ANZCTR search results

The purpose of this study is to determine if an indwelling catheter is more effective than surgical pleurodosis in treating malignant pleural effusion. Who is it for? You may be eligible for this study if you are an adult who is suffering from symptomatic proven pleural malignancy or an otherwise unexplained pleural effusion. Study details Consenting participants will be randomised to one of two treatment arms: - Arm 1: Indwelling pleural catheter. A long term catheter is inserted under the skin in order to allow ongoing drainage of the pleural fluid. Participants will then be instructed to undergo a daily drainage regimen for 14 days at home. - Arm 2: Surgical pleurodesis. Participants under a key-hole surgery to remove fluid and facilitate lung re-expansion. Participants will then be followed up at discharge, 14 days, monthly for 6 months and then every 3 months up to one year post-procedure. These visits will include completion of Quality of Life questionnaires, a chest xray, an ultrasound (if thought necessary) and if you are at the lead site (Sir Charles Gairdner Hospital) a review of your Actigraphy logs up to 6 months after discharge. It is hoped this research will help to provide effective symptom control with minimal intervention for those with malignant pleural effusion.

The aim of this study is to compare the concentration of fentanyl between maternal and cord blood in women administered intranasal (IN) or subcutaneous (SC) fentanyl for labour analgesia. A prospective observational study will be conducted at Gawler Health Service. Fentanyl is routinely offered (via the intranasal or subcutaneous routes) to women requesting pain relief in labour at Gawler Health Service. Maternal and cord blood samples will be collected at the time of birth to determine the plasma concentration of fentanyl in order to assess the relative exposure of the neonate to the maternal administration.. Maternal and cord blood samples will be collected in heparin tubes, within 30 minutes of each other and refrigerated at 4°C. Tthe samples will then be processed at SA Pathology where they will be centrifuged at 3000 rev min-1 for 10 minutes, the plasma removed and frozen at -20°C until the time of assay.

The aim of this study is to compare the accuracy of the glenoid placement with use of patient specific, image-derived instrumentation to that of standard instrumentation in reverse total shoulder arthroplasty. There will be two study groups: Group 1 (n=25), Conventional surgical technique (without guides) Group 2 (n=25), Patient specific, use of image derived instrumentation guides. The null hypothesis for this study is that the use of patient specific guides for the glenoid component positioning will make no difference in the accuracy of component placement. A total of 50 patients will be recruited for the study. Sites for the study include Townsville Hospital and Health Services and Mater Health Services North Queensland Ltd.

The overall aim of this study is to determine the clinical utility, efficacy and cost-effectiveness of the QuikFix risk-targeted brief intervention for reducing Alcohol and Other Drug (AOD) use and related harm when delivered by AOD workers in real world settings. In Part 1, a RCT design will be used to randomise young people aged 16-25 years to clinicians who have been trained or not trained in the QuikFix intervention. Clinicians trained in QuikFix will deliver 2-4 telephone sessions of QuikFix using the 'Clinician Companion' website, with sessions including assessment feedback (AF), motivational interviewing and cognitive behavioural coping skills training, while clinicians who aren't trained will deliver assessment feedback (AF) and usual AOD care. Participants' AOD use and related harm, mental distress, and functional outcomes will be assessed at baseline, and at 6 weeks, 3, 6 and 12 month follow-ups. In Part 2, an evaluation of the implementation and supervision program as well as the e-QuikFix ‘Clinician Companion’ website which will support clinicians to implement the program will be conducted.

This study will test the efficacy of a teacher professional development intervention (Thinking While Moving in English) for enhancing teachers’ understanding and competency to plan, deliver and evaluate movement-based learning in primary school English lessons. Thinking While Moving in English will be designed to positively enhance a range of key educational and health-related outcomes: increased moderate to vigorous physical activity within the intervention session and the school day, reduce sitting time, improve classroom behavior

The purpose of this study is to explore the clinical impart of providing telehealth for palliative care patients in rural and metropolitan Victoria. Who is it for? You may be eligible for this study if you are an adult with a diagnosis of a life-limiting illness. Study details If you participate in this research you will be randomly allocated either to the telehealth consultation group or the "usual" care group in which we will simply ask you to complete questionnaires which will greatly assist us to assess and compare telehealth to usual care. The random choice is done using a dedicated computer program to ensure it is completely random. If you are in the telehealth group then your GP/palliative care community nurse will make an appointment with the specialist palliative care doctor based at the Monash Medical Centre in Clayton for a video conference. Our team will provide all the equipment needed for this to take place in your home. Before you begin, the specialists will already have your information, from your GP and nurse. It is hoped that this research will provide the basis for more extensive research. The system used for the video conference is a special dedicated system is completely confidential and nothing from the consultation is stored

Aim: To evaluate the anti-inflammatory, antioxidant and bioavailability of polyphenols in obese populations post-coloured rice consumption. Design/Participants: The anti-inflammatory, antioxidant properties and polyphenol bioavailability will be tested by collecting fasting and post rice consumption blood samples from healthy but sedentary obese (perform < 3 hours of exercise weekly, BMI > 30) participants. Methodology: Visit 1: Health screening and questionnaires (recruitment). Visit 2: Fasting volunteers will be cannulated and baseline blood samples (25 mL) will be obtained. Volunteers will then be fed a serving of cooked coloured rice 1 (200 g or one cup). Post consumption, blood samples will be collected at different time points (30 min, 1h, 2h, 4h)a second blood sample (25 mL) will be taken and analysed. Visit 3 & 4: Crossover for coloured rice 2 and coloured rice 3 respectively. All blood samples will be analysed for Aanti-inflammatory properties will be evaluated for( pro-inflammatory cytokines and lipid peroxidation); antioxidant properties will be evaluated using( total antioxidant assays) and bioavailability of polyphenols will be determined by( HPLC). Expected outcomes: Consumption of coloured rice rich in polyphenols might potentially alleviate biomarkers of inflammation and oxidative stress in obese population.

During shoulder surgery patients are positioned into an upright sitting position for optimal access to the shoulder joint. In some patients blood pressure may become low during surgery and a concern of the anaesthetist is whether sufficient blood reaches vital organs, including the brain. Chronic disease such as hypertension can alter the size and shape of a patient’s heart, placing them more at risk of low blood pressure during surgery. This study aims to assess the heart with ultrasound before surgery and to further examine the heart during surgery. This examination will enable the anaesthetist to anticipate a major change in blood pressure and treat it effectively. Such information can be used to better protect the patient.

Introduction: External cephalic version (ECV) is a procedure whereby a fetus is manually rotated, by applying pressure to the maternal abdomen, from a bottom/feet first position to the preferred head first position to enable safer vaginal delivery. Whilst safe and low-risk, it has been associated with moderate pain, in part, due to the lack of administered analgesia. To address this, research groups around the world have experimented with various modalities of relief, including regional anaesthesia, hypnosis, and systemic opioids; but have not produced any conclusive demonstration of benefit to date. As such, there is a clinical gap in addressing pain during the procedure. Virtual reality (VR) is a technological medium that is used to create simulated scenarios in which users are immersed and able to interact with through stimulation of the senses. In recent years, there has been a growing interest in medicine for its potential to provide pain relief. To date, positive results have been observed in patients requiring port access, venepuncture, chronic wound/burn dressing changes, and episiotomy. The mechanism responsible for this phenomenon is not yet fully understood, but is attributed to its ability to distract users from perceiving pain and also due to neurophysiological changes that result from long-term use. Given the potential of VR to facilitate analgesia and the lack of effective pain relief during ECV, this study will function as a proof-of-concept to determine if VR technology can be used to reduce pain perception during this procedure. Aims: 1) Investigate the effect of VR on: * Pain scores during ECV. * Physiological parameters during and after ECV. 2) Elicit patient opinion about using VR during the ECV procedure (ie. what do patients think?) and investigate potential side effects and their acceptability. Participants: In this study, 50 pregnant women will be recruited from the Breech Clinic at Monash Medical Centre. To be considered as an eligible participant, the women must fulfill the criteria outlined previously. Methods: Participants will be screened for inclusion into the study. They will then be randomly allocated to either, the control (no VR) group or the intervention (VR) group. Immediately prior to the procedure, routine monitoring and tocolysis will be performed. The ECV will commence after and patients will receive either, routine care or routine care with VR intervention. Post-procedure, vital signs will be evaluated. Questionnaires about pain perceived and device experience will also be provided. Expected Outcomes: A demonstrated potential for VR as an analgesic will be demonstrated by: * Reduced pain scores in the intervention (VR) group. * Minimal side effects. * Positive feedback about the device and content.

This study has its objectives: To evaluate the safety and tolerability of multiple oral doses of NPI-001 Tablets in healthy adult subjects; To evaluate the effect of food on the pharmacokinetics (PK) of NPI-001 following single doses, 1500 mg and 750 mg, in the fed versus fasted state; To characterize the pharmacokinetics of NPI-001 following multiple doses over 5 days, fed; To evaluate the effect of NPI-001 on potential biomarkers of the pharmacodynamic effect (protein carbonyls, GSH/GSSG, cysteine/cystine (Cys/Cys-Cys)). Study design: This randomized, double-blinded, cross-over study will include an evaluation of PK of NPI-001 in fed versus fasted healthy volunteers followed by a 5-day dosing period to ascertain if multiple doses of NPI-001 can alter GSH and CYS levels in plasma. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to first dose administration. Subjects will be resident in the clinical facility from the evening prior to first dose (Day -1) until discharge on Day 10. A post-dose follow up visit will occur at Day 15. On Day 1 and Day 3, each subject will receive a single oral dose of NPI-001 or Placebo. The dose levels of NPI-001 will be 1500 mg for Cohort 1 (6 tablets), and 750 mg for Cohort 2 (3 tablets). Dosing on Days 1 and 3 will be a placebo-controlled, balanced, two-treatment two-sequence randomized fasted/fed crossover design, as follows: • 8 subjects in each cohort (6 NPI-001, 2 placebo) will be dosed on Day 1 following a 10 hour overnight fast and on Day 3 following a high fat breakfast [Fasted-Fed]. • 8 subjects in each cohort (6 NPI-001, 2 placebo) will be dosed on Day 1 following a high fat breakfast and on Day 3 following a 10 hour overnight fast [Fed-Fasted]. On Days 5-9, all subjects will receive NPI-001 or placebo three times per day, at approximately 8am (following a standard breakfast), 2pm and 8pm, with the last dose on the morning of Day 9. The dose levels of NPI-001 will be 500 mg per dose for Cohort 1 (2 tablets), and 250 mg per dose for Cohort 2 (1 tablet). Safety measures monitored throughout the study will include adverse events and use of concomitant medication, vital signs, and clinical laboratory tests. Blood samples for assessment of PK will be collected on Days 1, 3 and 9, at pre-dose, then at 0.25, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post-dose, and on Days 2, 4 and 10 at 24 hours post-dose. Blood samples for assessment of PD will be collected on Days 1 and 3 at pre-dose and 1 hour post-dose, on Day 9 at 1 hour post-dose, and at the follow-up visit.