ANZCTR search results

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

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31247 results sorted by trial registration date.
  • Personalised pelvic floor Muscle Training for Urinary incontinence after Prostatectomy

    The aim of this study is to evaluate efficacy of a personalised pelvic floor muscle training program on urinary incontinence after radical prostatectomy. Who is it for? Individuals may be eligible to join this study if you aged 30-70 years and are scheduled to undergo radical prostatectomy (open or robotic) for prostate cancer. Study details Study participants will be allocated by chance to one of the three groups, Urethral muscle training, Conventional training or No training. Urethral muscle training will involve an individualised program of pelvic floor muscle training that relies on the principles of motor skill training of the striated muscles that control urethral pressure with ultrasound imaging used for assessment and biofeedback. Participants in both treatment groups will attend up to 10 sessions of pelvic floor muscle training supervised by a physiotherapist, and participants in the No treatment group will not receive treatment. Participants in the treatment groups will attend a session 1-2 weeks prior to surgery and will commence training before surgery. They will attend up to 9 sessions post-surgery, 1 week apart, commencing on catheter removal (~2 weeks post-surgery). This study will provide new insight into whether individualised pelvic floor muscle training is more effective than current treatments or no treatment for management of post-prostatectomy incontinence.

  • The effect of Ketamine in combination with Dexmedetomidine or Fentanyl on measures of cognition, sedation and behaviour in healthy adults

    Both alone and in combination, the effects of Ketamine, Fentanyl and Dexmedetomidine are effective at providing analgesia to patients in the ICU. However, these drug combinations can potentially also have very important consequences for tasks involving complex cognitive and behavioural ability, which includes making important clinical decisions (in a clinical setting both during and post-treatment), and driving a car (post treatment discharge). Currently, it is unclear which clinically indicated drug combination (either KET/DEX or KET/FENT) has more favourable effects on sedation, alertness and cognitive/neurobehavioral outcomes. We therefore seek to test whether sub-anaesthetic KET/DEX combination will yield in better analgesic and alertness level when compared to KET/FENT, and if there are any differences in cognitive and neurobehavioral abilities between these drug conditions.

  • The role of continuous glucose monitoring (CGM) systems as a self-monitoring tool to optimise blood glucose control in individuals with type 2 diabetes (T2D) - Pilot

    The aim of this research is to determine how effective real-time continuous glucose monitoring (RT-CGMS) compared with standard care self-management blood glucose (SMBG) is for improving glycaemic control, and enhancing quality of life in response to the prescription of a lifestyle modification program in overweight and obese individuals with type 2 diabetes (T2D) If shown to be effective, this innovative public health, clinical service delivery model can be used in a cost effective manner to enhance current self-management approaches for diabetes and be incorporated by health professionals as part of mainstream diabetes management practice that will improve cardiovascular health on a wide-scale community level.

  • A hybrid functional electrical stimulation training program for persons with advanced multiple sclerosis

    Aim: To determine if hybrid exercise can improve fitness in persons with advanced MS. The primary outcome measures are the peak oxygen consumption achieved during the arm cranking and hybrid exercise trials. Secondary outcome measures will include the participant fatigue (Likert scale) and Fatigue Impact Scale, heart rate (Polar monitor) during arm cranking and hybrid exercise, Cardiopulmonary measures will be taken before exercise, during each workload, and after exercise. Intervention: Ten persons with advanced multiple sclerosis will undertake 12 weeks (2 days/weeks) of aerobic hybrid exercise training at the Faculty of Health Science, University of Sydney. Prior to commencement, 3 exercises tests will be conducted and repeated at the conclusion of the intervention. An incremental arm crank test will be conducted at the midpoint (6 weeks). The exercises tests include a maximum arm crank, incremental arm crank and hybrid FES cycling tests. Each test will be separated by between 2 days to a week. During the incremental arm crank and hybrid FES cycling test routine non-invasive measures of cardiorespiratory metabolism will be performed. Oxygen consumption and other cardiorespiratory metabolism will be measured by a metabolic cart. Heart rate will be monitored with a standard chest strap heart rate monitor. At the end of each exercise trial participants will be asked how hard the exercise felt and how fatigued they feel on a visual analogue scale. Training involves two sessions a week of hybrid FES cycling (total session duration including setup and debrief will be 60min). Arm cranking will be at 30:30 second intervals at 60% of maxPO and continuous FES cycling at maximum tolerable intensity (increased to this point over the first 20 minutes). During training perceived exertion will be taken every 5 minutes to ensure the participant is working at a rating of 14 (“somewhat hard”) on the 15-point BORG scale. Hypothesis: It is predicted the 12 weeks of hybrid FES cycling will be sufficient to illicit improvements in aerobic fitness. Therefore, the primary hypothesis tested is that hybrid FES exercise training will enhance the peak aerobic capacity elicited during arm crank exercise testing. Additional hypotheses will test other health related variables to determine if a program of Hybrid FES cycling has made any other impact on aerobic fitness and life in persons with advanced MS. The additional hypotheses are that: 1) Hybrid FES exercise training enhances the VO2Peak that can be produced during hybrid FES exercise testing and 2) Hybrid FES exercise training reduces the daily fatigue experienced (as measured by the fatigue impact scale [FIS]).

  • Probiotics to reduce infection in patients admitted to the Intensive Care Unit

    The primary purpose of this study is to determine whether probiotic therapy in critically ill patients admitted to an ICU reduces hospital-acquired infection, and hence reduces risk of death and time in hospital.

  • Reducing blood glucose related driving mishaps among adults with type 1 diabetes

  • Preventing the neurotoxic effects of hypoglycaemia in adolescents with Type 1 diabetes- a randomised placebo-controlled trial

    The aim of this study is to assess whether medium chain triglycerides (MCT) can protect the brains of adolescents with type1 diabetes mellitus (T1D) during hypoglycaemia. Glucose is the dominant metabolic substrate for brain function. Hypoglycaemia is an inevitable consequence of insulin therapy in type 1 diabetes mellitus (T1D). Even with good control, children and adolescents with T1D spend up to one hour per day with blood glucose levels in the hypoglycaemic range. If untreated, hypoglycaemia can lead to impaired cognition, loss of consciousness and potentially death. Fear of the neurologic consequences of hypoglycaemia is one of the main impediments to optimal metabolic control in children with T1D. Thus there is an imperative for neuroprotective therapies that mitigate or prevent the effects of hypoglycaemia. Using hyperinsulinaemic glucose clamp techniques and simultaneous neuroimaging we have previously investigated the effects of hypo- and hyperglycaemia on brain metabolism, neural networks and cognition in adolescents with T1D. Our studies found clinically important, novel, consistent and robust changes in regional brain perfusion, activation and metabolism during passage from euglycaemia to hypoglycaemia. These abnormalities in neuronal activity persist over hours despite return to euglycaemia. We now plan to exploit these novel findings and to study whether the observed changes can be mitigated or prevented by the prophylactic administration of MCT prior to hypoglycaemic challenge. We will test the efficacy of MCT during clamp-induced hypoglycaemia in a randomised, cross-over placebo-controlled trial. The study population will be 10 adolescents aged 12-18years with Type 1 diabetes, recruited from the Diabetes Clinic at the Royal Children’s Hospital, Melbourne. Our primary outcome will be difference in cerebral perfusion as measured by arterial spin labelling – ASL) during hypoglycaemia induced following MCT as compared with placebo.. Our secondary outcomes will be differences between groups in, functional connectivity /activation in the default mode network (measured using blood oxygen level dependent [BOLD] signalling), brain metabolism (measured using BOLD signalling), frontal lobe biochemistry (measured spectroscopically) and cognitive function (measured on a working memory task). We hypothesize that the changes in all of these outcome measures during hypoglycaemia will be mitigated or prevented by prior oral MCT administration. Our ultimate aim is to devise a simple oral therapy that can be taken by all children with T1D to protect the brain from hypoglycaemia. This will lead to improved neurologic outcomes and facilitate better overall metabolic control of their diabetes.

  • Acute effect of high calcium milk and calcium supplement on bone health in thin and overweight post-menopausal women

    Our research focuses on nutritional strategies for bone health to prevent osteoporosis and reduce the risk of fractures in overweight post-menopausal women. Osteoporosis and obesity both impose major cost burdens for their associated care. There is increasing evidence of a high prevalence of fractures in overweight and obese people. There are approximately 400 fractures per day in Australia as a result of osteoporosis. Breaking a bone is very painful but there are longer term effects such as difficulty in walking and it has now been shown that fracture contribute to premature death. Osteoporosis arises when bones lose calcium more quickly than it can be replaced, reducing their strength. Although only a small amount of calcium is present in blood; this calcium is essential for the functioning of the heart, muscles and nerves. So far, studies have mainly investigated impact of calcium supplementation in reducing bone loss in normal weight women. However there are increasing numbers of overweight women in our community and therefore it could be that dietary calcium does not have the same benefits for bone health in overweight women as it does in thin women. Our research aims to answer two important questions:- 1) Can dietary calcium protect the bones of overweight and obese post-menopausal women? 2) Which form of calcium intake, calcium from food or calcium as supplement, is better for overweight/obese post-menopausal women.

  • Modulated Light Therapy in Participants with Pattern Hair Loss

    The REVIAN study is designed as a prospective, randomized, controlled, double-blind, parallel study to evaluate the efficacy and safety of the REVIAN System in male participants with androgenic alopecia. An Active modulated light therapy REVIAN System will be compared to a Placebo Comparator non-active REVIAN System in participants using the device for a daily 10-minute treatment over the course of 26-weeks. At each follow-up visit, participants will be interviewed to determine if any adverse events (AEs) were experienced since the previous follow-up visit. All participants will be required to complete self-administering scalp hair growth and life quality questionnaires at each follow-up visit. Investigators will be required to complete global assessments of scalp hair growth for each enrolled participant at each follow-up visit. Macrophotography evaluations will be performed at baseline, 8-, 16-, and 26 weeks for all participants using standard Canfield blinded reviewer. Global photographs of superior and vertex scalp will be taken by participants and by PI to be assessed by a blinded reviewer once all photos have been captured for each participant per visit.

  • Pilot testing of a new Blood Pressure measuring device on healthy adult volunteers

    Project Summary This is a pilot study of a new, non-invasive, cuffless blood pressure measuring device, worn on the chest. This is a world first for Monash University engineers. Blood pressure (BP) measurement is an essential vital sign, and provides a cornerstone for diagnostic and treatment decisions in healthcare. Existing technology requires either uncomfortable arm cuff inflation, or invasive catheters placed into patient’s arteries. Monash University engineers have developed a device consisting of sensing pads (4 ecg dots) and a radar to be placed on the patient’s chest. Initial lab testing suggests that the device functions well in fit young volunteers. Further testing is now required on volunteers with a range of resting blood pressures and body shapes to determine how the device performs on a broader section of the adult population. We are evaluating this device at Cabrini on a reasonably healthy adult volunteer population aged 18 years and over. Some of the subjects need to have uncomplicated hypertension. The study requires most participants (N=29) to attend for an hour, wear the new device on their chest, and a normal ‘gold-standard’ BP cuff on their arm. The volunteer will then go through a range of tasks whilst having their BP measured both ways. The tasks involve resting on a bed, sitting up, clenching their hands and riding an exercise bike for a few minutes. A smaller sub-group of the healthiest participants (N=16) would be required to take a small dose of glyceryl trinitrate (GTN) to lower their blood pressure by a small amount, whilst resting on a trolley in a treatment room in the Emergency Department at Cabrini. We aim to establish the precision of the device by correlating what the new device against an established ‘gold standard’ method of BP measurement measures (arm cuff). The dataset of BP readings from the chest device allows the engineers to apply mathematical algorithms to convert the data into accurate blood pressure readings. The aim of the research is to develop a method whereby BP can be measured accurately, continuously, and without patient awareness or discomfort, thus in the future eliminating the need for a sphygmomanometer or arterial line catheter for patients.

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