ANZCTR search results

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

You can narrow down the results using the filters

32101 results sorted by trial registration date.
  • Impact of insulin resistance, obesity and the metabolic syndrome on time taken to examine the small bowel at capsule endoscopy

    All patients already referred for capsule endoscopy during the study period over the age of 18 years old and are able to provide informed consent are to be invited to participate in the study. Capsule endoscopy is where a camera and wireless transmitter are packaged in a small, pill shaped device. This is swallowed by the patient and images are recorded as the devices passes through the bowel. These images are then interpreted to help diagnose intestinal disorders. This procedure is usually undertaken to investigate anaemia and obscure gastrointestinal bleeding. Incomplete studies can limit the utility of the study and identification of factors that may impact transit will help identify patients at risk of incomplete examination. Those that do consent will have clinical parameters recorded (sex, age, height, weight, waist circumference, blood pressure and body mass index). A fasting blood sample will be collected for insulin, C-peptide, glucose and full lipid profile (total cholesterol, triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL)). Insulin resistance is to be calculated using the validated HOMA-IR (homeostasis model of assessment of insulin resistance) method. Participants are asked about the relevant past medical history (medically diagnosed diabetes, dyslipidaemia, hypertension, ischaemic heart disease, cerebrovascular disease or peripheral vascular disease) and medications. At capsule endoscopy gastric emptying and small bowel transit time are recorded as well as whether complete small bowel transit occurs and any pathology encountered. All capsule endoscopy studies will be interpreted by an experienced clinician. Standard capsule endoscopy techniques are to be followed. Patient information is to be de-identified before statistical analysis. No individually identifiable information will be included in the final results.

  • Cohort study of meso-Rex shunts in Queensland children with extra hepatic portal vein obstruction.

    Extrahepatic portal venous obstruction (EHPVO) is a condition where venous flow into the liver becomes obstructed. As a result, blood bypasses the liver via a series of other channels that open up. The liver consequently receives less blood flow. This can lead to abnormalities of liver function, and varices that can bleed (most commonly in the lower oesophagus). The Rex shunt is a selective shunt that is designed to relieve the complications of EHPVO by connecting mesenteric venous flow to the left portal vein, using one of a number of described conduits. Queensland Children's Hospital is the only facility in Queensland performing this operation. To date outcomes have not been collated or reported for any facility in Australia. This will be the first study to do so. As a part of this study, and to determine outcomes to report, a systematic review of the literature is being performed. This systematic literature review will identify reported outcomes in the extant literature. The most common, or important, of these reported outcomes will be used for this study cohort. Data related to this cohort have already been gathered during the course of clinical care. Where possible, outcomes will be reported. If an outcome is determined important, but has not been collected to date, this will inform future data gathering for these patients.

  • Impact of Epicardial plaQUe composition and geometry on coronary hemodynamics and flow (iEquate)

    After informed consent, patient’s undergoing coronary angiography who have moderate (50-75%) stenosis angiographically would undergo invasive hemodynamic assessments via a 0.014 inch coronary wire as part of routine clinical practice to determine need for percutaneous coronary intervention. Further to this, over the pressure wire, an optical coherence tomography (OCT) catheter would be passed to obtain intra-vascular imaging and plaque composition assessment. Data will be collected on the minimal luminal area (MLA), degree of calcification, fibroatheroma, necrotic core, lipid content and the geometry of the lesion. These variables will be examined in terms of relationship to the pressure wire value. If the lesion meets hemodynamic significance (i.e. iFR value less than or equal to 0.89 or FFR value less than or equal to 0.8). PCI may be performed if clinically suitable as per usual clinical practice.

  • teenAID - Evaluating first aid training for students in Year 8

    The teen Mental Health First Aid program for students in Year 7-9 (tMHFA7-9) teaches students aged 12-15 years how to: - recognise warning signs that a friend is developing a mental health problem - understand how to talk to a friend about mental health and seeking help - when and how to tell a responsible adult - where to find appropriate and helpful resources about mental illness and professional help - how to respond in a crisis situation The course was previously evaluated in an uncontrolled trial with year 8 students. As a result of the research findings a revised edition of the tMHFA 7-9 was developed in 2020 and is being piloted with year 8 students in two Western Australian secondary schools in 2021. The aim of this project is to provide evidence on the effectiveness of the tMHFA 7-9 Edition 3 course in a parallel randomised controlled trial with year 8 students, using the Red Cross "Let's Talk First Aid" course for Year 8 (LTFA) as the comparator.

  • Oestradiol positron emission tomography (PET) scans in metastatic breast cancer:investigation of utility of assessing disease burden and treatment response

    This is a pilot study investigating the use of oestradiol PET scanning (FES-PET) in helping to assess hormone receptor positive metastatic breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, of any gender, and you have been diagnosed with ER positive metastatic breast cancer. Study details All participants will undergo upto three oestradiol PET scans. Each scan will take less than 30 minutes. There will be one scan at enrolment, at 2 months, and at 6 months later. However if the first scan does not show any disease subsequent FES PET scans will not be undertaken. Participants will also receive standard FDG PET scans, as per usual care. Data relating to your care, treatment, outcome and your demographic information will be obtained from case notes. It is hoped this research will reveal whether FES-PET is useful in providing information about disease progress and treatment response in ER positive metastatic breast cancer, and help to improve future clinical diagnosis and monitoring.

  • Assessing the effect of instilling gentamicin into the bladder during Urodynamics on the rate of post procedure urinary tract infections in patients with spinal cord injuries

    The purpose of this study is to determine whether or not instilling gentamicin, a type of antibiotic, into the bladder during urodynamic assessment, will reduce rates of post-procedural urinary tract infections (UTI). Patients with spinal cord injuries suffer from an increased rate of urinary tract infections due to a number of factors arising from the injuries to the nerves in the spine impacting on communication with the bladder. Further to this, intermittent self-catheterisation devices and indwelling catheters promote introduction and colonisation of the urinary tract. While spinal cord injured patients are frequently colonised with micro-organisms, some can lead to symptomatic infections requiring frequent courses of antibiotics, hospitalisations and urosepsis in the most severe cases. It is therefore critical that when we perform invasive procedures such as urodynamic assessment that we identify ways to reduce new bacteriuria and symptomatic urinary tract infections. Currently rates of UTIs after urodynamics in patients with spinal cord injuries is significant, ranging between 5-30%. Using gentamicin, an antibiotic, during urodynamics could be a new way in reducing rates of UTIs. Studies have shown that intravesical administration for high risk patients such as those with spinal cord injuries reduces symptomatic UTIs, oral antibiotic use and antibiotic resistance. The use of intravesical (instilled within the bladder) gentamicin irrigation for prevention and treatment of recurrent urinary tract infections was first reported by McGuide and Savastono in 1987. A systematic review of intravesical antibiotic agents (gentamicin, neomycin, polymyxin, colistin) showed a good response with a reduction in symptomatic UTI of 78.2% for both treatment and prophylaxis groups. A success rate of 71% (n=120) was seen in the prophylaxis group in the short term, with discontinuation rate of 8% (n=14). To assess the true effect of gentamicin used during urodynamics, both participants and medical staff performing the urodynamics will be ‘blinded’. This means that neither the participants or the staff will be aware of whether or not the patient will be receiving normal saline (routine solution used during urodynamics) or normal saline mixed with 240mg of gentamicin. This is what researchers refer to a randomised blinded controlled trial.

  • Cardiac Rehabilitation for transient ischaemic Attack and Mild-Stroke: the CRAMS randomised controlled trial.

    One in three strokes in Australia are repeat events. These repeat strokes are more likely to result in death and are costly, for both individuals and the healthcare system. Cardiac rehabilitation is a well-established and widely available secondary prevention program that reduces disease risk and death from heart disease and could help prevent repeat strokes as both share similar risk factors, such as physical inactivity, high blood pressure and poor diet. However, our research has found that less than 2% of Australian cardiac rehabilitation programs include people with stroke. This is despite Australian stroke health professionals and cardiac rehabilitation coordinators agreeing that cardiac rehabilitation is suitable for people after a transient ischaemic attack (TIA) or mild-stroke. Here the University of Canberra (UC) will partner with Canberra Health Services and Calvary Public Hospital, supported by the Stroke Foundation and Heart Foundation, to investigate the effectiveness of a 6-week integrated (TIA, mild-stroke, heart disease) traditional cardiac rehabilitation program (Cardiovascular rehabilitation) at the UC Health Clinics. Together we will recruit 140 Canberrans who have had a TIA or mild stroke over 2-years. These study participants will be randomly allocated to the Cardiovascular Rehabilitation program or a 6-month wait list group. We will then measure physical fitness, hospital admissions, blood pressure and other risk factors for stroke to determine the effectiveness of the program, as well as costs. Feedback from participants and health professionals will also be sought to guide the implementation of this novel program in other health services. Results will be disseminated to health professionals and the public via presentations, webinars and publications. If successful, the results will guide future research, policy and practice, potentially reducing the risk of repeat strokes locally, nationally and internationally. By reducing the risk of further strokes through the use of this existing secondary prevention program, we aim to help more Canberrans live longer after TIA and mild-stroke and avoid hospital readmissions.

  • The effect of Budesonide on the occurrence of deteriorating Illness from Covid-19 in Pregnant patients ( BUDI trial)

    Budesonide is an inhaled corticosteroid which is commonly used to treat asthma. It is inexpensive and widely available. Budesonide is a category A drug in pregnancy. There is evidence that budesonide reduces hospital admission in patients with covid-19 who are not pregnant. The physiological changes that take place in pregnancy include increased minute ventilation and upwards displacement of the diaphragm which results in a high-risk state for any kind of respiratory compromise. As such, treatments that reduce the risk of these fit young mothers suffering respiratory decompensation are pertinent to the well-being of both the baby and the mother. This study seeks to determine if budesonide improves outcomes in those hospitalised with covid-19.

  • Effect of applying teledentistry in Residential Aged Care Facilities on oral health outcomes: a feasibility study

    This project aims to see if real-time video teledentistry can be used to look at your mouth, and give you some preventive dental advice. We want to determine whether teledentistry can be an option over traditional in person site visit.

  • The PersOnalising gEneTIc Counselling (POETIC) Trial: Testing the implementation and effectiveness of an intervention to personalise genetic counselling

    Genetic testing has become a central focus in cancer care due to the ability to identify individuals with an inherited predisposition to cancer and inform prognosis and treatment options. This trial is investigating the effectiveness of using the Genetic Psychosocial Risk Instrument (GPRI) in genetic counselling appointments for people with an inherited predisposition to cancer (for example a family history of cancer). Who is it for? You may be eligible for this trial if you are an adult aged 18 years and above and you have an increased risk of a hereditary cancer syndrome. Patients attending the Parkville Familial Cancer Centre for genetic testing will be invited to participate. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the GPRI intervention arm, or a standard care control arm. Participants in the intervention arm will complete baseline questionnaires and the GPRI online before their first appointment. During the first appointment, the clinician taking the appointment will use the results of the GPRI to inform the genetic counselling provided while discussing genetic testing. Participants will then return approximately 8 weeks later for their second genetics appointment where they will receive their genetic test results. Prior to this second appointment, participants will complete the GPRI online again. During this second appointment, the clinician will again use the results of the GPRI to inform the genetic counselling process when discussing genetic test results and personal and family implications. Participants in the control arm will also complete the baseline questionnaires but will not complete the GPRI. Instead, these participants will receive the current standard of genetic counselling which involves the clinician facilitating communication about the medical, psychological, and reproductive implications of an inherited cancer predisposition. All participants will be invited to complete three subsequent questionnaires about their experiences throughout the study period up to 6 months after the second genetics appointment. It is hoped that this study will demonstrate that the GPRI tool is useful and may help patients with an increased risk of cancer to feel more empowered about their health and future treatment options.

Tags:
  • Finding clinical trials