ANZCTR search results

This study proposes to explore the safety and efficacy of lenalidomide consolidation post allogeneic stem cell transplant in patients with high risk multiple myeloma who fail to achieve stringent complete response. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of multiple myeloma for which you plan to undergo stem cell transplantation. Study details All participants in this study will commence treatment with Lenalidomide 180 days after stem cell transplantation. Lenalidomide is a chemotherapy drug which is taken orally at an initial dose of 10mg daily for 21 of 28 days (1 cycle), increasing to 15mg for subsequent treatment cycles. This will be taken in combination with weekly oral dexamethasone for the first 2 cycles. Treatment will continue until any of the following occurs: a. Unacceptable toxicity/adverse event that may cause severe or permanent harm which rule out continuation of the study drug b. Relapse/progressive disease and alternative myeloma treatment is required c. Death d. The study may also be terminated early if safety concerns emerge with this treatment Participants will be regularly monitored until relapse or end of treatment in order to evaluate the safety and tolerability of the treatment, as well as disease response.

TThis study is being conducted to assess a new skin product against the standard skin care procedures at Townsville Cancer Center (TCC) in breast cancer patients receiving external beam radiation therapy. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have a confirmed diagnosis of breast cancer, for which you will be undergoing external beam radiation therapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive the current standard skin care management. That is, an aqueous cream, Sorbolene, applied daily after radiation therapy treatment. Participants in the other group will instead receive a new product called StrataXRT, which is a silicone based gel applied to the skin which acts as a barrier to prevent the development of radiation-induced skin reactions. The product is TGA approved in Australia; FDA approved in the United States and is being used clinically in other centres in Australia. All participants will be assessed at the beginning of treatment and weekly thereafter using a specific skin grading scale, and clinical photographs will be taken. The study is attempting to determine if StrataXRT is equivalent to current practices, and whether further study on the product is warranted.

Performing chest compressions for patients in cardiac arrest is tiring, and as rescuers become more tired their performance has been shown to deteriorate. Quality of Cardiopulmonary Resuscitation (CPR), especially chest compressions, is adversely affected by fatigue and is one of the few factors shown to be independently associated with the likelihood of a person surviving a cardiac arrest. The administration of supplemental low flow oxygen to a rescuer via nasal cannula may slow their fatigue, and increase the length of time that that the rescuer is able to provide good quality chest compressions. We intend to undertake a study to assess the effectiveness of supplemental low flow oxygen on healthy, volunteer rescuers in improving their quality and length of performance of chest compressions on a resuscitation manikin.

PURPOSE The primary purpose of this study is to determine the efficacy and safety of the addition of ixazomib and low dose dexamethasone maintenance therapy for transplant-eligible multiple myeloma (MM) patients who are undergoing single autologous stem cell transplantation (ASCT) as part of front-line therapy. WHO IS IT FOR? You may be eligible to join this study if you are aged over 18 years, have been diagnosed with symptomatic MM as per International Myeloma Working Group (IMWG) criteria, are eligible for front-line melphalan conditioned autologous stem cell transplant (ASCT), and do not have central nervous system involvement with the disease (MM). STUDY DETAILS Enrolled participants who have achieved clinical and haematological recovery following ASCT will undergo screening for study eligibility no earlier than 75 days following ASCT, complete screening within 15 days, and be randomised into treatment arms no later than 115 days after ASCT. Participants will then be randomised 1:1 to the control arm (thalidomide + dexamethasone), or the experimental arm (thalidomide + dexamethasone + ixazomib), for a maximum of 12 months or until the disease progresses, whichever occurs first. Outcomes It is hoped that the findings of this trial will provide information on: 1. Whether the addition of ixazomib to standard maintenance therapy will improve progression free survival in multiple myeloma patients who have undergone ASCT as part of front-line therapy; and 2. Provide information on the safety and efficacy of ixazomib addition to standard maintenance therapy.

Knee osteoarthritis (OA) is a leading cause of pain and disability around the world. OA involves the breakdown of joint cartilage, but it also appears to include the proliferation of blood vessels and nerves about the joint. It is suggested that these blood vessels and nerves contribute to the experience of pain. One pilot study found that embolising abnormal vessels about the knee substantially improved individual's pain. Prior to a full randomised trial, 10 participants will be recruited to this non-randomised pilot study. The purpose of the pilot study is to test the protocol for feasibility and assess for effects on pain and function and any unexpected effects due to the intervention in the first month post procedure. All pilot study participants will unblinded and will receive the intervention. Participants will be reassessed the day following the intervention and then once a week for the first month. At each assessment, participants will complete an abbreviated assessment (KOOS, Global Assessment of Change, Six Minute Walk Test and 30-second Chair Stand Test). Participants will then complete full assessments (using all assessment tools) at 1, 6, 12, and 24 months following the procedure.

Around 3-6% of newborn infants require positive pressure ventilation (PPV) in the delivery room (DR). However, delivering effective mask ventilation can be challenging, because of large leak around the mask. The presence of a large leak may lead to ineffective ventilation and an unsuccessful resuscitation. A new face mask called Resusi-sure (LSR Health care, NSW, Australia) uses suction to create a seal between the mask and the infant’s face. Primary objective is to test (in a randomised trial) the hypothesis that there will be less leak during intermittent positive pressure ventilation of term and near term infants (newly born infants greater than or equal to 34 weeks) in the delivery room if performed with the suction mask compared with the conventional mask.

Active minds, happy kids is a centre-based intervention feasibility study which aims to increase physical activity, decrease sedentary behaviour, and decrease screen time. The centre-based components will be implementing in 2016. It is a 10 week pre- and post-intervention feasibility study to develop, implement and evaluate centre-based behaviour change strategies. Four preschools and/or childcare centres (hereafter collectively referred to as centres), and five families per centre, will be recruited. This research is being conducted by Dr Trina Hinkley, Prof Jo Salmon, Prof Anna Timperio, and Dr Kylie Hesketh. We anticipate benefits of this research may include gains in knowledge, insight, understanding of child behaviours and strategies to support healthy levels of physical activity and sedentary behaviours. The collection of this data will inform the development of a larger intervention in this population. Once effective strategies are identified, these can be disseminated to a larger segment of the population.

Malabsorption of fructose occurs in 40% of healthy Australians but may be a major problem for individuals with Irritable Bowel Syndrome. The addition of glucose has been shown to assist in free fructose absorption in test solutions and juices however this effect has never been investigated using whole foods. The aim was to investigate the effect on fructose absorption when glucose was added to foods with naturally high levels of free fructose in a randomised, single-blinded, crossover intervention trial.

This study will utilise a randomised, double-blind, placebo-controlled, crossover design to investigate the following aims. 1. Determine if consumption of sweet cherries attenuates exercise-induced inflammation. 2. Determine if consumption of sweet cherries improves post-exercise recovery. 3. Determine if consumption of sweet cherries improves exercise performance. Inclusion criteria: competitive cyclists training for a minimum of 7 hours per week; an endurance training history of at least 3 years; Exclusion criteria: cardiovascular history; history of fainting; diabetes; history of allergy/reaction to stone fruit. Participants will be asked to refrain from ingesting dietary anthocyanins or flavonoids and will be provided with a food and exercise plan and diary to complete in the week prior to both the familiarisation and trial sessions. Participants will undergo an initial familiarisation session, at which time baseline blood samples will be taken. Participants will undertake a ramp incremental VO2max test to ascertain their level of cardiovascular fitness. Lactate and blood glucose measurements will be taken every 2 minutes via finger prick. Participants with a VO2max of between 4.5 and 5.0L/min will be included in the supplementation and trial sessions. Participants will be randomly assigned to the cherry or placebo group. Participants will be given blended cherry drinks containing cherries, water and lemon juice (at a ratio of 10:5:1) with an anthocyanin content of 540mg/drink or carbohydrate-matched, blended pear drinks containing 0% anthocyanin (placebo). Participants will be asked to consume one drink at 8pm for the 3 days prior to the cycling trial, and one drink 1 hour immediately prior to the commencement of the trial. To assess the efficacy of the blinding process, participants will be asked if they believe they have received the blended cherry drink or the placebo. The cycling trial will consist of 60second intervals of cycling on a cycle ergometer at a workload equivalent to 100%VO2max followed by 75 seconds of active recovery at 50%VO2max, until the 100%VO2max workload is unable to be maintained. A 10 minute warm-up and cool-down at 50%VO2max will be undertaken prior to and following the trial. Lactate and blood glucose measurements will be taken in each active recovery phase via finger prick. Venous blood samples will be collected immediately following exercise and at 24 hours post exercise. At 24 hours post exercise, participants will indicate perceived muscle soreness via a 10 cm visual analog scale. Following a washout period of at least two weeks, participant groups will crossover and the supplementation and cycling trial will be repeated. Blood samples will be tested for levels of the circulating inflammatory mediators IL-6, IL-10, TNFalpha, IL-1beta, CRP and MCP-1 using ELISA kits, and LOOH levels and creatine kinase levels will be monitored.

Parkinson’s disease (PD) is an age-related incurable disorder observed in 3% of persons aged 65 years old and over, and 10% of those aged over 80 years old, making it one of the more common neurological disorders of later life. In Australia, 1 in every 340 people lives with this condition. The prevalence of anxiety in PD exceeds 50%, and it is a major contributor to a poor quality of life of patients and caregivers. However, anxiety is poorly identified in PD. There is a paucity of clinical trials primarily focussed on treating anxiety, and there are no evidence based effective and safe pharmacological treatment for anxiety in PD. To complicate matters further, anxiety in PD presents with unique and complex symptomatology which must be understood and addressed if intervention is to be effective. There is an urgent need for empirically validated interventions targeting PD-specific anxiety symptoms for successful treatment. The present study will be the first to provide empirical evidence for Cognitive Behaviour Therapy (CBT) for anxiety by conducting a waitlist-controlled tailored and dyadic CBT trial including PD patients and caregivers. The study also focuses on caregiver well-being and the relationship quality and satisfaction for PD and caregivers. The ultimate goal of the present proposal is to improve diagnosis and treatment of anxiety in PD; thus improve quality of life of patients and their caregivers. METHODS PD patients will be recruited from neurology outpatient clinics in Brisbane. Their carers will also be invited to participate in the study. Apart from neurology outpatient clinics, PD patients and their carers who express interest to participate in PD research through other PD studies, support groups and advertisements will also be recruited. Research design: This study is a randomised wait-list controlled intervention design. PD patients with anxiety will be randomly allocated to either the Cognitive Behaviour Therapy (CBT) intervention group (group 1) or control group. The wait-list control group will receive clinical monitoring and educational material about PD. The wait-list group will receive the intervention after group 1 completes the intervention.