. Should your disease progress past what is deemed suitable, your treating oncologist will then remove you from the study. Quality of-life assessments will be performed prior to cycle three of chemotherapy and following cycle The aim of this study is to test the hypothesis that the results of chemotherapy in non small cell lung cancer can be improved by predictive testing without an unacceptable increase in toxicity.