There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment
The purpose of this clinical trial is to demonstrate the benefit of Pemigatinib, a drug that has indicated promising effects for relapse free survival in molecularly-selected, high-risk patients with urothelial carcinoma (UC) who have received radical surgery. Patients will receive Pemigatinib at a once-daily dose on a continuous schedule, continued until 12 months.
This project from the University Hospital of Parma (AOUPR) aims to verify the feasibility of a prevention program in our district, relying on advanced technological resources and highly experienced team in lung cancer early diagnosis, in order to identify useful elements towards the applicability of such a prevention program on a large scale (regional, national). Uncontrolled, monocentric experimental study with dynamic enrollment and prospective data collection, aimed at implementing a prevention program based on scientific evidence. This study is set to verify the applicability and feasibility of a lung cancer prevention program in a real context, including a preliminary evaluation at the smoking cessation clinic and a LDCT assessment with subsequent LDCT follow-up for participants who show indeterminate findings at the first LDCT (LDCT baseline) exam. The main objective of the study is to verify the feasibility of a lung cancer prevention program according to internationally validated scientific methods. Secondary objectives: 1. To evaluate the use of local smoking cessation clinics and their effects in terms of smoking cessation (primary prevention) 2. To evaluate the outcomes of the program in terms of number of patients with early (presymptomatic) lung cancer treated with minimally invasive surgery (secondary prevention) 3. To evaluate the number of false positives and their diagnostic work-up (PET-CT, CT-guided biopsy, bronchoscopy) Primary endpoint: - Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months Secondary endpoints: - To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization - To measure the variation in smoking habits in enrolled smokers - To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site - To measure the consequent demand for further diagnostic investigations and treatment - To measure the number of false positives Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program. Inclusion criteria - Age between 50 and 75 years - Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years - Status of current smoker or ex-smoker for <10 years. Exclusion criteria • Personal history of cancer within the prior 5 years We expect to recruit around 500 people in 1 year. This sample size is considered adequate based on the available resources, both human and economic. After closing and adjusting the database and before data analysis, a document called Statistical Analysis Plan (SAP) will be drawn up. It will consist of the following paragraphs: - Statistical methods planned in the study protocol; - Size of the sample; - Management of missing data; - Evaluation of the endpoints; - Statistical models that will be applied in the analysis. The socio-demographic characteristics of the enrolled subjects, the adopted organizational methods and the effects of the prevention program (endpoints) will be analyzed and described using tables and figures. The project "PRogetto Salute Parma: Primary and secondary prevention of smoking-related lung cancer" will be started once approved by the institutional Ethics Committee and authorized by the General Manager. The study is expected to be carried out over 2 years (from the inclusion of the first subject), with an expected period of 1 year for the enrolment and 1 further year for follow-up.
The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety and efficacy in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety and efficacy data obtained in this study will be included in regulatory product submissions as appropriate.
Phase II,single arm study designed to explore the activity of TSR-042, an immunotherapy agent, in patients with a diagnosis of advanced or metastatic clear cell sarcoma (CCS).
The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).
The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for further study. Moreover, the study characterized the pharmacokinetic profiles of NIZ985 as a single agent and in combination with spartalizumab or tislelizumab and identified preliminary anti-tumor activity.
Each investigator will have to collect data for 50 hospitalized patients in the Internal Medicine wards. If the center is randomized to Intentional Rounding, the staff of nurses and OSS will have to implement the new care strategy.
This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas. The study will have four parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors. Part D will study how well SEA-TGT with brentuximab vedotin works to treat classical Hodgkin lymphoma (cHL).