ANZCTR search results

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

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32885 results sorted by trial registration date.
  • Lip muscle strength training, sleep apnea and sleep quality

    The study proposes that lip muscle strength training using the Lip Trainer, The Patakara 'Registered Trademark' (DENTAL YOUME , Tokyo Japan), will improve labial closure force through strengthening of the orbicularis oris (lip muscle), and will reduce snoring and sleep apnea resulting in improved sleep quality.

  • A prospective, multi-centre randomised comparative study of implant fit, clinical outcomes and satisfaction with the Stryker Accolade II Hip Stem compared to the Corail Hip Stem

    This study is a prospective, multi-centre, randomised clinical study comparing the preoperative radiographic plan to the intra-operative femoral stem sizing, and assessing post-operative fit, clinical and satisfaction outcomes. The study will be conducted in patients with Non-inflammatory Degenerative Joint Disease. In addition, a substudy is running in NZ to evaluate the differences in peri-prosthetic bone remodelling post hip replacement in 3 different femoral component implants. The Lunar iDXA (GE Healthcare, Madison, WI) densitometer is a Food and Drug Administration (FDA) - approved device for measuring BMD and body composition. The relationship between bone loss, patient functional outcome and implant survival across the 3 femoral stems will also be investigated.

  • An Australian study evaluating a specialised blood collection drape to improve midwives' estimation of blood loss during labour.

    This pilot study aims to determine the accuracy of midwives' third stage labour blood loss estimations and the feasibility of a using a calibrated blood collection drape to measure third stage blood loss in the Australian setting. Australian clinicians tend to estimate third stage blood loss using visual estimation, which underestimates blood loss. Third stage blood loss, postpartum haemorrhage (PPH) and associated anaemia significantly contributes to serious postnatal health complications and maternal mortality. In Australia, PPH occurs in 6.8-9.2% of all births, with variation between states. However, Australian and overseas data has shown a trend increase in PPH and associated morbidity which have triggered a call for further research and improved management of the third stage of labour. One area that needs further research is blood loss estimation accuracy, as visual estimation of third stage blood loss leads to an under-diagnosis of PPH and poor identification of women at risk of complications from anaemia. Overseas researchers have piloted blood collection drapes, which have been found to be accurate for measuring third stage blood loss when compared to visual methods. No studies of the acceptability of these drapes have been conducted and they are untested in Australia. Furthermore, accuracy of Australian clinicians’ visual estimations has not been tested in the clinical setting. This study will compare the mean difference between clinician's visual estimation of third stage blood loss to third stage blood loss measured in a calibrated blood collection drape. Clinican's attitudes towards visual blood estimation and the acceptability of the drape will be surveyed. A cost benefit analysis will also be conducted. The results from this pilot study will inform the design of a multi-centre study involving a larger number of participants.

  • Cocoa for cognitive function, mood and cardiovascular function: acute and cumulative effect in younger adults.

    Study aims to investigate the effects of acute and cumulative doses of high-flavanol cocoa on cognitive function, mood, and cardiovascular health in a group of healthy younger adults.

  • A mixed methods study exploring the differences in communication between patients, the family care giver and health care professionals in an outpatient psychosocial clinic setting

    Research design: This will be conducted as a mixed methods study within the psychosocial outpatient clinic setting where patients are seen together by the Nurse Practitioner and Social Worker and then separated so that the patient is seen by the psychosocial nurse alone and the caregiver is seen by the Caregiver Network Facilitator alone. The Caregiver Network Facilitator is a relatively new role introduced into the palliative care team as a support role to assist family caregivers to mobilise their own social networks. Methods: Tape recorded interviews of patients and their caregivers seen both together and separately will be transcribed verbatim, and the content coded to quantify communication variables. The coding will identify the use of open and closed questions, cues that are ignored, who is dominating the conversation and any crying that takes place. Coding will be conducted by the chief investigator with one other investigator coding some of the transcripts to ensure coding reliability. A grounded theory approach is utilised for the qualitative component of the study, as it involves the reading of transcripts, identifying possible themes, comparing and contrasting themes and building theoretical models. NVivo software will be utilised to analyse the qualitative component of the study.

  • Training standing up following stroke: a feasibility trial

    To determine the feasibility and efficacy of a 2 week intervention of specific biofeedback about foot placement during training of standing up in people following stroke.

  • A Safety and Tolerability Study in healthy adult males for Tafuramycin-A attenuated Plasmodium falciparum NF54 blood stage parasites.

    This study is examining the safety, tolerability and immunogenicity in humans of an inoculum containing tafuramycin-A treated P. falciparum NF54. Participants will receive a single inoculum which consists of human red blood cells containing P. falciparum NF54 malaria parasites that have been attenuated with tafuramycin-A. Following administration of the inoculum, we will monitor participants for adverse events and for any symptoms/signs of a developing malaria infection (which would indicate that attenutation of the malaria parasite was incomplete). We will also be assessing the way the immune system responds.

  • Randomised trial of treatment for tennis elbow comparing the effects of different injection treatments on pain reduction

    Lateral epicondylitis (LE) or tennis elbow is a debilitating musculoskeletal condition that can result in significant disability, health care utilisation, lost productivity and costs. Glucocorticoid injection is of proven short-term benefit, but beyond 8 weeks its benefits have not been established and some studies have even suggested a rebound worsening of symptoms. Autologous platelet rich plasma (PRP) appears to be a promising new treatment for LE however strong evidence for its efficacy from high quality randomised placebo-controlled trials is currently lacking. The aim of this study is to compare the effectiveness of ultrasound-guided injection with either autologous platelet rich plasma or glucocorticoid using a three-arm randomised placebo-controlled trial design.

  • Dose ranging study to examine the infectivity of the Plasmodium falciparum NF54 cell bank MCB-002 in healthy adult males

    This study is examining the infectivity of different doses of a Plasmodium falciparum NF54 malaria cell bank in humans. Participants will receive a single inoculum of the malaria cell bank, which consists of human red blood cells containing P. falciparum NF54 malaria parasites. Following administration of the inoculum, we will measure the growth of the malaria parasites in the blood-stream and then administer anti-malarial treatment (Riamet) according to specific criteria (based on the number of parasites in the blood as well as clinical signs/symptoms of malaria). We will also be assessing the safety of the inoculum and also the way the immune system responds to it. Determining the infectivity and safety of the malaria cell bank is important as it will form a critical part of future clinical trials investigating the effectivness of a new malaria vaccine that is currently being developed.

  • A randomised controlled trial of bright light therapy to improve mood in residential care

    Many older people in residential aged care settings receive reduced levels of bright light. Bright light is essential for maintaining the body clock (circadian rhythm). This project is a randomised controlled trial to investigate whether bright light therapy can help reduce depressive symptoms in older people living in residential care. Residents from Vasey RSL Brighton East will be randomised into an intervention or control group. The intervention group will spend time in a lounge room equipped with bright lights (of at least 2,000 lux) for one hour each morning, Monday to Friday for 2 weeks. The control group will spend time in a room equipped with normal lights (300-500 lux) for one hour each morning, Monday to Friday for 2 weeks. Depressive symptoms will be measured using the Geriatric Depression Scale before and after the treatment period. Secondary outcomes to be investigated include cognition, behaviour and quality of life.

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