ANZCTR search results

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

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31306 results sorted by trial registration date.
  • The effect of critical illness on appetite in adult survivors

    Anecdotally, survivors of critical illness reported reduced appetite that persists after discharge from ICU, however this has not been quantified, Given critical illness is associated with an increased prevalence of malnutrition, and functional deficits occur well after ICU discharge, factors that may influence recovery of nutritional status and hence function require exploration. This study is a sub-study to 'The significance of hyperglycaemia in survivors of critical illness and potential mechanisms underlying development of type 2 diabetes (ACTRN12614000449639) that will recruit ICU survivors and a healthy cohort.

  • Activity Boost Challenge: Impact of the WalkAide (Registered trademark) device plus physiotherapy on walking and physical activity in children with hemiplegic cerebral palsy.

    Children with spastic hemiplegic cerebral palsy (CP) often have ankle control issues in one leg, with weakness and spasticity that causes trips and/or falls due to poor foot clearance when moving quickly. Many wear an ankle brace to stop their foot dragging. However, this blocks ankle motion and affects speed and performance during physical activity. The WalkAide is a device worn around a child’s calf, just under their knee, to stimulate the weak muscles that pull the foot up. Early research shows WalkAide use promotes better walking and can increase muscle size in this population. This study will determine the impact of a WalkAide and motor-learning, gait focused physiotherapy intervention on advanced motor skills and priority goal accomplishment for children aged 6-17 years old with hemiplegic CP. We know that the WalkAide is not suitable for all children and young people in this group. Results will also determine the clinical utility of the device and inform best practice prescription to maximise the benefits for children and families.

  • Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenous APL-2 in Healthy Volunteers

    APL-2 is an experimental drug being developed by Apellis Pharmaceuticals Inc for potential use as a treatment for people with ischemia-reperfusion injuries. In this study, single doses of APL-2 will be assessed in healthy volunteers. Assessments of safety, tolerability, pharmacokinetics, and pharmacodynamics parameters following administration of single doses of APL-2 will guide decisions to further develop the drug.

  • The STEP study: A Pragmatic, randomized, controlled trial comparing two post operative management pathways in knee or hip replacement surgery

    Prosthetic joint replacement is a high cost and high volume procedure in Australia. In 2015, it is expected that over 100,000 joint replacements will be performed. The aim of the STEP Study is to compare two different clinical care pathways to see which pathway is best at helping patients recover from their surgery. At present it is unknown if one of these clinical care pathways is better than the other or whether they are both equally effective. The study will compare length of stay and the costs associated with the care pathways, along with patient reported outcomes (in the form of questionnaires), health economic analysis and adverse event assessment. This is a single centre, parallel design, pragmatic randomised controlled trial.

  • A Randomised Controlled Trial of Activity Monitors to Improve Activity Level after Hip and Knee Arthroplasty

    In this study we will use these commercially available activity trackers to monitor and encourage higher activity levels in a series of participants before and TKA or THA performed at the Mater Hospital. We will assess whether participants who wear the device and are given daily goals and feedback of daily step count in the first 2 weeks after arthroplasty surgery have higher activity levels than those who do not receive goals or feedback of daily step count in a randomised controlled trial. We will also assess and whether higher activity levels impacts hospital length of stay, participant satisfaction, participant reported outcome measures, or subsequent activity level.

  • A randomized controlled trial evaluating the effects of intra-operative CT on the outcomes of zygomatic fractures.

    Patients with fractures of the cheekbone and related structures often require surgery to restore the profile and function of the face. This usually requires access to the fractures by small incisions around the eye and in the mouth. The fractured segments are not routinely completely exposed and visualized, so as to minimize scarring and trauma to other vital structures such as nerves and blood vessels. The fractures are reduced (to their correct position) by feel, through limited visualization through the small incisions, and by assessment of the facial profile. Once reduced, the fractures are fixed in place with metal plates and screws through the small access incisions. Radiographic information is required post-operatively in the form of multiple plain films or a CT scan of the face, to ensure appropriate reduction of the fracture segments. Owing to the difficulty in assessing fracture reduction through small incisions in an otherwise swollen and traumatized face, it has been suggested that the gold standard in the management of such fractures should be intra-operative, rather than post-operative CT. It has been proposed that intra-operative CT imaging would eliminate the need for revision surgery due to inadequate fracture reduction, and would improve other outcomes of surgery such as facial profile restoration and scar minimization. It should be noted that other surgical specialties, in particular Orthopaedics, rely heavily on intra-operative imaging modalities. In the proposed RCT, patients would be randomized to an intervention group and a control group. The intervention group would receive intra-operative CT scanning in addition to post-operative plain film post-operative scanning. The scanning would occur after initial fixation of fracture segments to confirm fracture reduction adequacy. If re-reduction were required, further intra-operative imaging would be utilized following each successive reduction attempt, thus allowing for rectification under the same general anaesthetic and eliminating the need to either return to theatre at a later date, or to accept a sub-optimal outcome. The control group would receive post-operative plain film imaging as per the current clinical policy. Participants would not be required to make any commitments additional to what is required of them as a patient of the Unit. Participants from both the intervention and control groups would undergo routine post-operative review, as for non-trial patients.

  • The feasibility of increasing inpatient rehabilitation therapy duration by implementing an additional self-directed independent exercise program: My Therapy.

    My Therapy is a proposed self-management program that patients complete outside of formal rehabilitation sessions. The program aims to compel the patient and, if required, their care-giver(s) to complete an independent therapy program as established by the team. The My Therapy program includes Occupational Therapy and Physiotherapy directed self-management elements including cognitive rehabilitation, relaxation and mindfulness, upper limb management, lower body dressing, surgical precautions, bed transfers, strength, balance and range of movement exercises. The program may be completed within business hours, in the evenings or over the weekends and is a way of promoting a partnership between clinical staff and the patient, in the hope of increasing not only the duration of rehabilitation, but also empowering the individual to better manage their health. The current research project shall examine the feasibility of implementation of the My Therapy program by examining the duration that patients spend completing therapy exercises when admitted as an inpatient to Cabrini Hopetoun or Cabrini Glenhuntly under the Orthopaedic or Reconditioning streams. The research project shall aim to address the following questions: a) Does the introduction of the My Therapy program increase the duration (in minutes) of rehabilitation therapy? b) Is it feasible to implement the My Therapy program to the targeted patient cohort with the current Allied Health equivalent full time (EFT)? c) How can adherence to the My Therapy Program be achieved and maintained? What are the barriers and facilitators to adherence? It is anticipated that the introduction of the My Therapy program to rehabilitation inpatients, shall result in greater duration of rehabilitation that the patient participates in, during their inpatient rehabilitation admission. This would be a significant finding as there is strong evidence that patients who participate in a greater duration of rehabilitation during their inpatient rehabilitation admission, do better when they leave the hospital with respect to their function, mobility and quality of life.

  • Efficacy of resistance training for the prevention of cognitive decline.

    Within an ageing population, high-intensity aerobic exercise has been suggested to enhance or maintain cognition; thus, providing evidence that exercise may help reduce the risk of dementia or delay the onset. Research examining the influence of resistance exercise; however, is currently lacking. This study will examine the influence of a 12 week high-intensity resistance training program in a healthy mid-life (40 to 70 years) population on cognitive function following the intervention. Furthermore, this study will examine change in cerebral blood flow and blood biomarkers associated with neural and vascular health to provide evidence for an effective cognition based resistance training program.

  • A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients with Advanced Solid Tumors

    Study details: This clinical trial aims to establish the safety and tolerability profile of the drug IMP4297, to determine the maximum tolerated dose (MTD) of IMP4297, and to evaluate the dose limiting toxicities (DLT) of IMP4297 in study participants with advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. The secondary purposes of this trial are to assess the distribution of IMP4297 at various time points (pharmacokinetics) and to also obtain preliminary information on the antitumour activity of IMP4297. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically documented, incurable, advanced solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. Patients with breast cancer, ovarian cancer and prostate cancer are preferred. Study details Participants in this trial will initially receive a single dose of the drug IMP4297 to allow an assessment of safety, tolerability and pharmacokinetics (PK). The drug is administered orally in a tablet form. If tolerated, participants will then proceed one week later to receive a daily dose of IMP4297 for 3 weeks. This treatment cycle will then continue until unacceptable toxicity is indicated, the disease progresses, or the study participant withdraws his/her consent; or the study participant meets any other criteria for withdrawal. Up to 6 dose levels are planned to investigate the maximum tolerated dose (MTD) of IMP4297. This trial employs a stepwise dose escalation scheme which allows the safety and tolerability of each dose level to be evaluated before study participants are exposed to a higher dose level. Participants will be required to give blood samples and undergo regular clinical assessments in order to evaluate treatment safety and tolerability.

  • Change of Respiratory Function during Extracorporeal Life Support (ECLS), a Pilot Study to identify Pulmonary Predictors of Outcome

    Pulmonary function tests including measures of electrical Impedance tomography (EIT) will be performed on a daily base whilst the patient is on Extracorporeal Life Support (ECLS) and preferentially one day after weaning off ECLS.The following proposed interventions and pulmonary function tests are part of our current standard treatment protocol and used for clinical assessment of patients on ECLS, except for the use of EIT. To facilitate easier use of the EIT system and measurement of pulmonary function tests, patients will be transitioned to a Hamilton G5 ventilator, which gives an easier access and download of pulmonary function data than our current fleet of ventilators (Evita XL, Servo I and Servo U). Mode and ventilation delivery of the Hamilton G5 ventilator is no different to our standard fleet. Based on the findings a potential interventional trial will be conducted investigating whether a different ventilation strategy on ECLS may improve outcome.

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