ANZCTR search results

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

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31380 results sorted by trial registration date.
  • Benztropine for the relief of acute non-traumatic neck pain – a randomised trial

    Patients present to the Emergency department with acute cervical muscle spasm and pain, which may be spontaneous in onset or related to non-traumatic twisting events. In lay speech this may be referred to as a ‘wry neck’. Conventional analgesics such as paracetamol, NSAIDs and oral opoids are the mainstay of treatment for wry neck, but often provide inadequate pain relief. Centrally acting anti-cholinergic drugs are used for the relief of pain/spasm from the chronic condition of idiopathic cervical dystonia and from drug induced dystonic reactions. The use of these drugs for acute spasmodic neck pain has been poorly studied. There is a single study in the literature assessing the centrally-acting anti-cholinergic drug benztropine (trade name cogentin) in the relief of pain and spasm from this condition. This is a case series of 5 patients with acute pain and spasm of the neck and demonstrated remarkable relief of pain and improvement in range of motion in all patients following an intra-muscular injection of benztropine. Our hypothesis is that IM benztropine will provide relief of neck pain and improve range of neck movement in patients presenting with wry neck. We aim to compare the effect of 2mg IM benztropine with placebo on pain scores and range of motion in patients presenting to the ED with wry neck.

  • When reconstructing defects in the skull is it safer and more cost effective to use a patients own bone or a custom made titanium plate

    Cranial bone defects are often left following brain surgery usually to allow swelling of the brain to recover before subsequently re-implanting protective covering of the brain at a later time (cranioplasty). These procedure are performed anywhere over the the cranial vault, either unilaterally or bilaterally. The original piece of bone (autologous bone plate = bone flap) is placed in a sterile container and stored in a refrigerator at temperature of -40degrees celcius. Weeks or months later, when the brain is relaxed, the scalp well healed, and the patient’s medical condition permits, the individual is taken back to the operating theatre and the bone is reimplanted (A procedure known as an autologous cranioplasty). The aim of the procedure is to restore cosmesis and protection to the underlying brain and it can sometimes also improve neurological symptoms by unknown mechanisms. Unfortunately these aims are not always achieved and whilst technically straightforward the procedure is known to be associated with a number of complications. Two of the most significant of which are infection (such that the bone flap needs to be removed and replaced) and resorption (such that the protective function is compromised). A less severe but cosmetically significant complication is injury to the frontal branch of the facial nerve during cranioplasty leading to weakness of eyebrow elevation. Between 2004 and 2009 in Western Australia 164 patients required either a unilateral (n = 78) or bilateral (n = 86) decompressive craniectomy for trauma. Of those patients that survived 138 had a cranioplasty procedure and in this cohort there was a high rate of infection and bone flap resorption. Infection A number of reports have now documented the higher than expected incidence of infection following decompressive craniectomy and subsequent cranioplasty. Within the Western Australian state-wide neurosurgical service the overall infection rate for cranial procedures has been consistently audited at 1 – 2%, however within the post-traumatic craniectomy/cranioplasty cohort of 138 patients, sixteen (11.6%) had to have the bone flap removed because of infection. It is not known why the infection rate is so high but a number of reasons have been proposed e.g. skin colonisation whilst in hospital, factors relating to long-term storage of the bone flap, immune compromise following trauma and reoperation. Some studies have reported lower rates of infection when using custom made titanium or ceramic cranioplasty plates however, meaningful interpretation of the published literature is difficult because other studies have demonstrated precisely the opposite. Bone flap resorption The incidence of bone flap resorption has been reported between 10% and 50% Within our post traumatic cohort, 10% of the bone flaps were so severely resorbed that they needed to be replaced. A further 12% showed significant radiological resorption and whilst these were not replaced they could be adjudged to have failed because there is concern that they do not provide adequate protection. In each case of absolute cranioplasty failure (overall approximately 20%) the patient requires readmission, a second operation to remove the bone flap, prolonged antibiotic therapy (in the case of infection), a custom-made titanium plate constructed and readmission for a third surgical procedure. The question addressed in this study is whether it would be more efficacious and cost effective to insert a custom-made titanium cranioplasty as a primary procedure.

  • Investigation of whether metformin can be used safely and effectively in patients with type 2 diabetes on haemodialysis

    This is a study aiming to evaluate whether metformin, an antidiabetic medication, can be used safety and effectively in patients with type 2 diabetes who are receiving haemodialysis for their end stage kidney disease. The study runs over 4 weeks and 500mg of metformin (one tablet) will be given to participants after each dialysis session in weeks 2-4 of the study (9 times). We hypothesise that metformin can be safely used in patients with type 2 diabetes with end stage renal failure if dosed based on predicted drug clearance.

  • An Evaluation of Stepped Care for Child Anxiety

    The aim of the current study is to evaluate a stepped care model of the delivery of treatment to young people with anxiety disorders. Our clinic will function as a "microsystem" to evaluate the cost-effectiveness of moving from the current gold standard one-size-fits-all model of treatment delivery to a stepped care framework. By introducing both low-intensity and high intensity steps into the stepped care approach, we predict that the stepped care model will result in both 1) greater efficacy (reductions in diagnoses, symptoms, and life impairment) and 2) improved cost effectiveness than traditional treatment.

  • An observational study on the safety and efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome patients

    The purpose of this study is to evaluate the safety, efficacy and patient acceptance of High Frequency (HF) Spinal Cord Stimulation (SCS) for the treatment of patients with chronic neuropathic pain due to Complex Regional Pain Syndrome (CRPS). Main study endpoints will assess pain relief, functional capacity and quality of life improvements over a 12 month period.

  • Oscar 2 blood pressure measuring device validation during aero-medical transportation of critically ill patients

    This study aims to assess the accuracy and reliability of the Oscar 2 non-invasive blood pressure measuring device during; 1. fixed wing; and 2. helicopter transportation of critically ill patients.

  • Stuttering and speech sound disorders: a phase I clinical trial using the Lidcombe Program

    The aim of this clinical trial is to establish whether stuttering and speech sound disorder can be treated simultaneously. It is estimated that between 30-40% of children who stutter also have a speech sound disorder. Both disorders are known to have effects that may continue into the child's school years and beyond if not treated early. Currently there are a number of effective interventions that aim to treat fluency and speech sound disorders when they present in isolation. A small number of participants will be recruited to carry out a combined stuttering/speech sound disorder treatment program to establish safety and correct clinical protocols.

  • A pilot study to investigate the effects of nocturnal humidification on sleep apnea and sleep quality, in patients with Primary Sjogren’s Syndrome(pSS)

    Excessive dryness of mouth and throat, occurs in patients with Sjogrens Syndrome. This could result in sleep disturbance and predispose to obstructive sleep apnea. A previous study has reported that nocturnal humidification (moistening the mouth and throat at night) improved mouth dryness and decreased sleep disturbance. It might be possible therefore to improve sleep apnea and sleep quality in patients with Sjogrens Syndrome by using special mask and device which will deliver humidified air and keep mouth and throat moistened, during night.Our aim is to find out the usefulness of nocturnal humidification (giving humidified air through a mask during sleep at night) in improving sleep apnea and sleep quality in patients with Sjogrens Syndrome.

  • Effect of resistance training on natural killer cell activity in women recovering from breast cancer treatment: A randomised controlled trial

    Breast cancer is the most commonly diagnosed invasive cancer in women. Breast cancer patients often suffer from suppressed immune functioning as a result of the cancer and its therapies. The aim of this project is to examine whether resistance exercise can enhance immune functioning in breast cancer survivors. Participants will undergo a testing protocol consisting of measurements of immune function (blood sample), strength and quality of life (questionnaires). Participants will then be randomly assigned to undertake a 16 week resistance training intervention or to continue on as normal in a control group. At the completion of the 16 weeks the participants will undergo the same tests as at baseline. These tests (strength and quality of life) will also be completed at a 6 month follow up. Who is it for? The study is open to postmenopausal women aged 40-70 years who are recovering from stage I to IIIA breast cancer and its associated treatment. Full details of the inclusion and exclusion criteria for this trial can be found in the relevant sections of this form. Trial details This study involves participating in a 16 week resistance exercise intervention, conducted 3 times per week in groups for approximately 1 hour per session encompassing full body weight training and progressive resistance training consisting of the use of free weights and machines, under the supervision of a qualified trainer who is assisted by 3rd year students.

  • Circulating Tumour DNA as a Sensitive and Specific Marker of Response to Therapy and of Occult Disease in Colorectal Cancer

    The purpose of this study is to measure cancer specific gene changes in the blood as a biomarker in monitoring disease status in colorectal cancer. Biomarkers are substances that can be found in blood and/or tumour tissue and may be used to measure the effects or progress of a disease or condition. Genes are substances in the body which contain information about characteristics us as individuals. Previous studies have found that the majority of colorectal cancers contain mutations in several genes (the gene is changed or different from the common form) and that these cancerrelated mutations can be detected in the blood. Identifying biomarkers are important because they may be linked with disease progression, they may help to identify people who are most likely to benefit from a certain treatment such as chemotherapy, or they may be used to track the status of cancer without the need for invasive procedures, such as biopsies.

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