ANZCTR search results

The primary objective of this study is to establish if exogenous glucose-dependent insulinotropic polypeptide in combination with glucagon-like peptide-1 (both hormones released from the gastrointestinal tract) has a glucose lowering effect in critically ill patients

Sleep disturbance occurs in a significant proportion of the Acquired Brain Injury (ABI) population. Traumatic Brain Injury, a type of ABI, has been associated with reduced sleep quality, more night-time awakenings and longer sleep onset latency's. Recent research has shown that TBI patients have significantly lower endogenous concentrations of melatonin in the evening as compared to healthy controls. Melatonin is a naturally occurring hormone in the body which is intricately involved in the regulation of sleep and more importantly with the timing of sleep. Specifically, recent work has shown that this reduced concentration of melatonin was related to reduced rapid eye movement sleep and that these patients had more arousals during the evening. In light of recent work which provides evidence that a prolonged release melatonin formula is efficacious in treating age-related insomnia in individuals who also have decreased bodily concentrations of melatonin, it is hypothesized that melatonin will reduce the time taken to sleep and will improve sleep quality in ABI patients. The current study will implement a randomized, placebo-controlled crossover study with the aim of recruiting 80 participants. ABI patients who report sleep disturbance post injury will be eligible to participate. As this is a crossover design every participant will receive both the placebo and active melatonin treatments. If melatonin therapy is successful in reducing latency to sleep and improved sleep quality this could substantially improve the quality of life of individuals with ABI. As melatonin is a naturally occurring hormone relatively devoid of side-effects, its use to treat sleep disturbance could be implemented into clinical practice.

Some patients are admitted to the intensive care unit (ICU) either with renal failure or develop renal failure during their stay. Renal failure in ICU is often treated with continuous renal replacement therapy, usually continuous veno-venous haemofiltration (CVVH) or continuous veno-venous haemodiafiltration (CVVHDF). The nature of continuous renal replacement therapy is that it is run over consecutive 24 hour periods (as long as the circuit remains patent). However, there is wide variability in the mobility restrictions imposed on patients undergoing CVVH or CVVHDF therapy in ICUs and patients may often remain immobilised and bed-bound whilst on renal replacement therapy. These mobility restrictions may contribute to the adverse effects of immobilisation in ICUs and there is some evidence to suggest that immobilisation secondary to a vascular catheter (vascath) increases risk of blood clots. Although there is no empirical evidence to suggest that mobilisation of patients with a vascath is detrimental, vascath manufacturers provide no guidance around the specifications of vascaths with movement. In some settings, patients undergoing CVVHDF or CVVH do mobilise out of bed and there is no evidence with which to guide practice around this. Empirical data is required to demonstrate the effects of patient movement on renal replacement therapy flows via vascath and treatment cessation in ICU. However, prior to determining the effect of movement on CVVHDF flows, the safety and feasibility of moving patients on renal replacement therapy must be established. This pilot study will look at patients who have been admitted to an ICU and are requiring continuous renal replacement therapy via a vascath. The aim is to see if it is safe to move and mobilise patients who are having continuous renal replacement therapy via the vascath. Possible adverse events may involve the vascath being pulled out, clotting at the catheter site or in the blood vessels, bleeding or bruising at the catheter site. The settings and parameters on the dialysis machine will be measured to establish a baseline standard of renal replacement therapy flows and performance for comparison in future studies. The collected data will be analysed for safety and assessed for the feasibility of moving the hip or mobilising patients on CVVH or CVVHDF. The project will be written up for publication in an Australian Journal. Depending on the result of this pilot study, a study powered to examine the effects of mobilisation on haemofiltration circuit life may follow.

This study will evaluate the efficacy of three feeding intervention programs for children recovering from cancer with feeding difficulties and/or restricted oral intake. Who is it for? Children can join this study if they are aged between 1 and 6 years, are stable and/or in their maintenance phase of treatment for cancer, and have a feeding difficulty and/or restricted range of oral intake (e.g. limited range of foods, prolonged mealtime duration, problematic behaviour at mealtimes, parent stress related to mealtimes). Trial details: Participants of this trial will be offered a comprehensive assessment of feeding, general development and nutrition in the first instance. Children identified as eligible, based on these assessments, will be randomly (by chance) divided into one of three groups. Group 1 will undergo an individual child-directed behaviour modification program, Group 2 will undergo small group child-directed sensory desensitisation program, and Group 3 will involve group parent education sessions on general nutrition and behaviour management for children with feeding difficulties. Treatment will be offered in weekly sessions for a 10 week block (10 sessions). Participants who are unable to commit for weekly intervention for 10 weeks will be offered the opportunity to be placed on a wait list for intensive intervention (10 sessions in 1 week). Assessments will be conducted at baseline, immediately post treatment, and 3 months post treatment to determine the impact of the programs on dietary variety, overall nutrition, maladaptive behaviours and parent stress.

The objective of this study is to assess to what extent cathodal transcranial Direct Current Stimulation (tDCS) of the temporal cortex, in conjunction with anodal tDCS of the prefrontal cortex, may reduce auditory hallucinations, and induce improvements in cognition, and negative symptoms in people with schizophrenia who are concurrently maintained on antipsychotic treatment. The central hypothesis is that cognitive deficits and negative symptoms, having been linked to prefrontal cortex dysfunction, will be reduced by anodal stimulation of the prefrontal cortex via facilitation of neural function, and that cathodal stimulation of the temporal cortex will reduce auditory hallucinations through disruption of pathological over-activity.

This study will be a randomised controlled trial to evaluate the clinical benefits and cost-effectiveness of two child-directed feeding intervention programs for children from complex medical backgrounds (cardiac, respiratory, gastrointestinal) with feeding difficulties and restricted range of oral intake (<30 foods across the food groups). Baseline assessments will include parent-completed questionnaires on-site (Herston) and feeding and growth evaluations. There are two arms of intervention. Arm One is an individual behaviour modification program. Arm Two involves small group sensory desensitization therapy. Intervention will be provided over three phases. In Phase One, interventions will be provided weekly, over a 10-week period. Phase Two will involve offering a further block of therapy, (Arm One or Arm Two), where appropriate, over a 10 week period. Phase Three will involve providing either arm one or arm two on an intensive basis.

Lung cancer is the most common cause of cancer-related deaths. Although some improvements in the treatment of early stage lung cancer have occurred, the majority of participants still present with advanced (non-operable) disease. The treatments for participants with advanced lung cancer are mostly palliative using various treatments, including chemotherapy, targeted therapies and radiotherapy. This study looks at whether response rates to an assay-directed chemotherapy regime - adenosine triphosphate tumour cell assay (ATP-TCA) - may be greater than in patients who are receiving current, standard chemotherapy for lung cancer. Who is it for? You may be eligible for this study if you have had a confirmed diagnosis of inoperable non small cell lung cancer or mesothelioma, are 18 years and above in age, have an ECOG performance status of 0, 1 or 2, and adequate bone marrow, hepatic and renal function as determined by clinical assessments. Trial details In this trial, you will be treated with either an assay-directed chemotherapy regime, ATP-TCA, or your physician’s choice of standard therapy for your condition. Which treatment you will receive will be determined by randomisation. If you are randomised to the ATP-TCA arm, you will be offered therapy based on your chemo-sensitivity profiles, from which a list of drugs that were positive on the ATP-TCA assay will be provided to your treating oncologist to decide the best first-line chemotherapy agents for you, provided in standard doses based on current clinical practice. The chemotherapy drugs that will be tested in the ATP-TCA assays include: Carboplatin, Docetaxel, Pemetrexed, Vineralbine, Gemcitabine, Irinotecan or Paclitaxel +albumin (Abraxane). If you are randomised to the standard chemotherapy treatment, you will receive carboplatin and docetaxel administered every 3 weeks in standard doses. For both treatments, a total of 6 cycles will be administered providing there is evidence of stable disease or partial or complete response by the RECIST criteria. CT scans will be performed after the 3rd and 6th cycles of chemotherapy treatment. Should your disease progress past what is deemed suitable, your treating oncologist will then remove you from the study. Quality of-life assessments will be performed prior to cycle three of chemotherapy and following cycle The aim of this study is to test the hypothesis that the results of chemotherapy in non small cell lung cancer can be improved by predictive testing without an unacceptable increase in toxicity.

This study will investigate whether the TAP block procedure using the local anaesthetic agent Ropivacaine is effective at managing pain in the first 24 hours after laparoscopic abdominal surgery.

Clinical supervision [CS], a structured staff support arrangement, has shown promise as a positive contribution to the clinical governance agenda and is now found reflected in health policy themes elsewhere in the world. However, CS is underdeveloped in Australia and the empirical evidence base for the informed implementation of CS, per se, has remained elusive. This large and generously funded pragmatic randomised controlled trial tested the relationships between Clinical Supervision, quality of care and patient outcomes, in mental health settings in Queensland, Australia. Twenty four mental health nurses attended a training course to equip them to provide Clinical Supervision to groups of colleagues in their respective work places across the State. A suite of outcome measures, each with established psychometric properties [including The Manchester Clinical Supervision Scale] measured differences within and between participants in the Intervention and the Control Arms of the trial, over a one year period. Findings confirmed that beneficial and sustainable CS outcomes accrued for Supervisors and Supervisees, and for patients in one private sector mental health facility. However, the effect Clinical Supervision had on nominated outcomes remained difficult to demonstrate across a broad front. Plausible explanations were offered for this and a new framework for future outcomes-related research studies was suggested, in the continuing attempt to strengthen an empirical evidence base for Clinical Supervision.

The Strong Without Anorexia Nervosa (SWAN) Study is evaluating three psychological treatments for anorexia nervosa and atypical anorexia nervosa in adults. It is funded by the National Health and Medical Research Council of Australia and will be one of the largest study of its kind worldwide. Men and women aged 17 years and older with anorexia nervosa or atypical anorexia nervosa, who are able to attend appointments in Perth, Adelaide or Sydney, are eligible to take part. Participation is free and the Study is running from 2010 to 2015. It is hoped that 120 individuals will participate across the three states