ANZCTR search results

Aim To determine the safety and efficacy of LUM/IVA in subjects >12 years of age with CF, homozygous for F508del mutation of CFTR and an FEV1<40% of predicted normal, by comparing those patients treated with LUM/IVA with a cohort of age and sex matched CF controls with another set of mutations that lead to severe CFTR dysfunction (belonging to Class I, II or III), with an FEV1<40%5.

This project is a pilot study in adults to investigate physiological measures as novel biomarkers of food addiction. Impaired physiological responses (e.g. heart rate variability, pupillary responses) have been found in other forms of dysfunctional eating patterns (e.g. binge eating, bulimia nervosa, obesity) and are linked to abnormal functioning of neural circulatory. This project will recruit males and females >18yrs to determine if physiological measures in response to visual food stimuli are associated with food addiction. It is hypothesised that adults presenting with moderate-severe food addiction symptom scores will have lower heart rate variability, increased sweat responses and greater attentional biases toward hyperpalatable foods (i.e. junk foods) compared to adults with low symptom scores.

Update The aim of this study is to assess the benefit of adding high precision radiotherapy to chemotherapy and surgery for the treatment of pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 to 75 years old, have pancreatic cancer and have adequate liver function. You must not have received prior treatment for your pancreatic cancer. Study details Participants will be randomised by chance into two groups. Both of the groups will undergo a chemotherapy regimen which includes either one of the following drug combinations; 1) mFOLFIRINOX or 2) Gemcitabine/Nab-paclitaxel. One of the groups will have additional high precision radiotherapy called stereotactic radiotherapy. After this treatment, you may go on to have surgery.. Whether or not you have surgery, the treating team will then have a discussion with participants about further treatment with chemotherapy. All participants will complete a number of questionnaires, consent to their biopsies and resected tissue being analysed in a laboratory. Participants will be followed up for up to 4 years. This research may demonstrate that the addition of high precision radiotherapy to pancreatic cancer treatment improves patient outcomes and reduces the rates of cancer recurrence.

In patients with diabetes, foot ulceration and infection occur commonly, and are associated with significant morbidity and use of health service resources. Diabetic foot infections are usually associated with ulcers, and can spread from the soft tissue to involve underlying bone (osteomyelitis). Diabetic foot infection with osteomyelitis (DFO) is associated with delayed ulcer healing and increased risk of amputation. Current guidelines for treatment of osteomyelitis include a prolonged course (4–6 weeks) of intravenous antibiotics, However, this requires hospital admission and/or use of ambulatory care nursing services, as well as establishment of intravenous access for the duration of therapy, all of which place considerable burden on health services and the individual patient. Also, the antibiotic-related costs are much higher than oral therapy. Despite this, there is no evidence to suggest that oral therapy results in inferior outcomes. We hypothesise that, the use of oral antibiotics, particularly agents with high bioavailability, good tissue penetration and activity against the known or likely pathogens, might be effective and potentially less costly than intravenous therapy for DFO.

Melasma is a common disorder of hyperpigmentation, manifesting as slowly-expanding tan-brown macules, primarily affecting the face. This study is a randomised, double-blind efficacy study of cysteamine cream compared to hydroquinone cream. Participants will be asked to come for study visits at weeks 0, 8, and 16. At weeks 2 and 4, participants will receive a phone call to assess for any adverse side effects. At the baseline visit, each participant will be randomised into one of two arms. Participants will apply the drug to which they have been randomised daily and use a supplied sunscreen to the entire face during the day. Efficacy of the treatments will be measured by clinical examination of the face including modified Melasma Area Severity Index, digital photographs and the MelasQOL (quality of life) questionnaire. Adverse events will be monitored at each study visit and phone call.

This trial will assess the clinical and cost effectiveness of two in pharmacy screening interventions to detect and enable early intervention with regards to Cardiovascular disease and prevent its complications or detect existing and related disease (eg type 2 diabetes).

Clinicians and researchers agree that neonates (infants between 0 and 27 days old following birth) admitted to the neonatal intensive care unit (NICU) experience pain. In addition to being a source of immediate distress and agitation for neonates, pain may also have consequences for neonates during their admission and also extending beyond discharge from the NICU. Researchers have hypothesised that early-life exposure to pain may alter the development of the brain, and thus hinder an infant’s ability to reach age-appropriate developmental milestones. Indeed, acute pain, or procedure-related pain, has been shown to result in long-lasting impacts on developmental outcomes such as brain development (neurodevelopment), growth, and psychosocial functioning. Specifically, researchers have suggested a dose-response relationship between pain in the NICU and poor long-term outcomes. Studies have shown that a greater frequency of painful procedures in the NICU may result in poor cognitive and motor development at eight and 18 months of age, poor cognitive outcomes at school age, increased sensitivity to pain in early childhood, higher rate of internalising behaviours at school age such as fearfulness and social withdrawal, and low weight and head circumference. Furthermore, the impact of painful experiences on the infant’s social wellbeing is unknown. In particular, the role of ongoing pain on the infant-to-parent relationship at such a critical period of relationship formation has not been investigated. Depending on their underlying medical condition, neonates and infants in the NICU undergo a wide range of interventions, some of which may contribute to ongoing pain and distress. It has been difficult to establish whether pain has a direct impact on the developmental trajectory of infants. In order to elucidate whether there is a dose-response relationship between pain experience and developmental outcomes, it is important to determine if there is an impact of the duration of treated pain on the developing infant. The primary objective of this study is to determine whether the persisting need for analgesia, operationalised as the duration of treated pain, during NICU admission has an impact on gross motor skills after discharge. Secondary objectives of this study are to determine whether the duration of treated pain during NICU admission has an impact on 1) other neurodevelopmental outcomes including cognition/problem-solving, fine motor skills, receptive and expressive language, and personal-social skills, 2) complications following surgery, 3) growth, and 4) psychosocial functioning, of the infant.

Acute respiratory distress syndrome (ARDS) is a condition where the lungs have become injured and do not work as they normally should to provide oxygen and remove carbon dioxide from the body. Patients may need higher levels of respiratory support and perhaps the use of a ventilator (breathing machine). Despite advances in the understanding and recognition of ARDS; novel therapies being developed and employed, ARDS can cause damage to other organs, causes a longer stay in the intensive care unit (ICU) and the hospital and significantly increases ICU costs. There is also a high risk of death at 40-50%. Previous studies have provided great insight and helped shape our understanding of the disease, however there remains limited information about the recognition, management and outcomes of patients with ARDS. Currently limited evidence exists regarding the management and outcomes of patients with moderate-severe ARDS in Australia and New Zealand to inform future trial design. This will be the first study to report this data in Australia and New Zealand. We plan to undertake study for 6 months in 25 ICUs in Australia and New Zealand to assess the management of moderate-severe ARDS. Trained research nurses in each ICU will collect data to describe management practises, use of ventilator strategies and additional therapies and describe outcomes in patients with moderate-severe ARDS; determine factors in early moderate-severe ARDS associated with survival; and determine the impact of artificial external heart lung machine use in these patients. We hypothesise that this data will give an accurate description of the characteristics and management of adult patients admitted to the ICU in Australia and New Zealand with moderate-severe ARDs. This data will be used to inform future trial design to test interventions to reduce further deterioration and death in these patients. We have a unique opportunity to prospectively collect high quality data regarding the management and outcomes of patients with moderate-severe ARDS admitted to ICUs in Australia and New Zealand. We will then compare this data to the data generated by our US colleagues to report and compare regional trends. Study findings will be presented at national and international meetings and published in high-quality peer reviewed journals.

The Tackling Tobacco in Community Mental Health Organisations trial aims to enhance the capability of community managed mental health organisations to address tobacco use by consumers and staff in a holistic, routine, consistent and comprehensive manner. Tackling Tobacco is a program that offers an organisational change based framework through which organisations can change or introduce new policies, procedures, and systems to address tobacco. The program aims to generate cultural change to ensure tobacco is viewed as a priority across the organisation. In the trial, community mental health services will be offered differing levels of the Tackling Tobacco program. We hypothesise that consumers from services receiving the more intense version of Tackling Tobacco will be more likely to report being offered support to quit (in the form of nicotine replacement therapy) than those consumers in the low intensity services. Addressing tobacco in communities that experience severe mental illness is important because it helps reduce the disproportionate health and economic affects of smoking.

This study seeks to detect chemotherapy-associated neurocognitive impairment in patients with Acute Myeloid Leukemia, using Neurocogntive Assessment and Magnetic Resonance Imaging. Who is it for? You may be eligible to join this study if you are aged 18 and above and are commencing induction chemotherapy for Acute Myeloid Leukaemia (AML). Study details This prospective longitudinal pilot study seeks to determine the prevalence and severity of chemotherapy-associated neurocognitive impairment (CANI) in patients undergoing treatment for AML, and to evaluate the feasibility of using magnetic resonance imaging as a biomarker of CANI in this population. Each participant will undergo Neurocognitive Assessment (NCA) and Magnetic Resonance Imaging Quantitative Susceptibility Mapping of brain iron (MRI-QSM) before and after their treatment for AML It is hoped that the findings from this trial will provide information regarding the incidence of chemotherapy associated neurocognitive impairment during AML treatment, and the feasibility of using MRI-QSM as a diagnostic tool in these patients.