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A randomised trial of stretching before and after physical activity to prevent soreness and reduce risk of injury
The primary objectives of this trial are to determine if a program of stretching before and after vigorous physical activity reduces risk of experiencing soreness after physical activity or reduces the risk of incurring an injury while participating in vigorous physical activity. The trial is internet-based and open to the whole world of English and Norwegian speakers.
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Emergency Department ocular ultrasound in patients with acute visual disturbance thought to be due to retino-vitreous pathology
The aim of the study is to compare diagnostic accuracy of emergency department ultrasound diagnosis with eventual ophthalmological diagnosis in patients with suspected posterior ocular pathology e.g vitreous haemorrhage, vitreous detachment, retinal detachment.
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From rehabilitation to recovery: A model to optimise consumer and carer involvement in the first year post stroke
Despite an acknowledgement of the significance of carer support and consumer involvement in recovery, to date there is a lack of empirical evidence regarding their impact on the outcome of rehabilitation programs for stroke patients. The aim of this study is to develop a consumer and carer centred model to assist with recovery and community reintegration in the first year after the onset of stroke.
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A study to determine the clinical value of measuring central blood pressure in patients with hypertension
Hypertension is a major risk factor for cardiovascular disease and the most frequent problem managed by General Practitioners (GP’s) in Australia. Blood pressure is traditionally measured by inflating a cuff around the upper arm, and doctors rely on this information when making treatment decisions. However, individuals with the same, or similar, brachial blood pressure may have very different central blood pressure (>30 mmHg difference). This difference is important because central blood pressure has been shown to have greater relevance to the structure and function of the heart and arteries. Moreover, several longitudinal trials show that central blood pressure indices are independently associated with severe cardiovascular events and mortality. When all these data are considered, relying solely on the measure of brachial blood pressure has severe limitations for assessing patient risk and determining the effect of treatment. Indeed, the evidence points toward an expectation that patient care will be improved by tailoring medical treatment based on central, rather than upper arm, blood pressure. However, there is no data to show that using central blood pressure changes decision-making or outcomes and, therefore, doctors continue to rely on brachial blood pressure to make therapeutic decisions. The technology is now available to measure central blood pressure non-invasively by radial applanation tonometry. This methodology should improve patient care by providing the treating clinician with a greater understanding of the “true” risk relating to blood pressure control and, therefore, make more appropriate treatment decisions. This research program aims to bridge the gap between the current method of managing patients with hypertension (focus on upper arm blood pressure) and the theoretical improvement in the quality of patient care that may be achieved with the use of new technology and consideration of central blood pressure. The research should provide the foundation model for a new way to undertake management of patients with hypertension. It is hypothesised that patients randomised to have treatment decisions based on central blood pressure will have no significant change in left ventricular mass; will have less use of medication and improved quality of life scores.
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Balance dysfunction and falls risk in early dementia-Magnitude of the problem, and effectiveness of balance training program.
Two hundred and fourteen participants with mild to moderate severity of Alzheimer’s disease will be recruited for the randomised controlled trial. Sixty-four age and gender matched (to first 64 people with Alzheimer’s dementia in the control group) healthy participants will be recruited for the longitudinal study. A series of laboratory and clinical measures will be used to investigate balance and mobility performances. All participants will undergo a full assessment process as the baseline, and will then be randomized to a control or an intervention group. The participants in the intervention group will undertake an individually tailored balance training at home programme of 6 months duration. This exercise programme will be based on the results of the balance assessment and conducted under the guidelines which is modified from the established “Otago” programme by a physiotherapist. For the control group, the participants will be provided six home visits by an occupational therapist. Both intervention group and control group will continue with their “usual care” programme as recommended by the Cognitive, Dementia and Memory Services (CDAMS). All participants will be re-assessed at the completion of the programme (after 6 months), and again in a further six months. Additionally, the first 64 participants of the control group with mild to moderate severity Alzheimer’s disease, and 64 age and gender matched healthy controls will be re-assessed on all measures again after 24 months to determine the longitudinal changes in balance performance and magnitude of balance dysfunction. This study will give improved understanding of the changes in balance performance associated with the progression of dementia and the degree of effectiveness of home based balance training in early stages of the disease on balance performance, risks of falls and quality of life in people with Alzheimer’s disease and their families.
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An open label cross-over study of direct transfers between methadone and buprenorphine maintenance
This project is designed to examine whether opiate subsititution on table doses of methadone or buprenorphine differentiall affect clinical outcomes (i.e. drug use), cognitive function (i.e. attention), endocirne function (i.e. libido), cardio-respiratory function (i.e. heart rate), sleep function (sleep activity) and driving skills.
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The effect of pre-operative oral immunonutrition therapy on postoperative outcomes in gastrointestinal surgery patients.
It is well known that major surgery causes a decrease in immune function, which in turn can lead to an increased rate of post operative inflammation and infection. Recently, research has been focused on the role of pre-operative oral immune enhancing nutrition and its positive influences on inflammation, metabolism and immune responses after surgery. The positive effects shown in recent studies have also been linked to a decreased in length of hospital stay and substantially reduced treatment costs. Given the strong support in medical literature, the Departments of Surgery and Clinical Nutrition wish to examine the effect of Impact Advanced Recovery (Novartis Nutrition Corporation, United States of America) on major upper and lower bowel surgery patients. Eligible patients (all patients undergoing upper and lower bowel surgery at The Royal Melbourne Hospital - excluding patients who are inmmunosupressed, have chronic infections, hepatic disease or renal failure), will be randomized into one of two groups, treatment or control. The treatment group will receive Impact Advanced Recovery (237ml packs) three times a day for the five days leading up to surgery. The control group will receive no nutritional supplements, which is in line with current treatment. After their operation, patients will receive normal clinical care as per their managing surgical team. Outcome measures such as length of hospital stay, infection rate, non-infective complications, unexpected ICU admission and death will be measured by means of direct data collection from medical charts during the patients admission. A statistical analysis using an unpaired t-test and Fisher's exact test will be performed on the data. We hope this trial will support the need for The Royal Melbourne Hospital to provide immune enhancing nutritional supplements to patients prior to major upper and lower bowel surgery patients.
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Transient amnesia assessment and management in an emergency department
Aims of the study: 1. To determine the eventual diagnoses of patients presenting to emergency departments with acute amnesia. 2. To determine the ED assessment and management of transient global amnesia and correlate with current diagnostic criteria and suggested management. 3. To compare proportions of patients with internal jugular vein backflow among those that present with TGA, either precipitated by an episode of straining, or not.
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Women's Evaluation of Abuse and Violence Care in General Practice: a Cluster Randomised Controlled Trial (weave)
Intimate partner abuse is a common hidden problem for women attending general practice. It has major emotional and physical consequences. This project aims to evaluate if an intervention in general practice involving screening for intimate partner abuse and feedback to GPs, a training program for GPs, a brief counselling intervention for women and practice organisational change increases abused women’s safety planning and behaviours, mental health and quality of life. The project also aims to increase women’s readiness for change, comfort to discuss abuse and health provider inquiry about safety, and determine if such a program is cost effective. The pilot study is complete. The main study involved sending 20000 women (16-50 years) a screening survey from 55 general practices in Victoria, Australia. Women who screen positive to being ‘afraid’ of their partner or ex-partner in the last 12 months and indicate an interest in being involved in next stage were invited to participate. Those in the intervention group were invited to attend their GP for up to 6 sessions of brief counselling, and be followed for 2 years with surveys at baseline, and 6 and 12 and 24 months following the invitation to see the GP. This study used a cluster randomised controlled trial to evaluate the intervention. General practitioners were randomised either to be intensively trained to deliver the intervention and their practice systems improved for care of abused women or to be briefly trained to ensure minimum safe practice and deliver ‘usual care’. Outcomes of this project include evidence of the effectiveness of this model to increase safety of women and their mental health and quality of life, and an updated continuing professional development curriculum will be available. The 24 month follow up (weave II) consists of: A. 2 year follow up to assess the longer term effect of the weave intervention on women’s experience of abuse; their quality of life; mental and physical health; and use of services. B. Economic modeling to estimate impact of measured outcomes on women’s lifetime health and wellbeing and on lifetime costs and savings for Australian health care and society. C. Qualitative process evaluation to understand context of extent to which weave is effective.
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The use of electroacupuncture with chemotherapy for early stage breast cancer : evaluating feasibility and safety
Background and Scientific basis: Curative chemotherapy for early stage breast cancer has high incidence (>30%) of multiple side effects including nausea, vomiting and neutropenia (drop in white cells which counter infections). Current treatments to counter these have multiple side-effects and are expensive. In initial studies, concurrent use of acupuncture has shown some benefit in reducing these side-effects. Aim & Hypothesis: The primary objective is to evaluate the feasibility and safety of conducting this trial. The secondary objective is to assess any benefits of electroacupuncture for chemotherapy induced nausea, vomiting and neutropenia in women receiving chemotherapy for early stage breast cancer. Study Population: We will study women aged 18 years and over, receiving AC or FEC chemotherapy for early stage breast cancer, who are well with no other significant illness and provide written consent to participate in the trial. They will be provided verbal and written information about the study. Participation in this study is voluntary and women can withdraw at any time. Women with certain conditions (existing neurological problems or strokes, cardiac pacemaker, defibrillator or any other implanted or topical electrical device, conditions causing excessive bleeding/bruising, regularly using medications for nausea/vomiting, women with fear of needles) will be excluded from the study. Methods: Participants will be randomly assigned to one of two groups, electroacupuncture treatment group or non-active/placebo group. Participants in the treatment group will receive electroacupuncture to four acupoints on days 1&2 for the first two cycles of chemotherapy. Participants in the placebo group will receive sham electroacupuncture via specially designed non-active devices at four points, close to the real acupoints. An experienced acupuncturist will perform the treatments in both groups. Neither the participant nor the doctors will know which group the participant is allocated to. All participants will continue to receive usual medications for chemotherapy side-effects. Participants will be required to undergo routine blood tests, keep diary records of side-effects and answer short questionnaires during the study. The study duration for each participant is six weeks.