ANZCTR search results

There are various agents used as injectable bulking agents for the the treatment of faecal incontinence. They are usually injected into the submucosa of the anus or at the site of sphincter defect . The aim of this randomised control trial is to compare the effectiveness of two of those agents, namely PTQ (Uroplasty BV, Geleen, The Netherlands), a silicone based implant, and Durasphere (Carbon Medical Technologies, St. Paul, MN), a pyrolytic carbon. As yet the two treaments have not been directly compared. The effectiveness of each technique will be assessed with pre- and post-proceedure incontinence scores (Wexner) and quality of life scoring (SF36) The results of the trial will indicate which of the two agents is more effective in the treatment of faecal incontinence.

The main objective of the study is to determine whether use of a phosphate binder (lanthanum carbonate) in subjects with chronic kidney disease (CKD) stages 3b and 4 will reduce the risk and burden of cardiovascular disease. Patients with CKD 3b and 4 have a substantially higher incidence of cardiovascular disease contributing to significant morbidity and mortality. Phosphate imbalance is a putative non-traditional risk factor for cardiovascular disease in this population (association studies) and lowering of serum phosphate levels with a phosphate binder may be associated with reduced morbidity and mortality. The use of lanthanum carbonate to reduce phosphate and calcium-phosphate product may improve arterial compliance and attenuate the development and/or progression of vascular calcification, reduce the incidence of secondary hyperparathyroidism, and potentially reduce the rate of CKD progression.

One of the ways to treat colorectal cancer that has spread to to the liver is by surgery to remove the tumours. Because surgery alone may not prevent the cancer from returning, chemotherapy may be given. The standard timing of the chemotherapy is to give all of the drugs after liver surgery. The purpose of this study is to investigate whether giving chemotherapy both before and after surgery is better at keeping the cancer from returning than giving all of the chemotherapy after surgery only.

Current cross sectional studies indicate that adolescents with CP perform on average significantly less PA, at a lower intensity, than typically developing adolescents, for all time periods of the week, including during structured physical activity classes (van den Berg-Emons et al. 1995; Bjornson et al. 2007; Maher et al. 2007). A study by Bjornson (2007) indicates that youth with cerebral palsy record on average 2000 steps less per day than youth who are developing typically (Bjornson et al. 2007). Due to these factors the promotion of PA in children and adolescents with CP has become a public health priority (Hogan et al. 2000). To date, there have been no studies evaluating the efficacy of a community based intervention for the promotion of physical activity in adolescents with cerebral palsy. This study aims to evaluate the efficacy of a novel, stage matched; community based intervention for; increasing habitual physical activity (HPA) counts (measured by the ActiGraph); increasing time spent in moderate intensity physical activity and; decreasing time spent sedentary in adolescents with cerebral palsy. The second aim of this study is to evaluate whether the novel stage matched, community based intervention increases; perceived quality of life; physical capacity; participation in life situations and self efficacy in adolescents with cerebral palsy. Finally this study aims to qualitatively evaluate the participants and parents/guardians perceived effectiveness and acceptability of a stage matched, community based intervention. In order to evaluate the efficacy of this intervention, the intervention will be compared to a health behaviour intervention comprising of oral health, sun safety and sleep. Participants enrolled in the intervention will be told that they are participating in a program that aims to investigate their thoughts and feelings regarding four health behaviours; physical activity, sun safety, oral health and sleep. All of the activities and discussions undertaken in the intervention will be introduced and facilitated based on this premise. This technique was chosen in order to facilitate discussion regarding physical activity without pushing the participant to discuss directly, or commit to, change. Parents will be informed that this type of discussion can lead to behaviour change.

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.