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 the study is to evaluate the change from baseline to 12 months after study enrollment in the number of the following non-invasive risk criteria: World Health Organization Functional Class (WHO/FC), 6-minute walk distance (6MWD), Brain Natriuretic Peptide (BNP) or N-terminal pro-brain Natriuretic Peptide (NT-proBNP).
The GINA 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. Even if there is a specific drug treatment for each stage of disease (From mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference Polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. The aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, ALOX5 and LTC4S, and CysLTR1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.
We will perform a randomized, double-blind, placebo-controlled trial to establish whether calcium butyrate relieves symptoms in children with irritable bowel syndrome (IBS). The direct effects of butyrate on inflammation and GI symptoms will be studied in children with IBS. The design used to study the effects of calcium butyrate will be a double blind randomized placebo-controlled parallel design.
This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when compared with Veltassa and S/CPS.
This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.
The primary aim of this study is to assess the efficacy of post-operatory HFNC in reducing the incidence of hypoxemia after gynecological oncology surgery, compared to the standard application of O2 through a Venturi mask; The secondary objectives are to investigate the occurrence and entity of lung atelectasis, to evaluate diaphragmatic function and respiratory discomfort, and to evaluate the incidence of respiratory complications after seven days in the two groups. Patients will be randomized into two groups: HFNC and Control. The patients will be studied with preoperative lung and diaphragmatic ultrasound. Standard general anesthesia will be administered in the two groups. Ultrasound will be performed at arrival in the recovery room (RR) and before discharge from the RR. In the HFNC group, high-flow O2 will be administered; in the control group standard O2 therapy with Venturi mask will be administered. Arterial blood gas analysis upon arrival in the RR and after two hours of O2 therapy in both groups will be checked. The incidence of post-operative respiratory complications will be monitored in the seven days following surgery.
Patients on dialysis are at risk for several infectious diseases, since they have reduced immunological and have to regularly attend dialysis centres even if a pandemic is going on. Dialysis patients and healthcare professionals of dialysis centres can become infected one with the other. The incident risk of COVID-19 in dialysis centres is still unknown. Given the challenges of an early diagnosis of COVID-19, the likely transmission with outbreaks, the possibility of reciprocal transmission of the infection among patients and healthcare professionals, the frequent clinical severity of COVID-19 in dialysis patients because of the coexistence of several comorbidities, CONTACT TRACING could be an effective and efficient tool to contrast COVID-19 spreading in dialysis centres.
This is a phase 2, open-label, non-randomized, single-arm study in patients with high-risk PCa diagnosed with prostate biopsy and undergoing RP and ePLND. Pembrolizumab will be administered at the dose of 200 mg intravenously, every 3 weeks, for a total of 3 cycles prior to RP and ePLND. Local, nodal and systemic staging with prostate mpMRI, abdominal and chest CT, PSMA-PET/CT and bone scans will be performed before the administration of pembrolizumab. Surgery will be planned at the time of study inclusion to be done within 3 weeks of the last dose of study drug (screening: 3 weeks; cycle 1 followed by 3 weeks; cycle 2 followed by 3 weeks; cycle 3 followed by 3 weeks to surgery = 12 weeks from inclusion to surgery). Patients will receive 3 cycles of pembrolizumab at 200mg 3 weekly prior to RP and ePLND. Surgery will take place within 3 weeks after the last dose of the study drug. After surgery, patients with the evidence of aggressive disease features (namely, pathologic grade group 4-5; pT3b-4 and/or LNI) will be managed according to local guidelines (adjuvant radiotherapy with or without ADT will be allowed). Further Anti PD-1 therapy will not be given post-operatively. PD-L1 status will be retrospectively assessed on both tumour cells and immune cells in tissue specimens from for all patients enrolled in the study.
The aim of this study was to analyze the association between serum and salivary Galectin-3 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum and salivary Galectin-3 levels
The aim oh this study is to determine the safety and recommended dose of trifluridine/tipiracil plus capecitabine and bevacizumab combination (part 1, dose escalation phase) and to assess its activity in previously untreated mCRC patients who are deemed not eligible for intensive chemotherapy (part 2, expansion phase).