ANZCTR search results

The study proposes to investigate whether a drug with specific effects which damp excessive nerve mediated activity can prevent the long term occurence of pain after chest surgery.

This study aims to evaluate whether treatment with Temozolomide, Irinotecan, and O6BG (O6-Benzylguanine) is tolerable, feasible, and effective for children with recurrent or resistant neuroblastoma (within the confines of a Phase 1 study). Who is it for? You or your child may be eligible to join this study if you/they are aged between 1-16 years and have had a diagnosis of neuroblastoma and it has recurred or is resistant to treatment. Patients need to have exhausted standard curative options of therapy, and must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Study details All participants in this study will undergo chemotherapy treatment with the drugs Temozolomide and Irinotecan, in conjunction with a new investigative agent known as O6BG (O6-Benzylguanine), followed by Peg-GCSF treatment. This is a dose escalation study design, which means that earlier patients will start on lower doses and this will determine the dose that later patients receive. The O6BG (120 mg/m2/day) is given first by intravenous infusion over one hour, followed by oral temozolomide (dependent on dose escalation stage of the study - 40/55/75 or 100 mg/m2/day) and after half an hour, the irinotecan (50 mg/m2/day) is given intravenously for one hour. This treatment is repeated for four more days (i.e. over a total of 5 days). On day 6, the patient is given Peg-GCSF (100 mcg/Kg). Each treatment cycle lasts a minimum of 21 days. Treatment will continue every 21 days until the doctor believes there is no more benefit for the patient. Participants will be regularly monitored to evaluate toxicity (weekly), feasibility of treatment and disease response (every 2 months) until the end of treatment and then every 3 months after treatment until the one year anniversary of the patient starting treatment; at which point patients will be monitored annually therafter up to 5 years.

The Australian Grace Risk Intervention Study (AGRIS) aims to enhance evidence based decision making and outcome delivery of Australian Acute Coronary Syndrome (ACS) patient care. Hospitals will be randomised to either implementation of objective risk stratification using the validated GRACE Risk score based decision support tool or to standard care. It is envisaged that the GRACE Risk tool together with recommendations for evidenced based care will improve the use of evidence based investigations and therapies and therefore enhance secondary prevention in hospital.

We will examine the effect of innovative programs for changing the way parents and teachers view manageable risk-taking for children with disabilities and increasing the level of responsibility that children take for their own actions. The program will have two arms: (1) risk reframing workshops to help parents and teachers distinguish manageable from unhealthy risk and recognise the benefits of manageable risktaking (e.g., becoming more responsible, vigilant) and (2) introducing materials with no obvious play value to the school playground to provide opportunities for adults and children to practice promoting and engaging in manageable risk-taking in the context of social, creative and active play.

The goal of this randomised controlled trial is to examine the effects of iron deficiency and compare its correction with either IV ferric carboxymaltose or iron sucrose on intact fibroblast growth factor 23 (FGF23)concentrations in individuals with end stage kidney disease undergoing chronic haemodialysis therapy.

This study aims to evaluate the influence of whole body 18F-FDG PET/CT and brain MRI on management of stage III melanoma patients with satellite or in-transit metastases as a first recurrence or at time of diagnosis. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have satellite or in-transit cutaneous melanoma metastases as a first recurrence or at time of diagnosis, in absence of clinical evidence of nodal and/or distant metastasis. Study details All participants in this study will undergo staging total body 18F-Fluorodeoxyglucose Positron Emission Tomography and Magnetic Resonance Imaging of the brain at time of diagnosis of any first in transit or satellite metastasis to routinely screen for any distant metastasis. A positron emission tomography (PET) scan is a non-invasive procedure that uses a small and safe amount of a radioactive substance to detect disease in your body. A computed tomography (CT or CAT) scan is also a non-invasive procedure and uses x-rays. Combined in a PET/CT scan this creates three-dimensional pictures of your body. A small amount of a radioactive material needs to be injected into a vein in your arm. The total duration of the procedure is usually 2 hours, the imaging itself usually 30-60 minutes. MRI (Magnetic Resonance Imaging) is a non-invasive procedure that uses a magnet and radiofrequency energy to produce detailed images of your body. An injection of contrast agent into a vein in the arm is required. The MRI examination usually lasts 30-45 minutes. MRI is not suitable for some participants with pacemakers or other metal implants. If the first scans do not show any suspective lesions and, after six months, there are no visible signs of distant spread of melanoma, both scans will be repeated once. We will determine the percentage of patients with change of disease management arising from these additional scans. Participants will be followed up at 6 months to determine the diagnostic accuracy of the scans and whether their disease stage has changed.

The aim of this pilot research is a simple test of probiotics to improve dysbiosis as a hypothesised casual factor in resistant depression and orotic acid as a treatment in conjunction wit SSRI medication. The signal group design is to establish signals for these approaches to provide preliminary efficacy data.

The change of dressing in burns patients is a painful procedure; however, the pain is only short-lasting. Therefore pain relief requires a fast, but short acting method. Options widely used are inhalation of Entonox (a pain relieving gas mixture), short acting morphine-like tablets or administration of morphine-like drugs by patient-controlled analgesia pumps. In Royal Perth Hospital ketamine, a short-acting pain killer has been used successfully via patient controlled analgesia pumps for many years and, since the Bali disaster, by use of administration under the tongue (as liquid or lozenge made by hospital pharmacy). A new preparation of ketamine as a wafer, to be administered under the tongue, has been shown to have a rapid onset of effect with minimal adverse effects in volunteers. This could be a promising way to provide pain relief for dressing changes without the need for an intravenous line and with minimal adverse effects. The new medication will be tried in in-patients of the burns unit requiring painful dressing changes. The medication will be compared to placebo wafers, but patients can at any time ask for rescue analgesia, which will include the methods mentioned above. It is expected that ketamine wafers provide better analgesia than placebo with less need for rescue analgesia than placebo. The results of this trial will permit further development of this promising new form of pain relief.

Methodology Randomised, Double-Blind, Placebo-Controlled, Multi-Centre trial of aggregated N-of-1 Trials compared to parallel group RCT on the Effects of melatonin on SOL in children and adolescents with ADHD who are receiving stimulant medication. Study Duration 6 weeks (3 pairs over a six week period) for each individual participant Objectives Hypotheses: 1) Melatonin is effective for alleviating initial insomnia in ADHD children who are receiving stimulant medication; and 2) N-of-1 trials provide a similar estimate of treatment effect with less uncertainty than a parallel group RCT. Objectives: 1) To determine the efficacy of melatonin in shortening sleep latency times in children with ADHD treated with stimulants 2) To determine whether n-of-1 trials provide similar estimate of treatment effect with less uncertainty than a parallel group RCT Number of Participants 300 participants (children), 300 parent/guardians from Queensland and Canada

Constipation is a common, distressing and serious problem, affecting between 50-90% of people referred to specialist palliative care services. Approximately half of these people do not achieve adequate management of their constipation. The number of people who do not achieve satisfactory symptom relief is not acceptable. So the researchers conducting this study are looking to see if there are more effective ways to treat constipation. The aim of this study is to explore whether people who are currently taking anticholinergic medications and suffer from constipation, will respond better to a cholinergic agent (pyridostigmine), without affecting other symptoms.