ANZCTR search results

Pregnant tobacco smokers with substance use problems are a highly vulnerable and priority population with an over-representation of Aboriginal women. To date, smoking cessation rates are negligible in this target group with few existing effective interventions to support them to quit smoking. This study aims to assess the feasibility and acceptability of the addition of current evidence-based smoking cessation care to routine prenatal care of women attending a substance use in pregnancy clinic. The package of care consists of financial incentives contingent on validated smoking reduction and abstinence; counselling for tobacco use in pregnancy and nicotine replacement therapy (short and long acting), tailored to individual needs. The intervention is single armed, using pre-post comparisons. A group of 100 women recruited from two NSW Health Substance Use in Pregnancy and Parenting Service (SUPPS) antenatal clinics will be provided the intervention. Comparison data will come from the electronic medical records of a historical control group comprising of women attending SUPPS antenatal services for one year prior to the commencement of the study. The study’s primary objectives are to: I. Assess the feasibility of addressing tobacco smoking amongst this population II. Evaluate the acceptability of addressing tobacco smoking and the intervention components among participants and staff of a substance use in pregnancy service. Its secondary objectives are to: I. Calculate the cost effectiveness of implementing the intervention into antenatal healthcare of women attending a substance use in pregnancy service II. Measure changes in tobacco smoking behaviours of study participants III. Examine the pregnancy and postpartum outcomes of study participants in comparison to those of a historical control group IV. Examine neonatal outcomes of infants born to study participants in comparison to those of a historical control group

Participation will entail answering a questionnaire and undergoing lower limb angiogram in which the Siemens Syngo PBV software will be used. It is important to emphasize that all included patients would undergo angiogram regardless of the study and that the participation on the study will allow the use of Siemens PBV software as adjunct during revascularisation and to have wound photos taken prior to revascularisation and during follow-up appointments. Clinical management, investigations and follow-up will be conducted as per standard of care practices. There is no requirement for additional follow-ups or tests as result of participation in the research. At recruitment Lower limb perfusion will be assessed using toe pressures and/or transcutaneous oxygen pressure and the WIfI classification system will be used to more precisely stratifying patients according to their initial disease burden. These are clinical information that are routinely obtained in the management of patients with diabetic foot ulcers. The WIfI classification was proposed in 2014 by the Society for Vascular Surgery for assessment of treatment limb which is especially applicable of patients with diabetic foot ulcer. The WIfI classification is intended to define the disease burden and allow accurate outcomes assessments and comparisons between similar groups of patients and alternative therapies. The WIfI classification system assesses three key components of a threatened limb (wound, ischemia, and foot infection), each with four grades of severity (none, mild, moderate, and severe) to predict the 1-year risk of amputation and benefit of revascularisation. WoundVue camera will be used for more accurate and reproducible assessment of wounds. It is a hand-held portable device that takes 2D and 3D images of wounds to objectively monitor wound healing. The device algorithms are able to interpret tissue types and automatically provide surface, volume and depth measurement. All participants will undergo an endovascular revascularisation procedure which will be performed by a Vascular Surgeon (Prof Robert Fitridge, Dr Ewan Macaulay, Dr Joseph Dawson, Dr Michael Herbert or Dr Kurian Mylankal) with vast experience in this procedure. The revascularisation aims to restore perfusion to the affected foot and subsequently promote wound healing, help to resolve infection and avoid or limit level of amputation. PBV which indicates the distribution of blood in lesions and surrounding tissue by means of color-coded cross-sectional blood volume maps will be assessed before and after angioplasty/stenting. Data on foot wound status, treatments administered and outcomes (wound healing or amputation) will be collected during follow up visits over 12 months. WoundVue camera will used for more accurate, frequent and reproducible assessment of wound healing. Details of data to be collected are giving in baseline data and follow up data forms

Aims: The aim of the proposed pilot RCT is to determine feasibility and efficacy of a strategy where MAP targets during management of shock in ICU are individualized for each patient based on his/her pre-illness MAP. Primary objective: To determine if, compared to standard care, among patients with shock in ICU, a strategy of targeting patients’ pre-illness MAP would substantially reduce the degree of BP-deficit during vasopressor therapy and result in lower rise in peak creatinine within the first 5 days of randomization. Secondary objectives: To compare the percentage time spent with at least 20% BP-deficit, and to compare area-under-curve for the change in serum cystatin C during the first 3 days of randomization in both arms. Other outcomes would be day 14 mortality, incidence of MAKE 14, time to death through day 14, renal replacement therapy (RRT) free days until day 28, and time to death through day 90. Methods: This is a prospective pilot multicenter RCT at academic ICUs. The study will randomly assign 50 patients to either standard care or to an individualized MAP target strategy. Besides demographics, severity score and clinical outcomes, the study will collect four hourly data on MAP-deficit i.e., the difference between pre-illness MAP and achieved-MAP, during the first five days of vasopressor therapy.

Background and justification. Inpatient rehabilitation is a hospital inpatient service that maximises patient's function prior to discharge from hospital by using an intensive daily therapy program. Sarcopenia is a medical condition characterized by low muscle mass and function, and it occurs in 5% to 50% of adults who live in the community (that is, not in hospitals, nursing homes or other institutions), depending on their age. Sarcopenia is associated with greater functional dependence and disability, which means that people who have it are more likely to need help from others or have difficulty with such basic everyday tasks as waling or taking a shower. The frequency with which sarcopenia occurs in inpatient rehabilitation is not known. Aim. The aim of this project is to investigate the prevalence of sarcopenia (or the frequency with which it occurs) in inpatient rehabilitation. Participant group. All cognitively intact patients who are admitted to inpatient rehabilitation unit of a tertiary referral inner metropolitan hospital will be eligible to participate in the study. Method. The patients will be assessed for the presence of sarcopenia. Expected outcomes. The anticipated outcome of this project is identifying the prevalence of sarcopenia in inpatient rehabilitation, both in the overall population and in diagnostic subgroups. Better understanding of this issue may lead to more appropriate clinical management of patients with sarcopenia in the setting of an inpatient rehabilitation unit.

This study aims to assess the safety and tolerability of Topical Endoxifen when administered as a topical application to the breast of healthy male volunteers. Who is it for? You may be eligible to join this study if you are a healthy male volunteers aged between 18 and 65 years Study details: This is a double-blind, placebo controlled, dose escalation trial investigating the safety and pharmacokinetics of Topical Endoxifen applied to the breasts of healthy male volunteers. Three dose levels of Topical Endoxifen will be investigated in 3 cohorts. In each cohort, participants will be randomized to receive Topical Endoxifen or placebo in a blinded fashion.

The study aims to investigate whether treatment with long-acting naltrexone implant (OLANI) as well as counselling is more effective than just counselling for preventing relapse to regular amphetamine use. Additionally, we are investigating the effect of naltrexone implant treatment on utilisation of WA Health Services (Hospital admissions, Emergency Department presentations and Mental Health services) in order to assess cost savings and cost effectiveness.

Standard treatment for metastatic prostate cancer involves a course of Androgen Deprivation Therapy (ADT). ADT controls disease in about 95% of men for approximately 18 months, however, it can cause considerable side effects that decrease patients quality of life. Stereotactic Ablative Radiotherapy (SABR) has been shown to offer good cancer control rates of around 80% and progression-free survival at two to five years in the vicinity of 20-30% compared to standard RT, while offering the potential benefits of avoiding unpleasant symptoms that may arise from disease progression or side effects from ADT. In our institutions experience, SABR either as a first line therapy, or second line therapy in men who have progressed on hormone therapy, shows a substantial proportion of these patients responded very well, with some men not yet required hormone therapy or actually ceasing further hormone therapy. The TRANSFORM study is a single-institution, non-randomised, open-label, prospective phase II study that will recruit patients with radiologically confirmed hormone naïve or castration resistant oligometatstaic prostate cancer with the primary aim of measuring the proportion of patients not requiring treatment escalation at 5 and 10 years following SABR, respectively. The TRANSFORM study also aims to measure several secondary outcomesincluding time to treatment escalation, Prostate Specific Antigen (PSA) response, and grade 3 SABR related toxicities. Patients will be required to undergo a screening and follow up process (for up to ten years post treatment) that involves physical exams, blood and PSA tests, multiple scans (CT, MRI and PET) as well as questionnaires that help determine how effective the treatment(s) have been in controlling their disease and how that has impacted on their health and lifestyle.

Phlebotomy is a central task performed by the Blood Service for the collection of whole blood, plasma and platelets from its voluntary blood donors. Currently there are no publications regarding how to routinely and systematically assess donor veins and the impact vein quality has on the success of blood donation. In the last 12 months up to 4% of phlebotomies attempted were unsuccessful. In addition, inadequate venous access resulted in needle dislodgement, underweight collections, protracted bleed times, component discard and substantial wastage of blood collected. The purpose of this study is to formally validate an internally developed vein score assessment tool to assess a donor's vein suitability for phlebotomy. The study will examine the extent of inter-rater variability in vein assessment between phlebotomist's and determine whether a score at or below a certain level is predictive of failed phlebotomy, needle dislodgement, underweight donation and prolonged donation duration.

The purpose of this research is to determine if the ability and sensitivity of adults to carbohydrate and sweet taste can modify how their body uses carbohydrate as an energy source. In this project, study participants will attend three morning sessions in total, separated by 3 or more days, after they have fasted overnight. Upon arrival to the research facility, participants will have their weight and body composition measured using a weighing scale, then asked to rest for 30 minutes before their resting energy expenditure is assessed with a machine that measures oxygen usage and carbon dioxide produced. This measurement involves the placement of a clear hood over the participant’s upper body. After the initial measurement, participants will drink a carbohydrate beverage, followed by the rinsing of their mouth with a carbohydrate solution, a sugar solution or water. After the oral rinsing, participants will continue the measurement of energy expenditure using the same machine for 90 minutes.

A 5ml slip-lock syringe with a fluorescent red plunger was introduced in Australia and New Zealand in the mid-1990s for use with muscle relaxants. Its aim was to reduce drug errors involving muscle relaxants in anaesthesia. To our knowledge, the impact of this syringe has not previously been formally evaluated. Reporting of drug errors is not mandatory in Australia and New Zealand, so it would be very difficult to determine if introducing the syringe has reduced patient deaths and suffering. The use of the syringe is not mandated. Our hypothesis is that most anaesthetists and trainees in Australia and New Zealand value the red plunger syringe as a drug safety intervention, and choose to use it voluntarily. We aim to test this hypothesis by surveying a large stratified random sample of anaesthetists and trainees across Australia and New Zealand. The survey will ask participants about availability, patterns of use, and attitudes towards the syringe. Suggestions for improving the syringe to better meet the needs of anaesthetists and trainees will also be sought. We also intend to undertake a retrospective analysis drug errors involving muscle relaxants that have been voluntarily reported to the WebAIRS recording system in Australia and New Zealand. The purpose of this is to determine if and how the red plunger syringe was used in each case.