ANZCTR search results

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

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31097 results sorted by trial registration date.
  • The effect of continuous versus intermittent delivery of enteral feeding on glycaemic control and gastrointestinal response in critically ill patients (CGM-ICU)

    This study aims to compare the effect of nutritional feeding pattern of standard feeding (continuous delivery of feeding over 24 hours) or intermittent feeding (4 boluses of feed every 6 hours) on blood glucose levels, the rate of stomach emptying and clinical outcomes. When patients are sedated and on a breathing machine in the intensive care unit (ICU) they are fed via a tube with liquid feed. Delivery of feed to critically ill patients is often provided continuously over the day as it is believed that this pattern may help control blood glucose levels and is easier logistically. However, intermittent feeding, by providing several larger boluses at 4-6 hourly intervals, follows more of a meal-like pattern, and is thought to have benefits on gut function and prevention of muscle loss. At this time, little is currently known about which pattern of feeding has the most benefit on blood glucose control, gut function and muscle mass.

  • Proof of concept study on the combined effect of dronabinol and acetazolamide on apnoea hypopnoea index (AHI) in adults with obstructive sleep apnoea

    This is a randomised crossover study to determine the therapeutic benefit of a combination of dronabinol and acetazolamide in subjects with suspected or diagnosed mild to moderate Obstructive Sleep Apnoea (OSA). Subjects will be required to undergo five sleep tests. Prior to each sleep test the Subjects will complete questionnaires to assess daytime somnolence, mood and quality of life. The first sleep test will confirm OSA and establish baseline levels for AHI, daytime somnolence, mood and quality of life. Once OSA is confirmed Subjects will be randomised into one of six treatment arms. All Subjects will undergo four treatment periods where they will receive treatment one of placebo or low, medium or high dose combination of dronabinol with acetazolamide. All subjects will receive all treatments over the course of the study but the order or treatment periods will be random. Each treatment will last for seven nights with a seven-night washout period between treatments. On night 7 of each treatment period the Subjects will undergo a sleep study using a polysomnography (PSG) machine at the sleep clinic. Sleepiness, mood and quality of life questionnaires with completed prior to PSG set up on night 7. AHI, daytime somnolence, mood and quality of life scores will be compared to baseline across the 4 treatments to establish the optimal dose for the therapeutic benefit for the combination of dronabinol with acetazolamide for treatment of OSA.

  • The Prediction modelling for Risk-Stratified care for women with Gestational Diabetes (PeRSonal GDM) study: Calculating the individualised risk of adverse outcomes for women with gestational diabetes.

    Background Gestational diabetes (GDM) is a common yet highly heterogeneous condition. The ability to calculate the absolute risk of adverse pregnancy outcomes for an individual woman would allow preventative and therapeutic interventions to be delivered to women at high-risk, sparing women at low-risk from unnecessary care. Research Aims 1. To examine the outcomes of GDM in the context of current care. 2. To develop a prediction model for adverse pregnancy outcomes in women with GDM. Participants All pregnancies within the existing Monash Health maternity outcomes database with a birth recorded from 1 January 2016 to 31 December 2018. All analysis will be conducted using non-identifiable data. Methods Epidemiologic questions will be examined with logistic regression analysis. A multivariable prediction model will be developed using clinical characteristics routinely available at the time of GDM diagnosis. Recent methodologic advances aimed at developing clinical meaningful and implementable models will be utilised. Expected Outcomes Obesity, excess gestational weight gain and ethnicity are significant contributors to adverse pregnancy outcome in women with GDM in this real-world population-based dataset. A method for stratifying women with GDM by risk of adverse pregnancy outcomes will be developed.

  • The C*STEROID Trial: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks of pregnancy.

    Birth by planned caesarean section poses some risk to babies, in particular, the need for admission to the neonatal unit for breathing support. Corticosteroid injections given to mothers expecting a preterm birth reduce neonatal respiratory morbidity but is not known if corticosteroids before a planned caesarean section at or near term have the same effect. Limited research suggests that as well as benefits on babies’ breathing these injections may lower babies’ blood sugar levels and so possibly cause harm. The C*STEROID Trial is a multi-centre, placebo-controlled, randomised trial to assess the effects of corticosteroids given to mothers before a planned caesarean section at or near term on neonatal and childhood health.

  • Prevalence of Hypomagnesaemia after Major Abdominal Surgery (Magmas-I Study)

    Magnesium is an essential macronutrient that exists in every human cell for the body to function, it plays a vital role in many body processes, including muscle (like heart muscles), nerve, bone health and mood. As such, inadequate magnesium in the body can cause a range of medical conditions and complications. While many studies have been carried out in the intensive care setting, reporting that magnesium deficiency is prevalent in those critically ill patients, few studies have investigated this problem after major abdominal surgery. However, in practice, low magnesium is often seen after a major abdominal operation, in particular bowel surgery, as such, some doctors may empirically prescribe magnesium for patients undergoing these procedures. Given that magnesium is readily available and easy to administer, there is an urgent need to know how bad the postoperative deficiency is so that correction can be made in a timely manner.

  • Clinical Trial of Perispinal Etanercept Treatment for Stroke patients to examine the effect on fatigue and muscle spasticity.

    1 in 6 Australians will have a stroke. Other than acute and supportive rehabilitative care – there is no effective treatment for chronic stroke. When brain tissue is damaged, the area around the dead area undergoes a long-term neuro-inflammatory process effectively shutting down the function of the area and extending the originally damaged area. By injecting an anti-inflammatory biologic medication currently used to treat Rheumatoid arthritis by a novel route to bypass the blood brain barrier with 2 doses, 2 weeks apart, it is proposed that this neuroinflammation will be reduced and some associated function regained. PSE 2020 will extend on the data from a recently published world-first RCT conducted by Griffith University School of Medical Science.

  • Gene Compatibility and Outcomes of Paediatric and Adolescent Patients of Parental Donor Kidney Transplants

    Kidney transplantation is the treatment of choice for patients with end-stage kidney disease (ESKD) because if confers a significant survival benefit compared to dialysis treatment. For the large majority of paediatric and adolescent patients with ESKD, parents are the preferred source of donor kidneys for transplantation. Recent study has suggested that kidneys from mothers are more likely to reject compared to kidneys from fathers, but the reasons for this observation is unknown. This study aims to examine in-depth the potential difference in genetic (i.e. immunological) compatibility between donors and patients) using novel molecular techniques, which may help to better stratify the risk of adverse allograft outcomes after kidney transplantation from mothers and fathers. With these findings, this will enable clinicians and patients/families to make a better-informed decision regarding the selection of the most appropriate parental donor kidneys for transplantation.

  • A Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of RS1805 Tablets in Healthy Adult Subjects

    Reistone Biopharma Co., Ltd is developing the study drug RS1805 as a potential new treatment for a condition called inflammatory bowel disease (IBD). Inflammatory bowel disease (IBD) is a common chronic inflammatory disease affecting the gastrointestinal tract. It is characterized by abdominal pain, abdominal distension, diarrhea, vomiting, and weight loss. People with Inflammatory bowel disease (IBD) usually require lifelong medical treatment and selective surgery according to the severity of condition The study drug, RS1805, is designed to moderate the activity of a specific protein found in the body called ROR-gamma. ROR-gamma can cause inflammation which lead to the symptoms experienced in patients with IBD. It is hoped by blocking the activity of ROR, symptoms associated with IBD may improve.

  • Making it Personal: Identifying Personalised Triggers of Fatigue in Multiple Sclerosis

    This research study aims to explore intra-individual variability in symptoms over time and intra-individual predictors of symptom severity. A series of N-of-1 observational studies with individuals with Multiple Sclerosis (MS) will be conducted. The study also aims to assess the acceptability and feasibility of participating in N-of-1 observational studies from the perspective of individuals with MS. This will be achieved by conducting semi-structured interviews with participants at the end of the study and by examining recruitment and retention rate and questionnaire completion rates.

  • Treatment of Medial Tibial Stress Syndrome using an Investigational Lower Leg Device. A Randomised Controlled Trial.

    Background: Medial tibial stress syndrome affects 4-20% of the population with increased incidence in athletes and the military. It has a complex aetiology of bone loading and fascial traction and is often difficult to treat. Stretching, calf strengthening, load management and rest have shown benefit, however, there remains a group of patients who do not benefit from these methods and for many athletes and military personnel prolonged rest is not ideal. Hypothesis: The purpose of this study was to examine the effect of an investigational device on MTSS symptoms compared to a placebo. Study Design: A prospective double-blinded randomised placebo-controlled trial. Methods: Included participants were those with symptomatic MTSS lasting 6 weeks or more. Excluded were those with other lower limb or systemic pathologies. Fourteen participants formed the study cohort. Participants were required to wear the devices daily for up to 2hrs, before and after exercise. Additional treatment modalities were recorded. The primary outcome was a MTSS Severity Score at the initial assessment and 1-6, 8, 12, and 24 weeks. Secondary outcomes were return to activity, exercise frequency and device usage data collected at the same time points.

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