ANZCTR search results

This study will investigate the mood, cognitive and performance impairments in obstructive sleep apnoea patients and shift workers compared to a control group. A series of questionnaires and tasks that measure driving ability, attention, reaction time, and higher thinking functions will be undertaken. The study hopes to determine whether different patterns of neuropsychological function and sleepiness predict simulated driving performance and accident risk.

The primary purpose of this study is to investigate how effective 10% Formalin is as a topical treatment for eradicating plantar warts. Our hypothesis is that 10% formalin will be more effective in curing plantar warts then the control over a maximum of 6 months.

Background: The main hypothesis of this study is that oral heme iron polypeptide (HIP; Proferrin ES [registered trademark]) administration will more effectively augment iron stores in erythropoietic stimulatory agent (ESA)-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation (Ferrogradumet [registered trademark]). Methods: Inclusion criteria are peritoneal dialysis patients treated with darbepoietin alpha (DPO; Aranesp, Amgen) for at least 1 month. Patients will be randomized 1:1 to receive either slow-release ferrous sulphate (1 tablet twice daily; control) or HIP (1 tablet twice daily) for a period of 6 months. The study will follow an open-label design but outcome assessors will be blinded to study treatment. During the 6-month study period, haemoglobin levels will be measured monthly and iron studies (including transferring saturation [TSAT] measurements) will be performed bi-monthly. The primary outcome measure will be the difference in TSAT levels between the 2 groups at the end of the 6 month study period, adjusted for baseline values using analysis of covariance (ANCOVA). Secondary outcome measures will include serum ferritin concentration, haemoglobin level, DPO dosage, Key’s index (DPO dosage divided by haemoglobin concentration), and occurrence of adverse events (especially gastrointestinal adverse events). Discussion: This investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their peritoneal dialysis patients determine whether HIP administration more effectively augments iron stores in ESP-treated PD patients than conventional oral iron supplementation.

A pilot study to investigate the short term outcomes of infants undergoing CPAP or High Flow treatment from 30 weeks corrected gestation.

The main focus of this study is to look at the effect of prematurity on kidney growth and function . Kidney size and function in a cohort premature babies (< 32 weeks) is compared with control group (term babies).The study also looks at the rate of kidney growth when a baby is born premature .It will also determine if retinal vasculature ( arterial/venous diameter and branching angles) has correlation to kidney size , kidney function , baby's sex and ethnicity. Most literature says that the foetal retinal matures by 36 to 37 weeks gestation . Baby with significant Retiopathy of prematurity (ROP) will be excluded from analysis .

Previous studies from our laboratories, have reported variation in taste sensitivity to fatty acids (fats) in humans, and that these variations may be asociated with fat intake and the perception of fat in food, that is, the ability to detect fats in food. Based on this evidence, we were interested in looking at environmental influences (i.e., the intake of a high- or low-fat diet, and how it may influence taste sensitivity to fats, given that habituation of the taste system in response to exposure or deprivation of certain nutrients (sodium, monosodium glutamate), has been previously established. Determinants of fatty acid taste sensitivity are of particular interest, given that sensitivity appears to be associated with specific dietary behaviours (i.e., fat intake) which may be associated with obesity. We hypothesized that the taste system would habituate to environmental conditions, and that consumption of a high- or low fat diet would shift sensitivity, i.e., consumption of a high fat diet would decrease taste sensitivity to fatty acids, meaning that greater concentrations would be required for detection, and conversely, a low-fat diet would increase taste sensitivity

The OSLER-2 is a common test which objectively measures daytime sleepiness. A limitation of the OSLER-2 test, however, is that it can only be performed by people who do not have hand or arm disabilities as it involves feedback to the presentation of a light via a hand-held response box. Our group has modified an OSLER-2 to accept responses from switches that do not require hand function, switches which are commonly used within the quadriplegia population. This research aims to examine the relationships between the modified switch OSLER-2 against the standard hand-held switch OSLER-2 as a measure of daytime sleepiness in able-bodied, sleep restricted people.

BACKGROUND AND SCIENTIFIC BASIS Coronary artery disease is an important cause of morbidity and mortality worldwide. Although much is known about the mechanism of myocardial infarction and its associated risk factors, many patients develop myocardial infarction in the absence of known risk factors. Two possible explanations for this are impaired angiogenesis (new blood vessel formation) and impaired endothelial (blood vessel lining) reparative processes in this group of patients. Endothelial progenitor cells (EPC) are thought to be involved in these two processes by: 1) incorporating into new vessels, or 2) coordinating the reparative process. Fenofibrate is a lipid-lowering agent, used in the setting of hypercholesterolemia, particularly among patients with coronary artery disease and diabetes. It has well documented beneficial effects by reducing myocardial infarction. In practice, it is commonly used when patients are intolerant of statins (another cholesterol lowering agent), or in combination with statins. Interest in fenofibrate has increased with recent observations of reduced diabetic microvascular complications. Little is known about EPCs and their function. It has been recently shown that EPCs derived from bone marrow circulate in the peripheral blood and can facilitate the formation of new blood vessels in tissues that are not getting enough blood supply, thereby helping to increase the blood supply to the affected tissue (Asahara T et al Science. 1997;275:964, Urbich C. Circ Res. 2004;95:343). Moreover, patients with coronary artery disease who have high blood levels of EPCs have a better prognosis than those with low EPC levels, possibly due to the beneficial reparative effects of these cells (Werner N. N Engl J Med 2005;353:999). It is unknown if the clinical outcomes of fenofibrate are partly related to EPC levels and function. Statins have been shown to have a positive effect on EPC number and function when used alone. Their effects in combination with fenofibrate have not been evaluated. HYPOTHESIS The central hypotheses of this project are that: 1) EPC levels are increased by fenofibrate 2) EPC levels are higher in those with vascular disease, 3) Fenofibrate augments EPC differentiation and function and 4) Effects of fenofibrate on EPC s occur with and without combination statin therapy. AIMS 1.To determine the number of EPC s after fenofibrate treatment. 2.To investigate if fenofibrate augments EPC function and number. 3.To see the additional benefit of statins on EPC number and function. POTENTIAL SIGNIFICANCE This study will be one of the preliminary studies in man, to identify if fenofibrate has a positive effect on EPCs, and provide an understanding of the clinical effects observed. This will have implications in understanding the role of EPCs in the pathogenesis of vascular diseases, as well as in the development of novel treatment strategies for reducing the impact of vascular disease and myocardial infarction.

This is a pilot study of the safety and effectives of the LIFT procedure as a treatment for fistula-in-ano. This study will collect data on patients who have undergone the LIFT procedure looking specifically at the cure rate of the procedure, post-operative sphincter function and complications. The LIFT procedure is a relatively new procedure and it has been reported to be successful at curing fistula in 82-94% of patients with minimal risk of incontinence and thus presents a very attractive alternative in the treatment of fistula-in-ano. However, prior to adaptation into mainstream practice at the Royal Prince Alfred Hospital, it was felt that a pilot study to assess the feasibility and safety of LIFT was necessary.

Recently five overseas studies have found an association between deep anaesthesia and subsequent mortality within one year. There is a need for a large prospective randomised trial of "deep" versus "light" anaesthesia to determine if the relationship is a causal one. This would require the study of about 6000 patients. In this pilot study, 100 patients will be randomised to either "light" or "deep" anaesthesia using the Bispectral Index depth monitor. In all other respects the anaesthesia will be unaltered in choice of anaesthetic drugs or techniques used. We will then follow up all patients for one year to ascertain the incidence of complications of anaesthesia and surgery, cancer recurrence if relevant and survival. The study has the support of the Clinical Trials group of the Australian and New Zealand College of Anaesthetists. If successful, the pilot study will be used as the basis for a large project grant to the Health Research Council in New Zealand (NZ), hopefully combined with an application to the National Health and Medical Research Council in Australia.