ANZCTR search results

A known risk factor for lower wisdom teeth removal is inferior alveolar nerve injury, due to the anatomical position and relationship of these two structures. Patients who are referred for wisdom teeth removal routinely have an orthopantomogram for preoperative assessment of these teeth. Cone beam scan, which is a low dose computed tomography scan providing 3-dimension representation of the site, is becoming increasingly popular for inferior alveolar nerve localization. However, there are no studies to show that additional scanning improves outcomes and decreases risk of post-operative numbness for the patient. Furthermore, there are currently no guidelines regarding clear indications for the use of cone beam scan as an adjunct. This project will look at the incidence of postoperative altered inferior alveolar nerve sensation in patients who have lower wisdom teeth removed – in groups where they have the routine orthopantomogram radiograph only, and those who have, in addition to the orthopantomogram radiograph, a cone beam scan. The project will aim to establish evidence based guidelines for the use of Cone beam scan imaging as an adjunctive tool for third molar surgery. Patients who agree to take part in the project will be randomised into two groups – the control is the group without additional imaging ("orthopantomogram only" group), and the intervention group is the group with the additional cone beam scan ("orthopantomogram and Cone beam scan" group). The imaging will be examined with respect to the relationship between the inferior alveolar nerve and lower wisdom teeth. During routine post-operative visits, patients are routinely monitored to establish the presence of inferior alveolar nerve injury. This data will be collected and analysed.

This study aims to investigate the antioxidant precursor, N-acetyl cysteine (NAC) as a treatment for children with autism. Recent evidence has shown children with autism to have imbalances in their antioxidant defences. The primary antioxidant in the brain, glutathione, has been shown to be decreased in these children. This study aims to increase the amount of available glutathione by administering NAC. The trial will be conducted in a total of 80 children, 40 of which will take the NAC treatment and the remaining 40 will take a matched placebo. The study will run over six months after which there will be a 12 and 18 month post-baseline follow up to determine the children’s symptoms following the trial. Standard rating scales will be used to assess the children at baseline, 1, 3, 6 and subsequently 12 and 18 months. Children will remain on any treatment regime they are currently taking part in. Treatment options are limited at present for children with autism and it is hoped that this trial will be efficacious and provide more options for these children.

Vision impairment is a growing public health problem in an ageing population, is an independent risk factor for falls, and compounds the effects of other risk factors by reducing mobility and physical fitness. This randomised controlled trial will investigate the effect of the Alexander Technique on balance and mobility in adults over 50 with vision impairments. 120 people over 50 years of age with vision impairments will participate in the trial. Participants will be independently mobile, with conversational English and no marked cognitive impairment. The intervention group will receive 12 home based lessons in the Alexander Technique on a weekly basis, and the control group will receive usual care. Outcome measures will be collected by assessors masked to group allocation at baseline, and at 3 and 12 months post randomisation. The primary outcome measure will be physical ability using the Short Physical Performance Battery. Secondary outcome measures will be mobility measured with actigraphy and falls measured with 12 monthly calendars. A smaller sub-study will investigate changes in gait patterns. Mood, quality of life, fall-related self-efficacy and functional vision will be measured with a series of validated questionnaires. If proven effective, the Alexander Technique will provide an additional modality to improve mobility and reduce falls risk in vulnerable adults with vision impairment.

Most preterm babies have the umbilical cord clamped within 10 seconds of birth. Placental transfusion is a simple way of giving the baby extra blood at birth by delaying the clamping of the umbilical cord by 60 seconds or more. There is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of pregnancy may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. However, we not know if babies born before 30 weeks of pregnancy benefit or if placental transfusion increases or decreases death or childhood disability. Despite this uncertainty more doctors are recommending that all very preterm babies are given a placental transfusion at birth. It is important to find out if placental transfusion does more good than harm, before it becomes even more widely used. The Australian Placental Transfusion Study will enrol at least 1600 women who will give birth to babies born less than 30 weeks of gestation. These participants will be randomly assigned to either standard treatment where the umbilical cord is clamped within 10 seconds of birth or a second method where the umbilical cord will be clamped after waiting for 60 seconds or more at birth while the baby is being held below the level of the placenta. The main research question is whether placental transfusion reduces death and disability when the baby is discharged from hospital and into childhood.

The study involves women who have had trouble falling pregnant. The study plans to offer women a course of either acupuncture treatment plus lifestyle modification or lifestyle modification only designed to improve menstrual regularity and improve the likelihood of pregnancy. Women who are trying to have a baby without success will be asked to either undertake acupuncture treatments plus diet and exercise programs for 3 months or to adopt a diet and exercise program only. Both options are designed to increase fertility. Acupuncture will be offered from either Campbelltown or a city clinic and each woman receiving acupuncture is expected to attend weekly for 1 hour.

This clinical trial is investigating the role different bacteria may play in the symptoms and quality of life of people with Coeliac disease. The study is looking to see whether there are differences in the different types of bacteria, yeasts and parasites that colonise the intestine of people with Coeliac disease compared to people without Coelaic disease. In addition this clincial trial will see if a specific blend of beneficial bacteria known as a probiotic can improve the ongoing symptoms and quality of life issues experienced by some people with Coeliac disease.

Lenalidomide has a variety of reported mechanisms in blood malignancy, including activation of immune cells and anti-proliferative effects on tumor cells and modulation of the bone marrow microenvironment. Currently approved doses of lenalidomide use up to 25 mg for 21 days out of 28. A recent pilot study in older AML patients used higher and continuous doses of lenalidomide (50mg lenalidomide for 28 days x 2 cycles followed by 10 mg daily for 12 months). This resulted in a 30% complete response rate. This schedule was well tolerated in an elderly AML population. Therefore, lenalidomide at higher doses has substantial activity in AML and deserves further exploration. To explore the potential clinical value of lenalidomide in prolonging remission in adult AML after chemotherapy, this multicentre Investigator Initiated Australasian study will first investigate the safety and tolerability of increasing doses of lenalidomide (10-50mg per day for 28 days for 2 months) followed by 10mg per day for 10 months.

This project aims to investigate whether a monitoring and self-help program delivered by mobile phone and computers can help people to manage their stress, anxiety or depression. Participants will be randomly assigned to either a full interactive self-help program, which will include access to real-time self-monitoring with prompts and brief online modules grounded in Cognitive Behavioural Therapy; or a cut-down version of the program where participants will receive motivational messages and minimal information about depression, anxiety and stress as a control condition; or to a waitlist control. We predict those using the full myCompass program will report reduced symptoms of depression, anxiety or stress after the 6 week program and at 18 weeks follow-up.

The aim of the study is to examine the effects of daily consumption of saccharides for 12 weeks on the ability to perform cognitive tasks, including memory and on psychological wellbeing (mood) in healthy middle-aged adults. Proposed beneficial effects include: enhanced memory, increased ability to deal with demanding mental activities, improved mood and ability to deal with stress (reduced tension, anxiety and perceived mental fatigue).

Ureteric colic (or Kidney stones) is a significant public health concern within Australia, affecting as many as 5-15% of adults. As a result, a significant number of Australians experience significant pain, hospital and outpatient visits, and the potential for more significant complications such as infection, kidney damage and the need for surgical treatments. Although several methods of medical treatments to improve care of such patients have been studied overseas, some of which appear promising, the practice of “medical expulsive therapy” for ureteric colic is not widely practiced in Australia. One such medication is Tamsulosin, which seems to have an effect on the ureter (tube from kidney to bladder) and helps stones pass. It is already in use for other urological conditions already in Australia, and studies overseas seem to show benefit for patients with Ureteric colic. Within Queensland Health there is substantial variation with regard to access to specialist urologist services. Benefits of medical therapies for ureteric colic may be even greater in geographically isolated areas without full time urology services. This study aims to determine if the addition of the drug Tamsulosin 0.4mg daily, in addition to usual standard care, will improve the rates of spontaneously passing stones less than 10mm in diameter, whether the drug has any effect on pain experienced by the patients, their need for surgery and complications. Patients who present to the participating emergency departments with Ureteric calculi, that fit the inclusion criteria will be randomly allocated to either the study medication (Tamsulosin 0.4mg daily) or placebo. The patients will then be closely monitored for four weeks, to determine if the stones pass spontaneously, or if any complications occur. At four weeks the study will be complete, patients who are yet to have passed the stone, would be referred to Urology for consideration of a procedure.