ANZCTR search results

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

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32856 results sorted by trial registration date.
  • 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.

  • Activity for Wellbeing: Promoting wellbeing through physical activity in aged care workers.

    This trial will test efficacy of a person-centred physical activity program (based in psychological theory) for promoting the adoption and maintenance of regular physical activity participation. The trial will also assess the efficacy of the program for promoting psychological wellbeing. The program is a workplace health promotion intervention aimed at frontline employees in aged-care. The program will use multiple strategies for supporting the basic psychological needs from a Self-Determination Theory perspective (autonomy, competence and relatedness) that is hypothesised to improve adoption and maintenance of activity and psychological wellbeing. The mixed-methods design will also assess the perceived effectiveness and limitations of the program for this population.

  • Comparison of artesunate parasite clearance of Plasmodium falciparum K13 and 3D7 isolates in healthy subjects

    This study will compare the ability of the antimalarial drug artesunate to kill 2 different P. falciparum malaria parasites administered to healthy subjects: the artemisinin-resistant K13 isolate and the artemisinin-sensitive 3D7 isolate. P. falciparum K13 was isolated from a person with malaria infection, and responds more slowly to artemisinin antimalarial drugs such as artesunate. However, P. falciparum K13 is still sensitive to other antimalarial drugs including piperaquine phosphate and atovaquone which can be used to completely kill the parasite. P. falciparum 3D7 is sensitive to the artemisinin antimalarial drugs such as artesunate. We expect that subjects randomised to receive the P. falciparum K13 isolate will clear the parasites more slowly after artesunate treatment than those subjects who receive the 3D7 (drug sensitive) isolate. The safety of the K13 and 3D7 isolates in healthy subjects will also be further assessed. Once the P. falciparum K13 isolate is properly characterised in this malaria infection model with respect to resistance to an artemisinin drug, it can then be used in future studies to investigate the activity of novel, antimalarial drugs in clearance of artemisinin-resistant parasites. This is important because artemisinin-resistant parasites are a growing problem and threaten to spread across the world.

  • SPRINT HEART: Study of Progressive Resistance and INterval Training in HEART disease

    Study of Progressive Resistance and INterval Training in coronary HEART disease (SPRINT HEART) is a 12-week, single blind, randomised controlled trial with a control group crossover. Participants will be randomised to either high intensity aerobic interval training (HIIT), high intensity resistance training (PRT) or usual medical care (control). The key aims of this investigation are to directly compare high-intensity aerobic and resistance training in terms of relevant physiological adaptations, fitness, safety and feasibility in a cardiac rehabilitation cohort.

  • Vasopressor dependent shock: Intravenous vitamin C versus placebo on vasopressor use. The VALENCIA study

    Vitamin C is an essential cofactor for multiple metabolic processes. Vitamin C levels are known to fall dramatically following the onset of acute inflammation from any cause. The resulting low levels of vitamin C are associated with worsening sickness and organ failure. Small studies suggest that replacing these levels may of benefit to critically ill patients.. This study is designed to study whether or not replacing Vitamin C will be of any benefit to very sick patients on life support in the intensive care unit. The study hypothesis is that replacement of vitamin C intravenously will result in an improvement in patient outcomes.

  • Profiling skeletal muscle loss during leg immobilisation and a reduced energy diet

    The nature of training and competition in the majority of popular sports dictates that debilitating injury is not uncommon when individuals engage in high musculoskeletal loading patterns and/or high impact collisions. A consequence of such injuries is that repair and remodelling of tissues and joints often requires significant periods of limb immobilisation. During immobilisation a reduction in the normal mechanical loading of skeletal muscle results in muscle wasting (atrophy). A challenge for individuals during periods of reduced physical activity (e.g. bed rest) or immobilisation is the management of body composition. The muscle unloading interaction with dietary intake has the capacity to modulate the effects of immobilisation on mechanisms regulating skeletal muscle mass. We (Areta et al. 2014) and others (Pasiakos et al. 2013) have shown that reduced total energy intake (30-40% below energy balance requirements) decreases muscle protein synthesis and results in a loss of fat mass but also muscle mass. However, higher protein intakes (>1.6 g/kg) during energy deficit may attenuate losses in lean mass (Pasiakos et al. 2013), despite an increased expression of genes associated with muscle protein breakdown (Carbone et al. 2013). How these dietary-muscle protein interactions change during periods of immobilisation is unknown. Decreased energy expenditure from cessation of physical activity with immobilisation necessitates restriction of energy intake to prevent undesirable gains in fat mass. However, whether implementing an energy deficit, despite higher protein intakes, exacerbates muscle wasting experienced during muscle unloading is unknown. Importantly, the effect of an energy deficit on the magnitude of muscle loss and the associated underlying molecular profile during immobilisation is currently unknown. The aim of this study is to determine changes in inducible gene/protein expression and skeletal muscle mass in the acute (3 d) and early (14 d) immobilisation period while under a moderate (30%) energy restriction with sufficient protein intake (1.4-1.5 g/kg). We will compare the effect of this energy deficit on muscle mass with immobilised participants in energy balance, a study previously completed in our laboratory. We hypothesize that 14 d of limb immobilisation with energy deficit will result in greater losses of total body fat, immobilised limb mass and gene expression for protein breakdown compared to immobilised limbs in energy balance.

  • Mindtrack: A randomised controlled trial testing different methods of communicating personal mental health risk profiles

    There is growing research on using risk algorithms to identify individuals at increased risk for future mental ill-health and for prevention interventions. However, there is lack of research on the effects of communicating personal mental health risk profiles on psychological or behavioral outcomes. There is potential that personal risk profiles can cause short term distress but motivate people to modify behavior to reduce their risks. Our research team has developed a risk algorithm to predict the 12-month risk of psychological distress in working Australian adults (Fernandez et al, 2017). This study explores the impact of communicating different types of personal mental health risk profiles on psychological outcomes and engagement with a smartphone App. The aim of this study is to investigate the effect of communicating different personal mental health risk profile on psychological distress and engagement with a smartphone App (Mindtrack). The secondary aim of the study is to explore how level of risk affects the psychological outcomes and engagement. The study’s purpose is to answer three main research questions namely: (1) What is the impact of different methods of communicating personal mental health risk profile on psychological outcomes in the medium term? (2) What is the impact of different methods of communicating personal mental health risk profile on engagement with an App? (3) Is an individual’s current or achievable risk an effect modifier of these outcomes? In order to achieve these objectives, a randomized controlled non-inferiority design will compare the effects of communicating (1) their current personal risk profile or (2) achievable personal risk profile or (3) no personal risk profile on psychological outcomes and engagement in the Mindtrack App. The 3 main study hypotheses are: i) The participants provided with the current risk profile and the achievable risk profile do not have unacceptably worse levels of psychological distress (defined as the lower bounds of the 95% CI is less than 4.6 points difference on the K10 between groups) compared to participants who do not receive personal risk profile at the endpoint (4 weeks). ii) The participants provided with the current risk profile and achievable risk profile will have higher levels of psychological distress (defined as a significant difference in K10) compared to participants who do not receive personal risk profile at 1-week post-test. iii) The participants provided with the current risk profile and the achievable risk profile do not have significantly different levels of wellbeing (defined as a significant difference in SF-12) compared to participants who do not receive personal risk profile at the endpoint (4 weeks). Other hypotheses available on request.

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