ANZCTR search results

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

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31326 results sorted by trial registration date.
  • The impact of a workplace-based hand therapy intervention on the return to work and clinical outcomes of injured workers with Lateral Elbow Tendinopathy.

    Background: Lateral Epicondylalgia (LE), also known as tennis elbow, is one of the most prevalent musculoskeletal disorders among the working population. Despite the numerous treatment methods available to manage the symptoms of this common condition, no sound clinical evidence is available to suggest long term relief and functional restoration for injured workers with LE. Workplace-based rehabilitation has been recognised in recent years to provide many benefits in the return to work process for injured workers for other health conditions. However, no studies have investigated this type of intervention for the management of LE. Consideration of the injured workers workplace as part of the rehabilitation program may not only possibly improve long term outcomes for workers with LE, but may also provide further information on preventative strategies to avoid the occurrence of LE. Purpose: The primary purpose of this study is to investigate the impact of adding a workplace-based hand therapy intervention to the usual clinic-based approach on the return to work outcomes of injured workers with LE, compared to the usual clinic-based hand therapy intervention only. Method: Mixed methodologies will be used in this study. A scoping review will be conducted to identify the effectiveness of current common conservative treatment methods for the management of LE and determine the impact of workplace-based interventions for the general management of injured workers in the return to work process. Surveys will be distributed to identify the current practice trends of medical practitioners and hand therapists in the management LE. A randomised controlled trial (RCT) will be conducted to identify (i) any differences in primary outcomes of claims costs and claims duration on the return to work status of injured workers who receive usual care vs. usual care + workplace-based intervention and (ii) any differences in secondary outcomes of pain, grip strength and function of injured workers who receive usual care vs. usual care + workplace based intervention. Finally, focus groups will be used to identify the lived experience of these injured workers with LE within the workers’ compensation system. Expected Results: The results from this study will inform the key stakeholders in the workers’ compensation system (employers, medical practitioners, insurance case managers, vocational rehabilitation providers, and hand therapists), to establish an evidence-based approach for the management of injured workers with LE.

  • Phase 2 Randomised controlled trial of bone-marrow derived mesenchymal stromal cells (MSC) for new onset chronic lung allograft dysfunction (CLAD)

    This is a phase 2 multi centre randomised study where consented Lung transplant patients that have met the criteria for new onset CLAD (and none of the exclusion criteria) will receive 4 doses of Mesenchymal Stromal Cells (MSC)/placebo intravenous infusions over a period of 2 weeks. Follow up review will be performed at weeks 3,6,10,14,28,41 and 54. It is hypothesied that MSC treatment will result in a progression free survival of patients with new-onset CLAD experiencing disease progression at 12 months.

  • Shock wave Lithotripsy And mechanical Percussion therapy for lower pole renal calculi (SLAP) trial.

    The aim of this study is to compare manual percussion and inversion therapy with observation alone to see if this therapy does improve the rate of stone clearance. To date there have only been two randomised trials to assess mechanical percussion and inversion therapy. Although both these studies show promising results, pooling data has some problems as the treatment methodology was also different in each study, with one study enrolling participants immediately and the other enrolling only those with persisting stone at three months. Also in both of these studies, treatment was given in the clinic and administered by staff. Many institutions do not have such resources, therefore the aim of this study is to see if the previous results could be replicated with percussion therapy administered in the home setting.

  • Determining normal anorectal physiology values in healthy females.

    Constipation and faecal incontinence (FI) are major health problems associated with significant personal and economic burden. First line treatment for these disorders is conservative and includes dietary modification and medication. If these fail, current guidelines recommend assessing physiological abnormalities by anorectal manometry (ARM) and balloon expulsion testing (BET). The results of these are then used to guide further management of the patients, including biofeedback therapy, neuromodulation and surgical interventions. Given the central role of ARM, a relative surprisingly lack of standardization is apparent in the literature. Factors such as catheter type, study protocol and analysis of results vary widely. With regards to FI, a wide range of values is reported as ‘normal’ for anal sphincter function, and experts recommend that each unit have their own range of values for defining abnormalities. For patients with constipation, ARM and BET are required for diagnosing dyssenrgic defecation, which has been shown to be a strong predictor of biofeedback success. Nevertheless, making this diagnosis, which includes evidence of an uncoordinated defection manoeuvre, is controversial at best, with conflicting data on the specifics of the procedure and diagnosis. The sensory component of the defecation process is also slowly being elucidated. Whereas patients with constipation may display rectal hyposensitivity, patients with FI may display either hypo or hyper sensitivity. This may have implications for the treatment of these disorders, as anorectal biofeedback can be used to teach patients how to modulate their sensory thresholds, leading to improved outcomes. Notwithstanding, how best to assess for these rectal sensory abnormalities, and what are the normal cut-offs that should be used, is still unclear. We thus aim to describe the normal sensorimotor physiology as assessed by ARM in healthy volunteers. Specifically, we aim to (1) establish normal range of values for our specific equipment and protocol and (2) evaluate comparative methods for assessing sensorimotor function. These results will be used to enhance our ability to define normal and abnormal defecatory physiology and help treat future patients with these distressing chronic conditions.

  • Exploring tissue reperfusion in two body positions and varied load periods in critically ill patients. (EXTREME II Pressure Study)

    The research project aims to better understand how pressure injuries occur and to explore blood flow in seriously ill patients in two lying positions used in the intensive care unit (ICU): on the back and on the side, at 2.5-hour and 4-hour time intervals. The body’s ability to carry oxygenated blood to the tissue is tested using non-invasive, pain-free Doppler technology which measures the time taken for the blood flow to return to the small blood vessels in the tissue, near the surface of the skin. The research project will look into the effect patient body mass index (BMI), level of sickness, patient lying position and the effect that length of time in one lying position has on blood flow to the skin for the ICU patients. The patients will be assessed in the first 72-hours of admission, when they are the most ill and skin checks for pressure injuries will be completed 3-4 times per week until the patients leave hospital.

  • Efficacy of inducing Ketogenesis in patients with Acute Brain Injury via oral administration of a ketogenic feed.

    Ketogenesis is the process by which ketone bodies, during times of starvation, are produced via fatty acid metabolism. Although much feared by physicians, mild ketosis can have therapeutic potential in a variety of disparate disease states. The principle ketones include acetoacetate (AcAc), Beta-hydroxybutyrate (BHB) and acetone. In times of starvation and low insulin levels, ketones supply up to 50% of basal energy requirements for most tissues, and up to 70% for the brain. Other than glucose, ketones are the only substances capable of fulfilling the energy requirements of the brain. We have previously demonstrated that the ketone levels in adults with acute brain injury (ABI) are low. The aim of this study is to provide a feeding regimen that has the potential to increase ketone levels in patients with ABI. 20 patients with ABI admitted to Princess Alexandra Hospital Intensive Care Unit will be included. Each patient will be fed with an enteral formulation consisting of ketocal and protifar (produced by Nutricia Australia), which will provide the necessary energy and protein requirements. Both feeds are commercially available in Australia and used extensively in the paediatric population. The major difference between this feed and standard feed is the lack of carbohydrates to stimulate ketogenesis. The feeds will be continued for 7 days or until the patient is extubated or discharged from ICU. We will be measuring ketone levels and a number of other metabolites on a daily basis. Our goal is to demonstrate that this feeding regimen is capable of inducing ketosis in adults.

  • An observational research study to examine the usefulness of a test called FoundationOne (Registered Trademark) in providing some recommended treatment options for patients with cancer where the location of the cancer cannot yet be found.

  • Phase I/2 trial of Deferasirox in patients with type 2 diabetes

    This study is an open-label, non-randomized, dose-defining study of daily deferasirox in overweight or obese patients with type 2 diabetes (T2D). This study is designed to assess the feasibility (safety and tolerability) of deferasirox administered daily, based on the rate of Dose Limiting Toxicities (DLTs), i.e. pre-defined adverse events. A DLT is defined as an adverse event or abnormal laboratory value occurring at any time which is assessed as clinically relevant which is considered to be related to the study treatment, unrelated to disease, disease progression, inter-current illness, or concomitant medications, and warrants stopping or reducing the medication. Toxicities will be assessed using the NCI CTCAE, version 3.0.

  • The effect of chitosan-dextran (Chitodex) gel with budesonide and mupirocin on recalcitrant rhinosinusitis

    This research is aimed at improving outcomes for patients with chronic rhinosinusitis, particularly the cohort of patients who experience persistent CRS symptoms despite optimum medical and surgical therapy, termed as recalcitrant CRS (rCRS). We hope that we are able to developed an agent that could help manage persistent infections in patients with chronic rhinosinusitis even after they have had surgery and potentially improve patient's symptoms and reduce the need for revision surgery. The primary end point of this study is to: 1. To assess the efficacy of Chitodex-Budesonide-Mupirocin gel in treating patients with recalcitrant chronic rhinosinusitits Measured by: 1) Eradication of bacteria confirmed with microbiological swab 2) Independently scored video endoscopic examination of sinuses pre and post treatment 3) Patient's symptoms score pre and post treatment The secondary end point of this study is to: 1. Assess the tolerability of the treatment gel vs oral antibiotics

  • Comparison of the mini sling or retropubic sling in the treatment of women with severe (Intrinsic Sphincter Deficiency -ISD) stress urinary incontinence (SUI)

    Stress incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Midurethral slings (MUS) have become the operation of choice for treatment of female stress urinary incontinence. MUS are synthetic tapes that are implanted transvaginally to support the urethra. The urethra is a tube that connects the bladder to the outside of the body and removes urine from the body. Midurethral slings can be deployed in a retropubic or transobturator fashion. A retropubic approach involves tunneling the sling from the suburethral region, in close contact to the bladder in the retropubic space (behind the pubic bone), to the lower abdominal wall. In contrast, the transobturator approach involves the passage of a sling through the obturator membrane which is further away from the bladder. This approach has been shown to have a reduced rate of intra-operative bladder perforation. Recent systematic reviews of retropubic or transobturator midurethral tapes suggest equivalent efficacy, at least in the medium term. Both midurethral systems continue to have clinically significant complications such as bladder injuries, vagina mesh exposures, voiding difficulty, denovo (new onset) urgency and groin/thigh pain reported. Retropubic slings have more hematoma, bladder perforations, whereas transobturator slings have less over active bladder symptoms and less voiding difficulties. The minisling is a single incision sling system with small integrated self-fixating tips that anchor into the obturator internus muscle. This potentially avoids complications associated with trocar passage through retropubic or transobturator route. Comparative trials of retropubic against transobturator slings have shown retropubic slings to be superior in the cure rates of women with intrinsic sphincter deficiency (a severe form of stress urinary incontinence – ISD) . Randomised trials of minislings against transobturator slings have shown similar results, with the added advantage of less overactive bladder symptoms and voiding difficulties. The self-fixating tips of the minislings allow them to be placed under more tension, whilst retaining the advantages of the transobturator sling. The retropubic sling comes with superior efficacy, but has higher risks of pelvic hematoma, bladder perforations, denovo urgency and voiding dysfunction. Minislings, placed under more tension, may provide equivalent or better results than retropubic slings in patients with ISD, whilst retaining the advantages of transobturator slings. We seek to examine if the minisling is as efficacious as the retropubic sling for women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD) and compare their clinical outcomes.

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