ANZCTR search results

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

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33673 results sorted by trial registration date.
  • Evaluation of the impact of surgical repair of rib fractures compared to non surgical management of rib fractures on pain and quality of life.

    The optimal management of patients with fractured ribs who are not ventilator dependent has still not been determined. Although various studies suggest improvements in both short and long term function in patients who are treated by operative stabilization, there is not enough good evidence to advise management practices. However, the evidence available suggests that significant improvements in patient management and long term outcomes could be achieved by surgical fixation of ribs in these patients. A definitive answer will only be achieved by a prospective trial examining the short-term and longer term outcomes for patients treated by operative stabilization of their rib fractures This study aims to assess early and late outcomes in patients with multiple painful displaced fractured ribs with and without operative fixation.

  • A study investigating movement, pain and activity in failed back surgery patients undergoing spinal cord stimulation.

    Spinal cord stimulation (SCS) is a treatment option for cases of persistent pain, refractory to other forms of treatment. The first wave of studies produced generally favourable results, with reductions in pain ranging from 49% (Alo, Redko & Charnov, 2002), 55% (Villavicencio et al., 2000) to 74% (Dario et al., 2001). Since this time, a systematic review of 63 publications, predominantly comprised of case series, found that 58% of patients achieved clinically meaningful pain relief at two year follow up (Taylor et al., 2014). Taking this finding at face-value, it appears approximately 42% of chronic pain patients under-going SCS do not achieve significant pain relief. However, among this population, there is presently a scarcity of research to examine change to mobility and function. This is important, as it is plausible that the analgesic effects of SCS could be mitigated by patients increasing their mobility; a clinically important outcome in and of itself. To the author’s knowledge, objective measures of movement pre and post SCS have not been reported in the literature. Thus, the key aim of the present clinical trial is to objectively assess change to motion and mobility in patients with persistent pain following SCS, and its relationship to change in pain levels. On this basis, the following hypotheses were generated: 1. Movement and pain will correlate in participants with FBSS undergoing SCS trial and implantation 2. Activity and the ODI index will correlate in participants with FBSS undergoing SCS trial and implantation.

  • Feasibility of performing measurements of airway collapse during tonsillectomy surgery in children.

    Obstructive sleep apnoea (OSA) is a condition involving repeated episodes of partial or complete blockage of the airway during sleep. Learning difficulties, behavioural problems as well as bed-wetting, sleep-walking, retarded growth, other hormonal and metabolic problems and even failure to thrive can be related to sleep apnoea. Children diagnosed with OSA usually undergo surgical removal of the tonsils and adenoids. However, there is a high rate of complications with approximately 50% of the children suffering from minor or major breathing problems during and/or after surgery requiring specialised care. Additionally, the younger the children are, the higher the risk of breathing problems, which have a potential for serious harm to their health. The impact on the healthcare system is significant; the number of unplanned admissions necessitating specialised treatment with prolonged hospital stays increases causing delays on theatre lists. This leads to potential cancellations of other children due to the lack of theatre time and consequently increases the waitlist time. Currently the pre-operative assessment by the ENT surgeon determines whether the child will be managed as a day case or a ward patient. In case of the latter, it is further distinguished if the child gets normal ward care, specialised ward care or whether an admission to the intensive care unit is required. If the child has not been sent to the preoperative anaesthetic clinic (which is the case for the majority of children), the anaesthetist on the day of surgery might need to organise more specialised care if he/she does not agree with the care pre-organised, which may lead again to cancellations. Currently, preoperative assessment relies heavily on the surgeons and the anaesthetists’ pre-operative diagnosis. It usually involves using a clinical questionnaire that relies mostly on parental observation and interpretation of symptoms to accurately identify the presence of OSA and grade its severity accordingly. Once the grade of OSA has been established, the risk of perioperative respiratory complications can be better established and preventative strategies can be implemented where deemed necessary. However the rate of complication and unplanned admissions remain high. This is due to the grading of OSA being impacted by the high variability in the answers to the clinical questionnaire; different parents interpret the same symptoms differently and thus introduce a high bias in the OSA grading. A more appropriate approach to diagnosis and grading OSA with a much higher degree of accuracy would be the use of a scientific marker that can easily, quickly and safely be measured at the point of care. It is well known and has been shown in the literature that children with OSA have upper airways that are more prone to collapse during sleep and thus anaesthesia. Thus measuring the propensity of upper airway collapse may provide the treating team with more accurate physiological data to grade OSA and consequently narrow down the variability in the estimated probability of perioperative respiratory adverse events. Our team of respiratory and sleep physiology experts have developed and trialled a quick, safe and easy technique to measurement the propensity of upper airway collapsibility in adults and with this study we are aiming to identify whether this technique can be used in everyday clinical practice during peri-operative management to screen children with OSA who are at a higher risk of perioperative respiratory adverse events (PRAE).

  • Research study of a new miniaturized (reduced size) left-ventricular assist device called “Miniaturized Ventricular Assist Device“(MVAD 'Registered Trademark' System), which is being developed for the treatment of advanced heart failure.

    This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare 'Registered Trademark' Miniaturized Ventricular Assist Device (MVAD 'Registered Trademark' Pump) system over 24 months in subjects with advanced heart failure

  • Short-term effect of hydrolized collagen (TENDOFORTE [Trademark] P) in the treatment of chronic midportion Achilles tendinopathy: a pilot study

    The aim of this pilot research project is to perform a case control study with a cross-over design to explore the potential clinical benefits of 2 times 12 weeks (twice daily) supplementation of TENDOFORTE [Trademark] P (containing 2.5g of highly bioactive collagen peptides) or PLACEBO in chronic midportion Achilles tendinopathy patients as an add-on therapy to 24 weeks of eccentric exercise therapy. To improve our understanding of the in vivo working mechanism of this nutraceutical, we aim to investigate the ultrastructural and microvascular changes of the Achilles tendon using contrast enhanced ultrasonography, ultrasonographic tissue characterization as well as bicomponent analysis of Achilles tendon volumes ultrashort echo spin (UTE) on a 3T MRI.

  • A Within-Subject Single Dose Trial on the Effects of Bremelanotide on Social Cognition

    The aim of this proposal is to conduct the first study of the impact of subcutaneous injection of PT-141 on key mechanisms involved in social communication in healthy adults. We hypothesize that PT-141 will, in comparison to an identical and matched placebo: increase gaze duration and fixations to key face regions, improve accuracy and the speed of identification of facial emotion recognition, increase heart rate variability, and improve accuracy of response to social cues.

  • A randomised controlled trial of an intervention to improve the implementation of nutrition guidelines in childcare services

    Childcare centres represent a promising setting for interventions to improve the dietary behaviours of children as they provide broad reach to a large number of children and opportunities to be exposed to a range of nutrition promoting practices. While nutrition guidelines recommend that childcare centres provides food consistent with dietary guidelines, the impact of improving childcare food service environment on children’s diet in care has not been previously quantified. Previous childcare-based interventions have largely examined the modification of food environments in conjunction with other components which limits the ability to assess the isolated impact of improving food environment and availability on child behaviour. This study aims to assess the effect of an intervention to improve childcare service menus to comply with National nutrition guidelines. The intervention will target childcare service managers and cooks. We hypothesise the intervention will positively impact on service menus and child food intake.

  • Radiation treatment prior to surgery for local spine metastasis

    The primary purpose of this study is to determine whether Stereotactic Body Radiotherapy (SBRT) given prior to surgery is technically feasible and clinically safe for the treatment of patients with localised spine metastases. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years, have any non-haematological cancer type, and have been diagnosed with spinal metastases in the past 4 weeks for which spinal surgery has been prescribed. Study details: SBRT is a type of radiation therapy in which a few, very high, doses of radiation are very accurately delivered to a small, well-defined target area. It is normally delivered after surgery in the treatment of spinal metastases however this approach has a number of drawbacks. In this study, all participants will receive radiation treatment at least 7 days before surgery, with doses ranging between 16 – 24 Gy over 1-2 days. Patients will be assessed for signs of toxicity and pain at 1 then 3 monthly intervals for 2 years following the SBRT treatment. It is hoped that the findings of this trial will aid understanding of whether it is technically possible, and safe, to deliver SBRT prior to surgery for spinal metastases, in place of the current standard care in which SBRT is delivered following surgery.

  • Reliability and validity of a wearable electromyography system in individuals with patellofemoral pain syndrome

    The purpose of this study is to analyze the reliability and validity of the Mshorts (a wearable EMG) in individuals with patellofemoral pain syndrome and those with no knee pain. We hypothesized that the Mshorts is reliable and accurate tool to assess muscle activation in individuals with and without patellofemoral pain syndrome.

  • Does exenatide improve post prandial glycaemic control in young people with cystic fibrosis related diabetes or impaired glucose tolerance?

    Aim to evaluate the effect of exenatide on postprandial glycaemia in patients with cystic fibrosis related diabetes (CFRD) and impaired glucose tolerance (IGT). CFRD has a detrimental impact on pulmonary function, mortality and prognosis after lung transplant, that is currently treated by intensive insulin regimen. GLP-1 is released in response to food ingestion and is known to stimulate insulin secretion, suppress glucagon secretion and slow gastric emptying. Exenatide is a GLP-1 (glucagon-like peptide 1) agonist that can be administered daily without significant risk of hypoglycaemia. It is anticipated that exenatide will normalise postprandial glycaemia. This is a double blinded crossover trial where participants will have 2 study days. On the first day they will receive the intervention or placebo, receiving the opposite on the second day. Once the intervention or placebo has been given, the participant will consume a pancake followed by assessment of glycaemia, incretin response and gastric emptying.

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