ANZCTR search results

Post-operative ileus (POI) is characterized by impairment of bowel motility and is a common complication after major abdominal surgery in general, and after colorectal surgery in particular. The principal features of POI include nausea and vomiting, inability to tolerate diet, significant abdominal distension and delayed passage of flatus and stool. POI as a complication has the largest overall effect on length of postoperative hospitalization. The purpose of this phase II trial is to determine the safety and effectiveness of oral pyridostigmine after elective colorectal surgery. We hypothesise that, within an optimised Enhanced Recovery Protocols (ERPs) setting, giving oral pyridostigmine to patients post-operatively will result in a reduction in the duration of postoperative Ileus.

This study will determine the pharmacokinetics and safety of the controlled released formulation of Lanreotide acetate in healthy male volunteers Who is it for? You may be eligible to join this study if you are male, aged 18-50, and in good general health. Study details After a screening period beginning up to 28 days before admission to the Clinical Research Unit (CRU), 8 participants in this study will receive one injection of Lanreotide acetate at a dose of 60mg. In the absence of safety issues, the remaining 8 participants will receive one injection of Lanreotide acetate at a dose of 120mg. As part of the study, participants will undergo safety assessments, Plasma/serum pharmacokinetic and global local tolerance assessment. Participants will be admitted to the CRU until day 2. Compared to the product already available on the market, this new lanreotide formulation [Lanreotide CRF] allows for a more convenient administration for both the patients and caregivers. The Lanreotide CRF is provided in a shorter and standard pre-filled syringe and a smaller needle is used for the injection (21G needle). In terms of PK profile, an equivalent performance is expected for the new Lanreotide CRF formulation when compared to the marketed product. It is hoped this research will determine whether this new lanreotide formulation can be administered safely without causing severe reactions. Once the PK profiles and safety have been determined in healthy volunteers, additional trials investigating the efficacy of Lanreotide CRF as a treatment for patients with neuroendocrine cancer or acromegaly may proceed.

In this feasibility trial, we will create a version of Aussie-FIT, a men’s health program that uses the appeal of sport to engage men, adapted for cardiac patients’ needs. We aim to recruit 72 participants; 36 men will complete “Aussie-FIT” and 36 will receive “usual care”. The Aussie-FIT program will consist of workshops on healthy eating and building physical activity habits, and will offer a range of exercises, ball skills and circuit training. We will take pre- and post- assessments of weight, diet, physical activity, well-being and biomedical markers of cardiovascular risk. The project will provide pioneering evidence of the feasibility and acceptability of this program among cardiac populations and will set the stage for a future, fully powered trial to assess the potential role such programs to complement existing cardiac rehabilitation options.

This will be a first-in-human safety and tolerability trial of a novel ophthalmic solution for the treatment of the visual disorder myopia (short-sightedness). Myopia has been hypothesised to be driven by a reduction in dopamine levels within the eye. Over the past five decades, levodopa (the precursor to dopamine) has been the primary treatment for neurological disorders involving the dysregulation of the dopaminergic system, such as Parkinson’s disease. Before we can examine the efficacy of this compound at inhibiting myopia, this study will assess the safety and tolerability of levodopa as a reformulated eye drop solution.

Parents with Borderline Personality Disorder (BPD) appear to experience additional burden in their parenting role than those with other mental illnesses (Eliot et al., 2014; Newman et al., 2007). Additionally, individuals with BPD frequently report their own history of childhood maltreatment, which they may find activated in their role as parents. Parenting stress has been shown to mediate the relationship between maternal history of maltreatment and parenting sensitivity (Pererire et al., 20120), and can influence a parent’s capacity to mentalise, that is, the capacity to be attuned to the mental states in self and others (Nolte et al., 2013). Parenting behaviours are, however, amenable to change, and these changes may have positive effects on children’s outcomes, especially when parenting skills deficits are targeted during early development (Stepp et al., 2011). Given the body of research outlining difficulties and impairments faced by parents with BPD, there is a significant dearth in literature on the efficacy of parenting interventions for personality disorders, with even less exploring parenting interventions specifically tailored for individuals with personality disorder. The current trial was therefore aims to compare, in parents with BPD, a brief parenting intervention versus treatment as usual, in terms of parenting stress and parental mental health functioning.

While a significant volume of research and resources are devoted to the diagnosis and management of myocardial infarction, chronic myocardial injury represents a far greater proportion of patients with high-sensitivity troponin T threshold above the upper reference limit of >14ng/L. In South Australia almost a third of patients presenting to emergency services have elevated troponin levels, of which approximately 40% are eventually diagnosed with chronic myocardial injury and are associated with greater rates of late cardiovascular deaths and events. Despite the overwhelming burden of chronic cardiac injury, currently no evidence-based recommendations exist for the management of these patients. SGLT-2 inhibitors such as dapagliflozin have shown to reduce heart failure related rehospitalisations and cardiovascular-related mortality among both patients with established diabetes and heart failure as well as patients with heart failure in the absence of diabetes, representing an exciting opportunity to improve the outcomes of patients with cardio-metabolic disease. This study will evaluate the impact of dapagliflozin on the cardiac biomarkers of myocardial injury among patients with chronic cardiac injury.

Smoking in the perioperative setting leads to increased surgical and anaesthetic complications. It has been demonstrated that by reducing perioperative smoking rates it can lead to a reduction in these complications, resulting in better outcomes for both patients and health care systems. Undergoing an operation creates a unique encounter between the patient and a variety of health-care professionals. It occurs at a time when patients maybe more receptive to lifestyle changes and provides an opportunity for a “teachable moment” when the patient may be willing to adopt and sustain a positive behavioural change. This project will utilise deliver a m-Health smoking cessation intervention opportunistically targeted to a time point at which patients have been shown to be particularly receptive to behaviour change (before a surgical procedure). Inclusion criteria will be patients booked for surgical procedures in a large metropolitan hospital who have a self-reported history of smoking. Inclusion criteria include access to an active mobile phone and ability to understand written English. Participants will be randomised 1:1 in a single blinded randomised control trial to either usual care, or usual care plus a 12 week smoking cessation intervention delivered via 4 SMS messages per week. SMS messages will include 24 smoking cessation messages and 24 general message which include 1) healthy lifestyle (i.e. diet and physical activity) and 2) information specific to Westmead Hospital pre-admission and surgical services (eg. Parking locations, typical clinic duration, items to bring etc.)

This study will investigate a new drug, sodium selenate, for the treatment of progressive supranuclear palsy (PSP). Up to 70 patients with PSP will be recruited in to the study. Half of the patients will receive 52 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The main outcome of the study will be the change in volume of specific brain regions over 52 weeks, comparing the treatment group to the placebo group. Additional outcomes will look at the overall safety and tolerability of the treatment, the change in mean diffusivity (a measure of neurodegeneration) on MRI, and the rate of disease progression observed in patients over the 52 weeks of treatment.

This study is a prospective, randomized, double-blind, placebo-controlled, Phase 1 clinical study to evaluate the safety, tolerability, PK and PD of single oral ascending doses of iN1011 N17 in healthy subjects. This study will be conducted in approximately 80 healthy subjects in up to 10 sequential dose cohorts. Ten cohorts will consist of up to 8 subjects including 2 subjects receiving placebo and 6 subjects receiving iN1011 N17, after at least 10 hours of fasting. iN1011 N17 will be administered as a capsule or in a suspension formulation, with matching placebo.

AIR is an observational study that aims to determine if oxygen saturations (SpO2) of newborn infants 32 to 36 weeks gestation can reach recommended levels suggested by international expert guidelines. Currently, international guidelines recommend that respiratory support for newborn infants at or above 35 weeks gestation and those between 32-34 weeks gestation be initiated with air (21% oxygen) and 21-30% oxygen, respectively. For the first 10 minutes of life, guidelines also recommend that the amount of oxygen given to the infants should be adjusted to target SpO2 of healthy, full-term infants. This is part of multicentre study of hospitals in New South Wales Australia aiming to recruit 200 babies.