ANZCTR search results

Stoma formation in the neonatal period is necessary in many surgical conditions. There remains debate surrounding a number of factors (such as indications, type, timing of closure) and a paucity of quality literature to inform these decisions. The study aims to give an accurate reflection of practice and outcomes in Australia and New Zealand. Results will be used to aid and improve decision-making for this vulnerable group of patients

Background: Anorexia Nervosa (AN) has one of the highest mortality rates of any mental illness and very low treatment success rates. AN is characterised by high anxiety around food and weight gain. There are no pharmacotherapies approved for the treatment of anorexia nervosa (AN) and a need to find novel interventions to improve outcomes. Cannabidiol (CBD) has shown promising anxiolytic therapeutic effects in young people (12-25 years) with severe anxiety as well as young adults with social anxiety disorder. Anxiety is both a major feature of AN and highly prevalent during active treatment of the disorder, providing a strong incentive to explore CBD in people with AN. In an open label design, CBD capsules will be administered as an adjunctive intervention alongside an outpatient psychological intervention for 12 weeks. Safety and preliminary efficacy will be determined in people with AN. Study Aim: To determine if CBD treatment is a safe and a well-tolerated intervention in persons with AN. Moreover, to elucidate whether CBD is effective to reduce anxiety Hypothesis: We hypothesise that CBD is highly tolerable with a high safety profile, with no associated serious adverse events reported in relation to the investigational product. We hypothesise that CBD will reduce anxiety scores throughout the study and at follow-up. Furthermore we hypothesise that CBD will improve eating disorder psychopathology, depression, obsessive and compulsive symptoms and quality of life.

The aim of this study is to explore the long-term pain relieving effect after receiving ketamine infusions. There is a need to monitor the psychological, social and functional outcomes of patients receiving this treatment. We hypothesise that ketamine infusions will improve the pain experience for those with chronic refractory pain. Your pain specialist will determine if you are eligible to participate based on your symptoms. You will need to sign a consent form prior to any further information being collected. After this you will need to complete a baseline questionnaire asking about your history with ketamine infusions as well as some common pain, psychological and social measures. You will receive three burst ketamine infusions lasting 4 hours, 2-3 weeks apart. At the end of the infusion you will be asked to complete several questionnaires about your pain as well as some information regarding any side effects experienced. At two months and three months after your course of burst ketamine treatments you will need to complete a set of questionnaires again on pain and psychosocial measures. At each point the questionnaires will take you about 30 minutes and you have the option to complete the majority of them online via email in order to make the process more convenient.

This is an open label, Phase Ib/II trial with a randomized platform design study for treatment of myelodysplasia. The purpose of this trial is to determine the safety and efficacy of treatment by adding SRA515 to ASTX727 in intermediate and high risk MDS. This multi-centre trial will recruit participants across Australia and New Zealand. Up to 26 subjects will be recruited for the dose-determining phase (Phase Ib) and at least a further 60 patients in the dose expansion phase. Who is it for? You may be eligible to join this study if you are aged 16 years or above and have a diagnosis of MDS or acute myeloid leukaemia (AML) with <30% blasts. Study Details This study will be conducted in two phases with cycles of 28 days. Phase Ib (Safety and Dose-Determination) will determine safety, tolerability and Recommended Phase II Dose (RP2D). Subjects will receive 35mg of ASTX727 by oral capsule on Days 1-5 of each cycle followed by a starting dose of 10mg of SRA515 by oral capsule on days 6-15. Phase II (Dose-Expansion) will assess preliminary signs of efficacy by monitoring overall response rates in participants for a minimum of 6 cycles. Patients will continue receiving therapy until experiencing an event as detailed in the MDS05 Master Protocol. During treatment participants will be assessed routinely for treatment-related toxicity events and investigators will modify treatment dosage or, if necessary, discontinue treatment. After treatment, disease will continue to be monitored and if participants have MDS progression or morphological relapse they will be assessed for the next best treatment option. It is hoped that the results of this trial will help determine if, and what dosage of, SRA515 in combination with ASTX727 is a safe and effective treatment option for patients with MDS or AML.

Uterine Artery Embolisation (UAE) is accepted in Australia to treat uterine leiomyomas (fibroids). There is also growing literature to support UAE for the treatment of symptomatic adenomyosis (a condition when the tissue that lines the uterus grows into the muscular wall of the uterus). Adenomyosis and endometriosis are both disorders of the endometrial tissue that lines the uterus. UAE is a procedure where an embolic agent (a gel or glue) is placed in the uterine artery to limit the blood flow to areas of the uterus. It is a minimally invasive procedure performed by an Interventional Radiologist under image guidance. A small incision is made in the groin or the arm and a catheter (a long narrow tube) is placed in the artery and, under image guidance the catheter is directed to the artery to be treated. Once the catheter is in place the embolic agent is placed in the artery and the catheter is removed. UAE is not approved to treat endometriosis. Therefore, it is an experimental treatment for endometriosis. This means that it must be tested to see if it is an effective treatment for endometriosis. In this trial, the researcher would like validate that embolisation is a safe procedure and will provide improvement in the symptoms of endometriosis for patients with endometriosis.

This study is a prospective, randomized, double-blind, placebo-controlled, Phase 1b clinical study to evaluate the safety, tolerability, PK, and PD of oral multiple-ascending doses (MAD) of iN1011-N17 after Oral Administration in Healthy Volunteers and OsteoarthritisPost-Herpetic Neuralgia Patients and to Assess the Relative Bioavailability of Mesylate vs Hydrochloride Salt Capsules in Healthy Volunteers. The study will be conducted with approximately in 3 parts. 56 healthy volunteers and 8 PHP patients will enrolled in up to 8 sequential MAD dose cohorts (Cohorts 1 to 8), each cohort can commence after the corresponding dose cohort has been completed and after Safety Review Committee (SRC) approval.

BACKGROUND Micromotion analysis supports effective cemented tibial component fixation in Total Knee Replacement (TKR) but a paucity of literature exists for medial pivot designs. This clinical study examined the tibial component micromotion and clinical scores in a second-generation medial pivot TKR. METHODS This prospective single-center clinical cohort trial involved 35 patients with a mean patient age of 71 years. Operations were performed by one experienced arthroplasty surgeon using the SAIPH implant (MatOrtho). All patients received fully cemented fixation with patella resurfacing. Other variables were standardized. Radiostereometric Analysis was performed at 6 weeks and 12 months to monitor tibial component behavior. The working hypothesis of this study is that the SAIPH tibial baseplate achieves stable fixation using bone cement in subjects undergoing TKR

Improving surgical and pain relief techniques in laparocopic cholecystectomy has been exhaustively studied. However, in contrast to that, strongly contradicting evidence exists. This study seeks to examine if changes in surgical technique may be able to lessen the impact of surgery on health, by minimising the surgical insult and therefore facilitating an earlier discharge from hospital.

Parenteral nutrition (PN), consisting of carbohydrate, lipid, and amino acid constituent parts, is used in newborns when enteral feeding is insufficient. Those newborns requiring major surgery in the immediate postnatal period, comprising 17% of all late preterm and term newborns admitted to Australian NICUs per annum, are one such group with current supportive management emphasizing the importance of early nutrition. Recent data in children challenges this and suggests potential benefit from delayed provision of amino acids in the acute phase of a critical illness. The PEPaNIC (early vs late parenteral nutrition in the Paediatric ICU) RCT found that delaying PN (specifically amino acids) for a week following PICU admission reduced the length of admission by 30% and duration of ventilation by 40%, effects magnified on post-hoc analysis of the youngest patients. Confirmation of a similar response in ill surgical newborns is needed to drive practice change and improve both short- and longer-term clinical outcomes. Although the exact mechanism(s) remains unclear, the well newborn is exposed to a period of fasting for 48-72 hours following birth before the establishment of maternal milk supply, with fasting also a natural response to illness or surgical stress. Fasting results in up-regulation of autophagy which defines a phenotype of healing and repair, and which critically is suppressed by provision of amino acids. We hypothesize that delayed compared to early provision of the amino acid component of PN in late-preterm and term newborns requiring major surgery in the immediate neonatal period will shorten the duration of neonatal intensive care admission. The aim of this multi-centre, parallel group, superiority, blinded randomised controlled trial is to investigate the impact of delayed provision of the amino acid component of PN (intervention) versus early initiation (standard care) in late-preterm and term newborns requiring major surgery in the immediate newborn period on the duration of neonatal intensive care admission.

Cannabidiol (CBD) is a safe non-psychoactive compound in cannabis. It is available with a prescription under the special access scheme. It is available without prescription when approved at dosages less than 150mg. CBD (100mg) in coconut oil (1ml) will be administered to healthy volunteers (n=16) to determine it is present in the blood over time at safe and effective levels. Taking CBD with a fatty meal has been shown to increase blood concentrations. It is not known if taking it with coconut oil will produce a similar effect. The volunteers will receive CBD in coconut oil when fasting and on the second visit after a high-fat breakfast. The CBD (and its metabolites) levels will be monitored via blood collection and LC-MS/MS analysis using a previously validated method. It is expected the CBD levels will approach that of the high-fat group when administered with coconut oil.