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.
Thyroidectomy is the most common iatrogenic cause of vocal fold paralysis. Patients complain of hoarseness caused by incomplete glottic closure and have effort to raise vocal intensity with consequent elevation of the larynx and/or involvement of supraglottic structures in phonation. These compensation mechanisms result in a shift of the fundamental frequency towards more serious tones or falsetto voice emissions. The first choice treatment is speech therapy which aims to obtain better glottic closure, preventing ankylosis of the crico-arytenoid joint. In order to promote better glottic closure without risking the onset or increase of dysfunctional compensation, the idea behind this project is to propose non-phonatory adduction exercises in the first post-operative week. The primary objective of the study is to compare patients who will perform non-phonatory exercises in parallel with medical therapy for one week and patients who will perform standard medical therapy only during the first week.
The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).
Spontaneous, pharmacological observational, no-profit, retrospective, multi-center. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected retrospectively/longitudinally. The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy. All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who met the inclusion criteria and none of the exclusion criteria.
Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse. This is a prospective and interventional study on a elderly population affected by type 2 diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be introduced to a targeted nutritional program aimed at improving the composition of the diet, in terms of both micro- and macro-nutrients.
It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure
The goal of this observational study is to learn about the feasibility of hemodynamic measurement by the UltraSonic Cardiac Output Monitor (USCOM) in very preterm or very-low-birth-weight infants. The main questions it aims to answer are: 1) establishing reference ranges for USCOM parameters in this specific population, 2) assessing the effect of patients' characteristics and other possible confounders on USCOM parameters, and 3) evaluating the short-term repeatability of the measurement. Participants will receive USCOM measurements on 3, 7, and 14 postnatal days.
The goal of this prospective study is to compare rapid molecular technique BioFire Pneumonia Panel Filmarray and conventional culture-based methods in the microbiologic diagnosis on bronchoalveolar lavage of lung transplant patients. The main questions it aims to answer are: - determine the microbiological concordance between molecular diagnostic and conventional culture techniques on donor's bronchoalveolar lavage before lung transplantation - determine the microbiological concordance between molecular diagnostic and conventional culture techniques on recipient's bronchoalveolar lavage, performed 72 hours after lung transplantation - determine the microbiological concordance between molecular diagnostic and conventional culture techniques in detecting molecular resistance patterns - determine the difference in time to microbiological results between molecular diagnostic and conventional culture techniques - determine time to clinical decision based on molecular diagnostic techniques compared to conventional culture techniques
The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaNaso (a nasal spray) in children, adolescents and adults with common cold symptoms, such as runny nose, nasal congestion and rhinitis. The main questions it aims to answer are: - Is the product effective in the treatment of common cold symptoms? - Is the product safe? After buying the product, participants will be asked to fill in a questionnaire, in order to: 1. Assess the cold symptoms before the use of the nasal spray. 2. Assess the resolution of cold symptoms after the use of the nasal spray. 3. Describe the adverse effect(s)/problem(s) observed while using the product (if any).
Canker sore, also known as aphthous stomatitis or ulcers and aphthae, is a common ailment, idiopathic in nature, with recurrent painful aphthous ulcers on the non-keratinized oral mucous membranes. Recurrent aphthous ulcer has higher prevalence in young adults and the frequency decreases with increasing age. The etiology of aphthous ulcer remains unclear. Other possible factors include trauma, drug use, deficiency in vitamin B12, folic acid, iron, stress, hormonal changes and metabolic diseases. Topical agents such as local antibiotics, local antiseptics, NSAIDs, and corticosteroids are generally prescribed for symptomatic relief. Several approved drug formulations such as pills, mouthwash, sprays and paste such as vitamin B12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer. Despite the available local treatments, still sometimes oral canker sores may represent a painful burden for the patient and the gel OR-AT0222 may represent a topical product easy to use, well tolerated and effective local pain reliever, by facilitating the healing of the lesion(s). The Sponsor, Devintec Sagl, presents OR-AT0222, indicated for the management of canker sores, aphthous stomatitis and small lesions of the mouth. The gel forms a persistent protective film with a "barrier effect" that promotes wound healing and protects the lesions of the oral cavity from contact with external agents, providing pain relief and reducing the risk of further irritation.
Term pre-labor rupture of membranes (PROM) occurs in about 12% of pregnancies and the time between PROM and delivery increases the risk of maternal/fetal infections. However, conflicting results are reported by studies investigating risks and benefits of expectant management versus induction of labor (IOL). Expectant management was associated with maternal and fetal infectious complications and subsequent increased risk of maternal and neonatal morbidity. Studies suggest that the increase in infectious risk for both is proportional to the increase in the time interval between the ROM and the birth, others reject this assumption. In PeRinatal Outcomes With ACTive Versus Expectant Management of Women With Pre-labor Rupture Of Membranes (PROACTIVE PROM) on admission, PROM will be diagnosed. After 6 hours from the rupture of membranes, the woman will then be assessed for eligibility. A 1:1 randomization will follow within two hours (6-8 hours from PROM) in two distinct arms: 1) Expectant management 2) Active menagement (early IOL within 8 hours of rupture of membranes). The first objective of this study is to evaluate whether active management of women with PROM (early induction) reduces the newborn need of respiratory support. The secondary objectives of this study are related to the safety of the active management assessed through the rate of stillbirths, the onset of infections in both mother and fetus and the length of hospitalization of the dyads. Moreover, another objective is to reduce the use of antibiotic treatments (ATB) in both mothers and newborns. The rationale of this study is that reducing the time between the PROM and delivery through an early IOL will reduce the adverse maternal and neonatal outcomes. The hypothesis underneath this trial comes from a preliminary retrospective cohort study conducted in Modena, which included 2689 mother-neonates dyads from singleton pregnant women at term. In deliveries of ROM >24 hours significantly more neonates required ventilatory support than those born within 24 hours, although no significant differences were found regarding overt infections. According to the Cochrane database, expectant management of PROM is associated with maternal and fetal infectious complications and subsequent increased risk of maternal and neonatal morbidity together with an increased risk of ATB use. The increase of infectious risk is proportional to the time elapsed since the rupture of the membranes (ROM) and birth. However, unpublished data from our group suggest that respiratory distress requiring interventions may be frequently caused by intrinsic inflammatory-related effects of prolonged ROM rather than infection; this is suggested by an increase of C-reactive protein levels in neonates with mild respiratory signs untreated with antibiotics. In addition, in a survey performed in our country expectant management increased intrapartum antibiotic prophylaxis (IAP), although not strictly indicated by the most current guidelines. On the light of these data, it appears reasonable to promote induction of labor, to prevent complication caused not only by the infectious risk mentioned above, but also respiratory distress, probably associated to a neonatal maladaptation, in non-infectious newborns. On the other hand, it should also be considered that 75% of women enter labor spontaneously within 24 hours from PROM and induction of labor (IOL) might not be needed in such cases.