ANZCTR search results

This study will be investigating the use of a new whooping cough vaccine in adults aged 18 - 30 years. Pertussis infection rates within this age group have been rising since the early 2000s and this is likely due to the short-term protection offered by the current pertussis booster vaccine. The study will compare the use of this new vaccine to the vaccine currently used in Australia. Randomisation will be based on the pertussis vaccination history of each particular subject and all subjects will be followed up for one year. They will have blood sampled before vaccination, at 28 days following vaccination and 1 year after vaccination. The expected outcome is that the new pertussis vaccine will demonstrate superior immune response and therefore extended protection against pertussis.

The purpose of this study is to determine whether enteral feeding (via a tube through the mouth to the stomach) is tolerated post allogeneic Haematopoietic stem cell transplant. Who is it for? Patients 18 and over that have been diagnosed with a haematological malignancy and are planned for an initial allogeneic haematopoietic stem cell transplant. Study details: Patients will be recruited to the study during a pre-transplant appointment with the Transplant clinical nurse consultant (CNC) and eligible patients will be consented and randomly allocated (by chance) to the intervention or control group. The study will examine the feasibility of using enteral feeding post transplant. Following transplantation, both groups will continue with standard nutrition practice, by eating and drinking orally as tolerated. If patients are unable to tolerate oral intake, Parenteral Nutrition may be considered. One group (the intervention group) will also have a nasogastric tube inserted on the day of the transplant and will receive enteral feeds throughout the patient's admission. The rate of feed will start at 20mL/hr for 24 hours continuously and will be increased by 10mL/day to a goal rate of 40mL/hr. Enteral feeds will cease once the patient is meeting 60-75% of their nutrition requirements via their oral intake and they have engrafted. It is hoped that this study will assist in better addressing the optimal use of nutrition support to improve outcomes post transplant.

An observational cross-sectional multi-centre multi-level study design evaluating the organisational and departmental quality management, clinical management processes, and patient outcomes associated with perineal and obstetric anal sphincter injury (OASIS) trauma, at three health services across six maternity units, assessing: 1. Quality of care governance, practice and culture for each maternity unit organisation, using a set of modified Quality Management System and departmental pathway assessment instruments. 2. Clinical treatment processes by auditing medical records of all women diagnosed with OASIS, 5% of women having vaginal deliveries not diagnosed with OASIS and those undertaking the (Patient Measures of Safety) PMOS will be conducted comparing content and quality of clinical documentation and management against the institution’s evidence-based guidelines including conduct of a comprehensive perineal assessment. 3. Safety culture and clinical leadership, and pathways using a staff survey 4. Raw and risk-adjusted OASIS incidence rates, analysing perinatal data routinely collected through the Birthing Outcome System, compared between the six maternity units. 5. Women’s understanding of perineal injury risk and perception of safety using an antenatal and postnatal patient survey

This study is a single-centre, single-blind, prospective clinical trial evaluating the effect of a new diagnostic test for discrimination of CD and controls. We hypothesised that Mycobacterium avium subspecies paratuberculosis (MAP) is the leading infectious cause for CD. Therefore, developing a simple diagnostic test for MAP detection is worthy of investigation for diagnosis of CD and determining success of anti-mycobacterial therapy in patients with CD. The results of the study will provide evidence for the association between MAP and CD as well as establishing an affordable, less invasive, accurate and efficient diagnostic test for CD and/or monitoring.’

Patients who are receiving invasive mechanical ventilation treatment are often prescribed a combination of medications to help keep them calm (sedated), and also to remove pain and discomfort. Two commonly used drugs to relieve discomfort are morphine and fentanyl. These are part of the narcotic group of drugs. Currently, either of these agents is prescribed to many thousands of patients in intensive care units in Australia and New Zealand every year. This study will aim to establish which of these two medications that are commonly used for pain relief and sedation in patients receiving treatment with a breathing machine is better with regards to being able to remove the breathing machine earlier, in addition to decreasing the amount of other medications that may be required for sedation and relief of pain or discomfort.

This study aims to identify the most appropriate cooling strategy for older adults with and without hypertension during a simulated hot and dry heatwave (45°C and 15% relative humidity) Research questions: The primary research question guiding this project is: 1. Are fans and/or skin-wetting effective in decreasing the physiological strain experienced by elderly during a simulated hot, dry heatwave (45°C and 15% relative humidity) The research hypotheses going into this study are: 1. All interventions will result in reductions in thermal and cardiovascular strain compared to no intervention (control) With fan and skin-wetting (FSW) being the most effective, then no fan and skin-wetting (NFSW), then fan (F), and finally, the control, no-fan (NF).

Hip fractures result in poor outcomes for older adults. Rehabilitation emphasises physical capacity and does not address lack of confidence. Motivational interviewing has a specific focus on increasing confidence for behaviour change. The primary aim is to determine if motivational interviewing increases walking at 12 months in community-dwelling people after hip fracture compared with an attention placebo control group. The secondary aims are to determine if motivational interviewing is a cost effective intervention that improves mobility-related function, physical activity, participation, and psychological outcomes, and reduces falls and hospital readmissions. In addition to receiving usual care, 270 people aged at least 65 years who have returned home after hip fracture will be randomly allocated to receive 10 telephone-based sessions of motivational interviewing to encourage walking or a control group receiving 10 telephone-based sessions of nutritional advice. Outcomes will be measured at 0, 9, 26, and 52 weeks. It is hypothesised that the motivational interviewing will be a cost effective intervention to help people return to living in the community after hip fracture.

Our study aims to use MRI to assess the effects of empagliflozin on kidney filtration compared to another glucose-lowering medication, sitagliptin. Sitagliptin is another approved drug used to treat high glucose levels; however it is not known to affect the kidneys in the same way as empagliflozin.

The purpose of this trial is to assess whether a high CBD/low THC medicinal cannabis oil product [CannEpil. 20:1 cannabidiol (CBD) to (-) -trans-9-tetrahydrocannabinol (THC)] causes driving impairment using a high fidelity driving simulator. In particular the study will assess whether this medicinal cannabis product causes changes in the standard deviation of the lateral position (SDLP) variable obtained from the driving simulator compared to placebo. Additionally, the project aims will explore the subjective mood and sedative effects of this medicinal cannabis product compared to placebo. 31 participants will undergo a screening and practice visit followed by two testing visits spaced at least one week apart. At each testing visit they will receive either CBD/THC treatment or placebo in a crossover design. Participants will be instructed to consume a standardised breakfast prior to each testing session. During each testing visit participants will complete a driving simulation, cognitive tasks and questionnaires as well as having blood and saliva samples taken.

Obese people comprise 33% of Western Sydney and are 6x and 10x more likely to develop diabetes and non-alcoholic fatty liver disease (NAFLD), respectively, compared to normal weight individuals. This trend will lead to alarming rates of cardiovascular death, liver cirrhosis (scarring) and liver cancer. Weight loss can lead to diabetes remission and can be achieved successfully using very low calorie diets (VLCD), with rates close to 86% in adults. Additionally, a widely available and effective diabetes therapy – glucagon-like peptide-1 receptor analogues (GLP1-RA) – also assist with weight loss. Both treatments lead to significant weight loss, improve diabetes, and can reverse liver damage caused by NAFLD, yet the combination of these treatments has never been studied. This is a pragmatic pilot study of patients attending the Metabolic and Weight Loss Program at Blacktown hospital to investigate the efficacy of VLCD +/- GLP1-RA in achieving diabetes control and reversal of liver injury. This will lead directly to practice change by senior clinicians involved in the study and improve patient care in the clinics at Blacktown hospital, and potentially further afield.