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.
  • Evaluating the effects on function and pain of two gels applied over the knee in people with mild to moderate osteoarthritis: a 2-week randomised control trial. The KnEe Guard (KEG) trial.

    Osteoarthritis (OA) is a common problem for many people, with pain and reduced function the main symptoms. As there is no cure and with many treatment interventions still under investigation, current management strategies are focused at reducing pain and improving joint function. These treatment options include medication, surgery, joint replacement, exercise etc. Studies have shown that a history of injury/trauma to a joint increases the risk of developing OA as you age. It has been reported that there is a greater than 5 fold increased risk of developing knee OA in those with a history of knee injury. Those with significant prior knee injury are therefore a key group to target for preventative interventions and are worthy of investigation and development. OA is characterised by wear and tear of the cartilage between the joint surfaces. Clinical trials have reported that the medications “chondroitin sulphate” and “glucosamine sulphate”, when taken orally have some beneficial effects on pain and function although results have been variable. Chondroitin and glucosamine therefore appear to offer potential benefits as a means of limiting the development of OA and have been supported by the recommendations of international guidelines. As issues regarding the effectiveness of these medications taken orally have arisen, alternative methods are being investigated. This study will assess the effectiveness of a newly developed knee guard device and its diamagnetic technology in people with knee injury/ previous knee surgery, who are at increased risk of developing osteoarthritis. Therefore this study endeavours to determine the effectiveness of the knee guard and investigate if the improvement in physical function with the knee guard device is equivalent to the improvement produced by an established non-steroidal anti-inflammatory (NSAID) formulation. AIMS OF STUDY: This study aims to determine if daily use of a knee guard device will improve physical function in individuals who engage in regular exercise but have knee discomfort related to previous knee injury/surgery. The knee guard product is a knee support intended to help users maintain a healthy knee joint and enhance their recovery from injury. It uses diamagnetic force to deliver therapeutic ingredients through the skin and into the body more effectively than creams or oral supplements. Another aim is to determine if the improvement in physical function with the knee guard device is equivalent to the improvement produced by a well-known non-steroidal anti-inflammatory formulation (NSAID gel).

  • Can Dietary Fibre Consumption Alter Fat Absorption in Ileostomates

    This study aims to quantify whether the co-consumption of a high fibre beverage can alter dietary fat absorption of a high fat breakfast meal in ileostomates.

  • The Health Anxiety Program: a pilot trial of an online program for people who worry excessively about their health

    The project aims to evaluate the acceptability and clinical efficacy of the online Health Anxiety Program. Up to 25 people with elevated health anxiety (either IAD or SSD) will be assigned to the active treatment group. The treatment group will commence the Health Anxiety Program immediately. The efficacy of the Health Anxiety Program will be determined by comparing the health anxiety symptom levels before and after treatment, and at 3 month follow-up.

  • A pilot study to assess feasibility, safety and efficacy of artificially introducing an air-pleura interface for detection of pleural nodules by computed tomography

    This study will evaluate the use of an artificial air-pleura interface by introducing air into the chest for a computed tomography (CT) scan to detect abnormalities in patients with known or suspected malignant pleural effusion. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have known or suspected malignant pleural effusion and have a chest drain in-situ. Study details: All participants will have two CT scans: one standard CT scan and one CT scan with an artificial air-pleura interface. The artificial air-pleura interface will be created by introducing 500mL of air via an in-situ chest drain [such as intercostal catheter (ICC) or indwelling pleural catheter (IPC)]. The air is introduced using a syringe connected to the chest drain. The findings on pleura detected by the two CT scans will be compared. No previous studies have specifically assessed pleural abnormalities through this technique. We hypothesize for this study that artificially creating an air-pleura interface will make the small pleural nodules (~1cm) more conspicuous and will allow significantly better detection of previously undetectable pleural abnormalities/ nodules by CT scan.

  • The Effects Of Dual, Inhaled Long-Acting Bronchodilators on Complex Lung Mechanics in Chronic Obstructive Pulmonary Disease

    This projects aims to study the effects of different inhaled bronchodilator medications used in the management of COPD. Clinical trials have demonstrated their effects on the large airways of the lungs, however their effects on the small airways are not yet known. This project will use sensitive tests of small airway function to identify the effects of bronchodilator therapy on the small airways in COPD. Specifically, we aim to determine if two different classes of bronchodilators have a greater effect when given in combination than when given alone. We hope to use this information to enhance our knowledge of how these medications work, which may help us improve the treatment of patients with COPD.

  • TROG 15.01 (SPARK) Efficacy of Kilovoltage Intrafraction Monitoring (KIM) in men with prostate cancer undergoing stereotactic prostate radiotherapy

    This study will determine the efficacy of the addition of Kilovoltage Intrafraction Monitoring during stereotactic prostate adaptive radiotherapy in prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically proven prostate adenocarcinoma with low or intermediate disease risk. Study details All participants will receive multi-fraction stereotactic prostate adaptive radiotherapy at 36.25 Gy in 5 fractions over 2-5 weeks. A new technology, known as Kilovoltage Intrafraction Monitoring (KIM), will be used which allows images of a tumour to be taken in real-time while the treatment is occurring. This enables strategies such as patient shifting or beam shifting during treatment which could potentially improve the accuracy of the treatment and reduce the patient’s side effects. In addition, due to the accuracy of KIM in targeting tumours, the number of treatment sessions this group of patients will require will be reduced to five as opposed to the 40 sessions required using more conventional treatment methods. Efficacy of KIM will be assessed by the dose accumulation method for each session. Participants will be followed for up to 2 years, in order to determine patient treatment outcomes, and toxicity. The researchers expect this trial to result in better targeted prostate cancer patient outcomes with lower toxicity. The potential application of KIM to other tumour sites will pave the way for additional trials with Australasian radiation oncology leading the world.

  • Novel approaches to manage glucocorticoid-induced diabetes in hospital inpatients

    High dose steroids can raise blood glucose levels. These can cause infections, prolong hospital stay and even rarely result in death. Little is known about the best way to manage patients with ‘steroid diabetes’. We will study various approaches to manage high glucose levels in patients treated with steroids in hospital. We will use minimally invasive continuous glucose monitoring, a contemporary technology, to compare and evaluate in detail two different treatment schedules. One intervention will combine longer acting and mealtime insulin (conventional regimen), and the other will combine liraglutide, a newer non-insulin injection, together with longer acting insulin. The results of this study will provide important objective pilot data on management of patients with ‘steroid diabetes’ in hospital.

  • Randomised Controlled Trial of Cognitive Behaviour Therapy for Journalists to Reduce Posttraumatic Stress Disorder

    The rationale of the study is to evaluate the benefits of Cognitive Behaviour Therapy for reducing PTSD in journalists. This study compares the relative effectiveness of (a) Cognitive Behaviour Therapy provided by therapists via telemedicine to journalists compared to the same components which journalists read in manuals provided to them.

  • Great Leaders, Active Students.- Evaluating the impact of a Peer Leadership Program for Grade 6 students on the movement skill competency and physical activity levels of students in Kindergarten, Grade 1 and 2

    Competency in a range of movement skills (e.g. kicking, running, throwing) provides the foundation for an active lifestyle and developing leadership skills is important for children of all ages. It may also serve as a protective factor against the decline in physical activity typically observed during adolescence. Our proposed project will evaluate the impact of the Peer Leadership Program for Grade 6 students and on the movement skill competency and physical activity levels of students in Kindergarten, Grade 1 and 2. Our aim is to recruit two primary schools with 40-60 Grade 6 students, approximately 180 Kindergarten, Grade 1, Grade 2 students. Schools who agree to participate will be allocated to receive the Peer Leadership program in Term 1, week 10, 2015 or Term 3, week 1, 2015. Members of the research team will deliver the 3-hour Peer Leadership Program during school sport time, which will provide Grade 6 students with the skills to run physical activity sessions during timetabled physical education, lunch and recess for kindergarten, Grade 1 and 2 students. The study will be evaluated over a 10-week period and students in BOTH groups will complete evaluation measures at baseline (before the program begins) and 10-weeks (post program).

  • Stereotactic Hypofractionated body radiosurgery for Oligometastatic Renal cell Tumours upfront, with Systemic Targeted agents On Progression

    This study aims to investigate the side effects, safety, and effectiveness of stereotactic hypofractionated body radiosurgery for oligometastatic renal cell tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically confirmed renal cell carcinoma and 1 to 3 extracranial metastases (with no prior systemic targeted therapy) or 4 to 6 extracranial metastases in patients currently on systemic targeted therapy AND no more than 1 to 3 progressing metastases. Study details Stereotactic ablative body radiotherapy (SABR) is a new form of cancer treatment involving high precision radiotherapy. SABR treatment appears to be effective in controlling cancer in other sites elsewhere in the body, including the lung, spine, liver and kidney. We aim to test the ability of this new technique to control cancers that have spread beyond the kidney to other organs or to the bones. This study will involve discussing your medical history and progress of your renal cell tumour with the doctor. A whole body bone scan and CT scan of the chest, abdomen and pelvis will be performed to confirm the location and number of secondary deposits of the tumour prior to treatment and at follow up visits. In addition to the bone and CT scans, an additional scan called a diffusion and perfusion MRI will be used before treatment and 3 months after treatment to investigate the changes in cancer blood flow before and after treatment. Up to three sessions of SABR treatment will be performed, depending on the location of your secondary cancer deposits. As part of the study, blood samples will be taken before and after treatment at 5 timepoints over a period of approximately 3-4 months. Questionnaires looking at quality of life and pain will be completed before treatment, and at each follow up visit. Follow up visits will be performed at approximately 1 month, and every 3 months until 2 years after the radiotherapy treatment. This is the first step of the research, and is a ‘pilot’ study. If the technique is shown to be both feasible and tolerable for this pilot study of 30 patients, we would then look at expanding this study.

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