ANZCTR search results

EUS guided fine-needle aspiration (FNA) or fine-needle biopsy (FNB) is a well-established and accurate method of obtaining tissue for the diagnosis of intra-abdominal or mediastinal lesions. Initial findings, have suggested that rapid on-site evaluation (ROSE) using cytological smears (with or without cell block preparation) has the biggest impact with increased diagnostic accuracy and reduced needle passes. However, newer evidence has brought the value of ROSE into question. Recent reports show conflicting results on whether ROSE actually does influence outcome in EUS FNA. Also a recent meta-analysis suggests that ROSE may not result in higher diagnostic yield, specimen adequacy or pooled sensitivity and specificity. The utilization of cell blocks or direct histological processing to prepare FNA specimens, involve placing all needle contents into liquid fixative and therefore do not require ROSE. Reports show high diagnostic yield with both, exceeding 89%. These also avoid the need for smear preparation, which requires training and can result in inadvertent loss of diagnostic material. Prospective randomised data comparing these techniques is lacking and therefore the best method for preparing EUS FNA specimens is unknown. We hypothesize that without ROSE, direct histology or cell block is the tissue preparation technique of choice, as smearing often has low diagnostic yield and may result in loss of diagnostic material. The aim of this study is to compare the diagnostic yield of the different methods for EUS FNA/FNB specimen processing in a randomized fashion and to identify the most optimal method of tissue preparation in the absence of ROSE. All patients who were referred to our unit for EUS guided FNA of a solid mass or lymph nodes in or adjacent to the upper GI tract over an 8-month period were prospectively recruited for the study.

Paediatric distal forearm fractures, usually of the radius, are a common presentation to the emergency department (ED). Buckle, or torus, fractures occur in children due to the deformation of their soft bone, without breech of cortex. The gold standard for diagnosis of these fractures is x-ray imaging, which can then be effectively treated with a wrist splint. It has also been demonstrated that they can be accurately diagnosed by a rapid ultrasound protocol that can be easily learnt. Ultrasound is not typically utilised in this fashion in a tertiary paediatric ED due to readily available x-ray imaging. However, regional services often have limited radiographic services after-hours. Nurse practitioners (NPs) are frontline workers in the ambulatory care area of the ED where they are heavily relied upon for the diagnosis and management of paediatric fractures. If it can be demonstrated that NPs with limited ultrasound experience can diagnose distal forearm buckle fractures with high accuracy after a short training course, there may be validity in similar front-line workers being trained in this modality in resource-limited environments. This pilot study will determine the acceptability, tolerability (pain compared to radiograph), feasibility (time of scan), and the accuracy of NPs to diagnose buckle fractures using ultrasound compared to radiograph as the gold standard. The results from the pilot study would be used to inform the development of a larger multi-centre research project that incorporates regional sites.

This project seeks to improve and maintain the oral health of people who move into residential aged care by providing an objective way to document they are receiving effective oral care. The project developed as the result of a suggestion by staff at a residential care community in northern Tasmania (Australia) during their participation in a current federally-funded initiative with researchers at the University of Tasmania. The purpose of this project is to determine the impact of a 6-week period of 2-minutes of teeth cleaning after meals, or daily denture cleaning, on the type and load of oral bacteria in the mouths of residents. The hypothesis is that the 6-week intervention will lead to a change in the type and load of oral bacteria, increase residents' oral health, and reduce their risk of aspiration pneumonia.

Anaemia, a global public health problem, is common in developing and developed countries, particularly among hospitalized patients. The World Health Organization defines anaemia as a haemoglobin concentration below 130 grams per litre in males and 120 grams in litre in females. A recent systematic review and meta-analysis on preoperative anaemia and outcomes after cardiac and non-cardiac surgery reported 39% of patients were admitted anaemic. These anaemic patients had three-fold higher odds of mortality, four-fold higher odds of acute kidney injury and twice the odds of infection. Not surprisingly, anaemia was also associated with increased transfusion, with anaemic patients five-times more likely to receive a red blood cell transfusion. As these results indicate, red blood cell transfusions are often administered to correct low haemoglobin levels. However, correcting anaemia with transfusion is problematic as red blood cell transfusion has a dose-dependent association with increased mortality, morbidity, hospital and ICU length of stay, readmissions, and cost. Large risk-adjusted observational studies demonstrate that even transfusing a single unit of red blood cells is associated with increased adverse outcomes in surgical patients, thus recommending caution before transfusing. In an attempt to find the “optimal” transfusion threshold, many randomized controlled trials have investigated the difference between using restrictive pre-transfusion haemoglobin thresholds compared with liberal thresholds. A restrictive strategy refers to a policy of administering red blood cell transfusions at comparatively lower pre-defined haemoglobin levels, with the goal of minimizing the use of blood. Though not always the case, restrictive transfusion thresholds are often defined as haemoglobin levels between 70 grams per litre and 80 grams per litre and liberal transfusion thresholds are commonly defined as haemoglobin levels between 90 grams per litre and 100 grams per litre. A recent systematic review and meta-analysis published in the Cochrane Library concluded there is no difference in morbidity or mortality between restrictive and liberal transfusion strategies. However, these trials are often confounded by transfusions administered pre-randomization, a lack of comparable transfusion dosing regimens between studies, and at times small differences in actual mean pre-transfusion haemoglobin levels between control and intervention arms. In addition, these randomized controlled trials do not address transfusion efficacy and still leave many important questions unanswered. For example, whether haemoglobin thresholds lower than 70 grams per litre are just as effective as haemoglobin levels higher than 70 grams per litre. Some have suggested lower haemoglobin thresholds may be just as effective. The aim of this study is to determine what effect red blood cell transfusion has on mortality and length of stay at various levels of nadir haemoglobin.

This study will qualitatively and quantitatively assess MRI and PET (18F-MISO and if available, 18FDG-PET) for the treatment response assessment of pancreatic cancer patients treated using mFOLFIRINOX chemotherapy (which is the current standard of care for chemotherapy) combined with SBRT. The feasibility of the combination of these two therapies will be assessed according to acceptable toxicity rates. Who is it for? You may be eligible to join this study if you are aged 18 years to 69 years and have been diagnosed with borderline resectable pancreatic adenocarcinoma or unresectable pancreatic adenocarcinoma. Study details: All patients who are enrolled in the study will receive the standard pre-treatment work-up, study treatment of mFOLFIRINOX chemotherapy combined with SBRT and post treatment surveillance. In addition patients will be subjected to 3 additional MRIs, 2 two additional 18FDG-PET and 3 additional 18F-MISO PET (if available) conducted up to 4 weeks following completion of SBRT. Patients will also be subjected to study blood tests. Some blood tests may be part of standard care but those that are not will be included with the standard of care blood tests with additional blood taken and if not part of standard collection, will be taken at the correct timepoint for the study. Patients will be asked to complete QoL questionnaires at 7 timepoints throughout the study. Those patients that are determined to have resectable cancer by the multidisciplinary team following their treatment will proceed to surgical removal of their tumour. Follow up will continue on patients who have resectable or unresectable cancer for 24 months following treatment. This study will inform the design of a larger, randomised, multicentre trial.

This research study is testing the safety and tolerability of a potential new drug called AB122 in subjects with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a pathologically confirmed solid cancer that is metastatic, advanced or recurrent with progression for which no alternative or curative therapy exists or standard therapy is not considered appropriate by the subject and treating physician. Study details A major purpose of this study is to find a safe dose range of AB122 that can be given to humans with cancer. To do this, multiple study cohorts will be enrolled and receive ascending doses of AB122. This means that if one dose has passed the safety and tolerability review, the next higher dose will be given to the subsequent patient cohort. The study will stop once the maximum tolerable dose is determined. In addition, the study will look at the amount of study drug in the blood to evaluate the way the body processes the study drug (pharmacokinetics) and the way the study drug affects the growth of tumours in cancer patients (pharmacodynamics). This research study will help us understand whether AB122, the study drug, can be safely given to patients with cancer.

This is a single-centre, randomised, open-label, two-way crossover, single dose study with three treatment periods conducted in healthy participants. The study is designed to compare the PK profiles of a single oral dose of an immediate and extended release formulation of propagermanium, and to identify if there is a food-effect on the extended release formulation. Participants who meet all inclusion and none of the exclusion criteria will be evaluated throughout the study. In addition to PK assessments, safety and tolerability data will be collected during the course of the study. Approximately 14 participants will be enrolled into two cohorts (Cohort A and Cohort B). Participants in Cohort A will receive the immediate release (IR) formulation while fasting at Dose 1, the extended release (ER) formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. Participants in Cohort B will receive the ER formulation while fasting at Dose 1, the IR formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. No participant will be a member of more than one cohort. Participants will be screened from -14 days prior to dose administration. Participants will be admitted to the unit on Day -1 and will remain confined to the unit for 24 hours post-dose. On Day 1, participants will receive Dose 1 and will complete procedures as detailed in Table 3. On Days 7 and 14 participants will return to the unit and will receive Doses 2 and 3 on Days 8 and 15, respectively and will complete procedures as detailed in Table 3. Participants will return to the clinic on Day 24 for follow-up visits.

This study aims to assess whether sulindac therapy (100mg TWICE daily orally for 14 days) prolongs gestation in women with a cervical length of <15 mm on transvaginal sonography between 18 and 23+6 weeks of pregnancy.

Our literature search failed to reveal any strength and conditioning program for chiropractic students to prevent injury whilst learning manipulative techniques or in the first years of practice. The concept of a strength and conditioning plan with the aim of reducing the likelihood of injury is worth considering as the implementation of such a program early in a practitioner’s career could reduce the prevalence and progression of injuries. The purpose of this large-scale study to examine the effectiveness of a strength and conditioning program to prevent injuries related to manual therapy training and practice. All participants will undergo a series of baseline measures over seven days. This will include demographic information, history of musculoskeletal injury, and maximal strength of muscle groups, which will be estimated using the multiple repetition test procedure (5-10 submaximal strength test) instead of traditional one repetition maximum test (1RM). 1RM will be calculated for each of strict shoulder press (SP), bench press, seated row, Latissimus Dorsi pull down, deadlift, and back racked lunge. Participants will be instructed on correct usage of equipment prior to the testing session and given time to familiarize themselves with the equipment. A warm-up will be completed prior to testing. Thereafter, 3-5 separate single attempts will be performed. Subjects will lift a weight initially 40%-60% of the perceived 1-RM. The increments of weight are dependent upon the effort required for the lift. The weight added will become smaller as the effort to lift the weight increases. If subjects are able to perform more lifts than designated by the testing protocol, subjects are allowed a minimum of four min rest and then reassessed. Participants will be instructed to perform each exercise to acute muscular exhaustion or form fatigue. Any repetitions that are not performed with a full range of motion will be discarded. When the subject can only lift the weight five to ten times, that weight and the number of repetitions are considered to estimate the 1-RM. Grip strength dynamometry will be performed during the strength testing procedure. After completion of all baseline measures, each participant will be randomly assigned to either the intervention (n=106) or comparison (n=106) group using a random number generator. Intervention group participants will undergo a 12-week strength and conditioning program, whilst the control group will perform 30 minutes of moderate intensity walking 3 days per week. After the 12-week period, all participants will undergo the same assessments completed at the baseline.

The project has several aims: (1) To examine the effectiveness of the 'Get Up & Go' peer-support walking program compared to a waitlist control condition in contributing to decreased levels of interpersonal suicide risk, depression symptoms and psychological distress, and increased levels of social support, school membership, wellbeing, and resilience in participating students at the Australian National University (ANU). (2) To explore engagement, adherence, use, and satisfaction of the 'Get Up & Go' peer-support walking program, both quantitatively and qualitatively in the treatment group. Based on previous research, it is hypothesised that participation in the 'Get Up & Go' peer-support walking program will contribute to improvements in students levels of social connectedness and wellbeing. These may be influenced by the following variables: - Participants baseline levels of social support and connectedness to the ANU, mental health (i.e., psychological distress, depression, anxiety) and interpersonal suicide risk factors (i.e., thwarted belongingness and perceived burdensomeness). - Dosage effects, such as frequency and duration of walking, and frequency and duration of social contact with partner - Satisfaction effects, such as perceived quality of social contact with partner and connection to the ANU community induced by the program