ANZCTR search results

Despite the fact that Polymyalgia Rheumatica (PMR) is the most common inflammatory rheumatic disease of the elderly, it is under-researched and poorly understood. With no diagnostic tests available, diagnosis is dependent upon a history of muscle pain and stiffness in the shoulder and hip regions, combined with raised inflammation levels in the blood. Treatment consists of prednisolone (commonly referred to as “cortisone”) prescribed in a “one size fits all” approach that lasts ~12 months in duration. However, the way in which PMR patients’ symptoms respond is very variable; some improve almost overnight, whilst other individuals require higher doses for much longer periods of time. Unfortunately, such long-term prednisolone use can result in many complications including osteoporosis, weight gain, high blood pressure and diabetes. This project therefore aims to identify the characteristics of PMR patients that have failed standard cortisone treatment and remain on long-term prednisolone. In addition, prednisolone-related treatment complications will be documented.

The purpose of the study is to determine if a planned Patient-Centred Family Meeting held soon after a patient’s admission to an inpatient palliative care unit, is feasible and acceptable to the patient, their family and clinicians. In addition, the study seeks to better understand the benefits and burden of participating in Patient-Centred Family Meetings from the perspective of the patient, family and clinician and to assess if the outcome measures that have been selected are suitable and feasible from the patient and family perspective. The primary hypothesis is that conducting a planned Patient-Centred Family Meeting soon after admission to a specialist inpatient palliative care unit is feasible and acceptable to patients, families and clinicians. The Patient-Centred Family Meeting will be the intervention in one of three specialist palliative care facilities. Two other facilities will be the control sites where standard care, that may include a family meeting, is provided and observed. Inpatients aged over 18 years with a terminal illness newly admitted to one of the two palliative care facilities who are able to consent and have a family member willing to participate will be included. A minimum of 10 patients and a minimum of an equivalent number of family members will be recruited for the intervention and control arms of the study.. More than one family member may be included in recruitment. At the intervention site, outcome measures will assess patient and family distress and satisfaction with quality of life at end-of-life, before and after the Patient-Centred Family Meeting. Interviews with patients and families and focus groups or individual interviews with clinicians will be undertaken after the Patient-Centred Family Meeting to understand the experience of these participants concerning the intervention. Focus groups or individual interviews with clinicians will also be undertaken at the control sites. A Family Meeting Observation Sheet will capture key components of both types of family meeting to enable comparison of family meeting practices and factors contributing to this practice. At the control site, the same quantitative measures will be undertaken at the same time points. Interviews with patients and families at the control site will only occur if a family meeting was convened as part of the standard care of the patient. A statistical electronic application will analyse the quantitative data and provide results. Patient, family and clinician interview data will be analysed using qualitative data analysis techniques. It is expected that this research will provide evidence about the acceptability, feasibility and value of family meetings in palliative care for patients, families and clinicians.

This randomised control trial will aim to explore the effectiveness of pre-formed, semi-rigid, customised foot orthoses (FOs) in reducing pain; improving quality of life; reducing swelling and tenderness; and improving gait parameters in children suffering from active lower limb involvement in juvenile idiopathic arthritis (JIA). Hypotheses: Primary Outcomes 1. Pre-formed FOs will reduce lower limb pain using visual analogue scale (VAS) in children with JIA Secondary Outcomes 1. Pre-formed FOs will improve quality of life in children with JIA using the Pediatric Quality of Life Questionnaire™ (PedsQL) Rheumatology Module – version 3.0 for children and parents. 2. Pre-formed FOs will improve foot disability in children with JIA using the Juvenile Arthritis Foot Disability Index (JAFI). 3. Pre-formed FOs will reduce localised swelling and tenderness of lower limb joints in children with JIA by visual inspection and palpation. 4. Pre-formed FOs will have an effect on quantitative kinematic and kinetic parameters of gait in children with JIA when barefoot, with shoes alone, and with shoes and FOs. Participant's who are eligible and consent to partake in the research based on the study's inclusion and exclusion criteria will be randomised into two groups. Thirty-three participants will be allocated to the trial intervention group, and the remaining thirty-three will be allocated to the control group. The trial group will receive a pre-formed, semi-rigid, customised foot orthoses, while the control group will receive a placebo device made from basic materials. The control orthoses will be made to resemble standard innersoles in athletic-style footwear. To help prevent participant's on knowing their allocated interventions, the top covers of both the trial and control groups will be made from the same materials. The participant's will be required to wear their allocated interventions for a maximum of 12 months. Primary outcome will be assessed at baseline,4-weeks, 3,6 and 12 months, Quality of life and foot disability will be assessed at baseline, 3,6 and 12 months. Joint swelling and tenderness, and gait parameters will be assessed at baseline, 3 and 6 months. Please note that one previous study was done with a similar methodological approach.(which was given a Clinical Trial ID with Clinicaltrials.gov: NCT02001844) [1]. This particular randomised control trial is unique to this previous study as it will investigate the effectiveness of foot orthoses in the treatment of swollen and tender lower limb joints. It will also be the first study to investigate any type of foot orthoses beyond 6 months in children with JIA. 1. Coda A, Fowlie PW, Davidson JE, Walsh J, Carline T, Santos D. Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial.

The Maxm Skate is a portable lower limb post-operative and post-injury rehabilitation exercise device for individual use in a hospital or home-based setting. It allows the patient to perform strengthening exercises with minimal joint loading during their rehabilitation period. The primary objective of this randomised controlled study is to assess the range of motion (ROM) achieved by patients whom received the Maxm Skate rehabilitation device compared with standard rehabilitative care, 3 months post total knee replacement. The secondary objectives of the study will be to compare functional, clinical performance and quality of life outcomes following use of the Maxm Skate compared with standard rehabilitative care. An economic evaluation assessing the relative cost-effectiveness of the Maxm Skate rehabilitation device compared to standard care will be also be conducted. Adverse event occurrences and complications will be screened from the time of consent to 1 year postoperatively. We aim to recruit a study sample size of 116 participants, with 58 per group. The primary endpoint is range of movement (ROM) which will be analysed on an intention to treat basis, using linear regression.

The specific aim of this study is to assess if recovery measures and next day performance can be enhanced in well-trained Water Polo athletes through exposure to the phytochemicals found in tart cherry juice. Results will be applicable to elite waterpolo players and team sport athletes. It is hypothesised that cherry jucie would improve recovery and limit any decline in performance at the end of 7 days of hard Water Polo training.

The primary purpose of this trial is to evaluate whether motivational interviewing, when added to a standard cancer rehabilitation program, improves physical activity levels and other health and well-being related outcomes. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over, have been diagnosed with any cancer for which you are currently undergoing treatment or have completed adjuvant therapy in the last 12 months, and have been referred for rehabilitation at Eastern Health. Study details All participants will receive the standard oncology rehabilitation program, which lasts 7 weeks and involves weekly group exercise and education sessions as well as a home exercise program and exercise diary. Participants will be randomly allocated (by chance) to receive this rehabilitation program alone, or to receive motivational interviewing from a physiotherapist via telephone in addition to the rehabilitation program. Participants allocated to this motivational interviewing group will receive 7 weekly telephone calls from a physiotherapist, of approximately 30 minutes in duration, to encourage participants to complete more physical activity. Participants will be asked to wear an activity tracking device and complete a number of questionnaires and physical function tests at the end of the 7 weeks, and some participants will also complete interviews with researchers to provide feedback on the program. It is hoped that this trial will provide evidence about the use of motivational interviewing during an oncology rehabilitation program to inform therapists and managers whether this is an effective intervention to facilitate positive physical activity behaviour.

this trial aims to improve the experiences of children with ASD having an operation in Royal Dental hospital and the Royal Children's Hospital . The participants will be selected from operating list and a preparation package will be sent after verbal consent. on the day of operation if the child requires premedication, they are randomised to clonidine plus midazolam at lower doses vs. placebo plus standard dose of midazolam. the primary end point is the quality of induction as measured by Almanrader scale.

This research project is being conducted to look at how safe, well tolerated and effective a new drug called DUR-928 is when given as an interlesional injection to participants with plaque-type psoriasis. The study will look at comparing the study drug’s safety, tolerability and effectiveness as a treatment for psoriasis using 2 different formulations when compared against placebo vehicle formulations, an active comparator and no treatment at all.

Project Aim: To determine whether there is a relationship between low Mannose Binding Lectin concentrations (a protein produced in the liver, that acts in the recognition of disease causing pathogens) and frequent Urinary Tract Infections (UTIs) in patients who have an autoimmune disease. Hypothesis: MBL deficiency predisposes to frequent UTIs in female patients with auto-immune diseases

This study aims to quantify clinical benefit of Magnetic resonance imaging (MRI) during lung cancer radiotherapy. Who is it for? Participants aged 18 years or over and have histological or cytological confirmed lung cancer scheduled to be treated with 12 or more fractions of treatment. Study details: All participants in this study will undergo MRI scans in addition to standard scans used during radiotherapy treatment (CT and PET). Participant of this trial will undergo a total of six MRI scans which will be performed before radiotherapy treatment starts, and at treatment day 1, day 11 and day 21 (where applicable), and three and six months post treatment completion. MRI scans acquired will not alter or impact participant’s treatment intent.This study will not impact on the participants standard treatment.