ANZCTR search results

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

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31018 results sorted by trial registration date.
  • The eCliPSE Project: implementing evidence-based eHealth interventions for comorbid mental health and alcohol/other drug use problems into health and community settings

    eCliPSE is an online clinical portal that facilitates access to evidence-based eHealth treatments for people with comorbid mental health and alcohol/other drug use problems. The present study aims to evaluate the uptake of eCliPSE. We will compare a direct-to-consumer marketing strategy (DtC) and an Integrated Translation and Engagement Model (ITEM) of implementation designed to engage 'users' (i.e. consumers and health services). The study will be a 3-level cluster randomised controlled trial that will compare the uptake of and outcomes of eCliPSE across consumers, services, and LHDs received the DtC intervention alone versus ITEM + DtC together.

  • Profile Study: Food and eating Problems as a predictor for multidisciplinary follow-up care and patient outcomes post-bariatric surgery an observational cohort study

    A cohort study of patients undergoing a medical intervention for weight loss at a bariatric surgery clinic (laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty, intragastric balloon or medication) between March 2019 and March 2020. A food and eating behavioural checklist developed by health professionals at the clinic was used to identify and record problems in the medical checklist. Patient demographic data, outcomes, number of follow-up appointments attended, psychology notes will be accessed via medical records. Data will be analysed to determine whether there is an association between food and eating behavioural problems, adherence to follow-up appointments and adverse events. Results may be used to patient outcomes by improving the multidisciplinary intervention model provided at bariatric surgery clinics.

  • ROBOTIC PELVIC SURGERY (ROPES) I: Robotic Extended Resection for Locally Advanced and Recurrent Pelvic Malignancy: An IDEAL 2B Prospective Study to Design a Phase III Randomised Controlled Trial

    This study aims to assess the current use of robotic surgery for patients with locally advanced and recurrent pelvic cancer. 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 locally advanced or recurrent pelvic cancer that requires extended resection (surgery to remove the lesions) and you are being treated at a centre where a robotic approach for surgery may be offered. Patients will be eligible regardless of whether they do or do not undergo surgery with a robotic approach. Study details This is an observational study, the decision to enrol in this study will not impact upon whether participants are, or are not offered surgery using a robotic approach. Participants who choose to enrol in this study will be asked to consent to their medical data being collected from their records, and will also be asked to complete a series of questionnaires about their quality of life and recovery post-surgery. It is anticipated that these questionnaires will be completed online usually and will take up to 30 minutes. Participants will be asked to complete these questionnaires at 4 timepoints, up to 1 year after their surgery. It is hoped this research will enable researchers to learn about the current use or robotic-assisted surgery, share their findings on techniques and help find out important information to plan and run a future trial to test the benefit of a robotic approach.

  • The effect of a Sigh on ventilator weaning after Cardiothoracic surgery

    This study will explore the impact that a sigh breath will have on ventilator weaning in post cardiac-bypass patients. Cardiac -bypass (a form of extra-corporeal support ) is utilised to allow Cardiothoracic surgeons to operate on the heart for a variety of procedures. Due to the complexity of the case and the impact of bypass on patients, these patients remain intubated at completion of the operation. Weaning from the ventilator occurs in ICU. Patients are required to be haemodynamically stable, with minimal respiratory support before being extubated. A sigh breath (a type of recruitment manoeuvre characterised by a high volume inspiration) has been shown to improve respiratory mechanics. It is hypothesised that patients who take a sigh breath as part of their assisted mode of ventilation will be able to be weaned off of a ventilator quicker. This study will introduce a sigh breath to a randomised sample of elective Cardiothoracic patients in order to demonstrate improvement in the primary outcome “Time to Weaning from mechanical ventilation”. It will examine for secondary outcomes like adverse effects, re-intubation rates and other physiological parameters. Mechanical ventilation is instituted in a variety of patients for respiratory support, to allow for certain procedures, for airway protection (e.g. in Traumatic brain injury). Mechanical ventilation is not without its dangers with longer periods of ventilation associated with increased risks. Clinicians routinely aim to extubate patients as soon as safely possible to mitigate these adverse effects. If Sigh ventilation can be shown to aid in a shorter duration of ventilation in this subset of patients , it may allow for further study into Sigh ventilation’s efficacy in other ventilated patient groups.;

  • Pharmacy-Based Screening and Quality Use of Medicines in Kidney Disease

    The objective of this Pharmacy-based Screening and Quality Use of Medicine in Kidney Disease Trial is to screen for people with or at risk of kidney disease and subsequently optimise the use of medications. The primary hypothesis is that the addition of a Point of Care Testing for kidney function markers to an online CKD risk assessment tool (POCT + QKidney® Risk Assessment; Intervention Group) will result in (i) a significantly increased proportion of newly diagnosed CKD cases and (ii) reduced inappropriate medication use (higher than recommended dose as per kidney function and/ contraindicated medications) when compared to the use of CKD risk assessment alone (QKidney® Risk Assessment; Control Group). Additionally, we hypothesise that there will be a long-term economic benefit resulting from the addition of POCT to CKD risk assessment alone.

  • Flash glucose monitoring and telehealth Rapid Access Diabetes Service (RADS) compared to finger prick blood glucose checking and face to face appointments for adults with diabetes who are undergoing discharge from an acute care hospital.

    Group One: Freestyle Libre blood glucose sensors and consults using telehealth Group Two: Freestyle Libre PRO combined with Freestyle Optium Neo blood glucose finger prick monitoring and face to face study visits. Aim: To compare Flash Libre glucose monitoring paired with Telehealth consultations versus standard SMBG monitoring with face-to-face clinic visits in people with diabetes who are undergoing discharge from hospital. Hypothesis: That, in at least 60 people with type 1 and type 2 diabetes who are being discharged from Royal Prince Alfred Hospital (RPAH) on insulin treatment, those randomised to the Freestyle Libre (Flash) will have favourable effect on glucose levels (time in range (TIR), estimated HbA1c (eHbA1c), hypoglycaemia frequency and glucose variability) compared to the traditional finger prick BGL group over a seven week period after discharge.

  • BiZactTM versus bipolar paediatric tonsillectomy: A double-blinded randomised control trial.

    Tonsillectomy, with or without adenoidectomy, is one of the most commonly performed otolaryngological procedures, occurring in 75 per 10,000 Australian children. The evolution of different techniques and devices throughout the years, along with the contradictory outcome measures, has resulted in there being no international consensus regarding the optimal technique for tonsillectomies and the decision on which technique is used often comes down to the surgeon’s experience and the perceived benefits of the different techniques. In this study, we aim to perform a prospective, randomized, blinded study to compare post-operative pain in patients undergoing BiZact tonsillectomy compared to bipolar tonsillectomy. We hypothesis less pain will be experienced post-operatively in patients undergoing BiZact tonsillectomy.

  • Investigating a combined approach of songwriting, psychology and social media on the mental health of care-partners and people living with younger-onset dementia

    MAPS is an online program which combines music/song writing and psychological therapies with a closed social networking group, for people living with younger-onset dementia (PLWYOD) and their spousal care-partners. The goals of the program are to improve well-being, social connections and coping, with a secondary goal of investigating whether non-cognitive symptoms related to dementia, called neuropsychiatric symptoms (NPS) might improve as part of the program.

  • Classification of Obstructive Sleep Apnoea Severity using Snore and Breathing Sound Recordings in Adult Patients in a Home Setting – Validation with Simultaneous Home Based Polysomnography

    This is an observational study investigating the use of the ResApp SleepCheck algorithms to determine the presence and severity of OSA in adult patients in a home setting. Breathing and snoring sounds recorded using a smartphone are analysed by the ResApp SleepCheck algorithms and compared to clinical diagnosis made via at-home polysomnography.

  • Study Investigating the Safety and Immunogenicity of AB-729 and VTP 300 in Virologically Suppressed CHB Participants

    The study will assess the safety, antiviral activity, and immunogenicity of AB-729 followed by VTP-300 in virologically suppressed CHB participants. The study will enroll 62 stably NA-suppressed participants to receive AB-729 in addition to their NA for 24 weeks to lower HBsAg. Participants will then be randomized into one of two groups. Group A will receive active VTP-300 and Group B will receive VTP-300 placebo in addition to their NA. Participants will remain on their NA and be followed every 2-12 weeks for safety and efficacy assessments through Week 48. Group C an additional arm will assess if the addition of low dose nivolumab (0.3 mg/kg) to the MVA-HBV boost component of VTP-300 will further stimulate reduction of HBsAg after initial treatment with AB-729 followed by the ChAdOx1-HBV prime. If participants meet certain criteria (low ALT, low HBV-specific viral markers) at Week 48, they will stop their NA and be followed every 2-4 weeks for an additional 48 weeks to evaluate for functional cure. If participants do not meet these criteria they will stay on their NA and be followed every 12 weeks for 24 weeks. Participation will be for approximately 79-103 weeks, depending on whether NA discontinuation criteria are met. It is hoped that this study may lead to better understanding of host immune responses against HBV, and potentially facilitate immune control of HBV (functional cure).

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