ANZCTR search results

The purpose of this research is to explore the early safety and feasibility of a device that might eventually be useful in delaying progression of Alzheimer’s Disease.

This is a single-centre, randomised, double blind, single and multiple ascending dose study to assess the safety and pharmacokinetics (PK) of OCX063 in healthy volunteers. Part A: Single Ascending Dose (SAD) cohorts will assess the safety and tolerability of single doses of OCX063. Part B: One SAD cohort will return for an additional dose to determine the effect of food on OCX063 PK. Part C: Multiple Ascending Dose (MAD) cohorts will assess the safety and tolerability of multiple doses of OCX063, when administered daily for 14 days.

Lung transplant recipients at Alfred Hospital are experiencing significant unintentional weight gain within the 12 months after their surgery; resulting in more overweight and obese patients within this cohort. There are no studies investigating the management of weight gain among this population. The aim of this study is to explore whether 4 group education sessions based on healthy eating and physical activity, followed by 4 phone calls and 2 face-to-face consultations with a dietitian over 12 months can assist in preventing unintentional weight gain better than current usual care. Hypothesis: Intensive group nutrition and exercise education combined with individual phone coaching over the 12 months following lung transplant will reduce unintentional weight gain in the healthy weight and overweight population, compared with usual care.

Pelvic girdle pain is a common problem experienced during pregnancy that affects pregnant women significantly. Treatment options are needed for pelvic girdle pain in pregnancy especially when provided under ‘real-life’ circumstances and in terms that matter to the patient. This study aims to investigate the feasibility of conducting a randomised controlled trial on the effectiveness of massage in treating pregnant women with pelvic girdle pain. The expected outcome from this study is information on recruitment, randomisation, and the outcome measures for use in a large-scale study. The industry partner will be able to teach massage using evidence-based research.

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.