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INVEST: Individualised vocational support for youth with borderline personality disorder: A randomised controlled trial
Young people with borderline personality disorder (BPD) have difficulty engaging in and maintaining employment or education, despite having the desire to do so. Despite this, no randomised controlled trial (RCT) has investigated the effectiveness of targeted vocational services in this group. This is a single-centre, 52-week, parallel arm, ‘single blind’ RCT of Individual Placement and Support (IPS), compared with Usual Vocational Services (UVS). The primary endpoint is 52 weeks. The background treatment will be standardised across both groups in the Helping Young People Early (HYPE) early intervention program for BPD at Orygen Youth Health. Potential participants will be identified by liaising with HYPE clinicians with regard to clients’ vocational wishes and by using HYPE’s standardised assessment for DSM-5 BPD. Following screening and baseline assessment, participants will be assigned randomly and consecutively in a 1:1 ratio to one of two interventions – IPS or UVS. Research assessments will occur at 13, 26, 39 and 52 weeks. The primary outcome is number of days in mainstream education/competitive employment since baseline. Secondary outcomes are cost effectiveness of intervention, quality of life, and BPD severity.
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Comparison of gut transit measurements for the Atmo Gas Capsule with the Smart Pill
When swallowed, the Atmo gas capsule consists of several gas and temperature sensors which provides information on oxygen concentrations, and therefore, passage of the capsule between aerobic (small intestine) and anaerobic regions (large intestine). That way, regional transit measurements can be accurately derived. To validate this device, simultaneous ingestion of this and an existing device measuring pH (SmartPill) to determine time comparison of gut transit will be conducted to show equivalence of the two devices in transit measurements.
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Volumetric Modulated Arc Therapy (VMAT) Irradiation in Skin Cancer Incidence Prevention
Who is it for? You may be eligible for the study if you are 70 years or older and have a past history of two or more keratinocyte cancers (BCC or SCC) with at least one on lower limbs( histologically confirmed disease). Alternatively, a past history of one or more keratinocyte cancers and multiple keratotic lesions on the lower limbs. Study details All participants will be randomly assigned (50/50 chance) treatment on one of their legs. The treatment will involve VMAT radiation treatment targeted to the skin cancer. The treatment will occur in two separate segments. The first segment will deliver 10-12 radiation fractions over 2 - 2.5 weeks. This will be followed by a mandatory mid-treatment break of at least 2 weeks (extended up to 4 weeks if necessary). The second treatment segment will deliver the remainder of the 25 fractions (13 - 15 fractions, depending on the number of prior fractions delivered) over 2.5 - 3 weeks. The other leg will serve as the control leg and will not receive any treatment. The overall treatment period will last no longer than 10 weeks. Participants will then be required to attend follow up visits 28 days, 3 months, 6 months, 9 month, 12 months, 18 months and 24 months after the end of treatment. During the study participants will answer questions about their Skin Pain and Quality of life. Benefits of this study The findings from this study will help medical researchers understand how radiation treatment with VMAT may help prevent skin cancers on people who have a high likelihood of disease recurrence.
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WOLF study: Weight loss with high intensity Functional exercise for men with Obstructive sLeep apnoea.
There is consistent evidence showing that very low energy diets (VLEDs) reduce weight amongst patients with obstructive sleep apnoea (OSA) and comorbid obesity. This method of obesity reduction although effective, may be accompanied by an associated change in body composition in patients with OSA, notably concurrent loss of muscle mass. Excessive loss of muscle mass may be undesirable because this tissue is responsible for the majority of resting metabolic rate, regulation of core body temperature, preservation of skeletal integrity, and maintenance of function and quality of life as the body ages. Our study has a pragmatic design and patients will attend a commercially available high intensity functional exercise training programme. To date, there have been no randomised trials of naturalistic exercise training that is practical and may promote exercise adherence in patients with OSA. We aim to show that this model of training can protect against the loss of muscle mass, as delivered through a programme that can be readily translated to real world settings. Furthermore, we will confirm whether there is an additive benefit of this model of training in addition to a VLED in reducing OSA severity as compared to dietary induced weight loss only.
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Anti-malarial activity of increasing doses of ZY-19489 in healthy volunteers
This study represents a first-in-human clinical trial for ZY-19489 and aims to determine the safety, tolerability and pharmacokinetics activity of the drug when administered to healthy human subjects. The study will be conducted in three parts. This registration is for Part 3. Part 3 is an open label study using the P. falciparum induced blood stage malaria (IBSM) model to characterise the antimalarial activity of a single-dose oral administration of ZY-19489 to healthy, malaria naïve, male and female subjects aged between 18-55 years old. Part 3 will be conducted in up to 3 cohorts of 8 subjects each, enrolled sequentially. Each subject will be intravenously inoculated with approximately 2,800 viable P. falciparum 3D7 parasite infected human red blood cells (RBCs) on Day 0. Adverse events and concomitant medications will be followed throughout the study. The study will be overseen by Principal Investigator, Dr James McCarthy, an Infectious Diseases physician experienced in the conduct of malaria challenge studies.
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Trial comparing intra-discal injection of ozone with platelet rich plasma (PRP) versus corticosteroid injection around the nerve versus surgical disc removal in patients suffering sciatica due to a lumbar disc herniation.
What is this research about ? Lumbar disc herniation (LDH) also known as disc prolapse or bulge in the lower back that may cause severe pains down the leg. This research project aims to improve our understanding on the condition and choosing between surgery versus spinal injections. What is the hypothesis ? Is there any benefit when we use non surgical injections to treat sciatica from a disc herniation ? What does it mean to be part of this trial ? You will be randomly allocated a treatment option that either involves a spinal injection procedure under x-ray scanning control or spinal surgery. You will not able to choose a treatment option. Aside from this allocation, the medical care you receive is the same as that you would have received as part of standard care. At regular intervals you are required to complete forms that provide information on your symptoms and quality of life.
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The Effects of Surgery on Plasma Vitamin C Levels and Cognitive Function in Adults Undergoing Elective Hip Surgery
The present study is designed to explore a link between cognitive decline post-surgery as a cause of vitamin C decline following the surgery. The aim of the study is to to determine whether surgery has an effect on vitamin C levels and cognition with the use of a neuropsychological test battery. It is hypothesised that elective hip surgery will result in significantly depleted plasma vitamin C concentrations which will contribute to compromised cognitive function on the cognitive assessments. Cognitive tests will involve both paper and pen and computer tests, while blood tests will be undertaken to measure plasma vitamin C and serum vitamin B12 levels and levels of inflammation. Testing will be conducted roughly 1-2 weeks prior to the scheduled surgery and subsequent testing sessions will be performed within 1 week, 4-6 weeks, 3 months and 6 months after surgery.
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Clinical Utility of Obstructive Sleep Apnoea Physiology in Predicting Response to Treatment
Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. While efficacious, CPAP is poorly tolerated. Nightly use may be inadequately brief and 50% of patients do not continue CPAP therapy beyond 3 months. Although alternative treatments such as mouth guard devices and surgery exist for CPAP-intolerant patients, individual responses to these treatments are difficult to predict and as such many clinicians and patients are stuck in a trial and error paradigm for these treatments. Traditionally OSA has been thought to be a disorder of aberrant upper airway anatomy. Recently, it has become clear though that OSA can be caused by both anatomical and non-anatomical pathophysiology. Much of this paradigm change can be attributed to recent developments to the ability to measure this physiology – work that has been carried out by our research team at Monash Health and Monash University. We have developed readily applicable clinical tool that can predict the patient’s response to upper airway surgery and mandibular advancement splint treatments. The tools we have developed are now ready for direct translation to the clinical setting. In this exciting research project we will run an observation study to assess the impact of making physiological information available to clinicians at the time of OSA diagnosis on the treatment referral patterns and treatment outcomes of OSA patients. We hope that this extra physiological data will be able to predict patient response to CPAP-alternative treatments and give clinicians and patients extra treatment options that are tailored to patients personal physiology.
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A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B
This is a phase 1/2 study in which subjects with chronic HBV infection will receive BRII-179 (VBI-2601) and will be assessed for safety, tolerability antiviral activity and pharmacodynamic effects.
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SHED-IT Recharge: Evaluation of an online weight loss program for men with low mood.
Depression and obesity in men are two of the largest public health concerns in Australia. These conditions also appear to be linked as men who are overweight or obese are ~30% more likely to develop depression than healthy weight men. Furthermore, men with depression are 43% more likely to develop obesity than men without depression. Behavioural weight loss programs have shown promise to reduce depressive symptoms and improve weight status in people who are overweight or obese, but few interventions have engaged men and most have included components that are not scalable (e.g., intensive face-to-face support). E-health programs targeting men’s physical and mental health may represent a more scalable solution to these concerns, but the evidence-base supporting their efficacy is limited. Primary aim: To develop and test the efficacy of a gender-tailored, e-health weight loss program (SHED-IT: Recharge) to improve the physical and mental health of overweight and obese men with elevated depressive symptoms. Primary hypothesis: Men in the SHED-IT: Recharge group will show greater improvements in i) weight and ii) depressive symptoms at 3 months post-baseline, compared to a wait-list control group. Secondary aim 1: To determine the effect of SHED-IT: Recharge on men’s weight and depressive symptoms at 6 month follow-up. Secondary aim 2: To determine the effect of SHED-IT: Recharge on a range of lifestyle health behaviours (e.g., physical activity, dietary habits), mental health outcomes (e.g., anxiety) and other health indicators (e.g., blood pressure, blood lipids). Secondary aim 3: To identify which behavioural changes (e.g., diet, sleep) result in the largest, independent contributions toward the overall intervention effect on weight and depressive symptoms.