ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32121 results sorted by trial registration date.
  • Using moisturiser to reduce the number of skin-tear injuries in a hospital setting.

    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.

  • Optimising mental health and wellbeing after post-stroke aphasia

    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.

  • Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding

    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.

  • Prevention of opioid-associated constipation in ventilated intensive care patients

    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.

  • Effect of a sugar-sweetened beverage price increase on healthiness of purchases and business outcomes in an Australian university

    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.

  • BrightHearts RCT: procedural pain management during botulinum toxin-A injections.

    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.

  • A Phase 1, Healthy Volunteer Study to Evaluate the Effect of Differing Bonding Strengths on the Adhesion of a Patch Delivery System for Alzheimer's type Dementia

    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.

  • Lignocaine for the prevention of chronic pain after caesarean section

    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.

  • Effects of a topical botanical cream on subcutaneous fat loss in athletes

    Weight – notably fat - reduction is commonly undertaken by athletes to improve locomotive efficiency and power-to-weight ratio, aesthetic appearance or to reach a target weight class. While energy restriction - or "dieting" - is typically implemented to achieve desired fat loss, this practice is accompanied by compensatory metabolic and hormonal responses that cause attenuation of weight loss, undesirable changes in appetite and mood, performance impairment, and an increase in the likelihood of weight rebound. Thus, novel strategies to achieve fat loss while minimising reliance on ER would be highly advantageous to athletes. This study will be the first to investigate the effects of a topical fat loss agent in a cohort of resistance trained athletes. This study will also be the first to investigate the effects of the popular topical fat loss agent, Subcut. If our hypothesis were to be supported, Subcut would be of extreme value to athletes desiring to lose fat locally without the need of energy restriction. If our hypothesis were to be refuted, consumers would be provided with information that would allow them to allocate their money and time into other, more effective fat loss strategies. Irrespective of the outcome, there is a benefit to the athletic community, as well as to the general population wanting to lose fat.

  • Glucagon-like peptide 1 (GLP-1) for lowering plasma glucose in type 2-diabetic patients: A systematic comparison of intravenous and subcutaneous routes.

    Certain gut hormones, like Glucagon like peptide 1 (GLP-1), have been proven to play a major role in the control of blood glucose. GLP-1 Receptor Agonists (GLP-1RAs) have been developed to treat type 2 diabetes mellitus (T2DM). So far, all GLP-1RAs that are marketed in Australia must be applied subcutaneously (SC). GLP-1RAs can cause gastrointestinal (GI) side-effects. In early studies on GLP-1 action through intravenous (IV) application, GI side-effects were less common or even absent. We want to compare the SC and the IV administration of GLP-1 regarding the potency of lowering BG and GI side-effects. 20 patients with T2DM managed by long-acting insulin will be studied. The study involves 2 study visits. Patients will be asked to withhold their long-acting insulin on the day before each visit. Patients will then, in a double-blind manner, receive continuous GLP-1 infusion. GLP-1 will be applied SC or IV on each study day. Infusion rate will be raised every 2 hours (max. 4 x per study day). Blood glucose and GI symptoms will be monitored closely. This experimental setup will allow to clarify the impact of the application route of GLP-1 on blood glucose and provocation of GI side-effects.

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