ANZCTR search results

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

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31134 results sorted by trial registration date.
  • Feasibility of testing the effectiveness of a theory-informed implementation intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial

    Imaging is overused in the management of low back pain, resulting in high healthcare costs and poorer patient outcomes. Previous strategies to reduce imaging have been largely ineffective. In prior work our research team has developed an intervention to reduce non-indicated imaging for low back pain. Prior to future effectiveness testing of the intervention, it is important to assess the feasibility of using the intervention in clinical practice and conducting a large-scale randomised controlled trial (RCT). The overall aim of this study is to perform a pilot cluster RCT to determine the feasibility of a fully powered effectiveness study, and to assess the feasibility of implementing the developed intervention in clinical practice. This is critical to gain funding for future effectiveness testing using a large high-quality cluster RCT.

  • A study to look at the safety and efficacy of Acalabrutinib and Rituximab followed by chemo with or without Autologous stem cell transplant (ASCT) and maintenance Acalabrutinib and Rituximab in fit patients with previously untreated mantle cell lymphoma.

    This purpose of this study to evaluate the efficacy and safety of Acalabrutinib and Rituximab followed by R-DHAOx chemo with or without ASCT and maintenance Aacalabrutinib and Rituximab in fit patients with previously untreated mantle cell lymphoma. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with positive mantle cell lymphoma. Study details All participants in this study will receive the following: 1. Induction phase: one day of Rituximab in the vein and 28 days Acalabrutinib orally for 2 cycles. 2. Chemotherapy phase: 4 cycles of chemotherapy (21 day cycles) 3. Consolidation phase: including stem cell transplant 4. Maintenance phase: Acalabrutinib orally for one year and Rituximab in the vein every 3 months for 2 years. During the trial patients will have blood tests performed and undergo up to 5 PET/CT scans to help determined the progress of the treatment. It is hoped that this research will help determine whether this treatment is safe for patients, and what kinds of side effects/complications may occur with this treatment.

  • An exploration of nurse decision making when managing high risk medications in the intensive care unit.

    It is estimated that 60% of patients admitted to intensive care units receive vasoactive medication to support patient blood pressure and/or heart function. Patients presenting with infection, shock, injury, drug overdose or heart failure are prescribed vasoactive medications by doctors, and nurses are responsible for many aspects of management including preparation, administration, adjustment of doses and weaning. These medications are fast acting and need careful management to prevent harms including stroke and heart attack. Possible problems include rapid administration of the vasoactive medication or incorrect dose adjustments. There has been little research on how nurses manage vasoactive medications and many of the guidelines in current use are not based on research evidence. The aims of this study are to identify the frequency and types of decisions that nurses make in managing vasoactive medications, the immediate impact of these decisions on patients and the underlying decision-making processes in use. The project objectives are to observe how nurses manage vasoactive medications and the decision-making processes they use to assess patients, prepare, initiate and administer the medication and the decisions that prompt dose-adjustments, such as titration and weaning. A systematic review completed by the researcher and PhD supervisors identified few published studies of nurses’ management of vasoactive medications and this lack of attention, coupled with anecdotal clinical experiences, prompted the conceptualisation of this study (Hunter, Manias, & Considine, 2018). These medications are ubiquitous in intensive care settings all over the world and are managed by nurses with little or no evidence based support. The potential for risk associated with the use of vasoactive medications highlights that nurse decision making is fundamental to the safe management of vasoactive medications (Hunter et al., 2018).

  • Improving brain health in at risk populations with aerobic exercise

    Dementia is the second leading cause of death in Australia and its rate is expected to double in the next 20 years. Obesity, physical inactivity, cardiovascular diseases and other chronic diseases can reduce the function of the blood vessels in the brain, which may subsequently decrease cognitive function and mood, which may lead to the development of dementia. Recent evidence suggests that aerobic exercise, such as walking, may improve the health of blood vessels in the brain, potentially also improving cognition and mood. Accordingly, we will undertake a 16 week randomised control trial that will investigate the effects of aerobic exercise training on brain circulatory function, mood and cognition in a physically inactive, middle-age to older (50-80 years old) and overweight/obese (body mass index > 25kg/m2) population, with the hypothesis that exercise training will improve cognition and mood in this cohort by improving cerebrovascular function, as well as improving general health and wellbeing.

  • Foot Exercise and Education in the Treatment of plantar heel pain (FEET trial): A feasibility study.

    Plantar heel pain is a common chronic condition that presents in a variety of populations. A characteristic feature is pain with weight bearing which limits an individual's occupational, recreational and activities of daily living. The high recurrence and persistence of plantar heel pain suggests that current management options may not address all modifiable factors, such as the intrinsic foot muscles, that are important contributors to optimal foot function. This study will determine the feasibility, credibility and acceptability of foot exercise and education for the management of plantar heel pain. Secondary outcomes will investigate whether foot exercise and education can improve pain, function and intrinsic foot muscle morphology and function in this population. The results of this study will inform the design of a full-scale randomised clinical trial for the treatment of plantar heel pain.

  • The Assessment of Fluoxetine in Stroke Recovery Imaging and Blood Biomarkers Sub - Study AFFINITY BM

    The main AFFINITY trial is investigating whether fluoxetine, 20mg once daily, started 2 -15 days after stroke onset and continued for 6 months, improves functional outcome at 6 months after randomisation. The aims of the sub study (AFFINITY BM) are to further investigate the underlying biological, structural and functional mechanisms by which treatment with fluoxetine may lead to improved functional outcomes following acute stroke.

  • Oxyfriend: A novel silicone device which aims to improve preoxgenation in healthy individuals.

    Preoxygenation is a process which occurs prior to anaesthetising patients prior to surgery. Preoxygenation is a difficult process as it requires placing a mask over a patient’s nose and mouth and creating an air tight seal forcing oxygen from the anaesthetic circuit into the patient’s lungs. The OxyFriend is a novel silicone device which was designed to be utilized with traditional anaesthetic mask. The OxyFriend was designed to improve preoxygenation and my reduce leaking during preoxygenation. The study aims to test whether the OxyFriend will make the process of preoxygenation more effective. A secondary aim to is test whether the OxyFriend will reduce the leakage around the anaesthetic mask.

  • Effects of exercise in controlling blood glucose in Type II Diabetes Mellitus patients.

    This study will involve a comparison of predominately eccentric (ET) versus concentric (CT) endurance exercise. Participants in one group will perform downhill walking, participants in second group will perform uphill walking and participants in the third group will perform level treadmill walking, twice a week for 12 weeks with 2-3 days between sessions. Exercise sessions will commence at 5 minutes duration at the same comfortable walking pace and progress to 30-minutes session by the last week. Outcome measures will be assessed at baseline and after the completion of the 12-week exercise program. Exercise will assess whether downhill walking is better than uphill or level walking in glucose handling among people with type 2 Diabetes Mellitus.

  • High-flow nasal oxygen vs standard care to prevent low oxygen levels during gastroscopy.

    Gastroscopy is a very common medical procedure undertaken to screen, diagnose and treat diseases of the upper gastrointestinal tract. Patients are sedated to allow them to tolerate the procedure but this carries a risk of low oxygen levels during the gastroscopy; this is more common in patients with higher body mass index. In order to protect against low oxygen levels, patients are normally given supplemental oxygen via the nose during gastroscopy. This project is comparing the normal way of giving oxygen versus a system that delivers high-flow, warmed, humidified oxygen (the Optiflow THRIVE device), for patients undergoing gastroscopy who have a body mass index greater than 30 or who weigh more than 100 kilograms. The hypothesis is that in these patients, high-flow, humidified nasal oxygen will reduce the incidence of desaturation (oxygen levels < 90%) versus the standard of care.

  • Weight loss outcomes in obese patients undergoing Laparoscopic Sleeve Gastrectomy

    Laparoscopic sleeve gastrectomy (LSG) has acquired considerable interest as preferred bariatric surgical procedure that leads to effective weight loss and control of type 2 diabetes and co-morbidities. However, there is marked individual differences in degree of weight loss achieved with little ability to detect individuals who will achieve less than expected weight loss outcomes before or early post-intervention. Additionally, no studies have assessed the relationship between weight loss outcomes, disease remission and biological and psychosocial factors influencing weight maintenance/ regain following LSG. The objective of the present cohort study is to better understand body triggers to optimise weight loss and health outcomes. This study involves comprehensive testing, metabolic characterisation (via biochemical analysis of blood and tissue), assessment of disease remission (diabetes, hypertension, hyperlipidemia, heart disease risk), general health and well-being and psycho-social factors influencing outcomes in patients undergoing LSG by same surgical team at Gold Coast Private Hospital.

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