ANZCTR search results

This study aims to assess the safety and efficacy of orally administered JBI-802 in subjects with Myeloproliferative Neoplasms (MPN) and Myelodysplastic/ Myeloproliferative Neoplasms (MDS/MPN) with Thrombocytosis. Who is it for? You may be eligible to join this study if you are aged 18 years and over have been diagnosed with Essential Thrombocythemia and either a Morphologically confirmed diagnosis of Myeloproliferative Neoplasms (MPN) or Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN). Study details: Participants in this study will receive JBI-802 administered orally daily for a 28 day treatment cycle for up to 2-years as long as the participant experiences clinical benefit in the opinion of the Investigator and shows no signs or symptoms of unequivocal progression of disease, unacceptable toxicity, or other reasons for study discontinuation. The starting dose of the study drug is 5 mg/day, a total dose of 35 mg. Dose escalation will occur as per the 3+3 design after an internal Safety Review Committee (SRC) review of each dose stage. Dose expansion to other subtypes of MPN and MDS/MPN will occur after Recommended Phase 2 Dose is determined from the dose escalation phase. Eligibility/Screening for this study will occur within 21 days prior to starting treatment. If the study is suitable for you, you will enter the treatment period. The dose level selected for evaluation in Phase 2 will only be selected if it was safe and well tolerated during Phase 1. The treatment cycles will continue until you wish to stop, or you do not tolerate JBI-802 treatment, Some of the study procedures that include during your treatment period are :Medical, surgical, and cancer history, Height and weight, Physical examination, Vital signs, Eastern Cooperative Oncology Group (ECOG) evaluation, Electrocardiogram, Myeloproliferative neoplasm symptom assessment questionnaire,CT/MRI scan, Bone marrow biopsy, medication usage, Side effects assessment, blood and urine Sampling , liver and thyroid function tests, haematology and coagulation tests, Participants will be followed-up at the start and end of each 28-day cycle to assess safety and tolerability Blood samples will be collected to assess safety and tolerability during the study. After the end of study, subjects will be treated in accordance with local practice. Compassionate use of JBI-802 may be allowed in subjects after study completion, based on the Investigator’s judgment in consultation with the Sponsor and on a case-by-case basis. Compassionate use will be controlled by a separate protocol or process as defined by the local regulatory authorities. Continuation of study therapy beyond 2 years may be approved by the Sponsor based on the safety profile and will be contingent on the continued availability of product.

Enhanced Recovery After Surgery (ERAS) has been accepted as a standard of care designed to achieve early recovery and reduce stress response following surgery. While penile prosthesis implantation is a safe and effective treatment for males with erectile dysfunction, it is not without complications including postoperative pain and scrotal hematoma. This study evaluates the concept of ERIC (Enhanced Recovery Implant Care) on clinical outcomes and patient satisfaction rates following inflatable penile prosthesis (IPP) surgery. ERIC pathway appears to improve clinical outcomes and postoperative recovery following IPP surgery in terms of pain score, the analgesic requirement, and time to IPP cycling, as well as the overall patient satisfaction rate.

The primary aim of this research is to investigate how acute exercise affects executive function and whether these effects are modulated by transcranial Direct Current Stimulation (tDCS) of the dorsolateral prefrontal cortex. While we are not directly measuring dopamine levels, we hypothesize that exercise may induce changes in dopamine, which in turn could influence the outcomes of tDCS on executive function. The study will explore the impact of different exercise intensities, ranging from very light to moderate, on these effects.

Depressive symptoms are prevalent among middle-aged women, especially during the menopausal transition. However, the impact of menopause on depression is often overlooked, leading to inadequate treatment and poor outcomes. While current guidelines recommend traditional antidepressants as first-line management, the evidence for hormonal therapy is limited. To address this gap, we propose a new clinical trial comparing the efficacy of Menopause Hormone Therapy and antidepressants in treating menopausal depression. Given that menopausal depression most likely stems from hormonal fluctuations, it is hypothesised that hormonal treatments are more appropriate than antidepressants.

Type 1 Diabetes (T1D) is a chronic lifelong illness that requires a complex treatment regime. T1D is a condition that is often difficult for parents to manage and can cause significant stress in parents who have trouble dealing with their child’s condition. Parental stress is compounded as the child transitions to adolescence. An Acceptance and Commitment Therapy (ACT) intervention has been developed that may have the potential in reducing parental stress in parents of adolescents with T1D. The content of the workshop sessions will focus on the six core processes of Acceptance and Commitment Therapy (ACT): cognitive defusion, acceptance, self as context (self-compassion), contact with the present moment, values, and committed action. The aim of this study is to assess feasibility, acceptability and efficacy of Acceptance and Commitment Therapy (ACT) in managing the parental stress in parents of adolescents with T1D..

This is a first-in-human, single-centre, randomised, double blind, three-part multiple dose study to assess the safety and tolerability of OXT-328 and how this drug acts in the body in patients with chemotherapy induced peripheral neuropathy (CIPN). Who is it for? You may be eligible for this study if you are over 18 years of age and have moderate-to-severe CIPN. Study details: All patients with CIPN who choose to enrol in this study will be assigned by chance to receive multiple doses of OXT-328 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with CIPN.

The primary aim of this research is to develop and examine the acceptability, feasibility and effectiveness of a malnutrition screening tool encompassing physiological, psychosocial, emotional, financial, and cultural determinants of malnutrition for patients with ALD (with or without ascites).

We want to find out how many women who test positive for Chlamydia Trachomatis infection in the urogenital region, are also infected in anal canal (back passage) . This study focuses on women who have no symptoms of infection and have had no anal sexual contact in the past six months. This is because, symptoms of chlamydia often do not show up in women. Also, anal canal chlamydia can be present when the vagina or urethra are infected, even when a woman has not participated in any anal sexual contact, and at this time we do not know how many women are cross infected in this way. This research help us understand how much anal chlamydia may be present in women infected with urogenital chlamydia but have no symptoms and no history of anal sexual contact. This is important as the medications used to treat the CT in the two different anatomical regions is different. ie the treatment for urogenital CT is not as effective as the optimal treatment for ano rectal CT. The research will help us to make any necessary policy changes to improve chlamydia detection and treatment, because if women with no symptoms are not tested correctly, this can result in several unpleasant health problems, with spread of infection to sexual partners and any unborn children the woman may carry. The study hypothesis is that In a North Queensland population of women with urogenital CT who are asymptomatic and report no previous anal sexual contact, 50% will test positive for concurrent anorectal CT (based on an estimate from data from a previous international study [Van Liere et al.,2014]).

Type 1 diabetes is a lifelong autoimmune condition characterised by high blood glucose levels. Children with early stage type 1 diabetes (defined as two or more (multiple) islet antibodies, Stage 1-2 type 1 diabetes) or at-risk of the condition (defined as a single antibody, pre-type 1 diabetes) require ongoing clinical monitoring for disease progression and to avoid life-threatening complications arising from late recognition of symptom onset and insulin requirement (i.e. Stage 3 type 1 diabetes). This study is a follow-on from The Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study. It aims to include up to 36 children with type 1 diabetes antibodies, detected via screening, to evaluate the feasibility and acceptability of the international clinical guidelines for ongoing monitoring of children with early stage- or pre- type 1 diabetes.

This study aims to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 to detect known tumour deposits in patients with advanced epithelial Ovarian Cancer. Who is it for? You may be eligible for this study if you are an adult with recurrent, histologically proven advanced ovarian cancer with a macroscopically visible tumour on diagnostic imaging. Study Details All participants who meet the eligibility criteria in this study will receive a single dose of 89Zr-hu/mo-10D7 as an intravenous infusion over 30 minutes to delivery maximum dose of 4.5 mg protein and 37 MBq radiation. During and after completion of the treatment participants will be assessed for safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 via vital signs, blood tests, ECG, urinalysis and PET/CT scan. It is hoped that this research project will demonstrate hu/mo-10D7 targets advanced ovarian cancer metastases in humans and therefore prove its potential utility as a theranostic in ovarian cancer.