ANZCTR search results

The purpose of this study is to test the feasibility of a care model involving specialists and GPs for early breast cancer post-treatment follow-up. Who is it for? You may be eligible for this study if you are aged 18 or older, and have recently completed treatment for breast cancer. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will receive standard follow-up (specialist lead) care and information from Cancer Council Australia. The other group will undergo the share-care model. This involves a series of 20 to 60 minute appointments with specialist nurses, GPs and cancer specialists for up to 5 years. As part of the study all participants will answer a series of questionnaires every 3 months for 12 months. It is hoped this research will demonstrate the feasibility and usefulness of the new model of care which could influence future post-treatment cancer care.

There is an unmet need for an effective way to treat poor responding patients to superovulation for IVF. We predict the Elonva Flare Protocol (EFP) may be an innovative way to treat fertility patients who are told their chances of conception are low. We hypothesise that the unique PK/PD profile of Corifollitropin alfa (CFA) will maximise follicle stimulating hormone (FSH) exposure and follicular recruitment in the critical early follicular phase. Additionally, we hypothesise that the unique PK/PD properties of Elonva when combined with a short agonist flare cycle will maximise FSH exposure at the critical time of antral follicle recruitment, leading to a higher oocyte yield and improved pregnancy rate. EFP involves sufficiently fewer injections when compared with antagonists or long down regulated cycles. We predict that this will be attractive to patients, with less injection associated stress.

The purpose of this study is to create a database of colorectal cancer patients. Who is it for? You may be eligible for this study if you are aged 16 or over, have colorectal cancer and are a patient at one of the participating sites. Study details This is an observational study, aiming to collect information and tissue samples on consecutive colorectal cancer (CRC) patients at participating sites over at least 10 years. All participants will be asked to consent to any removed cancer samples being stored in tissue bank. It is hoped this research will provide important information about all patients with colorectal cancer in routine clinical practice (in the real world).

This is a first-in-human, Phase 1 single center, open-label, randomized single ascending dose study of ES-481 to evaluate the PK, safety and tolerability of ES-481 in healthy subjects on a fixed dose.

Atrial fibrillation (AF) is common irregular rapid heart rhythm which happens in about 5% of people. Some patients have symptoms regardless of medication and a procedure is needed to get rid of these symptoms. This procedure uses an electrical current to burn the pathway between the top and the bottom part of the heart. What is not known is the way the heart changes after the procedure and if the benefits are due only to a slower heart rate or more complex processes. One way to measure the heart's response to the procedure is by taking blood to test for cardiac biomarkers (BNP and cTnI). Currently it is unknown how these biomarkers respond immediately after the procedure. Our study will enroll 30 patients who are having this procedure. Blood samples will be taken from the heart and artery during the procedure to measure BNP and cTnI. How the levels of BNP and TnI react during the procedure will help us decide the site in the heart where these are released from and what triggers their release.

There is a high prevalence of malnutrition, sarcopenia (loss of muscle), and frailty (weakness) in older adults, including in rehabilitation. This study aims to assess how these syndromes overlap and how well each diagnostic tool can predict patient outcomes. This information will help to determine which syndromes should be assessed for on admission to rehabilitation so that intervention is directed appropriately, patients are not subjected to unnecessary tests, and the risk of poor outcomes for patients can be reduced. It is hypothesised that all three diagnoses will identify the same patients and that we will be able to find the condition that is the best predictor of poor outcomes.

In this research study, we will be trialling a new potential way of preventing a common form of anxiety experienced by first-time mothers, specifically, postnatal obsessions and compulsions. Participants will be more than 20 and less than 32 weeks’ pregnant with their first child, and will be randomly allocated (like the toss of a coin) to either watch a short (5-10 minute) online video on negative thoughts associated with becoming a parent, or will be waitlisted to receive the video after the study is finished. Participants will be asked to do three online surveys and telephone interviews (including the mental health screening interview) at three different time points: in pregnancy (when you first enter the study), and at 2-3 months and 5-6 months after your baby's expected due date. The postnatal interviews will include questions about your mental health and thoughts and feelings that some parents have after having their baby. We predict that the results of our study will show that receiving antenatal education (i.e. viewing the video) about negative thoughts associated with becoming a parent is linked with lower obsessions and compulsions in the postnatal period.

The research project is to test and validate a new system for monitoring focal or generalised epilepsy. The new monitoring system is called Minder and is comprised of an implanted device that communicates to an external device, mobile phone and secure cloud. These components, known as the Minder system, will record each subject's electroencephalogram (EEG) data, also known as brain waves, and export it to a secure cloud via the mobile phone. The subjects will be required to use this Minder system continuously throughout the study for a period of 6 months with an optional long-term follow-up up to 3 years post-implant, during both wake and sleep. The subjects continuous EEG recordings during the study will be downloaded from the secure cloud and reviewed by trained clinical staff to detect seizures.

To implement and evaluate the effectiveness of nutrition and dietetic intervention in improving clinical and patient-centred outcomes in COPD outpatients at nutritional risk. Hypothesis: Dietary modification and oral nutritional support (ONS) is clinically more effective than dietary modification alone in the management of malnutrition in COPD. Study Design: Parallel randomised control trial. Intervention: The intervention involved 4 individual appointments with a dietitian ranging from 30-60minutes in length at initial, 6 and 12 weeks with a follow up at 26 weeks. Over the intervention phase the participants were given individualised dietary advice to improve energy and protein intake using either food modification and fortification (control group) or oral nutritional supplements (intervention group). Outcome measures • Dietary intake will be collected using 24 hour food recall to assess changes in energy and protein intake. • The St George’s Respiratory Questionnaire will provide an assessment of respiratory health status and quality of life. • Body Mass Index (BMI) for assessment of malnutrition status

Despite sleep problems being one of the most common symptoms experienced following concussion in children and adolescents, there is little scientific evidence for its treatment. Therefore, this study aims to determine: 1) the basic characteristics of sleep disturbance in children and adolescents following concussion; 2) the impact of post-concussion clinical insomnia (PCCI) on recovery; and 3) if the addition of melatonin to sleep education can improve patient outcome. Only children and adolescents with sleep disturbance following concussion, aged 8-17 years, will be eligible to participate in the study. Eligible participants will be randomly allocated to either Treatment Group 1 (i.e. sleep hygiene education) or Treatment Group 2 (i.e. sleep hygiene education plus melatonin) for a duration of 4 weeks, and will be monitored throughout this period until they have recovered. The findings from this study will facilitate a better understanding of the nature of sleep problems in children and adolescents following concussion, and will also provide scientific evidence of whether current interventions are effective in their treatment.