ANZCTR search results

Single centre exploratory unblinded observational study. Using a unique method that has been developed to label intact proteins rather than amino acids by infusing cows with large quantities of D5-phenylalanine and then collecting their labelled milk. This labelled cow milk can then be administered to humans for research purposes and the metabolic fate of the protein determined. This technique allows the fate of intact protein to be followed from ingestion, through digestion and absorption to muscle deposition. The biological value of the protein can thus be determined i.e. the proportion that becomes incorporated into body tissues, particularly muscle. This is relevant in the critically ill as the protein content of enteral feed formulae is usually presented as a protein such as casein or whey protein. Reduced amino acid absorption has been reported in rats following haemorrhagic shock, in patients with pancreatitis, and in critically ill patients following trauma. However the mechanisms underlying protein malabsorption are not well understood. A more comprehensive understanding of protein absorption during critical illness, and the effect of feeding intolerance on protein uptake will allow the rational development of feeding strategies to improve nutritional outcomes in these patients.

Sedation and analgesia during GI endoscopy under proceduralist guided sedation is limited by the dose dependent adverse effect profile of midazolam and fentanyl. Quality of sedation and patient comfort must be balanced against adverse effects such as respiratory depression, airway obstruction, and loss of verbal response. Intravenous lignocaine possesses a different side effect profile, with less sedative and respiratory effects. The airway reflex suppressive and analgesic properties of intravenous lignocaine may allow a reduction in the required dose of fentanyl and/or midazolam, limiting the incidence of clinically relevant adverse events (multimodal sedation) and allowing an improved quality of sedation. Intravenous lignocaine has shown to provide significant postoperative analgesia in open and laparoscopic abdominal surgery, with improved pain, reduced opioid requirements and improved quality of recovery. It has also been shown to improve tolerability of instrumentation of the upper airway, with improved haemodynamic following laryngoscopy and intubation, as well as decreased rates of coughing, gagging and laryngospasm with LMA insertion. The objective of this trial is to assess whether the addition of intravenous lignocaine as to standard sedation protocol reduces midazolam/fentanyl requirements, improves the quality of sedation and decreases adverse events in patients undergoing GI endoscopy. The trial will be a randomised, double-blind, placebo controlled trial. Patients will be stratified into those undergoing upper GI endoscopy, colonoscopy or both. Patients will be randomised to a loading bolus of 2mg/kg lignocaine or saline, at commencement of sedation, with further 0.5mg/kg lignocaine or saline boluses ever 15 mins for the duration of the procedure. Primary outcome will be midazolam/fentanyl dose. Secondary outcomes will be proceduralist rated quality of sedation, patient satisfaction with sedation, incidence of bradycardia, hypotension, desaturations, airway support and sedation failure.

The aim of the research project is to investigate whether the broad improvements seen across cognitive domains following tDCS in the healthy population are a result of general effects (i.e. improving speed of information processing) or specific effects (i.e. improving working memory capacity or social decision making ability).

The primary purpose of this trial is to explore the outcomes of the clinician-guided iCBT program for people experiencing anxiety and/or depression symptoms who have been diagnosed with advanced-stage cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 years or over, suffer from anxiety or depression and have been diagnosed with advanced-stage cancer. Study details The iCanADAPT Advanced Program is a 12 week online program which involves learning about tackling depression and anxiety with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 6 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1-2 weeks. There will also then be additional activities to do for around 3 hours per week. The program is tailored to unique aspects of the cancer context, such as fear of cancer progression, adapting to illness and end-of-life concerns. Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson. It is hoped that the findings of this trial will provide information regarding the efficacy of the iCanADAPT Advanced Program in reducing depression and anxiety in advanced cancer patients.

This study aims to determine proof-of-principle if a new medical device (rhythm.IC, GI Therapies) is able to improve symptoms of chronic constipation in children. the device delivers painless electrical stimulation across the skin. The new device has been designed using existing devices with additional safety features and better ease of use. The device has not yet been tested on patients. The study does not aim to measure overall effectiveness, but to determine if the new device is able to improve symptoms of chronic constipation in some patients. The primary objective is to determine if stimulation with rhythm.IC can improve constipation symptoms measured with a global measure (Wexner constipation scoring system) after 2 months stimulation.

This project is a randomised controlled double-blind trial. It will involve recruiting 55 children aged 4-6 years, who normally consume dairy products on a regular basis. The three month intervention will involve fortnightly delivery of plain packaged dairy products, either reduced fat or regular fat, tailored to suit the child’s normal intake. Assessments conducted at the start and end of the intervention period will include body composition assessment using a BOD POD; blood analysis of lipids, insulin resistance, inflammation and fatty acid biomarkers; blood pressure; strength testing; diet assessment, and gut health using faecal samples. The project will also include a follow up collection point three months after the completion of the intervention. At this time point only a 3-day food record and set of faecal samples will be collected. This project will provide proof of concept for a similar project on a large scale. The study procedures have been informed by preceding focus group research in a convenience sample of parents of young children (manuscript in preparation).

There is mounting evidence of widespread use of vaporised nicotine products (VNPs) among the general population of smokers. There is also evidence of their effectiveness at achieving short-term cessation with few reported side effects, although limited long term efficacy and safety data is available. VNPs may offer a harm reduction approach to tobacco in populations such as people living with HIV who have high rates of smoking and experience significant associated health consequences. This study will examine whether such products that deliver liquid nicotine are acceptable to people living with HIV who smoke and whether a larger, randomised controlled trial to assess long-term cessation outcomes and relapse prevention would be feasible.

The primary purpose of this trial is to evaluate the efficacy and tolerability of sunitinib on a 14/7 schedule with toxicity-adjusted dosing for the treatment of metastatic renal cell cancer (mRCC). Who is it for? You may be eligible to enroll in this trial if you are aged 18-80 years and have been diagnosed with metastatic renal cell cancer with a component of clear cell histology. Study details All participants enrolled in this trial will receive sunitinib capsules to be taken in cycles of 14 days on, then 7 days off, until either the disease becomes resistant to the treatment (disease progression), or due to intolerable side effects despite dose adjustment, in which case treatment will be ceased. Based on the occurrence of any side effects to the medication, the dose may be increased or reduced as required by the treating doctor. The dose is adjusted so as to aim for some side effects for up to four days per cycle. Participants will be asked to complete questionnaires relating to toxicity and quality of life, and will undergo scans to monitor disease progression for up to one year following the start of treatment. It is hoped that the findings from this trial will provide information on whether a 14/7 dosing schedule with toxicity-adjusted dosing is effective and tolerable for sunitinib treatment for mRCC.

Aim: This is a single blind randomised controlled clinical trial comparing a new therapeutic intervention in addition to Treatment As Usual (TAU) with TAU for patients with schizophrenia at the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU) who want to work. The new therapeutic intervention is called the Supported Employment Linkage Intervention (SEL).The primary hypothesis tested is the addition of SEL to TAU will improve engagement, by patient choice, with a local employment agency called EDGE and procurement of a competitive job. EDGE has good fidelity to the Individual Placement and Support Approach to Supported Employment. We will also see if psychiatric symptoms, cognition, hope and social inclusion will be improved with the addition of SEL to TAU significantly more than with TAU alone. Method: The outcomes measured will be change in: The Engagement with Edge Questionnaire (EEQ), Job Acquisition Questionnaire (JAQ), Brief Psychiatric Rating Scale (BPRS), Trail Making Test A+B, Digit Span Test (Wechsler Adult Intelligence Scale – Revised),, Adult Hope Scale, and the Activity and Participation Questionnaire (APQ-6). Measures will be collected at baseline by the research mental health nurse clinicians and 6 months and 12 months post recruitment by a blinded research officer unfamiliar with the site. Expected Outcomes: We expect successful engagement with an employment agency called Edge, as measured by the Engagement with Edge Questionnaire (EEQ), to equal a 6 month block of registration with Edge during the 12 month period post recruitment and to be significantly better with SEL + TAU compared to TAU over 12 months post recruitment. We expect yes to a competitive job, as measured by the Job Acquisition Questionnaire (JAQ), to be significantly greater with SEL + TAU compared to TAU at 4 varying time points over 2 years post recruitment. Hope, and social inclusion are anticipated to be significantly improved with SEL + TAU compared to TAU as measured the Adult Hope Scale and the Activity and Participation Questionnaire (APQ-6) respectively at 6 and 12, months post recruitment.

This study will investigate the safety of Complete Freund’s Adjuvant (CFA) in Patients with Refractory and Relapsed Solid Tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a histologically or cytologically confirmed locally advanced or metastatic solid tumor (melanoma, head & neck, sarcoma, renal and other cancers) for which no curable therapy exists. Study details This study involves the use of an investigational drug called CFA. "Investigational" means that the drug has not yet been approved by the Therapeutic Goods Administration (TGA) for treatment of cancer. CFA consists of three ingredients: mineral oil, surfactant, and heat-killed mycobacterium. Injection of CFA into tumour creates a localised depot of killed bacteria, which are slowly released over weeks. This causes an influx of immune cells to the site on injection, and initiates a powerful immune response. The other drug (pembrolizumab) is an approved novel agent for the treatment of metastatic melanoma. Participants in the study will receive CFA in combination with pembrolizumab. CFA will be administered in 42 day cycles starting at a dose of 0.5 ml for the first cohort of three patients. These patients will be monitored closely and provided there are no safety concerns additional patients will be enrolled and treated with 1.0 ml of CFA and subsequently a third cohort will be enrolled with a starting dose of 2.0 ml of CFA. Once a participant experiences an adverse event as a result of the CFA dose, this dose level will be expanded with three additional patients enrolled. If two of the six participants experience a reaction the dose will be decreased to the previous level and three additional patients will be added. If one of the six patients experience a reaction that dose will be declared the maximum tolerated dose for CFA. Pembrolizumab will be administered following approved guidelines (2mg/kg) on day 2 of the first cycle and then every three weeks. Safety of CFA will be assessed at Day 1 of each 42 day cycle. Participants will be followed for up to 30 days after removal from treatment to determine therapeutic benefit and anti-tumour effect of CFA. Patients removed from treatment for unacceptable adverse events will be followed up until resolution or stabilization of the adverse event.