ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31407 results sorted by trial registration date.
  • Study to Examine the Safety, Tolerability and Pharmacokinetics of ascending doses of KNX100 in healthy volunteers.

    This is Phase 1, single treatment, two-period (Part A and B), two-group (Group 1 and 2), open-label study of ascending doses of KNX100 administered to healthy volunteers once or twice daily. Up to 5 dose cohorts, ranging from 30mg twice daily (60mg) to 80 mg twice daily (160 mg) of KNX100 will be evaluated. Approximately 6 male and female adult healthy volunteers will be enrolled in Group 1, and approximately 6 elderly, male and female healthy volunteers, 65 years of age and over, will be enrolled in Group 2. The same set of participants will be involved in both parts A and B. The participants will attend in the clinic and stay inpatient during the dosing. In part A inpatient period for Group 1 is 4 nights and for Group 2 it is 2 nights. There will be approximately 3 weeks rest period between Part A and Part B. In Part B inpatient period for Group 1 is 3 nights and for Group 2 it is 2 nights.

  • Comparison of StrataMGT and Estrogen Cream for Treating Genitourinary syndrome of menopause in Women: A Non-Inferiority Study

    The main goal of the study is to determine the safety and efficacy of StrataMGT in the management of genitourinary syndrome of menopause. The primary objective of this study is to assess the improvement on patient quality of life for patients treating genitourinary syndrome of menopause with 940 compared to standard of care.

  • Is the Sway App a valid and sensitive tool to measure balance in healthy adults?

    The unilateral stance test (UST), where a person is asked to stand on one leg with eyes open and with eyes closed, is commonly used in the clinics. However, it is a crude measure of balance. The Sway App (a smartphone application), has been developed as a tool that claims to be accurate and is readily available. Investigating the validity of the Sway App against the gold standard is important to accurately measure balance in clinics. The primary purpose of the study was to determine validity and sensitivity to change of the smartphone application the Sway App in measuring balance before and after foot mobilisation when compared with the gold standard SMART EquiTest System. It is expected that the foot mobilisation will immediately improve participants’ balance and that the Sway App will prove to be a valid measure of balance sensitive to change in the clinical settings.

  • Effect of water soluble defoamer on colonoscopic bubble score in adult patients undergoing colonoscopy

    This is study aimed at determining whether propylene glycol (a water soluble food additive) is effective in reducing the number of bubbles at colonoscopy, thereby improving visualisation. The Propylene glycol will be administered into the colon via the colonoscope.

  • Multidisciplinary Treatment of Persistent Post-Surgical Pain

    The study aims to explore the feasibility and acceptability of a new outpatient Transitional Pain Management Clinic at St Vincent's Hospital for participants with risk factors for ongoing pain and opioid use after surgery or injury. The intervention will include three sessions with a pain medicine physician and three sessions with a pain physiotherapist over a three month period post-discharge from hospital. The study will also evaluate the relationship between completion of the intervention at the Transitional Pain Management Clinic key outcomes including pain-associated disability, opioid use, and healthcare utilisation. It is anticipated that this clinic will be feasible to implement and acceptable to patients. Given that this clinic is aimed at prevention and early-intervention before the development of persistent postsurgical and posttraumatic pain, significant changes in key pain-associated outcomes are not necessarily anticipated.

  • Does the addition of virtual reality while exercising in ICU increase patient motivation and participation in exercise therapy?

    Exercise is part of standard care in the ICU is associated with positive outcomes for patients including reduced ICU and hospital length of stay (LOS) and improved physical function at hospital discharge. For this study, we will conduct exercise to compare the effectiveness of exercise with and without the addition of Virtual Reality (VR). The aim of this study is to evaluate whether the addition of VR within an exercise session increases a patient’s exercise compliance and whether this translates into improved performance during the sessions. Additionally, the study will aim to explore the risks of infection and the potential health concerns associated with the introduction of VR headsets into the ICU by analysing swabs taken from the VR headset before and after use. It is hypothesised that VR will be an acceptable, feasible and safe method of improving exercise outcomes in adults admitted to ICU.

  • Evaluating the impact of a nurse practitioner-led outpatient memory clinic for people living with dementia and their carers/families: a feasibility and pilot study.

    Nurse practitioner (NP)-led memory clinics have the potential to be complementary models to help address the growing care for those living with dementia and their carers/ families. However, to date there is limited research evaluating the benefit of NP-led memory clinics. This research study will be a prospective cohort pilot design to evaluate a nurse practitioner-led memory clinic, Enhance. Enhance is a NP-led multidisciplinary clinic with the aim of supporting independence, wellbeing and function of people living with dementia. Both people living with dementia and their main carer will be able to clients at the clinic. Currently, most programs supporting people living with dementia and their main carer usually have a one-size fits all approach and rarely take into consideration the individual needs of the clients. The programs will be designed to meet the needs of the clients. Programs will consist of support groups, yoga, art therapy, cognitive simulation and exercise interventions. The NP will design cognitive rehabilitation and cognitive simulation programs tailored to match the cognitive abilities of the individual/ group

  • Optical coherence tomography imaging of the back of the eyes of healthy participants to develop automated measurement software

    Swept source optical coherence tomographers (SS-OCTs) provide high resolution images of the eye and have an enhanced depth of focus (greater scanning depth in tissue) compared to conventional (spectral domain) OCTs. These additional features allow for blood flow characteristics in the retina and choroid to be quantified (OCT Angiography) without the use of any additional dyes, drugs or contact with the eye. This is a prospective data collection study which aims to capture clinical data of the choroid with the Triton swept source OCT including angiography. In order to enhance the vascular characteristics analysis, software tools will later be developed by the project team.

  • Effects of Renally Excreted low-calorie Sweeteners On URinary gluCose Excretion and whole-body glucose homeostasis: A double-blind, randomised, placebo-controlled Trial in healthy and type 2 diabetes participants (RESOURCE-Trial).

    Low-calorie sweeteners (LCS) have been widely used in food and beverages in recent decades. While several international diabetes management guidelines recommend the use of LCS to replace sugar to prevent and manage type 2 diabetes, a recent World Health Organisation (WHO) report highlighted that people who consume LCS regularly may have an increased risk of developing type 2 diabetes. The current study is designed to investigate whether consumption of renally excreted LCS affects the amount of glucose excreted in the urine and blood glucose control in healthy people and people with type 2 diabetes. We will specifically study the most widely used LCS, acesulfame potassium (Ace-K), which is absorbed from the gut and excreted in the urine. We hypothesise that Ace-K is sensed by renal sweet taste receptors to enhance urinary glucose reabsorption and thus impair blood glucose control. Results will be compared with another LCS, sucralose, which is poorly absorbed and is excreted mainly in the faeces, and a flavourless dietary fibre, cellulose.

  • Evaluating protein supplementation in ulcerative colitis (SUPP-UC)

    The purpose of this study is to investigate whether consuming protein supplements are a helpful dietary strategy for people with UC. Protein supplements are widely available at supermarkets, pharmacies and gyms and are recognised for many health benefits including increasing muscle mass and helping the body to repair and heal. We do not know how much protein people with UC need to consume to achieve these health benefits without affecting inflammation. It is hypothesised that protein supplementation will alter body composition, the gut microbiome and disease activity. This study involves consuming daily supplements which contain protein for 24-weeks.

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