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Investigating methods of reducing cancer recurrence by changing tissue drainage systems at the time of operation.
The body’s lymphatics vessels have an important function and move fluid outside blood vessels through lymph glands. This role in ‘clean up’ of cell debris after surgery is very important to understand as these lymphatic channels are also mechanisms of spread of cancer cells. Lymph glands are a common site where cancer recurs after surgery. There is evidence to suggest that the movement of lymph through lymphatic channels alters under epidural/spinal anaesthesia. These sorts of anaesthesia techniques are sometimes performed at the time of surgery for pain relief; this study will consider whether they also have a role in the reduction of lymph flow at the time of surgery. Doctors may therefore be able to utilise another technique to reduce the risk of cancer recurrence after surgery. Primary research hypothesis: Lymphatic flow in the lower limb is reduced by sympathetic blockade (spinal anaesthesia).
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A trial of the Tailored Activities Program (TAP) for reducing challenging behaviours in persons with dementia
Behavioural disturbances associated with dementia are common amongst community-residing people with moderate to severe dementia and are associated with reduced quality of life for both the person with dementia and their caregiver. We propose a randomized trial to test the effectiveness and cost effectiveness of the Tailored Activities Program (TAP) to reduce the burden of behavioural and psychological symptoms of dementia. The 8-session intervention involves occupational therapists identifying preserved capabilities, deficit areas, and previous interests of the person from which they prescribe specific activities. Family caregivers are then trained to use activities as part of daily care at home as a management strategy to reduce behavioural symptoms.
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Preventing the risk of Multiple Sclerosis using Vitamin D in patients with a first demyelinating event in Australia and New Zealand (PrevANZ)
There is a great deal of lay information to suggest that people with MS or at risk of MS should take oral Vitamin D supplementation. However, no adequately powered scientific study has examined the role of Vitamin D3 supplementation as prevention or treatment for MS. There is insufficient commercial interest in conducting such a study, but the need for evidence is great. If effective, oral Vitamin D supplementation could provide a low cost MS therapy with virtually no side effects. Sponsored by Multiple Sclerosis Research Australia, we therefore plan to conduct a randomised, placebo controlled, double-blind clinical trial to assess the efficacy of oral Vitamin D3 in preventing the development of Multiple Sclerosis in participants at high risk of MS (participants with a first demyelinating event, FDE). We will compare three doses of oral daily vitamin D3 (1,000IU 5,000IU or 10,000IU/day) to placebo. After agreeing to participate, participants will be randomly and blindly assigned to one of these four study arms and will continue to take study medication for 48 weeks. Scope: We plan to enrol 240 participants with FDE from 21 Australian and New Zealand MS trial centres over the course of three years. We may invite additional centres depending on recruitment and trial progress.
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Identifying depression following a diagnosis of acute coronary syndrome: testing the predictive validity of a depression risk assessment questionnaire
This study has been designed to test a depression risk assessment questionnaire. Patients who have been admitted to hospital for severe chest pain or a heart attack often get depressed once they have returned home. By asking patient certain questions about their past mental health and recent events we hope to predict which patients may be at risk of becoming depressed.
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Effect of pre-operative education on patients' pain and anxiety following joint replacement: A feasibility study
Patients undergoing elective hip or knee replacement experience different levels of pain and anxiety before and after their surgery. Providing education to patients on strategies to help them manage the pain and anxiety they experience could help improve patients’ physical and psychological outcomes after surgery. This study hopes to test whether education provided to patients before surgery can assist in their management of pain and anxiety while undergoing hip or knee replacement. Patients who agree to participate in this study, will be randomly assigned to either receive a DVD with self-efficacy information and activities to take home combined with the usual pre-operative education (the ‘self-efficacy education intervention group’ [A]) OR receive the usual pre-operative education and care (without the DVD) only (the ‘routine care group [B]). Participants who are allocated to receive the DVD are asked to view this and perform the activities (ie., relaxation, breathing and imagery exercises) within 72 hours and then on three other occasions until their booked surgery. A research assistant (registered nurse) will call the ‘self-efficacy education intervention group’ [A] participants on the telephone after 72 hours and then again before admission to support their participation. All participants will be assessed for levels of pain, anxiety, self-efficacy at the first three time points (T0-2). Participants will also be asked to respond to a survey about their satisfaction with care in relation to pain management on the day of their discharge/day 4 post-operatively (T3). Ten to fourteen days following discharge (T4), patients will be contacted via telephone at a suitable time to rate their pain, anxiety and self-efficacy as well as their utilisation of health services and resources. Finally 6 weeks after surgery (T5), patients will be telephoned at a suitable time to rate their pain, anxiety, utilisation of health services and resources and utilisation of relaxation method(s). Apart from the day of surgery, all other time points (T0, T2-5) will record the use and frequency of pain medications via direct patient feedback or from the end-of-bed medication sheets. The time taken to complete the assessments at 6 time points will be approximately 10 – 15 minutes. The assessments will be in paper form, and participants will be required to respond to a series of questions.
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Investigating the role of transcranial direct current stimulation for pain relief in fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome patients
This study aims to seek whether longer treatment protocols than previously applied in research will result in longer-lasting and stronger improvements in pain relief in ME/CFS and FMS. The study also seeks to investigate whether pain reduction is associated with improvements in other chronic illness symptoms.
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A workplace-based exercise intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel
Non-specific neck pain is a major burden in industry in terms of lost productivity (reduced work performance, lost days) and personal suffering (pain, disability, reduction in quality of life and reduced job satisfaction). Non-specific neck pain is a particular threat to productivity at work due to its tendency for chronicity and its recurrence. With more than 50% of office workers experiencing neck pain at some stage of their working life, significant resources have been allocated to improve the individual’s ergonomic working environment aimed at primary prevention of this problem. Emerging evidence supports the effectiveness of ergonomic interventions in reducing absenteeism and improving productivity, but to date it has shown minimal impact in preventing or reducing neck pain in the workplace. In contrast, a workplace neck strengthening exercise protocol has demonstrated effectiveness for reducing the severity of neck pain in office workers but its impact on productivity has not been explored. Due to the recognised link between health and productivity, health initiatives at the workplace are gaining momentum. We propose that best practice ergonomic intervention combined with neck specific exercise is the optimal approach to minimise productivity losses and neck pain in the workplace. This project will test the impact of a workplace-based best practice combined ergonomic and exercise intervention on work productivity and severity of neck pain in a population of office personnel.
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Infectivity of the Plasmodium falciparum NF54 malaria cell bank, MCB-002, in humans
This study is examining the infectivity of a Plasmodium falciparum NF54 malaria cell bank in humans. Participants will receive a single inoculum of the malaria cell bank, which consists of human red blood cells containing P. falciparum NF54 malaria parasites. Following administration of the inoculum, we will measure the growth of the malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) according to specific criteria (based on the number of parasites in the blood as well as clinical signs/symptoms of malaria). We will also be assessing the safety of the inoculum and also the way the immune system responds to it. Determining the infectivity and safety of the malaria cell bank is important as it will form a critical part of future clinical trials investigating the effectiveness of a new malaria vaccine that is currently being developed.
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An Open-Label, 2-Part, Single Dose, Randomized Study to Evaluate the Pharmacokinetics of combination etoricoxib/tizanidine tablets in Healthy Adult Subjects
An open-label, 2-part, randomized, single-dose, crossover study to initially characterize the pharmacokinetics, safety, and tolerability of MK-0663B 90 mg/6 mg formulated as prototype tablets under fasted and fed conditions when compared to coadministration of the individual components. The change in pharmacokinetics for etoricoxib and tizanidine when administered under fasting (Part 1) and fed conditions (Part 2) will be characterized. MK0663B (combination treatment) is being developed for the treatment of acute pain in musculoskeletal conditions with swelling and muscle spasm. However, this study is in healthy volunteers only.
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A randomised controlled trial of MAXCOG (MAXimising COGnition in Preclinical and Early Dementia): an individualised early intervention program for people with Mild Cognitive Impairment or early dementia and their family supporters
Currently few services aim to support people in the community who are experiencing mild cognitive difficulties or who have early dementia. However, the experience of cognitive difficulties and worry about the future can be very stressful for the person and their close family members; and may make everyday tasks, such as interacting in a group or managing finances, much more difficult. In this project we will develop and evaluate a new face-to-face psycho-educational and counselling program for people with cognitive difficulties and their close family members. The aim of the intervention is to help people implement practical strategies to manage cognitive difficulties in their day-to-day life. By increasing strategy use, we also hope to reduce the anxiety and depression that people with mild cognitive difficulties and their family members can experience. We will evaluate our counselling program by comparing the outcomes for people who undergo the program with those of a comparison group who receive service as usual (a randomised controlled trial).