ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Remote consultation by video-conferencing for people with diabetes

    Diabetes is a chronic disease which has no cure, instead optimal glycaemic control is required to minimize complications. However, only 40% of people with diabetes are achieving target glycaemic control, demonstrating that effective disease management for people with diabetes remains a challenge. For some, particularly in rural areas, not achieving target glycaemic controls is at least in part due to poor access to qualified health care providers. Telemedicine has been shown to be effective in improving access to care and lowering the costs in some disciplines, but its application in chronic diseases such as diabetes is still controversial. This research project is designed to evaluate the accuracy and reliability of clinical decisions made when a diabetic patient is consulted by videoconference. This evaluation will be based on comparing the outcomes of specialist consultations provided through face-to-face encounter with video-consultation. Each patient will be seen by 2 doctors – either two face to face consultations one following the other, or a face to face and video consultation. Since doctors do not always agree on their decisions, this arrangement will enable us to determine whether any difference of opinion is a result of the video-conference method, or just normal variation between doctors. If shown to be as reliable as face-to-face consultation for managing diabetes, there will be valuable evidence to support substituting in-person consultation with video-consultation, which paves the way for at least some specialist consultation for people living in rural areas to avoid the expense and inconvenience of long distance travel. In some cases, it may open the door for specialist advice that is currently not available.

  • A randomised trial comparing two vaginal prolene sling surgeries for female urinary incontinence

    50 females with urodynamically proven stress incontience will be randomised to either Monarc or Miniarc suburethral sling surgery and compared with regard to postoperative pain relief, blood loss, and continence at 6 months

  • Lenalidomide with epigenetic therapy in relapsed or refractory Acute Myeloid Leukaemia (AML)-Phase II

    The outcome in patients with Acute Myeloid Leukaemia (AML) who fail to respond to treatment or relapse after treatment is extremely poor. There is no standard treatment for these patients. This study aims to compare various chemtherapy combinations, comprising romidepsin and high dose lenalidomide, azacitidine and lenalidomide and high dose lnealiodmide alone in the treatment of advanced AML. The study plans to treat 120 patients in a number of sites throughout Australia and New Zealand. This stage of the study follows on from an initial study that aims to find the appropriate dose of romidepsin. The initial study can be found at http://www.anzctr.org.au/trial_view.aspx?ID=343451 Trial details In this study you will be allocated to receive either: the drug romidespin delivered intravenously (i.v) on days 1 and 15, and possibly 8, of a 6-week treatment cycle with 50mg oral lenalidomide on a daily basis on days 8-28; the drug azacitidine delivered subcutaneously on days 1-5 and 8-9 of a 6-week treatment cycle with 50mg oral lenalidomide on a daily basis on days 8-28; or 50mg oral lenalidomide on a daily basis on days 1-28. Your response to the treatment will be assessed after 2 cycles, and overall, your treatment should continue for at least 6-12 cycles. Beyond this time, the decision as to whether or not your treatment continues will be at the discretion of the study's Principal Investigator (PI). Who is it for? This study is open to male or female patients aged 18-80 with either a diagnosis of Acute Myeloid Leukaemia (AML) and failing previous therapy, either primary refractory or relapsed after no more than 3 previous lines of chemotherapy OR a diagnosis of Myelodysplasia transformed to AML after previous treatment. The full details of this study's inclusion and exclusion criteria can be found in the relevant sections within this record.

  • The role of diet choice in long term weight reduction in type 2 diabetes

    The research project aims to show by offering a choice of three different weight loss diets plus the ability to change diet styles throughout the study participants are more likely to remain in the study and more likely to achieve the study goals of a 10% weight loss at 12 months compared with those having usual clinical care.

  • Telephone Coaching for Knee Osteoarthritis

    Knee osteoarthritis (OA) is one of the most common and costly chronic musculoskeletal conditions world-wide and is associated with substantial pain and disability. Many patients also experience co-morbidities such as obesity and cardiovascular disease that further add to the OA burden. Interventions that foster appropriate lifestyle behavioural change, particularly in the area of physical activity, are important for chronic diseases such as OA. Physical activity, encompassing both structured exercise and incidental physical activity, is recommended by OA and general health guidelines because of its positive impact on disease outcomes and health status. Both muscle strengthening and aerobic exercise are effective in reducing pain and improving function in the short-term in patients with knee OA. However, benefits are generally not sustained because adherence declines over time. Interventions are therefore needed to facilitate sustainability of physical activity behaviours in patients with knee OA in order to achieve longer-term clinical improvements and to reduce the risk and impact of associated co-morbidities. Evidence-based strategies to improve uptake and adherence to physical activity and/or exercise interventions for people with chronic musculoskeletal conditions include incorporating face-to-face visits with a health professional, support from telephone coaching, refresher or booster sessions, exercise and physical activity plans based on patient preference and individual goals, an educational component, and optional strategies including log-book recording of participation and step counting. Telephone coaching is a relatively inexpensive intervention using widely available technology. It has been shown to improve physical activity behaviours in older adults and in those with other chronic conditions, particularly if combined with face-to-face visits with a health professional. Thus telephone coaching aimed at changing physical activity behaviours may achieve longer-term improved patient outcomes in those with knee OA but there is limited research in this area. This pragmatic trial will investigate the clinical- and cost-effectiveness of a 6-month physical activity intervention on pain and function in people with knee OA. The intervention package incorporates 5 physiotherapy contacts together with 6-12 telephone coaching contacts. The intervention will be compared to a physiotherapy only condition.

  • Randomised Controlled Trial of Cognitive Behaviour Therapy versus Mindfulness for Adults with Prolonged Grief

    The rationale of the study is to evaluate the relative efficacies of Cognitive Behaviour Therapy and Mindfulness in reducing the symptoms of prolonged grief. This study compares the relative effectiveness of (a) Cognitive Behaviour Therapy, and (b) Mindfulness. It is hypothesised that both arms training will lead to grief symptom reduction but that Cognitive Behaviour Therapy will lead to greater symptom reduction at follow-up.

  • Living Well with Prostate Cancer: A randomised controlled trial of a mindfulness intervention for men with advanced prostate cancer

    This study evaluates an innovative therapeutic intervention to reduce psychological distress and improve quality of life for men diagnosed with advanced prostate cancer. Who is it for? This study is for men who have been diagnosed with advanced prostate cancer in Queensland, New South Wales, Victoria and Western Australia. Trial details In this study participants are randomly (by chance) divided into two groups. One group will receive patient education, i.e. currently available resource and support materials. The other group will receive a telephone delivered mindfulness-based cognitive therapy group intervention. This intervention includes group therapy phone calls for participants led by trained health professionals and daily meditation practice. The duration of this intervention is 8 weeks. Participants will complete questionnaires at 3, 6 and 9 months after enrolling in the study to evaluate their psychological well-being and quality of life.

  • Lenalidomide with epigenetic therapy in relapsed or refractory Acute Myeloid Leukaemia (AML)-Phase I

    The outcome in patients with Acute Myeloid Leukaemia (AML) who fail to respond to treatment or relapse after treatment is extremely poor. There is no standard treatment for these patients. This study aims to investigate the appropriate dose of the drug romidepsin (a type of chemotherapy) delivered with high dose lenalidomide (a type of chemotherapy) in the treatment of advanced AML. The study plans to treat up to 18 patients in a number of sites throughout Australia. The primary aim of this initial study is to find a safe dose of romidepsin when delivered with high dose lenalidomide. This initial stage of the study will flow into a larger study comparing 3 different treatments in advanced AML, however if you participate in this Phase I study, you will not then be eligible for the following Phase II study. Trial details: In this study you will receive the drug romidespin delivered intravenously (i.v) on days 1,8 and 15 of a 6-week treatment cycle at a dose of either 8, 10, 12 or 14mg/m^2, or on days 1 and 15 at 8mg/m^2. The actual dose will depend on what stage of the trial is currently open. At the same time as the romidespin treatment, you will also receive 50mg oral lenalidomide on a daily basis on days 8-28. The strength of the drug and your tolerance of it will be assessed after 2 cycles, and overall, your treatment should continue for at least 6-12 cycles. Beyond this time, the decision as to whether or not your treatment continues will be at the discretion of the study's Principal Investigator (PI). Who is it for? This study is open to male or female patients aged 18-80 with either a diagnosis of Acute Myeloid Leukaemia (AML) and failing previous therapy, either primary refractory or relapsed after no more than 3 previous lines of chemotherapy OR a diagnosis of Myelodysplasia transformed to AML after previous treatment. The full details of this study’s inclusion and exclusion criteria can be found in the relevant sections within this record.

  • A randomised, blinded, controlled study of percutaneous transluminal angioplasty (PTA) for extracranial vein stenoses in patients with multiple sclerosis (MS)

    To assess the safety and effectiveness of percutaneous transluminal angioplasty (PTA) for the treatment of extracranial and/or azygous vein stenosis in MS patients as measured by clinical parameters of physical and mental disability progression.

  • Treatment of Pancreatic Insufficiency Using Creon in Patients with Pancreatic Cancer

    This study is a randomised controlled trial for patients with metastatic or locally advanced pancreatic cancer, comparing a drug named Creon - which acts as a pancreatic enzyme supplementation - to placebo, in order to determine its influence on change in weight. We will also look at the drug's effect on quality of life, nutrition and survival, with our expectation being that Creon will decrease the rate of weight loss, improve quality of life, nutrition and length of life. This study is being performed due to previous research showing a benefit to pancreatic enzyme supplements in patients with pancreatic cancer with a bile duct stent in place to relieve a blockage caused by the cancer. It is known that pancreatic cancer causes weight loss, and thought that poor absorption of nutrients may contribute to that weight loss. This study aims to assess whether aiding the aborption of nutrients leads to better nutrition, weight stabilisation, improved quality of life and improved survival. Trial details In this study you will be randomly assigned to either the active medication (the Creon drug made of pancreatic enzyme), or to an identical, but non-active placebo capsule. In either group, you will take 2 capsules of Creon/placebo with meals, and one capsule with snacks every day. After one month and depending on how you have tolerated the drug, the dosage may be increased to 3 capsules with meals and/or two capsules with snacks, depending on whether you are feeling bloated, flatulent and/or have diarrhoea. Overall, you will continue the treatment for at least 2 months. During the study will be assessed by study personnel including the doctor, nurse and dietitian. The assessments are weight measurement, questionnaires about nutrition, symptoms and quality of life. These visits will be monthly for 2 months, then every three months while you and other participants remain on the study. Who is it for? You may be eligible for this study if you have metastatic or locally advanced pancreatic cancer and aged 18 and over. Full details of whether or not you can participate can be found in the Inclusion Criteria section of this record.

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