ANZCTR search results

The primary purpose of this trial is to assess the effectiveness of Rifaximin in preventing variceal bleeding (bleeding from enlarged veins due to increases in blood pressure) in at risk patients and to determine the effect of Rifaximin on gut bacteria. Who is it for? You may be eligible to participate in this trial if you are aged 40 or over with compensated cirrhosis (chronic liver disease) and are at high risk of variceal bleeding. You must be unable to take propranolol (a blood pressure medication) or have declined this treatment for variceal bleeding to be eligible for this trial. You are also eligible for the trial if you have recently commenced or are continuing with endoscopic variceal ligation (EVL - is a procedure where enlarged veins in the oesophagus are tied off using a rubber band) as preventative treatment for variceal bleeding. Study details All participants enrolled in this trial will receive Rifaximin. Before treatment begins, you will need to undergo a hepatic venous pressure measurement and provide a stool sample, so that your treating team of clinicians will be able to compare portal pressure (blood pressure in the liver) before and after Rifaximin treatment and determine the effectiveness of this new treatment. Treatment period will be for 6 months, where you will have to take one Rifaximin pill (each 550mg) twice a day, with or without food, every day until the end of the treatment period. You will need to return to your doctor’s office in the middle of the treatment period (3 months) to provide a stool sample, collect your next cycle of drugs and complete standard of care treatment for your cirrhosis. At the end your treatment, you will have to return to the hospital for some follow up procedures to determine the effectiveness of the treatment drug, Rifaximin. These procedures will include a repeat hepatic venous pressure measurement, an endoscopy and a proctoscopy to observe size of varices and obtain biopsy samples, and a stool sample. The biopsy samples, a duodenal and rectal biopsy, will be obtained to determine whether Rifaximin changed gut bacteria and if this had a role in treatment outcome. Post-treatment all participants will be asked to provide a stool sample at 12 months, so that the doctor can ensure that your bacteria is back to normal. We hope that Rifaximin will provide an alternative treatment option that may be better at controlling inflammation of the liver and reducing portal pressure that results in bleeding, without the associated side effects, compared to current treatment options. It is hoped that the findings from this study will help optimise treatment management of patients with cirrhosis.

We performed a prospective randomized clinical trial to compare the pain experienced by patients who undergo either topical pledget or subconjunctival injection anaesthetic prior to intravitreal injection. 112 patients were recruited, randomised, blinded to anaesthetic method and administered either a topical pledget anaesthetic with 0.5% amethocaine hydrochloride or a 2% lignocaine subconjunctival injection. 5 minutes after intravitreal injection, a Visual Analog Scale was used to determine pain and this was repeated at 24 hours post injection via phone. 67 patients returned to the clinic and underwent the opposite anaesthetic technique for their next intravitreal injection. Pain scores were repeated at 5 minutes and 24 hours post injection. Patients were asked whether they preferred the first or second injection. Median pain scores out of 10 were low in both groups, but median 5 minute post injection pain was significantly lower in the subconjunctival injection group compared with the topical pledget group (SC= 1/10, TP= 2.5/10, U=1063, z=-2.97, p=0.003, r=.28). No significant difference in pain was evident in 24 hours post injection. 24 hour pain scores were significantly higher in those who had less than 10 previous injections (p=0.005). The preferred injection was subconjunctival injection in 75% of patients who had a repeated injection. SCI over TP anaesthetic may provide a superior modality of pain relief for intravitreal injections.

Electromagnetic stimulator therapy (EMST) is a new technology in the care of chronic non-healing wounds [1]. The technology delivers high-energy pressure waves into the wound by enriching the ulcer with adequate blood through formation of new blood vessels. It also stimulates the body to produce natural growth factors which helps in repairing the damaged tissues of the wound [2]. Recently, EMST was reported to be effective in the initiation and acceleration of wound healing in various non-diabetic clinical settings most part involves small case series of bed sores and venous ulcers with scanty reports on diabetic wounds [1-2]. Thus, there is very little information on effect of electromagnetic stimulation in healing ulcers of diabetic foot. With our earlier report of high rate of diabetic limb amputations in our local population [3-4] we believe EMST technology may have a role to play in the care of our patients. This technology is simple and can be administered fortnightly as against daily administration in other form of therapies. The treatment with EMST is a non-invasive method and easily tolerated by patients. It is applied through an unfocused applicator which assures an almost painless treatment and no anaesthesia required. Each therapy session only takes about 15 to 60 minutes. As EMST being a viable option of diabetic foot ulcer (DFU) care in our high risk diabetic population yet there is no study to show EMST usefulness in treatment of non-healing DFU in Australia. It would be interesting to find out if this technology would change our current daily diabetic foot ulcer care practice for the betterment of the most costly diabetic complications -DFU. The main objective of the study was to evaluate the healing rates of chronic diabetic foot ulcers during a 12-week period in patients treated with EMST and usual care compared to usual care alone. Reference 1. Gaurav Thakral et al. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013; 4: 10.3402/dfa.v4i0.22081. 2. Jhamb S, Vangaveti VN, Malabu UH. Genetic and molecular basis of diabetic foot ulcers: Clinical review. J Tissue Viability. 2016. pii: S0965-206X(16)30041-9. 3. Rodrigues BT, Vangaveti VN, Malabu UH. Prevalence and Risk Factors for Diabetic Lower Limb Amputation: A Clinic-Based Case Control Study. J Diabetes Res. 2016;2016:5941957. 4. Gilhotra RA, Rodrigues BT, Vangaveti VN, Kan G, Porter D, Sangla KS, Malabu UH. Non-traumatic lower limb amputation in patients with end-stage renal failure on dialysis: an Australian perspective. Ren Fail. 2016 Aug;38(7):1036-43.

A number of studies have examined the impact of the MiniLit program on the reading ability of students participating in the program. Although these previous studies have shown promising benefits in terms of effect sizes on children’s reading (d = 1.1 to 1.8), results are derived from differences between pre- and post-training scores. In addition, there has been limited efficacy and effectiveness studies that compare children who complete MiniLit to those who receive “business as usual” classroom teaching or alternative RTI Tier 2 interventions. The current evidence for MiniLit consists of studies performed by the developer, including a small within-school, wait-list randomised controlled trial of the MiniLit program demonstrating its positive impact (5-8). Therefore, these promising findings now need to be evaluated in a large scale RCT to determine the impact of the program on student outcomes when scaled to system-level implementation. In addition, it is important to evaluate the process indicators that can predict the outcomes of the intervention, as well as the implementation cost-benefit. The overarching question of this project is whether the MiniLit intervention, offered to Year 1 students identified as being in the bottom 25% of readers, improves student reading and literacy outcomes 12 months post-randomisation? The primary research aim of this project is: 1To determine, for Year 1 students in the bottom 25% of readers, whether students who receive MiniLit have better reading outcomes at 12 months post-randomisation, compared to those who have usual classroom teaching We therefore hypothesise that students who receive the MiniLit intervention will have better mean reading ability scores on the Australian Edition of the York Assessment of Reading for Comprehension - Passage Reading (YARC – PR) at 12 months post-randomisation, compared to students who receive ‘business as usual’. The secondary aims are: 1. To determine student reading outcomes in both intervention and control groups 6 months (short term) post-randomisation. 2. To determine the proportion of students with ‘low reading ability’ in both intervention and control (‘business as usual’) groups at 6 and 12 months post-randomisation 3. To determine the implementation enablers and barriers that are predictive of program success and sustainability 4. To determine the cost per student, and cost-effectiveness of the intervention

The overarching aim of this study is to investigate the impact of a unique HIIT program (Uni HIIT) on cardiorespiratory fitness (primary outcome), physical activity, body composition, stress,executive function, well-being and psycho-social health outcomes in low active young adults when implemented in university settings. Using a randomised controlled trial (RCT) the Uni HIIT program will be implemented Phase 1: single site RCT at the UoN (n=60)

Gestational diabetes (GD) is a form of diabetes which occurs during pregnancy, and generally resolves after delivery. It is diagnosed as high blood glucose during pregnancy, and affects around 5–10% of all pregnancies in Australia. Recent changes to diagnostic criteria along with an increasingly obese population and older age at which women have their first child, mean the prevalence of GD is rapidly rising. Pregnancy is known to be an insulin-resistant state, and failure to adequately compensate for this inherent insulin resistance through increased insulin secretion results in hyperglycaemia. Whilst the precise mechanisms behind this insulin resistant state are unclear, there is increasing evidence that inflammation of adipose tissue is associated with GD development. Pregnancy is characterized by adipose tissue remodeling and growth, which is modulated by inflammatory markers. However, higher levels of inflammatory markers such as IL-6 and TNF-a, and lower levels of adiponectin are associated with the development of GD. Docosahexaenoic Acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3PUFA) that is critical to the neural development of the foetus during pregnancy, and may be beneficial to adipose tissue functioning during pregnancy. Pregnancies complicated by type 2 diabetes and GD are associated with a decline in erythrocyte DHA in late pregnancy when compared with normoglycaemic pregnancies. This fall can be ameliorated by DHA supplementation during pregnancy. Supplementation of n-3PUFAs in pregnancies affected by GD confers beneficial effects on insulin resistance when compared with control groups Furthermore, supplementation of EPA + DHA from weeks 10-16 of pregnancy until term results in reduced expression of IL-6, IL-8 and TNF-a in both adipose and placental tissue. The improved insulin sensitivity and adipokine profile and reduced levels of inflammatory markers suggest improved adipose tissue function in response to n-3PUFA supplementation, which could reduce the risk of developing GD. To date, research investigating the relationship between n-3PUFAs and GD as an outcome have not reported a relationship. However, supplementation in these trials commenced later in the second trimester, from 17 weeks’ gestation, with the majority not commencing until 24 weeks gestation. We postulate this is too late in pregnancy as GD has often become apparent by this point. No research has reported the effect of an n-3PUFA intervention in early pregnancy on insulin resistance, adipokines and markers of inflammation. We hypothesize that DHA supplementation supports healthy adipose tissue development and functioning during pregnancy, and this in turn reduces the risk of developing gestational diabetes. The aim of the current study is to determine the effect of a low-dose DHA-enriched n-3PUFA supplement on measures of insulin resistance, adipokine profile and inflammatory markers from early pregnancy in women at high risk of developing GD.

It has been reported that both the occurrence of primary postpartum haemorrhage (PPH) (birth to 24 hours postpartum) and rates of maternal overweight and obesity are increasing. For the ‘routine’ management of the third stage of labour and primary post partum haemorrhage prophylaxis, mothers are usually given the same dose of oxytocin without consideration of their weight or body mass index (BMI), which many other pharmaceutical products require. We propose that for those whose body mass index (BMI) would classify them as being either overweight/pre-obese (BMI 25.00-29.99 Kg/m2) or obese (BMI equal to, or more than, 30Kg/m2), that this ‘standard dose’ for all maybe insufficient to attain the therapeutic levels of oxytocin necessary to invoke uterine contractility, thereby predisposing this cohort of mothers to atonic PPH. The research study is an investigator initiated, single centre (Monash Health), phase 4, open label, prospective, randomized controlled trial, to evaluate the relationship between participant (maternal) BMI and the pharmacokinetics (PK) of a single dose of oxytocin administered either as: a 'slow' bolus (1-2 minutes) intravenous (IV) injection or an intramuscular (IM) injection, given for primary postpartum haemorrhage prophylaxis following birth. The trial seeks to collect blood samples from n=120 participants: Those who are having an elective (no labour) caesarean section (n=100) under regional anaesthesia, and are representative of BMIs: normal range, (BMI 18.5-24.99 Kg/m2), overweight/pre-obese (BMI 25.00-29.99 Kg/m2), obese class I (BMI 30- 34.99 Kg/m2) obese class II (BMI 35-39 Kg/m2) or obese class III (equal to, or more than, 40.00 Kg/m2). Those who are having a vaginal birth (n=20) and composed of only of those who have a BMI that is within the normal range (18.5-24.9 Kg/m2). Ultimately, there will be n=20 participants in each of the six study groups. Of these, following randomisation, each study group, will be composed of n=10 participants who have received 5 IU of oxytocin via a ‘slow bolus’ (1-2 minutes) intravenous (IV) injection, and n=10 who have been given 10 IU oxytocin through an intramuscular (IM) injection. Blood samples will be collected from participants for pharmacokinetic (PK) analysis: before birth (1 hour, or less) and then following birth, and timed from the commencement of oxytocin administration, at a 'desired' nine further targeted time points of: 3 (+/-0) minutes, 5 (+/-1) minutes, 10 (+/-2) minutes, 15 (+/-2) minutes, 20 (+/-2) minutes, 30 (+/-3) minutes, 60 (+/-5) minutes, 120 (+/-5) minutes and 180 (+/-5) minutes. Pharmacokinetic parameters include: Absolute bioavailability (F), absorption rate constant, (Ka), clearance (Cl) and volume of distribution (Vd). Bioanalysis and modelling will be used to determine maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration-time curve (AUC) and terminal phase half-life (t1/2).

Contact lens dissatisfaction is a major problem for contact lens wearers. Most research efforts have concentrated on contact lens discomfort as a source of contact lens dissatisfaction, but binocular vision disorders among contact lens wearers has not been researched as a potential source of contact lens dissatisfaction. This study aims to identify a questionnaire which measures dissatisfaction due to symptoms from binocular-vision disorders and discomfort in myopic non-presbyopic adult contact lens wearers and to determine the extent to which binocular-vision disorders contribute to contact lens dissatisfaction.

The Movember Foundation and Beyondblue have established the TrueNTH program to develop and implement an integrated multi-component care model to improve the lives of men with prostate cancer and their partner/carer in a variety of health care settings in Australia. The primary aim of this study is to implement and evaluate the impact of the program on men's health outcomes and quality of life. Who is it for? You may be eligible to participate in this study if you are over 18 years and have been diagnosed with prostate cancer and are receiving services from any of the participating sites. You may also nominate one partner/carer or support person, who will also be invited to participate if they are over 18 years and competent to give informed consent and complete questionnaires. Study details The study involves implementation of the following components of care to men with prostate cancer according to their stage of disease and individual needs: (1) care coordination, including screening, assessment, information provision and education, ongoing monitoring, navigation and referral, and practical and social support; (2) decision support; (3) lifestyle management, including individual exercise program and nutritional advice; (4) specialised clinical support services, including psycho-social support and management, sexual health support, continence management and other specialised clinical support; (5) prostate cancer comorbidities management; and (6) partner/carer support. While each component of the intervention is available for all participants, the intervention and each of its components are tailored to men’s stage of disease and their health related needs. Delivery of specialized support services will depend on resource availability, access, treating specialist /team preference and preference of the man. Men in this study will be asked to complete up to 5 surveys over a 12 month period in order to assess their prostate health symptoms, quality of life and mental health. Health service and carer-related outcomes will also be measured. At 6 months after the participation, men and/or their partner/carer may be asked to participate in individual interviews. Findings of the study will enhance our understanding of outcomes and areas for improvement, which in turn will benefit men with prostate cancer and their partner/carer.

Aims and Justification The induction of anaesthesia can be associated with a drop in oxygen saturation particularly when there is difficulty in intubation (the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway). We have recently published a study which showed that buccal (attached to the inside of the cheek) oxygen administration was highly effective at prolonging the time to oxygen desaturation in obese patients, at induction of anaesthesia. Nevertheless, a third of patients desaturated earlier than expected. This may have been due to the development of pulmonary shunt (collapse of the small airways) or a failure of the device to maintain a high oxygen concentration at the open glottis (start of the windpipe). The device may also be limited by accumulation of carbon dioxide during breaks in breathing (apnoea), and the degree of positive pressure generation at the glottis. This follow up study will repeat the methodology of the original project, whilst assessing glottic oxygen concentration and pressure, as well as carbon dioxide accumulation. The objective is to ascertain the reliability of this technique at maintaining glottic oxygen concentration >0.7 over 10 min apnoea. This will help us to further evaluate and refine this technique for oxygenation during apnoea. Project Design and Participant Groups This will be an open label, randomised, controlled trial in healthy, non-obese patients due for elective surgery. Methods The protocol is based on our previous study with two study groups: (a) 10 l/min oxygen via a buccal RAE tube attached to the inside of the cheek as the intervention group, compared to: (b) Standard care. Measurements of glottic oxygen concentration (FO2), glottic airway pressure and transcutaneous carbon dioxide (CO2) concentration will be taken during 10 min of apnoea from induction of anaesthesia. The primary outcome will be the maintenance of glottic oxygen concentration >0.7 after 10 min apnoea. We hypothesise that >80% patients will maintain a glottic FO2> 0.7 at 10 min apnoea using buccal oxygen in comparison to the <10% of control patients. Our secondary aim is to find out the pressure at the glottis and rate of rise of CO2 during this technique. This secondary information will delineate the possible length of its clinical use and further evaluate this technique.