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Alfentanil versus fentanyl with ketamine for emergency department rapid sequence intubation: The A-FAKT study, a randomised clinical trial.
A small number of patients presenting to emergency departments need intubation, a process to place a tube in their windpipe to protect their airway, and allow breathing support with a ventilator. Drugs are used to ensure that they are unconscious and to relax their muscles to make placement of the tracheal tube possible, but these drugs can cause changes to vital signs such as pulse and blood pressure, which could worsen their condition. Ketamine is often used as a sedative agent for intubation, and an opioid (morphine-like) drug is sometimes used to try and normalise the blood pressure during the procedure. Fentanyl is the most commonly used opioid for this purpose, but another drug called alfentanil is theoretically a better choice. In this clinical trial, we intend to randomise patients to receive equivalent doses of either fentanyl or alfentanil, in a blinded fashion, as part of a drug regimen with ketamine and a muscle relaxant called rocuronium. The study aims to test the null hypothesis that there is no difference in the outcomes measured between fentanyl and alfentanil.
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A randomised control trial to evaluate the online delivery of the Better Health Program for children aged 7-13 years who have overweight or obesity in Victoria
This study aims to test if the online Better Health Program helps to build healthy and long-term lifestyle behaviour changes in children aged 7-13 years who are above a healthy weight in Victoria. The program currently runs in Western Australia. When delivered face-to-face, the program has improved health outcomes for children who are above a healthy weight.
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Online support group for haemodialysis patients: a pre post study.
The intervention will be a support group conducted on TEAMs and will be a patient led group moderated by senior nursing staff. Allied health will be invited to contribute to the sessions as required and the content included in the sessions will be ascertained by engaging with patients to keep the initiative very patient focused. The sessions will be run weekly for approximately 1 hour over the course of 4 weeks. It will be an opportunity for patients to engage with and support each other as well as a chance to engage with relevant healthcare professionals who will provide relevant support and education. Two validated tools will used pre intervention to assess the participants anxiety and depression and quality of life. The same tools will then be used again after the 4-week intervention to reassess and provide quantitative data for the study. The online support group will be a patient centred approach to providing self-management support. This study will look at quality of life and anxiety and depression outcomes associated with the online education and support group intervention.
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The AUstralian multidomain Approach to Reduce dementia Risk by prOtecting brain health With lifestyle intervention study (AU-ARROW)
Background: People with unhealthy lifestyles are known to be more at risk of type 2 diabetes, heart disease, and hypertension; these conditions in turn lead to a higher risk of certain forms of dementia, especially Alzheimer’s disease. A recent clinical trial in Finland (the FINGER study: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) showed that a combination of lifestyle changes, aimed at reducing the incidence of the above conditions, can help to preserve brain function in people aged 60-77 years who were considered at higher risk of dementia. Hypothesis: Using the FINGER study as a model, the AU-ARROW 2-year study will help establish, in an Australian cultural setting, whether the combination of lifestyle changes including regular physical exercises, a healthier diet, regular brain training exercises, and regular health monitoring, will preserve brain function in people considered at higher risk of dementia. Study details: Australia’s AU-ARROW study will be run in Sydney (NSW) and Perth (WA), and will recruit 600 people aged 60-79 considered at high risk of developing dementia, who will be allocated randomly and evenly into 2 groups: the health education & coaching group (HC), or the multidomain lifestyle intervention group (ML). HC participants will attend information sessions about exercise, diet, and activities to keep mentally and socially active at five group meetings over the 2 years of the trial, and will also receive yearly medical counselling. The ML group will receive similar information more frequently (group meetings at least monthly), free gym memberships and personalised exercise regimes, monthly dietary counselling, 6-monthly medical counselling, and will carry out online brain training exercises 3-4 times per week, for 2 years. All AU-ARROW study participants will undergo six-monthly memory tests, blood tests and physical assessments, as well as complete several questionnaires, to help determine whether this combination of lifestyle changes can reduce the risk of dementia.
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The PALS Study: Picturing Aeration with Lung Ultrasound after Surfactant
A medication called surfactant is commonly given to preterm newborn babies to help with their breathing. We are conducting a study using ultrasound to measure how quickly surfactant works to help babies who need help breathing. To do this, we will get ultrasound recordings of newborn baby’s lungs before and after surfactant is given. The purpose of this study is to use ultrasound to see how quickly surfactant works. We are using ultrasound of the lungs to monitor how the amount of air in the lungs changes after surfactant treatment. We hope to use the results from this study in the future to improve our care for babies that need surfactant. If you decide to participate, we will get ultrasound images of your baby’s lungs by gently placing an ultrasound probe on each side of your baby’s chest or back. The lung ultrasound assessments are brief, less than 1 minute. We will perform a total of four ultrasound assessments – one before your baby receives surfactant, and three in the two hours after surfactant is given. The assessments will not interfere with cuddles. If you don’t wish to take part, you don’t have to. Your baby will continue to receive the best possible care whether you take part or not. The decision to give surfactant, or the way that surfactant is being given, will be decided by the treating doctors and will not be changed by your participation in this study.
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Three versus five years of adjuvant Imatinib as treatment for patients with operable gastrointestinal stromal tumour (GIST) with a high risk for recurrence: SSGXXII: A Randomised phase III study
The purpose of this study is to compare the effects of 3 years vs. 5 years of imatinib in patients with gastrointestinal stromal tumor (GIST). Who is it for? You may be eligible for this study if you are at least 18 years old, have been diagnosed with GIST, and have been treated with adjuvant imatinib for 3 years after surgery. Study details Once participants have already been receiving their usual standard of care imatinib treatment for 3 years, they will be randomly allocated into two groups. One group will stop their treatment. The other group will receive 400mg oral imatinib once a day for 2 more years. Participants will be followed up and take part in CT/MRI scans, clinical assessments, and questionnaires every few months (ranging from 3-12 month intervals) for 10 years. It is hoped this research will reveal if 5 years of imatinib ensues in better outcomes for GIST patients compared to 3 years of imatinib, thus contributing to improving cancer treatment.
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A 24-week Open Label, Basket Study of SLS-005 (Trehalose Injection 90.5 mg/mL Intravenous Infusion) in the Treatment of Adults with Neurodegenerative Diseases.
This is a study of safety and tolerability of a drug called SLS-005 in adults, aged 18 to 75 years with selected neurodegenerative diseases [up to 4 patients with amyotrophic lateral sclerosis (ALS), up to 10 participants with Huntington’s disease (HD), and up to 4 participants with spinocerebellar ataxia type-3 (SCA3)]. This study will also help to determine the treatment response of SLS-005 using a patient-reported outcome measure. The study comprises of a 2-week screening period, 24-week open-label treatment period of SLS-005 to be administered as a once weekly intravenous infusion, and a 2-week safety follow-up period. On the day of the infusion, the study participant is expected to remain at the study centre for up to 6-8 hours. All participants will be asked to undergo blood tests and answer questions regarding their health. It is hoped that information from this study informs researchers of how the body metabolises SLS-005 and thus how it may be used to treat neurogenerative diseases, such as ALS, HD and SCA3.
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Randomized Placebo-Controlled Clinical Trials on the Effect of human chorionic gonadotrophin (hCG) on Recovery from Non-Prescribed Androgen Use
AIMS OF THIS STUDY To test model PCT-style regimen of hCG , framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive function of abstinent androgen abusers. This randomized double-blind placebo-controlled clinical trial is designed to test the efficacy and safety of a pharmacological treatment as part of a future rehabilitation program for androgen abusers. To the best of our knowledge, no similar study has been undertaken or reported elsewhere. OBJECTIVES To investigate the efficacy of weekly hCG treatment over 4 weeks to accelerate recovery of the male reproductive system of abstinent androgen abusers at 4 and 8 weeks after cessation of trial drug treatment. STUDY POPULATION Androgen abusers who are planning to stop or have recently ceased androgen abuse will be recruited through local advertising, social media postings and word of mouth. STUDY DESIGN Randomized, double-blind, placebo-controlled, parallel group study with 4 weeks of drug (active or placebo) treatment. The primary endpoint is the extent of recovery of the male reproductive system as indicated by a composite measure of serum LH and FSH at 4 and 8 weeks after cessation of study drug treatment.
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The Sun-D Trial: the effect of high SPF sunscreen application on vitamin D
Finding the balance between the risks and benefits of sun exposure is extremely challenging. The Cancer Council Australia and other organisations now advise daily sunscreen use to reduce UV radiation-induced damage arising from incidental exposure. Sunscreen blocks vitamin D production in experimental settings but there are no data about the effect of frequent application of high SPF sunscreens in community settings. Despite this, there is a widely held perception that using sunscreen will increase the risk of vitamin D deficiency and this is undermining skin cancer prevention messages. We plan a two-arm open-label RCT with a one-year intervention phase. The primary aim is to determine whether participants randomised to provision of a broad-spectrum SPF 50+ sunscreen, and advice to apply it to all body parts uncovered by clothing on all days when the UVI is forecast to reach 3, have a lower mean 25 hydroxyvitamin D (25(OH)D) concentration at the end of either summer or winter than those randomised to usual discretionary sunscreen use. If daily sunscreen use reduces 25(OH)D concentration, we will model the impact on the prevalence of vitamin D deficiency in Australia to assess the public health significance of the change
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Randomized Placebo-Controlled Clinical Trials on the Effect of Letrozole on Recovery from Non-Prescribed Androgen Use
AIMS OF THIS STUDY To test model PCT-style regimens comprising either hCG or an antiestrogen, framed in the most plausible endocrinological context, to evaluate their efficacy in accelerating the recovery of male reproductive function of abstinent androgen abusers. These randomized double-blind placebo-controlled clinical trials are designed to test the efficacy and safety of pharmacological treatment as part of a future rehabilitation program for androgen abusers. To the best of our knowledge, no similar study has been undertaken or reported elsewhere. OBJECTIVES To investigate the efficacy of hCG or letrozole, an aromatase inhibitor, treatment over 4 weeks to accelerate recovery of the male reproductive system of abstinent androgen abusers at 4 and 8 weeks after cessation of trial drug treatment. STUDY POPULATION Androgen abusers who are planning to stop or have recently ceased androgen abuse will be recruited through local advertising, social media postings and word of mouth. STUDY DESIGN Randomized, double-blind, placebo-controlled, parallel group study with 4 weeks of drug (active or placebo) treatment. The primary endpoint is the extent of recovery of the male reproductive system as indicated by a composite measure of serum LH and FSH at 4- and 8- weeks after cessation of study drug treatment.