ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32712 results sorted by trial registration date.
  • Effectiveness of negative pressure wound therapy (NPWT) in the prevention of post-operative surgical wound dehiscence in at risk patients following abdominal surgery; a multicentre randomised control trial.

    Post operative wound healing plays a significant role in an individuals health and wellbeing following surgery. Current research has idenitifed that post surgical wound healing delays leads to increases in morbidity and mortality and increases the economic burden to wider healthcare system. The research will engage surgeons and clinicians in an interventional clinical trial of a negative pressure device, applied post-operatively to assist in the prevention of wound dehiscence and infection. The potential outcome of this trial will have a major impact in relation to post-surgical patient wound care and the potential to reduce the economic burden of post surgical wound dehiscence

  • Defining optimal glucose targets in critically ill patients with pre-existing type 2 diabetes and chronic hyperglycaemia.

    The purpose of this study is to determine the optimum blood glucose target for critically ill patients with high blood glucose levels. This will be done by changing the insulin protocol in ICU for a period of 6 months to compare to the current standard protocol.

  • A pilot study assessing the efficacy of the Capio device for sacrospinous ligament fixation.

    To analyse the outcomes of surgery to correct apical vaginal prolapse using the Capio Suturing Device.

  • Improving maternal and infant outcomes: A multicentre randomised controlled trial of midwifery and dental intervention

    Poor oral health during pregnancy can affect the well being of the mother and baby. Poor maternal oral health increases the chance of infants developing early dental decay and is strongly associated with adverse pregnancy outcomes such as preterm and low birth weight babies. Unfortunately, many expectant mothers are unaware of the implications of poor oral health. Further, due to various reasons, many women do not seek dental care during pregnancy. According to new Perinatal Oral Health guidelines, dental treatment is safe during pregnancy and this is the period when mothers need to be screened for oral risks, counseled on oral hygiene and receive necessary dental treatment. To achieve this, prenatal care providers need to play an important role. At present there is a lack of emphasis being placed on perinatal oral health by prenatal care providers in Australia. Pregnant women, have no system in place that can offer them regular oral assessment during pregnancy and prompt dental treatment at minimal or no cost as experienced in other countries. To address the oral health needs of pregnant women, the study investigators have developed a unique midwifery initiated oral health dental service (MIOH-DS) model to promote and maintain maternal oral health. This service incorporates oral health guidelines into normal midwifery practice and provides appropriate care pathways where pregnant women can be referred for prompt dental treatment. Extensive pilot work has been conducted by the study investigators to develop the MIOH-DS. We now propose to test the MIOH-DS more extensively through a mulitcentre randomised trial across three large hospitals in Western Sydney The aim of this study is to determine the effectiveness of a Midwife Initiated Oral Health-Dental Service (MIOH-DS). The MIOH-DS will provide pregnant women with oral assessments and dental referrals by midwives, and provide dental services which we expect will improve women’s oral health status, uptake of dental services, oral health knowledge, quality of oral health, and potentially influence the incidence of low birth weight and preterm births. We anticpate that pregnant woman receiving the MIOH-DS will have, a 20% increase in the access/uptake of dental services; a 30% improvement in women’s oral health and a 30% increase in their knowledge about maternal oral health.

  • Australian Cerebral Palsy Child: a prospective cohort study of motor development and brain structure in young children with cerebral palsy.

    This prospective, population based longitudinal study of children, with cerebral palsy, aged 18 months to 5 years will track early motor development and will utilise magnetic resonance imaging to determine the anatomical pattern and likely aetiology and timing of the brain lesion. This will help predict the likely need for, type and timing of interventions(spasticity management, rehabilitation, orthopaedic surgery) and their associated costs, this study will enable more informed resource planning for cerebral palsy in young children for the future.

  • Agreement between arterial and venous pH and partial pressure of carbon dioxide (pCO2) in patients undergoing non-invasive ventilation in the emergency department

    This project compared arteriovenous agreement between pH and pCO2 for patients undergoing non-invasive ventilation in ED

  • Are eggs good for people with type 2 diabetes?

    T2DM is the fastest growing chronic illness in Australia, with over 3.2 million people estimated to have diabetes and pre-diabetes, and a further 275 individuals being diagnosed with diabetes every day. As diabetes is the 6th leading cause of death in Australia, interventions to manage this condition and its complications should be a priority for Australian society. Despite many theoretical advantages of eggs in T2DM, there is a general paucity of good quality prospective data on the effects of high egg consumption in this group. There has only been one short duration clinical investigation in people with T2DM (Pearce KL, Clifton PM, Noakes M. Egg consumption as part of an energy-restricted high –protein diet improves blood lipid and blood glucose profiles in individuals with type 2 diabetes. Br J Nutr, 2011, 105: 584-592). After 12 weeks, participants with T2DM on a high cholesterol, reduced energy diet (2 eggs/day) lost the same amount of weight and had similar improvements in lipids, blood pressure and glycaemic control as those on an isoenergetic low cholesterol diet. The major limitations of this study were its short duration (12 weeks), the null finding in the primary outcome for which the study was powered (10% difference in the change in LDL-C between groups), and participants being prescribed a reduced energy diet which could be a confounding factor. Eggs contain a number of important nutrients that may reduce the risk of cardiovascular disease including folate, long chain omega 3 fatty acids, and arginine (a precursor for nitric oxide). They have also been shown to improve HDL-C (Pearce KL, Clifton PM, Noakes M. Egg consumption as part of an energy-restricted high–protein diet improves blood lipid and blood glucose profiles in individuals with type 2 diabetes. Br J Nutr, 2011, 105: 584-592; Mutungi G, Ratliff, J, Puglisi, M et al. Dietary cholesterol from eggs increases plasma HDL cholesterol in overweight men consuming a carbohydrate-restricted diet. J Nutr 2008; 138: 272-276). Improvements in HDL-C are known to reduce cardiovascular risk (Barter P, Gotto AM, LaRosa JC et al. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events, N Engl J Med 2007; 357: 1301-1310). Eggs are a nutrient-dense food, yet are not high in energy. Despite being rich in cholesterol, the amount of total fat and saturated fat in eggs is not high and the fat in eggs is predominantly unsaturated (44% monounsaturated; 11% polyunsaturated). In addition to potential beneficial effects of eggs on circulating lipid levels, higher protein eating patterns may have benefits for weight loss by inducing increased satiety and enhancing metabolic rate and lipid metabolism. Thus eggs are unlikely to be detrimental to people with T2DM and may be beneficial. Despite this, there is a negative perception toward egg consumption in people with diabetes. This notion largely results from world-wide press releases that have followed the publication of a number of epidemiological studies indicating that a high egg consumption, though not associated with adverse cardiovascular outcomes in the general population, may be associated with worse outcomes in people with T2DM (Hu FB, Stampfer MJ, Rimm EB et al. A prospective study of egg consumption and risk of cardiovascular disease in men and women, JAMA 1999; 281: 1387-94; Djousse L & Gaziano JM. Egg consumption in relation to cardiovascular disease and mortality: the Physicians’ Health Study. Am J Clin Nutr 2008; 87: 964-9). While epidemiological studies may provide insight into possible associations, they do not show causal relationships and findings are often affected by many confounding, and often hidden, factors. For example, at the time that these studies were being conducted, a public health campaign was advising people to limit their cholesterol intake, including their consumption of eggs. Therefore, individuals that were consuming > 7 eggs per week at this time may have been less likely to follow healthy dietary and lifestyle advice in general. It would be impossible to control for these factors from the available data. Furthermore the theoretical increase in cardiac risk from the cholesterol contained in eggs is likely to be minimal when compared to other cardiovascular risk factors including saturated fat intake, lack of physical activity, smoking, hypertension and obesity. To address the limitations of previously conducted research, this prospective, randomised controlled study will include both an active intervention (initial 3 month weight maintenance period followed by a 3 month weight loss period) and follow-up period (6 months) to determine the potential health benefits of a high egg diet in pre-diabetes and those with T2DM. Both groups will be stratified during the randomisation process according to medication usage. The palatability and acceptability of both the diets will be examined throughout the 12 month study.

  • Improving balance and mobility with a yoga program for older people

    This study aims to investigate the benefits of a yoga-based exercise program aimed at preventing falls in older people by improving their balance and mobility. The trial will evaluate the effect of a 12-week yoga program on balance and mobility in 54 older people, randomly split between two groups. The intervention group will participate in a twice weekly group-based program of yoga focusing on balance- challenging standing postures. An experienced yoga instructor will deliver the classes. The control group will receive information about falls risk factors and prevention, but will not participate in the classes. We expect that the yoga group participants will show significant improvements in measures of balance and mobility compared to the control group after the 12 week intervention period.

  • Telerehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD)

    What is the effect of an eight week telerehabilitation exercise program on exercise capacity, physical activity and quality of life in people with COPD compared to usual medical care? We hypothesize that telerehabilitation will increase exercise capacity and physical activity and improve quality of life compared to standard medical care in people with stable COPD. We also hypothesize that people with COPD will be satisfied with the telerehabilitation as an alternative for hospital-based pulmonary rehabilitation.

  • Is arthroscopic hip surgery beneficial for patients undergoing Peri-Acetabular Osteotomy (PAO)

    We aim to evaluate the importance of arthroscopy prior to the osteotomy procedure. This is to supply the surgeon with additional valuable pre-operative data which will establish a better treatment strategy. We will then evaluate patient outcomes following these two procedures. This kind of osteotomy surgery aims to address an uncommon entity - mild hip dysplasia. Evaluation of this unique operation and its outcomes in this type of patient population will be invaluable in further improving patient care. Key research questions: 1. Does PAO carry good long-term outcomes. 2. Is hip arthroscopy considered as a adjunctive procedure prior to PAO

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