Honolusu, Hawaii
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.
Phase
3Span
219 weeksSponsor
AstraZenecaCluj-Napoca
Recruiting
Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)
Stroke-induced motor and cognitive impairments often worsen after hospital discharge due to limited access to rehabilitation, creating a cycle of non-use and functional loss ("rehabilitation in vain"). The PHRASE system aims to counteract this by providing patient-tailored, continuous rehabilitation at home using the Rehabilitation Gaming System (RGS). This integrated approach leverages VR/AR technology, prognostic tools, and data-driven decision-making to improve motor and cognitive function, reduce costs, and enhance patient independence. The study seeks to validate the effectiveness of the PHRASE system, focusing on its impact on motor and cognitive recovery and its use as a diagnostic and prognostic tool. It hypothesizes that combining the RGS application with conventional therapy will lead to better recovery outcomes compared to conventional therapy alone. This randomized clinical trial (RCT) will compare the RGS-based intervention to conventional therapy in stroke patients in Spain and Romania. Participants will undergo a six-week intervention involving daily 20-30-minute RGS sessions. Assessments are at baseline, mid-study (3 weeks), end of study (6 weeks) and follow-up (14 weeks). Data will be collected on motor and cognitive function, quality of life, usability, and patient/therapist experiences. Participants must be stroke survivors (>3 months post-stroke), aged >18, with mild to moderate upper-limb impairment (ARAT <50) and minimal smartphone experience. The RGS-based PHRASE approach offers a scalable, cost-effective solution for continuous rehabilitation, improving patient recovery, quality of life, and reducing healthcare costs. The study aims to validate its clinical validity in real-world settings.
Phase
N/ASpan
27 weeksSponsor
Eodyne Systems SLCluj-Napoca
Recruiting
Robotic Medial Congruent Vs. Conventional Medial Pivot TKA
This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as >2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.
Phase
N/ASpan
84 weeksSponsor
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresCluj-Napoca, Cluj
Recruiting
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
Phase
3Span
312 weeksSponsor
Bristol-Myers SquibbCluj-Napoca, Cluj
Recruiting
Cluj-Napoca, Cluj
Recruiting
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
Phase
3Span
293 weeksSponsor
Daiichi SankyoCluj-Napoca
Recruiting
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Phase
3Span
148 weeksSponsor
AmgenCluj-Napoca
Recruiting
Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression
To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.
Phase
N/ASpan
65 weeksSponsor
Babes-Bolyai UniversityCluj-Napoca
Recruiting
A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
Phase
3Span
374 weeksSponsor
Merck Sharp & Dohme LLCCluj-Napoca, Cluj
Recruiting
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Phase
3Span
236 weeksSponsor
Boehringer IngelheimCluj-Napoca
Recruiting