Small doses of recombinant factor VIIa in acquired deficiencies of vitamin K dependent factors.
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Factor VIIa↗
Biomedical subjects
F Leo
Publications and source records attributed to F Leo.
Resection for bronchogenic carcinoma in the elderly.
BACKGROUND: The aim of this report was to assess postoperative complications, mortality and long term survival of surgical therapy for non small cell lung cancer in patients aged 70 years or more. Results and the significance of various prognostic factors were analysed. METHODS: At Thoracic Surgery Department of Torino, from January 1980 to December 1997, 258 patients aged 70 years or more were operated on for lung cancer. For the first 11 years of the series, more restrictive selection criteria were adopted (clinical stage I or II lung cancer, absence of major concomitant disease or previous malignancy in the last 5 years); 60 patients were operated in this period. After 1990, such criteria were no longer considered mandatory; since then 198 patients have been operated. Clinical data are reviewed in the search for predictors of mortality and morbidity and survival data are analysed. RESULTS: Overall postoperative mortality was 3.1% and morbidity was 39.1%. Pneumonectomy resulted in higher rate of mortality (9.1%, p 0.03). Complications proved to be more frequent in patients with concomitant disease (55.5%). Multivariate analysis on survival showed the importance of stage (5 years survival was 73.6% in stage I, 23% in stage II, 8.9% in stage IIIa) and type of selection (57% for the highly selected, 40% for the others). CONCLUSIONS: Selection criteria have the same impact on survival as stage in surgical treatment of lung cancer in the elderly. This factor should be analysed in series covering a long period of time. Low mortality and acceptable long term survival from this study confirmed that surgery is worthwhile in elderly patients.
Aged↗
The use of recombinant activated factor VII in congenital and acquired factor VII deficiencies.
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Adult↗
[Mediastinal Castleman's disease].
Castleman's disease(CD) is an uncommon lymph node syndrome, generally located in mediastinum side, rarely systemic. Two histhologic types are described: the more common, termed the hyaline-vascular type, generally asymptomatic, and the second termed plasma cell type, with systemic manifestations of the disease, like fever, anemia and weight loss. The authors present a case of a young man with Castleman's disease, treated by prednisone without reduction of the adenopathy, and thus successfully operated, and discuss about aetiopathogenic theories and treatment of this disease.
Adult↗
Right post pneumonectomy pleural empyema caused by an esophagopleural fistula due to an esophageal carcinoma.
A case report of a patient with pleural empyema resulting from esophagopleural fistula following perforation of squamous cell carcinoma of the esophagus is presented. The patient had previously received a right pneumonectomy for bronchogenic carcinoma with the adjunct of postoperative radiotherapy. Description of the case, differential diagnosis and therapy of esophagopleural fistulas (EPF) as well as a review of the Literature is described and discussed.
Carcinoma, Bronchogenic↗
A prototype device for nonimmersion shock wave lithotripsy using ultrasonography for calculus localization.
Extracorporeal shock wave lithotripsy has revolutionized the clinical treatment of renal calculi. A device was constructed with a spark gap for shock wave generation and a water-filled ellipsoidal reflector to focus the shock wave energy. A membrane coupled the device to the pig and an ultrasonic transducer was used for stone visualization. Initial in vitro experiments and in vivo studies using dwarf pigs demonstrated fragmentation of calculi.
Animals↗
A comparison of five methods for monitoring the precision of automated x-ray film processors.
Five different methods for preparing sensitometric strips used to monitor the precision of automated film processors are compared. A method for determining the sensitivity of each system to processor variations is presented; the observed statistical variability is multiplied by the system response to temperature or chemical changes. Pre-exposed sensitometric strips required the use of accurate densitometers and stringent control limits to be effective. X-ray exposed sensitometric strips demonstrated large variations in the x-ray output (2 omega approximately equal to 8.0%) over a period of one month. Some light sensitometers were capable of detecting +/- 1.0 degrees F (+/- 0.6 degrees C) variations in developer temperature in the processor and/or about 10.0 ml of chemical contamination in the processor. Nevertheless, even the light sensitometers were susceptible to problems, e.g. film emulsion selection, line voltage variations, and latent image fading. Advantages and disadvantages of the various sensitometric methods are discussed.
Automation↗
Application of membrane filtration for removal of diminutive bioburden organisms in pharmaceutical products and processes.
In this report, we present results of a recent investigation in our laboratories demonstrated the effect of process conditions and/or drug product composition on the ability of 0.2 micron and 0.22 micron sterilizing grade filters to fully retain Ralstonia (formerly Burkholderia, formerly Pseudomonas) pickettii. R. pickettii is a opportunistic pathogen widely distributed in nature as well as clinical specimens and there have been several reports of nosocomial infections due to intrinsic manufacture-related R. pickettii contamination in filter-sterilized parenteral fluids. This study documents the penetration of 0.2 micron nylon 66 and 0.22 micron modified PVDF sterilizing grade filters by R. pickettii (grown and challenged) in a drug solution under conditions that simulated a pharmaceutical filling operation. Penetration was not observed for every filter disc tested, and this may be explained, in part, by the stochastic nature (i.e., governed by the rules of probability) of the retention mechanisms involved. Scanning electron microscopy revealed significant changes in the microorganism's size and morphology as a result of exposure to the drug solution; these changes are consistent with those reported for bacteria subjected to nutrient deprivation. The SEM analyses of R. pickettii challenge suspensions in the drug solution showed that the average cell length decreased from 1.25 +/- 0.27 microns to 0.84 +/- 0.17 micron between zero and 24 hours. In addition, significant changes were observed in the size (length) distributions, with approximately 35% of the cells at 24 hours being smaller than any cell observed at the start of the challenge. These data suggest that the significant reduction in bioburden size and morphology that occurred as a result of exposure to the drug solution may play a role in the reduced ability of the 0.2 micron and 0.22 micron filters tested in this study to retain these organisms. Under the same test conditions where penetration of 0.2/0.22 micron filters was observed, 0.1 micron rated membrane filters qualified with both B. diminuta and Acholeplasma laidlawii mycoplasma consistently provided sterile effluent. Bacterial penetration of 0.2 (or 0.22) micron sterilizing grade filters was not observed under identical test conditions with either R. pickettii in a standardized solution (saline lactose broth) routinely used in challenge testing filters, or with the standard test organism, B. diminuta, in the drug solution. This study thus supports the renewed emphasis on both product- and process specific validation as well as routine bioburden monitoring expressed by regulatory agencies, and the use of enhanced bacterial removal efficiency 0.1 micron rated filters to provide enhanced sterility assurance in pharmaceutical processes.
Bacteria↗
Design, development and qualification of a microbiological challenge facility to assess the effectiveness of BFS aseptic processing.
A programme of work has been initiated to further the understanding of the impact of the environment surrounding a Blow/Fill/Seal (BFS) machine upon the microbiological quality of processed product. A dedicated facility (Challenge Room) has been constructed and qualified to provide for the production and containment of dispersions of micro organisms in air of a room housing an operating BFS machine of a given style and configuration. The facility achieves homogeneous distribution of generated dispersions throughout the Challenge Room air, including that within and close to the critical area in which aseptic BFS operations occur. Generated microbial dispersions can be maintained in the room over extended time periods (up to 600 min) at a desired concentration within the range 10(1) to 10(7) cfu m(-3). They can also be produced employing different cell types, including bacterial endospores, Gram-positive and Gram-negative vegetative cells and yeast cells. Effective containment of dispersions is achieved while 'cards of product' (vials in sets) are conveyed from the Challenge Room to an adjacent Packing and Storage Area. Decontamination of the room and the housed BFS machine is accomplished through exposure to chlorine dioxide gas at a concentration of 1.0 mg dm(-3) for 120 min at room temperature (approximately 23 degrees C).
Air Microbiology↗
[Major and repeated liver surgery in the multimodal treatment of synchronous and metachronous metastasis of colorectal cancer].
At the present, surgical treatment still represents the only chance of cure for liver metastases from colorectal cancer. Moreover in the last years the new chemotherapic adjuvant and neoadjuvant regimens and the use of radioablative techniques as radiofrequency have improved resectability and even survival. Besides, iterative surgery seems to show more and more encouraging results in terms of disease-free and overall survival, sometimes even in patients already resected for extrahepatic disease. The golden rule is in fact to try to perform every time an R0 resection, with no macro- and possibly microresidual disease.
Colorectal Neoplasms↗
[Surgical treatment of hepatocellular carcinoma: prognostic factors for long-term disease-free survival and tumor recurrence].
Hepatocellular carcinoma mainly develops in a cirrhotic liver; in the majority of the patients chronic hepatitis or cirrhosis are virus-related and/or postalcoholic. Liver resection is the gold standard treatment when there is no multifocality of the tumor and liver disease is not advanced (patients with Child-Pugh A score, or B in selected cases). In our experience the presence of vascular invasion and satellite nodules is clearly related to a decreased rate of disease-free survival and a higher percentage of intrahepatic recurrence.
Adult↗
Investigation of pulsed light for terminal sterilization of WFI filled blow/fill/seal polyethylene containers.
A study was performed to assess the ability of pulsed light to sterilize water for injection in blow/fill/seal polyethylene containers. Pulsed light uses intense, short duration flashes of broad spectrum white light to produce high levels of microbial kill. In a first phase of testing, containers of 0.5, 5, 15, and 120 mL nominal volume were inoculated with Bacillus pumilus endospores, Bacillus subtilus variety niger strain globigii endospores, Bacillus stearothermophilus endospores, and Aspergillus niger conidiospores. Approximately 10(6) colony forming units of each test spore were individually inoculated into 22 replicate containers of each sample volume. Two of these containers served as inoculation recovery controls, and 10 were treated using each of two pulsed light exposure methods: single-sided treatment, or treatment within a reflective cavity. Both treatments employed flashes of intense broad spectrum pulsed light delivered at one flash per second. Cavity treatment used 10 flashes to treat each container within a reflective cavity containing a single lamp. Cavity treatment yielded no recoverable survivors for any of the challenge spores from the contents of any of the 160 total samples. Single-sided treatment used 20 approximately 1-J/cm2 flashes from a single lamp-reflector projecting onto one side of the container. Single-sided treatment yielded no recoverable survivors from the contents of the containers for any of the bacterial endospores tested, but Aspergillus niger survival was detected in 4 of the 40 single-side treated samples. A second phase of tests examined the pulsed light inactivation of Bacillus pumilus spores for a range of inoculation levels. High levels of Bacillus pumilus spore kill were obtained using only a few cavity flashes. The results show that pulsed light can provide high levels of microbial lethality and possesses potential for use as a terminal sterilization method for water for injection in filled, sealed polyethylene containers.
Bacteria↗
[Spontaneous and traumatic pneumomediastinum. Analysis of 34 cases].
Pneumomediastinum (spontaneous, iatrogenic and traumatic) is a relatively uncommon infrequently reported entity. The most common cause is the rupture of marginal pulmonary alveoli, allowing bubbles of air to dissect along the vascular sheaths and connective tissue planes to the mediastinum. Rupture of the trachea or thoracic traumas are other causes of pneumomediastinum. The most common presenting complaint was retrosternal pain, dyspnea, dysphagia, weakness and neck pain. Physical finding revealed: subcutaneous emphysema extended to face, chest or neck, and Hamman's sign. Chest X-ray was made in all cases and diagnosis was completed with chest CT scan and tracheoscopy. We present our series of 34 PM between January 1.1993 to July 31.1995 and discuss about etiology, diagnosis and treatment of this entity.
Adolescent↗