ANZCTR search results

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

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31615 results sorted by trial registration date.
  • A Phase III Study Comparing Low Dose Cyclosporine, Methotrexate And Prednisone Versus Standard Dose Cyclosporine and Methotrexate As Graft Versus Host Disease Prophylaxis In Myeloblative Allogeneic Stem Cell Transplantation (ALLG BM10 trial). (Incorporating an Open-Label Sub-study Investigating The Use Of Valganciclovir In The Prevention Of Cytomegalovirus Infection In Hematopoietic Stem Cell Transplant Recipients (ML20712))

    Stem cell transplantation has the potential to cure many patients with blood cancers. These cures occur when immune cells from the donor attack blood cancer cells left in the patient. This is called the graft versus leukaemia (GVL) effect. These immune cells also cause a reaction against the patient called graft versus host disease (GVHD), which can be serious and life threatening. Thus, one of the major goals of transplantation today is is to reduce GVHD and increase GVL. The drugs cyclosporine and prednisone are used to reduce graft versus host disease in over 90% of transplants performed in Australia and New Zealand. The aim of this study is to reduce the dose of cyclosporine which may increase the GVL effect and add a higher dose of prednisone which may inhibit GVHD – this is the intervention. This new combination of these two drugs will be compared to the standard dose of cyclosporine which has been used for many years – this will be the control group. Patients will be followed for 2 years to assess whether this change in drugs will result in more patients being cured of their blood cancers.

  • A randomised, blinded, controlled trial of silicone disposable laryngeal masks during anaesthesia in spontaneously breathing adult patients

    We aim to demonstrate no difference (equivalence) in performance of the LMA® Classic™ compared to the Meditech Systems Limited (MSL) and ProAct (PA) silicone disposable laryngeal masks. The Laryngeal Mask Airway ClassicTM (LMAC) manufactured by The Laryngeal Mask Company Ltd in the United Kingdom is the current ‘gold standard’ for silicone LMAs when inserted for airway management during general anaesthesia. The laryngeal mask airway is a reusable supraglottic airway device that has been available since 1998 and is widely used during elective general anaesthesia where endotracheal intubation is not thought necessary. Newer single-use disposable supraglottic airway devices are now available, which potentially reduce the risk of infection transfer. The laryngeal mask is the most commonly used supraglottic device; its silicone construction ensures that it is easy to insert and minimises airway trauma. The Therapeutics Goods Administration in Australia has recently assessed a number of silicone disposable LMAs, and they are now available for use in Australia. The LMAC is easy to insert, creates an effective airway seal but provides only limited protection against aspiration. The LMAC is predominantly silicone construction with a PVC cuff. The major differences between the LMAC and the disposable devices are that the MSL and PA LMA have no aperture bars on the inferior surface of the laryngeal cuff.

  • The potential of selenium supplements provided as selenium-enriched dairy protein or yeast selenium to improve selenium status

    It is proposed to evaluate a selenised dairy product with regard to its safety and influence on selenium status, using plasma and rectal biomarkers. It will be compared for its efficacy & bioavailability with a selenium yeast product.

  • 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.

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