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Long term monitoring of multiple sclerosis patients on cladribine treatment
Expand descriptionMultiple sclerosis (MS) is the most common non-traumatic neurological disorder that affects young adults. Cladribine tablets (Mavenclad®) is a new oral therapy for MS. The current dosing for cladribine tablets is 2 courses given one year apart. This has been shown to be effective in reducing relapses in 75% of patients for up to 4 years (based on annualised relapse rate). However, re-initiation of treatment after year 4 has not been studied. This will be a multicenter, 6-year, phase IV, low interventional trial. Subjects meeting the eligibility criteria will receive an initial treatment course in year 1 and a continuing treatment course in year 2. After 3 years, patients will have the option for re-initiation of treatment, if clinically indicated or the option to switch to another disease modifying therapy (DMT). This study is testing the hypothesis that patients who receive an additional course of cladribine tablets will experience less disease activity than those who chose to change DMT. During the study we will evaluate blood-based molecules called biomarkers, brain scans and brain function tests. At the end of the study, we will use the results of these tests to determine if there are ways to decide if re-initiation of treatment after the initial 2-year course is appropriate. This may be one test or a combination of several tests. In addition, we determine if these biomarkers can be used at onset of disease to determine if patients will respond to cladribine therapy before they start.
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Post-dural puncture headache following lumbar puncture with/without intrathecal chemotherapy, how long should patients remain recumbent? A pilot randomised controlled trial (The PLANE Study)
Expand descriptionAt the Royal Brisbane and Women's Hospital, Herston, Queensland, Australia, procedure mandates that patients lie flat for two (2) hours following a lumbar puncture (LP) with or without intrathecal chemotherapy. Most research to date has examined the prevalence of post-dural puncture headache (PDPH) and the length of time a patient needs to lie flat following an LP in non-cancer settings, with limited research examining patients in a cancer setting following intrathecal chemotherapy via LP. It is not clear if time spent lying flat impacts on outcomes such as patient reported PDPH and its severity. Some medical facilities within Australia and overseas have patients lying flat for one (1) hour. However, there is minimal evidence to support this practice. This research seeks to compare the practice of patients lying flat for one (1) hour versus two (2) hours following an LP with/without intrathecal chemotherapy and the prevalence of PDPH. Who is it for? You may be eligible for this study if you are an adult with a haematological cancer diagnosis who requires lumbar puncture for either diagnostic or therapeutic purposes. Study details As a participant in this study, you will be randomly allocation to either lying flat on your back for 1 hour or two hours after your lumbar puncture. Routine bloods tests will be performed prior to your lumbar puncture. At the time of lumbar puncture cerebral spinal fluid will be collected for pathology. This is considered standard care and these tests do not form part of the research project. It is hoped that this research will help determine whether one or two hours of lying down is more beneficial in reducing post-dural puncture headaches.
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Optimising clinical and functional outcomes in older adults with Heart Failure (HF) using the Peripheral Remodeling through Intermittent Muscular Exercise (PRIME) approach: A pilot study
Expand descriptionGuidelines recommended moderate intensity aerobic exercise for all patients with HF, however many exercise training studies include a patient group much younger than the 'real world' patient with HF who is elderly. This study was designed with a dual focus to address the age gap seen in HF exercise trials, while simultaneous gathering preliminary data for a novel rehabilitation technique called Peripheral Remodelling through Intermittent Muscular Exercise: “PRIME”. The PRIME approach offers a ‘hybrid’ aerobic-resistance solution for individuals with HF who may be unable to participate in conventional exercise training. This study will assess the feasibility of conducting a future large trial, to determine if 4 weeks of PRIME training, followed by 4 weeks of traditional HF rehabilitation (combination aerobic plus resistance exercise) can produce superior gains in aerobic capacity and muscle strength in comparison to 8 weeks of traditional HF rehabilitation, in elderly patients with HF.
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Evaluating a specialist dementia training program for home care workers
Expand descriptionThis study is the second part of a larger project with the overall aim to establish an evidence-based program (the “PITCH program”) for dementia care that can be delivered to front-line home care workers (non-clinically trained paid personal carers). The first part of the project used participatory design workshops to develop the content of the PITCH program, as well as piloted PITCH by training a small number of participants to assess the feasibility and acceptability of the training program. The second part of the project (this study) will comprehensively evaluate the PITCH program in a larger randomized controlled trial. Approximately 120 people living with dementia at home and receiving a home care service will participate in the trial, as well as their family carers and paid home care staff. Over 200 home care workers will be trained in the PITCH program.
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A Pilot Study into a Pan-Enteric Capsule Endoscopy vs. Bidirectional Endoscopy In Patients With Iron Deficiency Anaemia.
Expand descriptionThis is a prospective pilot study into the performance of capsule endoscopy with bidirectional endoscopy (BDE) in patients with IDA. We plan to assess the accuracy and correlation of capsule endoscopy with pathology detection in patients receiving BDE for IDA. In doing so, we plan to assess for causes of IDA such as celiac and inflammatory bowel disease (especially Crohn’s disease) and can be missed by conventional endoscopy. The diagnosis of these conditions could potentially be increased with additional small bowel visualization. We plan to calculate their detection rate by capsule endoscopy.
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AMLM22/D1: The International Acute myeloid leukaemia (AML) Platform Consortium (IAPC) trial is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in patients with acute myeloid leukaemia in first complete remission.
Expand descriptionThis study will evaluate the safety and efficacy of Molibresib for Acute Myeloid Leukemia Who is it for? You may be eligible to join this study if you are aged 16 and above and have Acute Myeloid Leukemia in first complete remission. Study details This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive standard care which generally observation. Participants in the other group will receive the drug Molibresib daily for a total of 24 months. As part of the study, participants will have blood tests at the start of each cycle (every 28 days) as well as an ECG to monitor heart function. Molibresib is known to have adverse effects on the heart therefore, participants will also have a MUGA (MUltiple Gated Acquisition scan) or ECHO (echocardiogram) at screening, cycle 2 and then every 12 weeks thereafter. We hope that the results from this trial will be used to help these new treatments which may be better for people with AML than what is currently available ,become accessible to the general population at faster than the normal process.
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Haemoglobin measurement using three different techniques in women undergoing planned vaginal birth
Expand descriptionWe aim to compare two bedside haemoglobin (Hb) measurement techniques (Rad-67™ Pulse CO-Oximeter® and HemoCue® with laboratory Hb measurements in women undergoing planned vaginal birth. Each woman will have a blood sample taken to measure Hb as part of routine care as well as a finger prick blood Hb sample (HemoCue®), and a monitor Hb measurement that is attached to the woman's finger (Rad-67™ Pulse CO-Oximeter®). The finger prick and monitor Hb measurements will be compared to the laboratory Hb sample to see if they give the same reading. The purpose of this study is to determine whether a bedside test of Hb is accurate enough to replace laboratory based Hb testing in pregnant women. The hypothesis is that these bedside tests will be able to replace laboratory Hb measurements.
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Acceptability and effectiveness of using a secure electronic collaboration platform (myBeepr) to improve communication of test results between radiologists and emergency department doctors: controlled pre-post, mixed-methods, pragmatic trial
Expand descriptionAdequate communication and follow up of test results between radiologists and doctors is critical for patient care. However, in the emergency department (ED), up to 75% of test results are missed (Callen et al. 2015). The current trial examines the feasibility and effectiveness of an intervention aiming to improve the communication and actioning of radiology test results in an ED setting by using a secure electronic collaboration app, called myBeepr (www.mybeepr.com). References Callen, J., T. D. Giardina, H. Singh, L. Li, R. Paoloni, A. Georgiou, W. B. Runciman and J. I. Westbrook (2015). "Emergency physicians' views of direct notification of laboratory and radiology results to patients using the Internet: A multisite survey." Journal of Medical Internet Research 17(3): e60.
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Quitlink: Peer worker facilitated Quitline support for smokers receiving mental health services
Expand descriptionSmoking is the leading cause of preventable death in people with severe mental illness (SMI). Although smokers with SMI want to quit, tailored interventions are rarely delivered in practice. Quitlines are well placed but underutilised by this group. “Quitlink” will utilise peer workers within mental health services to engage smokers with SMI in a tailored Quitline intervention. 382 participants will be recruited across participating mental health services in Victoria. In addition to recruitment across participating mental health services in Victoria, recruitment will occur via community recruitment online across broader Victoria. All participants will receive a brief smoking cessation intervention. Participants will be randomly allocated to either no further intervention, or to the Quitlink intervention (proactively contacted by Quitline and offered a targeted smoking cessation counselling intervention with nicotine replacement therapy (NRT) provided over an 8 week period). All participants will be followed up at 2 months, 5 months and 8 months. We will also qualitatively examine facilitators and barriers to cessation in order to improve future interventions.
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Reducing periOperative Adverse Respiratory events (ROAR) in children undergoing adenotonsillectomy who present with recurrent respiratory symptoms
Expand descriptionChildren with asthma or recurrent respiratory symptoms are at an increased risk of developing respiratory complications such as bronchospasm in the perioperative period. These risks are higher in surgeries such as adenotonsillectomy. Seven out of ten children with both respiratory symptoms and airway inflammation experienced at least one respiratory complication compared with only 1 out of 10 children with respiratory symptoms but no active airway inflammation. We hypothesize that children with recurrent respiratory symptoms screened for the presence of airway inflammation using the non-invasive measurement of exhaled nitric oxide and randomised to receiving ICS (Fluticasone propionate 250mcg per day) for 14 days prior to their adenotonsillectomy will be at a lower risk of having respiratory complications in the perioperative period compared with those receiving routine clinical care.