ANZCTR search results

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

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32699 results sorted by trial registration date.
  • Randomised, double-blind, placebo controlled phase II study of the efficacy of Phospha-E biomarkers of inflammation, in patients with metabolic syndrome and mild to moderate hyperlipidemia.

    The study is for subjects who have a condition called metabolic syndrome. Metabolic syndrome is a condition in which people may have a number of clinically determined symptoms such as abdominal obesity, high cholesterol (lipid) and glucose levels in the blood and high blood pressure, as well as others. Some people may have only some of these clinical symptoms while others may have more. These clinical observations, and the severity of them, are recognised in a number of well known disease states such as cardiovascular disease and diabetes. Vitamin E has been around for decades and is widely used by people for its known antioxidant properties. D-alpha Tocopheryl Phosphate (Phospha-E™) has recently been discovered to be naturally occurring in the body (like vitamin E) and has shown promising effects in laboratory studies on inflammatory markers which are implicated in a number of disease states associated with a condition known as Metabolic Syndrome. The purpose of this study is to see if D-alpha Tocopheryl Phosphate (Phospha-E™) has any effect on your metabolic syndrome. The study would like to determine if D-alpha Tocopheryl Phosphate (Phospha-E™) is able to lower biomarkers such as cholesterol and various inflammatory markers, compared with placebo, a capsule that looks the same as D-alpha Tocopheryl Phosphate (Phospha-E™) but has no active ingredient. These biomarkers are important factors that contribute to the development of metabolic syndrome It is not known whether D-alpha Tocopheryl Phosphate (Phospha-E™) is better than receiving no drug or receiving classical vitamin E, and this is what is to be determined. The study will compare two different doses of the study drug, D-alpha Tocopheryl Phosphate (Phospha-E™) to placebo (an inactive look alike capsule). It will also compare classical vitamin E to placebo.

  • A randomised trial of the effectiveness of soft tissue massage in the treatment of shoulder pain

    The experimental hypothesis is that the addition of specific soft tissue massage will improve range of motion and reported function and reduce reported pain. The findings of this study will assist therapists to decide whether to add specific soft tissue massage to a rotator cuff exercise programme when treating patients with shoulder pain of local mechanical origin.

  • Implantation of marker seeds into the prostate; to improve quality of radiotherapy delivery and to allow dose escalation for men with localised prostate cancer

    This is a study of implantation of marker seeds into the prostate to assess the feasibility of using marker seeds to locate the prostate before daily radiotherapy treatment for men with localised prostate cancer. Who is it for? You can join this study if you are a man aged 50–80 years with localised prostate cancer and you are going to have radiation therapy. Trial details Participants will have three marker seeds inserted under local anaesthetic into the prostate before radiotherapy. The seeds are like small rods inserted into the prostate gland and act as ‘landmarks’ so radiotherapy can be given as accurately as possible. All participants will have radiotherapy for 7 weeks. During the 7 weeks of therapy, X-rays will be taken daily for the first 2 weeks to measure the position of the seeds. After that, X-rays will be taken twice a week for 5 weeks to continue to measure the position of the marker seeds. These seeds will stay in your prostate permanently.

  • The feasibility, acceptability and cost-effectiveness of nurse-led models of chronic disease management in general practice

    The feasibility, acceptability and cost-effectiveness of nurse-led models of chronic disease management in the Australian environment The aim of this project is to address significant gaps in the evidence for a practice nurse-led model of the management of patients with chronic disease in general practice. Our research questions are: 1) is it feasible from a systems perspective i.e., the impact of the changes on the service delivery of chronic disease management through primary care, 2) is it acceptable to key stakeholders as well as to patients/carers i.e., will the necessary changes associated with this model of care develop productive partnerships between health care providers stakeholders and consumers; 3) is it cost-effective within the current regulatory environment and 4) does it have an impact on patient health/quality of life? The chronic diseases to be managed in this study are diabetes Type II and cardio-vascular disease (hypertension and ischemic heart disease). Objectives of the Project: The study will determine if: a) the employment of a practice nurse (PN) in general practice to manage the day to day care of patients (and their carers) with chronic disease is feasible within the general practice environment. Issues to be considered will be the design of the general practice environment, the number of patient consultations per day, descriptions of the scope of practice of the nurse (are there education and legislative changes required to the scope of practice?). b) nurse-led patient care, rather than GP led care, is acceptable to: (i) patients and their carers (ii) staff within the general practice , General Practitioners (GPs), Practice Managers, other PNs) c) it is cost-effective. (i) does the employment of nurses in this capacity increase the number of patients who can be seen within general practice? (ii) is there any impact on the number of patients requiring after hours care (in hospital emergency departments as well as by the practice)? (iii) are waiting lists to see a general practitioner reduced within the practice? (iv) Is the current EPC model for Chronic Disease Management Plans sufficient payment to the practice for the employment of a practice nurse or are other models more cost-effective? The study duration will be 3 years, 12 months of which will comprise the comparison of the two models of care in each of the three participating general practices. The general practices have been purposively selected by their willingness to participate, the distance they are from each other (thus ensuring that patients would not visit one or more of the other practices), their rural classification, they are computerised and employ a PN. The general practices are: • The remote practice is Myall Medical Centre, Dalby Queensland • The rural general practice is Koinonia located in Toowoomba, Queensland • The regional practice is Kingscliff Medical Centre in Kingscliff NSW. This program addresses policy implications associated with the of role chronic disease as a national health priority, the huge burden of chronic disease and the statistical evidence of its growth. Finding better ways to manage these diseases are necessary to GPs who face increasing case loads of patients. This project will inform policy to establish such a role and ultimately improve chronic disease care within primary practice.

  • Omega-3 fatty acids for ADHD symptoms and learning difficulties in children

    The principal aim of this project is to investigate effects of supplementation with the omega-3 (n-3) polyunsaturated fatty acids (PUFA) EPA and DHA on symptoms of attention deficit hyperactivity disorder (ADHD), specifically hyperactivity, impulsivity, inattention and cognitive problems, in 7-12 year old children. We also aim to investigate blood fatty acid profiles before, during and after the intervention. This 12-month controlled intervention trial will be conducted in Adelaide and Brisbane in 2007/08.

  • THE IMPACT OF THREE DIFFERENT GLYCOPROTEIN PLATELET RECEPTOR IIb/IIIa ANTAGONISTS ON GLYCOPROTEIN IIb/IIIa PLATELET RECEPTOR INHIBITION AND CLINICAL ENDPOINTS IN PATIENTS WITH ACUTE CORONARY SYNDROMES

    Our aim is to compare the effects of downstream high-dose bolus tirofiban, double bolus eptifibatide and abciximab on the degree of glycoprotein IIb/IIIa platelet receptor inhibition and cardiac endpoints in high risk acute coronary syndrome patients treated with percutaneous coronary intervention. We also aim to assess bleeding and MACEs in patients wtih GPI and co-administered P2Y12 antagonists.

  • A Study of Belimumab, a Fully Human Monoclonal Anit-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

    The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of 2 different doses of belimumab administered in addition to standard therapy in subjects with active SLE disease.

  • A randomised controlled trial to determine the optimum frequency of Botulinum Toxin injections to the calf in children with cerebral palsy

    Cerebral Palsy (CP) is a disorder affecting around 2 in 1000 live births. Commonly, children with CP have spasticity in their muscles causing stiffness. When Botox (Botulinum Toxin A) is injected into a spastic muscle, it helps it to relax for around 3 months, after which the effect begins to wear off. During this relaxed time, the muscle is able to exercise through a greater range, helping to prevent contractures from forming. Botox is therefore used to both reduce spasticity in the short term, and to slow or prevent the development of contractures in the long term. This in turn, assists to delay corrective orthopaedic surgery until the later childhood years when surgical outcomes are more predictable and longer lasting. Currently, the most important clinical question is how often Botox should be used. More regular injections may provide additional time that the effects of Botox are working, and muscle contractures could be delayed more effectively. The aim of this study is to compare over a two-year period, the effects of Botox injections once a year compared to 3 times a year (every four months). The main measure will be the rate of development of contractures over the two years. Measurements (such as calf strength, questionnaires and blood tests) will also be made to determine whether either program negatively affects the muscle, whether the children in either group have a different level of function or quality of life and whether either program leads to the Botox having a reduced effect over time.

  • A Phase II study in adult patients with newly diagnosed chronic-phase chronic myeloid leukaemia of initial intensified imatinib therapy and sequential dose-escalation followed by treatment with nilotinib in suboptimal responders to determine the rate and duration of major molecular response

    This trial tests the hypothesis that molecular response can be maximised by a combined approach of higher dose imatinib for all de-novo CML patients plus a rapid switch to nilotinib in patients who are intolerant or have suboptimal response to imatinib.

  • Do rapid detection & isolation of colonised patients reduce Methicillin-Resistant Staphylococcus Aureus (MRSA) spread? An epidemiological, economic & modelling study.

    MRSA is a significant problem for hospital patients, causing increased length of stay and risk of complications. It is spread mainly on the contaminated hands of healthcare workers. Control of MRSA within hospitals still remains controversial, with some insisting that swabbing of all patients and use of special isolation precautions is mandatory for prevention of its spread. We plan to test whether swabbing all patients admitted to the intensive care unit and then putting patients who are found to be positive in single rooms and using gloves and gowns for all contact with these patients is more effective at preventing spread of MRSA from patient to patient than what we currently do ie looking after patients in the general ward, wearing plastic aprons at all times and only using gowns and gloves if we are likely to come into contact with bodily fluids (and not swabbing any patients). We plan to use the most rapid tests available to determine whether someone is carrying MRSA on their body which will give us a result within hours compared with the 2-3 days it currently takes to get a result. We also plan to do an economic evaluation to see if the intervention is worth the extra cost.

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