ANZCTR search results

The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for intra-arterial catheters (IAC). The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. You may be eligible to participate in this trial if you are an intensive care patient over the age of 16 and are having an intra-arterial catheter inserted as part of your therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of two IAC securement options. These will be either (i) the standard simple polyurethane dressing; or (ii) an integrated securement device and simple polyurethane dressing combined into a single device The allocated dressing will be applied from device insertion until the time of device removal. Participants will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, and device failures. It is hoped that the findings of this trial will provide information on which IAC securements are most effective in preventing IAC failure.

The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for peripheral intravenous catheters. The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. Your child may be eligible to participate in this trial if your child is a medical, cardiac or surgical patient under the age of 18 and are having a peripheral venous catheter inserted as part of their therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of three PVC dressing/securement options. This will be either the standard bordered polyurethane dressing; medical grade superglue, or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants and families will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PVC securements and dressings are most effective in preventing PVC failure.

Diabetes is a chronic disorder that affects over 346 million people worldwide. The estimated cost is more than $174 billion to the US. There are three categories, Type 1, Type 2 and gestational diabetes. Type 1 diabetes is an auto-immune condition in which the immune system is activated to destroy the cells in the pancreas which produce insulin. People with type 1 diabetes depend on synthetic insulin every day of their lives to replace the insulin the body cannot produce. Without insulin, the body burns its own fats as a substitute which releases chemical substances in the blood. Good glycaemic control reduces the risk for retinal, renal, and neuropathic complications in patients with type 1 diabetes mellitus. The conventional therapy for T1 and some T2 patients is a daily injections regimen. A mixture of rapid-acting and basal insulin is mixed to mimic the gold standard therapy. Elderly patients who use insulin are more at risk of hypoglycaemia because of a high prevalence of cognitive impairment and the patients’ potential ability to administer and monitor insulin therapy. The current challenge is how to get Type 1 patients to take insulin conveniently and non-invasive. Alternative oral delivery platforms have been attempted since 1925 but the hurdle is to move a large molecule like insulin across mucosal membranes. The dosage also was impractical and non-therapeutic. In addition, many patients view insulin therapy as confronting and uncomfortable, with side effects such as hypoglycaemia and weight gain. Previous studies on micellised formulations such as Oralgen, have compared the kinetics of different doses of Oralgen to standard subcutaneous regular human insulin injections. In both studies, Oralgen was associated with a higher maximum concentration [Cmax] and shorter time to reach the maximum peak [Tmax]. Medlab has developed a new platform for insulin delivery. The aim of the project is to mimic the pharmacokinetic data of naturally produced body insulin or the injectable insulin. The new platform will hope to achieve a better compliance rate with a less invasive delivery method. The aim of the project is to achieve a better Cmax and shorter Tmax.

This study will compare resection of oral cancer guided by Narrow Band Imaging with resection guided by white light panendoscopy. Who is it for? Participants over eighteen years of age with oral squamous cell carcinoma planned for surgical management will be invited to participate in the study. Study details: Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have Narrow Band Imaging and white light panendoscopy prior to surgery. Participants in the other group will have examination with white light panendoscopy prior to surgery, which is routine practice. Participants will have a pre-treatment PET scan, blood sample, and MRI and a post-treatment PET scan and blood sample. All surgical specimens will be examined by a pathologist as is routine practice. The molecular profiles of resection margins will be analysed to confirm that NBI surgical resection margins are molecularly distinct from WL margins and the tumour. This information will be used to create a molecular biomarker panel for head and neck cancer. Participants will be followed-up for up to 5 years post-treatment to determine local recurrence and disease free survival. A prospective Health Economic Assessment to demonstrate the cost benefit of the use of NBI in oral cancer management will be undertaken. Known and possible side effect(s) for each arm of the trial; Applicable to both arms: - Oral squamous cell carcinoma, as well as treatments for Oral squamous cell carcinoma, have the potential to significantly affect patients’ quality of life, in particular their speech and swallowing. - There is a direct relationship between the size of the resection/complexity of reconstruction and subsequent risks (including speech/swallowing impairment). Participants in one group will not universally have larger margins resected than participants in the other group, therefore increased risk of these treatment side-effects will not be universally applicable to participants in either group.

Lactoferrin is a protein involved in protection against microbial infections and the prevention of systemic inflammation, and is found in milk, saliva and other secretions. The study is designed to measure how well the lactoferrin absorbs into the digestive system, compared to a modified lactoferrin product. We will also be looking at how well the immune system is functioning before and after taking the lactoferrin/modified lactoferrin product. The purpose of the study is to improve understanding of the absorption and efficacy of bovine lactoferrin with a view to the creation of new functional food products in the future.

According to the cognitive models of Social Anxiety Disorder (SAD), negative rumination is a key maintaining factor in the vicious cycle of social anxiety. However, there is a lack of research investigating treatment effects on rumination in social anxiety, as well as other key cognitive variables. The current study aimed to determine the effectiveness of a brief intervention on a range of cognitive processes, most notably negative rumination. Furthermore, the predictors of negative rumination and state anxiety are investigated. Specifically, we hypothesise that: 1)Participants in the cognitive restructuring condition will report reduced negative affect, state anxiety, negative rumination, and threat appraisals, as well as stronger performance appraisal, objective performance, and positive self-beliefs relating to the speech task as comparted to SAD individuals who do not receive the intervention. 2) Despite recent evidence suggestion that more cognitive processes are at play during pre-event rumination than post-event rumination, making the process potentially more difficult to address in a single-session intervention, we further anticipate that the cognitive intervention will significantly reduce both pre-and post-event rumination, comparted to the socially anxious group whom do not receive the intervention 3) The predictors of levels of negative rumination, both pre- and post, will mirror those reported by Previous research

Chronically transfused patients receive multiple units of blood products over the course of their treatment. Multiple red blood cell (RBC) unit transfusions may lead to adverse transfusion related outcomes including the production of antibodies directed against RBC surface markers (antigens), haemolytic diseases and potential long-term donor cell survival, which is termed ‘microchimerism’. The phenomenon of microchimerism has been documented between a mother and her fetus during pregnancy or as a result of twin-to-twin transfer in utero. However, microchimerism could also occur following organ transplantation and blood transfusion. Transfusion-associated microchimerism (TAM) is hypothesised to result from the presence of donor leucocytes present within a RBC unit. Research from the Blood Service Research & Development Team in Australia and from the Blood Systems Research Institute in the US has shown that long-term surviving donor leucocytes have been detected in up to 10% of transfused trauma patients following blood transfusion. However, it is currently unknown whether chronically transfused Australian patients could also be vulnerable to microchimerism. Therefore, chronic RBC transfusion recipients will be investigated for the incidence of microchimerism.

Some adverse transfusion-related reactions are hypothesised to be primarily mediated by donor white blood cells (leucocytes) present in red blood cell (RBC) units. Leucodepletion (removal of leucocytes via filtration) has successfully reduced transfusion related reactions, however current clinical data suggests that RBC transfusion can still result in poor patient outcomes. One such undesirable outcome is the development of microchimerism, where genetically distinct donor leucocytes are detected within a transfused patient. Transfusion-associated microchimerism has primarily been reported in trauma patients who receive multiple blood units and often have an underlying disruption of their immune response. In Australia, we reported that despite the use of leucodepleted blood components 10% of trauma patients showed an incidence of microchimerism. However, it is still unknown whether there is an incidence of microchimerism in other Australian transfusion recipients. This study aims to gather preliminary data on the incidence of microchimerism in chronically transfused paediatric patients. These patients were chosen since they receive multiple RBC units and may be immunosuppressed at the time of transfusion. It is currently unknown whether chronic red blood cell treatment results in long term donor white cell survival (microchimerism) within this patient group and whether the use of gamma-irradiated blood components can affect any potential incidence found. To test for the presence of surviving donor cells in chronically transfused paediatric cases both a retrospective (look-back) and prospective (current) study will be collected. For the retrospective study, a single blood samples (1mL) will be analysed for an incidence of microchimerism. These patients will have been transfused 5-15 years ago and will enable data to be gathered on whether there is a long-term donor cell survival. For the prospective study, a blood sample (1mL) will be collected before transfusion, routinely before each red blood cell unit transfusion during the course of their treatment and at 12-18 months following treatment completion. Genomic DNA will be isolated from the blood sample which will undergo a sensitive genetic test for a series of insertion/deletion sequences which are diagnostic for the presence of microchimerism.

Social anxiety is one of the most prevalent anxiety disorders in both children and adults, with mean onset age in childhood. Historically, treatment programs for anxiety disorders in youth have been generic, which means that children have received the same intervention regardless of the type of anxiety disorder diagnosed. These generic cognitive behavioural treatment programs have shown good efficacy, with 50-60% of children achieving remission immediately after treatment, and 70% achieving remission after a few months. Despite the widespread use of generic anxiety management programs for young people, some evidence is beginning to suggest that specific anxiety management programs – that is, programs developed for a specific disorder – may show better efficacy. However, to date, this evidence comes only from cross-study comparisons through meta-analyses. Direct comparison between generic and specific anxiety management programs within the one randomised trial has not been conducted. Theoretical models of the maintenance of social anxiety disorder among adults (Clark & Wells, 1995; Rapee & Heimberg, 1997) have guided research and adult treatments for the past 20 years. More recently emerging research about the key cognitive and behavioural processes that underpin social anxiety in children predicts specific targets to build on within treatment to create specific treatments and optimise efficacy. We have recently developed a modified version of our widely used youth anxiety program, Cool Kids. This modification includes strategies to specifically target cognitive and behavioural processes that maintain social anxiety. The primary aim of the current study is to evaluate the efficacy of a specific, theoretically-derived intervention for social anxiety disorder in young people compared against generic child anxiety treatment, which is current best practice.

The primary purpose of this trial is to determine the maximum tolerated dose of stereotactic ablative radiotherapy (SABR) in combination with immunotherapy for the treatment of metastatic melanoma, and to determine whether the treatment has any clinical efficacy. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have been diagnosed with non-oligometastatic stage IV melanoma. Study details You will be participating in a phase I study. Although SABR is generally safe on its own, it is not clear how safe it is in combination with immune activating drugs. To find out we will start by giving a very low dose of SABR, which we think will be safe for almost all patients and slowly increase the dose to a level, which we think will be effective. Patients participating in this study will all receive a drug that activates their immune system and you will discuss this further with your doctor. These drugs will be delivered in a standard fashion, with at least 4 doses delivered every 3 weeks for up to 2 years or until you no longer are gaining benefit.. By participating in this study, a few days before you receive the drug you will receive SABR to one of your disease sites. You will be followed up for up to 5 years on this study It is hoped that findings from this trial will provide information on the maximum tolerated dose, and the level of efficacy of each dose level of SABR with immunotherapy for the treatment of metastatic melanoma.