ANZCTR search results

This study is looking to evaluate physical activity and sedentary behaviour in children and adolescents with type 1 diabetes using the Multimedia Activity Recall for Children and Adolescents (MARCA) and accelerometers. This study will also evaluate associations between physical activity/sedenatry behaviour and markers of diabetes control. Results from this study will be compared to a nationally representative sample of healthy children and adolescents that have similar evaluations of physical activity and sedentary behaviour.

Violence is a leading cause of death and injury worldwide and a large percentage of prison inmates have histories of violent offending. Numerous studies attest to a strong association between poor impulse control (impulsivity) and violent crime. Impulsivity has been shown to be associated with reduced tone in neural pathways within the brain for which serotonin is the principal neurotransmitter. In a number of studies of impulsive-aggressive individuals, the administration of selective serotonin reuptake inhibitors (SSRIs) has been associated with reduced aggression, impulsivity and depression. To date, there has been no systematic study of the potential benefits of SSRIs for incarcerated impulsive violent offenders who are at high risk of repeat offending. This trial will examine the effectiveness of treatment with an SSRI in impulsive violent offenders on reoffending using a double blind RCT design.

The aim is to investigate the effect on insulin sensitivity of a high lean red meat diet with minimal dairy; a high dairy diet with no red meat; and a diet that has no red meat and minimal dairy with protein coming from chicken, fish and other sources. Evidence is conflicting about the benefits or risks of consuming meat and dairy products and there is little understanding of the mechanisms behind the findings observed in epidemiological studies. The primary hypothesis was that the red meat diet would produce greater insulin resistance than the high dairy diet with secondary hypotheses that the high dairy diet would produce greater insulin sensitivity than the diet without dairy and that these changes would be greater in those with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) than in those with normal glucose tolerance (NGT).

Despite the best efforts of medical practitioners, a short period of severe post-operative pain is still experienced by many patients undergoing surgery. This is particularly so in patients that undergo laparoscopic repair of a hiatus hernia, since there are limited pain relief options that do not cause nausea and vomiting (as these could ultimately lead to disruption of the surgical repair). Many studies have shown that intravenous lignocaine infusion in the perioperative period is safe and has clear advantages in patients undergoing abdominal surgery. These same studies concluded that further research is needed to determine the optimum dose, timing and duration of infusion of lignocaine in this setting. This study aims to evaluate the benefits and validate the safety of intravenous lignocaine for pain relief for patients undergoing laparoscopic repair of hiatus hernia.

Modified-release fampridine is licensed in Australia for the symptomatic treatment of walking disability in multiple sclerosis (MS). However, many patients with MS have reported beneficial effects on other areas such as fatigue, vision and upper limb function. These benefits have not been formally studied in a trial. In addition, it is not known how modified-release fampridine works and why it seems to work better in some people than others. Electrophysiological techniques such as nerve conduction studies, evoked potentials and transcranial magnetic stimulation can be used to study the nervous system and the effects of drugs on it. These techniques can be used to identify where particular drugs might exert their effect and help to uncover more information about how the drugs work, with the eventual aim of developing new symptomatic treatments for MS. The aim of this study is to use these techniques to examine the nervous system in study participants on and off fampridine and to compare the findings between responders and non-responders to the drug.

This study is assessing the feasibility and safety of Stereotactic Ablative Body Radiosurgery (SABR) in patients with metastatic prostate cancer. Who is it for? You may be eligible for this study if you have Prostate Cancer that has spread to lymph nodes or the bones. Trial Details: The research project is testing a new treatment for prostate cancer that has spread beyond the prostate to the lymph nodes or bones. The new treatment is called Stereotactic Ablative Body Radiotherapy. Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. Stereotactic Ablative Body Radiotherapy (SABR) appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, kidney and the liver. We aim to test the ability of this new technique to control cancers arising from the prostate, and that have spread to bone or lymph nodes. As part of this study you will be required to discuss your past medical history and progress of your prostate cancer with the doctor. A general physical examination with a focus on where the cancer has spread to is part of the study. You will have standard blood tests including your hormone levels and prostate specific antigen (PSA) level. Also as part of this study you will be required to have a special scan called an 18F-PET/CT (stands for fluoride-positron emission tomography/computer tomography) scan. This involves an injection of a radioactive chemical and then a scan to see where your prostate cancer has spread to. If the tests show that the research study is suitable for you, and you still wish to take part, you can join the study and begin the treatment. Prior to your stereotactic body radiotherapy you will be required to fill out quality of life and pain questionnaires. This may take up to 20 minutes of your time. You will have either a single session of stereotactic body radiotherapy (SABR) or in the rare situation where there is not enough time available you may be required to return for two sessions (if you have two lesions) and three sessions (if you have three lesions). In order to deliver this treatment, you will need to attend a ‘planning CT scan’ session, where you will receive a CT scan and your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be smoothly delivered when it comes to the time of treatment. This session will take between 45 minutes and 90 minutes. When the treatment starts, the total time required to deliver the treatment will be approximately one hour. All sessions are usually conducted on different days and we will contact you to give you the dates and times to attend for these sessions once they have been booked for you. Follow-up will involve a visit at approximately 1 month, and every 3 months until two years after the radiotherapy treatment. At each visit you will be reviewed by the doctor and have a prostate blood test (PSA). At each visit you will be expected to indicate on a questionnaire if you have any pain. At the 1, 3, 12 and 24 month visits you will be expected to fill out a quality of life questionnaire which will take about 20 minutes of your time. You will have a whole body bone scan at 12 or 24 months after your treatment. At 6 months after your radiotherapy treatment you will have another 18F-PET/CT scan, which will be very similar to the scan before your treatment. The purpose of this scan is to assess the effect of the treatment on your lesion(s).

In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects and that this improvement can be measured in all men, not just those with diabetes. The aim of this study is to investigate the time course of this effect and explore the mechanisms involved when exposure to HBO induces an increase in peripheral insulin sensitivity. This study will also test whether the same thing happens in female subjects.

Atrial fibrillation (AF) is the most common heart arrhythmia affecting at least 240,000 Australians. Prevalence rises with age from approximately 1% of the whole population to 5% in those over 65 years. People with AF are up to seven times more likely to have a stroke than the general population, and AF related strokes are also likely to be more severe. In addition, one in every six strokes is AF related. Stroke is highly preventable in AF with the use of appropriate thromboprophylaxis. Therefore early identification and appropriate evidence based management of AF could lead to subsequent stroke prevention, significant reduction in the overall stroke burden and substantial savings to the health system. The study is designed to examine the feasibility of screening to identify undiagnosed AF in a primary care setting. Our hypothesis is that a simple primary care screening program may be effective in detecting those with undiagnosed AF. The specific aims are to: 1. Assess the feasibility and acceptability of screening for AF using a hand-held single-lead ECG device in people aged 65 years and over in the general practice setting. 2. Assess the satisfaction of GPs, reception staff and patients with the screening process in the general practice setting. 3. Examine process measures, such as the time taken to complete the intervention, competing demands for practice reception staff time, and the attitudes of patients and staff involved in the intervention. 4. Identify barriers (including technological barriers), enablers and other information relevant to the process of developing a larger-scale implementation study. We propose a cross-sectional study offered in up to 5 general practices in the Sydney metropolitan area. People aged 65 and over, attending general practices will be invited to volunteer for the screening. The screening will consist of an assessment with a handheld single-lead ECG device attached to an iPhone by the practice receptionist. This ECG will be transmitted to a secure website and reviewed by the patient's GP during their consultation. The primary outcome measure will be the acceptability of the screening process. A process evaluation will also be undertaken to better appreciate factors that might influence sustainability beyond the trial setting.

Insomnia is a common and distressing sleep disorder. Untreated insomnia is responsible for increasing health care utilisation through negatively impacting on mood (depression & anxiety), family and workplace behaviour which in turn increases a socioeconomic burden on the community (Ohayon 2002; Siebern & Manber 2010; Hilman et al., 2008). Cognitive Behavioural Therapy (CBT-i) is the most efficacious treatment for insomnia by enabling the individual to change current ineffective behaviours and challenge faulty beliefs about sleep (Morin et al., 2006). Effective behavioural sleep interventions include sleep restriction therapy (Edinger & Means, 2005) stimulus control therapy (Bootzin, 1972) paradoxical intention (Morin 1993) and sleep hygiene (Hauri, 1991). These behavioural sleep interventions have successful treatment outcomes when run by the equivalent of Practice Nurses in Scotland and do not require trained psychologists (Espie et al., 2001; Espie et al., 2007). Although CBTi has proven effectiveness, access to both sleep centres and professionals who are able to provide such services is limited in most major cities and is often absent in rural communities in Australia. More recently a “stepped care” model to treat insomnia has been proposed (Espie 2009). This model proposes a generic pyramid where the majority of patient care is undertaken at baseline with an evidence-based but less intense treatment intervention whilst “greater expertise” in both assessment and treatment is used towards the top step of the pyramid. This model has considerably validity in the treatment of insomnia patients using group CBTi which has an efficacious record in a number of different age groups and settings. For many rural families the cost of going to capital cities for an ongoing treatment intervention is not feasible. There are also the ongoing issues of social isolation and increased depression rates particularly in young men in rural communities. Treating insomnia symptoms is an effective first step to address these issues. Training Practice Nurses to undertake a predominantly Behavioural Therapy (BT) intervention will enable the provision of a treatment which is both easily accessible and has been shown to improve sleep and mood in most individuals. The primary aim of this project is to assess the outcomes of a BT intervention for insomnia when delivered by Nurse practitioners in a medical setting in rural NSW.

The present study examines whether transcranial direct current stimulation (tDCS) over the left dorsal lateral prefrontal cortex (DLPFC) impacts upon executive functioning in healthy older adults. Based on previous research, the following particular hypotheses may be proposed: (i) older adults will perform poorly on tests of executive function compared to younger adults (ii) anodal (excitatory) tDCS of left DLPFC will enhance performance on measures of executive functioning in older adults (iii) cathodal (inhibitory) tDCS of left DLPFC will lead to decreased performance on measures of executive functioning in older adults (iv) sham tDCS of left DLPFC will not impact upon performance on measures of executive function