ANZCTR search results

Despite recent increases in organ donation rates thanks to dedicated efforts from the National Organ and Tissue Authority, Australia continues to have one of the lowest organ donation rates of developed countries. The vast majority of people publicly support organ donation, but many do not make their wishes known by either registering their wishes on the national register (the Australian Organ Donor Register, or AODR) and/or communicating their wishes to their families. Very few studies have examined strategies to increase the likelihood of these behaviours, especially amongst young people. Objective: To compare the effectiveness of two interventions (brief and enhanced video) with a non-intervention control condition designed to increase the proportion of TAFE students registered on the Australian Organ Donor Register (AODR). Design: A 3 arm cluster randomised controlled trial. Method: TAFE classes in the Newcastle area will be randomised to one of three conditions (brief video, enhanced video, control). Students will be invited to complete a baseline and one-month follow-up survey to measure registration status as well as knowledge and attitudes towards organ donation. Classes in the intervention arms will view a video-based intervention: either a) a brief informative video about organ donation or b) an enhanced informative video with an interview with an organ donation recipient and relative. Students in both intervention conditions will also be given the opportunity to complete an organ donor registration form. The intervention will be carried out in class immediately following the completion of the baseline survey. Outcomes: The primary outcome will be AODR registrations. Self-reported family discussions regarding registration will also be examined, as well as changes in knowledge and attitudes. Significance: This study has the potential to increase registrations on the AODR and consequently save lives. If shown to be effective, the interventions could to be widely implemented throughout the TAFE system, and Universities.

This study will evaluate the effect of estradiol on bone architecture and fat mass in men with prostate cancer. Who is it for? You may be eligible to join this study if you are male, and have been diagnosed with prostate cancer for which you are about to commence treatment with GnRH agonists or antagonists to suppress androgen production (Androgen Deprivation Therapy; ADT) Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will apply estradiol gel to the skin once daily for six months. Participants in the other group will apply a placebo gel (contains no active ingredients) to the skin once daily for six months. Recent evidence suggests that in men, some important biological actions attributed to testosterone are mediated via its metabolite, estradiol, rather than directly via the androgen receptor. We propose to use ADT given to men with prostate cancer as a unique model of severe long-term untreated hypogonadism to investigate biological actions of estradiol when testosterone is reduced to castrate levels. On completion of treatment at six months, participants will undergo a high resolution peripheral quantitative computed tomography (HR-pCT) scan to assess bone architecture and a dual-energy X-ray absorptiometry (DEXA) scan to assess fat mass.

A randomised pilot study to assess which of the currently used treatments for 10-20mm renal stones provides the best stone free rate

Although informed consent for surgical procedures is a well-established practice between the surgeon and patient, if often fails to meet its purpose. The procedure to obtain consent must ensure that the patient understands the nature of his or her condition, the risks and benefits of the proposed treatment, its alternatives and agrees to it voluntarily. In a busy surgical setting including outpatient clinics, emergency departments or private rooms, this process is often time limited. The process can be inadequate and inconsistent, resulting in poorer health outcomes for such patients . Furthermore, patients have varying degrees of cultural backgrounds and educational levels that also influence patient comprehension and understanding. It has been demonstrated that patient comprehension highly correlates with patient care and postoperative complication. The aim of this study is to conduct a randomised controlled trial to determine if video based education delivered through a portable video media (PVM) enabled device improves patient knowledge and satisfaction regarding the consent process for cystoscopy compared with conventional standard verbal consent (SVC). Primary Objective To determine if video based education delivered through a portable video media enabled device improves patient knowledge and satisfaction regarding the consent process for cystoscopy compared with conventional verbal consent. Secondary Objectives To improve the patient education and consent process and provide new ways to communicate risks and benefits of procedures At the start of the trial, participants undergoing an emergency cystoscopy will be randomised in a simple 1:1 randomisation scheme to two study groups Group A: portable video media consent group Group B: standard verbal consent group Randomisation will be performed on appropriate randomisation software. The randomised group allocation sequence will be kept sealed in envelopes until each participant is ready to be randomised. In the video group, surgeons obtained informed consent using an education video. Participants will view this video on a portable video device (iPad). A cross-over will then be performed. At the conclusion of both the SVC and PVM patients will be given the opportunity to ask questions. Main outcome measures are differences in knowledge acquisition and degree of patient satisfaction comparing SVC to PVM consent.

This project aims to investigate whether a self-help interactive program delivered via tablet devices can help Indigenous youth to reduce their suicidal ideation. Participants will be randomly assigned to either the intervention group, which includes therapeutic activities grounded in acceptance and commitment therapy or a wait list control group. We predict those using the intervention program for 6 weeks will report reduced suicidal ideation, a reduction of reported suicide plans, and lower symptoms of depression, anxiety, hopelessness and impulsivity.

This study aims to evaluate the safety and tolerability of a new investigational drug called EBC-46 in participants with cancer. Who is it for? Patients may be eligible to join this study if aged 18 years or more and have been diagnosed with cutaneous, subcutaneous, head and neck* or nodal tumour(s). *except for pharyngeal, laryngeal and tongue base tumours and those tumours in the anterior neck (from posterior border of sternocleidomastoid on each side) Study details: All participants in this study will receive a single EBC-46 injection directly into tumours. EBC-46 may lead to breakdown of tumour blood vessels and recruitment and activation of white blood cells. This leads to rapid tumour cell death. This drug has not previously been tested in humans. Participants will be monitored for 3 weeks following EBC-46 injection in order to evaluate safety, tolerability, tumour response and pharmacokinetics (the action of the body on the drug). The results from this study will be analysed to see if it is worthwhile for this new drug to be tested in future studies involving larger numbers of cancer participants.

The primary objective of this study is demonstrating the effectiveness of feedback control on neural stimulation in patients with chronic pain with regard to pain relief and stimulation side effects in an extended trial. A new technique has been developed to measure Evoked Compound Action Potentials (ECAPs) or neural responses to neural stimulation, on the same lead that delivers the stimulation. Three devices have been developed to measure ECAPs and provide feedback control of stimulation current in patients undergoing a trial of SCS for the relief of chronic pain: Multi-Channel System (MCS), Body Worn System (BWS) and an External Trial System (ETS). All the participants may be tested with all these devices. MCS is not a portable system and is used in the operating room or at the clinic. BWS and ETS are similar and used for ambulatory testing, however due to short battery life of the BWS, this device will be used for ambulatory testing at the clinic and ETS is used as a take home device for an extended trial. This research will help advance neurostimulation technology.

The aim of the study is to investigate whether manipulation of the lumbar spine effects measures of deep and superficial pain intensity at local and remote locations, for up to 30 minutes post manipulation. We also aim to investigate whether, if differences exist, these changes follow a segmental or non-segmental pattern, and whether the side to which spinal manipulation (SM) is applied creates asymmetrical changes in pain intensity.

Purpose: To determine the safety of multiple subcutaneous (SC) injections ALD403 compared to placebo in healthy female and male subjects. To determine the pharmacokinetics, pharmacodynamics, and immunogenicity of ALD403 compared to placebo in healthy female and male subjects.

Stroke survivors who are in an Acute Stroke Unit have been found to spend the majority of their day inactive and alone. Growing evidence recommends that stroke survivors should retrain activities of daily living and ambulatory function as early and frequently as possible. One approach found to increase activity levels during inpatient rehabilitation is the use of an enriched environment whereby physical, cognitive and social activity is enhanced by creating a stimulating environment. The effect of an enriched environment in an Acute Stroke Unit has yet not been explored. This prospective non-randomized quasi-experimental block design intervention study is focusing on enhancing exposure to an enriched environment to increase activity in an Acute Stroke Unit. We will re-organize the Acute Stroke Unit and staffing to create an enriched environment that safely stimulates patients to be more active on a physical, cognitive and social level without increasing staffing levels. The study will determine if an enriched environment can increase activity levels in people with a stroke in an Acute Stroke Unit within existing staffing levels. We hypothesize that activity levels will increase and that there will be a corresponding trend towards fewer secondary complications and improved functional outcomes for stroke survivors.