ANZCTR search results

The aim of this study is to assess antibody persistence and cell-mediated immunity post administration of combined diphtheria-tetanus-acellular pertussis vaccine, Boostrix 'Trademark' (dTpa) in healthy adults who have received adult formulation diphtheria-tetanus-pertussis boosters 5-10 previously, compared to those that have not received a pertussis containing vaccine since childhood (<15 years of age). Health care workers (HCWs) in paediatric hospitals have been recommended to receive pertussis booster immunisations (Australian Immunisation Handbook 2013) as they are both at increased exposure to pertussis in the hospital and can cause nosocomial transmission to their patients. A booster dTpa immunisation (Boostrix™) is approved for use in Australia by the Therapeutic Goods Administration (TGA). It is now almost 10 years since Boostrix™ was introduced into Western Australia (2004) with high uptake by employees at Princess Margaret Hospital for Children in Perth and health care workers are being offered revaccination. Little is known about the duration of pertussis immunity in adults. No studies have yet provided an in-depth analysis of the immune responses induced by acellular pertussis vaccines and how fast these may wane over time. This study is a non-randomised cohort study. We propose to recruit a total of 150 healthy adults aged 23-64 years employed in the Child and Adolescent Health Service, University of WA School of Paediatrics and/or Telethon Kids Institute. Participants will be asked to attend 4 clinic visits over a 12 month period. These visits will take place at the Clinical Child Research Facility at Princess Margaret Hospital. Participants will be allocated to one of 2 groups depending upon whether or not they have previously received a booster for pertussis. During the first visit participants will be asked about their medical history, demographic data and previous reactions to vaccinations. Immunisation histories will be confirmed (if required) through hospital and GP records. In addition a brief medical directed medical examination may be conducted and vital signs will be taken. Females of child bearing potential will need to do a urine pregnancy test prior to vaccination. A blood sample of 25-30mls will be taken by trained staff before participants are vaccinated with Boostrix™. Following this, a 7 day diary documenting local reactions and adverse events will need to be completed. Further blood tests of 25-30mls will be taken 1 week, 4 weeks and 1 year post-vaccination. Safety data will be collected at each of these visits.

The primary objective of this study is to determine the safety and tolerability of SVF compared to placebo in patients with chronic migraine headaches. The secondary objective is to measure differences between placebo and SVF based therapies in several efficacy assessments including: improvement in migraine headache-free rates, migraine headache severity, duration, degree of disability associated symptoms, and use of concomitant headache medications in comparison to placebo.

After providing consent, if no contraindications to hydrotherapy are identified in the pre-study screening assessment, the child will be included in the study. A concealed randomized allocation procedure will assign each participant to either Group 1 or Group 2 (parent will select a sealed envelope allocating the child to a group). The duration of this study is 9 weeks. Group 1 will be asked to participate in a 45-min hydrotherapy class, 1x weekly for 4 weeks. Group 2; will receive no hydrotherapy intervention. At the end of 4 weeks, Group 1 will cease hydrotherapy, and Group 2 will commence hydrotherapy sessions. Hydrotherapy sessions will involve gentle therapeutic exercise in a warm, temperature controlled pool under the supervision of members of the research team. All parents/guardians will be required to complete the Child Behaviour Checklist (CBCL) at weeks 0, 4 and 8. The CBCL is a short and meaningful questionnaire that assesses a range of concepts associated with children's behaviours. The CBCL, which has been validated for use with children with ASD, will determine any behavioural changes of participants during the study. To limit the bias from the researchers conducting the intervention, parents/guardians will be asked to place their completed questionnaires into an envelope which will be sealed by the participant and returned to a third investigator who will not be in contact with the participants or their parents. The Enjoyment Scale is a visual scale in which the participants can express their willingness participant in the hydrotherapy activities throughout the study. The Enjoyment Scale will be used at the end of each hydrotherapy session to monitor level of enjoyment and willingness to continue with hydrotherapy sessions.

This is a Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of CMX-020 In Healthy Male and Female Subjects.

This prospective, single-centre, randomised, clinical study assesses the impact of a web-based coaching program for knee replacement patients on anxiety, pain, and recovery of physical function. All patients will receive an educative guidebook issued by Hollywood Private Hospital and detailing their surgical and recovery course (Standard care). Those randomised to recieve Your Coach (YC) for Knee Surgery training will be given access to the web portal and be asked to complete care modules combining cognitive and physical strategies to help patients cope with emotional and physical stressors experienced when having a total joint replacement. The primary objectives are to assess whether web-based program is effective in reducing anxiety and pain, and subsequently enables earlier attainment of physical milestones such as first stand, independence walking with an aid, and hospital discharge. The secondary objectives are to assess potential carry-over to improve joint function, quality of life and reported level of satisfaction with their care and surgical outcome in the longer term. The study will enrol 44 participants over a 12 month period. The study time points will be pre-operatively at baseline and just prior to surgery, 1-2 weeks, 3-months and 1-year following surgery.

This project involves a three-arm randomised controlled trial that aims to evaluate the effectiveness of the Internet-based prevention and early intervention program ProYouth OZ in reducing weight and shape concerns and/or eating disorder symptoms in young people. An additional aim of this project is to examine whether the addition of synchronous online peer-to-peer support (i.e. Internet-based chat sessions in a group format) increases treatment effectiveness. The project has several aims: (1) To examine the effectiveness of ProYouth OZ compared to a wait-list control condition on a range of outcomes including eating disorder attitudes and behaviours, barriers towards seeking help, self-esteem, symptoms of depression and anxiety, quality of life, and social support. (2) To examine the effectiveness of ProYouth OZ with online peer support compared to ProYouth OZ without peer support on a range of outcomes including eating disorder attitudes and behaviours, barriers towards seeking help, self-esteem, symptoms of depression and anxiety, quality of life, and social support. (3) To explore engagement, adherence and use of the online peer-to-peer support groups. (4) To examine and compare users satisfaction of ProYouth OZ with and without online peer support.

Cardiovascular disease (CVD) is the most common cause of morbidity and premature death worldwide. It is projected that the number of fatalities related to CVD will increase to more than 24 million annually by 2030. In Australia, 1 in every 5 adults had CVD based on self-reported data, and 11% of all hospitalizations are caused by this deadly disease. The growing epidemic of CVD has resulted in calls for a universal model of care to provide rehabilitative and preventive services for all patients with this disease. Cardiac rehabilitation/secondary prevention programs (CR/SPPs) are medically supervised programs that help patients with CVD to recover more quickly after a cardiac event and to stay healthy. CR/SPPs have been shown to reduce readmission and mortality. However, despite the accumulating evidence and potential benefits, less than 30% of eligible patients participated in CR/SPPs. The aim of this project is to assess the current status of CR/SP services at Fiona Stanley Hospital (FSH), identify strengths and limitations of the CR/SP program and to develop and implement strategies for improvement of services. This will involve review of previous data from medical records relating to the CR/SP program and a continuous quality improvement approach to refine services in accordance with international best practice. The project will use a mixed methods research approach. First, an audit of medical records will be performed to objectively quantify CR/SP referral, attendance and completion rates amongst acute coronary syndrome (ACS) patients at FSH. Second, stakeholder surveys, focus group discussions and face-to-face interviews will be conducted to investigate barriers and facilitators to CR/SP service provision. For this second stage, current patients will be asked to complete a survey (and some to attend focus groups) and Cardiology Ward staff will be invited to complete a survey (and some attend individual interviews with the researchers). This information will be used to guide changes to CR/SP systems with the objective of increasing the number of patients receiving the core components of CR/SP program: assessment, nutritional counseling, aggressive risk factor management (ie, lipids, hypertension, weight, diabetes mellitus, and smoking), psychosocial and vocational counseling, and physical activity counseling and exercise training. Study summary 1. Audit: Two six-month audit cycles of consecutively admitted ACS patients will be conducted (for the six month periods beginning 1 January 2016 and 2017 respectively) with CR/SP program performance improvement strategies developed and implemented in between; 2. Patient and staff surveys: 100 ACS patients and 50 staff who work on the cardiology ward will be recruited to participate in the second part of the study with the completion of a survey; 3. Focus group discussions and interviews: Subsequent to the surveys, 30 patient participants and 10 staff participants will be invited to take part in focus group discussions and face-to-face interviews respectively. The responses from the surveys will be evaluated to establish common themes and to guide discussions in the focus groups. Although the project at FSH is an independent process monitoring and quality improvement initiative, it is also a key component of a larger project that aims to develop culturally appropriate CR/SP models for two mainland Chinese populations.

This research is aimed at evaluating two Dialectical Behaviour Therapy (DBT) informed skills based programs.. One Program is stand alone DBT Skills and the other DBT skills plus art making. There is a growing body of evidence that suggests DBT is a very effective treatment for many other disorders for example, addiction, depression and anxiety, eating disorders. Standard DBT comprises five approaches to assist patients. One of those approaches is a DBT Skills training group. There is also evidence that DBT Skills Training programs alone are effective in reducing impulsive behaviour and depression. (Linehan, M. 2nd Edition DBT Skills Training Manual 2015 Guilford NY). People who suffer the symptoms of emotional dysregulation are often considered to be unpredictable, unreliable and likely to experience problems with relationships both in community, work and in their family relations. As a Registered Art Therapist, the principal researcher has integrated creativity/art making within a standard 8 Week DBT Skills Training Program for many years. Repeated group evaluation of this approach has been positive on measures of both outcome and satisfaction with treatment. As a result the approach has now been standardised and is ready for evaluation in a clinical setting. The aims of the research are to test a DBT-Art approach along side a standard DBT control for efficacy Outcome measures will be symptom improvement and interpersonal function and participant satisfaction with treatment.

This study aims to evaluate the effects of Flex-Aid on the frequency of nocturnal foot and/or leg cramps when self-administered within 45 minutes before going to bed. We aim to assess the effect of Flex-Aid on quality of life and pain/intensity of the nocturnal foot and/or leg cramps as well as the safety and tolerability of Flex-Aid. FlexPharma hypothesizes that the acetic acid contained in teh pickle juice of teh beverage works by activating certain ion channels (Transient Receptor Potential TRP) which are known to exist in primary sensory neurons in mouth, esophagus and gut, and that their activation upregulate inhibitory circuitry in the spinal cord to prevent repetitive firing of alpha motor neurons thereby relieving the cramp. This study investigates whether natural activators of TRP ion channels may relieve muscle cramps.

This is a double-blind, randomised, placebo-controlled study to evaluate the effect of a herbal extract. The aim is to investigatge if the formulation treats benign prostatic hyperplasia (BPH) symptoms in otherwise healthy males.