ANZCTR search results

Lenalidomide has a variety of reported mechanisms in blood malignancy, including activation of immune cells and anti-proliferative effects on tumor cells and modulation of the bone marrow microenvironment. Currently approved doses of lenalidomide use up to 25 mg for 21 days out of 28. A recent pilot study in older AML patients used higher and continuous doses of lenalidomide (50mg lenalidomide for 28 days x 2 cycles followed by 10 mg daily for 12 months). This resulted in a 30% complete response rate. This schedule was well tolerated in an elderly AML population. Therefore, lenalidomide at higher doses has substantial activity in AML and deserves further exploration. To explore the potential clinical value of lenalidomide in prolonging remission in adult AML after chemotherapy, this multicentre Investigator Initiated Australasian study will first investigate the safety and tolerability of increasing doses of lenalidomide (10-50mg per day for 28 days for 2 months) followed by 10mg per day for 10 months.

This project aims to investigate whether a monitoring and self-help program delivered by mobile phone and computers can help people to manage their stress, anxiety or depression. Participants will be randomly assigned to either a full interactive self-help program, which will include access to real-time self-monitoring with prompts and brief online modules grounded in Cognitive Behavioural Therapy; or a cut-down version of the program where participants will receive motivational messages and minimal information about depression, anxiety and stress as a control condition; or to a waitlist control. We predict those using the full myCompass program will report reduced symptoms of depression, anxiety or stress after the 6 week program and at 18 weeks follow-up.

The aim of the study is to examine the effects of daily consumption of saccharides for 12 weeks on the ability to perform cognitive tasks, including memory and on psychological wellbeing (mood) in healthy middle-aged adults. Proposed beneficial effects include: enhanced memory, increased ability to deal with demanding mental activities, improved mood and ability to deal with stress (reduced tension, anxiety and perceived mental fatigue).

Ureteric colic (or Kidney stones) is a significant public health concern within Australia, affecting as many as 5-15% of adults. As a result, a significant number of Australians experience significant pain, hospital and outpatient visits, and the potential for more significant complications such as infection, kidney damage and the need for surgical treatments. Although several methods of medical treatments to improve care of such patients have been studied overseas, some of which appear promising, the practice of “medical expulsive therapy” for ureteric colic is not widely practiced in Australia. One such medication is Tamsulosin, which seems to have an effect on the ureter (tube from kidney to bladder) and helps stones pass. It is already in use for other urological conditions already in Australia, and studies overseas seem to show benefit for patients with Ureteric colic. Within Queensland Health there is substantial variation with regard to access to specialist urologist services. Benefits of medical therapies for ureteric colic may be even greater in geographically isolated areas without full time urology services. This study aims to determine if the addition of the drug Tamsulosin 0.4mg daily, in addition to usual standard care, will improve the rates of spontaneously passing stones less than 10mm in diameter, whether the drug has any effect on pain experienced by the patients, their need for surgery and complications. Patients who present to the participating emergency departments with Ureteric calculi, that fit the inclusion criteria will be randomly allocated to either the study medication (Tamsulosin 0.4mg daily) or placebo. The patients will then be closely monitored for four weeks, to determine if the stones pass spontaneously, or if any complications occur. At four weeks the study will be complete, patients who are yet to have passed the stone, would be referred to Urology for consideration of a procedure.

This study is designed to assess the safety, tolerability and pharmacokinetic profile of seven (7) consecutive daily doses of EMA401 Sodium Salt in an elderly population (aged 56 years and over) at dose levels of 50 and 100 mg.

The study is to examine the impact of early warning scores, observation charts and education on the measurement of vital signs and subsequent review by medical staff.

Fish oil supplementation containing DHA and EPA omega-3 fatty acids has been shown to play an important role in the human nervous and vascular system. Omega-3 fatty acids have been associated with improved cognitive performance such as enhanced attentional skills and decreased reaction times. Recent studies suggest that there is improved cognitive performance in a population with ADHD, Alzheimer’s disease and metabolic disorders after omega-3 supplementation. Results are however controversial and seem to depend on the EPA/DHA ratio contained in the supplementation, the length of the supplementation period, the study design and the type of cognitive tasks utilized. In this double-blinded, placebo-controlled, parallel study, a group of 60 healthy volunteers and a population of 60 adults with ADHD will be randomly distributed into three diet groups and will be given either an EPA-rich diet (EPA/DHA ratio 4.5:1), a DHA-rich diet (EPA/DHA ratio 1:4) or a placebo treatment. The supplementation period will be three or six months long. Cognitive performance, brain activity and vascular parameters will be assessed using modern techniques, such as computer-generated and computer-measured tasks, fMRI, Visual Evoked Potentials (VEP) and Pulse Wave Velocity System (SphygmoCor). VEP will determine the speed of conduction of electrical responses through the brain and reflects the integrity/efficiency of neural tissues in response to visual stimuli. In every diet group a smaller group of participants (11-12 participants) will be randomly selected to perform part of their tasks while their brains are being scanned with an MRI scanner using functional magnetic resonance imaging (fMRI) and diffusion weighting imaging (DWI) techniques.

Aims: To evaluate the effects of erythromycin on small intestinal transit and glucose absorption. Hypotheses: Erythromycin will prolong small intestinal transit and, thereby, improve absorption of glucose. Background: Delayed gastric emptying is common in the critically ill and leads to inadequate nutrient delivery. This is usually treated with administration of prokinetic drugs such as erythromycin. While this increases nutrient delivery, the effect on nutrient absorption is unknown. However, in healthy subjects erythromycin has been reported to slow small intestinal transit and thereby increase absorption of nutrient . Research Plan: 15 critically ill patients will be studied in a randomised controlled, double-blind, cross-over fashion on consecutive days. On each study day either intervention (erythromycin 200mg IV) or placebo will be administered from t=-20 to 0min. At t= 0 min a test ‘meal’ consisting of a representative nutrient liquid (1kcal/ml), and 3 grams of 3-O-methyl glucose (3-OMG) mixed with 20MBq 99Tc sulphur colloid will be administered at 2ml/min until t=30 min. Small intestinal transit time will be measured using scintigraphy. Glucose absorption will be measured using plasma concentrations of 3-OMG. Significance: If the hypotheses are proven it would support the use of erythromycin in this group. The alternate outcome (i.e. erythromycin accelerates transit and reduces nutrient absorption) would challenge current feeding protocols common to most Intensive Care Units (ICUs).

Studies have shown that high protein diets containing lean cuts of meat can improve body composition. Lean pork as part of a high protein diet has not been studied. Data from our previous trial demonstrated that regularly eating lean fresh pork was not detrimental to cardiovascular health and in fact improved indices of body composition. These improvements were evident after only 3 months of eating pork (compared with habitual diets) and were achieved without restricting energy intake and while total protein intake (from all dietary sources) remained the same for both groups throughout the intervention. These data indicate that the changes in body composition seen are unlikely to be solely a protein related effect however we are unable to say if the changes in body composition were specific to pork or to pork protein or whether consumption of other high protein meat diets may have had the same benefit. Therefore the aim of the current project is to conduct a 3 month dietary intervention trial to compare the effect on body composition of regular consumption of lean pork with that of two other commonly consumed meats in the Australian diet, namely chicken and beef. We aim to demonstrate that regular consumption of pork is no worse, and possibly better, than the main alternative meat options in terms of improving indices of body composition.

A dearth of facts and abundance of opinions surround the optimal treatment of plantar heel pain. Despite its prevalence, financial burden and impact on the health-related quality of life, the Clinical Practice Guidelines for plantar heel pain proposed by the Orthopaedic Section of the American Physical Therapy Association do not recommend one treatment over another. In addition, two systematic reviews have found few interventions that are supported by good evidence. An alternative treatment for plantar heel pain is dry needling, which involves stimulation of myofascial trigger points (MTrPs) using a fine filament needle. Dry needling is increasingly used by physical therapists for the treatment of low back pain, neck pain, shoulder pain and posterior thigh pain and is thought to improve muscle activation patterns, improve joint range of motion and alleviate pain. However, there have been no published randomised controlled trials that have examined the efficacy or effectiveness of dry needling for plantar heel pain. Hence, the aim of this trial is to investigate the effectiveness of trigger point dry needling for plantar heel pain.