ANZCTR search results

This study aims to test the ability of a high protein / high soluble fibre drink to reduce the rise in blood glucose levels in people with type 2 diabetes following a high carbohydrate meal when taken 15 minutes before that meal, and subsequently show that daily supplementation of the drink can reduce blood glucose levels in the long term (3 - 6 months).

In healthy reproductive-aged women, circulating testosterone is produced by the ovaries and adrenal glands. The main cause of lowered testosterone levels in women is the natural decline with age, hypopituitarism, adrenal insufficiency, premature ovarian failure, bilateral oophorectomy, oral glucocorticosteroid therapy, and oral oestrogen therapy. Biological data support important physiological effects of testosterone in women. Studies have shown testosterone therapy in women who have low testosterone levels and a reduced libido improves sexual desire and general well-being. Testosterone replacement therapy has been used for many years utilising different routes such as injection, cream, gel and implant. Transdermal administration of testosterone has the advantages of avoiding the potential hepatic toxicity of oral androgens, is easily discontinued, and allows more physiological control of testosterone levels than subcutaneous implants. However, transdermal administration of testosterone in the form of a cream has the potential advantages of greater flexibility of dose adjustment and the absence of discomfort and irritation which may occur with other transdermal therapy such as a patch. Androfeme cream is currently the only available testosterone product in Australia with widespread use in clinical practice. No study has investigated the pharmacokinetics of the current dispensing method for Androfeme. Androfeme is supplied with a dose applicator calibrated in 0.5ml graduations. Each 0.5ml delivers a 5mg dose of testosterone. The patient should be directed to measure the appropriate dose using the graduated applicator and then apply to the skin. Presently patients are asked to commence with a 0.5ml dose (5mg) but we have no idea whether this dose is sufficient or whether a 1.0ml dose (10mg) is needed to achieve the desired blood levels for a therapeutic effect. This study will, for the first time, compare the pharmacokinetics of two doses of Androfeme in postmenopausal women: 0.5ml (5mg) and 1.0ml (10mg).

Background Between 17 and 45% of patients admitted to an Intensive Care Unit (ICU) are reported to receive a red blood cell (RBC) transfusion and these transfusions comprise almost 20% of all RBC use in Australia. Although RBC transfusion may be life-saving in patients with major haemorrhage, the majority of patients transfused in the ICU receive RBCs for other indications including minor haemorrhage, anaemia and augmentation of cardiac output. Observational studies in critical illness identify RBC transfusion as an independent and dose-dependent risk factor for mortality and serious morbidity including transfusion-related lung injury, transfusion-associated circulatory overload, transfusion-related immunomodulation and infection. In addition to the associated risks, transfusion is also costly. The product cost of transfusing a single RBC unit in Western Australia (WA) is $370 and the total cost is $875 and increasing. There is evidence that current ICU clinical practice complies with the National Health and Medical Research Council (NHMRC) Guidelines on restrictive RBC transfusion thresholds. As such, there is little scope to reduce transfusion through better compliance with existing evidence. Novel interventions to reduce transfusion requirement in critically ill patients are therefore required urgently. Intravenous (IV) iron has been shown to be effective for the management of iron-restricted erythropoiesis, reducing RBC transfusion, in multiple well conducted RCTs in a number of patient groups. If IV iron reduces transfusion requirement in patients admitted to the ICU it will represent a promising candidate intervention to also reduce mortality and serious morbidity. However, its clinical and cost-effectiveness in patients who are critically ill in the ICU is uncertain. Aim The primary aim of the study is to determine if the administration of IV iron compared with placebo to patients admitted to an ICU and who are anaemic reduces RBC transfusion prior to hospital discharge. The secondary aim is to determine if a phase III RCT of IV iron is warranted with such a trial having the aim of determining whether IV iron, compared to placebo, results in improved patient-centred outcomes. Objectives To determine whether the administration of IV iron in patients who are admitted to an ICU and are anaemic will: 1. Reduce the mean number of transfused RBC units 2. Improve clinical outcomes including mortality at hospital discharge and duration of admission to hospital and ICU 3. Be cost-effective Methods The proposed study will be a blinded, parallel group, phase II randomised trial comparing IV iron with placebo in patients admitted to the ICU and who are anaemic. Participants will be eligible if they are within 48 hours of admission to the ICU, have had one or more measurements of Hb <100g/L within the preceding 24 hours, are expected to require ICU care beyond the next calendar day, and fulfil none of the exclusion criteria. Participants will be randomised in a 1:1 ratio to the intervention or placebo group. Participants randomised to the IV iron group will receive 500mg of ferric carboxymaltose. Participants who are randomised to the control group will receive an equivalent volume of IV 0.9% saline. The intervention will be blinded to study staff and clinical staff caring for the patient. The study will be conducted in 4 metropolitan ICUs in Perth WA comprising Fremantle Hospital, Joondalup Hospital, Royal Perth Hospital, and Sir Charles Gairdner Hospital. Outcomes The primary end-point is the mean number of RBC units transfused. The study will also investigate the effect of intravenous iron on mortality and major morbidity as well as the costs and cost-effectiveness of IV iron.

Research over the last decade has shown that less sitting throughout the day is associated with a decreased risk of many chronic conditions such as type 2 diabetes, heart disease, and some cancers. While at work, office workers report high levels of sitting time, mostly due to the nature of their computer and desk based jobs. Height-adjustable workstations may provide a means of reducing sitting time at work. However, the most effective way to introduce such workstations to organisations is yet to be established. That is, whether the installation of height-adjustable workstations alone is sufficient to reduce sitting time in office workers, or whether additional aspects of the workplace (including indiviudual staff and managers, organisational social norms etc) need to be targeted as well. The objective of the Stand Up UQ study was thus to evaluate (in a three-arm study) whether a multifaceted intervention involving height-adjustable desks and organisational and individual behavioral change elements leads to greater reductions in objectively measured workplace sitting when compared to the use of height-adjustable workstations alone (and in comparison to a control group).

This study looks at: 1. The safety of two different dose levels of Veliparib when it is given together with WBRT 2. To determine if participants benefit more with veliparib and WBRT compared to placebo (a substance that looks like the real medication but has no active ingredients) and WBRT. Who is it for: Patients with brain metastases from non-small cell lung cancer. Trial details: Participants will take Veliparib/Placebo orally twice per day, every day while receiving WBRT. Participants will also dose the day following the last day of WBRT. Participants will then have monthly visits for 9 months, followed by visits every 3 months for up to 2 years.

The aim of this study is to evaluate the benefits of a new parasternal technique for continuous infusion of ropivacaine after coronary artery graft surgery (CAGS) in an Australian cardiac surgery population for adjunctive pain management. A randomised, double blind, pilot study using this technique is designed to be the pilot for a larger, multicenter trial. This pilot study will determine feasibility of, and provide evidence and a framework for a large, blinded, randmoised controlled, extension trial powered to show improved pain management. Reduction of pain can improve the treatment of cardiac surgical participants by enabling earlier extubation, allowing fast tracking of participants to a High Dependency Unit (HDU) bed on the ward, thereby reducing the need for intensive care beds. This would have potential important impact on cost, waiting times and through-put of cardiac surgery cases.

This is a prospective single arm study. Hypothesis Primary hypothesis is that patients are able to comply with the use of vaginal dilators after radical chemoradiation for anal cancer. Secondary hypotheses include that the use of vaginal dilators reduces grade 3-4 vaginal toxicity (stenosis), and therefore improves vaginal health, sexual function and quality of life. Inclusion Criteria Inclusion criteria are age greater than 18 years, female, histologically-proven non distant metastatic anal cancer (squamous cell carcinoma or adenocarcinoma), suitable for treatment with radical pelvic radiotherapy to greater than 45 Gray with or without concurrent chemotherapy (Mitomycin C (MMC) and/or 5-Fluorouracil (5FU). Exclusion Criteria Participants with pre-existing psychiatric illness or who had abdominoperineal resection are excluded. Radiation Therapy Treatment The standard regimen consist of external beam radiotherapy to a total dose of 50.4 to 54Gy using a three-phase technique. From 2011, some participants are treated with a two-phase Intensity Modulated Radiotherapy Technique (IMRT). Chemotherapy Treatment Standard concurrent chemotherapy consists of infusional 5FU 1g/m2 for 4 days in week 1 and 5, with MMC 10mg/m2 on day 1. Some participants will receive protracted infusional 5FU (PVI 5FU) 300mg/m2 for 96 hours each week. Device Vaginal dilators are smooth rigid cylinder-shaped pieces of plastic. There are four standard sizes of varying diameters. They are used with a lubricant or oestrogen cream. Standard recommendation for their use: initiate insertion within 6 weeks of completing chemoradiation; insert 3 times per week for 5 minutes duration. Follow-up Schedule At the completion of chemoradiation, participants will be reviewed at 4 weeks; and 3, 6, 9, 12, 18, 24 and 36 months. Sample Size and Duration A pragmatic sample size of forty participants will be accrued for this trial. The anticipated duration to complete accrual is 30 months. Participants will undergo 6 weeks of chemoradiation and then 3 years follow up. The total study duration is therefore expected to be 68 months. A planned interim analysis will take place after 15 participants have completed 12 months follow up.

This project will investigate the efficacy of intermittent or interval exercise training compared to graded exercise (steady state or constant load) for individuals with Chronic Fatigue Syndrome. Current evidence suggests that the graded exercise combined is beneficial for CFS, but there has been no research investigating intermittent exercise effects with CFS. Intermittent exercise has been shown to improve functional capacity with reduced perceived exertion and symptoms in individuals with cardiovascular and pulmonary disease, and it may be a more effective exercise strategy than graded exercise, as the exercise intervals are alternated with short periods of rest or very low intensity exercise. The project is a 12 week randomised controlled study, comparing intermittent, graded and control (usual care) groups. Efficacy of each type of delivery of exercise will be measured by outcomes such as aerobic capacity, exercise duration and tolerance, symptoms (pain and fatigue), perceived exertion, quality of life, immune cell counts and function, inflammatory cytokine responses, physiological adaptations and functional capacity for activities for daily living (ADL). Participants will exercise on a cycle ergometer in a supervised health clinic for three sessions per week. Outcome measures will be assessed pre- and post-training; resting and recovery heart rates, blood pressures and exercise Rate of Perceived Exertion (RPE) will be recorded at each exercise session. Participants will also keep an exercise and symptom diary to record muscle and general fatigue, weakness and pain (if any) on exercise and rest days. Data will be statistically analysed using ANOVA and Cohen’s Effect size (SPSS). The results will be applicable to CFS and other chronic disease-related fatigue sufferers (e.g. cancer and cardiac patients), and will contribute to further larger grant applications to NHMRC and ARC.

To study the clinical pharmacology of a number of drugs in overdose. Many medications behave differently in overdose than in clinical situations. There is limited data on the pharmacokinetics and dynamics of many new drugs in overdose. This study aims to model drug concentration and clinical effects from data collected from overdose patients

Research Question: Does splinting and early mobilization in the dart-throwers plane of motion improve functional outcomes and reduce postoperative complications in people after scapho-lunate ligament repairs? Hypothesis: A dynamic splint configured to allow motion only in the dart thrower’s plane applied after plaster cast removal (this is determined by the surgeon according to operative technique, and is usually 6 weeks post surgery, but can be 4-10 weeks post surgery)will result in faster return to usual activities (including self-care, work and recreation) better patient ratings of function, less pain, and less post-operative complications than a static splint. Aim/s: To compare outcomes between two groups of patients – one of whom received the dynamic splint, the other the static splint at 12 weeks post scapho-lunate ligament repair - to determine whether patients recover more quickly, and rate their function and pain differently; and To see if a larger multi-centre study is feasible. Both groups will be advised that splints are to be removed only for hygiene and 2 hourly exercise program for 4 weeks, after which time it is phased out over the following 2 weeks. This means it is taken off for light activity at first, then ceased altogether.