ANZCTR search results

An area of research that receives a lot of attention currently relates to the physiological mechanisms that are involved in maintaining the feeling of fullness after people have eaten (referred to as satiety). Previous studies have shown that the most satisfying foods were found to be high in carbohydrate or protein, and most were also high in water and fibre. Considering the high carbohydrate (> 60 grams per 100 grams) and high protein (>10 grams per 100 grams) content of Campbell Arnotts Vita-Weat range, these products may produce greater satiety and hence help produce weight loss for those needing to lose weight. The current randomised controlled trial is designed to investigate the beneficial effect of this food product in an overweight and obese population group.

A randomised controlled trial will be employed to investigate the effectiveness of the Mindfulness eHealth program and the Physical Activity eHealth program in comparison to a delayed access (8 weeks) wait control group as a means to increase wellbeing. People visiting the Wellbeing study website, in response to advertisements or through self interest, will be informed of the availability of the study and invited to participate. Following completion of the pre-intervention assessments, people taking part in the study will be randomly allocated to one of the three groups above. Participants allocated to the immediate start intervention groups (Mindfulness or Physical Activity eHealth) will complete online questionnaires at pre-intervention (Week 0), during-intervention, post-intervention (Week 4), 4 weeks post intervention (Week 8) and at a three month follow-up (Week 16). The delayed start wait group will be provided access to their choice of either the Physical Activity eHealth or Mindfulness eHealth program following the Week 8 assessment phase. Therefore participants allocated to the delayed start wait group will complete pre-intervention (Week 0), during-wait intervention, post-wait intervention (Week 4), 4 weeks post-wait intervention (Week 8) and a post intervention assessment once they have completed a ehealth program (Week 12). All participants will also be asked to meet with the researchers on two occasions (Week 0 and Week 8) to undertake three brief computerised cognitive tests (15 minutes), have their resting heart rate variability measured (10 minutes) and to provide a salivary cortisol and blood sample.

Perhexiline is the study drug that is being developed by Heart Metabolics, Ltd to potentially treat hypertrophic cardiomyopathy (HCM). HCM is a primary disease of the myocardium (the muscle of the heart) in which a portion of the myocardium is hypertrophied (thickened) without any obvious cause. The purpose of this study is to evaluate the effects of Perhexiline on heart conduction (the electrical activity of the heart) as compared to placebo (a tablet that will be made to look identical to the real drug but has no active ingredient) in healthy adult male and female volunteers. Moxifloxacin, also known as Avelox Registered Trademark', is a compound designed as an antibiotic that is indicated for the treatment of adults with infections. Moxifloxacin is known to have minor effects on heart conduction.

Diagnostic and therapeutic procedures performed in interventional radiology can provoke anxiety and may be painful. Mild sedation with analgesia is administered by the interventional radiologist to calm patient anxiety, reduce unwanted movements and alleviate patient discomfort. Central line placements are common, (including Hickman line placement, tunnelled dialysis catheter placement, injectable port implantation) and intravenous sedation would typically be used for these procedures. The most commonly used drug for sedation in radiology is midazolam, a benzodiazepine. Midazolam has a short half-life of 2-6 hrs, but very powerful anxiolytic (anti-anxiety), amnestic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative actions. It is administered at 1 milligram per dose to the desired response, has a 2 minute onset time and duration of 45 to 60 minutes. The most common analgesic used is fentanyl, a short acting opioid that is administered at an incremental dose of 25 micrograms and repeated every 5 minutes to a maximum dose of 100 micrograms. Its onset time is 2-3 minutes and it has a duration time of 30-60 minutes. Midazolam and fentanyl are usually administered concurrently, with 1 milligram midazolam and 25 micrograms fentanyl being the standard single dose. Multiple doses are titrated carefully to achieve and maintain adequate sedation and alleviation of anxiety, while preserving cardio-respiratory function, protective reflexes and the ability to respond appropriately to verbal and/or tactile stimulation. Doses are given incrementally, often starting with a double dose with at least 5 minutes interval before the next dose to allow evaluation of drug effect. Oxygen saturation, blood pressure, heart rate, and respiratory rate are monitored continuously and documented every 10 minutes. Neurological response is also monitored continuously by observing the patients response to command or conversation. Reversal "antidote" agents for these medications are flumazenil and naloxone respectively. The current practice is that the radiologist takes a history from the patient, looking for patient factors that may affect the safety and practice of sedation. These would include patient size, age, prior cardiac and respiratory disease, diabetes, renal failure, obesity, allergies, drug interactions, previous anaesthetic history, and airway issues. There will be assessment of the patient’s level of anxiety and expectation of procedural discomfort. The radiologist will then decide on the appropriateness of midazolam/fentanyl sedation, and choose an initial dose. As the procedure starts, the level of sedation is assessed, and if needed, further aliquots of midazolam/fentanyl are administered at the radiologists’ discretion. Our hypothesis is that this practice has problems in that there is a fear of the effects of oversedation (eg low blood pressure or slower respiratory rate), and this results in many patients being undersedated. The patient may be apprehensive to ask for more sedation and thus their overall experience of the procedure is suboptimal. Based on prior evidence in the literature in other medical settings, we believe that by giving the control of sedation to the patient (within a safe dose and lockout period), that the patient is more likely to seek sedation when required and hence will be at less risk of undersedation. We expect that this will lead to an overall greater experience for the patient. The medical procedure being performed (ie insertion of a tunnelled central line) will not be affected by this study.

The aim of this study is to validate the Pediatric Oncology Nutrition Assessment Tool against body composition measurements of nutritional status. Once the Tool has been validated it will play an essential part in the overall assessment of pediatric oncology patient in centers throughout Australia and assist in the prevention of severe nutritional problems in pediatric oncology patients. Patients diagnosed with an oncological disease between the ages of 5.00 and 17.99 years will be recruited from the Royal Children’s Hospital. Caregivers will be asked to accompany the patient to the Body Composition Laboratory for approximately an hour and a half period. Firstly, the Paediatric Oncology Assessment Tool will be completed by the investigator. Height, weight, total body potassium, air displacement plethysmography, skinfolds and mid arm circumference measurements will then be taken on all patients. Children and/or parent, may choose to have all or any combination of measurements. All tests performed will be non-invasive, painless and pose no known physical risk to patients.

High school students from a Sydney school will be recruited to participate in the study. Students will be randomly allocated to either control or intervention condition. The intervention group will receive 10 hours of the intervention over a school term. The intervention is a Dialectical Behaviour Skills Group, which includes training of skills in 4 domains: Mindfulness, Interpersonal Effectiveness, Emotion Regulation, and Distress Tolerance. A large volume of studies have demonstrated the effectiveness of these skills in improving emotion regulation, interpersonal relationships, and wellbeing. It is expected that this evaluation will demonstrate an improvement of wellbeing and decrease in psychopathology symptoms in the intervention group compared to control participants.

We will use a multicentre, single-blinded, randomised controlled trial (RCT) to evaluate the effectiveness of the provision of a wrist immobilising orthosis on impairment, activity and participation outcomes for children with cerebral palsy. This trial aims to maintain and/or increase range of movement in the wrist thumb and fingers of children aged 5-15 years.

We will use a multicentre, single-blinded, randomised controlled trial (RCT) to evaluate the effectiveness of the provision of a wrist immobilising orthosis on impairment, activity and participation outcomes for young children with cerebral palsy. The trial aims to prevent the occurrence of contracture and deformity in the wrist, fingers and/or thumb in children less than 3 years of age.

Prospective, observational study. Subjects who have inadequate pain relief from their currently implanted conventional spinal cord stimulator (Boston Scientific Corp.) will be evaluated for eligibility in this study. The study aims at investigating alternative programming combinations for these spinal cord devices. The programming algorithms are within the currently approved limits for the device. We hope to reduce the stimulation (paraesthesia) to a level in which it is no longer felt by the patient (subthreshold stimulation) but still provides improved pain relief and prolonged optimal therapy for patients with chronic back and leg pain. The potential outcomes of this project have vast applications in chronic pain patients, where patients will often tolerate side effects such as uncomfortable stimulation sensations, so that their pain may be controlled.

Latest research demonstrates that up to 40 million Americans (17%), and 4 million Australians (17%) suffer from snoring and/or Obstructive Sleep Apnoea (Kryger, Roth, Rement Principles and Pracice of Sleep Medicine, 5th Ed.). Nevertheless, only a small percentage have received treatment (5% in America and less than 1% in Australia; American Society of Sleep Medicine, USA, 2014). Current treatments are costly, time-consuming and difficult to tolerate. The Power Sleep (PS) oral device is a non-customised, self-fitted intra-oral mandibular advancement splint designed to manage snoring and sleep apnoea. This product has the potential to deliver a clinically effective outcome while reducing cost and increasing comfort levels. The current study aims to examine the efficacy and safety of the Power Sleep (PS) oral device in the management of snoring and sleep apnoea. A pre-post test design involving measures at baseline and using the oral device will be employed using approximately 30 participants aged 18-65 with sleep apnoea. It is hypothesized that the Power Sleep (PS) oral device will have a salutatory effect compared to baseline measures on: (a) snoring loudness; (b) snoring frequency; (c) Apnoea Hypopnea Index-REM (AHI-REM); (d) Apnoea Hypopnea Index-Total (AHI-Total); and (e) mean minimum oxygen saturation (min SaO2).