ANZCTR search results

This is a Phase 1, open-label, cross-over, randomized, study in healthy subjects conducted in two parts. Part A of the study is a three-way cross-over, partially randomized (for the first two treatment periods) design to evaluate the PK, safety, tolerability and PD of donepezil administered from two different formulations of a TDS (Donepezil TDS LF 50 cm2 and Donepezil TDS HF 50 cm2) compared to oral donepezil (Aricept). Part B of the study is a two-way cross-over, randomized design to evaluate the adhesive properties, safety, tolerability and PK of a larger donepezil TDS (either Donepezil TDS LF 150cm2 or Donepezil TDS HF 100cm2) with two different backing laminate compositions.

The primary purpose of this study is to determine whether simple mouthwashes can decrease symptoms of poor appetite, taste changes, nausea and vomiting due to chemotherapy. The study also aims to predict which patients will develop the most symptoms based on genetic and taste bud counting tests. Who is it for? You may be eligible to join this study if you are aged 18-85 years and due to receive intravenous chemotherapy of cyclophosphamide or 5-FU. Study details Prior to the first cycle of chemotherapy, genetic characteristics of each participant's taste will be tested using saliva samples, and the number of taste buds on the tongue will be counted. After 2 cycles of chemotherapy, participants will be asked to rate their symptoms of appetite, taste changes, nausea and vomiting. Patients with these symptoms will then test 6 different simple mouthwashes, including salt, sodium bicarbonate, sugar, ginger and peppermint oil, in a random order for 1 day per mouthwash. Patients will be asked to rate the effectiveness of each of the mouthwashes in reducing symptoms via questionnaire. It is hoped that these simple mouthwashes may be able to minimise symptoms, thus improving chemotherapy patient well-being, potentially increasing oral intake and thereby improving nutritional status.

The primary aim of the project is to evaluate the effectiveness of oral probiotics for the prevention of mastitis in lactating women. Secondary aims will assess maternal breastfeeding outcomes, infant infections including gastroenteritis, and the acceptability of a novel mobile app. The primary hypothesis is that regular ingestion of probiotics by women in the first two months following birth will decrease the incidence of mastitis in lactating women. The secondary hypotheses are that exposure to probiotics may also confer a benefit to breastfeeding mothers and reduce risk of infection among infants, particularly gastroenteritis.

The major focus of the study is to assess various key aspects of Abraxane-related neurotoxicity in cancer patients, including neurophysiological assessment to ascertain the prevalence and severity of neuropathy and careful assessment of the extent of functional impairment. Who is it for? You can join this study if you are aged 18-75 years and are scheduled to undergo chemotherapy with either one of the following drugs; abraxane, oxaliplatin or paclitaxel for the treatment of your cancer. Trial details In this study, the decision to commence abraxane treatment will be made by the treating oncologist rather than by the investigators. Measures of neuropathy severity, nerve function, quality of life and physical function will be obtained in all subjects at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment. This study will provide information regarding the prevalence and functional impact of neuropathy as well as providing insights into the potential mechanisms of neurotoxicity due to Abraxane. Comparative testing in a cohort of patients treated with oxaliplatin and paclitaxel will provide information regarding the severity of neurotoxicity in abraxane-treated patients.

Aims: - To determine whether the Integrated Cognitive & Sensory Program (ICSP) can reduce behavioural and psychological symptoms experienced by residents living in a nursing home. - To explore care staffs’ experience during the program, including changes in knowledge and behaviour used to address behavioural and psychological symptoms of residents. Hypotheses: For residents: 1. The ICSP will reduce the levels of agitation, anxiety, irritability, apathy and occupational disruptiveness. 2. The ICSP will reduce the levels of total behavioural and psychological symptoms. These will be demonstrated by the change in mean scores of the Neuropsychiatric Inventory-Nursing Home Version completed before and after intervention. For care staff: 1. Care staff will demonstrate an increase in knowledge of the cognitive, sensory and trauma-related needs of residents. 2. Care staff will demonstrate positive changes in their ability to identify, anticipate and address resident's behavioural and psychological symptoms. These will be demonstrated by a pre and post intervention knowledge questionnaire, as well as group interviews/ focus groups and auditing care files.

Background: Obstructive sleep apnea (OSA) reflects variable overlap of several quite different causal mechanisms. Some patients have obesity-related upper airway narrowing as the major cause, while for others intrinsic respiratory control abnormalities, ineffective upper airway muscle responses and interactions with arousal appear to play the major role. CPAP, the gold standard treatment for OSA, effectively overcomes upper airway anatomical deficiency. It is effective in patients who successfully use it but is burdensome and long term adherence remains poor. Thus, more appropriate treatment strategies are urgently needed for OSA. This will require strategic change to current diagnostic and treatment practices to achieve optimal long-term treatment outcomes. To succeed, this approach requires clinically validated practical methods to identify respiratory phenotypes, followed by personally-tailored treatment to best target the patient’s particular underlying causal factors using CPAP or alternatives as indicated by phenotype testing. The study aims to demonstrate the clinical utility of respiratory phenotyping for achieving improved treatment outcomes compared to current best-practice care. This main study will identify patients with unstable respiratory control who are most likely to benefit from O2 treatment, and more complex phenotypes who may benefit from alternative or combination treatments. Patients with a favourable single night O2 treatment response will be enrolled into a proof-of-concept multicentre, randomised controlled cross-over trial of 1 month of oxygen versus 1 month of CPAP (control) treatment to examine 1 month treatment outcomes (ACTRN12615000069550). Patients with a partial response to O2 and who demonstrate excessive awakening responses will be invited to participate in a pilot study of O2 plus sedative combination treatment (ACTRN12615000858594).

A two-arm cluster randomised controlled trial will be conducted examining the effectiveness of the Learn to Be Safe with Emmy and Friends protective behaviours program as compared to a waitlist control group in Queensland, Australia. Participants will be children in first grade classrooms at three locations. The Learn to Be Safe with Emmy Program consists of 5 one-hour weekly sessions teaching protective behaviour concepts such as emotions, safe/unsafe secrets, private/public body parts, early warning signs and disclosure networks. Waitlist control students will participate in educational activities as normally scheduled. Data will be collected at baseline, 6 weeks post-baseline (intervention completion) and 6 month follow-up for both conditions, with additional 1 year, and 18 month follow-ups for the program condition. Outcomes will include protective behaviours knowledge, intentions and skill.

Fatigue can impair standing balance and functional task performance in older people. We have recently found that general fatigue (induced by repeated sit-to-stand movements as fast as possibly until exhaustion) impaired movement control and foot positioning before and after negotiation of low-level obstacles in older people while walking. However, it is not known whether more ecological aspects of general fatigue may similarly impair balance and mobility and increase the risk of falling in older people. This study will determine whether a busy day of physical activity ("real world" fatigue) impacts balance and mobility measures in older people, compared to a more restful day.

This is a study to see if add-on peginterferon-alfa (pegIFNa) can help lose hepatitis B surface antigen in patients who have chronic hepatitis B and treated with longterm nucleotide analogue therapy. We hypothesize that in participants under long term viral suppression with potent oral therapy nucleoside analogues, addon pegIFNa will reduce serum HBsAg levels and lead to HBsAg loss. We propose an investigator initiated proof of concept study to evaluate the efficacy of add-on pegIFNa therapy in patients who have been treated with tenofovir or entecavir for at least 18 months Those suitable will be treated with a minimum 24 weeks of pegIFNa. Depending on their response, pegIFNa therapy may be extended for up to 48 weeks or ceased.

This study aims to investigate the effectiveness of an online based behavioural family interaction program. Behavioural family interaction programs are the treatment of choice for conduct problems in children. However due to issues of 'reach' (i.e geographical) and time restrictions not all families are able to access this treatment. Online based interventions have the potential to overcome these barriers and provide families with better access to treatments that would otherwise be unavailable. The aim of this current research is to evaluate whether a online based behavioural family interaction can lead to an increase in prosocial behaviour and effectively reduce aggression and anti-social behaviour comparable to standard behavioural family interaction programs which are usually delivered face to face in a clinic setting. This online based behaviour family interaction program aims to teach parents to modify unhealthy parenting practices by targeting negative reinforcement contingencies operating in the family. Parents through accessing modules in a virtual clinic and via follow-up phone calls with a clinical psychologist are taught to encourage good behaviour by giving positive reinforcement and rewards, and discourage bad behaviour through the provision of consistent, emotionally neutral punishment. It is hypothesised that families receiving the online based program will show comparable improvements in levels of disruptive behaviour, decrease in parental stress and improvements in parenting behaviour to those receiving face to face therapy.