ANZCTR search results

Neurological Impairment (NI) in children is often caused by conditions such as cerebral palsy. Many children with NI are prone to chest infections which can lead to long stays in hospital, additional impairment and even premature death. Despite the suffering caused to children and their families by these infections and the high cost to health services, there is very little information on how best to prevent them. Some doctors prescribe long-term antibiotics but we don't really know whether this treatment makes any difference to the numbers of chest infections children suffer from, or whether these antibiotics can cause long term harm. The trial is looking to recruit for 500 children and young people aged 3-17 years, with NI who are at risk of chest infections, along with their parents / primary care giver to take part. Children included in the trial will be given either azithromycin or a placebo for 12 months to compare the difference. The trial is taking place in the UK and Australia and each participant will be involved for a maximum of 18 months. The aim of the trial is to find out whether 12-month's treatment with the antibiotic azithromycin reduces how often children with NI have to stay in hospital with chest infections.

The purpose of the study is to identify whether or not the nociception level index (NOL) measured during surgery may allow a prediction of the severity of acute postoperative pain. NOL monitoring is non-invasive and only requires a sticky electrode on one finger. This study aims to observe the relationsship between NOL during surgery and acute postoperative pain in during the first 15 minutes after recovery room admission with the null-hypothesis that NOL in this setting does allow a prediction of pain.

The commonly used agents for treatment of migraines in the emergency department (ED) setting are chlorpromazine, prochlorperazine and sumitriptan, with variable success (up to 70% efficacy in several studies). A series of small studies and case reports have shown rapid relief of both chronic and acute migraine headache using Propofol, a lipid soluble short-acting intravenous anaesthetic. This study aims to determine whether the administration of intravenous (IV) Propofol at a procedural sedative dose (up to 1mg/kg) is associated with shorter length of stay compared to the standard therapy (IV Chlorpromazine or Prochlorperazine or Metoclopramide or SC Sumitriptan) for migraine relief, in an ED setting.

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.