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 randomised controlled trial of 'Wide Awake Parenting': A program for the management of parental fatigue.

    A efficacy trial of Wide Awake Parenting: A program for the management of parental fatigue in the postpartum Fatigue is reported to be one of the most common health concerns in the postnatal period, for both mothers and fathers (Ansara, Cohen, Gallop, Kung, & Shei, 2005; Glazener, Abdalla, & Stroud, 1995; Parks, Lenz, & Milligan, 1999). "Wide Awake Parenting" (WAP) is a psychologically informed, written resource for parents aimed to assist parents to manage fatigue and promote well-being in the early postpartum. A systematic cohort of 220 parents of a newborn infant aged between 0-4 months will be recruited from Maternal and Child Health Centres in a diverse range of Local Govt. Areas in Metropolitan Melbourne. The primary aim of this study is to assess the effectiveness of the Wide Awake Parenting Programme in reducing fatigue and improving well-being for parents. It is hypothesised that parents who receive the WAP intervention – either the WAP resources only (intervention group one), or with the addition of professionally-led enhanced support (intervention group two), will have reduced fatigue and improved well-being compared to parents who are receiving standard care (control group). The following parental outcomes will be assessed, using validated self-report, psychometric instruments, at baseline, two weeks and two-months post intervention: 1. Symptoms of fatigue 2. Parental mood, reduced symptoms of depression, confusion, anxiety and irritability 3. Improved parenting sense of competence 4. Reduced parenting stress

  • Clinical trial on the safety and effectiveness of Tissue Therapies extracellular matrix on healing of venous leg ulcers

    This is a multi-centre, clinical trial. A sample size of 40 participants is sought. Up to 58 participants will be recruited to account for an estimated drop out rate of 30%. The study will include patients who have chronic, hard-to-heal, venous leg ulcers and use the following treatment procedure: 1) Cleansing the wound bed using local practices, at dressing change, then topically applying VitroGro ECM and covering with a non-adherent wound dressing. 2) Securing the dressing to the wound with tubifast and compression bandaging Dressings will be changed and the treatment procedure will be repeated once per week for Cohort 1 and twice per week for Cohort 2 when clinical, planimetry and photographic assessments will be made. The effectiveness of the treatment procedure will be evaluated on the basis of a 12 week treatment period. In the case of a wound that has healed before the 12 week end point, the treatment period will be shortened. Additional dressing or bandage changes, outside of the scheduled clinic visits, will be also be documented. The primary end point will be the reduction of ulcer size, or numbers healed at the 12 week point. Secondary end points are; reduction of pain, exudate and smell, condition of wound bed and surrounding skin and patient tolerance to the treatment provided and cost effectiveness.

  • Evaluation of the efficacy of probiotic supplements on illness and immunity in healthy active individuals

    There is increasing interest in the use of nutritional supplements to improve health and wellbeing. Probiotics are proposed to boost immunity and reduce susceptibility to infection. Common infections, such as URTI, are a significant burden on the community. There is growing body of evidence that probiotic supplementation may reduce the prevalence of URTI and GI illness in the general population. Hypothesis: That a probiotic supplement will enhance immunity and ameliorate the heightened susceptibility to upper respiratory tract illness (URTI) and gastrointestinal tract illness in active well-trained community individuals.

  • Components of an Effective Early Supported Discharge Team For Stroke: A West Australian Perspective

    This study will evaluate an early supported discharge service for stroke using a recently compiled list of components identified by experts in stroke research. In order to understand the achievement or otherwise of these components, a mixed methods approach will be used involving secondary analysis of health service data and focus group discussions of early supported discharge service staff.

  • Randomised Controlled Trial of a Novel Cannabis Use Intervention Delivered by Telephone

    Aims To evaluate the efficacy of a telephone-based intervention consisting of four-sessions of motivational interviewing (MI) and cognitive behavioural therapy (CBT) designed to assist individuals to reduce their cannabis use and related problems. Design Random allocation to intervention or delayed treatment control with four- and 12-week follow-up assessments. Setting Counsellors from the Cannabis Information and Helpline (CIH), an Australian reactive telephone service, delivered the intervention to callers seeking treatment. Participants A total of 160 participants were recruited by the CIH, with 110 participants completing the final follow-up assessment (69% retention). Measurements Cannabis use, dependence and related problems, and other substance use, were assessed at baseline and follow-up. Findings Intervention participants reported greater reductions in dependence symptoms (p<0.001), and related problems (p<0.001) compared to control participants at both follow-up assessments. Compared to control, intervention participants reported greater confidence to reduce cannabis use (p=0.002), and in turn reported a greater percentage of abstinent days at twelve weeks (p=0.019). Conclusions The remote delivery of brief MI+CBT cannabis use interventions continues to show promise in assisting a wider audience of treatment seekers while achieving comparable treatment outcomes to those of face-to-face interventions in the short term.

  • Cognitive changes after saline or Plasmalyte infusion in healthy volunteers: blinded, randomized cross-over trial

    Intravenous crytsalloid fluids are one of the mainstays of in-hospital patient treatment with fluid intervention being ubiquitous for surgical and critical care patients. Cognitive changes such as a perceived difficulty in abstract thinking or mental arithmetic has been reported in subjects exposed to a commonly prescribed crystalloid solution - Normal Saline (0.9%). The postulated mechanism for the altered cognition is unclear but could be a result of NS 0.9% induced hyperchloraemia or NS 0.9% induced acidaemia (normal anion gap metabolic acidosis) that frequently occurs following saline administration. No study has attempted to formally investigate cognitive changes after the administration of saline or other commonly administered crystalloid solutions. Plasmalyte solution is a frequently used crystalloid solution with similiar properties to saline. However it is a more physiological and balanced crystalloid solution compared to saline as it has a significantly lower chloride concentration and physiochemical profile similar to normal plasma. Study hypothesis: Is normal saline associated with greater cognitive changes than Plasmalyte in healthy volunteers?

  • A randomized, placebo controlled, double blind, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single escalating doses of SAN-300 when administered to healthy subjects and patients with rheumatoid arthritis

    Study C2011-0301 is the first study in man for SAN-300. SAN-300 is being developed for the treatment of rheumatoid arthritis. SAN-300 will be administered intravenously in 9 cohorts and subcutaneously in 3 cohorts. Approximately 66 healthy volunteers and approximately 8 patients with active rheumatoid arthritis will be enrolled to receive a single dose of SAN-300 or Placebo. Participation in the study is approximately 1 month, including dosing and follow-up visits. Subjects will receive the dose of study drug and remain in the clinic for 24 hours. There are 5 follow up visits conducted over 1 month.

  • Can depression be prevented by reducing insomnia? The Good Night Sleep Study

    This project investigates the efficacy of a novel internet-based insomnia treatment program (SHUTi) as a prevention tool for Major Depressive Disorder.

  • Comparison of myofascial trigger point therapy to stretching and strengthening for maintaining or increasing muscle length in muscles with spasticity.

    The main aims of this research project are to compare the effects of routine therapy, considered as the combination of stretching, strengthening, casting and the application of botox, to the proposed therapy consisting only of stretching, strengthening and myofascial trigger point therapy. The effects of weekly myofascial trigger point therapy alongside stretching and strengthening will be measured in a group of children aged between 4 and 12 years with muscle spasticity. It is proposed that the study will be small due to limited resources, but the intention is to publish the results for further research in this area. We hypothesise that myofascial trigger point therapy when applied to spastic muscles is successful at maintaining or increasing muscle length.

  • Characterising the nature, and clinical significance of body and limb movements during adult sleep using multi-site accelerometry

    The general aim of this research is to investigate whether continuous tri-axial accelerometry is a usfull tool for the qunatification, and characterisation of movements during sleep in a clinical diagnosis setting. This research targets: - Movements as a consequence of movement disorders (Such as Periodic Leg Movements During Sleep), - Movements as a consequence of arousals during the night - Movements as a conqequence of respiratory events during the night 50 adults attending The Princel Charles Hospital Sleep Service for a Diagnostic Polysomnogram (sleep study) will be recruited. In addition to the standard physiological channels recorded in a sleep study, Multiple accelerometers will be strategically placed on each subject (ankle and big toe, wrist and middle finger and central thorax). Data will be analysed to determine whether: - The amplitude of movements observed using accelerometry predict cortical arousal - Continuous triaxial accelerometry may be used to automatically classify sleep from wake more accurately than commercial actigraphs - Multisite accelerometry allows primary limb movements to be distinguished from gross body movements as a consequence of arousal or other events - Indices of movement events correlate with qualtiy of life measures

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