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The Safety And Feasibility of Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC) in the treatment of Unresectable Disseminated Peritoneal Malignancy
The aim of this study is to assess feasibility, tumour response, adverse events, and quality of life of aerosolised chemotherapy in peritoneal cancer/s Who is it for? You may be eligible for this study if you are ages 18 or above and have clinical confirmation of unresectable peritoneal carcinomatosis from gastric, pancreatic, appendiceal or colorectal cancer Study details This study is for patients who have unresectable peritoneal metastases and have not responded to standard systemic chemotherapy. All eligible patients will receive the intervention. In a operating theatre, your belly/abdomen will have chemotherapy pumped directly into it. This study will involve blood tests, imaging, questionnaires and physical examinations. It is hoped this research will demonstrate the safety and effectiveness of this technique in the management of peritoneal metastases.
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The safety and effectiveness of tendon release in healing toe ulcers
The purpose of this study is to assess the effectiveness of the percutaneous flexor tenotomy when performed in the outpatient setting in people with diabetes, digital deformity and loss of protective sensation with a toe ulcer or pre-ulcerative lesion. Percutaneous flexor tenotomy is a minimally invasive procedure that involves cutting one or both tendons underneath the toe using a fine scalpel blade or needle. The procedure serves to remove the deforming force that causes deformity of a toe that generates an ulcer. Percutaneous flexor tenotomy is an alternative to conventional open surgical procedures performed in an operating theatre. Participants enrolled in the study are reviewed weekly until the percutaneous incision is healed, or until ulcer healing. Participants are then followed up at 3- and 6-months post procedure. The time to ulcer healing, re-ulceration rate, frequency of complications, such as infection or transfer lesion (a new onset ulcer or pre ulcerative lesion on an adjacent toe) and patient satisfaction are recorded.
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This study looks into the effects of FDY-5301 in relation to skeletal muscle loss after full knee replacement.
This is a phase 2, randomized, double-blind, placebo-controlled study of intravenous FDY-5301 in tourniquet induced sarcopenia in patients undergoing unilateral TKA. Study patients will be recruited at each investigational site (or referred to the investigative site from another institution) for first unilateral TKA. Patients will be screened and written informed consent will be obtained prior to initiation of any study related procedures in those patients who meet the inclusion and exclusion criteria for the study. A minimum of 30 evaluable patients will be enrolled and randomized to receive either FDY-5301 1.0mg/kg or volume-matched placebo. Study drug administration will occur by bolus injection at any time between 10 and 5 minutes prior to tourniquet release/limb reperfusion. All patients who receive study drug and have tourniquet use will be followed up for safety and efficacy for 6 weeks post-study drug administration.. Patients who do not undergo toirniquet inflation for any reason who received study drug will be followed up for safety, but will be replaced with a new patient.
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The Australasian Malignant PLeural Effusion (AMPLE) Trial - 3: A Randomised Study Comparing Combined Indwelling Pleural Catheter (IPC) and Talc Pleurodesis with Video-Assisted Thoracoscopic Surgery (VATS) for the Management of Patients with Malignant Pleural Effusion
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.
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A comparison of maternal and fetal fentanyl concentration following fentanyl use in childbirth
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.
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Accuracy of patient specific instrumentation for implant position for patients undergoing reverse total shoulder arthroplasty.
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.
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Implementation and effectiveness of an early intervention program (QuikFix) for young people experiencing alcohol and other drug-related harm
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"Thinking while Moving in English": Evaluation of a school-based program that integrated physical activity across the primary school curriculum
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
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Telehealth for palliative care patients in metropolitan and rural settings.
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
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Evaluating the health beneficial properties of coloured rice consumption in obese populations.
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.