ANZCTR search results

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

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31212 results sorted by trial registration date.
  • 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.

  • Effectiveness of Interpersonal Metacognitive Therapy in group (MIT-G) for Personality Disorders

    The present study aims to measure the effectiveness of a group, manual-based therapy (Metacognitive Interpersonal Therapy in group, MIT-G) at improving interpersonal functioning and psychological symptoms in patients with personality disorders (PDs). It is also intended to examine whether this approach yields gains in one core mechanism of change, which is metacognition and if these gains in metacognitive abilities are correlated with improvements in interpersonal functioning and psychological symptoms. Methods/Design: MIT-G will be evaluated in an international and multicentre randomized controlled trial. Several therapists in mental health institutions of Spain, Norway, Australia, Italy and United Kingdom will participate in this trial. Patients will be randomly assigned to either MIT-G plus treatment as usual (TAU) or a waiting list control group plus TAU. Discussion: If MIT-G proven effective, it can be a useful addition to the care for PDs patients. The design brings along some methodological difficulties, these issues are addressed in the discussion of this paper.

  • A BLINDED, CONTROLLED STUDY OF THE VALUE OF OBJECTIVE MEASUREMENT IN TREATING PARKINSON’S DISEASE.

    The research project is testing a new way of managing Parkinson’s Disease. The new way of managing this involves the use of the Parkinson’s Kinetigraph (PKG) system, which includes a small, smart-watch like device that measures movements, worn on the wrist for 7 days. In diseases such as diabetes or heart disease, “targets” exist (e.g. blood sugar levels, cholesterol levels) in order to obtain optimal health. We believe that by “measuring” Parkinson’s Disease using the PKG, we can develop targets around the movement problems in PD. These targets help us define whether a person with PD has controlled or uncontrolled movements. Previous research studies demonstrate that the PKG can identify uncontrolled symptoms and lead to changes which improve quality of life. The aim of this project is to demonstrate that by utilising these targets, we can identify people with uncontrolled PD and treat them accordingly. If we can improve movement difficulties, we can hopefully improve quality of life.

  • Short term evaluation of caffeine based eye-drops in healthy volunteers.

    The clinical trial aims to learn about the short-term effect on the eye surface of a caffeine-based eye-drop in a number of concentrations. Caffeine eye-drops have been used in humans to study their effect on reducing the development of eye-conditions such as cataract and glaucoma. Caffeine may also be useful in potentially slowing the increase in short-sightedness as it has been shown to slow the increase in short-sightedness in a primate model of myopia. Participants will be randomly assigned an eye-drop and will instil one drop in each eye two times per day, Once in the morning and once before bed for a minimum of 5 days (maximum 7 days). Four types of eye drops will be trialled over the course of the study with two days in-between eye-drops where there will be no use of eye-drops.

  • A Single-Center, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045 Administered Orally to Normal, Healthy Volunteers

    The purpose of this study is to establish the safety and tolerability of orally administered FP-045 in healthy subjects following multiple-dose escalation. This Phase 1 study will support dose selection for future studies in patients with Peripheral arterial disease.

  • ‘Re-engaging the disengaged’ in childhood cancer survivorship: A pilot study of a nurse-led, oncologist-supported, preventative program

    The purpose of this research is to assess the acceptability and feasibility of a nurse-led distance-delivered intervention for childhood cancer survivors who have become disengaged with their cancer follow-up. Who is it for? You may be eligible for this study if you are a childhood cancer survivor over the age of 16 or are parents of a childhood cancer survivor currently under the age of 18. Study details: Each participant will be provided with two nurse-led consultations aiming to facilitate access to care for survivors of childhood cancer who have not been followed up in the last 2 years. These consultations will be offered to the participant via WebEx – similar to Skype - or on the phone (as chosen by the participant). After the first consultation with the nurse, the participant’s medical case will be reviewed by a multi-disciplinary team to determine the appropriate route of care. All participants will be invited to complete a questionnaire prior to the intervention and questionnaires at two intervals subsequent to the delivery of the intervention: 1 and 6 months. This study will help to determine the acceptability of the consultations to participants, and we hope will also offer survivors whom currently have no access to healthcare, a new and low-burden way to improve their health.

  • A study of the connectivity measures of a resting-state brain network in patients with Epilepsy.

    Despite adequate treatment with two or more antiepileptic drugs, about one third of patients diagnosed as having epilepsy are not seizure-free. It is imperative to promptly diagnose and manage these patients, as recurrent seizures are correlated with important clinical, cognitive and socioeconomic consequences. The current project aims to recruit patients with temporal lobe epilepsy and idiopathic generalised epilepsy, and to study the connectivity measures of a resting-state brain network called the Default Mode Network (DMN) in these patients via functional Magnetic Resonance Imaging (fMRI). In addition, the concentration of various metabolites in one the key nodes of this network will be measured via Magnetic Resonance Spectroscopy (MRS). The results of these scans will be compared to data already collected from healthy controls to create a predictive model that will facilitate the diagnosis of patients with different types of epilepsy, and to distinguish between drug-resistant and drug-responsive cases, via a brief MRI scan.

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