ANZCTR search results

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

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31383 results sorted by trial registration date.
  • A pilot study to assess the feasibility of a prospective randomised controlled trial of a patient-centred medicines management approach to reduce the burden of iatrogenic symptoms in palliative care

    The meticulous management of symptoms is paramount in palliative care to relieve suffering and improve quality of life. The most common therapeutic intervention is the use of medicines. However, there is a limited evidence base to inform decision making with respect to efficacy, effectiveness and harm from medicines in palliative care. Complex clinical decisions have to be made in the face of much uncertainty balancing between efficacy and harms. Prescribing decisions require frequent review and reevaluation as the expected benefits may diminish and the likely harms increase. There is increasing recognition that chronic diseases should be managed differently in the setting of far advanced life limiting illness and that the focus of medicine use should be towards improving quality of life while preventing avoidable harms. Harm from medicines has been studied extensively in a number of settings but there is very limited research in palliative care. The understanding of prevalence of adverse drug events (ADE) including adverse drug reactions (ADR) and the burden of these events in palliative care is limited. This is despite these patients often being at high risk for adverse events given they are often older with multiple concomitant drug therapies both for symptom control and ongoing medicines for their underlying disease or other chronic conditions. The burden of advancing disease and multimorbidity often results in progressive increases in the number of medicines prescribed and the complexity of the medication regimens (Currow D 2007). This adds to the likelihood of experiencing an adverse event which may have significant functional consequences, the associated burden of managing complex medication regimens and costs for this vulnerable patient group. While there is uncertainty about the benefits and harms of medicines in the last months of life, it also becomes increasingly difficult to differentiate the pathology of the underlying disease processes from adverse drug reactions. One of the challenges is the recognition and correct attribution of adverse drug reactions by clinicians and patients alike in the presence of increasing symptom burden and progressive disease. Research is needed to inform a patient-centred approach to medicines management and prescribing for patients with advanced life-limiting illnesses that recognizes the benefits and harms from medicines especially for managing co-morbid illnesses within the specific needs of the patient’s remaining life expectancy. New approaches to medicines management have the potential to decrease iatrogenic burden and unintended functional decline, futile treatments, unnecessary suffering and inappropriate health care utilisation.

  • Cholecalciferol Supplementation in Kidney Failure Study: Effect on Quality of Life and Muscle Strength

    A one year trial comparing high dose nutritional vitamin D vs placebo that will primarily examine the effect on muscle strength and quality of life in patients with kidney failure.

  • Evaluation of the Innovance Immunoturbidimetric D-Dimer Assay for the Diagnosis of Disseminated Intravascular Coagulopathy (DIC) in different clinical settings

    Disseminated intravascular coagulation (DIC) remains a clinical challenge and a major cause of morbidity and mortality n different clinical situations. DIC is a clinical diagnosis supported by laboratory data but with no universally accepted diagnostic algorithm. However, the International Society on Thrombosis and Haemostasis (ISTH) recently proposed a DIC scoring system based on 4 laboratory parameters and the presence of a predisposing condition. Increase of a fibrin-related marker, such as D-dimer, represents a key element of the ISTH algorithm, which also scores elevations in the prothrombin time (PT) and reductions in the platelet count and fibrinogen concentration. A sensitive immunoturbidimetric D-dimer assay would probably provide an excellent sensitivity and negative predictive value for the diagnosis of DIC. The Innovance D-dimer assay is a new class of automated D-dimer test that is based on immunoturbidimetric techniques with a promising performance in terms of high sensitivity and specificity. Little is known about the performance of Innovance in the context of patient evaluation for suspected DIC in different clinical settings as proposed in this trial. Therefore, we are evaluating both the analytic and clinical performance of the Innovance (Dade Behring, Marbburg, Germany) immunoturbidimetric D-dimer assay in hospitalized patients not suspected of having DIC, and in patients who have had D-dimer assays ordered for suspected DIC. Because the measurement of D-dimer has not been harmonized among marketed assays, cutoff values for scoring D-dimer elevations in the ISTH algorithm (see table 1 and 2) need to be assay-specific. By using receiver operating characteristic (ROC) curve analysis, we will identify a prospective cutoff that maximizes sensitivity and specificity of the Innovance D-dimer assay. We are hoping by establishment of a cutoff value to compare the diagnostic performance of the Innovance D-dimer assay in the context of the ISTH scoring system. Furthermore, DIC is a serious complication of infection/sepsis, malignancy and in the acutely bleeding patient and it carries a considerable mortality rate, and once established it is difficult to reverse. Therefore it is crucial to establish a simple coagulation test like D-Dimer assay in order to predict the ocurrence of DIC.

  • Assessment of implication of Massive Transfusion Guidelines in conjunction with incidence of coagulopathy and outcome in the Northern Tasmania

    Massive transfusion (MT) is associated with serious often fatal complications including intractable disseminated intravascular coagulopathy (DIC). Therefore there is a growing need for guidelines and protocols that are addressing this issue. At a single institution we have implemented a MT-Protocol (MTP) in late 2007 and studied prospectively all patients (105) from Jan 2008 to Jan 2011 who required MT defined by replacement of half of blood volume within 4 hours with ongoing need for transfusion. The MTP included two phases and incorporated fixed volume of fresh frozen plasma (FFP), cryoprecipitate and platelets in addition to packed RBCs. The Launceston General Hospital is a tertiary referral centre for the North of Tasmania. This study will analyse data for the entire cohort of patients in Northern Tasmania who required Massive Transfusion.The main objective of the MTP is to provide appropriate and standardized different blood component therapy to prevent exsanguination, coagulopathy and thrombocytopaenia from occurring with subsequent inferior outcome. This study is aiming to avoid DIC and cease microbleeding as early as psossibel in MT setting and hence improving outcome. We conducted this study to demonstrate whether replacement of coagulation factors and platelets in timely fashion will influence outcome and also reduce DIC. This study, if published will deliver evidence based on local practice for a cohort of approximately 100-150 patients. This evidence would substantially improved evidence-based practice in trauma, surgery and emergency medicine.

  • Mobile Therapy: Get Happy Program Trial- A Randomized Control Study

    The purpose is to investigate the value of a new mobile therapy for depression using your mobile phone or tablet compared to doing the same therapy program on a computer. We have been modifying an existing internet therapy program for adults with depression and developed a new mobile version. It comprises an illustrated story of someone recovering from depression, take home tasks to facilitate this recovery, and regular clinician advice to improve progress. A username (your email address) and password is required for you to access this mobile therapy application. This is a trial that compares two groups: People who access the course via mobile app and people who access the course via computer. All participants will begin the course at the same time, starting in May.

  • Assessment of a single intravenous (IV) iron therapy versus oral iron in the management of preoperative anaemia patients undergoing elective surgery at the Launceston General Hospital

    The study is a prospective randomised trial screening elective surgical patients from both sexes with full blood count and iron studies during the study period. These patients will be offered to take part in the study at the Launceston General Hospital (LGH). In our interim analysis for a similar orthopaedic trial, approximately 15-20% of patients presented with low haemoglobin in this cohort of patients. This study is to be conducted by staff working within the Launceston General Hospital, (LGH) recruiting patients from the Northern half of the state of Tasmania and will be a collaborative project involving the Departments of Clinical Haematology, Anaesthesia, Surgery and Pathology as well as University of Tasmania as part of their collaborative work. It has agreement with the Admissions department of the hospital in regards to notification of prospective patients and their hospital booking dates. All patients who offered to participate in the trial will be counselled on any side effects of the iron therapy. If participants decide to withdraw from the study at any time, it will have no effect on their care or procedure.

  • Assessment of venous thromboembolic disease (VTE) in medical patients who presented to the Launceston General Hopspital (LGH)

    This study will investigate all medical patients who potentially at risk of developing blood clots (venous thrombo-embolism [VTE]) at any age group who are treated at the Launceston General hospital (LGH). We will study all factors that may influence clot formation such as Age, Weight, Gender, Mobility, presence of co-morbidities, presence of cancer, Personal history of VTE, Family history of VTE, other risk factors for VTE, additional laboratory markers such as blood count, coagulation study. The data of the trial will help to understand and know the risk factors for developing clots (VTE) among medical patients. This trial has the potential to change the treatment approach and the preventive strategies for medical patients in order to improve outcome and benefit all patients avoiding a relatively common VTE-complications of the treatment. This trial also reviewing the current protocols for prevention of VTE during the treatment of medical patients.

  • Parastomal Hernia Prevention Trial

    This is a prospective, single-blind, randomised, parallel-group, controlled proof-of-concept study to evaluate the safety and efficacy of the implantation of a prophylactic mesh at the time of the formation of a permanent stoma, compared to standard stoma formation, at preventing the incidence of herniae formation or the risk of stoma and non-stoma related complications.

  • Improving evidence based care for locally advanced prostate cancer.

    This study will evaluate the effectiveness of a Clinical Network led organisation intervention to improve evidence based care for locally advanced prostate cancer. The subjects of the research are the clinicians whose practice is being monitored. You may be involved in this study if you are a male of any age who has been diagnosed with locally advanced prostate cancer following radical prostatectomy. You must also be a patient at one of the 9 NSW based hospitals included in this study that have entered the active implementation phase of the intervention. Clinicians involved in this study will be involved in an educational session at their hospital. Clinical champions will be enlisted to persuade peers to attend the education sessions and to educate their peers and multidisciplinary teams. The objective is to use the Urology Clinical Network to increase referrals of patients to a radiotherapist for discussion about the appropriate use of adjuvant radiotherapy for high risk patients with locally advanced prostate cancer after radical prostatectomy. If you are a patient treated by one of the clinicians involved in the study you may be eligible for inclusion. This would involve medical record audit to determine whether you were referred to radiotherapy treatment, whether you completed radiotherapy, and if so, the time between surgery and radiotherapy.

  • Assessment of auto-titrating positive airways pressure in the management of treatment-related aerophagia.

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