ANZCTR search results

This aim of this international, multicentre trial is to evaluate the safety and efficacy of a comprehensive first line treatment strategy for paediatric and adolescent patients with Classical Hodgkin Lymphoma (cHL). Who is it for? You may be eligible to join this study if you are aged less than 25 years and have a histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma (cHL). Study details Based on risk factors at diagnosis, patient will be considered either low risk (TL-1), intermediate risk (TL-2) or advanced risk (TL-3) cHL. All patients initially receive 2 x 28 day cycles of the chemotherapy combination OEPA (Prednisone/Prednisolone, Vincristine, Doxorubicin and Etoposide/Etopophos). The response to OEPA treatment is measured using FDG-PET imaging and the next phase of treatment is determined. Treatment may include chemotherapy combinations called COPDAC-28 (consists of Prednisone/Prednisolone, Dacarbazine, Vincristine and Cyclophosphamide in a 28 day cycle) or DECOPDAC-21 (consists of Prednisone/Prednisolone, Dacarbazine, Vincristine and Cyclophosphamide, Etoposide/Etopophos and Doxorubicin in a 21 day cycle). Depending on risk level and response to treatment, patients may also be treated with Radiation Therapy. Patients in TL-2 and TL-3 will be randomly allocated to receive either the standard chemotherapy arm (COPDAC-28) or the experimental intensified chemotherapy arm (DECOPDAC-21). Patient response to therapy will be monitored using imaging and clinical exams for 5 years following completion of treatment. It is hoped that this study will maintain or improve survival while decreasing long term complications.

The aim of this study is to assess the diagnostic ability and safety in obtaining a core biopsy from peripheral lung lesions (PPL) using the novel Gen Cut tool with Radial EBUS. Who is it for? You may be eligible to join this study if you are aged 18 years or over and a have a peripheral lung lesions noted on CT chest/Chest X ray that require a biopsy. Study details Procedure: Informed consent will be taken for the procedure from the patient. Procedure will be performed under conscious sedation or general anaesthesia according to the institution. Once the patient is sedated, the bronchoscope "camera" is introduced via the mouth/nose to the required location. Then a thin USS wire called "Radial EBUS" will be introduced to locate the lesion. Following this the Gen cut biopsy tools will be introduced as the first mode of biopsy. How this study may be beneficial for research/treatment: ThIs study is exploring the new biopsy method (Gen cut) that is safer and can benefit many patients from this safer procedure at their hospital without requiring to transfer to a very specialised centre.

An electronic prescribing system will be implemented into three wards at Caboolture Hospital and one ward at the Royal Brisbane and Women's Hospital (RBWH) in 2018. This study will be used to assess the benefits to patients, and identify any risks or negative impacts. The aims of this project are to assess the effect of the implementation of an electronic prescribing system, including on the rates of prescribing errors, which may cause harm to patients, and may be preventable or unpreventable. The study will be an interrupted time-series study, which is conducted by acquiring a series of measurements over time, implementing the intervention (which is the electronic prescribing system), then continuing to take measurements after the intervention. This will allow comparison to determine if the electronic prescribing system can provide benefits to patient safety by reducing errors and clinical incidents. The methods used to collect the data will include review of the medical notes and medication chart, review of reported clinical incidents, and use of hospital coding data which identified an adverse effect of a medication which has occurred for a patient. A panel of pharmacists and doctors will review all of the identified incidents and potential incidents to determine the severity. The appropriateness of the medications prescribed will also be reviewed using a common tool.

This research aims to implement and evaluate a person-centred self-management program based on social-cognitive theory (SCT) for people with Stage 1 to 4 CKD. The project is a pre-post, repeated-measures design involving collection of quantitative data at T1 (baseline) and T2 (follow-up). Participants are patients with stage 1-4 CKD (eGFR greater than or equal to 25) who are attending specialist Kidney Health Services (KHS) in the Metro North Hospital and Health Service (MNHHS). All eligible patients are invited to participate, and those who agree provide informed consent. Participants are invited to complete questionnaires at T1 and T2 which are designed to capture patient-reported outcomes (e.g., disease-specific knowledge, self-management behaviour, self-efficacy, health-related quality of life (HRQoL)). To reduce burden on participants, clinical data is collected from patients' medical charts and records (e.g., blood pressure, comorbidities, kidney function etc.). It is hypothesised that participants will display improvements in patient-reported and clinical outcomes at T2 compared to T1.

The study aims to use a randomized controlled trial to investigate the impact of diabetes self-care educational intervention via mobile diabetes application on the clinical outcomes, knowledge of diabetes, ability to self-care, medication adherence and quality of life of people living with diabetes. Insulin requiring diabetes patients will be randomized on a 1:1 ratio to either intervention + standard diabetes care (n=75) or standard diabetes care alone (n=75) for a period of 12 months. Data to determine rate of improvement in Fasting Plasma Glucose, glycosylated haemoglobin, lipids, urine albumine/creatinine ratio, weight and height will be gathered through a retrospective check of respondents' hospital clinical records for the duration they were in the study. Intervention effect on diabetes knowledge, perceived ability for self care, perceived quality of life and medication adherence will be assessed pre ­and post ­intervention. The cost effectiveness of the intervention relative to standard care alone would also be elucidated.

The purpose of this study is to find out if a new formulation of a previously used anaesthetic medication has clinical advantages over the currently used anaesthetic agents. The anaesthetic agent alphaxalone was previously dissolved in a derivative of castor oil called CremophorEL, and included a similar drug alphadolone. This medication was called Althesin or Alfathesin and given to tens of thousands of patients for surgical anaesthesia between 1970 and 1983. It was regarded to be one of the safest intravenous anaesthetics because of a minimal effect on lowering blood pressure and suppressing breathing, both of which can be dangerous during and after surgery. However, it occasionally caused a serious allergic reaction and so was withdrawn from use. Investigations have since proved that the rare but serious allergic reactions were related to CremophorEL and not to alphaxalone. The drugs currently used in most anaesthetics in Australia are propofol, which is a drug given by intravenous injection, and sevoflurane, an anaesthetic gas. Both of these medications have several disadvantages including a drop in blood pressure and depression of breathing. Further, propofol can cause severe pain on injection. Propofol solution also supports bacterial growth and, especially with long term use, requires careful handling to prevent infections such as septicaemia. It has also become apparent in recent years that postoperative confusion, memory and thinking problems in older subjects occur frequently after some surgery. It has become clear in recent years that our current anaesthetic agents are not adequately protecting the brain against these conditions. Drawbridge Pharmaceuticals has developed Phaxan, a water based formulation of alphaxalone which does not need the use of CremophorEL to be dissolved. Preclinical studies have shown that alphaxalone given as Phaxan™ requires the same dose needed to induce anaesthesia as the previous drug, Althesin. Further, it produces the same speed of onset and offset of sedation (or ‘sleep’), the same minimal effect on blood pressure and breathing, and the same fast clear-headed recovery. It is also possible that it has a protective effect against confusion and changes in thinking after surgery, and that patients will be awake and clear headed faster. For the first time during the development process of a new anaesthetic preparation, the quality of recovery of brain function (cognition and memory) will be assessed before and for several months after surgery and anaesthesia.

Parkinson’s disease (PD) is a progressive disease, and is characterized by disabling movement problem including, gait difficulties and balance impairment. These affect activities of daily living, quality of life and increase the risk of falls that in turn lead to hospitalization and mortality. Gait difficulties and balance impairment are devastating problems in people with PD and continue to be an important topic for health professionals and scientists. Treatment for PD drug treatment as the first line of treatment and surgery for advanced stages. While surgical and pharmacological approaches to the treatment of PD can help to partially improve some gait difficulties, they do not always result in improvements. Allied health treatments are also used in treatment of PD. However, there is no firm consensus on the efficacy of these treatments. This suggests a need for additional and complementary approaches to manage gait and balance difficulties in PD. Recently transcranial direct current stimulation (tDCS) has been used extensively in neuroscience research. It has been used to improve movement and recovery in stroke and other neurologic disorders. It is considered to be safe with no serious adverse effects. Consequently this has raised interest in using tDCS as an intervention to improve movement in PD. This study proposes to undertake a randomized controlled study to investigate whether tDCS is effective in improving gait and balance in people with PD. If it is proved to be effective it may provide an alternative intervention strategy for treatment of movement complications of people with PD which hopefully could lead to improved quality of life and functional status.

The REMEDIAL study aims to better understand the effect of irregular heart rhythm (atrial fibrillation) on human feelings, emotions, clarity of thinking and intellect that impact one's level of functioning and how further management of this condition influences the human mind-heart relationship. Specifically, we intend to study whether management with catheter ablation (a medical procedure for atrial fibrillation) compared with medical therapy (continued treatment with medicines) improves one's level of functioning in these important areas that impact the quality of life. We hypothesise that this common heart rhythm irregularity causes significant psychological distress and impacts one's intellect and quality of life. We also hypothesise that successful management of atrial fibrillation with catheter ablation will result in a significantly greater improvement in markers of psychological distress and neurocognitive function compared to ongoing medical management.

30% of Australians will be affected by Insomnia making it the most common and socially costly sleep disorder. The total cost to Australia in 2010 was estimated to be $10.9 Billion. Insomnia patients suffer from poor health related quality-of-life, increased risk of depression, increased workplace disability and costs, impaired driving performance and increased risk of death from motor and unintentional fatal injuries. The current health system solution to this highly prevalent condition is hypnotic pharmacotherapy. This is despite substantial evidence that drugs are only marginally better than placebo and recommendations against long term drug therapy. Hypnotic therapy also comes with significant risk for a range of side-effects some caused by inappropriate use including falls, car crashes, accidents and potentially increased overall mortality. Cognitive Behaviour Therapy for Insomnia (CBT-I) is a much more effective long-term solution. However, CBT-I suffers from major drawbacks as it requires specifically trained therapists, and is a complex time consuming composite therapy that may include therapeutically redundant components. Sleep Consolidation Therapy is a standardised behavioural component of CBT-I that has been specifically tested in isolation and been found to be as effective as multi-component interventions. In Sleep Consolidation Therapy, patients are asked to ‘consolidate’ their sleep-wake schedules (minimum time in bed is five and a half hours). The clinical delivery time for Sleep Consolidation Therapy alone can be relatively short (typically 1 hour delivery + weekly 10 minute telephone calls), but still requires clinician input regularly. Sleep Consolidation Therapy maybe able to be delivered more widely as it has been shown to be feasible in Primary care settings. We have developed a proof-of-concept smartphone application following participatory design and user experience focus groups. We now wish to test the use of this smartphone application to deliver Sleep Consolidation Therapy in participants with Insomnia Disorder. The app has the potential to deliver population-based therapy for Insomnia patients thereby improving therapy options.

Perioperative hypoglycaemia during elective surgery can potentially cause serious consequences. In neonates, hypoglycaemia can cause lethargy, apnoea, seizures and coma (Pediatrics, 2011; 127(3): 575-579). In severe cases, neurodevelopment in neonates is impaired with white matter changes, haemorrhage, infarction and basal ganglia changes seen on MRI. (Pediatrics, 2008; 122(1)). A recent study has shown that children, especially infants, can be ketotic and have low normal BSL (Blood sugar level) following preoperative fasting periods (Eur J Anaesthesiol 2015; 32:857–861). Anecdotal reports at Royal Children's Hospital have indicated that children between 6-12 months may be at a higher risk of hypoglycaemia due to prolong preoperative fasting and physiology which has resulted in BSL in the 1.0-2.0 range which required urgent intervention perioperatively. There is belief that the stress response of surgery will mitigate the potential hypoglycaemic effects of fasting however, there are lack of literature to show the effect in this age group. There is a current lack of consensus regarding best practice fasting guidelines. Young children are extremely vulnerable to the risk of preoperative hypoglycaemia and determining evidence based fasting guidelines could have significant benefits for the patient and department. Methods. Using a prospective observational design of 200 infants, aged 6-12months with an ASA (American Society of Anaesthesiologist Score)of 1-2, and undergoing elective surgery will be observed during the perioperative period for hypoglycemia. Blood of around 6 microliters will be obtained to test blood sugar and ketones using commercially available handheld point of care testers at induction after insertion of IV cannula. Hypoglycemia will be defined as a BSL of 3.0mmol or less and hypoglycaemia will be treated as per local guidelines. On completion of surgery, a further 6 microliters will be obtained to test for blood sugar and ketones using the same testers. Outcome. Primary outcome is incidence of hypoglycemic events on induction. Secondary outcomes are change in BSL and ketone levels during the perioperative period. Sample size calculations were carried out using the G*Power software. We are planning to recruit a total of 200 children where 100 at Royal Children's hospital (RCH) and 50 each at both Lady Cilento Children's Hospital (LCCH) and Gold Coast University Hospital (GCUH) as per calculations. Statistics. Analyses will in the first instance compare LCCH and RCH patients, and hence their different fasting protocols, with respect to BSL and ketones by means of two sample t-tests immediately before and after anaesthesia. Linear regression analyses will also be undertaken to take into consideration the various covariates that may impact on BSL and ketones