ANZCTR search results

Who is it for? You may be eligible for this study if you are 18 years or older, and have been diagnosed with a “Malignant Hilar Biliary Stricture” (or MHS), and require a stent. Purpose of the Study To assess two types of established stent placement techniques: Stent-By-Stent (SBS) and Stent-In-Stent (SIS). They will be compared in terms of stent patency, technical success, and complication rates, which will be assess at the end of the procedure day, and two follow-up visits. Study Details All participants will undergo an Endoscopic Retrograde Cholandio-Pancreatography (or ERCP). This is performed under sedation, and you are not likely to feel the entire processs. The ERCP procedure uses a thin tube with a camera which passes into your throat so we can have a better view of your gastrointestinal tract. The scope will travel down into the place where the bile duct meets the small intestine. A special dye will be injected into the affected bile ducts and an x-ray will be used to watch the flow of the dye to see where the blockage is. Then the stents will be put inside the relevant bile ducts using small guide-wires. Once the stent is inserted in the right place the wire is removed, and the bile duct will be unblocked and should drain normally. Because of your condition, you will require two stents placed in the ‘left’ and ‘right’ hepatic ducts within the liver. If you agree to participate, you have an equal chance of being randomised to receive one of the two stent placement techniques; SBS or SIS. (1) For the SBS group, two separate guide-wires will be fed into the left and right bile ducts at the same time. The first stent will be deployed into the left duct, and then the second stent will then be deployed into the right duct, and the guide-wires are removed. (2) For the SIS group, the first guide-wire will be fed into the left or right duct, and the stent will then be deployed and the guide-wire will be removed. Then, the second guide-wire will pass through the mesh of the first stent, into the remaining duct, and the second stent will be deployed while sitting through the first stent (creating a “Y” shape). You will be asked to attend a review visit with the investigator at 3 months and 6 months following your procedure. Your ongoing treatment and follow up will then be planned by your treating practitioner. We are particularly interested in investigating the choice of placement with a type of metallic stent, which has shown superior patency to plastic stents in recent studies. However, it is not clear which type of placement is favoured for metal stents for MHSs. We hope this research will help provide further information on the safety and usefulness of stent insertion techniques of MHSs and potentially other gastrointestinal disorders that require stents

DOSE-UP will bring us closer to understanding what the optimal dose of upper limb therapy is to maximise recovery. Our project will identify the maximum tolerated dose regimen (MTDR) of upper limb therapy at two different recovery points after stroke. The early in recovery subgroup will recruit participants 3 to 14 days post stroke and late in recovery subgroup will recruit participants 3 to 9 months post stroke. At time of consent, participants will be allocated a dose of therapy to test, and their response will determine the dose to be tested with future participants. We expect this study to provide answers to the question, what is the tolerable dose of upper limb training and support better development of intervention protocols for testing with stroke survivors in clinical trials.

Research Question Hip and/or groin pain is common in young and middle-aged people, and may represent hip osteoarthritis (OA) in its early stages. These people have persistent pain, difficulty participating in work and functional activity and have worse quality of life compared to healthy people. This is at a time of peak work and family commitments. Improving the capacity of these individuals to participate fully in work and functional activity will have large positive personal and societal benefits. If modifiable risk factors associated with pain, quality of life, functional and work participation limitations are identified in the early stages of hip OA, the impact of the disease could be reduced. This study aims to establish modifiable risk factors associated with worsening of pain and quality of life in people aged 18-55 years with hip and/or groin pain Methodology This prospective longitudinal cohort study will be conducted in Tasmania, Australia. 100 people aged 18-55 years with hip and/or groin pain, fulfilling eligibility criteria will be recruited. Participants will undergo baseline radiographs, clinical and demographic assessment and complete patient-reported outcome measures. Participants will be followed up at 6 and 12 (primary endpoint) months. Modifiable risk factors at baseline that predict increase in pain and worsening of quality of life (primary outcome) and changes in physical activity, sports participation, work participation and progression to hip surgery (secondary outcomes) at 6 and 12 months will be determined. Signficance of the project to physiotherapy This information will assist physiotherapists and other health professionals in providing targeted rehabilitation programs, and will enable informed decisions regarding resource provision to optimise future health care.

This study of ultramicronized PEA (particle size between 0.6 and 10 µm) will investigate the safety, tolerability, PK of single and multiple ascending doses of ultramicronized PEA compared to placebo in healthy subjects. The effect of food on the absorption of the ultramicronized PEA will also be assessed..

In this randomised, double-blind, placebo-controlled study, 105 adults experiencing mild-to-moderate anxiety/stress will be randomly assigned to receive tablets containing a daily dose of either Echinacea angustifolia (40mg) (LOW DOSE), Echinacea angustifolia (80mg) (HIGH DOSE), or placebo for 6 weeks. We will assess changes in symptoms through the completion of validated questionnaires assessing anxiety, mood, quality of life, and sleep.

This study is an open-label, single-arm study in which each subject will serve as his/her own control. The study will assess the effect of DCP treatment on ascites formation in cirrhotic subjects with RA, by examining the frequency of LVP and the volume of ascitic fluid drained. All subjects will participate in a Dose exposure assessment visit, followed by a 90 day open label treatment period, followed by a 90-day follow-up period of additional data collection from medical records. Ascites history (relevant medications, LVP dates, and volume of drained fluid) for the 90 days prior to treatment and the 90 days after treatment will be collected and used for comparison with on-treatment frequency and volume. The study will be conducted in two parts. At the start of the study, subjects will be enrolled into Part A. When a sufficient number of subjects have been enrolled into Part A to provide information about preliminary efficacy, safety, and exposure, additional subjects will then be enrolled into Part B.

A case-control design was used to examine the use of Hartmann, MoliCare® skin and body lotion to reduce skin tears among patients between two wards in an Australian private hospital. The two wards identified for the study was a medical/oncology ward which provided the control and the rehabilitation ward where the intervention was instituted. These two settings are considered comparable on the basis of patient demography as well as the level of patient acuity. Longitudinal data were collected for these settings both pre and post intervention period to determine the treatment’s efficacy and impact.

Aphasia, an acquired communication disorder occurs in a third of the stroke population. It affects the ability to talk, understand, read and write. Aphasia also negatively impacts on the person's self-identity, relationships, work and daily activities. People with aphasia commonly experience depression and/or anxiety. However, there is a treatment gap in provision of modified psychological care for the communication disability associated with aphasia. This study will feasibility test a new program 'Aphasia PRevention and Support in Mental health' (PRISM) - a level 1, evidence-based communication support and psychological therapy to optimise mood and wellbeing. A mixed methods approach will be used to investigate the acceptability of the therapy program to participants in a community setting. Participants will participate in qualitative interviews and complete clinically valid and feasible outcome measures (e.g., acceptability ratings, mood, quality of life, communication confidence and community integration measures). Data will be collected and analysed. Findings will be disseminated via publications and conference presentations.

This study aims to evaluate the effect of a gel on postoperative bleeding in patients undergoing endoscopic mucosal resection for advanced mucosal/submucosal neoplasia. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are scheduled to undergo endoscopic mucosal resection (EMR) for ampullary lesions or duodenal lesions. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will undergo standard treatment for the prevention of bleeding, which involves routine endoscopic measures such as placing clips at sites of bleeding. Participants in the other group will have a haemostatic gel (Purastat, 3D-Matrix) applied endoscopically in addition to the standard measures such as the endoscopic clips. Following the procedure, we will compare the rates of clinically significant bleeding between the two groups. We will also record and compare any adverse events. We hope that the gel can reduce the risk of post EMR bleeding.

This study will provide information as to whether administration of naloxone to the gut prevents constipation (and its associated complications) in ICU patients; this is important, as it will potentially improve patient comfort, reduce the amount of interventions needed during a patient’s stay in ICU, and may reduce the amount of time that they require ICU care. In this study, one group of ventilated patients will receive a combined preparation of naloxone, while a second group will receive a placebo fluid only, This will be administered via a tube, placed via the nose, in the patient's stomach. This allows us to compare the effect of naloxone on gut function. We hypothesise that administering naloxone will reduce rates of constipation in ICU patients.