ANZCTR search results

The aim of this project is to investigate if a novel tracer called 64Cu­-SARTATE can be used to help accurately image neuroblastoma on PET/CT in pediatric patients. Who is it for? Paediatric patients aged 16 years or less diagnosed with high-risk neuroblastoma and life expectancy of 12 weeks or more are eligible for this study. Study details Eligible patients will be administered a single dose of 64Cu­-SARTATE and undergo whole body PET scans at 4hrs & 24hrs. Complete safety evaluations will occur during visit 2 (day 2) & the visit 3 (day 8). Three blinded assessors will compare the new scans to the standard of care imaging to determine if they are superior. We hope that by testing this investigational product in paediatric patients, we can confirm that the biodistribution of 64Cu­-SARTATE will facilitate specific and more sensitive identification of malignant tissues using PET/CT scanning. It is hoped that this method can then be translated into everyday clinical care.

This study is a Phase 2, open-label, PK study to assess the PK profile of nicotine over a 30 hour period in healthy Caucasian male volunteers who are smokers, using the Chrono Quit Smoking Solution (CQSS2) system. All subjects will receive the CQSS2. A strap (i.e., Comfort Band) will be the primary method used to attach the CQSS2 to the body. Subjects will be randomized in a 1:1 ratio to wear the CQSS2 in one of two application site locations, the upper arm (n = 5) or mid thigh (n = 5), for approximately 30 hours. Application site location, safety, and tolerability will be evaluated.

For over thirty years research has consistently shown that the use of sedatives (predominantly antipsychotic and benzodiazepine medication) in many residential aged care facilities (RACFs) is excessively high. These agents only offer modest effects, yet are associated with significant adverse effects such as falls, confusion and daytime drowsiness, and they increase the risk of stroke and death. Many strategies have been adopted to reduce sedative prescribing in aged care. The most effective interventions involve audit and feedback, health practitioner training and medication review. Combinations of these strategies appear to offer the most success. The strategies of audit cycles, nursing staff training and ACF medication review are currently promoted and funded by the Australian government; however, there has been limited training for pharmacists to effectively deliver them. Further, there are no coordinated audit/training/medication review packages that specifically target sedative prescribing. The initial ‘Reducing the Use of Sedatives’ (RedUSe) project was a 6-month controlled trial conducted in 25 Tasmanian ACFs during 2008/2009. RedUSe was pharmacy-led and involved a computerised clinical audit of sedative use. This information was then presented to each facility alongside an educational session on the appropriate use of these medications. The final component of the RedUSe project was a dedicated sedative review process which involved nursing staff, the GP and the reviewing pharmacist. The initial RedUSe project resulted in a significant decrease in the utilisation of sedative medication, an overall reduction in sedative doses used and the project was well received by participants. This study involves a significant expansion of the RedUSe project to a national sample of 150 RACFs, and is funded by the Australian Government as part of the second round of the ‘the Aged Care Service Improvement and Healthy Ageing’ grants fund. In this expanded RedUSe project the same format of sedative audit and feedback, an educational program for ACF nurses and carers, and a dedicated interdisciplinary sedative review will be followed. The overall RedUSe program will be enhanced by the involvement of collaborators; the National Prescribing Service MedicineWise, and the Pharmaceutical Society of Australia. The ultimate benefits for residents in ACFs following successful reduction in rates of sedative use should include increased mobility and alertness, decreased fall rate and an enhanced quality of life. Other interventions have also shown an increase in the level of staff satisfaction when sedative use is minimalised and we aim to evaluate these outcomes in the expanded RedUSe project.

The aim of this prospective, non-randomised, observational study is to characterise changes in lung ultrasound images from birth in preterm infants born at less than 29 weeks. We believe that lung ultrasound images obtained in the delivery room, in the first 20 minutes after birth, may be able to predict the level of respiratory support babies born at less than 29 weeks gestation will receive in the first 72 hours after birth. This will be a single centre observational study at the Royal Women’s Hospital. We plan to obtain serial lung ultrasound images in premature infants born at less than 29 weeks starting with in the delivery room in order to investigate if early lung ultrasound can predict the level of respiratory support the infant will need in the first 72 hours after birth. We plan to obtain 3 second lung ultrasound video clips of the right and left side of the chest between birth and 10 minutes after birth, between 10-20 minutes after birth, at 1-3 hours after birth (after being stabilized in the NICU) and at 24-48 hours after birth. Additionally, if the baby is intubated for surfactant delivery, we plan to obtain images immediately prior to surfactant delivery and after surfactant delivery (targeting 30 minutes to 3 hours depending timing of cares and infant wellbeing) and immediately prior to the first extubation attempt as well as after extubation (targeting 30 minutes to 3 hours depending on timing with cares and infant wellbeing). Lung ultrasound examinations are brief, requiring minimal handling and less than 1 minute of patient contact to obtain the two images for each exam. Images can be obtained with the patient in either supine or prone position. Each lung ultrasound exam (birth to 10 minutes, 10-20 minutes, 1-3 hours after birth, at 24-48 hours, and if intubated, pre and post surfactant administration and pre and post the first extubation attempt) will only be performed after discussion with the treating clinician or bedside nurse.

Background: Both ‘at-risk’ and clinical levels (abuse/dependence) of alcohol use are major causes of morbidity and mortality in Australia and are involved in many hospital presentations. However, few hospitals have instigated routine screening and brief interventions with referral to treatment (SBIRT), an approach that has been widely recommended. Objectives: To investigate the effectiveness of SBI with referral to general practicians (GP) in an Australian setting. Design: Eligible participants will be randomised to either 1) SBI with referral to their GP, or 2) SBI with no GP referral. Outcomes: Primary outcomes relate to measures of feasibility and implementation. The secondary outcomes related to changes in alcohol use and the tertiary outcomes will assess change is the use of hospital services. (Additional time and funds are required to evaluate tertiary outcomes via the WA Data Linkage System.) Participants: All people aged 18 or older entering the Fiona Stanley Hospital emergency short stay unit (ESSU) are eligible for screening (with the AUDIT-C). Those classified as ‘at-risk’ with receive a BI. Those classified as high-risk will receive a BI plus intervention by the hospital alcohol and other drug team. Those who consent will then be randomised. Sample size: Target sample per group 291. (Note we estimate that 146 will not have a GP and thus cannot be randomised). Follow-up: Telephone interviews will be conducted at 1 and 3 months to collect information on change in alcohol consumption and attendance at a GP for alcohol related treatment. At 6 months, data on FSH events (ED and admissions) will be extracted from the hospital databases including Bossnet, EDIS, Webpas. Analysis: The main analyses are descriptive. However, we will use multi-level mixed effect models to assess the interaction term of study group (GP referral vs no referral) by time (6 months pre vs 6 months post) for change in rate of presentations. We also plan two sub-studies. Firstly, validation of self-reports of contact with GPs will be conducted in three groups. From the GP referral arm of the study we will randomly select from those who: 1) report no GP contact (estimate n=10), 2) report GP contact from the moderate risk participants (n=20) and, 3) report GP contact in the high risk group (n=10). At three months we will contact the nominated GP to confirm if the patient has been seen in the interim period and if any information or treatment was provided and obtain GP feedback on the referral process. This is included in the main HREC application but is not an outcome measure for the study. Secondly, feasibility will be tested at Rockingham General Hospital emergency department, where alcohol screening and brief intervention will be introduced without additional research support. A clinical audit will be used to document the proportion of patients screened and receiving appropriate brief intervention. This clinical audit process does not require HREC approva

Bordetella pertussis is bacteria infecting the respiratory tract and leading to a range of symptoms from mild cough, to clinically typical whooping cough, to death. Antibiotic treatment is ineffective after the cough develops, so prevention by effective vaccines is essential to protect the most vulnerable. Maternal pertussis (whooping cough) immunisation is an effective way of reducing severe disease in young infants. In Australia, vaccinating pregnant mothers with adult formulation diphtheria-tetanus-acellular pertussis vaccine (dTap) is recommended for every pregnancy with ~50% uptake. However, dTap is not licensed for use in pregnancy and in a number of countries it has been found that infants whose mothers received pertussis immunisation during pregnancy had lower antibody responses to their infant vaccinations, although they remain protected. It is not known how long maternal immunity lasts after immunisation in pregnancy or if repeated doses have any effect on infant vaccine responses. This study involving 400 mothers and babies (mother and infant pairs) will be conducted in Western Australian and New South Wales. It will evaluate maternal immunity and the effect of pertussis vaccination in pregnancy on infant antibody responses to the routine vaccinations given at 6 weeks and 4, 6, 12 and 18 months of age. Infants will have a blood sample at 6 to10 weeks of age prior to their routine infant vaccines, Infanrix-hexa (DTaP-IPB-HBV/Hib), Prevenar13 (PCV13) and rotavirus vaccine with subsequent doses at 4 and 6 months of age. Blood samples will also be taken at 7 months, 18 months and 19 months of age to measure antibody responses to pertussis antigens, diphtheria and tetanus toxoids, Haemophilus influenzae type b (Hib) and pneumococcal serotypes contained in PCV13. Responses will be compared between children whose mothers received a pertussis vaccine during pregnancy with those whose mothers were not vaccinated. We will also evaluate the frequency of local and generalised reactions to vaccination and the development of allergies, eczema and asthma. Infant participants will have a swab collected from the inside of their nose (nasal swab) at 7, 12 and 19 months of age Mother’s will have their blood collected to measure their antibody levels 6 weeks and 18 months after giving birth. Responses will be compared between mothers who received a pertussis vaccine during pregnancy with who were not vaccinated. We will also compare antibody responses between mothers who received their first pertussis immunisation during pregnancy with those who received their second or subsequent dose. This study will provide important information to inform providers, parents and national policy and will be relevant to other countries using maternal pertussis immunisation and potentially future vaccine development.

With longstanding and widespread high rates of errors in child restraint use, there is a need to identify effective methods to address this problem. The study's hypothesis is that product materials developed using a consumer-driven approach will reduce errors in restraint use among purchasers of new child restraint systems. A randomised controlled trial (RCT) will be conducted. Participants (n=440) will opt-in to the study after hearing about it from a wide variety of promotional strategies within the greater Sydney area. They will join the study as they purchase of a new restraint, and study materials (intervention or control) will be sent to with with the new restraint. Outcome measures are errors in installation of the restraint as observed by a trained researcher during a six-month follow-up home assessment, and adjustment checks made by the parent when the child is placed into the restraint. Process evaluation measures will also be collected during the home visit. The content and format of the additional product information being tested will be supplied in an instruction booklet; a video, accessible through smartphones; as well as laminated labels attached to the restraint, which will serve as a permanent reminder of key aspects of correct installation and correct use. The intervention provides supplementary information to assist users to correctly use the restraint, i.e. (i) how to correctly adjust the restraint to fit their child (ii) how to correctly install the restraint in the vehicle, (iii) how to correctly secure the child in the restraint, and (iv) how to maintain correct use over time. These will be supplied in addition to the Australian Standards required product information. The number of installation errors, as well as correct use and adjustment checks made by the parent will be compared between control and intervention groups. This cluster randomised controlled trial will determine the effectiveness of targeted, consumer-driven information on actual error rates in use of restraints.

This study is a first-in-man clinical study of DLP-114, a Risperidone Para-aminobenzoate Implant product. The study is an open-label, single sequence design aimed at assessing the safety and tolerability of DLP-114 and evaluating its utility in achieving a PK profile that is comparable to the marketed oral form of risperidone. Healthy volunteers will be enrolled implanted with DLP-114 in groups of up to 3 volunteers per group. The first group of 3 healthy volunteers to receive the DLP-114 implant will be a sentinel group. The safety and tolerability of the DLP-114 implant will be assessed in the sentinel group for at least 28 days prior to any other volunteers being dosed implanted with DLP-114 in the study. Only if the safety and tolerability data, obtained from the sentinel group, are considered acceptable by the investigator and the sponsor, will the remainder of healthy volunteers commence implant treatment in the study. Treatment of each subject will be conducted in five sequential periods: 1. Oral risperidone (2 mg/day) – tolerability assessment; 2. Oral risperidone (1 mg/day) – PK assessment; 3. Washout; 4. DLP-114 implant treatment; 5. Follow-up.

This study is designed to evaluate the effects of the artificial sweetener, sucralose, compared to glucose and saline (control), on blood pressure, heart rate and superior mesenteric artery flow following intraduodenal infusion, in healthy older subjects. On three separate days, separated by at least 5 days, subjects will receive an ID infusion of either (1) 25 %w/v glucose at a rate of 3 kcal/min, (2) 4 mM sucralose in 0.9 %w/v saline, or (3) 0.9 %w/v saline all in a volume of 300 mL over 60 minutes (i.e. 5mL/min from t = 0 – 60 min). Saline (0.9%w/v) will be infused at a rate of 5mL/min for a further 60min (i.e. t = 60 – 120min). Measurements of blood pressure (BP), heart rate (HR) and superior mesenteric artery (SMA) blood flow by Doppler ultrasonography, cardiac output (CO), stroke volume (SV), blood glucose, serum insulin, plasma glucagon-like peptide 1 (GLP-1), gastric inhibitory polypeptide (GIP) and catecholamines under randomised, double-blind conditions. The primary hypotheses underlying the current study are that (i) compared to saline, intraduodenal infusions of glucose and sucralose will induce a larger reduction in blood pressure and increases in both heart rate and superior mesenteric artery flow and (ii) ID glucose will have a greater hypotensive response than sucralose.

The aim of this study is to evaluate whether a Chinese herbal medicine (SGLXD) can reduce hot flushes/night sweats in women treated for breast cancer. Who is it for? You may eligible to join this study if you are a female aged 18 years or above and have been diagnosed with Stage 1-3 breast cancer, for which you have completed surgery, chemotherapy and/or radiotherapy and are experiencing hot flushes/night sweats. Trial details Participants in this study will be randomly allocated (by chance) to either group 1 or group 2 for 12 weeks of treatment. After this there is a 4-week period with no treatment then you are crossed-over to the other group for a further 12-week period. One 12 week treatment period will consist of two daily doses of the Chinese herbal medicine, Shu Gan Liang Xue Decoction dissolved in warm water and taken orally. The formula has been used at Beijing University Cancer Hospital by Professor Li and has been proven to be safe and effective in studies in China. During the other 12 week treatment period you will take an inactive placebo. Participants are required to undergo blood tests at 3 time points during the study and fill out a hot flush diary and quality of life forms. You are required to visit the hospital every 4 weeks to hand in the forms and receive 4-week supply of the treatment intervention. Pre-and post treatment differences in results of hot flush scores, quality of life scores and blood tests will be assessed between groups. Study results may contribute to achieving a novel intervention alternative therapeutic option to alleviate hot flushes and improve quality of life for Australian women treated for breast cancer.