ANZCTR search results

The aim of this study is to evaluate the use of an internet guided education program for OCD. It is hypothesized that: 1. The treatment group will experience increased knowledge and understanding of OCD compared with baseline 2. The treatment group will show significant improvement on primary measures of OCD symptoms relative to baseline 3. Level of OCD severity will have no affect treatment response 5. The treatment will be deemed as acceptable by participants

Behaviours linked to better health outcomes for people with diabetes include regular blood glucose monitoring, appropriate insulin dosing, regulation of carbohydrate intake and increased physical activity. However, knowing what to do, and why, is often not enough to set-up and maintain the complex set of personal behaviours needed to improve health outcomes. This study examines the extent to which adding psychological intervention to usual medical care for young adults with type 1 diabetes can improve behavioural self-management of diabetes and associated health outcomes. Type 1 diabetics aged 18-25 years receiving regular outpatient multidisplinary care for their diabetes will be assigned to one of three conditions: (1) usual care alone; (2) behavioural self-management training based on the principles of applied behaviour analysis; and (3) stress-management training. Groups will be compared on behavioural adherence to diabetes self-management regimens, physiological health outcomes including metabolic control, and psychological wellbeing.

The aim of this study is to evaluate the effect of providing health professional students with the opportunity to observe and discuss a modelled role-play that demonstrates how to communicate evidence to patients and faciliate shared decision making. It is hypothesised that the intervention will be effective at improving students' ability to incorporate evidence into their communication and facilitate shared decision making with patients, and improve their confidence and attitude towards doing so.

BACKGROUND: Ectopic pregnancies are conceptuses that implant outside the womb, mainly the fallopian tube. They are life threatening since they can erode through major blood vessels causing fatal bleeding. While very small ectopic pregnancies can be treated medically (single injection of a chemotherapeutic agent ‘methotrexate’). The mainstay of treatment is surgery. We have undertaken 20 months of laboratory work to show placental tissue can be efficiently killed with the combination of two drugs: methotrexate and ‘gefitinib’. Gefitinib is an epidermal growth factor receptor (EGFR) inhibitor, never previously proposed to be used to treat ectopics. The EGFR pathway is used by the placenta an important survival signal. Thus using gefitinib to block EGFR activation can affect the viability of the ectopic pregnancy. Importantly, we have shown in preclinical studies that combining both drugs is supra-additive (i.e. the killing effects of adding both is stronger than the sum of each individual treatment). Importantly, the safety profile of each drug is known. Methotrexate is already used for small ectopic pregnancies where its toxicity profile is known. We plan using this exact same protocol that is used clinically (co-administered with gefitinib). Gefitinib is already used clinically in cancer treatment. After a primary lung cancer is treated, gefitinib tablets are taken once daily for life. It is thus not a traditional chemotherapeutic agent. It is well tolerated, but can cause a skin rash. Thus, we believe that combination treatment with methotrexate and gefitinib could be used to treat ectopic pregnancies. We now propose moving this idea into the clinic, starting phase I clinical trial toxicity studies. METHODS: The aim of this trial will be to determine whether a single injection of methotrexate and seven tablets of gefitinib is safe, and well tolerated. We propose recruiting 12 women presenting with a small stable ectopic pregnancy at Monash Medical Centre, Clayton. Treatment: Each participant will receive a single intramuscular injection of methotrexate (50mg/m2) on day 1, as per standard medical management of ectopic pregnancy. In addition, participants will receive one 250mg tablet of gefitinib daily for increasing amounts of time in subsequent cohorts: the first three women recruited (cohort one), will receive a single dose of 250mg gefitinib on day 1, the next three participants (cohort two), will receive three daily doses of 250mg gefitinib from day 1 to day 3. After review by the Human Research Ethics Committee (HREC) of an interim report on the first six participants and permission to proceed, the final six women recruited (cohort three), will receive seven daily doses of 250mg gefitinib orally from day 1 to day 7. Monitoring of toxicity: We will admit participants for up to seven days where they will be reviewed medically on a daily basis. Medical history and examination will be taken to monitor potential side effects (e.g. rash, diarrhoea, and respiratory symptoms). We will also look for any potential signs that the ectopic pregnancy has ruptured. If there are any such suspicions, we will offer prompt surgery. We will stop the medication if any significant side effects are noted. We will do regular blood tests to monitor potential toxicity to the renal, liver and haematological (blood) systems. Monitoring of treatment success: We will monitor human chorionic gonadotrophin (hCG) levels in the blood. This is a sensitive marker of placental cell mass. Thus, blood levels can tell clinicians whether the ectopic is disappearing (declining hCG levels). An hCG of zero would mean the women has been cured of their ectopic. Thus we will measure hCG regularly until it reaches zero. Expected outcome: Combination methotrexate and gefitinib is safe and well tolerated. We will generate critical toxicity data to justify a phase II trial to determine whether this proposed treatment can cure most ectopic pregnancies.

The purpose of this study is to test the hypothesis that by managing Emergency Department patients with uncomplicated cellulitis in a short stay unit with a continuous 24 hour infusion of 8g of intravenous flucloxacillin as opposed to the current standard treatment of four 2g intravenous blouses administered every six hours for 24 hours, significant nursing time and resources would be saved with there being no decrease in the clinical or microbiological cure rate of the cellulitis.

To compare the effects of a low GI diet versus a wholegrain diet during pregnancy in reducing prevalence of large for gestational age infants in women at high risk for developing gestational diabetes. The study hypothesis is that infants born to high risk pregnant women who received low GI dietary advice will have a lower birth weight z-score and percentage body fat than those whose mothers received advice on a macronutrient-matched wholegrain diet.

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.