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.
Oxygen supplementation in the inspired mixture is commonly used in critically ill patients and observational studies highlight that those patients remain hyperoxemic for substantial periods during Intensive Care Unit stay. However, exposure to inhaled oxygen-enriched mixtures is widely recognized as potentially harmful and cause of organ damage. Although, the specific level of arterial oxygen partial pressure (PaO2) considered harmful, or the dangerous duration of hyperoxia, is not determined yet as there are no clinical trials on humans that evaluate the appropriate percentage of oxygen considered safe to maintain an adequate tissue oxygen availability. The study is designed as a multicentre, open-label, two parallel groups, randomized superiority clinical trial. The study will involve 10 European intensive care units and will recruit adult critically ill patients requiring mechanical ventilation with an expected length of stay of more than 72 hours admitted to the Intensive Care Unit. Within the conventional group, participants will receive an inspired oxygen fraction (FiO2) aiming to maintain an oxygen saturation by pulse oximetry (SpO2) equal or major than 98 percentage, accepting an upper limit of PaO2 of 150 mmHg and a lower limit of 60 mmHg. Patients in the conservative group will receive the lowest FiO2 to maintain SpO2 between 94 and 98 percentage, or when available a PaO2 between 60 mmHg and 100 mmHg. The primary objective of this study is to verify the hypothesis that strict maintenance of normoxia improves survival in a wide population of mechanically ventilated critically ill patients compared to the application of conventional more liberal strategies of oxygen administration. Survival will be measured at Intensive Care Unit discharge. The confirmation of the efficacy of a conservative strategy for oxygen administration in reducing the mortality rate among critically ill patients will lead to a profound revision of the current clinical practice and a rationale revision of the current recommendations would be mandatory, maybe also in other clinical scenarios such as emergency departments.
The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children. The effects considered are divided into peri-partum and more long-term effects. Demonstration of safety in children born from mothers who received biologics during pregnancy will pave the way of their use in other women affected by autoimmune diseases unresponsive to standard treatment.
The present study is proposed for the identification of phenotype, biochemical and genetic markers in adult symptomatic spinal osteochondrosis to promote the early diagnosis of this pathological condition and to establish possible therapeutic targets that favor a conservative approach aimed at treating patients.
the evaluation of distribution of mechanical ventilation during robotic surgery
This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase III study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the 'main study'): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to their prior stable HES background therapy, and an open-label extension (OLE) period, during which all patients will receive benralizumab. Patients will continue to be recruited until approximately 38 patients have had their first HES worsening/flare during the DB treatment period at which point the data cut-off for the primary database lock (DBL) will occur. Treatment allocation will remain blinded until the primary DBL. After the study is unblinded for the primary analysis, patients and investigators will remain blinded to patients' individual treatment allocations until after the final patient completes the DB treatment period. The primary analysis will only include data from the DB treatment period of the study. A follow-up analysis will be performed once all patients have the opportunity to complete the 24-week DB treatment period. A patient must complete the 24-week DB treatment period on investigational product (IP) to be eligible to enter the OLE treatment period. The final DBL will occur after the last patient completes the OLE.
Cerebral palsy (CP) is the most frequent cause of motor disability worldwide, with a prevalence of 2-2.5 per 1000 live births. Children with CP may experience a variety of difficulties with communication including speech. Communication impairment has been identified in at least 40% of children with CP, with 36-90% of CP children experiencing motor speech impairment. The aims of the current project are to test the effectiveness of intensive PROMPT treatment in a group of preschool children with CP and motor speech disorders (dysarthria/apraxia of speech) and to evaluate differences to the intervention response according to CP type, brain lesion severity and white matter integrity of corticospinal tract. We hypothesize that children with CP and motor speech disorders will benefit from 3 weeks of daily administration of PROMPT treatment and show measurable improvement of speech intelligibility on clinical and kinematic assessments, with 3 months stability. Outcome measures will include a standardized speech motor assessment as well as improvement in kinematic speech measures detected by a computerized system. We also hypothesize that children with dyskynetic CP will show more improvement induced by the PROMPT treatment as compared to children with spastic CP. We finally hypothesize that corticospinal microstructural integrity positively impact on intelligibility recovery, with children with better integrity having bigger improvements. Our study of PROMPT with children with varying types of CP meets current international priorities of testing and implementing effective, earlier interventions, therefore investing in the improvement infant's health based on evidence, as a future investment for individuals and the community.
Objectives: The overall clinical question is whether LH supplementation to men in indication for FSH according to the AIFA note 74, or with HH, will improve spermatogenesis and pregnancy rate (spontaneous or after ART) over FSH alone or FSH+hCG. However, since LH has never been used in men so far, the first, specific object of this study is the assessment of pharmacodynamics and safety profile of LH in HH men. To this end, this study will evaluate the pharmacodynamics and safety profile of recombinant LH (Luveris) and compare the response to Luveris and urinary hCG (Gonasi HP) in HH men. The pharmacodynamics will be assessed primarily for testosterone levels in response to increasing doses of LH and the comparison of the response to a fix dose of hCG, and later for more extend steroid profile. Methods: Multicentre longitudinal, interventional, randomized, open-label, phase II, clinical trial, assessing pharmacodynamics of LH in acquired HH men. The statistical hypothesis is non-inferiority of the highest LH dose employed compared to a fix hCG dose. Primary endpoint: serum testosterone levels evaluated by liquid-chromatography, tandem mass spectrometry (LC-MS/MS). Secondary endpoints: Safety and tolerability as determined by AE reporting, vital signs, and ECG, stereognosis (inhibin B, free testosterone, sex hormone binding globulin (SHBG), estradiol, whole steroid profile provided by LC-MS/MS) and testicular volume. Patients: 32 men with acquired HH, including HH after neurosurgery for tumours or HH due to pituitary adenoma-related mass effect. Patients will be randomized (1:1) according to a permuted- blocks randomization list, to the study group, treated with Luveris (increasing doses at two weekly intervals), or to the control group treated with Gonasi HP (2000 IU twice/week). In the study group, increasing LH dosages will be administered to obtain a testosterone dose-response curve, starting with the minimum expected efficient dose (75 IU/d, sc) for two weeks followed by 150, 225 and 300 IU at two-weekly interval, respectively. The control group will be treated by the standard approach, i.e. hCG 2000 IU IM twice-weekly for 8 weeks. Patients will be further followed up for 4 weeks after treatment withdrawal. During the study, the patients will be evaluated two times per week during the treatment phase and every two weeks in the follow-up phase.
Observational prospective study investigating the plasmatic levels of miRNA according to AR-V7 mutational status in mCRPC patients receiving standard of care therapy. At the time of the enrollment, patients will undergo determination of AR-V7 splice variants on circulating tumor cells and periodic assessment of circulating levels of miRNA at different time points during the treatment course (initiation, 8-weeks assessment, progression); irrespectively of AR-V7 status patients will be allocated to endocrine therapy with enzalutamide or abiraterone plus LHRH agonist (decapeptyl every 3 months) according to standard of care. Integration of local treatment (in particular radiotherapy) will be allowed on oligoprogressive sites of disease and its impact on overall outcome and miRNA levels will be assessed.
The aim of htis study is to investigate the post intervention effects of daily feedback on actual physical activity levels derived from a wristworn accelerometer FITBIT combined with self-management training on in-clinic physical activity in persons with moderate to severe disability from MS.
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.