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.
To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.
The study is a prospective multicenter registry. Consecutive patients with indications of implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be enrolled. The primary objective of the study is to determine the predictors of appropriate anti-tachycardia therapy (with shock) in a non-selected population of patients implanted with an ICD. Secondary objectives of the study are: - the incidence of anti-tachycardia therapies; - the predictors of inappropriate therapy and onset of arrhythmia burden; - the adherence to the current guidelines in the Italian clinical practice; - the predictors of heart failure (HF) onset and response to cardiac resynchronization therapy (CRT).
Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients: Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma. Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma). Cohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component). Phase I: escalating dose of 1.3 or 1.5 mg/m2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg/m2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy/fraction). A translational substudy is developed to analyse different biomarkers predictive value. Cohorts A and B are closed to recruitment in 2023.
Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder (CKD-MBD)
The purpose of the study is to qualify, independently, tumor cell proliferation by 3'-Deoxy-3'-[18F]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological quantification (% of viable tumor cells) of the primary tumor after pre-operative chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).
The overall aim of this project is to improve the outcome of patients diagnosed with ependymoma by improving and harmonising the staging and the standard of care of this patient population and to improve the investigators understanding of the underlying biology thereby informing future treatment. The program will evaluate new strategies for diagnosis (centralized reviews of pathology and imaging) and new therapeutic strategies in order to develop treatment recommendations. Patients will be stratified into different treatment subgroups according to their age, the tumour location and the outcome of the initial surgery. Each subgroup will be studied in a specific randomised study to evaluate the proposed therapeutic strategies. Stratum 1: The aim of the stratum 1 is to evaluate the clinical impact of 16-week chemotherapy regimen with VEC-CDDP following surgical resection and conformal radiotherapy in terms of progression free survival in patients who are > 12 months and < 22 years at diagnosis, with completely removed intra cranial Ependymoma. Stratum 2: This stratum is designed as a phase II trial for patients who are > 12 months and < 22 years at diagnosis, with residual disease to investigate the possible activity of HD-MTX by giving to all patients the benefit of VEC chemotherapy whilst randomising half of patients to receive additional HD-MTX. Patients will receive conformal radiotherapy (cRT). For patients who remain with a residual inoperable disease after induction chemotherapy and cRT, an 8 Gy boost of radiotherapy to the residual tumour will be delivered immediately after the end of the cRT. Stratum 3 This stratum is designed as a phase II trial to evaluate the benefit of postoperative dose intense chemotherapy administered alone or in combination with valproate in children <12 months of age or those not eligible to receive radiotherapy .
In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure. This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing. The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.
The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.
Chronic hypercapnic respiratory failure is common in stable COPD patients in a terminal phase of their disease In an attempt to correct or slow down the rate of rise of PaCO2, long-term noninvasive mechanical ventilation (NIV) has been proposed. Only very few studies demonstrated the clinical efficacy of NIV. Indeed this technique is not always well tolerated and therefore it may be effective only in a subset of patients The aim of this study is to assess the feasibility and safety of "one shot" extrcorporeal CO2 removal device, in reducing the PaCO2 level
The general aim of the present study is to test a cell therapy with third-party allogeneic ex-vivo expanded MSCs as a strategy to induce tolerance in liver transplant recipients. MSCs will be prepared accordingly to established protocols , starting from diagnostic samples of bone marrow aspirates (2-5 mL) or using the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in GMP approved facilities and used for the present study in patients undergoing liver transplantation.