ANZCTR search results

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

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31122 results sorted by trial registration date.
  • 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.

  • Simulation training to manage challenging behaviours in children with autism.

    Our project is about using simulation training to teach nursing staff how to manage children with autism who are aggressive in hospital. Simulation training is the process where participants practise a set of skills in a simulated learning environment. Participants can test out their skills to see what works and what doesn’t in a safe environment, without any risk to patients. In this study we will provide training to clinical nurses who provide direct patient care. The intervention group will receive a web-based learning package on working with children with autism and challenging behaviours and a 1.5 hour simulation training session. The comparator group will receive the web-based training only. We will ask the participants to complete a short survey before the training, immediately after the training and again at three months after the training to find out what they thought of the training and whether it increased their confidence in managing aggression. We will also collect data from the participants’ wards about aggressive episodes.

  • Stability of the Score Mobile Bearing Total Knee Replacement

    SCORE® is a primary total knee arthroplasty implant designed to achieve stability through congruency, has a rotating platform and a mobile bearing surface. Unlike cemented fixed-bearing implants, more congruent rotating platforms aim to reduce contact stress peaks and polyethylene wear, also to reduce contact strain peaks at the bone-implant interface to reduce the risk of loosening.The design of the femoral trochlea has also become more anatomical to improve patellar stability and reduce the number of patellofemoral complications. SCORE®TKA (Amplitude, Valence, France) uses traditional instrumentation and computer navigation (Amplivision®) to control bone cuts, mechanical alignment and ligament balance. Very satisfying results for the Score implant have been reported in the literature however there we were unable to locate any published results affirming the stability this implant affords using high quality measurements, as that of RSA.

  • 20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients after Cardiac Surgery-II

    HAS FLAIR-II is a multi-centre, randomised controlled trial, looking at patients who require fluid bolus therapy (FBT) after cardiac surgery. FBT after cardiac surgery is a common intervention used to correct hypotension +/- optimise cardiac function. There are several types of intravenous fluid used for fluid resuscitation, which are broadly classified into crystalloids and colloids. After cardiac surgery, patients receive a combination of crystalloid and the colloid albumin in the form of 4% albumin. 20% albumin corrects low blood volume more rapidly and requires less volume to do so than crystalloid fluids and 4% albumin, and by doing so reduces the amount of chloride and fluid the body receives. This may avoid harm associated with chloride and large fluid administrations. Participants will be allocated in a 1:1 ratio to either the treatment group (FBT with 20% albumin) or to usual care (FBT with whatever fluid the treating clinicians consider appropriate and no use of 20% albumin in the first 7 days). We will evaluate the duration of vasopressor use in those who received 20% albumin compared to those that received usual care. We plan to enroll 470 patients post cardiac surgery from Intensive Care Units in Australia.

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