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 main purpose of this study was to assess the antitumor activity of three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in participants with advanced triple-negative breast cancer (TNBC) in first or second line therapy.
The aim of the study is to evaluate whether changes in Perfusion Index (PI) and Pleth Variability Index (PVI) during passive leg raising test can predict fluid responsiveness in spontaneously breathing patients. Fluid responsive patients are defined as showing an increase in cardiac output >10% during a passive leg raising test, measured semi-invaseively with FloTrac® (Edwards LifeSciences. Irvine, United States).
HCPs will complete questionnaires about their patients with Cerebral Palsy (CP) and invite parents/caregivers of these patients to fill in questionnaires as well. Questionnaires include questions on individualized treatment, nutritional profile and management, and patient characteristics.
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)
"Lateral Spreading Tumors" (LSTs) are dysplastic lesions whose protrusion within the lumens the colon is not more than twice as compared to the surrounding non-dysplastic mucosa. They can be divided into two groups: Granular type (LST-G) and Non Granular type (LST-NG) Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are currently the most used techniques to resect this type of lesions. Compared to other methods of tissue ablation, EMR allows to carry out the histological evaluation of the resected fragments and ESD of the lesion in toto ("en bloc") EMR is currently the most used technique for removal of LST, but for lesions of ≥ 30 mm the resection is performed "piecemeal", i.e. fragmentary. This can compromise an adequate histological evaluation of the lateral and deep margins of the lesion. Colonic EMR (EMR-S) is usually performed using a polypectomy snare, after lifting the lesion from the underlying layers with a submucosal injection of liquid (EMR standard or "inject-and-cut"). The aspiration of the lesion inside a plastic cap preloaded on the tip of the colonoscope ("cap-assisted EMR" - EMR-C) is almost exclusively used for the treatment of gastric and esophageal lesions. Its use for lesions of the colon and duodenum has been reported in limited experiences The principal aim of this study is to evaluate the efficacy and the safety of the EMR-C for the removal of large colonic LST-G and LST-NG, comparing it with EMR-S.
This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.
The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.
Despite the availability of evidence-based guidelines for disease management in patients with congestive heart failure (CHF), the uptake of these guidelines in clinical practice is sub-optimal and adherence rates are disappointing. Within the HeartMan project, a personal e-health system was developed to help CHF patients manage their disease, with the ultimate goal to improve health-related quality of life (HRQoL). The system uses wrist-band sensors to monitor patients' physical activity and physiological parameters. These data are connected to a decision support system, providing medical advice to patients concerning physical exercise, nutrition, medication intake, clinical measurements, environment management, and mental support. The decision support system is based on predictive models, clinical care guidelines and expert knowledge. The advice will be personalized according to each individual patient's medical and psychological profile, and will be presented to the patient through the user interface of a mobile application on a smartphone. A proof of concept trial with a 1:2 (control:intervention) randomization protocol was designed. The sample size calculation was based on primary outcome data from the previous CHIRON project, showing that 90 patients are needed to show at least -5.8 (± 6 to 8 s.d.) beats/min difference in average daily awake heart rate difference - as a fundamental parameter correlating with patient reported HRQoL - with 90% power between the two groups. Data collection will include an estimation of exercise capacity based on a six-minute walking test, and questionnaire assessments using standardized instruments. The trial will be initiated in two countries. In order to account for possible dropouts, 60 patients will be enrolled in Italy and 60 in Belgium (20 control and 40 intervention patients in each country). Target patients are stable ambulatory CHF patients (NYHA class 2-3; reduced left ventricular ejection fraction ≤40%). Eligible patients will be recruited by their treating physician from collaborating medical centers in both countries; they will be enrolled in the trial after giving informed consent for participation. After baseline assessment, patients will be randomized into either the intervention (duration of 6 months) or control (usual care) condition. Data collection will be repeated at the end of the trial.
The aim of this non-interventional study is to compare the blastulation rate per fertilized oocyte in two different single step culture media commercially available (GEMS and Irvine culture media).
The third trimester of pregnancy is typically characterized by the development of a marked respiratory alkalosis. The possible role of pregnancy-induced variations of cerebrospinal fluid (CSF) acid-base characteristics on the development of hypocapnic alkalosis is still unknown. Aim of this study is to characterize, according to Stewart's approach, the acid-base equilibrium of CSF and arterial plasma of pregnant women and compare the results with data obtained from fertile, non-pregnant women.