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A study to establish whether further study of sertraline in relieving severe breathlessness is warranted.
Breathlessness continues to be a major clinical problem for many people with advanced progressive illnesses such as cancer, end-stage cardiac failure or chronic obstructive pulmonary disease, even when they are receiving the best treatment for the underlying disease. Although there are some interventions that may offer benefit (oxygen therapy, sustained release low dose morphine), there is still a need for a wider range .of interventions to meet the needs of people with refractory breathlessness. Study design: This is a phase II (pilot) double blind randomised controlled multi-site study of sertraline (titrated to a mid-range dose) or placebo. It will run for 28 days and draw participants from across the services participating. Objectives: To establish feasibility of the study design and inform adequate power calculations for a definitive study of this intervention in the same sites in mid 2008.
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Cancer care after surgery – the CONNECT study
Patients with colorectal cancer are often required to navigate a complex system involving a diverse range of medical, nursing and allied health practitioners in both hospital and community settings. Improving care coordination, patients’ experience of care and patient outcomes are widely recognised as priorities for the improvement of cancer services. A simple strategy that could have wide application for patients in regional and rual Australia as well as those in metropolitan centres is a centralised telephone-based ‘remote access’ cancer care coordination intervention, administered by a cancer nurse. This strategy will be implemented and evaluated in this study to determine whether it improves care coordination and patient outcomes in the six months following cancer surgery. Over a period of 2 years, 720 patients who undergo surgery for a newly diagnosed colorectal cancer will be recruited. Participants will be randomised to the intervention or control (usual care) group. Those in the intervention group will receive the nursing care coordination and support service telephone calls from the cancer nurse at 3 days, 10 days, 1 month, 3 months and 6 months after discharge from hospital. Those in the control group will receive courtesy calls only from the research team in the first week following discharge from hospital, and then again at 1 month, 3 months and 6 months following discharge. All participants will be asked to complete questionnaires relating to quality of life and psychological distress at baseline (just prior to, or in the days following, surgery for colorectal cancer). They will then complete these questionnaires, as well as additional questions relating to satisfaction with treatment, health service utilisation and care coordination at 1, 3 and 6 months after discharge.
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Frailty Intervention Trial
Frailty is a term in common use amongst health care professionals and in the general community. It has often been used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. Attempts been made to improve clinical outcomes for frail older people using general interventions such as comprehensive geriatric assessment, and specific interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. A definition of frailty has been formulated allowing more precise identification of frail older people and this has been used in a number of subsequent studies. This empirically derived and validated definition for frailty is based on the presence of at least three or more defined characteristics (the “Fried frailty criteria”). These characteristics are shrinking (unintentional weight loss of more than 4.5 kg or greater than 5% of body weight in the previous year), weakness (grip strength in the lowest quintile adjusted for age and gender), self-reported exhaustion, poor endurance (in lowest quintile for walking speed adjusted for age and gender), and low activity (weekly energy expenditure of less than 380kcal/1600kJ in men and 270kcal/1130kJ in women). The presence of frailty as defined was independently predictive, over a three year period, of incident falls, worsening mobility, deteriorating function in activities of daily living, hospitalisation, and death. The low activity criterion is relatively complex to measure and alternatives have been described. This project aims to identify older people who are seen by the aged care service of a metropolitan hospital and who are frail and therefore at risk of hospitalisation and admission to residential aged care facilities, falls, and deteriorating mobility and function. These older people may be seen in the Emergency Department, as inpatients in the hospital wards, in the outpatient clinics, or in the community by the Aged Care Assessment Team. They will be offered the opportunity to participate in this project, when treatment from the hospital Rehabilitation and Aged Care service has been completed. Those who consent to participate will be assessed for frailty according to the Fried frailty criteria. Those who meet the definition of frailty will be randomised to receive either usual care or the multifactorial, multidisciplinary frailty intervention. The intervention will involve nursing, medical, physiotherapy, occupational therapy, dietetic and psychology input. In this intervention, functional limitations will be addressed through the use of exercise and supply of appropriate aids, nutritional status through the use of nutritional assessment and supplementation if necessary, falls risk through the use of a validated screening instrument and assessment of cause, psychological state through the use of neuropsychological assessment and cognitive behavioural therapy as necessary, and appropriate management of chronic health conditions will be facilitated. The primary outcome sought is a reduction in the rate of functional decline. The primary outcome measurements are the time required to complete the “Timed Up and Go” test, and the Short Physical Performance Battery, at three and 12 months after randomisation. Secondary outcomes, also measured at 3 and 12 months, are frailty assessment score, unplanned hospitalisation or admission to residential care facility, activities of daily living status (using Barthel Index), health related quality of life (using the EQ-5D), psychological status (using the GDS), satisfaction with service provision and incremental cost effectiveness. This project will confirm whether the Fried frailty criteria are able to be used in an aged care service setting, whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If this intervention is shown to be effective, there are major potential benefits to the frail older population in terms of decreased disability and improved quality of life, and significant cost savings for government if hospitalisation or institutionalisation can be postponed or avoided. The interventions being examined are readily transferable to routine clinical practice and can be applied in aged care services throughout Australia.
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A randomised controlled trial of outpatient cervical priming for induction of labour
Hospital versus home based induction of labour This study aims to find out whether or not it is good practice to permit pregnant women to go home to rest after they have had induction of labour started. The study is important because it will identify potential advantages and disadvantages to this approach, so that women can make properly informed choices about their care.
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The role of Gabapentin in the treatment of refractory chronic dry cough.
looking at effectiveness of treating persistent cough with a medication
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Effects of Exercise Training on Arterial Stiffness in Haemodialysis Patients
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Clinical implementation of a head-mounted display for anaesthesia patient monitoring
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IBCSG 35-07 / BIG 1-07 : Study of Letrozole Extension (SOLE). Letrozole in Preventing the Return of Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer.
This study aims to determine whether intermittent treatment with the drug letrozole is more effective than continuous letrozole treatment in preventing the return of cancer in postmenopausal women with endocrine responsive breast cancer who have undergone 4 to 6 years of prior endocrine therapy. Who is it for? You may be eligible join this study if you are a postmenopausal woman who has had operable, non-inflammatory breast cancer but are now clinically disease-free. You must have completed 4 to 6 years of prior endocrine therapy with selective estrogen receptor modulators (SERM(s)), aromatase inhibitors (AI(s)), or a combination of both. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will take one 2.5mg letrozole tablet per day for 5 years. Participants in the other group will take letrozole 2.5mg tablets intermittently, i.e. once daily for the first 9 months of years 1 through 4, followed by 12 months in year 5. Participants will be regularly assessed over the duration of the trial to determine whether continuous or intermittent letrozole treatment is more effective in preventing the return of cancer and prolonging survival.
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A Multicentre, Randomised, Double-Blind, Parallel Group Comparison Of The Efficacy And Safety Of Transdermal Buprenorphine (Norspan'registered trade mark' BTDS) And Placebo In Patients With Postherpetic Neuralgia.
The aim of this study is to evaluate the clinical efficacy and safety of Norspan (registered trademark)(Buprenorphine Transdermal Delivery System, BTDS) in reducing neuropathic pain in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo patch.
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Asphelia Trichuris Suis Ova in Moderately Active Crohn's Disease
Inflammatory bowel disease (IBD) is a chronic, relapsing condition of the gastrointestinal (GI) tract. IBD is thought to result from inappropriate T cell activation due to a combination of genetic and environmental factors. This leads to a deregulated immune response and characteristic inflammation. Crohn’s disease (CD) is a form of IBD. One theory suggests that underexposure to helminths is a major environmental factor in predisposing to CD. This “hygiene hypothesis” is based on epidemiologic findings of an inverse relationship between IBD incidence and helminthic colonization. In the proposed study, the pig whipworm Trichuris suis (T. suis), formulated as ASP1002 [Trichuris suis Ova (TSO)], a suspension for oral administration, will be administered in the clinic as a single dose for 6 times. T. suis is similar morphologically to the human whipworm but is cleared too rapidly from the human host to establish infection. Therefore, it has potential for being a natural immune modulator without significant risk of causing disease in humans. The expected duration of study participation is approximately 26 to 27 weeks, including up to 2 - 3 weeks screening, a 12 week treatment period and a follow-up visit at Week 24.