ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31593 results sorted by trial registration date.
  • Electrical stimulation-eccentric muscle strength training in people with spinal cord injury

    People with spinal cord injuries (SCI) experience changes in their muscles and health. One of these changes is muscle wasting typically due to disuse. One solution to reduce muscle wasting in people with SCI may be to use an eccentric-concentric strength training modality. Neuromuscular electrical stimulation (NMES) is commonly applied to muscles (using stick-on pad electrodes) to improve muscle strength in people with spinal cord injuries (SCI). This improvement in muscle strength is also thought to decrease muscle spasticity and improve quality of life. One modality that has promising results in muscle strength with lower loads is the use of eccentric contractions in combinations with concentric contractions. However, there is little research on NMES used as an eccentric-concentric mode in people with SCI. Thus, the current study is a proof-of-concept trial for the future use of eccentric-concentric training in people with SCI. The aim of the current study is to quantify the amount of force your thigh muscles produce during this type of electrical stimulation after a 6-week NMES intervention. Also, we will identify if this type of electrical stimulation produces less spasticity in the following days and after the 6-week intervention. Finally, we will identify if this type of NMES makes any changes in quality of life.

  • Effect of anthocyanins on exercise-induced bronchoconstriction

    Asthma is an inflammatory disease of the airways that affects over 7% of the world’s population (Papi et al., 2018). Exercise-induced bronchoconstriction (EIB) is a type of asthma which is defined as a transient narrowing of the airways in response to exercise and affects 90% of asthma sufferers and up to 15% of non-asthmatic individuals (Bonini & Usmani, 2018). Asthma and EIB can be managed either by rapid bronchodilatation to relieve respiratory symptoms or long-term suppression of inflammation. However, frequent use of reliever medicines can lead to the user becoming tolerant to the treatment and long-term control medicines have several undesirable side effects. Dietary and supplement interventions have been reported to reduce the effects of asthma and EIB (Williams et al., 2016). These may represent a cost-saving, effective and safe method for reducing the incidence of asthmatic attacks. Anthocyanins are coloured pigments that are responsible for the colours red, purple and blue in fruits and vegetables. Current animal studies have found that after consumption of anthocyanins, inflammation was reduced, and lung function was improved (Park et al., 2007). Whether anthocyanins could improve respiratory symptoms and lung function in otherwise healthy humans with EIB is unknown. This will be the first study to determine the role anthocyanins have on lung function and inflammation in individuals with EIB.

  • AUTO-CHECK: Molecular determinants of autoimmunity and immune related adverse events in advanced cancer participants treated with immune checkpoint inhibitors

  • Understanding the impact of maternal diseases in pregnancy

    Chronic kidney disease (CKD) and cardiac disease are two significant health conditions that can influence a woman’s pregnancy, however little is known about their prevalence and health impact within the South Australian population. These pregnancies are associated with significant risks of morbidity and mortality and propose a challenge to clinicians who manage them. The aim of this study is to prospectively record the incidence, prevalence, etiology, outcomes and follow up of maternal chronic diseases in the obstetric population of South Australia. This is a prospective cohort study of pregnant women with acquired or chronic cardiac or kidney disease.

  • Pilot RCT of a family program for reducing bullying victimisation and mental illness of adolescents

    This study aims to evaluate the efficacy of a novel relationships-focused family cognitive behavioural therapy intervention in reducing bullying victimisation and mental illness of adolescents. We hypothesise that Teen Connect Triple P (TCTP) will reduce bullying victimisation and symptoms of mental illness such as depression and anxiety in adolescents who participate, in addition to improving their supportive relationships. The efficacy of the intervention will be evaluated through online questionnaires before (0 months) and after the intervention (3 months), and through a 12-month follow-up online questionnaire. Adolescents will participate in the program over 6 x 1.5 hour weekly therapist led sessions conducted online via Zoom. Their parents will participate in separate sessions over the same time period. Adolescents learn how to strengthen friendships, interpret motives of peers, address issues calmly and assertively, resolve conflicts and seek help from their parents when needed. Parents learn how to support their adolescent’s friendships, listen to their adolescent’s concerns (without over-reacting or taking over), help their adolescent interpret peer motives, coach their adolescent in managing problems, and support their adolescents in making decisions and becoming independent. In each session, therapists educate participants about effective strategies through directed group discussions, skills-building exercises (modelling and role plays) and goal-setting for personal use. The TCTP intervention will be compared to an appropriate active control condition - 'The Blues program.' This is an existing cognitive behavioural program, previously found to reduce depressive symptoms compared with a waiting list control group. It is similar to the kind of psychological treatment adolescents with emotional problems would receive at an Australian mental health clinic. Both TCTP and the Blues Program could be delivered face-to-face. However, we are investigating the feasibility of delivering these interventions through facilitated online group Zoom sessions to minimise disruptions due to the current pandemic and to enable recruitment throughout Australia.

  • Impact of insulin resistance, obesity and the metabolic syndrome on time taken to examine the small bowel at capsule endoscopy

    All patients already referred for capsule endoscopy during the study period over the age of 18 years old and are able to provide informed consent are to be invited to participate in the study. Capsule endoscopy is where a camera and wireless transmitter are packaged in a small, pill shaped device. This is swallowed by the patient and images are recorded as the devices passes through the bowel. These images are then interpreted to help diagnose intestinal disorders. This procedure is usually undertaken to investigate anaemia and obscure gastrointestinal bleeding. Incomplete studies can limit the utility of the study and identification of factors that may impact transit will help identify patients at risk of incomplete examination. Those that do consent will have clinical parameters recorded (sex, age, height, weight, waist circumference, blood pressure and body mass index). A fasting blood sample will be collected for insulin, C-peptide, glucose and full lipid profile (total cholesterol, triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL)). Insulin resistance is to be calculated using the validated HOMA-IR (homeostasis model of assessment of insulin resistance) method. Participants are asked about the relevant past medical history (medically diagnosed diabetes, dyslipidaemia, hypertension, ischaemic heart disease, cerebrovascular disease or peripheral vascular disease) and medications. At capsule endoscopy gastric emptying and small bowel transit time are recorded as well as whether complete small bowel transit occurs and any pathology encountered. All capsule endoscopy studies will be interpreted by an experienced clinician. Standard capsule endoscopy techniques are to be followed. Patient information is to be de-identified before statistical analysis. No individually identifiable information will be included in the final results.

  • Cohort study of meso-Rex shunts in Queensland children with extra hepatic portal vein obstruction.

    Extrahepatic portal venous obstruction (EHPVO) is a condition where venous flow into the liver becomes obstructed. As a result, blood bypasses the liver via a series of other channels that open up. The liver consequently receives less blood flow. This can lead to abnormalities of liver function, and varices that can bleed (most commonly in the lower oesophagus). The Rex shunt is a selective shunt that is designed to relieve the complications of EHPVO by connecting mesenteric venous flow to the left portal vein, using one of a number of described conduits. Queensland Children's Hospital is the only facility in Queensland performing this operation. To date outcomes have not been collated or reported for any facility in Australia. This will be the first study to do so. As a part of this study, and to determine outcomes to report, a systematic review of the literature is being performed. This systematic literature review will identify reported outcomes in the extant literature. The most common, or important, of these reported outcomes will be used for this study cohort. Data related to this cohort have already been gathered during the course of clinical care. Where possible, outcomes will be reported. If an outcome is determined important, but has not been collected to date, this will inform future data gathering for these patients.

  • Impact of Epicardial plaQUe composition and geometry on coronary hemodynamics and flow (iEquate)

    After informed consent, patient’s undergoing coronary angiography who have moderate (50-75%) stenosis angiographically would undergo invasive hemodynamic assessments via a 0.014 inch coronary wire as part of routine clinical practice to determine need for percutaneous coronary intervention. Further to this, over the pressure wire, an optical coherence tomography (OCT) catheter would be passed to obtain intra-vascular imaging and plaque composition assessment. Data will be collected on the minimal luminal area (MLA), degree of calcification, fibroatheroma, necrotic core, lipid content and the geometry of the lesion. These variables will be examined in terms of relationship to the pressure wire value. If the lesion meets hemodynamic significance (i.e. iFR value less than or equal to 0.89 or FFR value less than or equal to 0.8). PCI may be performed if clinically suitable as per usual clinical practice.

  • teenAID - Evaluating first aid training for students in Year 8

    The teen Mental Health First Aid program for students in Year 7-9 (tMHFA7-9) teaches students aged 12-15 years how to: - recognise warning signs that a friend is developing a mental health problem - understand how to talk to a friend about mental health and seeking help - when and how to tell a responsible adult - where to find appropriate and helpful resources about mental illness and professional help - how to respond in a crisis situation The course was previously evaluated in an uncontrolled trial with year 8 students. As a result of the research findings a revised edition of the tMHFA 7-9 was developed in 2020 and is being piloted with year 8 students in two Western Australian secondary schools in 2021. The aim of this project is to provide evidence on the effectiveness of the tMHFA 7-9 Edition 3 course in a parallel randomised controlled trial with year 8 students, using the Red Cross "Let's Talk First Aid" course for Year 8 (LTFA) as the comparator.

  • Oestradiol positron emission tomography (PET) scans in metastatic breast cancer:investigation of utility of assessing disease burden and treatment response

    This is a pilot study investigating the use of oestradiol PET scanning (FES-PET) in helping to assess hormone receptor positive metastatic breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, of any gender, and you have been diagnosed with ER positive metastatic breast cancer. Study details All participants will undergo upto three oestradiol PET scans. Each scan will take less than 30 minutes. There will be one scan at enrolment, at 2 months, and at 6 months later. However if the first scan does not show any disease subsequent FES PET scans will not be undertaken. Participants will also receive standard FDG PET scans, as per usual care. Data relating to your care, treatment, outcome and your demographic information will be obtained from case notes. It is hoped this research will reveal whether FES-PET is useful in providing information about disease progress and treatment response in ER positive metastatic breast cancer, and help to improve future clinical diagnosis and monitoring.

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