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Investigating the effect of French bark extract, Pycnogenol, as a supplement to improve exercise performance in a population of cyclists.
Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. While the mechanisms for adaptations can be varied and can include increased energy expenditure, reduced catabolism, and increased protein synthesis, the intended outcome is an increase in the intended adaptations to training. Pycnogenol, a herbal dietary supplement extracted from French maritime pine bark, is widely marketed for its antioxidant effects. Health benefits purported for Pycnogenol include improved cognitive function, endothelial function, and blood pressure regulation. However, the effect of Pycnogenol on exercise performance, or exercise-induced oxidative stress and inflammatory responses is less clear. Consumption of Pycnogenol has been shown to increase serum NAD+ levels and more recently a study demonstrated that French maritime pine bark extract reduced markers of oxidative stress 48 hours post exercise. Substantially more investigation into the influence of Pycnogenol on exercise performance is required to confirm these results, to examine the optimal timing and dose amount of this supplement, as well as to establish the physiological mechanisms that explain the increased time to exhaustion during intense endurance exercise. Therefore, we hypothesize that Pycnogenol, could be a supplement that increases endurance and with greater adaptations when consumed in addition to training. Here we propose a study designed to establish whether Pycnogenol can improve endurance in highly trained Cyclists
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Evaluation of text messaging service on management of post-operative pain in opioid-naïve surgical patients
To evaluate the impact of a persona-based text-messaging service “Nellie” post-discharge on pain management and opioid use following surgery compared to standard care. The null hypothesis is that the use of Nellie does not reduce the use of opioids post-operatively in opioid-naïve patients undergoing surgery. The primary objective of this study is to evaluate the impact of a persona-based text-messaging service “Nellie” on the patient reported outcomes (PROMs) and opioid use after surgery compared to standard care. Patients are invited to take part in a research project to understand if SMS text messages could be helpful to them after surgery in understanding and managing their pain. This is because they maybe prescribed strong pain medication(s) to manage pain after surgery. Patients will receive SMS messages about managing pain once they have returned home from hospital. These messages can be about general pain information or to check-in with a choice for them to reply. The questions will ask about their pain after surgery their pain medication use and if any unused pain medications were returned to the local pharmacy. The messages will stop at day 30 after returning home. There will be two groups in the project; each group will be sent SMS messages at different time points. Patients will randomly be assigned to one of the two groups.
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Evaluating the impact of blood-based biomarkers on clinician diagnostic confidence and management in a Memory Clinic setting: A before and after study
The slow build-up of two toxic proteins called amyloid and tau, are believed to be the cause of Alzheimer’s disease (AD). Recently, there have been global breakthroughs in the ability of new blood-tests to detect a toxic form of the tau protein implicated in AD pathology (pTau181). It is suggested that a blood-test targeting this protein will improve diagnostic accuracy, particularly in early-disease stages, allowing for the earlier start of treatments. To date, we have yet to determine whether providing such a test result to the treating clinicians of people attending a memory clinic influences clinician diagnostic confidence and management. We aim to address this gap for people attending a Memory Clinic where there is diagnostic uncertainty or mild cognitive impairment.
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Clinical phenotypes and incidence of Anti-Neutrophilic Cytoplasmic Autoantibodies (ANCA) positive renal vasculitis in Queensland: The effect of environmental and occupational exposure
This is a retrospective multi-centre observational study that aims to determine the effect of environmental and occupational exposures on clinical phenotypes and incidences of ANCA positive renal vasculitis in Queensland.
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A First-In-Human, Dose Escalation and Expansion Study of GQ1007 Alone and in Combination with Envafolimab in Subjects with HER2-expressing Advanced Solid Tumors
This is first in human study of a new treatment drug, GQ1007 for patients with cancer that involves HER2-expression in solid tumors. This study aims to determine the maximum safest dose of GQ1007 that may be administered to cancer patients, firstly as a single therapy and secondly in combination with envafolimab therapy. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with any breast cancer, gastric cancer, gastroesophageal junction cancer, urothelial cancer, salivary gland carcinoma, gallbladder carcinoma, cholangiocarcinoma, or non-small cell lung cancer that involves solid tumours with HER2 gene expression. Additional heart and cognitive function tests will be conducted to determine suitability for enrolment. Study details This study will be conducted as four substudies (Parts 1-4), participants who choose to enrol in this study will only participate in one of the substudies. Participants enrolled into Parts 1 and 2 will receive subcutaneous injections (into the skin rather than a vein or muscle) of GQ1007 every 2 weeks for 2 years. Participants enrolled into Parts 3 and 4 will also receive subcutaneous injections of GQ1007 every 2 weeks for 2 years, and will also receive subcutaneous injections of envafolimab every 4 weeks for 2 years. All participants will undergo additional tests (including blood tests, echocardiograms and imaging) to assess the effect of the treatment on their cancer, and to monitor for side effects. Study participation is anticipated to be a maximum of approximately 26 months (up to 28 days for screening, up to 2 years of study treatment, and a Safety follow up Visit at 30 (+7) days after the last dose of any study treatment) plus long-term follow-up for subsequent anticancer therapy and overall survival. It is hoped this research will determine whether GQ1007 is safe and tolerable for patients with various cancer types. If GQ1007 is found to be safe, larger studies can then be conducted to determine the efficacy of this treatment which may then lead to improved quality of life and overall survival for future cancer patients. A Safety Review Committee (SRC) consisting of the Investigators and the Sponsor’s designated representatives will monitor safety throughout the study and make dose escalation decisions (including any decisions to explore intermediate, higher, or lower doses and/or alternative dosing schedules).
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Functional outcomes for persons with above knee amputation fitted with different prosthesis types.
The purpose of this study is to determine the feasibility of conducting a longitudinal cohort study at Sir Charles Gairdner Hospital (SCGH) to assess functional outcomes of persons with above-knee amputation with different prosthesis types. Each participant will undergo one assessment which will include a functional gait assessment, completion of questionnaires to measure balance confidence and quality of life, and a balance assessment using the SMART EquiTest system. It is hypothesised that it will be feasible to conduct a longitudinal cohort study at SCGH.
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Case series examining the use of depot buprenorphine formulation Buvidal® in the management of patients with co-occurring opioid dependence and chronic pain
The study examines patient outcomes and experiences in the use of depot buprenorphine formulation (Buvidal) in the treatment of patients with concurrent opioid dependence and chronic pain conditions using a prospective case series. Specifically the study will compare outcomes and experiences of patients before and after transfer from other opioid medications to Buvidal® treatment on the following measures: 1. Patient reported pain outcomes including measures of pain severity and pain interference using the Brief Pain Inventory (primary outcome); 2. Secondary outcomes include patient reported substance use (ATOP), general health and quality of life outcomes (PROMIS-29), adverse events, and patient satisfaction measures (TSQM), and use of other medications for pain management. These outcomes will be examined at baseline (in period before transferring to depot buprenorphine), and at 4 weekly intervals for 12 weeks following the first dose of depot buprenorphine, during which depot treatment will be continued. A prospective case series of patients treated in South East Sydney Local Health District Drug and Alcohol Services and Prince of Wales Hospital Department of Pain Management.
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Investigating the effect of French bark extract, Pycnogenol, as a supplement to improve exercise performance in a population of CrossFitters.
Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. While the mechanisms for adaptations can be varied and can include increased energy expenditure, reduced catabolism, and increased protein synthesis, the intended outcome is an increase in the intended adaptations to training. Pycnogenol, a herbal dietary supplement extracted from French maritime pine bark, is widely marketed for its antioxidant effects. Health benefits purported for Pycnogenol include improved cognitive function, endothelial function, and blood pressure regulation. However, the effect of Pycnogenol on exercise performance, or exercise-induced oxidative stress and inflammatory responses is less clear. Consumption of Pycnogenol has been shown to increase serum NAD+ levels and more recently a study demonstrated that French maritime pine bark extract reduced markers of oxidative stress 48 hours post exercise. Substantially more investigation into the influence of Pycnogenol on exercise performance is required to confirm these results, to examine the optimal timing and dose amount of this supplement, as well as to establish the physiological mechanisms that explain the increased time to exhaustion during intense endurance exercise. Therefore, we hypothesize that Pycnogenol, could be a supplement that increases endurance and with greater adaptations when consumed in addition to training. Here we propose a study designed to establish whether Pycnogenol can improve endurance in highly trained CrossFitters.
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Kids First Caring Dads and ODysseY House (KODY), an all-of-family response to co-occurring substance misuse and domestic violence: trialling an enhanced intervention with men and their family members to investigate its impact on safety and wellbeing for women and children
The KODY research is a three-year quasi-experimental study to trial a service response to the problem of domestic and family violence (DFV) where men using violence are also using alcohol or other drugs (AOD). The aims are to evaluate the effectiveness of the KODY program in supporting safety for mothers and children from DFV and other AOD-related harms, to deepen understanding of the combined impact of DFV and AOD, and identify the implications for service responses. The KODY program brings together a groupwork program for fathers who use violence (Caring Dads), incorporating specialist AOD content, with case coordination between Caring Dads and AOD practitioners, support for mothers and children, and with a linked intervention for all family members (children, mothers and fathers), including parenting education and support and recreational and therapeutic groups for children and their families.
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A controlled trial to evaluate a pharmacy prioritisation tool in an older adult inpatient setting
Early identification of patients at high risk of medication harm can allow for timely and targeted patient review and proactive monitoring to mitigate harm. An emerging approach involves predictive risk models, which use statistical algorithms to quantify the probability that an individual patient will experience medication harm, and facilitate timely, patient-specific interventions (e.g. therapeutic drug monitoring and deprescribing). A number of risk prediction models for medication harm, in various health settings, have been reported. A locally developed risk model, the Adverse Inpatient Medication Event Model (AIME), was developed and internally validated at the Princess Alexandra Hospital (PAH) using general medical and geriatric patient data from July to December 2017, which has been published in the British Journal of Clinical Pharmacology (Falconer, N, et al. Development and validation of the Adverse Inpatient Medication Event model (AIME). Br J Clin Pharmacol. 2021; 87: 1512– 1524.) where the AIME model evaluated and modified (using frailty as a variable), in a multisite retrospective study conducted using data from Princess Alexandra Hospital (PAH) and Logan Hospital (LGH). Frailty - which can also increase risk of medication harm and poor patient outcomes was also added to this model. In the new study incorporating frailty we modified the AIME model and tested its predictive performance in 3948 patients with median (IQR) age 67 (28) years. The mean (SD) HFRS was 6.2 (+/-5.9). When the HFRS was divided into three groups, 51% of patients were in the low-risk, 40% in intermediate-risk and 9% in high-risk group. A total of 187 (4.7%) patients experienced one or more medication harm events, including bleeding and severe hypoglycaemia. As a measure of predictive accuracy, the area under the curve (AUC) of the AIME-FRAIL was 0.79 (95% CI: 0.76-0.83), an improvement on the AUC of 0.70 of the original AIME model. Given this improved performance, we plan to conduct a pragmatic impact evaluation of the AIME-FRAIL model in the subacute medical setting (Geriatric and Rehabilitation Unit at PAH). We will use the model to estimate patient risk of medication harm (expressed as a risk score) and pharmacists will then use this score to prioritise their patients for timely and comprehensive medication review, and undertake any other necessary actions to avoid medication harm.