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.
  • A study to measure the efficacy of a manualised oral narrative intervention programme for school-age children with narrative delay

    This project will investigate the efficacy of a manualised theoretically driven oral narrative programme. Intervention will involve explicitly teaching macrostructure to 12 Pre-Primary children with narrative difficulties in small groups in a mainstream school. Multiple baseline repeated measures single-case design will be used to evaluate changes. Measures will include narrative macrostructure, microstructure and quality. The relationship between vocabulary and memory and response to intervention will also be investigated. This study has practical and theoretical significance as it will add to evidence for narrative intervention focusing on macrostructure and investigate the influence on vocabulary and sentence development.

  • A pilot study to measure the efficacy of a manualised oral narrative intervention programme for school-age children with narrative delay

    This project will design, develop and investigate efficacy of a manualised theoretically driven oral narrative programme. Intervention will involve explicitly teaching macrostructure to 12 Pre-Primary children with narrative difficulties in small groups in a mainstream school. Multiple baseline repeated measures single-case design will be used to evaluate changes. Measures will include narrative macrostructure, microstructure and quality. The relationship between vocabulary and memory and response to intervention will also be investigated. This study has practical and theoretical significance as it will add to evidence for narrative intervention focusing on macrostructure and investigate the influence on vocabulary and sentence development.

  • The effects of zopiclone on obstructive sleep apnoea

    The purpose of this study is to examine the effects of nightly administration of a standard dose of a common sleeping pill (sedative) zopiclone, over one month, on sleep apnoea severity, symptoms of daytime sleepiness, and measures of alertness in sleep apnoea patients

  • Home-based human papillomavirus (HPV) self-sampling for improving participation in cervical screening

    This study is evaluating whether mailing a human papillomavirus (HPV) self-sampling kit will increase participation in cervical screening. Who is it for? You may be eligible to join this study if you are a Victorian woman aged between 30-69 years with no record of a Pap test in the Victorian Pap Test Registry (never screened) or the last recorded Pap test was at least 5 years ago (underscreened). Study details: The National Cervical Screening Program based on conventional Pap test has substantially reduced deaths from cervical cancer; however, some women are missing out on the benefit because they do not have regular Pap tests. A new method of screening has recently become available. This is based on testing for human papillomavirus (HPV), which is the virus that causes cervical cancer. Because women can obtain their own HPV sample at home, this test has the potential to overcome some of the reasons why women don’t have Pap tests. Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will be mailed an invitation letter and a testing kit, which includes an information brochure, HPV self-sampling kit, instruction sheet, pathology information form and a reply paid envelope. Participants in the other group will receive a reminder letter to attend for a Pap test, which is standard practice in Victoria. We will evaluate the proportion of women in each group who participate in screening, the proportion of women with a positive screening test who undergo appropriate further investigation, and women’s experiences with self-sampling over a period of 12 months.

  • Central venous Access device SeCurement And Dressing Effectiveness: the CASCADE Trial

    Hospitals and health systems spend millions of dollars each year on dressings to secure Central Venous Access Devices (CVADs) to patients’ skin. Nurses and doctors spend hours applying and maintaining them; yet 20-40% of CVADs fail prior to treatment being complete, including many that partially or wholly ‘fall out’, become occluded or infect the bloodstream. The proposed study is a randomised control trial, designed to (i) identify clinical, cost-effective methods to prevent CVAD failure due to infection, occlusion, migration and accidental removal; (ii) to compare usual care dressings, with three novel methods; and (iii) to evaluate the acceptability of these devices to patients and health professionals.

  • STARflo Glaucoma Implant for Open Angle Glaucoma

    Assess the intraocular pressure (IOP) reduction induced by the STARflo glaucoma implant in eyes with open angle glaucoma. Absolute success is defined as an IOP < 21mmHg and > 5mmHg with a minimum 20% IOP reduction from baseline without the need for glaucoma medication. Qualified success is defined as an IOP < 21mmHg and > 5mmHg with a minimum 20% IOP reduction from baseline with the concomitant use of glaucoma medication. This is a prospective, single centre study of the CE marked and TGA approved STARflo glaucoma implant. Patients with open angle glaucoma requiring surgical reduction of IOP will be screened for suitability for inclusion in the study. Following implantation of the STARflo, participants will be followed for a minimum 12-months.

  • Increasing girls’ physical activity during an organised youth sport basketball camp: A randomised controlled trial

    The primary aims of this two-armed randomised controlled trial are to assess whether coaches who attended coach education sessions can increase their female athletes' moderate-to-vigorous physical activity and reduce their time spent inactive during training sessions over a 5-day basketball program; compared to a no-treatment control group. Therefore, we hypothesise that: 1) Girls who are being coached by coaches who have attended coach education sessions will spend a greater percentage of time moderately-to-vigorously physically active compared to girls who are coached by coaches who did not attend coach education sessions. 2) Girls who are being coached by coaches who have attended coach education sessions will spend a lower percentage of time inactive compared to girls who are coached by coaches who did not attend coach education sessions. The target population for this study will be girls aged 9-12 years willing to partake in a 5-day basketball camp; and coaches, with basketball coaching certification and experience coaching girls, willing to coach a 5-day basketball camp.

  • Cry Baby: evaluation of an online program for parents.

    During the first few months of life, parent reported infant sleep and crying problems are common (20-40% and 20% of infants, respectively; Bayer et al, 2007; Wake et al, 2007), as well as costly to treat (Hiscock et al 2007). Six randomised controlled trials have shown that providing parents with information on normal infant sleep and crying, and strategies to encourage good sleep habits, can improve infant sleep as well as reduce maternal postnatal depression symptoms (Hiscock et al , in preparation). While there is evidence that such strategies are of significant benefit to families and are well accepted by families, dissemination of this information to all families with newborns will be challenging. Our research team, in consultation with other health care professionals, has developed Cry Baby – an interactive online program that draws on prior research findings to provide parents with evidence based strategies for how to cope with infant sleep and crying problems. The aim of this research is to: (1) trail two different recruitment processes for providing the Cry Baby program in order to determine the best way to ensure it effectively reaches the families who would benefit; (2) collect data on how families engage with the resource (i.e., when they access it, what they access, how useful they find it) to better refine the program; (3) collect data on whether email support increases program participation, and; (4) collect preliminary data on outcome measures. Parents will be recruited from two settings: (1) the Maternal and Child Health (MCH) service at the 2 week visit, and; (2) through advertisements on the Raising Children Network (RCN) website. Parents will be randomly assigned to either receive the Cry Baby program with email support from the research team, or to receive the Cry Baby program without additional email support. Data collected from this pilot study will indicate: (1) whether recruitment via online advertising (RCN) or via known health professional (MCH) result in a sample of participants more reflective of the general community (household income, education, socioeconomic status, language); (2) whether providing weekly email support results in parents (a) logging in to the program more often, (b) completing a greater proportion of the program, and (c) increased retention to the program; and (3) whether parents find the program useful/helpful.

  • Evaluation of the Pharmacokinetics of IPX237 Formulations in Healthy Volunteers

    To characterize the pharmacokinetics (PK) of esketamine hydrochloride from 2 oral and 1 sublingual formulations of IPX237 compared to that from intravenous esketamine hydrochloride.

  • A randomized, placebo-controlled, double blind, parallel design study of Xolair (omalizumab) for the management of treatment-resistant systemic and cutaneous mastocytosis.

    The study aims to assess the effect of omalizumab (Xolair) on systemic and cutaneous mastocytosis

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