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N-acetyl cysteine (NAC) augmentation in Obsessive-Compulsive Disorder (OCD): A 24-week, randomized, double blind placebo controlled trial
Expand descriptionThis study seeks to elucidate the benefits of NAC augmentation (2-4 grams/day) compared to placebo in the treatment of OCD, in a 24-week, multi-centre, randomized, double-blind, placebo controlled trial. It is hypothesized that NAC will be superior over placebo for improving OCD symptoms as measured by a reduction in Y-BOCS scores from baseline against each subsequent time point (W4, W8, W12, W16, W20 and W24). Additional benefits are anticipated for relieving anxiety as well as improving mood, functioning and overall quality of life.
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Dose escalation, placebo-controlled phase 1 study to assess the safety and tolerability of CSL324 in healthy adults
Expand descriptionThis is a first-in-human, randomised, double-blind, placebo-controlled study. The study is designed to assess the safety, tolerability and pharmacokinetics of single ascending dose (Parts A and B) and repeated (Part C) intravenous infusions of CSL324 or placebo (saline) in healthy subjects. Subjects will have blood collected at various time points for safety laboratory evaluations, absolute neutrophil count (ANC) and pharmacokinetic (PK) and pharmacodynamic (PD) sampling, and will be assessed for 3 months after infusion to assess immunogenicity and longer term safety. Skin test(s) will be used to assess the anti-inflammatory effect of CSL324 in response to an inflammatory stimulus (Parts A and B). Cerebrospinal fluid will be collected by lumbar puncture from subjects in the highest dose group in Part A after the last infusion of CSL324 or placebo, to determine whether CSL324 distributes into the cerebrospinal fluid. Subjects in Part B will also receive multiple subcutaneous doses of filgrastim to stimulate an increase in circulating neutrophils and provide additional PD data.
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Comparing the efficiency of 2 cold snare polypectomy techniques during colonoscopy
Expand descriptionThis study aims to compare the efficiency of two common procedures for the removal of colorectal polyps. Who is it for? You may be eligible to join this study if: - You are aged 18 years or above, - Are undergoing elective colonoscopy, - And have at least one colorectal polyp of size 9mm or less. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo conventional cold snare polypectomy. This involves inserting the polyp removal device (i.e. the snare) into the colonoscope channel for removing your polyp. Then removing the snare out of the colonoscope channel prior to retrieving your polyp. Participants in the other group will undergo snare-within-the-scope-channel (SWITCH) cold snare polypectomy. This involves leaving the polyp removal device (i.e. the snare) in the scope channel prior to and after removing your polyp, and during retrieval of your polyp. Participants will not know which group they are in until after the study is completed. Procedure time will be measured in all participants and compared across groups. This will enable us to determine which of the two procedures is more efficient.
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A pilot study involving pre-surgery breast Magnetic resonance Imaging (MRI) for target volume delineation for breast- conserving radiation therapy
Expand descriptionThis study aims to provide proof of principle for the use of pre-surgery breast MRI to guide radiation oncologists in determining radiotherapy treatment volumes. Who is it for? You may be eligible to join this study if you are a female aged 18 years or more and have an early stage breast cancer and are scheduled to undergo breast conserving surgery at Liverpool Hospital, NSW. Study details The study will involve participants completing MRI scans in the supine and prone positions and as per their routine care, will also undergo routine radiotherapy planning CT scans. These scans will be performed before surgery, after surgery and before radiotherapy for patients that are also receiving chemotherapy treatment. These images will be used to compare treatment volumes used to determine where the radiation is delivered generated based on the MRI information and based on the standard of care the CT information. Standard practice will be used for treatment, that is treatment volumes will be based on CT with no change in standard practice. It is hoped that this study will provide a proof of principle that pre-surgery MRI can be used to guide radiation oncologists in determining radiotherapy treatment volumes.
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Effect of sugar sweetened beverages on glycaemic control during prolonged sitting periods in sedentary overweight and obese adults
Expand descriptionWe propose to assess the impact of Sugar Sweetened Beverages (SSB) on glycaemic control in 29 sedentary, overweight/ obese participants. Each participant will complete two experimental conditions in a randomised, cross-over design at the Baker IDI clinical research suite, Level 4 of the Alfred Centre, involving (i) 7 hours of uninterupted sitting together with the consumption of water 90 minutes after a standardised breakfast and lunch meal and (ii) 7 hours of uninterupted sitting together with the consumption of a SSB 90 minutes after a standardised breakfast and lunch meal. Glycaemic control will be measured directly through blood samples every 30 minutes and the use of a continuous glucose monitor (CGM) to collect data for a 22 hour period from the morning of each trial condition until the following morning. Resting blood pressure will be taken every 60 minutes throughout both interventions using an automated blood pressure monitor. Endothelial function will be recorded at baseline (0 time), 3 hours (just prior to lunch) and at 6 hours (just after the final blood sample.
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An interventional study to evaluate the effects of formulation on the Pharmacokinetics (PK, the measure of how the human body processes a substance) and adhesion (how well the patch sticks to the skin) of two Donepezil Transdermal Delivery System (TDS, a patch that delivers a drug) formulations, worn for seven days, applied to the backs of healthy participants.
Expand descriptionThis research project is being conducted to look at the adhesion, Pharmacokinetics (PK, how the human body processes a substance), safety and tolerability of formulations of Corplex ('Trademarked') Donepezil TDS (Transdermal Delivery System) when applied to healthy volunteers for seven days. It is anticipated that Corplex ('Trademarked') Donepezil TDS could be a treatment for Alzheimer's Disease.
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The GAINS trial - Growth and Anabolism in Intensive Care Survivors
Expand descriptionICU acquired weakness, the result of catabolism, immobility and critical illness polymyoneuropathy is of significant consequence to long-stay ICU patients. Recent advances have tried to prevent ICU acquired weakness by early mobilisation of patients and optimising nutrition. The loss of lean body mass in critical illness is also associated with misalignment between catabolic and anabolic hormones. One potential treatment may be to provide anabolic support in the recovery phase from prolonged critical illness. Nandrolone is a synthetic anabolic steroid that has greater anabolic (growth) and less androgenic (masculinizing) properties than testosterone. It has previously been used successfully in patients with weight loss in HIV/AIDS, and muscle wasting in patients with chronic obstructive pulmonary disease and end stage renal failure. This is a pilot multicentre randomized placebo controlled trial that will look at the effects of nandrolone given weekly for three weeks, versus placebo, in patients who have lost significant amounts of weight or strength while in the ICU. Our primary outcome will be changes in muscle strength, but we will also be looking for changes in weight and length of stay.
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Falls and Balance in Parkinson's Disease (PD): Comparing Land Based vs Traditional Aquatic and Novel Aquatic Physiotherapy
Expand descriptionThe purpose of this research is to determine if there are changes in your function (for example balance and falling) after completing different aquatic (pool) or land exercises. It is also going to increase the understanding of how people feel about aquatic (pool) and land physiotherapy. One pool group will complete exercises such as stretching, cardiac and general strengthening exercises whilst the other pool group will practise core exercises such as floating, rolling and other specific exercises. The land based exercise group will complete stretching, balance, strengthening and aerobic exercises. Participants will be asked to attend a 1hr class once a week for 12 weeks and will be invited to attend a focus group 3 months after finishing the trial.
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Real life assessment of SGLT2 inhibitors for type 2 diabetes
Expand descriptionThis study will prospectively assess the clinical effects of SGLT2 inhibitors in people with type 2 diabetes who attend RMH diabetes clinic. The primary aim is to determine their effect on HbA1c after 3 months of therapy. We hypothesise that people who take these drugs will on average lower their HbA1c by 0.5%.
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A study on the kinematics on participants with either Mobic or M6C artificial cervical discs.
Expand descriptionThis study aims to compare the range of movement (neck moving forward/backwards) provided by two of the most common cervical disc replacements: MOBIC, M6C artifical discs.