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Bisphosphonate and Anastrozole trial - Bone Maintenance Algorithm Assessment
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A randomised controlled trial to evaluate the effect of modified constraint induced movement therapy or conventional occupational therapy following injection of botulinum toxin-A to improve bimanual performance in children with hemiplegic cerebral palsy.
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A phase II trial of gemcitabine in a fixed dose rate infusion combined with cisplatin in patients with operable biliary tract carcinomas
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PRA-216 Atopic Dermatitis Safety and Efficacy Study
Expand descriptionThis study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with moderate to severe Atopic Dermatitis (AD)
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A Single and Multiple Dose Study to Evaluate the Safety and Effects of Inhaled ICF001 Dry Powder in Healthy Participants
Expand descriptionThe primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetic characteristics of ICF001 following inhaled administration of single and multiple ascending doses in healthy participants.
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A Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of SFL-0821 in Adults With FSHD
Expand descriptionThe purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SFL-0821 in adult patients with Facioscapulohumeral Muscular Dystrophy (FSHD)
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Feasibility Study of Blood Biomarker Identification in Cervical Cancer
Expand descriptionThis study aims to explore whether a simple blood test can be used to help detect and monitor cervical cancer. The investigators are studying tiny fragments and particles found in blood, called cell-free DNA (cfDNA) and extracellular vesicles (EVs), to determine whether these can act as early warning signs (biomarkers) of cervical cancer. Cell-free DNA (cfDNA) refers to tiny fragments of genetic material (DNA) that are naturally released from cells into the bloodstream when cells die or renew. Cell-free DNA circulates naturally in the blood. In people with cancer, some of the cfDNA originates from cancer cells; this component is called circulating tumour DNA (ctDNA). Analysis of cfDNA can detect signs of cancer, such as specific genetic changes or pieces of viral DNA, including human papillomavirus (HPV) DNA, without requiring removal of tissue from the cervix. Extracellular vesicles (EVs) are very small "packages" released by cells into the blood and other body fluids. EVs carry messages between cells and contain important information such as proteins, fats, and genetic material, including RNA. In cancer, tumour cells release EVs that reflect tumour behaviour and activity. Analysis of EVs can provide information about cancer growth and response to treatment. Together, cfDNA and EVs can act as tiny messengers or "fingerprints" of biological processes occurring inside the body. Analysis of cfDNA and EVs in blood samples may support the development of a simple, less invasive, more comfortable, and more accessible approach to detecting and monitoring cervical cancer compared with current screening and diagnostic methods. A blood test could also assist doctors in monitoring treatment response or detecting early signs of recurrence without requiring a surgical biopsy. The expected outcomes of this study are to identify specific patterns or "signatures" in extracellular vesicles (EVs) and cell-free DNA (cfDNA) found in blood samples. These signatures could help to: Detect cervical cancer earlier, before symptoms appear or the disease progresses. Monitor treatment response in real time without the need for invasive tests. Predict whether cervical cancer might recur or spread after treatment. Support more personalised care by helping doctors select the most suitable treatment for each participant.
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Supplementation Absorption Comparison
Expand descriptionThe goal of this interventional study is to compare the absorption of supplements with and without absorption enhancing technology in healthy volunteers. We will be testing vitamin D3 and omega 3 in both males and females 18 years and older. Part A will comprise of two arms receiving a single dose of omega-3 supplement, and two arms who will receive vitamin D3 supplement daily for 7 days. Part B comprises of two arms who will receive vitamin D3 supplement daily for 6 weeks.
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Swabs in Screening for HPV (SWISH)
Expand descriptionThis trial aims to evaluate if self-collected anal swabs (SCS) can be used for anal cancer screening. Currently, only clinician-collected anal swabs (CSC) are recommended for anal cancer screening, and this may be a barrier for people to access screening. About 700 people living with HIV (PLHIV) in Australia will randomly undergo a SCS followed by a CSC, or the other way around. Swabs will be tested for high-risk human Papillomavirus (HRHPV, which causes most anal cancer) and if the swab is positive for HRHPV, it will also be tested for pre-cancerous cells. The anal swabs will be tested for new biomarkers, "methylation", which might help us predict if precancerous lesions will develop into anal cancer. Everyone will be asked about their preferences for swab collection. If someone tests positive for HRHPV, they will receive further care. We expect that more screening options will result in more people being screened.
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Comparison of a New Non-invasive Device With the Invasive Gold-standard Investigation to Assess Function of the Large Bowel in Children
Expand descriptionThe goal of this clinical trial is to learn if the new non-invasive device (Body Surface Colonic Mapping) works to accurately assess colonic movement and function in children.The main questions it aims to answer are: * Are Body Surface Colonic Mapping (BSCM) recordings comparable with gold-standard colonic manometry recordings (HRCM - High Resolution Colonic Manometry) in the paediatric population? * What are the effects of bowel preparation on colonic function assessed using BSCM? Children with clinical recommendation of colonic and/or anorectal manometry (clinical tests used to assess colonic function) for investigation of persistent bowel dysfunction symptoms will be invited to participate. We will perform and compare simultaneous recordings of manometry and BSCM in children, in order to demonstrate same colonic function measurements recorded by the two devices in this population. Eligible participants who consent to inclusion in the study will undergo colonoscopy and placement of a large bowel catheter, according to usual Royal Children's Hospital (RCH) practice. These involve administration of oral laxatives for bowel preparation and maintaining a clear fluids diet 24 hours prior to the investigation. Ahead of the simultaneous devices recordings, patients will also be invited to attend the hospital 2-4 weeks prior to have non-invasive BSCM recording only. The aim of this part of the study is to have a BSCM recording in the same patient once with the "physiological state" colon (early hospital visit without any bowel preparation administration) and once with the "non-physiological state" colon (time of colonoscopy, colonic manometry and BSCM with bowel preparation).