ANZCTR search results

It is well­-documented that burns and the associated wound care procedures are painful and distressing for children. Non-­pharmacological techniques are used in addition to pharmacological methods for control of pain and anxiety. Medical hypnosis in adults undergoing burn wound debridement (wound-cleaning and removal of dead tissue) has resulted in reductions in pain and anxiety. To our knowledge, there have not been any randomised controlled trials that have examined the efficacy of medical hypnosis to decrease healing times and pain/anxiety scores in paediatric burn patients. The aim of this study is to investigate whether medical hypnosis reduces pain and anxiety and enhances re­-epithelialisation (i.e. wound-healing) in children with acute burn injury. We hypothesise that there will be significantly lower pain and anxiety scores, lower levels of biological stress markers (cortisol and alpha-­amylase) and faster wound re-epithelialisation in the intervention group compared with the control group.

Congenital heart disease in adults is an increasingly important area. Aortic coarctation is a congenital cardiac condition; clinical presentation may vary from a patient with no symptoms to severe, early cardiac failure. Aortic coarctation is typically associated with high blood pressure or hypertension. Survival into adult life is excellent, however, a number of late complications are increasingly recognized. These include a tendency to difficult to control hypertension and the potential formation of cerebral aneurysm. An aneurysm is a weak area in a blood vessel that usually enlarges. It is often described as a “ballooning” of the blood vessel. Such cerebral, or brain aneurysms are potentially lethal. In this study, we are looking to determine whether patients with previous aortic coarctation repair may have disturbances in the blood flow in their brain. We will use transcranial Doppler ultrasound (TCD) to measure blood flow in the brain to compare patients who have previous surgical repair of aortic coarctation with healthy control participants.

In this prospective case series participants with cystoid macula oedema secondary to Central Retinal Vein Occlusion (CRVO) who are treatment naive will receive treatment with Eylea using an ‘inject and extend’ treatment protocol. In this study we aim to assess whether a ‘treat and extend’ regimen is a useful option in the treatment of CME associated with CRVO. We hypothesise that visual acuity outcomes will be non-inferior to that achieved in the pivotal trials and that this will be achieved with fewer visits to the clinic. The study will run for approximately 36 months. The recruitment period will last approximately 12 months. Participant involvement will last approximately 24 months.

Repetitive transcranial magnetic stimulation has been shown to be efficacious for treating depression and has been approved by the TGA for the treatment of depression in adults who have not responded to at least 2 trials of antidepressant medications. However, some people do not respond to the treatment. Sleep-wake cycle disruption, reduced cognitive functioning and changes in brain chemistry are prominent features of depression. It is unclear how rTMS affects these features and whether they are associated with response to rTMS treatment. We seek to investigate whether these features of patients are associated with rTMS treatment response.

There is currently a lack of research investigating interventions which target oral inferential comprehension in children with specific language impairment (SLI). This is despite the knowledge that children with SLI demonstrate poor oral inferential comprehension, and the evidence showing the importance of this skill for later reading comprehension and learning. Therefore, this study will involve developing and piloting an intervention targeted at improving oral inferential comprehension in a small randomised controlled trial of children with specific language impairment. The intervention is evidence-based, designed based on the intervention principles pertaining to the large body of research in speech pathology journals regarding interventions for children with specific language impairment . The findings will therefore add to the evidence-base of interventions and effective practice in the area of language comprehension, leading to improved long-term language and literacy outcomes for children with specific language impairment. The participants will be randomly allocated to one of two intervention groups (the inferential comprehension intervention or the comparison intervention targeting phonological awareness). The participants will then take part in the intervention, implemented by the researcher. The intervention will involve small group (4 children) activities, for approximately 30 minutes, twice per week for 8 weeks over the course of one Term. It is anticipated that the participants receiving the inferential comprehension intervention will demonstrate a significant improvement in their oral inferential comprehension compared to the participants receiving the phonological awareness intervention. It is also anticipated that the participants receiving the phonological awareness intervention will demonstrate a significant increase in their phonological awareness skills compared to the participants receiving the inferential comprehension intervention. This finding will provide preliminary support for the effectiveness of oral inferential comprehension intervention with this age group and population, and inform the practice of speech pathologists and educators working with children with SLI.

This clinical trial aims to compare the safety and efficacy of Cannabinoid Nasal Spray Micelle as an adjunct therapy for the treatment of chemotherapy induced nausea and vomiting in chemotherapy-naive oncology patients. Who is it for? All chemotherapy-naive patients receiving moderate-high emetogenicity chemotherapy aged 18 years or over. Study details: All participants in this study are randomly allocated to one of the two groups. Participants in one group will use a cannabinoid derived nasal spray in addition to standard nausea and vomiting treatment for five chemotherapy days. Participants in the second group will use a nasal placebo spray in addition to standard nausea and vomiting treatment for five chemotherapy days. There is a 50% chance of being assigned to one of the two groups. Participants are expected to have routine blood tests as standard of care provided by the medical oncologists. In addition, participants are expected to complete multiple questionnaires provided by the study investigators. The questionnaires will include 1) One RINV questionnaire per day (one on the day of chemotherapy, and one each of the 4 days post chemotherapy. 2) Two FACT-G/FACIT-F questionnaires per cycle. 3) One FLIE-5DR questionnaire per cycle. 4) Two ESAS questionnaires per cycle. 5) One Adherence Questionnaire for each day the participant receives the study medication. This study aims to see a 'complete response', where 'complete response' is defined as no vomiting and no use of rescue medication.

This study aims to improve sleep and pain post operatively after total knee replacement. It will compare 3 well known medications used for pain and sleep management post operatively.

Selective Decontamination of the Digestive Tract (SDD) is a treatment designed to reduce the risk of infection and improve survival for critically ill patients. SDD is the application of antibiotics and antifungal drugs to the throat and their instillation into the stomach, combined with a short course of intravenous antibiotics. Although many trials suggest that SDD works, the research results have not been convincing enough to lead to the widespread uptake of SDD around the world. Additionally clinicians are concerned that SDD will increase antibiotic resistance amongst endemic bacteria. As a result, SDD is not currently widely practiced. This trial aims to resolve this uncertainty. We will be conducting the definitive randomised study examining the effect of implementing SDD. For 24 months, ICUs in Australia will be randomly assigned to either deliver SDD in the first 12-month period and be a control ICU in the second 12-month period, or to be a control ICU first and deliver SDD in the second period. 8000 critically ill mechanically ventilated patients will be enrolled. Mortality rates will be compared between the SDD and control groups antibiotic resistance rates will be evaluated in samples from all patients prior to, during and after the trial to determine the effect of SDD on the microbial ecology. The SuDDICU trial will provide definitive answer to a fundamental question in intensive care medicine - does SDD reduce critically ill patients’ risk of dying without increasing antibiotic resistance rates? If SDD is found to be effective without increasing antibiotic resistance, the study will have a global impact, leading to improved survival and reduced infection rates in critically ill patients. The results of this study will change practice and be of immense value to clinicians, policy makers and regulators.

Venous cannulation via peripheral intravenous catheters (PIVC) is the simplest and most frequently used method for drug, fluid and blood product administration. Researchers estimate that up to 70% of patients in acute care hospitals require a PIVC. However, PIVC are associated with inherent complications which can be mechanical or infectious. Failure rates of these devices is unacceptably high, affecting up to 40% of patients receiving this therapy. Of these, 30% failed due to occlusion and infiltration (fluids into surrounding tissues) meaning patients had to have the PIVC replaced, which has implications for patient comfort, therapy and health care costs.There have been a range of strategies developed to prevent or reduce PIVC related complications including flushing regimes to maintain PIVC patency. However, current flushing practice is widely varied, with poor outcomes. There is little evidence that flushing of PIVC is actually happening in practice. To achieve best and evidence based practice it imperative that trial research is conducted to establish the best regime for maintaining PIVC patency. The study aims to establish the feasibility of conducting a four arm, factorial, randomized trial evaluating the efficacy and cost effectiveness of different flushing frequencies and volumes in a paediatric population.

This study aims to evaluate the safety and effectiveness of a combination of veliparib with radiotherapy, followed by a combination of veliparib with temozolomide (a chemotherapy), to treat patients with newly diagnosed glioblastoma multiforme (a type of brain tumour). Who is it for? You can join this study if you are a person who is recently diagnosed with glioblastoma multiforme (brain tumour), underwent surgery (or have been scheduled to undergo surgery) for this diagnosis and are considered for further treatment with radiotherapy plus temozolomide treatment. Study details: If you like to join this study you will first be screened by your specialist to see if you meet the eligibility criteria to participate in this study. If you are deemed eligible to participate you will be randomly (by chance) assigned to one of two possible treatment groups: Group 1 will receive veliparib together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with a combination of temozolomide and veliparib. Group 2 will receive receive temozolomide together with radiotherapy for 6-7 weeks, followed by a 4 week treatment break, which is again followed by a 6 month treatment with temozolomide. Your chance to receive the group 1 treatment is twice as high as to receive the group 2 treatment. Participants will be asked to attend clinic visits every 2-4 weeks during the treatment period and then two times more (1 month and 3 months after having received the last treatment). During these visits the specialist will assess the status of your glioblastoma and your physical and mental health, and ask you about your well-being. Participants will also be asked to undergo tests and procedures, such as blood testing, urine testing, scans, and questionnaire completion and to give tissue samples for laboratory research.