ANZCTR search results

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

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32814 results sorted by trial registration date.
  • Protocol for choledocholithiasis at emergency surgery study (ProCESS)

    Gallstone disease is very common, and results in a large number of hospital admissions per year. Some patients with gallstones can develop a blockage in their main bile duct due to stones, which can put them at risk of severe infection, jaundice or other problems like pancreatitis. There are several ways in which surgeons can go about removing the stones from the bile duct, including during surgery or via endoscopy (camera test down the mouth). There is also an option of placing a stent in the bile duct. There is currently no agreement between surgeons on which of these options is the best. We have developed a new protocol to determine if patients can be safely sent home after surgery with a bile duct stent, and then return for an endoscopy electively. We aim to prove that this option is safe, and also improves and steamlines the patient experience.

  • Investigating the performance of a novel cardiovascular implantable electronic device (CIED) capable of natural (physiological) pacing of the heart. A new cardiac ultrasound (echocardiography) analysis technique, known as Global Longitudinal Strain (GLS), will be used to assess the performance of cardiac contraction during this physiologic pacing.

    The purpose of this study is to investigate the performance of the novel physiologic pacing cardiac implant. Patients with cardiac rhythm disorders may require implantation of a permanent pacemaker (PPM) to stimulate myocardial contraction by leads implanted into the heart. Technology now allows lead implantation at more physiological sites for ventricular activation. The performance of myocardial contraction can be evaluated using transthoracic echocardiography (TTE) with the analysis technique of global longitudinal strain (GLS) which we will utilize to assess patients with physiologic pacing.

  • The Effects Of Brain Stimulation On Balance Control In Parkinson's Disease

    Parkinson’s disease (PD) is a degenerative disease of the central nervous system. When asked to perform motor and cognitive tasks at the same time, stance control can deteriorate further. Transcranial Direct Current Stimulation (tDCS) can be used to safely regulate the excitability of brain without serious adverse effects. It has been employed to improve executive function, attention and working memory in healthy older people and has been shown have potential benefits for people with PD. Functional near infra-red spectroscopy (fNIRS) as a non-invasive functional neuroimaging technique, has been used in brain research through measuring changes on blood circulation in a specific brain region. The purpose of this study is to investigate the effects of tDCS on dual task performance in people with Parkinson’s disease, and to evaluate alternation of blood circulation changes induced by tDCS.

  • Neurocognitive Outcomes of Cardiac Arrest: Effects of Online Cognitive Training.

    This study aims to test the feasibility and effectiveness of an online cognitive training programme to enhance cognitive functioning and psychosocial functioning after cardiac arrest. This is a randomised controlled research project designed to compare different treatment approaches. Participants are randomly allocated to one of two groups and each group is provided with a different treatment approach, receiving either (1) eight weeks of online neurocognitive training (30 minutes, three times per week), or (2) Normal clinical management from their cardiac team.

  • Exploring the effectiveness of a self-guided internet-administered cognitive behavioural treatment for obsessive-compulsive disorder

    By conducting this project we hope to: 1) explore the effectiveness of a self-guided internet delivered cognitive behaviour therapy (ICBT) intervention for obsessive-compulsive disorder; 2) explore the predictors of treatment response to self-guided ICBT; and 3) explore reasons for utilizing ICBT and previous treatment experiences of individuals who undertake ICBT. The results will inform us about who is likely to benefit from this treatment protocol and how best to administer this program.

  • A Pilot Study using Non-Contact Smartphone Cough Sound Recordings to Screen for Chronic Obstructive Pulmonary Disease in an Indigenous Australian Adult Population

    ResApp Health Limited has developed an innovative smartphone-based software application (COPDCheck) to screen adults for COPD. COPDCheck analyzes patient cough sounds together with a few simple questions asked of the patient and instantaneously reports a diagnosis. In this study we plan to test the COPDCheck diagnostic algorithms and application at the Geraldton Regional Aboriginal Medical Service with the goal of investigating its clinical performance and usage when compared to standard-of-care clinical diagnosis in an Indigenous Australian population. This study is important to validate the algorithms more broadly as previous Australian studies have not focused on specifically testing efficacy and applicability in the Indigenous Australian population.

  • Assessing the tolerability and health benefits of soluble tapioca fibre: Phase Two

    Dietary fibre includes parts of food derived from plants which do not get fully broken down and absorbed during digestion. Increased dietary fibre is associated with several health benefits such as lower rates of cardiovascular disease, type 2 diabetes and colon cancer. Unfortunately, less than 20% of Australian adults meet the suggested dietary target (28g for women, 38g for men) to reduce the risk of chronic disease (based on 2011-2012 survey). Food manufacturers can increase fibre content in a range of foods to improve their nutrient value. Here, we seek to assess the tolerability and health benefits of a type of soluble, plant-based fibre derived from tapioca, known as fiberSMART®. Tolerability will be assessed in Phase One (reported in a separate clinical trial registration record) of the trial, where participants will be asked to consume various quantities of fiberSMART®, ranging from 0g to 40g over three successive days. Tolerability will be assessed using questions about changes in bowel movements or gastrointestinal distress (e.g. bloating). Phase Two will then ask participants to consume either 0g, 20g, or 40g of fiberSMART® per day for a 6-week period. Outcomes will include changes in blood chemicals (e.g. cholesterol), body-composition, diet, appetite and tolerability.

  • Assessing the tolerability and health benefits of soluble tapioca fibre: Phase One

    Dietary fibre includes parts of food derived from plants which do not get fully broken down and absorbed during digestion. Increased dietary fibre is associated with several health benefits such as lower rates of cardiovascular disease, type 2 diabetes and colon cancer. Unfortunately, less than 20% of Australian adults meet the suggested dietary target (28g for women, 38g for men) to reduce the risk of chronic disease (based on 2011-2012 survey). Food manufacturers can increase fibre content in a range of foods to improve their nutrient value. Here, we seek to assess the tolerability and health benefits of a type of soluble, plant-based fibre derived from tapioca, known as fiberSMART®. Tolerability will be assessed in phase one of the trial, where participants will be asked to consume various quantities of fiberSMART®, ranging from 0g to 40g over three successive days. Tolerability will be assessed using questions about changes in bowel movements or gastrointestinal distress (e.g. bloating). Phase two (reported in a separate clinical trial registration record) will then ask participants to consume either 0g, 20g, or 40g of fiberSMART® per day for a 6-week period. Outcomes will include changes in blood chemicals (e.g. cholesterol), body-composition, diet, appetite and tolerability.

  • Phase I trial of multi-virus-specific T cells for paediatric haploidentical -stem cell transplant recipients

    Patients who receive a type of transplant called a haploidentical haematopoietic stem cell transplant (haplo-HSCT), which is not an ideal tissue match for the patient, are at a high risk of developing a viral infection. This is because the immune cells that can fight viruses (called T cells) are removed from the transplant before it is given. In this trial, we will test a new preventative T cell therapy for four common viruses in patients who have received a haplo-HSCT. The therapy will be grown from the blood of the transplant donor and given to patients after their transplant. One aim of this trial is to see if this T cell therapy is safe for transplant patients. In addition, we would like to see if the T cells that we grow in the laboratory from the transplant donors can help to restore the recipients’ immune systems. This may help prevent infectious complications from developing.

  • Utilization of a portable hand-held electrocardiogram (ECG) monitor for mapping normal heart signals to investigate the optimal placement of insertable cardiac monitors for patient having heart rhythm disorders investigated.

    Patients with suspected heart rhythm disorders or syncope are often offered insertable cardiac monitors (ICM) for prolonged cardiac rhythm monitoring. Early models required surgical implantation (larger incision, more complicated implant tools) which limited acceptance by physicians and patients. Improved technology allowed miniaturization of ICM size and a simplified insertion method with an “injectable” tool which has increased acceptance. One manufacturer's recommended insertion position for ICM spans the V2–V3 electrocardiogram (ECG) electrode location in an oblique 45 degree angle, although data supporting this recommendation for adequate cardiac sensing is limited to R-wave signal analysis only. We will analyze non-invasive surface ECG recordings from healthy participants to measure the P-wave signal seen at the manufacturer's recommended insertion point and in other locations to find the optimal location for p-wave visualisation.

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