ANZCTR search results

This trial is a dose escalation study to determine the maximal tolerable dose of human amnion stem cell for the treatment of acute ischaemic stroke (focal brain ischaemia from blood clot obstructing the vessel lumen).

In COPD, inhaler capability may be impaired due to advanced age, comorbid illness and airway mechanics. Observational study - looks at COPD patient characteristics and how they relate to inhaler capability in acute COPD exacerbation and recovery phase. Interventional study - published pharmaceutical trials predominantly compare drug effects on lung function without accounting for differing inhaler devices or exploring outcomes reflecting chronic disease morbidity. This trial specifically compares two devices in terms of clinical outcomes.

Amongst the attributable factors, hypertension is the predominant risk leading to atrial fibrillation (AF) and premature cardiovascular events. As compare to brachial blood pressure, central blood pressure and aortic stiffness assessment even in “normotensives”, has shown improve predictability of cardiovascular outcomes including atrial fibrillation. Cardiovascular risk stratification based on central blood pressure indices can be more relevant as it demonstrates the central pulsatile load an organ is exposed to and reveals early vascular remodelling of central arterial tree resulting in aortic stiffness. Non-invasively derived central hemodynamic indices have been demonstrated to predict cardiovascular outcomes in a variety of settings. We propose a single blinded, randomised prospective trial to risk profile our AF patients according to their non-invasive assessment of peripheral or central blood pressure including aortic stiffness estimate. The impact of central or peripheral blood pressure treatment , on AF outcomes will be analysed. In addition, the relationship between central or peripheral high blood pressure and non-invasive indicators of end organ (cardiac, vascular, renal and retinal) injury will be explored.

About 25% of very preterm infants in the neonatal intensive care unit will develop a suspected infection, or late onset sepsis. Current empirical late onset sepsis treatment regimens usually include vancomycin, however this antibiotic is associated with the development of drug resistance. Antimicrobial resistance threatens the effective prevention and treatment of infections and is a serious threat to public health. Patients with infections caused by drug-resistant bacteria are at increased risk of worse clinical outcomes and consume more health resources. The aim of this study is to lead to the development of a safe and effective antibiotic regime for late onset sepsis in preterm infants using a randomised controlled trial design. Preterm infants <29 weeks with suspected late onset sepsis will be randomised to receive either a vancomycin or cephazolin containing antibiotic regimen, both of which should appropriately treat common bacterial causes of late onset sepsis. The trial results will potentially lead to reduced vancomycin use in Australasia and subsequently reduce the development of multi drug resistant organisms, and an overall reduction in health care costs.

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.