ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31428 results sorted by trial registration date.
  • Oesophageal capsule assessment of gastroesophageal reflux disease in chronic lung disease patients awaiting lung transplant and lung transplant recipients.

    Gastroesophageal reflux is an important cause of lung transplant rejection and so it is important to diagnose and treat in patients who hvae undergone or are to undergo transplantation. The Given ESO oesophageal capsule is a non-invasive disposable capsule endoscopy system which allows examination of the oesophagus. It has been trialled in many populations but not yet in the proposed study population.

  • Acceptance and Commitment Therapy (ACT) to enhance stress resilience in police recruits: A randomized control trial

    Stress is a major issue for police. Officers face a range of stressors related to operational duties, such as exposure to violence and trauma, in addition to a range of organisational stressors. These stressors have been associated with a range of physical and psychological problems, in addition to low morale, absenteeism and increased turnover. They have also been found to impact negatively on an officer’s relationships with family members, friends and colleagues. The nature of police work means it is not possible to remove all stressors. However, it is possible for police organisations to help develop skills in officers that foster resilience, such that officers are better able to adapt, or bounce back from stress, without experiencing the negative consequences outlined above. Coping refers to thoughts and behaviours that individuals use to deal with stressors. While no single coping strategy has been found to be good or bad in all situations, coping flexibility, the ability to flexibly choose different strategies that fit the needs of the situation has been associated with positive adaptation (Folkman & Moskowitz, 2004). Studies have found that police have a tendency to use unhelpful, avoidant coping strategies to deal with difficult emotional experiences (Evans, Coman, Stanley, & Burrows, 1993), strategies such as emotional detachment and excessive use of alcohol (Richmond, Wodak, Kehoe, & Heather, 1998). Emotional detachment has been found to undermine the ability of officers to emotional engage and maintain healthy relationships and social networks (Madamba, 1986). Avoidant coping is socialised among new recruits when they are encouraged to take control of situations and not to let their emotions affect their work (Paton, et al., 2009). The primary objectives of the current study is to enhance resilience of police officers by providing training in coping flexibility skills and reducing the use of maladaptive coping skills. Experiential avoidance, the extent to which individuals: 1) are unwilling to stay in contact with aspects of their private experience; and 2) take steps to alter these experiences (Hayes, Strosahl, & Wilson, 1999) has been found to mediate the effects of maladaptive coping on psychological distress and wellbeing (Fledderus, Bohlmeijer, & Pieterse, 2010) and make people more vulnerable to a range of stressors (Biglan, Hayes, & Pistorello, 2008). As Acceptance and Commitment Therapy (ACT) aims to reduce experiential avoidance, it is thought to be particularly beneficial for preventing severe psychological distress. Furthermore, by enabling officers to persist with valued actions in the face of adversity, ACT is also likely to lift performance and wellbeing. A range of workplace stress management studies have been conducted using ACT. The current study aims to extend the research of Bilich and Ciarrochi (2009) who conducted a trial of group based acceptance and commitment therapy for senior police officers. The transition from training to active policing environment is a particularly stressful period for new recruits. The current intervention is designed to provide coping skills training to police recruits just before they make the transition to operational duties, and before maladaptive coping strategies have been socialised. Measures of mental health, sick leave and coping strategy use will be used to assess the effectiveness of the training, the sustainability of that effect and measures such as the AAQ, the VLQ and the MAAS will be used to assess mechanisms of change.

  • Developing effective imaging methods to assess chemotherapy response in Malignant Pleural Mesothelioma

    Mesothelioma is an aggressive tumour with a poor outcome and not all patients respond to current best-practice chemotherapy. Response to chemotherapy is currently assessed by measuring tumour size on regular CT scans. Detecting changes in tumour size for Mesothelioma can be difficult due to the growth pattern of the tumour, it grows as a rind around the lining of the chest. Significant changes in 'size' of Mesothelioma on Computerised Tomography (CT) scans may not occur until 2 - 3 months after commencing chemotherapy. The aim of chemotherapy is to cause the tumour cells to die, this process of cell death is called apoptosis. CT scans are able to detect this apoptosis, from chemotherapy treatments, after approximately 3 months. During the past few years, Annexin V has emerged as an agent that can be used to detect cell death. Attaching a radioactive tracer (Technetium -99m), to Annexin V and using a Single Photon Emission Computerised Tomography-CT (SPECT-CT) camera to detect if cell death is occurring one to two days after chemotherapy has started may predict the effectiveness of chemotherapy earlier. This would result in fewer patients continuing ineffective treatment, individualization of chemotherapy treatments, and more rapid and reliable identification of new drugs which may be effective in this disease.

  • The effect of a short cognitive and behavioural therapy intervention on illness representations and quality of life in individuals who sustain a traumatic injury: A pilot study.

    Specific aims of this research project include: 1.Examining whether previous findings about associations between illness representations and health related quality of life in people who have had a traumatic injury are replicated. 2.The development and evaluation of a brief CBT intervention designed to enhance self-regulation in trauma injured patients and assist them to develop realistic and helpful cognitive representations which would in turn facilitate their coping and recovery processes. It is hypothesized that: 1.Illness perceptions will be associated with health-related quality of life. 2.Following the intervention, the intervention group will show more adaptive illness perceptions than the control group. 3.Following the intervention, the intervention group will report better health-related quality of life than the control group.

  • Reducing disability in older Australians through secondary stroke prevention.

    Stroke survivors can be faced with many problems including the physical disability resulting from the stroke, interruption and often cessation of gainful employment, disruption to family life and the onset of post stroke depression. Stroke survivors are also at a much higher risk of experiencing further stroke. Effective management of stroke risk factors including, high blood pressure, high cholesterol, smoking, excessive alcohol intake and obesity, can significantly reduce the likelihood of a recurrent stroke. However, there remains a considerable gap between published and evidence-based guidelines for stroke prevention and the reality of care received by stroke survivors. The Integrated CAre for the RedUction of Secondary Stroke Project (ICARUSS) is an integrated, multi-modal model of care for the management of risk factors in stroke survivors that was developed from a shared care model. Its goal is to reduce mortality and disability by reducing the recurrence of stroke. Initial results of a pilot study suggest that it is practical, feasible and of great importance to stroke survivors, there carers, and the community in general. The model is now being tested on a broader scale throughout Australia.

  • Relationship between Executive Function and the Nature and Function of the Brain Injury in Children with Congenital Hemiplegia.

    BROAD AIM: This investigation aims to examine executive functioning (EF) and related constructs (i.e., intelligence, memory, attention, concentration, psychological functioning, adaptive functioning, and functional ability) in children with congenital hemiplegia. It also aims to examine the relationship between EF and the underlying brain structure alterations and abnormalities including location of the lesions, extent of the lesions, and the presumed timing of the lesions, using MRI. In addition the relationship between performance on EF and white matter density as measured by DTI and functional connectivity will be analysed. Finally, it aims to examine the brain structure-function relationship between performance on an EF task (the Flanker task) which focuses on executive attention and brain lesion location and extent and the neurovascular changes based on the Blood Oxygen Level Dependent (BOLD) response, as measured with functional MRI. HYPOTHESES: 1.It is hypothesised that compared to matched controls, children with hemiplegia would show EF impairments in the following specific domains: (a) attentional control; (b) cognitive flexibility; (c) goal setting; (d) information processing; (e) working memory; (f) verbal fluency; and, (e) in everyday life (as measured by parent and teacher report). 2.It is hypothesised that EF will correlate with the lesion site, and in particular, we will test correlations with: (a) side; (b) location; and, (c) extent (as measured by structural MRI). 3.It is hypothesised that poor EF will correlate with the nature, density, and location of white matter damage/connectivity (as measured by DTI). 4. It is hypothesised that poor performance on the Flanker task will correlate with altered activiation patterns which can be mapped based on the changes in the Blood Oxygen Level Dependent (BOLD) response as measured by functional MRI. The changes in blood axygenation resulting from brain activation produce a measurable effect in MR images. SPECIFIC AIMS: 1.To examine executive function (i.e., skills necessary for novel, goal-directed, and complex activity, such as planning and organisation) in children with congenital hemiplegia 2.To examine the relationship between the presence, location, extent, and timing of brain lesions (using structural MRI scans) and executive function in children with hemiplegia. 3.Establish whether children with left and right hemiplegia exhibit the same executive function profile; alternatively, do children with right hemiplegia have different strengths/impairments on executive function compared to children with left hemiplegia, and vice versa. 4.To examine the relationship between white matter connectivity and executive functions using diffusion tension imaging (i.e., a technique that is part of an MRI that evaluates white matter pathways in the brain). 5. to examine the relationship between the performance on a specific executive function task (the Flanker) task and neurovascular changes using the BOLD response as measured by fMRI (i.e., a technique which shows changes in cerebral blood flow in response to behavioural activation). BACKGROUND: Congenital hemiplegia is the most common type of CP among children born full term and the second most common type in children born prematurely. In addition to motor deficits seen in congenital hemiplegia, associated difficulties, such as cognitive impairments, have been identified. In spite of this, there is a paucity of literature on congenital hemiplegia examining neuropsychological consequences, in particular EF. Dysfunction in the executive system can result in numerous cognitive deficits that negatively influence daily functioning, such as impaired planning, monitoring, reasoning, concept formation, mental flexibility, social judgments, and attention. Having a better understanding of potential EF deficits in congenital hemiplegia will aid future rehabilitative interventions aimed at improving functional independence in this population. Further, if we are able to correlation EF with specific lesion sites, we will be able to predict potential EF impairments in children and thus provide earlier rehabilitative interventions. The Flanker task is used to emphasize the stimulus-response inhibitory processing which is an important part of attention. The task activates the executive attention network, including the midline frontal areas (anterior cingulated) and the lateral prefrontal cortex (Bush et al., 2000; MacDonald & Carter, 2000), which is associated with conflict in responses (Fan et al., 2002). The Flanker task challenges the ability to inhibit irrelevant information (Hazeltine et al., 2000). It is found that during tasks which explore inhibitory processes the main focus of increased brain activity is at the right inferior frontal cortex (Collette et al., 2006; Hazeltine et al., 2000). Problems with attention and EF are associated with lesions in the periventricular white matter in anterior (Schatz et al., 2001; White & Christ, 2005) or parietal regions (Pavlova et al., 2008). Furthermore, it is suggested that lesions of the basal ganglia, the thalamic systems, or both affect focused attention (Mirsky, 1989) as well as EF. The changes in cerebral blood flow as measured with fMRI will show activation patterns associated with the Flanker task. Poor performance on the Flanker task in children with congenital hemiplegia may correlate with an altered pattern of cerebral blood flow compared to normal children. RESEARCH PLAN: 40 children with congenital hemiplegia aged 8 – 16 years (20 with right congenital hemiplegia and 20 with left congenital hemiplegia) will be recruited. Twenty further children without congenital hemiplegia will also be recruited and will be matched as closetly as possible for age and gender (N = 60). All 60 children will complete a battery of neuropsychological assessments and parents will be asked to complete self-report measures in approximately a 2 1/2 hour assessment session. School teachers will also be asked to complete one self-report measure. Children with congenital hemiplegia will also either complete an MRI scan or previous MRI scans will be accessed from the Queensland Cerebral Palsy Children’s Health Services Database. In the second phase of this study the children are invited to complete a first or second scan (if they had a previous scan in phase 1) in which the diffusion tensor imaging and functional MRI data will be collected. Before the real scan the children have the chance to practice in a “mock scanner”. During the fMRI scan the Flanker task is performed which can also be practised outside the scanner before the scanning procedure. This phase of the study will approximately take 1 1/2 hour of which 40 to 50 minutes will be spend inside the scanner.

  • Quantitative Motor Assessment in patients with mild to moderate Alzheimer’s Disease

    The prevalence of dementia in Australia is expected to triple by 2051. Over 165,000 Australians are affected by Alzheimer's disease (AD), and it is expected that 500,000 Australians will be diagnosed by 2040. AD is currently incurable. Motor signs of AD include problems with speech/facial expression, rigidity, balance, posture/gait, bradykinesia (slowed ability to start and continue movements), tremor, incoordination, apraxia (inability to perform coordinated movements or manipulate objects) and dysarthria (difficulty articulating words). Current clinical rating scales lack sensitivity, have floor or ceiling effects (task items too challenging or not challenging enough), and require long observation periods to show changes. There are no known currently used quantitative assessments of motor signs in AD. This pioneering study uses four isometric motor tasks as novel objective and quantitative measures for the assessment of observable motor characteristics and dysfunction in AD. Twenty participants diagnosed with mild to moderate AD, both women and men, and 20 cognitively healthy and age-matched control participants will complete these motor tasks, in addition to tasks measuring cognitive performance and level of dementia. The performance of participants with AD will be compared to the healthy control participants. Knowledge of the characteristics of motor signs in AD is important, given their predictive ability for rates of cognitive decline and mortality and their association with increased cost of care. Assessment of the variability of tongue protrusion forces, grip force, and tapping may provide objective and quantitative measures that (1) provides much needed empirical data on the motor symptoms of AD and help elucidate a motor pattern, and (2) correlates with illness severity (thus may be a measure of disease progression). This knowledge, in addition to improvements in the efficiency and precision of objective measurements of disease progression in individuals with AD, could lead to techniques that are better able to assess disease progression and measure effectiveness of therapeutic interventions.

  • Two colours pale: a randomised trial to test the differential effectiveness of sending mail printed on white or yellow paper to promote GP interest in participating in research.

    We aim to approach 2,500 randomly selected GPs. GPs will receive a cover letter and form advising GPs return the form indicating their interest in receiving further information about an ongoing education program. We propose that half are randomised to receive the cover letter and form printed on white paper and half receive the cover letter and form printed on yellow paper. Based on results of a Cochrane systematic review, some studies evaluating the effect of yellow versus white paper indicate improved response amongst non-clinician samples. We wish to trial this easily administered and cheap response-aiding strategy in a clinician sample. Reference: Edwards PJ, Roberts I, Clarke MJ, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: MR000008. DOI: 10.1002/14651858.MR000008.pub4

  • Assessment of a low energy diet using meal replacements before surgery for weight loss

    The purpose of this study is to assess the effect of the pre-operative very low energy diet on liver function tests and weight loss, and to correlate these outcomes with compliance to the program. Our hypotheses are: 1. Pre-operative weight loss will be associated with an improvement in liver function tests 2. Increased compliance to the program will be associated with greater weight loss

  • Assessing the impact of a sweetened beverage tax in Australia

    Participants, responsible for the grocery shopping of their household will be recruited via telephone and randomised to receive one of four groups. All participants will be read a list of beverages frequently purchased from Australian supermarkets and asked the quantity of each they would intend to purchase during a typical grocery shop. The price of caloric sweetened beverages read to participants will be 10%, 20% and 30% higher then the market price for groups randomly allocated to group 1, 2 and 3 respectively. The price of beverages for participants allocated to the comparison group (group 4) will be consistent with market price. All participants will provide data regarding their intended purchase of beverages during the telephone survey.

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