ANZCTR search results

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

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31352 results sorted by trial registration date.
  • Comparison of embryonic growth following intracytoplasmic sperm injection (ICSI) between two hyaluronan binding based sperm selection methods - physiological intracytoplasmic sperm injection (PICSI) dish vs liquid hyaluronan

    PICSI dish and Spermslow (liquid hyaluronan) are both hyaluronan binding-based sperm selection methods. Publications have shown benefits of sperm selection by either method before intracytoplasmic sperm injection. However few study has compared the efficacy between these two methods. The proposed study will compare sibling embryos resulted from these two methods by using time-lapse analysis.

  • Comparison of the performance of two sperm preparation methods for conventional in vitro fertilisation (IVF) insemination by assessing subsequent embryo development with time-lapse technology

    Both Swim-up and Density gradient centrifugation are routine sperm preparation methods in IVF laboratory. However the content of seminal fluid might mix with separated sperm in the Swim-up method while centrifugation is involved in the other method which are both considered harmful to fertilisation and embryo development. The proposed study will use time-lapse technology to reveal the differeces in the subsequent embryo development.

  • A Phase I, Randomised, Double-Blind, Placebo-Controlled,Ascending Single- and Repeat-Dose Study of the Safety,Tolerability and Pharmacokinetics of Orally Administered PRN473.

    Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN473 in healthy volunteers. Partipants in Part A of the study will recive a single dose of PRN473. Partipants in Part B of the study will recieve one dose of PRN473 per day for up to 14 days.

  • A randomised controlled trial of physiotherapy intervention compared to no intervention in pre-school children born extremely preterm.

    The purpose of the study is to investigate the effect of a physiotherapy intervention program with able-bodied 4 year old children born extremely preterm or with extremely low birth weight on their motor co-ordination, postural stability and functional performance compared to no intervention. Also the study will examine the impact of the intervention on behaviour. OBJECTIVES 1. To evaluate the movement benefits of a specifically developed 6 week small group physiotherapy intervention program for children aged 4-4.5 years. 2. To compare the motor development of children with and without intervention. 3. To evaluate the impact of intervention compared to no intervention on general abilities, activity levels and behaviour 12 months post baseline assessment. HYPOTHESES It is hypothesised that a physiotherapy intervention program will improve motor co-ordination, postural stability and functional performance in 4 year old children born extremely preterm or with extremely low birth weight. It is hypothesised that improvements in motor abilities amongst this group of children will have a positive effect on activity levels and behaviour compared to children who receive no intervention. Furthermore, it is hypothesised that there is a close link between motor performance and the ability to cope with social interactions and that early improvement will continue to impact on the child's motor development, attention and behaviour, not just in the short term but will have long term effects.

  • Get Healthy- Stay Healthy: a text message-delivered intervention on physical activity, dietary behaviours and weight loss

    The aim of this study is to evaluate, in a randomised controlled trial, the feasibility, acceptability and efficacy of a text message-delivered intervention to enhance physical activity, dietary change and weight loss among adults who have completed the 6-month Get Healthy Coaching Service. It is expected that this extended contact via text messaging will lead to sustained behaviour change and weight loss compared to no on-going contact.

  • A randomised controlled trial of Baby Triple P: An evaluation of an antenatal parenting program to improve parental responsiveness in first-time parents

    The transition to parenthood is a very exciting time for new parents, but it also is a time of great demands and challenges. After the baby is born, parents are faced with sleep deprivation, mastering infant caregiving tasks, changes in their relationships and lifestyle. At the same time, these early months are crucial for the infant's development and wellbeing. The proposed project aims to evaluate Baby Triple P, a preventative intervention designed to support parents during the transition to first­time parenthood. It aims to give babies a healthy start in life by enhancing their parent’s knowledge, skills and confidence in early parenting practices. In addition, it intends to protect the mental and emotional wellbeing of parents. The transition to parenthood can be particularly challenging for families where a range of risk factors are present, and it is couples who are at risk for experiencing difficulties at the transition that may benefit most from a preventative intervention. Specifically, this project focuses on couples who experience at least two of the following risk factors: unplanned pregnancy, low education, experience financial strain, low relationship satisfaction, low social support, history of and/or current depression or anxiety, low confidence in ability to parent or low life satisfaction. This was done as these couples may benefit the most from Baby Triple P. Participants will be approximately 150 couples where the mother is 20­-35 weeks pregnant. Recruitment will be done through primary care settings, GPs, hospitals in the Brisbane and Ipswich area and targeted mail­out and media campaigns. The research will be carried out as a randomised controlled trial comparing the Baby Triple P group to a care as usual group. The study is a 2 (Baby Triple P vs care as usual) x 3 (time­points: pre­test, post­test, 6­month follow up) design. The intervention consists of four weekly 2­hour group sessions during pregnancy, and four weekly 20­ minute telephone consultations starting when the baby is about 6 weeks old. Assessment will include a series of self­report questionnaires (pre­, post­, and follow­up) and a home observation, which will observe mothers as they normally interact with the baby (post­ and follow­up). The primary outcome variable for this study is parental confidence/ self-efficacy. Accordingly, it is hypothesised that compared to the care as usual group: H1: Participation in Baby Triple P will lead higher levels of parenting confidence and perceived competence. This study will also look at several secondary outcome variables. For these,it is hypothesised that, compared with the care as usual control group, participation in Baby Triple P will lead to: H2: higher levels of parental responsiveness and bonding to the baby., H3: higher relationship happiness, H4: higher levels of life satisfaction H5: fewer instances of depression or anxiety H6: Infants will show less fussing, crying and fewer sleeping p

  • Non-invasive brain stimulation and cognitive enhancement in healthy volunteers: investigating the effects of theta burst stimulation (TBS) on learning and memory.

    The purpose of this project is to investigate whether brain stimulation techniques will lead to an improvement of working memory (‘working memory’ refers to the temporary storage and processing of information) in healthy volunteers. We are conducting a study to see whether TMS applied at the front of the brain can improve performance on tests of working memory. The type of TMS we are using is called Theta Burst Stimulation (TBS). Theta burst stimulation (TBS) is a type of TMS where the magnetic pulses are applied in very short bursts (three pulses at a time) at a high frequency (30-50 pulses a second).

  • A study of peginterferon-alfa intervention to achieve hepatitis B surface antigen loss in multi-drug resistant chronic hepatitis B participants under long-term viral suppression with tenofovir DF +/- lamivudine salvage therapy (TDF-109 cohort)

    This is a study to see if add-on peginterferon-­alfa (pegIFNa) can help lose hepatitis B surface antigen in participants who have multi­drug resistant chronic hepatitis B and treated with long­term tenofovir DF +/- lamivudine salvage therapy (TDF­109 cohort) 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 and/or lamivudine therapy for at least 5 years as part of the TDF­109 study. We will aim to recruit all the TF­109 patients into this study. Those suitable will be treated with 48 weeks of pegIFNa.

  • Upper limb rehabilitation following lung transplantation

    Musculoskeletal complications following bilateral lung transplantation represent a significant problem which may delay recovery and return to normal daily activities. There is no evidence to support the current upper limb rehabilitation exercise program that form part of post transplantation programs. Therefore this study was designed to investigate the impact of the current exercise programs on the healing breast bone, muscle strength recovery and importantly on pain levels to aid return to functional performance.

  • Changing the health system to increase the adoption of "clot busters" in stroke treatment

    This study will examine whether a hospital-focussed multicomponent multidisciplinary collaborative approach can increase stroke thrombolysis rates, while maintaining accepted benchmarks for low rates of intracranial haemorrhage and high rates of functional outcome at three months. The approach will be tested using a cluster randomised controlled trial involving 20 hospitals in the early stages of thrombolysis implementation. Outcomes will include thrombolysis rates in intervention and control hospitals at follow up as well as intracranial haemorrhage rates and functional outcomes at 3 months.

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