ANZCTR search results

To investigate the residual effects of temazepam and zolpidem, and to investigate the analysis of speech for objectively measuring these changes.

A significant and well-established impact of Chronic Obstructive Pulmonary Disease (COPD) is poor balance and high rates of falling. People with COPD have well identified falls risk factors such as reduced balance, poor strength, and irregular walking patterns. However, further investigation into how balance changes during exertion is required in order to implement strategies for reducing the incidence of accidental falls in this population. The aim of the proposed study is to determine if adults with chronic obstructive pulmonary disease (COPD) have deterioration in their walking pattern (gait) regularity during walking with exertion, and have worse dynamic balance after exertional walking. This study examines changes in balance control (as measured by gait regularity and limits of stability) in adults with COPD during self-paced walking (6 Minute Walk Test) and externally paced walking with regular increases in pace (Shuttle Walking Test). Measures of exertion (Modified Borg Dyspnoea Scale, SPO2 and HR) will be recorded concurrent to each walking task. The study design is repeated measure crossover study in which twenty people with COPD will be recruited from the University Exercise Clinic. Participants with stable COPD will perform both a 6 Minute Walk Test and a Shuttle Walk Test one week apart in a randomised order with gait regularity and oxygen saturation recorded at one minute intervals. Both the walking tasks will be performed on a GAITRite sensor mat recording walking pattern and gait regularity. Before and after each walking task balance (Functional Reach) and perceived level of dyspnoea measures will be taken. Gait regularity will be analysed using linear regression modelling for within task and between task comparisons. If the residuals from linear modelling do not meet the requirements of linear regression then data will be analysed using logistic regression. A paired T test will be used to compare functional reach prior to and after each of the exertional tasks. Covariance accounting for baseline values will be undertaken.

Aims The primary aim of this study is to investigate the efficacy of adjunctive mangosteen pericarp 1000mg/day for the treatment of bipolar depression using a 24 Week randomised, placebo controlled trial. The primary outcome measure will be the change in severity of mood symptoms, measured using the Montgomery Asberg Depression Rating Scale (MADRS). Secondary outcomes include global psychopathology, substance use, functioning, quality of life, and safety and tolerability data. A follow-up interview will be conducted 4 weeks posttreatment to determine any outcomes following cessation of the trial agent. Method We plan to recruit a total of 150 participants aged 18+years with moderate to severe bipolar depression (having a DSM5 diagnosis of bipolar I or II or bipolar disorder not elsewhere classified (NEC), determined using the Structured Clinical Interview for DSM Disorders 5 (SCID5), currently be in a major depressive episode on SCID5, and meeting criteria of a Montgomery Asberg Depression Rating Scale (MADRS) score of greater than or equal to 20. Participants will attend a screening visit to ascertain suitability and once randomized they will receive a month’s supply of either 1000mg/day of mangosteen or matched placebo to be taken in addition to their treatment as usual. Participants take two capsules per day. Participants will visit the study site at weeks 4, 8, 12, 16, 20 24 and 28 (4 weeks posttreatment discontinuation) where a battery of validated outcome measures will be administered by trained research staff. Participants will be asked to discuss their symptoms, side effects and any issues the participant would like to raise regarding the trial. Participants will be notified of which arm of the study they took part in and a summary of results at the completion of the study.

Adults admitted to an acute care facility frequently require the insertion of a peripherally inserted central catheter (PICC) for the administration of medication and fluids. These PICCs are associated with a high rate of failure, including PICC-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU) and sutureless securement devices (SSD), are used to protect the PICC insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), absorbent dressings, and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for PICC. It is not known whether these new products are effective at reducing PICC failure and complication, in comparison to standard care. The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on PICC failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for adults with PICC in acute care.

The small intestine is the key interface between ingested food and the human body, particularly given its capacity to “sense” the presence of nutrients in much the same way as the tongue, through activation of similar taste receptors. This taste perception can influence nutrient uptake, as well as the release of gut hormones and neurotransmitters involved in the regulation of gastrointestinal motility, energy intake and blood glucose homeostasis. The purpose of the study is to provide proof of concept that intestinal bitter taste sensing has a favourable effect on metabolic control. Specifically, the study will evaluate the hypothesis that activation of intestinal bitter taste receptors (by intraduodenal administration of a bitter chemical, denatonium benzoate) augments secretion of gut hormones, thereby increasing insulin, suppressing glucagon and ghrelin, and modulating antropyloroduodenal motility (to slow gastric emptying), with a consequent reduction of the blood glucose response to small intestinal glucose infusion and potentiation of the reduction in energy intake in healthy human participants.

The coronary arteries supply the heart muscle with oxygen rich blood. The Left Anterior Descending artery (LAD) supplies the front part of the heart muscle. Narrowing of the coronary arteries can cause angina and if one of the narrowings block off it can cause a heart attack.. Preventative medication can help to relieve or prevent these problems. When the LAD is narrowed in many places (diffusely diseased) it can often cause angina or breathlessness and medications alone may not be sufficient to treat the diseased artery. In addition to tablets coronary bypass surgery is often the best treatment when there are many narrowings, but for technical reasons it is not a suitable treatment when the LAD is diffusely diseased. It is still possible to reconstruct the artery using long stents during a coronary catheterisation procedure. Reconstruction of the artery with conventional drug eluting metal stents such as Xience can be a very effective treatment, but leaves the vessel in a permanent metal cage with risk of restenosis and stent thrombosis. The standard Xience stent is a metal stent and contains the drug everolimus to prevent the heart artery from re-narrowing. Individual case reports show that diffuse disease in the LAD may be reconstructed using bioreabsorbable scaffolds. The Absorb bioreabsorbable scaffold is made of a special type of plastic consisting of materials called polylactide polymers and copolymers. Over time these materials will gradually break down and be completely resorbed into the artery wall, leaving nothing behind and in principle restoring the natural ability of the artery to change in size in response to the needs of the heart (vasomotion). The Absorb scaffold is also coated with the drug everolimus which helps to prevent the heart artery from re-narrowing. When a narrowing in the arteries is stretched open the scaffolding effect, which prevents the artery from collapsing down again, is needed for only 3-6 months after which the artery grows larger by itself through a process called remodelling. As such the scaffolding effect from metal stent lasts much longer than needed and this can sometimes lead to problems. In theory the reabsorption of the scaffold over time may allow for future bypass grafting of the vessel if needed . While the bioreabsorbable stent seems like a good idea on many levels and initial study results are encouraging, there is much less experience with this new technology Commercial-in-Confidence and in particular whether the long term effects compared to a modern metal stent are better, worse or the same are not known. The aim of the trial is to evaluate whether, in addition to medical therapy, reconstructing the LAD with bioreabsorbable vascular scaffolds may improve outcomes versus treatment with standard Xience stents and specifically whether the artery may become suitable for coronary bypass surgery. The trial is a prospective randomised single blind, blinded end-point assessment; controlled trial

Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality in the Western World and diabetes mellitus confers a doubling of CVD risk. Vascular calcification (VC) or hardening of the arteries is one of the most powerful independent predictors of cardiovascular events. VC is accelerated in patients with diabetes mellitus advancing vascular age by 5-10 years above chronological age. Progression of coronary calcification is associated with an adverse prognosis that is proportional to the rate of increase of coronary calcification over and above baseline calcification levels, indicating a pressing need for novel preventative therapies. The prevention of VC is a novel target that may effectively reduce risk of vascular events. Active vascular calcium deposition as opposed to stable patches of calcium may be detected with 18F-Fluoride PET/CT. This randomized double-blind placebo controlled 2x2 factorial trial will evaluate 2 novel therapies targeting a reduction of VC activity: Vitamin-K (VitK) 10mg per day targeting the increased activation of MGP, a potent local inhibitor of VC, and Colchicine 0.5mg per day, targeting inflammation via the accumulation of white blood cells in atherosclerotic plaque, a prerequisite for calcification. The effect of active treatment vs placebo for 3 months on the vascular calcification activity measured by PET-scan will be tested. Subsequently a natural history study will aim to define in a local patients with contemporary preventative treatment the rate of accumulation of VC (measured as the difference on Computed tomography (CT) between baseline and at 2y follow up). The study will be coordinated from the Department of Cardiology, Royal Perth Hospital. This study aims to determine whether one of these two novel therapies will reduce vascular calcification activity measured by positron-emission tomography/computed tomography (PET/CT) scan at baseline and after 3 months of: Oral Vitamin-K 10mg/day vs. placebo in patients with DM Oral colchicine 0.5mg/day vs. placebo in patients with DM Secondary aims are to determine the rate of accumulation of VC (measured as the difference on CT scan between baseline and at the 2yr follow-up). Patients with diabetes (type I, type II), aged 50 – 80yrs , will be approached at their regular clinic visit or during a hospital admission. Once randomised, they will be telephoned at 1 and 2 weeks to assess compliance, then asked to return to the cardiology clinic at 1, 2 and 3 months. Blood tests will be performed at 1 and 3 months.

Background: Ultra-endurance and adventure racing are increasingly becoming popular with recreational and elite athletes. These athletes routinely carry some form of external loads, to transport various equipment for survival, navigation and sustenance. It has been well reported that load carriage impairs gait performance, with subsequent training studies conducted to identify if gait performance improved. However, most of these training studies were not of a randomized, controlled trials design, and they were largely conducted within the military setting. More importantly, exercise selections within current studies have not been based on known neuromuscular demands involved in load carriage gait patterns. Previous studies on load carriage in running have identified potential adaptive and mal-adaptive biomechanical alterations when load is imposed on running. Adaptive mechanical alterations are changes whose functions are to needed to sustain running speed, enhance postural control, support an increased weight and absorb shock. Mal-adaptive alterations are changes which could heighten the risk of incurring injuries, and reduce gait performance. It is hypothesized that a neuromuscular training that is targeted to known neuromuscular demands of load carriage running would compare better than a generic strength training program in improving load carriage running mechanics. Methods: This study will be a two-arm, parallel randomized controlled trial with single assessor blinding. 30 healthy runners, aged 18 to 60 years, will be enrolled. The total duration of this study is 8 weeks, broken up into two phases. In the first phase, participants will undergo a common two weeks familiarization training sessions. They will undergo a pre and post biomechanics and strength testing assessment. A permuted block randomization procedure will be used as participants will be stratified based on gender (male/female). Allocation will be concealed using sealed-opaque envelopes. After baseline assessments, participants will be randomized into either a targeted or a general neuromuscular training program. Both programs will involve three supervised sessions per week for six weeks. A mid assessment will be conducted during the 3rd week with regards to maximal jumps and hops. Statistical analysis: Baseline demographic variables will be compared using parametric and non-parametric tests, where appropriate. Descriptive statistics (mean and standard deviation) will be calculated. A linear mixed model will be used to identify between group and within group by time changes in discrete dependent variables. Statistical Parametric Mapping will be used to identify between and within group by time changes in time-continuous dependent variables. Statistical inference will be made at a family wise error rate of a = 0.05.

The primary purpose of this feasibility pilot study is to examine the efficacy of an exercise regime and dietary advice prior to colorectal surgery in frail older adults. Who is it for? You may be eligible to participate in this study if you are aged 50 years or older, are considered frail, and are scheduled to undergo major colorectal surgery. You will also need to be willing and able to attend exercise and dietary advice sessions in the Townsville area. Study details Participants in this study will be randomly allocated (by chance) to receive either usual care prior to their surgery, or to receive a tailored exercise regime from exercise physiologists. Regimes will be tailored to each individual's level of fitness and health, but will all include elements of strength, aerobic and balance training to be carried out during a maximum of three, 1-hour sessions per week for 4 weeks. It is hoped that the findings of this pilot study will inform researchers primarily as to whether the exercise and dietary advice intervention is feasible and effective in this patient group.

Sleep and circadian disturbances are intricately linked to the onset, co-morbidity and chronicity of various mental disorders. For instance, shortened or extended sleep duration, increased sleep fragmentation and delayed and disorganized sleep-wake schedules have been observed in young people with a range of affective and psychotic disorders. Increasing evidence suggests that changes in sleep and circadian rhythms may modulate the trajectory of mental disorders and treatment outcomes, but little is currently known about sleep and circadian rhythms during critical mental illness episodes leading to hospitalization and how this may relate to the recovery process. The current observational study will use novel ambulatory devices to monitor sleep, general activity levels, body temperature and ambient light exposure across multiple days in inpatients admitted to a young adult mental health service. Potential associations between sleep-wake and circadian parameters and changes in self-reported clinical symptoms measured across the course of hospitalization will also be investigated. This study has the potential to deepen our understanding of sleep and circadian disturbances in acute phases of mental disorders and how they relate to the recovery process.