ANZCTR search results

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.

Improved participation in screening for bowel cancer is desirable. Currently population scale bowel cancer screening program delivery is by mailed offer, without prior warning, from a central screening service and invitations include a occult blood kit. Invitees may reject this process as they are unprepared to receive such an offer. One approach is to improve communication between screening providers and invitees through improved population scale interpersonal contact. We have developed a preliminary letter to precede an postal invitation to bowel cancer screening. The letter simply informs invitees that they will soon receive a screening invitation and provides them with some basic information about bowel cancer screening. We will randomly select invitees from the electoral roll and compare population screening participation between groups with or without the preliminary letter to determine which program results in the greater participation rate. Improved participation in screening will ultimately reduce deaths from bowel cancer

The response to two different gait training protocols will be compared

To evaluate the efficacy and the safety of I-131 rituximab in relapsed large B cell lymphoma administered as induction treatment and followed by standard non-radioactive rituximab as consolidation and maintenance treatment for one year in 40 patients in a single centre phase II open-label non-randomised study.

The study is a multi centre double blind, randomised, placebo controlled parallel design. There will be three arms - placebo, sea cucumber extract and sea cucumber extract plus Boswellia serrata. Three comparisons can be undertaken from this design - 1. sea cucumber extract alone versus placebo 2. the combination of sea cucumber extract with Boswellia serrata extract versus placebo 3. sea cucumber extract alone versus the combination of sea cucumber extract with Boswellia serrata extract.A sample size calculation, setting a and b at 0.05 and 0.8 respectively, was undertaken based on the variability of FEV1 in men (mean 3.5, SD 1.5) and setting d at 15% (0.7L) required 60 subjects in each arm. The study will aim to recruit 72 subjects in each arm. Total 216 subjects. Allowing for up to 15% drop-out should secure a minimum of 60 subjects in each arm.Randomisation and BlindingSubjects will be randomly allocated to one of the two treatments or placebo. Study subjects and investigators will not know the treatment assignment. Use of the double blind design will prevent ascertainment bias. The placebo will be identical in size, shape, colour and weight to the active counterparts. Both preparations will be odourless.Study SitesThe study will be carried out in four centres Lismore, Ballina, Casino and Brisbane. In Lismore the study will be based at the Teaching Clinic of the School of Natural and Complementary Medicine. The study will be based at local council facilities in Ballina and Casino. In Brisbane the study will be conducted at Greenslopes Private Hospital using the University of Queensland Department of Surgery clinic facilities. In NSW Lismore is the largest population centre and it is therefore considered that Lismore is likely to be the largest contributing centre to the study. Lismore will have four clinics per week on Monday, Tuesday, Wednesday and Thursday, Ballina two clinics on Monday and Wednesday, Casino two clinics on Tuesday and Thursday. Clinics will be held between 4pm and 8pm. In Brisbane, clinics will be held on Monday and Thursday between 4pm and 9pm.Safety MonitoringA full blood count, liver function test; and urea, creatinine and electrolytes will be taken at the start of the study, the mid-point of the study (week 8) and at the end of the study. At each follow up visit subjects will be carefully assessed for adverse events ie any new complaint or symptom that emerges during treatment with the study medication or any new complaint or pre-existing symptom that increases in frequency and/or intensity during treatment with the study medication.

Potential subjects attended a screening clinic where they were assessed by the principal investigators. Those included were photographed (full face and left and right profile) and the film and frame numbers recorded in the subjectÿ¢ÿ¿ÿ¿s records. The study nurse, who was blinded throughout the study by the wearing of a rhino clip, then applied the active and placebo treatments to opposite sides of the face and forehead. Fresh gloves were worn during the application of each separate treatment. In subsequent clinics a study nurse washed and dried the subjectÿ¢ÿ¿ÿ¿s face with a mild dermatological soap and recorded subjective opinions of perceived changes in acne. Four photographs were taken of each subjectÿ¢ÿ¿ÿ¿s face representing the upper and lower parts of each of the treated and placebo sides. Active and placebo treatments were applied as described above. Subjects were photographed using a Minolta Dynax 600si camera with a Sigma 105mL macro lens, multi-directional studio flash lighting with soft boxes and Fuji Reala film. This film was used because it has high acutance and extended tunnel range. Colour was standardised against 18% grey card to ensure reproducibility. The camera was fixed to a tripod and the position marked on the floor to maintain consistency in future photography. Subjects were collected and returned to their homes by a University car to maximise compliance.