ANZCTR search results

Obstructive defaecation (OD) is a challenging clinical problem not uncommonly encountered in colorectal practice. OD is associated with depression, anxiety and impaired quality of life (QOL).1 Unfortunately, because the underlying anatomic and pathophysiology of OD is poorly understood, large number of medical, surgical and behavioural treatment have been described with no panacea. A recent meta-analysis suggests that biofeedback is effective in the treatment of OD, although only a handful of randomized trials, each with different biofeedback regime have been completed to date.2 Most trials have also focused on symptomatic improvement with relative neglect of impact of treatment on QOL or psychological state.2 In amongst the seemingly vast literature surrounding OD and its treatment, some fundamental questions remain unanswered: 1) is it the counselling and support that makes biofeedback effective; 2) is balloon retraining effective as a biofeedback modality; 3) does treatment improve QOL or psychological state. The biofeedback protocol at Royal Prince Alfred Hospital (RPAH) for OD is a comprehensive program entailing education, counselling (conservative management) and balloon retraining. Balloon retraining has only been evaluated in 1 randomised trial in 1995 (Koutsoumanis et al)3 and although improved treatment success have been noted since it was introduced at RPAH, whether or not this represents a biased observation remains unclear. A randomized controlled trial (RCT) is proposed to: 1) determine if biofeedback improves QOL and psychological state of patients with OD; 2) to determine if balloon retraining as a biofeedback modality is effective; 3) to determine if balloon retraining confers any additional benefit to patient receiving conservative management.

Inflammatory insults including pneumonia, sepsis, aspiration, trauma, prolonged hypotension, cardiac surgery and pancreatitis can cause lung damage. One mechanism by which inflammation mediates lung injury is through deposition of fibrin in the pulmonary microcirculation. This study will investigate if limiting fibrin deposition through administration of tissue plasminogen activator reduces lung damage.

Regular physical activity has many health benefits. More specifically, physical inactivity is an identified risk factor for global mortality, and can contribute to the incidence of non-communicable diseases such as obesity and heart disease. In generally healthy adults at least 150 minutes of moderate-vigorous intensity physical activity each week is required to improve cardiorespiratory fitness, bone health and reduce the risk of non-communicable diseases and depression. In individuals with CF there are no established targets for physical activity participation. Consequently, physical activity interventions are shaped around guidelines for healthy adults. Improving and maintaining physical activity is a cornerstone of therapy for CF patients. Aerobic fitness is associated with improved survival and those with better physical fitness have better quality of life. Despite this, participation in exercise decreases with increasing perception of disease severity, with patients ascribing decreased importance and increased burden to exercise over other therapies. In previous studies of physical activity in CF, both children and adults have been found to undertake less moderate-vigorous physical activity than their healthy peers. It is hypothesised that: 1. Physical activity decreases over time in CF and is more marked in particular sub-groups such as females and those with repeated need for intravenous (IV) antibiotics. 2. Factors such as higher baseline respiratory function, fulltime employment/study, higher fitness levels, younger age and male gender will all be associated with better long-term participation in physical activity. 3. Physical activity is decreased after respiratory exacerbation requiring IV antibiotics, and does not return to baseline after 4 weeks. 4. Decline in physical activity is associated with a more rapid decline in respiratory function over 12 months.

The aging population in Australia is growing and associated age-related cognitive impairment is also increasing. Cognitive impairment however is not limited to the domain of neurodegenerative diseases such as dementia and can affect otherwise healthy individuals. Current treatment interventions for healthy individuals with cognitive impairment are somewhat limited, however Chinese Herbal Medicine (CHM) typically uses various combinations of herbal products to treat illnesses and improve the quality of life in both healthy and pathological populations. The CHM formulation, Wei-Nao-Kang (WNK), consisting of extracts from Panax ginseng, Ginkgo biloba and Crocus sativus. These herbs are amongst some of the most widely used plant based medicinal products currently available on the market today. Each of these herbs has either shown, or been implicated in, cognitive and cardiovascular enhancing effects when administered individually in healthy and/or pathological populations. Although early evidence exists to demonstrate that the ginseng/ginkgo combination has synergistic effects on cognitive functions, very few studies have investigated the combined effects of these herbal products. This study aims to determine the possible cognitive and cardiovascular benefits of the WNK formulation in a cohort of healthy volunteers to further expand on the body of research surrounding this CHM formulation. This study will employ a randomised, placebo controlled, double-blinded crossover design spanning a period of three weeks. Fifteen (22-75 years) healthy volunteers will be recruited and randomly assigned to receive treatments of WNK formulation or placebo over two weeks with a 10 day washout period between each week. Participants will be tested before and after each of the interventions to assess their cognitive and cardiovascular changes. The primary outcome measure is the Comppas test battery, which assesses various domains of cognitive function. Secondary outcome measures include an electroencephalography (EEG) recording while being exposed to a visual stimulus paradigm designed to elicit event related potentials (ERP), and cardiovascular measurements including pulse velocity waveforms and electrocardiography (ECG) recordings. Once the trial is completed, participants will be debriefed and asked to complete a short survey for confirmation of compliance and successful blinding. Following this, results from the Compass, EEG, pulse velocity waveforms and ECG will be analysed and prepared for publication.

This prospective, randomized controlled trial will examine the effects of combined aerobic and resistance training on left ventricular remodeling and its relationship to VO2peak in diabetic patients with diastolic dysfunction.

Open heart surgery is being performed on increasing numbers of obese patients. Almost a third of patients undergoing open heart surgery are classified as obese. It is known that these patients are more prone to post operative complications, particularly lung collapse and that they recover more slowly from these complications. This increase in complications and slower recovery leads to longer intensive care unit and hospital stays. Our previous research has shown that high flow nasal prongs (HFNP) create positive airway pressure and that patients who are obese benefit even more from the positive effects of HFNP. Our study also showed that the patients' oxygen levels improved and their breathing felt more comfortable with the HFNP. Therefore, it is necessary that we further investigate the effects of HFNP on obese patients after cardiac surgery, in an attempt to reduce complications, particularly lung collapse.

Exercise Physiologists are a relatively new allied health profession. The exercise physiologist provides exercise counselling with the objective being to improve various health related parameters for the client. However to date there is virtually no research available to confirm or refute the efficacy of the exercise physiologist in producing meaningful improvements in the health of an individual. A number of studies have reported exercise training leads to positive health outcomes in type II diabetes. An issue with these studies is that they are highly controlled. While this is desirable from the point of view of determining effects, it is often not reproducible in an applied setting and may not readily transform to patients continuing the exercise in a less controlled setting such as occurs in clinical practice. The study will follow the changes in health markers in approximately 500 type II diabetics who undergo exercise physiology counselling in a clinical practice setting. A range of measures of physical function, participation in physical activity, quality of life and clinical prognosis will be measured on commencement in the study and after six months of treatment. The number of sessions with an exercise physiologist and whether or not patients received treatment with another allied health professional will be used as co-variates in the statistical analyses.

MRSA bacteraemia has a mortality of 30-40%, exceeding that of sensitive Staphylococcus aureus primarily due to the shortcomings of vancomycin, the standard therapy for MRSA bacteraemia. Whilst several new antibiotics have become available for MRSA, none have been shown to be superior to vancomycin. Although MRSA is by definition resistant to oxacillin, multiple in-vitro and animal studies have demonstrated synergy of vancomycin with beta-lactams (including oxacillin) against MRSA and hetro-resistant vancomycin intermediate Staphylococcus aureus (hVISA). This study aims to answer the following question: In hospitalised adults with MRSA bacteraemia, does combination therapy with vancomycin and flucloxacillin lead to a shorter time to clearance of bacteraemia than vancomycin alone?

The primary purpose of this trial is to develop and test a model of shared care follow-up for men with prostate cancer with the aim of reducing unmet needs and psychological distress. Who is it for? You may be eligible to join this trial if you are aged 18 years or over and have been diagnosed with prostate cancer for which you have completed surgery and / or radiotherapy with curative intent at Royal Perth Hospital and at Fremantle Hospital in Western Australia, within three weeks of study entry. You will also need to have a GP who agrees to participate in the trial. Trial details: Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will receive usual care (in accordance with local hospital practice). Participants in the other group will receive shared care, whereby some of the routine hospital visits are replaced by GP visits over the 12 month follow-up period. The trial aims to test whether a shared care model of follow-up for prostate cancer may reduce rates of psychological distress and unmet psychosocial and psychosexual needs and improve satisfaction with care at lower cost compared to usual care.

There is emerging that the medication, Quetiapine (trade name: Seroquel) is clinically useful in treating clinically significant depression (major depressive disorder) and in the augmentation of antidepressant medication in this condition and depression that occurs in bipolar disorder (manic-depression). Quetiapine is currently approved for the treatment of schizophrenia and bipolar disorder. This study will look at whether the addition of the medication Quetiapine XR (trade name: Seroquel XR) to standard antidepressant medication is better than antidepressant medication alone in keeping symptoms of depression to a minimum after a clinically beneficial course of electroconvulsive therapy (ECT) within the previous 3 weeks for clinical depression (major depressive disorder). Participation in the study will occur after remission (disappearance) of clinically significant depression has occurred after treatment with ECT, when there has been failure to respond to an adequate trial of at least one antidepressant medication, or when ECT is the preferred treatment. People will be invited to participate in the study if they: are aged 18-65 years ;have been diagnosed as experiencing major depressive disorder; have had a course of ECT completed within the previous 3 weeks, which has led to remission of depression sustained over the last 2 ECT treatments of the ECT course, after failure to respond to an adequate trial of at least one antidepressant medication, or when ECT is the preferred treatment. People will not be able to participate in the study if they are: at immediate risk to themselves or others; dependent on alcohol or other substances, apart from caffeine or nicotine; or have diabetes mellitus that is not stable or well controlled. Women who are pregnant, or may become pregnant, or are lactating during the course of the study, will also not be able to participate in the study. There will be 2 groups of 20 participants, each, in the study. One group will be treated with the medication Quetiapine XR in combination with an antidepressant medication. Another group will be treated with an antidepressant medication alone. The antidepressant medications, either a selective serotonin reuptake inhibitors (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) that has not been previously prescribed, or previously not helpful in preventing relapse of clinically significant depression, will be prescribed by treating doctors. The addition of Quetiapine XR to the antidepressant medication will be randomly determined, so that the study doctors or treating doctors will have no prior knowledge nor influence on whether this medication is added to prescribed antidepressant medication. The dose of Quetiapine XR will range from 50 milligrams to a maximum of 300 milligrams per day, with doses adjusted according to clinical response to, and tolerability of this medication. Psychiatric medications other than the prescribed antidepressant medication or Quetiapine XR, will not be prescribed or permitted during the course of the study. The duration of the study is 6 months, with weekly study visits for the first month and monthly, thereafter for the remaining 5 months. Participants will be asked questions about the presence of depressive symptoms and how they are tolerating their medication, as well as a physical examination as part of each study visit. Participants will have blood tests (clinical chemistry, haematology) prior to commencing the study, and at 1,2,3 and 6 months. Participants will also have a fasting (not having eaten, or drunk anything other than water since midnight) prior to commencing the study, and at 3 and 6 months. Participants will also have a urine drug test and electrocardiogram (ECG) prior to commencement. Participants will be free to withdraw their consent at any stage without affecting or prejudicing their clinical care in any way. In the event of depressive relapse (recurrence of clinically significant depression), participants will be discontinued from study, with alternative treatment arrangements made in consultation with their primary treating medical practitioner.