ANZCTR search results

Osteoarthritis of the knee is common in older people, giving rise to pain and loss of function. Exercise is a key treatment for knee osteoarthritis with studies revealing short-term benefits of exercise for pain and function. However, exercise is generally not effective in the longer-term due to reduced adherence. Following an initial period of more intensive exercise supervision, this randomised controlled trial will investigate whether a limited number of additional physiotherapy visits will improve outcomes with home exercise over 24 weeks.

Vascular endothelium is known to have a pivotal role in the maintenance of vascular haemostasis including effects on vasomotor and platelet function, thrombus formation and fibrinolysis, cell growth and inflammation. Altered endothelial function (endothelial dysfunction), largely evaluated by vasodilator responses to endothelial dependent stimuli (ie. shear stress, acetylcholine, salbutamol), occurs in the setting of atherosclerosis and traditional cardiovascular risk factor. Furthermore, endothelial dysfunction measured in both the peripheral and coronary circulation, is associated with adverse risk of future cardiovascular events. The exact mechanism behind how endothelial function impacts on clinical events remains uncertain. We plan to embark on a set of experiments to assess the dynamic relationship between segmental coronary endothelial function and regional plaque progression or regression over time in patients with stable coronary artery disease. We are also interested to examine this relationship with the evolution of the lipid core content of an atheromatous plaque, a known marker of plaque vulnerability. Our patients will undergo a clinical follow up every 3 month until 18 months, when another endothelial function assessment will be performed to mark the end of the study. Although this is largely a mechanistic study, we believe that the result of this study will provide some initial data to provide a "gold standard" invasive assessment of vulnerable plaque, which in turn will aid in predicting individual future coronary event with more accuracy.

There are a large number of disadvantaged pre-school children who suffer tooth decay. Unfortunately, many of them require extensive treatment necessitating general anaesthesia with its risks and high costs. Preformed stainless steel crowns are the best method of restoring decayed baby molar teeth and a simplified method of placing them, without using general anaesthesia, has been found to be successful with school age children. We wish to test whether this method would be successful with pre-school children at high risk to dental caries in a community dental clinic at a success rate comparable to conventionally placed stainless steel crowns. Research Investigators include the Director of Clinical Leadership, Education and Research of Dental Health Services Victoria; senior academic staff of the Melbourne Dental School, University of Melbourne; the Manager Oral Health Program North Richmond Community Health, and a senior dentist from the North Richmond Community Dental Clinic. Participants will include North Richmond Community Health management and staff, preschool children patients (and their primary carers) of the North Richmond Community Dental Clinic. As part of the standard clinical care for patients at high risk to dental caries, the preschool children will have x-rays taken beforehand to diagnose decay and exclude from the study patients with extensive disease for which this treatment is not indicated. Multi-language brochures and dental examination with questionnaire will precede an interview to elicit verbal and written consent. Immediately after treatment, carers will be asked to fill in another questionnaire. At the 12 months review visit another x-ray will be taken, again according to standard clinical care for patients at high risk to dental caries, and a further questionnaire filled. The prime statistic will be the number of crowns deemed to be a success at six months, and 12 months (for Phase 1 of the study), using criteria established by previous research. Secondary findings will be the acceptance of this mode by patients, carers and staff. A key aspect is that, in appropriately selected cases, this treatment does not drill out any of the decay; so, does not require any injection of local analgesia, is less uncomfortable, and so is faster and likely to be better tolerated by pre-school children than conventional stainless steel crowns. A key issue is ascertaining that there is no unexpected progression of decay with poor outcomes. Research has shown that the decay of deciduous molars that is isolated under the crowns ceases and causes no further destruction to the teeth.

Low vitamin D levels in the blood are a common problem in the elderly. One of the main functions of vitamin D is to help absorb calcium to keep bones strong, but low vitamin D levels have been associated with muscle weakness and an increased risk of falls. Low vitamin D levels have also been linked to a number of neurological conditions such as multiple sclerosis and Parkinson’s disease. Since the role of the nervous system is to send signals to the muscles to produce smooth and coordinated movements to maintain balance and prevent falling, it is possible that the increased risk of falling that has been associated with low vitamin D levels is related to its effects on the brain and nervous system. This study has been designed to investigate the effects of 3-months of vitamin D supplementation on muscle strength, muscle power and function as well as neural activity in the brain and nervous system in older women with mild vitamin D deficiency. Women aged 60 years and over will be randomised to receive either 2000 IU of vitamin D supplementation daily or a matched placebo control. Women will undergo muscle strength and function tests as well as non-invasive neural testing prior to study commencement and after 3 months' supplementation.

Total hip replacement is now a well established operation to reliably alleviate pain from osteoarthritis of the hip joint. Over the years a number of bearing surfaces have been used in order to minimise the wear within the joint itself. One such bearing surface is a metal socket articulating with a metal ball. However we know now that although this provides very low wear rates, it can result in metal ions being released into the blood stream as a result of this wear process. It is the precise effects of these metal ions within the blood stream that we are beginning to understand more about. In particular we know very little about the effect that metal ions have on the eyesight and if metal ion levels are high whether this can cause changes in visual acuity. This study aims to measure blood levels of Cobalt and Chrome in your blood stream and then potentially carry out specific tests to look at the functioning of the cells within the eyes to assess whether this is abnormal.

Previous research has shown that many people living with spinal cord injury demonstrate great resiliency and lead happy, productive lives. However, there are also many others who experience emotional difficulties such as depression or anxiety. Of particular concern is that the majority of people experiencing those difficulties do not receive any specific treatment or psychological support. To address this problem, a new flexible psychological treatment has been developed - ePACT. ePACT is delivered electronically and supplemented with personal contact by email and/or phone with a mental health clinician. The recent pilot of ePACT was well received, easily accessible and effective for participants who each found it acceptable and helpful. This current study will expand the distribution of ePACT to provide further evidence supporting the effectiveness of ePACT. This aim of this study is to build on the previous pilot study by investigating the suitability and effectiveness of ePACT on a larger body of people.

Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. Current treatment strategies of IBS are unsatisfactory. Currently there are three common modes of treatment for IBS including: drugs, diet and psychological therapies. Pharmacologic interventions are generally not effective in treating IBS and no drug has been shown to relieve the full spectrum of gastrointestinal symptoms that make up IBS. Two common modes of treatment, however, that have been scientifically proven to relieve the symptoms of IBS include hypnotherapy and the low FODMAP diet. Gut-focused hypnotherapy uses hypnosis to induce a deep state of relaxation allowing the subconscious mind to become highly receptive to suggestions directed towards the control and normalisation of gut function. Recently published scientific research has shown that gut-focused hypnotherapy can have a 70+% success rate in the reduction of abdominal symptoms including abdominal pain, bloating, constipation and diarrhoea. Additionally, gut-focused hypnotherapy has been shown to improve overall well-being and quality of life, reduce anxiety and depression and reduce medication needs. Furthermore, these improvements have been shown to be maintained for 2-5 years. FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols) are a group of dietary sugars that can be poorly absorbed in people with IBS. When these sugars are poorly absorbed in the small intestine they continue along the gastrointestinal tract and arrive at the large intestine where they act as a food source to the bacteria that normally live there. The bacteria of the large intestine then ferment these FODMAPs and can cause symptoms of IBS. Recently published scientific research has shown that dietary restriction of these poorly absorbed FODMAP sugars (the low FODMAP diet) can have a 75% success rate in the reduction of abdominal symptoms including abdominal pain, bloating, constipation and diarrhoea. Additionally, the low FODMAP diet has been shown to improve levels of fatigue amongst this population. While both the low FODMAP diet and hypnotherapy significantly reduce symptoms in the majority of IBS patients, the benefit of combining these therapies has not yet been investigated. It is anticipated that this study will shed light on the benefit of applying these therapies both individually and in combination with one another, allowing GPs and gastroenterologists to direct IBS patients to the best available treatment which may be tailored to each individual patient. Aims To assess the effectiveness of using dietary carbohydrate restriction (the low FODMAP diet) and hypnotherapy as complimentary therapies for the effective management of IBS To compare the combined treatment of the low FODMAP diet and hypnotherapy to each of the standalone therapies To assess the long term effectiveness of each of the treatment conditions Hypotheses Hypnotherapy will improve IBS symptom severity and psychological status amongst the IBS population The low FODMAP diet will improve IBS symptom severity and psychological status amongst the IBS population Hypnosis and the low FODMAP diet as complimentary therapies will improve IBS symptom severity and psychological status to a greater extent than if these two therapeutic modalities were administered independently Improvements in IBS symptom severity and psychological status will be maintained at 3 and 6 months following each of the treatment conditions

Intrauterine growth restriction (IUGR) describes conditions where fetuses are smaller than expected for their gestational age. This puts the fetus at risk of death, hypoxia and preterm birth. If IUGR occurs early in pregnancy (i.e before 28 weeks gestation) survival rates are only 70% and survival free of major handicap (intact survival) is much lower at 20%. Current management involves intensive fetal surveillance and delivery when there is evidence of serious compromise (to avoid death in utero) but this leads to the consequent risks of prematurity. There is no known treatment for IUGR. This is a double blind randomised placebo controlled trial of Sildenafil, a nitric oxide donor drug, that has the potential to vasodilate uteroplacental vessels improving placental function. It may represent a novel therapy for IUGR. It has been used in pregnancy without adverse events and in a small case-control study it improved daily fetal growth velocity. Women with severe early onset IUGR will be invited to take part in the study at MFM units across NZ and Australia. This study will demonstrate if Sildenafil improves fetal growth, the results will be used in collaboration with other similar studies planned worldwide to demonstrate if Sildenafil improves rates of survival free of major handicap. This trial incorporates the STRIDER NZAus Childhood Outcome Study: a follow up assessment of all surviving children at 2-3 years’ corrected age to determine whether any benefit (or harm) seen in the newborn as a consequence of antenatal sildenafil therapy is sustained, or develops, through childhood.

The QH Rural Stroke Outreach Service and the Queensland Rehabilitation Physiotherapy Network are investigating the use of the Bioness NESS L300 (L300) to support gait recovery in people following stroke with foot drop. A prospective clinical controlled study involving eight rehabilitation units is planned. Each participating site has nominated to be either an intervention or a control site. Following familiarisation, participants will use the L300 during physiotherapy treatment once medically stable until they are discharged or the L300 is no longer clinically required. Participants will be followed up by phone at 4, 8 and 12 weeks following recruitment to the study.

An Open-label, Single-Dose, 3-Period Crossover Study To Evaluate the 2-Way Interaction of Sitagliptin and Losartan in Healthy Adult Subjects MK0431G (combination treatment) is being developed for treatment of patients for whom treatment with both Sitagliptin and Losartan is appropriate. However, this study is in healthy volunteers only.