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Evaluation of the effects of a mixture of amino acids (Amixea) on lean body mass and muscle strength of patients with unresectable advanced non small cell lung cancer: A randomized, double blind, placebo controlled, multicentre study
The aim of this clinical study is to investigate whether a new food supplement called Amixea can prevent or slow the loss of muscle mass and strength in patients with non small cell lung cancer undergoing chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with Stage III or IV unresectable non small cell lung cancer (NSCLC) for which you are undergoing, or plan to undergo chemotherapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take a new food supplement called Amixea 3 times a day for 10 weeks. Amixea is a mixture of amino acids designed to prevent or slow the loss of muscle mass and strength in patients with cancer, particularly in those who show signs of cachexia. Participants in the other group will instead take a placebo (inactive) treatment for 10 weeks. The study will be double blind, which means that neither the patient nor the investigators will know which treatment the patients are receiving until after the study is completed. All participants will undergo a number of assessments before and after the 10 week treatment period, including dual-energy X-ray absorptiometry (DEXA) scans to evaluate body composition, muscle strength testing of the quadriceps (thigh muscles), and blood tests. They will also be asked to complete a number of questionnaires to evaluate nutritional status, quality of life, satisfaction with treatment, adherence and product tolerability. Results from patients treated with Amixea will be compared to those obtained from patients treated with placebo, in order to investigate the study product effects on cachexia.
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The potential benefits of high and low carotenoid-rich fruits and vegetables on preserving skeletal muscle mass in overweight/obese older adults when placed on a weight loss diet.
Sarcopenic obesity is associated with an increased risk of frailty and loss of independence with advanced age. Management of sarcopenic obesity presents a complex challenge when prescribing dietary interventions; a conundrum is the potential harmful effects of energy restricted diets on the loss of skeletal muscle mass and the potential exacerbation of sarcopenia and associated functional decline. There is observational evidence supporting that higher intakes of fruit and vegetables and olive oil is inversely associated with muscle strength, physical performance and disability. Therefore, the aim of this study is to investigate the effects of diet induced weight loss on lean tissue mass in older overweight and obese adults. Moreover we aim to investigate the independent and combined effects of diet induced weight loss and carotenoid-rich fruit and vegetables plus extra virgin olive oil (EVOO) on body composition, muscle strength, physical performance, physical activity and quality of life in overweight and obese older adults.
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Profiling skeletal muscle loss during leg immobilisation
The nature of training and competition in the majority of popular sports dictates that debilitating injury is not uncommon when individuals engage in high musculoskeletal loading patterns and/or high impact collisions. A consequence of such injuries is that repair and remodelling of tissues often requires significant periods of limb immobilisation. It is during immobilisation that normal mechanical loading of skeletal muscle is significantly reduced and muscle wasting (atrophy) ensues. Disuse atrophy is a secondary complication that exacerbates the aetiology of injury and complicates the return to appropriate quality and quantity of training. Better understanding of the genetic bases of disuse muscle atrophy in athletes following abrupt cessation of regular training and competition may ultimately result in improved countermeasures to mitigate short term muscle wasting. Specific strategies such as individualised nutrition and exercise rehabilitation to promote the prompt return of functional capacity may be entirely plausible with greater understanding of changes in inducible expression in skeletal muscle with shortterm immobilisation. The primary aim of the proposed study is to determine changes in inducible gene expression in the early (3 d) and short term (14 d) immobilisation period. The research question is novel and will have the capacity to inform sports medicine and exercise science in characterising individuals ‘at risk’ of rapid degeneration of muscle mass with disuse or those that may be “protected” from muscle loss with short term unloading. It is hypothesised that 14 days of limb immobilisation will modulate expression of the transcriptome in skeletal muscle and generate a distinct genomic profile associated with the early time course of muscle atrophy in healthy, young men.
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The MIRROR2 pilot study: prevention of Major depressIon among older people living in Regional and RemOte aReas of Western Australia
Symptoms of low mood and depression are common in later life and can include; feeling sad, empty or down, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, poor concentration and thoughts about death. There is now evidence that depression is 23% more frequent among people living in regional Australia than in the city, possibly because of difficulty accessing relevant health services. When feeling low, a person’s motivation to do things can decrease. Some may find that they give up hobbies or activities previously enjoyed, and over time might end up doing very little. This can lead to a further decline in mood and start a vicious cycle that can be difficult to break. One of the ways of overcoming depression and low mood is by changing behaviour, such as gradually increasing activity levels. The results of several studies show that the more activities people engage in the better they feel. Behavioural Activation (BA) interventions encourage participants to meaningfully increase their engagement in activities with the aim of improving mood and sense of achievement. The current pilot study is seeking to test out (pilot) whether a supported self-help behavioural activation intervention designed for older Western Australians living in regional and remote areas is effective at: preventing the onset of depression among those with some depressive symptoms. The results will be used to improve the program and make it ready for a full clinical trial so that definitive evidence of the effectiveness of the intervention can be obtained. Specific aim of definitive trial: To determine the effect of a BA intervention on the 1 year incidence rate of Major Depression in older adults with subsyndromal depression living in regional Western Australia.
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Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia
The ALL SCTped 2012 FORUM is a multinational study that explore the efficacy and efficiency of two different chemo-conditioning regimens (Flu/Thio with Treo or ivBu) in comparison to the standard conditioning regimen (TBI/VP16) for children and adolescents with Acute Lymphoblastic Leukaemia undergoing Allogeneic Stem Cell Transplantation. Who is it for? Patients with Acute lymphoblastic leukaemia diagnosed before or equal to the age of 18 and will be undergoing an Allogeneic stem cell transplantation before or equal to the age of 21. Study details: This study will compare 2 different conditioning regimens. Eligible patients will be randomised (allocated by chance) to either total body irradiation containing regimen (TBI) or to non-total body irradiation regimen (non-TBI) and this will be followed by haematopoietic stem cell transplant (HSCT). The study will compare the outcome of children with ALL who receive a total body irradiation conditioning regimen versus irradiation free conditioning followed by haematopoietic stem cell transplant (HSCT). The study will also compare the outcome after mismatched donors, haploidentical family donors or mismatched cord blood.
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What’s in a name: a study protocol for a randomised controlled trial to identify the influence of diagnostic labels for mild depression and acute bronchitis on intended medication use.
The current study will conduct a randomised controlled trial via an online survey. Recruitment will be conducted by Survey Sampling International (SSI) in order to obtain the desired 1600 participants. The current study aims to identify whether individuals given a diagnostic label for either a psychological (“mild depression”), or physiological condition (“acute bronchitis”) are more likely to decide to take medication than if given a symptomatic description only. We hypothesise that a higher proportion of those provided with a diagnostic label will decide to take medication for that condition, than those given a symptomatic description.
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Pilot assessment of the utility and acceptability of a new ‘goals of care and not for cardiopulmonary resuscitation’ documentation tool/form
Health care delivered at the end of life should aim to deliver the outcomes desirable to the patient and family. Understanding the priorities for the outcome of care requires open and honest communication about health care options, prognosis, likelihood of survival and risks for cognitive impairment or functional decline. As prediction of death in any one admission is difficult, conversation about goals of care and undesirable outcomes should occur for those patients who are at risk of dying in the next 12 months (Gibbins, McCoubrie, Alexander, Kinzel, & Forbes, 2009). Completion of an NFR form is often the result of the conversation regarding outcomes acceptable to the patient or which may have a reasonable chance of success. The survival to discharge outcomes for CPR in those aged 80 years and over is poor and there is significant morbidity especially in impaired cognitive function. However, the completion rate of NFR in the first 24 hours for those patients aged 80 years and over admitted acutely unwell to public or private hospitals is less than 20%. (Levinson and Mills, 2016 (in press)). The rate is significantly lower in private compared to public hospitals. Hospitals and the Australasian College for Emergency Medicine policy around NFR documentation strongly encourages discussion of resuscitation status with the patient. While NFR completion does not confirm that discussion of goals of care has occurred, absence of NFR in those who have a poor outcome from CPR (hospital inpatients aged 80+ years) is highly suggestive of an absence of goals of care discussion at least as it relates to acute deterioration and resuscitation. There are many published barriers to end of life conversations. These include time, knowledge of the law, expertise and a desire not to rob the patient of hope. At Cabrini there are no decision-making tools to assist with the issues to be addressed at end of life. There is a perceived need for a goals of care discussion to be documented in the patient file (personal communication senior nursing staff 4S, 3C and MET registrars) associated with the completion of NFR if appropriate to improve patient centred care and reduce futile cardiopulmonary resuscitation. The aim of this study is to evaluate the utility and relevance of a document to assist with the conversation about goals of care at the end of life, and to facilitate the completion of Not For Resusitation forms where appropriate in the Emergency Department at Cabrini Malvern. The forms will be trialed over a 12 week period. At the end of this time, the forms will be evaluated for: Adequacy and completeness of the documentation the utility and acceptability of the GCR forms in guiding and promoting discussion Evaluate the interviews for themes relating to use of the forms. Evaluation of patient outcomes (length of stay; discharge or death) and evidence of discussion documentation
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A randomised controlled pilot trial to assess the efficacy of Intravesical Pethidine in treating bladder spasm in children who have undergone Ureteric Reimplantation Surgery
Aim: The aim is to assess the efficacy of intravesical pethidine in controlling bladder spasm in children after ureteric reimplantation surgery. Hypothesis: Children receiving intravesical pethidine will have less episodes of bladder spasm requiring therapy, lower pain scores and lower intravenous opioid requirements compared with children receiving placebo (saline) following ureteric reimplantation surgery
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Diagnostic accuracy of Digital Retinal Photography (DRP) in screening for Retinopathy of Prematurity (ROP) by non- ophthalmologists-a prospective study.
Retinopathy of Prematurity (ROP) is an eye disease which occurs in preterm infants. In severe cases, it can lead to blindness. Hence, preterm infants born at less than 31 weeks or birth weight less than 1250 grams are screened for ROP by ophthalmologists during their admission in the hospital. However, there are only limited number of Paediatric Ophthalmologists who are available to do ROP screening and treatment. With increasing number of preterm survival, ROP screening has increased the burden on already overworking ophthalmologists. Digital retinal photography (DRP) has theoretical advantages over Binocular Indirect Ophthalmoscope (BIO) because a trained non-ophthalmologist (e.g., neonatal nurse) can take the digital images and upload onto a secure server, so that the remotely located ophthalmologist can view and interpret. This has the potential to decrease the workload on ophthalmologists and even improve the outcomes for preterm infants. This technology also enables storage of the images for future reference which is not possible with the current screening with BIO. Objectives: The objective of this study is to measure the diagnostic accuracy of DRP compared to the standard BIO in diagnosing ROP. Trial Plan: The retinal images of preterm infants will be taken by trained neonatal nurses using the wide angle digital retinal camera and uploaded onto a secured pass word protected computer. These images will be sent to the ophthalmologists and reviewed by the remotely located ophthalmologist . The standard BIO examination will be done by another experienced ophthalmologist. This will enable us to study the feasibility and validity of the telemedicine approach in identifying the at risk infants who needs a referral to ophthalmologist (RW-ROP). This will be a prospective study involving eligible preterm infants who are admitted in our neonatal units.
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Intravenous Immunoglobulin (IVIg) in Spinal Cord Injury
Our extensive pre-clinical studies have indicated that intravenous immunoglobulin (IVIg) therapy is highly beneficial and significantly improves the neurological recovery if administered during the acute phase of SCI. As IVIg is already in clinical use as an immunomodulatory treatment for a variety of other disorders (incl. neurological conditions) and has a good safety profile, we now wish to explore the feasibility of treating human patients that have suffered either a cervical or thoracic spinal cord injury with IVIg. The specific aims of our Phase 1 study are as follows: 1) To test the feasibility of delivering IVIg within 12 hours of acute traumatic SCI. 2) To obtain data on the safety of IVIg in SCI using registry data for comparison. 3) To study the pharmacokinetics of IVIg in SCI 4) To relate the pharmacology of IVIg in SCI to safety and outcome measures 5) To obtain exploratory pilot data on the effect of IVIg treatment on the neurological outcome. Blood samples will be used for assessment of biomarkers of injury (e.g. cytokines) and studies on the pharmacological properties (e.g. half-life) of IVIg in the context of SCI. Serious adverse events will be recorded and compared to registry data / untreated patients to explore a possible (though unexpected) relationship with IVIg treatment. Suitable controls will be identified based on age, gender, nature and level of injury. De-identified data on the functional outcome of these individuals will also be used to obtain exploratory pilot data on therapeutic efficacy of IVIg. All participants will be followed for up to a year after their injury at set intervals, using physical examination to accurately determine motor and sensory recovery and questionnaires which would indicate functionality and social and emotional states.