ANZCTR search results

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

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31617 results sorted by trial registration date.
  • The Concord Repatriation General Hospital Intensive Care Quality of Care Study

    BACKGROUND It is speculated that involvement of Palliative Care teams with patients in the Intensive Care Unit (ICU) receiving end-of-life care may lead to better patient, family, and staff satisfaction with the care provided in the ICU, but this has not been studied before. Palliative Care teams have been shown to improve many measures of outcome, such as symptom control, patient and family or carer satisfaction, and health care costs in several other medical settings. AIM The aim of this study is to examine the effect that the Palliative Care team has on outcomes in patients receiving end-of-life care in the ICU. HYPOTHESIS Our hypothesis is that the involvement of the palliative care team in patients receiving end-of-life care in the ICU improves patient and staff quality indicators for end-of-life care. RESEARCH PLAN This pilot study is a single centre, unblinded, prospective, randomised, controlled trial in patients in the ICU, in whom the treating doctors believe that the current medical condition is terminal or pre-terminal, and that treatment should either be withdrawn or not escalated. Patients will be eligible for the study, if they suffer from a terminal or pre-terminal condition, and if the treating ICU physician, in consultation and agreement with the treating parent team, deems it appropriate for end-of-life care to be started, and deems it appropriate that current treatment either should have limitations imposed and should not be escalated, or should be withdrawn or withheld. Enrolment will begin after the treating ICU consultant has discussed the medical issues with the patient and/or their family and has indicated that it is their professional belief that treatment should not be escalated and palliative care should be instituted. Enrolment will be via direct approach from research staff. Consenting patients will be divided randomly into 2 groups. The control group will have usual, standard ICU care. The study group will have usual, standard ICU care, and in addition, a Palliative Care Team will consult. Consenting families will be asked to complete 2 questionnaires; one soon after the initial enrolment discussion, and a second questionnaire after the patient's death or transfer out of the ICU. Medical and nursing staff will also be asked to complete similar questionnaires. The questionnaires will ask questions on several quality indicators for end-of-life care, such as communication, continuity of care, emotional and practical support, symptom management, decision making, and other aspects of support. As outcome data is currently unknown, a blinded analysis will occur after 40 patients have been enrolled to determine the sample size required for significance. We intend to enrol 180 patients, in line with our current predictions for statistical significance. Analysis will be on intention to treat. Non-parametric testing will be used to analyse differences between the two groups. This study is a 3 year pilot study, with the aim of constructing a larger, multi-centre trial after completion. OUTCOMES AND SIGNIFICANCE The primary outcomes will be composite scores for patient/family satisfaction with care in the ICU, composite scores for staff satisfaction with care in the ICU, and length of ICU and hospital stay. End-of-life care in the ICU is currently a significant problem in Australia. With the change in philosophy in medical care from paternalism to consumerism, many patients are now demanding expensive, but futile medical care. Many patients receive treatment and organ support, not because the treatment is indicated, but for other reasons. Palliative Care has been shown to improve end-of-life care in many areas outside of ICU, and has also been shown to reduce health care costs in these areas. We expect this study will be significant in demonstrating that Palliative Care teams can help improve end-of-life care outcomes, and reduce health care costs in the ICU.

  • A Randomised Controlled Trial Comparing Two Different Knee Exercise Programmes in the management of Adolescents with Symptomatic Joint Hypermobility

    Joint Hypermobility Syndrome is a common but poorly recognised condition which mainly affects children. Joint hypermobility or double-jointedness can result in significant symptoms of pain, often described as growing pains, and symptoms of fatigue. This research study aims to find out what the best set of physiotherapy exercises is to reduce knee pain in individuals with joint hypermobility and pain. We are looking to recriut 40 teenagers aged 12-16 with knees that bend backward and are sore and give them 8 weeks of physiotherapy to see if it helps with the pain. Physiotherapy is the recommended treatment in this situation but reaserch to prove that it works has never been done, also different hospitals recommend different types of physiotherapy exercises and we will try and find out which ones work best or if there is no difference.

  • The impact of Biannual followup at a specialist Endocrinology Clinic to manage osteoporosis through medication and lifestyle modification on compliance with medication, incidence of fractures and changes in bone mineral metabolism, in Patients Presenting to Hospital with a Minimal Trauma Fracture

    A prospective study to screen for osteoporosis in all patients presenting to Concord Hospital with a minimal trauma fracture, and to initiate appropriate treatment in osteoporotic patients. The aim is to assess, in a randomised study, the efficacy of semi-annual specialist reviews vs. GP follow-up in terms of compliance and osteoporosis complications.

  • Weight Loss & Cardiovascular Risk in Type 2 Diabetes Study

    The principal aim of this research project is to determine the separate effects of energy restriction/weight loss and aerobic exercise training on blood vessel function in sedentary overweight and obese subjects with type 2 diabetes. It is a secondary aim to evaluate whether physical exercise training and weight loss will enhance antioxidant capacity, reduce oxidative stress and increase nitric oxide bioavailability

  • Prediction of obstructed breathing after elective surgery.

    Up to 20% of patients over 50yr presenting for elective surgery may have episodes of obstructed breathing e.g. snoring, which is likely to worsen and become a significant risk after surgery. Use of a recorder to continuously monitor breathing for the 12 hours immediately after surgery may help us to identify the most useful risk factors to look for during the assessment of patients at the clinic prior to surgery.

  • Treatment of School Refusal

    This project aims to determine if combined cognitive behaviour therapy (CBT) and antidepressant medication (fluoxetine) treatment of school refusing children (11-16.5 years) improves their response to treatment and longer term outcome, compared to CBT only group. In order to determine that this predicted improvement in outcome is due to the active effects of medication rather than expectancy effects associated with taking a pill, a third group comprising CBT + placebo treatment will be included.

  • Neuropsychiatric, Neurocognitive And Quality Of Life Outcomes In Patients With Epilepsy Treated With Levetiracetam (Keppra) Verses Older AEDs As First Substitution Monotherapy.

    Epilepsy is a chronic condition with complex effects on a person’s social, vocational, and psychological function. Physicians are increasingly recognizing that there is more to managing epilepsy than seizure control alone. Side effects of Anti epileptic drugs (drugs used to treat epilepsy), psychiatric and cognitive problems associated with epilepsy are increasingly recognised. Cognition can be loosely explained as an individual’s mental ability to process information and accounts for virtues such as memory, worldly knowledge and problem solving to name a few. It is becoming increasingly recognized that these problems could adversely influence the quality of life of patients, even in those whose seizures are well controlled. The psychiatric and cognitive problems could be due to illness itself or could be due to the side effects of antiepileptic medications. By effectively managing these problems we could maximise the quality of life (QOL) and over all well-being of patients suffering with epilepsy. Only six antiepileptic drugs were available prior to 1990. In the last decade several new anti epileptic drugs have become available increasing our therapeutic options. There has been great deal of research into formulating better anti epileptic drugs, primarily spurred by the fact that the available anti epileptic drugs did not provide adequate control or patients’ were experiencing side effects from drugs. Older Anti epileptic drugs have many undesired side effects. As a group, they have been shown to adversely influence body’s ability to process bodily hormones and drugs. This leads to unwanted side effects such as sexual dysfunction, bone thinning (Osteoporosis), and failure of oral contraceptives to name a few. Side effects such as drowsiness, lethargy and psychiatric and cognitive problems are also more common with older anti epileptic drugs. The newer drugs as a group overall have been shown to have less side effects and are better tolerated. The efficacy of newer drugs is comparable if not superior to older drugs but with less side effects. It is a well-known fact that approximately two thirds of patients would become seizure free with the first or second drug given to them. In recent studies, these treatment responsive patients responded to low doses of essentially all the anti epileptic drugs studied, both old and new. Because these patients will remain on the initial or second therapy for several years, and because they will respond to most drugs, the burden is on the treating physician to select the anti epileptic drug that is most tolerable, has the lowest potential for harm, and has the least likelihood of negatively impacting quality of life.Despite their potential benefits, use of newer anti epileptic drugs thus far is largely limited to refractory cases and to tertiary centres. The newer drugs such as Levetiracetam (Keppra), have the potential to improve quality of life in subjects with epilepsy. The rationale of this project is to compare the tolerability, side effect profile and quality of life outcomes in treatment with levetiracetam versus the “older AEDs” - carbamazepine and valproate; the two drugs most commonly used as first line treatment. We hypothesize that levetiracetam’s efficacy and favourable side effect profile will enhance QOL and will improve health outcomes. We intend to test our hypothesis by prospective assessments of seizure control, cognitive and psychiatric effects and QOL. Cognitive assessments are done through a computerized battery of tests called IntegNeuro. We will also, as part of this study, perform a pilot study of to assess the utility of ocular motility (eye movement) testing as a practical method of assessing anti epileptic drug effects on cognitive performance. It is being increasingly recognized that subtle abnormalities of eye movements are seen in cognitive dysfunction. We intend to perform computerized eye movement testing in a subgroup of 20 patients randomized to each drug, and assess its use as an index of cognitive dysfunction that could be associated with anti epileptic drug use. Psychiatric and QOL assessments are done through well-validated questionnaires. The study population will be patients with epilepsy who have failed treatment with first anti epileptic drug. Failure is defined as lack of efficacy in controlling seizures or need to stop the drug because of side effects. Previous studies of Levetiracetam have been performed in either medically refractory patients who have taken multiple anti epileptic drugs or newly treated patients, whose clinical course is not yet clear. If positive the results of this study will provide evidence for the earlier use of newer anti epileptic drugs, in particular levetiracetam, especially in early stages of epilepsy and help improve the health outcomes of patients with epilepsy.

  • The DEPTH Project: Detection, Evaluation, and Psychological Therapy for Health

    The study will compare the effectiveness of cognitive behaviour therapy (CBT) and a non-directive psychotherapy matched for therapist input in delaying or preventing transition to psychosis among young people at high risk for psychosis. It is expected that patients assigned to CBT will: (1) show lower rates of transition to psychosis during the 12-month follow-up period; (2) survive longer without becoming psychotic even if they do make a transition during the 12-month follow-up period; (3) show better outcomes at 6 and 12 months in terms of psychotic and non-psychotic symptoms, quality of life and social functioning, whether or not they become psychotic.

  • Baclofen for Alcohol Dependence

    Ethics application submitted and responses to comments are being drafted presently.

  • An Open Label, Multi Centre, Phase II Study to Evaluate the Safety and Efficacy of Coramsine Injection in Patients with Renal Cell Carcinoma

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