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Three years of experience : the Italian registry and safety data update
2011
At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%. Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability…
The pharmacovigilance program on natalizumab in Italy: 2 years of experience.
2009
At the end of 2006 a country-based surveillance program on natalizumab therapy in multiple sclerosis was settled in Italy by a collaborative effort of the Italian Drug Agency (AIFA) and a group of experts and neurologists appointed by the National Society of Neurology (SIN). After 2 years, 1,818 patients are registered in the database. The majority of cases (88.6%) failed the therapy with beta interferon or glatiramer acetate and had relapses or accumulated disability during immunomodulating treatment, while 11.4% of patients enrolled in the surveillance study were not previously treated with immunomodulating therapies and had a rapidly evolving clinical course. Almost 10% of the patients t…
Casteldaccia eye study: prevalence of cataract in the adult and elderly population of a Mediterranean town.
1994
Prevalence of cataract was studied in a population based survey performed in adults aged 40 years or more living in Casteldaccia, a small Sicilian town. Lens opacities of moderate or severe grade (type II or worse, according to the Lens Opacity Classification System II) were found at the following rates: nuclear opalescence in 18.5%, cortical cataract in 12.9%, posterior subcapsular cataract in 10.8%. All these types of cataract were much more frequent in the elderly population and were about 1.5 times more common in women than in men. Late cataract was found in about 1/3 of subjects aged 60 to 69 years, in 2/3 of subjects aged 70 or more, but rarely under 60 years of age. However, early ca…
Tunica vaginalis Free Grafts for Closure of Urethrocutaneous Fistulas
1990
In 32 patients a tunica vaginalis free graft was used for closure of urethrocutaneous fistulas (n = 26) or complicated hypospadias repair (n = 6). All patients had at least one operation (average 3.9) for urethral reconstruction prior to this procedure. 12 patients had recurrent fistulas (average 2.2). The technique proved to be very successful. Only 2 patients had to undergo subsequent reoperation for recurrent fistulas. The use of a free tunica vaginalis graft interposed between skin and urethra is our method of choice in the repair of recurrent or complicated urethrocutaneous fistulas.
Laparoscopy is an available alternative to open surgery in the treatment of perforated peptic ulcers: A retrospective multicenter study
2018
Abstract Background Perforated peptic ulcers (PPU) remain one of the most frequent causes of death. Their incidence are largely unchanged accounting for 2–4% of peptic ulcers and remain the second most frequent abdominal cause of perforation and of indication for gastric emergency surgery. The minimally invasive approach has been proposed to treat PPU however some concerns on the offered advantages remain. Methods Data on 184 consecutive patients undergoing surgery for PPU were collected. Likewise, perioperative data including shock at admission and interval between admission and surgery to evaluate the Boey’s score. It was recorded the laparoscopic or open treatments, the type of surgical …
One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass
2019
The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease.This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composi…
Patient reported feasibility and acceptance of Montreal Cognitive Assessment (MoCA) screening pre- and postoperatively in brain tumour patients.
2018
Abstract Background Montreal Cognitive Assessment (MoCA) represents a short screening tool for neuropsychological deficits. The study’s aim was to test feasibility and acceptance of MoCA in patients with brain tumours perioperatively. Methods Patients with supratentorial located brain tumours were assessed preoperatively (t1, day −1) and postoperatively (t2, day 3–5) using EORTC-QLQ-C30 + BN20, Distress Thermometer (DT) and the MoCA test (different versions). Feasibility was evaluated by a feedback form and patients were asked about perceived discomfort, overstraining or complexity of MoCA. Results of MoCA were correlated with clinical factors. Results 63 patients participated, 19 were male…
Age-related neuromuscular function and dynamic balance control during slow and fast balance perturbations.
2013
This study investigated age-related differences in dynamic balance control and its connection to reflexes and explosive isometric plantar flexor torque in 19 males (9 Young aged 20–33 yr, 10 Elderly aged 61–72 yr). Dynamic balance was measured during Slow (15 cm/s) and Fast (25 cm/s) anterior and posterior perturbations. H/M-ratio was measured at 20% of maximal M-wave (H/M20%) 10, 30, and 90 ms after perturbations. Stretch reflexes were measured from tibialis anterior and soleus during anterior and posterior perturbations, respectively. In Slow, Elderly exhibited larger peak center-of-pressure (COP) displacement (15%; P < 0.05) during anterior perturbations. In Fast, Young showed a tren…
Afferent contribution to locomotor muscle activity during unconstrained overground human walking:an analysis of triceps surae muscle fascicles
2010
Plantar flexor series elasticity can be used to dissociate muscle–fascicle and muscle–tendon behavior and thus afferent feedback during human walking. We used electromyography (EMG) and high-speed ultrasonography concomitantly to monitor muscle activity and muscle fascicle behavior in 19 healthy volunteers as they walked across a platform. On random trials, the platform was dropped (8 cm, 0.9 g acceleration) or held at a small inclination (up to ±3° in the parasagittal plane) with respect to level ground. Dropping the platform in the mid and late phases of stance produced a depression in the soleus muscle activity with an onset latency of about 50 ms. The reduction in ground reaction force…
Retracted: Do patients profit from physostigmine in recovery from desflurane anaesthesia?
2007
Background: Physostigmine is the drug of choice in the central anticholinergic syndrome, but has also been used in post-operative mental derangement secondary to sedatives and volatile anaesthetics. The aim of this double-blind, randomized, prospective study was to determine whether physostigmine alters recovery after desflurane anaesthesia. Methods: One hundred patients undergoing urologic or surgical procedures were enrolled to receive either NaCl 0.9% (n= 50) or 2 mg of physostigmine (n= 50) at the end of general anaesthesia with propofol, fentanyl, cisatracurium and desflurane. Times to extubation, stating name, birthday and place of residence, and obeying commands such as eye opening…