ANZCTR search results

The aim is to determine if professional advice for perceived insufficient milk supply results in a change in perception of milk supply, and whether objective measurement of milk supply before and after receiving professional advice shows a measurable difference in breastmilk production and affects the change in perception. When participants have a perception of insufficient breastmilk supply, we predict that there will be a significant change in the participants’ perceptions from before to after receiving advice from a lactation consultant, and there will be a measurable difference in milk production. We would like to know if objective measurement of milk production before and after following advice affects the change in perception.

Advances continue to be made in the diagnosis and treatment of coronary heart disease. As well as innovations in opening up blocked arteries, ways of accessing the heart arteries have improved leading to reduced complications following a procedure. One such approach uses the radial artery, an artery in the wrist. Various methods exist to stop the bleeding following a procedure with the most common device being a TR BandTM (Terumo) which is applied to the wrist. A balloon in the device, when inflated with air, applies pressure to the puncture causing it to close. The manufacturers of the device recommended an inflation time of 120 minutes. Yet, no research was conducted to determine if that time was effective. Anecdotally, there are variations on the inflation time with little evidence to support those choices. The ORBIT trial will compare the manufacturer's inflation time (120 mins) [Control} with a 60 minute inflation time.[Experiment]. Two cohorts of patients will be recruited: people only having a diagnostic procedure, and people who are having a procedure to open up a blocked heart artery. IT is hypothesized that there will be no difference in bleeding [Primary Endpoint} between the control (120 mins) and experimental (60 min) groups.

Melasma is a common disorder of hyperpigmentation, primarily affecting the face. It can affect all racial types but predominately affects women with darker skin types. The exact cause of melasma is unknown, but it is thought to be due to many things including pregnancy, hormonal contraception, and sunlight. Melasma can be very difficult to treat and often frustrating for the participant and doctor with evidence showing that it may adversely affect quality of life. Over the past decade, there has been growing use of topical, oral and injectable TXA in Asia. More recently, clinical research in Asia has shown promising results with oral tranexamic acid for the treatment of melasma. The dose used in melasma is less than that for menorrhagia. Typically 500-750mg daily is used for melasma. Despite promising results with oral TXA for the treatment of melasma in Asian studies, none have been conducted in the western world to date. You will be asked to come for 6 study visits. An initial screening visit will be followed (if you qualify for the study) by a review at weeks 0, 4, 8, 12 and 24. You will be randomly allocated into one of 2 arms. In the TXA group, participants will take two 250 mg tablet (this will be a 500mg tablet that will be broken into a half). This will be taken daily for 12 weeks from the baseline visit. Participants in the placebo arm will follow an identical protocol with placebo capsule, which does not contain the active medication. All participants will use sunscreen to the entire face during the day. After week 12 participants will stop taking the medication and continue sunscreen for an additional 12 weeks. The researchers will be providing all participants with a standard sunscreen of at least SPF 30. Participants will be instructed not to use any other medications for melasma during the study period. Although no adverse effects have been reported with TXA in pregnancy and no theoretical basis of risk exists, it has not been formally studied in pregnant women. Therefore, we requested to avoid becoming pregnant and use non-hormonal contraceptive methods during the study if you are sexually active. If pregnancy occurs please discontinue the study medication and inform the study investigators if pregnancy occurs. This study aims to determine how effective oral tranexamic is for melasma and also assess its safety.

The primary purpose of this trial is to evaluate the safety and feasibility of exercise in women who are either undergoing treatment or have recently completed treatment for Stage II+ breast cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, reside or work in greater Brisbane, and have been diagnosed with stage II+ breast cancer for which you are either still undergoing treatment, or completed treatment within the last 24 months. All participants must also report at least one cancer-related or treatment-related health condition, e.g. fatigue, obesity, high blood pressure etc. Study details All participants in this trial will be randomly allocated (by chance) to receive the exercise program at enrolment, or 12 weeks following enrolment. The exercise program lasts for 12 weeks and involves completing 150 minutes of moderate intensity aerobic and resistance exercise under the guidance of an accredited exercise physiologist (an allied health professional with expertise in prescribing exercise to people with chronic diseases). Supervised session (between 5 and 20 sessions) will be scheduled for a time and location that is convenient to each participant. Participants will be asked to report any side effects of the treatment and complete questionnaires and function/fitness testing to evaluate the exercise program. It is hoped that the findings from this study will inform physicians and patients on the safety and feasibility of exercise in breast cancer patients with a high disease burden, in the hopes that it may be prescribed as a safe and effective adjuvant therapy for these patients to improve function, quality of life and survival.

Type 2 diabetes mellitus and dementia are two of the commonest and most disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment (worsening memory, thinking, perception) common in patients type 2 diabetes, and a strong association between type 2 diabetes and Alzheimer’s disease, the most common form of dementia. Better markers are needed for the prediction of cognitive decline in people with diabetes. Left ventricular hypertrophy (LVH) is an enlargement and thickening (hypertrophy) of the walls of the hearts main pumping chamber, which is common in type 2 diabetes. To date there have been no studies on the association between LVH and cognitive decline in type 2 diabetes. The purpose of this study is to establish whether people with type 2 diabetes and LVH have increased rates of brain volume changes and cognitive impairment. An understanding of whether LVH is contributing to cognitive decline will allow us to identify patients at particular risk.

This knowledge translation (KT) study uses a pragmatic cluster randomised controlled trial (C-RCT) design that will measure the effectiveness and cost effectiveness of a facilitation intervention to improve nurses’ vital sign (VS) measurement, interpretation, treatment and escalation of patients with abnormal VS. We will compare outcomes and costs from standard implementation of clinical practice guidelines (CPGs) with facilitated implementation. This study will include both process and health economic evaluations.

Background & Project Aims Mental health disorders form a substantial proportion of overall disease burden in young people in all societies (Patel, Flisher, Hetrick, & McGorry, 2007). Internalising disorders, such as anxiety and depression, are consistently reported as the most common mental health problems amongst Australian children aged between 7 and 14 years and are often less likely to be detected compared to externalising disorders (Australian Institute of Health, 2012; Klein, Jacobs, & Reinecke, 2007; Letcher, Sanson, Smart, & Toumbourou, 2012; Seligman, Ernst, Gillham, Reivich, & Linkins, 2009). Poor mental health often begins in early adolescence (12 years of age), and a shift toward early intervention has seen some promise in preventing the trajectory of later diagnosable conditions as well as enabling adolescents to fulfil their potential (Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013). Within this context of rising mental health disorder incident rates, early interventions which target underlying contributors to poor mental health are likely to prevent later trajectories of disorders. Perfectionism has recently gained attention as is a transdiagnositic entity. This means it underlies many other series pathologies such as depression, social anxiety, generalized anxiety disorder, eating disorders and even personality disorders (Dimaggio et al., 2015; Holland, Bodell, & Keel, 2013). Perfectionism refers to a tendency to strive for flawlessness and set exceedingly high standards for performance, accompanied by tendencies for overly critical evaluations (Stoeber, Eklund, & Tenenbaum, 2014). Its transdiagnostic nature positions perfectionism to be an ideal target for early intervention in addition to low mood and social worry to prevent the longitudinal development of future mental health disorders. Self-compassion is a construct gaining prominence over recent years and may directly target the key features of perfectionism, low mood and social worry (Neff, 2011; Neff & Germer, 2013; Neff, 2010). Self-compassion refers to an adaptive way of relating to ones self when considering personal inadequacies or difficult life circumstances. Self-compassion has also been shown to be an effective intervention target for adolescents suffering from negative world views (Neff, 2010). When working with a non-clinical high school population, it is important to ensure content is relevant and engaging, and appropriate for this population. Thus the combined framework of ACT, CBT and positive psychology approaches have been adopted in developing a psycho-educational workshop series, COmpassionate Mind. In addition, high schools are an appropriate target for early intervention programs given their access to a large group and capacity for the provision of ongoing support. The current study seeks to evaluate the effectiveness of the Compassionate Mind program which targets self-compassion and mindfulness.

The purpose of the study is to improve how we teach doctors, nurses and midwives how to breath for babies not breathing at birth. The primary objective is to compare the leak from mask ventilation performed on a mannequin, after learning using a respiratory function monitor and after learning without using a respiratory function monitor. The design is a single centre, randomised controlled trial. The participants will be randomised to either the intervention group (neonatal mask ventilation taught with a respiratory function monitor) or control (standard teaching of neonatal mask ventilation). Adult health care professionals attending the Victorian Neonatal Resuscitation training program (a structured simulation training program, NeoResus) in the Royal Children’s Hospital during the study period will be eligible to participate. 382 (191 in each arm) participants are expected, over 2 years 3 months. The primary outcome is the difference in leak measured after neonatal mask ventilation training between the control and intervention groups. Secondary outcomes are difference in the volume of breaths, the stability of breaths and the number of obstructed breaths.

Introduction Degenerate intervertebral disc can cause back pain or neck pain and /or arm or leg pain (if compressing on the nerve root). Correlation between MRI scan findings of degenerate disc and back pain is poor. It is not uncommon to find poor correlation between arm or leg pain symptoms and degree of compression of the nerve root (on MRI scan). Inflammatory mediators have been implicated as the cause for this discrepancy. A few investigators have found infection of disc by low virulent organisms in these degenerate discs and in sciatica in a surprising 45% of cases. The organisms found are skin commensals and there is a high likelihood that these are contaminants. Treating all back pain or sciatica patients with long-term antibiotics is unreasonable and harmful without a strong proof of infection. Unfortunately these studies are underpowered and do not have a stringent contaminant control arm. Aims Primary: To find the rate of true infection in degenerate discs Secondary: To find the risk factors for true infection Proposal research design This is a case control study comparing incidence of true infection of intervertebral disc in degenerate disc disease patients undergoing spine surgery to patients undergoing spine surgery without degenerate disc (trauma/scoliosis/tumour). Methods All patients undergoing discectomy for various indications will be eligible to participate. At the time of surgery, disc removed as a part of the intended procedure (discectomy or fusion) will be sent for culture. A small amount of tissue generally removed as a part of the procedure (fat/muscle/ligamentum) will serve as contamination control and will also be sent for culture. Prolonged cultures will be performed to identify low virulent organisms. Data collected will include demographic data (age, sex, pre-existing health problems, diabetes, smoking, medications, immunocompromised status, smoking, family history etc), radiological data and type of surgery. If the disc culture is positive and other tissue culture is negative it will be assumed to be infected. But if the other tissue is also positive then it is presumed to be contamination. Two other arms were added to the original study: . 1. Contamination (Sham) arm: paraspinal cultures were also undertaken in patients undergoing spinal surgery without discectomy. We aim to obtain contamination rate from this cohort. 2. Histopathological arm: A subset of patients also underwent histopatholgical evaluation to review inflammatory changes in the disc samples. this was planned to augment the notion of disc infection in degenerated discs

This study aims to evaluate if patients undergoing pancreaticoduodenectomy (Whipple’s procedure) managed by intraoperative goal directed therapy with the Flotrac/Vigileo deviceTM will have a shorter length of hospital stay with fewer post-operative complications compared to patients managed by standard care. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo pancreaticoduodenectomy (Whipple procedure). Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will have their haemodynamic variables (fluid dynamic and blood flow) managed by intraoperative goal directed therapy (GDT) using the Flotrac/Vigileo deviceTM (FloTrac/Vigileo Version 3.02, Edwards Lifesciences, Irvine, CA, USA). This minimally invasive device automatically calculates key flow parameters every 20 seconds and recognizes and allows for adjustments in haemodynamic variables in patients undergoing major surgery. Importantly, it enables the anaesthetist to make a differential diagnosis leading to either a volume or cardiovascular intervention (preload, afterload and contractility), by providing continuous information on the patients cardiac output, stroke volume, and systemic vascular resistance. Participants allocated to the control group will have fluid management and inotropic use guided by the routine cardiovascular monitoring in place i.e. arterial line, and central venous catheter, which will be at the discretion of the anaesthetist, who will be blinded to Flotrac data. The Control group anaesthetist will be allowed to have the Flotrac haemodynamic data unblinded if needed for clinical decision making but patients will be removed from analysis if this occurs. There is now compelling evidence that fluid optimization and GDT in patients undergoing colorectal surgery leads to better outcomes, particularly in high risk patients. This study will contribute to understanding if similar benefit of GDT is also observed in patients undergoing major pancreatic surgery - pancreaticoduodenectomy (Whipples Procedure).