ANZCTR search results

With longstanding and widespread high rates of errors in child restraint use, there is a need to identify effective methods to address this problem. The study's hypothesis is that product materials developed using a consumer-driven approach will reduce errors in restraint use among purchasers of new child restraint systems. A randomised controlled trial (RCT) will be conducted. Participants (n=440) will opt-in to the study after hearing about it from a wide variety of promotional strategies within the greater Sydney area. They will join the study as they purchase of a new restraint, and study materials (intervention or control) will be sent to with with the new restraint. Outcome measures are errors in installation of the restraint as observed by a trained researcher during a six-month follow-up home assessment, and adjustment checks made by the parent when the child is placed into the restraint. Process evaluation measures will also be collected during the home visit. The content and format of the additional product information being tested will be supplied in an instruction booklet; a video, accessible through smartphones; as well as laminated labels attached to the restraint, which will serve as a permanent reminder of key aspects of correct installation and correct use. The intervention provides supplementary information to assist users to correctly use the restraint, i.e. (i) how to correctly adjust the restraint to fit their child (ii) how to correctly install the restraint in the vehicle, (iii) how to correctly secure the child in the restraint, and (iv) how to maintain correct use over time. These will be supplied in addition to the Australian Standards required product information. The number of installation errors, as well as correct use and adjustment checks made by the parent will be compared between control and intervention groups. This cluster randomised controlled trial will determine the effectiveness of targeted, consumer-driven information on actual error rates in use of restraints.

This study is a first-in-man clinical study of DLP-114, a Risperidone Para-aminobenzoate Implant product. The study is an open-label, single sequence design aimed at assessing the safety and tolerability of DLP-114 and evaluating its utility in achieving a PK profile that is comparable to the marketed oral form of risperidone. Healthy volunteers will be enrolled implanted with DLP-114 in groups of up to 3 volunteers per group. The first group of 3 healthy volunteers to receive the DLP-114 implant will be a sentinel group. The safety and tolerability of the DLP-114 implant will be assessed in the sentinel group for at least 28 days prior to any other volunteers being dosed implanted with DLP-114 in the study. Only if the safety and tolerability data, obtained from the sentinel group, are considered acceptable by the investigator and the sponsor, will the remainder of healthy volunteers commence implant treatment in the study. Treatment of each subject will be conducted in five sequential periods: 1. Oral risperidone (2 mg/day) – tolerability assessment; 2. Oral risperidone (1 mg/day) – PK assessment; 3. Washout; 4. DLP-114 implant treatment; 5. Follow-up.

This study is designed to evaluate the effects of the artificial sweetener, sucralose, compared to glucose and saline (control), on blood pressure, heart rate and superior mesenteric artery flow following intraduodenal infusion, in healthy older subjects. On three separate days, separated by at least 5 days, subjects will receive an ID infusion of either (1) 25 %w/v glucose at a rate of 3 kcal/min, (2) 4 mM sucralose in 0.9 %w/v saline, or (3) 0.9 %w/v saline all in a volume of 300 mL over 60 minutes (i.e. 5mL/min from t = 0 – 60 min). Saline (0.9%w/v) will be infused at a rate of 5mL/min for a further 60min (i.e. t = 60 – 120min). Measurements of blood pressure (BP), heart rate (HR) and superior mesenteric artery (SMA) blood flow by Doppler ultrasonography, cardiac output (CO), stroke volume (SV), blood glucose, serum insulin, plasma glucagon-like peptide 1 (GLP-1), gastric inhibitory polypeptide (GIP) and catecholamines under randomised, double-blind conditions. The primary hypotheses underlying the current study are that (i) compared to saline, intraduodenal infusions of glucose and sucralose will induce a larger reduction in blood pressure and increases in both heart rate and superior mesenteric artery flow and (ii) ID glucose will have a greater hypotensive response than sucralose.

The aim of this study is to evaluate whether a Chinese herbal medicine (SGLXD) can reduce hot flushes/night sweats in women treated for breast cancer. Who is it for? You may eligible to join this study if you are a female aged 18 years or above and have been diagnosed with Stage 1-3 breast cancer, for which you have completed surgery, chemotherapy and/or radiotherapy and are experiencing hot flushes/night sweats. Trial details Participants in this study will be randomly allocated (by chance) to either group 1 or group 2 for 12 weeks of treatment. After this there is a 4-week period with no treatment then you are crossed-over to the other group for a further 12-week period. One 12 week treatment period will consist of two daily doses of the Chinese herbal medicine, Shu Gan Liang Xue Decoction dissolved in warm water and taken orally. The formula has been used at Beijing University Cancer Hospital by Professor Li and has been proven to be safe and effective in studies in China. During the other 12 week treatment period you will take an inactive placebo. Participants are required to undergo blood tests at 3 time points during the study and fill out a hot flush diary and quality of life forms. You are required to visit the hospital every 4 weeks to hand in the forms and receive 4-week supply of the treatment intervention. Pre-and post treatment differences in results of hot flush scores, quality of life scores and blood tests will be assessed between groups. Study results may contribute to achieving a novel intervention alternative therapeutic option to alleviate hot flushes and improve quality of life for Australian women treated for breast cancer.

The overall aim of this study is to improve treatment outcomes for patients with ulcerative colitis (UC) primarily focusing on improved patient care and empowerment through patient involvement in the decision making around their disease management. It aims to trial the first decision aid for UC which explains the risks and benefits of treatment in a clear, understandable and balanced way to greatly enhance patient understanding of their disease and management options. This in turn is expected to improve medium-term quality of life by better patient empowerment and quality of decision making in UC. Improvements in anxiety, adherence to chosen therapy, disease outcomes and prevention of complicatons will ideally follow. This will be the first study in the world to trial a decision aid developed to help decision making in UC treatment, making this a highly significant research project with the potential to contribute to routine UC care worldwide.

With increasing demands of patients concerning their refractive outcome after cataract surgery, a variety of advanced technology intraocular lenses have become available in the last years. The modifications include advanced optic designs, improved haptic materials and designs and combinations of both. A new era of cataract surgery has entered the market recently, the femtolaser-assisted cataract surgery (FLACS). This advanced technique replaces various steps of cataract surgery which had to been done manually or by ultrasound devices. The femtolaser can do highly precise incisions for access to the crystalline lens which needs to be replaced in cataract patients. The capsulorrhexis, the manual opening of the capsular bag can be replaced by a high precision capsulotomy with the laser. Furthermore, many FLACS devices can divide the opaque natural lens in mini-fragments which can easily be aspirated afterwards. This step was traditionally performed with phacoemulsification using ultrasound. Furthermore, the correction of mild astigmatism by arcuate incisions can be performed with these types of laser which was done manually, based on nomograms, before. Major advantages of FLACS are the improved ability of planning and controlling incisions and capsulotomy, the higher precision with regards to size and shape and the lower amount of energy induced in the eye, compared with ultrasound phacoemulsification. In parallel to the development of the FLACS technology a new lens type has been developed: the FEMTIS. The highly precise execution of the laser allows to exactly predict the size and position of the capsulotomy. The FEMTIS has been designed to be locked in place in the opening of the capsule. In traditional lens implantation, the IOL was placed in the capsular bag and kept in place by the back-pressure of the capsule against the haptics. Capsular shrinkage and fibrosis increases the pressure on the haptics which can lead to decentration, tilt and rotation of the lens, resulting in induced higher order aberrations which decrease the optical quality of the visual system. If a lens, like the FEMTIS is locked in place in the capsular bag opening, IOL decentration, tilt and rotation should be minimized, which should result in a higher predictability and refractive precision. In this study we will investigate the stability of lens position and the visual outcome after implantation of the new FEMTIS® Comfort using FLACS capsulotomy. The FEMTIS® Comfort is a rotational asymmetric refractive lens with a sector-shaped IOL part providing an addition of 1.5 dioptres. The extended depth of focus should effected a higher visual acuity for far and intermediate distances with greater spectacle independence.

Amyotrophic Lateral Sclerosis (ALS) is a devastating disease, characterised by a progressive degeneration and loss of motor neurons, and is currently incurable. The reduction or avoidance of physical activity by patients with ALS (pALS) exacerbates the loss of physical function attributable to the disease itself, and sets up a deleterious cycle of progressive impairment. One potential way to break this cycle is exercise. The main aim of this proposal is to provide the first physiological evidence of the beneficial effect of exercise training in pALS, by counteracting the muscle weakness, due to cardiovascular deconditioning and muscle disuse, caused by the avoidance or reduction of physical activity in these patients. Our primary hypothesis is that involvement in a moderate-intensity, aerobic and strength training program will be tolerated and will attenuate reductions in physical performance (muscle strength and aerobic capacity) and physical function in pALS, and will consequently improve their quality of life. If the proposed hypothesis is confirmed, this study will change the role of physical activity in the clinical management and treatment of pALS.

Knee osteoarthritis (OA) is a major public health problem. Exercise is recommended by all clinical guidelines for managing pain in knee OA, however, effects of exercise on pain and function outcomes are only modest. This may be due to poor exercise adherence amongst knee OA sufferers. There is evidence that the use of text messaging as a behaviour change adherence tool can be effective in the healthcare setting for a variety of conditions. To date the use of SMS messages as an adherence tool for exercise has not been assessed in the knee OA population. Our primary aim will therefore be to investigate the effects of adding a behaviour change embedded text message intervention, to a 6 month home based exercise program for knee osteoarthritis. Participants who complete a previous RCT (ACTRN 12617001013358) will be randomly allocated to one of two groups: i) SMS adherence intervention - a home based exercise program completed three times weekly for 24 weeks PLUS an automated, semi-personalised, mobile phone text message intervention, embedded in behaviour change theory to promote adherence to the exercise program. ii) No adherence support control - a home based exercise program completed three times weekly for 24 weeks, independently with no adherence support. Primary outcomes are self-reported adherence measures and secondary outcomes include self-reported pain and function. The primary timepoint is 24 weeks.

This study will look at the safety and feasibility of endoscopic ultrasound (EUS) guided portal vein blood sampling as an ultimate staging procedure in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you have been diagnosed with metastatic pancreatic cancer, locally advanced pancreatic cancer, or resectable pancreatic cancer. Study details All study participants will undergo endoscopic ultrasound (EUS) guided portal vein blood sampling. EUS is a procedure that safely allows the imaging of the digestive tract and surrounding tissue through ultrasound testing. The use of EUS is currently the preferred method for sampling pancreatic masses. The portal vein is a blood vessel that provides blood to the pancreas, and other gastrointestinal organs. Blood samples taken from the portal vein can be used to determine if pancreatic cancer cells are present, providing a useful technique for diagnosing pancreatic cancer. This procedure will involve finding portal vein under EUS guidance, and EUS portal vein sampling is done via a trans-hepatic approach that allows the liver tissue to act as a cushion that seals the needle tract, reducing the risk of bleeding complications. Blood samples will be analysed to count circulating tumour cells, which can be used for molecular characterisation of pancreatic cancers. A way to detect these is to analyse the % of mutated KRAS; a specific protein found in over 90% of patients with pancreatic cancer. Unfortunately, techniques cannot reliably detect small numbers of mutant KRAS copies. In peripheral blood samples, there is only a reported sensitivity of approximately 50% in patients with pancreatic cancer. This may be higher in portal venous samples where there is no filtering by the liver. All participants will also be monitored for safety for up to 7 days post procedure. Final follow-up will occur at 6 months. It is hoped that EUS guided portal vein blood sampling could represent the most sensitive technique for biological staging in pancreatic cancer.

This multi-site parallel groups randomised controlled trial will aim to recruit 300 alcohol-dependent patients (aged 18-65) admitted for inpatient detoxification at De Paul House (St. Vincent’s Hospital Melbourne), Wellington House (Eastern Health) or Windana Drug and Alcohol Recovery. The primary aim is to determine the effectiveness of CBM training during inpatient alcohol detoxification in terms of increased abstinence rates 2 weeks following discharge,relative to controls who receive sham training. We also aim to explore rates of abstinence, 3, 6, and 12 months post-discharge as a secondary outcome. Another secondary aim is to determine if pre-training levels of approach or attentional bias moderate the effectiveness of CBM, based on the hypothesis that those who drink due to strong cognitive biases are likely to benefit from treatments targeting these biases, while those with low cognitive biases, whose drinking is driven by other factors (e.g. relief from distress) may benefit less from CBM. We also aim to measure the difference between groups in rates of use of further inpatient withdrawal and acute health services during the year following discharge to assess whether CBM training leads to cost savings to the health system, and to measure differences between groups in cue-induced desire for alcohol following CBM training. We hypothesise that, compared to those receiving sham training, participants receiving CBM training will show significantly higher rates of abstinence from alcohol at all followups. We also anticipate that stronger baseline attention and approach bias will be associated with a larger effect of CBM (i.e., baseline attention/approach biases will moderate CBM’s effect on abstinence). We expect significant net cost saving in the CBM group compared to controls in terms of reduced cost of repeated inpatient detoxification treatment and acute health care use during the year following discharge (after accounting for the costs of implementing CBM training in the CBM group). Compared to those receiving sham training, participants receiving CBM training will show significantly reduced cue-induced desire to alcohol images (but not to images of non-alcoholic beverages). We expect that this interaction will remain, with similar effect size, when analyses are restricted to images not included in the training task, demonstrating generalisation of reduced cue-induced desire beyond the specific stimuli that participants were trained to avoid.