ANZCTR search results

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

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33074 results sorted by trial registration date.
  • ‘Stand Up For Health’ an intervention to reduce adolescent sitting time during the school day

    The aim of the study is to investigate whether an intervention to reduce sitting time in the high school setting will result in less sitting time for adolescents aged 12-14 years and to assess whether a reduction in sedentary time has a positive effect on student cognition. Schools will be randomised to either a control or intervention after baseline data is collected. The six-month intervention will introduce a number of strategies to encourage adolescents to sit less or stand more during the school day by breaking up or reducing sitting time.

  • Internal Evaluation of Continuous Positive Airway Pressure Mask Systems in Healthy Volunteers: Comparison of Cushions, Frames, Headgear, Components and Accessories

    Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) therapy acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. CPAP compliance is strongly influenced by the patient’s mask system. As masks are worn every night the comfort, seal, stability and ease of use of a CPAP mask is highly important. ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients.

  • Evaluation of Continuous Positive Airway Pressure Mask Systems: Comparison of Cushions, Frames, Headgear, Components and Accessories

    Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) therapy acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. CPAP compliance is strongly influenced by the patient’s mask system. As masks are worn every night the comfort, seal, stability and ease of use of a CPAP mask is highly important. The product development of mask systems is an iterative process. Evaluation of the comfort, seal, stability and ease of use of the mask system by patients in their home environment provides the required information for these iterative design changes. This project will allow the iterative testing of mask systems by patients by comparing them to already released masks or acceptable subjective levels.

  • Investigating the prevalence of Urinary Incontinence in young women

    Background Whilst pregnancy is a risk factor for urinary incontinence (UI), this condition may precede pregnancy. The prevalence of UI in nulligravid women has not been reported. Objective To investigate the prevalence of UI in young nulligravid women, potential risk factors and the impact on quality of life. Design Single centre, cross-sectional, self-administered questionnaire-based study. Setting University clinical research department Participants Nulligravid Australian women aged 16 to 30 years. Measurements The Questionnaire for Urinary Incontinence Diagnosis, the Psychological General Wellbeing Index (PGWB), the King’s Health Questionnaire and the International Physical Activity Questionnaire. Demographic variables and potential risk factors were also documented. Results 1002 women, mean age 22.4 (SD 3.2) years, provided data. The rate of any UI was 12.6% (95% confidence interval (CI), 10.5-14.7%). The rate of stress-only UI was 6.2% (95% CI, 4.7-7.7%), urge-only UI 4.5% (95% CI, 3.2-5.8%) and mixed UI 1.9% (95% CI, 1.1-2.7%). In logistic regression analyses, ever being sexually active (OR 2.33, 95%CI 1.40 to 3.88) was associated with an increased likelihood of UI, whereas current use of the combined oral contraceptive (COC) was associated with a reduced likelihood of UI (OR 0.38 95% CI 0.24 to 0.61). Women with UI had significantly lower wellbeing than women without UI (mean difference in total PGWB score 5.3 (95% CI 2.3-8.3). Statistically significant lower scores were seen for the PGWB domains of for anxiety (P<0.001), depression (P<0.001), positive well-being (P=0.02) and self-control (P=0.001). Limitations The findings relate to a relatively healthy and active cohort. Conclusions UI was common in this sample of healthy, nulligravid young women and was significantly associated with lower general psychological wellbeing. Further study is required to understand the pathophysiology of UI in young women and management options.

  • Analysis of the profile of males with hypogonadism in the regional setting of North Queensland.

    The rationale of this project is to study hypogonadism in the background of regional north Queensland. In the setting of a small population with a relatively variable socioeconomic status attributed to the mining and farming industry, it is interesting to evaluate the different causes of hypogonadism ranging from pathological causes to lifestyle choices with respect to exogenous steroid intake and a widespread use of complementary and alternative medicines. This study will also be stratifying how the level of testosterone may provide an insight to the primary general practitioner as to the possible causes of hypogonadism and if there is any correlation between the two parameters. Furthermore, a study on males with hypogonadism in regional Australia has not been previously undertaken. With the knowledge that a low serum testosterone is known to provide various clinical complications such as increased microvascular disease, hyperlipidaemia, osteopenia, fatigue, weakness and psychological distress from impaired libido it is important to conquer these patients early and attempt to find any underlying cause behind these patients’ hypogonadism.

  • An investigation of the effects of intranasal oxytocin spray on socio-emotional brain regions in participants with Body Dysmorphic Disorder.

    The overall aim of the current study is to examine the brain correlates of emotion recognition in patients with Body Dysmorphic Disorder using a double-blind placebo controlled intranasal oxytocin design and two MRI techniques involving fMRI and diffusion tensor imaging (DTI).

  • High-Frequency Spinal Cord Stimulation at 10kHz (HF10 SCS) for the Treatment of Pelvic Pain Patients

    Chronic pelvic pain (CPP) is one of the most common medical problems among women, though it also affects men with a lower incidence . It is defined as pain in the pelvis that lasts more than six months and affects the patient’s quality of life. There are many potential sources of pelvic pain. Pelvic pain may involve the urinary, reproductive, gastrointestinal, neurological, psychological and musculoskeletal systems. Patients with chronic pelvic pain typically receive multidisciplinary care, including medication (antimicrobials, anti-inflammatories, opioids, muscle relaxants, etc), psychotherapy, physical therapy, and interventional treatments (surgery for distension and ablative procedures). A significant proportion of these patients fail however to derive adequate benefits from these therapies and these CPP patients are often left with few options. Traditional spinal cord stimulation (SCS) is a widely accepted cost-effective therapy for patients with chronic pain, especially in patients with post- surgery back and leg pain. SCS has been used successfully to treat intractable CPP patients. A newer treatment, High-Frequency Spinal Cord Stimulation at 10 kHz (HF10TM SCS) using the Senza system (Nevro Corp, USA) has established itself as a key treatment in treating patients with chronic back pain: data from European and Australian pain centers has shown that HF10 SCS is safe and effective at reducing pain, improving function and sleep, and reducing opioid in patients with predominant back pain. The purpose of this study is to investigate the feasibility of using HF10-SCS to provide pain relief and quality of life improvements to CPP patients.

  • Should we treat iron deficiency anaemia of pregnancy with lactoferrin? A randomised controlled trial Lactoferrin Evaluation in Anaemia in Pregnancy: LEAP-1

    Iron deficiency - the world’s commonest nutritional disorder affects over 2 billion people (WHO 2008), with women and children at greatest risk. This study aims to evaluate, in a randomised controlled trial (RCT), oral bovine lactoferrin (bLF) vs iron sulphate (FeSO4) in iron deficiency anaemia in pregnancy (IDAP). This study will comparerandomised groups on the following co-primary endpoints: 1) Fetal growth (birth weight for gestational age) 2) Whether oral bLF therapy reduces the proportion of women with IDAP who receive intravenous iron infusion according to standard protocol OR who do not respond to treatment and remain anaemic at any time between 34 weeks gestation and delivery.

  • The effects of recurrent hypoglycaemia on gastric emptying, glucose absorption, autonomic nerve function, cardiac function, glucagon, pancreatic polypeptide and catecholamine secretion.

    Diabetes is a disorder of blood sugar and requires treatment for high blood sugar levels using drugs such as insulin. However, treatments like insulin can cause excessively low blood sugar levels (hypoglycaemia). If unrecognised and untreated hypoglycaemia can induce a coma. To protect against hypoglycaemia certain physiological responses occur. These include release of hormones that break down stores of sugar within the body and emptying the stomach quicker so that nutrient can be absorbed more rapidly. Both physiological responses will increase blood sugar levels. Recent evidence suggests that episodes of low blood sugar levels impair the hormonal response to subsequent episodes of hypoglycaemia, but the effect of these antecedent episodes of hypoglycaemia on gastric emptying rate during subsequent hypoglycaemia is unknown. This study aims to investigate whether there are changes in gastric emptying following repeated hypoglycaemic episodes. In addition this study will assess changes in glucose absorption, autonomic nerve function, secretion of catecholamine, glucagon and pancreatic polypeptide and cardiac function. Null hypothesis: Recurrent hypoglycaemia does not effect hypoglycaemia-induced acceleration of gastric emptying.

  • Screening Tests to identify poor Outcomes in Pregnancy (STOP) Study

    The four major pregnancy complications, preeclampsia, preterm birth, intrauterine growth restriction and gestational diabetes mellitus, afflict 25% of first pregnancies and are life-threatening to the mother and/or her baby in more than 6% of pregnancies. Although many aetiological risk factors have been identified, at present we cannot effectively predict which women will develop pregnancy complications. Our previous research has identified a combination of potential clinical and lifestyle factors and genetic and biochemical biomarkers that predict the risk of these pregnancy complications at 15 weeks of gestation. We aim to validate our algorithms in a new cohort of participants and expect to be able to predict the risk of development of pregnancy complications as early as at the 12th week of gestation. Those found to be at increased risk can be managed with a combination of preventive strategies and early targeted interventions that would reduce the risk of developing these complications.

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