ANZCTR search results

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

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31198 results sorted by trial registration date.
  • Doxycycline as a cardioprotective agent in ST-elevation myocardial infarction: a pilot study addressing pre- reperfusion administration

    This study investigates the effect of doxycycline, a commonly used antibiotic, on reducing heart muscle injury when given before angioplasty and stenting of the coronary artery is performed. Patients will be assessed with cardiac magnetic resonance imaging (the current gold-standard test) to determine the amount of heart muscle damage and heart function. Doxycycline is an inexpensive antibiotic that has numerous other beneficial effects, which might make it useful as an additional therapy for the emergent treatment of patients presenting with heart attacks. This medication has been used safely in adults for various infectious disease and has been tested in critically ill patients and found to be safe. If doxycycline can help lessen heart muscle injury and preserve heart function, it could change the way heart attacks are currently treated. Furthermore, it will be a very cost-effective add-on therapy.

  • Living with dementia and driving: A telehealth delivered Intervention to improve driving cessation outcomes for people with dementia and their families

    This project investigates the effectiveness of a telehealth delivered, evidence-based driving cessation intervention for people with dementia and their family members who are retiring from driving, through a cluster randomised controlled trial. Stopping driving impacts health and quality of life for people with dementia and their care partners, and poses considerable challenges to health professionals who monitor driving issues. Without intensive practical and emotional support to plan for, and eventually, cease driving, people with dementia are at high risk for depression, anxiety, grief, social isolation, unsafe and unlicensed driving and injury. Telehealth or telemedicine – the transmission of clinical health care using telecommunication and information technologies – has been successfully used across a variety of practice contexts in rural and remote settings. It has been shown to improve access to health care for people living in geographically isolated areas - highly relevant for Australia’s dispersed population. Additionally, for the growing numbers of older people living with dementia and their carers who wish to remain in their own homes for as long as possible, telehealth provides important health services which might otherwise be difficult to access in-home and cost-saving advantages over traditional face-to-face delivery. Videoconferencing eliminates the need to travel for treatment, which is important in the context of driving cessation. The CarFreeMe program is a comprehensive support- and education-based intervention targeted at people with dementia and their care partners and family members to manage the transition from driving to non-driving status. CarFreeMe for people with dementia is a translation of a proven driving cessation intervention for people without cognitive decline (formerly UQDrive) and is based on what people who have experienced driving cessation said that they needed to adjust, and stay active and engaged. The intervention is unique in that it is focused on both the practical and emotional issues that are experienced as a result of driving cessation. The intervention includes seven modules that cover education and practical support, delivered by an experienced health professional who is trained in CarFreeMe delivery. In the telehealth format, health professionals (e.g. occupational therapists, psychologists) will be trained to deliver aspects of the intervention directly via a secure telehealth videoconferencing app at the client end, and delivering the program via the telerehabilitation clinic at The University of Queensland (UQ) in Brisbane. The telehealth intervention is designed to be flexible. The individualised program could involve a combination of one-to-one sessions and virtual groups, practical outings and activities with the support of a local experienced health professional, as well as home-based independent written and verbal activities in a provided work book.

  • Testing a new online program to improve teenage eating and lifestyle behaviours

    The Health Online for Teens (HOT) program is a 14-week multi-disciplinary healthy lifestyle and wellbeing program delivered via Moodle Mobile and a new innovative chatbot (HOT-BOT). HOT consists of diet, physical activity, and wellbeing educational modules. The aims of the program are to improve adolescent lifestyle through reducing obesity risk factors of poor diet and insufficient activity. This project involves pilot testing feasibility, engagement and accessibility, and changes in pre-post outcomes of interest (e.g. diet, physical activity measures). Research Objectives are as follows: - To assess engagement and use of the HOT program and its components, and HOT-BOT by teenage participants - To assess engagement and use of HOT parent resources by parents/caregivers of the participants - To determine the reach of HOT pilot recruitment and representativeness of the target population - To determine the effectiveness of the program to support teenagers to achieve healthy lifestyle goals, and improve weight, diet and activity behaviours, and self-perception (outcome evaluation) - To assess the agreement of adolescent-reported diet intake with parent-reported scores obtained with the Children’s Dietary Questionnaire. - To determine program satisfaction and process evaluation data from participants - To conduct focus groups and/or interviews to deeply explore the participants HOT experience (impact evaluation) and their thoughts on the content and design of the program

  • Abdominal Functional Electrical Stimulation to improve bowel and bladder function in Multiple Sclerosis

    Bowel and bladder problems, mainly in the form of constipation and urinary incontinence, affect more than half of people with Multiple Sclerosis (MS). These problems have traditionally been managed using a combination of manual and pharmacological interventions. However, such solutions are usually only partially effective. Therefore, a non-invasive method of improving bowel and bladder function for people with MS is urgently needed. The abdominal muscles play a major role during defecation and urination. Surface electrical stimulation of the abdominal muscles, termed Abdominal Functional Electrical Stimulation (Abdominal FES), has been shown to improve bowel function after spinal cord injury, with a case study suggesting this technique may also improve bowel function in MS. There is also limited evidence that Abdominal FES can improve bladder control. Therefore, we propose the first significant study to investigate the effectiveness of Abdominal FES to improve the bowel and bladder function of people with MS. Hypothesis: Abdominal FES can improve bowel and bladder function for people with MS. Individual aims of this project are to assess the effect of Abdominal FES on: 1) whole gut and colonic transit time 2) constipation and laxative use 3) incontinence related quality of life 4) frequency of defecation and nocturia

  • Does an infusion of lidocaine, around the time of breast surgery, reduce the chance of ongoing pain in the site of surgery after 6 months?

    The purpose of this study is to determine whether a study to look at the safety and efficacy of an infusion of lidocaine at the time of breast surgery is feasible. Who is it for? You may be eligible for this study if you are over the age of 18 and are undergoing breast cancer surgery. Study details Participants will be randomised to one of two groups. One group will be given a lidocaine infusion during and for 12 hours after breast cancer surgery, and the other group will be given a placebo infusion. Participants will then undergo a number of tests including lidocaine levels in the blood at two different time points after your surgery and inflammatory proteins to see if these are altered by the infusion. They will also be followed up by researchers for 6 months following the breast cancer surgery. It is hoped that this research will help expand research in long-term pain relief for those undergoing breast cancer surgeries.

  • This Study intends to study the pain relief potential of transcutaneous electrical nerve stimulation (TENS) machines in people suffering from kidney stones.

    Background: Kidney stones are a common presentation to Emergency Departments throughout Australasia, with a lifetime prevalence of 10 to 15%. The main aim of management in the ED is to provide fast, effective and safe analgesia to patients. The most commonly prescribed analgesia in renal colic are non steroidal anti-inflammatory drugs(NSAIDS), opioids and paracetamol. TENS has been used to complement traditional analgesia in both labour and postoperative pain control. Hypothesis: Patients with renal stones using transcutaneous electrical nerve stimulation (TENS) experience the same amount of pain as well as requiring similar doses of pharmacological analgesia compared with patients not using transcutaneous electrical nerve stimulation who present to the Angliss Emergency Department Methods: This is a prospective randomised control study aiming to study 2 arms of patients – with and without the use of TENS equipment as an adjunct in the management of pain associated with renal colic. Significance: The research undertaken will help understand help a better understanding of the analgesic options available to patients suffering renal colic who present to the emergency department. This will help medical practitioners explore options to better manage the pain associated with renal colic and complement with a potential decrease in the use of opioid prescription of pharmacotherapy. Furthermore if successful in the emergency department, then there is potential for TENS to be used in the community as an adjunct for patients to better manage their pain in regards to renal colic.

  • vSHADE - An internet-delivered, evidenced-based treatment program for mental health and alcohol use in contemporary Veterans

    The mental health and well-being of serving and ex-serving Australian Defence Force (ADF) personnel is of paramount importance, with a recent national audit indicating mental health disorders including depression, anxiety, post-traumatic stress, substance use, and suicide, are a major cause of reduced quality of life for many members, with direct impacts on their families. SHADE is a 10-session internet delivered program which has demonstrated effectiveness in the general population for reduction of depressive symptoms and hazardous alcohol use. This study will pilot and evaluate the use of the SHADE program amongst ex-serving ADF personnel with and without the addition of a psychologist moderated social netoworking site, "Breathing Space."

  • Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous TIMP-GLIA in Healthy Volunteers.

    The phase 1 trial will be conducted in two parts, initially, it will comprise of a single-centre, subject blinded randomised single ascending dose study of TIMP-GLIA to 6 cohorts. Each cohort will contain six participants two will be randomised to placebo and four to TIMP-GLIA. At the beginning of each dose level, one sentinel (TIMP-GLIA) participant and one placebo participant will be dosed. The remaining four participants will be dosed 48 hours after the sentinel participants. A Safety Committee will meet after the completion of each cohort dosing to ascertain safety prior to the next dose level is given. In the second part of the trial, a repeat dosing strategy will be employed (maximum, two doses seven days apart) at the Level 4 and Level 6 dose. Following a screening period (up to 28 days), eligible participants will be randomised to TIMP-GLIA or placebo using a computer generated randomisation schedule which will be held by an unblinded pharmacist.

  • Can motor imagery improve strength during periods of restricted weight bearing in older adults?

    The negative effects of immobility such as reduced muscle strength and cardiac function are evident after a few days in care, particularly for older adults. These effects are more profound in those older adults with restricted weight bearing status as they are more confined to bed. There is a need to identify interventions that can be completed in bed while reducing the effects of immobilization. One such intervention is motor imagery, where participants imagine performing certain tasks without overt muscle activity. Motor imagery has been used successfully in stroke patients but has not been used in older adults during periods of immobilization. The aim of this study is to identify whether motor imagery combined with standard physiotherapy care is superior at improving strength and mobility compared to standard physiotherapy care alone. Participants will be subacute residents undergoing rehabilitation, aged 65 years or more that have been prescribed restricted weight bearing for at least one week. Participants will be allocated to standard physiotherapy (Control) or standard physiotherapy plus motor imagery (experimental). It is expected that participants in the experimental group will have more rapid gains in strength and mobility than those in the control group.

  • Tuning in to Teens for Residential Care Workers: A Pilot Study

    When parenting does not meet the subscribed Department of Health and Human Services (2013) standard of good enough parenting it may result in children and young people being removed and placed in residential, foster or kinship care due to concerns for their safety and wellbeing. When a young person is placed in residential care, the workers must fulfil the function of a good enough parent. But residential houses are often filled with conflict and difficulties, and many houses are troubled by constant critical incidents and problems with residents and staff. Parenting and parent-adolescent relationships play a central role in adolescent wellbeing. Problems in this relationship are closely associated with poorer emotional functioning in the young person. Little is known about what works for improving the quality of ‘parenting’ care provided to children and young people residing in residential care settings. Tuning in to Teens for Residential Care Workers (TINT RCW) is based on a parenting program (Tuning in to Teens) and aims to improve relationships within residential homes by delivering the program to residential care workers. This study will examine whether TINT RCW increases responsive patterns of parenting/care, reduces negative escalating interaction cycles, improves house functioning, and increases residential care workers’ emotion coaching. Several residential care homes will be recruited to the study and randomised into immediate intervention or a care as usual control condition. Self-report and observational measures will be used to examine differences between houses in the two conditions and to see whether there are changes over time. TINT RCW aims to teach residential care workers to assist the adolescents in their care in understanding and regulating emotions while also helping workers to manage their own emotional reactions. The program aims to increase skills in the RCWs and it is expected that these skills will assist the residents to better manage emotions, reduce conflict, and for the residential houses to function more effectively.

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