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Mean (± SEM) weight loss adjusted for baseline values was significantly greater in the meal replacement group (n=20) than the control group (n=21) at three months (4.7± 0.8 vs 1.3 ± 0.8 kg, P=0.007) and at six months (5.0± 5.2 vs 1.5± 5.2 kg, P=0.04) (Figure 1). The reduction in waist circumference was 1.4 cm greater in the meal replacement group than the control group at six months, but this difference was not significant. BMI reduced by 1.8kg/m2 in the meal replacement group and by 0.6kg/m2 in the control group (P=0.05).

To investigate whether risperidone either alone or in combination with an intensive psychological treatment can delay or prevent the onset of an acute psychotic episode in young people thought to be at heightened risk of illness. The secondary aim was to investigate whether the interventions were effective in reducing general pscyhopathology in the participants whilst improving functioning.

In this study we wish to find out how much of the pain relieving drug tramadol, given to women after caesarean section, passes into breast milk. The information will be used to inform lactating women about the risk versus benefit of taking tramadol during early breast feeding. Tramadol has been used overseas for many years but only became available in Australia in 1998. It is now widely used in the treatment of many types of pain and is particularly useful after surgery. There is very little information about the transfer of tramadol and its break-down products into breast milk. One study looking at a single dose of tramadol suggests single doses are unlikely to be a problem, but there is not enough information to be certain about the safety of tramadol for new-born babies when mothers who are breast feeding are taking repeated doses. If the infant was affected in any way this would probabvly be seen as sleepiness, floppiness and poor feeding. We aim to obtain iformation about how much tramadol passes to the breast feeding infant and be able to advise about the likelihood of significant adverse effects. 75 women taking oral tramadol regularly (100 mg every 6 hours)for postoperative pain control will be recruited after removal of their patient controlled epidural analgesia device, usually on day 3 post caesarean section. Breast milk samples will be taken just before the fourth dose and in between the 4th and 5th doses along with a single blood sample. The milk and blood sample will be sent to the laboratory to measure the amount of tramadol and its break-down product. The baby will also be assessed afte the 4th dose for tone and alertness.

Each study sites will apply for their own ethics approval from their local ethics committee. All study sites have been granted approval.

We will conduct an open-label extension of a prospective, single centre, double-masked, placebo-controlled clinical trial of IVTA for diabetic macular oedema that persists or recurs after laser treatment. Sixty four of the originally enrolled 69 (93%) eyes are available to be followed. The primary outcome measures will be an increase of =5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. The incidence of moderate or severe adverse events over the 3 years of the open-label extension will also be a primary outcome. Secondary outcomes will include change in macular thickness by OCT, any change in visual acuity and number of laser treatments required. Standardised protocols have been developed for intravitreal injection, macular laser treatment, refraction and measurement of visual acuity. Treatment with triamcinolone will be offered to all patients, whether they previously received placebo or active treatment, on exit from the TDMO study. IVTA will be administered in the clinic under local anaesthesia. Treatments will be given at least 6 months apart according to prospectively identified criteria that take into account the previous and current visual acuity and macular thickness measured by OCT. The safety data will be monitored 6 monthly by an independent Safety Monitoring Committee.

This study aims to quantify the prevalence of fractures and of vitamin D deficiency in people with intellectual disability, and to measure the effectiveness of vitamin D replacement.

The aim of this study is to determine whether infiltration and then continuous infusion of the wound with local anaesthetic reduces pain after caesarean section. Secondary outcomes include the effect on the need for opioid pain killers (e.g. morphine) and recovery after caesarean section. Currently the common methods used for post-caesarean pain relief include opioid pain killers (intravenous and oral), non-steroidal anti-inflammatory drugs, paracetamol and epidural analgesia. Opioids have unwanted side effects such as drowsiness, nausea and vomiting, itchiness and constipation, and pass to the newborn in breast milk. Epidural analgesia requires an indwelling epidural catheter and has infection risks, as well as being labour intensive. Numerous studies have looked at the effectiveness of local anaesthetics administered by infiltration and/or infusion as a means of postoperative analgesia after abdominal surgery. Several demonstrated a clear benefit to this approach, while others found no advantage. Two studies of wound infusion following caesarean delivery showed a reduced need for opioid painkillers but the new local anaesthetic levobupivicaine has not yet been studied for wound infusion. Recently, two wound infusion catheters have been developed to aid local anaesthetic infusion to surgical wounds. Information on absorption of local anaesthetics into the blood after wound infiltration is limited. Bupivicaine is the most widely used local anaesthetic. A study determined venous bupivicaine levels follwing total abdominal field block but this regimen did not inlcude continuous infusion. The effects of repeated ropivacaine instillation into the wound has been assessed and unbound ropivacaine concentrations were below the toxic range, however accumulation was noted. An alternative to bupivucaine and ropivicaine is levobupivicaine which has a better side effect profile than bupivicaine. There is no information about its absortion after wound instillation. A second aim of this study would be to determine venous levobupivicaine concentraions resulting from wound infiltration and a 24 hour postoperative period of irrigation by infusing through a wound catheter.