ANZCTR search results

This study aims to investigate the efficacy of a social cognitive remediation program for adult individuals with schizophrenia. The program is tailored to individual ability discerned from baseline assessment but conducted in a group setting for increased peer support and interaction. It is hypothesised that completion of the program will result in improved social cognitive ability in three primary domains. It is also hypothesised that such improvements will extend to social functioning in the community and overall symptomatology.

The aim of this project is to assess the effectiveness of an online system designed for healthcare consumers, called healthy.me, to support healthcare management. healthy.me provides consumers condition specific information, as well as online tools to manage their care including a personal health record. We hypothesise that use of healthy.me will improve the uptake of preventative activities and this randomized controlled trial will specifically test whether system use is associated with an increased rate of influenza vaccination among university students and staff over the respiratory infections season.

Cerebral Palsy (CP) is a neurodevelopmental disorder secondary to injury of the fetal or infant brain causing dystonia, choreoathetosis, and / or spasticity. Deep Brain Stimulation (DBS) improves motor function and quality of life in other forms of dystonia. There are case reports suggesting that DBS improves motor function in dystonic CP as well. This is a proposal to investigate the impact of DBS on motor function and quality of life in adolescents and adults with CP in a randomized, blinded, placebo-controlled design.

The purpose is to investigate whether one method of removing a chest drain is better than another with at reducing complications such as pneumothorax (“collapsed lung”) which can occur when a chest drain is removed. Chest drains are commonly removed in one of two ways – either after the patient has taken a deep breath in, or whilst the patient is blowing out. Pneumothorax is a known complication following removal of chest drains, but it is not clear which of these two methods of chest drain removal results in a lower incidence of pneumothorax.

Aboriginal children have repeated pneumonia episodes; some get better while others develop bronchiectasis (a chronic lung disease). The risk factors associated with progression to bronchiectasis, and the natural history of bronchiectasis in this population is little known. Given the similarities of these diseases among indigenous populations of affluent countries and to increase study size, a collaborative and international study of Indigenous children (Aboriginal and Torres Strait Islander, New Zealand Maori or Pacific Islander and Alaskan Native) has been initiated. We plan to follow up Aboriginal children aged 12 months to 8 years diagnosed with bronchiectasis or chronic moist cough. For those diagnosed with bronchiectasis, after fully informed consent is obtained from the parent(s), the child will be allocated by chance to one of the 2 treatment regimes: (1) Azithromycin nce/week or (2) placebo once/week. Children will receive the medication or the placebo for a period of 24 months. All these children will be clinically seen 2x/year by the study's paediatrician and 2x/year by the research nurse for the duration of the study. The study size and study power calculations were based on our Central Australia data (Valery et al, Paed Inf Dis J, 2004) where Indigenous children diagnosed with bronchiectasis had on average 1 hospitalised episode of pulmonary exacerbation every 6 months (standard deviation=5.4), so the ‘placebo’ group is expected to have 4 episodes during a 24-months follow-up. Assuming we will follow these children for 24 months, if intervention is effective, assuming 50% reduction in the number of pulmonary exacerbation, the intervention group is expected to have 2 episodes vs. 3.4 episodes for the ‘placebo’ group (assuming we have 15% reduction in the placebo group as well due to better medical care due to the study) we have 95% power with 51 children in each group. Importantly, these estimates used hospitalised exacerbation rates as a conservative estimate of total exacerbation rates. In fact, if we determine the sample size required to estimate the difference between the rate parameters of two Poisson distributions over 24 months, 34 observations from each sample (68 child years at risk) are required to have a 90% chance of rejecting the null hypothesis when the true difference over 2 years equals 1.7 using a two-sided test (www.statlets.com/sample_size_rates.htm). By documenting, for the first time, the epidemiology and natural history of children with chronic moist cough and bronchiectasis, the study will provide a much-needed rationale for their management. If we can scientifically show that this is true, that Azithromycin is effective in reducing the number of respiratory infections, this would be an achievable advance in the treatment "in the field" for these children.

Infants born before 33 weeks are at high risk of developmental disorders and learning disabilities. We confirmed the importance of dietary docosahexaenoic acid (DHA) in preterm infants born <33 weeks gestation in a large, National Health and Medical Research Council funded (ID 250322), multi-centre randomised controlled trial (the DINO trial; ACTRN 12606000327583; JAMA. 2009;301:175-82). We demonstrated that DHA given at a dose designed to approximate the in utero accumulation rate (3 times the standard dietary dose) resulted in fewer preterm children with significant mental delay at 18 months corrected age compared with control. The effect of DHA-supplementation was most pronounced in girls born <33 weeks gestation and in infants born weighing <1250g. Despite this some children (boys, infants born >1250g) failed to respond leading us to suspect that higher doses of DHA may be required. This was confirmed when we observed that the DHA level of preterm infants did not achieve levels seen in term infants. This was most likely caused by a number of factors: biological variability and compliance variation influenced the amount of DHA that appeared in breast milk, delay in reaching target infant milk volumes and losses due to oxidation for energy. A randomised controlled trial of higher-dose is warranted. Before undertaking such a trial a pilot study is needed to determine the effect of a higher DHA dose on plasma and erythrocyte phospholipid levels, and to assess the feasibility of giving DHA directly to the infant rather than as an addition to milk or formula.

The design of the study is a phase IV, 2-arm, 8-week, randomised, double-blind, placebo-controlled trial using one 3.2 gram tablet of Kava (Piper methysticum), twice per day equal to 120mg of kavalactones (but in non-responders at week 3 this will be doubled to two tablets twice per day equal to 240mg of kavalactones), or matching placebo, in 100 currently anxious participants with diagnosed generalised anxiety disorder (GAD). Participants are required to fill out assessment forms throughout the study and to have 3 blood tests (liver function tests and a genetic test providing information on liver enzyme function and neurochemistry). Assessment will occur at Healthscope hospital sites in Victoria and at Swinburne University of Technology, Hawthorn VIC. Data collection will occur during week 0 at baseline and at weeks 1,2,4,7,8 by trained research assistants. Assessment tools used: Compulsory a) Structured Clinical Interview for DSM disorders (automated version) b) HAM-A (primary outcome) c) MADRS d) Weekly safety checklists (for adverse reactions) e) Current health & medications questionnaire to assess their current health and any medications they are currently taking f) Drug Check to assess alcohol and other drug use g) Demographics questionnaire to assess age, education, marital status, employment h) The Arizona Sexual Experience Scale (ASEX) to assess the difference in sexual dysfunction between paroxetine, placebo, and Kava. i) Addiction assessment scale to observe whether any perceived addictiveness to the interventions is occurring j) Three blood tests (liver function test and a genetic test providing information on liver enzyme function and neurochemistry). Participants will be required to attend 6 visits at the Brain Science Institute, Hawthorn. The first visit is a baseline session. Participants will be asked to complete all tests: screening assessments, consent forms, mood and anxiety questionnaires. Testing for all subsequent visits will follow the same outline of their baseline session (excluding consent forms and including an adverse effects safety questionnaire). Participants will be given $100 each at the completion of the study to compensate for their time and to cover travel expenses if required. The recruitment, data collection and analysis period will be approximately 1 year. Data will be analysed by research team using SPSS 17.0. Repeated measures ANOVAs will be used to assess any changes between groups across time.

A majority of the falls prevention interventions shown to effectively reduce the risk of falling in community dwelling older people, such as Tai Chi, or programs such as ‘Stepping On’ and the ‘Otago exercise program’, involve specialised training or instruction. This specialised activity places limits on the accessibility of such interventions: due to a lack of qualified instructors, the costs involved in joining programs, or the barriers inherent in attending physical activity classes. Only a small proportion of older people benefit from these interventions. In contrast, walking is a simple activity that can be done by virtually anyone, any time and anywhere without the need for specialised training or equipment. However to date only two studies have examined the effect of walking on falls; one study as a secondary outcome measure the other study combined walking with a home-based exercise program. No studies have explicitly looked at the impact of walking of falls in older people. The Easy Steps to Health study is a randomised controlled trial investigating the effectiveness of a self-managed one year (48-week) walking program in reducing the number of falls in sedentary, community-dwelling people aged 65 years and over. People will be excluded if: they are already physically active (i.e. engage in physical activity for more than 120 minutes per week or on more than three occasions per week); they cannot communicate in English, and; they have any conditions that limit their ability to participate in a physical activity program. A total of 484 participants will be randomised into either the intervention or control group. Participants randomised into the intervention group will receive instruction in the walking program via mail and telephone coaching at week 0, 12, and 24 with additional telephone support at weeks 2, 8, 18 and 36. The control group will receive the self-managed walking program at the end of the study period. During the study period the control group will receive healthy lifestyle information. Falls during the study will be recorded prospectively using a daily calendar. Baseline and end-of-study telephone interviews will be conducted using structured questionnaires assessing ‘Quality of Life’, levels of Physical Activity, confidence in avoiding a fall, confidence in ability to walk, and the ‘walkability’ of their neighbourhood. Baseline interviews will also gather basic demographic information, falls history, and a brief description of current medical conditions and medications being used. In addition, a sub-sample of 194 participants will receive physical performance assessments. These assessments will gather data on lower limb functionality (using the Short Physical Performance Battery), quadriceps strength and lower limb reaction time (using choice step reaction time). Accelerometers will also be used as a more objective measure of participants’ levels of physical activity. These measures on a sub-sample of participants will occur at weeks 0 (baseline), 12, 24, and 48.

The purpose of this study is to characterize the safety, pharmacokinetics, and pharmacodynamics of CEP 37251 following single ascending doses in healthy postmenopausal women. This study is intended to identify a dose of CEP-37251 having a sustained effect on biomarkers of bone resorption.

This study has been designed to investigate how the load and duration of Whey Protein Hydrolysate effects gut motility, gut hormones, and appetite sensations. Volunteers are required to visit the clinic on 4 occassions no less than 3 days apart. Visits will last for approximately 5 hours. A long felxible tube will be inserted through an anaethetised nostril and passed through into the small intestine to monitor stomach and small intestinal contractions. Through this tube, a whey protein or saline solution will be infused over a 60 minute period (4mL/min). Blood samples will be taken (through a cannula, which is a long flexible tube inserted into a vein) and questionnaires on appetite sensations will be completed every 15 minutes. At the end of the 60 minute infusion, a buffet meal will be provided. This meal will be consumed over 30 minutes until the volunteer is comfortably full.