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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Age: 18Years +All Genders
61 locations
A

Actively Recruiting

Researchers are evaluating the use of benralizumab in adults with severe eosinophilic asthma to understand its effectiveness in achieving partial and complete clinical remission. This multicenter, observational, prospective study called the ATHENA study aims to add real-world evidence on benralizumab's role in clinical practice. The study also seeks to explore the immunological effects of benralizumab to better understand asthma biology and to collect long-term safety data. Participants will receive benralizumab, administered as a 30mg subcutaneous injection following the approved prescribing information. The study focuses on patients who have either recently started benralizumab treatment within 7 days before enrollment or plan to start within 7 days after enrollment. Treatment and monitoring will follow routine clinical practice without additional interventions. During the study, researchers will track the number and percentage of patients who achieve clinical remission according to the SANI definition over 24 months. Participants will be closely monitored for treatment effectiveness, immunological changes, and safety outcomes throughout this period. The study involves collecting relevant clinical data and ensuring participants adhere to treatment and follow-up visits as per standard care.

Age: 18Years +All Genders
28 locations
A

Actively Recruiting

Researchers are studying ischemic stroke cases in patients who are taking oral anticoagulants for atrial fibrillation or other heart rhythm problems that can cause clots. This study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate short- and long-term outcomes related to different secondary prevention strategies to prevent stroke recurrence. The study includes two parts: a retrospective phase (ASPERA-R) and a prospective phase (ASPERA-P), involving multiple centers worldwide. The University of L'Aquila coordinates data collection, analysis, and management. The retrospective part (ASPERA-R) will collect data for 5 years from the study start, with centers having 6 months to enter existing patient data. The prospective part (ASPERA-P) will enroll patients for 2 years after study approval, followed by 5 years of follow-up. Participants must have had an acute ischemic stroke while on oral anticoagulants, with confirmed imaging showing stroke lesions. The study will observe different secondary prevention treatments, including continuing the same anticoagulant or switching therapies, to compare outcomes. Participants undergo baseline assessments of demographics, clinical status, and brain imaging at the time of their stroke. Researchers will track new strokes or transient ischemic attacks at 90 days, 1 year, and 5 years after the initial stroke. They will also monitor safety events like bleeding complications and other major ischemic events such as heart attacks. Data collection includes ongoing clinical evaluations and imaging studies to identify factors linked with stroke recurrence and treatment safety.

Age: 18Years +All Genders
47 locations
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Actively Recruiting

Researchers are studying women who carry mutations in the BRCA1 or BRCA2 genes, which increase the risk of developing breast and ovarian cancers. Despite many studies over the past two decades, the best ways to manage these mutation carriers are still not fully established. In Italy, about 140,000 to 150,000 individuals carry these mutations, and it is estimated that 87% of women with these mutations will develop a genetically linked tumor during their lifetime. Approximately 20% of ovarian cancer cases in Italy each year have a genetic origin and could benefit from preventive approaches. Currently, there is no national prospective data collection specifically for women with BRCA mutations in Italy.

Age: 18Years +FEMALE
40 locations
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