ANZCTR search results

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

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31604 results sorted by trial registration date.
  • Hepcidin and Iron Storage Sub-Study: The relationship of hepcidin to patient outcomes after cardiac surgery

    This project will be part of a larger international effort that is examining the best way to transfuse patients who are 65 years old or younger and undergoing cardiac surgery, We will determine if there is an association between baseline hepcidin values and patient outcomes 28 days after cardiac surgery, after taking into account iron storage, haemoglobin values, transfusion strategy and other factors known to influence cardiac surgical outcomes, which has not been examined previously. We will also explore the association between hepcidin and the recovery of haemoglobin levels back to normal 30 days post-surgery after accounting for other factors that may cause haemoglobin to recover slowly.

  • Pilot study of Neoadjuvant Stereotactic Radiosurgery for Breast Cancer and Non-small Cell Lung Cancer Intracranial Metastases NEST Trial (NEoadjuvant STereotactic)

    This study will investigate the feasibility of performing stereotactic radiosurgery prior to operative management to remove brain lesions in patients with metastatic breast or non-small cell lung cancer. Who is it for? You may be eligible for this study if you are aged 18 or older and have confirmed metastatic breast cancer or non-small cell lung cancer with between 1-4 identified brain lesions that require surgical removal. Study details Participants enrolled in this study will attend a radiotherapy planning appointment where they will undergo a brain CT scan and a MRI brain. At the time of the CT scan a stereotactic radiotherapy mask will be made for immobilisation during radiotherapy treatment. Radiation treatment will take place after an appropriate treatment plan has been formulated. Within 48 hours of the stereotactic radiotherapy a neurosurgeon will then operate to remove the cancer tissue from the brain. Participants will then be asked to attend follow-up visits with their doctor and have regular follow up MRI scans, as normal, and information regarding their disease progress after the procedure will be shared with the research team. Participants will also be asked to complete a short study questionnaire about their satisfaction with the radiosurgery intervention at 6 and 12 months after the procedures were completed. It is hoped this research will demonstrate that the combination of radiotherapy prior to surgical intervention for the treatment of brain lesions is feasible, and that a larger trial to investigate the efficacy of these treatments for cancer patients can be conducted in the future.

  • Urinary sodium to manage patients with acute heart failure

    Heart failure is one of the most common causes of hospital admissions globally. Typical signs and symptoms of acute heart failure (HF) are mostly related to congestion, driven by sodium retention and subsequent fluid retention. Removal of excess sodium and water (decongestive therapy) by diuretics is the cornerstone of treatment. Assessing the efficacy of treatment by current methods, such as weight loss and net fluid balance is very challenging. Diuretics act by diminishing sodium reabsorption at different sites in the kidney, thereby increasing urinary sodium and water loss. Hence, a limited number of small prospective observational studies have suggested the role of urinary sodium content (UNa) as a tool to rapidly assess the response to decongestive therapy and to estimate future outcomes. Aims and Objectives: 1. To assess the feasibility and efficacy of adjusting diuretic therapy using UNa in patients presenting with AHF in an Australian metropolitan hospital 2. To evaluate the safety of this method 3. To determine if UNa guided diuretic therapy improves clinical outcomes Design: A prospective, randomized controlled trial. Study population 60 patients >18 years old admitted under cardiology team with the primary diagnosis of AHF, requiring intravenous diuretics. Recruitment period: 6month. Expected number: 60 patients.

  • A non-invasive treatment for Otitis Media with Effusion

    We aim to establish the usability and effectiveness of a new insufflation device, as a way to open the Eustachain Tube and drain the middle ear fluid in children with chronic otitis media with effusion (OME).

  • Training gynaecology trainees using an integrated Visual Reality Stimulator curriculum

    Gynecology trainees continue to face difficulty in obtaining adequate procedural experience due to increased trainee numbers, restrictions on working hours and advances in medical management. A prospective cohort study was conducted assessing the efficacy of a virtual reality stimulation (VRS) -integrated curriculum for gynecology trainees The primary outcome of interest was the impact of the virtual reality training program on live operating performance at 6 months, hypothesising that involvement in a VRS-integrated curriculum should improve live-operating performance for novice and experienced trainees.

  • Safe Treatment of Atrial fibrillation in the communitY (STAY): A feasibility study

    The study aims to evaluate feasibility, safety and acceptability of an integrated community-based model-of-care for low risk patients with AF and to gather data that will allow this new model-of-care to be implemented system-wide. The research hypothesis is that it is feasible for Ambulance Victoria and specialist AF clinics to deliver an integrated safe and timely community-based model-of-care for AF patients with low risk acute presentations. By implementing a novel clinical pathway supported by cardiology consultation, paramedics can accurately and safely treat AF in the homes, avoiding the need for transport to ED.

  • Point of Care Subepidermal Moisture (SEM) Scanning Technology to Detect Pressure Injury: A Pilot Study

    A pressure injury, sometimes known as a bedsore, is an injury to the skin and/or underlying tissue. They usually occur on bony areas of the body like the sacrum (tail bone) and heels. Pressure injuries, are caused by pressure, from not being able to move easily, lying or sitting in the same position for too long, or sliding down the bed or chair. Patients are at risk of developing pressure injuries in hospital. Pressure injuries are largely preventable, and are painful, may become infected, can take a long time to heal, and can mean a longer time spent in hospital. Better strategies are needed to prevent pressure injuries in hospital patients. The Subepidermal Moisture (SEM) Scanner is a tool that can be used to detect early changes in tissue that may develop into a pressure injury. The SEM Scanner does this by measuring changes in the tissue moisture and inflammation just below the skin. The differences in the tissue moisture and inflammation are caused by tissue damage early in the development of a pressure injury, and before the pressure injury can be seen. The SEM scanner can detect tissue changes 3-5 days before a pressure injury can be seen. The main aims of this study are to test whether using a SEM scanner in addition to routine care, compared to routine care only, in hospital patients, is acceptable and feasible, and to compare the number and severity of pressure injuries that develop in both groups.

  • A pilot randomised controlled trial: Joint Walkers, a Group of Rheumatology Outdoor Walkers (GROW Study)

    Proof of concept. We would like to explore the feasibility of implementing a build a self-sustaining walking group of similar people from the rheumatology outpatient clinic with musculoskeletal conditions living with chronic disease who are motivated to improve their lifestyle. In addition, to increase the physical activity levels & self-efficacy with exercise for rheumatology physiotherapy outpatients. We hypothesise that Joint Walkers will increases in walking activity, and Achievement of Performance of physical activity guidelines. We also hope to increase the patients self-efficacy with exercise & engage with others of similar health conditions in a supportive environment

  • Comparison of brain oxygen levels in preterm newborns during three different methods of surfactant administration using a near-infrared spectroscopy device.

    Preterm infants develop respiratory distress syndrome (RDS) soon after birth due to immaturity and lack of surfactant. Several studies have demonstrated the effectiveness of artificial surfactant treatment in improving the outcome from RDS with reduced morbidity and improved survival. There is significant variation in clinical practice on how surfactant is administered. Traditionally, medications are administered to reduce pain prior to endotracheal intubation for surfactant administration. Several trials have demonstrated that the use of premedication for intubation of the newborn significantly improves intubating conditions, decreases the time and number of attempts needed to complete the intubation procedure, and minimizes the potential for intubation-related airway trauma. However, some centres continue to not use pain medications during this procedure as it can delay extubation and supress spontaneous breathing efforts of the baby. Recently, a minimally invasive surfactant therapy (MIST) has been reported and is used to administer surfactant. This method does not use premedications or endotracheal tube, instead it uses a very small catheter in spontaneously breathing preterm infants. There is limited knowledge on the effects of the different methods of surfactant administration on brain oxygen levels in preterm infants especially when premedications are not used. This observational study aims to compare the effects of three different methods of surfactant administration on brain oxygen levels in preterm infants born at 26 weeks gestation to 31+6 weeks of gestation. Once a specialist clinician in each participating unit determines the need to administer surfactant treatment, near-infrared spectroscopy (NIRS) monitoring will be started to collect data on brain oxygen levels for infants consented to participate in the study. Findings of this novel study will significantly improve the understanding and gaps in knowledge of the impact of different ways of administration of surfactant on stability of oxygen delivery to the brain as well as overall physiological stability of the baby. The study will aim to identify the best method for delivering surfactant to preterm babies with respiratory distress at birth.

  • Investigating the effectiveness of Prophylactic Hypotension Avoidance iN arThrOplasty using Midodrine (PHANTOM) pilot trial

    The PHANTOM trial is a randomised, placebo controlled, blinded pilot trial looking at the use of prophylactic and perioperative Midodrine, in patients undergoing elective and emergency arthroplasties. This will determine if it is safe and effective in preventing clinically significant hypotension, intraoperatively and post-operatively, within a 24hr period. Patients will be followed up for 1 month following the index surgical procedure.

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