ANZCTR search results

Androgenetic Alopecia (AGA) which is also known as male patern baldness is a common form of hair loss in both men and women. Samumed Company is developing SM04554 for the treatment of AGA. SM04554 is a small molecule which activates proteins involved in maintaining hair growth The purpose of this study is to learn more about the safety and activity of a SM04554. This study drug is a solution to be rubbed onto the scalp once every day for 14 days. To obtain information on the how the body absorbs distributes and removes the drug form the body (pharmacokinetics), blood samples will be taken to measure the concentration of the study drug over the 14 days of application. This study will also check safety by measuring heart, liver and kidney function, number of blood cells, vital signs and scalp assessments.

This project will evaluate the Training in Interaction, Communication and Literacy (TICL) program through a cluster randomised trial. TICL is a 10 week professional development program for Early Childhood Educators (ECEs), delivered by Speech Pathologists, and designed to improve the language and early literacy skills of preschoolers. Pre and post measures of changes in the knowledge and skills of ECEs and the language and literacy skills of the preschoolers they care for will be taken. These results will be compared with a control group of ECEs and preschoolers. We hypothesise that TICL will improve the language and early literacy skills of preschoolers when compared with no treatment.

Pain is a common feature of major traumatic injuries. Little research has been done into the utilisation of low dose Ketamine for analgesia in the ED. Ketamine has the potential to be a highly effective method of analgesic management in haemodynamically unstable trauma patients who are unsuitable for large doses of opioid drugs but it is not utilised for this purpose due to a lack of supporting evidence and clinical concern about potential side effects. The clinical impact of this trial is in the development of an evidence base to support the use of Ketamine for analgesic purposes in the ED. Our hypothesis is that low-dose Ketamine provides effective (statistically significant reduction in pain score), safe (low rates of emergence and adverse events) and tolerable (patient reported effects/willingness to use again) analgesia when used in sub-anaesthetic doses in patients with traumatic injuries. If proven this will have significant implications for the clinical care of patients and in pain management guidelines with traumatic injuries in the ED. The proposed research design is a single blind randomised trial of low dose Ketamine in trauma patients. Participants will be randomised to receive a single dose of 'study drug' which will be either Ketamine (0.2mg/kg) or IV opiate (the dose determined by the clinician), this will be followed up by ongoing standard care for pain management (intravenous morphine or equivalent). Participants will record pain scores every 15 minutes for one hour post analgesic dose. Participants will also be clinically assessed every 15 minutes and have their vital signs and any side effects recorded. Additional 'rescue' analgesia will be available across both arms to ensure that patients are treated for ongoing pain.Rescue analgesia use will also be recorded during the follow up period. Participants will be followed up 24-72hours after trial enrolment. Participants will have their vital signs recorded, will be assessed for adverse effects from the study drug and will be asked to complete a participant questionnaire. This short questionnaire will assess patient's satisfaction with pain management in the emergency department, their satisfaction with the 'study drug', any side effects experienced from the 'study drug' and their overall willingness to receive the 'study drug' again. Patients will be contacted at 6 and 12 months post enrolment to evaluate patient satisfaction and long term safety of Ketamine as an analgesic.

Children admitted to the paediatric intensive care unit frequently require the insertion of a CVAD for the administration of medication and fluids. These CVADs are associated with a high rate of failure, including CVAD-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU) and chlorhexidine-impregnated discs, are used to protect the CVAD insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), and integrated securement and dressing products (ISD), are available to clinicians to provide securement and dressings for CVAD. It is not known whether these new products are effective at reducing CVAD failure, in comparison to standard care (BPU and suture). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on CVAD failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with non-tunnelled CVAD in the paediatric intensive care.

Despite a decade of substantial investments in programs to improve access to primary care for Aboriginal mothers and infants, over 50% of Western Australian Aboriginal babies are still not receiving primary and preventative care in the early months of life. Western Australian hospitals now input birth data into the Western Australian ‘Stork’ electronic birth registration system within 24 hours of birth. However, there have been difficulties in ensuring that the appropriate primary care providers receive birth notification and clinical information by the time babies are discharged from hospital. There is no consistent process for ensuring that choices about primary care are discussed with Aboriginal families. We will undertake a population based stepped wedge cluster randomised controlled trial of an enhanced model of early infant primary care. The intervention is targeted support and care coordination for Aboriginal families with new babies starting as soon as possible during the antenatal period or after birth. Dedicated health professionals and research staff will: consult with families about their health care needs; provide information about health care in the first three months of life; offer assistance with birth and Medicare forms; consult with families about their choice for primary care provider; offer to notify the chosen primary care provider about their baby’s health needs; and offer assistance with health care coordination at the time of discharge from hospital. We will evaluate this model of care using rigorous stepped wedge approaches. Our primary outcome measure is reduced hospitalisation rates in infants aged under 3 months. Secondary outcome measures include emergency department presentations, completed Aboriginal and Torres Strait Islander child health screening assessments, immunisation coverage and satisfaction of families about early infant primary care. We will also assess the cost effectiveness of the model of care. This study will be conducted over a four year period in partnership with birthing hospitals and primary care providers including Western Australian Aboriginal Community Controlled Health Services and the new Primary Health Networks. The results of our trial will be used to develop improved primary care models and to improve health outcomes for all Aboriginal infants. These are vital steps towards more equitable health service delivery for Aboriginal and Torres Strait Islander children in Australia.

The primary purpose of this study is to evaluate the current smoking cessation care provided to cancer patients in New South Wales (NSW) and identify opportunities and barriers to achieving routine clinician delivery of smoking cessation care. Who is it for? You may be eligible to participate in this study if you are aged 18 or over and have been diagnosed with any form of cancer in the past 12 months and attend a medical, radiation or surgical oncology clinic at one of the recruiting hospitals in NSW. Study details All participants in this study will complete one survey. Patients will answer a survey with questions regarding the smoking cessation care they have been offered, while staff will be asked questions regarding the smoking cessation care offer to cancer patients. Results from the surveys will be reviewed and used to evaluate the current smoking cessation care provided, and identify opportunities for implementing routine care across NSW. It is hoped that information gained as part of this study will provide information on the current care provided to cancer patients who smoke, and provide the first step towards achieving a system-wide smoking cessation protocol for these patients.

There is currently no randomised controlled trial (RCT) evidence that treating gestational diabetes (GDM) prior to 24-28 weeks gestation benefits babies or their mothers, and there is potential for harm through fetal undernutrition, inappropriately medicalising some pregnancies, and increasing overall clinical workload. We are planning an RCT testing whether GDM treatment from <20 weeks gestation (‘booking GDM’) is associated with benefit or harm. This pilot study aims to have midwives and women with GDM risk factors review the study plan and to pilot the study procedures. The pilot is a full RCT of 100 women, 20 of whom are expected to have GDM.

Background Deep sternal wound infection is a devastating complication of cardiac surgery. In the current era of increasing patient co-morbidity, newer techniques must be evaluated in attempts to reduce the rates of deep sternal wound infection. Methods A randomised controlled trial comparing sternal closure with traditional sternal wires in figure-8 formation with the Pioneer cabling system [Registered Trademark] from Medigroup after adult cardiac surgery was performed. Results 273 patients were enrolled with 137 and 135 patients randomised to sternal wires and cables group, respectively. Baseline characteristics between the two groups were well balanced. Deep sternal wound infection occurred in 0.7% of patients in the wires group and 3.7% of patients in the cables group (absolute risk difference = -3.0%, 95% confidence interval: -7.7% to 0.9%; p=0.12). Patients in the cables group were extubated slightly earlier than the patients in the sternal wires group postoperatively (9.7 vs. 12.8 hours; p=0.03). There was, however, no significant difference in hospital and follow-up pain scores or analgaesia requirements. Conclusions The Pioneer sternal cabling system appears to facilitate early extubation after adult cardiac surgery, but it does not reduce the rate of deep sternal infection.

The primary purpose of this study is to determine whether offering a screening blood test to people who do not participate with standard faecal-based testing method can increase overall bowel cancer screening participation compared to a program that only offers a faecal occult blood test (FOBT). Who is it for? Participants for this study will be randomly selected from the South Australian electoral roll, all between 50 and 74 years of age, who have not had an FOBT or colonoscopy carried out in the last 12 months. Study details: All participants will be mailed an offer for FOBT, with a reminder letter sent 6 weeks later to non-participants. For those who will not or can not complete the FOBT, they will be randomly allocated (by chance) to receive an immediate offer of screening with a new blood test, or after 12 weeks will receive either another offer for screening with FOBT, or an offer to screen with the blood test. Additional reminder letters will be sent another 6 weeks later to non-participants. A second round of screening offers will be provided in Round 2 of the study 24 months after initial invitation. For the participants who completed either the blood test or FOBT in the first round of the study, they will be offered the same test again to assess adherence to screening. For those who did not complete any test in the first round of the study, they will be randomly allocated (by chance) an offer to screen with the blood test, the FOBT, or have a choice of the tests. Reminder letters will be sent after 6 weeks to people who have not completed a test. Rates of participation with the different tests will be determined 12 weeks after the screening offer. It is hoped that the findings of this trial will aid understanding of whether a screening test for bowel cancer by blood test rather than faecal testing methods shows greater participation rates as well as adherence to ongoing screening, and thus whether this alternative method shows potential for reducing mortality from bowel cancer in the long term.

The trial is the third phase of a complex intervention that by definition, involves large variability in a target population and is a placed-based initiative for highly vulnerable families. Our research is informed by a needs assessment (Phase 1) and feasibility study (Phase 2). We will assess the impact of child nutrition and active play advice delivered in community-based early childhood settings to vulnerable families. We will train Supported Playgroup facilitators and bicultural workers to will deliver six key messages (chosen from 10) about child health and development issues. Building on established relationships between facilitators, bicultural workers and their families, the program is delivered by facilitators in their existing Supported Playgroups using place-based resources, during one school term. We previously found that children attending Supported Playgroups were over-represented among those consuming sweet drinks and ‘packaged’ foods, and viewing excessive hours of television. Parents reported concerns about the safety of their children during active play and some powerlessness in providing healthy food. Supported Playgroup parents also described greater difficulties accessing, understanding, and using health information than other families in the same locations of social disadvantage. Our subsequent feasibility study co-designed by stakeholders demonstrated effective communication about key messages in child nutrition and active play by Supported Playgroup facilitators. More specifically, it resulted in improved knowledge and confidence of SP facilitators and parents, and changes in parenting behaviours. Although key messages in child nutrition and active play have been successfully used in early childhood interventions in Australia, culturally and linguistically diverse and significantly disadvantaged families have not participated. Innovation in effective delivery of child nutrition and active play messages is urgently required for high needs families. Research questions Can early childhood settings be used as a platform to convey key child health and developmental messages to parents of young children living with significant social and economic disadvantage? Can Supported Playgroup facilitators effectively communicate key messages about child nutrition and active play? How can the evidence-based knowledge be best disseminated for specific family and playgroup contexts? What knowledge will families recall away from Supported Playgroups and will it translate into child-health practices and better connections to existing services? To this end, the general hypothesis is that when well-considered and sensitively delivered messages about child nutrition and active play are embedded into Supported Playgroups, parental knowledge will increase and child-health practices will improve. This experience will also increase the social connectedness and ultimately the self-efficacy in parenting of highly disadvantaged parents. Specific Hypotheses 1. That increased parental knowledge and self-efficacy about child nutrition and active play will promote improved child health-related behaviours. 2. That Supported Playgroups are an effective place-based setting to convey child health and development information to vulnerable families. Aim Our overall research goal is to address health and social inequalities among vulnerable families with young children. Specifically this project aims to 1. Improve child nutrition and active play-related behaviours in vulnerable families. 2. Advance knowledge about effective strategies for achieving translation of the research findings into policy in early childhood settings. The trial has not been previously registered. Relevant citations arising from Phase 1 are: Myers, J., K. Gibbons, G. Naughton, et al. (2015). "Early childhood nutrition, active outdoor play and sources of information for families living in highly socially disadvantaged locations." Journal of Paediatrics and Child Health 51(3): 287-293. Myers, J., S. Thorpe, et al. (2014). "Early childhood nutrition concerns, resources and services for Aboriginal families in Victoria." Australian and New Zealand Journal of Public Health 38(4): 370-376.