ANZCTR search results

The purpose of this study is to look at the safety, tolerability and effectiveness of the combination of three drugs cetuximab, cobimetinib and palbociclib in patients with advanced or metastatic colorectal cancer with certain mutations, who have not responded to standard therapies. Who is it for? You may be eligible to join this study if you are aged 18 years and above, and have been diagnosed with advanced or metastatic colorectal cancer which has tumour expression of BRAF or KRAS mutations, and you have not responded to available standard therapies. Study details All participants in this study will receive cetuximab, cobimetinib and palbociclib. This study will have 2 stages: Phase 1 and Phase 2. In Phase 1, there will be up to 6 groups of participants. Each group receives different dosages of each drug. Cetuximab will be given intravenously once a week, while cobimetinib and palbociclib will be given orally once a day for 21 consecutive days for at least two 28-day cycles. In Phase 2, all participants will receive the same dose of cetuximab, cobimetinib and palbociclib; with the dose being determined by results from Phase 1. Cetuximab will be given intravenously once a week, while cobimetinib and palbociclib will be given orally once a day for 21 consecutive days for at least two 28-day cycles. Participants will be monitored for side effects, disease response and survival. Blood tests, physical exams, eye exams, electrocardiograms and CT scans may be performed at various timepoints including pre-treatment screening and Days 1, 4, 8, 15 and 22 of each 28-day cycle. It is hoped this trial will provide information on the safety and effectiveness of the proposed combination drug therapy in treating advanced or metastatic colorectal cancer, and be an option for patients who have not responded to current therapies.

This study seeks to trial a community pharmacist-led physical health monitoring program for mental health consumers taking at least one second generation antipsychotic medication on a regular basis. Participants will be required to attend a total of five consultations with the pharmacist (initial session and then every 3 months thereafter for 12 months). The sessions will involve assessment of medical history, lifestyle factors and measurement of blood glucose and cholesterol level involving finger prick tests. Blood pressure, height, weight, waist circumference and calculated body mass index will also be measured. Screening for obstructive sleep apnoea using a questionnaire will be conducted at the first appointment only. Each consultation may take approximately 45 to 60 minutes. The length of the consultation will depend on the findings from the assessment. Only one cohort will be recruited. Although community pharmacists have previously provided programs in-store to help support mental health consumers, there are insufficient published data on pharmacists providing metabolic monitoring for mental health consumers on medications with high risk of metabolic syndrome. This study is expected to explore the feasibility of community pharmacists in conducting physical health monitoring (that includes metabolic monitoring) in store and explore whether intervention was able to result in any detectable change. We expect our data to at least reveal that the program is feasible in a community pharmacy environment and that consumers find the service accessible and convenient. We also expect that responses will indicate that mental health consumers feel supported in the management of known side effects of second generation anti-psychotic use (e.g. weight gain) and any trend towards differences in metabolic responses to the initial baseline findings. Findings from each session will be discussed with the consumer by the pharmacist and advice (including diet or lifestyle) will be provided where necessary. Should it be required, referrals will be made to participant's regular doctor will be made and the pharmacist will communicate the findings with participant's regular doctor and arrange for a follow-up appointment.

The aim of this trial is to examine the impact of the drug semaglutide on metabolic risk factors and hunger/satiety in individuals with psychosis at risk of developing type 2 diabetes (T2D). This study will use an RCT design with an intervention group and treatment as usual (control) group. Metabolic risk will be measured using changes to weight, waist circumference, and blood glucose levels pre- and post-intervention and whether any changes were still present at a 12-month follow-up. Hunger/satiety will be assessed throughout the intervention by comparing the intervention and control group. Service utilisation, quality of life and general health will also be assessed pre- and post-intervention. Findings from this study will provide further information on the suitability of this drug in preventing T2D in this group and the feasibility of its use as part of routine care. A sub-study will include a small group of individuals from the intervention group who will complete additional measures of body composition and bone density. This will provide further information on the impact of antipsychotic medications on the body and whether the study drug affects their impact.

The assessment of Autism Spectrum Disorder (ASD) in children takes into account the perspectives of many professionals across the education, health and community sectors. Within Queensland Health, Allied Health Professionals (such as Psychologists, Speech Pathologists and Occupational Therapists) work with medical specialists for children (also known as Paediatricians) in the assessment of ASD. However, there is variability in the clinical care pathways available in the assessment of ASD. This includes the order and timing of allied health assessments in relation to Paediatrician appointments. At some facilities, children are seen by allied health professionals first before seeing a Paediatrician. While in other facilities, the opposite occurs where children are seen by a Paediatrician first, then are later seen by allied health professionals. Both clinical care pathways for the assessment of ASD are safe and appropriate. However, we do not know which clinical pathway results in more efficient and satisfying care for children and their families. Understanding which clinical care pathway is more efficient and satisfying for families will help inform which clinical care pathway is offered more consistently across Queensland. This will ensure children have access to early intervention as soon as possible and avoid any delays. In this study, we are aiming to determine whether first contact with a Paediatrician or Allied Health Professional results in more efficient and satisfying care for children and their families. We hypothesize that an allied health first-contact model of care reduces service healthcare costs and results in comparable patient quality of life and satisfaction with care, when compared to a traditional medical first-contact model of care for the assessment of ASD in children.

We are testing a different method of receiving the patient outcomes survey for our national stroke registry. The Australian Stroke Clinical Registry traditionally collects outcomes data between 90-180days after stroke using a paper-based survey that is mailed to the registrant. If registrant does not respond after two attempts by mail, we telephone them to complete the survey. Use of short-message-service (SMS) with an electronic link to the survey form that is sent to the registrant's mobile phone number may be a more feasible and cost-effective approach to receiving the outcome survey data from registrants. We hypothesise that, compared to our traditional methods, those receiving an SMS will have greater response rates and more timely completion of the outcomes survey with less missing data, and that this new method will reduce costs for collecting these data. A process evaluation to determine why some patients might choose to complete the follow-up questionnaire via the SMS method, while others do not, will also be undertaken. The outcome of this project is to provide evidence on whether the option of electronic collection of outcome data via SMS should be incorporated as part of our usual registry processes.

The overall project will evaluate an evidence-informed brief contact intervention comprising a series of text messages for people bereaved by suicide. This study is focused on finding out if this text message intervention is helpful and improves people's wellbeing. To test if it is helpful, half of all those who decide to take part will be sent a sequence of text messages over a 6-week period. The text messages comprise key messages and information that other people bereaved by suicide and international experts have identified as important. Everyone who takes part will be able to continue with their usual supports and after 6 weeks, we will see if receiving the text messages was helpful. Participation involves completing two online surveys (pre-test and post-test). These surveys will take about 30 minutes to complete and cover a range of questions, including questions about your mental health and wellbeing. Those people allocated to the intervention group will receive text messages over a 6-week period between the two survey assessment time-points. Allocation to the intervention group will be random. Anyone who didn't receive the text message intervention will be able to receive these texts messages at the end of their participation period. After the 6-week intervention period, participants will be requested to complete a post-test survey. A subset of people in the intervention group will also be invited to participate in a one-on-one (virtual or phone) interview to share their experiences of the intervention

This study is focused on preventing falls in people with stroke. Falls are common, particularly in the early stages following stroke and following the transition from hospital to home, with around half of people falling in the first 6 months after stroke. These falls can have serious consequences such as bone fracture, head injury, or death. There are a number of factors which can increase a person’s risk of falls, including poor balance, environmental hazards, sensory deficits, and medications. Evidence suggests effective falls prevention programs should include a tailored approach addressing individual risk factors, and include balance-specific exercises. This study will pilot an individualised, multifactorial telehealth-supported falls prevention program for people with stroke who are being discharged from hospital to home. The study will test the feasibility and potential benefit of this program in 16 individuals with stroke who are at risks of falls following discharge home from an inpatient setting. Participants will be recruited prior to discharge home and will undertake a 4-week program in addition to their usual care. The program will include a comprehensive falls risk assessment and tailored intervention based on identified risks and agreed goals, and using health behaviour change techniques (exploration of individual barriers and facilitators to recommended fall prevention behaviours). This will involve twice weekly physiotherapy sessions (in person or via videoconferencing or phone call) to review or supervise home exercises, review goals and discuss barriers and strategies for falls prevention. Environmental modifications and referral to other services will be undertaken as required. Participants will undergo in person home-based testing at baseline (within one week after discharge home) and at 4 weeks. Participants will also be interviewed within 3 weeks of completion, asking about their experience of the program. This project will inform the development of a randomised controlled trial and may help inform development of future falls prevention programs that can be delivered with greater efficiency.

Initial treatment for Idiopathic childhood nephrotic syndrome is prednisolone. In Victoria our routine duration of prednisolone treatment has been 12 weeks, with a multi-step tapering dose used after 4 weeks of treatment. An alternative regime is used elsewhere in Australia, which has a two-step wean over 8 weeks. Prednisolone courses can rarely be complicated by a side effect called adrenal suppression, which is where natural adrenal gland steroid production is reduced. The Initial Prednisolone Weaning and Adrenal Suppression in Childhood Nephrotic Syndrome study is a clinical trial that will compare the two different courses of prednisolone, the multi-step wean over 12 weeks and the two-step wean over 8 weeks, in patients with their first presentation of idiopathic childhood nephrotic syndrome. The study will find out how frequently adrenal suppression occurs after different courses of prednisolone, and whether there is any association with nephrotic relapse.

The aim of this study is to assess the visual performance and wearability of prototype ophthalmic lenses compared to commercially available ophthalmic lenses

The primary aim of this pilot trial is to determine whether a larger definitive trial is worthwhile and feasible. Success will be defined by all of the following: (i) A patient/family member consent rate at least 40% (ii) Complete study drug administration at least 80% (iii) A reduction in the extent of NSTI at least 25% (within 95% CI of median total area) (iv) Serious study drug-related adverse events less than 5%. Study Hypotheses (i) Feasibility – A multicentre randomised trial evaluating tranexamic acid (TxA) in necrotising soft-tissue infections (NSTI) is feasible (ii) Clinical efficacy - TxA administration in patients admitted to hospital with a suspected diagnosis of NSTI reduces the spread of tissue infection when compared with placebo. Methods This multicentre, double-blind, parallel group, randomised trial will enrol 60 patients admitted to hospital with a diagnosis of NSTI. We will evaluate intravenous TxA, 1 gm, administered twice daily for 4 days.