ANZCTR search results

Of interest to this study is the role specific species and strains of probiotics could play in reducing the incidence and/or severity of respiratory and gastrointestinal symptoms infections in elite team sport athletes who travel frequently. The impact of endurance exercise on immune function is well established with a body of research to support that in a significant number of athletes, the physical and mental stress endured by elite athletes can result in an increased susceptibility to gastrointestinal and respiratory infections. Furthermore, a number of trials have investigated the efficacy of supplementing with specific Lactobacilli and Bifidobacteria in reducing respiratory infections.

This study will evaluate the feasibility and safety of adjuvant chemotherapy in patients with oesophageal cancer who received neoadjuvant chemotherapy and undergone curative surgery. You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically proven adenocarcinoma of the oesophagus or oesophagastric junction. All participants will receive adjuvant cisplatin and 5-fluorouracil (CF) chemotherapy intravenously every 3 weeks for 12 weeks (4cycles). The intervention will start within 8-10weeks after the neoadjuvant CRT and surgery. Participants will be followed every 3weeks before each chemotherapy treatment for 12 weeks to determine the feasibility and safety of adjuvant CF chemotherapy . After completion of treatment, follow up would be every 3months for 3 years to the 1 year and 3 years disease free survival.

The primary aim of this project is to evaluate the effectiveness of shoe stiffening inserts in the treatment of pain associated with osteoarthritis of the first metatarsophalangeal joint (MTPJ) of the foot. This study is a parallel group, participant- and assessor- blinded, randomised controlled trial with a 52 week follow-up. Ninety participants will be randomised to a control group (‘sham’ shoe inserts) or an experimental group (shoe stiffening insert(s). Both groups will be prescribed the same ‘rehabilitation therapy’ program. Primary and secondary outcome measures will be collected at baseline and at 4, 12, 26 and 52 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include foot-related disability, severity of foot pain when walking, self-reported magnitude of symptom change, level of physical activity, health-related quality of life, and use of paracetamol rescue medication and co-interventions.

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.