ANZCTR search results

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

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33678 results sorted by trial registration date.
  • Effectiveness of the intercostobrachial nerve block to reduce upper limb tourniquet pain in patients undergoing forearm surgery

    Pneumatic tourniquet has been used in hands and forearm surgery to reduce blood loss. When the tourniquet is used for a longer period under general anaesthesia, rapid heart rate and high blood pressure can be observed. This is often referred to as ‘tourniquet pain’. In awake patients, tourniquet pain is experienced as a vague, dull aching pain in the affected limb associated with an increased blood pressure. Intercostobrachial nerve supplies sensation to the skin of the armpit and inner side of the upper arm. The nerve lies just below the skin and can be easily blocked to help with upper arm tourniquet pain. The purpose of this study is to determine the efficacy of intercostobrachial nerve block which could reduce pain from tourniquet on the upper arm. Patients who suit the participation in the study will be randomised to either group (intercostobrachial nerve block with lignocaine or saline). The pain score will be assessed every 5 minutes after the touniquet is inflated.

  • Evaluating use of the CommunicAid: Can access to a communication tool assist people with mild to moderate dementia to communicate their basic wants and needs and make decisions more effectively?

    The proposed proof of concept study aims to identify factors that influence successful use of the CommunicAid App within a residential aged care setting. Using a case series design the study aims to create five in-depth case profiles of CommunicAid App use, characterising individual client factors (e.g. communication profile, previous use of technology) and environmental factors (e.g. communication opportunities, available communication support, lighting and noise levels within the facility). Systematic analysis and interpretation of the individual case profiles will allow the critical factors to be identified that influence successful use of the App during everyday interactions. This will provide direction for the development of tailored training and communication support strategies to embed use of the App into routine care delivery.

  • Stand Up for Health Project: Using a ‘whole room calorimeter’ to assess the effects of sitting on adolescents health

    The aim of the study is to assess how reducing adolescent sitting time affects adolescents’ energy levels, cardio-metabolic measures and their level of concentration. To accurately assess these outcomes, the study involves the use of the whole room calorimeter. The whole room calorimeter is a room around the size of an adolescent’s bedroom that measures the oxygen consumption and carbon dioxide production of the person inside. These measurements enable energy levels to be accurately measured. Research shows that adolescents spend more than 50% of their waking hours sitting. The total period of time they sit for per day is only slightly less than the total time the elderly (65 years and older) sit. Research involving adolescent sitting- time and health outcomes is limited. It has been reported that high levels of sitting are associated with lower levels of cardiorespiratory fitness, and higher levels of cholesterol, and body fat. Given the potential harmful effects of excessive sitting and that a large majority of an adolescent’s waking day is spent at school, it is important to understand how much more energy is expended if an adolescent sits for less total time during a typical school day. Currently adolescents spend approximately 240 minutes (4 hours) each day sitting during school time. This study plans to investigate a reduction in sitting time amongst adolescents during a typical day at school. It has the potential to improve the energy expenditure, which can impact health and developmental outcomes of adolescents. This study will provide the highest level of evidence available to move this research field forward, due to use of the University of Wollongong’s whole- room calorimeter, as it is the only one in Australia.

  • Phase I open label trial of intraperitoneal paclitaxel in combination with intravenous cisplatin and oral capecitabine in patients with advanced gastric cancer and peritoneal metastases

    This is a Phase I trial to determine safety and tolerability of paclitaxel in combination with cisplatin and capecitabine in patients with advanced gastric cancer and peritoneal metastases. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with gastric cancer and peritoneal metastases, and have not had previous chemotherapy for metastatic gastric cancer. Study details All participants will be given the combined treatment of paclitaxel, given through an intraperitoneal catheter (a thin tube surgically inserted through the stomach cavity), cisplatin, given intravenously (through a tube inserted into the vein), and capecitabine, given orally. Different doses will be tested to determine the maximum tolerated dose for paclitaxel. Participants will be follow-up for up to 6 cycles, or 18 weeks, during treatment and then for a further two years post treatment in order to determine safety and tolerability of paclitaxel, response rate, survival and effect of treatment on quality of life.

  • The effect of an internet based patient education on informed consent for elective orthopaedic surgery: A randomized controlled trial

  • QUADPILL Pilot Feasibility Study: Can an ultra low-dose 'hypertension polypill' provide better blood pressure control with fewer side effects?

    To establish the feasibility, patient acceptability, effect on blood pressure and thereby overall potential of a simplified treatment strategy with 'hypertension polypill', which includes four common blood pressure lowering medications each at 1/4 strength dose. This pilot study will be double blind randomised placebo- controlled crossover trial of 50 patients with established hypertension not on any medical therapy. Subjects will be randomised into two arms - intervention (Quadpill) and control (placebo)- for a period of four weeks. They will undergo office blood pressure as well as 24 hour ambulatory BP assessment at baseline and in 4th week in addition to safety monitoring blood tests. Thereafter there will be a 2 week washout phase prior to crossing over to opposite arm of the study. The patients will undergo another baseline blood and 24 hour ambulatory BP assessment. The study will conclude at 10 week with repeat measurements. The outcomes assessed will be change in the mean blood pressure, safety, tolerability and acceptability.

  • A prospective study of the effect of chemotherapy on metabolic and cardiovascular function in women with early stage breast cancer

    This study will investigate the impact of chemotherapy on vascular and metabolic parameters that may predispose to cardio-metabolic illness after cancer. Who is it for? You may be eligible to join this study if you are a female aged at least 18 years who has been diagnosed with early stage breast cancer, for which you are due to commence chemotherapy. Healthy age and gender matched control patients will also be recruited to provide a benchmark for comparison. Study details All participants in this study will undergo interviews, questionniares, cardiovascular investigations, and metabolic investigations. This will involve insertion of intravenous cannulas (i.e. into the vein), so that blood samples can be taken. Breast cancer patients will be assessed at 3 timepoints over 9 months, i.e. at baseline (just prior to first chemotherapy) 3 months and then 9 months later. Healthy volunteers will be assessed on a single occasion only. The following assessments will take place at each visit; Study procedures: Participant presents after overnight fast. The visit will take about 5-6 hours. General Assessment: Measuring weight, height, waist and hip circumference, heart rate, blood pressure and temperature will be recorded. Assessment of cardiovascular risk: Measurement of arterial stiffness: assessed by measuring the pressure wave the heart produces in arteries with a small blunt probe. Assessment is not painful and usually takes about 30 minutes to complete. Measurement of autonomic nervous system activity: measured non-invasively: small changes in heart rate and blood pressure will be measured. Urine test: the specimen will then be sent to the lab to be tested for the amount of some chemicals which help measure the activity of the sympathetic nervous system. Measurement of endothelial function: measured by placing a probe on one finger of each hand to record pulsation of the arteries in the finger. By measuring the change in blood vessels after a blood pressure cuff on the arm is inflated and then deflated. Blood tests: A needle will be inserted into a vein in one arm, with a small plastic tube (drip) left in from which we will take blood samples. A baseline blood sample will be taken from you. You will then be asked to eat a meal over 15 minutes; then a series of blood samples will be collected from intravenous catheter over the two hours following the meal. In all, about 75mL of blood (less than one sixth of a blood donation) will be collected as part of this test. The results from these blood tests will tell us how much insulin the body makes in response to the meal. Additional blood samples: When we take the first blood sample before the meal we will also take an additional sample. This could be used to measure the cholesterol and other markers of cardiovascular risk that show up in your blood. Assessment of energy intake and expenditure: Estimating Energy intake: through an interview by on the doctors or nurses involved in the study, and asking to tell us what you have eaten over the last 24 hours. (10 to 15 minutes.) Physical activity: We will ask you to complete a questionnaire to tell us of your physical activity levels over the last 7 days. (10 to 15 minutes) Indirect calorimetry: measures the rate of energy expenditure before and after the meal. A clear plastic hood will be placed over the head for 20 minutes. You can breathe normally while under the hood and it does not restrict the amount of oxygen you inhale. The hood is connected to a machine that measures the energy expenditure Measurement of brown fat activity: by taking a picture with a special infrared camera before and after the meal that measures the temperature in the supraclavicular fossa (lower neck) very accurately. Measurement of body composition using a DEXA machine (the same machine that is used to measure bone density). You will be asked to lie on a bed while a scanner takes a picture of you. The scan is painless and takes about 10 minutes.

  • Pilot study to evaluate the prognostic and metabolic effects of metformin during treatment of metastatic prostate cancer with androgen deprivation therapy

    This study will investigate the effects of combining metformin with androgen deprivation therapy (ADT) in men with metastatic prostate cancer. You may be eligible to join this study if you are male, aged 18 years or above and have been diagnosed with metastatic prostate adenocarcinoma, for which you have not received any ADT. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 3 x 500mg oral tablets of metformin hydrochloride daily for 30 weeks, whilst participants in the other group will take 3 oral tablets of placebo (inactive treatment) daily for 30 weeks. Participants will be followed-up every 6 weeks for 54 weeks, in order to determine metabolic and tumour responses and tumour progression.

  • A randomized clinical trial to determine the efficacy of Affron, a standardised extract of Saffron (Crocus sativus) on mood and cognitive function in healthy adults over 4 weeks.

    Preliminary scientific evidence suggests that Saffron (Crocus sativus) may have beneficial effects on the central nervous system (CNS), and have therapeutic applications for mood, anxiety, depression, insomnia, memory and as an anticonvulsant. The aim of this study is to conduct a preliminary study of a Affron, a standardised extract of Crocus sativus (Saffron) for potential efficacy for mood and cognitive function in healthy adults.

  • Brain stimulation, aging and cognition: Investigating neuroplasticity and cognitive enhancement following brain stimulation in healthy ageing and amnestic mild cognitive impairment.

    Amnestic mild cognitive impairment (a-MCI) is believed to represent a transition period between normal aging and Alzheimer's disease. People with a-MCI experience problems with their memory without it impacting on their daily functioning. As a-MCI represents a stage prior to irreversible neurodegeneration, it is important from a therapeutic perspective that neural changes occurring in a-MCI are determined in order to see if there remains potential for response to treatment. Neuroplasticity refers to the brains ability to re-organize its function in response to the environment. One aspect of this is known as long-term potentiation (LTP), which is imperative in learning and memory. LTP-like plasticity can be induced through brain stimulation techniques including transcranial direct current stimulation (tDCS). Application of tDCS through a gentle electrical current can increase brain activity as measured through electroencephalography (EEG) and behavioural outcomes. When transcranial magnetic stimulation (TMS) is applied in combination with EEG, the cortical excitability of the stimulated and surrounding brain regions can be determined. This provides information about the LTP-like plasticity that is present. Together with cognitive performance, this information can help to determine the changes occurring in a-MCI compared to younger and older adults, and the relationships between plasticity and cognition. The aim of our study is to investigate whether LTP can be induced in a-MCI and if there are differences in LTP-like plasticity compared to younger and older healthy adults, and the relationship of plasticity to cognitive performance.

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