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.
Patients with Stage IV obstructing colorectal cancer and unresectable liver metastses, with general and local conditions not a risk for coliorectal resection, will be randomized to have either endoscopic stenting or colorectal resection
Per-Oral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter (8cm). The clinical efficacy of both procedure is comparable. This study intends to investigate if clinical outcomes of POEM depends on the length of esophageal myotomy, in patients with classic-type achalasia (type I and type II according to Chicago Classification)
Study to investigate response to sunitinib in patients with thymic epithelial tumours who had progressive disease after at least one previous regimen of platinum-based chemotherapy.
This is a Phase 2 multicenter, open label, non-randomized, interventional study enrolling 53 patients.The objectives and purposes of the clinical study described herein are to determine if concomitant Pembrolizumab (Keytruda) and ECT treatments are safe and able to improve local and systemic response rates.ECT will be performed with the CLINIPORATOR and a single IV dose of Bleomycin
Patients sedated under mechanical ventilation with acute hypoxemic respiratory failure with a PaO2/FiO2 equal or less than 200mmHg (Acute Respiratory Distress Syndrome, ARDS and non-ARDS) will be included in the study early in the course of the disease (first week of mechanical ventilation). At enrollment, data on the clinical condition of the patient will be recorded together with ventilation settings: ventilation mode, the fraction of inspired oxygen (FiO2), PEEP, tidal volume, set pressure, respiratory rate, time of the respiratory cycle, recent blood gas parameters. Airway pressure, flow, and esophageal pressure (or alternatively electrical activity of the diaphragm, Eadi) will be recorded 3 times a day for 7 days: 1. Period 1 (morning): duration 20-30 minutes 2. Period 2 (afternoon): duration 20-30 minutes 3. Period 3 (evening / night): duration 20-30 minutes Registration will be ended at extubation, death or at eight days from the first recording. Monitoring of vital parameters (hemodynamic and respiratory) will be continuous throughout the duration of the study, as per normal clinical practice. All drugs used during the day of the measurements will be recorded. The patient will then be followed until discharge from the ICU and after 60 days of discharge to evaluate mortality. As an ancillary study, in a subgroup of patients continuous simplified measurement of respiratory recordings together with hourly clinical data on sedation and extended simplified polysomnography recordings will be performed within the first 7 days from inclusion. The analysis of the recorded waveforms will be performed in a single center by a centralized system that will quantify dyssynchrony and its intensity, calculate pressure time product, collect clinical and physiological data and outcome, and investigate possible correlations.
The recent introduction of robotics for locomotor training in paraplegic patients, and in particular the use of anthropomorphic exoskeletons, has opened new frontiers in rehabilitation. Existing literature, though encouraging, is still scarce and studies demonstrating efficacy are highly heterogeneous and have a small sample size. Evidence is also needed about cortical plasticity after SCI, in conjunction with the use of innovative rehabilitation devices, through indicators like neurophysiological and neuroradiological markers, as the knowledge of such mechanisms is crucial to improve clinical outcomes. Cortical circuits controlling prosthetic devices are different from those controlling normal parts of the body and remodeling mechanisms following prosthetic use have been documented, but in conditions other than SCI. The aims of this randomized controlled trial, with a 2-arm parallel-group design, are: 1. to evaluate and quantify the efficacy of locomotor rehabilitation with a robotic anthropomorphic exoskeleton (EKSO-GT) in terms of clinical and functional outcomes, and the persistence of such efficacy; 2. to investigate the presence and persistence of brain neuronal plasticity and cortical remodeling mechanisms underlying the robotic rehabilitation approach. Fifty patients will be recruited and randomly assigned to 2 treatment arms. Both groups will follow a program of standard locomotor rehabilitation for 8 weeks. One group will also undergo an overground locomotor training with the EKSO-GT during the first 4 weeks.
The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or telephone interview. Such assessments will include the administration of questionnaires to determine the patient's functional symptoms and the objective examination of the knee during a medical examination to quantify its stability.
Hyperglycemia is a common finding in patients diagnosed with acute coronary syndrome (ACS), and an independent predictor of mortality in patients with and without diabetes. Though percutaneous coronary intervention (PCI) is the cornerstone of ST-segment elevation myocardial infarction (STEMI), the incidence of heart failure, re-infarction and death in hyperglycemic patients remains significant, with a mortality of more than 40% one year after the event. In these STEMI patients dual anti-aggregation therapy is currently the gold standard after PCI, but bleeding phenomena, and therapeutic resistance may reduce their therapeutic efficacy. Therefore, it is likely that the individual response to the dual anti-aggregation therapy, and the hyperglycemic stress, may influence resistance mechanisms, and/or lead to an increase in pharmacological functional deactivation by the microbiotic flora. The term microbiota indicates the totality of the genomes of microorganisms that reside in an ecological niche, and which constitute the "human microbiota". In this context, the analysis of the faecal microbiota before PCI, at hospital discharge and at follow-up, could be considered useful for identifying hyperglycaemic patients with alteration of metabolic-oxidative processes, and pro-thrombotic correlates with worse post procedural prognosis. Therefore, the analysis of faecal microbiota during the STEMI event could theoretically identify hyperglycemic patients with excessive inflammatory and oxidative tone caused by hyperglycemia, conditioning resistance to double anti-aggregation therapy and coronary stenting, and conditioning pro-thrombotic phenomena after coronary reperfusion by PCI. Therefore, authors will conduct a study to analyze the microbiota in patients with acute hyperglycaemic and normoglycemic coronary syndrome. The primary objective of this study will be to evaluate any changes in the microbiota and its activity on faecal material taken before PCI, and after 6 and 12 months in patients with hyperglycemic STEMI, and also evaluate if the changes in the microbiota can be related to the 12-month prognosis.
The progressive rising of multimorbidity, which has been always considered the hallmark of clinical complexity (CC), has made management of the "complex" patient one of the most topical and challenging issues in medicine. However, patient-related factors (multimorbidity, age, frailty, disease severity) pertain only to the biological complexity, while CC is the result of the dynamic interaction between biological complexity and a number of other coexisting factors (socio-economic, cultural, behavioural, environmental). Starting from these premises, the investigators designed a five-year observational prospective longitudinal study that aims to validate and compare a CC score system on a large cohort of patients (n=1000) admitted in internal medicine wards. Clinicians, biostatisticians and epidemiologists will cooperate into the project. A questionnaire that encompasses the main biological and extra-biological factors was designed (Clinical Complexity Index, CCI) by a multiprofessional consensus. This questionnaire will be administered by the investigators to the patients and validated. Consecutive patients will be enrolled every other week for two years and followed-up for 5 years. The primary endpoint will be the validation of the CCI. Thereafter, the investigators will evaluate the correlation between the CCI and the length of stay of the index hospitalization, assuming that a higher CCI score is associated with longer length of stay. The secondary endpoints will be the demonstration of the association between higher CCI score and more health resources utilization (i.e., evaluating occurrence of hospital readmissions, number of accesses to the emergency room, visits at the outpatient clinic, different drugs prescribed and hospital reimbursement according to the local diagnosis-related group [DRG] system) along with worse prognosis (mortality at 1 and 5 years).
The admission of a loved one in an ICU is a hard experience for family members. They frequently feel fear and grief, develop anxiety and depression symptoms, or even show some behaviors as this event was a real traumatic one, like hyper-arousal, avoidance and intrusion in the daily life.To improve the communication between them and the ICU staff members, and to meet their needs in terms of medical comprehension and emotional legitimization, a specific website was built, and a brochure was printed to make them welcomed in the ICU; moreover, a series of poster was prepared for the family waiting room outside the ICU. These instruments appeared able to improve the correctness of prognosis comprehension and to decrease the post-traumatic stress symptoms in a multicenter study involving Italian ICUs. The proposal of the present study is to verify on a larger scale if these instruments can really ameliorate the empathic communication among staff members, without increase in workload, and to make less traumatic, for the family members, their experience during and after the ICU stay.