ANZCTR search results

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

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32850 results sorted by trial registration date.
  • Abdominal Functional Electrical Stimulation To Assist Ventilator Weaning In Critically Ill Patients: a randomised controlled trial

    The primary objective of this study is to investigate whether Abdominal Functional Electrical Stimulation (Abdominal FES) can reduce mechanical ventilation duration in critically ill patients. The secondary objectives of this study are to analyse whether this intervention also affects: (1) the thickness of respiratory muscles, (2) respiratory function, (3) Intensive Care Unit (ICU) length of stay, (4) ICU and hospital representations, (5) re-intubations and (6) mortality.

  • Mouthguard and positional trainer( vibrating collar) in supine sleep apnoea..

    In this study, we propose to study the effects of 2 types of treatment for positional sleep apnoea. Positional sleep apnoea is when you have more sleep apnoea, when you sleep on your back. The first treatment is called MAS or a mouthguard which is like a denture worn during sleep to improve sleep apnoea. the second treatment is called night shift, this is a vibrating collar, which will vibrate when you sleep on your back. We are hoping to try these two treatments in a controlled fashion by adding the collar in different time periods of the trial. Our study hypothesis is that adding the vibrating collar will improve the treatment efficacy. We are hoping to look at the benefits of treatments by looking at the treatment compliance which will be assessed by a chip inserted in the outhguard and by llong at the data obtained by the vibrating collar. We will also look at how your sleepiness scores have improved.

  • PARTICIPATE-CP: Optimising participation in physically active leisure for children with Cerebral Palsy

    In Australia, 35,000 people are living with cerebral palsy (CP). People with CP have poorer health outcomes, are less active and have a 1.2 to 1.6 greater risk of chronic health conditions such as diabetes, hypertension and stroke compared with those without a disability. We have promising data about a new intervention called Participate-CP, which is a therapy that improves children’s participation in physical activity goals that are meaningful to them. In this trial for 100 children with CP, we will compare Participate-CP to Standard Care to see whether or not the intervention delivers additional benefits over Standard Care.

  • A healthy volunteer study to test the safety and tolerability of a single dose of the Dexmedetomidine Transdermal System as well as how your body takes it in and disposes and breaks it down.

    The DMTS has been evaluated in 3 completed clinical studies. This study was designed to evaluate the safety and pharmacokinetics of a 4-day application of DMTS as well as to identify an appropriate oral water/liquid hydration volume to be administered starting 2 hours before DMTS application through 6 to 12 hours after DMTS application.

  • Angiotensin-Converting Enzyme (ACE) inhibitor cessation in the setting of well-functioning Fontan hearts

    This study will look at the impact of angiotensin receptor inhibitors (ACEI) cessation in children and adults with a Fontan circulation and normal heart contraction. Many children born with a single cardiac pumping chamber undergo a Fontan operation. Due to concerns about potential late heart failure, many are prescribed ACEI although they have good heart function, possibly exposing them to unnecessary risk of adverse drug reactions and the burden of lifelong medication. Evidence has shown ACEI are of benefit in a failing 2-ventricle heart, but there is no literature to suggest they are of benefit in the Fontan circulation. This project aims to demonstrate that cessation of ACEI, or closely related angiotensin receptor blockers (ARB), is safe and non-inferior to ACEI/ARB continuation in children and adults with a Fontan circulation with good cardiac systolic function and without other indications for continuation such as moderate or greater valvar regurgitation and/or hypertension. We hypothesise that: 1. Cessation of ACEI or ARB does not result in a significant decline in peak exercise capacity or cardiac function over a 12-month follow-up period. 2. Cessation of ACEI or ARB results in improved quality of life and reduced medical expenses over 12 months. If the hypotheses hold true it will dispel a historical concern that will relieve a large number of Fontan patients and their families of an unnecessary burden, improving quality of life and sense of well-being. It will improve the futures and the lives of people affected by childhood heart disease. Lifelong medication carries with it an important psychological burden because of the effects on one’s sense of well-being and “normalness”. This can be especially burdensome for children and their families. Medications also impose a risk of adverse reactions, and may also be costly, for example an adult on a standard dose of ACEI without a Healthcare Card could expect to pay $265 per year. Although, in this current era, we strive for evidence-based medical practice, there is little evidence to guide us in many areas of congenital heart medicine. Some practices, that have been routine for many years, may actually be useless or even cause harm. The implementation of ACEI as a routine for people with the unique single-ventricle Fontan circulation is practiced in many centres, although there is virtually no evidence to support their use. Future implications of this trial would include reduced morbidity related to unnecessary medication administration, insight into the disease processes that may or may not contribute to late Fontan failure, a better understanding of the consequences of ACEI use including the social and psychological impact, improved quality of life, and streamlined and improved management strategies for people living with a Fontan heart.

  • A study of initial total hip replacement using a cementless hip implant that has been coated with a bio-active material.

    This is a prospective, multi-centre, clinical study using a product that has been registered for use in Australia by the TGA. The primary purpose of the study is to measure micro-movement of a cementless total hip replacement implant within the bone at timepoints up to three years. The micro-movement (if any) will be measured using X-Rays. 222 participants will be recruited and will be followed up for a period of three years. Quality of Life will also be analysed using two questionnaires.

  • Comparing the effectiveness and safety of two treatments (OZURDEX® intravitreal implant versus Avastin®) for diabetic eye disease in adult Indigenous patients living in Western Australia.

    DMO is the most common cause of visual loss in people with diabetes. Regular injections with bevacizumab (Avastin), given as frequently as every month, remain the current standard of care for centre-involving DMO, but this regimen is impractical for many Indigenous patients. Limiting injections to 3-6 monthly with Ozurdex may be as effective as the currently used Avastin injections. The specific aim of the study is therefore to test the following hypothesis: 1. Ozurdex® is a safe and non-inferior treatment to Avastin® when administered during or following cataract surgery in Indigenous patients with/at risk of DMO. 2. Ozurdex ® requires fewer injections when compared with Avastin® in Indigenous patients with/at risk of DMO.

  • Effects of dietary fat structure on fat deposition in healthy Australian adults

    Excessive accumulation of fat in the body, particularly around the internal organs, is associated with increased risk of type 2 diabetes and cardiovascular disease. Hence the prevention and management of body fat accumulation is important and diet plays an important role. Dietary saturated fatty acids are often implicated to cause more fat deposition than unsaturated fatty acids, despite limited scientific evidence to support this notion. Very few studies to date have directly compared different types of fats and the results are inconsistent. Inconsistencies may be explained by differences in the chemical structure of different dietary saturated fat sources. Specifically the way in which fatty acids are distributed within triglyceride (lipid) molecules may affect their absorption and hence their physiological and biochemical responses. In light of this, the main aim of the study is to compare the effects of three vegetable fats (palm olein, cocoa butter and soybean oil), differing in their content of saturated fatty acids but comparable in chemical structure, on changes in fat deposition in the body (specifically liver and fat tissue content) in a healthy population. The primary hypothesis is that consumption of dietary fats high in SFA (palm olein and cocoa butter), but containing the majority of SFA in sn-1, 3 positions with mostly unsaturated fatty acids in the sn-2 position will not result in unfavourable body fat accretion compared to a dietary fat high in unsaturated fatty acids (soybean oil).

  • The intermittent fast diet for adolescents with obesity: a pilot study

    This study will examine the effect of a 12 week eating plan, an intermittent modified fast diet, that involves 3 days each week of a Very Low Energy Diet (VLED, consuming a very limited amount of food) and a healthy diet on the other 4 days, in adolescents with obesity. We think this diet will be more acceptable and therefore more likely to be adhered to by adolescents than a diet requiring them to limit their food every day. We speculate that this will result in body weight and body fat loss, and a reduction in cardiometabolic risk factors. Adolescents with obesity will be invited to participate in the study by their clinician when attending Endocrinology, Dietetics or Weight Management services at The Children’s Hospital at Westmead. The details of the study will be explained to them and they will be given written information. If they agree to be in the study and their parent/carer also gives consent, a 3 hour appointment will be made for them to see the study dietitian, who will explain the diet and will measure their height, weight, waist circumference, blood pressure and percentage body fat. At baseline questionnaires on demographic, medical and family history will be completed by the parent/carer, and adolescents will complete questionnaires on their quality of life and eating behaviours. Adolescents will have vascular structure and function tests and have a fasting blood test to measure their blood sugar, insulin, blood fats and liver function at The Children’s Hospital at Westmead. All of these measurements, tests and questionnaires will be repeated at week 12 and at the final visit during week 26 of the study. Participants will return to the hospital for appointments with the study dietitian at 2, 4, 8 and 12 weeks for their diet to be reviewed. The 12 week appointment will be for 3 hours during which they will have an interview with the study dietitian to determine how acceptable the diet was for them, as well as complete the measurements, tests and questionnaires as at the start of the study. During weeks 1, 3, 6, 9 and 11 of the study, adolescents will receive support from a dietitian via their choice of email, Short Messaging Service (SMS) or telephone call. At the 12 week visit, adolescents will choose one of four diets to follow for weeks 13 to 26: (1) Three VLED days per week plus 4 days of a healthy diet or (2) Two VLED days per week plus 5 days of a healthy diet or (3) One VLED day per week plus 6 days of a healthy diet or (4) Seven days per week of a healthy diet Participants will meet with the study dietitian at 16 and 20 weeks, and receive regular support up to the final visit. At 26 weeks from the start of the study, participants will return to the hospital for a final 3 hour visit during which they will have final measurements, testing and questionnaires completed, as well as an interview with the study dietitian about the acceptability of the diet chosen for the final 14 weeks of the study.

  • Paramedic administered antibiotics for patients with severe sepsis: Does this reduce the time to appropriate antibiotic therapy?

    In patients with severe sepsis, we aim to conduct a Phase 2, prospective, randomised controlled trial of intravenous antibiotics administered by paramedics in the prehospital setting, compared with standard care. Sepsis is a common reason for presentation to an emergency department and has an annual incidence in adults of up to 300 cases per 100,000 persons per year. It is known that patients in the community with severe sepsis are more likely to arrive at hospital by ambulance than by other means. Importantly, existing evidence from observational studies suggests that increased time to administration of antibiotics in these patients has a significant impact on mortality. However there is currently a considerable period of time between arrival of the patient with sepsis at the emergency department and administration of antibiotics. As such, this study aims to test the hypothesis that, in patients with severe sepsis when evaluated by paramedics, prehospital administration of antibiotics will result in a significant reduction in the time to appropriate antibiotic treatment when compared with standard care.

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