ANZCTR search results

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

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32712 results sorted by trial registration date.
  • An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system in people with type 1 and type 2 diabetes.

    Until recently, insulin administration has been based upon finger-prick measurements of capillary glucose readings. RT-CGM involves using a subcutaneous sensor to measure interstitial fluid glucose levels continuously and provides the patient with the glucose level in real-time, as well as the rate and direction of change in the glucose. While there is an increasing body of evidence indicating that RT-CGM in combination with an insulin pump results in an improvement in glycaemia and reduces hypoglycaemia, compared with self monitoring of blood glucose (SMBG) and MDI in people with T1D, data is limited regarding the use of RT-CGM in conjunction with MDI. The study aims to evaluate the user acceptance of the RT-CGM device in patients with T1D, and T2D on MDI, as well as to evaluate its' impact on glycaemic control.

  • A Phase 1 Investigator Initiated Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of AB-SA01 in Patients with Chronic Rhinosinusitis Associated with Staphylococcus aureus Infection

    CRS is a debilitating inflammatory and infection based condition, affecting up to 9% of the Australian population (AIHW, 2010). Currently available therapies to treat this condition include steroids, antibiotics and surgical intervention (Fokkens et al., 2012). Unfortunately there remains a cohort of patients that are resistant to both medical and surgical interventions who experience persistent CRS symptoms, which is termed recalcitrant CRS (rCRS). The presence of bacterial biofilms in the sinonasal tract is one aspect of the condition shown to contribute to this recalcitrance and symptom persistence. Biofilms are 1000-fold more resistant to antibiotics compared to non-biofilm bacterial, making them resistant to the current place antibiotic therapies that are used to treat infections in CRS. There is, therefore, a need to develop novel therapies that are effective against these biofilms if we are to succeed in treating these rCRS patients. Bacteriophage-based treatment, AB-SA01, could be the answer to the problem of biofilms in rCRS. Bacteriophages or phages, identified almost 100 years ago, are bacterial viruses that specifically target bacterial cells, leading to cell death. Given their specific mechanism of action, bacteriophages are not able to infect mammalian cells, and have thus far shown few adverse effects when applied to humans for use as antimicrobial treatments (Chanisvilli, 2012; Brussow, 2005). The Primary endpoint of the study is to: 1. To assess the safety and tolerability of three dosage regimens of AB-SA01 in patients with Chronic Rhinosinusitis associated with Staphylococcus aureus infection. The secondary objectives of the study are: 2. The preliminary assessment of effectiveness of three dosage regimens of AB-SA01 by endoscopic evaluation by the Investigator using the Lund-Kennedy scale. 3. The preliminary assessment of effectiveness of three dosage regimens of AB-SA01 by patient assessment of symptoms.

  • Self-compassionate writing for breast cancer survivors: An online intervention

    The purpose of the study is to further understand women's experiences, regarding how they feel about themselves, their body, weight and appearance after completing treatment for breast cancer. This study has two parts. The first part is an on-line questionnaire to be filled in upon signing up for the study, with participants then undertaking follow up questionnaires one week, one month and 3 months after completing a writing activity. Participants will be asked about demographic information in the first questionnaire. Participants will also be asked about their current feelings and the impact of breast cancer or lymphoedema upon their body. It is expected that participants will need no more than 30 minutes to complete each on-line questionnaire. The second part of the study involves doing a writing activity. Participants will be allocated to one of two writing groups (structured or unstructured writing formats). Participants will be asked to do an online writing exercise and will be asked to write about their unpleasant feelings and experiences during treatment for their cancer or lymphoedema as well as its impact upon their body. It is expected that this part will take about 30 minutes. This activity is completed anonymously, and participants will have the option to voluntarily submit their writing.

  • Evaluating new guidelines based on high-sensitivity troponin for those presenting to the emergency department with suspected acute coronary syndrome (ACS)

    The health sciences are replete with innovations promising improvements in health care delivery and outcome. Yet their clinical application based on intuition is often imprecise, conservative and beset with biases leaving these potential gains unrealised. To translate healthcare innovations into real patient and system benefits, clinical decisions and practice must evolve in parallel, supported by objective validated evidence. One such innovation is troponin testing for suspected acute coronary syndrome in the Emergency Department (ED), the most common cardiac test undertaken in Australia. Each new generation troponin assays offer greater diagnostic differentiation, but as yet no discernible improvement in management efficiency or effectiveness has occurred. Translating improved test performance into better patient care will require a more structured approach. In all South Australian (SA) public hospitals, 5th generation troponin assays have been implemented, but reporting of results has remained at previous generation levels (conventional reporting), providing a unique opportunity to robustly evaluate the impact of test reporting on patient outcomes.

  • The efficacy of supra-scapular nerve block for the treatment of frozen shoulder: A randomised controlled trial

    Frozen shoulder is a condition which involves pain and stiffness of the shoulder joint and is often associated with a significant restriction of arm function and quality of life or well-being. We would like to see whether there are treatments that are better at reducing pain and improving the stiffness than our current treatments. The current treatment approach is called a “glenohumeral joint corticosteroid injection”. The glenohumeral joint is the shoulder joint capsule. It involves an injection of a steroid medication and a local anaesthetic agent into the shoulder joint capsule. Physiotherapy exercises are then given. It is thought that the steroid reduces the inflammation and pain around the shoulder joint which then allows the shoulder to be moved more easily with physiotherapy exercises. The newer approach we want to test is called “supra-scapular nerve block”. This has been shown to be safe and helpful in reducing pain for people with other types of shoulder problems. The treatment involves an injection of a steroid medication and a local anaesthetic agent into the tissues over the shoulder blade. This injection temporarily blocks the supra-scapular nerve which transmits the pain associated with frozen shoulder. Like the current treatment approach, once the pain has been reduced it should be easier to get the shoulder moving again with physiotherapy exercises. It is possible to repeat the suprascapular nerve block up to 4 times, at 3 monthly intervals, if the pain and stiffness remain. We think that the rate of recovery from frozen shoulder might be faster when current treatment and repeated supra-scapular nerve blocks are done together. In order to test this, participants will be randomly placed into one of two groups. One group will receive the supra-scapular nerve block injection and the other group will receive the placebo (saline) injection. These injections may be performed up to 4 times over the course of 1 year. In addition to receiving either the supra-scapular nerve block or the placebo injection, participants will receive the current best treatment available (glenohumeral joint injection and physiotherapy). Baseline information will be collected including age, general medical health, current medications, duration of shoulder symptoms, severity of shoulder symptoms and previous treatment for shoulder symptoms. Measures of shoulder range of motion, participant’s pain scores and levels of satisfaction will be measured at 3, 6, 9, 12, 18 and 24 months in order to compare both treatment approaches.

  • Perispinal Etanercept therapy in Australian patients with chronic stroke.

    The primary aim of the study is to determine the safety and tolerability of perispinal injection of Etanercept in subjects who have had a stroke and have stable and persistent chronic neurological dysfunction, cognitive impairment, and chronic and intractable pain due to stroke. The effects of the perispinal Etanercept treatment on neurological dysfunction, cognitive impairment, and chronic post-stroke pain will be examined as secondary aims by neurological examination as well as by the use of standarized measures.

  • The addition of nitric oxide to cardiopulmonary bypass in children - a randomised controlled trial

    We hypothesised that adding nitric oxide to the cardiopulmonary bypass circuit may reduce the occurrence of low cardiac output syndrome on ICU and improve patient outcomes (such as reducing the need for mechanical ventilation and shorten ICU length of stay)

  • Driving and Dementia: This study aims to investigate the positives and negatives associated with people with dementia continuing to drive and to identify the factors associated with the decision of people with dementia to stop driving.

    This study will follow-up drivers who have a diagnosis of dementia for a period of 2 years - which is the period after diagnosis in which many people with dementia stop driving. The primary objective is to identify the factors which are associated with participants deciding to give up driving and also to record how both the participant and the carers feel about the changes in the participants driving over the two year period following a diagnosis of dementia or Alzheimer’s disease.

  • Lung Ultrasound STudy - Diaphragm dysfunction after lung transplant

    Diaphragmatic dysfunction (DD) represents an important clinical problem after lung transplant and has a considerable influence on respiratory function and recovery. It frequently results in longer time on the ventilator; longer time in Intensive Care and longer time in hospital, which as a result may lead to further muscle weakness. The incidence of diaphragmatic dysfunction following lung transplant surgery has been estimated at more than 40 per cent. There is little documentation in the literature regarding the natural history and prognosis of diaphragmatic dysfunction in these patients. Ultrasound has been used to identify severe diaphragmatic dysfunction after heart surgery (Lerolle et al., 2009). Bedside ultrasound has been shown to be accurate for the assessment of diaphragmatic dysfunction in patients after heart surgery (Sanchez de Toledo et al., 2010). This assessment can be performed at the bedside and avoids the exposure to radiation. By documenting the incidence and extent of this problem, we hope to identify risk factors for diaphragm dysfunction and determine if any of these are preventable with future studies. Patients will be identified from the active lung transplant waiting list and approached for enrolment when they attend their routine heart-lung clinic appointments, or scheduled assessments. Protocolised diaphragm ultrasound assessments will occur whilst on active list, in Intensive Care on day 1 after transplant, in hospital in week 1, in hospital/heart-lung clinic at one month and three months post lung transplant. Measurements of diaphragm excursion (descent) and thickness will be taken at each assessment.

  • Intravenous iron versus packed cells in acute post-partum anemia

    Acute post partum anaemia is a common complication of pregnancy. It is principally iron deficient and is largely predicted by blood loss >1000mL. Ten percent of women with post partum anaemia develop severe anaemia (haemoglobin Hb<8g/dL) and this is associated with significant lethargy, fatigue and poor concentration which impair women from being able to care for their newborn and place them at increased risk of post natal depression. Current management of hemodynamically stable women with acute post partum anaemia is highly variable. Most clinicians opt to administer multiple red blood cell (RBC) transfusions to correct symptoms and restore Hb. No guideline or consensus exists to inform clinicians exactly when to transfuse women and the inherent risks associated with RBC transfusion, including life threatening adverse reactions, infection and thromboembolism, warrant investigation into alternative therapies. Currently, intravenous iron has been proposed as one alternative therapy to RBC transfusion in selected women though the comparative clinical efficacy and safety of this method has not yet been evaluated. Our study aims to compare intravenous iron polymaltose with RBC transfusion in women who sustain peri-partum blood loss >1000mL with resultant Hb 5.5-8.9g/dL after stabilisation and are symptomatic for anaemia. The study will employ an open label randomised design and be carried out at Westmead Hospital. Primary outcomes will measure Hb, CRP and ferritin levels at Day 7. Secondary outcome will measure Hb ferritin and CRP levels at Day 14 & 28 as well as improvement in anaemia symptoms as measured by Health Related Quality of Life (HRQoL) questionnaires at the same time points.. Treatment safety will also be compared between the groups by looking at incidence and severity of adverse events including infection. All women with blood loss >1000mL will be identified by Obstetrix, the mandatory hospital record. Once stabilised, these women will be consented by the study researcher and baseline bloods (Hb, reticulocytes count and ferritin) and symptom data will be collected. Women with resultant Hb 5.5-8.9g/dL who remain clinically stable but symptomatic will then be randomised to receive either RBC or intravenous iron polymaltose All adverse reactions will be recorded during and immediately after treatment and again by telephone at Day 1 and 2. Participants will then be reviewed by a midwife or doctor on Day 7, Day 14 and Day 28 where they will have repeat bloods. repeat symptom scores and clinical assessment for infection. Outcomes between treatment groups will then be compared and statistically analysed.

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