ANZCTR search results

Over the last decade, the ‘off label’ use of fluoxetine and other selective serotonin reuptake inhibitor (SSRIs) in children with autism has become increasing common, both in Australia and overseas. However based on the current available literature, the efficacy of SSRIs for the treatment of repetitive behaviours and other symptom domains in autism, is yet to be established. It is therefore of importance that high quality, controlled, and reproducible studies are performed to address the efficacy and safety of SSRIs in children with autism. The aim of this project is to determine the efficacy and safety of Fluoxetine for the treatment of restricted, repetitive and stereotyped behaviours in children and adolescents with autism. Participants will be aged between 7.5 and 18 years, have a known diagnosis of an autism spectrum disorder, and have troublesome restricted, repetitive and stereotyped behaviours causing functional impairment (as defined by the DSM-IV criteria for Autistic Disorder). The study will be a randomised double-blind placebo-controlled trial, with parallel group design. 146 subjects will be randomised into two groups (active and placebo). The duration of participation will be 22 weeks, 16 weeks of study medication. Prior to commencement of the trial, a medical history and physical examination will be performed. Four questionnaires will also be administered: Repetitive Behaviour Scale - Revised, Yale-Brown Obsessive Compulsive Scale, Spence Children’s Anxiety Scale, and the Clinical Global Impression Scale. A neuropsychological battery of tests will also be performed. The study medication will be commenced at 4mg or 8mg/day depending on body weight < or > 40 kg). Following this, further weekly increments will be made if side effects do not emerge, until an effective dose is reached. The maximum dose utilised will be 20mg or 30mg/day by week 4. The effective dose will then be maintained between weeks 5 and 16 of the trial. Repeat assessments will be performed in week 16. This testing will include the previously administered questionnaires. Participants will then be weaned off the study medication between weeks 17 and 20. The active and placebo groups will be compared using independent sample t-tests.

In medical practice and published research, it is well documented that in some patients with respiratory failure due to chronic lung disease, breathing high concentrations of oxygen can cause carbon dioxide levels to increase, sometimes to potentially harmful levels. The effect of oxygen on patients who have chronic respiratory failure from other causes such as obesity hypoventilation syndrome is less clear. We would like to test the effect of two concentrations of oxygen on breathing pattern and carbon dioxide levels in patients who have chronic respiratory failure due to obesity hypoventilation syndrome. We expect that breathing high concentration oxygen will cause an increase in carbon dioxide levels and alter breathing pattern in this group. It has also been proposed that this group, treating (and reversing) hypercapnia through the use of nocturnal positive airway pressure therapy may improve responsiveness to carbon dioxide, thereby minimising the potentially harmful effects of supplemental oxygen. We hypothesised that three months of treatment with nocturnal positive airway pressure would lessen any adverse responses to supplemental oxygen observed during testing at initial presentation.

This study looks at whether support groups that teach about fatigue can help reduce fatigue and improve quality of life in cancer patients undergoing radiotherapy, compared with standard treatment. Who is it for? You can join this study if you are a patient at the Princess Alexandra Hospital, receiving radiotherapy for cure or control of cancer but are not receiving chemotherapy at the same time. Trial details Participants will be randomly divided into four groups. Three groups will attend a patient fatigue education and support (FES) group at different stages in their treatment, to learn strategies they can use to improve their levels of fatigue and thus their quality of life. These three intervention groups will be compared to a control group that receives only standard care. In standard care, the radiation oncologist and nursing staff provide brief education to the patient about the radiotherapy process, with no specific patient fatigue education and support group. Patients will be assessed on a variety of questionnaires to investigate the effects of the FES groups and will also be asked to keep a log of the strategies they used to improve their fatigue levels.

1.1 To identify the variation in health related quality of life (HQOL) of patients with advanced prostate cancer treated with intermittent maximal androgen blockade therapy (IMAB). 1.2 To observe the effects of intermittent androgen blockade therapy on the rate and extent of androgen dependent physiological parameters as well as noting serial side effects and patient compliance with the treatment program. 1.3 To gain information regarding time to disease progression and overall survival of patients with advanced prostate cancer treated with intermittent maximal androgen blockade therapy. 1.4 To quantify the relative and absolute amounts of time achieved off treatment from the commencement of active therapy

Each year 53,000 Australians have a stroke and 88% return home to the community. Stroke survivors struggle to recover quality of life at home.Self management programs are a new initiative designed to help people living with a chronic condition manage their day to day lives more effectively, improve quality of life and live a more healthy lifestyle. In 2004/06, the National Stroke Foundation developed and piloted a stroke self management program. The Phase 1 trial demonstrated positive outcomes for the participants. The aim of this Phase 2 trial is to test the proposed research protocol and outcome measures, whilst validating the effect size calculation in preparation for a Phase 3 larger RCT. Participants will be recruited from six hospitals in Adelaide with a letter from the HEad of the Stroke Unit, through advertising in local Adelaide newspapers, through Stroke SA, general practice or word of mouth. Stroke survivors returning home or already living in the community,3/12 after their stroke will be invited to participate. Participants will be randomly allocated to one of three groups: The first group, "Standard Care" will receive their usual care when they are discharged from hospital. They may be managed by their GP, referred to community services, given information about life after stroke, or join a stroke support group. The second group will receive usual care and undertake the Chronic Condition Self Management Program. This generic, six week education program runs with a range of disease groups including stroke. The third group will receive usual care and undertake the Stroke Self Management Program. This eight week education program is designed to help "get life back on track" after stroke. All participants will be assessed prior to admission to the program, at 6-8 weeks and at 6 months. The assessor will be unaware of the group allocation. The primary outcome measure is improvements in positive and active engagement in life as measured by the hei-Q. The hei-Q is designed to measures changes in self management programs. Improvements in quality of life, mood and cost benefits are secondary outcomes. This is the first time in the world that the impact of cognition, language and physical disability on a person's ability to self manage will be explored. An accurate record of adverse events shall be maintained. Participants will be informed of their right to withdraw at any time without prejudice

The purpose of this research study is to investigate if Glypromate® can reduce changes in brain functioning which may occur following cardiopulmonary bypass (CPB) surgery. Glypromate® is a synthetic (man-made) drug derived from a naturally occuring human protein. Two previous human studies have been performed to look for side effects of the medicine, but this is the first study to see if Glypromate® can limit the changes in brain functioning following open heart surgery. Approximately 672 people from the United States, Australia and New Zealand will participate in this study. Neuropsychological tests (to measure brain functioning), and questionnaires designed to examine normal daily activities, mood and intelligence will be done before and after surgery (at 4-6 weeks and 12-14 weeks).

A randomised-controlled trial of a shared approach to risk management (the intervention) versus standard care (control) following stroke. Outcome is blinded and analysis is intention-to-treat. A cost-effectiveness analysis is included. It is hypothesised that at 12 months following stroke a shared nurse/doctor team approach to risk factor management will result in improved management of patients risk factors, result in fewer adverse events, and will be cost-effective.

This project will determine whether standard care or cardiology care improves survival for patients undergoing emergency orthopaedic-geriatric surgery with a troponin rise. A pilot study conducted at The Northern Hospital in 2006 revealed that at one year mortality rate was 21% in this population and those with a troponin rise were more at risk of dying. Therefore, this RCT is proposed to see if cardiology care is any better than standard care to improve survival.

Numerous studies have demonstrated comorbidity between migraine and tension-type headache on the one hand, and depression on the other. It is not clear whether this reflects a causal relationship between headaches and depression or common predispositional factors. Presence of depression is a negative prognostic indicator for behavioral treatment of headaches. Despite the recognised comorbidity, there is limited research literature evaluating interventions designed for comorbid headaches and depression. Sixty six participants (49 female, 17 male) suffering from migraine and/or tension-type headache and major depressive disorder were randomly allocated to a Cognitive Behavior Therapy program, or a control group (Routine Primary Care). The treatment program involved 12 weekly 50-minute sessions administered by clinical psychologists. Participants in the treatment and control groups significantly differed from baseline to post-treatment on measures of headaches, depression, anxiety, and quality of life. Improvements achieved with treatment were maintained at four month follow-up. Changes in headaches and depression were not significantly correlated suggesting that the relationship between them may not be causal. Comorbid anxiety disorders were not a predictor of response to treatment, and the only significant predictor was gender (men improved more than women). The new integrated treatment program appears promising and worthy of further investigation.

We aim to measure the migration pattern of the tibial base plats using RSA. We would also like to compare RSA and clinical questionnaire data (oxford knee score and EQ5D score) regarding Genesis II MIS tibial base plate to a previous study involving standard Genesis II tibial base plates