ANZCTR search results

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

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32856 results sorted by trial registration date.
  • The impact of obesity on the quality of CPR: a randomised cross over trial

    There is little research regarding the efficacy of CPR in obese patients. The primary aim will be to assess whether hospital staff trained in BLS can deliver effective chest compressions in the setting of a CPR simulation using a dummy which is modified to reflect a patient with morbid obesity. Aim of study: * The aim of this study is to explore whether chest compressions in an obese patient are an effective part of the BLS and ALS algorithm and should continue to be used as part of resuscitative efforts during a cardiac arrest. In addition, this study aims to explore whether providers of CPR fatigue more rapidly when delivering CPR to morbidly obese patients. Primary Outcome: * The primary outcome is to measure the efficacy of chest compressions in a morbidly obese scenario. This will use digital mannequins to record the quality and adequacy of chest compressions over a period of 2 minutes of uninterrupted CPR. Effective CPR will be defined as a composite measure of adequate depth of compression, adequate time for recoil and at an adequate rate for more than 90% of compressions delivered. Secondary outcomes: * Adequacy of each component of CPR (namely depth, adequate recoil and rate). * Time taken for staff to fatigue when performing CPR on a morbidly obese mannequin. It is known that the maximum amount of time a member of staff can perform effective CPR for is 2 minutes in a normal scenario. * Staff discomfort/pain experienced performing CPR. * The association between perceived effectiveness of chest compressions by staff and recorded adequacy.

  • Effect of a pulmonary rehabilitation program of 8 weeks duration compared to 12 weeks on exercise capacity in people with chronic obstructive pulmonary disease (PuRe Duration): A randomised controlled trial

    Pulmonary rehabilitation (PR) guidelines and reviews of current research repeatedly state that PR programs should be between six and 12 weeks, with a recommended duration of eight weeks, but have been unable to draw significant conclusions regarding an optimal duration of PR programs to achieve improvements in exercise capacity and health-related quality of life. Aim : To evaluate the effect of an eight week pulmonary rehabilitation program compared to a 12 week program on exercise capacity and quality of life in people with COPD. Hypothesis: An eight week PR program is equivalent to a 12 week PR program at improving exercise capacity in people with COPD. Design: This is a multi-centre study where 68 participants will be recruited from pulmonary rehabilitation sites across the Sydney Local Health District. A randomised controlled trial design will be used with participants randomally allocated to one of two groups: 1. an eight week PR program or 2. a 12 week PR program. Participants will be asked to complete exercise tests and questionnaires at baseline, four weeks, eight weeks, 12 weeks, six months and 12 months follow-up. Participants will also be asked to wear physical activity monitors at baseline, seven weeks, at completion of their respective exercise programs (eight weeks or 12 weeks), six months and 12 months follow-up. This research will determine if an eight week PR program is equivalent to a 12 week PR program.

  • The effect of reducing salt in bread on sales and total salt intake in remote Indigenous Australian community stores

    Aim: To investigate the effects of a reduced sodium bread on sales and overall sodium intake in remote Indigenous communities. Study design: Communities stores will receive salt-reduced study bread (300mg/100g) (intervention communities) or regular salt study bread (400mg/100g) (control communities) to stock on store shelves for 12 weeks. Population: Remote Indigenous communities serviced by Arnhemland Progress Aboriginal Corporation (ALPA) or Outback Stores (OBS) in Northern Territory, Western Australia or South Australia and where Study bread represents >=45% of the market share for bread sales will be invited to the study (29 communities meet this criteria). Outcomes: - Change in sales (market share and total dollars) - Change in total sodium of all food and drink purchases

  • Impact of antibiotic treatment regimen on sexual behaviour following urogenital Chlamydia trachomatis infection

    Azithromycin and doxycycline are antibiotics that are widely used in the management of sexually transmissible infections (STIs). STI management guidelines in Australia, the UK and US all recommend the use of azithromycin (1g single dose, orally) or doxycycline (100mg, orally, twice daily for 7 days) for uncomplicated urogenital chlamydia with the former preferred for its ease of dose and minimalisation of non-adherence. The most recent meta-analysis shows that the regimens are comparable with only a marginal increase (3%) in efficacy in favour of doxycycline over azithromycin. However, it has been hypothesised that treatment regimen may influence patient’s sexual behavior, placing them at increased risk of early re-infection. Patients on doxycycline – a 7-day daily regimen, may be more mindful of their infection status because they need to take a daily dose and may not re-engage in unprotected sex until dosage is completed. On the other hand, those on single dose regimens may feel more confident that their condition has been treated or may forget about their infection and may re-engage in sexual activity earlier than those taking doxycycline, potentially making them more at risk of re-infection. To our knowledge, this has never been formally studied and represents a knowledge gap in the literature, necessitating this study.

  • Speech treatment in Autosomal recessive spastic ataxia of Charlevoix-Saguenay

    We have designed a home-based, intensive four week speech exercise program designed to improve speech in patients with ARSACS. The treatment protocol is based on principles of motor learning and neuroplasticity with a focus on improving intelligibility and vocal control. Exercises and feedback were created to enhance self-monitoring and include computer based aural, visual and results feedback and self-management.

  • Speech treatment for spinocerebellar ataxia and Friedreich ataxia

    We have designed a home-based, intensive four week speech exercise program designed to improve speech in patients with spinocerebellar ataxia or Friedreich ataxia. The treatment protocol is based on principles of motor learning and neuroplasticity with a focus on improving intelligibility and vocal control. Exercises and feedback were created to enhance self-monitoring and include computer based aural, visual and results feedback and self-management.

  • Longitudinal study of early Alzheimer's disease using genetics, brain imaging and behavioural assessments.

    The PISA project seeks to reduce Australia’s future dementia burden by elucidating methods to identify those Australians at the very early stages of dementia. This project aims to achieve this goal by monitoring participants’ physical, cognitive and neurobiological ageing in a cross-sectional, longitudinal design. The tests used in this study include cognitive testing, MRI examinations, PET imaging examinations and blood sample collection. Participants will undergo testing once every two years, over a five year period. Participants will also be given a wearable smart sensing device that will record personalised health data in day to day life, over the course of the study.

  • A Study of Anti-Lewis Y Chimeric Antigen Receptor-T Cells (LeY CAR T) in Patients With Solid Tumours

    This study will test the safety, tolerability and effectiveness of an experimental treatment called “LeY CAR-T cell therapy”in treating solid tumours that carry the Lewis Y marker. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have an advanced solid tumour that is positive for the Lewis Y antigen. Study details The Lewis Y antigen is a molecule that coats the surface of a cancer cell and is not usually detected by T-cells. The “LeY CAR-T cell therapy” may help the T-cells to find and destroy the cancer cells more easily. In this study, the T-cells will first be collected using a procedure called “Apheresis” that takes part before the study treatment. Apheresis collects some of the white blood cells (also called Leukocytes) including T-Cells from the blood. The collected T-cells will then be modified in the laboratory by a viral vector, to specifically target the cancer cells that have the Lewis Y marker on their surface. After T-cells have been modified, the viral vector will be separated from modified T-cells and removed. Modified T-cells can now be called CAR-T cells. The finished LeY CAR-T cells will then be infused back into the body, without the viral vector. As well as the LeY CAR-T cell therapy, patients will receive by lymphodepleting conditioning chemotherapy as intravenous fludarabine and cyclophosphamide for 3 consecutive days prior to cell infusion to increase immunosuppression and improve persistence of engineered T-cells. LeY CAR-T cell therapy is an experimental treatment. This means that it is not an approved treatment for LeY expressing solid tumours in Australia.

  • Comparing peripherally inserted central catheter outcomes in adults; a pilot randomised controlled trial

    Peripherally inserted central catheters (PICCs) were developed to provide short to medium term vascular access for patients requiring the infusion of vessel irritant medications, or frequent blood sampling. While PICC’s provide necessary, reliable and accessible vascular access; they are associated with biological, mechanical or infectious complication. These complications result in delayed treatment, need for reinsertion, and delayed treatment of the underlying complication - causing extended admission time, increased healthcare costs, venous depletion and increased morbidity and mortality. Microbial biofilm formation makes treatment of infections more complicated since the detached microbial cells from the biofilm can repeatedly infect the blood, and these microorganisms are highly resistant to many antimicrobial agents, frequently requiring PICC removal and antibiotic treatment. Maintaining catheter function is vital for the safe provision of treatment. BioFlo (trademark) PICC (by Angiondynamics; NY) claims to provide a novel solution and the manufacturers claim the material is resistant to blood products and biofilm development, reducing the risk of standard PICC complications including infection, fracture, thrombosis, leakage, localised swelling, accidental removal and dislodgement . These PICCs are now on the basis of some clinician preference at some Australian facilities. The effectiveness of this product at reducing PICC-associated complications as previously described has not been undertaken. We plan to undertake a randomized controlled trial at the RBWH. Patients who consent to participate in the trial will be randomly assigned to either study group. 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 this new PICC technology compared to older generation PICC relating to failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for adults with PICC in acute care.

  • Fetal focus: fetal intramuscular steroids for diabetic women at risk of preterm birth

    Background: Administration of corticosteroids prior to birth is of clear benefit to the preterm neonate, with reductions in respiratory, neurological, gastrointestinal, and infectious morbidity, as well as decreased mortality. This benefit was previously proven to exist up to 34 weeks’ gestation but has recently been demonstrated to apply to all neonates born prior to 37 weeks. This benefit is not achieved without potential complications, however, including hyperglycaemia and ketoacidosis in diabetic mothers and neonatal hypoglycaemia. Direct fetal administration of corticosteroids, by ultrasound-guided intramuscular injection may provide the neonatal benefits of steroids while avoiding the maternal and neonatal complications. Objectives: This pilot study aims to assess the feasibility of a larger randomised controlled trial of direct fetal administration versus maternal administration of corticosteroids with the following objectives: a. To assess the effects of directly administered fetal corticosteroids upon maternal glucose homeostasis (hyperglycaemia and ketoacidosis). b. To demonstrate that direct administration of fetal corticosteroids is not associated with adverse fetal/neonatal outcomes including excess preterm birth or neurovascular injuries Trial plan: This pilot randomised controlled trial will recruit 20 pregnant women with pregestational type 1 or type 2 diabetes who are planned for delivery between 34+0 and 36+6 weeks’ gestation and therefore candidates for antenatal corticosteroid administration. Consenting women will be randomised to receive either standard maternal administration of two doses of betamethasone or direct fetal intramuscular injection of a single dose of betamethasone. The primary outcome will be the rate of hyperglycaemia or ketoacidodis requiring treatment. Secondary outcomes will include neonatal rates of respiratory morbidity, hypoglycaemia, and sepsis, and maternal infectious morbidity.

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