ANZCTR search results

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

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33655 results sorted by trial registration date.
  • Treatment of disordered sleep and anxiety in primary school-aged children

    This study aims to determine whether changes in REM sleep stability (during treatment for insomnia) can account for reductions in anxiety in primary school-aged children. Compared to children in the control group, we expect children in the treatment group to show improvements in sleep, anxiety and REM sleep stability..

  • Exercise for diagnosis and treatment of heart dysfunction among breast cancer patients

    The chemotherapy medications used for breast cancer treatment are important for achieving a cure but a potential side effect is that they can affect heart function. Current tools used to assess your heart function during and following breast cancer treatment cannot accurately predict those who will go on to develop heart problems. Aerobic fitness is an important predictor of outcomes in people with certain forms of heart disease, and having a particularly low level of aerobic fitness (termed functional disability) appears very closely linked with the risk of developing heart failure. Importantly, functional disability also reflects an exercise capacity that would limit your ability to perform basic activities of daily living such as walking briskly, climbing stairs or gardening. We are conducting a study which aims to identify how anthracycline chemotherapy affects your exercise capacity and risk of functional disability. We would also like to assess how the standard test used to measure your heart function at rest compares to state of the art MRI imaging of the heart in being able to predict your risk of becoming functionally disabled. Furthermore, we are testing whether exercise training during and following your chemotherapy is helpful in protecting against functional disability. Who is it for? You may be eligible to join this study if you are between the ages 40 and 75 years old, have been diagnosed with breast cancer and are scheduled for Anthracycline-based chemotherapy. What is involved? You will be participating in a randomised controlled research project. You will be randomly assigned to one of two groups (just like a coin toss); the control group which receives usual care for your breast cancer, or the exercise group which participates in a 12 month supervised exercise intervention plus usual care. You will have an equal chance of being randomised into either the exercise or usual care group. You will then undergo a series of assessments at the Baker Heart and Diabetes Institute within two weeks of starting your chemotherapy (Baseline), after finishing chemotherapy (4 months) and again at 12 months after starting chemotherapy. Each round of testing will be split across two days, and last between 1.5-3.5 hours each. This means you will visit the Baker Heart and Diabetes Institute on 6 occasions, totalling approximately 15 hours. The testing sessions will include assessment of your heart function, exercise capacity, body composition, muscle strength/function, cognitive function and quality of life. The exercise program will consist of three to four sessions 60-minute exercise sessions per week of moderate-high intensity endurance (i.e cycling, walking, jogging) and resistance exercise aimed at improving your heart and muscle function. The training program will be prescribed by an Accredited Exercise Physiologist (AEP) who is experienced in prescribing exercise for individuals undergoing cancer treatment.

  • Study of the use of MRI for radiation therapy treatment planning for patients with complex pelvic cancers

    The aim of this study is to evaluate the feasibility of MRI only planning for rectal, anal canal and gynaecological cancer radiation therapy.  Who is it for? You may be eligible to join this study if you are aged 18 years or over and have a histological diagnosis of a malignancy of the rectum, anal canal, cervix or endometrium and are about to be treated definitively with radical Radiotherapy at Calvary Mater Newcastle.  Study details All participants enrolled into this study will receive an additional MRI scan at the Diagnostic Imaging Department, Calvary Mater Newcastle, scheduled on the same day as the participants planning CT scan. There will be no change to the participant’s treatment in this study – they will receive the gold standard of care and treatment as per departmental protocols. The MRI scan will be used for comparative purposes only. The MRI will be used to create a "synthetic CT scan" which will be used prospectively to compare to the participants previously acquired CT scan. The use of MRI alone for radiotherapy planning will eliminate the potential inaccuracies in the current fusion process between the MRI and CT scan. This method has the potential to improve radiotherapy planning techniques by better utilising the superior soft tissue contrast that MRI affords.

  • Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial

    This trial will investigate the effect of using a Fitbit device to facilitate a walking intervention in addition to usual care provided by a physiotherapist. We will be able to determine the effect of progressive walking in management LBP. We have developed the Fitbit facilitated walking intervention program to improve the patients’ adherence to the graded walking program and then increasing the physical activity level. Results from this study will inform clinical practice by providing evidence about the effectiveness of this program in reducing disability and pain, increasing physical activity levels, and improving functional and psychological status in participants with LBP.

  • Evaluation of the effectiveness of an interactive avatar-based education application for improving heart failure patients’ knowledge and self-care behaviours: A pragmatic randomised controlled trial

    Heart failure (HF) is a large public health burden. Heart failure is a debilitating illness especially among older people and is a major cause of mortality, morbidity and poor quality of life worldwide. Despite advances in medical, pharmacological, and surgical treatment, the outcomes of heart failure remain poor with high rates of death and hospitalisation. Self-care is the core for health programs to prevent acute decompensation in heart failure. Studies have shown that optimal outcomes in heart failure can be achieved through effective self-care. Limited health literacy is associated with high system cost, and it is a challenge to the healthcare system globally. In 2011 the Australian Bureau of Statistics reported that 47% of Australians are functionally illiterate. This means they cannot read the instruction on a medicine bottle, read a map, or a recipe. Self-care is pivotal in heart failure management. Lack of knowledge in self-care is associated with non-adherence to medication and lifestyle recommendations; as well as failure to detect deterioration that eventually leads to potentially preventable hospitalization. An avatar is an icon or figure representing a particular person in a computer game, internet forum, etc. An avatar-based application will enhance patient learning by using modern computerized tools such as animation (heart and anatomy, links to videos (demonstrating how to self-care), voice (no need to read) and touch screen response. The use of an avatar will make the teaching, more engaging and relevant to patients, therefore achieve greatest impact on patients' outcomes and make significant contribution to nursing practice in clinical setting as well as in primary care. The benefit of technology in education has already been demonstrated in a small number of conditions. Avatar based technology has been used as an aid in chronic diseases patient education such as cancer, diabetes, and depression for improving knowledge, self-care behaviors, and quality of life. Findings from these studies demonstrate positive outcomes in clinical practice. For example, an avatar-based intervention embedded into an online self-management program improved over-active bladder health-related quality of life (HRQoL) and symptoms in women. In another study, an avatar-based interactive application improved knowledge and stoma care self-efficacy in hospitalized patients with a new ileostomy. Avatar technology also reduced depressive symptoms over time in a group of young adults and prevented relapse in smoking in hospitalized cancer patients. This study is a pragmatic randomised controlled trial. There are two parallel groups, the usual care group, and the intervention group. The intervention group will be received usual care plus the avatar-based education application during the study period of six months. Both groups will be followed-up at one-month and six-month post discharge from heart failure clinic.

  • Cytokine response in the pleural fluid and blood in minimal-invasive and open esophagectomy

    To investigate cytokine Response in the blood and pleural fluid in laparoscopic versus open esophagectomy in esophageal cancer. Prospective non randomised Trial.

  • Probiotics for newborn babies with surgical conditions of the gut

    Newborn babies with serious surgical conditions of the gut are admitted to intensive care units, undergo surgery, and receive intravenous drips and strong antibiotics. The administration of breast milk is often delayed in these infants. All these factors interfere with the normal development of healthy bacteria in their intestines and enhance the proliferation of harmful bacteria. Such an imbalance between healthy and unhealthy bacteria in the gut can be harmful to the health and well-being of these babies. In this study, we plan to give healthy bacteria called probiotics orally for 30 surgical newborn babies and placebo for 30 surgical newborn babies to see if probiotics help improve their intestinal bacteria and overall health. The results of this study will help us design a much larger study in the future. If that larger study confirms the benefits, probiotics will then be used routinely for all newborn babies with surgical conditions of the gut.

  • Pelvic Floor Muscle Exercise Training in Prostatectomy Patients

    The aim of this study is to evaluate the effect of two different pelvic floor muscle exercise training (PFMET) methods on urinary function, erectile dysfunction and quality of life in prostatectomy patients. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have prostate cancer about to be treated by radical prostatectomy. Study details Participants will be allocated by chance to one of two exercise training programs which will complement usual components of continence management completed over a three months period. One group will receive the high intensity pelvic floor muscle exercise training (PFMET) and the other will receive sham PFMET. Other usual care components of management which both groups will receive include general continence, avoidance of caffeine and alcohol, and lifestyle modification advice. Measurement of urinary incontinence, erectile dysfunction and Quality of Life will be taken at completion of the intervention program. This study may be beneficial to medical health care teams providing pre and post rehabilitation strategies for men undergoing surgery for prostate cancer. Both urinary incontinence and erectile dysfunction are expected side affects for men from treatment and methods to improve these have limited evidence in research currently.

  • Does the provision of patient information brochures for adult emergency appendicectomy surgery patients, reduce their anxiety ?

    To determine the effectiveness of printed emergency appendicectomy surgery patient information leaflets on reducing anxiety in adult pre-operative patients. Secondary objective: To determine the patient satisfaction with information given before emergency appendicectomy surgery. To determine the patient satisfaction with printed emergency surgery patient information leaflets. Hypothesis: that printed emergency surgery patient information leaflets provided to adult patients before appendicectomy surgery will reduce pre-operative anxiety.

  • Endoscopic Ultrasound Guided Drainage of Bile in Patients with Benign Strictures of the Bile Duct

    Endoscopic retrograde cholangiopancreatography has been the standard of care for the management of bile blockage. This procedure combines the use of x-rays and an endoscope (a long, flexible, lighted tube). During the procedure, the doctor can see the inside of the stomach and small intestine, and inject dye into the drainage tubes (ducts) of the pancreas or bile to see them more clearly on x-ray. However, this procedure is not always possible or successful due to altered anatomy related to surgery or disease related causes. Percutaneous transhepatic biliary drainage has been used as an alternative in these cases. During this procedure a tube to drain the bile ducts is introduced through the skin and liver. However, this procedure is associated with a number of complications such as bile leak, peritonitis, tube dislodgement, recurrent infection and bleeding. Endoscopic ultrasound is another procedure that uses sound waves to create visual images of the digestive tract, including the liver, bile ducts and pancreas. This procedure provides real time images and access to organs which are inaccessible by other means. Endoscopic ultrasound guided bile drainage is not a new procedure: several studies have looked at the safety and efficacy of this procedure in the management of bile blockage, however more studies are needed. This study aims to determine the efficacy and safety of bile drainage via endoscopic ultrasound for benign blockage when endoscopic X-ray procedure was unsuccessful. Data collected in the study will help to understand if endoscopic ultrasound is an equivalent or is better for bile drainage than a procedure performed introducing a tube via the skin into the bile duct.

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