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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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AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
Expand descriptionThe purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
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Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Expand descriptionThis is a Phase 3, multi-center, randomized and intrasubject controlled study to evaluate the safety and efficacy of abenacianine for injection, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer using NIR imaging in participants undergoing surgery for cancer in the lung. Approximately 132 partiipants will be enrolled to ensure a minimum of 115 evaluable participants receiving abenacianine and undergoing NIR imaging and a control group of 12 participants who will receive abenacianine but no NIR imaging.
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Safety and Efficacy of HB-1 for PTSD: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study
Expand descriptionThe purpose of this study is to determine the safety and efficacy of HB-1, versus placebo in male and female adult patients aged 18 to 65 years, inclusive, with Post-Traumatic Stress Disorder (PTSD).
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A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
Expand descriptionThe main aim of the study is to evaluate the pharmacokinetic (PK) biosimilarity of B-3E07 and European Union (EU) - sourced Forsteo® in healthy adult female participants.
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Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women
Expand descriptionA Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age
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A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Expand descriptionThis Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19/CD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 and be followed for 12 months to assess safety, B cell depletion, disease activity, immunologic biomarkers, and renal outcomes.
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A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
Expand descriptionThis is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.
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EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection
Expand descriptionThe overall aim of the EARLY study is to systematically evaluate the impact of blood collection protocols, storage temperatures, transport conditions, and time to processing on the stability of extracellular vesicle (EV) biomarkers associated with ovarian cancer, with the potential to inform and improve future ovarian cancer screening practices. This prospective study will inform future screening studies by: 1. Assessing the feasibility of participant recruitment and blood sample collection for extracellular vesicle analysis in a real-world healthcare setting, including evaluation of the practicality and effectiveness of these processes. 2. Evaluating the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage. A total of 1,500 participants will be recruited through community groups across Queensland, Australia, in collaboration with the Mater Research Biobank. Eligible participants who provide informed consent will have approximately 30 mL of blood collected for extracellular vesicle analysis. Data will also be collected on demographics (e.g. age and ethnicity), lifestyle factors (e.g. smoking status), medical, surgical and gynaecological history, family history of cancer, date of last menstrual period, and use of hormone replacement therapy (HRT). Participation in the study will conclude after blood sample collection.