ANZCTR search results

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

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31102 results sorted by trial registration date.
  • SMART MUMS WITH SMART PHONES 2 (SMs2) Text messaging support for women after gestational diabetes

    To evaluate in a randomised comparative effectiveness trial, whether a structured lifestyle modification program for women immediately after a GDM pregnancy, delivered via customised text messages and further individualised using data from activity monitors, improves diabetes risk factors, namely weight, physical activity (PA) and diet. A diabetes prevention program of lifestyle modification delivered to mothers post-GDM pregnancy via customised mobile phone text messages and customised to diabetes risk factors as well as additional incoming data during the program from activity monitors, will promote the adoption of a healthier lifestyle and improve weight management. Healthy lifestyle programs developed in intervention studies have generally been resource intensive and would not be easily accessible for many women at this stage of their lives. Our trial aims to use technology to establish a healthy lifestyle program which is affordable, sustainable and potentially transferable to health services. Successful widespread implementation of the program may have profound public health implications and impact on maternal health and the population prevalence of diabetes. Our targeted lifestyle program can be conducted at relatively little expense, but if dysglycaemia can be prevented or delayed, it may result in significant reductions in morbidity and cost savings to the health system.

  • Increasing immunisation in general practice against invasive pneumococcal disease and influenza in people under 70 years old whose chronic conditions put them at higher risk of and from these infections.

    The aim of the research is to increase immunisation of people aged 18-69 years with chronic (long term) health problems against invasive pneumococcal infection and influenza, by increasing immunisation reminders that GPs receive, and that clinics deliver to their patients. This before -after study consists of using reminders generated by practice software to increase pneumococcal and influenza vaccination among patients aged 18-69 years with chronic conditions. When eligible patients book an appointment, if they have consented to SMS communication by the practice, the preventative health software Doctor's Control Panel will automatically send a brief and generic immunisation reminder SMS encouraging them to discuss their immunisation status with their GP. On the day of the consultation, patients will receive a second brief reminder SMS, and, if they attend in-person, a printed reminder letter to read in the waiting room. The reminder letter explains why each outstanding preventive service is recommended and encourages the patient to ask about those services during the current consultation with the GP. Aggregated tablulated results at baseline and end of the study will be used to evaluate the success of the intervention.

  • Pilot study to assess safety and feasibility of bronchoscopic radiofrequency ablation in non-small cell lung cancer delivered via the EUSRA™ probe.

    The purpose of this study is to assess the feasibility and safety of a minimally invasive treatment technique in the treatment of lung cancer called bronchoscopic (tube down the throat) radiofrequency ablation. Who is it for? You may be eligible for this study if you are aged 18 or older and are a suitable candidate for surgical resection of a lung cancer tumour. Study Details All participants will receive one treatment of radiofrequency ablation via a bronchoscope. This will be performed 2 to 14 days prior to undergoing their scheduled surgical lung resection. The procedure will be performed under a general anaesthetic in a day surgery area. All patients will be followed up using standard hospital procedure. The aim of this research is to provide information into non-surgical treatment options for lung cancer and as such will provide future non-surgical related options for the disease.

  • The MEND (MEseNchymal coviD-19) Trial: a pilot study to investigate early efficacy of mesenchymal stem cells in adults with respiratory failure due to COVID-19 or another underlying condition.

    The purpose of this study is to assess the early efficacy of mesenchymal stem cells (Cynata Therapeutics Limited, CYP-001) in adults admitted to intensive care with Respiratory Distress due to COVID-19 or another underlying condition.

  • The effect of mediterranean diet on the microbes community and immune response in fatty liver disease.

    The purpose of this study is to see how the microbial community and immune system in people with liver disease responds to a Mediterranean diet. Who is it for? You may be eligible for this study if you or a member of your immediate (household) family have fatty liver disease, including liver cancer. Study details All participants in this study will be provided with 5 meals a day of the Mediterranean diet. This includes 3 main meals and two snacks. The Mediterranean diet is rich in polyunsaturated fats, fibres, polyphenols, vitamins and carotenoids. As part of this study, participants will provide stool, urine, blood and mouth swab samples and complete dietary and quality of life questionnaires. The results of those with liver disease and liver cancer will be compared to the results of their family members without these conditions. It is hoped this study will show the change in diet drives a more diverse gut microbial community and this has a positive effect on the immune and anti-cancer profile of participants.

  • Improving the knowledge and utility of flexible bronchoscopy in children

    FB is primarily used in children for diagnostic purposes and sometimes is also therapeutic. It involves viewing airways with a flexible instrument, and obtaining lower airway specimens. FB is commonly used in paediatric respiratory centres around the world to help in diagnosis and to help guide management in patients with respiratory complaints like chronic cough, recurrent croup and recurrent wheeze. Publications on indications, contraindications and complications of FB are based on expert opinion and retrospective studies. Indeed, two international thoracic societies (American Thoracic Society and European Respiratory Society) highlighted the paucity of prospective studies and absence of any RCTs. This is a critical gap, as FBs are undertaken using general anaesthesia. There are risks associated with general anaesthesia in addition to those from FB itself (e.g. hypoxia, nausea, vomiting, headaches, confusion and unscheduled hospitalisation). There are also cost implications to the health system and the family. Thus, it is not surprising that different centres have varying approaches resulting in vast differences in the number of FBs undertaken. At Queensland Children’s Hospital, Brisbane, ~550 FBs/year are undertaken but other Australian paediatric centres carry out less than half of this number. Thus, a RCT is required to define the efficacy and benefits to address this gap. Our study’s goal is to examine the impact of FB on quality of life (patient reported outcome) and change in management in children under the rigour of an RCT with the hypothesis that paediatric FB leads to improvement in quality of life and to change in managment. Ultimately, this will clarify the utility of FB in children and will improve clinical outcomes for children.

  • Covid-19 Biobank of clinical samples and data for use in research to help understand the immune characteristics of people who are diagnosed with COVID19.

    Establish a clinical database and biological bank of clinical samples from individuals with COVID-19 infection to better characterise the clinical course and pathogenesis of the infection and provide insights into potential therapeutic agents. Individuals that provide consent to give additional samples of blood and nose/throat swabs will be referred to as the intensive sampling group. This group will be recruited when they are hospital inpatients or from the community if they have been diagnosed with COVID-19 and not been admitted to hospital. These individuals will also consent to clinical data being collected from their medical record and any residual samples obtained for routine clinical care being stored in the Bio-bank.. Individuals who are unable to provide informed consent will be referred to as the observational group; these may consist of individuals who have been identified following hospital discharge that are not able to be contacted to be consented for intensive sampling . These individuals will have clinical data collected from the medical record retrospectively and any residual samples obtained from clinical care also being stored in the bio-bank. Individuals for whom no residual specimens are available will not be included in this study.

  • Does music during flexible cystoscopy reduce pain and anxiety?

    Purpose : Flexible cystoscopy is a common urological procedure, however it is often painful and this pain can lead to loss of patients to follow up. Music has been studied as an adjunct to pain management in multiple fields including urology. Previous research has been performed unblinded, we believe this may be a contributor to previous positive findings of the effect of music on pain. Methods: We performed a patient blinded randomised control trial of music during flexible cystoscopy comparing the pain, measured by visual analogue scale (VAS), anxiety (measured by the state trait anxiety inventory (STAI)) and vital signs of 109 patients across two public hospitals in NSW, Australia. Patients were blinded to the purpose of the study until after results had been collected. Results: No statistically significant differences were detected between the Non-Music and Music groups in VAS pain score (2.04±1.94 vs 2.10±1.90, P=0.86), change in STAI anxiety score (4.87±9.87 vs 6.8±11.07, P=0.33) or post procedural vital signs (HR 74±14 vs 72±13, P=0.66, SBP 144±20 vs 141±19, P=0.47) between the two groups. Conclusion: Music does not appear to decrease perceived pain or anxiety when used during flexible cystoscopy. These findings may differ from the literature due to a number of factors including patient blinding, ethnic makeup of the study population or no of choice of music.

  • Does provision of computerised cognitive training for an extended period of time in older hospitalised patients help in improving their frailty status?

    Studies indicate that over half of the older patients admitted to hospitals are frail. Frail patients are at a high risk of falls, nursing home placement, unplanned readmissions and death. Currently, there are limited treatment options to reverse frailty. Currently only limited studies have explored benefits of cognitive training in frail subjects. This study will determine whether provision of computerised cognitive training in older hospitalised patients improve their frailty status and quality of life.

  • Imaging in Inflammatory Bowel Disease (IBD)- A 4 way comparison study

    The diagnosis and monitoring of inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis, involves many different tests including blood and stool tests, imaging tests and endoscopic tests. These tests are used to assess disease extent and severity. The technology involved in imaging and endoscopic tests has advanced significantly in recent times. Newer generations of these tests are available and are being used in clinical practice. However, to date, these tests haven’t been compared directly with each other. This study aims to assess the accuracy of different disease assessment tests in patients with inflammatory bowel disease. Participants will undergo diagnostic assessments (colonoscopy, MRI, ultrasound and Pillcam Crohn's capsule) at 2 time points- 1 year apart. Colonoscopy, MRI and ultrasound all form part of routine disease assessment for patients with IBD and the use of these assessments during the study will not be different to standard care. The Pillcam Crohn's capsule is not yet part of routine care, but is merely an updated, higher definition iteration of existing capsule endoscopy systems. The risks associated with the Pillcam Crohn's capsule are no different to standard capsule endoscopy. Previous versions of capsule endoscopy have been shown to be comparable to other diagnostic modalities in the assessment of inflammatory burden in inflammatory bowel disease patients. The study protocol describes the interventions in more detail including the preparation required and disease indices measured. We believe that the Pillcam Crohn's device will be as accurate as the current diagnostic methods at detecting extent and severity of inflammation related to inflammatory bowel disease.

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