ANZCTR search results

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

You can narrow down the results using the filters

33077 results sorted by trial registration date.
  • Evaluation of Forced Oscillation Technique variability in asthmatic children

    This study is an observational study examining the day to day variation in FOT measures in 20 asthma subjects, and examining the relationship between the variability seen and asthma severity and symptom control

  • Is muscle lengthening or bony surgery better for young children with cerebral palsy who have hip displacement?

    This study aims to find out if muscle lengthening surgery or bone surgery is more successful for improving hip displacement in young children with cerebral palsy (CP) who have severe hip displacement. Hip displacement refers to the ‘ball’ (femoral head) of the hip joint moving out of the ‘socket’ (acetabulum) and is common amongst children with CP. Hip displacement can lead to changes in shape of the hip joint, degeneration of the joint, loss of function and eventual pain. In severe cases, or when untreated, displacement can lead to complete dislocation of the hip. Studies have demonstrated that the success of surgery to lengthen tight hip muscles (soft tissue release, or STR) has a limited effect. This surgery is most unsuccessful for children who are not able to walk independently. Up to 86% of these children go on to require further surgery or develop severe hip displacement. The surgical alternative to STR is invasive surgery to change the shape of the hip (varus derotation osteotomy, or VDRO). It has been thought that the earlier the age at which VDRO is done, the higher the chance that it will need to be repeated in the future. At present, efforts are made to delay this surgery in young children by using STR as a ‘temporising’ measure. Previous studies suggest that VDRO is likely to be more successful than STR in managing hip displacement, but it is less clear what the impacts are on factors such as burden of care, parent satisfaction and quality of life. This study will compare the effects of STR and VDRO surgery. To find out the effect of each surgery on hip displacement, the primary outcome measure will be Migration Percentage, a reliable measure of hip displacement that can be taken from a standard hip xray. Impact on factors such as comfort, burden of care and quality of life will be measured through a reliable parent-report questionnaire. All outcome measures will be assessed at baseline, 3 months after surgery (12 weeks) and then at 6, 12 and 24 months after surgery.

  • Does Bowel Preparation Alter Diagnostic Yield in Capsule Endoscopy?

    This prospective randomised trial will compare the diagnostic yield of capsule endoscopy (CE) findings between three patient groups undergoing CE to investigate obscure gastrointestinal bleeding (OGIB). A control group who will take no bowel preparation will be compared to two groups undergoing different bowel preparation regimens. CE is a standard test for the investigation of OGIB. A video capsule device is swallowed by the patient and passes through the gastrointestinal tract taking 2-6 images per second. The examination is then reviewed for abnormalities that may represent a source of bleeding. The study is specifically aimed at examining the small bowel mucosa although abnormalities can be picked up in other areas. The diagnostic utility of CE can be adversely impacted by small bowel residue obscuring mucosal views. Mucosal views in endoscopic examinations can be improved by pretest preparation regimens, such as bowel preparation in colonoscopy, or washing and suctioning during the procedure. The capsule device is unable to directly clean the mucosa hence prepration regimens are the only option to improve mucosal views by reducing the amount of residue present. Currently there is limited data to recommend routine use of bowel preparation regimens for capsule endoscopy. Our hypothesis is that bowel preparation taken prior to capsule ingestion will improve small bowel mucosal visualisation thereby improving the diagnostic utility of the test.

  • Does artificial sweetener affect energy expenditure and food intake?

    I hypothesise that, compared to a milk-based jelly preload sweetened with table sugar, similar preload sweetened with artificial sweetener sucralose reduces postprandial carbohydrate oxidation but does not affect energy expenditure. I further hypothesise that artificially-sweetened preload does not increase hunger sensations, subsequent food intake, and total daily energy intake. Diet products (sugar free) are widely used as a strategy to reduce energy intake by individuals who continuously monitor their body weight and by overweight individuals who are trying to lose weight. This practice is supported by findings from intervention studies that reported greater weight loss in adults and less weight gain in children when diet beverages were supplemented. However, some observational studies failed to observe the beneficial effects of artificial sweetener use on body weight, or have even reported positive association between body weight and artificial sweetener use. While it is possible that the relationship observed may be explained by reverse-causation (overweight individuals included more diet products to assist weight loss), there is evidence proposing a neurobiological explanation to heightened food intake induced by artificial sweeteners, which has been documented in animal studies. According to this hypothesis, increased appetite and food intake may be due to the infidelity between sweet taste signals (hinting the body of potential carbohydrate intake) and absence of carbohydrate after the ingestion of artificial sweeteners. While this hypothesis may be plausible, this effect has yet to be replicated in humans, where human studies have found no effect of diet beverages on food intake or hunger sensations. However, what remains unknown is whether artificial sweeteners promote appetite and food intake when they are added to foods in forms other than liquid and where sugar is the only energy source.

  • Q fever within the Mackay Health District

    Q fever is a zoonotic disease caused by the highly infectious agent Coxiella Burnetti. This agent is transmitted via animal’s urine, faeces and bodily fluids in which they dry up and become contaminated dust in air. Humans contract this intracellular bacterium via the respiratory route, as they breathe the contaminated air. Literature provides some ideas on the exposure risks for developing Q fever such as; being a farmer, sheep and dairy workers, veterinarians, laboratory workers, and many more. However not much has been shown on specific animals transmitting Q fever, especially the comparison of the well-established risk of exposure to cattle verse the native mammals such as macropods. In addition acute Q fever can develop into chronic Q fever within some patients, thus creating an array of complications such as endocarditis, pneumonia, hepatitis, pregnancy related problems, and meningitis. These complications delineate the importance of identifying the exposure risks in order to develop possible preventative regimes against Q fever. In the setting of a regional and rural population consisting of approximately 160,000 people which is mainly known for its’ mining, farming, cane-farming industry as well as its’ diverse native fauna, it is interesting in analysing the different exposure risks for developing Q fever. This exposure ranges from contact with different animals (such as sheep, cattle, macropods), living in different climates (such as wet and dry season) and those within different professions (such as farming, cane-farming, meat workers, veterinarians, laboratory workers). In addition, the study will hopefully illustrate any underlying medical conditions which may predispose patients to contracting Q fever. Researching both of these outcomes will help create a risk profile for humans in developing Q fever.

  • 18-Fluoride (18F) labelled Sodium Fluoride (NaF)) Positron Emission Tomography (PET)/Computer Tomography (CT); the impact on pre-operative staging of intermediate and high risk prostate cancer

    This study will investigate the management impact of staging with a diagnostic scan known as 18-F Sodium Fluoride PET/CT compared to bone scintigraphy in men with prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged at least 18 years with newly diagnosed, untreated, biopsy confirmed, intermediate to high risk prostate cancer. Study details: All participants in this study will undergo two different diagnostic tests. The first test is called 18-F Sodium Fluoride Positron Emission Tomography (PET)/Computed Tomography (CT), and this involves the injection of a small amount of radioactive tracer into your veins. You body is then scanned to look for areas of tracer-uptake which may suggest cancer in your bones. The second test is called bone scintigraphy, and this involves a different radioactive tracer. Surgeons will first view the bone scintigraphy and use this to record a management plan and treatment goals. They will then view the 18-F Sodium Fluoride PET/CT and record a separate management plan. It is suggested that 18-F Sodium Fluoride PET/CT can pick up prostate cancer that has spread to the bone better than Bone Scintigraphy (BS). We wish to assess whether having access to 18-F Sodium Fluoride PET/CT actually changes the surgeons intended management of men with intermediate to high risk prostate cancer, and whether the detection of bone metastases (cancer spread to bone) is different between tests.

  • Improving radiotherapy outcomes with smoking cessation: Feasibility trial in head and neck cancer patients

    This study will determine whether a smoking cessation program may improve radiotherapy outcomes in patients with head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, a smoker and have been diagnosed with head and neck cancer (including skin cancer), for which you are scheduled to undergo radiotherapy. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will participate in a multicomponent smoking cessation program which includes an initial three-month course of oral tablets (Varenicline), with the possibility of an additional three-month course to maintain abstinence, as well as 10 behaviour change sessions with a psychologist. Participants in the other group will receive standard NSW Health tobacco assessment and smoking cessation advice. Both groups will receive their standard radiotherapy treatment. Participants will be followed-up for up to 6 months, in order to determine compliance to and side effects of the smoking cessation program, behaviour change and tumour response to radiotherapy.

  • Novel feeding system to promote the establishment of breastfeeding after preterm birth a randomised controlled trial.

    The use of the novel teat to feed expressed breastmilk when mother not available to breastfeed preterm baby resulted in a shorter length of stay in hospital (2.5 days corrected for gestational age at discharge (p=0.026) and weight (p=0.006). Infants in the novel teat group had less formula feeding a discharge (novel 35%, control 16%, p=0.036) but otherwise did not differ in respect to feeding.

  • A pilot randomised controlled trial of omega-3 fatty acid supplements to prevent skin cancer in lung transplant recipients

    This study aims to evaluate the effectiveness of fish oil for the prevention of skin cancer in lung transplant recipients. Who is it for? You may be eligible to join the study if you are over 18 years of age, and are a lung transplant recipient for at least 1 year. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 4 x 1000mg oral capsule of omega-3 fish oil supplement daily for 12 months. Participants in the other group will take 4 x 1000mg of placebo (olive oil) daily for 12 months. Participants will not know which treatment they are taking until the end of the study. All participants will be asked to complete questionnaires, blood tests and skin exams at baseline and at the end of the study at 12 months.

  • Early Psychological Interventions for Post Traumatic Stress post Burn Injury

    Severe burn injuries are associated with considerable psychological trauma and burns patients are at increased risk of developing Post Traumatic Stress Disorder (PTSD), depression and other mental health disorders. EMDR is an effective evidence-based treatment for psychological trauma, it has been well researched, however there have been very few studies on early EMDR intervention as a means of preventing PTSD. To date there is no research on EMDR and burns related trauma in a primary care setting. Hypothesis and Aims Effective early intervention may enhance patients’ outcome, resilience and coping. The aim of this research is to establish that early EMDR intervention is safe and effective in this acute and medically complex setting. It is hypothesised that early EMDR intervention integrates traumatic memories thus preventing the development of chronic pathology. This research then aims to explore the effects and efficacy of early EMDR interventions on burn patients’ mental health outcomes with a primary focus on posttraumatic symptoms and secondarily tracking mood and coping, which are often poorly addressed during rehabilitation. The opportunity to promptly intervene with simple and effective psychological treatment to avoid sequelae in those who were previously well warrants investigation and sits with clinical observation that even good psychological “first aid” with counselling and Consultation-Liaison Psychiatry support appears to be insufficient to support best recovery. The hypothesis that early EMDR intervention/treatment has a positive effect on burns patients’ mental health outcomes, in terms of reduction in PTSD and depression will be tested. This study aims to improve psychosocial care of burns patients. Knowledge gained from the proposed research can be utilized to inform and further develop more effective early trauma interventions. Early EMDR interventions may facilitate improved psychosocial recovery of burns patients and this study is aims to establish basic proof of concept that early EMDR intervention is safe, useful and valuable in this acute and medically complex setting. Research Plan Protocol Stages: Stage 1- Screening for posttraumatic symptoms. All patients admitted to the SBIU, RNSH will be screened within the first two-four weeks following injury (or the first 2 weeks following discharge from Intensive Care using the Impact of Event Scale –Revised (IES-R). Patients whose baseline scores on this scale indicate moderate-to-severe posttraumatic stress symptoms will be considered for recruitment (IES score =26).The remainder of the questionnaires are used to track depression, anxiety and coping style, pain and alcohol use. Information re burn depth, size and location will also be obtained (collected routinely in all burns patients).These measures will be repeated at Burns outpatient follow-up visits at 3 monthly intervals over the first year and then annually for five years. Stage 2_- Clinical assessment to identify exclusions and pre-treatment variables. The subgroup of patients with elevated IES scores from the screening study will be evaluated further via a full psychiatric assessment by the Consultation-Liaison Psychiatry team to determine clinical exclusions and Ms Kwiet will also perform a fuller psychosocial research assessment, including evaluation of dissociative symptoms via interview and the Dissociative Experiences Scale (DES). Past trauma history as well as other risk and resilience factors, such as past psychiatric illnesses, family history, medications, premorbid personality and functioning and levels of social support will also be assessed. This will be obtained via a semi-structured interview incorporating these clinical domains, the Adult Attachment Interview (Burns Modified with Social Support probes) and the CAPS (the gold standard interview measure of PTSD). Patients identified as having unresolved chronic complex trauma (including prior PTSD) and high levels of dissociation will not be considered for inclusion in the RCT, as they are likely to require a prolonged period of stabilization and treatment within a longer term therapeutic relationship. Other potentially relevant biopsychosocial variables were obtained by the screening study to which will be added the (PCL-C), and current medications and pain relief. Stage 3: Randomized treatment Patients with (uncomplicated) moderate to severe posttraumatic stress symptoms will be recruited and randomly allocated into two groups. One group will receive three hours of EMDR as per the Acute – Traumatic Incident Procedure (A-TIP) and the other group will receive three hours of supportive psychotherapy, which will include basic psychological stabilization and stress management, considered as psychological “first aid”, provided within a supportive psychotherapeutic relationship. At commencement and completion of each session of treatment the IES will be repeated to track any change in the interval between screening and treatment and any interval changes between sessions. Stage 4: Residual symptoms and crossover to EMDR. Those patients in the control group whose IES scores remain elevated at the end of 3 sessions will be offered the EMDR treatment after 3 months out of ethical concern. Stage 5: Outcome and Follow-up assessments The IES (24) will be administered to all patients following each treatment intervention and at 3 months follow-up the Clinician-Administered PTSD Scale (CAPS) the gold standard for PTSD symptoms will be administered to all participants from both groups. At the 12-18 month follow up Ms Kwiet will perform another Burns Modified Adult Attachment Interview to all participants from both groups. The COPE , DASS and DES will also be re-administered to each patient at each follow up. Outcomes of both groups will then be compared to evaluate the effectivness of EMDR in improving burns patients mental health outcomes (specifically reduced reate of PTSD, depression, anxiety and greater quality of life)

Tags:
  • Finding clinical trials