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Emergency Department Anaphylaxis Trial II B - preliminary trial to confim pharmacokinetic profiles and study feasibility in patients with anaphylaxis treated with either intramuscular vs. intavenous adrenaline
Expand descriptionAnaphylaxis is a severe potentially life-threatening allergic reaction. The accepted management is intramuscular adrenaline. With intravenous adrenaline being a last resort therapy. The investigators believe that intravenous adrenaline given slowly as a dilute infusion is a better therapy, with more rapid onset (especially in patients with low blood pressure) with a similar side-effect profile to intramuscular adrenaline. This study is part of a wider PhD assessing this hypothesis and also the pharmacological behaviour of adrenaline.
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Continued Evaluation of Percutaneous Single Port Access Placement of a Paragastric Implant for the Treatment of Morbid Obesity
Expand descriptionThe PREVAIL (Trademark) Single Port Access Paragastric Implant System is a novel approach to the treatment of morbid obesity. The saline-filled Paragastric Implant is placed in a minimally invasive fashion into the abdominal cavity in the space adjacent the stomach, thereby reducing the ability of the stomach to expand and reducing oral intake. The Paragastric Implant volume can be adjusted by the addition or removal of sterile saline through a subcutaneous port. This trial is a single-arm, prospective, multi-center study designed to demonstrate the safety and effectiveness of the Vibrynt PREVAIL (Trademark) Paragastric Implant System in the treatment of morbid obesity. The primary end point of this study will be the six-month efficacy rate, as measured by the average percent excess weight loss for subjects treated with the PREVAIL(Trademark) Single Port Access Paragastric Implant System . Subjects will be followed for three years for long term safety and efficacy evaluations.
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Ten year follow-up of a prospective randomized controlled comparison of best practice medical management versus placement of the Lap-Band System to effect weight loss (ACTRN12605000113651)
Expand descriptionThe primary purpose of this study is to compare best practice medical management versus placement of the Lap-Band System, mostly in terms of weight loss.
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My Road Ahead: An Online Psychological Intervention for Men with Prostate Cancer
Expand descriptionObjectives: The overarching objective of this proposal is to develop and assess the efficacy of a unique online psychological intervention that is accessible, user friendly and engaging to men with CaP and that reduces the stigma of psychological distress in the context of prostate cancer. Aims: This project will be conducted over three phases. Phase 1: Development of resources - Develop an online assessment template to assess the psychological status of men with prostate cancer and to highlight specific areas of distress to the patient and the researchers. - Develop a 6 module self-directed online CBT-based psychological intervention for men with CaP. Phase 2: Consumer evaluation of developed resources - Assess the usability and acceptability of the online program with a consumer population Phase 3: Randomised controlled trial examining the efficacy of the online intervention - Assess the efficacy of the online intervention as compared to a usual care group across a number of domains including: Mental Health -Anxiety, Depression, Stress (DASS); Marital Satisfaction; Prostate-Specific Quality of Life (QoL) 1. Urinary control; 2. Sexual intimacy; 3. Sexual confidence; 4. Spouse affection 5. Masculine self-esteem; 6. Health worry; 7. PSA concern; 8. Cancer control; 9. Informed decision; 10. Regret; and, 11. Positive outlook.
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A randomised controlled trial to increase fruit and vegetable consumption in parents
Expand descriptionThe Cancer Council NSW has implemented the Eat It To Beat It Program designed to decrease cancer risk, with the focus on changing individual food purchasing decisions to increase fruit and vegetable consumption. Strategies target parents and carers of primary school aged children in the Hunter region of NSW. The goals of this nutrition intervention program are to increase the consumption of fruit and vegetables by the target group by 0.4 serves per day by the end of 2010. The Eat It To Beat It Program has a number of strategies to achieve its aims. One of the strategies for the program is The Fruit & Veg $ense Program. This program consists of: * The Shopping and Budgeting session. * Two newsletters sent to participants at weeks 2 and 5. The randomised controlled trial will determine the efficacy of the Fruit & Veg $ense Program. The research hypothesis is that “Compared with the control group, the participants who complete the Fruit & Veg $ense Program will consume more fruit and vegetables.”
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Adipose-derived stem cells in patients with knee osetoarthritis: A randomised controlled trial evaluating pain, function and cartillage repair
Expand descriptionKnee osteoarthritis (OA) is a progressive degenerative condition of articular cartilage and subchondral bone that leads to significant physical and psychological disability, and adversely affects daily function and quality of life. Current treatment of knee OA is associated with limitations and side effects that restrict their ability to effectively treat the symptoms of the condition and stop its progression. Recent research has demonstrated that Human adipose-derived stem cells (ADSCs) are safe for use in Humans and can differentiate into cartilage and bone, suggesting a potential treatment in osteoarthritis. This study aims to assess the changes in pain, cartilage and bone appearance, activity levels and lower extremity functional ability of patients with knee OA following intra-articular ADSC injection compared to usual treatment of Hylan G-F 20 (Synvisc [Registered Trademark]).
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Estimating the lacrimal punctum size in an adult population
Expand descriptionThis study is been carried out to investigate the variation in size of the lacrimal punctum in a normal adult population. The lacrimal punctaare are the openings on the inner aspect of your eye which drains tears from the eye into the nose. This opening is important for correct drainage of tears and abnormalities in its size can lead to problems such as watery eye, or dry eye disease.
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Oesophageal capsule assessment of gastroesophageal reflux disease in chronic lung disease patients awaiting lung transplant and lung transplant recipients.
Expand descriptionGastroesophageal 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.
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Acceptance and Commitment Therapy (ACT) to enhance stress resilience in police recruits: A randomized control trial
Expand descriptionStress 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.
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Developing effective imaging methods to assess chemotherapy response in Malignant Pleural Mesothelioma
Expand descriptionMesothelioma 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.