ANZCTR search results

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

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31350 results sorted by trial registration date.
  • COgnitive bias modification to Prevent dEpression (COPE trial)

    Previous research has found that people with subsyndromal depression, (those who have symptoms of depression but do not meet criteria for clinical depression), are significantly more likely to develop clinical depression within one year compared to those without subsyndromal depression. Research has shown that Cognitive Behavioural Therapy (CBT) is the most successful psychological intervention to treat depression to date. The theory behind CBT for depression suggests that depressed people have more difficulty than non-depressed people keeping their attention away from negative stimuli and are also more likely to interpret vague and unclear stimuli in a negative way. Research has shown that people at risk of developing depression, including those with subsyndromal depression, also seem to display this attentional bias to negative information. Cognitive Bias Modification (CBM) is a relatively new therapeutic technique that aims to shift dysfunctional biased beliefs through using a computer based program. Recent research using the CBM approach has been promising in reducing symptoms of depression. However it is unknown how effective CBM is in preventing clinical depression from developing in those with subsyndromal depression. Therefore this study aims to determine if CBM decreases the 1-year onset of a major depressive episode among adults with subsyndromal depression.

  • Is dry needling an effective physiotherapy management strategy for adults with cervicogenic or tension-type headache?

    This study's purpose is to generate preliminary data on the efficacy of the addition of dry needling to standard physiotherapy management in the treatment of headaches, as well as to determine the feasibility of running an efficacy trial for this condition. This will involve the collection of a small set of data on the efficacy of dry needling for headaches, and to determine the feasibility of running a trial collecting this data. This will allow determination of a sample size estimate, the availability of eligible participants, the willingness for subjects to be recruited, and adherence rates to management, enabling evaluation of the feasibility of a future successful, cost-effective large-scale efficacy trial. We hypothesise that: 1. An efficacy trial is a feasible means to study the impact of dry needling on cervicogenic and tension-type headache 2. Standard physiotherapy plus dry needling changes the severity, frequency and disability of cervicogenic and tension-type headache pain in adults

  • Clinical Treatment of Acute and Chronic Wounds using Autologous Stromal Vascular Fraction Isolated from Lipoaspirate

    Clinical Treatment of Venous Ulcers using Autologous Stromal Vascular Fraction Isolated from Lipoaspirate INTRODUCTION Stromal vascular fraction (SVF) harvested from lipoaspirate consists of a heterogenous mixture of cell types including adipose-derived stem cells (ASC), fibroblasts and endothelial cells. There is evidence to suggest that the cells contained in SVF have angiogenic and regenerative properties that may be effective in treating venous ulcers. OBJECTIVE The goal of this study is to determine the effectiveness of autologous stromal vascular fraction (SVF) from lipoaspirate for the treatment of venous ulcers. METHODS Prospective randomized controlled study of patients from Royal Adelaide Hospital with venous ulcers on their leg. Autologous lipoaspirate will be collected from all patients using syringe aspiration from a healthy donor site. Group 1 will have their lipoaspirate sample centrifuged in the operating theatre and subsequently injected into the wound. Group 2 will have their lipoaspirate sample processed in a sterile laboratory to isolate the SVF and subsequently injected into the wound. Group 3 will have no injection. The primary outcome measured will be time to complete wound closure. CONCLUSION The results of this study will be statistically analysed and summarised, will be presented at a plastic surgery conference, and will be submitted for publication in a peer-reviewed journal.

  • A randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability of Nexvax2 in patients with celiac disease.

    A Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of Nexvax2 in Patients with Celiac Disease. Primary objective: *To determine the safety and tolerability of Nexvax2 when administered intradermally to human leukocyte antigen (HLA)-DQ2.5+ patients with celiac disease on a gluten free diet (GFD) Secondary objectives: *To assess the pharmacokinetics (PK) of Nexvax2 when administered intradermally to patients with celiac disease on a GFD *To assess the effect of Nexvax2 on the immunological response and on clinical tolerance to gluten when administered intradermally to patients with celiac disease on a GFD Exploratory objective: *To assess the effect of Nexvax2 on small bowel mucosal histology in patients with celiac disease on a GFD

  • An open trial of a guided internet-delivered cognitive behavioural therapy intervention to determine the benefits of the Wellbeing Course for Arab Australians with symptoms of anxiety and depression

    This study tests the short and medium term efficacy of the online Wellbeing Course with consumers of an Arabic speaking background who experience symptoms of anxiety and/or depression.

  • Prophylactic dressing to minimise sacral pressure injuries in high risk hospitalised patients: A pilot study

    Pressure injury (PI) causes pain, discomfort and immobility for patients, leading to increased length of hospital stay and cost. Although preventable, hospital acquired PI in Queensland in 2011 was 8.8% for patients overall. The sacrum is identified as one of the most common PI sites for patients. Special dressings may reduce PI, however rigorous testing has not been undertaken thus their benefit remains unclear. Further investigation using a pilot randomised controlled trial will assess the feasibility of undertaking a full-scale trial to test the efficacy of this dressing in reducing sacral PI with the potential of improving patient health and economic outcomes.

  • OSSIES: Obese Subcuticular Sutures versus Interrupted Evaluation at caesarean Section: a randomized control trial

    Throughout the world, rates of obesity and rates of caesarean sections are simultaneously increasingly. Moreover, women who have a body mass index (BMI) in the obese category ( that is >30) are much more likely to undergo caesarean section. These women there is a higher rate of wound infections and other wound complications such as wound breakdown and collection. In our study we propose that using interrupted stitches to close skin at caesarean section will reduce the rate of wound complications compared to using a continuous stitch.

  • Identification and characterisation of risk factors for atrial and ventricular arrhythmias in chronic kidney disease (CKD) patients using implantable cardiac monitoring

    The purpose of this project is to study the abnormal processes in the heart that can occur in people with chronic kidney disease. These processes may lead to significant heart rhythm disturbances. In this study we will assess people with chronic kidney disease who may be at high risk of developing these disorders. By doing so we aim to identify factors in chronic kidney disease that may lead to development of life-threatening heart rhythm disorders and determine potential measures to prevent sudden death.

  • Low-dose heparin in critically ill patients undergoing extracorporeal membrane oxygenation – Feasibility study

    Extra corporeal membrane oxygenation (ECMO) in intensive care unit (ICU) is a rescue therapy for reversible cardiac and/or respiratory failures. It can also provide support until cardiac or lung transplantation. Haemorrhagic complications are the most frequent of the complications occurring on ECMO, and they have been shown to independently impact on patients’ prognosis. Although some of the haemorrhagic complications may be related to patient severity or patient disease, improving anticoagulation management may prevent some bleeding events and improve patient outcome. The primary aim of this study is to determine the feasibility of administrating low dose anti coagulation in critically ill patients on ECMO when there is no indication for full systemic anticoagulation We will randomise 20 patients so that 10 will receive low dose heparin and compare their complications and outcomes to the other 10 patients treated with the standard dose of heparin.

  • Effects of lipid supplementation in contact lens wear comfort

    Tear film lipid layer plays an important role in maintaining tear film stability and ocular comfort. Contact lens wear compromises ocular surface equilibrium by disrupting the lipid layer which results in lens related ocular dryness and discomfort. The troublesome symptom of the contact lens wear often leads to discontinuation of lens wear and hence is critical for the researchers to design ways to overcome the challenge. Artificial tear supplements have been used to increase ocular comfort. This study aims to understand tear film lipids of contact lens wearers and also to evaluate the effect of exogenous lipid supplements on different aspects of tear film lipid layer. Hypotheses: 1. Improved contact lens comfort is associated with a thicker lipid layer and decreased lipid degradation resulting in reduced tear evaporation. 2. Use of an exogenous tear lipid supplement increases lipid thickness, reduces lipid degradation, increases tear stability, reduces tear evaporation and consequently improves contact lens comfort.

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