ANZCTR search results

The aim of the study is to determine if Palmitoylethanolamide can reduce diabetic induced neuropathic pain and inflammation over a 8 week period. The study is a randomised clinical trial comparing Palmitoylethanolamide (active treatment) with a control (placeb0). The active treatment is a 350mg capsule taken twice daily (total 700mg/day) for 8 weeks. The outcomes being evaluated in the study are: the severity of neuropathic pain and the characteristics of the neuropathic pain, the effect of the neuropathic pain on quality of life, the use of rescue medications used during the study and the effect of the active treatment on general health pathology and inflammation markers.

The first five years of life is an important period for establishing children’s liking and intake of vegetables. About half of Australian children aged 2-5 years attend formal early childhood education and care, where they consume 40-60% of their daily food intake. Therefore, early care and education settings can play a pivotal role in shaping young children’s dietary intake and there is a need to better support early care settings to provide supportive environments for promoting vegetable intake. The aim of this study is to develop and evaluate a package of initiatives for use in long day care to increase children’s vegetable intake in care. Three initiatives will be developed which support cooks to provide more vegetables on the menu, provide training for educators to encourage children to taste and enjoy vegetables at mealtimes, and support educators to teach a sensory and experiential vegetable-focused curriculum. A factorial experiment will be conducted, which will test all possible combinations of the three initiatives to determine the optimum initiative package for increasing children’s vegetable intake in care. The effectiveness of the initiative package for increasing children’s vegetable intake will be tested in a future randomised controlled trial (reported in separate trial registration).

The purpose of this research project is to identify which factors are important in explaining the benefit obtained after implantation. The ability to understand words and sentences in noise varies across people who have been implanted with the cochlear implant. This study is particularly interested in understanding differences in the way in which cochlear implant recipients can discriminate the important cues of pitch and timing in speech sounds. The discrimination of these cues is essential for speech understanding. The study will investigate the influence of a range of factors on the ability to discriminate these cues; factors such as the anatomy of the cochlea, the health of the nerve fibres in the cochlea and the sound processor MAP settings.

We aim to assess the effectiveness of a new model of care (SC4C) compared to standard GP care in: (a) reducing GP referrals to hospital emergency departments (EDs) and outpatient (OP) clinics for children and young people < 18-years; (b) increasing GP quality of care and (c) confidence in paediatric care, and (d) family trust in primary care, whilst reducing family preference for paediatrician referral; (e) cost-effectiveness and cost-benefit of SC4C; (f) the factors that help or hinder the implementation of SC4C, and; (g) the sustainability and enduring effects of SC4C on our outcomes of interest. Participants include GP practices, GPs, families that choose to participate, practice managers, administrative staff, and the study paediatricians. The trial will be implemented in a stepped-wedge design, with a new practice adopting SC4C month-by-month for the duration of 12 months in total per practice. We expect to find a 4% absolute decrease in GP referrals to ED/OP clinics, increased provision of GP care that is adherent to guidelines for 5 common exemplar conditions, a 10% improvement in GP confidence in paediatric care, and parent confidence in GP care, and a 10% reduction in family preference for paediatrician care.

We aim to compare the efficacy of two novel prevention programs aimed at building resilience to manage worry, anxiety and depression in children, namely an Emotion Regulation-based (ER) program, and a Behaviour Activation-based (BA) program. The Emotion Regulation-based program has a main focus on identifying and understanding emotions, and developing positive emotion regulation strategies to manage these emotions. Developing healthy emotion regulation has been shown to improve wellbeing and successfully reduce anxiety and depression in children. The Behavioural Activation-based program aims to teach children about worry and what behaviours might be helpful to deal with these situations. Students will learn to problem solve ways to manage their worry and increase their engagement in activities that they enjoy and that are important to them. These in turn, will improve their resilience and increase resources for dealing with emotional difficulties. South Australian students between the ages of 8-13 are eligible to participate in this study. Participating schools will be randomly selected to receive one of the two programs, or into a control group whereby students will complete lessons as normal. All participating students are requested to complete questionnaires measuring worry, resilience, anxiety, depression, emotion regulation, behavioural activation, and working memory at pre-program, post-program, and at 6-, 12-, and 24-month follow-up periods. It is expected that participants in the ER and BA programs would report fewer symptoms of worry, anxiety and depression, and greater levels of resilience and working memory at post-program and at 6-, 12- and 24-month follow-up periods, compared to those in the control condition.

Ear disease is a major cause of preventable hearing loss and is very common in rural communities, estimated to affect 1.3 million Australians. Rural community pharmacists are well placed to provide improved ear health care to people who are unable to easily access a general practitioner (GP). The purpose of this study is to apply an ear health intervention to the rural community-pharmacy setting to improve the management of ear disease. Two rural community pharmacies will be recruited for the pilot study. Rural community pharmacists have been identified as highly qualified and easily accessible health professionals in rural and remote communities. They are often the first point of call for many people with minor ailments. Training pharmacists to perform otoscopy (visual examination of the ear canal and the eardrum with an otoscope), tympanometry (testing that measures the function and movement of the ear drum and middle ear) and generate appropriate referrals to general practitioners, may see patients receive ear health care in the most appropriate locations and result in economic savings by avoiding attending emergency departments unnecessarily. An ear health intervention in rural community pharmacy is anticipated to provide additional avenue for patients to access ear care which may result in ear complaints being managed in a more timely manner and thus a reduction in complications with associated financial and societal benefits. Utilising rural community pharmacists to provide an ear health program may improve health outcomes for rural and remote populations.

Antibiotic adverse drug reactions (ADRs), commonly known as "allergies", are a major burden on patients and hospitals. Currently, up to one in four Australian and American patients admitted to hospital will report an antibiotic "allergy" (so-called antibiotic allergy “labels” [AAL]), many of which limit appropriate antibiotic usage. In many instances, patients may undergo challenge with the antibiotic due to incorrect allergy reporting and recording. The nature of a patient’s antibiotic allergy and what antibiotics should be avoided are a common source of confusion for both doctors and patients alike. Penicillin allergy labels in the perioperative space have been associated with inferior patient (e.g. increased rates of periprosthetic infection), hospital (e.g. increased surgical time), and prescribing outcomes (e.g. vancomycin > cefazolin utilization), and conversely in observational and non-controlled studies penicillin allergy “de-labelling” has been associated with improved utilization of beta-lactams and patient outcomes. Further, whilst direct oral penicillin challenge has increasing observational evidence for safety and efficacy, it has not been applied to the perioperative assessment of orthopaedic patients reporting a penicillin allergy. This project is a collaboration between Austin Health, Alfred Health and Royal Melbourne Hospital. The PREPARE study is a feasibility and safety randomized control trial examining feasibility and safety of enhanced antibiotic allergy assessment and penicillin allergy testing in the perioperative setting in surgical patients planned for elective surgery. The PREPARE study will examine the utility of decision support (via smartphone app) utilizing a validated Antibiotic Allergy Assessment Tool9 for patients reporting a penicillin allergy in the perioperative arena in identifying those patients appropriate for a direct oral penicillin challenge in the perioperative clinic. PREPARE hopes to provide a useful point of care toolkit to improve clinician antibiotic allergy knowledge, antibiotic prescribing and medication safety, subsequently benefiting patients, clinicians and hospital networks.

The purpose of this trial is to investigate the acute dose-related effects of intraduodenal administration of calcium alone and in combination with the amino acid, L-tryptophan, on gastrointestinal (GI) hormone secretion, upper gastrointestinal motility, appetite perceptions and ad libitum energy intake in healthy males. We will also evaluate the acute impact of intraduodenal calcium administration on circulating markers of bone turnover (collagen type 1 C-terminal telopeptide (CTX) and parathyroid hormone (PTH)).

Thirty (30) research participants will undertake at-home Sonomat sleep studies, for 3 nights. Screening for sleep disordered breathing with preliminary STOP-Bang questionnaire, Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI) to take place prior to overnight testing. A subset of ten (10) will be referred for concomitant diagnostic PSG and Sonomat studies prior to the first at-home Sonomat recording, whilst breathing room air. This will take place within an outpatient technician-supervised sleep laboratory. Disease severity indices including respiratory function tests and a 6-minute walk test, will be obtained at baseline, 6 and 12 months. The three (3) questionnaires (STOP-Bang, ESS and PSQI), lung function tests and 6 minute walk test will be repeated at 6- and 12-months following sleep studies.

This clinical trial is to evaluate the PK, safety, tolerability and food effects of PRAX-562 in healthy participants aged 18 to 55 years inclusive.