Sassuolo

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.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating the clinical benefits and safety of Tropho Tend in treating painful Rotator Cuff Tendinopathy (RCT). This is a prospective, open-label, controlled exploratory study comparing standard rehabilitation physiotherapy alone to rehabilitation physiotherapy combined with Tropho Tend injections. The study involves adults aged 18 and older with painful RCT lasting at least 6 weeks, aiming to assess pain relief and functional improvement over several months. Participants are randomly assigned to either the control group receiving standard rehabilitation physiotherapy or the therapy group receiving rehabilitation plus Tropho Tend injections. Tropho Tend is given as three perilesional injections at the muscular-tendineal or osteo-tendineal junctions using a fine needle, administered at the baseline visit, 2 weeks, and 4 weeks. The total treatment period lasts 1 month, followed by a 3-month follow-up. The study lasts about 4 months for each participant, including five visits: baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. Ultrasound evaluations of the tendon are performed at baseline and the final visit to assess tendon condition. Researchers will measure pain variation, functional impairment, and shoulder disability using scales like VAS, SPADI, and SANE. Patient satisfaction with treatment is also recorded using a 5-point scale. Safety and clinical outcomes are monitored throughout the study.

The trial investigates early stage Follicular Lymphoma (grades I-IIIA) in patients who have not received prior treatment. It is a prospective, multicenter, open-label, phase III randomized clinical trial comparing two treatment approaches. The study aims to evaluate the progression-free survival over up to 33 months, including a 9-month treatment period followed by 24 months of follow-up. Participants will be randomly assigned to one of two groups. The first group will receive standard involved-site radiation therapy at a dose of 24 Gy. The second group will receive the same radiation therapy followed by obinutuzumab infusions: 4 weekly doses and then 4 additional doses every 3 weeks, totaling 8 doses. This design allows comparison of radiation alone versus radiation combined with obinutuzumab. During the study, participants will have assessments including PET/CT scans for staging, bone marrow biopsies, and blood tests for specific lymphoma markers. Performance status will be monitored, and liver and kidney function will be evaluated. Safety and effectiveness will be tracked throughout treatment and for two years afterward. The main outcome measured is progression-free survival from treatment start through the follow-up period.

This research investigates Diffuse Large B-cell Lymphoma (DLBCL) and High-Grade B-cell Lymphoma (HGBCL), which are diverse types of lymphomas affecting adults. The study aims to understand how genetic changes in the MYC gene relate to the lymphoma's genetic makeup and immune environment, and how these factors might influence patient outcomes. It focuses especially on MYC rearrangements and gain of copy number (GCN), which may affect prognosis and response to treatment. Participants in this observational study include patients diagnosed with nodal or extranodal DLBCL or HGBCL, including certain subtypes like double and triple hit lymphomas. The research examines patients who have received curative first-line treatments such as R-CHOP or intensified chemotherapy regimens. The study involves reviewing histological samples, including immunohistochemistry and genetic analyses, to explore the relationship between MYC alterations and lymphoma characteristics. During the study, researchers evaluate clinical, genetic, and histopathological features from diagnosis through up to 36 months of follow-up. Detailed tissue analysis and genetic testing are performed to assess MYC rearrangements or GCN. The study also looks at the lymphoma's immune environment and tracks patient outcomes to identify correlations that could improve prognostic markers and treatment strategies.

Researchers are evaluating the impact of a healthy lifestyle-based Survivorship Care Plan (LS-SCP) on the quality of life in long-term lymphoma survivors who have been in remission for at least 3 years and up to 10 years. This prospective, randomized, open-label, multicenter study includes adults aged 18 to 50 who were treated for classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL), or Primary mediastinal large B-cell lymphoma (PMBCL). The study aims to assess how lifestyle changes influence the quality of life in these survivors. Participants are divided into two groups: the experimental group receives the LS-SCP intervention, which includes a Survivorship Care Plan, nutritional guidance, and physical activity, all followed for 6 months. Compliance in this group is monitored through bi-monthly automatic calls. The control group receives usual follow-up care without any specific lifestyle intervention. Both groups complete validated questionnaires and clinical assessments at the start, and then at 6 and 12 months after randomization. During the study, participants complete several quality of life and health-related questionnaires and undergo clinical evaluations at baseline, 6 months, and 12 months. The study measures global quality of life over a period of up to 30 months. Researchers track adherence to the intervention through regular calls in the experimental group and monitor all participants for safety and health outcomes through follow-up visits and questionnaires.

Researchers are conducting an open-label, multicenter, randomized phase III trial to compare two treatment approaches in elderly patients aged 65 and older with Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular grade IIIb lymphoma. The study evaluates the addition of vitamin D supplementation to a standard prephase treatment with oral prednisone, followed by six cycles of immunochemotherapy with either R-CHOP or R-miniCHOP. The study aims to explore the effects of vitamin D supplementation during immunochemotherapy in this patient population, with a focus on progression-free survival over 54 months. Participants are randomly assigned in a 1 to 1 ratio to either the standard arm (Arm A) or the experimental arm (Arm B). Both arms receive a prephase of oral prednisone for 7 days followed by six 21-day cycles of immunochemotherapy with R-CHOP or R-miniCHOP. Patients in Arm B also receive vitamin D3 (cholecalciferol) supplementation starting with a loading dose based on baseline vitamin D levels, followed by weekly maintenance doses throughout immunochemotherapy and the option to continue monthly supplementation for up to two years. Adjustments to vincristine dosing during prephase and immunochemotherapy are allowed based on clinical judgement. Throughout the study, participants undergo baseline assessments and regular monitoring including vitamin D levels, treatment toxicity, and response evaluations. Patients experiencing treatment-related delays longer than four weeks discontinue study treatment but continue survival follow-up. The primary outcome measure is progression-free survival assessed at the end of treatment and up to 54 months. The study also includes safety monitoring and long-term follow-up to assess sustained outcomes and adverse events.