ANZCTR search results

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

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32894 results sorted by trial registration date.
  • A pilot trial of a hypertonic saline bolus in early sepsis

    Patients with sepsis have the potential to become very unwell in a rapid period. The progression from being moderately unwell to severely unwell may be due to the body’s immune system responding to the infection, rather than the infection itself. A fundamental and accepted practice in the management of patients with suspected sepsis is the administration of intravenous fluids. There is no consensus that any particular fluid is better than the other. In particular, we do not know whether any time of fluid has a beneficial effect on this immune response to infection. Hypertonic saline fluid has been shown in some animal and human studies to influence the immune response to infection. In this pilot study we will assess whether hypertonic saline has an advantage over normal saline in producing beneficial immunomodulation. If this can be shown, it will inform the design of a larger multicentre trial with clinical endpoints.

  • Steroids for Emergency Department Patients with Low Back Pain and Radiculopathy

    Based on current medical literature, there are some suggestions that a single dose of steroid treatment may help improve back pain due to low back pain with radiculopathy. However, the research this has been based on has not been performed in the Emergency Department (ED), or do not necessarily measure important factors such as return to normal functioning, visual analogue pain scores or improvement in straight leg raise. The aim of project is to measure and compare the effect of a single dose of intravenous steroid treatment (8 mg of Dexamethasone) versus a placebo (normal saline) on visual analogue pain scores. We are also trying to measure the time to return to normal functional level, improvement in straight leg raising and improvement in Oswestry Disability Index symptom scores. The overall aim is to make a recommendation regarding management of patients with acute back pain and radiculopathy.

  • Tramadol administration in the critically ill

    The study enabled dosing intervals, peak plasma concentration and rate of absorption of subcutaneous tramadol to be determined in Intensive Care Step Down Unit patients. It also permitted pharmacokinetic comparison with other subcutaneous opioids and assist in clinical decision-making about optimal opioid dosing regimens for moderate to severe acute pain.

  • MATADOR: Minimising Adaptive Thermogenesis And Deactivating Obesity Rebound

    There are more than 7 million overweight or obese adults in Australia and on average only about 5% of this population achieve permanent weight reduction of any significance to their health. Many questions remain regarding the best way to achieve long-term weight loss, and how a person’s metabolic rate is affected both in the short- and long-term during dieting. The overall aim of this project is to design more effective and sustainable weight loss strategies for overweight and obese adults. This study, funded by the National Health and Medical Research Council (NHMRC), aims to compare changes in weight and health using two different dieting approaches; one in which the energy intake (kilojoule value) changes every two weeks, and the other where the energy intake changes every four weeks. Throughout the intensive phase of the study, participants are provided with a healthy, balanced, energy-regulated diet delivered to their home. Measures of body composition, metabolic rate and energy expenditure, hunger and satiety, blood hormone levels, body fuel usage, and metabolic health will be taken at a number of time points throughout the study.

  • Trial of high flow nasal prong (HFNP) oxygen therapy for viral bronchiolitis in children's wards of south-west Sydney.

    The primary purpose of the study is to conduct a clinical trial on the use of HFNP therapy on infants with viral bronchiolitis requiring ventilator support and compare it with the standard care at the Campbelltown and Mt Druitt Hospitals to see effect of HFNP therapy in reducing the need for intubation and cost of transferring children to specialized children hospitals.

  • A randomised control trial of the impact of the implementation of case management compared with usual care in the transition of young adults with type 1 diabetes mellitus from paediatric to adult services

    The incidence of Type 1 diabetes mellitus (T1DM) has increased over the last several decades, for reasons which are largely unclear. It is an autoimmune process characterised by a lack of insulin. This insulin deficiency leads to elevated blood sugars, which in turn causes damage to the small blood vessels and nerves in the body, leading to problems such as kidney failure, blindness and lack of blood flow to essential organs. The aim of management is to minimise the risk of these potential complications by ensuring that blood sugar levels are maintained as close to normal as possible. Despite increasing medical knowledge and technological advances, this remains a difficult goal to achieve, particularly during adolescence. In addition to the decreasing metabolic control during young adulthood, we know that many young adults with T1DM have difficulty maintaining contact with hospital services after transfer from paediatric to adult services. This lack of engagement with medical professionals often leads to a further deterioration in blood sugar control during this time, putting these vulnerable young adults at significant risk of long term health problems. The issue of transition in T1DM is one with which clinicians struggle with worldwide. Interventions such as continuity of treating physician or continuing attendance at a paediatric centre into the third decade are effective but not practical in most centres. Case management during adolescence has been shown to be effective at improving clinic attendance for teenagers, but to date there is no randomised controlled trial of case management in the transition of youth with T1DM. We hypothesise that a case management programme in this population will lead to improved clinic attendance rates after transfer to the adult services, and is both feasible and reproducible.

  • A Phase II clinical trial to assess the safety and tolerability of PBT2 and its effect on amyloid levels in the brains of patients with prodromal or mild Alzheimer's disease.

    This is a Phase II clinical trial to examine the safety, tolerability and effect of 52 weeks treatment with PBT2 in patients with prodromal or mild Alzheimer's disease (AD). The primary objective is to compare the effect of PBT2 vs placebo on the amount of amyloid in patients brains after 52 weeks of treatment when measured by a particular type of brain scan, PiB-Positron Emission Tomography (PET). The effects of PBT2 on safety and tolerability, brain volume, brain metabolic activity, and cognition plus functional abilities will also be investigated.

  • Diabetes Case Detection through Emergency Department Admissions

    This health services research study aims to evaluate, using a single blind, cluster randomised control design the novel system of routine blood glucose testing amongst all patients admitted to hospital via Emergency, followed by automatic notification of the relevant hospital’s Diabetes Services for those who are hyperglycaemic, to assess related improvement in diabetes case detection and subsequent implementation of diabetes care.

  • Accommodative Lag with Multifocal Contact Lenses

    The aim of this study is to compare the accommodative lag response and accomodative adapation obatianed with different contact lens designs.

  • The average level of blood thinning, resulting from an individual weight determined dose of Clexane, when given to women after caesarian section to prevent blood clots.

    Following major surgery patients are at increased risk of developing blood clots in the veins of the lower limb and in some patients these may dislodge, travel to the lung as pulmonary emboli, resulting in breathing difficulties and rarely death. The situation is no different after caesarian section, where patients are at increased risk of blood clots, however the risk is not the same for all but influenced by factors such as previous history of blood clots, the need for emergency surgery, age and body weight. After your surgery we can minimize the risk of blood clots by mobilizing you as soon as possible, using below knee compression stockings, which prevent pooling of blood in calf veins and in certain patients by once daily injections under the skin of a blood thinning low molecular weight heparin drug (LMWH) called enoxaparin. For many years the dose of enoxaparin has been fixed and not adjusted for body weight, however there is evidence from studies in overweight non-pregnant patients that as body weight increases an increase in dose is required to maintain prevention. Pregnancy also alters the way these enoxaparin is handled by the body resulting in an increase in the dose required (at the end of pregnancy and immediately after delivery) to provide the same action as in the non-pregnant patient. Recently, the Royal College of Obstetrician and Gynaecologists (RCOG) in the United Kingdom have updated their guidelines for prevention of thrombosis after caesarian section and recommend that patients classified as intermediate risk or greater should be given LMWH with the dose determined by their actual body weight at 8 -16 weeks of gestation (usually referred to as the booking weight). We believe that you fall into the intermediate (or high) risk category and therefore would benefit from having LMWH preventative treatment. The dose given to you will be that recommended by the RCOG guideline and will be calculated based on your body weight at the time of registering for care at the Mercy Hospital for Women. For patients of less than 90 kg you will receive what for many years has been the standard dose of enoxaparin. For patients above 90 kg you will receive a dose greater than this fixed dose, which we believe is safe and is likely to result in better prevention of clots compared to the usual dose. We are asking that you consent to having three samples of blood (10 mls each) taken and analyzed for LMWH blood thinning activity (antiXa levels). The first and second samples will be taken immediately prior to & then four hours after your first preventative injection some 4-12 hours after completion of your caesarian section. A third sample will be taken four hours after your third or fourth dose given on the day prior to your discharge from hospital. An additional small plastic cannula will be inserted into a arm vein at the time of your caesarian section and the first blood sample taken at that time. A second sample, hopefully via the cannula, will be taken 3 – 5 hours after the injection of Enoxaparin some 4-12 hours after your caesarian delivery. The third sample will require a separate blood test to be taken. The study does not change the obstetric or anaesthetic management of your delivery. Breast feeding is considered safe whilst on enoxaparin. All blood thinners lead to a slightly increased risk of wound and uterine bleeding. We don't believe that the risk of bleeding is increased over that seen in non pregnant patients given enoxaparin to prevent blood clots following surgery.

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