ANZCTR search results

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

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32127 results sorted by trial registration date.
  • Pharmacokinetics and Safety of Rivastigmine Nasal Spray versus Exelon (Registered Trademark) Capsule in Healthy Men

    Rivastigmine (RIV) is an acetylcholine esterase inhibitor which prevents neurotransmitter breakdown. As such it is currently approved for the treatment of neurological disorders such as Alzheimer's and Parkinson's disease dementia. RIV is available in two forms, oral (capsule) and as a transdermal (through the skin) patch. The latter was developed as a consequence of the oral forms causing nausea, vomiting and diarrhoea predominantly caused by the low oral bioavailability of this drug. Although the transdermal patch overcomes a lot of these side effects, a high percentage of people suffer from skin irritation and possible sleeplessness. This study will investigate whether delivering RIV nasally (into the nose) provides RIV therapeutic levels in the blood plasma that are comparable to Exelon (Registered Trademark) oral capsule and whether nasal RIV results in lower side effects. Each intervention will be as a single dose with thorough blood sampling over 24 hours to assess drug levels; each intervention will be separated by a 2 day washout period. This is a phase 1 trial in 16 young healthy males aged 18 to 55 years. While comparing the two delivery methods, this study will also investigate the safety and tolerability of Rivastigmine nasal spray.

  • Does stopping folic acid at 12 weeks of pregnancy reduce the amount of unmetabolised folic acid in the blood of pregnant women - The Folic Acid in Pregnancy Study

    Australian women receive 0.15-0.2 mg/d of folic acid from food containing fortified bread flour. In addition, >80% of Australian women take a multivitamin during pregnancy, with one of the most popular brands containing double the amount of folic acid recommended for pregnant women until 3 months gestation. (0.8 mg/d). There is no question that taking folic acid in early pregnancy is important to prevent neural tube defects. However, there is no proven benefit and potential harm from taking folic acid after neural tube closure at approximately 28 days post conception. We aim to determine if removing folic acid from prenatal supplements after 12 weeks of gestation results in lower blood concentrations of unmetabolised folic acid, a biomarker of excess folic acid, at 36 weeks’ gestation. We will also determine if removing folic acid from prenatal supplements after 12 weeks’ gestation allows women to maintain red blood cell folate concentrations >905 nmol/L at 36 weeks’ gestation.

  • The impact of reminiscence therapy using virtual reality in residential aged care to improve quality of life.

    Apathy is one of the most common of the behavioural and psychological symptoms of dementia and can have devastating effects on quality of life for older adults, particularly those in residential aged care. People with apathy are at greater risk of cognitive decline and reduced quality of life. Pharmacological interventions can have limited effectiveness and side effects, therefore, non-pharmacological interventions are a preferred approach. This projects aims to reduce levels of apathy in older adults living in residential aged care using virtual reality as a tool for reminiscence therapy. It is expected that greater improvements in apathy will be found in a virtual reality reminiscence group compared with a traditional reminiscence therapy and no treatment group.

  • The impact of thought processes on sleep outcomes in adults aged 60 - 80 years

    Sleeping well is an essential part of good health, but about 60% of people over 60 years of age report that they have trouble sleeping. Whilst some research suggests that sleep problems are due to age-related changes, other studies have proposed that cognitive or thought processes may contribute to poor sleep. This study will examine sleep quality in adults aged 60 - 80 years residing in Western Australia. It will investigate whether thought processes influence treatment outcomes of online CBT in people with and without sleep problems.

  • The BEKind Study: Psychological Wellbeing of Women with Endometriosis

    This research aims to assess and measure various aspects of psychological wellbeing, self-compassion and body image disturbance in women with endometriosis over a six-month period. A secondary aim includes mapping and exploring the trajectories of psychological distress this duration of time. It is hypothesized that women with endometriosis will report high levels body image disturbance, anxiety and depression, and that this will correlate with reduced levels of self-compassion. In order to be able to mitigate these issues and help women cope with the day-to-day challenges of living with endometriosis, the crucial first step is quantifying the level of body image distress and its relationship to other psychological variables. Through a longitudinal design, we may be able to firstly identify the trajectory of psychological distress in this population, and furthermore delineate predictors of psychological distress over time. This research will form a foundation on which development of interventions that can address body image concerns and improve coping in women with endometriosis.

  • A trial to see how educational websites for cancer doctors, nurses, patients and family carers affect family carer involvement medical consultations.

    The purpose of this study is to test some online training modules for those involved in cancer consultations. Who is it for? You may be eligible for this study if you are aged over 18 and any of the following: a) a hospital-based medical/radiation/surgical nurse or oncologist treating cancer patients. b) a person diagnosed with cancer of any type, whose nurse/oncologist is participating in the study c) a person related to a participating patient who supports the patient inside and outside a consultation. Study details Medical staff in this study will be randomised by chance (like flipping a coin) into two groups. one group will use the eTRIO resources, and the other will use existing NSW Health resources. Patients and carers will use separate resources, based on which group their medical staff are allocated to. The use of these resources involves reading websites, watching videos and completing activities. As part of this study, participants will answer questionnaires and have their consultations recorded. It is hoped this research will contribute to increased carer involvement in cancer consultations, and improved psychological outcomes through better communication.

  • Detection of Testosterone Microdosing in Healthy Men

    This study aims to determine the effectiveness (sensitivity and specificity) of individual serum and urine steroid, hematological and peptide hormone profiles within the Athletes Biological Passport to detect testosterone micro-dosing in men, and determine the applicability of venous and capillary blood analysis as complimentary testing procedures to those stated for the Athletes Biological Passport. Furthermore, the data for individuals would be collated and evaluated to include legal planning and expert opinion as to how a case against a potentially doping athlete could be undertaken and what data would be required. This information would enable WADA laboratories to identify future testing requirements of samples to ensure all applicable data is available for the Athletes Biological Passport.

  • Predicting the successful resolution of Obstructive Sleep Apnoea following weight-loss surgery

    Obstructive sleep apnoea (OSA) is a common disorder and is an independent risk factor for cardiovascular morbidity and mortality, making OSA a major health concern. Importantly obesity, which is the strongest risk factor for OSA, is a growing epidemic and is one the western world’s leading health care concerns. However, the exact mechanisms by which obesity increases the risk of OSA are poorly understood. Therefore, this study aims to examine the effect that obesity has on the underlying physiology known to cause OSA. Using well-established physiological and imaging techniques, we will measure the physiology both before and after weight loss surgery in a group of obese OSA patients. Additionally, using all the variables measured in this study, we aim to be able to predict the important factors involved in the successful resolution of OSA following weight loss. Understanding the important factor(s) involved linking obesity with OSA is crucial for developing more effective interventions and treatment strategies.

  • Reducing musculoskeletal diagnostic imaging requests in general practice

    The aim of this study is to evaluate the effectiveness of feedback for reducing musculoskeletal diagnostic imaging requests in general practice compared with control. A secondary aim is to evaluate which forms of feedback are most effective in reducing musculoskeletal diagnostic imaging requests.

  • Continued investigation of the effect of low energy availability and low carbohydrate availability on hormone status, metabolism and performance in elite race walkers ('Supernova 5")

    Greater knowledge of the effects of reduced LEA on various body systems is required to allow better education, prevention and management of damaging scenarios, while assisting athletes to be able to include shorter periods of tolerable reductions of EA within their programs. The Supernova 5 research camp aims to: 1. To increase the sample sizes in our previous investigations of the effect of a 5 d exposure to a diet of LEA (15 kcal/kg LBM/d) or low carbohydrate availability with high energy availability (i.e. LCHF diet) on a range of hormones and markers of body systems and metabolic function at rest and in interaction with prolonged strenuous exercise in elite endurance athletes, with specific interest in a. Changes in fasting concentrations of metabolic and reproductive hormones b. Changes in the overnight pulsatility of these hormones c. Changes in measurements of metabolic rate d. Bone metabolites 2. To confirm our observations that the effect of a 5-6 d period of low energy within a training block on performance of a 10,000 m race walking event is minimal when athletes have opportunity to acutely restore muscle glycogen content in the 24 h pre-race 3. To investigate some final questions about performance of a high-intensity endurance event with the LCHF; does keto-adaptation change the metabolism of a ketone ester supplement, leading to enhanced performance of a 10,000 m race walking event

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