ANZCTR search results

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

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31276 results sorted by trial registration date.
  • General Practice Optimising Structured MOnitoring To Improve Clinical outcomes in Type 2 Diabetes: An individually randomised trial of the effect of retrospective continuous glucose monitoring (rCGM) for people with type 2 diabetes in general practice on HbA1.

    Our aim is to test the effect of a new wearable device (a continuous glucose monitor) on the achievement of evidence-based targets for overall glucose levels (glycemic targets). The general way of measuring glycaemic targes is to measure HbA1C in the blood, which gives an average of the glucose levels over the last 3 mths. Based on this measure about half of people with T2D in the community are not in the glycemic target of 53 mmol/mol.. We think knowing more about the day-to-day variation in glucose levels may be important, because that sort of information might help GP and patient to make more personalised and rational changes in treatment (including lifestyle changes and medicines). Our research question are: 1. Does the judicious use of intermittent retrospective continuous glucose monitoring (r-CGM) in primary care improve glycaemic control as measured by HbA1c? 2. Is intermittent r-CGM cost-effective? This is an individually randomised controlled trial set in General Practices in Victoria. Up to 60 practices and up to 300 patients will participate. Eligible patients are people with T2D who are out of glycaemic target despite moderately intensive therapy. People will be asked to complete a survey and have a blood test at the beginning and at 12 months. Patients randomised to the intervention group are asked to wear the r-CGM device every three months for a period of 2 weeks then to meet their GP to discuss it. Patients in the control group just continue to have usual diabetes care.

  • Genetic link between Fibrous Dysplasia and Intramuscular Myxoma in patients suffering from Mazabraud syndrome

  • Impact of continuing or withholding blood pressure reducing drugs on the blood pressure stability and quality of recovery following day surgery procedures

    Ambulatory surgical procedures are increasingly being performed worldwide; patient complexities such as obesity, advanced age along with other medical conditions will be frequently encountered. Major perioperative morbidites or mortalities are reported to occur once in every 1000-day surgical cases according to a recent large review on approximately 250,000 cases. One of the significant predictors for adverse outcomes was hypertension. Increasing number of patients on ACEI and ARBs are seen undergoing day surgery procedures. While we have strong recommendations about preoperative beta-blockers, the evidence on these antihypertensives that act on the renin- angiotensin pathway is insufficient and controversial There is insufficient evidence on whether ACEI and ARBs should be continued or ceased before ambulatory surgeries. As there have been limited data in terms of recommendations on ACEI/ARB agonist in ambulatory surgeries, more research seems necessary to provide evidence on the risks of continuation these drugs, in terms of both high and low blood pressure responses. Primary aim: To investigate the association between i)Preoperative angiotensinogen converting enzyme inhibitor (ACEI) and ii)angiotensin II receptor blocker (ARB) therapy and perioperative blood pressure changes in patients undergoing ambulatory surgical procedures Secondary aim: 1. To study the haemodynamic influence of continuation of other antihypertensive agents. 2. To examine the effect of hemodynamic fluctuations on the quality of recovery and complication rates Following ethics committee approval, preoperative data from the consented patients that undergo day surgery procedures will be collected from patient records and face-to-face interview. Patients are allowed to follow their medication order as per the surgical/ anaesthetic teams’ instructions. No specific instruction on the antihypertensive treatment shall be given for this study. The preoperative data collected include but not limited to the antihypertensive therapy details and the time of last dose of medication. Management of the case will be left to the anaesthetic team involved. The details on the anaesthetic management, intraoperative hemodynamic changes and postoperative recovery details will be collected at the end of surgery. Endpoints measured: Primary: Significant hypotension b. Change in mean perioperative systolic blood pressure from mean pre-operative measures. c) Variability in systolic blood pressure d) Preoperative hypertensionSecondary outcomes: Length of stay in recovery room. Unplanned readmission or any major surgical or medical complications, quality of recovery within 24 hours of the day-surgery procedure, correlation between the primary outcome measures Vs type antihypertensive agents and the timing of discontinuation in patients on monotherapy.

  • Influence of the Insights program (a teacher led emotional health program) in increasing tolerance of uncertainty and resilience in secondary school students.

    The aim of the project is to examine the effectiveness of a PDHPE program. The program will be run as part of the year 8 or 9 curriculum. The overall objective of the project is to investigate the ability of the Insights program to lower intolerance of uncertainty and envy in students.

  • Evaluating the ability of exercise to suppress tumour growth in advanced breast cancer patients with osteolytic bone metastases.

    Aim? To examine whether a targeted and supervised exercise program can suppress tumour formation, growth and activity in advanced breast cancer patients with bone metastases in Humans and examine the feasibility, safety and efficacy of combining spinal isometric training with a modular multi-modal program M3EP program. Who is it for? You may be eligible to join this study if you are a female aged 18 years or more and have histologically confirmed breast cancer with one or more metastatic lesions in the thoracic or lumbar spine. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a 12 week exercise intervention. The exercise intervention group will receive a 3-month, supervised and individually tailored modular multi-modal exercise program (M3EP) with spinal isometric training (SIT). M3EP component of the program will be comprised of resistance, aerobic and flexibility exercises undertaken 3 times per week in an exercise clinic setting, supervised by an accredited exercise physiologist. The SIT component of the program will comprise of exercises that isometrically load deep spinal muscles. These will be performed 5 times per week (3 in clinic and 2 at home). Participants in the other group will receive usual care for the duration of the trial. Following the trial, the control group will be offered the same exercise program if the intervention is deemed to be feasible and efficacious. All participants will complete assessments at baseline and after 12 weeks in order to evaluate tumour formation and growth, muscle-bone health, adiposity, physical fitness, functional capacity, and psychosocial health.

  • The relationship between methotrexate drug and blood pressure in patients with rheumatoid arthritis

    Rheumatoid arthritis (RA) is a chronic disabling autoimmune condition characterized by local and systemic inflammation, joint pain, stiffness and fatigue. RA patients also suffer from so-called ‘extra-articular’ manifestations, affecting several organs and systems such as the skin, eye, lung, heart, kidney, blood vessels, and bone marrow. Patients with RA and cardiovascular risk factors such as high blood pressure and diabetes are known to be at an increased risk of cardiovascular disease. Since cardiovascular disease is known to be an inflammatory condition, RA patients without cardiovascular risk factors may have an additional increased risk of developing cardiovascular disease. However, some evidence suggests that the use of methotrexate (MTX) drug, a traditional anti-inflammatory drug for use in RA patients, may lower the risk of cardiovascular disease. In order to establish whether MTX lowers specific risk factors for CVD in RA patients, any comparison of risk factors such as blood pressure and arterial function between patients receiving and not receiving MTX must take into account other factors that might influence these risk factors and which may be different between groups of patients receiving and not receiving MTX. These factors include the dose and concentration of MTX, levels of exercise, dietary nutrient intake, alcohol intake, and clinical and biological characteristics. The main aim of our study is to examine whether taking MTX drug can improve blood pressure and arterial function in the RA. The novelty of our results will likely translate into a) substantial changes in clinical practice, in particular cardiovascular risk management in RA patients and, possibly, in the general population; b) high-impact research outputs in leading journals in rheumatology, cardiovascular medicine, pharmacology, molecular biology and chemistry; c) invitations to present data at key national and international meetings; and d) ongoing collaborations with the pharmacological industry in relation to the synthesis and further development of MTX analogues.

  • Instilling hope for a brighter future: A mentor-mentee support program for people with an eating disorder

    The aim of this project is to develop and evaluate, in consultation with stakeholders (Eating Disorder sufferers and recovered individuals), a support program for young people in New South Wales following treatment for anorexia nervosa (AN), Bulimia Nervosa (BN), Other Specified Feeding or Eating Disorder (OSFED) or Binge eating disorder (BED). This study is a mixed methods participatory action research project whereby the participants in the project (Eating Disorder (ED) suffers and their matched mentors) develop a support program that aims to encourage and support the ED sufferer on their road to recovery and to improve the quality of life for people with an Eating Disorder. Quantitative questions will be used to assess the project's success along with a qualitative interviews and/or focus group discussion post intervention.

  • Lumbar microdiscectomy and post-operative activity restrictions

    Lumbar discectomy is the most commonly performed spine surgical procedure. Lumbar discectomy is performed to treat radicular pain (pain radiating along the distribution of a nerve) unresponsive to conservative management, neurological deficit or less commonly cauda equina syndrome. Lumbar discectomy has evolved to a relatively minimally invasive surgical procedure performed as a day procedure in many centres in North America. Traditionally surgeons have advised patients to restrict post-operative activity due to the hypothesis that this may reduce the risk of disc reherniation and progressive instability at the operated level. In contemporary practice many surgeons do not advise any post-operative activity restriction. Observational studies conducted to date investigating the effect of removal of activity restrictions demonstrated similar outcomes to those reported in the literature for traditional post-operative care. No randomized controlled trial has been performed to investigate this question. The purpose of this study is to directly compare in a randomized controlled trial patients following post-operative activity restrictions and those without post-operative activity restrictions for a period of one month following lumbar microdiscectomy. Patients will undergo standard lumbar microdiscectomy and then be randomized into either the treatment (no restrictions) or control (restrictions groups). For a period of one month following their procedure patients will wear an electronic monitoring device that will record activity and posture. Patients will complete surveys pre-operatively and post-operatively at day one, one month, three months and six months. Patients will also undergo clinical review at one month following their operation. The primary endpoint is a composite endpoint of change in visual analogue scale for pain (for back and legs), Oswestry Disability Index, absence of disc herniation recurrence or reintervention at six months. Additional secondary endpoints will also be assessed.

  • Determination of human oral carbohydrate taste function and its association with food consumption and Body Mass Index (BMI)

    The aim of this project is to investigate if humans are able to detect small amounts of carbohydrate orally and investigate links with dietary consumption and weight. Over the past decades, behavioural studies demonstrated that rats are very attracted to starch and that starch is preferred to sucrose at low concentrations, suggesting that rats have different taste receptors for sucrose and starch. Carbohydrates, in the form of sugar and starch, represent a major source of food energy. Except for some fruits, plants contain much more starch than sugar, but it is sugar with its sweet taste that is the most sought after carbohydrate. Compared to sugar, starch is rather bland to the human palate, and has been assumed to be tasteless for other animals as well. However, in the past decades, studies using animal models reported that rats are very attracted to the taste of maltodextrin (starch). The results of these studies suggest that starch and sucrose stimulate different taste qualities, indicating there is an independent taste receptor for polysaccharides. Recent studies investigating carbohydrate sensing in the human oral cavity through exercise performance have also found that exercise performance significantly improved after participants rinsed their mouth with solutions containing maltodextrin (see review by e-Silva et al., 2014). The results suggest that there may be an independent mechanism and pathway for oral carbohydrate detection, but as yet, there is not method for assessing carbohydrate detection thresholds in humans. A total of 30 people will participate in this project and subjects must be over the age of 18 years. It is also preferred that subjects are non-smokers.

  • Comparing the effectiveness of PowerPICC(Trademark) with BioFlo(Trademark) on Peripherally-Inserted Central Catheter(PICC)-related Occlusion and Infection Rates in the Oncology/Haematology Setting: A Randomised Controlled Trial

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