ANZCTR search results

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

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31330 results sorted by trial registration date.
  • A pilot assessment of the feasibility of a notification system for patients with high-risk laboratory abnormalities in acute surgical wards

    In a previous audit, we retrospectively studied 418,897 batches of tests in 42,701 patients for a total of 2.5 million individual measurements of nine laboratory results (Loekito et al, Common laboratory tests predict imminent death in ward patients, Resuscitation 2013; 84(3):280-285). We identified simple laboratory abnormalities (e.g. high plasma urea, low blood bicarbonate level, low albumin), which either alone, but even more so when clustered together in particular pattern were associated with a higher risk of poor outcome (MET call, ICU admission or death) by the following calendar day. This finding suggested that, using routinely measure laboratory results, we might be able to identify those patients, who are at high risk of such outcomes and that, we might, therefore, be in a position to notify the ward where these patients are located of such increased risk. In this pilot study, we plan to extend our assessment the feasibility of such a notification system following a pilot study approved by the Human Research Ethics Committee in 2011. Specifically, we plan to continuously scan the raw data emerging form the pathology lab computers with focus on the 8th floor wards. Then, using a computerized risk identification system based on our retrospective analysis, we plan to identify patterns of laboratory data that identify patients at high risk of the above adverse outcomes by the next calendar day. Once such identification has been achieved, we plan to send every second notification to a dedicated pager carried by the Medical Emergency Team (MET) registrar, who will then visit the patient, review his/her laboratory results, contact the primary team to inform them of the laboratory concerns and modify treatment (if appropriate and agreed) following such discussion . Such notification will occur electronically by automated messages sent to the pager. The purpose of the pilot study is to assess: 1. How many notifications such a system would generate per day for the 8th floor wards; 2. Whether such a system can reliably deliver such notifications; 3. How many at risk patients are identified by such a system and how many are missed per month; 4. The outcome of patients identified by such a system.

  • Evaluation of a telephone counselling intervention for people with asthma.

    This study aims to trial an intensive telephone counselling service for adults with poorly controlled asthma. We aim to improve asthma control and therefore reduce asthma flare-ups, hospitalisations and absenteeism.

  • Next Generation Sequencing and Induced Pluripotent Stem Cell Applications in Genetic and Inheritable Forms of Renal Disease

    Recent advances in genetic sequencing technology have resulted in remarkable improvements in the speed, throughput and cost of sequencing all, or part, of an individual's genome. Our hypothesis is that emerging high throughput sequencing technologies will lead to the rapid identification of new disease genes in genetic renal disease. This project will attempt to elucidate the genetic basis for inheritable kidney disease using next generation sequencing (NGS). The NGS employed may be targeted to a panel of genes of interest, to the whole exome (i.e. canonical protein-coding genes), or the entire genome. The patient cohort will include those whose family history and/or phenotype strongly suggests a genetic aetiology and in whom routine genetic testing is: a) not clinically available b) not feasible given high genetic heterogeneity of the suspected disorder, or c) has failed to arrive at a diagnosis for the likely disorder. Patients will be seen and assessed by a nephrologist and/or clinical geneticist in a Renal Genetics Clinic. Patients meeting minimum requirements for participation will be offered enrolment to the study and informed consent will be obtained. Once consent has been given, a DNA sample will be obtained via a blood test or buccal swab. The DNA will be analysed using NGS technologies. Where possible, family members including parents, siblings and possibly offspring of the affected individual will be recruited and included in the NGS testing. Genomic testing on first-degree relatives is necessary in most cases for the accurate interpretation of genetic variants found in the affected patient. Disease-causing mutations will be specifically sought in genes thought to be related to the patient's condition. If found, these variants will be confirmed with specific testing in a clinical laboratory, if available. Validation studies may be performed in a research capacity on selected novel potentially disease-causing variants or where disease pathobiology is not known. This will include patient-derived induced pluripotent stem cell (iPSC) validation after further patient consent for skin biopsy, urine sample, blood sample or buccal swab. iPSC technology enables ex vivo “disease in a dish” cellular and functional research of human disease owing to the ability to redifferentiate iPSC to many different cell types and thus model and validate how a genetic variant may mediate disease. Mutations previously reported to be disease-causing may also be discovered in genes not related to the patient's condition. Participants will be informed of known or expected, disease-causing variants in primary genes of interest. If chosen at the time of consent, participants will be informed of mutations in genes predicted to be associated with unrelated disease, and for which intervention is available.

  • Standing Tall - a home-based exercise program using mobile technology for preventing falls in older people

    Accidental falls remain an important problem for older people. Exercise has proven to be the single most effective intervention to reduce falls. However, sustained adherence to these interventions is poor. Our Standing Tall program is designed in line with evidence-based, best-practice principles for fall prevention that will not only aim to improve balance and reduce falls but also has the potential to maximize long-term adherence.

  • Evaluation of the Impact of Exercise on the Performance of an Artificial Pancreas

    Insulin delivery via an insulin pump can mimic the normal action of the pancreas more closely than multiple daily injections of short and long acting insulin. With the development of continuous glucose monitoring devices, glucose levels can be measured continuously over 24 hours. These two devices have now been linked by a computer to create an “artificial pancreas” or Closed Loop system. The computer’s function is to calculate accurately the amount of insulin to be delivered by the pump based on the sensor glucose readings. Overnight Closed Loop systems have been tested in both children and adults with Type 1 diabetes. Overall, the results show that the systems are safe and effective. However, important gaps in our knowledge remain to be explored. For example, while exercise is healthy for people with diabetes it can result in unpredictable changes in glucose levels that may challenge an artificial pancreas. In addition, different types of exercise have differing effects on glucose levels in people with Type 1 diabetes. Short intense bursts of exercise (anaerobic exercise) may initially increase glucose levels while less intense exercise (aerobic exercise) tends to reduce glucose levels. This study aims to collect information about how well the Closed Loop system is able to control glucose levels of people with type 1 diabetes when they undertake aerobic and anaerobic exercise. Outcomes of interest will include the risk of hypoglycaemia and time in healthy glucose range. Insulin and counter-regulatory hormones will also be measured providing insights into changes in glucose levels with exercise in Type 1 diabetes patients.

  • The effects of massage therapy on secondary conditions in people with spinal cord injury: psychological and physiological outcomes

    This RCT investigated the efficacy of massage therapy as a non-pharmacological, non-invasive treatment for people with SCI. It found that massage therapy can provide improvements in secondary conditions of SCI such as pain and fatigue

  • Benefits to early identification of Obesity Hypoventilation Syndrome (too shallow or too slow breathing) in obese patients by measuring blood carbon dioxide levels while lying flat and sitting upright.

    The aim of this study is to identify obese patients who are at risk of developing Obesity Hypoventilation Syndrome (OHS) by investigating the relationship between daytime measures (including supine hypercapnia (elevated carbon dioxide levels when lying flat), distribution of body fat, and lung volumes) with the presence of hypoventilation during sleep. Hypothesis: Supine hypercapnia is a useful marker for identifying sleep hypoventilation, an early sign of the development of OHS.

  • The effects of alcohol consumption on blood pressure in women

    Alcohol consumption by Australian women, especially younger women, has been steadily increasing together with the prevalence of episodic or binge drinking by such subjects. The increase in alcohol intake has been occurring in the setting of an increased public health recognition that the regular consumption of 1-2 standard alcoholic drinks per day may confer protection against coronary artery disease. However, the balance of potential risks and benefits for alcohol consumption have, more often than not, been generated on the basis of data from studies in men. This is especially true with respect to the effects of alcohol on blood pressure and hypertension. There is continuing controversy with respect to the amount of alcohol which will influence blood pressure in women and uncertainty as to the direction of any effect. Population-based epidemiological studies suggest that low level alcohol consumption (4-7 drinks per week) may lower blood pressure in women while higher levels of consumption (2 or more drinks per day) have been associated with higher levels of blood pressure. The present proposal will directly test these assumptions by measuring BP over 24 hr on a carefully controlled basis in women who are drinking at these levels over 4-week periods. The results will be compared to levels of BP measured after 4 weeks of abstinence from all alcohol.

  • The effects of alcohol consumption on cardiovascular risk in patients with type II diabetes mellitus

    The current epidemiological literature suggests that regular higher consumption of alcohol raises blood pressure (BP). In view of the well-known association between BP and cardiovascular disease (CVD), and the fact that patients with diabetes have increased risk of CVD, this trial tests the hypothesis that a reduction in alcohol intake in Type II diabetic patients who are regular drinkers, will reduce cardiovascular risk.

  • Researching Intervention in Chronic Cough in Kids Study

    ARI in children is a leading cause of hospitalisation and preventable death and repeat episodes in infancy are associated with an increased risk of chronic lung disease. Cough in children, commonly triggered by a viral ARI is a substantial cause of morbidity and associated health and societal economic costs. Chronic wet cough in children implies increased airway secretions and lower airway infection. This novel proposal aims to determine whether a validated evidence-based cough algorithm initiated at the development of chronic cough, defined as >4 weeks duration, following an ARI improves clinical outcomes in Indigenous children compared to standard care.

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