ANZCTR search results

Despite the fact that Polymyalgia Rheumatica (PMR) is the most common inflammatory rheumatic disease of the elderly, it is poorly understood. With no diagnostic tests available, diagnosis is dependent upon a history of muscle pain and stiffness in the hip and shoulder regions, combined with raised inflammation levels in the blood. Treatment consists of Prednisolone (commonly referred to as “cortisone”) prescribed in a “one size fits all” approach. However, the way in which PMR patients’ symptoms respond is very variable; some improve almost overnight, whilst other individuals require higher doses for much longer periods of time. Unfortunately, such long-term Prednisolone use can result in many complications including osteoporosis, weight gain, high blood pressure and diabetes. Similarly, uncontrolled PMR is associated with increased risk of heart attacks and stroke. This project aims to identify the characteristics of patients that fail to respond adequately to Prednisolone treatment. It is hypothesized that this information will delineate a distinct subset of “refractory” PMR patients, thereby permitting further study of alternate therapy in this group and minimizing the side effects of Prednisolone use long-term.

This study aims to determine the effects of short-term treatment with endocrine therapy (tamoxifen or letrozole) when given to women with newly diagnosed oestrogen receptor positive (ER+) breast cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above, have been recently diagnosed with oestrogen-receptor positive breast cancer. Eligible candidates must have already provided consent to be part of the Breast Biomarker Project at Royal Melbourne Hospital. Study details All participants in this study will receive endocrine therapy for 5-7 days prior to surgery. Pre- or peri- menopausal women will receive 20mg oral tablet of tamoxifen per day whilst post-menopausal women will receive 2.5mg oral tablet of letrozole per day. Blood and tumour samples taken at the time of diagnosis will be compared to those taken at the time of surgery to determine changes in the tumour cells. The findings from this study will provide valuable information on the changes in breast cancer cells and their "signatures" following short-term exposure to endocrine therapy, and help with development of future breast cancer treatment.

This study will determine the effects of Denosumab on normal breast tissue in women with BRCA1 and BRCA2 mutations. Who is it for? You may be eligible to join this study if you are a pre-menopausal woman aged between 18 years to 50 years and have documented BRCA1 or BRCA2 mutation considering prophylactic mastectomy, OR willing to undergo two breast biopsies on separate occasions. Study details This is a proof-of-concept pilot study to determine if short-term treatment with Denosumab is a feasible chemoprevention option against breast cancer for BRCA1 and BRCA2 mutation carriers. All women participating in the study will receive 3 doses of 120mg per dose of Denosumab subcutaneously (injected into the skin) monthly for three months. Women will then proceed to their surgery as planned, or have their second breast biopsy. Participants will be followed up for up to 3 months after the last treatment dose. The change in the number of doses of Denosumab (from 4 to 3) was implemented in September 2015, after 6 patients had been enrolled.

The current study will trial the effectiveness of the new Stepping Stones Triple P Discussion Group Program. Stepping Stones Triple P has been found to result in a variety of benefits for parents of children with a disability, including improvements in positive parenting skills, parenting confidence, child relationships, reduced parental stress and child problem behaviour. As such, it is anticipated that the Discussion Group program being evaluated in this study will result in similar improvements. Results from the study are likely to improve the accessibility of the program to a wide range of parents that require brief positive parenting assistance.

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.