ANZCTR search results

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

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31170 results sorted by trial registration date.
  • Effectiveness of Psychedelic Therapy for Treatment Resistant Depression (TRD)

    We intend to measure the effectiveness of psilocybin when combined with talking therapy for the treatment of Treatment Resistant Depression (TRD) in real world patient groups We will test how effective psilocybin is for TRD and treat patients who have had limited benefit from existing treatments for these hard to treat conditions

  • Integrative Supportive Care Trial to Enhance physical Activity in Malignant pleural effusion (The Australasian Malignant PLeural Effusion (AMPLE)-5 Trial)

    Patients with malignant pleural effusion (MPE) and their carers report high rates of unmet supportive care needs. Multi-disciplinary interventions, specifically addressing nutrition, targeted physical activity counselling, and psychological support are recommended by international guidelines for advanced cancer. This study aims to find out if integrated supportive care involving nutritional, physical activity, and psychological well-being care plans can improve participation in daily physical activity in people with MPE. The study also aims to find out if this multidisciplinary counselling can improve quality of life, malnutrition risk, psychological well-being, and symptoms. Who is it for? You may be eligible for this study if you are aged 19 years or older, and have been diagnosed with a malignant pleural effusion and you are willing to comply with the research procedures. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. The first group will take part in the integrated supportive care program. This program lasts for 12-weeks and includes counselling sessions in week 1, week 4, and week 8. Each counselling session will take about one hour to complete. This includes about 20 minutes each for dietetics, physical activity, and psychological well-being. The second group will will receive standard medical care as per attending physician, with referral to supportive services if indicated. This group will be called by a member of the research team at week 4 and week 8 to discuss any adverse events that have happened to you. Both groups will receive standard medical care from their treating physician throughout the study, including access to support services.

  • A Phase IIb trial assessing a Chinese Medicine for Dizziness and Vertigo.

    Dizziness is a common but poorly defined condition in people, particularly those over 50 years old. In people 50 years or older, the self-reported prevalence of dizziness and vertigo is over 34 percent. The impact that dizziness and vertigo can have on people over 50 is very relevant as it’s linked with conditions such as isolation, depression, reduced self-autonomy and self-control. It can hamper the social, functional, and psychological well-being of those experiencing dizziness and vertigo which in turn, can reduce quality of life. The trial aims to examine the efficacy and safety of the Chinese formula for preventing and treating dizziness.

  • In vitro study of the effects of sugammadex on the measurement of serum concentrations of progesterone in premenopausal women – an assay validation study

    This research project is looking at whether sugammadex interacts with progesterone assay testing, and therefore affects the reliability of progesterone concentration measurements. An interaction at 104micromol/L is reported by the manufacturer of Sugammadex. This research project will look at the accuracy of progesterone assay testing in the presence of various sugammadex concentrations.. This study is important to assess the reliability of data that utilising progesterone assay testing when using sugammadex.

  • Wait a Minute or More: A pragmatic stepped wedge cluster randomised implementation trial assessing a quality improvement program to increase delayed cord clamping for preterm infants.

    Delayed umbilical cord clamping after 60 seconds improves outcomes for preterm infants born before 37 weeks. However, delayed clamping is neither reliably recorded nor routinely implemented across Australian hospitals. This study will investigate whether funded basic, accurate data collection and sharing between sites together with a funded, locally adapted quality improvement program increases the average number of seconds before cord clamping (NSCC) by 30 seconds, compared to funded basic, accurate data collection and sharing alone.

  • Restoration of gut microbiota in Persistent Critical illness using Faecal Microbiota Transplantation (The ROCIT-FMT Trial): a pilot phase I/II trial

    In this prospective, 2 stage interventional pilot study we aim to evaluate the safety and feasibility of FMT as a therapeutic intervention for dysbiosis associated with persistent critical illness, in patients who have been admitted to the intensive care unit (ICU) at a tertiary hospital in Western Australia. Subsequent preliminary evaluations of the efficacy of FMT at restoration of microbial diversity, richness and evenness in the recipient together with important clinical outcomes including the incidence of infection and burden of MDRO colonisation will be secondary endpoints.

  • A Phase 1b, Single-centre, Open-label Study to Evaluate Food Effect and the Drug-Drug Interaction of Omeprazole, Itraconazole and Rifampin on Tinlarebant in Healthy Adult Subjects

    This is an open-label study to evaluate the effect of food and drug-drug interaction with tinlarebant. This study will assess the effect of omeprazole, itraconazole,rifampin and food on the pharmacokinetics of tinlarebant.

  • Patient empowered monitoring in patients with heart failure and kidney disease at high risk of hospital readmission.

    This is a proof of concept trial of a phone application with patient self-monitoring of biometrics in patients with heart failure and kidney disease. This patient population is at high risk of recurrent hospital admissions and require careful monitoring of their health and fluid status at home. The trial will involve the use of a wearable device (smart watch), digital scales and blood pressure machine, in combination with a phone application, to aid patients to self-manage their condition at home. They will be provided with a 24-hour phone service to call for advice and also provides triage to services based on need. The proof-of-concept study will run for 6 months and will evaluate usability, feasibility and acceptability of the model of care.

  • Evaluate the effectiveness of a chocolate intervention as a strategy for menstrual and hormonal contraceptive cycle symptoms management in sportswomen.

    This study will be a feasibility intervention-based Randomised Controlled Trial (RCT) study in menstruating and hormonal contraceptive user sportswomen who experience cycle-related symptoms. The proposed study will consist of a screening stage, an initial stage, a baseline stage covering two menstrual/hormonal contraceptive cycles, and an intervention stage covering two menstrual/hormonal contraceptive cycles. This study will involve dietary supplementation with chocolate with high or low cocoa solids, questionnaires on menstrual and reproductive health, self-monitoring of cycle-related symptoms, training and nutrition, monitoring of body composition, inflammatory markers and sex hormones, and an interview. The investigators hypothesise that chocolate supplementation will help ameliorate cycle-related symptoms, as reported on the Menstrual Distress Questionnaire, and reduce serum inflammatory markers (C-reactive protein).

  • Enhancing allied health for older people in residential care: EAHOP RC

    Complications due to frailty and injury after falls are a significant problem in Residential Aged Care Facilities (RACFs) in Australia. Over 65% of people living in RACFs have dementia which poses an additional challenge when dealing with frailty and falls. The recent Royal Commission into Aged Care Quality and Safety received many submissions highlighting these problems and the lack of allied health and other services available to address these challenges. This project directly relates to addressing recommendations 37, 38, 61 and 69 made in the Royal Commission calling for increased allied health intervention to meet the unmet need in residential aged care. This project will deliver evidence-based allied health interventions to people living with dementia in residential aged care facilities specifically related to frailty and preventing falls. This will be done by utilising existing General Practice networks based at a selected RACF in Canberra to coordinate a suite of evidence-based allied health services, including occupational therapy, physiotherapy, speech pathology, dietetics and optometry to residents in the RACF. We will recruit 60 residents at a RACF in Canberra to be a part of this project who will receive a transdisciplinary allied health intervention consisting of an occupational therapist, physiotherapist, dietitian, speech pathologist, pharmacist and optometrist and allied health assistants. The outcomes of this project will provide a guide for other RACFs in Australia to follow to implement evidence-informed allied health interventions to improve the quality of life of their residents. We will also provide an economic evaluation which will provide evidence to inform funding models for the provision of allied health into RACFs.

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