ANZCTR search results

The primary purpose of this study is to evaluate the safety of a new cancer drug, ACT001 which has not yet been tested in humans. The study will also look at the amount of drug in the blood to evaluate the way the body processes the drug and the way the drug acts on the growth of tumours in cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with advanced or metastatic solid tumor, including glioblastoma, with no standard treatment options. Study details All participants in this study will receive a specified dose of ACT001 each day for 56 days (two 28 day cycles). The first set of participants will start on the lowest dose level, with the next highest dose only commencing in the next set of participants once the safety of the first dose has been confirmed. Researchers will take a number of blood samples on days 1, 2, 3, 17, 18 and 29 of dosing in each participant to examine the rate that the body processes the drug. Further blood samples, as well as CT and MRI scans will be taken before treatment and at the end of treatment to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether ACT001 can be safely given to cancer patients, and provide information on the rate of processing of the drug in the body. Using this information, researchers hope to find the best dose to use for further testing of ACT001 in cancer patients.

Emergency doctors are required to complete a range of administrative tasks including typing medical notes, ordering imaging and blood tests, following up on results and corresponding with external departments. These administrative tasks do not require advanced clinical training and so the medical skillset of the emergency physicians is being underutilised. The Emergency Department also loses money due to under-billing patients when at the end of the patients’ attendance by forgetting to include some billable items (e.g. an ECG). A medical scribe completes administrative tasks for the emergency physician so that more time can be spent on medical tasks. The scribe is also responsible for completing billing requirements and can bill for events as they happen, reducing the likelihood of under-billing. While it is important to improve the efficiency of the Emergency Department, it cannot be done at the detriment of patient comfort. However, there is no research in Australian patients’ perceptions of having a non-medically qualified staff member present while being examined by an emergency physician. The current study aims to identify patients’ views and thoughts on medical scribes and uncover any problems that might arise from having additional staff in the room while a consultation takes place.

To properly manage type 1 diabetes (T1DM), individuals are required to measure blood glucose levels regularly and adjust the amount of insulin to be given accordingly. This is done by matching the insulin doses to the carbohydrate content of a meal. Recent studies have shown that meals high in dietary protein may cause postprandial hyperglycaemia. The paediatric diabetes research team at the John Hunter Children’s hospital published a study demonstrating that meal protein content can significantly affect postprandial blood glucose levels. More recently, our group have published a further study, looking at the impact of pure protein- independent of carbohydrate and fat- on postprandial blood glucose levels in T1DM. We are now in the process of completing a further study that was designed to investigate the effect of consuming protein with carbohydrate only (no fat) on postprandial blood glucose levels and have demonstrated a dose response to increasing amounts of protein when consumed with carbohydrate. These findings have led to recommendations to give additional insulin for meals high in protein to avoid postprandial hyperglycaemic excursions. However, at the present time there is still insufficient data regarding how to safely and effectively calculate and deliver mealtime insulin doses for protein. Therefore, we need to conduct further research in order to determine a safe and effective insulin dosing algorithm for meals high in protein.

Many Australian families are unable to access evidence-based psychological treatments for their child’s Disruptive Behavioural Disorder (DBD) due to their geographical location and limited availability of appropriate mental health services. For these families, Internet-delivered treatment may be a promising means of overcoming these barriers. The aim of this study is to test the feasibility, acceptability, and efficacy of Internet-delivered Parent Child Interaction Therapy (I-PCIT), as compared to standard, clinic-delivered Parent-Child Interaction Therapy (PCIT), using a non-inferiority, randomized control trial. It is expected that I-PCIT children will show non-inferior reductions in ODD/CD rates, and in oppositionality, aggression, noncompliance, and hyperactivity, relative to standard PCIT children. It is also expected that I-PCIT parents, relative to standard PCIT parents, will show (i) non-inferior increases in the use of effective commands, labeled praise for child compliance, behavioural descriptions, verbal reflections, and household consistency and follow-through, (ii) non-inferior reductions in the use of criticisms and indirect commands, (iii) non-inferior improvements in family functioning, and (iv) non-inferior reductions in parental stress and depressive symptoms. Families are eligible to participate if their 2-7 year old child meets clinical criteria for a DBD, parent(s) are fluent in English, not intellectually disabled or with a history of severe physical or mental impairments, and own a computer. Eligible parent-child dyads randomly allocated to I-PCIT will receive 14 weekly one-hour PCIT therapy sessions delivered over secure online videoconferencing software by a trained PCIT therapist under the supervision of a Master Trainer. Dyads allocated to the standard PCIT condition will similarly receive 14 weekly one-hour PCIT therapy sessions delivered in-clinic at the UNSW Parent-Child Research Clinic. All participating dyads will complete four identical 1.5 hour assessment sessions over videoconference or in-person at pre-treatment, mid treatment, immediately post-treatment, and 3-months post-treatment. These sessions will involve coded observations of parent-child interactions, computer-based questionnaires completed by parent(s), and a clinical interview with a research assistant blind to treatment condition.

1.To demonstrate the feasibility of conducting a RCT using omega-3 supplementation with a community sample of impulsive, repeat-violent offenders. Secondary objectives 1.To collect information about the effectiveness of omega-3 supplementation on 3-month behavioural measures of impulsivity, anger, depression and irritability in impulsive, repeat-violent offenders. 2.To collect information about the effectiveness of omega-3 supplementation in reducing self-reported offending among impulsive, repeat-violent offenders.

Preterm infants are highly susceptible to bacterial late-onset sepsis (LOS) and necrotizing enterocolitis (NEC), both are major causes of systemic inflammation and contribute to brain injury and long-term disability in premature infants. Treating LOS and NEC are essential for survival, but suppressing systemic inflammation can also help reduce mortality, hospital stay and disability due to brain injury. The current treatments for NEC and LOS are limited to antibiotics, supportive care and surgery in some NEC cases, all of which do not aid in reducing systemic inflammation, therefore there is a need to reduce systemic inflammation. Pentoxifylline is a safe, low-cost, non-steroidal drug with potent immune-modulating activity with the potential of suppressing systemic inflammation induced by LOS or NEC. A recent Cochrane Review of 6 randomised controlled trials (RCT) suggests that PTX, given with antibiotics in neonatal sepsis, reduces mortality and length of hospital stay. We will enrol and consent 23 preterm infants (<29 weeks gestational age) and intravenously administer Pentoxifylline, adjunct to standard care, for 48hrs within 6 hours of the onset of symptoms suggestive of sepsis or NEC. After 48 hours treatment will cease if diagnosis is refuted or will continue for 4 days if diagnosis is proven. To measure the pharmacokinetic profile of Pentoxifylline a series of four small blood samples will be taken prior to starting treatment and during treatment. The pharmacokinetic profile will allow us to model the optimal infusion frequency and duration, which will be used as a guideline in larger randomised controlled trials that will assess white matter injury and long-term disability.

As a low risk, readily available treatment, PRP injections are becoming an increasingly popular therapeutic adjunct offered by musculoskeletal clinicians. However, there is a clear need to scientifically assess the merits of this treatment option for athletes with ankle syndesmosis injury in order to establish recommendations for evidence-based practice. We published a pilot study entitled- "Effectiveness of a single platelet-rich plasma injection to promote recovery in rugby players with ankle syndesmosis injury". Available at http://bmjopensem.bmj.com/content/1/1/e000033.full.pdf+html We found a reduction in return to play by 20.7 days for the intervention (PRP) group, when compared to an historical control treated with the same rehabilitation protocol. The study supports the viability of an RCT to fully evaluate this treatment. We have calculated that a minumum of 30 participants would be required to detect a significant difference between groups in return to play, but would define a clinically significant difference as a minimum of one week. We will conduct a prospective randomised controlled trial comparing single US-guided PRP injection to an active placebo prolotherapy. Assessors, investigators and participants will be blinded to their allocation and only the treating radiologist who will only interact with particpants to perform injections, will know allocations. Prospective participants from Rugby union clubs within the Sydney Rugby Union Championship will be invited to enrol. On clinical assessment, only those with a low probability for ASI will not be referred for MRI. After MRI, those meeting enrolment criteria and consenting to participate will be randomly allocated to PRP or active placebo groups, and given usual injury management in accordance with our previously published milestone based rehabilitation protocol (Samra et al 2015). A single injection by co-author JL will be provided within 14 days of injury. A central randomisation register will provide the allocation to JL only. The injection protocol will be identical between groups, except for lack of injection of the PRP in the active placebo group. 1-2mL of 2% lignocaine will be infiltrated to the skin and superficial tissues. Blood will be drawn and centrifuged at 3000RPM for 8 minutes. The PRP will be manually aspirated. 0.5-1mL of PRP will be injected with a 25 guage needle into the defect of the AITFL seen on ultrasound in the intervention group. The active placebo group will undergo the same process with the omission of injection of the PRP. Instead, a peppering technique of 5 passes into the AITFL will be performed. Participants will be given oral analgesia and post-injection care information and followup. No other injections of the ankle will be permitted during the rehabilitation of these athletes or within 1 week of return to play. Return to play will be recorded in days from injury onset to first competitive match (of any duration) played since injury

ABSTRACT Background: People with low literacy and low health literacy have poorer health outcomes. Literacy and health literacy are distinct but overlapping constructs that impact wellbeing. Interventions that target both could improve health outcomes. Methods & Design This is a cluster randomised controlled trial with a qualitative component. Participants are 300 adults enrolled in basic language, literacy and numeracy programs at adult education centres across New South Wales, Australia. Each adult education institute (regional administrative centre) contributes (at least) two classes matched for student demographics, which may be at the same or different campuses. Classes (clusters) are randomly allocated to receive either the health literacy intervention (an 18-week program with health knowledge and skills embedded in language, literacy, and numeracy training (LLN)), or the standard Language Literacy and Numeracy (LLN) program (usual LLN classes, specifically excluding health content). The primary outcome is functional health literacy skills – knowing how to use a thermometer, and read and interpret food and medicine labels. The secondary outcomes are self-reported confidence, health literacy; shared decision making skills, patient activation, health knowledge and self-reported health behaviour. Data is collected at baseline, and immediately and 6 months post intervention. A sample of participating teachers, students, and community health workers will be interviewed in-depth about their experiences with the program. Ethics and dissemination The study has ethical approval from the University of Sydney and 10 NSW Institutes of TAFE. Results will be published in peer reviewed journals, and reported to partner organisations.

Background: Continuous enteral feeding mode that is aimed at achieving daily caloric target is the standard practice in ICU. However, there is no strong evidence in favour of continuous enteral feeding over intermittent feeding. Continuous feeding infusions are interrupted for nearly 25% of the time and are often delivered at a reduced rate for reasons such as perceived gut intolerance or dysmotility and the need to withhold feeds for concurrent medical, surgical and diagnostic procedures. Consequently, patients in ICU are often underfed. Intermittent enteral feeding is more physiological. It mimics the natural ingestion-fasting cycle and preserves the natural cyclical secretion of gut hormones such as gastrin and motilin. These hormones are closely related to the cycle of meal ingestion and the period of fasting between two meals. It is plausible that continuous feeding interferes with ingestion-fasting cycle and interrupts the natural rhythm of hormonal secretion that is primarily responsible for gastrointestinal motility. Further, intermittent feeding mode is less affected by frequent interruptions, and therefore may also be more effective in achieving daily caloric target. Additionally, there is evidence for more efficient gastric emptying in the right lateral position (J Nucl Med. 1996). Delivering intermittent feeds while in right lateral position seems feasible, as regular posture turns are part of standard nursing care. However, such posture-aided intermittent feeding has not yet been investigated. Aim: To determine whether intermittent enteral feeding during the right lateral tilt position results in less gastrointestinal intolerance compared to standard care among mechanically ventilated patients. Methods: 120 eligible patients who are likely to require mechanical ventilation in ICU for at least 24 hours will be randomly allocated to either standard care arm or intermittent feeding arm. The feeding formulae and target feed volume and continuous infusion rate will be determined prior to randomization. Patients in the intermittent feeding arm will be fed at least three times a day with one third of daily target feed volume infused over one hour each time. Informed consent will be sought from the person responsible or the legal surrogate. Patients will be followed until ICU discharge or maximum 14 days whichever is earlier. Primary end-point: Incidence rate of gastrointestinal intolerance (vomiting, diarrhea or constipation). Secondary end-points: Days free of gastrointestinal intolerance (vomiting, diarrhea or constipation) until day 14, episodes of vomiting and diarrhea per patient, time to vomiting or diarrhea, mean diet volume ratio (diet received/ diet prescribed) expressed as percentage, ventilator-free days until day 14, and all-cause hospital mortality.

For patients that survive ICU there are considerable long-term burdens from being so unwell and the treatments administered in ICU. Because of the long-term health issues it has been proposed that patients who survive ICU should be able to access specialised services via so-called ‘follow-up clinics’. However, the health budget is relatively fixed and so an increase in provision of one health service means that another health service must be reduced. Follow-up clinics are expensive and currently there is no evidence that these follow-up clinics benefit patients. Accordingly, it is imperative that we establish whether these follow-up clinics are helpful or represent a waste of valuable resources. We will study a very specific group of patients, those with diabetes who have survived ICU. We are studying this group of patients as patients with diabetes make up a significant proportion of patients in ICU. It is also likely, but not yet known, that patients with pre-existing diabetes who survive ICU may be particularly vulnerable to poor health outcomes after ICU. The intervention we will study is a follow-up clinic run by physicians with expertise in ICU (intensivist) and diabetes (endocrinologist). Our study will provide preliminary information as to whether this type of ICU follow-up clinic is of benefit. If the preliminary data are promising we will undertake a much larger study so that we can precisely measure the effects of these clinics.