ANZCTR search results

The aim of the project is to examine if changes in the maternal diet can reduce the colicky symptoms of infants with infantile colic, resulting in a more settled baby and reduced parental stress and exhaustion. There is limited evidence to support that changes in the mother's diet can lead to a more settled baby despite this being common practice by breastfeeding mothers and health professionals. This study will use rigorous and controlled methods to investigate if the properties of breast milk and infant faeces changes when the mother's diet is altered, which is currently unclear.

The primary purpose of this trial is to investigate the efficacy of StrataXRT in reducing the incidence and rate of onset of radiation dermatitis in head and neck cancer patients undergoing radiotherapy. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with a head or neck cancer for which you are receiving radiotherapy (>50Gy) with or without concurrent chemotherapy or biotherapy. Study details Participants enrolled in this trial will be randomly allocated (by chance) to receive either StrataXRT gel or 10% Glycerine (Sorbolene). The allocated dressing will be applied to the irradiated skin, twice a day until the skin reaction subsides, up to 4 weeks post treatment. Participants will complete a range of questionnaires by interview every week from the start of radiotherapy and four weeks following the completion of radiotherapy, in addition to collecting data on radiation dermatitis symptoms, healthcare costs and side effects. It is hoped that results from this trial will provide information on whether StrataXRT is more safe and effective than Sorbolene for the prevention and treatment of radiation dermatitis in head and neck cancer patients undergoing radiotherapy.

This study aims to investigate the effectiveness, safety, tolerability and blood levels, of twice daily ZYN002, in addition to regular seizure medication, for 12 weeks in 180 adults with partial onset seizures. This will be done by analysing a daily seizure and skin irritation diary, drug levels in the blood at various times following drug administration, and side effects. Skin at the application sites will be checked to see if there is any irritation or reactions present after applications. Who is if for? You may be eligible to join this study if you are aged between 18 and 70 years, have epilepsy with partial onset seizures and are currently on a stable regimen of AED(s). Study details: This study will investigate two doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes a screening visit; a baseline period of up to 8-weeks; a 12 week study treatment period; dose reduction at Week 13 and 14; and an end of study (EOS) visit at Week 15. Participants should fast prior to four study visits. Participants will be instructed to record their seizure frequency and type in their daily diary. During the baseline period, participants will record seizures in the daily diary, and blood samples will be collected at two visits. During the treatment period four clinic visits are required for: blood sampling; review of daily diary, medications, AEs and skin irritation; measurement of blood pressure, heart rate, breathing rate and temperature ; suicide risk; and possibly, a brief physical and neurological exam, pregnancy tests (females only, if applicable) and an ECG. Participants withhold their morning application until after blood sample collection at these visits. Two additional clinic visits are also required for blood sampling. Additional out-patient visits may be required if there is skin irritation present at the application site.

The study will compare the safety, tolerability and pharmacokinetics (the levels of drug in the blood) of 3 drugs when given intravenously (into a vein). The drugs tested are: *a new drug called ABP 959, *a marketed drug called Eculizumab (Soliris registered trademark) approved in United States (US) *a marketed drug called Eculizumab (Soliris registered trademar) approved in European Union (EU) The study is to test that these drugs behave the same in the body, for example, produce the same drug levels in the blood. who is it for? You may be eligible to join this study if you are a healthy male 18 to 45 years of age, inclusive. Non-Japanese subjects will have a BMI of 18.0 to 30.0 kg/m2, inclusive, at screening and check-in. Japanese subjects must have a BMI of 18.0 to 25.0 kg/m2, inclusive, at screening and check-in. Trail Details Participants in this study will be randomly (by chance) allocated into one of three groups to receive either: - ABP 959 300 mg intravenously once only. - US approved Eculizumab 300 mg intravenously once only. - EU approved Eculizumab 300 mg intravenously once only. All participants will be followed-up at 50 days post allocation to one of the three drugs used in this trial.

This study aims to obtain a real-time gas profile of the entire gastrointestinal tract of healthy human volunteers on a standardised diet using a novel medical device entitled “human gas capsule”. The clinical trial will also evaluate the viability of the gas capsule in the human body, accessibility of the graphical user interface for the data acquisition system and the reliability of the data analysis.

Pulmonary rehabilitation is a highly effective intervention for people with COPD. However, attendance to pulmonary rehabilitation programs remain to be poor throughout the world. It may be possible that attendance to pulmonary rehabilitation may improve if rehabilitation is implemented at a much earlier time frame such as during an acute exacerbation of COPD or immediately after. This trials aims to investigate the impact on uptake and completion rates when pulmonary rehabilitation is implemented at these various time frames (during hospital admission, 4 weeks and 8 weeks post hospital discharge). Secondary outcomes include physical function, mortality and number of hospital readmissions.

This project aims to investigate the use of a mobile application (app), and a wearable activity tracking device to support patients in preparing for and recovering from Total Knee Replacement (TKR) surgery. This study will test whether the TKR program, a mobile guide to surgical preparation and recovery, including a wearable activity tracking device, can assist TKR patients and their carers by delivering a) information and assistance to patients in their preparation and recovery from Total Knee Replacement (TKR) surgery, b) and a portal for clinician care teams (e.g. surgeons and physiotherapists) to support and monitor patient progress. The project will evaluate the TKR platform through a Randomised Control Trial (RCT), conducted at multiple trial sites in New South Wales and Queensland. The project will compare existing service delivery models with models enhanced by the proposed TKR platform technology. Qualitative and quantitative analysis will be conducted.

This study will investigate a novel treatment for Mild Cognitive Impairment in older adults. We will explore if the dietary supplement creatine (Cr) is able to enhance the effects of computer-based cognitive training. The study will randomly allocate 50 eligible participants into one of two groups: cognitive training and Cr, or cognitive training and placebo (Maltodextrin). All participants will take part in a 12-week cognitive training program involving twice- weekly sessions, while Cr/placebo will be taken at home on a daily basis. Cognitive training incorporates games and tasks that target various cognitive domains such as memory and attention, allowing for graded and progressive increases in difficulty. Creatine (Cr) has been successfully evaluated across a range of neurological, neuromuscular and medical conditions. It is a naturally occurring compound that is acquired from high protein foods such as meat, and can also be taken as a dietary supplement. Cr is thought to aid effective brain functioning through its impact on a particular neurotransmitter, glutamate. Both cognitive training and Cr have shown positive effects on cognitive functioning in prior research, however to-date they have never been combined as a therapeutic bundle. In this trial, participants and all clinicians involved will not know whether the participant is taking Cr or placebo, in order to keep the results objective and unbiased. We hypothesize that combining cognitive training and Cr will be more effective at improving cognitive functioning and other relevant outcomes than cognitive training and placebo. We will assess for improvements via standardized neuropsychological tests, self-report measures and non-invasive at-home sleep measurement which will be conducted before and after the intervention.

School canteens represent an ideal setting in which to deliver public health nutrition strategies given their wide reach, frequent use and access by children. Online lunch ordering services in school canteens represent an attractive opportunity to deliver public health interventions to improve healthy canteen purchases at scale with high fidelity. The aim of this study is to assess the efficacy of an online intervention in reducing the total energy, saturated fat, sodium and sugar content of online lunch purchases for primary school students. The study will employ a cluster randomised controlled trial design, with schools currently using an online canteen ordering system randomised in a 1:1 ratio to receive either the intervention or control (standard online ordering only). The intervention will include the evidence based strategies shown to influence healthy food purchasing (availability, menu labelling, placement and prompting). The intervention will be assessed through between group comparison of nutritional analysis of purchasing data automatically recorded by the online ordering system over a 2 -month period post-intervention commencement.

Physical inactivity is significantly higher among Indigenous populations and is a strong predictor for chronic disease which affects Indigenous people disproportionately. This project will evaluate a culturally-based physical activity intervention in Indigenous communities in Far North Queensland.