ANZCTR search results

The aim of this project is to evaluate the impact of a school-based health-related fitness intervention (Fit 4 Fun) on the fitness and activity levels, and attitudes towards phsyical fitness, of Stage 3 primary school students. The study will assess changes over 10 weeks and the feasibility and efficacy of the program for use in primary schools will be assessed.

Myelodysplastic Syndrome (MDS) is a disease of the bone marrow characterized by anemia, neutropenia, and thrombocytopenia (low red blood cell, white blood cell, and platelet counts). MDS patients with thrombocytopenia who fail standard therapies require regular platelet transfusions which are expensive and inconvenient, and are a risk for further serious bleeding complications. The new treatment of MDS using azacitidine has shown to increase the survival rate of MDS patients including to improve platelet production over time. However, in the early cycles of treatment with azacitidine, the low platelet counts tend to exacerbate before they provide any clinical benefit. Eltrombopag is a drug designed to activate the thrombopoietin receptor. Eltrombopag has been able to increase platelet counts in healthy volunteers and in patients with chronic Immune Thrombocytopenia Purpura (ITP), a disease where patients destroy their own platelets very rapidly and thus develop thrombocytopenia. Eltrombopag is administered orally and is Therapeutic Goods Administration (TGA) approved for the treatment of thrombocytopenia in patients with chronic ITP who failed to respond to standard treatment. This study is a single arm pilot study to evaluate the safety and tolerability of Eltrombopag in the treatment of low platelet counts in adult subjects with MDS treated using azacitidine This study also incorporates a correlative laboratory component designed to determined the mechanism of action of 5-azacitidine +/- Eltrombopag and to determine a baseline profile which may predict those most responsive. These studies will incorporate gene methylation and expression, and immunoprofiling.

Elinogrel is under development for the treatment of patients with chronic coronary heart disease and acute coronary syndromes. Patients treated for these conditions are likley to be on a statin therapy such as atorvastatin in addition to other anticoagulants such as elinogrel. Hence the need to investigate the potential drug-drug interaction between elinogrel and atorvastatin.

A known risk factor for lower wisdom teeth removal is inferior alveolar nerve injury, due to the anatomical position and relationship of these two structures. Patients who are referred for wisdom teeth removal routinely have an orthopantomogram for preoperative assessment of these teeth. Cone beam scan, which is a low dose computed tomography scan providing 3-dimension representation of the site, is becoming increasingly popular for inferior alveolar nerve localization. However, there are no studies to show that additional scanning improves outcomes and decreases risk of post-operative numbness for the patient. Furthermore, there are currently no guidelines regarding clear indications for the use of cone beam scan as an adjunct. This project will look at the incidence of postoperative altered inferior alveolar nerve sensation in patients who have lower wisdom teeth removed – in groups where they have the routine orthopantomogram radiograph only, and those who have, in addition to the orthopantomogram radiograph, a cone beam scan. The project will aim to establish evidence based guidelines for the use of Cone beam scan imaging as an adjunctive tool for third molar surgery. Patients who agree to take part in the project will be randomised into two groups – the control is the group without additional imaging ("orthopantomogram only" group), and the intervention group is the group with the additional cone beam scan ("orthopantomogram and Cone beam scan" group). The imaging will be examined with respect to the relationship between the inferior alveolar nerve and lower wisdom teeth. During routine post-operative visits, patients are routinely monitored to establish the presence of inferior alveolar nerve injury. This data will be collected and analysed.

This study aims to investigate the antioxidant precursor, N-acetyl cysteine (NAC) as a treatment for children with autism. Recent evidence has shown children with autism to have imbalances in their antioxidant defences. The primary antioxidant in the brain, glutathione, has been shown to be decreased in these children. This study aims to increase the amount of available glutathione by administering NAC. The trial will be conducted in a total of 80 children, 40 of which will take the NAC treatment and the remaining 40 will take a matched placebo. The study will run over six months after which there will be a 12 and 18 month post-baseline follow up to determine the children’s symptoms following the trial. Standard rating scales will be used to assess the children at baseline, 1, 3, 6 and subsequently 12 and 18 months. Children will remain on any treatment regime they are currently taking part in. Treatment options are limited at present for children with autism and it is hoped that this trial will be efficacious and provide more options for these children.

Vision impairment is a growing public health problem in an ageing population, is an independent risk factor for falls, and compounds the effects of other risk factors by reducing mobility and physical fitness. This randomised controlled trial will investigate the effect of the Alexander Technique on balance and mobility in adults over 50 with vision impairments. 120 people over 50 years of age with vision impairments will participate in the trial. Participants will be independently mobile, with conversational English and no marked cognitive impairment. The intervention group will receive 12 home based lessons in the Alexander Technique on a weekly basis, and the control group will receive usual care. Outcome measures will be collected by assessors masked to group allocation at baseline, and at 3 and 12 months post randomisation. The primary outcome measure will be physical ability using the Short Physical Performance Battery. Secondary outcome measures will be mobility measured with actigraphy and falls measured with 12 monthly calendars. A smaller sub-study will investigate changes in gait patterns. Mood, quality of life, fall-related self-efficacy and functional vision will be measured with a series of validated questionnaires. If proven effective, the Alexander Technique will provide an additional modality to improve mobility and reduce falls risk in vulnerable adults with vision impairment.

Most preterm babies have the umbilical cord clamped within 10 seconds of birth. Placental transfusion is a simple way of giving the baby extra blood at birth by delaying the clamping of the umbilical cord by 60 seconds or more. There is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of pregnancy may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. However, we not know if babies born before 30 weeks of pregnancy benefit or if placental transfusion increases or decreases death or childhood disability. Despite this uncertainty more doctors are recommending that all very preterm babies are given a placental transfusion at birth. It is important to find out if placental transfusion does more good than harm, before it becomes even more widely used. The Australian Placental Transfusion Study will enrol at least 1600 women who will give birth to babies born less than 30 weeks of gestation. These participants will be randomly assigned to either standard treatment where the umbilical cord is clamped within 10 seconds of birth or a second method where the umbilical cord will be clamped after waiting for 60 seconds or more at birth while the baby is being held below the level of the placenta. The main research question is whether placental transfusion reduces death and disability when the baby is discharged from hospital and into childhood.

The study involves women who have had trouble falling pregnant. The study plans to offer women a course of either acupuncture treatment plus lifestyle modification or lifestyle modification only designed to improve menstrual regularity and improve the likelihood of pregnancy. Women who are trying to have a baby without success will be asked to either undertake acupuncture treatments plus diet and exercise programs for 3 months or to adopt a diet and exercise program only. Both options are designed to increase fertility. Acupuncture will be offered from either Campbelltown or a city clinic and each woman receiving acupuncture is expected to attend weekly for 1 hour.

This clinical trial is investigating the role different bacteria may play in the symptoms and quality of life of people with Coeliac disease. The study is looking to see whether there are differences in the different types of bacteria, yeasts and parasites that colonise the intestine of people with Coeliac disease compared to people without Coelaic disease. In addition this clincial trial will see if a specific blend of beneficial bacteria known as a probiotic can improve the ongoing symptoms and quality of life issues experienced by some people with Coeliac disease.