ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Evaluating the effects of the Let’s Read professional development program on the literacy promoting practices of early childhood educators

    Let’s Read is a professional development program for early childhood educators that aims to improve their emergent literacy promoting practices and help them talk to families about their child's emergent literacy. This project aims to evaluate the effectiveness of the Let's Read professional development program through a cluster randomised trial. Participants will be educators working with children aged birth to five years in the Early Childhood Education and Care centres taking part in the study, and parents/guardians of children attending the participating centres who speak and understand English. Educators working in centres who are allocated to receive the Let's Read professional development will complete a Let's Read eLearning course, and then they will receive ongoing support from a literacy skills coach who will assist them in carrying out Let's Read strategies in their work. Coaches will also receive training on how to support educators to carry out Let’s Read. Pre and post intervention measures of changes in educators' emergent literacy promoting practices, and their knowledge, understanding, skills, values, and confidence in relation to emergent literacy and engaging with families about emergent literacy, will be taken. Pre and post intervention measures of changes in parents'/guardians' attitudes towards emergent literacy and engagement in literacy promoting activities with their children will also be taken. These results will be compared with a control group of educators and parents/guardians from centres who did not receive the intervention. We hypothesise that the Let's Read professional development program will enhance the emergent literacy promoting practices of educators working in Early Childhood Education and Care centres, compared to standard practice.

  • Evaluating the efficacy and adherence of administration of a PCSK9 inhibitor Alirocumab in Aboriginal participants with hypercholesterolaemia

    Studies have shown that abnormal amounts of fat (lipids) in the blood are an important cause of heart disease and stroke. Some treatments that lower blood fat level reduce the risk of heart attacks or other cardiovascular events. One type of cholesterol, low density lipoprotein cholesterol (LDL-c), has been found to be a bad type of cholesterol. The purpose of this study is to see if we can significantly reduce blood levels of LDL-cholesterol when the medication Alirocumab (study treatment) is injected under the skin once per month. Participation in this study will last for 24 weeks in total. Once commenced in the study, participants will receive an inactive dose (placebo) for 4 weeks to make sure they don’t have any troubles with the ‘small’ injections. They will then be randomly (like the toss of a coin) assigned to receive active treatment, or continue on the inactive (placebo) therapy. This is important to make sure we can tell how well the study treatment does its job.

  • What factors influence discharge from General Medicine to Geriatric Evaluation and Management?

    Medical patients often present to hospital with both medical and functional problems, including social dependency, reduced mobility and cognitive impairment. As such, discharge planning forms an important part of a patient’s hospital stay. At present, an allied health team – consisting mainly of physiotherapists, occupational therapists, social workers, dieticians and speech pathologists – make recommendations for a discharge destination based on clinical experience. If the patient is not for discharge home they may require further allied health intervention at subacute. This process is potentially problematic when clinicians disagree on discharge destination. This can delay discharge and increase the patient’s length of stay. It can also detrimentally impact on the patient and family experience. We hypothesis that deficits in mobility (both pre-admission and during admission), impaired cognition and inadequate social supports will be closely related to patients needing subacute on acute hospital discharge. There are a number of commonly used tools to measure such factors in the General Medical population. These include the de Morton Mobility Index (DEMMI) which has been used to assess mobility and predict discharge destination in this population, however, it has not considered the interplay of other factors. Other tools, such as the Alpha Functional Independence Measure (AlphaFIM), Charlson Co-morbidity Index (CCI), and the Blaylock Risk Assessment Screening Score (BRASS) and the Rowland Universal Dementia Screening Scale (RUDAS) have considered function, cognition, co-morbidities and social support but they have generally been used to assess current function, predict mortality and length of stay, rather than holistically determine the need for subacute. It is currently unknown which of these tools, when administered during an acute hospital stay, can best predict need for subacute.

  • Brain Injury Research in Prisons (BIRP): Prevalence of a history of acquired brain injury in South Australian prisoners and evaluation of behavioural impacts.

    A number of studies have reported a high prevalance of people with an acquired brain injury are incarcerated in prisons throughout the world. This study will investigate the prevalence of prisoners in SA prisons who have a history of traumatic or non traumatic brain injury from incident, stroke or substance abuse. This prevalence study forms phase 1 of the trial. Phase 2 of the trial will investigate the neurobehavioural sequelae of those who have experienced an ABI. Phase 3 will involve a qualitative investigation with prisoners being interviewed about their experiences in prison, and preparing to leave prison to manage in the community.

  • Efficacy of health promotion interventions in adults with lifestyle and health risk factors for dementia

    This project evaluates the efficacy of lifestyle management programs in adults to in reducing scores on questionnaire that evaluates risk profile for dementia. The interventions are the Body Brain Life - GP (BBL-GP) and Lifestyle Modification Program (LMP). There will also be an Active control group which receives email informatio

  • Effects of 16-week Bikram yoga program on heart rate variability and cardiovascular disease risk factors in sedentary, stressed adults.

    The purpose of this parallel-arm RCT was to investigate the effects of a 16-week Bikram yoga program on the high frequency (HF) component of HRV and secondary related outcomes (i.e., additional HRV measures, anthopometric, haemodynamic, haematological, and psychological measures) in a population of sedentary, stressed adults. We hypothesised that engaging in 16 weeks of Bikram yoga, 3-5 times per week, would improve HF HRV, secondary measures of HRV, and associated CVD risk factors when compared with a no-treatment control group. Participants were recruited via word of mouth, flyers, and social media and were screened via email/phone/in person for eligibility to participate. Sixty-three participants were enrolled in the trial with 34 in the control group and 29 in the experimental group. The experimental group was required to attend 3-5 Bikram yoga classes each week for 16 weeks, whereas the control group was asked to continue with their current lifestyle. Both groups were asked not to change their diet and exercise habits (aside from the intervention) throughout the trial period. Baseline measures and completion measures were assessed at week 0 and week 17 respectively. Body composition, waist circumference, HRV, blood pressure and psychological questionnaires were done at a 1.5 hour appointment at University of Canberra with the primary investigator. Blood tests were done at various Capital Pathology collection centres in Canberra. Both testing sessions took place in a fasted state in the morning and were done on separate days to one another. All participants were followed up with weekly via email/phone/in person to record changes in health status or lifestyle throughout the trial. Upon completion of the trial, participants had the option to fill out an exit survey to gain a better understanding of their experience as a participant.

  • A randomised control trial of Social Skills Training (SCIT) in those diagnosed with psychosis.

    The social cognition training (SCIT) is a groupbased therapy that has a goal of improving thinking skills about social situations for individuals with psychotic disorders. Two trained therapists deliver the group over 12 weekly sessions, with each session lasting approximately 2 hours. Participants will be able to attend one of the sites convenient to where they live. The therapy involves education about emotions and social interaction using games and technology such as watching DVD’s. Participants will be asked to attend a clinical assessment at three times points (beginning of the study, end of study and 3 months post study)that will take approximately 2 hours of their time. The clinical assessment will include tests of thinking and problem solving skills, and questions about how people think in social situations and skills in identifying emotions from photographs of people. At the completion of the entire study, a summary of the results will be sent out to participants informing them of the outcomes of the study.

  • Stability, functional and clinical outcomes following Reverse Total Shoulder Arthroplasty (RSA); Repair versus Non-Repair of the Subscapularis

    The importance of the subscapularis in patients with a Reverse Shoulder Arthroplasty prosthesis and consequently, the need of repair following implantation, remains controversial. The aim of the study is to determine the stability, functional and clinical outcomes of a repaired versus non-repaired/irreparable subscapularis following Reverse Total Shoulder Arthroplasty. The primary objective of this study is to assess the difference in the function, as measured by the self-reported ASES score, between two RSA treatment groups up to 5 years post-surgery. Secondary objectives are to: Compare outcomes of patients implanted with a medialised versus lateralised Reverse Total Shoulder prosthesis between the two treatment groups. Consider the influence of scar tissue development on functional and clinical outcomes between the two treatment groups. A physiotherapy focused substudy will evaluate the intra- and inter-rater reliability of range of motion (ROM), manual muscle testing (MMT) and hand held dynamometry (HHD) strength testing for assessment of Reverse Total Shoulder Arthroplasty patients.

  • Functional MRI assessment of primary and secondary brain tumour response to radiation therapy: A pilot study

    This pilot study will determine the relationship between of pre-, during treatment and post-radiotherapy (+/- chemotherapy) MRI sequences (including DW and DCE-MRI) with respect to CNS tumour response and local intra-cranial control, post radiotherapy. and also determine the utility of MRI for assessing changes to the hippocampal region from CNS radiation therapy Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been newly diagnosed with primary or secondary brain cancer. Study details Participants will undergo normal MRI testing at baseline with an addition of 3 more times. During RT (Week 3 and 6) and then again 4 weeks post RT

  • Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Subcutaneous APL-9 in Healthy Volunteers

    APL-9 is a PEGylated peptide wherein a small pharmacologically moiety binds to primate complement C3 and exerts a broad inhibition of the complement cascade. The PEG portion of the drug molecule imparts longer residence time in the body after administration of the drug. APL-9 for SC injection is currently in development as a potential treatment for paroxysmal nocturnal hematuria (PNH), which is an acquired hematological disease characterized by complement-mediated red blood cell (RBC) hemolysis, with or without hemoglobinuria, and increased susceptibility to thrombotic episodes, and/or some degree of bone marrow dysfunction. This single ascending dose study is the first study in a planned series of studies for the clinical development of APL-9. The primary objective of the study is to assess the safety and tolerability of single subcutaneous (SC) doses of APL 9 in healthy volunteers. The secondary objective of the study is to assess the pharmacokinetics (PK) of single SC doses of APL 9 in healthy volunteers. An exploratory objective of the study is to assess the pharmacodynamics (PD) of single SC doses of APL 9 when administered to healthy volunteers. The study will recruit 21 subjects in four dose cohorts. Subjects will participate in only one cohort and will receive a single dose of APL 9 or placebo administered subcutaneously. Safety will be assessed throughout the study; serial blood samples and urine samples will be collected for these assessments. Blood samples will also be collected for the PK, PD, and immunogenicity assessment of APL 9. Dose escalation to the next dose level (i.e. next cohort) will not take place until a Safety Monitoring Committee (SMC) comprised of the Principal Investigator (PI), the Medical Monitor, and the Sponsor have determined that adequate safety and tolerability from the previous cohort has been demonstrated to permit proceeding to the next cohort. Subjects will be resident in the clinical facility (Nucleus Network Ltd) from the day before dosing until 168 hours (Day 8) after dosing. Subjects will return for follow-up visits and the exit visit for subsequent study procedures.

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