ANZCTR search results

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

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31349 results sorted by trial registration date.
  • Effect of skin-to-skin care compared with incubator care on cerebral oxygenation in preterm infants on respiratory support

    Skin-to-skin contact (SSC) is defined as placing a baby prone directly onto their mother’s or father’s chest. SSC has advantages for newborn babies. It increases weight gain, reduces mortality, severe infection, and length of hospital stay. There are, however, conflicting results from studies, which measured physiological parameters (heart rate, breathing frequency and oxygen saturation) of preterm babies. Some studies showed an increase in oxygen desaturations and a decrease in regular breathing, others however a decrease in oxygen desaturations during SSC. This uncertainty is a barrier to implementation of SSC especially in very immature preterm babies. Both too much and too little oxygen supply to the brain contributes to morbidity and mortality in very preterm babies. Regional brain oxygenation (rcO2) can now be measured by a technology called near-infrared spectroscopy (NIRS). There is a lack of knowledge about brain oxygenation during SSC and there are no data in very preterm babies during their first days of life. If stability in rcO2 during SSC could be demonstrated this would provide reassurance that SSC is “safe” and could be used in immature babies who are receiving breathing assistance. The primary objective of this study is to measure rcO2 during SCC compared with measurements when the baby is being cared for in their incubator or cot. We aim to include 68 very preterm babies with a gestational age at birth less than 33 weeks receiving breathing assistance. We hypothesise that rcO2 remains stable during SSC (non-inferiority trial). The brain oxygen levels will not be visible to the medical and nursing staff. The primary outcome will be changes (mean of the differences) in rcO2 between SSC (intervention) and incubator care (baseline) (1 hour period for each observation). Secondary outcome will be changes (mean of the differences) in physiological and ventilation parameters e.g. peripheral oxygen saturation (SpO2), fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, inspired oxygen (FiO2), heart rate (HR), and respiratory rate (RR), axillary body temperature between SSC (intervention) and incubator care (baseline), the number of hypoxemic (SpO2 less than 80%) and bradycardic episodes (bradycardia: fall in instantaneous HR by one third of the infants’ baseline HR lasting for at least 5 seconds between SSC (intervention) and incubator care (baseline), changes (mean of the differences) in rcO2, SpO2, fractional tissue oxygen extraction (FTOE) equal to (SpO2 – rcO2)/SpO2, HR, RR, FiO2, number of hypoxemic and bradycardic episodes, axillary body temperature between post-intervention incubator care and pre-intervention incubator care (baseline) (1 hour period for each observation). Further sub group analysis will be changes (mean of the differences) in rcO2 obtained during washout period with those obtained during the main observation period for all three periods (baseline, intervention, post-intervention), changes in rcO2 (mean of the differences) obtained during feeding periods with the rest of the observation period for all three periods (baseline, intervention, post-intervention), changes in rcO2 (mean of the differences) between baseline and intervention period of ventilated infants with those from infants on CPAP and High-Flow nasal cannula.

  • Is antibiotic treatment effective in the management of chronic low back pain? A clinical trial.

    Low back pain is a major public health problem in Australia, ranking 2nd only to cancer as the leading cause of disability. While its prevalence is high, with 80% of Australians experiencing low back pain during their lifetime, effective treatments are limited. In 2013 a study was published which showed that antibiotics were effective in treating a specific type of low back pain involving injury to the disc and oedema of the bone. The trial was based on the hypothesis that following a disc injury (experienced as acute back pain) a secondary infection develops in the disc which leads to a chronic, disabling condition. There has been both immense interest and controversy regarding this trial. While leading, international surgeons suggest that it should be nominated for a Nobel prize, others have called for further research. To date the results of the trial have not been translated into clinical practice, as there are unanswered questions regarding the approach. The specific group of patients who need to be targeted is unclear, the effectiveness of this treatment in conjunction with standard care is unknown, and the costs and associated resistance to the antibiotic therapy has not been investigated. We aim to perform a clinical trial to investigate the effectiveness of antibiotic treatment in a broader group of individuals with chronic low back pain and a disc injury, to determine whether specific Magnetic Resonance Imaging (MRI) changes predict response to this approach, and to examine the cost-effectiveness and antibiotic resistance of this therapy. If antibiotics are found to be a cost-effective and safe treatment for some patients with chronic low back pain, this will provide a novel approach for the prevention of long term pain and disability in these individuals.

  • Evaluating the effects of two approaches to oxygen therapy in Intensive Care Unit patients requiring life support (mechanical ventilation)

    Adequate delivery of oxygen to the organs is essential for human life and all organs of the body require oxygen to function normally. Normally, oxygen makes up just under a quarter of the gas in the air we breathe. In patients who require life support, much higher amounts of oxygen (up to 100% oxygen) can be used. Sometimes it is necessary to provide higher than normal amounts of oxygen to patients on life support in order to achieve normal levels of oxygen in the blood. However, patients who require life support often receive more oxygen than is absolutely necessary to achieve normal oxygen levels in the blood. This commonly causes abnormally high levels of oxygen in the blood. The purpose of this study is to find out whether a conservative oxygen strategy, which avoids giving more oxygen than is necessary to maintain normal levels of oxygen in the blood, improves ventilator-free days (the number of days free from life support) compared to standard care.

  • Plant sterols and Curcumin for the Prevention of Cardiovascular Disease

    Cardiovascular disease (CVD) is the leading cause of death worldwide.Two major risk factors for CVD are high levels of blood cholesterol and inflammation. It is well known that dietary supplementation with foods enriched with plant sterols lower cholesterol levels by 10% in 3 weeks. It is also known that curcumin (found in tumeric) has anti-inflammatory properties. This project aims to investigate if combined dietary supplementation with plant sterols and curcumin reduces blood cholesterol and inflammation to a larger extent than either of the treatments alone.It is expected that participants will have improved levels of blood cholesterol, fatty acids and markers of inflammation as well as an overall reduced 10-year risk of developing CVD. The findings of this research could translate to wider public health benefits through the development of a single functional food that combines both phytosterols and curcumin (e.g. margarine spread or reduced-fat milk). This could be easily incorporated into the regular diet of the general Australian adult population in order to minimise the risk of developing cardiovascular disease.

  • Iron Infusion in Heart Failure Study

    The purpose of our current study is to characterize the immediate short term impact of iron repletion on heart failure patients’ quality of life, exercise tolerance, hemodynamic indices, and serum BNP and ST2 levels; this will in turn add to the growing body of evidence supporting the investigation and treatment of iron deficiency in patients with congestive cardiac failure. Our hypothesis is that intravenous ferric carboxymaltose in congestive cardiac failure patients with concomitant iron deficiency will improve quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire Score), short term exercise capacity (as measured on the six minute walk test), hemodynamic indices (as measured via impedance cardiography), and blood profile (BNP and ST2 levels )when compared with a placebo infusion of 0.9% sodium chloride.

  • Cancer Nutrition and Exercise rehabilitation program (CaNE) for patients with advanced cancer at risk of cancer cachexia syndrome – a phase II feasibility study

    The primary purpose of this study is to evaluate the feasibility of delivering a combined nutritional and exercise intervention in patients with inoperable gastrointestinal (GI) or lung cancer, who are at risk of developing cancer cachexia. The ultimate aim is to determine whether the combined intervention prevents or slows progression of cancer cachexia, and improves performance status, nutritional status, and quality of life. Who is it for? You may be eligible to join this study if you are aged 18 or over, have advanced incurable upper gastrointestinal cancer (including gastric, pancreatic, biliary), or lung cancer, and a BMI of 20 or higher. Study details Participants in this study will be randomly chosen (by chance) to receive either standard treatment or the nutrition and exercise intervention program. The program involves completing two supervised 1 hour strength-based exercise sessions per week, taking a high protein nutritional supplement drink after each exercise session and taking daily fish oil supplement tablets. The program will last for 12 weeks. Outcomes will be measured at 6 weeks and 12 weeks into the program, and at 6 months. Participants will complete a number of questionnaires, will be asked to keep a 3-day food diary and complete strength and walking tests. It is hoped that the findings of this study will provide information on the efficacy and feasibility of the nutrition and exercise intervention in cancer patients, with the hope that it will slow or prevent the development of cachexia in these individuals.

  • A study to assess whether two different doses of antenatal intravenous iron administration (500 mg and 1000mg ferric carboxymaltose) are equivalent in replenishing and sustaining iron stores successfully in pregnant iron deficient women

    The aim of this study is to assess whether two different doses of antenatal intravenous iron administration (500 mg and 1000mg ferric carboxymaltose) are equivalent in replenishing and sustaining iron stores successfully in pregnant iron deficient women.

  • The intramuscular and circulatory responses to various resistance training programs in healthy males

    This study comprises part of a PhD project. It aims to identify what are the primary mechanisms responsible for muscle growth following light-load blood-flow restriction training in the legs, and how it can also affect muscles in other limbs. This will be compared with an equal-intensity training group without blood-flow restriction, a heavy-load resistance training group, and an untrained control group. This will be investigated using a seven week strength training study.

  • Does blocking intestinal sweet taste sensing decrease glucose absorption in patients with type 2 diabetes?

    A family of receptors in the gut recognises all known sweet tasting molecules, including glucose. We, and others, have shown that activation of these ‘sweet taste receptors’ triggers a series of events, mediated by gut hormones, which coordinate the absorption and metabolism of glucose, increasing the capacity for both. These gut hormones increase insulin release in the presence of glucose, and increase levels and function of the major gut glucose transporter, sodium-glucose co-transporter 1 (SGLT-1). Accordingly, the activation status of gut sweet taste receptors has the potential for substantial influence on the control of blood glucose. Patients with type 2 diabetes have increased capacity for glucose absorption from their gut, a trait which can worsen their blood glucose control, and increase disease progression. We recently published important data showing that sweet taste receptors in the duodenum were abnormal in patients with type 2 diabetes during high blood glucose, in association with increased glucose absorption. Blocking duodenal sweet taste receptors is known to reduce the release of gut hormones linked to increases in the glucose transporter SGLT-1 in both rodents and humans, however, it is unknown whether blocking sweet taste receptors in patients with type 2 diabetes can reduce glucose transporter function and, therein, glucose absorption, as a new approach to therapy. We now plan to test the effects of the sweet taste receptor blocker, lactisole, on blood glucose control in patients with type 2 diabetes following a glucose infusion.

  • Improving access to mental health services for children with anxiety.

    Anxiety disorders are the most common mental disorder in children with 1 in 5 experiencing an anxiety disorder before adulthood. The Centre for Emotional Health at Macquarie University has developed a program, Cool Kids, which is effective in treating these disorders. Improving access to care is an essential next-step in the dissemination of effective treatments for anxiety disorders – particularly in Australia, given the vast regional and remote areas. We will conduct a randomized clinical trial comparing treatment to waitlist conditions to evaluate the efficacy of the Cool Kids program delivered online for the treatment of anxiety disorders in young people. The project hypotheses are as follows: 1) the Cool Kids Online program will produce significantly better outcomes than waitlist control (no treatment) on anxiety diagnoses, symptoms and life interference, 2) treatment gains following the Cool Kids Online program will be maintained over a six month follow-up period, and 3) families completing the Cool Kids Online program will report high levels of treatment satisfaction.

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