ANZCTR search results

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

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31346 results sorted by trial registration date.
  • Exercise intervention for subacromial impingement syndrome. A randomised controlled trial of two rehabilitation protocols.

    Exercise therapy has been shown to be effective in treating subacromial impingement syndrome. The purpose of this research project is to compare two different exercise treatment protocols. The first protocol has been researched and shown to be of benefit. The second protocol has a sound physiological basis and has been used by therapists for many years. This will be the first time it has been the subject of a research project. If proven to be effective the second protocol will simplify the treatment of subacromial impingement syndrome.

  • Video-game based exercises for older people with chronic low back pain.

    The aim of this study is to investigate how well people with low back pain can manage their symptoms following a video-game exercise program. We are specifically interested in people who are currently awaiting treatment for their back at the Physiotherapy Department of Westmead Hospital. Low back pain is the leading cause of disability in Australia and is more disabling in older people. Exercise programs are frequently used to treat low back pain and are known to offer moderate improvements for pain and function. However, usually exercise programs require supervision and the need for patients to travel to treatment sites, which can be problematic for older people with disability. Additionally, limited availability of health resources and an increasing number of people with chronic diseases means patients are often on long waiting lists for treatment. Video-game exercises for low back pain could be particularly useful in older people because they can be implemented at home and therefore reduce the need to travel to treatment sites. This has the potential to reduce the number of people waiting for treatment in public hospitals and reduce management costs of chronic low back pain. Video-game exercises are starting to be used to treat a variety of conditions and have been shown to increase motivation for completing a home-based exercise program. Therefore, this study will determine whether video-game exercises done in the home are effective in the management of low back pain.

  • An early phase study of ABT-199 in combination with tamoxifen in metastatic oestrogen receptor positive breast cancer

    This is a study exploring the safety and efficacy of the combination of ABT-199 and tamoxifen in patients with metastatic ER-positive breast cancer. Who is it for? You may be eligible to take part in this study if you are aged over 18 and have metastatic breast cancer that is oestrogen receptor positive. Study Details Participants are recruited into either the dose escalation phase or dose expansion phase of the study depending upon when they decide to enrol. Before the study starts, they are asked to sign a consent form. Each participant then goes through a series of tests to see whether the study is suitable for them. These tests include reviewing the participants medical and medication history, a physical examination, an electrocardiogram (ECG), CT and bone scans (to locate and measure tumours), taking urine and blood samples for testing and asking about how able they are to do their usual daily activities. If a participant's test results are satisfactory, they are enrolled into the study. They are asked to visit the study hospital once a week for the first 4 weeks, and then at least once a month after that. Both the study medications (ABT-199 and tamoxifen) are tablets to be taken once a day by mouth with breakfast and a glass of water. Participants are given their first dose of both study medications in the hospital clinic. Subsequently, both tablets are provided for the participants to take at home every day with clear instructions on how to take the tablets. During the visits to the hospital, each participant has blood tests, CT scans and bone scans (if applicable) to determine if they are responding to treatment and to ensure that they are not having major side-effects as a result of the treatment. They are also asked if they are happy to have tissue biopsies of their cancer about a month after treatment. This is optional but strongly encouraged as it provides valuable information about how the drug affects the cancer. Each participant continues to take the study tablets as long as they are able to tolerate them, and if their cancer continues to respond. Each participant is monitored for side-effects after they have completed the study. Participants can, of course, choose to withdraw their participation from the study at any time.

  • Growth Hormone testing after stroke (GROWTH)

    Ischaemic stroke may affect a number of hormone pathways involving the pituitary gland in the brain, including the production of human growth hormone (HGH). Disruption of HGH production may contribute to a number of the long-term clinical symptoms experienced by stroke survivors. This study aims to investigate whether HGH deficiency is common in stroke survivors. This is a hypothesis-generating pilot study which may lead to bigger studies in the future.

  • Concordance of temperature measurements in the preterm and term infant using oesophageal and axilla method

    The study will compare the oesophageal and axilla method of temperature taking and evaluate levels of agreement. All infants who are admitted to the neonatal intensive care unit, who have parental consent will be eligible for enrolment. Each infant will have an OGT/NGT inserted which incorporates a thermistor so the clinician can monitor core temperature on a continuous basis. Infants will also have their axilla temperature taken at the relevant care times. Each infant will be enrolled in the study for no longer than one week. We hypothesise at the oesophageal method of temperature taking will be in agreement with the axilla method of temperature taking.

  • Developing an educational intervention for high risk women with Gestational Diabetes Mellitus (Eat for your baby)

    Objectives: The approved project aimed to develop an effective educational program for use by Australian women with gestational diabetes mellitus (GDM) and by health professionals involved in their care. Educational materials from this project include an information booklet, a web-based program that can be accessed at an information kiosk (touch screen computer) at the hospital diabetes clinic, home PCs, and mobile technologies. Educational materials are initially available in English and Vietnamese languages. Programs contain culturally appropriate information such as typical food for the different ethnic groups, relevant in the area. Methods: Pregnant women aged 18-45 years with GDM who have a singleton pregnancy, are eligible to participate in this study. Women who agree to participate in the study will be given a participant information sheet and consent form. Participants will be recruited from the Pregnancy diabetes Clinic, at Sunshine Hospital and introduced to the GDM educational modules using the touch screen computer located in the clinic. Participants will also be given the URL to access to the program and they can learn the modules at home by using their home PCs, mobile phones, or tablets. At the end of the 4 weeks programs, participants will be asked to complete the questionnaire. The final result will be analysed by using statistic software SPSS v. 20. An appropriate statistical analysis will be used to find out the effectiveness of a web-based educational program on women's knowledge of GDM, including the influence of the program on weights of the women after delivery, baby weights and blood glucose level after delivery. The biostatistician will be consulted when the study is published.

  • Treatment for Children with Childhood Apraxia of Speech

    The aim of this study is to explore the effectiveness of Kaufman Speech to Language Protocol in improving the accuracy of words in children with CAS. The hypothesis is that the implementation of the K-SLP approach for CAS will result in more accurate speech production in target words than no treatment.

  • Acceptability and impact of a web-based Lifestyle and sElf management Education Program (LEEP) for people with epilepsy

    People with epilepsy consistently report the importance of lifestyle factors that can predispose a seizure. Despite this, lifestyle education is not a standard feature of patient care in clinical practice. Using a randomized controlled trial the objectives of this study are– (1) to inform clinical care practice by examining the impact of a Lifestyle Education Intervention (LEEP) on seizure frequency, well being, quality of life and resilience, (2) to provide information related to seizure control and health related quality of life related to lifestyle self-management, (3) assess the acceptability of LEEP to consumers and (4) to translate the package to practice in a sustainable and effective manner. The study will use a randomized controlled trial design to test six hypothesis which are as follows - H1 Lifestyle self-management education for people with epilepsy program (LEEP) will make a difference seizure frequency; H2 LEEP will improve the patient’s experience of subjective wellbeing; H3 LEEP will make a positive difference to resilience scores; H4 LEEP will improve the person’s health related quality of life (HRQoL); H5 LEEP will improve the person’s self management abilities; and H6 LEEP will be acceptable and affordable to people living with epilepsy. The objectives of this study are– (1) to inform clinical care practice by empirically examining the impact of a Lifestyle Education Intervention on seizure frequency, wellbeing, quality of life, self management abilities and resilience in order to reduce frequency of seizures and unplanned emergency department and hospital re-admissions (2) to provide information related to seizure control and health related quality of life, enhancing resilience and self management and (3) to translate the education package to practice in a sustainable and cost effective and acceptable manner.

  • Preventing tooth decay in children in a remote community in Australia.

    Background: The aim of the study is to reduce the high prevalence of tooth decay in children in a remote, rural Indigenous community in Australia, by application of a single annual dental preventive intervention. The study seeks to (1) assess the effectiveness of an annual oral health preventive intervention in slowing the incidence of dental caries in children in this community, (2) identify the mediating role of known risk factors for dental caries and (3) assess the cost-effectiveness and cost-benefit of the intervention. Methods/Design: The intervention is novel in that most dental preventive interventions require regular re-application, which is not possible in resource constrained communities. While tooth decay is preventable, self-care and healthy habits are lacking in these communities, placing more emphasis on health services to deliver an effective dental preventive intervention. Importantly, the study will assess cost-benefit and cost-effectiveness for broader implementation across similar communities in Australia and internationally. Discussion: There is an urgent need to reduce the burden of dental decay in these communities, by implementing effective, cost-effective, feasible and sustainable dental prevention programs. Expected outcomes of this study include improved oral and general health of children within the community; an understanding of the costs associated with the intervention provided, and its comparison with the costs of allowing new lesions to develop, with associated treatment costs. Findings should be generalisable to similar communities around the world.

  • Randomised trial of adjuvant versus delayed stereotactic radiotherapy to resection cavity of brain metastases and quality of life outcomes

    The study aims to address whether the timing of stereotactic radiotherapy (SRT) after surgical removal of brain metastases impacts on quality of life; that is, whether treatment on local recurrence (disease returning at the surgical cavity) impacts on quality of life more than upfront SRT following resection of brain metastases. Who is it for? You may be eligible to participate in this study if you are aged 18 years or above and have had 1-4 brain metastases surgically removed. Study details: After surgical removal of brain metastases, in the absence of further treatment, about half of patients will develop a recurrence (disease returning) within the surgical cavity(s), while about half will not. For patients who had 1-4 brain metastases surgically removed, SRT targeting the surgical cavity(s) has been shown to provide local control rates of 70-90% at 1 year. Nevertheless, approximately 50% of patients are destined to never recur at the surgical cavity(s); hence close observation, with radiotherapy at the first sign of recurrence is also often practised. This approach spares treatment in potentially half of patients. By using regular 3-monthly MRIs of the brain, most recurrences should be detected while they are small and before symptoms develop. The study aims to address whether the timing of SRT after surgical removal of brain metastases impacts on quality of life. We are also studying the effect of treatment on patient’s neurocognitive function (memory, thinking processes). It is hypothesized that delivering SRT on local recurrence is no worse than upfront SRT to resection cavity in terms of patient’s quality of life.

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