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.
Study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.
Sedation management of the critically ill patients is still a challenge for the pediatric intensivists. Worldwide the most common sedation approach includes the concomitant use of opioids and benzodiazepines. The use of these drugs is associated with adverse events contributing with morbidity, such as decreased spontaneous ventilation, withdrawal syndrome and delirium onset. Moreover, benzodiazepine demonstrated a neurotoxic apoptotic effect that could potentially impact neurocognitive outcome. Dexmedetomidine (DEX) is a selective alpha-2-adrenergic agonist with sedative, analgesic and anxiolytic effects. Its unique pharmacological profile allows reaching a conscious sedation state with minimal respiratory depression, promoting faster ventilation weaning and better collaboration with the medical staff. Moreover, DEX seems to present adjuvant properties towards withdrawal syndrome and delirium. Finally, some studies in animals suggested that Dexmedetomidine might have a role of neuro-protection, especially in a contest of cerebral ischemia. Currently, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved DEX only for the adult population and for sedation lasting not more than 24 hours. The Italian Medicines Agency (AIFA), in January 2016, approve DEX in children for specific indications including difficult sedation in mechanically ventilated critically ill patients. Up to now, few data are still available regarding its efficacy and safety for prolonged sedation in Pediatric Intensive Care Units (PICUs) and no studies have reported the use of DEX after AIFA's approval so far. Aims of the study are: to evaluate the characteristics of DEX use for prolonged sedation ≥24 hours in critically ill children (indication, dosages, time of infusion, time of infusion weaning, association with other drugs); to evaluate its efficacy in terms of comfort and conventional drug sparing, using standardized and validate measures; further, to evaluate its efficacy in terms of reduction of incidence of withdrawal syndrome and delirium; to evaluate its safety profile collecting any adverse event potentially correlated with its administration; to define if efficacy and safety could differ among approved indications versus not-approved ones. Design: Multicenter observational prospective study, involving tertiary-care PICUs. Study period: From January 2016 up to reaching of the calculated sample size (N patients =163). Population: All critically ill patients <18 years who received prolonged sedation including DEX for ≥24 hours. In case of multiple infusions, only data regarding the first infusion will be included. Exclusion criteria: extreme prematurity (<28 weeks of gestational age), hypersensitivity to the active substance, incomplete data form. . Collecting data strategy: Data will be prospectively collected from each Institution by means of a anonymous standardized form completed by two different investigators per center. For each patient, the following variables will be collected: demographics characteristics (age, gender, race, weight) and clinical features (main diagnosis, associated morbidities, PIM3 score ad admission, number of high intensity interventions during PICU-stay, mechanical ventilation features, inotropic drugs use, length of stay, survival at discharge); DEX administration characteristics (indication, loading dose, minimum and maximum dosages, duration of DEX infusion, duration of DEX infusion weaning) and information on concomitant use of analgesics or sedative drugs (name of drugs and respective dosages at DEX starting time and 24 hours later); clinical scores of analgesia and sedation (Comfort Behavior Scale, CBS), withdrawal syndrome (Withdrawal Assessment Toll-1, WAT-1) and delirium (Cornell Assessment of Pediatric Delirium, CAPD) depending on the respective indication, registered immediate pre-DEX and 24 hours later; any adverse event potentially related to DEX administration and any related intervention, if present. In particular, we the investigators evaluate if bradycardia, hypotension (with or without poor perfusion), hypertension, agitations or other events are registered during the infusion. Further, investigators will register if any sign of DEX withdrawal (tachycardia, hypertension, agitation, other) are present immediately after the infusion. Statistical analysis: Descriptive and analytic statistics will be performed according with the variable characteristics. A causal multivariate model will be developed to identify any significant risk or protective factors towards adverse outcomes (ineffective sedation, onset of adverse events).
Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF). The aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).
Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.
The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo
single institution cases series review of histological and clinical data
The investigators tested the hypothesis whether the treatment with Citicoline in oral solution (OS-Citicoline) would increase or stabilize visual acuity, retinal ganglion cells (RGCs) function and neural conduction along the visual pathways (neuroenhancement), and/or induce preservation of RGCs fibers' loss (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).
Aims of this study were 1) to evaluate early CV abnormalities in infants born small for gestational age (SGA) at 24 months of age compared with age and sex-matched subjects that were born adequate for gestational age (AGA) 2) to investigate the effect of catch-up growth and the role of breastfeeding on CV risk.
All procedures are performed in the investigator's outpatient gastroenterology and digestive endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower intestinal tract. Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion the lumen will be completely decompressed with aspiration of the gas, and then again relaxed with the instillation of only water. The EleviewTM will be injected into the submucosa in such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic evidence of complete resection. All the removed material will be stored and sent to histological analysis. Tolerability score will be recorded during the procedure. Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome, stenosis or death in the 6 months following the procedure will be born "complication". A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months after the procedure
Different therapeutic approaches have been proposed for the treatment of furcation defects and the regeneration of periodontium within the furcation area is considered one of the most challenging aspect of surgical periodontal therapy. Periodontal regeneration is a highly predictable therapeutic option for the treatment of different furcation defects, particularly class II furcation involvements in the lower molars. In particular, the application of a combined therapeutic approach (i.e., barrier, bone re-placement graft with or without biological agents) seems to offer better results as compared with monotherapeutic treatments. Several studies have demonstrated that platelet concentrates, such as platelet-rich plasma (PRP), platelet-derived growth factor (PDGF) and, more recently, leukocyte and platelet-rich fibrin (L-PRF) can represent new therapeutic options for bone regeneration procedures by increasing the healing potential of natural blood clot in the surgical site. Leukocyte and Platelet-rich fibrin (L-PRF) is a second-generation platelet concentrate, developed by Choukroun et al. It is prepared without the addition of any anticoagulants and consists of a slowly polymerized complex fibrin network which incorporates leukocytes, glycan chains, structural glycoproteins and an high concentration of growth factors such as transforming growth factor β (TGF-B), platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF). The three-dimensional architecture and the specific biochemical properties, which facilitate the wound healing processes, have led to a widespread use of this biomaterial in plastic surgery, maxillofacial surgery, oral and periodontal surgery. A large clinical and histological evidence supports the concept that autogenous bone grafts (ABG) are highly effective regenerative materials in the treatment of intrabony defects. Moreover, with respect to the treatment of furcation defects, outcome data from a number of studies generally indicate positive clinical benefits with the use of bone grafts in the treatment of Class II furcations. Therefore, on the basis of such considerations, the aim of this study was to evaluate the effectiveness of a combined regenerative treatment by L- PRF and ABG in the treatment of mandibular molars degree II furcation defects and to compare the outcomes of such a treatment with those from (OFD)+ABG and OFD alone treatments.