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.
  • The effect of Chinese herbal medicine on sleep quality in stressed people suffering from insomnia

    Insomnia is a very common sleep disorder, which is defined as difficulty initiating or maintaining sleep, early awakening, and interrupted or non-restorative sleep. Additionally, there is clinically significant impairment in daytime function, including poor concentration, memory, and work efficacy. Stress is a strong predict factor and thus closely associated with the onset of chronic insomnia, and its related anxiety forms a vicious cycle to further affect sleep quality and daytime efficiency. While 85% of the general population reports a complaint of difficulty falling and/or staying asleep, about 10% present chronic insomnia and seek medical help. The common side effects of sleeping aids or sleeping medication prescribed by the GP or provided by the pharmacist are drowsiness and headache during the day, which significantly affects daily time performance of tasks. This side effect prevents the patients from continuing such treatment, if no dependence has been developed. Abuse can happen by using such medications. Traditional Chinese medicine (TCM) uses different theoretical system explantion and thus has a different approach to address insomnia due to stress. It is considered to be due to heat in the heart, liver and kidney, which causes restless nerves. Additional symptoms recognised by the TCM diagnosis include uneasy dreams, waking up between 1 -3am, and not feeling refreshed in the morning. According to the herbal practice by our team members, we have developed three new herbal concoctions which aim to calm the body and nerves. The concoctions were developed based on the characteristics of the individual herbs as well as the ancient concoction recorded in the Chinese Pharmacopoeia. In addition, a TGA listed concoction for stress management will also be used, which can improve sleep quality in patients with stress. We want to know which one works most effectively to carry out a large scale clinical trial on it.

  • Safety and feasibility of a specialised diabetes team for the individualised management of older adults with type 2 diabetes

    In this study, 43 people with diabetes referred to a community nursing organisation which visits patients in their home will be recruited in a prospective study. The current diabetes management of this group will be described. Participants’ individual needs will be assessed by a Diabetes Team, consisting of an endocrinologist linked to an in-home credentialled diabetes educator (CDE) through video-conferencing. The impact of individualised management on outcomes important to older people, that is, quality of life, wellbeing, treatment satisfaction, as well as biomedical markers will then determine the resources needed to undertake the assessments and management.

  • The Impact of Pancreatic Exocrine Insufficiency and Pancreatic Enzyme Replacement Therapy on Gastric Emptying, Gut Hormone and Glycaemic Responses to a Meal in Type 2 Diabetes Mellitus

    Control of low blood sugar following a meal is a priority in many patients with T2DM, particularly in those with better overall glycaemic control (HbA1c <~7.5%). The rate of gastric emptying is a pivotal determinant of postprandial glycaemia in type 2 diabetes. Gut peptides released in response to meals; glucagon like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), modulate postprandial glycaemia through their insulinotropic effects; GLP-1 also inhibits glucagon release and slows gastric emptying. The suggestion of abnormalities of the exocrine pancreas in patients with diabetes was reported over half a century ago. The pathophysiology of pancreatic exocrine insufficiency (PEI) in patients with type 1 and type 2 diabetes remains unclear, however possible mechanisms include exocrine dysfunction due to diabetic neuropathy or vasculopathy, a shared common pathway of damage to both islets and exocrine glands and a loss of the direct trophic effects of insulin. This 'pancreatogenic' form of diabets mellitus classified as type 3c, can result from a variety of conditions involving the exocrine pancreas, e.g. chronic pancreatitis, fibrocalculous pancreatopathy or haemochromatosis. Traditionally, type 3c diabetes has been thought to comprise of only ~1-2% of all cases of diabetes, but it has been suggested that more careful evaluation of cases yields a proportion of 8% or more. The presence of PEI in patients with diabetes is important, because it potentially impacts on glycaemic control, as well as nutritional status, bone homeostasis and gastrointestinal symptoms. In particular, ingested fats must be digested in the small intestine in order to stimulate GLP-1 and GIP secretion and induce feedback mechanisms that slow gastric emptying; as discussed, the rate of the latter is a major determinant of the postprandial blood glucose excursion. Our group showed in patients with cystic fibrosis who had documented PEI, that a high fat/carbohydrate meal emptied abnormally rapidly from the stomach, associated with deficient incretin hormone secretion and marked postprandial glycaemia. PERT addition slowed gastric emptying, augmented GLP-1 and GIP secretion, and substantially lowered the blood glucose excursion. Few studies have evaluated the role of PERT in diabetes and there have been conflicting results. Of note, there is limited information on postprandial hyperglycaemia and in those patients with T2DM. We therefore propose to study patients with a diagnosis of T2DM, who have evidence of PEI on a faecal elastase assay. We will evaluate the effects of PERT versus placebo on postprandial glycaemia, gastric emptying and incretin responses following a high fat/high carbohydrate meal.

  • Evaluating a novel smartphone-assisted coping focused intervention for people who experience distressing voices (SAVVy)

    Hearing voices are a phenomenon experienced in a number of mental disorders, especially schizophrenia, mood disorders and trauma-related disorders. Voice hearing can be persistent for many, resulting in a potentially distressing and disabling experience. Existing psychological treatments are effective for some, but costly to deliver, and require specialist expertise that is not widely available. New interventions have been called for that are simpler and more targeted, and which empower people to self-manage their own experiences. Such interventions may be enhanced by recent developments in e-mental health, particularly the use of smartphone technology. These technologies can increase accessibility, reduce costs, and promote autonomous recovery. An important development in e-mental health is the use of ecological momentary assessment (EMA) and intervention (EMI) in the context of treatment. EMA utilises mobile devices to collect multiple recordings of momentary experiences through self-monitoring in the context of the person’s daily life. This can provide individualised feedback on how symptoms evolve in real time in relation to the person’s environment, psychological processes, and how the person responds to them. EMI extends the use of smartphones to delivery of reminders and symptom self-management instructions during daily life. The aim of this work is to develop and evaluate a new intervention which unifies the unique monitoring capabilities of EMA with the momentary intervention capabilities of EMI in a coping-focused intervention for distressing voices (SAVVy: Smartphone-Assisted coping focused interVention for Voices). The second aim is to investigate variables which influence fluctuations in voice hearing experiences in daily life using EMA, in addition to increasing understanding of the nature and use of coping strategies in the daily life of voice hearers. The design of the current study is a randomised controlled trial (RCT) comparing a group of participants who will complete the SAVVy intervention whilst receiving regular treatment (17 participants), with a group only receiving regular treatment (17 participants). The intervention will involve receiving four, one-to-one sessions with a therapist whilst completing smartphone-based EMA and EMI between sessions. Information gathered during initial EMA monitoring of voice hearing experiences will be provided as feedback to participants during therapy and will inform the choice of specific coping strategies for self-managing the voices. The coping strategies will then be sent to participant via EMI reminders from the smartphone app between remaining sessions. Assessments will be taken before the intervention and 8 weeks following randomisation (post assessment blinded). The primary focus of this trial is to establish feasibility and acceptability of the intervention, and a preliminary indication of efficacy.

  • HOMeCare: Caring for the Dementia Caregiver and their Loved One via the HOMeCare Exercise and Mindfulness for Health Program

    Home-based care is generally seen as the most humane and cost effective means of providing dementia care. Such ageing-in-place is supported by 2.5 million informal caregivers in Australia, however, increasing cognitive and physical frailty are a threat to ageing-in-place, and exacerbate caregiver burden. Importantly, caregiver depression and stress markedly increase the risk of institutionalisation of their loved one, independently of the actual level of disability or behavioural difficulties. Increasing interest has been given recently to Mindfulness-Based Stress Reduction (MBSR), which has shown promise for improving caregiver burden. Notably, such stress reduction efforts do not directly address a large component of the strain: the progressive physical dependency or behavioural disturbance of the frail elders themselves. Slowing this decline is thus critical. This is the explicit purpose of the HOMeCARE project. Research have demonstrated that exercise programs for those with dementia may improve physical and cognitive function, behavioural disturbance, sleep, and thus caregiver stress, although results and interventions varied. One study found that promotion of regular walking in dementia caregiver/cared for dyads did not improve the behavioural and psychological symptoms of dementia, but attenuated caregiver burden. However, uptake of this community-based walking was suboptimal and not sustained. What is missing is an evidence-based, sustainable program that can integrate these disparate approaches by simultaneously targeting modifiable functional and behavioural disturbances in the individual with dementia, while providing caregivers the means to cope with stress and improve their own health. In other cohorts, Internet delivery of Mindfulness training is efficacious for a variety of mental health outcomes, although this approach has never been tested in dementia caregivers specifically. Internet delivery would markedly extend reach and viability, given the difficulties inherent in traveling to a centre. Similarly, delivery of robust exercise in the home setting would also be a leap forward in terms of translation of successful exercise trials to the community. We will conduct the first randomised controlled trial investigating the efficacy of HOMeCARE: a completely novel e-Health system for the dementia caregiver/cared-for dyad. HOMeCare begins with a Mindfulness-based Stress Reduction Training program for the caregivers. This will be followed by home-based, strength and balance training intervention, designed to improve functional mobility and psychological wellbeing in the person with dementia, during which time the Mindfulness practice will continue to be reinforced. We hypothesize that together, these 2 complementary, remotely monitored interventions will combine to reduce caregiver burden and improve function in the participants with dementia compared to usual care.

  • Developmental differences in circadian rhythm establishment in preterm and term infants

    A circadian rhythm is any endogenous biological process exhibiting an entrainable daily oscillation. Circadian rhythms are essential for normal physiological and behavioural functioning and alignment with the 24 h light/dark cycle. Circadian rhythms are coordinated by a set of rhythmically expressed clock genes. A ‘master clock’ in the hypothalamic suprachiasmatic nucleus (SCN) synchronises peripheral cellular clocks and hormonal rhythmicity (e.g., plasma melatonin and cortisol concentrations). Light is the dominant environmental cue setting the rhythm of the SCN master clock. The developing fetus is not exposed to light. The development of the fetal circadian system is driven by maternal variation in circadian hormones transmitted to the fetus via the placenta. The fetus cannot synthesise its own hormones until near term. Premature delivery deprives the fetus of these materno-placental circadian cues. Hospitalisation of preterm infants in the neonatal intensive care unit (NICU) further disrupts circadian input and rhythm development due to constant lighting and noise, and invasive procedures/therapies. This prospective study is observational and investigates the circadian rhythm development across infants of different gestational ages; gestation specific patterns will be identified from physiological, hormonal and molecular outcome variables. This study will inform a second prospective study; a randomised-controlled trial of two interventions to normalise circadian rhythm development in preterm infants: modification of environmental light/dark information; and environmental modification with additional time-specific supplementation of endogenous circadian hormones (melatonin and cortisol). The clinical trial will identify if a circadian intervention improves short-term clinical outcomes.

  • Propofol on Trial for Headaches in the Emergency Department Setting

    Headache is a common reason why patients present to the hospital emergency department. Often patients are presenting to hospital for the simple reason that they are experiencing a headache that is not responding to commonly available medications used to get rid of headaches. Unfortunately there is not good evidence to support which available hospital medications consistently offer effective pain relief to individuals with these types of refractory headache. Understandably this is a challenging scenario in the emergency department setting for both the patient and physician that often leads to inadequate or unsatisfactory symptom relief. However a few small trials to date have shown promising evidence that the medication propofol is potentially an effective, safe and quick treatment alternative for stubborn headaches. It is important to note that propofol is not a new medication and is routinely used on a daily basis throughout hospitals for both general anaesthesia and procedural sedation. It is the intention of this research project to demonstrate that infusing a low dose of this medication over a relatively short period of time is an effective new use for a familiar and already commonly utilised medication. This has the potential to introduce a new safe and effective treatment option for stubborn headaches that can significantly reduce treatment times by rapidly restoring patients to baseline levels of function and comfort. Furthermore it reduces overall lengths of stay in the emergency department and contributes to overall improved emergency department patient flow.

  • Enhancing Language Learning in Ageing with Exercise.

    There is now compelling evidence demonstrating the importance of exercise in maintaining and improving cognition in late adulthood (Hillman et al. 2008), but little is known about the effect of acute exercise on age-related problems in language function and memory consolidation. In order to tackle this issue, we will examine the influence of acute exercise on how older adults learn and consolidate new word representations. New word learning is impacted by ageing (Service & Craik, 1993; Whiting et al. 2011) and involves the hippocampus and the striatum; regions that are both implicated in exercise effects on cognition and vulnerable in ageing (Erickson et al., 2011) suggesting candidate mechanisms for exercise-induced enhancement of word learning. The proposed research will examine how exercise affects new word learning when different intensities of exercise and types of learning are involved. This project will employ an innovative combination of behavioural and biomarker measurement to achieve the following overall aims: 1) Determine the effects of acute exercise on new word learning and brain function in older adults; 2) Identify the relationship between word learning and exercise-induced changes in neurotrophins and neurotransmitters; 3) Examine the influence of acute exercise on initial acquisition versus consolidation of new words.

  • Investigating two different refeeding formulations to improve safety and efficiency of hospital management of adolescent and young adults admitted with anorexia nervosa

    Patients admitted to hospital with anorexia nervosa (AN) require nutritional rehabilitation to reverse malnutrition and its complications. However, conservative guidelines advocate reintroducing nutrition at a very slow rate to avoid refeeding complications. At the Children’s Hospital Westmead and the Adolescent ward of Westmead Hospital, adolescents with AN have been successfully treated with more aggressive nutrition intervention without adverse side effects, and with a more rapid improvement of weight status. Evidence in higher caloric feeding is not as robust in the adult AN population as compared with adolescent patients. Of particular concern is the reintroduction of carbohydrate in a starved patient, which can lead to electrolyte derangement and increase the risk of developing refeeding complications. The standard enteral feed provided to patients provides 54% carbohydrate, while the literature suggests the use of continuous feeding strategies with less than 40% of energy from carbohydrate. The aim of this study is to test if a lower carbohydrate (CHO) content enteral feed will provide better health outcomes to adolescent and young adult patients with AN. This study will be multi-centred, including Westmead Hospital and RPAH. Patients admitted with AN and requiring enteral tube feeding (TF) during an 18 month data collection period, will be randomly assigned to receive either: 1. Standard treatment regime of nasogastric feeding (using an enteral feed with a carbohydrate content similar to standard care) commencing at 35mL/hr for 12 hours, providing 630kcal, 26g protein, 86g carbohydrate, 21g fat in 420mL feed, using a standard polymeric formula (Ensure Plus 54% CHO, 26% fat), and progressing to a rate up to 70mL/hr as tolerated; 2. Trial treatment regime of nasogastric feeding commencing at 35mL/hr for 12 hours, providing 630kcal, 26g protein, 45g carbohydrate, 39g fat in 420mL feed, using a lower carbohydrate, higher fat formula (Pulmocare 28% CHO, 56% fat), and progressing to a rate up to 70mL/hr as tolerated. Expected total number of patients, n = 48, with 24 in each arm. Inclusion and exclusion criteria will apply to participants. Primary outcome measure: Hypophosphataemia. Secondary outcome measures: Change in weight, Length of hospital stay (LOS), hypoglycaemia (nocturnal and postprandial), oedema, thiamine, electrolyte replacement, admission to ICU, days required to reach medical stability. This study has the potential to change practice in the nutritional management of young adults admitted with AN across the state, with the goal to inform future policy in this field. It will include the 2 hospitals in NSW with specialised inpatient treatment programs for adult patients with AN.

  • A new e-health model of care for management of chronic disease: determining safety, efficacy and satisfaction to patients and health care providers

    The primary purpose of this trial is to assess the feasibility of using an innovative web-based platform to unite patients, Specialist Nurses, General Practitioners (GPs) and Specialists and to improve multidisciplinary care for patients with chronic hepatitis C infection. Who is it for? You may be eligible for this study if you are aged between 18 and 85 years, have chronic hepatitis C (CHC) and have recently commenced therapy or are currently receiving ongoing monitoring and/or therapy. You will also need to have access to internet to take part in this study. Study details All participants involved in this study will be enrolled into our electronic platform called HealthELink. Enrolment on to this platform will be in addition to your standard of care treatment for your condition. At the time of recruitment you will be trained by a qualified investigator to use HealthELink. Through this portal, you will be able to engage with your care team electronically. You will be able to send and receive messages about your health to and from your care team in real time. This includes your Specialist Nurse, Specialist and GP. This will enable you to be up to date with your necessary tests and appointments, as well as your medical information, including diagnoses and medications. Your usual care will continue, however, should you need to talk to a doctor, or a problem arises between appointments, you will be able to communicate with your Specialist care team and GP directly. Likewise, should you be well (including a lack of symptoms and normal blood results), you may forgo a scheduled face-to-face appointment provided you and your care team agree. Hopefully, through effective electronic communication we can avoid unnecessary hospital appointments. You will also be asked to provide feedback on HealthELink and how it has impacted on your care. We hope that the HealthElink platform will be able to improve the management of your care by enabling you to have electronic access to your health care team between appointments. Without compromising your care or Specialist supervision, we hope this will enable fewer unnecessary Outpatient Department appointments, hospital admissions and emergency presentations. Every element of your care will be recorded, thus providing quality control for the care delivered.

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