ANZCTR search results

Study Aim The primary aim of this project is to evaluate the feasibility, acceptability and appropriateness of implementing a comprehensive adherence protocol into the Queensland Children's Hospital Cystic Fibrosis clinic. Study Design This is a mixed method, implementation study design. The four-phase Replicating Effective Programs (REP) framework developed to translate effective health services interventions into community-based settings, will inform implementation. Focus groups and interviews will form the needs assessment (pre-conditions), Descriptive data will be collected throughout implementation and interviews will be conducted post implementation to evaluate the change process. Pre-Conditions Phase: The researchers will review literature, existing adherence promotion interventions, clinic processes and resources. From this, the team will determine the core components of the iCARE intervention and create an implementation strategy that will support translation into the existing LCCH clinic structure and resourcing. Pre- Implementation Phase: The iCARE protocol, business case and draft implementation plan will be presented to the Cystic Fibrosis care team. Focus groups and consumer interviews will be used to gather qualitative data on adherence assessment and intervention and inform the implementation plan. Implementation Phase: All children and family’s accessing the clinic will receive the adherence promotion protocol as part of their routine clinic attendance. The research team will continue to collaborate with consumers and staff to troubleshoot, provide feedback and booster training as indicated. The implementation plan will continue to be modified and refined according to staff and consumer input. The researchers will record all facilitator input via technical assistance and training logs. Retrospective chart audit and a protocol checklist will be utilised to monitor fidelity and uptake of each aspect of the protocol into routine care. Maintenance and Evolution: Following three months of clinic implementation, the implementation process will be evaluated by the research team. Participants (staff and consumers) will be recruited to complete qualitative evaluation of the protocol and its components. Following the completion of the project, it is anticipated that the protocol will continue to be used in the clinic as standard care, if deemed acceptable to staff and consumers and sustainable within the existing resourcing of the clinic.

The purpose of this study was to create a nutrition education website to improve accessibility and immediacy of trustworthy nutrition information targeted at young people with T1D and their families. The website also aims to improve engagement of patients with longer diabetes duration, thereby improving their nutritional management of T1D. The primary aim of this study was to determine the effect of this online nutrition education website on nutrition knowledge (primary outcome), clinical outcomes, and treatment satisfaction, compared to standard care, on patients with T1D and their carers attending the WCH diabetes clinic. It was hypothesised that those who had access to the pilot website would have a higher nutrition knowledge score than those receiving standard care alone.

This is a proof of concept trial to deliver an early pharmacological intervention to enhance sleep spindle EEG features to optimise sleep quality and improve memory in those presenting with subjective memory complaints. Participants will receive a short-acting, non-benzodiazepine zolpidem or a placebo immediately prior to an overnight 8 hour sleep opportunity in a randomised order with a 5 to 10 day washout at the Woolcock Institute’s sleep and chronobiology laboratory using high-density electroencephalography (EEG). It will be hypothesized that memory consolidation will be significantly better with active drug compared to placebo.

In this study we aim to collect dental, saliva, blood and stool samples to characterise the gut microbiome profile of individuals with cardiovascular disease, specifically acute coronary syndrome and chronic stable angina and compare their microbiome profile to that of healthy individuals. Individuals with cardiovascular disease will have an alteration in the composition and functionality of their gut microbiome compared to healthy individuals.

Researchers have begun delivering mindfulness and aerobic exercise training concurrently on the premise that a combination intervention will yield salutary outcomes over and above each intervention alone. An estimate of the effect of combination training on chronic psychosocial stress in a nonclinical population has not been established. The objective of this trial was therefore to assess the preliminary efficacy of combination training for reducing chronic psychosocial stress in a healthy sample, and to establish assurance of protocol feasibility in preparation of a definitive RCT. This trial was designed as a prevention-focused (i.e., primary) intervention to be used by all individuals and not just those presenting with mental health risk factors.

This Phase 1b study is designed to assess the safety and tolerability of repeated topical ocular administration of CMB-012, 2 times per day , in participants with chemical burns of the cornea and/or persistent corneal epithelial defect, to allow a preliminary assessment of a safe and efficacious dose to be studied in further clinical studies.

CHI-541 is a standardized cannabis oil softgel preparation that contains an approximate 26:1 ratio of THC to CBD (2.5 mg THC and <0.25 mg CBD). At present, regulatory approval, physician acceptance, and the utilization of CHI-541 in Phase 2/3 clinical trials for specific indications are hampered by the absence of critical Phase 1 data regarding its safety, tolerability, and PK profile. Therefore, the aim of this randomized, double-blinded, placebo-controlled, multiple-dose study is to rigorously evaluate the safety, tolerability, and PK of CHI-541 in healthy participants.

This is a double blind, randomised, clinical study with a maximum 4-month participant duration with 2 groups (1 active ingredient group and 1 inactive placebo group). Isenolic® is a commercial product standardised for Elenolic acid (ELA). ELA is derived from oleuropein extracted from olive oil and olive leaves. The aim of this study is to assess the effectiveness of an olive leaf extract (standardised for elenolic acid) on reducing cold and flu duration and severity in otherwise healthy adults aged over 18 years, compared to a placebo.

This study aims to investigate the efficacy of oral glucocorticoids in reducing leg pain intensity in people with acute sciatica. Participants will be randomised to receive either active medication (oral prednisolone) or placebo for up to 13 days (from commencement to cessation). We hypothesise that orally administered glucocorticoids will produce a clinically worthwhile improvement in leg pain.

The purpose of this study is to collect clinical data on Colorectal cancer patients with Stage II and Stage III disease and process this on the colorectal cancer data registry in order to generate a personalised care plan summary. Who is it for? You may be eligible for this study if you are a patient with Stage II or III colon cancer and fit for chemotherapy. You may also be eligible for this study if you are a GP monitoring patients with colorectal cancer fitting the inclusion criteria. Study details A personalised care plan summary will be provided during the second consultation visit with the oncologist and has the following components including cancer stage, planned treatment, planned follow-up visits and cancer helpline resources. This care plan summary will be created by your oncologist and will take an additional 10 minutes to generate the care plan from the database and then go through the information with you. You will be requested to complete a questionnaire after completion of your treatment. It is hoped that results generated from this study will help us determine if the provision of a personalised care plan can be extended to other tumour streams to help other patients.