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.
An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior to desensitized with imlifidase and subsequent kidney transplantation. Two non-comparative reference cohorts are included to assess the impact of differences in post-transplantation management and outcome in less sensitized patients.
This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
Primary objective: To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D). Secondary objectives: To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters. To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D. Exploratory objectives (if site is able and deems appropriate to accommodate and conduct these objectives): To determine the effects on insulin sensitivity and circulating markers of inflammation (leukocytes and inflammatory cytokines). Glycemic variability by additional CGM parameters. eGDR and BMI assessments.
Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. Pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering. Methods. The aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value. We evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B).
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD5305 when given in combination with new hormonal agents (NHAs) in patients with Metastatic Prostate Cancer.
Endometriosis is the presence of endometrial glands and stroma outside the uterine cavity. About 5% of women of reproductive age suffer from the disease. The pelvis is the most frequent site of endometriotic lesion and the most common pelvic localisations are peritoneal, ovarian, and deep infiltrating endometriosis. However, endometriosis can also localize outside the pelvis, for example involving the umbilicus, omentum, appendix, liver, diaphragm, pleura and lungs, vulva, and surgical scars. The majority of extrapelvic endometriosis implants are located in the skin, and most of them are of iatrogenic origin, following laparotomy, laparoscopic procedures, and episiotomies; only a minority of cases are of primary origin. Umbilical endometriosis is a very rare presentation of endometriosis (0.5-1% of cases of extrapelvic endometriosis). Pathogenetic hypotheses of primary umbilical endometriosis include: hematic or lymphatic dissemination of endometrial cells from the peritoneum to the umbilicus through obliterated umbilical arteries; migration of endometrial cells through the venous or lymphatic circulation; metaplasia of urachus remnant or release of endometrial cells that during labor and delivery may contaminate the umbilical cord emergence. Secondary umbilical endometriosis is probably due to the proliferation and subsequent dissemination of iatrogenically implanted endometrial cells in laparotomy or laparoscopic scars. In 20% of cases, umbilical endometriosis is associated with pelvic endometriosis. In these patients, it is probable that endometriotic cells may migrate from the endometriotic implants to the umbilical site. This migration process could be favored by fascia defects at the umbilical level. In fact, reports in the literature describe cases of umbilical endometriosis coexisting with umbilical hernia. The clinical presentation consists of an umbilical nodule of variable color (red, blue, black, flesh-colored), ranging in size from 0.5 to 3 cm. Pathognomonic symptoms are: bleeding and/or pain in the umbilical site of catamenial type, cutaneous hyperesthesia. Catamenial symptomatology associated with the nodule, which makes the diagnosis easier, is present in only 75% of cases. In asymptomatic cases the differential diagnosis of the nodule of umbilical endometriosis is more difficult (hernia, hematoma, cyst, dermatological disorders, tumor metastasis). Instrumental examinations useful for differential diagnosis and definition of nodule size include soft tissue ultrasound, CT scan and MRI. Definitive diagnosis is only by histologic examination of the tissue. Exploratory laparoscopy is not indicated unless concomitant pelvic endometriosis is suspected. The recommended treatment of umbilical endometriosis is surgical, consisting of complete removal of the endometriosis nodule, omphalectomy, and subsequent reconstruction of the umbilicus. Recurrence rates after surgery are around 6% at 12 months in a large Japanese court, with no difference between taking and not taking postoperative hormonal therapy, while they are reduced to almost 0% in case of resection including a large portion of peritoneum. Medical therapy, on the other hand, alleviates the associated algic symptoms by reducing the size of the nodule. There are very few data on the efficacy of medical therapy; in a study with a very small number of cases an efficacy of 91.7% with dienogest and 51.1% with estroprogestinic pill is reported. There are no studies comparing medical and surgical therapy for the treatment of umbilical endometriosis. Radical excision is recommended to avoid local recurrences and to avoid the risk of malignant transformation, although it is extremely rare (only 2 cases reported). In literature, spontaneous resolution has been described in only one pregnant woman. To date, few studies have evaluated umbilical endometriosis. Moreover, no study has ever formally compared the long-term efficacy of surgical or medical therapy for umbilical endometriosis. This is a observational, retrospective/prospective and monocentric study; it is based on the review of medical records and on outpatient follow-up visits of patients in our clinic with umbilical endometriosis from 1990. The principal aim of the study is to evaluate the effectiveness of medical and surgical treatments in terms of satisfaction, psychological state, health-related quality of life of patients suffering from this clinical condition. Moreover, global patient's condition and severity of the patient's symptoms are evaluated The secondary aim is to investigate the pathogenetic aspects of this clinical condition.
A multicenter, prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation to evaluate the superiority of physiological ventricular pacing (proposed modality) vs. managed ventricular pacing (control) for prevention of persistent AF (PeAF) occurrence in patients with prolonged atrioventricular interval (PR≥180 ms) and indication for pacing: sinus node disease and/or paroxysmal type 1 or 2-second degree AV block.
The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.
Background: An innovative, non-invasive, and reversible Intra Auricular Device (IAD) has recently been introduced to treat temporomandibular muscle and joint disorders.Aim: To evaluate the effects of the IAD on pain, psychosocial domain and Pressure Pain Threshold (PPT) of masticatory muscles in patients with TMD pain. Methods: Ten subjects with TMD pain and with pain intensity higher than 30 mm on a VAS scale were included in the study. Patients received the IAD and counselling. Assessments included questionnaires of the DC/TMD Axis II questionnaires (Characteristic Pain Index, Interference, Jaw Functional Limitation Scale, Patient Health Questionnaire 9, Patient Health Questionnaire 15, Generalized Anxiety Disorder scale, Oral Behavior Checklist and Oral Health Impact Profile-22, Axis I clinical examination and PPTs at baseline (T0), after one month (T1), three months (T2) and six months (T3) from the first use of the device. PPTs were measured at anterior temporalis muscles, masseter muscles and right thenar as a control site.The Shapiro-Wilk test was used for the normal distribution of data. The difference among the longitudinal timepoints for variable was analysed with ANOVA. Statistical significance was accepted at p < 0.05.
The present project on sport rehabilitation aims at validating a rehabilitation protocol in immersive virtual reality (IVR) for restoring motor functions following peripheral injuries of the lower limbs. Sport injuries are related to direct and indirect costs and, in many cases, cause an interruption of motor activity for prolonged periods. Sport physiotherapy aims at recovering the motor functionality in order to guarantee the fastest possible return to sport. It employs plasticity and compensatory mechanisms within the injured motor system. However, being primarily based on the execution of movements that can be largely compromised, the treatment might be intrinsically complicated. It has been suggested that the motor system can be activated by observing one's own body perform the movements, without any actual movement execution. By using multisensory integration and sense of presence in IVR, it is possible to create an illusory experience that a moving virtual body (avatar) temporarily becomes one's own moving body. Moreover, this experience activates the motor system similarly to the activation from one's own actual movements. Based on these considerations, the present study hypothesizes that observation of one's own virtual body, without any movement execution, might activate the motor system to the extent of significantly improving functional recovery. The randomized clinical trial will recruit participants that underwent knee surgery and are in the first phase of the rehabilitation period (starting within two weeks after the surgery). Together with the traditional training protocol (4-6 weeks) participants will be administered a training in IVR that will include a virtual avatar performing a series of standard lower limb rehabilitation exercises. Participants will be randomly assigned to the experimental group (avatar observed from the first-person perspective, i.e., perceived as one's own body), the active control group (avatar observed from the third-person perspective, i.e., perceived as another person's body) and the group with no intervention. Before, at midpoint and after intervention, a standard battery of tests will be administered to evaluate the state of the motor system), as well as measures of embodiment for controlling the efficacy of the virtual scenario. The hypothesis is that the experimental group will show greater improvement of the motor functionality compared to the two control groups.