ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32814 results sorted by trial registration date.
  • Curcumin as a palliative treatment for malignant pleural effusion

    This study is investigating whether it is safe to administer curcumin packaged into small biological spheres called liposomes, to patients with malignant pleural effusion via a long-term chest drain directly into their pleural (lung) cavity. Who is it for? You may be eligible for this study if you are aged 18 years or older with an existing diagnosis of malignant pleural effusion, and you have failed to respond to approved systemic therapies (chemotherapy, immune therapy or molecular targeted therapies), or you have progressive cancers following initial response to these therapies. Study details The first three participants enrolled in this study will be administered 100 milligrams of curcumin per metre squared of body surface area, delivered directly into the tumour site via a pre-existing long-term chest drain, once only. If these participants do not present with any adverse effects, a second group of participants will be administered 200 milligrams of curcumin per metre squared of body surface area via their long-term chest drain. If the second group show no adverse effects a third, and final, group of participants will be administered 300 milligrams of curcumin per metre squared of body surface area. If the third group show no adverse effects, the maximum tolerated dose will not be reached within this pre-determined dose range, and the study will stop. All participants regardless of the maximum dose received will be asked to provide blood and tissue samples at ten different timepoints over the 25 weeks of the study. Additionally all participant will be asked to attend a total of 5 follow visits over the 25 weeks of the study. It is hoped this research will determine whether curcumin given directly into the tumour site is safe, and whether it has any therapeutic effect on the cancer in the pleural cavity that is causing an MPE.

  • Evaluation of the Alleviant Medical Percutaneously Created Inter-atrial Shunt on Heart Failure Symptoms in Patients with Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction

    The purpose of this study is to evaluate the safety and feasibility of the Alleviant Medical Percutaneous Interatrial Shunt System for patients with Heart Failure with preserved or mid range Left Ventricular Ejection Fraction (HFpEF). Who is it for? You may be eligible for this study if you are aged 40 or older and have Class 2 (and a history of greater than Class 2), Class 3 or ambulatory Class 4 Heart Failure Study details All participants will have the interatrial shunt created during a procedure under general anaesthesia in a cardiac catheterisation laboratory. All participants will be followed-up according to the protocol specific endpoints. Patients will undergo diagnostic tests during screening including transthoracic echocardiography, exercise haemodynamic evaluation, and laboratory (blood) tests. These tests will be repeated during follow-up. Additional imaging may occur during the index procedure (transoesophageal or intracardiac echocardiography), and additional imaging studies may be performed during follow-up including cardiac MR and/or cardiac CT. Additional questionnaires and a study specific activity monitor will be utilized during screening and follow-up It is hoped that this research will provide information into the non-pharmacologic treatments of heart failure symptoms thereby providing future non-pharmacologic related options for the disease.

  • Stereotactic Radiotherapy for Oligoprogressive ER-positive Breast Cancer. AVATAR.

    Who is it for? This study will investigate the safety and efficacy of Stereotactic Radiotherapy treatment in combination with aromatase inhibitor and cyclin-dependent kinase (CDK) 4/6 inhibitor for metastatic breast cancer." You may be eligible to join this study if you are aged 18 and above, have histologically proven ER-positive, HER2-negative advanced breast cancer with metastases and receiving an aromatase inhibitor in combination with a CDK 4/6 inhibitor Study details All participants in this study receive stereotactic radiotherapy (between 1 -5 doses as ascertained by treating Doctor after consultation) in combination with prescribed aromatase inhibitor and CDK 4/6 inhibitor. Participants will be monitored for reactions and treatment effectiveness, and provide blood and urine for analysis throughout the 2 year study. This research will give us information about whether adding radiotherapy to a CDK 4/6 inhibitor increases the amount of time participants can stay on CDK 4/6 inhibitor therapy.

  • Evaluating the impact on in-hospital orthopaedic waitlists after the introduction of subsidised access to out-of-hospital allied health services for patients with chronic musculoskeletal conditions

    Patients referred to orthopaedics (ortho) commonly face long wait times for outpatient appointments and surgery. After study participants are offered assessments by hospital funded advanced physios -to referred chronic musculoskeletal patients – they will be offered community-based allied health services at different subsidy rates. This study aims to determine the most acceptable cost of community-based allied health services to meet consumer needs.

  • “A survey on the perioperative analgesic practice among thoracic anesthesiologists in Australia and New Zealand”

    Thoracic surgery induces severe postoperative pain and has depended on thoracic epidural and opioids in the management of pain in the perioperative period. The increasing availability of ultrasonography to identify fascial layers has led to development of several techniques for analgesia of chest wall with promising results(1). Also, recent studies have hypothesized that opioids may result in an increase in cancer metastases(2) resulting in a trend towards avoiding opioids while utilising more regional techniques. However, it is not clear to what extent the results of these studies have changed daily clinical practice. Literature search shows that studies looking at perioperative practice in thoracic patients were conducted by Cook et al 1997(3) [post-thoracotomy patients, 24 anaesthetists in Australian Hospitals] and Kotemane (4) 2010 (major thoracic surgery, 240 anaesthetists, United Kingdom). The only recent survey available by Shanthanna (5) 2018 looked only at video -assisted thoracoscopic surgery (VATS) procedures among anaesthetists in Canada (response rate only 19%). We have limited information on the current trends in analgesia management for the patients undergoing thoracic surgery in Australia and New Zealand (ANZ) We hypothesize that despite the emergence of other regional blocks, thoracic epidural would still be the choice of the majority (> 50%) of the anaesthetists for open thoracotomy. The purpose of this cross-sectional survey across thoracic anaesthetists across ANZ is to understand the current practice and preferred mode of analgesia as well as the perception of anaesthetists towards various modalities of pain management of the patients undergoing thoracic surgery. In addition, it would also act as a benchmark for future studies especially with regards to prevalence of opioid-sparing anaesthetic techniques that might become a standard of practice in the future. References (1) Chin KJ. Thoracic wall blocks: from paravertebral to retrolaminar to serratus to erector spinae and back again–a review of the evidence. Best Practice & Research Clinical Anaesthesiology. 2019 Apr 5. (2) Maher DP, Wong W, White PF, McKenna Jr R, Rosner H, Shamloo B, Louy C, Wender R, Yumul R, Zhang V. Association of increased postoperative opioid administration with non-small-cell lung cancer recurrence: a retrospective analysis. British journal of anaesthesia. 2014 Jul 1;113(suppl_1):i88-94 (3) Cook TM, Riley RH. Analgesia following thoracotomy: a survey of Australian practice. Anaesthesia and intensive care. 1996 Oct;24(5):520-4. (4) Kotemane NC, Gopinath N, Vaja R. Analgesic techniques following thoracic surgery: a survey of United Kingdom practice. European Journal of Anaesthesiology (EJA). 2010 Oct 1;27(10):897-9. (5) Shanthanna H, Moisuik P, O’Hare T, Srinathan S, Finley C, Paul J, Slinger P. Survey of postoperative regional analgesia for thoracoscopic surgeries in Canada. Journal of cardiothoracic and vascular anesthes

  • Dose Determination and Efficacy Evaluation of the Gastrointestinal ReProgramming (GaRP) Dietary supplement in Irritable Bowel Syndrome patients

    This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and determine the optimal dose of a potential new treatment called GaRP in adults with irritable bowel syndrome. The aim of this study is to determine the efficacy of two different doses of GaRP in IBS patients after 8 weeks of intervention.

  • Measuring the impact of anaesthetic drug volume during surgery

    There has been recent interest in fluid balance during surgery and the impact on patient recovery. However, it is currently unknown whether any anaesthetic drugs substantially impact upon fluid balance during surgery. The aim of this study is to provide a thorough analysis of the medications and infusions provided to patients during a pancreaticoduodenectomy (also known as a Whipple procedure). Who is it for? You may be eligible for this study if you are an adult who underwent a pancreaticoduodenectomy (Whipple procedure) at the Austin Hospital between January 2011 and June 2020. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a pancreaticoduodenectomy at the Austin Hospital between 1st January 2011 and 1st June 2020. It is hoped that this research will help to provide a better understanding of fluid balance during surgery and the impact of fluid balance on complications and outcomes after surgery.

  • Topical Skin Adhesive versus Nylon Sutures For Incision Closure In Forefoot Surgery: A Randomised Controlled Trial

    Postoperative infections are the most common cause of complications in surgical patients and result in an average increase of four days in the hospital. Foot and ankle surgery may have a higher infection rate than other surgical areas since surgical preparation cannot fully reduce the bacterial load prior to incision. Due to the increased rate of infection and wound breakdown surgeons routinely reinforce absorbable subcuticular wound closures with non-absorbable skin sutures. Removal of these sutures can be painful and leave unsightly scars. 2- Octyl-cyanoacrylate tissue adhesive is available in Australia as an alternative to skin suturing for wound closure. There have been mixed results with this product with some studies showing good wound closure and low infection rates and others showing high rates of wound dehiscence and infection. The high rates of wound dehiscence with tissue adhesive has been postulated to be due to high wound tension. We believe that tissue adhesive may be successful an occlusive reinforcement after proper skin closure with appropriate methods to reduce tension such as subcuticular stitching. There have been no studies looking at using tissue adhesive in this fashion in foot and ankle surgery. The hypothesis of this study is that using tissue adhesive rather than non absorbable sutures to reinforce forefoot wounds will reduce patient pain and anxiety at dressing change whilst not affecting the quality of wound healing. The study will be powered to assess these two parameters.

  • Evaluation of an evidence-informed physical activity policy for early childhood education and care (ECEC) services in Western Australia.

    Physical activity is vital for children’s health, well-being and development. It is important to establish healthy physical activity and sedentary behaviour habits early in life. Only one third of young children meet the recommended 3 hours of daily physical activity. ECEC services play an important role in encouraging young children to be physically active, healthy and developing well. Only 16% of ECEC services in Perth, WA have a formal written physical activity policy. This study aims to evaluate the effectiveness of the Play Active program tailored to ECEC services on ECEC educators physical activity practices. We hypothesise that educators from ECEC services implementing the Play Active physical activity policy will increase the amount of time and opportunities provided for children in their care to be physically active.

  • Investigating the efficacy of sound stimuli for apnoea inhibition in preterm infants

    Apnoea, a pause in respiration, reflects the immaturity of a preterm infant’s respiratory control and is the major contributor to requiring protracted respiratory support, mostly spent on non-invasive forms of support which is reliant on an adequate respiratory drive and airway patency, at a time when both are prone to failure. Despite current administration of therapies to reduce apnoea burden, including non-invasive respiratory support and caffeine, bedside staff are still often required to react urgently to apnoeic events by providing tactile stimuli to re-establish respiratory efforts. Such an approach to management of apnoeic events makes adverse consequences of apnoea (hypoxia and/or bradycardia) in preterm infants inevitable. The ARIA study uses a crossover study design to investigate whether targeted auditory stimulus applied opportunistically soon after the onset of a respiratory pause in preterm infants born at <30 weeks gestation has an effect on shortening apnoea duration and mitigating the adverse apnoea-associated physiological consequences, when compared to standard care. The auditory stimuli examined in the ARIA study includes the mother's voice (attenuated), and a non-vocal sound. The primary outcome measure of the ARIA study is the frequency of apnoeic events lasting >= 5 seconds (per hour).

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