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CD-40 activating antibody (CP-870,893) in combination with cisplatin and pemetrexed in unresectable malignant mesothelioma: a phase Ib study
Expand descriptionThis is a study to determine the maximum dose of CP-870,893 that can be safely administered in combination with standard chemotherapy (cisplatin and pemetrexed) as the treatment of patients with malignant pleural mesothelioma that can't be removed surgically. Who is it for? You can join this study if you have malignant pleural mesothelioma that cannot be removed surgically and are planned to receive treatment with standard chemotherapy (cisplatin and pemetrexed) . Trial details: Participants will receive standard treatment with cisplatin and pemetrexed chemotherapy which is given intravenously every 3 weeks, with the addition of CP-870,893 (CD40 activating antibody) on day 8 of each cycle. CP-870,893 activates the immune system which might help treat the cancer. Assessment for side effects by patient questionnaires and assessment by health professional, and collection of blood tests will occur weekly whilst on treatment and at 90-day follow-up visit. Tumour response will be measured with scans after the first cycle of treatment (PET scan), and after every 2 cycles of treatment (CT scan). The study aims to determine the maximum dose, side effects and effectiveness of CP-870,893 that can be safely administered in combination with standard chemotherapy as the first line treatment for malignant mesothelioma. It will also help to characterise the body's immune response to the treatment. After the maximum dose of CP-870,893 has been determined, 6 patients receiving the treatment at the maximum dose will have biopsies taken of the cancer before treatment starts and at the completion of treatment.
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Specific Treatment Of Problems of the Spine (STOPS) Trials: Effect of advice versus physiotherapy functional restoration on pain and function for people with multi-factorial persistent low back pain.
Expand descriptionThe primary aim of this trial is to compare the outcomes and adverse events of two different physiotherapy treatment approaches for people with multi-factorial persistent low back pain. A secondary aim is to determine the perspectives of participants on the functional restoration program utilised in the trial.
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Extubation in children with a high risk for postoperative respiratory complications –awake or anesthetized?
Expand descriptionRemoval of the tracheal tube can be performed while children are still deeply anesthetized or when they are awake. Each technique has its own advantages and disadvantages. In healthy children, it has been shown that there are no clinical differences between extubation in the awake state vs anesthetized state. In patients with a high risk of developing a postoperative respiratory complication such as those with asthma, it may be preferable to remove the tracheal tube while the patients are still anesthetized to avoid airway stimulation and consecutively bucking, coughing and bronchospasm. The results of a recent large prospective cohort study at our institution with over 9000 children allow to identify children with a high risk for developping postoperative respiratory complications. The aim of this present randomized controlled trial is to assess whether children at a high risk for respiratory problems benefit from anethetized extubation as compared to awake extubation following adeno-/tonsillectomy. We hypothesize that children with a high risk for respiratory problems defined by the presence of either airway susceptibility, eczema or a positive family history will demonstrate less respiratory problems when extubated anaesthetised compared with high risk children who are extubated awake.
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A comparison of oral prednisolone and oral dexamethasone in children with croup: a prospective, randomised, double blinded multicentre trial
Expand descriptionThis clinical trial is designed to test whether the three commonly used oral steroid treatment regimes for croup, are equally effective. Children will receive one of the three treatments, decided by a random process, and their improvement and outcomes monitored by investigators who are blinded to the treatment received.
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Ocular measures for detection of driving impairment due to sleep loss, alcohol and benzodiazepine use
Expand descriptionThis study will examine whether the impairing effects of sleep loss, alcohol and hypnotic drugs can be detected using a simulated driving task and drowsiness monitoring technology in the laboratory setting. The hypothesis of this study is that performance deterioration, as a result of sleep restriction and acute benzodiazepine administration, can be detected by increases in slow eyelid closure, a reduction in amplitude of eyelid opening and a reduction in saccadic eye movements, as measured by Optalert.
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Effect of acupuncture on psychosocial outcome for women experiencing infertility
Expand descriptionInfertility can lead to emotional distress which may place some people at risk of developing a mental health problem. The use of complimentary and alternative therapies are growing in popularity and there is some evidence that acupuncture may increase pregnancy rates in women undergoing In Vitro Fertilisation (IVF). Research findings suggest acupuncture given to women when trying to get pregnant may also lead to an improvement in their emotional well being, and that women may cope better with their IVF treatment. We propose to undertake a pilot randomised controlled trial of acupuncture to explore these effects.
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Weight Loss and Type 2 Diabetes: A prospective randomised controlled trial intervention study of best practice medical management versus the additional placement of the Lap-Band System in overweight patients
Expand descriptionThe primary aim of this proposal is to compare LAGB surgery with optimal medical therapy over the period of the 2-year trial. The hypothesis is LAGB provides better results.
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An assessment of arterial stiffness, oxidative stress and inflammation in acute kidney injury
Expand descriptionVascular disease, characterised by premature atherosclerosis and large artery stiffness, is a feature of advanced chronic kidney disease (CKD) [1, 2]. Central pulse pressure, augmentation index (AIx) and aortic pulse wave velocity (PWV) are all predictors of morbidity and mortality in patients with CKD [1, 3, 4]. Large artery stiffness may also be related to the progression of CKD. The mechanisms and time frames for the development of arterial stiffness are unclear but may include traditional cardiovascular risk factors such as dyslipidemia and hypertension as well as non-traditional risk factors such as oxidative stress and inflammation. Moreover, to our knowledge no studies have assessed the relationship between arterial stiffness in the uraemic environment of acute kidney injury. Measuring arterial stiffness in this setting would enable us to determine whether changes in arterial stiffness occur due to the biochemical changes associated with acute kidney injury without the interference of factors that exist in chronic kidney disease. This may in turn help to understand the potential for reversibility of uremic biochemical effects on arterial stiffness.
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Does adding otolith specific exercises to a standard vestibular rehabilitation programme improve outcomes for adults with inner ear dizziness?
Expand descriptionThe main aim of the project is to compare the response to treatment of patients with vestibular dysfunction between those receiving a standard program of Vestibular Rehabilitation (VR) versus those receiving the standard VR plus additional exercises that specifically target the otolith structures of the inner ear.The research hypotheses are: 1. That additional otolith training exercises will improve the short term effectiveness of a customized program of vestibular rehabilitation, and 2. That the improved short term outcomes from vestibular rehabilitation with additional otolith training exercises will be maintained in the longer term.
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1. ASPECT - ASIA PACIFIC EVALUATION OF CHEST PAIN TRIAL An observational study of the diagnostic utility of a biomarker panel in the assessment of patients presenting to asia-paciifc hospitals with chest pain of possible cardiac origin
Expand descriptionThis is a prospective observational study of the diagnostic utility of the "Triage" multi-marker point of care blood testing device to measure the levels of the cardiac markers Troponin I, Creatine Kinase MB and myoglobin: - in people presenting to the Emergency Deprtment with chest pain of probable caridac origin. Blood samples will be taken and tested on arrival and again at 2 hours. Participants will undergo risk evaluation by a means of a set series of questions. Participants will recieve a phone call at 45 days, 6 months and 1 year post discharge to record any major adverse cardiac event (MACE) they may have experienced.