ANZCTR search results

This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people. The purpose of this study is to determine the effectiveness of NTI164 in patients with ASD when treated with 20mg/kg/day for 8 - 54 weeks. The study comprises of an 8-week double-blinded randomised controlled treatment period followed by an 8-week open-label maintenance period followed by a 2-week wash-out period. Participants who wish to continue receiving the study treatment beyond the 16 week period may do so for up to fifty-two weeks (Extension phase) Efficacy will be measured and monitored by performing participant- and psychologist- led questionnaires specific to measuring changes in the behaviour of patients with ASD. Safety will be measured and monitored by performing full blood examinations and liver and renal function tests throughout the study. Additional assessments include microbiome and inflammatory marker assessments.

Our previous work has established that social media presents a unique opportunity for suicide prevention initiatives, particularly with young people. However, only recently have we started exploring the impact of using social media for the purpose of delivering suicide prevention interventions. Further, while it is known that young people often turn to social media to discuss and share information about suicide, little is known about the types of social media content that young people find most helpful and informative when it comes to educating them about safe online communication about suicide, and what impact such information has on their communication behaviours. To extend this body of work and to develop a social media campaign that is safe, acceptable and helpful for young people, Orygen has received funding to conduct a randomised controlled trial (RCT) with young people across Australia. This project will not only further test the impact of the #chatsafe suicide prevention social media campaign in a controlled study, it will add to the body of knowledge relating to youth-friendly and effective suicide prevention initiatives that can be delivered to young people directly through social media.

We will implement an intervention to improve the quality of care for residents in aged care facilities. The intervention consists of an electronic dashboard on falls and quality of life. It is intended for use by aged care staff and predicts the risk of falls and poor well-being and presents information, action areas and clinical evidence-based recommendations that can be inputted by staff to minimize the resident risk of poor health outcomes. To evaluate the dashboard we will be conducting a cluster-randomised controlled trial where we will randomise 20 facilities into intervention and control groups (i.e. 10 in each group). The intervention will be introduced across all intervention sites at the same time in early 2023. A 1-month intervention wash-in period will be allowed to allow the integration of the dashboard into routine practice. Since the intervention is an add-on to an existing system, 1 month will be sufficient to allow users to familiarise themselves with the dashboard. The impacts of the dashboard will then be compared between the intervention and the control sites after 12 months (excluding the wash-in period data). We will include two additional sites for the pilot testing. The primary outcome we will look at is the rate of all falls (i.e., any falls regardless of whether an injury was involved, or hospitalisation was required). We hypothesise that the intervention will reduce the rate of falls in the intervention group in comparison to the facilities in the control group. The secondary outcomes include: injurious falls, falls requiring hospitalisation, client wellbeing, social service use (attendance at leisure and lifestyle activities), hospital service use, use of the Peninsula Health Falls Risk Assessment Tooland change in use of Falls-Risk Increasing Drug use.

The primary aim of this study is to evaluate the feasibility and acceptability of conducting a randomised controlled study that includes pelvic floor muscle (PFM) exercise and mindfulness delivered in a hybrid mode (four face-to-face sessions and four remote sessions) for women with endometriosis associated pelvic pain. In addition, we will measure the changes in PFM dimensions before and after the eight weeks of the treatment protocol. We aim to recruit 56 participants with a confirmed diagnosis of endometriosis from health services or via social media. Participants will be asked to complete online questionnaires and undergo ultrasound assessments before and after eight weeks of PFM exercises and mindfulness. All participants will also be invited to participate in an interview after the completion of the eight weeks of the treatment protocol to talk about their experience and the acceptability of the pelvic floor exercises and mindfulness interventions. We will recruit a purposive sample of women for this interview.

Hypothesis of this study is application of anterior chest wall compression on mechanically ventilated patients will prevent ventral lung overdistention. We aim to examine changes in respiratory system compliance, oxygenation, ventilation and CT changes in lungs after applying anterior chest wall compression in mechanically ventilated patients We intend to enrol 10 patients in this single centre study. This trial will be conducted in the Southern Adelaide Local Health Network, Intensive and Critical Care Unit, Flinders Medical Centre. Screening and Recruitment Patients will be referred by treating ICU clinicians. Referral will be made as soon as possible after admission for patients who are intubated and ventilated Consent will be sought prior to enrolment Intervention Patient will have a 100 gm/kg weight placed on the anterior chest wall, while in supine position. The weight will be placed on the patients’ chest wall for 10 minutes and then removed. A number of measurements will be recorded before and after the procedure. Similar intervention repeated during CT chest. Device: weight on the anterior chest of the patient (soft and smooth weight (saline bags) placed and secure around each hemithorax) After enrolment, each patient will be treated as follows: Patients will be sedated and paralysed while mechanical ventilation settings will be kept unchanged over the course of the entire study. Initial baseline in the lying on the back ( Supine) position (T0) 10-minute period in supine position with 100 gm/kg soft and smooth weight (saline bags) placed and secure around each hemithorax (T1) In case of drop of oxygen level ( SPO2) , increase in delivered oxygen ( FiO2) will be allowed to achieve the previously described oxygen target. During the study, each patient will undergo standard ICU monitoring:

This is a randomised, open-label, multiple-dose, 2-period crossover study to evaluate the PK and bioavailability of Smartech (diclofenac sodium topical solution) 2% w/w compared to PENNSAID® (diclofenac sodium topical solution) 2% w/w, This trial is the first clinical study to evaluate Smartech (diclofenac sodium topical solution) 2% w/w. PENNSAID® (diclofenac sodium topical solution) 2% w/w is a marketed product. Smartech’s PK study is intended to confirm that the use of optimised Penetration Enhancer (PE) ingredient/s in the Smartech product will deliver a higher amount of drug through the skin and joint, and into the blood, such that the systemic exposure for the Smartech products would be higher than PENNSAID® (diclofenac sodium topical solution) 2% w/w. This study is a relative PK study planned to determine the PK parameters (Cmax and AUC) between a Smartech (diclofenac sodium topical solution) 2% w/w compared to PENNSAID® (diclofenac sodium topical solution) 2% w/w. Up to 32 healthy male and female participants will be screened within 28 days (Days -28 to -2) of the first treatment period. Smartech (diclofenac sodium topical solution) 2% w/w will be applied as a 40 mg dose to each knee. The dose will be dispensed as 2 pump actuations (20 mg [1mL] per actuation) from an airless container for each knee. PENNSAID® (diclofenac sodium topical solution) 2% w/w will be applied as a 40 mg dose (2 pump actuations, 20 mg [1mL] per actuation) to each knee, which is the recommended dose. For each product, the dose will be applied twice daily (in the morning and in the evening, 12 hours apart) from Days 1 to 7. On Day 8, a morning dose only will be applied. The doses should be applied at the same time each day. Assessment of the safety and tolerability of Smartech (diclofenac sodium topical solution) 2% w/w is a primary objective of this study. Safety and tolerability will be determined by physical examination findings, vital signs, ECGs, clinical laboratory parameters, and AEs. Safety and tolerability assessments may also be performed at various unscheduled time points or different assessments may be performed, if deemed necessary for participant safety by the PI.

Biliary fully-covered self-expanding metal stents are increasingly used over plastic or uncovered self-expanding metal stents due to their long-term patency and removability. However, there is concern that their placement across the papilla may lead to post-ERCP pancreatitis. Thus, this study aimed to assess the rates of post-ERCP pancreatitis with and without the use of fully-covered self-expanding metal stents for both benign and malignant indications. Our hypothesis for this study was that the use of fully-covered self-expanding metal stents would be associated with a higher risk of post-ERCP pancreatitis. This is a retrospective study involving three Australian tertiary referral centers. Consecutive adults who underwent ERCP for biliary indications between October 2016-October 2019 were included. We analysed the rate of post-ERCP pancreatitis, severity of pancreatitis, other procedure- and stent-related adverse events occurring within 90 days.

Currently, patient reported outcome measures (PROMs) such as the Oswestry Disability Index (ODI) and Visual Analogue Scale (VAS) are the standard method to assess improvement after spine surgery. However, these measures are subjective and do not provide an objective measure of physical capacity. To provide patients with an accurate representation of their function, it seems most beneficial to provide patients with a standardised objective tool which reflects the requirements of daily living. However, the necessary equipment needed to conduct some of these tests may not be accessible for some clinicians. Therefore, the aim of this study is to develop a tool which can be easily and reliably administered within clinical practice. The hypothesis of this study is that test scores are responsive to changes over time, more so than the standard measures of pain (VAS) and disability (ODI). The secondary hypothesis is that changes in clinical tests (e.g. the fingertip to floor) will correlate with the changes seen in their objective counterparts (e.g. the DorsaVi wearable sensors).

This is a parallel, randomized, placebo-controlled, two-part, Phase 1, Investigator- and participant blinded, first-in-human (FIH) study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity of single (SAD17442) and multiple (MAD17443) ascending, subcutaneous doses of SAR444559 in male and female healthy participants aged 18 to 55 years. Part 1 – SAD17442: - The study duration per participant will be up to 12 weeks, including screening period. - The treatment duration will be 7 weeks including a 4-day in-house institutionalization period after single dose administration and a follow-up period up to the end of study (EOS) visit. PD is as assessed as exploratory part of the protocol. The number of visits will be 10 ambulatory on-site visits and one 4-day in-house period, and 4 to 5 ambulatory visits to the ophthalmologist. Part 2 – MAD17443: - The study duration per participant will be approximately 16 weeks, including screening period and treatment period of 11 weeks. - The treatment duration will be approximately 11 weeks including 4-day in-house institutionalization periods after each dose administration (3 total doses) and follow-up periods between and after each of the three institutionalizations up to the end of study (EOS) visit. PD is as assessed as exploratory part of the protocol. The number of visits will be 10 ambulatory on-site visits and three 4-day in-house periods, and 4 to 5 ambulatory visits to the ophthalmologist.

RoboSTER is a prospective cohort trial designed to evaluate the outcomes following robotic removal of pelvic tumours and attached organs during multivisceral complete soft tissue extended resections (STER). The procedure is split into three parts, Firstly, there is removal of the bowel, then removal of the bladder, +/- prostate (male) or gynaecological organs (female) as well as lymph nodes. The second part involves reconstruction of a new urinary tract (urinary diversion) using a section of small bowel attached to the ureters to drain urine produced by the kidneys. The third part involves construction of a faecal diversion, ileostomoy/colostomy, using a section in the bowel to drain faecal matter produced in the intestines. The main objective is to investigate whether performing the operation inside the body (via a "keyhole surgery approach") with robotic assistance (using the da Vinci Xi surgical robot) is safe and feasible. Who is it for? You may be eligible for this study if you are aged over 18 years, and are undergoing an elective robotic multivisceral complete soft tissue extended resections for pelvic cancers. Study details All participants will undergo a multivisceral complete soft tissue extended resection using robotic surgical techniques. This will involve using the robotic equipment to perform the resection, and is anticipated to take approximately 13 hours to complete. For all participants conversion to traditional approach rates, quality of life measures, morbidity data and other clinical data (ie: blood loss, oncological outcomes etc) will be recorded to test the safety and feasibility of the approach. It is hoped that this study may demonstrate that intracorporeal pelvic tumour removal following robotic multivisceral complete STER is a safe and feasible approach and may result in better patient outcomes.