ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Implementation of online data collection website into an orthopaedic clinic for Orthopaedic surgeons and patients with knee pain attending for consideration for a total knee joint replacement.

    The purpose of this study is to implement an online database which has the ability to easily collecting clinical data from patient sand orthopaedic surgeons. Participating clinics have been selected from Orthopaedic clinics that are located in a variety of hospitals in the SVHA group. This proves different environments to test the implementation. The aim is to ensure that the database is embedded into the clinic workflow to ensure that there burden required by patients and orthopaedic surgeons is low, which will encourage long term use. At conclusion of this study all sites will have an online data collection tool capable of reporting on patient suitability for TKR and their outcomes of the patients to surgeons due to the step-wedge trail design.

  • Preoperative exercise therapy for patients with cancer: A randomised-controlled trial

    This study aims to generate new knowledge on the feasibility and effectiveness of pre-operative exercise training (‘prehabilitation’) to induce clinically relevant improvements in physical fitness (cardiopulmonary function) in patients with prostate, colorectal or breast cancer undergoing surgery in the Grampians region of Victoria. Who is it for? You may be eligible to join this study if you are aged 18 years or more, are scheduled for prostate, colorectal or breast cancer surgery, and are able to partake in exercise training. Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will continue to receive usual care. Participants in the other group will undertake a supervised exercise training session once every three days (estimated four weeks) up to 3-5 days before surgery. Sessions will involve aerobic training on apparatus such as treadmill, stationary bicycle and cross-trainer for 45-60 minutes. All participants will undertake physical assessments at enrolment, post- exercise intervention completion (approximately 48 hrs pre-surgery), and at 30 days following surgery. They will also be required to complete questionnaires to measure quality of life and physical and emotional well-being. Given that the body of physical activity research in cancer prevention, management and therapy has focused almost entirely on post-operative exercise regimens, we are hoping to address this gap in the literature in regards to pre-operative exercise and provide a pathway to fixed pre-operative exercise model for future use in the Grampians region of Victoria

  • Understanding the biological responses to sun exposure in healthy adults

    This study is aiming to examine the minimum dose of solar exposure required to cause cellular damage and induction of repair pathways. Who is it for? You may be eligible for this study if you are aged 18 years of age or older with skin type 1-3 fair skin. Study details Participants will receive graded sub-erythemal UV doses on their back equal to sunlight in Brisbane during summer at 7 am for 15, 30 and 40 minutes and skin biopsies will be collected 24 hours post UV exposure to analyse the level of cellular damage. A control site will also be biopsied to examine non-exposed UV skin. It is hoped this research will help to assess the current UV exposure guidelines and whether the suggested dose limit is safe or not.

  • Dressings used over the nasal bridge for patients undergoing Acute Non-Invasive Ventilation therapy: A randomised, controlled non-inferiority trial of two dressings for pressure injury prevention and patient and nurse satisfaction.

    Pressure injuries, also known as pressure ulcers, pressure sores or bedsores, are a usually preventable adverse outcome of hospitalisation. Pressure injuries may cause a patient pain or increase their hospital length of stay, and in severe cases may lead to death. Some pressure injuries are related to the use of medical devices, such as the nasal bridge when a non-invasive ventilation (NIV) mask is in place. These pressure injury may be prevented by a protective dressing applied over the nasal bridge. The aim of this study is to compare two dressings used over the nasal bridge for patients undergoing NIV therapy for pressure injury prevention. Patients initiated on NIV therapy within an Australian tertiary hospital who are recruited will be randomly allocated to have one of the dressings applied to their nasal bridge under the NIV mask. Until NIV therapy is ceased, or for up to 7 days, research and ward nurses will monitor the patient for pressure injury and collect information (e.g. information about pressure injury risk and prevention, NIV usage, nurse and patient satisfaction with the dressing). There is currently minimal research and no guidelines on which to base the decision of which dressing to use to prevent pressure injury when a patient is receiving acute NIV. The results of this study will provide information to assist in evaluating these dressings for future use in pressure injury prevention in NIV intervention. The results may present a way of selecting the most appropriate dressing for standard use or for meeting certain patient criteria.

  • Colonisation of Probiotic in Neoplasia.

    The purpose of this study is to examine the colonisation potential of an existing probiotic in normal human tissue and cancerous tissue. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are undergoing endoscopy for pre-cancer or cancerous bowel tissue or surgical resection at the Royal Adelaide Hospital or St Andrew's Hospital. Study details Participants will be randomly sorted into two groups according to chance. Each group will take two tablets per day for 14 to 28 days prior to surgery. In one group, the tablets will be probiotic bacteria, and in the other group the tablets will be sugar tablets – however participants will not know which tablets they are taking. The length of time from enrolment in the study until surgery will determine whether participants take tablets for 14 or 28 days. Participants will consent to their surgical samples being tested and a small blood sample sample (9 ml, equivalent to 2 teaspoons) being taken. It is hoped this research will provide information about where probiotics colonise the patient, so novel probiotic-based therapies can be developed.

  • A Longitudinal Cohort Study of ‘Watch and Wait’ in Complete Clinical Responders after Chemo-radiotherapy for Localised Rectal Cancer

    The purpose of this study is to determine the effectiveness of a ‘wait and watch’ strategy in patients with rectal cancer who have completed chemoradiotherapy. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with advanced rectal cancer and will be undergoing chemoradiotherapy. Study details After chemoradiotherapy you will be reviewed for any evidence of cancer, through physical exams, imaging and sigmoidoscopy. If there is evidence of cancer you will have surgery to remove this cancer. If there is no evidence of cancer you will not have surgery but instead be followed up at set time points over 5 years, having further imaging, physical exams blood tests and sigmoidoscopies. it is hoped that this research will provide support for the pathway of not conducting surgery on patients who have no evidence of cancer after their chemoradiotherapy.

  • Measurement of severity of aortic stenosis in patients using aortic acceleration time

    Aortic valve replacement for aortic stenosis is a common procedure. Preoperative transthoracic echocardiography (TTE) and intraoperative transesophageal echocardiography (TOE) are commonly used to guide surgical decision making in the management of aortic stenosis. The maximum aortic valve jet velocity, mean gradient and aortic valve area and aortic acceleration time are normally used to grade the severity of aortic stenosis. The aim of this study was to assess the validity of AAT and the ratio of AAT/ET as a reliable marker of the severity of aortic stenosis using intraoperative transesophageal echocardiography and to compare these findings to those obtained using preoperative transthoracic echocardiography in patients undergoing aortic valve replacement.

  • Double-blind randomised controlled trial of low pressure vs standard pressure in keyhole surgery for the gallbladder: a study to reduce pain following surgery

    Recent literature has suggested that laparoscopy with higher intra-abdominal pressures may increase post-operative pain, theorised to be because of increased tension of the peritoneum, the highly sensitive inner lining of the abdominal wall. This studyis a randomised controlled study and aims to answer the question whether it is beneficial to perform laparoscopy at low intra-abdominal pressure (8mmHg) compared to normal pressure (12mmHg) in a laparoscopic cholecystectomy operation (keyhole surgery to remove the gallbladder). Our hypothesis is that laparoscopic surgery can be performed safely at lower intra-abdominal pressures, and that this leads to lower post-operative pain.

  • A study examining the effect of blood and plasma donation on serum per- and poly-fluoroalkyl substances (PFAS) levels in Metropolitan Fire Brigade staff

    This is a study to assess the effect of 12 months of blood or plasma donation on serum PFAS levels in a cohort of Metropolitan Fire Brigade (MFB) firefighters. The purpose of the study is to determine if regular blood donation (i.e. whole blood, or plasma donation) will be effective in reducing serum PFAS levels. Participants will be randomly allocated into one of the following three groups: a whole blood donation, a plasma donation or an observation only for a 12-month period. Group 1: Blood donation every 12 weeks Group 2: Plasma donation every 6 weeks Group 3: Observation alone The study will run for a total of 18 months (approximately 3 months screening and randomisation, 12 months intervention and 3 months follow up).

  • Feasibility of an Intervention Targeting Health through Exergaming as an Alternative to Routine Treatment (FIT HEART)

    Despite elevated risk of cardiovascular disease and diabetes among those with serious mental illness, and widespread recognition that interventions designed to promote increased physical activity are required, there are barriers at the patient, healthcare provider, and organisational levels to implementing typically recommended physical activity programs in a secure psychiatric inpatient setting. This project aims to investigate the feasibility, acceptability and potential effectiveness of a novel intervention (exergaming) to promote physical activity among patients of secure mental health units. Research Questions: 1. Is a physical activity program based on exergaming able to be conducted within the setting of a secure mental health unit? 2. Do patients and staff consider exergaming to be an acceptable intervention for promoting physical activity among patients of such units? 3. Is the proposed intervention associated with improved physical and mental health outcomes for patients? Study Objectives: 1. To determine whether the FIT-HEART program is a feasible intervention for improving physical activity levels among patients in a secure mental health unit, as measured by retention in the program, and client and staff acceptability ratings. 2. To assess whether participants who receive the FIT-HEART program demonstrate greater improvements in physical activity levels, and clinical physical health measures (anthropometry; blood parameters; blood pressure), compared to those who only receive routine treatment. Expected Outcomes: This project will be the first, in Australia and internationally, to determine the feasibility, acceptability and potential effectiveness of exergaming to promote physical activity and improve health outcomes in a secure psychiatric inpatient setting. As such, this research will build upon the current evidence base and generate new evidence to inform policy and clinical practice. If feasibility, acceptability and positive patient outcomes are demonstrated, with minimal impact on resources and patient safety, the intervention has the potential to be: 1. embedded into routine clinical practice; 2. made sustainable; and, 3. scalable across the NSW Health system and, potentially, health systems in other national and international jurisdictions.

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