ANZCTR search results

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

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31604 results sorted by trial registration date.
  • Do pressure garments help burn donor sites to heal?

    Pressure garment therapy (PGT) is well accepted and commonly used by clinicians in the treatment of burns scars and grafts. The medium to high pressures (24–40 mmHg) in these garments can support scar minimisation, and evidence is well documented for this particular application. However, PGT specifically for burn donor sites, of which a sequela is also scarring, is not well documented. This study protocol investigates the impact of a low pressure (4–6 mmHg) interim garment on donor site healing and scarring. With a primary purpose of holding donor dressings in place, the application of the interim pressure garment (IPG) appears to have been twofold. IPGs for donor sites have involved inconsistent application with a focus on securing wound dressing rather than scar management. However, anecdotal and observational evidence suggests that IPGs also make a difference to some patient’s scar outcomes for donor sites. This study is a randomised controlled trial designed to test the effectiveness of this treatment on reducing scarring to burn donor sites. Methods/design This study is a single-centre, single (assessor)-blinded, randomised control trial in patients with burns donor sites to their thighs. Patients will be randomly allocated to a control group (with no compression to donor sites) or to an experimental group (with compression to donor sites) as the comparative treatment. Groups will be compared at baseline regarding the important prognostic indicators: donor site location, depth, size, age, and time since graft (5 days). The IPG treatment will be administered post-operatively (on day 5). Follow-up assessments and garment replacement will be undertaken fortnightly for a period of 2 months.This study focuses on a unique area of burns scar management using a low-pressure tubular support garment for the reduction of donor site scars. Such therapy specifically for donor scar management is poorly represented in the literature. This study was designed to test a potentially cost-effective scar prevention for patients with donor sites to the thigh. No known studies of this nature have been carried out to date, and there is a need for rigorous clinical evidence for low-pressure support garments for donor site scar minimisation.

  • Acute effects of dietary salt intake on blood vessel function

    A high salt diet can damage the blood vessels so that they are less responsive and expand less to the need for greater blood flow. This may cause the accumulation of fat in the artery and lead to heart disease and strokes. There is research to suggest salt can decrease blood vessel function. We are testing whether a salty meal has any short-term effects on blood vessel function in healthy people. We are doing this because we previously showed a higher than recommended salt intake made blood vessel less responsive after 2 weeks.

  • Common thoughts occuring in insomnia and a comparison of psychological treatments

    The study has two main parts: 1) An exploration and comparison of the primary thoughts occuring in people with healthy sleep compared to those with insomnia. This may contribute to future treatment planning and the understanding of insomnia in Australia. 2) A comparison of two psychological treatment components for insomnia (cognitive therapy and problem-solving training) with the purpose of determining the effectiveness of these components for treating insomnia and improving psychological wellbeing. This may contribute to additional treatment options for people with insomnia in the future.

  • Dietary intervention to maintain a consistent rectal volume for patients receiving radical radiotherapy to the prostate: A Randomised Study

    Prostate cancer is the most commonly diagnosed cancer in Australia, making up 16% of all diagnosed cancers (excluding skin cancers). Fortunately, survival in prostate cancer is relatively good, with 84-88% of men living at least five years after diagnosis. Many men who are diagnosed with prostate cancer choose radical external beam radiation therapy (EBRT) for their treatment. EBRT is a radiation treatment usually given by one treatment per weekday over eight weeks. This treatment method offers very good treatment outcomes for controlling prostate cancer, however, it can produce some unwanted side effects. As most men who have EBRT live for at least 10-15 years after diagnosis, minimising these side effects is very important to offer the best quality of life to survivors. Diet invervention is a novel approach to solving one of the biggest challenges in prostate radiotherapy. The prostate gland constantly moves within the patient during radiotherapy because of its position close to the rectum. Changes in rectal filling is identified as the main cause of prostate movement. This movement means a larger volume must be treated to ensure all parts of the prostate receive enough radiation dose to cure the patient. Unfortunately treating a bigger area means healthy tissues next to the prostate such as the rectum and bladder also receive radiation dose. Irradiation of these organs is responsible for the sometimes debilitating side effects associated with radiotherapy. Short term side effects of treatment can include frequent and painful urination, diarrhoea and rectal discomfort. Long term side effects may include frequent, urgent and loose bowel motions, rectal bleeding and some may suffer from urinary incontinence. To reduce dose to these organs and to improve the dose delivery to the prostate they need to be kept stable during treatment. The aim of our study is to test the activity of a diet which is designed to keep the organ positions more consistent to see if it will reduce rectal variation. This has the advantage of empowering patients to be actively involved in their treatment. The study will utilise cone beam computed tomography (CBCT) scanning to assess prostate movement and rectal filling. This study will include 30 participants over 12 months who will be randomly assigned to either study arm. The study will change the diet of 15 patients receiving radiotherapy over the full course of their planning and treatment (about 11 weeks). To make a comparison we include 15 patients on the normal treatment arm who will eat their usual diet. All participants will record a diet diary so we can make sure the diet intervention arm follow their diet and also see what foods are being eaten in the normal diet which may produce bowel gas. CBCT scans will be taken on days 1 to 5 and then every second day for all participants. In this study we will assess if we can obtain reliable information about the rectum and prostate positions and their shape on all CBCT scans. We will then measure the difference of the organ positions between the diet intervention arm and the normal treatment arm and use this information to determine the sample size of a larger follow on study. We will also compare side effects and quality of life between the two study arms to see if there are any unexpected impacts associated with the diet intervention. If successful this study will follow on to a bigger study to see if the diet change is really better at keeping the prostate stable than eating a normal diet. The potential outcome for the studies will be a cheap, non-invasive method of reducing prostate movement during EBRT. This could improve the control of prostate cancer with EBRT and also reduce side-effects from the treatment. There is potential to further reduce the area treated to spare even more of the healthy tissue from radiation dose. The overall outcome would be to offer better quality of life to patients with prostate cancer who are treated with EBRT.

  • Efficacy and safety of Ginkgo Biloba for cognitive function and fatigue in breast cancer patients after primary adjuvant treatment

    This study looks at the effectiveness and safety of treatment with the herb ginkgo biloba in preventing or reducing changes in thinking, memory and concentration (cognitive function) experienced by some women after treatment for early breast cancer. Who is it for? You can join this study if you have been diagnosed with early invasive breast cancer and you have had surgery for this, and have completed primary adjuvant treatment. What does it involve? Participants will be divided into two groups. One group will receive treatment with standardized extracts of the herb ginkgo biloba. The other group will receive a non-active compound (placebo). Both groups will take two tablets (120mg) of study treatment each day for a period of 6 months. All participants will have their cognitive function monitored, along with fatigue, quality of life, blood tests, other possible symptoms, Assessments are at baseline, 6 and 12 months after randomization. Each assessment will take approximately 90 minutes. Most women who receive chemotherapy become tired; some complain of memory & concentration problems. Studies have found subtle cognitive impairment ("chemobrain") that can disturb the return to a normal life and there are no known treatments. Ginkgo biloba has been shown to improve cognition in healthy younger volunteers & improve cognition & mood, without side effects, in elderly people.

  • International Sarcoma Kindred Study: Identification of inherited risk in individuals with sarcoma

    This study aims to identify inherited risk in individuals with sarcoma to aid in the creation of a research resource consisting of biospecimens and associated data. Who is it for? You may be eligible to join this study if you have been diagnosed with sarcoma. Study details Participants will be identified at key sarcoma clinics, asked to complete a questionnarie and provide biospecimens (blood and tissue). The biospecimens will be stored indefinitely in a tissue bank to be utilised by researchers investigating genetic factors contributing to cancer. Information obtained from the questionnaire will be used to ascertain the family history of cancer and other factors that may contribute to development of the disease. The ongoing nature of the project will enable continual provision of important practical information for clinicians and patients leading to more favourable outcomes. Sarcomas contribute disproportionately to cancer burden in our community, because they affect the young, treatment is costly and prolonged and morbidity and mortality is high. Genetic factors appear important in sarcomas, although they have not been well studied for the adult population. Early detection by identifying those at risk may lead to better prognoses. This project aims to create a vital research resource to enable further study into the genetic factors contributing to the hereditary risk of developing sarcoma.

  • A Multicentre, Controlled Trial to Determine the Safety and Efficacy of Hypertensive Extracorporeal Limb Perfusion (HELP) in Treating Patients with Critical Limb Ischaemia (CLI)

    The HELP treatment implants two Peripheral Access Devices (PAD) in to a patients thigh. The devices are connected to a pump (outside of the body). Blood is taken from the upper device and pumped at higher pressure back in to the lower device. The higher pressure increases perfusion in to the diseased limb, reducing pain and promotes growth of new vessels.

  • Augmented Renal Clearance in The Intensive Care Unit - A Multicenter Study

    The kidneys have a range of essential functions in the body. Central to their role in the excretion of waste products and pharmaceuticals is the filtration of plasma (the non-cellular component of blood). During this process, substances (such as glucose, amino acids, electrolytes, waste products and some drugs) leave the circulation and enter the renal tubule. Subsequently, drugs / metabolites can be added to or reabsorbed from the filtrate as it passes along the tubule prior to excretion in the urine. In this manner the kidney is responsible for the elimination of a wide range of drugs and toxins. The rate at which plasma is filtered by the kidneys is referred to as the glomerular filtration rate (GFR) and is largely determined by renal blood blow (RBF). Ideal filtration markers (substances that are only filtered and neither secreted nor reabsorbed by the kidneys) are used to accurately measure GFR (eg Sinistrin), although are not routinely available in a clinical setting. Creatinine is a small molecular weight amino acid derivative that is freely filtered and secreted (10%) by the kidneys. A clinically useful measure of GFR involves calculating a timed creatinine clearance, which reflects the rate at which plasma is cleared of creatinine over a given period of time. Although research has largely focused on patients with declining renal function, there has been little attention on those with augmented renal clearances (ARC). We believe this phenomenon is likely to be common in patients on admission to the intensive care unit, and to date, has been largely under appreciated, although the implications are significant. For example, more rapid excretion of antibiotics may result in sub therapeutic levels, treatment failure or the selection of resistant micro-organisms. These complications in turn could significantly impact on morbidity and mortality associated with the patients ICU stay. This study will investigate this phenomenon in a population considered “at risk”, and define the role of commonly employed therapeutic inventions in promoting augmented clearances. This research will lead to further prospective work on tailoring dosage regimens in patients admitted to the ICU.

  • Evaluation of the effects of oral nutrients on gastric emptying, small intestinal transit, gastrointestinal hormones and appetite in humans

    To investigate the hypothesis that in overweight and obese subjects, oral ingestion of nutrients will be associated with attenuated slowing of gastric emptying and suppression of appetite and energy intake, when compared with lean subjects

  • High- versus low-energy density preloads in overweight/obese men: acute effects on gastric emptying, gut hormone release and energy expenditure

    The primary aims are to determine: i) the acute effect of manipulating the energy density of a meal by increasing its fat content, on subsequent energy intake at lunch, in obese men. ii) whether the effect of energy density is related to changes in mediators of energy intake including gastric emptying, gut hormone release, postprandial thermogenesis and appetite sensations.

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