ANZCTR search results

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

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33074 results sorted by trial registration date.
  • The To2rpido Study: Targeted Oxygenation in the Resuscitation of Premature Infants and their Developmental Outcome

    The problem with oxygen: Oxygen (O2) is essential for life but too much (hyperoxia) is toxic and may cause cell inflammation and death. The extremely premature infant is particularly susceptible to O2 toxicity because they do not develop or acquire appropriate defense mechanisms until the 3rd trimester (after 28 weeks gestation). Prolonged or excessive exposure to O2 may, in fact, cause problems like bronchopulmonary dysplasia (BPD) or retinopathy of prematurity (ROP). Children with BPD are in and out of hospitals with chest infections and asthma. They also have lower intelligence and grow more poorly because of repeated episodes of hypoxia (low body O2) from lung damage and steroids. The latter improves lung function but may also impair brain growth. Children with ROP may be severely short-sighted and even blind. Unfortunately, many premature infants, if they survive, still develop BPD and ROP despite considerable advances in prenatal care (e.g. maternal steroids that accelerate lung maturation), postnatal care (e.g. artificial surfactant that aids lung expansion) and an awareness of the profound consequences of O2 toxicity in this population. The use of oxygen during resuscitation: More than 1 million infants around the world do not breathe after birth and require resuscitation. For more than a century, pure or 100% O2 has been given to such infants through breathing masks or tubes. A change in color from blue or white to pink is generally taken to be a positive response to resuscitation. However, recent studies of full-term human newborn infants now advocate caution because there is increasing evidence giving an infant 100% O2 may cause excessive formation of toxic reactive oxygen species (ROS) that injure vital cellular components like membranes and DNA (deoxyribonucleic acid). This may delay the infant’s recovery and even double the risk of death. What about the premature infant? Studies have shown that full-term infants may be resuscitated with room air (RA, 21% O2) with good result. However, premature infants often have some lung immaturity and may need a bit of O2 after birth to prevent hypoxia. How much O2 that is, is not certain. Whether giving a preterm infant lower amounts of O2 during resuscitation may improve outcome is also not known. The aim of the To2rpido study is to see if using RA to start the resuscitation of very premature infants (<31 weeks gestation) reduces oxidative injury and complications such as BPD, ROP, cerebral palsy (CP) and death. Location: This is an international study in Australia (n=3), Malaysia (n=6), Singapore (n=1) and India (n=1). These sites are important to show that the resuscitation techniques used in the To2rpido study may be applied to neonatal intensive care units in both developed and developing nations. How the study will be conducted: We will compare RA to 100% O2 to start the resuscitation of premature infants below 31 weeks gestation in the delivery suite. O2 will be changed depending on the infant’s oxygen saturations (percentage of oxygenated hemoglobin, SaO2) and the infant’s blood will be tested for O2-related stress products. Complications such as death, CP, BPD and ROP will be compared and survivors will be tested at 18-24 months of age for neurological and physical development. Significance: There is still no cure for prematurity, which affects more than 8% of infants worldwide. The number of premature infants has increased by 15% over the last two decades in the USA alone and their care costs more than $30 billion a year. In addition, most of the premature babies are born in non-Western countries and the techniques used in the To2rpido may therefore also have far-reaching consequences for the almost 13 million premature infants born around the world each year.

  • A randomized controlled trial of the effects of different levels of graded support on symptoms of anxiety and depression in adults using the Internet-based Wellbeing Course

    This project is part of a research program funded by the NHMRC (No. 630560) to develop and evaluate Internet based transdiagnostic education and treatment programs for people with anxiety and depression. This project examines the efficacy of a 5-lesson education course for people with depression, social phobia and/or panic disorder (with or without agoraphobia) and/or generalized anxiety disorder. It also explores the relative effect of different types of reminders (none vs. automatic email reminders) on outcomes and acceptability to consumers. We expect that differences will be observed between groups in symptoms of anxiety and depression (Groups 3>2>1) and in acceptability to consumers (Groups 3>2>1) and in completion rates (Groups 3>2>1).

  • Rehydration with Intravenous Fluid and Oral Glycerol in Athletes: Effects on Cardiovascular, Hormonal, Thermoregulatory, Metabolic and Performance Variables

    The major aim of this study is to assess whether rehydration in athletes can be improved by the use of intravenous fluids and/or oral glycerol, compared to oral fluids alone. It was hypothesised that both intravenous fluids or oral glycerol would improve rehydration, but that a combination of intravenous fluids and oral glycerol together would improve rehydration more than either of the interventions alone.

  • Propofol or Ketofol for Emergency Medicine Procedural Sedation- A Randomised Controlled Trial utilising eHealth methodology.

  • Development and feasibility testing of a "consumer questions" program to increase health literary and empower consumers to participate in decisions about their health.

    Aims To explore the feasibility and implementation issues of a program to train consumers to use simple consumer questions to enhance their understanding and decision-making in a clinical consultation. Specific aims i) To develop and produce a program to train and support consumers to use consumer questions (the Consumer Questions Program CQP) to elicit information for decision making and to integrate this information with their personal preferences, and; ii) To test the feasibility of consumers using this program in FPNSW consultations. Research questions The effects of the program results on: 1) consumers' knowledge of the questions 2) consumers' understanding of when and why they might want to ask the questions 3) consumers' willingness to ask the questions in the consultation 4) consultation processes, particularly in consultation length and complexity Health professionals' reactions to the questions will also be examined.

  • Heritability of fat taste sensitivity and its association with obesity

    A recent discovery in our laboratory demonstrated that in comparison with lean subjects, the alimentary canal (oral and gastrointestinal tract) response to fats and fatty acids in foods was attenuated in overweight and obese human subjects. This data supports evidence that overweight and obese individuals consume excess dietary fat. There are two possibilities for these findings, first, that consumption of a high-fat diet induces environmental adaptive changes in the body’s sensitivity to fat, or, second, that genetic predisposition determines an individual’s fat sensitivity. Using both monozygous and dizygous twin pairs; we will estimate the magnitude of fat sensitivity heritability and its links to obesity.

  • Acupuncture and mucosal immunity in the upper respiratory tract

    There is evidence to suggest that acupuncture can modulate both non-specific and specific immunity. Published literature suggests that this modulation is most prominent in subjects with chronic inflammatory diseases including allergic rhinitis. Claims are also made regarding the “uniqueness” of acupuncture treatment in that it can have differing effects with an identical stimulus, depending on the starting state of the organism. The overall objective of this research is to investigate the effects of acupuncture on the mucosal immune response in the upper respiratory tract. We will study patients with allergic rhinitis where there is evidence that acupuncture treatment is clinically beneficial. We will also study healthy subjects without allergic disease to investigate any differences in effects that the same acupuncture treatment might have on mucosal immune responses compared to patients with allergic rhinitis.

  • Stepping Stones Triple P for Parents of Children with Acquired Brain Injury

    An acquired brain injury (or ABI) refers to an injury to the brain that has occurred after birth. Common causes of traumatic brain injury (the most common subtype of ABI) are motor vehicle accidents, falls, sporting injuries, or assaults. Other causes of brain injury include stroke, tumor, infection, or hypoxia. In children, brain injury can cause existing skills and abilities to be lost at least temporarily, and can also cause delays in the development of new skills. Some children recover very well, however it is quite common for children to experience some form of behavioural, social, academic, physical, emotional or developmental problems. It is recognised that acquired brain injury can impact on the entire family system. Not only do parents have to manage the stress associated with the difficulties that their child is experiencing, they are also often dealing with many emotions related to the ABI, attending many appointments for their child, and dealing with schools and various other agencies. This study aims to assess the efficacy of a behavioural family intervention, plus an ACT-based intervention addressing the emotional costs of ABI, tailored specifically for parents of children with ABI, with an emphasis on the difficulties that might be unique to these families. It is predicted that this intervention will lead to decreases in child problem behaviour and emotional difficulties, improvements in parenting style, and improvements in parental adjustment.

  • Potential of Functionalised tri-Calcium Phosphate in the relief of dentine hypersensitivity

    Introduction The currently accepted definition of dentine hypersensitivity states that ‘Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentin in response to stimuli, typically thermal, evaporative, tactile, osmotic, or chemical, and which cannot be ascribed to any other form of dental defect or disease.’ The hydrodynamic theory is the most widely demonstrated and accepted pathophysiological theory of dentine hypersensitivity. The theorem proposes that dentine hypersensitivity is a result of movement of fluid within the dentine tubules. Most pain-producing stimuli cause movement of dentinal tubule fluid, the most common being cold and evaporative stimuli. This results in a pressure change across the dentin which activates intra-dental nociceptive nerve fibers, via a mechanoreceptor response, to cause pain. Currently available dentine desensitisers can be divided into two categories by their modus operandi: one is to interrupt the neural response to pain stimuli; the other is to occlude open tubules to block the hydrodynamic mechanism. Clinpro Tooth Creme is a white paste that contains 950 ppm fluoride ion (similar to regular toothpaste) and a functionalised tri-calcium phosphate ingredient Aims 1) Investigate the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity 2) Assess the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity in comparison to an alternative desensitising agent 3) Compare the efficacy of Functionalised tri-Calcium Phosphate in relieving dentine hypersensitivity when applied topically and with brushing vs application during brushing only

  • Using Personal and environmental resources to reduce falls risk for older people with dementia

    Seventy to eighty-five percent of people with cognitive impairment fall each year. This alarming rate is twice that seen in cognitively normal older people. In addition, people with cognitive impairment and dementia are at increased risk of serious injury and have a poorer prognosis following a fall. Falling in older age can markedly change an individual’s health trajectory, having debilitating and isolating consequences. Falls can start a downward spiral of immobility, reduced confidence and incapacity leading to institutionalization, and can be a cause of premature death. Typically, fall studies conducted with community-residing people exclude those with cognitive impairment. Thus little is known about how to best conduct falls prevention in this population. This project will refine, trial and pilot a program that integrates the known evidence for falls prevention for environmental adaptation along with a dementia-specific approach to safe activity engagement in fall risk situations. Assessment of functional abilities and functional cognition will be conducted using Allen’s Cognitive Disability Model of practice. This will frame the intervention which will utilise the older person’s personal and environmental resources to make adaptations to the environment and behaviours that will significantly reduce their risk of falling.

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