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A randomised trial of colchicine for osteoarthritis of the hand (COLAH)
BACKGROUND: Osteoarthritis (OA) is the most common joint disease and frequently involves the hand. Painful hand OA is associated with a significant disease burden and reduced quality of life. Indeed, the effect of symptomatic hand OA on quality of life is comparable to rheumatoid arthritis, but affects considerably more people (prevalence ~20% versus ~1% in older adults). With an ageing population, the burden and health-care costs related to hand OA will increase. Patients often rely on NSAIDs or opiates with concomitant adverse effects in this age group to control pain. Hand OA is a heterogeneous condition with approximately 50% of patients having evidence of synovitis. This phenotype of hand OA with inflammatory signs i.e. those with evidence of synovitis is associated with increased pain. In addition, hand OA joints with synovitis are 3.5 times more likely to experience rapid joint destruction and radiographic progression than those without synovitis. Ultrasound (US) has been shown to reliably detect synovitis in the joints of the hand when performed by an experienced technician. Therefore, this is the subgroup of patients with hand OA that are most in need of evidence-based therapies. Previous study to assess treatments for hand OA using of plaquenil, etanercept or adalimumab found not superior to placebo to alleviate pain. There is possible effect if structural modification with etanercept and adalimumab has been shown to be beneficial in erosive and inflamed hand OA. The cost however of these medications in 20K/per year, therefore there use is an expensive alternative. Currently, there are no proven pharmacological treatments for hand OA. The lack of categorization of hand OA according to inflammatory phenotype may have contributed to previous negative outcomes in clinical trials. Cost-effective therapies targeting synovitis may offer a novel approach for reducing disease burden from hand OA. Colchicine is a low cost drug which has long been used in the anti-inflammatory treatment of acute gout. There has been recent renewed interest in this ancient drug, particularly its effects in cardiovascular diseases such as pericarditis. The primary mechanism of action of colchicine is tubulin disruption leading to subsequent down-regulation of multiple inflammatory pathways and modulation of innate immunity. Preliminary studies in knee OA have indicated that colchicine may have a beneficial effect on pain and a larger randomized clinical trial of colchicine in knee OA is currently underway. No studies of colchicine have been undertaken in hand OA. STUDY AIMS Primary hypothesis: Colchicine decreases pain (assessed by 100mm VAS) by 10mm more than identical placebo over 12 weeks in patients with clinical hand OA. STUDY DESIGN Randomised, placebo-controlled double-blind clinical trial. This study will be carried out at The Queen Elizabeth Hospital and Royal Adelaide Hospital.
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Evaluation of the Exploring Together program for primary school children with behavioural and emotional problems.
A cluster-randomised trial was conducted comparing two versions of delivery of the early primary school version of the Exploring Together program; one form had separate child and parent group sessions (Exploring Together-Adapted; ET-Adapted) and the other form included some parent-child group time in the intervention (Exploring Together; ET). The sample analysed consisted of 136 parents and their children (aged 5-10 years) with externalising and/or internalising problems, recruited from government (n = 20) and catholic (n = 4) primary schools from within the south east metropolitan suburbs of Melbourne and Mornington Peninsual region, Victoria. Child outcome measures included parent- and teacher-reported child externalising and internalising problems. Parent outcome measures included parent self-report of positive and negative parenting behaviour, parenting stress, satisfaction and efficacy. All outcomes were assessed post intervention and at 6- and 12-month follow ups. In regard to child outcomes, significant reductions in parent- and teacher-reported child externalising and internalising problems were evident across both treatment groups at post intervention. At the 6- and 12-month follow-ups significant reductions were maintained on parent-reported child externalising and internalising problems only. Change on all child outcome variables did not vary significantly between treatment conditions at any time point. In regard to parent outcomes, significant changes averaged across both treatment groups over time were found for parent-reported negative parenting practices at post intervention (maintained up to 12 month follow-up) and parenting efficacy at post intervention (maintained up to 6-month follow-up). Results showed non-significant changes averaged across both treatment groups over time for parenting stress, positive parenting practices and parenting satisfaction. There was evidence of a significant group (intervention) by time interaction for parenting efficacy at post intervention, with greater improvement for participants in the ET program. There was also evidence of a significant group (intervention) by time interaction for parenting satisfaction at 12-month follow-up, with greater improvements for participants in the ET-Adapted program. Overall, study results did not demonstrate that the inclusion of parent-child interactive groups (ET program) was associated with consistently greater improvements in child behaviour or parenting outcomes relative to the version (ET-Adapted program) that omitted the combined groups.
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An N-of-1 trial to assess the effectiveness of Manual Lymphatic Drainage with and without Non-thermal Laser in lipedema.
The project aims to assess whether manual lymphatic drainage (MLD) with non-thermal laser is more effective than MLD alone for reducing pain and swelling in a 43-year old female patient with bilateral lipedema-like symptoms of the legs. The trial is designed as a single-blind, randomised, controlled n-of-1 trial. The trial participant will attend weekly clinic sessions for eight weeks. Weeks 1 and 8 will be assessment sessions. Weeks 2-7 are treatment clinics where the participant will receive either manual lymphatic drainage massage (MLD) plus active laser therapy or MLD plus placebo laser therapy in a randomised sequence. The placebo therapy consists of the laser device without power.
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Breaking Up Sitting Time After Stroke (BUST-BP-Dose)
Living a sedentary lifestyle significantly increases the risk of developing cardiovascular disease and having a subsequent cardiovascular event, such as a stroke. People who have had a stroke spend 75% of their waking hours at home sitting down, which is much higher than healthy age-matched individuals without stroke. This sedentary behaviour is damaging for stroke survivors already comprised cardiovascular health, and is likely a significant contributing factor to the recurrent stroke which 30% of survivors have after their initial event. Stroke survivors are very inactive; with very few able to engage in the level of physical activity recommended to improve their cardiovascular health. In people without stroke, breaking up prolonged sitting using regular activity breaks (walking or simple strengthening exercises) significantly improves cardiovascular disease risk factors such as blood pressure and glucose metabolism. Results from our recently completed pilot study indicates that breaking up prolonged sitting time in stroke survivors achieves similar cardiovascular benefits. Breaking up stroke survivor sitting time with simple resistance activities significantly reduced systolic blood pressure (mean 3.6 mmHg reduction). Lowering of blood pressure reduces the risk of hypertension, the leading modifiable risk factor associated with recurrent stroke, and thus has the potential to reduce the risk of recurrent stroke. Therefore, breaking up sitting time is a promising and innovative physical activity alternative to employ with stroke survivors to improve their cardiovascular health and subsequently, reduce recurrent stroke risk. The next important step is to determine the minimum amount and duration of activity breaks (dose) required to improve these cardiovascular risk factors in this population. This study will be the first to determine the optimal dose of simple resistance activities needed to reduce blood pressure and improve glucose metabolism in stroke survivors. Stroke survivors (n = 10 per cohort) living at home who are able to stand and walk will complete a baseline uninterrupted sitting condition followed by 2 dose-escalation conditions. Breaks in sitting will be light-intensity exercise while standing which will increase in 10-min increments each condition. Blood samples will be taken at regular intervals throughout each condition and blood pressure and physical activity will be monitored during and up until 24-hours post-condition. Outcomes of blood pressure (primary), blood glucose, insulin levels (secondary) and safety and feasibility indicators will be collected.
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MOM trial. MOntelukast Myeloma A pilot study to determine whether Montelukast added to standard Chemotherapy improves response in patients who have failed standard Chemotherapy for Multiple Myeloma.
This pilot study aims to test whether Montelukast and Gemfibrozil when added to CyBorD chemotherapy (Bortezomib Cyclophosphamide and Dexamethasone 28 day cycle) induces responses in patients not responding to this chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18-80 years with progressive multiple myeloma after at least 8 weeks (two cycles) of treatment with a standard Bortezomib/Cyclophosphamide/Dexamethasone chemotherapy. Study details A total of 6 patients will be enrolled prior to a decision to expand or shut down the trial, depending on toxicity and response. Participants will receive further two cycles of CyBorD chemotherapy regimen with the addition of Montelukast. and Gemfibrozil.. Patients will be able to continue Montelukast and Gemfibrozil following completion if a response is observed depending on side effects The hypothesis is that Montelukast which is an extremely well tolerated medication used to treat Asthma in all age groups, will sensitize patient’s tumour to chemotherapy which was previously shown to be resistant to the same therapy.
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A randomised controlled trial of antenatal melatonin supplementation in fetal growth restriction for fetal neuroprotection.
During pregnancy, fetal growth restriction (FGR) is a recognised causal pathway to neurodevelopmental injury, which manifests, following birth, as cognitive and behavioural impairment as well as cerebral palsy. Currently, antenatal care is focused on detecting FGR and assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize gestational age at birth to minimise the risks of prematurity, while delivering the fetus in time to minimise the likelihood of stillbirth. However, no therapies exist that can maximize fetal wellbeing in the setting of FGR and minimise the frequency of antenatally acquired brain injury. This double-blind RCT seeks to recruit n=332 women with FGR pregnancies to determine if antenatal maternal Melatonin administration can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.
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Improving neural function through targeted exercise in older adults
The aim of this study is to identify and compare the efficacy and time-course of three different centrally demanding interventions (challenging balance; visuomotor; and externally-paced strength training) at inducing use-dependent neuroplasticity and driving functional improvements in community dwelling older adults aged 65 years and over. It is hypothesised that a single training session (independent of training type) will induce transient increases in corticospinal excitability and reductions in inhibition, and that older adults will experience use dependent neuroplasticity over the 12-week intervention period compared to a control group, It is further hypothesised that changes in the performance of lower-limb physical tasks will be dependent on the specific training group; and that neurological adaptations and changes to lower-limb task performance will decay after four weeks of no training. The results from this trial will provide insight into the potential for centrally demanding interventions to exploit the flexibility of the central nervous system's of older adults, and induce positive training related improvements in functional ability.
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Remini-Sing: Therapeutic choirs to improve wellbeing and relationship quality for community dwelling people with dementia and their family caregivers
Relationship quality between community-dwelling people with dementia (PwD) and their family caregivers (FCG) is recognised as a major factor that influences health and wellbeing of both, and consequently impacts their ability to live together in the family home. The family home with familiar people and surroundings is recognised as the optimal care environment for PwD. Supporting PwD to remain in the family home also reduces care costs to individuals and society, and is recognised as a strategic priority by the Australian Government. The primary aim of this proposed randomised controlled trial is to determine whether therapeutic choir participation and supported home-based music engagement improve relationship quality between community-dwelling PwD and FCG. Secondary aims will examine whether the choir intervention is cost effective and can improve wellbeing and quality of life indicators for PwD and FCG. Key questions to be addressed by this randomised controlled trial ask whether therapeutic choir participation and home-based music engagement for community-dwelling people living with dementia and their family caregivers improve ratings for: • the primary outcome measuring relationship quality between PwD and FCG • and secondary outcomes measuring: 1) quality of life for PwD and FCG 2) depression for PwD and FCG 3) social connectedness for PwD and FCG 3) caregiver experience for FCG 4) observations of anxiety in PwD Using a single-blind, randomised controlled trial, 180 PwD + FCG dyads will be randomised to either 20 weekly choir sessions with home-based music program facilitated by a registered music therapist or a waitlisted control group. Eligible participants, recruited from 6 sites (4 metropolitan and 2 rural), will be community-dwelling people with a diagnosis of dementia and family caregivers who provide the majority of care in the home. Outcome measure questionnaires, collected by a blinded assessor, will be taken prior to the intervention (baseline), midpoint (week 11), and following completion of 20 choir sessions (week 21).
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A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First in Human Study of PRAX-330 to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses in Healthy Subjects
The study is a Phase 1, double-blind, randomized, placebo-controlled, first in human study of PRAX-330 to assess the safety, tolerability and pharmacokinetics of single ascending oral doses in healthy subjects.
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Targeted exercise to reduce risk of fracture in postmenopausal women with low bone mass who may or may not be on antiresorptive bone medication: The MEDEX-OP trial
Osteoporosis is a condition of greatly increased risk of low trauma fracture. Certain medications and exercises have been shown to increase bone density and decrease fracture risk. The additive effect of those two interventions might yield greater benefits as they have distinct individual effects. While osteoporosis medication has been shown to increase bone mass and reduce fracture, exercise improves bone, muscle and balance thereby reducing falls. This study will determine the independent and combined effect of exercise and bone medication on bone health in postmenopausal women at risk of osteoporosis. It will also compare the efficacy of two different exercise programs – a resistance and impact training program (HiRIT) and a Pilates exercise program.