ANZCTR search results

In this randomised, double-blind, placebo-controlled study, 105 adults experiencing mild-to-moderate anxiety/stress will be randomly assigned to receive tablets containing a daily dose of either Echinacea angustifolia (40mg) (LOW DOSE), Echinacea angustifolia (80mg) (HIGH DOSE), or placebo for 6 weeks. We will assess changes in symptoms through the completion of validated questionnaires assessing anxiety, mood, quality of life, and sleep.

This study is an open-label, single-arm study in which each subject will serve as his/her own control. The study will assess the effect of DCP treatment on ascites formation in cirrhotic subjects with RA, by examining the frequency of LVP and the volume of ascitic fluid drained. All subjects will participate in a Dose exposure assessment visit, followed by a 90 day open label treatment period, followed by a 90-day follow-up period of additional data collection from medical records. Ascites history (relevant medications, LVP dates, and volume of drained fluid) for the 90 days prior to treatment and the 90 days after treatment will be collected and used for comparison with on-treatment frequency and volume. The study will be conducted in two parts. At the start of the study, subjects will be enrolled into Part A. When a sufficient number of subjects have been enrolled into Part A to provide information about preliminary efficacy, safety, and exposure, additional subjects will then be enrolled into Part B.

A case-control design was used to examine the use of Hartmann, MoliCare® skin and body lotion to reduce skin tears among patients between two wards in an Australian private hospital. The two wards identified for the study was a medical/oncology ward which provided the control and the rehabilitation ward where the intervention was instituted. These two settings are considered comparable on the basis of patient demography as well as the level of patient acuity. Longitudinal data were collected for these settings both pre and post intervention period to determine the treatment’s efficacy and impact.

Aphasia, an acquired communication disorder occurs in a third of the stroke population. It affects the ability to talk, understand, read and write. Aphasia also negatively impacts on the person's self-identity, relationships, work and daily activities. People with aphasia commonly experience depression and/or anxiety. However, there is a treatment gap in provision of modified psychological care for the communication disability associated with aphasia. This study will feasibility test a new program 'Aphasia PRevention and Support in Mental health' (PRISM) - a level 1, evidence-based communication support and psychological therapy to optimise mood and wellbeing. A mixed methods approach will be used to investigate the acceptability of the therapy program to participants in a community setting. Participants will participate in qualitative interviews and complete clinically valid and feasible outcome measures (e.g., acceptability ratings, mood, quality of life, communication confidence and community integration measures). Data will be collected and analysed. Findings will be disseminated via publications and conference presentations.

This study aims to evaluate the effect of a gel on postoperative bleeding in patients undergoing endoscopic mucosal resection for advanced mucosal/submucosal neoplasia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are scheduled to undergo endoscopic mucosal resection (EMR) for ampullary lesions or duodenal lesions. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo standard treatment for the prevention of bleeding, which involves routine endoscopic measures such as placing clips at sites of bleeding. Participants in the other group will have a haemostatic gel (Purastat, 3D-Matrix) applied endoscopically in addition to the standard measures such as the endoscopic clips. Following the procedure, we will compare the rates of clinically significant bleeding between the two groups. We will also record and compare any adverse events. We hope that the gel can reduce the risk of post EMR bleeding.

This study will provide information as to whether administration of naloxone to the gut prevents constipation (and its associated complications) in ICU patients; this is important, as it will potentially improve patient comfort, reduce the amount of interventions needed during a patient’s stay in ICU, and may reduce the amount of time that they require ICU care. In this study, one group of ventilated patients will receive a combined preparation of naloxone, while a second group will receive a placebo fluid only, This will be administered via a tube, placed via the nose, in the patient's stomach. This allows us to compare the effect of naloxone on gut function. We hypothesise that administering naloxone will reduce rates of constipation in ICU patients.

This 2 year randomised controlled trial (RCT) aims to test the effect of two interventions (i) a 20% ‘red’ drink price increase, and (ii) prominent price labelling, on healthiness of vending purchases (‘red’, ‘amber’, and ‘green’ volume sales) and vending revenue in a university. We hypothesise that the price increase and combined price and prominent price labelling, will be associated with a decrease in 'red' drinks purchases. This study will help inform vending machine pricing interventions and potential policies for universities and other institutions who wish to promote customers’ health, while considering the business outcomes for retailers.

Many children with neurological physical disabilities routinely receive intramuscular botulinum toxin-A (BoNT-A) injections for the management of spastic muscle tone. There are limited non-pharmacological strategies for pain management during this medical procedure. This study compares distraction therapy vs. BrightHearts (a relaxation training application) for the management of procedural pain in children and adolescents undergoing BoNT-A injections.

This is a single-site phase 1, randomized, crossover study to assess the effects of 4 different bond strengths on the performance of a patch delivery system to be used in Alzheimer's type dementia. The study will enroll 36 participants. The total study duration is 98 days which includes a 42-day screening window, 4 consecutive treatment periods, and 3 follow-up visits over 28 days.

Chronic postsurgical pain (CPSP) after caesarean section surgery occurs in approximately one in five women. In Australia about one-third of women who give birth have caesarean section surgery. This means that in Australia over the next five years nearly 105,000 young women will be affected by CPSP. The impacts of this condition are significant with reduction in quality of life, reduced maternal-baby bonding, decreased mobility, and social isolation, and present an added burden for women facing the physical and emotional challenges of motherhood. The problem of chronic pain also has other complications including the risk of dependence on morphine-based medications, poor mental health and loss of work productivity. Due to the far-reaching implications of chronic pain, there is an ongoing search for ways to prevent this. Data suggests that different types of anaesthesia and management around the time of surgery may minimise the risk of patients developing chronic pain following surgery. A local anaesthetic drug, lignocaine, which has a long history of use and is safe in pregnancy and breastfeeding, has shown promising benefits in reducing chronic pain when it is given with an anaesthetic during other types of abdominal surgery. It has not been used in caesarean section surgery however we hope that it could be used in this surgery to reduce CPSP. Before conducting a large study in this area, we need to collect information about the safety of lignocaine in women having caesarean section, information about whether a study is feasible on a large scale, and what the rate of CPSP is in women in contemporary Australia.