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Evaluation of the usefulness of a decision aid in patients with advanced colorectal or breast cancer
Expand descriptionWe have developed two user-friendly decision aids (DAs) for patients with incurable breast or bowel cancer. These include an instrument used by doctor and patient in the consultation, and a take-home booklet and audiotape for patients. The DAs outline treatment options, benefits and likely side effects. Information is presented in different visual formats. This should help patients participate in their cancer treatment decisions. Patients and doctors have reviewed the DAs, and their usefulness will now be tested in a randomised trial. Hypotheses being examined in this study (in the randomised trial): Patients receiving DAs at the time of making a treatment decision about management of advanced cancer compared to patients not receiving DAs at this time will have enhanced achievement of their involvement preference, participate in decision-making more actively and have improved understanding of their prognosis, treatment goals and side effects, as well as be more satisfied with their care. Doctors using the DAs in consultations will have enhanced satisfaction with treatment decision-making. This project is also being run in Toronto, Canada. The recruitment target of 210 includes 105 from Canada. Recruitment is complete in all sites and analysis is underway.
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A Cluster Randomised controlled trial of an Automated versus manual device for Blood pressure management.
Expand descriptionHypertension is the commonest problem managed in general practice. In this setting as in others control remains less than ideal. As there is a linear relationship between blood pressure level and risk of death any change in standard management that leads to improved blood pressure control is likely to be beneficial. CRAB will compare the measurement and management of sequential adults attending a general practice over a week. It will use the endpoints of digital preference, the number of individuals who have a blood pressure measurement, the number of measurements an individual has, mean systolic and diastolic blood pressure, and drug management where hypertension is treated. It is a trial of clinical effectiveness in general practice where the majority of hypertension is managed. This study will provide evidence for the potential changes in blood pressure recording and hypertension management of the introduction of new devices not containing mercury which are inevitable due to occupational health and safety concerns of this toxic material. The OMRON HEM-907 device is a validated blood pressure measurement device. We hypothesize that the use of automated measurement devices will increase the number of people who have a blood pressure measurement, the number of recordings per individual and will improve the management of individuals with hypertension.
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A pilot study to evaluate the feasibility, safety and tolerability of neoadjuvant triple therapy with zoledronic acid, docetaxel, and luteinising hormone-releasing hormone (LH-RH) analogue for men with high-risk prostate cancer to be treated by radical prostatectomy
Expand descriptionCertain patients are at high risk of developing secondary, or metastatic, prostate cancer, after radical prostatectomy. These are patients whose prostate biopsy shows that they have a high Gleason grade, or aggressive prostate cancer, patients whose PSA level is high (>10ng/mL) or whose prostate feels abnormal on digital rectal examination. The standard treatment approach for men with this high risk of secondary prostate cancer is close observation by their treating doctor and appropriate treatment if prostate cancer returns. This study aims to compare this standard approach with giving patients the combination of a drug called zoledronic acid (also known as Zometa®) a drug called docetaxel (also known as Taxotere®) and luteinising hormone-releasing hormone (LH-RH) analogue also known as hormone therapy. Zoledronic acid, docetaxel and hormone therapy are routinely used in men with prostate cancer that has spread to the bone or other parts of the body (metastatic disease). Zoledronic acid is used in this situation to prevent bone complications from the cancer including fractures. Docetaxel is a chemotherapy drug that is used in this situation to control symptoms and prolong survival. Both drugs are routinely used in a variety of other cancers for the same reasons. Hormone therapy used to reduce testosterone production. Testosterone stimulates the growth of prostate cancer. An additional, non-compulsory part of the study will be to look at the usefulness of examining patient’s prostate tumors to determine reasons why some tumors respond to therapy and others do not.. You will be given a second Plain Language Statement regarding this additional study.
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Multidisciplinary osteoarthritis of the knee study
Expand descriptionPeople with osteoarthritis of the knee who complete the OA knee self-management program will report decreased pain, improved knee function and improved quality of life, at 8 weeks, and 6 months, compared with those managed conventionally.
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A phase Ia study of MRC202 in patients with malignant ascites caused by cancer.
Expand descriptionThe study is aimed at evaluating the suitablility of MRC202 as a therapy for malignant ascites associated with cancer. based on extensive animal studies MRC202 has been shown as potential an effective agent to slow or treat malignant ascites. This initial study is aimed as determining an appropriate dose concentration. Data from the study will be used to design a more comprehensive study assessing the efficacy of the drug.
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Prospective Study to investigate the ability of the Glutathione S- transferase Pi (GSTP1) methylation assay to assess response to chemotherapy in patients with metastatic hormone-refractory prostate cancer
Expand descriptionThe purpose of this study is to find out if a new genetic test (GSTP1 methylation) is a better way of assessing patients’ response to chemotherapy compared to the standard methods (eg PSA blood test). In addition, this study will attempt to find new ways of predicting patient’s response to chemotherapy before they start treatment.
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Combat Agility Program.
Expand descriptionAim The aim of this project is to examine the efficacy of a Neuromuscular Control training program for preventing knee and ankle injuries in army recruits undergoing basic training. Hypothesis ‘That integration of a neuromuscular control training program into Army basic training will reduce the incidence of training-related knee and ankle injuries.’
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A prospective, randomized, placebo-controlled, double-blind, cross-over study of the usefulness of sustained-release opioids in the subjective sensation of dyspnoea secondary to advanced disease with no reversible components in opioid naive patients.
Expand descriptionSometimes drugs such as morphine help people who have severe lung disease feel less breathless when the course of the disease cannot be treated. Although morphine is frequently prescribed, there are limited data to quantify the benefit in this setting. There is growing evidence that different causes of breathlessness can lead to a variety of uncomfortable sensations (for example, “feeling tight” vs. “feeling suffocating”). Because of the recent availability of once daily morphine capsules, we are now able to do this important study and answer questions that will affect the quality of life of tens of thousands of people.
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A double blind randomised placebo controlled trial of NAC in bipolar disorder.
Expand descriptionTo evaluate the efficacy of n-acetyl cysteine treatment in individuals with bipolar disorder who are continuing treatment as usual with the adjuct of n-acetyl cysteine treatment.
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Caseload midwifery for women at low risk of medical complications: a randomised controlled trial
Expand descriptionIn Australia and internationally, there is concern about the growing proportion of women being delivered by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies, and decreased fertility; and significant resource implications. Randomised controlled trials (RCT) of continuity of midwifery care have reported reduced caesareans, and other interventions in labour. They have also found increased satisfaction, with no statistically significant differences in perinatal morbidity or mortality. One Australian RCT comparing continuity of care (team midwifery) with standard care demonstrated a decrease in women having caesarean birth from 18% to 13%. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6-12 midwives) with very few testing caseload care. We want to determine whether caseload (one on one) midwifery care decreases the proportion of women having a caesarean section birth, compared with women in ‘standard’ care models (for women at low risk of medical complications). We will also explore other outcomes such as rates of instrumental vaginal births, analgesia, perineal trauma and induction of labour; postnatal depression; satisfaction with care; the proportion breastfeeding at 6 weeks and 6 months; smoking; andthe cost of this model. A final area is about midwives: to explore how this model affects midwives.