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This study is assessing the safety and tolerability of using T cell therapy targeting Human Cytomegalovirus (HCMV) in treating brain cancer (glioblastoma multiforme or GBM) alongside standard treatment.
Expand descriptionThis study is assessing the efficacy, safety and tolerability of using T cell therapy targeting human cytomegalovirus (HCMV) in treating brain cancer (glioblastoma multiforme ). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with glioblastoma multiforme , and have not yet begun standard treatment for this disease . Trial details: Patients will be eligible if they have been recently diagnosed with glioblastoma multiforme and are about to begin standard radiotherapy and chemotherapy regimens. A blood sample will be taken from patients prior to beginning standard radiotherapy and chemotherapy, in order to grow the cells for the experimental therapy. These cells, known as T cells (a type of white blood cell) will be grown in the laboratory from each patient’s blood sample. After completing standard radiotherapy and chemotherapy regimens, all participants in this study will receive treatment with killer T cells (a type of white blood cell) which have been grown in the laboratory from the participant’s own white blood cells. Treatment consists of up to 6 infusions of T cells (given fortnightly or monthly, depending on the standard treatment regimen), and patients are monitored for 12 months afterwards to see if treatment is safe and to measure any reduction in tumour and amount of virus in the blood. Recent studies suggest that most gliomas carry a common virus, called human cytomegalovirus (HCMV), which is normally controlled by killer T cells. The study aims to see if killer T cells grown in the laboratory and trained to recognise components of the virus can also kill HCMV infected gliomas. The standard first-line treatment is usually surgery, radiotherapy and a chemotherapy drug called temozolomide. If the cancer then grows back, there are no known effective treatments.
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Assessing the effect of an interactive decision-aid smartphone smoking cessation application (app) on quit rates: a double-blind randomized control trial
Expand descriptionIn 2012, we conducted a review of free smoking cessation apps in the Apple store and Android market and found that all 130 apps lacked the informational content about smoking which is necessary to help quit. For instance, none of the identified apps provided information about evidence-based treatment (Not published). In phase 1 of this study, we found that of 394 participants, 43% have used smoking cessation apps before, and of them 55% have made a quit attempt using an app. Given that most of the available apps are not of a high quality, our aim is to develop an evidence-based decision aid smartphone app, to help smoker decide on the best available quitting method suitable for them, and follow up their quitting process. The intervention and control apps will be compared in terms of helping participants making quitting attempts and abstinence rate at 4 time-points (10 days, 1 month, 3 months, and 6 months).
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A Phase I, Proof of Concept, Open Label, Escalating Dose Study to Assess the Safety, Tolerability and Immunogenicity of a Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) Vaccine
Expand descriptionSafety, Tolerability and Immunogenicity of a HSV DNA Vaccine
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Analysis of the factors affecting outcome for oncology patients admitted to the Intensive Care Unit (ICU) during the course of their treatment at Launceston General Hospital, Tasmania.
Expand descriptionOncology and Haematology patients are at increased risk to be admitted to the ICU during the course of their treatment, especially when they present with an advanced or aggressive disease. Unfortunately there is high mortality rate among this cohort of patients. There are many factors that may play a crucial role such as presence of organ failure, intubation status, oxygen saturation and compromise to the cardiovascular system. It is important to study all these factors as well as other factors such as underlying disease and disease status in order to predict patient outcome. There are paucity of data in this regard and therefore it highlights the importance of this audit in our hospital.
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Prescribing physical activity for patients with hip fracture during rehabilitation
Expand descriptionWe already know that the amount of walking completed by people in rehabilitation is very low and people find it hard to regain their walking ability in the community after having a hip fracture. This study will find out how much walking can be feasibly and safely completed by people in rehabilitation after having a hip fracture. The results will help guide therapists as to how much walking they could prescribe to optimise patient outcomes.
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Pilot trial of Aspirin versus Ticagrelor in Congestive Heart Failure
Expand descriptionThe purpose of this trial is to investigate whether Aspirin and Ticagrelor have different effects on blood vessel and heart function in the setting of heart failure.
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A Pilot Study on the Clinical Significance of Cerebrovascular Autoregulation Monitoring during Non-Cardiac Anaesthesia
Expand descriptionThis study is a prospective, single centre, observational pilot study examining the clinical relevance and outcomes of changes in cerebral vascular autoregulation during general anaesthesia in patients presenting for non-cardiac surgery. Primary outcome is post-operative quality of recovery, and secondary outcomes are patient mortality and major morbidity. This study is a sub-study of a larger, multicenter study on the effect of depth of anaesthesia on patient outcomes (BALANCED study). Recent animal and human studies have investigated indices of cerebrovascular autoregulation (CVAR), including the tissue oxygenation index (TOx), cerebral oximetry index, haemoglobin volume index, and pressure reactivity index. These indices are derived from measuring different surrogates of cerebral blood volume or cerebral blood flow, and calculating a moving correlation coefficient between the surrogate and mean arterial pressure. Specifically, the TOx index measures cerebral tissue oxygenation using non-invasive near infrared spectroscopy (NIRS) as a surrogate of cerebral blood flow and correlation with mean arterial pressure (MAP). Thus, a TOx index can reflect CVAR changes in blood vessel diameter to maintain a constant cerebral blood flow despite changes in systemic arterial blood pressure. The TOx index is thus a novel measure of adequacy of cerebral perfusion. We hypothesise that patients who have impairment in CVAR may be exposed to episodes of cerebral ischaemia resulting in end organ dysfunction. In a number of prospective observational studies recruiting cardiac surgical patients undergoing cardiopulmonary bypass, impaired autoregulation has been associated with cerebral injury, stroke and acute kidney injury. These studies have also defined a threshold level of MAP when autoregulation is lost, as well as a range of MAP when autoregulation is optimised. However, our understanding of this association is incomplete. This study will improve this understanding in a non-cardiac surgical population who are at higher risk of complications after anaesthesia. Elderly patients greater than or equal to 60 years old admitted for major non-cardiac surgery will be monitored using NIRS to derive a real-time TOx index. We will prospectively measure patient outcomes including post-operative quality of recovery, symptoms and signs of major organ dysfunction, and mortality. Statistical analysis will be performed to determine the strength of association between patient outcomes and episodes of cerebral ischaemia as detected by TOx. This study will also provide essential data to help design a future randomised clinical trial. We would plan an interventional arm using the TOx index and the optimal autoregulation MAP value, as goal-directed therapy to minimise the time that patients are exposed to potential cerebral ischaemia.
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The causes of pneumonia in paediatric patients in North Queensland – should we reconsider our antibiotic strategy?
Expand descriptionThis study will be conducted as a retrospective audit at the Townsville Hospital and will utilise existing hospital records and databases to answer a number of important clinical questions including: 1. What are the identified aetiologies for pneumonia in children in Townsville? 2. In what proportion of cases does the treatment of pneumonia conform to the published guidelines? Where it is not, is a reason for this identified? 3. Are the empirical antibiotics used in the Townsville Hospital for treatment of pneumonia in children appropriate? In what percentage of cases are organisms not sensitive to initial treatment identified (or change of antibiotics required when the patient does not respond)? 4. Are there clinical, demographic, geographic or other features which would indicate that empirical antibiotic treatments recommended in the guidelines are inappropriate in our setting?
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The effect of a year 9 and 10 high school program, Headstrong, on adolescent depression and mental health literacy.
Expand descriptionThe HeadStrong program is a mood disorders prevention program delivered to Years 9 and 10 secondary school students in NSW. The program is delivered by teachers within Personal Development, Health, and Physical Education (PDHPE) classes. Schools will be randomly allocated to the intervention or control condition with measures being administered at baseline, immediately post program completion and 6 months follow up. The goal is to determine whether the HeadStrong program causes lasting improvements in students’ knowledge, attitudes, intentions, and symptoms, with regard to mental health, well being, and help-seeking.
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Is moderate intensity cardiovascular fitness training in addition to usual care feasible following stroke? A pilot randomized controlled trial.
Expand descriptionThis project is a pilot randomised controlled trial. The main aim is to test whether it is possible to recruit and follow trial procedures in addition to working out how much benefit may come from the treatment in order to make sure enough participants are recruited for a future large randomised controlled trial. The main hypothesis is that adding cardiovascular (or fitness) training to normal rehabilitation in people who have had a stroke will be possible to do and safe for the patient. The next aim is to test the effect of the fitness training on cardiovascular fitness, walking speed and endurance; quality of life (QOL) and depression. The objective of the future randomised controlled trial will be to determine whether the moderate-intensity CV training program significantly improves the defined outcomes compared to ‘usual’ rehabilitation care. The trial will be run in an outpatient rehabilitation service of a tertiary public hospital in metropolitan Melbourne. People will be eligible to be in the trial if they have been diagnosed with a stroke more than six weeks prior; are over 18 years old; able to walk by themselves with or without a gait aid or supervision of another person; and do not have medical or other limitations to exercise. Participants currently taking medications that may affect heart rate response to exercise will be included in the trial. 20 people will be selected to receive either the treatment or normal care. People measuring outcomes won't know which group the patient is in. All participants will be tested for fitness (VO2 peak); walking speed; and quality of life and depression. The treatment group will receive two supervised sessions of moderate-intensity fitness training each week for twelve weeks. Exercise will commence at 10 minutes, and progress incrementally, as tolerated, to 30 mintues duration, prior to progression of exercise intensity. Progression of duration and intensity will be determined by trained physiotherapists, using the Karvonen method (ACSM 2010). People will either exercise with a recumbent or standard stationary bike, treadmill, stepper or cross-trainer. Participants currently taking heart rate control medications will utilise a scale of how hard they are working to monitor exercise intensity. A home exercise program of CV training will be prescribed, and gradually increased in frequency. People should progress to doing a total of 150 minutes of CV exercise in weeks 9-12 of the trial, as recommended by the NHF guidelines for aerobic exercise (Briffa et al 2006). People assigned to the usual rehab group will receive two sessions per week of a light strengthening and balance exercise program. These participants will have heart rate monitoring at five-minute intervals to maintain low-intensity exercise. Session length will be progressed from 10 minutes for 4 weeks, to 20 minutes for 4 weeks, and 30 minutes for final 4 weeks. A general home exercise program will also be given to this group.