ANZCTR search results

Stress cardiomyopathy (Tako-Tsubo Cardiomyopathy; TTC) was once thought to be a relatively rare form of transient regional cardiac dysfunction, occurring largely in ageing women. Given the apparently benign course of this condition, little attention has been directed until recently to its cause, or to appropriate treatment. However, it is now apparent that TTC is neither rare nor benign and accounts for about 10% of “heart attacks” in women. Our studies have led to expedited diagnosis, and have delineated a number of aspects of the natural history of TTC. Specifically, attacks, presenting usually as episodes of chest pain and/or breathlessness, TTC actually represents a form of catecholamine-triggered myocardial(heart muscle) inflammation of varying severity, which may engender lethal arrhythmias (abnormal heart rhythms), However the main cause of death post hospital admission is the development of severe hypotension (low blood pressure), which causes death in 2 – 3% of cases. The recovery is slow, due to persistent inflammation and energetic impairment within myocardium (heart muscle), and is associated with prolonged impairment of quality of life. There is also a substantial risk of recurrence. Furthermore, we have data from post-mortem studies and from a rat model of TTC developed in our laboratory that the myocardial inflammation is associated with increased nitrosative stress. Currently, there has not been an established treatment for TTC. We wish to test the hypotheses that agents that limit nitrosative stress (such as NAC and ramipril) might:- (i) Reduce the severity of inflammation and associated myocardial energetic impairment in TTC, and (ii) Accelerate recovery from TTC

The overall objective of the study is to investigate if a personalised education and medication management intervention reduces medication related problems for patients with decompensated cirrhosis. The morbidity and healthcare costs associated with complications of decompensated liver cirrhosis are substantial, as patients require complex medical care and have very high use of hospital services. People with cirrhosis are often prescribed multiple medications for therapeutic or prophylactic use, and the number of medications prescribed on hospital discharge is a risk factor for early readmission. Medication-related problems (MRPs) contribute to patient morbidity, hospitalisation and mortality in many chronic health conditions in the Australian community. The prevalence of MRPs has not been formally investigated in patients with cirrhosis, although a recent pilot study identified the prevalence of discrepancies between patient-reported and medical-record documented medications, and a lack of patient knowledge about their liver disease, medications and self-care tasks. The study identified only 44.5% of all medication entries to be concordant between patients and their medical records. Discrepancies of clinical significance were identified in 27 of 50 patients (54%) with a mean of 3.12 discrepancies per patient (range 1 to 8 discrepancies). Medication discrepancies were associated with older age (p=0.04), polypharmacy (p<0.01) and poorer levels of adherence (p<0.01). Gaps in patients’ disease-specific knowledge, medication-management skills, and lower levels of engagement in treatment may be a barrier to effective clinician-patient interaction and impair disease management. Limitations within the current outpatient model of care for cirrhosis patients include: * No designated clinician role for medication reconciliation or regular disease education * Lack of patient assistance to develop skills in the day-to-day management of their health condition * Lack of adequate information about opportunities for self-management or the need for medication adherence * Time constrained hepatologists and limited contact with patients Pharmacist-driven education and medication-management interventions have been shown to reduce hospital admissions, increase adherence to therapy and improve patient outcomes in other studies of collaborative outpatient practice. It is hypothesised that patient-centred education and medication-management intervention may address the complex relationship between patient knowledge, adherence and medication-management to improve outcomes for people with cirrhosis and reduce the burden on hospital resources.

Return to sports and physical activity is increasingly being evaluated as a factor in judging orthopaedic surgical outcomes, in particular, joint arthroplasty. Furthermore, patient satisfaction is closely correlated with the resumption of regular activities, and in the case of RSA, it has been shown that those who return to their pre-surgery physical activity and recreational sports after RSA, report greater levels of satisfaction post-surgery. There currently exists a clinically unmet need to evaluate the best and “optimal” course of management before and after reverse shoulder arthroplasty (RSA), and whether this translates to a more successful return to activities of daily living (ADL) and recreational sports. Furthermore, the use of activity monitors in the upper extremity as an alternative method for evaluating patient function post-surgery may allow for a more accurate and objective measurement of the frequency, duration, and intensity of shoulder function in patients after RSA, compared to self-reported questionnaires. Therefore, this research aims to investigate the benefit of a structured, postoperative exercise program in patients following RSA, compared with control subjects who receive the usual conservative course of management. Furthermore, this study will also investigate the effectiveness of using upper limb activity monitors to objectively capture upper extremity function in patients following RSA. Patients being offered RSA that meet the inclusion criteria for this study will be invited to participate in the trial, and upon acceptance and enrollment, will be randomised into one of the two rehabilitation arms of the study: usual management (UM) group or the exercise management (EM) group. Patients assigned to the exercise group will be required to participate in an 18-week postoperative rehabilitation, whereas those assigned to UM group will follow conservative care. All patients will be assessed clinically using validated subjective and functional assessment measures at specific time-points throughout the postoperative timeline, including body-worn activity monitors. Data obtained from these activity monitors, using previously described algorithms, will be compared between the operated and non-operated upper limbs of patients in both rehabilitation pathways, as well as a matched, healthy control group.

Depression is common in people with Alzheimer’s disease (AD) and their carers and is a frequent cause of distress and reduced quality of life (QoL). Pharmacological treatment is modestly effective in treating major depression, although this is largely ineffective in those with milder depression (subsyndromal depression - SSD) and in people with dementia ,and is frequently associated with unacceptable side effects. It is therefore essential that we are able to identify safe and easily accessible therapies for these debilitating symptoms. Cognitive bias modification (CBM) is a simple, novel and safe intervention that targets attentional and interpretative biases associated with anxiety and depression. CBM has been shown to be effective in reducing depressive symptoms in younger adults but studies in people with cognitive impairment and their carers are lacking. Our preliminary research has indicated that CBM is well tolerated by people with AD and could be easily accessed at home, making it a potentially invaluable intervention for depression in this population. The aims of this study are to determine; The effect of CBM in reducing the severity of depressive symptoms in AD, the effect of CBM in improving mood in carers of people with AD, and the effect of CBM on QOL of people with AD and their carers. People with AD and their carers (dyads) will be randomly assigned to an active or control CBM intervention in a 2 x 2 double-blind, parallel design. The intervention will be conducted over 6 months. For AD participants and carers, change in severity of depressive symptoms, and change in QoL, after 12 weeks, will be outcomes of primary interest. For AD participants and carers, change in severity of depressive symptoms after completion of treatment at 26 weeks, and incidence of major depression at 6 months, will be secondary outcomes of interest. Burden of care as reported by carers at 12 and 26 weeks will also be a secondary outcome of interest. Dementia is a common condition and is frequently associated with a diverse range of neuropsychiatric symptoms, including depression and anxiety. Our current understanding of the cause and management of these symptoms is far from optimal. The proposed study trials a simple and safe treatment that could be easily implemented into everyday clinical practice. This study will provide high quality evidence for the efficacy of CBM in improving the quality of lives of people with AD.

This study proposes to explore the safety and efficacy of lenalidomide consolidation post allogeneic stem cell transplant in patients with high risk multiple myeloma who fail to achieve stringent complete response. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of multiple myeloma for which you plan to undergo stem cell transplantation. Study details All participants in this study will commence treatment with Lenalidomide 180 days after stem cell transplantation. Lenalidomide is a chemotherapy drug which is taken orally at an initial dose of 10mg daily for 21 of 28 days (1 cycle), increasing to 15mg for subsequent treatment cycles. This will be taken in combination with weekly oral dexamethasone for the first 2 cycles. Treatment will continue until any of the following occurs: a. Unacceptable toxicity/adverse event that may cause severe or permanent harm which rule out continuation of the study drug b. Relapse/progressive disease and alternative myeloma treatment is required c. Death d. The study may also be terminated early if safety concerns emerge with this treatment Participants will be regularly monitored until relapse or end of treatment in order to evaluate the safety and tolerability of the treatment, as well as disease response.

TThis study is being conducted to assess a new skin product against the standard skin care procedures at Townsville Cancer Center (TCC) in breast cancer patients receiving external beam radiation therapy. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have a confirmed diagnosis of breast cancer, for which you will be undergoing external beam radiation therapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive the current standard skin care management. That is, an aqueous cream, Sorbolene, applied daily after radiation therapy treatment. Participants in the other group will instead receive a new product called StrataXRT, which is a silicone based gel applied to the skin which acts as a barrier to prevent the development of radiation-induced skin reactions. The product is TGA approved in Australia; FDA approved in the United States and is being used clinically in other centres in Australia. All participants will be assessed at the beginning of treatment and weekly thereafter using a specific skin grading scale, and clinical photographs will be taken. The study is attempting to determine if StrataXRT is equivalent to current practices, and whether further study on the product is warranted.

Performing chest compressions for patients in cardiac arrest is tiring, and as rescuers become more tired their performance has been shown to deteriorate. Quality of Cardiopulmonary Resuscitation (CPR), especially chest compressions, is adversely affected by fatigue and is one of the few factors shown to be independently associated with the likelihood of a person surviving a cardiac arrest. The administration of supplemental low flow oxygen to a rescuer via nasal cannula may slow their fatigue, and increase the length of time that that the rescuer is able to provide good quality chest compressions. We intend to undertake a study to assess the effectiveness of supplemental low flow oxygen on healthy, volunteer rescuers in improving their quality and length of performance of chest compressions on a resuscitation manikin.

PURPOSE The primary purpose of this study is to determine the efficacy and safety of the addition of ixazomib and low dose dexamethasone maintenance therapy for transplant-eligible multiple myeloma (MM) patients who are undergoing single autologous stem cell transplantation (ASCT) as part of front-line therapy. WHO IS IT FOR? You may be eligible to join this study if you are aged over 18 years, have been diagnosed with symptomatic MM as per International Myeloma Working Group (IMWG) criteria, are eligible for front-line melphalan conditioned autologous stem cell transplant (ASCT), and do not have central nervous system involvement with the disease (MM). STUDY DETAILS Enrolled participants who have achieved clinical and haematological recovery following ASCT will undergo screening for study eligibility no earlier than 75 days following ASCT, complete screening within 15 days, and be randomised into treatment arms no later than 115 days after ASCT. Participants will then be randomised 1:1 to the control arm (thalidomide + dexamethasone), or the experimental arm (thalidomide + dexamethasone + ixazomib), for a maximum of 12 months or until the disease progresses, whichever occurs first. Outcomes It is hoped that the findings of this trial will provide information on: 1. Whether the addition of ixazomib to standard maintenance therapy will improve progression free survival in multiple myeloma patients who have undergone ASCT as part of front-line therapy; and 2. Provide information on the safety and efficacy of ixazomib addition to standard maintenance therapy.

Knee osteoarthritis (OA) is a leading cause of pain and disability around the world. OA involves the breakdown of joint cartilage, but it also appears to include the proliferation of blood vessels and nerves about the joint. It is suggested that these blood vessels and nerves contribute to the experience of pain. One pilot study found that embolising abnormal vessels about the knee substantially improved individual's pain. Prior to a full randomised trial, 10 participants will be recruited to this non-randomised pilot study. The purpose of the pilot study is to test the protocol for feasibility and assess for effects on pain and function and any unexpected effects due to the intervention in the first month post procedure. All pilot study participants will unblinded and will receive the intervention. Participants will be reassessed the day following the intervention and then once a week for the first month. At each assessment, participants will complete an abbreviated assessment (KOOS, Global Assessment of Change, Six Minute Walk Test and 30-second Chair Stand Test). Participants will then complete full assessments (using all assessment tools) at 1, 6, 12, and 24 months following the procedure.

Around 3-6% of newborn infants require positive pressure ventilation (PPV) in the delivery room (DR). However, delivering effective mask ventilation can be challenging, because of large leak around the mask. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation. A new face mask called Resusi-sure (LSR Health care, NSW, Australia) uses suction to create a seal between the mask and the infant’s face. Primary objective is to test (in a randomised trial) the hypothesis that there will be less leak during intermittent positive pressure ventilation of term and near term infants (newly born infants greater than or equal to 34 weeks) in the delivery room if performed with the suction mask compared with the conventional mask.