ANZCTR search results

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

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32707 results sorted by trial registration date.
  • A phase I, placebo controlled, dose escalation safety and pharmacokinetic study of Topical Endoxifen in healthy male volunteers.

    This study aims to assess the safety and tolerability of Topical Endoxifen when administered as a topical application to the breast of healthy male volunteers. Who is it for? You may be eligible to join this study if you are a healthy male volunteers aged between 18 and 65 years Study details: This is a double-blind, placebo controlled, dose escalation trial investigating the safety and pharmacokinetics of Topical Endoxifen applied to the breasts of healthy male volunteers. Three dose levels of Topical Endoxifen will be investigated in 3 cohorts. In each cohort, participants will be randomized to receive Topical Endoxifen or placebo in a blinded fashion.

  • A randomised (non-blinded) trial comparing the clinical efficacy of naltrexone implant plus Cognitive Behavioral Therapy versus Cognitive Behavioral Therapy in the management of problem amphetamine use

    The study aims to investigate whether treatment with long-acting naltrexone implant (OLANI) as well as counselling is more effective than just counselling for preventing relapse to regular amphetamine use. Additionally, we are investigating the effect of naltrexone implant treatment on utilisation of WA Health Services (Hospital admissions, Emergency Department presentations and Mental Health services) in order to assess cost savings and cost effectiveness.

  • High dose Radiation therapy to eradicate early metastatic prostate cancer as an alternative to hormone or chemotherapy: a prospective phase II study

    Standard treatment for metastatic prostate cancer involves a course of Androgen Deprivation Therapy (ADT). ADT controls disease in about 95% of men for approximately 18 months, however, it can cause considerable side effects that decrease patients quality of life. Stereotactic Ablative Radiotherapy (SABR) has been shown to offer good cancer control rates of around 80% and progression-free survival at two to five years in the vicinity of 20-30% compared to standard RT, while offering the potential benefits of avoiding unpleasant symptoms that may arise from disease progression or side effects from ADT. In our institutions experience, SABR either as a first line therapy, or second line therapy in men who have progressed on hormone therapy, shows a substantial proportion of these patients responded very well, with some men not yet required hormone therapy or actually ceasing further hormone therapy. The TRANSFORM study is a single-institution, non-randomised, open-label, prospective phase II study that will recruit patients with radiologically confirmed hormone naïve or castration resistant oligometatstaic prostate cancer with the primary aim of measuring the proportion of patients not requiring treatment escalation at 5 and 10 years following SABR, respectively. The TRANSFORM study also aims to measure several secondary outcomesincluding time to treatment escalation, Prostate Specific Antigen (PSA) response, and grade 3 SABR related toxicities. Patients will be required to undergo a screening and follow up process (for up to ten years post treatment) that involves physical exams, blood and PSA tests, multiple scans (CT, MRI and PET) as well as questionnaires that help determine how effective the treatment(s) have been in controlling their disease and how that has impacted on their health and lifestyle.

  • VALidation of a tool to score veIn AssessmeNTs (VALIANT) in adult whole blood donors

    Phlebotomy is a central task performed by the Blood Service for the collection of whole blood, plasma and platelets from its voluntary blood donors. Currently there are no publications regarding how to routinely and systematically assess donor veins and the impact vein quality has on the success of blood donation. In the last 12 months up to 4% of phlebotomies attempted were unsuccessful. In addition, inadequate venous access resulted in needle dislodgement, underweight collections, protracted bleed times, component discard and substantial wastage of blood collected. The purpose of this study is to formally validate an internally developed vein score assessment tool to assess a donor's vein suitability for phlebotomy. The study will examine the extent of inter-rater variability in vein assessment between phlebotomist's and determine whether a score at or below a certain level is predictive of failed phlebotomy, needle dislodgement, underweight donation and prolonged donation duration.

  • The effect of a carbohydrate oral rinse on energy expenditure in a fed state in individuals with high and low sensitivity to carbohydrate taste

    The purpose of this research is to determine if the ability and sensitivity of adults to carbohydrate and sweet taste can modify how their body uses carbohydrate as an energy source. In this project, study participants will attend three morning sessions in total, separated by 3 or more days, after they have fasted overnight. Upon arrival to the research facility, participants will have their weight and body composition measured using a weighing scale, then asked to rest for 30 minutes before their resting energy expenditure is assessed with a machine that measures oxygen usage and carbon dioxide produced. This measurement involves the placement of a clear hood over the participant’s upper body. After the initial measurement, participants will drink a carbohydrate beverage, followed by the rinsing of their mouth with a carbohydrate solution, a sugar solution or water. After the oral rinsing, participants will continue the measurement of energy expenditure using the same machine for 90 minutes.

  • Red plunger syringes for muscle relaxant drug safety: brilliant or bothersome? A survey of anaesthetists and anaesthetic trainees in Australia and New Zealand, and review of incident report data involving muscle relaxant drug errors

    A 5ml slip-lock syringe with a fluorescent red plunger was introduced in Australia and New Zealand in the mid-1990s for use with muscle relaxants. Its aim was to reduce drug errors involving muscle relaxants in anaesthesia. To our knowledge, the impact of this syringe has not previously been formally evaluated. Reporting of drug errors is not mandatory in Australia and New Zealand, so it would be very difficult to determine if introducing the syringe has reduced patient deaths and suffering. The use of the syringe is not mandated. Our hypothesis is that most anaesthetists and trainees in Australia and New Zealand value the red plunger syringe as a drug safety intervention, and choose to use it voluntarily. We aim to test this hypothesis by surveying a large stratified random sample of anaesthetists and trainees across Australia and New Zealand. The survey will ask participants about availability, patterns of use, and attitudes towards the syringe. Suggestions for improving the syringe to better meet the needs of anaesthetists and trainees will also be sought. We also intend to undertake a retrospective analysis drug errors involving muscle relaxants that have been voluntarily reported to the WebAIRS recording system in Australia and New Zealand. The purpose of this is to determine if and how the red plunger syringe was used in each case.

  • Personalised 3D printed ankle-foot orthoses for children and adolescents with Charcot-Marie-Tooth disease (printhotics™ trial)

    The aim of this project is to evaluate 3D printed AFOs compared to traditional handmade AFOs in children and adolescents with Charcot-Marie-Tooth disease (CMT) during walking. Three AFO designs will be evaluated traditional AFO, replicated 3D printed AFO and optimised 3D printed AFO and compared to a shoe only condition. Traditional AFOs will be handmade by an Orthotist from plaster casting methods of the participant’s lower limb followed by thermoplastic vaccum forming. The positive plaster cast mould will then be digitised using a 3D surface scanner to create a 3D model. Computer aided models of a replicated AFO and optimised AFO will then be generated from the 3D model and manufactured using the state of the art 3D printer. 3D gait analysis and inshoe plantar pressure data will be collected to assess differences in walking.

  • A study to determine the safety, maximum tolerable dose and ability to provoke an immune response of the Codavax Influenza Vaccine in healthy volunteers. Part 2

    CodaVax, the study drug being researched in this project, is an experimental vaccine being developed by Codagenix, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. CodaVax is a vaccine that is intended to prevent influenza. The primary objective of this study is to determine the safety and tolerability of CodaVax influenza vaccine compared to placebo controls when administered to healthy adults.

  • Does inflating a balloon in the aorta (to reduce blood flow) stop severely injured adults from bleeding to death at a Level 1 Australian Trauma Centre (The ACE Study)?

    Non-compressible torso haemorrhage is a leading cause of preventable trauma death. Although Trauma Systems have optimised access to surgery and interventional radiology for definitive haemorrhage control, a significant proportion of deaths occur before this can be achieved. Resuscitative thoracotomy with aortic compression is a means of temporary haemorrhage control. This procedure is effective in patients with a thoracic source of haemorrhage that can be directly controlled, but is invasive and has poor outcomes in those with sub-diaphragmatic haemorrhage. Temporary occlusion of the aorta with an endovascular balloon is a technique used to control haemorrhage in shocked patients with ruptured aortic aneurysms. This technique has also been described in other forms of non-compressible haemorrhage such as gastro-intestinal bleeding and post-partum haemorrhage. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock has recently been promoted. REBOA provides a means of temporary haemorrhage control in patients with severe non compressible haemorrhage - potentially enabling these patients to access means of definitive haemorrhage control and survive. However, the procedure requires specific technical expertise as well as integration into current models of trauma reception and resuscitation - and there are conflicting reports about whether REBOA contributes to survival. This pilot study involved the introduction of Balloon Occlusion for Aortic Control of Exsanguinating Trauma Related Haemorrhage (The ACE Study) at an Australian Adult Major Trauma Centre, to determine whether REBOA would be a feasible and effective strategy to provide temporary circulatory support to trauma patients with critical, refractory, hypovolaemic shock and hypovolaemic cardiac arrest - allowing transfer to an operating theatre for definitive haemorrhage control surgery. The primary purpose was to determine if the introduction of REBOA outcome was feasible and, if so, it would improve survival of blunt or penetrating trauma patients aged 18-60 years with exsanguinating sub-diaphragmatic haemorrhage.

  • The Dementia Lifestyle Coach: a pilot study of a support and coaching program for people recently diagnosed with early dementia

    The Dementia Lifestyle Coach aims to test the feasibility of delivering and evaluating the Dementia Lifestyle Coach program for people newly diagnosed with early dementia The Dementia Lifestyle Coach fills a gap in dementia care in Australia and internationally by supporting people with early dementia to adjust psychologically to having the condition, stay active and involved in their community. If shown to be efficacious in a fully-powered trial, the availability of an early support program for people with dementia may increase the motivation of general practitioners to make earlier diagnoses of dementia. The Dementia Lifestyle Coach program is a 14 session psychoeducation, counselling and coaching program for people recently diagnosed with dementia. Sessions are hour-long and held weekly for the first 2 months, then fortnightly for 2 months, then monthly for the last 2 months (14 sessions in total). Sessions are delivered by a registered psychologist or rehabilitation counsellor. In addition, participants receive support (monthly conversations) from a trained peer who lives with dementia. This parallel group design will have an intervention group and a wait-list control group. The wait-list control group will receive the intervention after 6 months. A wait-list control group was selected rather than no-treatment control group because the study investigators considered it unethical to offer no support to participants, further offering the intervention to the control group would allow a greater sample with which to test acceptability of and fidelity to the intervention.

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