ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Magnetic Resonance Imaging (MRI) and radiological study of Rheumatoid Arthritis treated with Adalimumab and non-biological agents to assess the impact of disease control on MRI manifestations and joint structure preservation.

    Rheumatoid Arthritis (RA) is a chronic disease which when left untreated leads to long term joint damage, loss of function and a reduced life expectancy. There is evidence that by treating RA early with combination therapies the damage to the joints may be much less and function preserved. Following on from this observation, many rheumatologists think aiming for a specific end point to prevent progressive joint damage should be introduced. However, new TNF agents such as Adalimumab seem to protect against damage more than do conventional therapies even when signs and symptoms of arthritis are equally controlled. The explanation for this is unclear and needs to be explored further.

  • A randomised controlled trial investigating the effect of duration of immobilisation on function and pain following open reduction and internal fixation (ORIF) for adult distal radius fractures managed with a locked volar plate.

    Although distal radius fractures commonly occur, factors that affect treatment outcomes have not been well defined. There is a gap in our current knowledge regarding how long a wrist should be immobilised in a cast following surgical repair. The aim of this investigation is to compare participants following surgical repair of their distal radius fracture and immobilised in a cast for either one, three or six weeks. The hypothesis for this investigation is that three or six weeks of immobilisation is not superior to one week of immobilisation for participants following surgery for acute distal radius fracture for any of the recorded outcomes when measured over a six month period from the date of surgery. The information gained from this investigation will enable us to improve the management of distal radius fractures following surgical repair in the future. It is known from previous investigations that moving the fractured area as early as one to two days following surgical repair of a fracture is safe. Previous investigations also tell us that immobilisation periods ranging from less than one week up to six weeks have their advantages and disadvantages. This investigation aims to compare the immobilisation periods of one, three and six weeks so we can determine the best management for participants following a surgical repair for distal radius fracture.

  • Randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic colorectal cancer (CRC) with either KRAS WT or G13D mutation.

    Who is it for? You can join this study if you have metastatic colorectal cancer and have either a KRAS wild type or KRAS G13D mutation Trial details: Patients that pass all screening assessments, including CT scan and blood test will randomly divided into two groups. One group wiil receive cetuximab alone ( Arm A) and the other group will receive cetuximab in combination with irinotecan ( Arm B). In both groups, the chemotherapy is given intravenously. Cetuximab is administered weekly to both groups and patients in Arm B will receive irinotecan every 14 days. The study aims to evaluate the response to the different therapy regimens, by looking at the response on CT scans, survival rates and quality of life.

  • Markers of Brain injury study (MOBI)

    Measurement of neuroprostane and isofuran levels in plasma and CSF may give prognostic information in traumatic brain injury. The study aims are: 1) To establish the correlation between plasma and CSF levels of these markers in a population of severely brain injured patients and 2) To establish correlation between neuroprostane and isofuran levels and outcome as measured by glasgow outcome score and anterograde amnesia score.

  • Increasing adherence to Obstructive Sleep Apnea treatment with a coaching intervention.

    This project aims to (1) assess the effectiveness of a coaching intervention (C) in increasing adherence to CPAP compared with an enhanced education or treatment as usual (TAU) intervention; (2) to identify individuals with low self-efficacy scores who are at risk of stopping treatment and (3) to examine the role of mood, quality of life and well-being in the treatment response. The hypothesis is that the C intervention will increase uptake and adherence to CPAP and will improve low baseline self-efficacy scores as individuals feel they can perceive themselves using CPAP effectively. By using CPAP on a nightly basis for most of the night, mood and well-being, sleepiness and sleep related quality of life and self-efficacy will also be improved. A total of 60 individuals diagnosed with OSA will be recruited into the study on the basis of being naive to CPAP treatment and having low self-efficacy scores (<4). Participants will be randomised to either the current treatment as usual group (TAU) which consists of psycho-education and mask fitting (1.5 - 2 hours) before the CPAP titration night or a coaching group (C). The C group will undergo the psycho-education and mask fitting but will also undertake 4 individual coaching sessions at baseline (3 face-to-face session and 1 by telephone). All participants will be asked attend 4 CPAP data usage download sessions and to complete questionnaires at baseline, 1 week after starting CPAP, 1 month after starting CPAP, 12 weeks after starting CPAP and 3 months after study end. All participants will receive a CPAP machine and tubing free of charge for the duration of the study. Past CPAP research has found that self-efficacy predicts CPAP adherence, and as SF/CBC has been found to enhance self-efficacy and goal attainment and adherence, thus advancing knowledge and practice in CPAP and contributing to the broader emerging area of health coaching.

  • Acupuncture for weight loss and mental health

    Obesity is a major health concern of epidemic proportions, with acupuncture being used and investigated as a potential treatment modality. Elevated eating, weight and shape concerns potentially have deleterious effects on mental health. To date few acupuncture studies have evaluated the effect of a weight loss program on the mental health of obese/overweight participants in a trial and none have looked at eating, weight and shape concerns. Objectives: To investigate the effect of Traditional Chinese Medicine (TCM) acupuncture on the mental and physical health of individuals undertaking a weight loss program, with particular reference to individuals who have eating concerns (undue influence of weight or shape on self-evaluation). Methods: Thirty five consenting overweight/obese males and females participated in a single blinded randomised cross-over study. The two intervention phases were i) nutritional counselling plus TCM acupuncture and ii) nutritional counselling plus sham acupuncture. Outcome measures: The outcome measures were the EDI-3 Eating Disorder Risk Composite (EDRC), the Becks Depression Inventory (BDI-2), the State-Trait Anxiety Inventory (STAI), the SF-36v2 Health Survey (physical and mental quality of life) and body weight change. Results: There were no significant beneficial effects on the mental health of participants during the acupuncture or sham acupuncture phase. However when certain components of outcome measures were analysed, significant improvements were observed for overweight females with eating concerns during the acupuncture phase compared to the sham phase. These were STAI State (p= 0.004) and Trait anxiety (p= 0.04), BDI-2 depression (p= 0.04) and the mental aspect of the SF-36 Health survey (QoL) (p= 0.0001). Conclusion: TCM acupuncture was found to have beneficial effects on the mental health of overweight women with elevated eating and weight concerns. Further research is needed as these individuals are at greater risk for pathological eating issues and psychological distress.

  • Non invasive end tidal carbon dioxide monitoring study in patients presenting to the Emergency Department with an Acute Respiratory Illness: establishing whether there is a correlation between arterial blood gas and non-invasive monitored, carbon dioxide levels.

    Blood gas monitoring, especially carbon dioxide (CO2), is often needed for the appropriate management of patients with acute respiratory illnesses in the Emergency Department. Currently, the only accepted method to monitor CO2 is via arterial blood gas sample, however, repeated arterial blood sampling is invasive, causes patient discomfort, and fails to provide a continuous picture of changes in blood gas levels, in response to therapeutic interventions. Measuring oxygen saturation and carbon dioxide continuously provides more information about changes than single arterial measurements. This study will monitor CO2, using a non-invasive oral nasal cannula attached to a monitor and compare this to the traditional arterial CO2 reading. A CO2 reading will be recorded at the same time that a blood gas is taken, to see if there is a correlation between non invasive CO2 (NIET-CO2) and ABG results.

  • Short Multi -disciplinary Acute Rehabilitation Team (SMART) to acute care

    The aim of this research project is to investigate the efficacy and benefits of an in-reach multi disciplinary rehabilitation program. Patients will be assessed for egibility to attend rehab program by rehabilitation coordinator or rehab physician after referral received via medical/surgical teams. This will be done in accordance with SMART inclusion/ referral criteria. Research Project officer will enroll patients in study, complete informed consent and perform baseline data assessments. Participants will then be randomized into intervention and control group via a computer generated program. Intervention group will receive rehabililtation on ward 8D and the intervention group will receive standard care on any acute ward within RNSH. Functional measures will be conducetd by the research project officer in both control and intervention group at 7 day post enrollment or prior to discharge if this should be earlier. Hypothesis: Provision of a short term multi-disciplinary acute rehabilitation program to patients in acute care will lead to reduced length of stay, improved mobility and ADL function as well as improved quality of life.

  • Replacing missing lower back teeth with an implant-supported removable partial denture.

    The puropse of this study is to compare two treatment options for the replacement of missing lower back teeth; one option is the standard treatment using a removal partial denture, and the other option is use of a removable partial denture held in place by dental implants (a dental implant is an artificial tooth root, surgically placed into the jaw bone, to hold a tooth or denture in place). The hypothesis is that the implant-supported option provides significant benefits over the conventional removable partial denture in terms of function (ability to chew and break-down food), comfort, and overall patient satisfaction.

  • Study to determine whether low-dose aspirin in healthy older adults prevents cognitive decline in those identified as having moderate to severe sleep apnoea: the SNORE-ASA substudy of the Aspirin in Reducing Events in the Elderly (ASPREE) study.

    Sleep Disordered Breathing (SDB) is very common in older adults. Previous studies have identified that approximately 50% of adults aged 70 and over have some degree of SDB. Obstructive Sleep Apnoea (OSA) is the most common form and refers to intermittent obstructions to airflow during sleep, most often associated with snoring. While OSA has been shown to be associated with cognitive dysfunction in middle aged adults, the effect of OSA on cognitive outcomes in older adults is less well established, as there have been few prospective studies. SNORE-ASA will investigate whether sleep apnoea in healthy older adults is associated with cognitive decline over three years of follow-up, and whether daily low dose aspirin is protective against this cognitive decline associated with sleep apnoea. The study will also examine how sleep apnoea may cause cognitive decline in older adults, by using brain MRI and retinal photography to determine whether sleep apnoea causes hypoxaemia-induced small blood vessel flow problems (ischaemia), and whether aspirin alters this process.

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