ANZCTR search results

Smoking rates are extremely high among people cycling through Australian prisons, estimated at 74% of prison entrants in 2015. Indigenous Australians and people with mental illness are markedly over-represented in prisons and experience increased smoking-related health inequalities compared to both their community counterparts and non-Indigenous prisoners. Around one in two people entering prison in Australia who smoke expresses a desire to quit smoking. As a result, correctional authorities in Australia and elsewhere are implementing smoke-free policies that prohibit tobacco smoking on prison grounds for prisoners and prison staff. On 1 July 2015, a total smoking ban was introduced in all Victorian prisons. This randomised controlled trial (RCT) aims to test the effect of an intervention that promotes tobacco abstinence after release from prison among previously-smoking adults subjected to enforced abstinence in smoke-free prisons in Victoria. 200 participants will be recruited in prison (within 6 weeks of release) and will complete a baseline survey. Following baseline assessment, participants will be randomised 1:1 to intervention or usual care; randomisation will be stratified by intention to quit. Australian Community Support Organisation (ACSO) case workers will deliver a brief intervention to intervention group participants at three time points: prior to release, on the day of release and 2 weeks post-release, supplemented by a telephone calls from Quitline in the first 28 days post-release. Participants will receive a nine-day supply of nicotine spray on the day of release and again during the 2-week post-release intervention contact. ACSO staff will encourage participants to see a GP to discuss smoking cessation and access PBS-subsidised NRT patches if appropriate. The aims of this study are to evaluate the effects of a brief smoking cessation intervention on: 1. Prevention of smoking relapse, defined as the combination of (a) self-report of not smoking for any 7 consecutive days since release from prison, (b) self-reported 7-day abstinence at follow-up, and (c) biochemically verified (carbon monoxide breath test) point prevalence abstinence at follow-up, measured at 1 and 3 months following release from prison 2. Among those reporting relapse (defined as smoking for 7 or more consecutive days), recovery from relapse, defined as the combination of (a) 7-day period prevalence abstinence at follow-up, and (b) biochemical validation (carbon monoxide breath t of point prevalence abstinence at follow-up,measured at 1 and 3 months following release from prison 3. Utilisation of abstinence supports in the first three months after release from prison: Quitline, GPs, nicotine replacement therapy (NRT), measured at 1 and 3 months following release from prison

A hybrid closed-loop (HCL) system or ‘artificial pancreas’ provides automated control of basal insulin delivery, with ongoing requirements for manual boluses of insulin for meals. These systems offer the potential to reduce significant glucose excursions outside of a healthy glucose range compared with current available therapies. Some people with type 1 diabetes have difficulty recognising when they are having a hypoglycaemic episode, which is called hypoglycaemic unawareness. This often leads to fear of exercise due to the unpredictable changes in glucose levels that can occur with exercise. It is known that short intense bursts of exercise (anaerobic exercise) may initially increase glucose levels, whilst less intense exercise (aerobic exercise) tends to reduce glucose levels. This study aims to collect information on how well the HCL system controls glucose levels in people with type 1 diabetes and hypoglycaemia unawareness when they undertake anaerobic and aerobic exercise. Outcomes of interest will include time spent in healthy glucose range, and time spent in hypoglycaemic range. Insulin and counter-regulatory hormones will also be measured providing insights into changes in glucose levels with exercise in this group of people.

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.