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 purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).
Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr. The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.
It remains unknown if the association between moderate to low intensity statin therapy and ezetimibe and nutraceuticals might have a therapeutic role in high-intensity statin intolerant patients
Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream
This observational study aims at developing and validating a simple questionnaire to be routinely applied in the clinical practice, for the evaluation of the quality of life in children with concomitant asthma and allergic rhinitis. The study consists of two phases: Phase 1: Development of the RAPP-children questionnaire starting from the validated RHINASTHMA-children questionnaire. Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline and after one month, the RAPP children and several other standardized questionnaires will be administered.
This is a randomized controlled monocentric study on 114 diabetic patients with the aim of evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that are candidates for a minor amputation in the foot. In particular, it will be evaluated whether the lipofilling will be able to shorten the healing times and to reduce the number of major amputations, with consequent positive impact on the quality of life. Patients will be randomized to the treatment group with Lipogems® (local injection of autologous micro-fractured adipose tissue) or to the control group, thus, treatment according to standard clinical practice.
The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.
OTL-300 is a gene therapy drug product consisting of autologous hematopoietic stem/progenitor cluster of differentiation (CD) 34+ cells genetically modified with a lentiviral vector (GLOBE) encoding the human beta globin gene. The TIGET-BTHAL is a phase I/II study evaluating safety and efficacy of OTL-300 in subjects with transfusion dependent beta-thalassemia for two years post gene-therapy. Subjects with rare disease who have undergone gene therapy are followed for efficacy and possible delayed adverse events. Thus, this study is designed to follow patients who have received gene therapy on TIGET-BTHAL for an additional six years (for a total of eight years).
Prospective randomized study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) eye drops in patients affected by acanthamoeba keratitis. 130 subjects were assigned to one of the following 2 treatment groups: Group 1: 0.08% polihexanide (PHMB) + placebo Group 2: 0.02% polihexanide (PHMB) + 0.1% propamidine
A dietary intervention trial will be performed on patients affected by Behçet's syndrome. Three different diets will be compared, analyzing their effects on the gut microbiota composition, on endogenous butyrate production and on the general symptoms in Behçet's patients.