ANZCTR search results

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

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31196 results sorted by trial registration date.
  • 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.

  • A Randomised, Double Blind, Placebo-Controlled Trial of Medicinal Cannabis in Adults with Tourette's Syndrome

    Tourette’s syndrome (TS) is a neurological disorder that develops in childhood and often continues into adulthood. Individuals with TS make involuntary movements and vocalisations (known as tics), which may be painful, embarrassing and functionally impairing. There is no cure for TS, but certain medications (particularly antipsychotics) are effective at suppressing tics when taken continuously. Unfortunately, these medications have significant and independently-disabling side effects, which limit their acceptability for many sufferers. The human body has its own (‘endogenous’) cannabinoid neurotransmitter system, which facilitates communication between nerve cells in the brain. This system is implicated in the control of normal movement and the development of movement disorders such as TS. The ‘endocannabinoid’ system could therefore be a new therapeutic target for tic suppression. There is some early evidence to support the effectiveness of cannabinoids in TS, but well-designed clinical trials have yet to be conducted. We plan to use an oral formulation of medicinal cannabis containing two cannabinoids: tetrahydrocannabinol and cannabidiol. This formulation does not intoxicate or cause the unpleasant psychiatric effects of ‘street’ cannabis. We predict that treatment with tetrahydrocannabinol and cannabidiol will significantly reduce tics, when compared to placebo, as well as improving psychiatric and cognitive symptoms associated with TS. We also predict that this formulation will be well tolerated, without psychiatric side effects, and will not lead to craving or intoxication. Therefore, this study may support the development of a new, safe and effective treatment for TS, with potential applications to other neurological disorders.

  • Stoma closure using bio-absorbable reinforcement (SCUBAR).

    The rate of incisional hernia formation following closure of a temporary intestinal stoma is approximately 30%. Hernias following abdominal surgery are a significant cause of morbidity and may adversely affect a patient's quality of life and may require emergent repair. Currently closure of the abdominal fascia is accomplished with sutures however, newer surgical materials are now available to reinforce fascial closure which have shown promise in their abilities to reduce IH formation and tolerate bacterial contamination that is present in these contaminated wounds. We propose a randomised clinical trial in patients undergoing reversal or resiting of an intestinal stoma to have placement of a new synthetic tissue reinforcement material or standard repair to determine if this material can reduce incisional hernia formation with low morbidity, specifically surgical site infection which has prohibited the use of existing materials.

  • A Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of PBT434 in healthy volunteers.

    This is a Phase 1 Single and Multiple Ascending Dose Study of PBT434 in Healthy Volunteers. The first in human study consists of two parts, both of which are randomised, double-blind, and placebo-controlled: The single ascending dose (SAD) and the multiple ascending dose (MAD) parts of the study will be conducted in sequential stages. Key safety and PK data from the SAD portion will be reviewed before progressing to the MAD part of the study.

  • Meaningful Engagement in Nutritional Understanding (MENU): Best choices for aged care

    Research suggests that the majority of Australians with dementia in residential aged care are malnourished or at risk of malnourishment. This project seeks to change this unacceptable situation by trialling a practical multi-component nutrition support intervention (MENU: Meaningful Engagement in Nutritional Understanding) that arose from suggestions from staff in a Tasmanian aged care home on how to improve care and support of people with dementia. The project will trial MENU in two Wicking-partner aged care facilities. The impact of MENU on raising staff awareness of best nutrition care and support for residents with dementia and reducing malnutrition prevalence will be evaluated. There are two specific objectives: 1. raise awareness (knowledge and practice change) among care facility staff/care volunteers/family of best nutrition care for residents with dementia; 2. reduce residents’ malnutrition risk. The project findings, outputs and the MENU approach will be disseminated across Tasmania.

  • Does very early therapy reduce the time spent hospital and improve the recovery of people with serious illness?

    The aim of the study was to determine whether early, structured rehabilitation is effective in critically ill patients in aiding physical and psychological recovery. The study was conducted as a trial and compared patients receiving early rehabilitation versus usual care. Patients were assessed on commencement on the study, on discharge from hospital, and at 6 and 12 months. The study was conducted at St. Vincent’s Hospital Sydney. Patients were eligible for the study if they were critically ill patients and were in intensive care (ICU) for at least 5 days. The early rehabilitation group received early routine screening by a rehabilitation physician, routine multidisciplinary assessment and provision of individualised, structured rehabilitation programme (up to two 30-minute therapy sessions per day) with formal coordination through case conferencing. This was be provided through the Mobile Rehabilitation Team (MRT). The participants were followed-up by the rehabilitation clinic The key components were daily team communication, higher intensity of therapy than usual care, and weekly case conferencing. In the usual care group, therapy could be provided by usual therapists in the ICU or acute ward. A rehabilitation physician was still able to review the patient at the request of the treating team and the MRT may have been involved if deemed necessary. The 2 groups were followed at hospital discharge and at 6 and 12 months. Outcomes assessed at discharge included their length of hospital day; muscle strength; mobility/endurance; functional independence/ability to carry out activities of daily living; and symptoms of depression, anxiety and stress. The outcomes assessed at 6 and 12 months included: ability to carry out activities of daily living; symptoms of depression, anxiety and stress; and quality of life.

  • PLENVU vs Prepkit-C Bowel Preparation for Colonoscopy

    The study aim is to compare the efficacy and patient tolerability of PLENVU®, a new low volume bowel preparation which has demonstrated safety and overall bowel cleansing success in three European and American trials, with the current standard bowel preparation at Alfred for patients undergoing colonoscopy for clinically accepted reasons, which uses Prepkit-C®. PLENVU is a registered trademark of the Norgine Group of companies. Who is it for? You may be eligible for this study if you are aged 18 or over and undergoing an outpatient colonoscopy. Study details Participants in this study will be randomly assigned (by chance) to receive one of two bowel preparation methods, either PLENVU or Prepkit-C. Participants will use the kits before their procedure according to the instructions provided by Alfred Hospital. The effectiveness of the two kits in preparing the bowels for colonoscopy will be compared using two validated scoring methods to assess quality of bowel preparation for colonoscopy. Participants will be asked to complete a brief (10 minute) questionnaire on the day of the colonoscopy, in the waiting area, ahead of going through for their procedure. The questionnaire will ask about their experience in taking the bowel preparation they received. The study will aim to determine whether PLENVU leads to a similar quality of bowel cleanliness as Prepkit-C and also whether patients' tolerance, acceptance and compliance is similar between the two bowel preparations.

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