ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Evaluating a targeted cognitive training program for the treatment of Freezing of Gait in Parkinson's Disease

    We will evaluate whether a course of cognitive training can reduce symptoms of FOG in PD. This study will randomize patients into either a 7-week program of cognitive training or a sham control condition. Treatment response will be assessed by video recordings of specific walking tasks (TUG), taken before and after training. In addition, functional brain imaging whilst patients perform a validated virtual reality gait paradigm will be used to determine the brain activation patterns associated with improvements in FOG. This project will hopefully identify an effective novel treatment for FOG that does not involve pharmacological or surgical intervention. The use of brain imaging will also allow us to see why patients might have differential responses to therapy. Identifying the nature of these relationships will hopefully advance our understanding of freezing and lead to new directions for targeting therapy.

  • Azacitidine use in elderly patients (over 65) with high risk myelodysplasia/acute myeloid leukaemia.

    This study is evaluating the effect of less frequent azacitidine treatment in elderly patients with high risk myelodysplasia/acute myeloid leukaemia. Who is it for? You may be eligible to join this study if you are aged over 65 years and have been diagnosed with high risk myelodysplasia or acute myeloid leukaemia on bone marrow biopsy. Trial details: All participants in this trial will received the drug azacitidine at a dose of 75mg/m2 three times a week (Monday, Wednesday, Friday) for two consecutive weeks every 4 weeks. Participants will be assessed for up to 18 months post treatment in order to evaluate survival and response to treatment.

  • Rapid Administration of iron Polymaltose whilst In the operating Department for patients with iron deficiency The RAPID Study

    The RAPID Study – Lay Description Rapid Administration of iron Polymaltose whilst In the operating Department Background, aims & objectives We aim to show that giving intravenous iron polymaltose over 15 minutes to patients who are under general anaesthesia is safe and not associated with a significant incidence of low blood pressure or other adverse effects. Anaemia and iron deficiency are very common in surgical patients, a recent audit at KEMH showed an incidence of around 18%. In patients undergoing surgery it has been linked with an increased risk of needing a blood transfusion, slower recovery from surgery and an increase in postoperative complications. Patient often suffer from decreased energy, fatigue and poor ability to concentrate, all of which will affect their quality of life. Iron polymaltose is an intravenous iron medication commonly used to correct anaemia and iron deficiency. It has been used in Australia for over 40 years, has a very good safety record and about 4-500 women a year receive iron polymaltose at KEMH currently. It is usually administered as a slow infusion over 1.5 – 2.5 hours in a general ward setting. Common adverse effects can include headache, nausea, flushing and muscle cramps all of which are not as relevant to patients whilst they are under general anaesthesia. Low blood pressure can occur less commonly. Serious adverse events such as anaphylaxis are extremely rare and are not related to the speed at which iron polymaltose is given. Oral iron tablets are not effective in many patients for a number of reasons. It would labour intensive, expensive and inconvenient to bring all these patients back to a ward for a 1-2 hour infusion of iron polymaltose after surgery. Many other intravenous iron preparations, with similar pharmacological properties, have been shown to be safe when given over similar short periods of time and we believe this will be the case with iron polymaltose too. Some anaesthetists (in Australia and NZ) have already administered iron polymaltose in this manner with no anecdotal reports of any problems, however we believe it warrants formal evaluation. Study Population 100 Adult patients with anaemia or iron deficiency, undergoing general anaesthesia. Study Design and Methods Prospective, interventional study. Patients will act as their own controls. Temporary low blood pressure is quite common after the initial injection of anaesthetic medications used to start a patients general anaesthetic. We think that the proportion of patients with low blood pressure following iron polymaltose administration will be significantly less than this. We estimate we would need 83 patients, but because we anticipate some dropouts, or incomplete data we aim to recruit 100 (across both sites). Because anaemia is so common we think we should be able to get this many patients in 12 months or less. Outcomes Primary outcome will be the incidence of significant low blood pressure following the administration of iron polymaltose (definition = systolic BP less than 80). Secondary outcomes, will be the incidence of all adverse effects as ascertained by questionnaire 2 hours and 2 days after surgery.

  • Facilitating training transfer of evidence-based recovery practices through values-focused interventions in a multi-site program for mental health workers.

    The purpose of this study is to investigate the effectiveness of values-focused interventions for mental health support workers on their uptake of newly-acquired evidence-based recovery practices. Main hypothesis: Staff who participate in values-focused interventions (i.e. clarification during training and 12 x 1 monthly values-based coaching) will have higher rates of transfer than those in the control (implementation) condition.

  • The effects of a personalised home exercise DVD program on exercise adherence in patients who have fractured their hip

    Hip fracture is a major cause of death and loss of independence for older people. Exercise prescription after hip fracture is vital to return the patient to the highest possible level of function. Previous studies have shown that older people have difficulty in adhering to exercise programs. This pilot project aims to investigate whether providing the older person with a personalised DVD of their exercises will help them to adhere to the program

  • AspiriN To Inhibit SEPSIS (ANTISEPSIS) trial

    The ANTISEPSIS study will investigate whether the low doses of aspirin being trialled in the randomised controlled ASPREE study work to reduce the severity of infection in the patients who have been taking aspirin. There are numerous pieces of information from test tube and laboratory animal studies that show us that low dose aspirin helps to reduce inflammation which contributes to the disease caused by severe infection. If we can show that low dose aspirin safely reduces the severity of infection in elderly patients we will be able to recommend that it should be taken in all patients who are not at high risk of side effects of this drug. We hypothesise that severe outcomes relating to sepsis in the elderly may be prevented by daily low-dose aspirin. We have the opportunity to test this hypothesis through a substudy of the ASPirin in Preventing Events in the Elderly (ASPREE) trial. ASPREE is a major, Australian/US randomised controlled primary prevention trial of low dose aspirin in the elderly. Our aims are to use the ASPREE randomised controlled trial (RCT) framework and extend data collection relating to sepsis events in its participants to assess our primary endpoint: reduction of deaths contributed to by sepsis in participants receiving aspirin versus placebo. We will also conduct an analysis of two secondary endpoints: reduction of severe infection episodes requiring hospital admissions reduction of ICU admissions among patients hospitalised for severe sepsis The ASPREE study, which will provide a sufficient sample size to assess our primary outcome, represents an ideal chance to assess the impact of aspirin on outcomes of sepsis in the trial population of elderly participants.

  • The prophylactic use of a Bakri balloon for women undergoing caesarean section for placenta praevia – a randomised controlled trial

    Placenta praevia remains a significant cause of peri-partum morbidity. It is associated with an increased risk of postpartum haemorrhage and subsequent surgical procedures to control bleeding including caesarean hysterectomy. The use of the Bakri balloon prophylactically at the time of caesarean section may provide a significant benefit in reducing blood loss and avoiding the need for other more extensive surgical procedures.

  • The Neurocognitive effects of Lacprodan(Registered Trademark) PL-20 in elderly participants with age-associated memory impairment.

    In order to reduce the effects of age-associated memory impairment (AAMI) the Phospholipid Intervention for Cognitive Ageing Reversal (PLICAR) was developed so as to test the efficacy of a milk protein concentrate rich in phospholipids (Lacprodan(Registered Trademark) PL-20) for the improvement of cognitive function in elderly individuals with AAMI. ). On the basis of previous human clinical studies with bovine and plant-derived phospholipids, it is hypothesised that Lacprodan(Registered Trademark) PL-20 supplementation over 180 days will result in significant improvements to memory and other cognitive functions.

  • A Phase II Study of Lenalidomide Induction, Autologous Peripheral Stem Cell Transplant and Adjuvant Vaccination with Autologous Dendritic Cells and Lenalidomide Maintenance in Multiple Myeloma.

    This study is evaluating Lenalidomide induction chemotherapy, autologous peripheral stem cell transplant, and adjuvant vaccination with autologous dendritic cells and lenalidomide maintenance in patients with multiple myeloma. Who is it for? You may be eligible to join this study if you are aged above 18 years and have a bone marrow biopsy confirmed diagnosis of multiple myeloma (MM). Trial details Doctors are looking for better ways to improve the duration that the myeloma remains under control. Previous research within Australia and internationally has shown that many blood diseases may be controlled by utilizing the body’s own immune system to fight the abnormal cells. It is possible this may be the case with the vaccine therapy included in this study. In this research project, the researchers will test whether giving a vaccine of immune stimulating cells after treatment with lenalidomide and transplantation followed by lenalidomide maintenance treatment is better than treatment with lenalidomide and transplantation alone or the current standard chemotherapy treatment with transplantation. Lenalidomide is a man-made drug that alters and stimulates the immune system, causes abnormal plasma cells to die, and it may also interfere with the development of tiny blood vessels that help support myeloma cell growth. The researchers running this study believe that the use of lenalidomide may be the best way of controlling myeloma initially and may enhance the effect of the vaccine. The vaccine used in this study is manufactured using a sample of your myeloma cells combined with immune stimulating cells known as dendritic cells. Dendritic cells are normal immune stimulating cells found in everyone. We have the ability to produce large numbers of these cells in the laboratory from your normal white blood cells. We believe that the combination of large number of dendritic cells carrying fragments of the abnormal myeloma cells may be able to increase your immune system’s ability to fight the myeloma cells, which remain after the initial lenalidomide therapy and bone marrow transplant. This vaccine is an experimental treatment. This means that it is not an approved treatment for myeloma in Australia or other parts of the world. This means that it must be tested to see if it is an effective treatment for myeloma. A total of 22 people will take part in the initial research project. 12 people will actively participate in the vaccination part of the study, whilst the other 10 will act as a control group who have treatment with lenalidomide and transplantation for their myeloma and can be compared to the vaccinated group to see if there are any differences between them. A further 20 patients will be recruited into the study to examine the effects of different doses of lenalidomide with or without steroids on the immune system. Thus a total of 42 patients in total will be enrolled.

  • Changes to visual acuity (clearness of vision) after Hyperbaric Oxygen Therapy

    The purpose of the study is to compare the extent of refractive change in patients receiving HBOT via hood vs mask. The results will aid in the understanding of the etiology of HBOT induced myopia, and aid in choosing the delivery method of HBOT in future treatment sessions. The investigators hypothesise greater refractive change in the hooded group, in keeping with results of previous studies.

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