ANZCTR search results

There are clinical trials that have examined the benefits of supervised exercise training in addition to “optimal medical care” in peripheral arterial disease (PAD). However, aggressive risk factor modification was not the focus, as it has been in other (non-PAD) cardiovascular studies. This randomised controlled trial will evaluate the impact of a systematic physician-led approach to aggressive risk factor modification in PAD. Hypothesis: A multifactorial intervention in patients with PAD, compared to standard practice, will lead to improved functional status (as assessed by maximum walking distance [MWD]), cardiovascular risk factor control, and quality of life (as measured by Peripheral Artery Questionnaire). This systematic physician-led program will increase adherence to guideline-based therapies. There will be beneficial effects on the atherosclerotic disease process (as measured by exploratory biomarkers of inflammation). TRIAL DESIGN This is an investigator initiated, local, multicentre, randomised controlled trial in South Australia. A total of 150 participants will be randomised into two groups. The intervention arm (group A) will undergo multifactorial intervention under a physician-led program of behaviour modification with stepwise introduction of pharmacologic therapy. This group will have follow-up over a 12-month study period. The follow-up frequency will be up to the discretion of the study physician. The standard therapy arm (group B) will have conventional treatment (e.g. follow-up with general practitioner and/or vascular surgeon) for the length of the 12-month study period. These patients will be offered multifactorial intervention after completion of the protocol. The clinic reviews and investigations in this study are intended to complement standard practice. All participants will continue to see their usual treating clinicians throughout the study period.

PRN1008-011 is a single center, four-period, open-label, randomized, complete cross-over study in healthy adult participants.This study will evaluate the relative bioavailability of two novel formulations of PRN1008 (Test Formulations #1 and #2) compared to an existing tablet formulation (Reference Formulation), which has previously been administered in Phase 1 and Phase 2 studies. The information obtained in this study will evaluate the potential of the two novel formulations for use in future PRN1008 patient studies, and determine if any dosage adjustments are needed to obtain similar plasma exposures between the formulations. PRN1008 is a novel, reversible covalent, investigational drug that inhibits Bruton’s agammaglobulinemia tyrosine kinase (BTK). PRN1008 acts as an adenosine triphosphate (ATP) competitive inhibitor that is both potent and selective for BTK. PRN1008 has a slow off-rate for binding to the target site, resulting in prolonged target occupancy relative to its low systemic exposure. This study will also evaluate the PK of PRN1008 when co-administered with a customary dose of famotidine, an H2-receptor antagonist. Co-administration of PRN1008 in the morning after famotidine use, as well as in the evening 2 hours prior to famotidine will be studied. A prior study (PRN1008-006) found that PRN1008, when administered in combination with a proton-pump inhibitor (esomeprazole), demonstrated approximately a 50% reduction in plasma exposure, most likely due to the impact of esomeprazole on gastric pH. Based on these results, proton-pump inhibitors are currently excluded from PRN1008 clinical trials. The objective of this evaluation is to assess the potential impact of co-administering PRN1008 with H2-receptor antagonists, which are less potent reducers of gastric pH compared to proton-pump inhibitors. The results of these evaluations will inform the use of PRN1008 in future clinical studies. Finally, this study will evaluate the potential for PRN1008 to alter the PK of midazolam when co-administered under various scenarios; this information will inform the use of PRN1008 in autoimmune diseases where drugs like midazolam and other CYP 3A substrates may be co-administered.

The Tuning in to Teens program (Havighurst, Harley, Pizarro & Kehoe, 2012) is a program aimed at improving emotion socialisation to promote adolescent development of emotional competence and strengthen parent-adolescent relationships. The program has shown to be efficacious in helping parents' develop skills in recognising, understanding and responding to emotions in themselves and to their teen and to reduce adolescent mental health difficulties, such as internalising and externalising problems.. This study evaluated a whole school approach version of the evidence-based Tuning in to Teens parenting program, targeting parents, teachers and year 8 & 9 students. This allowed directly teaching emotion regulation skills to teens, as well as helping their parents, teachers and peers learn ways of responding that assist the young person with their emotional development.

Image guided radiotherapy (IGRT) has recently emerged as a technique for delivering high doses of radiation accurately over a short time span. It has advantages over conventional external beam radiation (EBRT) by minimising radiation exposure to the surrounding tissues and thus potentially reducing toxicities. This has been utilised at a variety of sites, including the pancreas, oesophagus, lung and prostate. Image guidance is best achieved with the implantation of target markers called fiducials or seeds. These are typically composed of gold and there are currently several available on the market. In pancreatic cancer, fiducials are superior to biliary stents in terms of showing tumour position. The technique for implanting fiducials has traditionally been done percutaneously or surgically, but such approach often limited by its invasiveness or the deep location of the cancers such as those from the esophagus or pancreas. Given the ability of EUS to reach these “difficult” organs, the efficacy and safety of EUS guided fiducial insertion for these GI malignancies have been demonstrated recently. The technique of inserting fiducials almost identical to that of FNA/FNB. Compared to percutaneous method, EUS guided fiducial insertion is likely to associated with a reduction in peritoneal seeding risk and obviates the need to traverse other organs. Up to now, 10mm gold Visicoils of various diameter is the fiducial system for EUS insertion. This approach, however, requires individual loading of a single fiducial to the tip of a FNA needle prior to each single deployment, which is tedious and time consuming. More recently, Cook Medical has specifically designed a dedicated 22G EUS guided fiducial needle with 4 x 5mm gold bars preloaded at the tip of the needle. This allows the fiducials to be deployed to target lesions consecutively in a short amount of time, and avoid the need of withdrawing the needle to load the subsequent fiducials. In live porcine model, the use of this needle prototype was associated with safety, high technical success rate and high visibility score on fluoroscopy. Who can participate? Recruitment for this study was done on a retrospective and prospective basis. Data on patients who underwent EUS-guided fiducial placement for SBRT or brachytherapy for GI malignancies were recruited over a 4 year period. Only patients with confirmed malignancy by a cytopathologist and able to give informed consent were included. Aim: The aim of this study is to compare the performance of a new EUS preloaded fiducial needle (Cook Medical) against the conventional coil fiducial (Visicoil) for SBRT and brachytherapy. Hypothesis: It is hypothesized that the new EUS guided preloaded fiducial needle will perform just as well as the conventional coil fiducial, with a 100% technical success rate.

The RECELL® autologous cell harvesting device enables rapid autologous epidermal replacement. The paucity of data substantiating its implementation in acute paediatric burn injuries warrants further evaluation. This study aims to compare effectiveness of three commercially available burn wound management approaches used for burn injuries. Informed consent of parent/guardians of children meeting the inclusion criteria will be obtained the demographic data collected. Participants will be randomised to standard silver dressing or Biobrane® with RECELL® or Biobrane® only. These will be initially applied under a general anaesthetic in the operation theatre. Data acquisition will be from digital imaging, sonography, colorimetry and assessments of pain, itch, dressing application ease, treatment satisfaction, intervention fidelity, health- related quality of life, scar assessment and health resource utilisation will be recorded. Intervals for data collection will be at baseline, at all 3-5 day dressing changes until wound is 95% or more re-epithelialised and at outpatient follow up at 3, 6 and 12 months post injury.

Hypothesis It is estimated that >30% of early breast cancer patients who have received systemic adjuvant treatment will experience survivorship issues in the subsequent 5 years following diagnosis. During this period, it may affect physical and psychosocial functioning, with changes to their employment and/or financial status, and the severity and incidence will diminish over time. Aim The aim is to identify how a prior diagnosis of breast cancer and its treatment impacts on physical and psychosocial functioning over time. For this trial, no study specific visit at the clinic is required. Who is it for? In this trial, any participant aged 18 years and above who has been diagnosed with early breast cancer, undergone breast surgery and completed their adjuvant treatment under the care of clinicians at Breast Cancer Research Centre-WA will be asked to complete a questionnaire of 192 questions. It will assess the prevalence and magnitude of physical and psychosocial issues in breast cancer survivors. In addition, some demographic information will be collected. Study details Upon return of signed Participant PICF a delegated BCRC-WA trial staff and PI will review eligibility. The Participant will be emailed their unique survey code ID with a link to the SurveyMonkey questionnaire to complete within 42 days of the consent signature. It is anticipated that this will take them 15-30 minutes overall. The trial data collected will only be analysed after recruitment is complete and all data has been collected. It is clearly stated in the Patient Informed Consent that data is not collected for treatment purpose. The trial recruitment period is planned to last 6-12 months, the expected duration of the project is January 2018 to January 2020. It is anticipated that 200 participants will be recruited.

Myopia, also known as short-sightedness, is a condition of the eye that is said to affect nearly a quarter of the world population. Whilst spectacles and contact lenses compensate for the myopia and allow the eye to see clearly, they do not control the increase in eye growth that is responsible for myopia. As a result, one is required to change their spectacles or contact lenses on a regular basis to be able to see clearly. Furthermore, the more the short-sightedness progresses, the greater the risk of complications such as retinal detachment, glaucoma and myopic macular degeneration. Recent research has shown that experimental contact lenses have the potential to slow the progression of myopia by 25 to 40% on average in a group of Chinese children. These lenses have a unique design profile that is intended to discourage the eye from further growth that leads to more myopia. This study aims to find out whether we can slow down the progression of short-sightedness in Australian children when experimental contact lenses are worn compared to standard commercially-available single vision contact lenses (1-Day Acuvue Moist, Johnson & Johnson Vision Care). To achieve this, the experimental contact lens will be worn in one eye and the standard single vision lens in the other eye over a period of 1 year. The lenses will be swapped between the eyes after 6 months.

This project evaluates an innovative model involving the delivery of psychological interventions by mental health trainees (MHTs) to residents with mild to moderate dementia. Interventions are provided to residents over 6 months (approximately 20 face-to-face sessions). Training in understanding dementia is also provided to their caregivers (family and friends) and to facility staff. In addition, caregivers are invited to join a monthly support group. Hence, the treatment involves a systemic approach involving residents, their caregivers and facility staff. Using a cluster-randomised controlled trial, this project compares the effectiveness of the model over and above usual practice, for improving depression and anxiety levels in residents with dementia.

‘A good recovery’ after anaesthesia and surgery is a key objective for patients and their treating team. It is not simply avoidance of complications, but also freedom from discomfort, postoperative nausea, and a rapid return to preoperative levels of function and psychological wellbeing. Delayed or incomplete recovery can have wide-ranging effects on an individual and those around them. The concept of a ‘good recovery’ is patient-centred, thus it is the patient’s assessment of their recovery that is of interest. Our aim is to determine whether stage of menstrual cycle affects quality of recovery after surgery in premenopausal women. Cycle stage will be measured by questionnaires and preoperative hormone blood levels. Quality of recovery will be assessed on the day after surgery by a patient-reported questionnaire which assesses pain, physical comfort, physical independence, emotions and psychological support. This study may provide information on why women generally have a worse recovery after anaesthesia and surgery when compared with men. If a link between menstrual cycle and postoperative recovery is found, women could choose the best time for elective surgery, to improve recovery, reduce pain, nausea and vomiting, as well as limit the side-effects of treatment of these conditions. The study's findings may encourage research into quality of recovery in peri- and postmenopausal women receiving hormone replacement therapy, a group who typically undergo more extensive surgery with a prolonged recovery. This study will be undertaken at Epworth HealthCare, a large tertiary healthcare organisation in Victoria, Australia. The researchers are anaesthesia and women’s health clinicians with an interest in patient-centred clinical outcomes research.

Aim: This experimental study will explore whether breaking up prolonged sitting is an effective strategy in reducing glucose, insulin and androgen markers in women with polycystic ovary syndrome (PCOS). Participants: 22 women of reproductive age (aged 18-45 years), a BMI between 25-35 kg/m2 and with medically diagnosed polycystic ovary syndrome (PCOS). Study design: Crossover trial of two 3-hour laboratory-based interventions involving prolonged sitting (control, SIT); and sitting with simple resistance activity breaks (SRA). Primary outcomes: Glucose incremental area under the curve (iAUC), changes in pre and post insulin and androgen levels Expect outcomes: It is hypothesised that compared to the SIT condition, the SRA condition with have reduced glucose iAUC, and post insulin and androgen levels. The study outcomes will help to better understand the potential importance of reducing sedentary behaviour in women with PCOS, and provide an additional lifestyle strategy in reducing their risk of future type 2 diabetes and cardiovascular disease (CVD).