ANZCTR search results

The REVITAHIP trial is a multicentre randomized-controlled trial examining the effects of early high-dose vitamin D replacement compared to placebo in improving mobility and reducing disability in older people following a hip fracture

Recent research indicates that shoe inserts are effective in treating some individuals with knee pain. However, not all individuals benefit from shoe inserts and research to determine who is most likely to benefit is limited. Therefore, this study is aiming to identify predictors of individuals with knee pain most likely to benefit from shoe inserts.

This pilot study aims to gain preliminary information on the utility of C-MET and FLT PET-CT imaging for distinguishing ‘pseudoprogression’ from ‘true’ progression in patients receiving chemoradiotherapy for high grade glioma. C-MET and FLT PET-CT scans will be performed at the same time as their routine mid-treatment MRI (after 2-3 cycles of chemotherapy. Patients will be followed to record radiological and clinical responses to chemotherapy. Patients will also be followed up for survival. This data will be used to obtain preliminary information of the prognostic significance of C-MET and FLT PET-CT imaging in glioma

Food allergies are common and result in a significant burden to families and the health care system. One approach to prevent food allergies may be to introduce specific foods earlier than currently recommended. The study will compare early regular introduction of egg from 4-6.5 months of age compared to the more common practice of egg avoidance until 10 months of age. If successful at reducing egg allergy, this approach will have a significant impact on reducing the burden of allergic disease.

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.