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

32856 results sorted by trial registration date.
  • Left Ventricular Pressure as a Treatment Target in Patients with Myocardial Infarction.

    For this acute hemodynamic study, we will measure pressure within the main pumping chamber of the heart (the left ventricle) with a plastic tube (called catheter) after treating the heart attack. In the intervention group, we will give increasing doses of a medication (Glyceryl trinitrate) through the drip for 10 minutes if there are no contraindications or concerns and will simultaneously measure the pressure within the main pumping chamber. Patients will also be given 40 mg of a fluid medication (frusemide). In the control group, pressure in the main pumping chamber will be measured for 10 minutes but no trial medication will be administered. The aim of this study is to find a dose of these medications that will reduce pressure within the main pumping chamber of the heart without affecting blood pressure or causing any side effects. These medications are routinely used during all the angiography and stenting procedures but have never been used to reduce the pressure within the heart.

  • What Happened to Older People after Surgical Repair of a Broken Hip and How Much Did it Cost?

    Australian Medicare expenditure will continue to increase at potentially an ever-increasing rate with more complex and expensive health care and an aging population. Older people are more prone to hip fractures. In 2013, there were 23,000 cases with direct health care costs estimated at $762 Million, which is forecast to reach 32,000 cases with a cost of over $1 billion by 2022. Of this, most are spent on hospital treatment but these expenditure estimates do not include informal community care and productivity loss due to fractures. Despite advances in perioperative care, the death rate remains high in the elderly after hip fracture surgery. In Australia, there unfortunately exists a gap in this regard, since local data on such outcomes are limited in literature. Up to date, only a handful of small studies reported death rates with little research on the “dollar”. Given that hip fracture imposes such heavy medico-economic burden on our health system and current evidence base is weak, particularly in relation to its financial implications, a recent editorial has called for more international large observational studies so that cost-effectiveness analysis is possible for this population. Since identifying risk factors (and then, risk adjustment) may improve patient outcomes, a pilot study was designed for patients over the age of 70 who underwent hip fracture surgery between July 2011 and July 2015 at a Victorian Metropolitan Hospital. This study intends to find out whether some variables are independent risk factors, being increased risk of death, greater hospital costs or both. After institutional ethics approval, the hospital Database identified 1163 eligible patients and their data were retrieved. The investigators will then break down these data and assess the impact of perioperative variables on the early (30-day) deaths and associated hospital costs. To achieve the study goals, it is necessary to clearly define those to-be-tested variables, since there exist diverse definitions for certain variables, for example, early surgery is recommended in the current guidelines, but its definition varies from 24h to 72h. This is unsatisfactory because such inconsistent definitions could lead to different interpretations, and thus, inconclusive results. Accordingly in this instance, delayed surgery will be defined as operations undertaken after 48h post orthopaedic admission and then to examine whether such delay causes more deaths and/or costs, if so, delayed surgery is an independent risk factor and should be avoided in future practice. This pilot study is expected to provide valuable local data on some potentially unfavorable perioperative variables and also to fill the gap by estimating associated hospital costs for each fracture. Based on this information, a future multi-center study should facilitate and guide further research into potentially modifiable variables that may reduce the death rates and/or hospital costs of elderly hip fractures

  • The effect of post-exercise water immersion on muscular performance in athletes.

    Research Question: What are the acute (less than or equal to 7 days) effects of a single session of hot, cold or thermonetural water immersion on the time-course of inflammatory adaptive responses following a single bout of resistance training (RT) in athletes? Title: The acute effects of a hot, cold or thermoneutral water immersion strategy on the time-course of inflammatory adaptive responses to RT in athletes Specific Hypothesis: CWI will attenuate; HWI will further enhance and NWI or a passive seated rest strategy at room temperature (i.e. no-treatment control condition) will not alter the acute inflammatory adaptive responses to RT. This project seeks to enhance performance in athletes by optimising muscular adaptation and physical preparation through the periodization of post-exercise (resistance training) recovery practices (water immersion).

  • A prospective, multicentre, clinical study using Robotic-Assisted Total Knee Replacement, Mako and the Triathlon Total Knee System

    This study will be a prospective, multicentre, clinical study examining clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving Total Knee Replacement using the Triathlon Total Knee System performed using Stryker’s robotic-arm assisted surgery system Mako. Functional and radiographic outcomes will be additionally collected as part of this study. The study will be conducted in patients with non-inflammatory degenerative joint disease who require a primary Total Knee Replacement, with a minimum 2 year patient evaluation period.

  • The effect of cognitive training on cognitive function in older people with mild to moderate dementia: a single-blind randomised control trial

    The primary aim of this project is to evaluate the effect of cognitive training has on cognitive performance in older people with mild to moderate dementia. Additionally we will examine the effect cognitive training has on physical and functional performance and quality of life (participant and carer), as well as adherence to the intervention. Eighty community-dwelling older people with mild to moderate dementia will be recruited from routine health services and randomised to either intervention or control. Participants will be over 60 years old and have a carer with a minimum of 3.5 hours face-to-face contact each week. Consent will be gained from both the participant and their carer/person responsible. The intervention will consist of six months of home-based cognitive training. The cognitive training will target executive function, processing speed and attention. Both the participant and the carer/person responsible will be trained in how to use the program. Participants will be encouraged to train three times per week for 10 – 30 minutes depending on cognitive ability. The control group will receive usual care and healthy living information. Participants will be assessed at baseline, at six months (at completion of CT for intervention group) and at 12 months (six months after completion of CT for the intervention group). Falls will be recorded prospectively for 12 months using diaries (with the assistance of carers) and telephone calls. This study will provide valuable evidence in relation to the effect of cognitive training on cognitive, physical and functional performance measures in community-dwelling older people with dementia. Further, this study will also act as a pilot/feasibility study for a future study more suitably powered to determine whether cognitive training can reduce falls in community-dwelling older people with dementia.

  • Developmental Outcome of Children Assessed by the Child Development Unit Infant Developmental Team at the Women's & Children's Hospital between January 2013 to December 2014

    The Infant Development Team at the Child Development Unit, Women's & Children's Hospital provides a team approach to the assessment of babies and children under three years who have developmental difficulties and provides support for their families. This study aims to evaluate the developmental outcome and the prevalence of persisting developmental difficulties in children who were assessed by the Infant Development Team at the Child Development Unit in 2013 and 2014. This will help identify the ongoing needs, The Infant Development Team at the Child Development Unit, Women's & Children's Hospital provides a team approach to the assessment of babies and children under three years who have developmental difficulties and provides support for their families. This study aims to evaluate the developmental outcome and the prevalence of persisting developmental difficulties in children who were assessed by the Infant Development Team atthe Child Development Unit in 2013 and 2014. This will help identify the ongoing needs, particularly the need for follow up and developmental monitoring, for this group of children.

  • A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle relaxation & low back pain in two different populations.

    Low back pain commonly occurs in the general population, making it an important target for intervention. ThermaCare HeatWraps may prevent and relieve pain in regions such as the low back through continuous, low-level, direct heat therapy. The objective of this Investigator Initiated study is to evaluate the effectiveness of ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in patients experiencing pain, reducing pain during movement. This study is an intervention trial on two discrete subject samples; (1) people with recent back pain, and (2) people who regularly play sport. ViMove wearable sensors provide precise objective measurements of low back muscle activity and movement in real time and can capture a patient’s reporting of pain during movement. Outcomes will be assessed through standard ViMove protocols in conjunction with multiple validated measures of pain, perception of change, and function.

  • The effect of nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') on blood glucose levels in prediabetes and type 2 diabetes- A pilot study

    This study will investigate the potential of commercially available nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') is similar to the dipeptidyl peptidase-4 (DPP-4) inhibitor group, also known as gliptins, which are second line anti-diabetic drugs after metformin and sulfonylureas. The gliptins block the action of DPP-4, an enzyme which inhibits a group of gastrointestinal hormones called incretins which stimulate the production of insulin post meal and reduce the production of glucagon by the liver during digestion. DPP-4 inhibitors help regulate blood glucose levels by inhibiting incretins reducing the financial burden for antidiabetic medicine equivalent to AU$193.8 million per year. This study aim:- To determine the effect of nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP-4 inhibitor on glycemic control in patients with type 2 diabetes mellitus. The study will include a total of 80 T2D participants recruited from the community. After an overnight fast (12-hr), participants will attend the clinical areas of the Medical Science Precinct, and the School of Health Sciences, University of Tasmania (UTAS) to undergo the following: 1) Medical & lifestyle questionnaires 2) Anthropometrics 3) Blood tests to measure blood glucose, HbA1c, serum lipids, insulin, & oxidative markers. 4) Glucose metabolism (2hr oral glucose tolerance test). 5) Hemodynamic measures (blood pressure, heart rate & ECG). 6) Urinary electrolytes & kidney function. 7) Pregnancy test for woman during their reproductive life. Venous blood & urine samples will be collected at the start and end of the two phases of the study. Nutraceutical supplements will be provided to the participants for 12 weeks. These natural products possess anti-diabetic activities & the suggested course of supplements will maintain a constant level of dosage of these nutraceutical supplements to improve the overall metabolic functions in T2D cohort. Biomarkers of metabolic response included in this study include measuring 8-hydroxy deoxyguanosine (8-OHdG) (oxidative DNA damage), total lipid peroxidation (lipid peroxidation) & resistin (adipocytokine response).

  • Study of the impact of insulin pump therapy, augmented with continuous glucose monitoring, on outcomes for mother and baby, in pregnant women with Type 1 diabetes when compared to conventional treatment with insulin pump therapy alone or multiple daily insulin injections.

    This study aims to determine the benefit of using sensor augmented insulin pump (with a predictive suspend before low feature) therapy to determine if tighter control of diabetes with less hypoglycaemia can be achieved and have an impact on maternal and foetal outcomes when compared to non sensor augmented pump therapy and multiple daily injections in pregnant women with type 1 diabetes. Outcomes will be benchmarked against historical outcomes in women with Type 1 diabetes in pregnancy who have delivered in the hospital and health service prior to the study. It will assess if women using this therapy are more satisfied with their treatment, whether it has an impact on other maternal and foetal outcomes and economic implications for the use of this technology. The study will generate data about glycaemia and insulin requirements after diagnosis of pre eclampsia, during labour and early breastfeeding.

  • Better Evidence for Selecting Transplant Fluids (BEST-Fluids)

    Delayed or slow graft function (DGF), i.e. the requirement for dialysis, or poor kidney transplant graft function early after transplantation, affects 20-50% of deceased donor kidney transplants, and increases the risk of graft failure and mortality. DGF reflects acute kidney injury caused by ischaemia-reperfusion injury during transplantation, and is driven by donor, recipient and transplant factors. Intravenous fluids are a critical, albeit inexpensive, aspect of care that impacts early transplant function. Currently, isotonic sodium chloride (‘normal’ or 0.9% saline) is standard of care at the majority of transplant centres. However, 0.9% saline may be harmful due to its high chloride content relative to plasma, which causes metabolic acidosis and may promote acute kidney injury, and thus DGF. Studies of low-chloride balanced solutions versus normal saline in transplantation have shown reduced acidosis, but have been too small to show differences in transplant outcomes. The BEST-Fluids study (Better Evidence for Selecting Transplant Fluids) is a clinical trial investigating the difference between two standard practice fluids (Plasmalyte and normal saline) used before, during and after surgery in improving the lives of people who have a kidney transplant. The primary outcome investigates the requirement of dialysis in participants with delayed graft function (proportion of participants who require dialysis within first seven days) . Secondary outcomes include graft function, survival, and cost-effectiveness. This trial will show if Plasmalyte is better to normal saline in kidney transplantation, may result in cost savings and will rapidly translate into clinical practice.

Tags:
  • Finding clinical trials