Search Bar & Filters
Found 9 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease CAD. This observational registry focuses on individuals treated with this specific stent and planned for a short dual antiplatelet therapy DAPT of up to 3 months. The study aims to collect real-world data on clinical outcomes including safety and effectiveness over a 12-month period. Participants in this single-arm registry have undergone percutaneous coronary intervention PCI using the Vivo ISAR stent and will receive standard care short DAPT treatment for no more than 3 months. The study does not affect treatment choices or standard care procedures. After the PCI, eligible patients will be invited to join the registry and followed up at 1 month, 3 months, and 12 months. During the study, researchers will collect baseline medical data and conduct telephonic follow-ups at 30 days, 3 months, and 12 months. These follow-ups will check on medication use, laboratory assessments, adverse events, and any further interventions. The main outcomes measured include ischemic and bleeding events at 12 months, along with secondary outcomes such as mortality, heart attacks, strokes, stent thrombosis, and need for additional vessel treatments. The total participation duration is one year from the PCI procedure.
Actively Recruiting
Researchers are conducting a non-interventional, retrospective observational study to better understand the diagnosis and treatment of patients with early-stage and locally advanced non-small cell lung cancer NSCLC, specifically stages I to III. The study addresses the variability in treatment approaches, as there is no clear consensus on the best timing, sequence, or combination of surgery, chemotherapy, and radiotherapy for these patients. This research aims to collect real-world data to improve knowledge on how these patients are managed across different healthcare settings. This study involves reviewing past medical records of patients diagnosed with stage I-III NSCLC who underwent curative surgery or radiotherapy between January 2018 and June 2019. The data collection covers treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs from January 2018 to January 2021. There are no interventions or treatments being given directly as part of this study since it is observational and retrospective. Participants involvement consists of allowing access to their medical charts and treatment records for data capture. Researchers will evaluate treatment timelines and approaches as they occurred in routine clinical practice. The study also tracks the extent of healthcare resources used and costs involved. Data privacy is maintained by obtaining informed consent from patients or their representatives. The study is expected to conclude in June 2025.
Actively Recruiting
Psoriatic arthritis PsA is a type of arthritis that causes joint swelling and stiffness, often occurring in people with the skin condition psoriasis. This study aims to understand how long patients continue treatment and how effective risankizumab RZB is compared to other advanced treatments for PsA in everyday clinical settings. The study will take place outside the United States across about 15 countries, involving between 900 and 1200 adult participants. Participants will receive either risankizumab or other biologic disease-modifying antirheumatic drugs bDMARDs as prescribed by their doctors following local guidelines. Treatments will be given as part of regular medical care without additional interventions from the study. Participants will be followed and observed for 24 months during their routine clinical visits. During the study, participants will attend their usual medical appointments where doctors will monitor their treatment persistence and response. The main outcome measured is how many participants continue their prescribed treatment up to 24 months. There is no expected extra burden or additional procedures for participants beyond their standard care.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of colchicine and non-enteric coated aspirin, used alone or together, to improve heart-related outcomes in high-risk adults aged 55 to 80 with type 2 diabetes. This study focuses on preventing major cardiovascular events such as heart attacks, strokes, and urgent hospitalizations in patients who have no prior history of coronary artery disease but possess other risk factors. Participants will be randomly assigned to one of four groups receiving either colchicine, aspirin, both drugs, or placebos. Aspirin is given as a 40 mg non-enteric-coated tablet twice daily, while colchicine is taken as a 0.5 mg tablet once daily. Those who cannot take aspirin will only be assigned to colchicine or its placebo groups. The study lasts up to 60 months, during which cardiovascular events and cognitive function using MoCA scores will be monitored. During the study, participants will undergo regular assessments to track cardiovascular events including heart attacks, stroke, cardiac arrest, atrial fibrillation, heart failure hospitalizations, and coronary procedures. Researchers will also evaluate cognitive function yearly. Safety checks and follow-up visits occur throughout the 5-year period to monitor the participants health and treatment adherence. The primary outcome is the time to the first major cardiovascular event after starting the study medications.
Actively Recruiting
This research aims to study the epidemiology of invasive bacterial diseases caused by Streptococcus pneumoniae pneumococcus, Neisseria meningitidis meningococcus, and Haemophilus influenzae hemophilus. These infections can cause severe illness and serious complications. The study focuses on monitoring these infections to guide public health efforts, evaluate vaccine impacts, and plan prevention and treatment strategies by identifying circulating strains and assessing vaccine failures. The study uses molecular diagnostic testing to identify these bacteria from blood samples, even when traditional culture methods may fail due to prior antibiotic use or sample handling issues. Pediatric and adult patients diagnosed with invasive bacterial diseases caused by these pathogens are included. This approach enables more accurate detection and characterization of the bacteria. Participants diagnosed with these invasive bacterial infections will have their samples analyzed using molecular methods. Researchers will monitor the incidence rates of these infections in children, the distribution of bacterial types, and the proportion of cases preventable by vaccination. The study will also assess vaccine failure rates. The average study duration for outcome measurement is about one year, supporting improved surveillance and public health interventions.
Actively Recruiting
Researchers are evaluating the EuroHeart program, an observational and prospective multicenter initiative designed to improve quality of care for patients with common cardiovascular diseases such as Acute Coronary Syndrome ACS, heart failure, and atrial fibrillation. EuroHeart collects standardized and harmonized patient data to support continuous quality improvement by monitoring adherence to quality indicators defined by the European Society of Cardiology ESC. The program aims to understand how well proven treatments are applied in everyday clinical practice. The study involves continuous data collection from consecutive patients hospitalized or treated for these cardiovascular conditions. Participants enter a 12-month follow-up period during which clinical events and health status data are gathered. This registry specifically evaluates adherence to ESC quality indicators in Italian clinical practice, including measures such as time to reperfusion and prescription of recommended medications at discharge. Participants will be monitored through regular collection of clinical data over the 12 months following enrollment. Researchers will assess adherence to multiple ESC quality indicators related to treatment and management of STEMI and NSTEMI patients, including evaluations of left ventricular function, lipid levels, and use of dual antiplatelet therapy and other medications. The study also tracks cardiovascular and non-cardiovascular events during follow-up to support quality improvement efforts. Participation involves consent and data collection without experimental treatments.
Actively Recruiting
This research aims to evaluate financial toxicity FT in patients undergoing radiotherapy for various cancer types in Italy. Financial toxicity refers to the financial burden and distress patients may experience during cancer treatment. The study is observational and multicenter, focusing on assessing FT using the PROFFIT questionnaire, a validated tool designed specifically for Italian cancer patients. Researchers will also explore how changes in financial toxicity relate to quality of life, treatment side effects, and overall survival. Participants will complete the PROFFIT questionnaire, which consists of 16 items measuring financial toxicity and its possible causes. The questionnaire will be administered before starting radiotherapy, at the end of radiotherapy treatment, and during the first follow-up visit 1 to 2 months after treatment. Additional assessments include the EORTC QLQ-C30 questionnaire to measure quality of life and the PRO-CTCAE to evaluate treatment-related symptoms. The study compares financial toxicity across different groups based on cancer type, radiotherapy type, treatment, age, and sex. During the study, patients will be asked to complete questionnaires at specific time points baseline, end of radiotherapy, and first follow-up visit within 1 to 2 months post-treatment, with follow-up up to 12 months. Researchers will monitor financial toxicity scores and analyze how these relate to patients quality of life and treatment effects. Participation involves completing surveys and clinical monitoring without any experimental treatment. The study duration varies depending on individual follow-up schedules.
Actively Recruiting
This research aims to evaluate the effects of adding Vitamin D supplementation to standard immunochemotherapy in elderly patients diagnosed with Diffuse Large B-Cell Lymphoma or Follicular grade IIIb lymphoma. This open-label, randomized phase III trial compares two treatment approaches to understand whether Vitamin D affects outcomes in patients aged 65 and older undergoing immunochemotherapy. Participants are randomly assigned to one of two groups. Both groups receive a prephase of oral prednisone followed by six cycles of immunochemotherapy with R-CHOP or R-miniCHOP every 21 days. The experimental group also receives Vitamin D supplementation starting before treatment and continuing through immunochemotherapy according to a set schedule, including loading doses based on baseline Vitamin D levels and weekly maintenance. Patients may continue Vitamin D supplementation after treatment for up to two years. During the study, participants undergo baseline assessments and are monitored regularly through the treatment cycles. Researchers track progression-free survival over 54 months as the primary outcome, along with overall survival, response rates, Vitamin D levels, physical functioning, and fatigue. Safety and treatment adherence are also monitored, with follow-up visits extending up to several years to evaluate long-term outcomes.
Actively Recruiting
Oligometastatic breast cancer occurs when breast cancer has spread to a limited number of other body sites. Patients with this condition may live longer than those with more widespread metastases. Researchers are investigating whether adding local treatments like stereotactic body radiotherapy SBRT, a non-invasive radiation therapy delivering high doses in a few sessions, can improve disease control and survival in these patients. This study is a multicenter retrospective analysis aiming to better understand SBRTs role in this setting. The study focuses on patients who have received SBRT to their oligometastatic sites, delivering a minimum radiation dose of 50 Gy EQD2 in up to 12 sessions, following the Oligocare definition. This local treatment is considered alongside standard systemic therapies like chemotherapy or hormonal therapy. The study collects data from treatments performed between January 2010 and December 2023 to evaluate outcomes. Participants data will be reviewed retrospectively to measure progression-free survival as the primary outcome. Secondary outcomes include local control of treated sites, overall survival, and acute or late radiation-related toxicities. The study covers treatments applied outside the brain and aims to provide insights into the safety and effectiveness of SBRT in managing oligometastatic breast cancer. The overall participation involves analysis of existing patient records from multiple centers up to the end of 2023.