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.
  • A tape stripping study for early diagnosis of melanoma.

    This study evaluates a new non-invasive technique for early diagnosis of melanoma. Who is it for? You may be eligible to join this study if you are at least 18 years old and have a pigmented lesion that is suspected of being a melanoma which requires surgical removal. Trial details: This research study proposes to use a novel non-invasive method called Epidermal Genetic Information Retrieval or EGIR to assess skin lesions that are suspicious for melanoma. The method of retrieval is via tape stripping. Tape stripping allows recovery of cells of the upper epidermis (superficial most skin layer). These skin cells will be studied to identify markers capable of distinguishing between melanoma and benign (harmless) pigmented lesions. Unlike standard biopsies, tape stripping is non-invasive, rapid, easy to perform and painless. Therefore, the identification of such markers by this method could help physicians determine the nature of suspicious lesions of the skin without having to perform a biopsy. Tape stripping has been tested previously and has shown promise in identifying markers for other skin disorders and is now being tested through this research study for melanoma. All participants in this study will undergo collection of skin samples via the tape stripping procedure. The tape (0.7inches in diameter), similar to a band-Aid will be applied to the skin lesion and rubbed in circular motions. 4 skin tapes will be placed on the same skin lesion. A normal looking skin area (an area that does not have a lesion) will be used as a comparator. After the skin taping procedure is completed, the skin lesion will be biopsied or removed as per the normal clinical practice. The tape strips will be couriered to the Sponsor DermTech International where they will be analysed. The Biopsy specimen will be sent to a nominated pathologist for this study and results will be sent back to the investigator. The tissue slides will be sent to an independent pathologist for a second review.

  • Parental presence on bedside clinical rounds (PPBCR) in a neonatal intensive care unit (NICU).

    Why are we doing this study? * ACT Health and The Canberra Hospital are motivated to provide care that is both family and patient centred. Currently in the Centre for Newborn Care parents are not involved in clinical bedside rounds. This study will allow parents to attend these rounds for a specified period and gain feedback from the experience via surveys. * We aim to use the information gained from this study to introduce a new way of doing clinical beside rounds in our soon to be completed Womens’ and Childrens’ Hospital. What does the study involve? * After obtaining consent, the participant (parents or guardian) will be randomised to one of two arms: 1. PPBCR group (attending bedside clinical rounds with health care professionals) or 2. Non-PPCBR (non-attending bedside clinical rounds with health care professionals). * Each group depending on the baby’s gestation will rotate between attending and not attending rounds spending 3 (if the infant gestation is more than 30 weeks) or 7 (if the infant gestation is less than or equal 30 weeks) days in each group with a similar break in between. * The participant will be given regular updates on their baby condition during non-PPCBR and washout break * At conclusion of each arm, the participant will be asked to complete: 1. NICU parental stressor scale and 2. A satisfaction survey about being involved in clinical bedside rounds What do we hope to achieve with this study? Through your involvement in this study we aim to: * Improve communication between families and the clinical team within the Centre for Newborn Care. * Families being more aware of current clinical management and care plan for their babies, in turn reducing stressors they may experience.

  • Can omega 3 fatty acids improve respiratory outcomes in preterm infants?

    The purpose of this study is to determine the degree to which Docosahexaenoic acid (DHA) supplementation reduces the incidence of bronchopulomonary dysplasia (BPD), as assessed by the requirement for supplemental oxygen and/or assisted ventilation at 36 weeks post menstrual age.

  • The effect of exercise in a reduced oxygen environment on changes in body composition.

    This study seeks to examine the effect of normobaric hypoxia exposure and exercise on changes in body mass and body composition. It is hypothesised that there will be no additional effect of exercising in normobaric hypoxia on the rate of change in body composition induced by regular exercise.

  • Train High Eat Low for Osteoarthritis: THE LO Study

    Knee osteoarthritis may reduce physical activity due to associated pain, depression, impaired gait and balance and lower-extremity muscle weakness. Abnormal joint loading (in particular increased knee adduction forces due to malalignment of the knee); obesity, muscle weakness, systemic and local inflammation, dietary intake of fat, antioxidants and other micronutrients alter the risk and progression of osteoarthritis. Elevated knee adduction forces are vitally important, as it has been shown to increase the risk of radiographic medial knee osteoarthritis progression by 6.5-fold, more than any other characteristic. Lifestyle programs have great potential to target these underlying factors, thus acting as disease-modifying interventions rather than simply providing pain relief. This distinguishes lifestyle therapy from pharmacologic/analgesic therapy for osteoarthritis, justifying its role as central to the treatment of osteoarthritis. A theoretically-grounded lifestyle modification program that better addresses the aetiology of disease onset and progression is needed if we are to actually alter the underlying pathophysiology of knee osteoarthritis. Postural control and gait training to reduce abnormal joint loading and progressive resistance training are far more specific for the impairments of knee osteoarthritis than aerobic exercise, for example, which may be intolerable in moderate-to-severe knee osteoarthritis. Similarly, a low glycaemic index/load weight loss diet has been shown to be more effective at reducing weight and lowering systemic inflammation/insulin resistance than standard energy and fat restriction. We hypothesise that participants with medial knee osteoarthritis randomised to either Gait Training or Progressive Resistance Training or High Protein/Low Glycaemic Index Group or all three interventions combined will have significant reductions in abnormal joint loading (KAM) compared to controls given standard lifestyle advice at 12 months.

  • Type 1 Keystone Flap versus Simple Primary Closure for wound closure - A Prospective Randomised Controlled Trial

    Surgical defeects that are predicted to be difficult to close may be considered for type one ketstone closure. The theoretical advantage of this method is that the release of the longitudinal tension in the wound allows greater stretch along the transverse axis. There is no reliable evidence in the literature to prove that this is the case in human models, indeed in our small study the increase in transverse stretch enabled by longitudinal release was less than 1mm. With this in mind the advantage of a keystone flap over other wound closure techniques is unclear. We aim to compare the keystone flap with simple primary wound closure, with primary outcome measured as wound healing, using the ASEPSIS wound score. The type one keystone flap was first described by Behan in 2003, for use in "suitable defects over most areas of the body up to 2cm in width". Patients will be recruited into the study based upon this selction criteria and then randomised to keystone flap or primary closure. Short and longterm follow up centered around the ASEPSIS wound score will be used to compare wound healing in the two groups.

  • Can thrice a week of resistance training during dialysis improve cardiovascular health and other outcomes in patients with kidney failure?

    Cardiovascular mortality and morbidity are high in end-stage renal disease (ESRD) patients compared to general population. Arterial stiffness is a cardiovascular measure that predicts mortality in ESRD patients. Although exercise can counteract many risk factors contributing to arterial stiffness, research on its effect on arterial stiffness in ESRD patients is inconclusive and limited to aerobic exercise. The aim of this project is to examine the affect of intradialytic resistance training on arterial stiffness and other secondary health outcomes in ESRD patients. Participants will undergo a 12 weeks usual care control period followed by a 12 weeks resistance training intervention period. Participants will be recruited from dialysis centres and will undertake their exercises in their centres. All participants will undergo a series of measurements before and after control period and after intervention period. Measures include arterial stiffness, blood sample measures, quality of life, depression level, physical fitness and activity level.

  • Alzheimer's disease, cognition and cerebrospinal fluid: Are they associated?

    The overarching hypothesis for this study is that in older adults who undergo surgery, occult or preclinical Alzheimer’s Disease (AD) increases the risk of adverse central nervous system (CNS) outcomes, including acceleration of the AD disease process itself and subsequent earlier clinical expression. The specific hypotheses are: 1. In older people undergoing elective orthopaedic surgery, the presence of a cerebrospinal fluid (CSF) signature of Alzheimer’s Disease (AD) at baseline will be associated with a greater incidence and or severity of decline in Clinical Dementia Rating scale at 18 months post-operatively, compared with a non-surgical group with a CSF signature of AD and equivalent baseline cognition. 2. At baseline, a CSF signature of AD in surgical patients will be associated with a higher incidence of PostOperative Cognitive Dysfunction (POCD) and functional change at 3, 12, and 18 months post-operatively compared to surgical patients without the CSF AD signature. 3. Individuals classified with POCD will be at higher risk of conversion from cognitively normal to MCI or to dementia, or from MCI to dementia, compared with those who are not classified with POCD.

  • Effect of Shift Work on Post Prandial Dysmetabolism

    This study aims to explore the impact of an imposed de-synchronisation between circadian rhythms, sleep cycles and eating patterns - as would occur during a rotation between day and night work, on postprandial dysmetabolism.

  • Is the healing rate in diabetes related foot ulcers improved with low frequency ultrasonic debridement versus non-surgical sharps debridement? A randomised control trial.

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