ANZCTR search results

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

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32885 results sorted by trial registration date.
  • Sedentary behaviour and memory functions

    Recently, data from observational (AusDiab) and experimental (IDLE breaks study) research indicates people who break up their sitting time throughout the day with light-intensity activity (such as light walking) may have better blood glucose and blood fat levels than people who sit for prolonged periods without activity breaks. This experimental study will examine the acute effect of prolonged sitting with and without light intensity activity bouts on memory functions (long-term and short-term memory and executive functions) in adults. Nineteen sedentary overweight/obese adults aged between 45-75 years will be recruited to attend two separate trial days interspersed by a one week washout period: control condition (sitting – 7 hours), a similar duration of sitting but with 3 minute light intensity activity bouts every 30 minutes. Cognitive testing, measurements of neurotrophic, metabolic, inflammatory, cortisol and catecholamine markers will be conducted. The proposed study will provide initial insights into whether breaking up sitting time with intermittent light-intensity activity has the potential for cognitive benefits whilst also describing the acute cognitive effects of prolonged sitting.

  • Acute effects on vascular function of palm olein and olive oil in the context of a high protein test meal.

    This studies aims to compare blood vessel elasticity after two protein-rich meals which are high in either olive oil or palmolein (further purified fraction of palm oil). The study also aims to compare the effect of these test meals on blood markers of heart health.

  • Evaluating the effect of Limiting Radiographic Contrast Use in Patients Undergoing Emergent Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarct by Reflux Reduction.

    The purpose of this study is to assess the utility of a simple device that reduces coronary contrast reflux in STEMI patients undergoing percutaneous coronary intervention. The safety and efficacy of this device has recently been demonstrated in Alfred Hospital Study a performed at The Alfred Hospital (Project 347/12) in patients undergoing routine coronary angiography and non-acute PCI. This study showed that the device reduced overall contrast requirement by approximately 40%.

  • Using Mindfulness-Based Music Therapy for young people with cancer

    This study will assess the effectiveness and feasiblity of a newly developed brief intervention for young persons with cancer termed Mindfulness-Based Music Therapy (MBMT). Who is it for? You may be eligible to join this study if you are a cancer survivor aged 14 to 25 years old, or are actively attending treatment at metro Adelaide hospitals. Participants must be fluent in English. Trial details All participants in the study will undergo at least two sessions with the music therapist. During meetings with the music therapist, participants will learn some attention focusing techniques ("mindfulness") and music therapy techniques. Participants will also be provided with some pre-recorded songs and voice recordings to practice the exercises at home on a regular basis. Participants will be asked to complete questionnaires at baseline, 2 weeks and 8 weeks after the intervention completion in order to evaluate psychological wellbeing across the cancer journey. The intervention is expected to decrease psychological distress, and improve quality of life, mindfulness and self compassion.

  • Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors

    A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-504 in Patients with Advanced Solid Tumors. You may be eligible to join this study if you are aged 18 years or more and have been diagnosed with incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior systemic therapy. Trial details Participants in this trial will be allocated to take Volitinib (HMPL-504) tablets once daily for a period of [a cohort /21 days] at one of six dose levels (100, 200, 400, 600, 800 or 1000 mg/day). Patients will be assigned to dose levels sequentially as they are enrolled. Participants will be assessed for up to 20 months in order to determine safety and tolerability of the treatment. They will also be asked to give blood samples to assess the pharmacokinetics (i.e. action of the drug in the body) over a 21 day period.

  • Dietary prebiotic supplementation in adults with prediabetes

    Advanced glycation endproducts (AGEs) are formed within the human body as a normal consequence of metabolism, but their formation is accelerated in people with elevated blood glucose levels such as those with diabetes. Excessive AGEs are known to have negative effects within the body including contributing to kidney damage, stimulating inflammation and promoting changes in blood vessels which lead to heart disease. AGEs have been shown to contribute to the development of the complications of diabetes and more recently it has been hypothesised that AGEs may play a major role in the development of type 2 diabetes. Simple therapies aimed at reducing the progression of inflammation and insulin resistance are urgently needed to prevent or slow type 2 diabetes development in susceptible individuals. Dietary supplements (called prebiotics) which promote the growth of beneficial bacteria in the human bowel have been shown to reduce inflammation and improve insulin resistance, but their effect on AGEs is unknown. Taking a daily prebiotic dietary supplement which stimulates the growth of beneficial bacteria in the human bowel might offer protection against AGE-related pathology in people at risk of developing type 2 diabetes. This study aims to determine the effect of 24-week consumption of a prebiotic dietary supplement on tissue AGE (advanced glycation endproduct) levels, insulin resistance and inflammatory biomarkers in adults with pre-diabetes in comparison to those receiving a placebo supplement.

  • A new surgical system for use in the treating patients who have chronic rhinosinusitis (CRS) and have elected to undergo sinus surgery.

    The current standard of practice for the treatment of CRS includes antibiotics either given by mouth or through an injection in your arm, nasal sprays and rinses, oral and nasal corticosteroids and/or anti-allergy medicines. Despite these treatments some patients are still unable to get relief from their sinus symptoms. When the above treatments fail and the disease continues then some patients will move forward to surgery. This type of surgery is called “Functional Endoscopic Sinus Surgery (FESS)”. The surgery is quite difficult and requires great surgical skill. One of the problems associated with FESS surgery is making sure that the area being treated is clear of blood so the surgeon can see the area he is treating. There are a number of complications associated with bleeding with this type of surgery which your doctor will explain to you. A potential solution to try and improve the visibility when performing FESS surgery is to use laser throughout the procedure. Laser is used in many types of surgery, including surgery for ears, nose and the throat (otolaryngology). The laser being tested during this study is a new laser. It has been designed so that it delivers the laser through a much smaller fibre (a tube that delivers the light to the tissue) and also uses very low power to avoid unwanted damage to nearby healthy tissue, which will hopefully help achieve better results from surgery and also fewer complications with this type of surgery. This study is being done to look at the safety and the performance of this new laser when it is used during FESS procedures. It is important to remember that you would have undergone the surgery regardless of this new laser – the new laser is an additional treatment being used during the procedure.

  • Salt and its effects on endothelial function in patients with type two diabetes

    A high salt diet is associated with an increased risk of hypertension. By contrast, in patients with type 2 diabetes, a low salt diet is associated with an increased risk for cardiovascular and total mortality. As a low salt intake may increase sympathetic nervous system (SNS) activity, we aim to determine baseline SNS activity and endothelial function in patients with diabetes consuming a habitual low salt diet and determine whether salt loading reduces SNS activity and enhances endothelial function.

  • The anaesthesia pre-oxygenation trial - using O2 Flush and Nasal oxygen for pre-oxygenation compared to traditional methods.

    Prior to general anaesthesia the standard of care is to pre-oxygenation all patients. This involves the patient breathing 100% oxygen via a face mask. The 3 most common methods of pre oxygenation involve 4 deep breaths over 30 seconds, 8 deep breaths over 60 seconds or 3 minutes of tidal volume breathing (normal breathing) using high flow 100% oxygen (15L per minute via the anaesthesia machine with a face mask). The most common reasons for poor preoxygenation is an inadequate face mask seal resulting in the patient breathing room air (low oxygen content) through the leak. Nasal oxygen and the anaesthesia machine oxygen flush delivery higher flow rates than the standard method by the the anaesthesia machine so may reduce the amount of inspired air from the leak. Study Hypothesis - High flow oxygen with nasal oxygen or anaesthesia machine oxygen flush produces higher end tidal oxygen levels (better pre oxygenation) in the simulated mask leak scenario.

  • Primary prevention of gestational diabetes for women who are overweight and obese: a randomised controlled trial

    Gestational Diabetes Mellitus (GDM) has well recognised adverse health implications for the mother and her newborn that are both short and long term. Obesity is a significant risk factor for developing GDM and the prevalence of obesity is increasing globally. It is a matter of public health importance that clinicians have evidence based strategies to inform practice and currently there is insufficient evidence regarding the impact of dietary and lifestyle interventions on improving maternal and newborn outcomes. The primary aim of this study is to measure the impact of a telephone based intervention that promotes positive lifestyle modifications on the incidence of GDM. Secondary aims include: the impact on gestational weight gain; large for gestational age babies; differences in blood glucose levels taken at the Oral Glucose Tolerance Test (OGTT) and selected factors relating to self-efficacy and psychological wellbeing. A randomised controlled trial (RCT) will be conducted involving pregnant women who are overweight (BMI >25 to 29.9 kg/m^2) or obese (BMI >30kg/m^2), less than 14 weeks gestation and recruited from the Barwon South West region of Victoria, Australia. From recruitment until birth, women in the intervention group will receive a program informed by the Theory of Self-efficacy and employing Motivational Interviewing. Brief (less than 5 minute) phone contact will alternate each week with a text message/email and will involve goal setting, behaviour change reinforcement with weekly weighing and charting, and the provision of health information. Those in the control group will receive usual care. Data for primary and secondary outcomes will be collected from medical record review and a questionnaire at 36 weeks gestation. Evidence based strategies that reduce the incidence of GDM are a priority for contemporary maternity care. Changing health behaviours is a complex undertaking and trialling a composite intervention that can be adopted in various primary health settings is required so women can be accessed as early in pregnancy as possible. Using a sound theoretical base to inform such an intervention will add depth to our understanding of this approach and to the interpretation of results, contributing to the evidence base for practice and policy.

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