ANZCTR search results

Catheter based atrial fibrillation (AF) ablation is an effective treatment option for AF patients who are intolerant or who do not respond to medications. Ablation using radiofrequency energy in the back wall (posterior wall) of the left atrium is associated with a risk of causing esophageal thermal injury (ETI). Current strategies to minimise the risk of ETI include reducing the ablation power setting to 25 Watts and using an esophageal temperature probe. Recent studies have shown that the use of high power (50 Watts) but shorter duration (HPSD) ablation results in more effective AF lesion formation with no increase in complication rates, including rates of ETI. This single center randomised trial is designed to compare HPSD ablation to standard lower power longer duration (LPLD) ablation and the effects on ETI rates. Patients with paroxysmal or persistent AF undergoing their first AF ablation procedure at the Alfred Hospital will be recruited and randomised into the 2 treatment arms. A multisensor esophageal temperature probe will be used in all cases. All participants will undergo an endoscopy within 24 hours after their ablation to look for evidence of ETI, with 12 months of follow up after. We expect the study to show that HPSD ablation is non- inferior to LPLD ablation in terms of ETI, with significantly lower procedural times and exposure to radation

Psychological distress after TBI is high and Acceptance and Commitment Therapy (ACT) has been used effectively to treat this distress using the ACT-Adjust program. Access problems to psychologists in Australia in rural and regional areas are limited and this is exacerbated for individuals with a TBI accessing appropriately trained and skilled psychologists. Video consulting is one solution to improve access and though ACT has been delivered by this media, there is currently no evidence base to support the delivery of psychological therapy by video consulting to individuals with a TBI. This study will examine the effectiveness of ACT-Adjust delivered by video consulting to individuals with a TBI, promoting improved access for those living in regional and remote areas of Australia and having a TBI.

The study hypothesis is that exposure to infrasound, compared with the sham exposure, is associated with impaired sleep quality. We will randomly allocate participants to one of two groups. One group will receive speakers that generate wind farm simulated infrasound and the other group will receive speakers that generate no sound (sham). The speakers will be installed in the bedroom, will operate continuously and remain in place for 1 month. In addition, to impairment of sleep quality we will assess whether six months exposure to wind farm simulated infrasound is associated with other health effects such as annoyance, impaired neurobehavioural and neurocognitive performance, impaired vestibular function, increased arterial stiffness, increased blood pressure, mood, anxiety and stress. Secondly, to investigate whether experiencing an excess of symptoms that have been attributed to Wind Turbine Syndrome is related to baseline levels of stress and anxiety.

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.