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.
Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial. Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery. Randomized active controlled, parallel group, single-centre, trial (category IIb medical device). 88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia). PedsQLscale (23 items) two weeks after surgery. Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.
Peripherally Inserted Central Catheters (PICC) and midline placement requires the catheter size to be one third of the venous diameter, or less. However, measurements during CPAP (Continous Positive Airway Pressure) might overestimate the diameter of veins in patients requiring a PICC line. The investigators will enroll 28 healthy subjects to measure their basilica vein diameter at atmospheric pressure and at 10 cmH2O of Positive End-Expiratory Pressure (PEEP). PEEP will be applied through a CPAP helmet with the straps placed under the arms or tied to the bed. The investigators will test the hypothesis that positive airway pressure significantly increases vein diameter. Under this hypothesis, the indication of avoiding catheters larger than one third of the vein diameter should be revised, as venous enlargement during PEEP may lead to the placement of inappropriately large catheters.
Randomized controlled trial aimed at evaluating the efficacy and safety of the use of a local anesthetic spray, commonly used in clinical practice as off-label, during the suturing of perineal lacerations in post-partum, comparing it with the standard technique that involves the infiltration of lacerated tissues, by administering a NRS card at the end of the procedure.
Identifying patients at high risk for recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT) represents a challenging issue. The present study aims to develop and validate an accurate post-LT recurrence prediction calculator using the machine learning method.
The TI.VA algorithm is a new method to titrate the anesthetic drug concentrations whenever the planned level of anesthesia results to be not appropriate to blunt the patient's reaction to surgical stimulation. TI.VA is a multiple inputs/multiple outputs algorithm. The control variables are the bispectral index (BIS) and the mean arterial pressure (MAP) combined in a decision-making matrix. The optimal range for the two control variables (BIS: 540-60 and MAP: 65-75 mmHg) identified the Optimal Anesthesia Zone (OAZ) at the center of the matrix. Any time one or both control variables escape from the PAZ, the algorithm proposes an intervention on the hypnotic and/or opioid levels (algorithm outputs). A First-in-Humans study was designed to capture preliminary data on the safety and performance of the TI.VA algorithm.
This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)
Physical activity helps to improve health and prevent chronic diseases. However, the fatigue usually hampers the training and execution of physical exercises, especially in people with chronic fatigue syndromes (CFCs), such as persons living with HIV (PLWH). We hypothesize that the "activity pacing", i.e. the strategy to optimize daily physical activity into manageable exercises in a way that should not exacerbate fatigue symptoms, may help a progressive improvement in physical activity of a group of PLWH with fatigue symptoms. Motivation and adherence to exercise will be monitored through the use of digital supports.
The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of a hyaluronic acid-based gel, compared to MINSD alone. A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: hyaluronic acid group (HA) and no-hyaluronic acid group (No-HA).
Action Observation Therapy (AOT) and Motor Imagery (MI) are two rehabilitation approaches based on Mirror Neuron System (MNS). The MNS refers to a series of neurons able to activate both when one observes an action being performed or when one physically performs the action themselves. Previous studies reported that functional recovery is facilitated by asking patient observing videos with motor content (AOT) and after imagining (MI) the gestures observed. These rehabilitative apporach have been used in particular to promote functional recovery in patients with neuromotor problems, in particular in patients with stroke. To date, few studies have investigated the effectiveness of this therapeutic approach in functional recovery after orthopedic surgery and none of these applied AOT and MI in a single pre-operative session. The objective of the study is to verify whether a single administration consisting of two pre-operative sessions of AOT associated with MI can lead to an improvement of functional recovery in hip arthroplasty patients.
The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged >60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.