ANZCTR search results

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

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32894 results sorted by trial registration date.
  • Diabetes Care Project - how does a specific primary care intervention focused on multidisciplinary teams affect clinical and overall health outcomes when compared to usual care?

    Diabetes Care project - Overview Brief Project Description: The Diabetes Care Project (DCP) is an approximately two-year pilot which is part of the Australian Government’s response to the growing incidence of chronic disease in Australia. The pilot will test new ways of providing more flexible, better coordinated care, to improve the management of care for people with diabetes. Approximately 150 general practices and over 10,000 patients across three states will be participating in the pilot. What does the project involve? The project is piloting four key changes in how care is delivered to people with diabetes: 1. A new IT tool will be used by the care team to support care planning, share information with the patient and the team, and support a streamlined referrals process 2. An education and training program will ensure that people (both practitioners and people with diabetes) can navigate the resources available to them and improve people’s understanding of diabetes management. This training will be delivered online, in person, and on paper. 3. A new funding model will make more funding available for the care of those with the greatest need, and will reward practices for improving patient health outcomes, improving patient experience, and delivering best-practice standards of care. This funding model will only replace care planning MBS items and those items associated with diabetes-related PIPs/SIPs—typical GP consults continue to be claimed through Medicare 4. A new Care Facilitator role will be created. Care Facilitators, in collaboration with the general practice team and other members of the care team, will support the patient in finding the best available care options To ensure proper evaluation of the impact of the pilot’s new model of care, participants must experience a different mix of arrangements. After enrolling, each practice will be placed into one of the following three groups: 1. Control Group: This group practices care as usual with no major changes 2. Intervention Group 1: care is funded as usual. Practices will receive support through a new online IT tool and there will be a greater focus on care coordination (changes 1-2 above) 3. Intervention Group 2: This group introduces a Care Facilitator role in patient care, support from a new online IT tool, and new funding arrangements for practices and allied health professionals (changes 1-4 above)

  • Pilot Study of the V501 Product - Protocol 501: A pilot study of the ForSight Ocular System on Safety and Efficacy in Anterior Segment Eye Disease in Australia

    Pilot study of sustained release Ocular System for treatment of Anterior Segment Eye Disease to determine Safety and Efficacy of the ForSight V501 Product. Data will be analysed qualitatively, a formal statistical hypothesis is not being tested in this pilot study.

  • Reduction of sternotomy pain with “self-hug"

    A sternotomy (cut through the breastbone) for heart surgery is associated with some pain. The pain can be increased with activities like mobilisation but also deep breathing and coughing. We intend to assess whether the pain is less with self-hugging the chest (arms around the shoulder pulling them together) compared to the standard method of compression of the chest with the hands crossed over a pillow in front of the chest.

  • Computer Based Rehabilitation of Cognition in healthy elderly participants.

    The aim of this project to investigate the effects of computerized cognitive rehabilitation on healthy elderly. This project is initiate and replicate from schizophrenia project which having problem in recruiting the participant. The project looks at the importance of electrophysiological measures as indices of cognitive decline and rehabilitation in healthy elderly

  • Effects of a 12 week yoga program on negative moods in post- cardiac rehabilitation patients

    Cardiac rehabilitation programs have been proven to improve a range of cardiovascular and psychosocial risk factors in cardiac patients; however, the decline in sustained exercise in post-cardiac rehabilitation patients suggests the need for interventions to both maintain physical activity as well as offsetting the risks of future cardiac incidents. Evidence supports the use of yoga highlighting strong adherence rates to yoga exercise and significant improvements in stress, depression, anxiety and physical aspects of health in a range of healthy and clinical populations. This current study aims to determine whether a standardised yoga intervention will improve stress, anxiety, depression, cardiovascular function and cognitive function in post-cardiac rehabilitation patients. This is a 16 week randomised control trial using a range of psychological and physical tests to determine the effects of a 12 week yoga intervention and whether beneficial effects persist 4 week after the end of the intervention.

  • PUMA: A pilot study to assess the utility of magnetic resonance imaging in the staging of liver fibrosis.

    The purpose of this study is to explore the potential for a non-invasive MRI-based method to diagnose and quantitate liver fibrosis. The results will be compared to the current standard of care which is the histopathologists visual examination of tissue obtained via an invasive liver biopsy as well as FibroScan an ultrasound-based liver imaging method.

  • A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability in Patients With Celiac Disease

    This a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability in patients with celiac disease who are on a gluten-free diet.

  • Benztropine for the relief of acute non-traumatic neck pain – a randomised trial

    Patients present to the Emergency department with acute cervical muscle spasm and pain, which may be spontaneous in onset or related to non-traumatic twisting events. In lay speech this may be referred to as a ‘wry neck’. Conventional analgesics such as paracetamol, NSAIDs and oral opoids are the mainstay of treatment for wry neck, but often provide inadequate pain relief. Centrally acting anti-cholinergic drugs are used for the relief of pain/spasm from the chronic condition of idiopathic cervical dystonia and from drug induced dystonic reactions. The use of these drugs for acute spasmodic neck pain has been poorly studied. There is a single study in the literature assessing the centrally-acting anti-cholinergic drug benztropine (trade name cogentin) in the relief of pain and spasm from this condition. This is a case series of 5 patients with acute pain and spasm of the neck and demonstrated remarkable relief of pain and improvement in range of motion in all patients following an intra-muscular injection of benztropine. Our hypothesis is that IM benztropine will provide relief of neck pain and improve range of neck movement in patients presenting with wry neck. We aim to compare the effect of 2mg IM benztropine with placebo on pain scores and range of motion in patients presenting to the ED with wry neck.

  • When reconstructing defects in the skull is it safer and more cost effective to use a patients own bone or a custom made titanium plate

    Cranial bone defects are often left following brain surgery usually to allow swelling of the brain to recover before subsequently re-implanting protective covering of the brain at a later time (cranioplasty). These procedure are performed anywhere over the the cranial vault, either unilaterally or bilaterally. The original piece of bone (autologous bone plate = bone flap) is placed in a sterile container and stored in a refrigerator at temperature of -40degrees celcius. Weeks or months later, when the brain is relaxed, the scalp well healed, and the patient’s medical condition permits, the individual is taken back to the operating theatre and the bone is reimplanted (A procedure known as an autologous cranioplasty). The aim of the procedure is to restore cosmesis and protection to the underlying brain and it can sometimes also improve neurological symptoms by unknown mechanisms. Unfortunately these aims are not always achieved and whilst technically straightforward the procedure is known to be associated with a number of complications. Two of the most significant of which are infection (such that the bone flap needs to be removed and replaced) and resorption (such that the protective function is compromised). A less severe but cosmetically significant complication is injury to the frontal branch of the facial nerve during cranioplasty leading to weakness of eyebrow elevation. Between 2004 and 2009 in Western Australia 164 patients required either a unilateral (n = 78) or bilateral (n = 86) decompressive craniectomy for trauma. Of those patients that survived 138 had a cranioplasty procedure and in this cohort there was a high rate of infection and bone flap resorption. Infection A number of reports have now documented the higher than expected incidence of infection following decompressive craniectomy and subsequent cranioplasty. Within the Western Australian state-wide neurosurgical service the overall infection rate for cranial procedures has been consistently audited at 1 – 2%, however within the post-traumatic craniectomy/cranioplasty cohort of 138 patients, sixteen (11.6%) had to have the bone flap removed because of infection. It is not known why the infection rate is so high but a number of reasons have been proposed e.g. skin colonisation whilst in hospital, factors relating to long-term storage of the bone flap, immune compromise following trauma and reoperation. Some studies have reported lower rates of infection when using custom made titanium or ceramic cranioplasty plates however, meaningful interpretation of the published literature is difficult because other studies have demonstrated precisely the opposite. Bone flap resorption The incidence of bone flap resorption has been reported between 10% and 50% Within our post traumatic cohort, 10% of the bone flaps were so severely resorbed that they needed to be replaced. A further 12% showed significant radiological resorption and whilst these were not replaced they could be adjudged to have failed because there is concern that they do not provide adequate protection. In each case of absolute cranioplasty failure (overall approximately 20%) the patient requires readmission, a second operation to remove the bone flap, prolonged antibiotic therapy (in the case of infection), a custom-made titanium plate constructed and readmission for a third surgical procedure. The question addressed in this study is whether it would be more efficacious and cost effective to insert a custom-made titanium cranioplasty as a primary procedure.

  • Investigation of whether metformin can be used safely and effectively in patients with type 2 diabetes on haemodialysis

    This is a study aiming to evaluate whether metformin, an antidiabetic medication, can be used safety and effectively in patients with type 2 diabetes who are receiving haemodialysis for their end stage kidney disease. The study runs over 4 weeks and 500mg of metformin (one tablet) will be given to participants after each dialysis session in weeks 2-4 of the study (9 times). We hypothesise that metformin can be safely used in patients with type 2 diabetes with end stage renal failure if dosed based on predicted drug clearance.

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