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How many people suffer from bowel problems following surgery for colorectal cancer, and what treatments are the best for managing these problems?
Expand descriptionColorectal cancer is the third most common cancer worldwide with 5,000 patients in Australia being diagnosed with rectal cancer per year. Over half of those patients will undergo major resectional surgery. Low Anterior Resection Syndrome (LARS) is a consequence of this surgery and describes a constellation of bowel symptoms including urgency, faecal incontinence, stool clustering and incomplete evacuation. The purpose of this study is to determine: a) if sacral nerve modulation and/or transanal irrigation will reduce the severity of LARS symptoms in patients who underwent anterior resection surgery when compared to an optimised conservative treatment, and b) understand more about how LARS changes over time. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with rectal or sigmoid cancer and has received a low or high anterior resection in the last 10 years. Study details There are two parts to the POLARiS Study. In the first part of the study, all participants will complete surveys every three months over a two-year period regarding their quality of life and bowel symptoms. These surveys will take around 30 minutes to complete the full set of questionnaires at each timepoint. For participants who have major symptoms, they can progress to part 2 of the study, if they wish, where they will be randomly placed (by chance) into one of 3 treatment groups: - Sacral nerve stimulation, called neuromodulation, involving a minor surgical procedure under anaesthetic to insert a wire close to the sacral nerve, which is in the lower part of the back above the buttocks. - Self-administered bowel flushes, called transanal irrigation, completed at home every 1-2 days for 24 months. - Optimised Conservative Management with a clinician. Participants who progress to part 2 of the study will complete questionnaires designed to capture health-related quality of life at baseline and 3 monthly throughout the 24-month follow-up period. It is hoped that this study will see how well the treatment for LARS works and to determine if there is a ’best’ treatment overall. Note: this brief summary is intended for lay audience.
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The impact of hamstring muscle length during isometric strengthening exercise on muscle structure and function adaptations
Expand descriptionIn running-based sports, hamstring strain injuries (HSIs) are one of the leading causes of time lost from competition for athletes. HSI also has a high reoccurrence rate, with the risk of sustaining a HSI only increasing with a history of previous HSIs. Training interventions that load the hamstrings while they lengthen, known as eccentric strengthening exercises, have demonstrated the ability to reduce HSI incidence by modifying the hamstring internal structure (known as muscle architecture) and strength of the hamstring muscle. Eccentric strengthening exercises are believed to be effective as they occur where the muscle is being stretched, mimicking the hamstring position where most HSI occur. As such, hamstring eccentric strengthening protocols have been recommended and attempted to be adopted by many professional sporting organisations. However, a common adverse side effect of eccentric strengthening exercise is muscle soreness, stiffness and tenderness, which often persists for 24-72 hours post-training. As a result, compliance with eccentric strengthening exercise programs can be poor. Isometric strengthening exercises, where the muscle is loaded but does not change in length, is associated with less muscle soreness and has been proposed as a possible alternative to eccentric strengthening exercise due to the ability to still train the hamstrings in a lengthened muscle positions. However, there is minimal evidence surrounding the impact of isometric strengthening exercises on hamstring muscle structure and strength. Thus, the effect of isometric strengthening exercises at lengthened muscle positions on markers of HSI risk is unknown. This proposed project will determine if an isometric strengthening exercise intervention can lead to favourable adaptations in the structure and function of the hamstrings.
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Assessing treatment effectiveness of the 'Repurposing-Drugs-in-Oncology' (ReDO) protocol for cancer: The ReDO cancer treatment study
Expand descriptionBackground The ReDO protocol is an abbreviation for ‘Repurposing Drugs in Oncology’, which is an ongoing worldwide project to find off-patent drugs that have anti-cancer effects. The ReDO protocol consists of multiple medication and nutrients, which are already approved by the FDA and TGA and have been used individually clinically for decades for a variety of clinical conditions. The Study This trial will be one of a number of clinical trials around the world to use a combination of medications and supplements to see if the ReDO protocol has any effects on cancer status. Each trial uses their own unique combination of medication and nutrients. This trial will use a combination of 19 medication and nutrients. Cancer status is measured by Circulating Tumour Cells (CTC) found in the blood, other cancer markers and standard diagnostic tools such as imaging. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with any cancer, and are able to come to the Willow Vale Clinic at the Gold Coast in QLD. Study details All participants in this study will be asked to commence use of 19 medications/supplements, one at at time, over a period of two months. Once participants have successfully used all medications/supplements, they will continue to take these for three to six months. Throughout this time, participants will be followed up via blood tests, scans, and questionnaires to monitor side effects, cancer status and quality of life. It is hoped that this study will systematically investigate the effectiveness of the updated ReDO protocol, consisting of 19 medication and nutrients, on cancer cell count, a biomarker for cancer status togather with other standard diagnostic tests.
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Evaluation of two dietary patterns in people with depression: A proof-of-concept trial
Expand descriptionOPTIMISM is a 4-week double-blind placebo-controlled feeding trial in 44 adults with a major depressive disorder. The study aims to investigate the effect of two dietary patterns on depressive symptoms, other psychological endpoints and various biological endpoints to understand potential mechanisms. All meals and snacks will be provided to participants for the duration of the study. Study visits will be conducted at baseline and week 4 at either the Health Education and Research Building (HERB), Barwon Health, Geelong, or at the Alfred Centre, Monash University, Melbourne.
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A Phase I Randomised, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect of Food on the Bioavailability of SKY-0515 in Healthy Volunteers
Expand descriptionThis is a randomised, double-blind, placebo-controlled, single ascending dose (SAD), multiple ascending dose (MAD) multi-cohort study to assess the safety and tolerability of SKY-0515 and how this drug acts in the body in healthy volunteers. SKY-0515 may be indicated for use in patients with Huntington’s Disease, but a trial of the drug in healthy volunteers is needed before trials in patients with Huntington's Disease can proceed. Who is it for? You may be eligible for this study if you are a healthy male or female volunteer aged 18 to 70 years of age who has met all inclusion criteria and do not meet any exclusion criteria will be eligible to be enrolled. Study details All healthy volunteer participants who choose to enroll in this study will be assigned by chance to receive either a single dose of SKY-0515 or placebo once daily for 14 days. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of SKY-0515 or placebo once daily for 14 days, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of SKY-0515 that can be administered safely without causing severe reactions. Once the dose of SKY-0515 has been determined in healthy volunteers, a trial investigating the safety of SKY-0515 as a treatment for patients with Huntington's Disease may proceed.
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Storage of Digital Mental Health Data for Research: MindSpot Research Databank
Expand descriptionPatient data, including demographics, health information, and treatment outcomes, is routinely collected by MindSpot in accordance with Australian Privacy Principles for highly sensitive health information. This information is used to provide services to patients and their health professionals; report to funders; and for quality assurance and service development. The primary purpose of the MindSpot Research Databank is to allow data that is gathered as part of the routine operations of MindSpot to be stored in deidentified format for research purposes.
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The influence of amitriptyline on human thermoregulation in young healthy adults
Expand descriptionThe influence of amitriptyline on critical thermal limits. Primary objective is to assess whether oral ingestion of amitriptyline influences critical thermal limits and thermal and cardiovascular strain during an acute heat stress. With a secondary outcome to assess whether oral ingestion of amitriptyline influences heat and thirst perception during an acute heat stress. Participants will be asked to complete a humidity ramp heat stress test 7 hours after oral ingestion of either i) 75 mg placebo (PLA) or, ii) 75 mg amitriptyline hydrochloride (AT). The heat stress test involves participants being exposed to 43°C, 20% relative humidity (RH) for 30 minutes before a stepwise increase in relative humidity occurs (4% every 8 min until 64% RH). The heating protocol is a standard methodological approach within the field of human thermoregulation. We anticipate that amitriptyline, an anticholinergic, may decrease sweat output, and as a result exacerbate the rectal temperature and heart rate response to a given heat stress.
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68Ga-NTA-476 Imaging in Prostate Cancer
Expand descriptionThis study is investigating a new agent to be used in PET imaging for prostate cancer, called 68Ga-NTA-476. It aims to find out where 68Ga-NTA-476 goes in the body once it is injected into a person and whether there are any side effects or issues with tolerating the compound. This will be compared to an existing imaging compound which is currently used in Australia called 68Ga-PSMA-11. 68Ga-NTA-476 has been developed and tested in the laboratory; however, this is the first time that it will be tested in humans. Who is it for? You may be eligible for this study if you are an adult older than 18 years of age, you have been diagnosed with prostate cancer and do not have any significant other health issues. Study details All participants who choose to participate will complete a Screening Visit to make sure that they meet the eligibility requirements for the study. Procedures completed during this visit will include demographic details, medical history, physical examination, vital signs, ECG, blood samples to check overall health status and a 68Ga-PSMA-11 PET scan. Following confirmation of eligibility, participants will complete an Imaging Day Visit. During this visit, single dose of 68Ga-NTA-476 will be injected via a vein into the body. Following this, PET scans will be completed at about 1 hour and 2-3 hours. Participants will be observed in the clinical for a total of 4 hours to check vital signs and record any side effects. Between 7-9 days after this, a final study visit will be completed. Blood samples will be collected to check overall health status and the research team will check to see if any side effects were experienced. A total of 10 participants will be enrolled in this study at GenesisCare Murdoch in Australia.
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Can novel far-infrared (FIR) socks keep the feet warm in older adults?
Expand descriptionMany older adults complain of cold feet, but little is being done to alleviate this problem because it is generally not considered limb-threatening. Fabrics functionalised with inorganic additive minerals reflect far-infrared (FIR) rays. Socks made from these ‘FIR’ fabrics have thermo-regulating properties in-vitro. They could reduce discomfort and complications related to cold feet in older adults, resulting in benefits such as reduction of thermal injuries from placing cold feet too close to a heat source or falls from wearing thick socks. We hypothesize that ‘FIR’ socks are effective in thermo-regulation and keeping feet warm.
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Effect of probenecid or ibuprofen on flucloxacillin exposure in healthy adults
Expand descriptionFlucloxacillin is the treatment of choice for proven or suspected Methicillin-susceptible Staphylococcus aureus (MSSA) infections in Australian Therapeutic Guidelines. However, it needs to be given at least four times a day, which can be difficult for patients to adhere to. In this study, we would like to determine whether the use of probenecid or ibuprofen can reduce flucloxacillin dosing frequency. Healthy adult volunteers will be enrolled into two parallel groups (10 people in each group), and prescribed probenecid or ibuprofen, in combination with flucloxacilin.