ANZCTR search results

Otitis media (OME/AOM) is a major problem amongst Indigenous children living in remote Australian communities. Medical treatment often fails and ENT surgeons are called upon to provide surgical care. This multi-centre randomised trial compares the outcomes of two current treatments (Myringotomy/ adenoidectomy V grommet tubes/ adenoidectomy). There are 11 sites proposed across WA, NT & N Qld. 280 Indigenous children aged 3-10 years will be randomized into 2 groups; (1) adenoidectomy with ventilation tubes (VTA) (2) adenoidectomy with myringotomy only (MA) The children will be followed up with monthly phone calls for 12 months following surgery by which time the OM will likely have recurred if were to do so. At the end of 12 months study staff will visit the children in their community for hearing assessments and nasal swabs. The outcome measures will be a reduction in the prevalence of OME/AOM, hearing impairment, aural discharge / perforation, and the also effect of treatment on nasal colonisation with pathogenic bacteria.

Although intramuscular (IM) injections of androgen's are known to be effective, they result in varying degrees of pain at the injection site that may last for a day or two. These injections need to be given into a precise location of the buttocks and require staff with expert training. Unlike many other injections these cannot be self-injected due to the difficulty of safely injecting into the buttocks. A SC injection, if effective, may be given by yourself in your own home, which would be more convenient to avoid extra medical visits as well as saving GP and hospital resources. Many men who require androgen replacement therapy may have bleeding disorders or are on medications that may intentionally slow the ability of their blood to clot. These men have a theoretical risk of bleeding and a very large bruise deep in an important muscle may later become infected and cause significant disability. As a result men using these anti-clotting drugs are usually prescribed other forms of androgen replacement therapy that are not always optimal. A subcutaneous (SC) injection, if effective, may be used in these men. This is a randomised crossover study of testosterone Undecanoate given subcutaneously and intramuscularly in patients receiving testosterone replacement therapy. Each participant will receive a single IM injection and a single (SC) injection of TU. An IM injection is standard of care and duration of action is approximately 12 weeks. It is expected a SC injection will have a duration of action of 12 weeks. Thus the study will take 24 weeks for each participant to complete both arms. This is the second stage of a 2 stage research study. This is stage 2 of study ACTRN12613000068763

This study will evaluate whether combination dietary supplementation of selenium and green tea can reduce the risk of developing bowel cancer in healthy humans. Who is it for? You may be eligible to join this study if you are a healthy man or woman aged between 50-75 years, with no active bowel disease. You should have no previous colorectal cancer and no allergy or intolerance to nuts or green tea products. Trial details Participants will be randomly (by chance) divided into three groups. Participants in one group will eat 6 brazil nuts per day (providing 48mcg selenium/day). Participants in the second group will take 4 green tea extract capsules daily. A third group will take both of these in combination. All dietary interventions are continued for 6 weeks. Participants will be required to give blood samples and rectal biopsies before and after treatment (at 6 weeks) in order to assess response to the different dietary interventions. This study will provide valuable information on how a combinational dietary approach may reduce the risk of developing colorectal (bowel) cancer in humans.

We propose a randomised control study to assess the use of prophylactic Non-steroidal Anti-inflammatory Drugs for the prevention of Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis.

Accurate fluid management in the peritransplant period is crucial. In many cases the donor renal allograft will have established acute tubular necrosis due to prolonged cold ischaemic time and will therefore have delayed graft function. A common complication of transplant surgery is over aggressive fluid replacement in a patient who is essentially anuric which may precipitate pulmonary oedema requiring urgent dialysis. On the other hand, inadequate volume replacement in a renal allograft recipient who has immediate graft function can result in hypovolaemia and potentially delayed graft function. The ODM has been used in case series of renal transplantation demonstrating efficacy and safety. This prospective, randomized trial looks at goal directed fluid therapy using the oesophageal doppler monitor versus standard of care fluid therapy in renal transplant patients to determine if there is a reduced length of stay and reduced incidence of delayed graft function.

Background: With the popularity of sports involving contact or collision worldwide, there is an obligation of health care professionals to focus efforts on the better detection, prevention and treatment of the potentially damaging neurological, social, and psychological effects of sports related concussion. Chronic Traumatic Encephalopathy (CTE) is one potential consequence of a career in collision sports but very little knowledge regarding the the onset and progression of the clinical manifestations of CTE is known. The current study seeks to examine this issue amongst current and former professional football players within the National Rugby League (NRL) in Australia. Methods/Design: This is a cross-sectional, prospective study utilising a sample of current (n=30), short-term retired (<10 years, n=30) and long-term retired (10yrs+, n=30) players who will be recruited through their club, or former club to undertake neurological, psychological and cognitive testing, although with ApoE genotyping, balance testing and olfactory stress testing. Initial baseline assessments will be conducted with a subsequent follow-up/review assessment conduted at 18-24 months post-baseline. The primary outcomes (objective cognitive perfromance, neurological examination, psychological questionnaires and neuroimaging data) will be correlated and compared to each player's exposure to concussive injury. Discussion: This study will provide information about the potential cognitive, neurological and psychological consequences of a career in collision sports and may help to identify potential at-risk characteristics for the development of long-term consequences, such as CTE. This study may have far-reaching application in terms of modifing exposure rates through mandatory rest periods or governing body rule modifications.

Infants born very prematurely (under 30 weeks gestation) often require support with their breathing after birth as their lungs are stiff and they find it hard to fill them with air. In order to help infants breathe we use a flow of gas (oxygen and air) to provide pressure to help open their lungs. In this study we are comparing whether it is better to use a gas flow that has been warmed and moistened (humidified), compared to the standard method of using gas directly from the cylinder or wall (unconditioned). Humidifying gases is routine within the setting of the neonatal intensive care but is not extended to use in the delivery room setting. The purpose of this study is to find out whether the use of humidified gases in the delivery room is better in helping premature infants stay warm immediately after birth. The primary outcome will be measurement of rectal temperature on admission to the neonatal and intensive care unit (NISC).

To assist clinical decision making pre-operatively in renal failure patients having fistula formation, using a trans-thoracic echo, in order to improve patient well-being post-operatively

All patients presenting for PICC line insertion will be offered follow-up in this audit of Nurse led PICC insertion at the RMH. Time of insertion, success, complications and patient satisfaction will be measured and this data will be compared to same data subsets acquired from same patient population in 2008, but when the service was physcian led.

Posttraumatic stress reactions have been indetified as a predictor or poorer outcomes for individuals with whiplash injury in longitudinal studies and poorer response to physical therapy in previous research. This study aims to investigate whether or not stress innoculation training added to standard exercise program will decrease pain and disability in people with acute whiplash injury. It is hypothesised that stress iccoculation will decrease physiological arousal and stress reponses in those at risk individuals and thus facilitate the effects of the exercise program.