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Sample records for multicenter safety study

  1. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

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    Reinaldo Menezes Martins

    2004-12-01

    Full Text Available The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang® were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70% met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566, children 1 to 10 years old (484, adolescents from 11 to 19 years (740, adults from 20 to 30 years (568, and adults from 31 to 40 years (396. Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults or 0, 1, and 7 months (children. Vaccine dose was intramuscular 10 µg (infants, children, and adolescents or 20 µg (adults. Percent seroprotection (assumed when anti-HBs titers were > 10mIU/ml and geometric mean titer (mIU/ml were: newborn infants, 93.7% and 351.1 (Butang® and 97.5% and 1530.6 (Engerix B®; children, 100% and 3600.0 (Butang® and 97.7% and 2753.1 (Engerix B®; adolescents, 95.1% and 746.3 (Butang® and 96% and 1284.3 (Engerix B®; adults 20-30 years old, 91.8% and 453.5 (Butang® and 95.5% and 1369.0 (Engerix B®; and adults 31-40 years old, 79.8% and 122.7 (Butang® and 92.4% and 686.2 (Engerix B®. There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults.

  2. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine.

    NARCIS (Netherlands)

    Beck, D.E.; Cohen, Z.; Fleshman, J.W.; Kaufman, H.S.; Goor, H. van; Wolff, B.G.

    2003-01-01

    INTRODUCTION: Seprafilm adhesion barrier (Seprafilm) has been proven to prevent adhesion formation after abdominal and pelvic surgery. This article reports safety results, including the postoperative incidence of abdominal and pelvic abscess and pulmonary embolism, from a large, multicenter trial

  3. Multicenter safety study on cetuximab combined with intensity modulated radiotherapy and concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Chen Chunyan; Zhao Chong; Gao Li

    2012-01-01

    Objective: To evaluate the safety of cetuximab combined with intensity-modulated radiotherapy (IMRT) plus concurrent cisplatin chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC) in a Chinese multicenter clinical study. Methods: From July 2008 to April 2009, 100 Patients with primary stage III- IV b non-keratinizing NPC were enrolled. The planned dose of IMRT to gross tumor volume and positive cervical lymph nodes was 66.0-75.9 Gy and 60-70 Gy in 30-33 fractions. Cisplatin (80 mg/m 2 , q3 week (w)) and cetuximab (400 mg/m 2 one w before radiation, and then 250 mg/m 2 per w) were given concurrently. The adverse events (AEs) were graded according to common terminology criteria for adverse events v3.0. Results: The compliance of the entire group of patient was satisfactory. Actual median dose to gross tumor volume was 69.96 Gy, and the median dose to positive cervical lymph nodes was 68 Gy. Median dose of cisplatin was 133 mg, median first-dose of cetuximab was 690 mg, and median weekly dose was 410 mg. AEs were well tolerated and manageable, mainly consisting of acneiform skin eruptions,dermatitis and mucositis. Grade 4 mucositis was observed in 2% of the patients and no other grade 4 AEs were observed. Conclusions: The combined treatment modality of IMRT + concurrent chemotherapy + cetuximab in loco-regionally advanced NPC is well tolerated. (authors)

  4. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study.

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    Jeong-Whun Kim

    Full Text Available There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA with those of power-assisted adenoidectomy.Prospective multi-institutional study.Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C or without cauterization (PAA-C due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated.A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1 CA (n = 116; (2 PAA+C (n = 153; and (3 PAA-C (n = 119. Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001 and degree of intraoperative bleeding was significantly less (P < 0.001 compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016.This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding.

  5. The Safety and Feasibility of Image-Guided BrainPath-Mediated Transsulcul Hematoma Evacuation: A Multicenter Study.

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    Labib, Mohamed A; Shah, Mitesh; Kassam, Amin B; Young, Ronald; Zucker, Lloyd; Maioriello, Anthony; Britz, Gavin; Agbi, Charles; Day, J D; Gallia, Gary; Kerr, Robert; Pradilla, Gustavo; Rovin, Richard; Kulwin, Charles; Bailes, Julian

    2017-04-01

    Subcortical injury resulting from conventional surgical management of intracranial hemorrhage may counteract the potential benefits of hematoma evacuation. To evaluate the safety and potential benefits of a novel, minimally invasive approach for clot evacuation in a multicenter study. The integrated approach incorporates 5 competencies: (1) image interpretation and trajectory planning, (2) dynamic navigation, (3) atraumatic access system (BrainPath, NICO Corp, Indianapolis, Indiana), (4) extracorporeal optics, and (5) automated atraumatic resection. Twelve neurosurgeons from 11 centers were trained to use this approach through a continuing medical education-accredited course. Demographical, clinical, and radiological data of patients treated over 2 years were analyzed retrospectively. Thirty-nine consecutive patients were identified. The median Glasgow Coma Scale (GCS) score at presentation was 10 (range, 5-15). The thalamus/basal ganglion regions were involved in 46% of the cases. The median hematoma volume and depth were 36 mL (interquartile range [IQR], 27-65 mL) and 1.4 cm (IQR, 0.3-2.9 cm), respectively. The median time from ictus to surgery was 24.5 hours (IQR, 16-66 hours). The degree of hematoma evacuation was ≥90%, 75% to 89%, and 50% to 74% in 72%, 23%, and 5.0% of the patients, respectively. The median GCS score at discharge was 14 (range, 8-15). The improvement in GCS score was statistically significant ( P < .001). Modified Rankin Scale data were available for 35 patients. Fifty-two percent of those patients had a modified Rankin Scale score of ≤2. There were no mortalities. The approach was safely performed in all patients with a relatively high rate of clot evacuation and functional independence. Copyright © 2016 by the Congress of Neurological Surgeons

  6. Safety of gadobutrol in more than 1,000 pediatric patients: subanalysis of the GARDIAN study, a global multicenter prospective non-interventional study

    International Nuclear Information System (INIS)

    Glutig, Katja; Bhargava, Ravi; Hahn, Gabriele; Hirsch, Wolfgang; Kunze, Christian; Mentzel, Hans-Joachim; Schaefer, Juergen F.; Willinek, Winfried; Palkowitsch, Petra

    2016-01-01

    Gadobutrol is a gadolinium-based contrast agent, uniquely formulated at 1.0 mmol/ml. Although there is extensive safety evidence on the use of gadobutrol in adults, few studies have addressed the safety and tolerability of gadobutrol in pediatric patients. This subanalysis of data from the GARDIAN study evaluated the safety and use of gadobutrol in pediatric patients (age <18 years). The GARDIAN study was a large phase IV non-interventional prospective multicenter post-authorization safety study performed in Europe, Asia, North America and Africa. A total of 23,708 patients were included who were scheduled to undergo cranial or spinal MRI, liver or kidney MRI, or MR angiography with gadobutrol enhancement. The primary study endpoint was the overall incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) following gadobutrol administration. The GARDIAN study included 1,142 children (age <18 years) who received gadobutrol at a mean dose of 0.13 (range 0.04-0.50) mmol/kg body weight. Gadobutrol was well tolerated in these children, with low rates of ADRs (0.5%) and no SAEs, consistent with results in adults enrolled in the GARDIAN study. Rates of adverse events and ADRs were unrelated to pediatric age or gadobutrol weight-adjusted dose. There were no symptoms suggestive of nephrogenic systemic fibrosis. Investigators rated the contrast quality of gadobutrol-enhanced images as good or excellent in 97.8% of pediatric patients, similar to the main study population. Gadobutrol is very well tolerated and provides excellent contrast quality at the recommended weight-adjusted dose in children (age <18 years), similar to the profile in adults. (orig.)

  7. The diagnosis accuracy and safety of 99Tcm-MIBI myocardial perfusion imaging-a retrospective multicenter study

    International Nuclear Information System (INIS)

    Wang Rongfu; Qiu Yanli; Wang Liqin

    2012-01-01

    Objective: To evaluate the diagnostic accuracy and safety of 99 Tc m -MIBI MPI by retrospectively analyzing data from this multicenter study. Methods: Participating centers included six hospitals: Peking University First Hospital, Beijing Fuwai Hospital of Chinese Academy of Medical Science and Peking Union Medical College, Anzhen Hospital of Capital Medical University, Beijing Hospital of Health Ministry, Beijing Tongren Hospital of Capital Medical University and Peking University People's Hospital. According to the inclusion and exclusion criteria, 500 subjects (335 male, 165 female, mean age (60.1 ±11.1) years) who underwent MPI between April 1998 and April 2006 were enrolled. All subjects were investigated with stress/rest MPI and CAG within 1 month. Stress test was performed with bicycle ergometry or with intravenous dipyridamole, adenosine or ATP. Perfusion defects on MPI were allocated to corresponding coronary arteries. During the stress and imaging period,any discomfort or symptoms were recorded. Coronary stenosis with ≥ 50% luminal narrowing was considered significant in CAG and taken as the gold standard. 99 Tc m -MIBI MPI results for the number of stenosed vessels, stenotic severity and coronary artery allocation were compared using χ 2 test. Results: There were 280 subjects that underwent exercise stress tests and the remaining 220 received pharmacological stress tests (117 adenosine, 32 dipyridamole, 71 ATP). Two hundred and forty-nine patients had significant coronary stenosis and 251 had normal CAG. Out of the 249 patients with positive CAG results, 101 had one-vessel, 66 had two-vessel and 82 had three-vessel disease. Significant stenosis of the LAD was present in 205 patients, 144 had RCA stenosis and 130 had stenosis of the LCX. The sensitivity,specificity, accuracy, positive predictive and negative predictive values of MPI for detection of coronary artery disease were 65.1% (162/249), 81.3% (204/251), 73.2% (366/500), 77.5% (162

  8. Injection-associated pain in femoral arteriography: A European multicenter study comparing safety, tolerability, and efficacy of iodixanol and iopromide

    International Nuclear Information System (INIS)

    Justesen, Per; Downes, Mark; Grynne, Birthe Hougens; Lang, Hanne; Rasch, Wenche; Seim, Eva

    1997-01-01

    Purpose. To evaluate injection-associated pain, safety, and efficacy with the isotonic contrast medium iodixanol (Visipaque 270 mg I/ml) compared with iopromide (Ultravist 300 mg I/ml) in femoral arteriography. Methods. A multicenter, double-blind, randomized, parallel-group clinical investigation was carried out in 54 hospitals in Europe. Of the patients evaluated, 1225 received iodixanol and 1227 iopromide in conventional and/or digital subtraction angiography. Results. The iodixanol group reported statistically significantly less injection-associated pain (0.9%) than the iopromide group (9.5%) (p<0.001). Further, 4.1% in the iodixanol group experienced pain and/or severe heat sensation vs 19.8% in the iopromide group (p<0.001). In the iodixanol group, 1.8% of the patients experienced contrast-related adverse events vs 2.4% in the iopromide group (p=NS). Overall diagnostic information was optimal for 94.1% in the iodixanol group and 95.3% in the iopromide group (p=NS). Conclusions. Iodixanol 270 mg I/ml causes significantly less injection-associated pain during femoral arteriography and is as safe and efficatious as iopromide 300 mg I/ml

  9. Results of a Multicenter, Randomized, Double-Masked, Placebo-Controlled Clinical Study of the Efficacy and Safety of Visomitin Eye Drops in Patients with Dry Eye Syndrome.

    Science.gov (United States)

    Brzheskiy, Vladimir V; Efimova, Elena L; Vorontsova, Tatiana N; Alekseev, Vladimir N; Gusarevich, Olga G; Shaidurova, Ksenia N; Ryabtseva, Alla A; Andryukhina, Olga M; Kamenskikh, Tatiana G; Sumarokova, Elena S; Miljudin, Eugeny S; Egorov, Eugeny A; Lebedev, Oleg I; Surov, Alexander V; Korol, Andrii R; Nasinnyk, Illia O; Bezditko, Pavel A; Muzhychuk, Olena P; Vygodin, Vladimir A; Yani, Elena V; Savchenko, Alla Y; Karger, Elena M; Fedorkin, Oleg N; Mironov, Alexander N; Ostapenko, Victoria; Popeko, Natalia A; Skulachev, Vladimir P; Skulachev, Maxim V

    2015-12-01

    This article presents the results of an international, multicenter, randomized, double-masked, placebo-controlled clinical study of Visomitin (Mitotech LLC, Moscow, Russian Federation) eye drops in patients with dry eye syndrome (DES). Visomitin is the first registered (in Russia) drug with a mitochondria-targeted antioxidant (SkQ1) as the active ingredient. In this multicenter (10 sites) study of 240 subjects with DES, study drug (Visomitin or placebo) was self-administered three times daily (TID) for 6 weeks, followed by a 6-week follow-up period. Seven in-office study visits occurred every 2 weeks during both the treatment and follow-up periods. Efficacy measures included Schirmer's test, tear break-up time, fluorescein staining, meniscus height, and visual acuity. Safety measures included adverse events, slit lamp biomicroscopy, tonometry, blood pressure, and heart rate. Tolerability was also evaluated. This clinical study showed the effectiveness of Visomitin eye drops in the treatment of signs and symptoms of DES compared with placebo. The study showed that a 6-week course of TID topical instillation of Visomitin significantly improved the functional state of the cornea; Visomitin increased tear film stability and reduced corneal damage. Significant reduction of dry eye symptoms (such as dryness, burning, grittiness, and blurred vision) was also observed. Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage. Mitotech LLC.

  10. The Erasme Study: A Multicenter Study on the Safety and Technical Results of the Palmaz Stent Used for the Treatment of Atherosclerotic Ostial Renal Artery Stenosis

    International Nuclear Information System (INIS)

    Bakker, Jeannette; Goffette, Pierre P.; Henry, Michel; Mali, Willem P.T.M.; Melki, Jean-Pierre; Moss, Jon G.; Rabbia, Claudio; Therasse, Eric; Thomson, Kenneth R.; Thurnher, Siegfried; Vignali, Claudio

    1999-01-01

    Purpose: To assess, in a multicenter setting, safety, technical results, and restenosis rate of the Palmaz stent for treatment of atherosclerotic ostial renal artery stenosis. Methods: Ten centers enrolled 106 patients (120 treated renal artery stenoses) in the study. Patient selection was based on unsuccessful percutaneous transluminal renal angioplasty (residual stenosis ≥ 20%) performed for treatment of ostial stenosis ≥ 50%, in patients with hypertension and/or impaired renal function. Safety was assessed by means of the complication rate, and technical results by the number of successful stent placements and occurrence of restenosis (>50%) at intraarterial angiographic follow-up. Results: Stent placement was successful (n = 112) or partially successful (n = 5) in 117 (98%) arteries. Complications occurred in 19 procedures; seven were of serious clinical significance. Angiographic follow-up was performed in 89 of 117 (76%) cases, at a mean of 8 months (range 2.5-18 months). Fifteen stents (16.9%) showed restenosis (at a mean of 8.5 months), of which 10 were successfully redilated. Conclusion: Renal artery stenting has a high technical success rate, a complication rate comparable to percutaneous transluminal renal angioplasty, and a low rate of restenosis at 8 months angiographic follow-up

  11. Safety and efficacy of thromboprophylaxis using enoxaparin sodium after cesarean section: A multi-center study in Japan

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    Maki Goto

    2015-06-01

    Conclusion: The current study demonstrates the safety and efficacy of enoxaparin for thromboprophylaxis after C/S. Further studies are required to determine the best method of preventing asymptomatic DVT.

  12. The effectiveness and safety of amisulpride in Chinese patients with schizophrenia: An 8‐week, prospective, open‐label, multicenter, single‐arm study

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    Liang, Ying; Cao, Changan; Zhu, Cheng; Wang, Chuanyue; Zhang, Congpei; Dong, Fang; Yang, Fude; Deng, Hong; Yu, Jingjie; Tang, Jisheng; Su, Lei; Xin, Limin; Hong, Ling; Gao, Minglong; Tang, Muni; Xie, Shiping; Lu, Shuiping; Liu, Tiebang; Xu, Xiaojin; Wang, Xijin; Li, Xuanzi; Wang, Xueyi; Li, Yi; Zhang, Yong; Chen, Zhiyu

    2016-01-01

    Abstract Introduction This study evaluated the effectiveness and safety of amisulpride in Chinese schizophrenia patients. Methods A multicenter, single‐arm Phase IV study (NCT01795183). Chinese patients with schizophrenia received amisulpride for 8 weeks. The primary endpoint was ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Results A total of 316 patients were enrolled; 295 were included in the effectiveness analysis; 66.8% (197/295) achieved ≥50% decrease in Positive and Negative Syndrome Scale total score from Baseline to Week 8. Nine patients discontinued treatment because of adverse events. Discussion Amisulpride had clinical effectiveness and was relatively well tolerated in Chinese patients with schizophrenia. PMID:27020720

  13. Efficacy and safety of long-acting pasireotide in Japanese patients with acromegaly or pituitary gigantism: results from a multicenter, open-label, randomized, phase 2 study.

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    Tahara, Shigeyuki; Murakami, Mami; Kaneko, Tomomi; Shimatsu, Akira

    2017-07-28

    A multicenter, open-label, phase 2 study was conducted to investigate the efficacy and safety of long-acting pasireotide formulation in Japanese patients with acromegaly or pituitary gigantism. Medically naïve or inadequately controlled patients (on somatostatin analogues or dopamine agonists) were included. Primary end point was the proportion of all patients who achieved biochemical control (mean growth hormone [GH] levelsacromegaly, n=32; pituitary gigantism, n=1) were enrolled and randomized 1:1:1 to receive open-label pasireotide 20mg, 40mg, or 60mg. The median age was 52 years (range, 31-79) and 20 patients were males. At month 3, 18.2% of patients (6/33; 90% confidence interval: 8.2%, 32.8%) had biochemical control (21.2% [7/33] when including a patient with mean GHacromegaly or pituitary gigantism.

  14. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study.

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    Donnenfeld, Eric D; Karpecki, Paul M; Majmudar, Parag A; Nichols, Kelly K; Raychaudhuri, Aparna; Roy, Monica; Semba, Charles P

    2016-06-01

    To evaluate the 1-year safety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease compared with placebo. SONATA (Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution) was a multicenter, randomized, prospective, double-masked, placebo-controlled phase 3 study (NCT01636206). Adults (≥18 years) with dry eye disease (Schirmer test score ≥1 and ≤10 mm; corneal staining score ≥2.0) were randomized 2:1 to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 360 days. The primary objective was percentage and severity of treatment-emergent adverse events (TEAEs). Secondary objectives were ocular safety measures: corneal fluorescein staining, drop comfort, best-corrected visual acuity, slit-lamp biomicroscopy, and intraocular pressure over 7 visits. Exploratory objectives included concentration of lifitegrast in plasma. The safety population comprised 331 participants (220 lifitegrast; 111 placebo). There were no serious ocular TEAEs. Overall, 53.6% of participants receiving lifitegrast experienced ≥1 ocular TEAE versus 34.2% in the placebo group; most TEAEs were mild to moderate in severity. Rates of discontinuation because of TEAEs were 12.3% (lifitegrast) versus 9.0% (placebo). The most common (>5%) TEAEs occurring in either treatment group were instillation site irritation (burning), instillation site reaction, visual acuity reduced, dry eye, and dysgeusia (change in taste). Ocular safety parameters for lifitegrast were similar to placebo. The mean plasma lifitegrast concentration at 360 days (n = 43) was below the limit of detection. There was no indication of systemic toxicity or localized infectious complications secondary to chronic immunosuppression. Lifitegrast ophthalmic solution 5.0% seemed safe and well tolerated in this study, with no unexpected adverse events.

  15. A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients.

    Science.gov (United States)

    Saito, Shuji; Yoshida, Shuntaro; Isayama, Hiroyuki; Matsuzawa, Takeaki; Kuwai, Toshio; Maetani, Iruru; Shimada, Mamoru; Yamada, Tomonori; Tomita, Masafumi; Koizumi, Koichi; Hirata, Nobuto; Kanazawa, Hideki; Enomoto, Toshiyuki; Sekido, Hitoshi; Saida, Yoshihisa

    2016-09-01

    Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study. Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery. A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively. This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute

  16. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI

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    Chuchalin Alexander

    2013-01-01

    Full Text Available Abstract Background Acute exacerbations of chronic bronchitis (AECB, including chronic obstructive pulmonary disease (AECOPD, represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox®, although moxifloxacin is widely approved in this region based on evidence from international clinical studies. Methods AVANTI (AVelox® in Acute Exacerbations of chroNic bronchiTIs was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected. Results In the efficacy population (N = 2536, chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I was 6.4 ± 1.9 days. Symptom improvement was reported after a mean of 3.4 ± 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672, 57 (2.3% patients had treatment-emergent adverse events (TEAEs and 4 (0.15% had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin. Conclusions A significant number of patients in this

  17. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study.

    Science.gov (United States)

    Nolan, Terry; Chotpitayasunondh, Tawee; Capeding, Maria Rosario; Carson, Simon; Senders, Shelly David; Jaehnig, Peter; de Rooij, Richard; Chandra, Richa

    2016-01-04

    Cell culture-derived inactivated influenza vaccines (TIVc) are necessary for scale and predictability of production to meet global demand. This study compared the safety and tolerability of TIVc with an egg-derived trivalent influenza vaccine (TIVf) in 4-17 yearolds. A Phase 3 observer blind, multicenter study enrolled 2055 healthy participants randomized 2:1 to receive either TIVc or TIVf, respectively (1372 TIVc and 683 TIVf evaluable subjects). Participants received one dose each on Days 1 and 28 (4-8 year-olds not previously vaccinated [NPV]) or one dose on Day 1 (4-8 and 9-17 yearolds previously vaccinated [PV]). Solicited adverse events (AEs) occurring within 7 days after each vaccination were assessed; participants were followed up for 6 months after their last dose for safety. Most solicited and unsolicited AEs were mild to moderate with vaccine-related SAEs were reported. TIVc and TIVf were similar in percentages of participants reporting solicited reactions in 4-8 years NPV group after the 1st dose: local reactions, TIVc: 48%, TIVf: 43%; systemic reactions, TIVc: 34%, TIVf: 32%; percentages were lower following the 2nd dose in TIVc; local reactions: TIVc: 40%; TIVf: 43%; systemic reactions: TIVc: 21%; TIVf: 22%. In 4-17 years PV group, solicited reactions were lower following TIVf, local reactions: TIVc: 53%; TIVf: 43%; systemic reactions: TIVc: 37%, TIVf: 30%. Injection-site pain was the most common solicited reaction, and was similar following TIVc and TIVf in 4-8 yearolds (TIVc: 56%; TIVf: 55%), and lower following TIVf in 9-17 years group (TIVc: 52%; TIVf: 42%). Reporting of unsolicited AEs was similar for TIVc and TIVf across the two age groups. TIVc was well tolerated and had a safety and reactogenicity profile similar to that of TIVf in healthy 4-17 yearolds (NCT01857206). Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. An Open-Label Uncontrolled, Multicenter Study for the Evaluation of the Efficacy and Safety of the Dermal Filler Princess VOLUME in the Treatment of Nasolabial Folds

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    Daisy Kopera

    2015-01-01

    Full Text Available The dermal filler Princess VOLUME is a highly cross-linked, viscoelastic hyaluronic acid injectable gel implant used for aesthetic treatment. To evaluate the efficacy and safety of Princess VOLUME in the treatment of nasolabial folds, an open-label uncontrolled, multicenter study was conducted. Forty-eight subjects were recruited who had moderate to deep wrinkles, according to the Modified Fitzpatrick Wrinkle Scale (MFWS. Subjects received Princess VOLUME in both nasolabial folds at Day 0. Nasolabial fold severity was evaluated at 30, 90, 180, and 270 days after treatment, using the MFWS and the Global Aesthetic Improvement Scale (GAIS. Adverse events and treatment site reactions were recorded. Among the 48 subjects, 93.8% were female with a median age of 52 years. There were significant improvements (P<0.0001 in the MFWS scores at 30, 180, and 270 days after treatment compared with those at baseline, with a mean decrease of 1.484 (±0.408, 1.309 (±0.373, and 1.223 (±0.401, respectively; hence the primary endpoint was achieved and clinical efficacy demonstrated. Princess VOLUME was well tolerated, and most adverse events were injection site reactions of mild to moderate severity. Subject satisfaction (97.9%, subject recommendation of the treatment (93.6%, and investigators GAIS scores (97.9% improvement were high.

  19. Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation.

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    Takahashi, Kota; Saito, Kazuhide; Takahara, Shiro; Fuchinoue, Shohei; Yagisawa, Takashi; Aikawa, Atsushi; Watarai, Yoshihiko; Yoshimura, Norio; Tanabe, Kazunari; Morozumi, Kunio; Shimazu, Motohide

    2017-08-01

    Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m 2 at day -14 and day -1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

  20. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study - Efficacy, safety, and pharmacokinetics

    NARCIS (Netherlands)

    Sparr, Harald J.; Vermeyen, Karel M.; Beaufort, Anton M.; Rietbergen, Henk; Proost, Johannes H.; Saldien, Vera; Velik-Salchner, Corinna; Wierda, J. Mark K. H.

    Background: Sugammadex reverses the neuromuscular blocking effects of rocuronium by chemical encapsulation. The efficacy, safety, and pharmacokinetics of sugammadex for reversal of profound rocuronium-induced neuromuscular blockade were evaluated. Methods: Ninety-eight male adult patients were

  1. A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

    Science.gov (United States)

    Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

    2018-04-01

    Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

  2. The effectiveness, safety, and economic evaluation of Korean medicine for unexplained infertile women: A multi-center, prospective, observational study protocol.

    Science.gov (United States)

    Kim, Su-Hyun; Jo, Junyoung; Kim, Dong-Il

    2017-12-01

    Infertility is a condition in which a woman has not been pregnant despite having had normal intercourse for 1 year. The number of unexplained infertile females is increasing because of late marriage customs, as well as environmental and lifestyle habits. In Korea, infertile females have been treated with Korean medicine (KM). However, these effects have not been objectively confirmed through clinical trials. Therefore, this study was conducted to demonstrate the effectiveness of herbal medicine treatment in infertile patients and to demonstrate the economic feasibility through economical evaluation with assisted reproductive technology.This study is designed as a multicenter, single-arm clinical trial. All participants included will be from 3 Korean Medicine hospitals in Korea and will voluntarily sign an informed consent agreement. All recruited patients will conduct related surveys and tests, and be provided with treatment according to their menstrual cycle. Patients will take herbal medicines for 4 menstruation cycles and receive acupuncture and moxibustion treatment at 3 times (menstrual cycle day 3, 8, 14) during 4 menstruation cycles. They will also undergo an approximately 4 menstrual cycle treatment period, and 3 menstrual cycle observation period. If pregnant during the study, participants will take the herbal medicine for implantation for about 15 days. In this study, the primary outcome will be the clinical pregnancy rate, whereas the secondary outcome will include the implantation rate, ongoing pregnancy rate, and live birth rate.Ultimately, this study will provide clinical data regarding the effectiveness and safety of KM treatment for females with unexplained infertility and important evidence for establishing standard KM treatments for unexplained infertility. Moreover, we will identify the most cost-effective way to treat unexplained infertility. Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002235. Date: February 21, 2017

  3. The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease.

    Science.gov (United States)

    van der Linden, Michelle; Meeuwis, Kim; van Hees, Colette; van Dorst, Eleonora; Bulten, Johan; Bosse, Tjalling; IntHout, Joanna; Boll, Dorry; Slangen, Brigitte; van Seters, Manon; van Beurden, Marc; van Poelgeest, Mariëtte; de Hullu, Joanne

    2017-09-06

    Vulvar Paget disease is a rare skin disorder, which is most common in postmenopausal Caucasian women. They usually present with an erythematous plaque that may show fine or typical "cake icing" scaling or ulceration that may cause itching, pain, irritation, or a burning sensation. Although most cases are noninvasive, vulvar Paget disease may be invasive or associated with an underlying vulvar or distant adenocarcinoma. The histological evidence of so-called "Paget cells" with abundant pale cytoplasm in the epithelium confirms the diagnosis. The origin of these Paget cells is still unclear. Treatment of choice is wide local excision with negative margins. Obtaining clear surgical margins is challenging and may lead to extensive and mutilating surgery. Even then, recurrence rates are high, ranging from 15% to 70%, which emphasizes the need for new treatment options. A number of case reports, retrospective case series, and one observational study have shown promising results using the topical immune response modifier imiquimod. This study aims to investigate the efficacy, safety, and immunological response in patients with noninvasive vulvar Paget disease using a standardized treatment schedule with 5% imiquimod cream. Topical 5% imiquimod cream might be an effective and safe treatment alternative for vulvar Paget disease. The Paget Trial is a multicenter observational cohort study including eight tertiary referral hospitals in the Netherlands. It is ethically approved by the Medical-Ethical Committee of Arnhem-Nijmegen and registered in the Central Committee on Research Involving Human Subjects (CCMO) Register by as NL51648.091.14. Twenty patients with (recurrent) noninvasive vulvar Paget disease will be treated with topical 5% imiquimod cream three times a week for 16 weeks. The primary efficacy outcome is the reduction in lesion size at 12 weeks after end of treatment. Secondary outcomes are safety, immunological response, and quality of life. Safety will be

  4. [The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study].

    Science.gov (United States)

    Rafal'skiĭ, V V; Dovgan', E V; Kozyrev, Iu V; Gustovarova, T A; Khlybova, S V; Novoselova, A V; Filippenko, N G; Likhikh, D G

    2013-01-01

    The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25.2 +/- 6.6; in group 2--26.6 +/- 5.8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94.8 and 92.7% of women treated with cefixime, and in 98.2 and 92.5% of women treated with amoxicillin/clavulanate, respectively (P > 0.05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1.7; respectively; P = 0.02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

  5. Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients.

    Science.gov (United States)

    Lee, Kyung Hee; Kim, Min Kyoung; Hyun, Myung Soo; Kim, Jin Young; Park, Keon Uk; Song, Hong Suk; Lee, Sun Ah; Lee, Won Sik; Bae, Sung Hwa; Ryoo, Hun Mo; Cho, Yoon Young

    2012-01-01

    To evaluate the effectiveness of OROS® hydromorphone in reducing breakthrough pain (BTP) medication frequency in Korean patients with chronic cancer pain. Multicenter, prospective, open-label, phase IV study. Patients with chronic malignant pain using immediate-release oxycodone more than two times per day for BTP. Patients were stabilized on their ongoing drug for 3 days immediately before baseline measurements (day 0). Medication was changed to OROS® hydromorphone at a dose equianalgesic to oxycodone using a 2.5:1 controlled-release oxycodone to hydromorphone hydrochloride conversion ratio; the patients were observed for 7 days. Dose was titrated, if required, and the patients were observed for another 7 days. Effectiveness and safety parameters were measured at baseline, day 7, and day 14. BTP medication frequency on days 7 and 14, compared to baseline. Of the 141 patients screened, 114 received study drug and 98 completed the study. Compared to day 0, daily BTP medication frequency on day 14 decreased from 2.93 to 2.00 (p > 0.0001), daily BTP frequency decreased from 3.67 to 2.44 (p > 0.0001), and end-of-dose pain frequency decreased by 44 percent. Pain was controlled adequately during daytime and night-time. Pain intensity decreased by 11 percent as assessed using the Korean Brief Pain Inventory and by 17 percent as assessed using the numerical rating scale. About 61.2 percent patients and 60.2 percent physicians were satisfied with the treatment. Common adverse events, which occurred in 91.2 percent patients, were constipation, somnolence, and dizziness. Once-daily OROS® hydromorphone is efficient in the reduction of cancer pain-related BTP episodes, including end-of-dose pain.

  6. Original Paper Multicenter study on antibiotic susceptibility ...

    African Journals Online (AJOL)

    Multicenter study on antibiotic susceptibility/resistance trends in the western region of Cameroon ... antibiotic era, IDs used to be serious threats because of lack or insufficient ...... antimicrobial use in livestock; AMR. Control., 116-122. Vandini ...

  7. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study.

    Science.gov (United States)

    Karpecki, Paul; Depaolis, Michael; Hunter, Judy A; White, Eric M; Rigel, Lee; Brunner, Lynne S; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

    2009-03-01

    Besifloxacin ophthalmic suspension 0.6% is a new topical fluoroquinolone for the treatment of bacterial conjunctivitis. Besifloxacin has potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. The primary objective of this study was to compare the clinical and microbiologic efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle (the formulation without besifloxacin) in the treatment of bacterial conjunctivitis. This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study in patients with acute bacterial conjunctivitis. Patients received either topical besifloxacin ophthalmic suspension or vehicle administered 3 times daily for 5 days. At study entry and on days 4 and 8 (visits 2 and 3), a clinical assessment of ocular signs and symptoms was performed in both eyes, as well as pinhole visual acuity testing, biomicroscopy, and culture of the infected eye(s). An ophthalmoscopic examination was performed at study entry and on day 8. The primary efficacy outcome measures were clinical resolution and eradication of the baseline bacterial infection on day 8 in culture-confirmed patients. The safety evaluation included adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings in all patients who received at least 1 dose of active treatment or vehicle. The safety population consisted of 269 patients (mean [SD] age, 34.2 [22.3] years; 60.2% female; 82.5% white) with acute bacterial conjunctivitis. The culture-confirmed intent-to-treat population consisted of 118 patients (60 besifloxacin ophthalmic suspension, 58 vehicle). Significantly more patients receiving besifloxacin ophthalmic suspension than vehicle had clinical resolution of the baseline infection at visit 3 (44/60 [73.3%] vs 25/58 [43.1%], respectively; P suspension compared with vehicle at visit 3 (53/60 [88.3%] vs35/58 [60.3%]; P suspension 0.6% given 3 times daily for 5 days

  8. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study

    Directory of Open Access Journals (Sweden)

    Kuptniratsaikul V

    2014-03-01

    Full Text Available Vilai Kuptniratsaikul,1 Piyapat Dajpratham,1 Wirat Taechaarpornkul,2 Montana Buntragulpoontawee,3 Pranee Lukkanapichonchut,4 Chirawan Chootip,5 Jittima Saengsuwan,6 Kesthamrong Tantayakom,7 Supphalak Laongpech8 1Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; 2Sirindhorn National Medical Rehabilitation Center, Ministry of Public Health, Nonthaburi, Thailand; 3Department of Rehabilitation Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; 4Department of Rehabilitation Medicine, Ratchaburi Hospital, Ministry of Public Health, Ratchaburi, Thailand; 5Department of Rehabilitation Medicine, Songkhla Hospital, Ministry of Public Health, Songkhla, Thailand; 6Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 7Department of Rehabilitation Medicine, Rajvithi Hospital, Ministry of Public Health, Bangkok, Thailand; 8Department of Rehabilitation Medicine, Vachira Phuket Hospital, Ministry of Public Health, Phuket, Thailand Objective: To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement. Methods: 367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks. The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC total, WOMAC pain, WOMAC stiffness, and WOMAC function scores. Adverse events (AEs were also recorded. Results: 185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups, respectively. The baseline characteristics were no different between groups. The mean of all WOMAC scores at weeks 0, 2, and 4 showed significant improvement when compared with the baseline in both groups. After using the noninferiority test, the mean difference (95% confidence interval of WOMAC total

  9. Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study

    Science.gov (United States)

    Kuptniratsaikul, Vilai; Dajpratham, Piyapat; Taechaarpornkul, Wirat; Buntragulpoontawee, Montana; Lukkanapichonchut, Pranee; Chootip, Chirawan; Saengsuwan, Jittima; Tantayakom, Kesthamrong; Laongpech, Supphalak

    2014-01-01

    Objective To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement. Methods 367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks. The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, WOMAC pain, WOMAC stiffness, and WOMAC function scores. Adverse events (AEs) were also recorded. Results 185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups, respectively. The baseline characteristics were no different between groups. The mean of all WOMAC scores at weeks 0, 2, and 4 showed significant improvement when compared with the baseline in both groups. After using the noninferiority test, the mean difference (95% confidence interval) of WOMAC total, WOMAC pain, and WOMAC function scores at week 4 adjusted by values at week 0 of C. domestica extracts were noninferior to those for the ibuprofen group (P=0.010, P=0.018, and P=0.010, respectively), except for the WOMAC stiffness subscale, which showed a trend toward significance (P=0.060). The number of patients who developed AEs was no different between groups. However, the number of events of abdominal pain/discomfort was significantly higher in the ibuprofen group than that in the C. domestica extracts group (P=0.046). Most subjects (96%–97%) were satisfied with the treatment, and two-thirds rated themselves as improved in a global assessment. Conclusion C. domestica extracts are as effective as ibuprofen for the treatment of knee osteoarthritis. The side effect profile was similar but with fewer gastrointestinal AE reports in the C. domestica extracts group. PMID:24672232

  10. The efficiency and safety of tocilizumab in rheumatoid arthritis(intermediate results of a Russian multicenter study

    Directory of Open Access Journals (Sweden)

    E L Nasonov

    2010-01-01

    Thus, preliminary analysis of the data of the Russian study strongly suggests that TCZ is effective in severe RA resistant to therapy with DMARDs, primarily MT. TCZ therapy makes it possible to achieve a very rapid reduction in the clinical and laboratory activity of the disease and to substantially enhance the functional activity and quality of life of patients.

  11. Efficacy and safety of eslicarbazepine acetate monotherapy for partial-onset seizures: Experience from a multicenter, observational study.

    Science.gov (United States)

    Toledano, Rafael; Jovel, Camilo Espinosa; Jiménez-Huete, Adolfo; Bayarri, Pau Giner; Campos, Dulce; Gomariz, Elena López; Giráldez, Beatriz González; García-Morales, Irene; Falip, Mercé; Agredano, Paula Martínez; Palao, Susana; Prior, María José Aguilar Amat; Pascual, María Rosa Querol; Navacerrada, Francisco José; González, Francisco Javier López; Ojeda, Joaquín; Sáez, Aránzazu Alfaro; Bermejo, Pedro Emilio; Gil-Nagel, Antonio

    2017-08-01

    Eslicarbazepine acetate (ESL, Aptiom™) is a once-daily anticonvulsant, approved as adjunctive treatment of partial-onset seizures (POS). Historical-controlled trials investigating the use of ESL as monotherapy have demonstrated a favorable efficacy and tolerability profile in patients with POS. This prospective, non-interventional study recruited POS patients in 17 hospitals in Spain. After a 3-month baseline period, ESL therapy was initiated as 400mg QD and up-titrated to an optimal maintenance dose based on clinical response and tolerance. The incidence of seizures was assessed via seizure calendars and the nature and severity of adverse events (AEs) were also recorded. A total of 117 patients (aged 9-87years) enrolled in the study and were treated with ESL at either 400mg/day (3.4% patients), 800mg/day (61% patients), 1200mg/day (27.1% patients) or 1600mg/day (8.5% patients). At 3months, 82.0% (n=72) of patients achieved a ≥50% reduction in seizure frequency, compared to 79.7% (n=67) of patients at 6months and 83.0% (n=49) at 12months. Patients who suffered secondary generalized tonic-clonic (SGTC) seizures had seizure-free rates of 71% (n=27), 69.6% (n=29), and 72.7% (n=16) at 3, 6, and 12months, respectively. Overall, 18 patients (15.3%) reported AEs of instability and dizziness (n=9), somnolence (n=3), mild hyponatremia (n=3), headache (n=1), hypertriglyceridemia (n=1), and allergic reaction (n=1), which caused ESL discontinuation of ESL treatment. ESL is effective and well tolerated as monotherapy for patients with POS, which supports previous findings. Early use is supported by its frequent use as monotherapy in this study and lack of severe side effects. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. A multicenter, open-label study of the efficacy and safety of telmisartan in mild to moderate hypertensive patients

    Directory of Open Access Journals (Sweden)

    Plavnik Frida Liane

    2002-01-01

    Full Text Available OBJECTIVE: To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM. METHODS: Initially, 163 patients over 18 were selected, regardless of sex, with blood pressure levels >140/90mmHg at visit 1, which was confirmed at visit 2. One hundred thirty-four patients completed the study. After a 4-week placebo run-in phase, telmisartan 40mg/daily was given for 6 weeks. In those patients whose blood pressure (BP levels were lower than 140/90mmHg, the same dosage was kept for an additional period of 6 weeks. For those who had BP higher than 140/90mmHg, the dosage was increased to 80mg/daily. Sixty-two patients were included in a subgroup that underwent ABPM 3 different times during the study. RESULTS: In the overall group, blood pressure reduction ranged from 162.3±14.5/101.3±5.75 mmHg (baseline to 147.3±20.1/90.8±10.9 mmHg (week 12 (p<0.05. Mean blood pressure decreases were 14.4mmHg for systolic BP and 10.3mmHg for diastolic BP, after 12 weeks of active treatment. A subanalysis showed that 47 (35% patients took telmisartan 40mg throughout the study and 81 (65% had the dosage increased to 80mg daily. Using ABPM, an 8-mmHg reduction in systolic BP as well as a 5-mmHg reduction in diastolic BP were observed, when compared with baseline values in the final 6 hours (18-24 hours after the last dose of study medication. CONCLUSION: Our results confirm that telmisartan given once a day is effective in reducing blood pressure levels in mild to moderate hypertensive patients. This reduction occurs in a sustained and gradual manner during a 24-hour period confirmed by ABPM.

  13. Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

    Directory of Open Access Journals (Sweden)

    Momoeda M

    2017-05-01

    Full Text Available Mikio Momoeda,1 Masami Kondo,2 Joerg Elliesen,3 Masanobu Yasuda,2 Shigetomo Yamamoto,4 Tasuku Harada5 1Department of Integrated Women’s Health, St Luke’s International Hospital, Tokyo, 2Product Development, Bayer Yakuhin Ltd, Osaka, Japan; 3Global Clinical Development, Bayer AG, Berlin, Germany; 4Medical Affairs, Bayer Yakuhin Ltd, Osaka, 5Department of Obstetrics and Gynecology, Tottori University Faculty of Medicine, Tottori, Japan Background: Dysmenorrhea is a common condition in women, which is characterized by menstrual pain. Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms, and a 28-day cyclic regimen of ethinylestradiol/drospirenone (28d regimen is approved for this indication in Japan. Aim: The aim of this study was to assess the safety and efficacy of a flexible extended regimen of ethinylestradiol/drospirenone (flexible regimen in Japanese women with dysmenorrhea. Methods: This multicenter, open-label study was performed in Japanese women with dysmenorrhea who, after a baseline observational phase, were randomized to receive ethinylestradiol 20 µg/drospirenone 3 mg in a flexible regimen (one tablet each day for 24–120 days followed by a 4-day tablet-free interval or in the standard 28d regimen (one tablet each day for 24 days, followed by 4 days of placebo tablets for six cycles. The primary endpoint was the number of days with dysmenorrhea of at least mild intensity over a 140-day evaluation period. Dysmenorrhea scores, bleeding patterns, and other pain-related parameters were also assessed. Results: A total of 216 women (mean age 29.7 years were randomized to the flexible regimen (n=108 or 28d regimen (n=108 and 212 were included in the full analysis sets (flexible regimen, n=105; 28d regimen, n=107. Women in the flexible-regimen group reported a mean of 3.4 fewer days with dysmenorrheic pain than women in the 28d-regimen group, with similar decreases in

  14. Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in 1130 children: results of an European prospective multicenter observational postauthorization safety study (PASS)

    NARCIS (Netherlands)

    Sümpelmann, Robert; Kretz, Franz-Josef; Luntzer, Robert; de Leeuw, Thomas G.; Mixa, Vladimir; Gäbler, Ralf; Eich, Christoph; Hollmann, Markus W.; Osthaus, Wilhelm A.

    2012-01-01

    Introduction: Third-generation hydroxyethyl starch (HES) is now approved also for the use in children, but safety studies including large numbers of pediatric patients are still missing. Therefore, we performed an European multicentric prospective observational postauthorization safety study (PASS)

  15. Pharmacokinetics, safety, and tolerability of varenicline in healthy adolescent smokers: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

    Science.gov (United States)

    Faessel, Helene; Ravva, Patanjali; Williams, Kathryn

    2009-01-01

    Varenicline is approved as an aid to smoking cessation in adults aged > or =18 years. The goal of this study was to characterize the multiple-dose pharmacokinetics, safety, and tolerability of varenicline in adolescent smokers. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled healthy 12- to 16-year-old smokers (> or =3 cigarettes daily) into high-body-weight (>55 kg) and low-body-weight (daily. The apparent renal clearance (CL/F) and volume of distribution (V/F) of varenicline and the effect of body weight on these parameters were estimated using nonlinear mixed-effects modeling. The high-body-weight group consisted of 35 subjects (65.7% male; 77.1% white; mean age, 15.2 years). The low-body-weight group consisted of 37 subjects (37.8% male; 48.6% white; mean age, 14.3 years). The pharmacokinetic parameters of varenicline were dose proportional over the dose range from 0.5 to 2 mg/d. The CL/F for a 70-kg adolescent was 10.4 L/h, comparable to that in a 70-kg adult. The estimated varenicline V/F was decreased in individuals of small body size, thus predicting a varenicline C(max) approximately 30% greater in low-body-weight subjects than in high-body-weight subjects. In high-body-weight subjects, steady-state varenicline exposure, as represented by the AUC(0-24), was 197.0 ng . h/mL for varenicline 1 mg BID and 95.7 ng . h/mL for varenicline 0.5 mg BID, consistent with values reported previously in adult smokers at the equivalent doses. In low-body-weight subjects, varenicline exposure was 126.3 ng . h/mL for varenicline 0.5 mg BID and 60.1 ng . h/mL for varenicline 0.5 mg once daily, values at the lower end of the range observed previously in adults at doses of 1 mg BID and 0.5 mg BID, respectively. Among high-body-weight subjects, adverse events (AEs) were reported by 57.1% of subjects in both the high- and low-dose varenicline groups and by 14.3% of subjects in the placebo group; among low-body-weight subjects, AEs

  16. Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Seungwon Shin

    2016-01-01

    Full Text Available This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

  17. Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.

    Science.gov (United States)

    Davis, Thomas; Ramaiah, Venkatesh; Niazi, Khusrow; Martin Gissler, Hans; Crabtree, Tami

    2017-12-01

    Objectives To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions. Methods This prospective, multicenter, nonrandomized investigational device exemption trial was conducted across 16 US and German centers between August 2010 and April 2013. Intention-to-treat enrollment was 128 patients (mean age: 71.8 years, 59% male) with 149 lesions (mean length: 34 mm, mean diameter stenosis: 89.5%), and the primary analysis per-protocol population consisted of 105 patients with 123 lesions. The primary efficacy endpoint, technical success, was the achievement of acute debulking with a post-atherectomy residual diameter stenosis ≤50% (before adjunctive therapy). The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Results For the primary analysis per-protocol population, the rate of lesion technical success was 95.1% (117/123), with the lower limit of the 95% CI 90.6%, meeting the prospectively established target performance goal of ≥86%. After post-atherectomy adjunctive therapy, residual stenosis was ≤30% for 99.2% (122/123) of lesions (mean final diameter stenosis 10.5%). Improvement of ≥1 Rutherford class occurred for 74.5% of patients through 30 days and for 80% through six months. MAEs were experienced by 5.7% (6/105) of patients through 30 days (with the upper limit of the 95% CI 11.0%, meeting the target performance goal of Atherectomy System is safe and effective for the debulking of lower-extremity arterial lesions. ClinicalTrials.gov identifier NCT01541774.

  18. A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

    Science.gov (United States)

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  19. A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study: Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

    Directory of Open Access Journals (Sweden)

    Seungwon Shin

    2017-01-01

    Full Text Available This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD, in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere’s disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale and frequency of dizziness, balance function (Berg Balance Scale, fatigue (Fatigue Severity Scale and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire levels, and depression (Korean version of Beck’s Depression Inventory and anxiety (State-Trait Anxiety Inventory levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions’ questionnaire and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided. This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017.

  20. Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study.

    NARCIS (Netherlands)

    Boer, H.D. de; Driessen, J.J.; Marcus, M.A.; Kerkkamp, H.E.M.; Heeringa, M.; Klimek, M.

    2007-01-01

    BACKGROUND: Reversal of rocuronium-induced neuromuscular blockade can be accomplished by chemical encapsulation of rocuronium by sugammadex, a modified gamma-cyclodextrin derivative. This study investigated the efficacy and safety of sugammadex in reversing rocuronium-induced profound neuromuscular

  1. Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp.

    Science.gov (United States)

    Buechner, Stanislaw A

    2014-06-01

    This study investigated the non-inferiority of efficacy and tolerance of 2% miconazole nitrate shampoo in comparison with 2% ketoconazole shampoo in the treatment of scalp seborrheic dermatitis. A randomized, double-blind, comparative, parallel group, multicenter study was done. A total of 274 patients (145 miconazole, 129 ketoconazole) were enrolled. Treatment was twice-weekly for 4 weeks. Safety and efficacy assessments were made at baseline and at weeks 2 and 4. Assessments included symptoms of erythema, itching, scaling ['Symptom Scale of Seborrhoeic Dermatitis' (SSSD)], disease severity and global change [Clinical Global Impressions (CGIs) and Patient Global Impressions (PGIs)]. Miconazole shampoo is at least as effective and safe as ketoconazole shampoo in treating scalp seborrheic dermatitis scalp.

  2. Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study.

    Science.gov (United States)

    Fleseriu, Maria; Rusch, Elisha; Geer, Eliza B

    2017-01-01

    Pasireotide long-acting release is a somatostatin analog that is indicated for treatment of patients with acromegaly. This analysis documents the safety of pasireotide long-acting release in patients with acromegaly enrolled in the ACCESS trial (ClinicalTrials.gov identifier: NCT01995734). ACCESS is an open-label, multicenter, single-arm, expanded-treatment protocol designed to provide patients access to pasireotide long-acting release pending regulatory approval. Patients received pasireotide long-acting release 40 mg administered intramuscularly every 28 days. The primary outcome was the proportion of patients having a treatment-emergent grade ≥3 or serious adverse event. Efficacy data were not collected. Forty-four adult patients with active acromegaly were enrolled in the study for an average of 37.6 weeks (range, 4-70 weeks). Twenty-five grade ≥3 treatment-emergent adverse events were reported in 11 patients (25.0 %), 3 of whom (27.3 %) experienced grade ≥3 hyperglycemia. In patients treated with pasireotide long-acting release for ≥3 months (n = 42), mean glycated hemoglobin and fasting plasma glucose levels increased significantly from 5.9 % and 100.4 mg/dL at baseline to 6.8 % and 135.9 mg/dL at 3 months, respectively. Ten patients (22.7 %) were treated with pasireotide long-acting release for ≥15 months, after which mean glycated hemoglobin and fasting plasma glucose levels were 6.3 % and 123 mg/dL, respectively. Twenty-one patients (48 %) initiated antidiabetic medication. Grade ≥3 adverse events (primary outcome) were reported in 25.0 % of acromegaly patients treated with pasireotide long-acting release in a clinical setting. Hyperglycemia-related adverse events were reported in 45.5 % of patients, but were typically manageable, supporting the role of pasireotide long-acting release as a safe treatment option for acromegaly patients.

  3. The expert meeting dedicated to the discussion of results of a local open-label multicenter observational study of the efficiency and safety of tofacitinib in patients with active rheumatoid arthritis with the inefficiency of disease-modifying antirheumatic drugs and to the elaboration of recommendations for the use for tofacitinib in the therapy of rheumatoid arthritis

    Directory of Open Access Journals (Sweden)

    2016-01-01

    Full Text Available The expert meeting dedicated to the discussion of results of a local open-label multicenter observational study of the efficiency and safety of tofacitinib in patients with active rheumatoid arthritis with the inefficiency of disease-modifying antirheumatic drugs and to the elaboration of recommendations for the use for tofacitinib in the therapy of rheumatoid arthritis.

  4. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study

    DEFF Research Database (Denmark)

    Massin, Pascale; Bandello, Francesco; Garweg, Justus G

    2010-01-01

    The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center.......The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center....

  5. Oral cancer: A multicenter study

    Science.gov (United States)

    Rojanawatsirivej, Somsri; Thosaporn, Watcharaporn; Kintarak, Sompid; Subarnbhesaj, Ajiravudh; Darling, Mark; Kryshtalskyj, Eugene; Chiang, Chun-Pin; Shin, Hong-In; Choi, So-Young; Lee, Sang-shin; Shakib, Pouyan-Amini

    2018-01-01

    Background To determine the prevalence and clinicopathologic features of the oral cancer patients. Material and Methods Biopsy records of the participating institutions were reviewed for oral cancer cases diagnosed from 2005 to 2014. Demographic data and site of the lesions were collected. Sites of the lesion were subdivided into lip, tongue, floor of the mouth, gingiva, alveolar mucosa, palate, buccal/labial mucosa, maxilla and mandible. Oral cancer was subdivided into 7 categories: epithelial tumors, salivary gland tumors, hematologic tumors, bone tumors, mesenchymal tumors, odontogenic tumors, and others. Data were analyzed by descriptive statistics using SPSS software version 17.0. Results Of the 474,851 accessioned cases, 6,151 cases (1.30%) were diagnosed in the category of oral cancer. The mean age of the patients was 58.37±15.77 years. A total of 4,238 cases (68.90%) were diagnosed in males, whereas 1911 cases (31.07%) were diagnosed in females. The male-to-female ratio was 2.22:1. The sites of predilection for oral cancer were tongue, labial/buccal mucosa, gingiva, palate, and alveolar mucosa, respectively. The three most common oral cancer in the descending order of frequency were squamous cell carcinoma, non-Hodgkin lymphoma and mucoepidermoid carcinoma. Conclusions Although the prevalence of oral cancer is not high compared to other entities, oral cancer pose significant mortality and morbidity in the patients, especially when discovered late in the course of the disease. This study highlights some anatomical locations where oral cancers are frequently encountered. As a result, clinicians should pay attention to not only teeth, but oral mucosa especially in the high prevalence area as well since early detection of precancerous lesions or cancers in the early stage increase the chance of patient being cured and greatly reduce the mortality and morbidity. This study also shows some differences between pediatric and elderly oral cancer patients as well as

  6. Oral cancer: A multicenter study.

    Science.gov (United States)

    Dhanuthai, K; Rojanawatsirivej, S; Thosaporn, W; Kintarak, S; Subarnbhesaj, A; Darling, M; Kryshtalskyj, E; Chiang, C-P; Shin, H-I; Choi, S-Y; Lee, S-S; Aminishakib, P

    2018-01-01

    To determine the prevalence and clinicopathologic features of the oral cancer patients. Biopsy records of the participating institutions were reviewed for oral cancer cases diagnosed from 2005 to 2014. Demographic data and site of the lesions were collected. Sites of the lesion were subdivided into lip, tongue, floor of the mouth, gingiva, alveolar mucosa, palate, buccal/labial mucosa, maxilla and mandible. Oral cancer was subdivided into 7 categories: epithelial tumors, salivary gland tumors, hematologic tumors, bone tumors, mesenchymal tumors, odontogenic tumors, and others. Data were analyzed by descriptive statistics using SPSS software version 17.0. Of the 474,851 accessioned cases, 6,151 cases (1.30%) were diagnosed in the category of oral cancer. The mean age of the patients was 58.37±15.77 years. A total of 4,238 cases (68.90%) were diagnosed in males, whereas 1911 cases (31.07%) were diagnosed in females. The male-to-female ratio was 2.22:1. The sites of predilection for oral cancer were tongue, labial/buccal mucosa, gingiva, palate, and alveolar mucosa, respectively. The three most common oral cancer in the descending order of frequency were squamous cell carcinoma, non-Hodgkin lymphoma and mucoepidermoid carcinoma. Although the prevalence of oral cancer is not high compared to other entities, oral cancer pose significant mortality and morbidity in the patients, especially when discovered late in the course of the disease. This study highlights some anatomical locations where oral cancers are frequently encountered. As a result, clinicians should pay attention to not only teeth, but oral mucosa especially in the high prevalence area as well since early detection of precancerous lesions or cancers in the early stage increase the chance of patient being cured and greatly reduce the mortality and morbidity. This study also shows some differences between pediatric and elderly oral cancer patients as well as between Asian and non-Asian oral cancer patients.

  7. [Multicenter paragliding accident study 1990].

    Science.gov (United States)

    Lautenschlager, S; Karli, U; Matter, P

    1992-01-01

    During the period from 1.1.90 until 31.12.90, 86 injuries associated with paragliding were analyzed in a prospective study in 12 different Swiss hospitals with reference to causes, patterns, and frequencies. The injuries showed a mean score of over 2 and were classified as severe. Most frequent spine injuries (36%) and lesions of the lower extremity (35%) with a high risk of the ankles were diagnosed. One accident was fatal. 60% of the accidents happened during landing, 26% during launching and 14% during flight. Half of the pilots were affected during their primary training course. Most accidents were caused by inflight error of judgement--especially incorrect estimation of wind conditions--and further the choice of unfavourable landing sites. In contrast to previous injury-reports, only one equipment failure could be noted, but often the equipment was not corresponding with the experience and the weight of the pilot. To reduce the frequency of paragliding-injuries an accurate choice of equipment and an increased attention to environmental factors is mandatory. Furthermore an education-program regarding the attitude and intelligence of the pilot should be included in training courses.

  8. Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study.

    Science.gov (United States)

    Brunori, Giuliano; Viola, Battista F; Parrinello, Giovanni; De Biase, Vincenzo; Como, Giovanna; Franco, Vincenzo; Garibotto, Giacomo; Zubani, Roberto; Cancarini, Giovanni C

    2007-05-01

    A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. Mortality, hospitalization, and metabolic markers. 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

  9. An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence

    DEFF Research Database (Denmark)

    Lose, Gunnar; Sørensen, Helle Christina; Axelsen, Susanne Maigaard

    2010-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence.......Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence....

  10. Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study.

    Science.gov (United States)

    Olde Rikkert, Marcel G M; Verhey, Frans R; Blesa, Rafael; von Arnim, Christine A F; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F J; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J G H; Scheltens, Philip

    2015-01-01

    The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.

  11. Coordination of international multicenter studies: governance and administrative structure

    Directory of Open Access Journals (Sweden)

    Bangdiwala Shrikant I.

    2003-01-01

    Full Text Available A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. The organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented. The elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration. The experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (WorldSAFE, illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators.

  12. Open-label, randomized, multicenter, phase III study to evaluate the safety and efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris: A secondary publication.

    Science.gov (United States)

    Kawashima, Makoto; Nagare, Toshitaka; Katsuramaki, Tsuneo

    2017-06-01

    An open-label, randomized, multicenter study was conducted to evaluate the safety and efficacy of long-term use of 2.5% and 5% benzoyl peroxide (BPO) gels administrated once daily for 52 weeks to Japanese patients with acne vulgaris. The efficacy of the study drugs was evaluated by counting inflammatory lesions and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. In total, 458 subjects were included in the efficacy and safety analyses. The total lesion count, the efficacy end-point, was similarly changed both in the 2.5% and 5% BPO groups over the course of the study. The median rates of reduction from baseline to week 12 were approximately 65%. Thereafter, the counts were maintained at a reduced level without increasing until week 52. The median rates at week 52 were approximately 80%. Similar trends were observed for inflammatory and non-inflammatory lesion counts. Bacteriological evaluation indicated similar distribution of the minimum inhibitory concentration of each of the antibacterial drugs against Propionibacterium acnes between the values at baseline and at week 52, suggesting that long-term use did not result in changes in the drug sensitivity. The incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5% BPO group. Many of the adverse events occurred within the first month and were mild or moderate in severity and transient. The results suggest that both 2.5% and 5% BPO gels are effective and safe for long-term treatment of patients with acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

  13. A multicenter study on Leigh syndrome

    DEFF Research Database (Denmark)

    Sofou, Kalliopi; De Coo, Irenaeus F M; Isohanni, Pirjo

    2014-01-01

    BACKGROUND: Leigh syndrome is a progressive neurodegenerative disorder, associated with primary or secondary dysfunction of the mitochondrial oxidative phosphorylation. Despite the fact that Leigh syndrome is the most common phenotype of mitochondrial disorders in children, longitudinal natural...... history data is missing. This study was undertaken to assess the phenotypic and genotypic spectrum of patients with Leigh syndrome, characterise the clinical course and identify predictors of survival in a large cohort of patients. METHODS: This is a retrospective study of patients with Leigh syndrome...... to thrive, brainstem lesions on neuroimaging and intensive care treatment were significantly associated with poorer survival. CONCLUSIONS: This is a multicenter study performed in a large cohort of patients with Leigh syndrome. Our data help define the natural history of Leigh syndrome and identify novel...

  14. A single-arm, multicenter, safety-monitoring, phase IV study of icotinib in treating advanced non-small cell lung cancer (NSCLC).

    Science.gov (United States)

    Hu, Xingsheng; Han, Baohui; Gu, Aiqin; Zhang, Yiping; Jiao, Shun Chang; Wang, Chang-Li; He, Jintao; Jia, Xueke; Zhang, Li; Peng, Jiewen; Wu, Meina; Ying, Kejing; Wang, Junye; Ma, Kewei; Zhang, Shucai; You, Changxuan; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

    2014-11-01

    The phase 3 ICOGEN trial established the non-inferiority of icotinib to gefitinib in terms of progression-free survival (PFS) in non-small cell lung cancer (NSCLC) patients, and this led to the approval of icotinib for NSCLC by the China Food and Drug Administration. A phase 4 study was conducted to assess the safety and efficacy of icotinib in a broad range of patients with advanced NSCLC across China. This study retrospectively analyzed data from unresectable, recurrent, and/or advanced NSCLC patients who received oral icotinib 125 mg three times per day. The primary endpoint was safety. The secondary endpoints included objective response rate (ORR) and disease control rate (DCR), which were investigated overall and in subgroups such as patients with an EGFR mutation and elderly patients. Between August, 2011 and August, 2012, a total of 6087 advanced NSCLC patients were registered in this study, of which 5549 were evaluable for safety and tumor response. The median age was 63 years (range 21-95 years), and 1571 (28.3%) patients were over the age of 70. The majority of patients were non-smokers, and had adenocarcinoma and stage IV disease. The overall incidence of adverse drug reactions (ADRs) of any grade was 31.5%. The most common ADRs included rash (17.4%) and diarrhea (8.5%), and three patients experienced interstitial lung disease (ILD). The ORR and DCR were 30.0% and 80.6%, respectively, for the overall population, and 33.4% and 81.2%, 30.3% and 80.3%, and 30.4% and 89.3%, for first-line, second-line, and third-line or multiple line subsets, respectively. In 665 EGFR-mutated patients who were evaluable for tumor response, the ORR and DCR were 49.2% (327/665) and 92.3% (614/665), respectively. The data from over 6000 patients was consistent with the results of the ICOGEN study. Icotinib demonstrated a favorable toxicity profile and efficacy in the routine clinical setting. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  15. Safety and tolerability of aripiprazole for irritability in pediatric patients with autistic disorder: a 52-week, open-label, multicenter study.

    Science.gov (United States)

    Marcus, Ronald N; Owen, Randall; Manos, George; Mankoski, Raymond; Kamen, Lisa; McQuade, Robert D; Carson, William H; Findling, Robert L

    2011-09-01

    Evaluate the long-term safety and tolerability of aripiprazole in the treatment of irritability in pediatric subjects (6-17 years) with autistic disorder. A 52-week, open-label, flexibly dosed (2-15 mg/d) study of the safety and tolerability of aripiprazole in outpatients with a DSM-IV-TR diagnosis of autistic disorder who either had completed 1 of 2 antecedent, 8-week randomized trials or were enrolled de novo (ie, not treated in the randomized trials). Safety and tolerability measures included incidences of adverse events, extrapyramidal symptoms, weight, metabolic measures, vital signs, and other clinical assessments. Subjects were enrolled between September 2006 and June 2009. Three hundred thirty subjects entered the treatment phase: 86 de novo, 174 prior aripiprazole, and 70 prior placebo. A total of 199 (60.3%) subjects completed 52 weeks of treatment. Adverse events were experienced by 286/330 subjects (86.7%). Common adverse events included weight increase, vomiting, nasopharyngitis, increased appetite, pyrexia, upper respiratory tract infection, and insomnia. Discontinuations due to adverse events occurred in 35/330 randomized subjects (10.6%)-most commonly aggression and weight increase. One patient discontinued from the study due to a laboratory-related adverse event (moderately increased alanine transaminase and aspartate transaminase). Nine subjects experienced serious adverse events-most frequently aggression. Extrapyramidal symptoms-related adverse events occurred in 48/330 subjects (14.5%)-most commonly tremor (3.0%), psychomotor hyperactivity (2.7%), akathisia (2.4%), and dyskinesia (not tardive, 2.4%). At > 9 months' aripiprazole exposure (n = 220), mean change in body weight z score was 0.33 and body mass index z score was 0.31. The percentages of subjects with clinically significant fasting metabolic abnormalities at > 9 months were 2% for glucose, 5% for total cholesterol, 7% for low-density lipoprotein cholesterol, 30% for high

  16. An open-label multicenter study to assess the safety of dextromethorphan/quinidine in patients with pseudobulbar affect associated with a range of underlying neurological conditions.

    Science.gov (United States)

    Pattee, Gary L; Wymer, James P; Lomen-Hoerth, Catherine; Appel, Stanley H; Formella, Andrea E; Pope, Laura E

    2014-11-01

    Pseudobulbar affect (PBA) is associated with neurological disorders or injury affecting the brain, and characterized by frequent, uncontrollable episodes of crying and/or laughing that are exaggerated or unrelated to the patient's emotional state. Clinical trials establishing dextromethorphan and quinidine (DM/Q) as PBA treatment were conducted in patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS). This trial evaluated DM/Q safety in patients with PBA secondary to any neurological condition affecting the brain. To evaluate the safety and tolerability of DM/Q during long-term administration to patients with PBA associated with multiple neurological conditions. Fifty-two-week open-label study of DM/Q 30/30 mg twice daily. Safety measures included adverse events (AEs), laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations. #NCT00056524. A total of 553 PBA patients with >30 different neurological conditions enrolled; 296 (53.5%) completed. The most frequently reported treatment-related AEs (TRAEs) were nausea (11.8%), dizziness (10.5%), headache (9.9%), somnolence (7.2%), fatigue (7.1%), diarrhea (6.5%), and dry mouth (5.1%). TRAEs were mostly mild/moderate, generally transient, and consistent with previous controlled trials. Serious AEs (SAEs) were reported in 126 patients (22.8%), including 47 deaths, mostly due to ALS progression and respiratory failure. No SAEs were deemed related to DM/Q treatment by investigators. ECG results suggested no clinically meaningful effect of DM/Q on myocardial repolarization. Differences in AEs across neurological disease groups appeared consistent with the known morbidity of the primary neurological conditions. Study interpretation is limited by the small size of some disease groups, the lack of a specific efficacy measure and the use of a DM/Q dose higher than the eventually approved dose. DM/Q was generally well tolerated over this 52 week trial in patients with PBA

  17. Multicenter Phase 2 Study about the Safety of No Antimicrobial Prophylaxis Use in Low-Risk Patients Undergoing Laparoscopic Distal Gastrectomy for Gastric Carcinoma (KSWEET-01 Study

    Directory of Open Access Journals (Sweden)

    Oh Jeong

    2017-01-01

    Full Text Available Background. Recent studies have shown a lower risk of surgical site infections (SSI after laparoscopic distal gastrectomy compared to open surgery. This is a phase 2 study aiming to determine the incidence of SSI after laparoscopic distal gastrectomy without using antimicrobial prophylaxis (AMP. Methods. cT1N0 gastric cancers that were subject to laparoscopic distal gastrectomy were enrolled. Based on the unacceptable SSI incidence of ≥12.5% and the target SSI incidence of ≤5%, 105 patients were enrolled with an α of 0.05 and a power of 80% (ClinicalTrials.gov, NCT02200315. Results. In intention-to-treat analysis, patients did not reach the target SSI rate (12.4%, 95% confidence  interval=6.8%–19.8%. Of patients, 44 patients had a protocol violation, such as extended lymph node dissection (LND or inappropriate nonpharmacological SSI prevention measures. Per-protocol analysis excluding these patients (n=61 showed a SSI rate of 4.9%, which was within the target SSI range. Multivariate analysis revealed that extracorporeal anastomosis and extended LND were independent risk factors for SSI. Conclusions. This study failed to reach the target SSI rate without using AMP. However, per-protocol analysis suggests that no AMP might be feasible when limited LND and adequate SSI prevention measures were performed.

  18. Efficacy and safety of escitalopram versus citalopram in major depressive disorder: a 6-week, multicenter, randomized, double-blind, flexible-dose study.

    Science.gov (United States)

    Ou, Jian-Jun; Xun, Guang-Lei; Wu, Ren-Rong; Li, Le-Hua; Fang, Mao-Sheng; Zhang, Hong-Geng; Xie, Shi-Ping; Shi, Jian-Guo; Du, Bo; Yuan, Xue-Qin; Zhao, Jing-Ping

    2011-02-01

    S-citalopram (escitalopram) is the very active moiety of citalopram. It has been shown in many studies to be an effective and safe antidepressant for treating major depressive disorder (MDD). The aim of our study was to compare the efficacy and safety of escitalopram vs citalopram in Chinese MDD patients. In the double-blind study, 240 MDD patients were randomly assigned to treatment for 6 weeks either with escitalopram (10-20 mg/d) or citalopram (20-40 mg/d). The primary efficacy measurement was the change of 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the end of study. The secondary efficacy measurements were response and remission rates. The adverse events (AEs) were recorded by the investigator. Two hundred and three (85%) patients completed the trial. The average dose was 13.9 mg/d in the escitalopram group and 27.6 mg/d in the citalopram group. No significant differences were found between the two groups in the change in HAMD-17 total score, response, and remission rate. These results were similar in severe MDD patients. No significant differences were found between the two groups in AEs. No serious AEs were observed in this study. The study suggests that escitalopram 10-20 mg/d are as effective and safe as citalopram 20-40 mg/d in the short-term treatment for Chinese MDD patients.

  19. Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study.

    Science.gov (United States)

    Ruperto, Nicolino; Brunner, Hermine I; Zuber, Zbigniew; Tzaribachev, Nikolay; Kingsbury, Daniel J; Foeldvari, Ivan; Horneff, Gerd; Smolewska, Elzbieta; Vehe, Richard K; Hazra, Anasuya; Wang, Rong; Mebus, Charles A; Alvey, Christine; Lamba, Manisha; Krishnaswami, Sriram; Stock, Thomas C; Wang, Min; Suehiro, Ricardo; Martini, Alberto; Lovell, Daniel J

    2017-12-28

    Juvenile idiopathic arthritis (JIA) is the most common pediatric rheumatic disease and a leading cause of childhood disability. The objective of this study was to characterize the PK, safety, and taste acceptability of tofacitinib in patients with JIA. This Phase 1, open-label, multiple-dose (twice daily [BID] for 5 days) study of tofacitinib in patients with active (≥ 5 joints) polyarticular course JIA was conducted from March 2013-December 2015. Patients were allocated to one of three age-based cohorts: Cohort 1, 12 to Tofacitinib was administered according to age and body weight as tablets or oral solution (grape flavor). PK were assessed on Day 5; safety was assessed at screening, Day 1, and Day 5. Taste acceptability of the oral solution was evaluated. Twenty-six patients (age range 2-17 years) were enrolled: Cohort 1, N = 8; Cohort 2, N = 9; Cohort 3, N = 9; median tofacitinib doses were 5.0, 2.5, and 3.0 mg BID, respectively. The higher median tofacitinib dose in Cohort 3 versus Cohort 2 reflected implementation of an amended dosing scheme following an interim PK analysis after Cohort 2 recruitment. Geometric mean AUC at steady state (AUC tau ) was 156.6 ng•h/mL in Cohort 1, 118.8 ng•h/mL in Cohort 2, and 142.5 ng•h/mL in Cohort 3; C max (ng/mL) was 47.0, 41.7, and 66.2, respectively. C trough , C min , and t 1/2 were similar in Cohorts 2 and 3, but higher in Cohort 1. Median time to C max (T max ) was similar between cohorts. Apparent clearance and volume of distribution decreased with decreasing age. Tofacitinib was well tolerated, with no serious adverse events or discontinuations due to adverse events reported. Taste acceptability was confirmed. PK findings from this study in children with polyarticular course JIA established dosing regimens and acceptable taste for use in subsequent studies within the tofacitinib pediatric development program. ClinicalTrials.gov: NCT01513902 .

  20. Randomized, Multicenter, Double-Blind Study of the Safety and Efficacy of 1%D-3-Hydroxybutyrate eye drops for Dry Eye Disease.

    Science.gov (United States)

    Kawakita, Tetsuya; Uchino, Miki; Fukagawa, Kazumi; Yoshino, Kenichi; Shimazaki, Seika; Toda, Ikuko; Tanaka, Mari; Arai, Hiroyuki; Sakatani, Keiko; Hata, Seiichiro; Okano, Takashi; Tsubota, Kazuo

    2016-02-11

    In a previous study, we demonstrated that topical D-beta-hydroxybutyrate ameliorates corneal epithelial erosion and superficial punctate keratopathy in a rat model of dry eye disease. In the current investigation, we performed a prospective, randomized, multicentre, double-blind, placebo-controlled study to assess the safety and efficacy of 1% D-3-hydroxybutyrate eye drops in patients with dry eye disease. A total of 65 patients were randomly assigned to either the placebo group or the 1% D-3-hydroxybutyrate group, and the treatments were administered 6 times a day for 4 weeks. We then evaluated corneal fluorescein staining, corneal and conjunctival rose Bengal staining, tear film break-up time (BUT), Schirmer score, and subjective symptoms. At both 2 and 4 weeks, the corneal rose Bengal score was significantly better in the 1% D-3-hydroxybutyrate group than in the placebo group. Among patients with an initial Schirmer score of ≤5 mm, the corneal fluorescein staining score was significantly better in the 1% D-3-hydroxybutyrate group than in the placebo group at two weeks. Mild ocular symptoms occurred in both groups, and these spontaneously resolved. The present study suggested that 1% D-3-hydroxybutyrate eye drops are safe and effective in treating ocular surface disorders in patients with tear-deficient dry eye disease.

  1. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine.

    Science.gov (United States)

    Munjal, Sagar; Brand-Schieber, Elimor; Allenby, Kent; Spierings, Egilius L H; Cady, Roger K; Rapoport, Alan M

    2017-12-01

    DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and a permeation-enhancing excipient comprised of 0.2% 1-O-n-Dodecyl-β-D-Maltopyranoside (DDM). This composition of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation and exhibit pharmacokinetics comparable to subcutaneously administered sumatriptan. Rapid rate of absorption is suggested to be important for optimal efficacy. The objective of this study was to evaluate the safety and tolerability of DFN-02 (10 mg) in the acute treatment of episodic migraine with and without aura over a 6-month period based on the incidence of treatment-emergent adverse events and the evaluation of results of clinical laboratory tests, vital signs, physical examination, and electrocardiograms. This was a multi-center, open-label, repeat-dose safety study in adults with episodic migraine with and without aura. Subjects diagnosed with migraine with or without aura according to the criteria set forth in the International Classification of Headache Disorders, 2nd edition, who experienced 2 to 6 attacks per month with fewer than 15 headache days per month and at least 48 headache-free hours between attacks, used DFN-02 to treat their migraine attacks acutely over the course of 6 months. A total of 173 subjects was enrolled, 167 (96.5%) subjects used at least 1 dose of study medication and were evaluable for safety, and 134 (77.5%) subjects completed the 6-month study. A total of 2211 migraine attacks was reported, and 3292 doses of DFN-02 were administered; mean per subject monthly use of DFN-02 was 3.6 doses. Adverse events were those expected for triptans, as well as for nasally administered compounds. No new safety signals emerged. Dysgeusia and application site pain were the most commonly reported treatment-emergent adverse events over 6 months (21% and 30.5%, respectively). Most of the treatment-emergent adverse events were mild. There were 5 serious adverse events, all

  2. A Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Mesalamine Suppositories 1 g at Bedtime and 500 mg Twice Daily in Patients with Active Mild-to-Moderate Ulcerative Proctitis

    Science.gov (United States)

    2010-01-01

    Abstract Background Ulcerative proctitis (UP) is a prevalent condition associated with increased morbidity and mortality. Topical mesalamine (5-aminosalicylic acid [5-ASA]) inhibits inflammatory processes in UP. Methods We evaluated effects of mesalamine 1-g suppository administered QHS compared with 500-mg suppository administered BID on UP activity (e.g., disease extension/mucosal appearance), remission, onset of response, safety and compliance in 97 patients with UP. A 6-week, randomized, multicenter, parallel-group, noninferiority study was conducted (and published) with Disease Activity Index (DAI) at week 6 as the primary efficacy variable and individual components of DAI at week 6 (i.e., stool frequency, rectal bleeding, mucosal appearance, global assessment) as secondary variables. Unreported outcomes were remission (DAI 70%) after 6 weeks in both groups. Mesalamine was well tolerated. Compliance was >96%. Conclusions Mesalamine 500-mg BID and 1-g QHS suppositories are safe and effective for patients with UP. Most patients reported significant improvement within 3 weeks and UP remission and reduced disease extension after 6 weeks of treatment. Validity of QHS administration was confirmed. PMID:20676771

  3. The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: results from a multicenter observational study

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Hyun Cheol [Dept.of Radiation Oncology, Seoul National University College of Medicine, Seoul (Korea, Republic of); Ahn, Seung Do [Dept.of Radiation Oncology, Asan Medical Center, Seoul (Korea, Republic of); Choi, Doo Ho [Dept.of Radiation Oncology, Samsung Medical Center, Seoul (Korea, Republic of); Kang, Min Kyu [Dept.of Radiation Oncology, eungnam University College of Medicine, Daegu (Korea, Republic of); Wu, Hong Gyun [Dept.of Radiation Oncology, Chonnam National University Hwasun Hospital, Huasun (Korea, Republic of)

    2014-09-15

    This study was designed to evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in cancer patients. From December 2010 to April 2012, a total of 1,172 cancer patients who received radiotherapy (RT) of more than 50 Gy were prospectively enrolled and treated with EGF-based cream. An acute skin reaction classified according to the Radiation Therapy Oncology Group 6-point rating scale was the primary end point and we also assessed the occurrence of edema, dry skin, or pruritus. The percentage of radiation dermatitis with maximum grade 0 and grade 1 was 19% and 58% at the time of 50 Gy, and it became 29% and 47% after completion of planned RT. This increment was observed only in breast cancer patients (from 18%/62% to 32%/49%). Adverse events related to the EGF-based cream developed in 49 patients (4%) with mild erythema the most common. Skin toxicity grade >2 was observed in 5% of the patients. Edema, dry skin, and pruritus grade > or =3 developed in 9%, 9%, and 1% of the patients, respectively. Prophylactic use of an EGF-based cream is effective in preventing radiation dermatitis with tolerable toxicity. Further studies comparing EGF cream with other topical agents may be necessary.

  4. The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: results from a multicenter observational study

    International Nuclear Information System (INIS)

    Kang, Hyun Cheol; Ahn, Seung Do; Choi, Doo Ho; Kang, Min Kyu; Wu, Hong Gyun

    2014-01-01

    This study was designed to evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in cancer patients. From December 2010 to April 2012, a total of 1,172 cancer patients who received radiotherapy (RT) of more than 50 Gy were prospectively enrolled and treated with EGF-based cream. An acute skin reaction classified according to the Radiation Therapy Oncology Group 6-point rating scale was the primary end point and we also assessed the occurrence of edema, dry skin, or pruritus. The percentage of radiation dermatitis with maximum grade 0 and grade 1 was 19% and 58% at the time of 50 Gy, and it became 29% and 47% after completion of planned RT. This increment was observed only in breast cancer patients (from 18%/62% to 32%/49%). Adverse events related to the EGF-based cream developed in 49 patients (4%) with mild erythema the most common. Skin toxicity grade >2 was observed in 5% of the patients. Edema, dry skin, and pruritus grade > or =3 developed in 9%, 9%, and 1% of the patients, respectively. Prophylactic use of an EGF-based cream is effective in preventing radiation dermatitis with tolerable toxicity. Further studies comparing EGF cream with other topical agents may be necessary.

  5. Short-term outcomes and safety of computed tomography-guided percutaneous microwave ablation of solitary adrenal metastasis from lung cancer: A multi-center retrospective study

    Energy Technology Data Exchange (ETDEWEB)

    Men, Min; Ye, Xin; Yang, Xia; Zheng, Aimin; Huang, Guang Hui; Wei, Zhigang [Dept. of Oncology, Shandong Provincial Hospital Affiliated with Shandong University, Jinan (China); Fan, Wei Jun [Imaging and Interventional Center, Sun Yat-sen University Cancer Center, Guangzhou (China); Zhang, Kaixian [Dept. of Oncology, Teng Zhou Central People' s Hospital Affiliated with Jining Medical College, Tengzhou (China); Bi, Jing Wang [Dept. of Oncology, Jinan Military General Hospital of Chinese People' s Liberation Army, Jinan (China)

    2016-11-15

    To retrospectively evaluate the short-term outcomes and safety of computed tomography (CT)-guided percutaneous microwave ablation (MWA) of solitary adrenal metastasis from lung cancer. From May 2010 to April 2014, 31 patients with unilateral adrenal metastasis from lung cancer who were treated with CT-guided percutaneous MWA were enrolled. This study was conducted with approval from local Institutional Review Board. Clinical outcomes and complications of MWA were assessed. Their tumors ranged from 1.5 to 5.4 cm in diameter. After a median follow-up period of 11.1 months, primary efficacy rate was 90.3% (28/31). Local tumor progression was detected in 7 (22.6%) of 31 cases. Their median overall survival time was 12 months. The 1-year overall survival rate was 44.3%. Median local tumor progression-free survival time was 9 months. Local tumor progression-free survival rate was 77.4%. Of 36 MWA sessions, two (5.6%) had major complications (hypertensive crisis). CT-guided percutaneous MWA may be fairly safe and effective for treating solitary adrenal metastasis from lung cancer.

  6. COMPARATIVE CONTROLLED STUDY OF ANTIHYPERTENSIVE EFFICACY AND SAFETY OF CARVEDILOL IN PATIENTS WITH HYPERTENSION AND OBESITY OR DIABETES 2 TYPE (BASED ON RESULTS OF MULTICENTER TRIAL ACCORD

    Directory of Open Access Journals (Sweden)

    Yu. V. Yu.V. Lukina

    2009-01-01

    Full Text Available Aim. To study efficacy and safety of beta-blocker with vasodilating properties carvedilol (Acridilole, Akrihin, Russia as a part of the combined therapy of patients with arterial hypertension (HT and diabetes mellitus 2 type (DM2 and/or obesity.Material and methods. 592 patients: 176 men (29,7% and 416 women (70,3% with HT were examined. 194 patients had D2 and 398 patients had obesity. Patients were randomized for carvedilol therapy (n=291 or control group (n=301. Carvedilol was prescribed additionally to current therapy in dose of 6,25 mg BID, in 2 weeks the dose was increased to 12,5 mg BID if it was necessary. Blood pressure (BP and heart rate, number of angina attacks were registered at visits. ECG, laboratory analysis (plasma lipide profile, serum glucose, glycolised haemoglobin, serum K+ and Na+, evaluation of depression and anxiety status (according to special questionnaires were performed on the first and the last visits.Results. 582 patients completed the study. 7 patients dropped out from carvedilol group and 3 patients - from control group. The levels of systolic BP (SBP and diastolic BP (DBP were decreased during study, more significantly in carvedilol group (р<0,0001. SBP decreased on 24,8 mm Hg in patients of carvedilol group and on 21,4 mm Hg in patients of control group. DBP decreased on 12,5 mm Hg and 11 mm Hg respectively. Angina attacks were registered less often in patients of carvedilol group (р=0,001. Serum glucose and lipid spectrum did not change in both groups. Depression level decreased in patients receiving carvedilol. 17 side effects were registered in carvedilol group and 15 - in control group (р=0,575Conclusion. High antihypertensive efficacy of carvedilol is confirmed in hypertensive patients with DM2 and/or obesity. Good tolerability and metabolic neutrality of carvedilol is also observed.

  7. COMPARATIVE CONTROLLED STUDY OF ANTIHYPERTENSIVE EFFICACY AND SAFETY OF CARVEDILOL IN PATIENTS WITH HYPERTENSION AND OBESITY OR DIABETES 2 TYPE (BASED ON RESULTS OF MULTICENTER TRIAL ACCORD

    Directory of Open Access Journals (Sweden)

    Yu. V. Yu.V. Lukina

    2016-01-01

    Full Text Available Aim. To study efficacy and safety of beta-blocker with vasodilating properties carvedilol (Acridilole, Akrihin, Russia as a part of the combined therapy of patients with arterial hypertension (HT and diabetes mellitus 2 type (DM2 and/or obesity.Material and methods. 592 patients: 176 men (29,7% and 416 women (70,3% with HT were examined. 194 patients had D2 and 398 patients had obesity. Patients were randomized for carvedilol therapy (n=291 or control group (n=301. Carvedilol was prescribed additionally to current therapy in dose of 6,25 mg BID, in 2 weeks the dose was increased to 12,5 mg BID if it was necessary. Blood pressure (BP and heart rate, number of angina attacks were registered at visits. ECG, laboratory analysis (plasma lipide profile, serum glucose, glycolised haemoglobin, serum K+ and Na+, evaluation of depression and anxiety status (according to special questionnaires were performed on the first and the last visits.Results. 582 patients completed the study. 7 patients dropped out from carvedilol group and 3 patients - from control group. The levels of systolic BP (SBP and diastolic BP (DBP were decreased during study, more significantly in carvedilol group (р<0,0001. SBP decreased on 24,8 mm Hg in patients of carvedilol group and on 21,4 mm Hg in patients of control group. DBP decreased on 12,5 mm Hg and 11 mm Hg respectively. Angina attacks were registered less often in patients of carvedilol group (р=0,001. Serum glucose and lipid spectrum did not change in both groups. Depression level decreased in patients receiving carvedilol. 17 side effects were registered in carvedilol group and 15 - in control group (р=0,575Conclusion. High antihypertensive efficacy of carvedilol is confirmed in hypertensive patients with DM2 and/or obesity. Good tolerability and metabolic neutrality of carvedilol is also observed.

  8. Efficacy and safety of sorafenib in combination with gemcitabine in patients with advanced hepatocellular carcinoma: a multicenter, open-label, single-arm phase II study.

    Science.gov (United States)

    Srimuninnimit, Vichien; Sriuranpong, Virote; Suwanvecho, Suthida

    2014-09-01

    Currently, the only standard systemic treatment for advanced hepatocellular carcinoma is sorafenib monotherapy. The study was conducted to assess the efficacy and safety of the novel combination of sorafenib and gemcitabine in the treatment of advanced hepatocellular carcinoma. Between March 2008 and October 2010, patients with advanced pathologically proven hepatocellular carcinoma who had not received previous systemic therapy and had Child-Pugh liver function class A or B received sorafenib plus gemcitabine. Treatment included 4-week cycle of gemcitabine (1000 mg/m(2) days 1, 8, 15) to the maximum of six cycles together with sorafenib (400 mg twice daily). Patient continued sorafenib until disease progression or withdrawal from other reasons. The primary end point is progression-free survival. Forty-five patients were enrolled in this study. The median progression-free survival was 3.7 months (95% CI 3.5-3.8). The overall response rate was 4% with no complete responses and the disease control rate was 66%. The median overall survival (OS) was 11.6 months (95% CI 7.4-15.9). The median time to progression was 3.6 months (95% CI 3.4-3.7). The most frequently reported grade 3/4 treatment-related adverse events included thrombocytopenia 33%, neutropenia 16% and hand-foot skin reaction 13%. The study regimen was well tolerated. The combination of sorafenib and gemcitabine in advanced hepatocellular carcinoma is generally well tolerated and has modest clinical efficacy. The median OS is up to 1 year. However, well-designed randomized controlled trials with a sorafenib alone comparator arm are needed to confirm this finding. © 2014 Wiley Publishing Asia Pty Ltd.

  9. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study.

    Science.gov (United States)

    Ha, Chul-Won; Park, Yong-Beom; Choi, Chong-Hyuk; Kyung, Hee-Soo; Lee, Ju-Hong; Yoo, Jae Doo; Yoo, Ju-Hyung; Choi, Choong-Hyeok; Kim, Chang-Wan; Kim, Hee-Chun; Oh, Kwang-Jun; Bin, Seong-Il; Lee, Myung Chul

    2017-05-26

    This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. ClinicalTrials.gov ( NCT01510535 ). This trial was registered on January 6, 2012.

  10. Safety and efficacy of paliperidone palmitate 1-month formulation in Chinese patients with schizophrenia: a 25-week, open-label, multicenter, Phase IV study

    Directory of Open Access Journals (Sweden)

    Zhao JP

    2017-08-01

    Full Text Available Jingping Zhao,1,* Lehua Li,1,* Jianguo Shi,2 Yi Li,3 Xiufeng Xu,4 Keqing Li,5 Lili Zhang,6 Shangli Cai,6 Yu Feng,6 Jianmin Zhuo,6 Weihong Liu,6 Huafei Lu6 1Department of Psychiatry, The Mental Health Institute, The Second Xiangya Hospital of Central South University, 2Department of Psychiatry, Mental Health Center of Xi’an City, 3Department of Psychiatry, Mental Health Center of Wuhan City, 4Department of Psychiatry, First Affiliated Hospital of Kunming Medical University, 5Department of Psychiatry, The Sixth People’s Hospital of Hebei Province, 6Department of Medical Affairs, Xi’an Janssen Pharmaceutical Ltd., Beijing, People’s Republic of China *These authors contributed equally to this work Rationale: Long-acting injectable (LAI paliperidone palmitate 1-month formulation (PP1M has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest.Objective: The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia.Methods: In this 25-week, open-label, Phase IV study, patients (18–65 years diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS total score of 60–120 (inclusive were enrolled. All patients received injections of PP1M 150 mg eq. (day 1 and 100 mg eq. (day 8, followed by a flexible once-monthly maintenance dosing (75, 100, or 150 mg eq..Results: Of the 353 patients, 234 (66.3% completed the study treatment (mean age, 31.1 years; 52.7% men. The PANSS total score (primary end point improved significantly over the 6-month treatment period (mean [standard deviation] change from baseline to end of treatment, -27.2 [18.30]; P<0.0001. The Clinical Global Impressions-Severity and Personal and Social Performance scores (secondary end points also improved

  11. Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 chinese cancer patients.

    Science.gov (United States)

    Zhu, Yu-Lin; Song, Guo-Hong; Liu, Duan-Qi; Zhang, Xi; Liu, Kui-Feng; Zang, Ai-Hua; Cheng, Ying; Cao, Guo-Chun; Liang, Jun; Ma, Xue-Zhen; Ding, Xin; Wang, Bin; Li, Wei-Lian; Hu, Zuo-Wei; Feng, Gang; Huang, Jiang-Jin; Zheng, Xiao; Jiao, Shun-Chang; Wu, Rong; Ren, Jun

    2011-12-01

    Although a new matrix formulation fentanyl has been used throughout the world for cancer pain management, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. This study aimed to assess the efficacy and safety of the new system in Chinese patients with moderate to severe cancer pain. A total of 474 patients with moderate to severe cancer pain were enrolled in this study and were treated with the new transdermal fentanyl matrix patch (TDF) up to 2 weeks. All the patients were asked to record pain intensity, side effects, quality of life (QOL), adherence and global satisfaction. The initial dose of fentanyl was 25 μg/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days. After 2 weeks. The mean pain intensity of the 459 evaluated patients decreased significantly from 5.63±1.26 to 2.03±1.46 (P<0.0001). The total remission rate was 91.29%, of which moderate remission rate 53.16%, obvious remission rate 25.49% and complete remission rate 12.64%. The rate of adverse events was 33.75%, 18.78% of which were moderate and 3.80% were severe. The most frequent adverse events were constipation and nausea. No fatal events were observed. The quality of life was remarkably improved after the treatment (P<0.0001). The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.

  12. Efficacy and safety of dextromethorphan/quinidine at two dosage levels for diabetic neuropathic pain: a double-blind, placebo-controlled, multicenter study.

    Science.gov (United States)

    Shaibani, Aziz I; Pope, Laura E; Thisted, Ronald; Hepner, Adrian

    2012-02-01

    To evaluate dextromethorphan coadministered with quinidine as treatment of diabetic peripheral neuropathic pain. In a 13-week, phase 3, randomized controlled trial, 379 adults with daily symmetric diabetic peripheral neuropathy (DPN) leg pain for ≥3 months received double-blind placebo, dextromethorphan/quinidine (DMQ) 45/30 mg, or DMQ 30/30 mg, administered once daily for 7 days and twice daily thereafter. Efficacy measures included four pain rating scales applied daily using patient diaries, and another two applied at five clinic visits. On all six scales, DMQ 45/30 mg was significantly superior to placebo, including the primary efficacy analysis, which utilized mixed-effects modeling to test all scores on an 11-point numerical Pain Rating Scale (P < 0.0001). Sensitivity analyses gave consistent results. Efficacy vs placebo was also seen for diary ratings of present pain intensity, and pain interference with sleep and with activities (all P < 0.0001). Among clinic visit assessments, DMQ 45/30 mg demonstrated greater leg pain relief (P = 0.0002) and greater reduction of leg pain intensity (P = 0.0286) vs placebo. The efficacy of DMQ 30/30 mg was numerically less than for 45/30 mg but for most outcomes remained significantly greater vs placebo. Adverse events were mostly mild or moderate and of expected types. Discontinuation for adverse events in the DMQ groups was at least twice as common as placebo. Throughout a 13-week trial, DMQ was effective, with an acceptable safety profile, for treatment of DPN pain. Other fixed-dose combinations of DMQ should be studied to improve overall tolerability while maintaining significant efficacy. Wiley Periodicals, Inc.

  13. A US Multicenter Study of Safety and Efficacy of Fully Covered Self-Expandable Metallic Stents in Benign Extrahepatic Biliary Strictures.

    Science.gov (United States)

    Saxena, Payal; Diehl, David L; Kumbhari, Vivek; Shieh, Frederick; Buscaglia, Jonathan M; Sze, Wilson; Kapoor, Sumit; Komanduri, Srinadh; Nasr, John; Shin, Eun Ji; Singh, Vikesh; Lennon, Anne Marie; Kalloo, Anthony N; Khashab, Mouen A

    2015-11-01

    Endoscopic therapy is considered first line for management of benign biliary strictures (BBSs). Placement of plastic stents has been effective but limited by their short-term patency and need for repeated procedures. Fully covered self-expandable metallic stents (FCSEMSs) offer longer-lasting biliary drainage without the need for frequent exchanges. The aim of this study was to assess the efficacy and safety of FCSEMS in patients with BBS. A retrospective review of all patients who underwent ERCP and FCSEMS placement at five tertiary referral US hospitals was performed. Stricture resolution and adverse events related to ERCP and/or stenting were recorded. A total of 123 patients underwent FCSEMS placement for BBS and 112 underwent a subsequent follow-up ERCP. The mean age was 62 years (±15.6), and 57% were males. Stricture resolution occurred in 81% of patients after a mean of 1.2 stenting procedures (mean stent dwell time 24.4 ± 2.3 weeks), with a mean follow-up of 18.5 months. Stricture recurrence occurred in 5 patients, and 3 patients required surgery for treatment of refractory strictures. Stent migration (9.7%) was the most common complication, followed by stent occlusion (4.9%), cholangitis (4.1%), and pancreatitis (3.3%). There was one case of stent fracture during removal, and one stent could not be removed. There was one death due to cholangitis. Majority of BBS can be successfully managed with 1-2 consecutive FCSEMS with stent dwell time of 6 months.

  14. Immunogenicity and safety of the new reduced-dose tetanus-diphtheria vaccine in healthy Korean adolescents: A comparative active control, double-blind, randomized, multicenter phase III study.

    Science.gov (United States)

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Kim, Sang Yong; Kim, Jong-Hyun; Kim, Hyun-Hee; Lee, Kyung-Yil; Kim, Hwang Min; Choi, Young Youn; Ma, Sang Hyuk; Kim, Chun Soo; Kim, Dong Ho; Ahn, Dong Ho; Kang, Jin Han

    2017-04-01

    A new reduced-dose tetanus-diphtheria (Td) vaccine was developed in Korea, and phase I and II clinical trials were successfully undertaken. We conducted this double-blind, randomized, multicenter phase III clinical trial to assess the immunogenicity and safety of the new Td vaccine. Healthy adolescents 11-12 years of age were enrolled and randomized to receive the new Td vaccine (study group) or a commercially available Td vaccine (control group). Blood samples were collected prior to and 4 weeks after the vaccination. Between the study and control groups, seroprotection rate, booster response, and geometric mean titer of antibodies against diphtheria and tetanus toxoids were compared after the vaccination. All solicited and unsolicited adverse events and serious adverse events during the 6-week study period were monitored. A total of 164 adolescents received vaccination, and 156 of them were evaluated to assess immunogenicity. The seroprotection rate and geometric mean titer for antibodies against diphtheria were significantly higher in the study group, whereas those against tetanus were significantly higher in the control group. However, all seroprotection rates against diphtheria and tetanus in the study and control groups were high: 100% against diphtheria and tetanus in the study group, and 98.7% against diphtheria and 100% against tetanus in the control group. No significant differences in the frequency of solicited and unsolicited adverse events were observed between the two vaccine groups. The new Td vaccine is highly immunogenic and safe, and this new Td vaccine can be effectively used for preventing diphtheria and tetanus. Copyright © 2015. Published by Elsevier B.V.

  15. Acute necrotizing pancreatitis: a multicenter study.

    Science.gov (United States)

    Fernández-Cruz, L; Navarro, S; Valderrama, R; Sáenz, A; Guarner, L; Aparisi, L; Espi, A; Jaurietta, E; Marruecos, L; Gener, J

    1994-04-01

    A multicenter study of acute necrotizing pancreatitis (ANP) classified in accordance with the Balthazar criteria (grades D and E), has been performed in 12 teaching hospitals. A total of 233 patients were reviewed, and the mortality rate was 26.6%. The most common etiology was biliary pancreatitis (45.5%). Among the complications, shock, renal insufficiency, pulmonary insufficiency and hemorrhagic gastritis were associated with a mortality rate of 51-66%. Diffuse fluid collections were associated with a higher mortality rate (26.8%) than localized fluid collections (14.5%). In 106 patients with gallstone pancreatitis, early surgery was performed in 17, and 5 patients (29.4%) died. No mortality was observed in 32 patients with delayed surgery. Sphincterotomy was performed in 13 patients, and 4 (30.7%) died. Early surgery (necrosectomy and closed peritoneal lavage) was undertaken in 75 patients, with a mortality rate of 39%. In conclusion, the morbidity and mortality rates of ANP can be improved with proper monitoring, adequate supportive care and the judicious use of surgery based on clinical and morphological findings.

  16. An open-label, multicenter, flexible dose study to evaluate the efficacy and safety of Viagra (sildenafil citrate) in Korean men with erectile dysfunction and arterial hypertension who are taking antihypertensive agents.

    Science.gov (United States)

    Park, Hyun Jun; Park, Nam Cheol; Shim, Hong Bang; Park, Jong Kwan; Lee, Sung Won; Park, Kwangsung; Kim, Sae Woong; Moon, Ki Hak; Lee, Dong Hyeon; Yoon, Sang Jin

    2008-10-01

    Erectile dysfunction (ED) is common among men taking antihypertensive agents to control blood pressure. We evaluated the efficacy and safety of sildenafil citrate in men with ED taking antihypertensive agents. A total of 198 male subjects, aged 20 years and older were enrolled. This study was conducted for 10 weeks as an open-label, multicenter and flexible dose trial with a 2-week screening period and an 8-week treatment phase. Subjects were asked to complete Event Log Worksheets, as well as the International Index of Erectile Function (IIEF) and the Global Efficacy Assessment Questions (GEAQ) questionnaires during the study period. The average age among the 167 subjects who completed the study was 55.8 (31.7 to 77.1). The scores for questions 3 and 4 of IIEF improved from 2.3 and 1.8 at baseline to 3.7 and 3.4 at week 4 and 3.8 and 3.4 at week 8, respectively. There were 86.3% of the patients reported improved erectile function at week 8; 88.3% of the patients reported improved ability to achieve sexual intercourse at week 8. There were no significant differences observed in the responses to questions 3 and 4 of IIEF and GEAQ by the number of antihypertensive agents taken. The adverse events were facial flushing (20.1%), headache (11.7%), palpitation (5.0%), rhinitis (2.8%), URI (2.8%), dizziness (2.2%), dyspnea (2.2%), and nausea (1.7%). Sildenafil citrate is an effective treatment for ED; it is safe and well tolerated by patients with ED taking multiple antihypertensive agents for arterial hypertension.

  17. Effectiveness, pharmacokinetics, and safety of a new sustained-release leuprolide acetate 3.75-mg depot formulation for testosterone suppression in patients with prostate cancer: a Phase III, open-label, international multicenter study.

    Science.gov (United States)

    Marberger, Michael; Kaisary, Amir V; Shore, Neal D; Karlin, Gary S; Savulsky, Claudio; Mis, Ricard; Leuratti, Chiara; Germa, Josep R

    2010-04-01

    A microencapsulated, sustained-release formulation of leuprolide acetate 3.75 mg has been developed. This study investigated the effectiveness, pharmacokinetics, and safety profile of a 1-month leuprolide acetate 3.75-mg depot formulation for suppressing testosterone concentrations in patients with prostate cancer. This was a Phase III, open-label, international multicenter clinical trial. Patients with prostate cancer who, in the judgment of the investigators, could benefit from androgen deprivation therapy received 6 monthly intramuscular injections of leuprolide acetate 3.75-mg depot. Plasma testosterone concentrations were determined at specific times throughout the study. The primary end point was the proportion of successful patients over the total number of evaluable patients (ie, patients with evaluable testosterone concentrations at all monthly assessments and no missing values due to treatment-related adverse events). Treatment success was defined as testosterone suppression below the clinical castration level (ie, n = 12), showed sustained release of leuprolide from the formulation. Values for AUC(0-t) calculated from day 0 to day 28, days 28 to 56, and days 56 to 84 were 25,976.5 (7892.0), 30,685.5 (9348.4), and 31,030.9 (10,745.0) pg/mL per day, respectively. The most common treatment-related adverse event was hot flashes (45.0% [72/160]). Fatigue, hyperhidrosis, night sweats, and headache each occurred in study in this cohort of patients with prostate cancer. ClinicalTrials.gov identifier: NCT00128531.

  18. Long-Term Efficacy and Safety of Cyclosporine in a Cohort of Steroid-Refractory Acute Severe Ulcerative Colitis Patients from the ENEIDA Registry (1989-2013): A Nationwide Multicenter Study.

    Science.gov (United States)

    Ordás, I; Domènech, E; Mañosa, M; García-Sánchez, V; Iglesias-Flores, E; Peñalva, M; Cañas-Ventura, A; Merino, O; Fernández-Bañares, F; Gomollón, F; Vera, M; Gutiérrez, A; Garcia-Planella, E; Chaparro, M; Aguas, M; Gento, E; Muñoz, F; Aguirresarobe, M; Muñoz, C; Fernández, L; Calvet, X; Jiménez, C E; Montoro, M A; Mir, A; De Castro, M L; García-Sepulcre, M F; Bermejo, F; Panés, J; Esteve, M

    2017-11-01

    To determine the efficacy and safety of cyclosporine (CyA) in a large national registry-based population of patients with steroid-refractory (SR) acute severe ulcerative colitis (ASUC) and to establish predictors of efficacy and adverse events. Multicenter study of SR-ASUC treated with CyA, based on data from the ENEIDA registry. SR-ASUC patients treated with infliximab (IFX) or sequential rescue therapy (CyA-IFX or IFX-CyA) were used as comparators. Of 740 SR-ASUC patients, 377 received CyA, 131 IFX and 63 sequential rescue therapy. The cumulative colectomy rate was higher in the CyA (24.1%) and sequential therapy (32.7%) than in the IFX group (14.5%; P=0.01) at 3 months and 5 years. There were no differences in early and late colectomy between CyA and IFX in patients treated after 2005. 62% of patients receiving CyA remained colectomy-free in the long term (median 71 months). There were no differences in mortality between CyA (2.4%), IFX (1.5%) and sequential therapy (0%; P=0.771). The proportion of patients with serious adverse events (SAEs) was lower in CyA (15.4%) than in IFX treated patients (26.5%) or sequential therapy (33.4%; P<0.001). This difference in favor of CyA was maintained when only patients treated after 2005 were analyzed. Treatment with CyA showed a lower rate of SAE and a similar efficacy to that of IFX thereby supporting the use of either CyA or IFX in SR-ASUC. In addition, the risk-benefit of sequential CyA-IFX for CyA non-responders is acceptable.

  19. An open, parallel, randomized, comparative, multicenter study to evaluate the cost-effectiveness, performance, tolerance, and safety of a silver-containing soft silicone foam dressing (intervention) vs silver sulfadiazine cream.

    Science.gov (United States)

    Silverstein, Paul; Heimbach, David; Meites, Herbert; Latenser, Barbara; Mozingo, David; Mullins, Fred; Garner, Warren; Turkowski, Joseph; Shupp, Jeffrey; Glat, Paul; Purdue, Gary

    2011-01-01

    An open, parallel, randomized, comparative, multicenter study was implemented to evaluate the cost-effectiveness, performance, tolerance, and safety of a silver-containing soft silicone foam dressing (Mepilex Ag) vs silver sulfadiazine cream (control) in the treatment of partial-thickness thermal burns. Individuals aged 5 years and older with partial-thickness thermal burns (2.5-20% BSA) were randomized into two groups and treated with the trial products for 21 days or until healed, whichever occurred first. Data were obtained and analyzed on cost (direct and indirect), healing rates, pain, comfort, ease of product use, and adverse events. A total of 101 subjects were recruited. There were no significant differences in burn area profiles within the groups. The cost of dressing-related analgesia was lower in the intervention group (P = .03) as was the cost of background analgesia (P = .07). The mean total cost of treatment was $309 vs $513 in the control (P < .001). The average cost-effectiveness per treatment regime was $381 lower in the intervention product, producing an incremental cost-effectiveness ratio of $1688 in favor of the soft silicone foam dressing. Mean healing rates were 71.7 vs 60.8% at final visit, and the number of dressing changes were 2.2 vs 12.4 in the treatment and control groups, respectively. Subjects reported significantly less pain at application (P = .02) and during wear (P = .048) of the Mepilex Ag dressing in the acute stages of wound healing. Clinicians reported the intervention dressing was significantly easier to use (P = .03) and flexible (P = .04). Both treatments were well tolerated; however, the total incidence of adverse events was higher in the control group. The silver-containing soft silicone foam dressing was as effective in the treatment of patients as the standard care (silver sulfadiazine). In addition, the group of patients treated with the soft silicone foam dressing demonstrated decreased pain and lower costs associated

  20. Statistics of the Iomazenil-multicenter study

    International Nuclear Information System (INIS)

    Hasler, P.H.; Beer-Wohlfahrt, H.; Schubiger, P.A.

    1990-01-01

    The 123 I-Ro 16-0154 (= Iomazenil) has been shown as a very potent benzodiazepine antagonist by Beer et al. (1990). In this study the in vitro and in vivo characteristics have been described. The preliminary clinical results revealed clearly images of the benzodiazepine receptor density in the brain. Also storage defects due to pathological CBF and changed receptor density were detected. The Iomazenil showed potential usefulness and therefore extended clinical tests in a multicenter study have been performed. The goals were twofold, first to define the normal benzodiazepine receptor distribution in a healthy human brain and second to investigate the possible diagnostic usefulness of Iomazenil in the case of partial epilepsy. Furthermore, on a few normal volunteers the pharmacokinetics should be determined and some patients with other dieseases (e.g. Alzheimer) would be screened. Some preliminary clinical results have already been published. Hoell et al. (1989) compared the biodistribution of Iomazenil in normal humans with the animal data published (Beer et al., 1990). They concluded that the distribution was similar. The radioactivity concentration in the plasma was virtually cleared after 15 min., cerebral uptake reached a maximum of 10-15 min p.i. and remained stable for about 20 min. Bangerl et al. (1990) found a reduction of benzodiazepine receptors in patients with Lennox-Gaustaut-syndrome. Bartenstein et al. (1989) compared early (30 min.) and late (2h) SPECT-images. They found that early images showed flow-phenomena and receptor binding, whereas late one corresponded clearly to receptor binding. Their findings confirm the results published by Beer et al. (1990). In this work the patient data of all participating clinical centers are evaluated and discussed. (author) 3 figs., 7 tabs., 5 refs

  1. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia.

    Science.gov (United States)

    Liu, Yang; Zhang, Yingyuan; Wu, Jufang; Zhu, Demei; Sun, Shenghua; Zhao, Li; Wang, Xuefeng; Liu, Hua; Ren, Zhenyi; Wang, Changzheng; Xiu, Qingyu; Xiao, Zuke; Cao, Zhaolong; Cui, Shehuai; Yang, Heping; Liang, Yongjie; Chen, Ping; Lv, Yuan; Hu, Chengping; Lv, Xiaoju; Liu, Shuang; Kuang, Jiulong; Li, Jianguo; Wang, Dexi; Chang, Liwen

    2017-12-01

    To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. One hundred ninety-two patients with CAP were randomized to receive oral nemonoxacin (500 mg or 750 mg) or levofloxacin (500 mg) once daily for 7-10 days. Clinical and bacteriological responses were determined at the test of cure (TOC) visit in the full analysis set (FAS). The clinical cure rate of nemonoxacin (500 mg), nemonoxacin (750 mg), and levofloxacin (500 mg) was 93.3%, 87.3%, and 88.5%, respectively, in the FAS (n = 168), and 93.0%, 93.9%, and 88.9%, respectively in the per protocol set (n = 152). At the TOC visit, nemonoxacin at 500 mg and 750 mg was proven to be noninferior to levofloxacin at 500 mg in the FAS in terms of clinical efficacy. The overall bacteriological success rate was 83.3% in both nemonoxacin groups and 80.0% in the levofloxacin 500 mg group in the bacteriological FAS. The comprehensive efficacy rate was comparable among the three groups (87.5% for the nemonoxacin 500 mg group, 93.8% for the nemonoxacin 750 mg group, and 81.3% for the levofloxacin 500 mg group). Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes. No drug-related serious adverse events occurred. Either 500 mg or 750 mg of oral nemonoxacin taken once daily for 7-10 days demonstrated high clinical and bacteriological success rates in Chinese adult patients with CAP. Nemonoxacin at 500 mg once daily for 7-10 days is recommended for future Phase III clinical trials. ClinicalTrials.gov identifier: NCT01537250. Copyright © 2015. Published by Elsevier B.V.

  2. Multicenter observational prehospital resuscitation on helicopter study.

    Science.gov (United States)

    Holcomb, John B; Swartz, Michael D; DeSantis, Stacia M; Greene, Thomas J; Fox, Erin E; Stein, Deborah M; Bulger, Eileen M; Kerby, Jeffrey D; Goodman, Michael; Schreiber, Martin A; Zielinski, Martin D; O'Keeffe, Terence; Inaba, Kenji; Tomasek, Jeffrey S; Podbielski, Jeanette M; Appana, Savitri N; Yi, Misung; Wade, Charles E

    2017-07-01

    at any time point, although only 10% of the high-risk sample were able to be matched. Because of the unexpected imbalance in systolic blood pressure, Glasgow Coma Scale, and Injury Severity Score between systems with and without blood products on helicopters, matching was limited, and the results of this study are inconclusive. With few units transfused to each patient and small outcome differences between groups, it is likely large, multicenter, randomized studies will be required to detect survival differences in this important population. Level II.

  3. Levobupivacaine for epidural anaesthesia and postoperative analgesia in hip surgery: a multi-center efficacy and safety equivalence study with bupivacaine and ropivacaine

    NARCIS (Netherlands)

    Koch, T.; Fichtner, A.; Schwemmer, U.; Standl, T.; Volk, T.; Engelhard, K.; Stevens, M. F.; Putzke, C.; Scholz, J.; Zenz, M.; Motsch, J.; Hempel, V.; Heinrichs, A.; Zwissler, B.

    2008-01-01

    BACKGROUND AND OBJECTIVES: The aim of this randomized, single blind phase IIIb study was to evaluate the efficacy of 0.5% levobupivacaine versus 0.5% bupivacaine and 0.75% ropivacaine administered as epidural anesthesia and 0.125% levobupivacaine versus 0.125% bupivacaine and 0.2% ropivacaine for

  4. Efficacy and Safety of a Traditional Herbal Medicine, Hochu-ekki-to in the Long-Term Management of Kikyo (Delicate Constitution Patients with Atopic Dermatitis: A 6-Month, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study

    Directory of Open Access Journals (Sweden)

    Hiromi Kobayashi

    2010-01-01

    Full Text Available Hochu-ekki-to is a traditional herbal (Kampo medicine that has been shown to be effective for patients with Kikyo (delicate, easily fatigable, or hypersensitive constitution. Previous case reports have suggested that this herbal drug was effective for a certain subgroup of patients with atopic dermatitis (AD. We aimed to evaluate the efficacy and safety of Hochu-ekki-to in the long-term management of Kikyo patients with AD. In this multicenter, double blind, randomized, placebo-controlled study, 91 Kikyo patients with AD were enrolled. Kikyo condition was evaluated by a questionnaire scoring system. All patients continued their ordinary treatments (topical steroids, topical tacrolimus, emollients or oral antihistamines before and after their protocol entry. Hochu-ekki-to or placebo was orally administered twice daily for 24 weeks. The skin severity scores, total equivalent amount (TEA of topical agents used for AD treatment, prominent efficacy (cases with skin severity score = 0 at the end of the study rate and aggravated rate (more than 50% increase of TEA of topical agents from the beginning of the study were monitored and evaluated. Seventy-seven out of 91 enrolled patients completed the 24-week treatment course (Hochu-ekki-to: n = 37, placebo: n = 40. The TEA of topical agents (steroids and/or tacrolimus was significantly (P < 0.05 lower in the Hochu-ekki-to group than in the placebo group, although the overall skin severity scores were not statistically different. The prominent efficacy rate was 19% (7 of 37 in the Hochu-ekki-to group and 5% (2 of 40 in the placebo group (P = 0.06. The aggravated rate was significantly (P < 0.05 lower in the Hochu-ekki-to group (3%; 1 of 37 than in the placebo group (18%; 7 of 39. Only mild adverse events such as nausea and diarrhea were noted in both groups without statistical difference. This placebo-controlled study demonstrates that Hochu-ekki-to is a useful adjunct to conventional treatments for AD

  5. A phase III, randomized, multi-center, double blind, placebo controlled study of safety and efficacy of lofexidine for relief of symptoms in individuals undergoing inpatient opioid withdrawal.

    Science.gov (United States)

    Gorodetzky, Charles W; Walsh, Sharon L; Martin, Peter R; Saxon, Andrew J; Gullo, Kristen L; Biswas, Kousick

    2017-07-01

    Lofexidine is an alpha-2-adrenergic receptor agonist approved in the United Kingdom (UK) for the treatment of opioid withdrawal symptoms. Lofexidine has demonstrated better efficacy than placebo for reducing opioid withdrawal symptoms in patients undergoing opioid withdrawal with less reported hypotension than clonidine. Designed as an FDA registration trial, this 8-day, randomized, double-blind, placebo-controlled, parallel-group study in 264 patients dependent on short-acting opioids evaluated the efficacy of lofexidine hydrochloride in reducing withdrawal symptoms in patients undergoing opioid withdrawal. The primary efficacy measures were SOWS-Gossop on Day 3 and time-to-dropout. Secondary endpoints included the proportion of participants who were completers; area under the 5-day SOWS-Gossop - time curve (i.e., AUC 1-5 ), and daily mean SOWS-Gossop, OOWS-Handelsman, MCGI (subject and rater), and VAS-E scores. Participants received lofexidine HCl 3.2mg daily in four divided doses or matching placebo on Days 1-5, followed by 2days of placebo. Lofexidine significantly decreased mean Day 3 SOWS scores compared to placebo, 6.32 versus 8.67, respectively, p=0.0212. Fewer lofexidine patients were early terminators compared to placebo (59 versus 80, respectively); and non-completers in the lofexidine group remained in the study longer than those assigned to placebo (p=0.0034). Secondary endpoints consistently favored lofexidine. Lofexidine was well tolerated in this trial. Lofexidine significantly decreased SOWS scores compared to placebo and demonstrated better retention rates in participants undergoing opioid withdrawal. Lofexidine potentially offers a useful non-opioid alternative to treat opioid withdrawal symptoms. Copyright © 2017. Published by Elsevier B.V.

  6. Efficacy and safety of leflunomide in patients with rheumatoid arthritis in real-life clinical practice (results of the Russian multicenter surveillance study

    Directory of Open Access Journals (Sweden)

    R.M. Balabanova

    2014-01-01

    Full Text Available Methotrexate or leflunomide is recommended to be used as the first synthetic disease-modifying anti-rheumatic drug to treat rheumatoid arthri- tis (RA. In 2011, ELAFRA (leflunomide, Haupt Pharma Munster GmbH, Germany; license LP-000804 registered October 3, 2011 was cer- tified and approved in Russia. This surveillance study was aimed at assessing the effectiveness and tolerability of ELAFRA in RA patients in real-life clinical practice. Material and Methods. The study involved patients corresponding to the 1987 RA classification criteria, with varying disease duration. The patients were monitored at 33 Russian medical institutions in March–December 2013. According to the drug label, ELAFRA was prescribed at a dose of 10 mg/day during the first 3 days and subsequently at a dose of 20 mg/day. In case of adverse effects (AEs, the daily dose was recommended to be reduced to 10 mg. The patients were examined before the drug was prescribed; as well as 1, 3, 6 months after therapy was started. The number of painful swollen joints and pain intensity according to the Visual Analog Scale (VAS were assessed. The patients were subjected to laboratory exam- ination (blood test; ESR test; C-reactive protein (CRP test. RA activity was determined using the DAS28 index. AEs were identified. The data on 99 patients (87 females and 12 males; mean age: 51.1±11.1 years; mean disease duration 74.9±65.7 months were used for sta- tistical analysis. Disease activity was moderate in 9 patients and high in 90 patients.Results. Six-month therapy with ELAFRA reduced the mean number of swollen joints from 13.7 to 5.1 and the number of painful joints, from 14.9 to 9.5. VAS pain intensity decreased from 62.7 to 29.6 mm; ESR decreased from 38.8 to 22.18 mm/h; SRP, from 24.9 to 13.0. Low and moderate RA activity according to DAS28 and CDAI indices after treatment was observed in 63 and 46 patients, respectively. No serious AEs have been revealed; non-serious AEs were

  7. A randomized, multicenter, controlled study, comparing efficacy and safety of a new complementary and alternative medicine (CAM) versus Solifenacin Succinate in women with overactive bladder syndrome.

    Science.gov (United States)

    Vecchioli-Scaldazza, Carlo; Morosetti, Carolina; Maruccia, Serena; Casellato, Stefano; Rociola, Wilma; Illiano, Ester; Garofalo, Francesco

    2017-12-31

    To assess efficacy and tolerability of a new complementary and alternative medicine (CAM) consisting of vitamins (C and D), herbal products (cucurbita maxima, capsicum annum, polygonum capsicatum) and amino acid L-Glutammina, in the treatment of female Overactive Bladder syndrome (OAB). 90 consecutive women with OAB symptoms were enrolled in this prospective, randomized, controlled study. Women were divided randomly into two groups of 45 patients each. In group A, women received Solifenacin Succinate (SS), 5 mg. once a day for 12 weeks. In group B, women received CAM, 930 mg, twice daily for 12 weeks. Women were assessed with 3-day micturition diary, Patient Perception of Intensity of Urgency Scale (PPIUS), Overactive Bladder questionnaire Short Form (OAB-q SF) and Patient Global Impression of Improvement questionnaire (PGI-I). 8 patients in group A and 1 patient in group B dropped out from therapy because of side effects. A reduction in the number of daily micturitions, nocturia and episodes of urge incontinence was present with both SS and CAM with statistically highly significant differences, but CAM was significantly more effective than SS. PPIUS and OAB-q SF showed improvements with both SS and CAM with a more significant efficacy of CAM. PGI-I, demonstrated improvements in the two groups of patients with a greater satisfaction expressed by patients treated with CAM. the small number of patients does not permit definitive conclusions; however, the results of the research showed the greater effectiveness and tolerability of CAM.

  8. A randomized, multicenter, controlled study, comparing efficacy and safety of a new complementary and alternative medicine (CAM versus Solifenacin Succinate in women with overactive bladder syndrome

    Directory of Open Access Journals (Sweden)

    Carlo Vecchioli-Scaldazza

    2017-12-01

    Full Text Available Introduction: To assess efficacy and tolerability of a new complementary and alternative medicine (CAM consisting of vitamins (C and D, herbal products (cucurbita maxima, capsicum annum, polygonum capsicatum and amino acid L-Glutammina, in the treatment of female Overactive Bladder syndrome (OAB. Materials and methods: 90 consecutive women with OAB symptoms were enrolled in this prospective, randomized, controlled study. Women were divided randomly into two groups of 45 patients each. In group A, women received Solifenacin Succinate (SS, 5 mg. once a day for 12 weeks. In group B, women received CAM, 930 mg, twice daily for 12 weeks. Women were assessed with 3-day micturition diary, Patient Perception of Intensity of Urgency Scale (PPIUS, Overactive Bladder questionnaire Short Form (OAB-q SF and Patient Global Impression of Improvement questionnaire (PGI-I. Results: 8 patients in group A and 1 patient in group B dropped out from therapy because of side effects. A reduction in the number of daily micturitions, nocturia and episodes of urge incontinence was present with both SS and CAM with statistically highly significant differences, but CAM was significantly more effective than SS. PPIUS and OAB-q SF showed improvements with both SS and CAM with a more significant efficacy of CAM. PGI-I, demonstrated improvements in the two groups of patients with a greater satisfaction expressed by patients treated with CAM. Conclusions: the small number of patients does not permit definitive conclusions; however, the results of the research showed the greater effectiveness and tolerability of CAM.

  9. Stakeholders' views on data sharing in multicenter studies.

    Science.gov (United States)

    Mazor, Kathleen M; Richards, Allison; Gallagher, Mia; Arterburn, David E; Raebel, Marsha A; Nowell, W Benjamin; Curtis, Jeffrey R; Paolino, Andrea R; Toh, Sengwee

    2017-09-01

    To understand stakeholders' views on data sharing in multicenter comparative effectiveness research studies and the value of privacy-protecting methods. Semistructured interviews with five US stakeholder groups. We completed 11 interviews, involving patients (n = 15), researchers (n = 10), Institutional Review Board and regulatory staff (n = 3), multicenter research governance experts (n = 2) and healthcare system leaders (n = 4). Perceptions of the benefits and value of research were the strongest influences toward data sharing; cost and security risks were primary influences against sharing. Privacy-protecting methods that share summary-level data were acknowledged as being appealing, but there were concerns about increased cost and potential loss of research validity. Stakeholders were open to data sharing in multicenter studies that offer value and minimize security risks.

  10. Safety of Percutaneous Patent Ductus Arteriosus Closure: An Unselected Multicenter Population Experience

    Science.gov (United States)

    El‐Said, Howaida G.; Bratincsak, Andras; Foerster, Susan R.; Murphy, Joshua J.; Vincent, Julie; Holzer, Ralf; Porras, Diego; Moore, John; Bergersen, Lisa

    2013-01-01

    Background The technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences. Methods and Results Outcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and June 2010, 496 PDA closures were recorded using a device in 338 (68%) or coils in 158 (32%). Most patients had an isolated PDA (90%). Fifty percent of patients were between 6 months and 3 years old, with only 40 patients (8%) closure and 1 mm (range 0.5 to 6 mm; IQR 1 to 2 mm) for coil closure (P2 mm (all P1.5 mm. In 9% of cases (n=46), an AE occurred; however, only 11 (2%) were classified as high severity. Younger age was associated with a higher AE rate. Coil‐related AEs were more common than device‐related AEs (10% versus 2%, Pclosure in the present era has a very low rate of complications, although these are higher in younger children. Technical intervention‐related events were more common in coil procedures compared with device procedures. For PDAs ≤2.5 mm in diameter, institutional differences in preference for device versus coil exist. PMID:24284214

  11. Internalized stigma in psoriasis: A multicenter study.

    Science.gov (United States)

    Alpsoy, Erkan; Polat, Mualla; FettahlıoGlu-Karaman, Bilge; Karadag, Ayse Serap; Kartal-Durmazlar, Pelin; YalCın, Basak; Emre, Selma; Didar-Balcı, Didem; Bilgic-Temel, Asli; Arca, Ercan; Koca, Rafet; Gunduz, Kamer; Borlu, Murat; Ergun, Tulin; Dogruk-Kacar, Seval; Cordan-Yazici, Ayca; Dursun, Pınar; BilgiC, Ozlem; Gunes-Bilgili, Serap; Sendur, Neslihan; Baysal, Ozge; Halil-Yavuz, Ibrahim; Yagcioglu, Gizem; Yilmaz, Ertan; Kavuzlu, Ufuk; Senol, Yesim

    2017-08-01

    Internalized stigma is the adoption of negative attitudes and stereotypes of the society regarding a person's illness. It causes decreased self-esteem and life-satisfaction, increased depression and suicidality, and difficulty in coping with the illness. The primary aim of this study was to investigate the internalized stigma state of psoriatic patients and to identify the factors influencing internalized stigma. The secondary aim was to identify the correlation of internalized stigma with quality of life and perceived health status. This multicentre, cross-sectional study comprised 1485 patients. There was a significant positive correlation between mean values of Psoriasis Internalized Stigma Scale (PISS) and Psoriasis Area and Severity Index, Body Surface Area, Dermatological Life Quality Index and General Health Questionnaire-12 (P psoriasis (P = 0.016), family history of psoriasis (P = 0.0034), being illiterate (P psoriasis. Involvement of scalp, face, hand, genitalia and finger nails as well as arthropathic and inverse psoriasis were also related to significantly higher PISS scores (P = 0.001). Our findings imply that psoriatic patients experience high levels of internalized stigma which are associated with psoriasis severity, involvement of visible body parts, genital area, folds or joints, poorer quality of life, negative perceptions of general health and psychological illnesses. Therefore, internalized stigma may be one of the major factors responsible from psychosocial burden of the disease. © 2017 Japanese Dermatological Association.

  12. Efficacy and safety of 1 % terbinafine film-forming solution in Chinese patients with tinea pedis: a randomized, double-blind, placebo-controlled, multicenter, parallel-group study.

    Science.gov (United States)

    Li, Ruo Yu; Wang, A P; Xu, J H; Xi, L Y; Fu, M H; Zhu, M; Xu, M L; Li, X Q; Lai, W; Liu, W D; Lu, X Y; Gong, Z Q

    2014-03-01

    Superficial fungal skin infections are treated using topical antifungals. The aim of this study was to demonstrate the efficacy of a single application of 1 % terbinafine film-forming solution (FFS) versus placebo for the treatment of tinea pedis in the Chinese population. Six centers in China randomized 290 patients in a 1:1 ratio to receive either 1 % terbinafine FFS or FFS vehicle (placebo) once on the affected foot/feet. Efficacy assessments included microscopy and mycologic culture, and assessing clinical signs and symptoms at baseline, and at weeks 1 and 6 after the topical treatment. All adverse events were recorded. At week 6, 1 % terbinafine FFS was superior to placebo for effective treatment rate (63 vs. 8 %); clinical cure (30 vs. 6 %); mycological cure (86 vs. 12 %); negative microscopy (90 vs. 24 %); and negative mycological culture (90 vs. 27 %): all p ≤ 0.001 and clinically relevant. At week 6, 1 % terbinafine FFS was clinically superior to placebo for the absence of: erythema (69 vs. 29 %); desquamation (33 vs. 8 %); and pruritus (70 vs. 30 %): all p ≤ 0.001 and clinically relevant. At week 6, differences in the average total signs and symptoms scores were significantly lower for 1 % terbinafine FFS versus placebo (p ≤ 0.001). Both 1 % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments. This double-blind, randomized, multicenter study demonstrated one single topical application of 1 % terbinafine FFS was safe and effective in the treatment of tinea pedis in the Chinese population.

  13. Intraoperative Death During Cervical Spinal Surgery: A Retrospective Multicenter Study.

    Science.gov (United States)

    Wang, Jeffrey C; Buser, Zorica; Fish, David E; Lord, Elizabeth L; Roe, Allison K; Chatterjee, Dhananjay; Gee, Erica L; Mayer, Erik N; Yanez, Marisa Y; McBride, Owen J; Cha, Peter I; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel

    2017-04-01

    A retrospective multicenter study. Routine cervical spine surgeries are typically associated with low complication rates, but serious complications can occur. Intraoperative death is a very rare complication and there is no literature on its incidence. The purpose of this study was to determine the intraoperative mortality rates and associated risk factors in patients undergoing cervical spine surgery. Twenty-one surgical centers from the AOSpine North America Clinical Research Network participated in the study. Medical records of patients who received cervical spine surgery from January 1, 2005, to December 31, 2011, were reviewed to identify occurrence of intraoperative death. A total of 258 patients across 21 centers met the inclusion criteria. Most of the surgeries were done using the anterior approach (53.9%), followed by posterior (39.1%) and circumferential (7%). Average patient age was 57.1 ± 13.2 years, and there were more male patients (54.7% male and 45.3% female). There was no case of intraoperative death. Death during cervical spine surgery is a very rare complication. In our multicenter study, there was a 0% mortality rate. Using an adequate surgical approach for patient diagnosis and comorbidities may be the reason how the occurrence of this catastrophic adverse event was prevented in our patient population.

  14. Chest radiographic data acquisition and quality assurance in multicenter studies

    International Nuclear Information System (INIS)

    Cleveland, R.H.; Schluchter, M.; Easley, K.A.; Wood, B.P.; Berdon, W.E.; Boechat, M.I.; Meziane, M.; Mellins, R.B.; Norton, K.I.; Singleton, E.; Trautwein, L.

    1997-01-01

    Background. Multicenter studies rely on data derived from different institutions. Forms can be designed to standardize the reporting process allowing reliable comparison of data. Objective. The purpose of the report is to provide a standardized method, developed as a part of a multicenter study of vertically transmitted HIV, for assessing chest radiographic results. Materials and methods. Eight hundred and five infants and children were studied at five centers; 3057 chest radiographs were scored. Data were entered using a forced-choice, graded response for 12 findings. Quality assurance measures and inter-rater agreement statistics are reported. Results. The form used for reporting chest radiographic results is presented. Inter-rater agreement was moderate to high for most findings, with the best correlation reported for the presence of bronchovascular markings and/or reticular densities addressed as a composite question (kappa = 0.71). The presence of nodular densities (kappa 0.56) and parenchymal consolidation (kappa = 0.57) had moderate agreement. Agreement for lung volume was low. Conclusion. The current tool, developed for use in the pediatric population, is applicable to any study involving the assessment of pediatric chest radiographs for a large population, whether at one or many centers. (orig.)

  15. Effectiveness and Safety of MLC601 in the Treatment of Mild to Moderate Alzheimer's Disease: A Multicenter, Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hossein Pakdaman

    2015-03-01

    Full Text Available Background: MLC601 is a possible modulator of amyloid precursor protein processing, and in a clinical trial study MLC601 showed some effectiveness in cognitive function in Alzheimer's disease (AD patients. We aimed to evaluate the effectiveness and safety of MLC601 in the treatment of mild to moderate AD as compared to 3 approved cholinesterase inhibitors (ChEIs including donepezil, rivastigmine and galantamine. Methods: In a multicenter, nonblinded, randomized controlled trial, 264 volunteers with AD were randomly divided into 4 groups of 66; groups 1, 2, 3 and 4 received donepezil, rivastigmine, MLC601 and galantamine, respectively. Subjects underwent a clinical diagnostic interview and a cognitive/functional battery including the Mini-Mental State Examination (MMSE and Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog. Patients were visited every 4 months, and the score of cognition was recorded by the neurologists. Results: There were no significant differences in age, sex, marital status and baseline score of cognition among the 4 groups. In total, 39 patients (14.7% left the study. Trend of cognition changes based on the modifications over the time for MMSE and ADAS-cog scores did not differ significantly among groups (p = 0.92 for MMSE and p = 0.87 for ADAS-Cog. Conclusion: MLC601 showed a promising safety profile and also efficacy compared to 3 FDA-approved ChEIs.

  16. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.

    Directory of Open Access Journals (Sweden)

    Xingsheng Hu

    Full Text Available Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC previously treated with platinum-based chemotherapy.Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day. The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety.From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m and 5.4 months (95%CI 3.1-7.9 m, respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127, diarrhea (12.6%, 16/127 and elevation of transaminase (15.7%, 20/127.In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy.ClinicalTrials.gov NCT02486354.

  17. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study.

    Science.gov (United States)

    Hu, Xingsheng; Zhang, Li; Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

    2015-01-01

    Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125 mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9-6.6 m) and 5.4 months (95%CI 3.1-7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. ClinicalTrials.gov NCT02486354.

  18. Descriptive epidemiology of the Multicenter ACL Revision Study (MARS) cohort.

    Science.gov (United States)

    Wright, Rick W; Huston, Laura J; Spindler, Kurt P; Dunn, Warren R; Haas, Amanda K; Allen, Christina R; Cooper, Daniel E; DeBerardino, Thomas M; Lantz, Brett Brick A; Mann, Barton J; Stuart, Michael J

    2010-10-01

    Revision anterior cruciate ligament (ACL) reconstruction has worse outcomes than primary reconstructions. Predictors for these worse outcomes are not known. The Multicenter ACL Revision Study (MARS) Group was developed to perform a multisurgeon, multicenter prospective longitudinal study to obtain sufficient subjects to allow multivariable analysis to determine predictors of clinical outcome. To describe the formation of MARS and provide descriptive analysis of patient demographics and clinical features for the initial 460 enrolled patients to date in this prospective cohort. Cross-sectional study; Level of evidence, 2. After training and institutional review board approval, surgeons began enrolling patients undergoing revision ACL reconstruction, recording patient demographics, previous ACL reconstruction methods, intra-articular injuries, and current revision techniques. Enrolled subjects completed a questionnaire consisting of validated patient-based outcome measures. As of April 1, 2009, 87 surgeons have enrolled a total of 460 patients (57% men; median age, 26 years). For 89%, the reconstruction was the first revision. Mode of failure as deemed by the revising surgeon was traumatic (32%), technical (24%), biologic (7%), combination (37%), infection (MARS Group has been able to quickly accumulate the largest revision ACL reconstruction cohort reported to date. Traumatic reinjury is deemed by surgeons to be the most common single mode of failure, but a combination of factors represents the most common mode of failure. Allograft graft choice is more common in the revision setting than autograft. Concomitant knee injury is extremely common in this population.

  19. A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA Smallpox Vaccine (IMVAMUNE in 18-40 Year Old Subjects with Diagnosed Atopic Dermatitis.

    Directory of Open Access Journals (Sweden)

    Richard N Greenberg

    Full Text Available Replicating smallpox vaccines can cause severe complications in individuals with atopic dermatitis (AD. Prior studies evaluating Modified Vaccinia Ankara virus (MVA, a non-replicating vaccine in humans, showed a favorable safety and immunogenicity profile in healthy volunteers.This Phase II study compared the safety and immunogenicity of MVA enrolling groups of 350 subjects with AD (SCORAD ≤ 30 and 282 healthy subjects.Subjects were vaccinated twice with MVA, each dose given subcutaneously 4 weeks apart. Adverse events, cardiac parameters, and the development of vaccinia virus humoral immune responses were monitored.The overall safety of the vaccine was similar in both groups. Adverse events affecting skin were experienced significantly more often in subjects with AD, but the majority of these events were mild to moderate in intensity. Seroconversion rates and geometric mean titers for total and neutralizing vaccinia-specific antibodies in the AD group were non-inferior compared to the healthy subjects.The size of the study population limited the detection of serious adverse events occurring at a frequency less than 1%.MVA has a favorable safety profile and the ability to elicit vaccinia-specific immune responses in subjects with AD.ClinicalTrials.gov NCT00316602.

  20. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  1. Long-term efficacy and safety of prophylaxis with recombinant factor VIII in Chinese pediatric patients with hemophilia A: a multi-center, retrospective, non-interventional, phase IV (ReCARE) study.

    Science.gov (United States)

    Li, Changgang; Zhang, Xinsheng; Zhao, Yongqiang; Wu, Runhui; Hu, Qun; Xu, Weiqun; Sun, Jing; Yang, Renchi; Li, Xiaojing; Zhou, Rongfu; Lian, Shinmei; Gu, Jian; Wu, Junde; Hou, Qingsong

    2017-07-01

    The first recombinant factor VIII (rFVIII) product was launched in China in 2007. However, until now, no study has been conducted to describe the efficacy and safety of prophylaxis with rFVIII in Chinese pediatric patients with hemophilia A (HA). To summarize the efficacy and safety data on prophylaxis with rFVIII in Chinese pediatric patients with HA. ReCARE (Retrospective study in Chinese pediatric hemophilia A patients with rFVIII contained regular prophylaxis) was a retrospective study conducted in 12 hemophilia treatment centers (HTCs) across China. The primary endpoints included reduction in annualized bleeding rate (ABR); the secondary endpoints included evaluation of joint function (number and sites of target joints) using Gilbert score and Hemophilia Joint Health Score (HJHS), quality of life (QoL) and factors affecting treatment choices. Safety assessment of rFVIII was also conducted. We analyzed a total of 183 male pediatric patients (mean age, 7.1 ± 4.23 years) who received prophylaxis between 1 November 2007 and 31 May 2013. Compared with baseline, prophylaxis with rFVIII significantly reduced overall annualized joint bleed rate (AJBR) (p < .001) and ABR (p < .001). Inhibitor formation was reported in 5 (2.7%) patients and hemarthrosis was reported in 1 patient. The mean number of target joints was positively related to age (p < .001) and weight (p = .003) at baseline. Responses from survey questionnaires reported that effective bleeding control, joint protection, improvement in quality of life, favorable medical insurance policies, and economic capability were reasons for choosing prophylaxis. Prophylaxis with rFVIII reduced bleeding and number of target joints, even with a low-dose regimen, in Chinese pediatric patients with HA. Other than the efficacy and safety, factors such as poor disease control, improved economic stability and stable financial support made prophylaxis as an attractive treatment option. ClinicalTrials.gov ID

  2. Quality of life after neck dissection. Multicenter study

    International Nuclear Information System (INIS)

    Nibu, Ken-ichi; Onitsuka, Tetsuo; Kawabata, Kazuyoshi

    2010-01-01

    To assess the impact of modifications to radical neck dissection and radiotherapy on the postoperative quality of life, the study group 'Study on Standardization of Treatment for Lymph Node Metastasis of Head and Neck Cancer' performed a multicenter cross-sectional study using our self-administered neck dissection questionnaire and arm abduction test. While sparing levels IV and V improved most postoperative symptoms, such as stiffness and constriction of the neck were avoided as long as the sternocleidmastoid muscle (SCM) and the spinal accessory nerve were preserved. Resection of the SCM and spinal accessory nerve resulted in a drop shoulder and neck pain, respectively. Irradiation with a total dose of 50 Gy or more worsened stiffness of neck and shoulder. (author)

  3. A national multicenter registration study. Omalizumb in children in Denmark

    DEFF Research Database (Denmark)

    Spangberg, Katrien; Jørgensen, Inger Merete; Agertoft, Lone

    Background: In Denmark, Omalizumab is approved to treat children with severe persistent allergic asthma older than 6 years of age. No systematic registration of the efficacy in the Danish child population according to asthma symptoms or of the efficacy on co-morbid allergic symptoms exists. Results...... from a pilot study show that a broad panel of outcome measures is necessary to evaluate the efficacy of Omalizumab treatment as no change in lung function could be demonstrated Aim: To provide a standardized systematic registration in order to create a database enrolling children with severe allergic...... asthma treated with Omalizumab. Method and study design: A national multicenter registration and follow-up study based on children with clinical persistent severe allergic asthma including both retrospective and prospective registration. Inclusion criteria: • 6-18 years of age. • Severe persistent...

  4. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  5. A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch

    DEFF Research Database (Denmark)

    Berrevoet, Frederik; Doerhoff, Carl; Muysoms, Filip

    2017-01-01

    PURPOSE: This study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (Parietex™ Composite Ventral Patch [PCO-VP]). PATIENTS AND METHODS: A single-arm, multicenter prospective study of 126 patients undergoing...

  6. Gabapentin in traumatic nerve injury pain: A randomized, double-blind, placebo-controlled, cross-over, multi-center study

    DEFF Research Database (Denmark)

    Gordh, Torsten E; Stubhaug, Audun; Jensen, Troels S

    2008-01-01

    A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400mg/day. The study comprised a run...

  7. Studies of kinematic elements in two multicenter sunspot groups

    International Nuclear Information System (INIS)

    Korobova, Z.B.

    1983-01-01

    Some features of kinematic elements (KE) in two multicenter sunspot groups were studied using Tashkent full-disc white light heliograms. KE and morphological elements do not reveal any relationship. A KE coincides with a unipolar or multipolar spot or with part of a spot. It may also contain an extended stream including several spots. Relation of KE to large-scale photospheric magnetic fields is less clear. The line of polarity reversal is, in most cases, the deviding line between two adjacent KE. At the same time, a KE can contain spots of both polarities. Sunspot trajectories in the leading polarity regions show the best similarity. Interactions of KE are greatly influenced by the meridional drift. (author)

  8. Safety study application guide

    International Nuclear Information System (INIS)

    1993-07-01

    Martin Marietta Energy Systems, Inc., (Energy Systems) is committed to performing and documenting safety analyses for facilities it manages for the Department of Energy (DOE). Included are analyses of existing facilities done under the aegis of the Safety Analysis Report Upgrade Program, and analyses of new and modified facilities. A graded approach is used wherein the level of analysis and documentation for each facility is commensurate with the magnitude of the hazard(s), the complexity of the facility and the stage of the facility life cycle. Safety analysis reports (SARs) for hazard Category 1 and 2 facilities are usually detailed and extensive because these categories are associated with public health and safety risk. SARs for Category 3 are normally much less extensive because the risk to public health and safety is slight. At Energy Systems, safety studies are the name given to SARs for Category 3 (formerly open-quotes lowclose quotes) facilities. Safety studies are the appropriate instrument when on-site risks are limited to irreversible consequences to a few people, and off-site consequences are limited to reversible consequences to a few people. This application guide provides detailed instructions for performing safety studies that meet the requirements of DOE Orders 5480.22, open-quotes Technical Safety Requirements,close quotes and 5480.23, open-quotes Nuclear Safety Analysis Reports.close quotes A seven-chapter format has been adopted for safety studies. This format allows for discussion of all the items required by DOE Order 5480.23 and for the discussions to be readily traceable to the listing in the order. The chapter titles are: (1) Introduction and Summary, (2) Site, (3) Facility Description, (4) Safety Basis, (5) Hazardous Material Management, (6) Management, Organization, and Institutional Safety Provisions, and (7) Accident Analysis

  9. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBACCA) nested within a compassionate use program

    International Nuclear Information System (INIS)

    Adenis, Antoine; Fouchardiere, Christelle de la; Paule, Bernard; Burtin, Pascal; Tougeron, David; Wallet, Jennifer; Dourthe, Louis-Marie; Etienne, Pierre-Luc; Mineur, Laurent; Clisant, Stéphanie; Phelip, Jean-Marc; Kramar, Andrew; Andre, Thierry

    2016-01-01

    Randomized trials have shown a survival benefit for regorafenib over placebo in patients with metastatic colorectal cancer (mCRC) that progressed after standard therapies. We evaluated survival and safety outcomes in patients treated with regorafenib in a real-life setting. REBECCA is a cohort study nested within a compassionate use program designed to evaluate survival, safety, and potential prognostic factors for outcome associated with regorafenib in patients with mCRC refractory to standard therapies. Treatment effects according to various patient and tumour characteristics were evaluated using univariate and multivariate Cox proportional hazards regression models. Of 1178 patients in the compassionate use program, 654 were in the full analysis set. Median follow-up was 16.5 months. Median survival was 5.6 months. The 12-month survival rate was 22 %. Survival was independently and unfavourably affected by the following variables: poor performance status, short time from initial diagnosis of metastases to the start of regorafenib, low initial regorafenib dose, >3 metastatic sites, presence of liver metastases, and KRAS mutations. We identified prognostic groups of patients with low, intermediate, and high risk of death, with a median survival of 9.2, 5.2, and 2.5 months, respectively. Five-hundred-twenty-four patients (80 %) experienced at least one regorafenib-related adverse event, most commonly, fatigue, hand-foot skin reaction, diarrhea, anorexia, arterial hypertension, and mucositis. The safety and efficacy profile of regorafenib in REBECCA are similar to those in randomized trials. Our prognostic model identified subgroups of mCRC patients who derived a minimal and maximum benefit from regorafenib. Clinicaltrials.gov: NCT02310477

  10. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study.

    Science.gov (United States)

    Lal, Himal; Poder, Airi; Campora, Laura; Geeraerts, Brecht; Oostvogels, Lidia; Vanden Abeele, Carline; Heineman, Thomas C

    2018-01-02

    In phase III trials, 2 doses of a herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01 B Adjuvant System) administered 2-months apart in older adults (≥50 and ≥70 years) demonstrated >90% efficacy in preventing HZ and had a clinically acceptable safety profile. Here we report immunogenicity, reactogenicity and safety following administration of 2 HZ/su doses at intervals longer than 2 months. In this Phase III, open-label trial conducted in the US and Estonia, 354 adults ≥50 years were randomized 1:1:1 to receive 2 HZ/su doses 2, 6, or 12 months apart. gE-specific humoral immune responses were evaluated at pre-vaccination, 1 and 12 months post-dose 2. Co-primary objectives were to compare immune responses to HZ/su 1 month post-dose 2 when given 6-months or 12-months apart to those administered 2-months apart. For each participant, safety information was collected from dose 1 to 12 months post-dose 2. 346 participants completed the study and 343 were included in the according-to-protocol cohort for immunogenicity. One month post-dose 2, vaccine response rates were 96.5% (97.5% confidence interval [CI]: 90.4; 99.2) and 94.5% (97.5% CI: 87.6; 98.3) for the 0, 6- and 0, 12-month schedules, respectively, both schedules meeting the pre-defined criterion. Non-inferiority of anti-gE geometric mean concentrations was demonstrated for HZ/su administered on 0, 6-month compared to a 0, 2-month schedule; however, HZ/su administered on a 0, 12-month schedule did not meet the non-inferiority criterion. Injection site pain was the most commonly reported solicited adverse event (AE). 26 participants each reported at least 1 serious AE; none were assessed as related to vaccination. Immune responses to HZ/su administered at 0, 6-month were non-inferior to those elicited by a 0, 2-month schedule. HZ/su exhibited a clinically acceptable safety profile for all dosing intervals. Clinicaltrials.gov (NCT01751165

  11. Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III, randomized, observer-blind, multicenter, parallel-group study.

    Science.gov (United States)

    Togashi, Takehiro; Mitsuya, Nodoka; Kogawara, Osamu; Sumino, Shuji; Takanami, Yohei; Sugizaki, Kayoko

    2016-08-31

    Broad use of monovalent Haemophilus influenzae type b (Hib) conjugate vaccines based on the capsular polysaccharide polyribosyl-ribitol phosphate (PRP), has significantly reduced invasive Hib disease burden in children worldwide, particularly in children aged vaccine has been widely used since the initiation of public funding programs followed by a routine vaccination designation in 2013. We compared the immunogenicity and safety of PRP conjugated to a non-toxic diphtheria toxin mutant (PRP-CRM197) vaccine with the PRP-T vaccine when administered subcutaneously to healthy Japanese children in a phase III study. Additionally, we evaluated the immunogenicity and safety profiles of a diphtheria-tetanus acellular pertussis (DTaP) combination vaccine when concomitantly administered with either PRP-CRM197 or PRP-T vaccines. The primary endpoint was the "long-term seroprotection rate", defined as the group proportion with anti-PRP antibody titers ⩾1.0μg/mL, after the primary series. Long-term seroprotection rates were 99.3% in the PRP-CRM197 group and 95.6% in the PRP-T group. The intergroup difference (PRP-CRM197 group - PRP-T group) was 3.7% (95% confidence interval: 0.099-7.336), demonstrating that PRP-CRM197 vaccine was non-inferior to PRP-T vaccine (pvaccination was higher in the PRP-CRM197 group than in PRP-T. Concomitant administration of PRP-CRM197 vaccine with DTaP vaccine showed no differences in terms of immunogenicity compared with concomitant vaccination with PRP-T vaccine and DTaP vaccine. Although CRM197 vaccine had higher local reactogenicity, overall, both Hib vaccines had acceptable safety and tolerability profiles. The immunogenicity of PRP-CRM197 vaccine administered subcutaneously as a three-dose primary series in children followed by a booster vaccination 1year after the primary series induced protective levels of Hib antibodies with no safety or tolerability concerns. Registered on ClinicalTrials.gov: NCT01379846. Copyright © 2016 The Authors

  12. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair - A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Safety and Feasibility.

    Science.gov (United States)

    Greiner, Stefan; Ide, Junji; Van Noort, Arthur; Mochizuki, Yu; Ochi, Hiroshi; Marraffino, Shannon; Sridharan, Sudhakar; Rudicel, Sally; Itoi, Eiji

    2015-08-01

    Recombinant human bone morphogenetic protein-12 (rhBMP-12) has been shown to induce tendon and ligament formation in rats and to improve tendon healing; however, the safety and feasibility of implanting rhBMP-12/absorbable collagen sponge (ACS) in humans are not known. To investigate the safety and feasibility of rhBMP-12 on an ACS as an adjuvant therapy in open rotator cuff repair. Randomized controlled trial; Level of evidence, 2. This study consisted of 20 patients with full-thickness rotator cuff tears. Patients were randomized either to standard of care (SOC) treatment (open rotator cuff repair) or to receive 0.015 mg/mL rhBMP-12/ACS and SOC treatment during their open rotator cuff repair (rhBMP-12/ACS group) at a rate of 1/4 SOC/rhBMP-12/ACS. The feasibility of implanting the product and the safety of the product were evaluated during the 1-year follow-up period. The evaluation involved up to 10 postoperative visits, which included physical examinations, radiographs, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans with an emphasis on heterotopic ossification (HO), pharmacokinetics, immunogenicity, laboratory evaluations, and local and systemic adverse events at specified time points. Small amounts of HO were seen on follow-up CT scans in 10 of 16 patients in the rhBMP-12/ACS group and in 2 of 3 patients in the SOC group. HO did not increase at 26 weeks and was not associated with any adverse events or unsatisfactory clinical outcomes. Pharmacokinetics demonstrated that circulating levels of rhBMP-12 were not detectable after administration. Five of 16 patients showed a postoperative immunogenic response but did not show any correlating adverse events. Complete healing of the rotator cuff was observed in 14 of 16 patients; 2 of 16 imaging results could not be analyzed because of artifacts in the rhBMP-12 group on MRI scans. In the SOC group, 1 of 4 patients showed a retear at 12 weeks after surgery. The use of rhBMP-12/ACS has been shown

  13. Efficacy and safety profile of a topical methyl salicylate and menthol patch in adult patients with mild to moderate muscle strain: a randomized, double-blind, parallel-group, placebo-controlled, multicenter study.

    Science.gov (United States)

    Higashi, Yoshinobu; Kiuchi, Takehito; Furuta, Kenichi

    2010-01-01

    An occlusive patch formulation containing 10% methyl salicylate and 3% l-menthol was recently approved by the US Food and Drug Administration for the treatment of mild to moderate pain. Despite widespread use of counterirritants, including methyl salicylate and menthol, for topical pain relief, published efficacy and safety data regarding the use of the agents alone or in combination are limited. The goal of this study was to determine the efficacy and safety profile of a patch containing 10% methyl salicylate and 3% l-menthol compared with a placebo patch in adult patients with mild to moderate muscle strain. Eligible patients were men or women aged >or=18 years with a clinical diagnosis of mild to moderate muscle strain. Patients were randomly assigned to receive either 1 active patch or 1 placebo patch applied to the skin at the affected area (ie, shoulder, upper back, upper arm, neck, calf, thigh, forearm, abdomen). Pain intensity was assessed on a 100-mm visual analog scale while at rest and with movement for 12 hours after patch application. The primary efficacy end point was the summed pain intensity difference score through 8 hours (SPID8) with movement. Analyses included use of descriptive statistics and an ANOVA model. Safety data, including adverse events, and secondary efficacy end points were also evaluated. A total of 208 patients (104 men, 104 women; age range, 18-78 years) were randomized to 1 of 2 study groups (105 in the active-patch group [mean age, 37.3 years], 103 in the placebo-patch group [mean age, 38.1 years]). The primary efficacy analysis (SPID8 with movement) indicated that patients receiving the active patch experienced significantly greater pain relief (approximately 40%) than those patients receiving a placebo patch (mean [SD], 182.6 [131.2] vs 130.1 [144.1]; P = 0.005). Analysis of the per-protocol population also found significantly more relief (P = 0.024) in the active-patch group (176.2 [131.4]; n = 92) versus the placebo

  14. Report of a Brazilian multicenter study on nephropathic cystinosis.

    Science.gov (United States)

    Vaisbich, Maria Helena; Koch, Vera H

    2010-01-01

    The Brazilian Multicenter Nephropathic Study Group, founded in 1999, is currently composed of 16 pediatric nephrology units, which are coordinated by the Pediatric Nephrology Unit of Instituto da Criança--HCFMUSP. This Study Group intends to better know our patients, their special characteristics and facilitates the treatment. To present an update on the demographics of the ongoing study participants with interest on renal function status, response to therapy, and extra-renal complications. Patient recruitment to the study is based on informed consent and has been supported by the Brazilian Society of Nephrology, by the creation of an electronic homepage and by the participation in medical meetings and publications in medical periodicals. Our study protocol involves the initial and follow-up questionnaire, the measurement of intraleukocyte cystine content, initiation and follow-up therapy with cysteamine, and clinical patient follow-up based on a protocol of subsidiary exams. We identified 102 patients (42 females) with nephropathic cystinosis in Brazil since 1999. Forty-six children are followed at the Instituto da Criança/SP, 15 at the Hospital Pequeno Príncipe/PR, 12 at the UNICAMP/SP, 10 at the Unidade de Transplante Renal - HCFMUSP/SP and 3 at the Santa Casa/SP; the remaining patients are followed at the Instituto da Criança and at their respective doctors' offices in different nephrology services in Brazil. Of these patients, 23/102 (22.5%) have normal renal function, 19/102 (18.6%) are in chronic renal failure with conservative treatment, 26/102 are on dialysis (18 on peritoneal dialysis and 8 on hemodialysis), and 34/102 received a renal transplant. The extra-renal involvement diagnosed was: hypothyroidism in 63 patients, diabetes mellitus in 8 patients, muscular involvement in 7 patients, a compromised central nervous system in 5 patients, hepatic complications in 5 patients, and deglutition dysfunction in 2 patients. During this period, 10

  15. Palbociclib in Combination With Fulvestrant in Women With Hormone Receptor-Positive/HER2-Negative Advanced Metastatic Breast Cancer: Detailed Safety Analysis From a Multicenter, Randomized, Placebo-Controlled, Phase III Study (PALOMA-3).

    Science.gov (United States)

    Verma, Sunil; Bartlett, Cynthia Huang; Schnell, Patrick; DeMichele, Angela M; Loi, Sherene; Ro, Jungsil; Colleoni, Marco; Iwata, Hiroji; Harbeck, Nadia; Cristofanilli, Massimo; Zhang, Ke; Thiele, Alexandra; Turner, Nicholas C; Rugo, Hope S

    2016-10-01

    Palbociclib enhances endocrine therapy and improves clinical outcomes in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Because this is a new target, it is clinically important to understand palbociclib's safety profile to effectively manage toxicity and optimize clinical benefit. Patients with endocrine-resistant, HR-positive/HER2-negative MBC (n = 521) were randomly assigned 2:1 to receive fulvestrant (500 mg intramuscular injection) with or without goserelin with oral palbociclib (125 mg daily; 3 weeks on/1 week off) or placebo. Safety assessments at baseline and day 1 of each cycle included blood counts on day 15 for the first 2 cycles. Hematologic toxicity was assessed by using laboratory data. A total of 517 patients were treated (palbociclib, n = 345; placebo, n = 172); median follow-up was 8.9 months. With palbociclib, neutropenia was the most common grade 3 (55%) and 4 (10%) adverse event; median times to onset and duration of grade ≥3 episodes were 16 and 7 days, respectively. Asian ethnicity and below-median neutrophil counts at baseline were significantly associated with an increased chance of developing grade 3-4 neutropenia with palbociclib. Dose modifications for grade 3-4 neutropenia had no adverse effect on progression-free survival. In the palbociclib arm, febrile neutropenia occurred in 3 (<1%) patients. The percentage of grade 1-2 infections was higher than in the placebo arm. Grade 1 stomatitis occurred in 8% of patients. Palbociclib plus fulvestrant treatment was well-tolerated, and the primary toxicity of asymptomatic neutropenia was effectively managed by dose modification without apparent loss of efficacy. This study appears at ClinicalTrials.gov, NCT01942135. Treatment with palbociclib in combination with fulvestrant was generally safe and well-tolerated in patients with hormone receptor (HR)-positive metastatic breast cancer. Consistent with the drug's proposed

  16. Economic Impact of Dengue: Multicenter Study across Four Brazilian Regions

    Science.gov (United States)

    Martelli, Celina Maria Turchi; Siqueira, Joao Bosco; Parente, Mirian Perpetua Palha Dias; Zara, Ana Laura de Sene Amancio; Oliveira, Consuelo Silva; Braga, Cynthia; Pimenta, Fabiano Geraldo; Cortes, Fanny; Lopez, Juan Guillermo; Bahia, Luciana Ribeiro; Mendes, Marcia Costa Ooteman; da Rosa, Michelle Quarti Machado; de Siqueira Filha, Noemia Teixeira; Constenla, Dagna; de Souza, Wayner Vieira

    2015-01-01

    Background Dengue is an increasing public health concern in Brazil. There is a need for an updated evaluation of the economic impact of dengue within the country. We undertook this multicenter study to evaluate the economic burden of dengue in Brazil. Methods We estimated the economic burden of dengue in Brazil for the years 2009 to 2013 and for the epidemic season of August 2012- September 2013. We conducted a multicenter cohort study across four endemic regions: Midwest, Goiania; Southeast, Belo Horizonte and Rio de Janeiro; Northeast: Teresina and Recife; and the North, Belem. Ambulatory or hospitalized cases with suspected or laboratory-confirmed dengue treated in both the private and public sectors were recruited. Interviews were scheduled for the convalescent period to ascertain characteristics of the dengue episode, date of first symptoms/signs and recovery, use of medical services, work/school absence, household spending (out-of-pocket expense) and income lost using a questionnaire developed for a previous cost study. We also extracted data from the patients’ medical records for hospitalized cases. Overall costs per case and cumulative costs were calculated from the public payer and societal perspectives. National cost estimations took into account cases reported in the official notification system (SINAN) with adjustment for underreporting of cases. We applied a probabilistic sensitivity analysis using Monte Carlo simulations with 90% certainty levels (CL). Results We screened 2,223 cases, of which 2,035 (91.5%) symptomatic dengue cases were included in our study. The estimated cost for dengue for the epidemic season (2012–2013) in the societal perspective was US$ 468 million (90% CL: 349–590) or US$ 1,212 million (90% CL: 904–1,526) after adjusting for under-reporting. Considering the time series of dengue (2009–2013) the estimated cost of dengue varied from US$ 371 million (2009) to US$ 1,228 million (2013). Conclusions The economic burden

  17. Surgical site infections in Italian Hospitals: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    Ippolito Giuseppe

    2008-03-01

    Full Text Available Abstract Background Surgical site infections (SSI remain a major clinical problem in terms of morbidity, mortality, and hospital costs. Nearly 60% of SSI diagnosis occur in the postdischarge period. However, literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence. A national prospective multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI, and the associated risk factors. Methods In 2002, a one-month, prospective national multicenter surveillance study was conducted in General and Gynecological units of 48 Italian hospitals. Case ascertainment of SSI was carried out using standardized surveillance methodology. To assess potential risk factors for SSI we used a conditional logistic regression model. We also reported the odds ratios of in-hospital and postdischarge SSI. Results SSI occurred in 241 (5.2% of 4,665 patients, of which 148 (61.4% during in-hospital, and 93 (38.6% during postdischarge period. Of 93 postdischarge SSI, sixty-two (66.7% and 31 (33.3% were detected through telephone interview and questionnaire survey, respectively. Higher SSI incidence rates were observed in colon surgery (18.9%, gastric surgery (13.6%, and appendectomy (8.6%. If considering risk factors for SSI, at multivariate analysis we found that emergency interventions, NNIS risk score, pre-operative hospital stay, and use of drains were significantly associated with SSI occurrence. Moreover, risk factors for total SSI were also associated to in-hospital SSI. Additionally, only NNIS, pre-operative hospital stay, use of drains, and antibiotic prophylaxis were associated with postdischarge SSI. Conclusion Our study provided information on risk factors for SSI in a large population in general surgery setting in Italy. Standardized postdischarge surveillance detected 38.6% of all SSI. We also compared risk factors for in-hospital and postdischarge SSI

  18. [Motivations for a consultation before adoption: A multicenter study].

    Science.gov (United States)

    Thieblemont, M; Francois, P; Poirier, V; Bosdure, E; Munck, M-R; Borsa-Dorion, A; Hazart, I; Moukagni-Pelzer, M; Brunel, D; Peyron, F; de Monleon, J-V

    2016-01-01

    While the number of international adoptions in France is decreasing, adopted children are older and in poorer health than they used to be. This phenomenon has resulted in an increase in the demand for preadoption consultations over the past several years. This study analyses the reasons for these consultations. Prospective multicenter study conducted from 1 January to 31 December 2013. Ten centers contributed to the study, i.e., 196 preadoption consultations. Seeking medical advice was the reason for 88% of the consultations, whether the advice was based on the study of an identified child's medical file (32%) or a country's healthcare characteristics, whether the country was identified (34%) or not (23%). In 6% of cases, the motive for preadoption consultations was social and familial, and in the last 5% it was to obtain general information about adoption and its procedures. In more than 40% of the cases, whether the child or the country identified, Russia is the subject of the consultation because of the complexity of the files and because of the dreaded but rarely mentioned fetal alcohol syndrome. The deterioration of adopted children's health is an additional worry for future adoption applicants. To provide them with the best information possible without making choices for them, specialists should have substantial experience in adoption before going into these preadoption consultations. Copyright © 2015. Published by Elsevier SAS.

  19. Recurrent Laryngeal Nerve Palsy After Cervical Spine Surgery: A Multicenter AOSpine Clinical Research Network Study

    OpenAIRE

    Gokaslan, Ziya L.; Bydon, Mohamad; De la Garza-Ramos, Rafael; Smith, Zachary A.; Hsu, Wellington K.; Qureshi, Sheeraz A.; Cho, Samuel K.; Baird, Evan O.; Mroz, Thomas E.; Fehlings, Michael; Arnold, Paul M.; Riew, K. Daniel

    2017-01-01

    Study Design: Multicenter retrospective study. Objectives: To investigate the risk of symptomatic recurrent laryngeal nerve palsy (RLNP) following cervical spine surgery, to examine risk factors for its development, and to report its treatment and outcomes. Methods: A multicenter study from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was performed. Each center screened for rare complications following cervical spine surgery, including RLNP. Patient...

  20. The filtering, clear-cornea diathermal keratostomy: a minor Danish multicenter study

    DEFF Research Database (Denmark)

    Kessing, S.V.; Nissen, O.I.; Thygesen, J.

    2008-01-01

    PURPOSE: Is the new micropenetrating, clear-cornea procedure, intrastromal diathermal keratostomy (IDK), an alternative to the intricate "modern trabeculectomy"? METHODS: Prospective multicenter study. Four surgeons from 4 Danish eye departments attended an IDK course and subsequently decided whe...

  1. Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial.

    Science.gov (United States)

    Soto, Roy; Jahr, Jonathan S; Pavlin, Janet; Sabo, Daniel; Philip, Beverly K; Egan, Talmage D; Rowe, Everton; de Bie, Joris; Woo, Tiffany

    Complex surgical procedures are increasingly performed in an outpatient setting, with emphasis on rapid recovery and case turnover. In this study, the combination of rocuronium for neuromuscular blockade (NMB) reversed by single-dose sugammadex was compared with succinylcholine followed by spontaneous recovery in outpatient surgery. This multicenter, randomized, safety assessor-blinded study enrolled adults undergoing a short elective outpatient surgical procedure requiring NMB and tracheal intubation. Patients were randomized to NMB with either rocuronium 0.6 mg/kg for tracheal intubation with incremental doses of rocuronium 0.15 mg/kg and subsequent reversal with sugammadex 4.0 mg/kg at 1-2 posttetanic counts or succinylcholine 1.0 mg/kg for intubation with spontaneous recovery. The primary efficacy end point was the time from sugammadex administration to recovery of the train-of-four ratio to 0.9; for succinylcholine, time from administration to recovery of the first twitch (T1) to 90% was assessed. From 167 patients enrolled, 150 received treatment. The all-subjects-treated population comprised 70 patients in the rocuronium-sugammadex group and 80 in the succinylcholine group. Geometric mean (95% confidence interval) time from the start of sugammadex administration to recovery of the train-of-four ratio to 0.9 was 1.8 (1.6-2.0) minutes. Geometric mean (95% confidence interval) time from succinylcholine administration to recovery of T1 to 90% was 10.8 (10.1-11.5) minutes. Health outcome variables were similar between the groups. Adverse events were reported in 87.1% and 93.8% of patients for rocuronium-sugammadex and succinylcholine, respectively. In conclusion, rocuronium for intubation followed by sugammadex for reversal of NMB offers a viable treatment option in outpatient surgery without prolonging recovery duration or jeopardizing safety.

  2. Oral cancer in the UAE: a multicenter, retrospective study

    Science.gov (United States)

    Anis, Raeefa; Gaballah, Kamis

    2013-01-01

    Aim To determine the prevalence of various malignant oral lesions in the UAE and correlate cases of squamous cell carcinomas with age, gender, site, grade, clinical presentations at the time of diagnosis, and the prevalence of neck metastasis. Materials and methods A multicenter, retrospective study was conducted at four major hospitals in the UAE. The study was based on histopathology reports of biopsies of oral tissues. Results Of the 992 oral biopsy reports retrieved, 147 cases of malignant tumors were found which accounted for 14.9% of the total biopsies. Fifteen different types of malignant lesions were diagnosed, of which oral squamous cell carcinoma (OSCC) was the most prevalent and made up 11.4% of the overall oral biopsies retrieved. The commonest presentation of cancer was ulceration (31.17%), followed by lumps and white lesions. The most common site where the lesions were diagnosed was the tongue (51.9%), followed by the cheeks and lips. OSCC accounted for 77% of all malignancies reported. Neck dissections were conducted in only 20.8% of all OSCC cases diagnosed at Mafraq and Tawam hospitals, of which 43.75% showed evidence of neck metastasis. Conclusion Oral cancer is not an uncommon disease in the UAE. This may mandate more awareness campaigning, including screening procedures for early detection of cancerous lesions and other potentially malignant oral diseases. Elective neck dissections to detect lymph node metastasis should be more routinely performed, in particular for tongue carcinomas because of the early neck involvement potential. PMID:23985381

  3. Bronchiectasis diagnosed after renal transplantation: a retrospective multicenter study.

    Science.gov (United States)

    Dury, Sandra; Colosio, Charlotte; Etienne, Isabelle; Anglicheau, Dany; Merieau, Elodie; Caillard, Sophie; Rivalan, Joseph; Thervet, Eric; Essig, Marie; Babinet, François; Subra, Jean-François; Toubas, Olivier; Rieu, Philippe; Launois, Claire; Perotin-Collard, Jeanne-Marie; Lebargy, François; Deslée, Gaëtan

    2015-11-07

    Bronchiectasis is characterized by abnormal, permanent and irreversible dilatation of the bronchi, usually responsible for daily symptoms and frequent respiratory complications. Many causes have been identified, but only limited data are available concerning the association between bronchiectasis and renal transplantation. We conducted a retrospective multicenter study of cases of bronchiectasis diagnosed after renal transplantation in 14 renal transplantation departments (French SPIESSER group). Demographic, clinical, laboratory and CT scan data were collected. Forty-six patients were included (mean age 58.2 years, 52.2 % men). Autosomal dominant polycystic kidney disease (32.6 %) was the main underlying renal disease. Chronic cough and sputum (50.0 %) were the major symptoms leading to chest CT scan. Mean duration of symptoms before diagnosis was 1.5 years [0-12.1 years]. Microorganisms were identified in 22 patients, predominantly Haemophilus influenzae. Hypogammaglobulinemia was observed in 46.9 % patients. Bronchiectasis was usually extensive (84.8 %). The total bronchiectasis score was 7.4 ± 5.5 with a significant gradient from apex to bases. Many patients remained symptomatic (43.5 %) and/or presented recurrent respiratory tract infections (37.0 %) during follow-up. Six deaths (13 %) occurred during follow-up, but none were attributable to bronchiectasis. These results highlight that the diagnosis of bronchiectasis should be considered in patients with de novo respiratory symptoms after renal transplantation. Further studies are needed to more clearly understand the mechanisms underlying bronchiectasis in this setting.

  4. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.

    Science.gov (United States)

    Iwata, Satoshi; Nakata, Shuji; Ukae, Susumu; Koizumi, Yoshitugu; Morita, Yasuyuki; Kuroki, Haruo; Tanaka, Yoshiyuki; Shizuya, Toshiyuki; Schödel, Florian; Brown, Michelle L; Lawrence, Jody

    2013-08-01

    Rotavirus is the most common cause of severe gastroenteritis in children under 5 y of age. Estimates of disease burden in Japan suggest that between 26,500 and 78,000 children in this age group need hospitalization each year, resulting in a direct medical cost of 10 to 24 billion Yen. Since being introduced in routine infant immunization schedules in the United States in 2006, the oral live pentavalent rotavirus vaccine RV5 (RotaTeq™) has contributed to dramatic reductions in the incidence of rotavirus gastroenteritis (RVGE) and in health care resource utilization. This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of a 3-dose regimen of RV5 in healthy infants, age 6 to 12 weeks, at 32 sites across Japan. The results indicate that RV5 was significantly efficacious in preventing any severity [74.5% (95% confidence interval [CI]: 39.9%, 90.6%; pvaccine. The observed cases of RVGE included rotavirus types G1 (n=19), G3 (n=9), G9 (n=5) and one unspecified G serotype with P1A[8]. No G2 or G4 RVGE cases were observed, and this study was not powered to evaluate efficacy against individual serotypes. RV5 was generally safe and well tolerated in Japanese infants. These results are comparable to those observed in clinical studies conducted in other developed countries. Introduction of the vaccine in Japan may reduce disease burden and associated health care costs.

  5. Effectiveness and Safety of Transdermal Buprenorphine Versus Sustained-release Tramadol in Patients With Moderate to Severe Musculoskeletal Pain: An 8-Week, Randomized, Double-Blind, Double-Dummy, Multicenter, Active-controlled, Noninferiority Study.

    Science.gov (United States)

    Leng, Xiaomei; Li, Zhanguo; Lv, Houshan; Zheng, Yi; Liu, Yi; Dai, Kerong; Yao, Chen; Yan, Xiaoyan; Zeng, Xiaofeng

    2015-07-01

    The aim of this noninferiority study was to investigate clinical effectiveness and safety of buprenorphine transdermal system (BTDS) in patients with moderate to severe musculoskeletal pain inadequately controlled with nonsteroidal anti-inflammatory drugs, compared with sustained-release tramadol tablets. Eligible patients were randomized (1:1) to receive low-dose 7-day BTDS (5, 10, and 20 μg/h, maximum dosage of 20 μg/h) or sustained-release tramadol tablets (100 mg, maximum dosage of 400 mg/d) over an 8-week double-blind treatment period (3-week titration, 5-week maintenance). The primary endpoint was the difference in the visual analogue scale (VAS) pain scores from baseline to treatment completion. Noninferiority was assumed if the treatment difference on the VAS scale was within ±1.5 cm, this threshold indicating a clinically meaningful result. ClinicalTrials.gov identifier: NCT01476774. Two hundred eighty patients were randomized to BTDS (n=141) or to tramadol (n=139). Both treatments were associated with a significant reduction in pain by the end of the treatment. The least squares mean difference of the change from baseline in VAS scores between the BTDS and tramadol groups were 0.45 (95% confidence interval, -0.02 to 0.91), which was within the ±1.5 cm predefined threshold, indicating that the effectiveness of BTDS was not inferior to the effectiveness of sustained-release tramadol tablets. The incidence of adverse events was comparable between the 2 treatment groups. Our results suggest that BTDS is a good therapeutic option for patients experiencing chronic musculoskeletal pain of moderate to severe intensity that is insufficiently controlled by nonsteroidal anti-inflammatory drugs.

  6. A Multicenter Study To Evaluate The Safety And Efficacy Of Heber On (Interferon Alfa-2b In Combination With Ribavirin For The Treatment Of Chronic Hepatitis C In Iran

    Directory of Open Access Journals (Sweden)

    H. Mirmomen

    2005-05-01

    Full Text Available Combination therapy with interferon and ribavirin is the most effective treatment for chronic hepatitis C today. The aim of this study was to evaluate the efficacy and safety of thrice-weekly Heberon (interferon alfa-2b in combination with ribavirin as first -line treatment of chronic hepatitis C. Methods: A total of97 treatment-naive patients received Heberon three million units thrice-weekly subcutaneously in combination with ribavirin for 12 months. Serum HCV RNA levels were measured before and during therapy and 6 months after the end of therapy. End-of-treatment and sustained virological responses was defmed as an undetectable HCV-RNA level at the end of treatment, and 6 months after treatment was completed (end of follow-up, respectively. Results: In an intent-to-treat analysis, HCV-RNA was undetectable at the end of treatment in 49.5% of patients. At the end of follow-up, sustained virological response was 36.1 %. Combination treatment was generally well tolerated. Six patients stopped therapy because of side effects: severe cytopenia (n=4, depression (n=1, and hyperthyroidism (n= 1 . Common side effects of therapy include: Flu-like syndrome (85.6%, generalized alopecia (41.2% , injection site inflammation (37.1% , mood changes (36% , anorexia (34% and weight loss (32% . Conclusion: Heberon as an IFN product in combination with ribavirin for treat-ment of patients with chronic hepatitis Cis relatively safe, feasible, and potentially efficacious. It has comparable results in achieving end-of-treatment and sustained virological responses in chronic hepatitis C.

  7. RESULTS OF MULTICENTER STUDY OF PIDOTIMOD FOR THE PROPHYLAXIS OF ACUTE RESPIRATORY INFECTIONS IN FREQUENTLY AILING CHILDREN

    Directory of Open Access Journals (Sweden)

    L.S. Namazova-Baranova

    2010-01-01

    Full Text Available The article describes actual pediatric problem — frequent development of respiratory infections in children. Authors present the results of Russian multicenter study of effectiveness and safety of pidotimod (Imunorix in frequently ailing children. It was shown that treatment with pidotimod during 30 days resulted in decreased rate of acute respiratory infections and their complications including ones with necessity of antibacterial therapy compared to children from control group. The dynamics of immunological rates in blood serum was studied.Key words: frequently ailing children, acute respiratory infections, prophylaxis, pidotimod.(Voprosy sovremennoi pediatrii — Current Pediatrics. 2010;9(2:40-44

  8. The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: A phase IIIb, randomized, multi-center study in Italy.

    Science.gov (United States)

    Durando, Paolo; Esposito, Susanna; Bona, Gianni; Cuccia, Mario; Desole, Maria Giuseppina; Ferrera, Giuseppe; Gabutti, Giovanni; Pellegrino, Angelo; Salvini, Filippo; Henry, Ouzama; Povey, Michael; Marchetti, Federico

    2016-08-05

    Multiple vaccination visits and administrations can be stressful for infants, parents and healthcare providers. Multivalent combination vaccines can deliver the required number of antigens in fewer injections and clinic visits, while vaccine co-administration can also reduce the number of visits. This non-inferiority study was undertaken to evaluate the feasibility of co-administering a combined measles-mumps-rubella-varicella (MMRV) vaccine with conjugated meningococcal C (MenC) vaccine in a large cohort of healthy Italian toddlers. Healthy subjects aged 13-15months were randomized (2:1:1) to receive single doses of either: co-administered MMRV+MenC at the same visit (MMRV+MenC group); or MMRV followed 42days later by MenC (MMRV group); or MenC followed 42days later by MMRV (MenC group). Blood samples were collected before and 43days after vaccination. Antibody titers against MMRV were measured using ELISA. Functional-anti-meningococcal-serogroup activity (rSBAMenC) was assessed using a serum bactericidal test. Solicited local and general reactions were recorded for up to 4 and 42days post-vaccination, respectively. Non-inferiority of MMRV+MenC to MMRV (post-dose-1 seroconversion rates) and MMRV+MenC to MenC (post-dose-1 seroprotection rates) was achieved if the lower limit (LL) of the 95% confidence interval (CI) for the group difference was ⩾-10% for each antigen. 716 subjects were enrolled in the study. At 42days post-vaccination, the MMRV seroconversion rates were 99.3% (measles), 94.5% (mumps), 100% (rubella) and 99.7% (varicella) in the MMRV+MenC group, and 99.4%, 93.2%, 100% and 100%, respectively, in the MMRV group. The seroprotection rates against rSBA-MenC were 98.3% in the MMRV+MenC group and 99.3% in the MenC group. Non-inferiority was reached for all the vaccine antigens. The safety profiles were as expected for these vaccines. The immune responses elicited by co-administered MMRV+MenC were non-inferior to those elicited by MMRV or MenC alone and

  9. Isolated optic nerve gliomas: a multicenter historical cohort study.

    Science.gov (United States)

    Shofty, Ben; Ben-Sira, Liat; Kesler, Anat; Jallo, George; Groves, Mari L; Iyer, Rajiv R; Lassaletta, Alvaro; Tabori, Uri; Bouffet, Eric; Thomale, Ulrich-Wilhelm; Hernáiz Driever, Pablo; Constantini, Shlomi

    2017-12-01

    OBJECTIVE Isolated optic nerve gliomas (IONGs) constitute a rare subgroup of optic pathway gliomas (OPGs). Due to the rarity of this condition and the difficulty in differentiating IONGs from other types of OPGs in most clinical series, little is known about these tumors. Currently, due to lack of evidence, they are managed the same as any other OPG. METHODS The authors conducted a multicenter retrospective cohort study aimed at determining the natural history of IONGs. Included were patients with clear-cut glioma of the optic nerve without posterior (chiasmatic/hypothalamic) involvement. At least 1 year of follow-up, 2 MRI studies, and 2 neuro-ophthalmological examinations were required for inclusion. RESULTS Thirty-six patients with 39 tumors were included in this study. Age at diagnosis ranged between 6 months and 16 years (average 6 years). The mean follow-up time was 5.6 years. Twenty-five patients had neurofibromatosis Type 1. During the follow-up period, 59% of the tumors progressed, 23% remained stable, and 18% (all with neurofibromatosis Type 1) displayed some degree of spontaneous regression. Fifty-one percent of the patients presented with visual decline, of whom 90% experienced further deterioration. Nine patients were treated with chemotherapy, 5 of whom improved visually. Ten patients underwent operation, and no local or distal recurrence was noted. CONCLUSIONS Isolated optic nerve gliomas are highly dynamic tumors. Radiological progression and visual deterioration occur in greater percentages than in the general population of patients with OPGs. Response to chemotherapy may be better in this group, and its use should be considered early in the course of the disease.

  10. Underweight and malnutrition in home care: A multicenter study.

    Science.gov (United States)

    Lahmann, Nils A; Tannen, Antje; Suhr, Ralf

    2016-10-01

    This study aimed to provide representative figures about the prevalence of underweight and malnutrition among home care clients, and to determine the associated risk factors and the provided nutritional nursing interventions. In 2012, a multicenter point prevalence study was conducted among 878 randomly selected clients from 100 randomly selected home care services across Germany. Following a standardized study protocol, demographics, nutritional assessments (Body Mass Index, Malnutrition Universal Screening Tool (MUST), Mini nutritional Assessment - short form (MNA-sf), nurses' clinical judgment on nutritional status) and interventions were assessed. Common nutritional risk factors for underweight and malnutrition were analyzed in a logistic regression model. Malnutrition figures varied between 4.8% (MNA-sf) and 6.8% (MUST), underweight between 8.7% (BMI malnutrition assessments (MNA-sf 48.8%, MUST 39.1%) due to a lack of information on many clients' loss of weight within the past 3-6 months. Regular weighing was performed in 33.6-57.3% of all clients, depending on weight and nutritional status. Mental overload (OR 8.1/4.4), needs help with feeding (OR 5.0/2.8) and loss of appetite (OR 3.6/3.9) were highly associated with malnutrition/underweight. Malnutrition and underweight are important issues in home care clients. Regular weighing should be performed in all home care clients so that a potential weight loss can be detected in time. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  11. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial.

    Science.gov (United States)

    Levkovitz, Yechiel; Isserles, Moshe; Padberg, Frank; Lisanby, Sarah H; Bystritsky, Alexander; Xia, Guohua; Tendler, Aron; Daskalakis, Zafiris J; Winston, Jaron L; Dannon, Pinhas; Hafez, Hisham M; Reti, Irving M; Morales, Oscar G; Schlaepfer, Thomas E; Hollander, Eric; Berman, Joshua A; Husain, Mustafa M; Sofer, Uzi; Stein, Ahava; Adler, Shmulik; Deutsch, Lisa; Deutsch, Frederic; Roth, Yiftach; George, Mark S; Zangen, Abraham

    2015-02-01

    Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22-68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p=0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p=0.013; remission: 32.6 vs. 14.6%, p=0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. © 2015 World Psychiatric Association.

  12. Albumin Administration in Acute Ischemic Stroke: Safety Analysis of the ALIAS Part 2 Multicenter Trial.

    Directory of Open Access Journals (Sweden)

    Michael D Hill

    Full Text Available Albumin treatment of ischemic stroke was associated with cardiopulmonary adverse events in previous studies and a low incidence of intracranial hemorrhage. We sought to describe the neurological and cardiopulmonary adverse events in the ALIAS Part 2 Multicenter Trial.Ischemic stroke patients, aged 18-83 and a baseline NIHSS ≥ 6, were randomized to treatment with ALB or saline control within 5 hours of stroke onset. Neurological adverse events included symptomatic intracranial hemorrhage, hemicraniectomy, neurological deterioration and neurological death. Cardiopulmonary adverse events included pulmonary edema/congestive heart failure, acute coronary syndromes, atrial fibrillation, pneumonia and pulmonary thromboembolism.Among 830 patients, neurological and cardiopulmonary adverse events were not differentially associated with poor outcome between ALB and saline control subjects. The rate of symptomatic intracranial hemorrhage in the first 24h was low overall (2.9%, 24/830 but more common in the ALB treated subjects (RR = 2.4, CI95 1.01-5.8. The rate of pulmonary edema/CHF in the first 48h was 7.9% (59/830 and was more common among ALB treated subjects (RR = 10.7, CI95 4.3-26.6; this complication was expected and was satisfactorily managed with mandated diuretic administration and intravenous fluid guidelines. Troponin elevations in the first 48h were common, occurring without ECG change or cardiac symptoms in 52 subjects (12.5%.ALB therapy was associated with an increase in symptomatic ICH and pulmonary edema/congestive heart failure but this did not affect final outcomes. Troponin elevation occurs routinely in the first 48 hours after acute ischemic stroke.ClincalTrials.gov NCT00235495.

  13. Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study.

    Science.gov (United States)

    Kloimstein, Herwig; Likar, Rudolf; Kern, Michael; Neuhold, Josef; Cada, Miroslav; Loinig, Nadja; Ilias, Wilfried; Freundl, Brigitta; Binder, Heinrich; Wolf, Andreas; Dorn, Christian; Mozes-Balla, Eva Maria; Stein, Rolf; Lappe, Ivo; Sator-Katzenschlager, Sabine

    2014-02-01

    The goal of this study was to evaluate the long-term efficacy and safety of peripheral nerve field stimulation (PNFS) for chronic low back pain (cLBP). In this prospective, multicenter observational study, 118 patients were admitted to 11 centers throughout Austria and Switzerland. After a screening visit, all patients underwent a trial stimulation period of at least seven days before implantation of the permanent system. Leads were placed in the subcutaneous tissues of the lower back directly in the region of greatest pain. One hundred five patients were implanted with a permanent stimulating system. Patients' evaluation of pain and functional levels were completed before implantation and one, three, and six months after implantation. Adverse events, medication usage, and coverage of the painful area and predictive value of transcutaneous electrical nerve stimulation (TENS) were monitored. All pain and quality-of-life measures showed statistically significant improvement during the treatment period. These included the average pain visual analog scale, the Oswestry Disability Questionnaire, the Becks Depression Inventory, and the Short Form-12 item Health survey. Additionally, medication usage with opioids, nonsteroidal anti-inflammatory drugs, and anti-convulsants showed a highly significant reduction. Complications requiring surgical intervention were reported in 9.6% of the patients. The degree of coverage of painful areas seems to be an important criterion for efficacy of PNFS, whereas TENS is presumably no predictor. This prospective, multicenter study confirms that PNFS is an effective therapy for the management of cLBP. Significant improvements in many aspects of the pain condition were measured, and complications were minimal. © 2013 International Neuromodulation Society.

  14. Decision making in liver transplant selection committees: a multicenter study.

    Science.gov (United States)

    Volk, Michael L; Biggins, Scott W; Huang, Mary Ann; Argo, Curtis K; Fontana, Robert J; Anspach, Renee R

    2011-10-18

    To receive a liver transplant, patients must first be placed on a waiting list-a decision made at most transplant centers by a multidisciplinary committee. The function of these committees has never been studied. To describe decision making in liver transplant committees and identify opportunities for process improvement. Observational multicenter study. 4 liver transplant centers in the United States. 68 members of liver transplant committees across the 4 centers. 63 meetings were observed, and 50 committee members were interviewed. Recorded transcripts and field notes were analyzed by using standard qualitative sociologic methods. Although the structure of the meetings varied by center, the process was uniform and primarily involved inductive reasoning to review possible reasons for patient exclusion. Patients were excluded if they were too well, too sick (in the setting of advanced liver disease), or too old or had nonhepatic comorbid conditions, substance abuse problems, or other psychosocial barriers. Dominant themes in the discussions included member angst over deciding who lived or died, a high correlation between psychosocial barriers to transplantation and the patient's socioeconomic status, and the influence of external forces on decision making. Unwritten center policies and confusion regarding advocacy versus stewardship roles were consistently identified as barriers to effective group decision making. The use of qualitative methods provides broad understanding but limits specific inferences. The 4 centers may not reflect the practices of every transplant center nationwide. The difficult decisions made by liver transplant committees are reasonably consistent and well-intentioned, but the process might be improved by having more explicit written policies and clarifying roles. This may inform resource allocation in other areas of medicine. The Greenwall Foundation and the National Institutes of Health.

  15. Burnout Among Otolaryngology Residents in Saudi Arabia: A Multicenter Study.

    Science.gov (United States)

    Aldrees, Turki; Badri, Motasim; Islam, Tahera; Alqahtani, Khalid

    2015-01-01

    Determine the prevalence of, and associated risk factors for, burnout among otolaryngologist residents in Saudi Arabia. A cross-section study of multicenter hospitals in Saudi Arabia conducted in March 2013. Registered residents in Saudi Otolaryngology Board Program. The Maslach Burnout Inventory was used to measure burnout status. Questions supplementary to the Maslach Burnout Inventory were also included to identify associated potential risk factors such as demographic data, resident satisfaction, and work conditions. Of the initial 123 questionnaires that were distributed, 85 yielded responses, a rate of 69%. The mean age (standard deviation [SD]) of respondents was 29 (2.3) years. Of those, 67% (57/85) were men and 66% (55/85) were married. Resident levels were delineated: level 2, 19%; level 3, 33%; level 4, 29%; and level 5, 19%. The mean number of on-call days/month (SD) was 7 (2), clinics/week (SD) was 3 (1), sleep hours/day (SD) was 6 (1), and operations/week (SD) was 2 (1). The mean emotional exhaustion (EE) and depersonalization scores were high at 29.5 (SD = 9.6) and 10.7 (SD = 6), respectively. The mean personal accomplishment was low at 32.33 (SD = 6). The mean of all subscales did not differ by sex (EE p = 0.5; depersonalization p = 0.09; personal accomplishment p = 0.4). Mean EE differed by marital status, which was 31.2, 31.3, and 25.6 for married, divorced, and single, respectively, analysis of variance test p = 0.045. Burnout prevalence was found to be high among otolaryngologist residents in Saudi Arabia. The associated variables examined in this study should be addressed to decrease this level of burnout and provide residents with a less stressful work environment. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  16. Divorce and Severity of Coronary Artery Disease: A Multicenter Study

    Directory of Open Access Journals (Sweden)

    Amin Daoulah

    2017-01-01

    Full Text Available The association between marital status and coronary artery disease (CAD is supported by numerous epidemiological studies. While divorce may have an adverse effect on cardiac outcomes, the relationship between divorce and severe CAD is unclear. We conducted a multicenter, observational study of consecutive patients undergoing coronary angiography during the period between April 1, 2013, and March 30, 2014. Of 1,068 patients, 124 (12% were divorced. Divorce was more frequent among women (27% compared to men (6%. Most divorced patients had been divorced only once (49%, but a subset had been divorced 2 (38% or ≥3 (12% times. After adjusting for baseline differences, there was no significant association between divorce and severe CAD in men. In women, there was a significant adjusted association between divorce and severe MVD (OR 2.31 [1.16, 4.59] or LMD (OR 5.91 [2.19, 15.99]. The modification of the association between divorce and severe CAD by gender was statistically significant for severe LMD (Pinteraction 0.0008 and marginally significant for CAD (Pinteraction 0.05. Among women, there was a significant adjusted association between number of divorces and severe CAD (OR 2.4 [95% CI 1.2, 4.5], MVD (OR 2.0 [95% CI 1.4, 3.0], and LMD (OR 3.4 [95% CI 1.9, 5.9]. In conclusion, divorce, particularly multiple divorces, is associated with severe CAD, MVD, and LMD in women but not in men.

  17. Determination of serum albumin, analytical challenges: a French multicenter study.

    Science.gov (United States)

    Rossary, Adrien; Blondé-Cynober, Françoise; Bastard, Jean-Philippe; Beauvieux, Marie-Christine; Beyne, Pascale; Drai, Jocelyne; Lombard, Christine; Anglard, Ingrid; Aussel, Christian; Claeyssens, Sophie; Vasson, Marie-Paule

    2017-06-01

    Among the biological markers of morbidity and mortality, albumin holds a key place in the range of criteria used by the High Authority for Health (HAS) for the assessment of malnutrition and the coding of information system medicalization program (PMSI). If the principle of quantification methods have not changed in recent years, the dispersion of external evaluations of the quality (EEQ) data shows that the standardization using the certified reference material (CRM) 470 is not optimal. The aim of this multicenter study involving 7 sites, conducted by a working group of the French Society of Clinical Biology (SFBC), was to assess whether the albuminemia values depend on the analytical system used. The albumin from plasma (n=30) and serum (n=8) pools was quantified by 5 different methods [bromocresol green (VBC) and bromocresol purple (PBC) colorimetry, immunoturbidimetry (IT), immunonephelometry (IN) and capillary electrophoresis (CE)] using 12 analyzers. Bland and Altman's test evaluated the difference between the results obtained by the different methods. For example, a difference as high as 13 g/L was observed for the same sample between the methods (p albumin across the range of values tested compared to PBC (p albumin values inducing a difference of performance between the immunoprecipitation methods (IT vs IN, p albumin results are related to the technical/analyzer tandem used. This variability is usually not taken into account by the clinician. Thus, clinicians and biologists have to be aware and have to check, depending on the method used, the albumin thresholds identified as risk factors for complications related to malnutrition and PMSI coding.

  18. Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury.

    Science.gov (United States)

    Tefertiller, Candy; Hays, Kaitlin; Jones, Janell; Jayaraman, Arun; Hartigan, Clare; Bushnik, Tamara; Forrest, Gail F

    2018-01-01

    Objective: To assess safety and mobility outcomes utilizing the Indego powered exoskeleton in indoor and outdoor walking conditions with individuals previously diagnosed with a spinal cord injury (SCI). Methods: We conducted a multicenter prospective observational cohort study in outpatient clinics associated with 5 rehabilitation hospitals. A convenience sample of nonambulatory individuals with SCI ( N = 32) completed an 8-week training protocol consisting of walking training 3 times per week utilizing the Indego powered exoskeleton in indoor and outdoor conditions. Participants were also trained in donning/doffing the exoskeleton during each session. Safety measures such as adverse events (AEs) were monitored and reported. Time and independence with donning/doffing the exoskeleton as well as walking outcomes to include the 10-meter walk test (10MWT), 6-minute walk test (6MWT), Timed Up & Go test (TUG), and 600-meter walk test were evaluated from midpoint to final evaluations. Results: All 32 participants completed the training protocol with limited device-related AEs, which resulted in no interruption in training. The majority of participants in this trial were able to don and doff the Indego independently. Final walking speed ranged from 0.19 to 0.55 m/s. Final average indoor and outdoor walking speeds among all participants were 0.37 m/s ( SD = 0.08, 0.09, respectively), after 8 weeks of training. Significant ( p exoskeleton.

  19. Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study.

    Science.gov (United States)

    Altman, Daniel; Mikkola, Tomi S; Bek, Karl Möller; Rahkola-Soisalo, Päivi; Gunnarsson, Jonas; Engh, Marie Ellström; Falconer, Christian

    2016-09-01

    The objective was to assess safety and clinical outcomes in women operated on using the Uphold™ Lite Vaginal Support System. We carried out a 1-year, multicenter, prospective, single cohort study of 207 women with symptomatic Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 apical pelvic organ prolapse, with or without concomitant anterior vaginal wall prolapse. Safety data were collected using a standardized questionnaire. Anatomical outcome was assessed by the POP-Q and subjective outcomes by the Pelvic Floor Distress Inventory after 2 months and 1 year using a one-way repeated measures analysis of variance. Pain was evaluated using a visual analog scale. The overall rate of serious complications was 4.3 % (9 out of 207 patients), including 3 patients with bladder perforations, 1 with bleeding >1,000 ml, 2 who had undergone re-operations with complete mesh removal because of pain, and 3 surgical interventions during follow-up because of mesh exposure. POP-Q stage ≤1 after 1 year was 94 % and subjective symptom relief was reported by 91 % of patients (p transvaginal mesh kits.

  20. Conversion to belatacept in maintenance kidney-transplant patients: A retrospective multicenter European study.

    Science.gov (United States)

    Darres, Amandine; Ulloa, Camillo; Brakemeier, Susanne; Garrouste, Cyril; Bestard, Oriol; Del Bello, Arnaud; Sberro Soussan, Rebecca; Dürr, Michael; Budde, Klemens; Legendre, Christophe; Kamar, Nassim

    2018-03-22

    The use of belatacept is not yet approved for maintenance kidney-transplant patients. This retrospective multicenter European study aimed to assess the efficacy and safety of conversion to belatacept in a large cohort of patients in a real-life setting, and to identify the predictive factors for improved kidney function after the switch. Two-hundred and nineteen maintenance kidney-transplant patients from 5 European kidney-transplant centers were converted to belatacept at 21.2 (0.1-337.1) months posttransplantation, mainly because of impaired kidney function. Thirty-two patients were converted to belatacept within the first 3 months posttransplantation. The mean duration of follow-up was 21.9±20.2 months. The actuarial rate of patients still on belatacept-based therapy was 77.6%. Mean estimated glomerular-filtration rate (eGFR) increased from 32±16.4 at baseline to 38±20 mL/min/1.73 m (ppredictive factor for a significant increase in eGFR (of 5 and 10 mL/min/1.73 m at 3 and 12 months after the switch, respectively). Eighteen patients (8.2%) presented with an acute-rejection episode after conversion; 3 developed a donor-specific antibody (DSA). Overall efficacy and safety were good, including for the 35 patients that had a DSA at conversion. The conversion to belatacept was effective, especially when performed early after transplantation.

  1. [Enterococcal endocarditis: a multicenter study of 76 cases].

    Science.gov (United States)

    Martínez-Marcos, Francisco Javier; Lomas-Cabezas, José Manuel; Hidalgo-Tenorio, Carmen; de la Torre-Lima, Javier; Plata-Ciézar, Antonio; Reguera-Iglesias, José María; Ruiz-Morales, Josefa; Márquez-Solero, Manuel; Gálvez-Acebal, Juan; de Alarcón-González, Arístides

    2009-12-01

    Although enterococci occupy the third position among microorganisms producing infectious endocarditis (IE) following streptococci and Staphylococcus aureus, few multicenter studies have provided an in-depth analysis of enterococcal IE. Description of the characteristics of 76 cases of enterococcal left-sided infectious endocarditis (LSIE) (native: 59, prosthetic: 17) retrieved from the database of the Cardiovascular Infections Study Group of the Andalusian Society of Infectious Diseases, with emphasis on the comparison with non-enterococcal LSIE. Enterococci were the causal agent in 76 of the 696 episodes of LSIE (11%). Compared with non-enterococcal LSIE, enterococcal LSIE was more commonly seen in patients older than 65 (47.4% vs. 27.6%, P<0.0005), and those with chronic diseases (75% vs. 54.6%, P<0.001), calcified valves (18.6% vs. 10%, P<0.05), and previous urinary (30.3% vs. 2.1%, P<0.00001) or abdominal (10.5% vs. 3.1%, P<0.01) infections, and produced a higher rate of relapses (6.6% vs. 2.3%, P<0.05). Enterococcal LSIE was associated with fewer peripheral vascular or skin manifestations (14.5% vs. 27.1%, P<0.05) and fewer immunological phenomena (10.5% vs. 24%, P<0.01). Among the total of patients with enterococcal LSIE, 36.8% underwent valve surgery during hospitalization. In-hospital mortality was 32.9% for enterococcal LSIE, 9.3% for viridans group streptococci (VGS) LSIE and 48.6% for S. aureus LSIE (enterococci vs VGS: P<0.0001; enterococci vs S. aureus: P=0.02). Enterococcal LSIE patients treated with the combination of a penicillin or vancomycin plus an aminoglycoside (n=60) and those treated with ampicillin plus ceftriaxone (n=6) showed similar in-hospital mortality (26.7% vs 33.3%, P=0.66). High-level resistance to gentamicin was detected in 5 of 38 episodes of enterococcal LSIE (13.1%). Enterococcal LSIE appears in patients with well-defined clinical characteristics, and causes few peripheral vascular or skin manifestations and few immunological

  2. Study protocol for a multicenter investigation of reablement in Norway.

    Science.gov (United States)

    Langeland, Eva; Langland, Eva; Tuntland, Hanne; Førland, Oddvar; Aas, Eline; Folkestad, Bjarte; Jacobsen, Frode F; Kjeken, Ingvild

    2015-09-15

    Reablement is a promising new rehabilitation model, which is being implemented in some Western countries to meet current and future needs for home-based services. There is a need for further investigation of the effects of reablement among community-dwelling adults in terms of clinical and economic outcomes. This study will investigate the effectiveness of reablement in home-dwelling adults compared with standard treatment in terms of daily activities, physical functioning, health-related quality of life, coping, mental health, use of health care services, and costs. The study is a multicenter controlled trial. In total, 44 Norwegian municipalities will participate, including eight municipalities as a control group. For three municipalities with two zones, one will be assigned to the control group and the other to the intervention group. The experimental group will be offered reablement and the control group standard treatment. The sample will comprise approximately 750 participants. People will be eligible if they are home-dwelling adults, understand Norwegian, and have functional decline. Participants will be assessed at baseline, and after 10 weeks, 6 months, and 12 months. The primary outcome will be activity and participation measured by the Canadian Occupational Performance Measure. Physical functioning will be measured by the Short Physical Performance Battery and health-related quality of life by the European Quality of Life Scale. Coping will be measured by the Sense of Coherence questionnaire and mental health by the Mental Health Continuum Short Form. Costs will be generated based on registered working hours in different professions. Data analyses will be performed according to intention to treat. Univariate analysis of covariance will be used to investigate differences between the groups at baseline and the end of intervention. The data will be organized into two levels using a multilevel structure, i.e., individuals and municipalities, which will be

  3. Efficacy and safety of adjunctive rasagiline in Japanese Parkinson's disease patients with wearing-off phenomena: A phase 2/3, randomized, double-blind, placebo-controlled, multicenter study.

    Science.gov (United States)

    Hattori, Nobutaka; Takeda, Atsushi; Takeda, Shinichi; Nishimura, Akira; Kato, Masafumi; Mochizuki, Hideki; Nagai, Masahiro; Takahashi, Ryosuke

    2018-04-27

    Rasagiline, a selective, irreversible monoamine oxidase-B inhibitor, is in development in Japan as adjunctive therapy to levodopa. This Phase 2/3 trial evaluated the efficacy and safety of adjunctive rasagiline in Japanese patients with Parkinson's disease (PD) and wearing-off phenomena. Patients aged 30-79 years with diagnosed PD and stable levodopa use were randomized 1:1:1 to rasagiline (0.5/1 mg/day) or placebo for 26 weeks. The primary endpoint was change from baseline in mean daily OFF-time during the treatment period. In total, 141, 134, and 129 patients were randomized to placebo, rasagiline 0.5 mg, or rasagiline 1 mg, respectively. Baseline characteristics were well balanced. Least squares (LS) mean differences vs. placebo for change from baseline in mean daily OFF-time were -0.84 h (rasagiline 1 mg/day) and -0.60 h (rasagiline 0.5 mg/day); both differences were statistically significant. LS mean differences vs. placebo for change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and Part III total scores (in ON-state) and Parkinson's Disease Questionnaire-39 Summary Index Score were: -1.27, -1.74, and -2.51 (0.5 mg/day) and -1.27, -2.14, and -3.84 (1 mg/day); all statistically significant. Treatment-emergent adverse events (TEAEs) occurred in 50.4/69.9/73.6% of the placebo, 0.5 mg/day, and 1 mg/day groups, respectively (most common TEAEs were nasopharyngitis [9.2/18.0/14.7%] and dyskinesia [7.1/8.3/16.3%]). As an adjunct to levodopa, rasagiline reduced OFF-time and improved PD symptoms/signs (MDS-UPDRS scores) and quality of life in Japanese patients with PD and wearing-off phenomena. No important safety concerns were raised. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Day-Case Treatment of Peripheral Arterial Disease: Results from a Multi-Center European Study

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    Spiliopoulos, Stavros, E-mail: stavspiliop@med.uoa.gr, E-mail: stavspiliop@upatras.gr; Karnabatidis, Dimitrios, E-mail: karnaby@med.upatras.gr [Patras University Hospital, Department of Interventional Radiology (Greece); Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr; Diamantopoulos, Athanasios, E-mail: adiamantopoulos@gmail.com [Guy’s and St Thomas’ Hospitals, NHS Foundation Trust, King’s Health Partners, Department of Interventional Radiology (United Kingdom); Ali, Tariq, E-mail: tariq.ali@addenbrookes.nhs.uk [Addenbrooke’s University Hospital, NHS Foundation Trust, Department of Interventional Radiology (United Kingdom); Kitrou, Panagiotis, E-mail: panoskitrou@gmail.com [Patras University Hospital, Department of Interventional Radiology (Greece); Cannavale, Alessandro, E-mail: alessandro.cannavale@hotmail.com; Krokidis, Miltiadis, E-mail: miltiadis.krokidis@addenbrookes.nhs.uk [Addenbrooke’s University Hospital, NHS Foundation Trust, Department of Interventional Radiology (United Kingdom)

    2016-12-15

    PurposeThe purpose of the study was to investigate safety and feasibility of day-case endovascular procedures for the management of peripheral arterial disease.Materials and MethodsThis was a multi-center, retrospective study including all patients treated over a 30-month period with endovascular angioplasty or stenting for intermittent claudication (IC) or critical limb ischemia (CLI) on a day-case basis, in Interventional Radiology (IR) departments of three European tertiary hospitals. Exclusion criteria were not related to the type of lesion and included unavailability of an adult able to take care of patient overnight; high bleeding risk and ASA score ≥4. Primary efficacy outcome was the rate of procedures performed on an outpatient basis requiring no further hospitalization and primary safety outcome was freedom from 30-day major complications’ rate.ResultsThe study included 652 patients (male 75 %; mean age 68 ± 10 years; range: 27–93), 24.6 % treated for CLI. In 53.3 % of the cases a 6Fr sheath was used. Technical success was 97.1 %. Haemostasis was obtained by manual compression in 52.4 % of the accesses. The primary efficacy outcome occurred in 95.4 % (622/652 patients) and primary safety outcome in 98.6 % (643/652 patients). Major complications included five (0.7 %) retroperitoneal hematomas requiring transfusion; one (0.1 %) common femoral artery pseudoaneurysm successfully treated with US-guided thrombin injection, two cases of intra-procedural distal embolization treated with catheter-directed local thrombolysis and one on-table cardiac arrest necessitating >24 h recovery. No major complication was noted after same-day discharge.ConclusionsDay-case endovascular procedures for the treatment of IC or CLI can be safely and efficiently performed in experienced IR departments of large tertiary hospitals.

  5. Approaches to facilitate institutional review board approval of multicenter research studies.

    Science.gov (United States)

    Marsolo, Keith

    2012-07-01

    Gaining Institutional Review Board (IRB) approval for a multicenter research study can be a lengthy and time-consuming process. It can increase the complexity of consent forms, decreasing patient understanding and lowering recruitment numbers. It also leads to increased costs through the duplication of effort. This paper examines some of the strategies used to streamline the IRB review process for multicenter studies and provides examples used by 2 existing multicenter comparative effectiveness research networks. A literature search was conducted to identify sources that described the challenges and potential strategies to facilitate multicenter IRB approval. The most promising avenues were identified and included in this review. Phone interviews were conducted with the Principal Investigators and Project Managers of 2 successful multicenter research networks to learn their "keys to success" and their lessons learned. Three strategies were identified that held the most promise: working with IRBs before submission, the use of central and/or federated IRBs, and the establishment of an umbrella protocol. Each of these strategies was used to some degree by the case study projects. Although the approaches documented here can help streamline the IRB approval process, they are not a "silver bullet." Because some of these approaches are still relatively new, empirical data are sparse. However, it is believed that they will significantly reduce the administrative burden of the project as a whole and lead to a decrease in the overall time to protocol approval.

  6. Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open-label, controlled trial (DIrecT Study).

    Science.gov (United States)

    Yamanishi, Tomonori; Asakura, Hirotaka; Seki, Narihito; Tokunaga, Shoji

    2017-07-01

    To evaluate the efficacy and safety of a combination therapy with dutasteride and imidafenacin in patients with benign prostatic hyperplasia and persistent overactive bladder symptoms. A total of 163 patients presenting an enlarged prostate (volume >30 mL) and persistent overactive bladder symptoms despite at least 8 weeks of tamsulosin were randomized to receive tamsulosin and dutasteride, or tamsulosin, dutasteride and imidafenacin at a 1:1 ratio. The primary end-point was the mean change from baseline to week 24 in total overactive bladder symptom score. The mean change in total overactive bladder symptom score from baseline at week 24 was -1.99 (95% confidence interval -2.57 to -1.41) in the tamsulosin and dutasteride group, and -3.12 (95% confidence interval -3.72 to -2.52) in the tamsulosin, dutasteride and imidafenacin group. The tamsulosin, dutasteride and imidafenacin group significantly improved total overactive bladder symptom score at week 24 as compared with the tamsulosin and dutasteride group; the mean difference was -1.18 (-2.02 to -0.34). The between-group difference was statistically significant as early as week 4. The total International Prostate Symptom Score, storage subscore, quality of life index, and benign prostatic hyperplasia impact index also significantly improved in the tamsulosin, dutasteride and imidafenacin group. Tamsulosin, dutasteride and imidafenacin combination therapy improves overactive bladder symptoms and quality of life without causing serious adverse drug reactions in patients with enlarged prostate not responding to tamsulosin. This combination therapy seems to represent a promising therapeutic option in these patients. © 2017 The Japanese Urological Association.

  7. A multicenter qualitative study on preventing hospital-acquired urinary tract infection in US hospitals.

    Science.gov (United States)

    Saint, Sanjay; Kowalski, Christine P; Forman, Jane; Damschroder, Laura; Hofer, Timothy P; Kaufman, Samuel R; Creswell, John W; Krein, Sarah L

    2008-04-01

    Although urinary tract infection (UTI) is the most common hospital-acquired infection, there is little information about why hospitals use or do not use a range of available preventive practices. We thus conducted a multicenter study to understand better how US hospitals approach the prevention of hospital-acquired UTI. This research is part of a larger study employing both quantitative and qualitative methods. The qualitative phase consisted of 38 semistructured phone interviews with key personnel at 14 purposefully sampled US hospitals and 39 in-person interviews at 5 of those 14 hospitals, to identify recurrent and unifying themes that characterize how hospitals have addressed hospital-acquired UTI. Four recurrent themes emerged from our study data. First, although preventing hospital-acquired UTI was a low priority for most hospitals, there was substantial recognition of the value of early removal of a urinary catheter for patients. Second, those hospitals that made UTI prevention a high priority also focused on noninfectious complications and had committed advocates, or "champions," who facilitated prevention activities. Third, hospital-specific pilot studies were important in deciding whether or not to use devices such as antimicrobial-impregnated catheters. Finally, external forces, such as public reporting, influenced UTI surveillance and infection prevention activities. Clinicians and policy makers can use our findings to develop initiatives that, for example, use a champion to promote the removal of unnecessary urinary catheters or exploit external forces, such public reporting, to enhance patient safety.

  8. Intraorganizational Communication and Job Satisfaction Among Flemish Hospital Nurses: An Exploratory Multicenter Study.

    Science.gov (United States)

    Vermeir, Peter; Downs, Cal; Degroote, Sophie; Vandijck, Dominique; Tobback, Els; Delesie, Liesbeth; Mariman, An; De Veugele, Myriam; Verhaeghe, Rik; Cambré, Bart; Vogelaers, Dirk

    2018-01-01

    Intraorganizational communication affects job satisfaction and turnover. The goal of this study was to explore relationships between communication and job satisfaction, intention to leave, and burnout among Flemish hospital nurses. A multicenter questionnaire study was conducted in three hospitals using the Communication Satisfaction Questionnaire, the Turnover Intention subscale of the Questionnaire on the Experience and Evaluation of Work, and the Maslach Burnout Inventory. A visual analog scale measured job satisfaction. The mean job satisfaction score was 7.49/10 (±1.43). Almost 7% of nurse participants (93/1,355) reported a high intent to leave, and 2.9% of the respondents (41/1,454) had a score indicative of burnout. All dimensions of communication were associated with job satisfaction. A low score on any dimension of communication satisfaction, except "Relationship With Employees," was associated with higher intent to leave and burnout. Study findings support the need for management interventions to enhance efficient communication and ensure high-quality care and patient safety.

  9. Efficacy and safety of a low-level laser device in the treatment of male and female pattern hair loss: a multicenter, randomized, sham device-controlled, double-blind study.

    Science.gov (United States)

    Jimenez, Joaquin J; Wikramanayake, Tongyu C; Bergfeld, Wilma; Hordinsky, Maria; Hickman, Janet G; Hamblin, Michael R; Schachner, Lawrence A

    2014-04-01

    Male and female pattern hair loss are common, chronic dermatologic disorders with limited therapeutic options. In recent years, a number of commercial devices using low-level laser therapy have been promoted, but there have been little peer-reviewed data on their efficacy. To determine whether treatment with a low-level laser device, the US FDA-cleared HairMax Lasercomb®, increases terminal hair density in both men and women with pattern hair loss. Randomized, sham device-controlled, double-blind clinical trials were conducted at multiple institutional and private practices. A total of 146 male and 188 female subjects with pattern hair loss were screened. A total of 128 male and 141 female subjects were randomized to receive either a lasercomb (one of three models) or a sham device in concealed sealed packets, and were treated on the whole scalp three times a week for 26 weeks. Terminal hair density of the target area was evaluated at baseline and at 16- and 26-week follow-ups, and analyzed to determine whether the hypothesis formulated prior to data collection, that lasercomb treatment would increase terminal hair density, was correct. The site investigators and the subjects remained blinded to the type of device they dispensed/received throughout the study. The evaluator of masked digital photographs was blinded to which trial arm the subject belonged. Seventy-eight, 63, 49, and 79 subjects were randomized in four trials of 9-beam lasercomb treatment in female subjects, 12-beam lasercomb treatment in female subjects, 7-beam lasercomb treatment in male subjects, and 9- and 12-beam lasercomb treatment in male subjects, compared with the sham device, respectively. Nineteen female and 25 male subjects were lost to follow-up. Among the remaining 122 female and 103 male subjects in the efficacy analysis, the mean terminal hair count at 26 weeks increased from baseline by 20.2, 20.6, 18.4, 20.9, and 25.7 per cm2 in 9-beam lasercomb-treated female subjects, 12-beam

  10. Post-marketing surveillance of the safety profile of iodixanol in the outpatient CT setting. A prospective, multicenter, observational study of patient risk factors, adverse reactions and preventive measures in 9953 patients

    International Nuclear Information System (INIS)

    Mueller, Frank Hugo Heinz

    2014-01-01

    Non-interventional study in outpatient, contrast-enhanced CT: 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least 'possible' relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. About 55.5% of patients showed one or more risk factors (e.g. impaired renal function 4.4%, diabetes mellitus 8.5%, hypertension 20.6%). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5-50.5%). Oral hydration was the main preventive measure in patients with renal risk factors (<8%) followed by intravenous hydration (1%). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74%), but were classified as serious in only 3 patients (0.03%). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10 000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found between risk factors, preventive measures and

  11. Post-marketing surveillance of the safety profile of iodixanol in the outpatient CT setting. A prospective, multicenter, observational study of patient risk factors, adverse reactions and preventive measures in 9953 patients

    Energy Technology Data Exchange (ETDEWEB)

    Mueller, Frank Hugo Heinz [Radiology and Nuclear Medicine Center, Ludwigshafen (Germany)

    2014-11-15

    Non-interventional study in outpatient, contrast-enhanced CT: 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol. 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least 'possible' relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. About 55.5% of patients showed one or more risk factors (e.g. impaired renal function 4.4%, diabetes mellitus 8.5%, hypertension 20.6%). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5-50.5%). Oral hydration was the main preventive measure in patients with renal risk factors (<8%) followed by intravenous hydration (1%). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74%), but were classified as serious in only 3 patients (0.03%). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated more often, depending on their history. In the routine outpatient setting, iso-osmolar iodixanol was very well tolerated in almost 10 000 patients undergoing diagnostic CT. The rate of acute and delayed adverse reactions was low. No correlation could be found between risk factors, preventive

  12. Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

    LENUS (Irish Health Repository)

    Unterscheider, Julia

    2013-04-01

    The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

  13. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study

    NARCIS (Netherlands)

    von Renteln, Daniel; Fuchs, Karl-Hermann; Fockens, Paul; Bauerfeind, Peter; Vassiliou, Melina C.; Werner, Yuki B.; Fried, Gerald; Breithaupt, Wolfram; Heinrich, Henriette; Bredenoord, Albert J.; Kersten, Jan F.; Verlaan, Tessa; Trevisonno, Michael; Rösch, Thomas

    2013-01-01

    Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months

  14. AN OPEN-LABEL MULTICENTER OBSERVATIONAL STUDY OF THE EFFICACY, TOLERABILITY, AND SAFETY OF THE NONSTEROIDAL ANTI-INFLAMMATORY DRUG AMTOLMETIN GUACIL IN PATIENTS WITH KNEE OSTEOARTHRITIS AND DYSPEPSIA

    Directory of Open Access Journals (Sweden)

    E. S. Tsvetkova

    2016-01-01

    Full Text Available Objective: to investigate the efficacy and tolerability of amtolmetin guacil (AMG; Niselat®, Dr. Reddy's Laboratories Ltd, India versus previous therapy with nonsteroidal anti-inflammatory drugs (NSAIDs in patients with knee osteoarthritis (OA and signs of dyspepsia.Subjects and methods. The open-label observational study included 220 patients aged 30–65 years who suffered from knee OA and intense pain during NSAID intake and had symptoms of dyspepsia in the absence of contraindications to the use of AMG. Among the comorbidities that generally occurred in 68% of the patients, there was a preponderance of hypertension (42%, lower extremity varicose veins (6.4%, and diabetes mellitus (6%. Treatment efficacy was evaluated using three domains of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, by also taking into account pain intensity and general health assessment on the visual analogue scale. A Severity of Dyspepsia Assessment (SODA scale was used to rate dyspepsia.Results and discussion. AMG had a marked analgesic effect confirmed by 40% or more pain reduction that occurred in 72.5% of the patients. The high analgesic effect of AMG was confirmed by a statistically significant (p <0.001 reduction in the WOMAC index (pain and stiffness and by an increase in functional activity. There was a significant decrease in painless and painful signs of dyspepsia, as well as positive changes in the measures “overall assessment of dyspepsia severity” (p < 0.001 and “satisfaction with treatment”. Overall assessment of AMG tolerability was only positive: excellent (33%, good (56%, and satisfactory (11%. There were no serious adverse events (AE. AE were graded as moderate and mild in 8 and 82% of cases, respectively. AE were recorded in 7.7% of the patients. Conclusion. The findings suggest that AMG offers good prospects for knee OA treatment.

  15. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia

    DEFF Research Database (Denmark)

    Branco, Jaime C; Zachrisson, Olof; Perrot, Serge

    2010-01-01

    This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population.......This randomized, double-blind, placebo-controlled, multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia (FM) in a European population....

  16. Early and Late Retrieval of the ALN Removable Vena Cava Filter: Results from a Multicenter Study

    International Nuclear Information System (INIS)

    Pellerin, O.; Barral, F. G.; Lions, C.; Novelli, L.; Beregi, J. P.; Sapoval, M.

    2008-01-01

    Retrieval of removable inferior vena cava (IVC) filters in selected patients is widely practiced. The purpose of this multicenter study was to evaluate the feasibility and results of percutaneous removal of the ALN removable filter in a large patient cohort. Between November 2003 and June 2006, 123 consecutive patients were referred for percutaneous extraction of the ALN filter at three centers. The ALN filter is a removable filter that can be implanted through a femoral/jugular vein approach and extracted by the jugular vein approach. Filter removal was attempted after an implantation period of 93 ± 15 days (range, 6-722 days) through the right internal jugular vein approach using the dedicated extraction kit after control inferior vena cavography. Following filter removal, vena cavograms were obtained in all patients. Successful extraction was achieved in all but one case. Among these successful retrievals, additional manipulation using a femoral approach was needed when the apex of the filter was close to the IVC wall in two patients. No immediate IVC complications were observed according to the postimplantation cavography. Neither technical nor clinical differences between early and late filter retrieval were noticed. Our data confirm the safety of ALN filter retrieval up to 722 days after implantation. In infrequent cases, additional endovenous filter manipulation is needed to facilitate extraction.

  17. A multicenter, long-term study on arrhythmias in children with Ebstein anomaly.

    NARCIS (Netherlands)

    Delhaas, T.; Sarvaas, G.J.; Rijlaarsdam, M.E.; Strengers, J.L.; Eveleigh, R.M.; Poulino, S.E.; Korte, C.L. de; Kapusta, L.

    2010-01-01

    To assess the prevalence, history, and treatment of arrhythmias, in particular preexcitation and Wolff-Parkinson-White (WPW) syndrome, in patients with Ebstein anomaly (EA) during childhood and adolescence, we performed a multicenter retrospective study of all consecutive live-born patients with EA,

  18. A Multicenter, Long-Term Study on Arrhythmias in Children with Ebstein Anomaly

    NARCIS (Netherlands)

    Delhaas, Tammo; Sarvaas, Gideon J. du Marchie; Rijlaarsdam, Marry E.; Strengers, Jan L.; Eveleigh, Rhona M.; Poulino, Sumayah E.; de Korte, Chris L.; Kapusta, Livia

    To assess the prevalence, history, and treatment of arrhythmias, in particular preexcitation and Wolff-Parkinson-White (WPW) syndrome, in patients with Ebstein anomaly (EA) during childhood and adolescence, we performed a multicenter retrospective study of all consecutive live-born patients with EA,

  19. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  20. Sucralfate versus cimetidine in reflux esophagitis. A single-blind multicenter study

    NARCIS (Netherlands)

    Hameeteman, W.; v d Boomgaard, D. M.; Dekker, W.; Schrijver, M.; Wesdorp, I. C.; Tytgat, G. N.

    1987-01-01

    A single-blind randomized multicenter study was performed in 42 patients with endoscopically documented reflux esophagitis. Patients were randomly given 400 mg cimetidine q.i.d. or a suspension of 1 g sucralfate q.i.d. for a period of 8 weeks. Forty patients were evaluated after 8 weeks. Symptomatic

  1. Simplified Therapeutic Intervention Scoring System : The TISS-28 items - Results from a multicenter study

    NARCIS (Netherlands)

    Miranda, DR; deRijk, A; Schaufeli, W

    Objectives: To validate a simplified version of the Therapeutic Intervention Scoring System, the TISS-28, and to determine the association of TISS-28 with the time spent on scored and nonscored nursing activities. Design: Prospective, multicenter study. Setting: Twenty-two adult medical, surgical,

  2. Performance of Ultrasound in the Diagnosis of Gout in a Multi-Center Study

    DEFF Research Database (Denmark)

    Ogdie, Alexis; Taylor, William J; Neogi, Tuhina

    2017-01-01

    OBJECTIVES: To examine the performance of ultrasound for the diagnosis of gout using presence of monosodium urate (MSU) crystals as the gold standard. METHODS: We analyzed data from the Study for Updated Gout Classification Criteria (SUGAR), a large, multi-center observational cross-sectional stu...

  3. HBOC-201 as an alternative to blood transfusion: efficacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery.

    Science.gov (United States)

    Jahr, Jonathan S; Mackenzie, Colin; Pearce, L Bruce; Pitman, Arkadiy; Greenburg, A Gerson

    2008-06-01

    The ability of hemoglobin based oxygen carrier-201 (HBOC-201) to safely reduce and/or eliminate perioperative transfusion was studied in orthopedic surgery patients. A randomized, single-blind, packed red blood cell (PRBC)-controlled, parallel-group multicenter study was conducted. Six hundred eighty-eight patients were randomized to treatment with HBOC-201 (H, n = 350) or PRBC (R, n = 338) at the first transfusion decision. Primary endpoints were transfusion avoidance and blinded assessment [Mann-Whitney estimator (MW)] of safety noninferiority. Groups were compared directly and by paired/matching group analyses predicated on a prospectively defined dichotomy [treatment success (HH) vs. failure (HR)] in the H arm and an equivalently defined dichotomy [3 (R3+) units PRBC] in the R arm, based on need (moderate vs. high) for additional oxygen carrying capacity. A total of 59.4% of patients in the H arm avoided PRBC transfusion. Adverse events (8.47 vs. 5.88), and serious adverse events (SAEs) (0.35 vs. 0.25) per patient were higher in the H versus R arms (p 80 years), volume overload and undertreatment contributed to this imbalance. HBOC-201 eliminated transfusion in the majority of subjects. The between arms (H vs. R) safety analysis was unfavorable and likely related to patient age, volume overload, and undertreatment and was isolated to patients that could not be managed by HBOC-201 alone. However, patients transfusion when treated with up to 10 units of HBOC-201.

  4. Efficacy and Safety of Rituximab in Children with Refractory Nephrotic Syndrome; A Multicenter Clinical Trial

    Directory of Open Access Journals (Sweden)

    Yo Han Ahn

    2014-06-01

    Conclusions: In this interim analysis of clinical trial to evaluate the efficacy and safety of RTX in children with refractory NS, RTX treatment for refractory NS was safe and effective, especially in patients with DNS.

  5. Immunogenicity and safety assessment of a trivalent, inactivated split influenza vaccine in Korean children: Double-blind, randomized, active-controlled multicenter phase III clinical trial.

    Science.gov (United States)

    Han, Seung Beom; Rhim, Jung-Woo; Shin, Hye Jo; Lee, Soo Young; Kim, Hyun-Hee; Kim, Jong-Hyun; Lee, Kyung-Yil; Ma, Sang Hyuk; Park, Joon Soo; Kim, Hwang Min; Kim, Chun Soo; Kim, Dong Ho; Choi, Young Youn; Cha, Sung-Ho; Hong, Young Jin; Kang, Jin Han

    2015-01-01

    A multicenter, double-blind, randomized, active-control phase III clinical trial was performed to assess the immunogenicity and safety of a trivalent, inactivated split influenza vaccine. Korean children between the ages of 6 months and 18 y were enrolled and randomized into a study (study vaccine) or a control vaccine group (commercially available trivalent, inactivated split influenza vaccine) in a 5:1 ratio. Antibody responses were determined using hemagglutination inhibition assay, and post-vaccination immunogenicity was assessed based on seroconversion and seroprotection rates. For safety assessment, solicited local and systemic adverse events up to 28 d after vaccination and unsolicited adverse events up to 6 months after vaccination were evaluated. Immunogenicity was assessed in 337 and 68 children of the study and control groups. In the study vaccine group, seroconversion rates against influenza A/H1N1, A/H3N2, and B strains were 62.0% (95% CI: 56.8-67.2), 53.4% (95% CI: 48.1-58.7), and 54.9% (95% CI: 48.1-60.2), respectively. The corresponding seroprotection rates were 95.0% (95% CI: 92.6-97.3), 93.8% (95% CI: 91.2-96.4), and 95.3% (95% CI: 93.0-97.5). The lower 95% CI limits of the seroconversion and seroprotection rates were over 40% and 70%, respectively, against all strains. Seroconversion and seroprotection rates were not significantly different between the study and control vaccine groups. Furthermore, the frequencies of adverse events were not significantly different between the 2 vaccine groups, and no serious vaccination-related adverse events were noted. In conclusion, the study vaccine exhibited substantial immunogenicity and safety in Korean children and is expected to be clinically effective.

  6. Multicenter study differentiated thyroid carcinoma (MSDS). Diminished acceptance of adjuvant external beam radiotherapy

    International Nuclear Information System (INIS)

    Biermann, M.; Pixberg, M.K.; Schober, O.; Schuck, A.; Willich, N.; Heinecke, A.; Koepke, W.; Schmid, K.W.; Dralle, H.

    2003-01-01

    Aim: The Multicenter Study Differentiated Thyroid Carcinoma (MSDS) is an ongoing study in Germany, Austria, and Switzerland on the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated thyroid carcinoma (DTC) in TNM stages pT4 pNO/1/xMO/x (5th ed. 1997). Methods: MSDS was designed as a prospective randomized trial. Patients receive thyroidectomy, radioiodine therapy (RIT) to ablate the thyroid remnant, and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical iodine-131 uptake (http://msds-studie.uni-muenster.de). Results: 311 patients were enrolled between January 2000 and March 2003. 279 patients met the trial's inclusion criteria. 45 consented to randomization, of whom 17 were randomized into treatment arm A (RTx) and 18 into arm B (no RTx). Advised by the trial's independent Data Monitoring and Safety Committee, the MSDS steering committee decided to terminate randomization in April 2003 and continue MSDS as a prospective cohort study. 23 of the 234 patients in the observation arm of the trial were prescribed RTx by their physicians. Thus, 14% of the trial cohort were randomized or assigned to receive RTx (intention-to-treat analysis). In contrast, at least 44% of all patients with pT4 papillary DTC in Germany in the nationwide PCES study underwent RTx in 1996 (p 2 -test). Conclusions: Acceptance of external beam RTx as a treatment modality for DTC has receded to a degree that accrual of a sufficient number of patients for a randomized trial has been impossible. Observation of the trial cohort is continued in order to assess clinical event rates with and without RTx and chronic RTx toxicity. (orig.) [de

  7. A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).

    Science.gov (United States)

    Haddara, Sami; Jacques, Jeremie; Lecleire, Stéphane; Branche, Julien; Leblanc, Sarah; Le Baleur, Yann; Privat, Jocelyn; Heyries, Laurent; Bichard, Philippe; Granval, Philippe; Chaput, Ulriikka; Koch, Stephane; Levy, Jonathan; Godart, Bruno; Charachon, Antoine; Bourgaux, Jean-François; Metivier-Cesbron, Elodie; Chabrun, Edouard; Quentin, Vincent; Perrot, Bastien; Vanbiervliet, Geoffroy; Coron, Emmanuel

    2016-12-01

    Background and study aims: The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice. Patients and methods: The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding. Results: A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy. Conclusion: These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed. ClinicalTrials.gov (NCT02595853). © Georg Thieme Verlag KG Stuttgart · New York.

  8. A short-term trial of tacrolimus ointment for atopic dermatitis. European Tacrolimus Multicenter Atopic Dermatitis Study Group

    NARCIS (Netherlands)

    Ruzicka, T.; Bieber, T.; Schöpf, E.; Rubins, A.; Dobozy, A.; Bos, J. D.; Jablonska, S.; Ahmed, I.; Thestrup-Pedersen, K.; Daniel, F.; Finzi, A.; Reitamo, S.

    1997-01-01

    Tacrolimus (FK 506) is an effective immunosuppressant drug for the prevention of rejection after organ transplantation, and preliminary studies suggest that topical application of tacrolimus is effective in the treatment of atopic dermatitis. We conducted a randomized, doubleblind, multicenter study

  9. Carotid Artery Injury in Anterior Cervical Spine Surgery: Multicenter Cohort Study and Literature Review

    OpenAIRE

    H?rtl, Roger; Alimi, Marjan; Abdelatif Boukebir, Mohamed; Berlin, Connor D.; Navarro-Ramirez, Rodrigo; Arnold, Paul M.; Fehlings, Michael G.; Mroz, Thomas E.; Riew, K. Daniel

    2017-01-01

    Study Design: Retrospective study and literature review. Objective: To provide more comprehensive data about carotid artery injury (CAI) or cerebrovascular accident (CVA) related to anterior cervical spine surgery. Methods: We conducted a retrospective, multicenter, case series study involving 21 high-volume surgical centers from the AOSpine North America Clinical Research Network. Medical records of 17?625 patients who went through cervical spine surgery (levels from C2 to C7) between Januar...

  10. Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

    Science.gov (United States)

    Walden, Anita; Nahm, Meredith; Barnett, M Edwina; Conde, Jose G; Dent, Andrew; Fadiel, Ahmed; Perry, Theresa; Tolk, Chris; Tcheng, James E; Eisenstein, Eric L

    2011-01-01

    New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models. We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models. The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers. Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models. Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.

  11. Detection of multidrug-resistant tuberculosis from stored DNA Samples: A multicenter study

    OpenAIRE

    Marie Sylvianne Rabodoarivelo; A Brandao; M C Cergole Novella; A G C. Bombonatte; B Imperiale; N Rakotosamimanana; N Morcillo; V Rasolofo; J C Palomino; A Martin

    2018-01-01

    Background: In low-income countries, rapid detection of tuberculosis (TB) drug resistance is often restricted by the difficulties of transporting and storing sputum samples from remote health centers to the reference laboratories where molecular tests are available. The aim of this study was to evaluate the performance of four transport and storage systems for molecular detection of rifampicin (RIF) and isoniazid (INH) resistance. Methods: This was a multicenter study. Molecular detection of ...

  12. Sarcopenia in patients with hip fracture: A multicenter cross-sectional study

    OpenAIRE

    Steihaug, Ole Martin; Gjesdal, Clara Gram; Bogen, Bård Erik; Kristoffersen, Målfrid Holen; Lien, Gunhild; Ranhoff, Anette Hylen

    2017-01-01

    Background: Sarcopenia is prevalent in older persons and is a risk factor for falls, fractures, and mortality. The aim of this study was to determine a) the feasibility of determining sarcopenia in patients with acute hip fracture, b) the prevalence of sarcopenia and c) associations of sarcopenia with nutritional status and comorbidities. Methods: A multicenter cross-sectional study on sarcopenia in male and female patients with acute hip fracture. Participants were previously ambulatory a...

  13. Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial.

    Science.gov (United States)

    Tomusiak, Anna; Strus, Magdalena; Heczko, Piotr B; Adamski, Paweł; Stefański, Grzegorz; Mikołajczyk-Cichońska, Aleksandra; Suda-Szczurek, Magdalena

    2015-01-01

    The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. The study was a multicenter, randomized, double-blind, and placebo-controlled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4-6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag(®), or a placebo (one capsule for seven consecutive days vaginally). The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Administration of inVag contributed to a significant decrease (between visits) in both vaginal pH (Pvaginal microbiota, as demonstrated by predominance of the Lactobacillus bacteria in vaginal microbiota.

  14. Segmentation of age-related white matter changes in a clinical multi-center study

    DEFF Research Database (Denmark)

    Dyrby, Tim B.; Rostrup, E.; Baare, W.F.C.

    2008-01-01

    Age-related white matter changes (WMC) are thought to be a marker of vascular pathology, and have been associated with motor and cognitive deficits. In the present study, an optimized artificial neural network was used as an automatic segmentation method to produce probabilistic maps of WMC...... in a clinical multi-center study. The neural network uses information from T1- and T2-weighted and fluid attenuation inversion recovery (FLAIR) magnetic resonance (MR) scans, neighboring voxels and spatial location. Generalizability of the neural network was optimized by including the Optimal Brain Damage (OBD......) pruning method in the training stage. Six optimized neural networks were produced to investigate the impact of different input information on WMC segmentation. The automatic segmentation method was applied to MR scans of 362 non-demented elderly subjects from 11 centers in the European multi-center study...

  15. [Role of multicenter study groups for clinical research in hematology and oncology].

    Science.gov (United States)

    Gökbuget, N; Hoelzer, D

    2009-04-01

    During the past 25 years a highly effective infrastructure for clinical trials was developed in hematology. Following initial funding by the BMFT (Ministry for Research and Technology) a number of large multicenter study groups for leukemia and lymphoma were developed. Treatment results from these studies often represent the"gold standard". However, since no standard therapy is defined for these diseases, the study groups aim to treat all patients within treatment optimization trials (TOT) to combine research and care. They contribute considerably to quality control in therapy and diagnostics, e.g., by establishing central reference laboratories. The regulatory requirements for clinical trials were extended considerably after the activation of the 12th drug law and TOTs now have to fulfill requirements similar to registration trials in the pharmaceutical industry. Due to the considerable bureaucratic effort and increased costs, only few large multicenter trials could thereafter be initiated and a substantial disadvantage for independent academic research becomes clearly evident.

  16. Participation of a coordinating center pharmacy in a multicenter international study.

    Science.gov (United States)

    Jeon, Jihyun Esther; Mighty, Janet; Lane, Karen; McBee, Nichol; Majkowski, Ryan; Mayo, Steven; Hanley, Daniel

    2016-11-15

    The activities of a coordinating center pharmacy (CCP) supporting a multicenter, international clinical trial are described. Serving in a research support role comparable to that of a commercial clinical trial supply company, a CCP within the Johns Hopkins Hospital Investigational Drug Service (JHH IDS) uses its management expertise and infrastructure to support multicenter trials, such as the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage, Phase III (CLEAR III) trial. The role of the CCP staff in supporting the CLEAR III trial was overall investigational product (IP) management through coordination of IP-related operations to ensure high-quality care for study participants at study sites in the United States and abroad. For the CLEAR III trial, the CCP coordinated IP supply activities; provided education to site pharmacists; developed study-specific documents, including pharmacy manuals; communicated with trial stakeholders, including third-party IP distributors; monitored treatment assignments; and performed quality assurance monitoring to ensure compliance with institutional, state, federal, and international regulations regarding IP procurement and storage. Acting as a CCP for a multicenter international study poses a number of operational challenges while providing opportunities for the CCP to contribute to research of global importance and enrich the skill sets of its personnel. The development and implementation of the CCP at JHH IDS for the CLEAR III trial included several responsibilities, such as IP supply management, communication, and database, regulatory, and finance management. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  17. [Multicenter Ozurdex® assessment for diabetic macular edema: MOZART study].

    Science.gov (United States)

    Guigou, S; Hajjar, C; Parrat, E; Merite, P Y; Pommier, S; Matonti, F; Prost-Magnin, O; Meyer, F

    2014-06-01

    To evaluate the efficiency and safety of intravitreal implant of 0.7mg dexamathasone in visual impairment due to diabetic macular edema (DME). This was a retrospective, multicenter, study. Seventy-four patients, with a mean age of 65 years, followed for at least 6 months (mean follow-up: 9.8 months) were included in 5 French eye clinics (P 1.5 collective). The mean systolic blood pressure was 138mmHg and the mean HbA1c was 7.2%. We monitored 2 systemic parameters: blood pressure and glycemic balance. Best-corrected visual acuity (BCVA), central retinal thickness (CRT, Spectralis OCT), intraocular pressure (IOP) and cataract progression are studied at baseline and then at 1, 2, 4 and 6 months. The average CRT decrease was: 239μm at month 2 (M2) and 135μm at month 6 (M6). The mean improvement from baseline of BCVA is 8.5 letters at M2 and 7.6 letters at M6. A gain greater than 15 letters is found in 27% of patients at M6. For naive patients the BCVA is 71 letters versus 60 letters (P<0.05). Patients with a baseline CRT <500mmHg have a BCVA of 66 letters versus 57 letters (P<0.05). The mean rate injections was 1.2 at 6 months with an average of 5.4 months for reinjection. Ocular hypertension greater than 25mmHg, managed by topical treatment, is observed in 13.4% of patients. No glaucoma surgery was necessary. Dexamethasone has an anatomical and functional effectiveness in the treatment of DME. Outcomes for naive patients and lower CRT suggest that the duration of diabetes mellitus and previous treatments are negative factors of recovery. Side effects are rare and manageable. Ozurdex(®) seems to be a treatment for visual impairment due to DME with a favorable safety profile. Patient follow-up must be adapted to half-life of the product with a control before M1 (intraocular pressure) and before M5 (DME recurrence, BCVA). Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  18. LORIS: A web-based data management system for multi-center studies.

    Directory of Open Access Journals (Sweden)

    Samir eDas

    2012-01-01

    Full Text Available LORIS (Longitudinal Online Research and Imaging System is a modular and extensible web-based data management system that integrates all aspects of a multi-center study: from heterogeneous data acquisition (imaging, clinical, behavior, genetics to storage, processing and ultimately dissemination. It provides a secure, user-friendly, and streamlined platform to automate the flow of clinical trials and complex multi-center studies. A subject-centric internal organization allows researchers to capture and subsequently extract all information, longitudinal or cross-sectional, from any subset of the study cohort. Extensive error-checking and quality control procedures, security, data management, data querying and administrative functions provide LORIS with a triple capability (i continuous project coordination and monitoring of data acquisition (ii data storage/cleaning/querying, (iii interface with arbitrary external data processing pipelines. LORIS is a complete solution that has been thoroughly tested through the full life cycle of a multi-center longitudinal project# and is now supporting numerous neurodevelopment and neurodegeneration research projects internationally.

  19. [Information management in multicenter studies: the Brazilian longitudinal study for adult health].

    Science.gov (United States)

    Duncan, Bruce Bartholow; Vigo, Álvaro; Hernandez, Émerson; Luft, Vivian Cristine; Ahlert, Hubert; Bergmann, Kaiser; Mota, Eduardo

    2013-06-01

    Information management in large multicenter studies requires a specialized approach. The Estudo Longitudinal da Saúde do Adulto (ELSA-Brasil - Brazilian Longitudinal Study for Adult Health) has created a Datacenter to enter and manage its data system. The aim of this paper is to describe the steps involved, including the information entry, transmission and management methods. A web system was developed in order to allow, in a safe and confidential way, online data entry, checking and editing, as well as the incorporation of data collected on paper. Additionally, a Picture Archiving and Communication System was implemented and customized for echocardiography and retinography. It stores the images received from the Investigation Centers and makes them available at the Reading Centers. Finally, data extraction and cleaning processes were developed to create databases in formats that enable analyses in multiple statistical packages.

  20. Multicenter Retrospective Analysis of the Effectiveness and Safety of Rituximab in Korean Patients with Refractory Systemic Lupus Erythematosus

    Directory of Open Access Journals (Sweden)

    So-Young Bang

    2012-01-01

    Full Text Available Objective. Although two recent randomized placebo-controlled trials of rituximab (RTX failed to demonstrate efficacy in systemic lupus erythematosus (SLE, clinicians continue to use off-label RTX for cases refractory to current treatments. We evaluated the effectiveness and safety of rituximab for patients with refractory SLE in Korea. Methods. We retrospectively analyzed multicenter patients treated with RTX in Korea. Results. 39 SLE patients treated with RTX were included in the following manner: lupus nephritis 43.6%, hematologic 33.3%, arthritis 7.8%, myositis 7.8%, and others 7.7%. All patients had responded poorly to at least one conventional immunosuppressive agent (mean 2.5 ± 1.1, cyclophosphamide 43.6%, mycophenolate mofetil 48.7%, and other drugs before RTX. Clinical improvements (complete or partial remission occurred in patients with renal disease, hematologic disease, arthritis, myositis, and other manifestations at 6 months after RTX. The SLEDAI score was significantly decreased from 10.8±7.1 at baseline to 6.7±4.0 at 6 months, 6.2±4.1 at 12 months, and 5.5±3.6 at 24 months after RTX (P<0.05. Among 28 clinical responders, 4 patients experienced a relapse of disease at 25±4 months. Infections were noted in 3 patients (7.7%. Conclusion. RTX could be an effective and relatively safe therapeutic option in patients with severe refractory SLE until novel B-cell depletion therapy is available.

  1. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis.

    Science.gov (United States)

    Thalmann, Markus; Grubitzsch, Herko; Matschke, Klaus; Glauber, Mattia; Tan, Erwin; Francois, Katrien; Amorim, Mario J; Hensens, Ab G; Cesari, Francesco; Feyrer, Richard; Diegeler, Anno; Veit, Franz; Repossini, Alberto

    2016-01-01

    The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes. Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm. At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤ 30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m(2) at discharge to 122 g/m(2) at 1 year. At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  2. Reliability analysis of GEM® Premier™ technology: a multicenter study

    Directory of Open Access Journals (Sweden)

    Francesco Faggiano

    2015-10-01

    Full Text Available This paper describes how specific blood gas analyzer characteristics can support the emerging clinical and organizational user’s needs while ensuring patient safety. A oneyear data set from two Italian hospitals was analyzed from 10 different blood gas analyzers. Performance measurements in terms of mean down time (MDT were calculated to show how technical characteristics declared by the manufacturer compare to the analyzer availability in real clinical settings. Results show a high level of reliability for the analyzed technology, associated with very low MDT of each sensor integrated in the cartridge. Moreover, results show a high level of efficiency in cartridge usage. Such results are consistent with the specification of the GEM® Premier™ maintenance- free technology and are particularly relevant in the point-of-care testing setting.

  3. Implementing an error disclosure coaching model: A multicenter case study.

    Science.gov (United States)

    White, Andrew A; Brock, Douglas M; McCotter, Patricia I; Shannon, Sarah E; Gallagher, Thomas H

    2017-01-01

    National guidelines call for health care organizations to provide around-the-clock coaching for medical error disclosure. However, frontline clinicians may not always seek risk managers for coaching. As part of a demonstration project designed to improve patient safety and reduce malpractice liability, we trained multidisciplinary disclosure coaches at 8 health care organizations in Washington State. The training was highly rated by participants, although not all emerged confident in their coaching skill. This multisite intervention can serve as a model for other organizations looking to enhance existing disclosure capabilities. Success likely requires cultural change and repeated practice opportunities for coaches. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.

  4. Nordic studies in reactor safety

    International Nuclear Information System (INIS)

    Pershagen, N.

    1993-01-01

    The Nordic Nuclear Safety Research Programme SIK programme in reactor safety is part of a major joint Nordic research effort in nuclear safety. The report summarizes the achievements of the SIK programme, which was carried out during 1990-1993 in collaboration between Nordic nuclear utilities, safety authorities, and research institutes. Three main projects were successfully completed dealing with: 1) development and application of a living PSA concept for monitoring the risk of core damage, and of safety indicators for early warning of possible safety problems; 2) review and intercomparison of severe accident codes, case studies of potential core melt accidents in nordic reactors, development of chemical models for the MAAP code, and outline of a system for computerized accident management support; 3) compilation of information about design and safety features of neighbouring reactors in Germany, Lithuania and Russia, and for naval reactors and nuclear submarines. The report reviews the state-of-the-art in each subject matter as an introduction to the individual project summaries. The main findings of each project are highlighted. The report also contains an overview of reactor safety research in the Nordic countries and a summary of fundamental reactor safety principles. (au) (69 refs.)

  5. Multicenter retrospective study of cetuximab plus platinum-based chemotherapy for recurrent or metastatic oral squamous cell carcinoma.

    Science.gov (United States)

    Yanamoto, Souichi; Umeda, Masahiro; Kioi, Mitomu; Kirita, Tadaaki; Yamashita, Tetsuro; Hiratsuka, Hiroyoshi; Yokoo, Satoshi; Tanzawa, Hideki; Uzawa, Narikazu; Shibahara, Takahiko; Ota, Yoshihide; Kurita, Hiroshi; Okura, Masaya; Hamakawa, Hiroyuki; Kusukawa, Jingo; Tohnai, Iwai

    2018-03-01

    The purpose of this study was to assess the efficacy and safety of cetuximab plus platinum-based chemotherapy for patients specifically diagnosed with recurrent or metastatic oral squamous cell carcinoma (OSCC). We conducted a multicenter retrospective observational study of patients who underwent first-line cetuximab plus platinum-based chemotherapy between December 2012 and June 2015. 65 patients received weekly cetuximab (week 1, 400 mg/m 2 ; subsequent weeks, 250 mg/m 2 ) plus a maximum of six 3-weekly cycles of cisplatin (80 or 100 mg/m 2 , day 1) or carboplatin (at an area under the curve of 5 mg/mL/min as a 1-h intravenous infusion on day 1) and 5-fluorouracil (800 or 1000 mg/m 2 /day, days 1-4). Patients with stable disease who received cetuximab plus platinum-based chemotherapy continued to receive cetuximab until disease progression or unacceptable toxicities, whichever occurred first. The median follow-up was 10.5 (range 1.2-34.2) months. The best overall response and the disease control rates were 46.2 and 67.7%, respectively. The median overall survival and progression-free survival rates were 12.1 and 7.8 months, respectively. The most common grades 3-4 adverse events were skin rash (9.2%) followed by leukopenia (6.2%). None of the adverse events were fatal. The results of our multicenter retrospective study, which was the largest of its kind to date, suggest that first-line cetuximab plus platinum-based chemotherapy is suitable and well-tolerated for the systemic therapy of recurrent or metastatic OSCC.

  6. Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region.

    Science.gov (United States)

    Sundaram, Hema; Gold, Michael; Waldorf, Heidi; Lupo, Mary; Nguyen, Vivien L; Karnik, Jwala

    2015-12-01

    This multicenter, open-label pilot study evaluated safety, efficacy and tolerability of a topical formulation containing a multipotent growth factor resignaling complex (MRCx), when applied to infraorbital and lateral canthal skin. Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales. Subjects' self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved. This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.

  7. The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

    Science.gov (United States)

    Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

    2015-06-18

    Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany. PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted. PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.

  8. Extracorporeal shockwave myocardial therapy is efficacious in improving symptoms in patients with refractory angina pectoris--a multicenter study.

    Science.gov (United States)

    Prasad, Megha; Wan Ahmad, Wan Azman; Sukmawan, Renan; Magsombol, Edward-Bengie L; Cassar, Andrew; Vinshtok, Yuri; Ismail, Muhammad Dzafir; Mahmood Zuhdi, Ahmad Syadi; Locnen, Sue Ann; Jimenez, Rodney; Callleja, Homobono; Lerman, Amir

    2015-05-01

    Medically refractory angina remains a significant health concern despite major advances in revascularization techniques and emerging medical therapies. We aimed to determine the safety and efficacy of extracorporeal shockwave myocardial therapy (ESMT) in managing angina pectoris. A single-arm multicenter prospective study was designed aiming to determine the safety and efficacy of ESMT. Patients of functional Canadian Cardiovascular Society class II-IV, despite stable and optimal medical management, with documented myocardial segments with reversible ischemia and/or hibernation on the basis of echocardiography/single-photon emission computerized tomography (SPECT) were enrolled from 2010 to 2012. A total of 111 patients were enrolled, 33 from Indonesia, 21 from Malaysia, and 57 from Philippines. Patients underwent nine cycles of ESMT over 9 weeks. Patients were followed up for 3-6 months after ESMT treatment. During follow-up, patients were subjected to clinical evaluation, the Seattle Angina Questionnaire, assessment of nitrate intake, the 6-min walk test, echocardiography, and SPECT. The mean age of the population was 62.9±10.9 years. The summed difference score on pharmacologically induced stress SPECT improved from 9.53±17.87 at baseline to 7.77±11.83 at follow-up (P=0.0086). Improvement in the total Seattle Angina Questionnaire score was seen in 83% of patients (Pangina.

  9. Recurrent Laryngeal Nerve Palsy After Cervical Spine Surgery: A Multicenter AOSpine Clinical Research Network Study.

    Science.gov (United States)

    Gokaslan, Ziya L; Bydon, Mohamad; De la Garza-Ramos, Rafael; Smith, Zachary A; Hsu, Wellington K; Qureshi, Sheeraz A; Cho, Samuel K; Baird, Evan O; Mroz, Thomas E; Fehlings, Michael; Arnold, Paul M; Riew, K Daniel

    2017-04-01

    Multicenter retrospective study. To investigate the risk of symptomatic recurrent laryngeal nerve palsy (RLNP) following cervical spine surgery, to examine risk factors for its development, and to report its treatment and outcomes. A multicenter study from 21 high-volume surgical centers from the AOSpine North America Clinical Research Network was performed. Each center screened for rare complications following cervical spine surgery, including RLNP. Patients were included if they underwent cervical spine surgery (levels from C2 to C7) between January 1, 2005 and December 31, 2011. Data were analyzed with regard to complication treatment and outcome. Cases were compared to a control group from the AOSpine CSM and CSM-I studies. Three centers reported 19 cases of RLNP from a cohort of 1345 patients. The reported incidence of RLNP ranged from 0.6% to 2.9% between these 3 centers. Fifteen patients (79%) in the RLNP group were approached from the left side. Ten patients (52.6%) required treatment for RLNP-6 required medical therapy (steroids), 1 interventional treatment (injection laryngoplasty), and 3 conservative therapy (speech therapy). When examining outcomes, 73.7% (14/19) of cases resolved completely, 15.8% (3/19) resolved with residual effects, and in 10.5% (2/19) of cases this could not be determined. In this multicenter study examining rare complications following cervical spine surgery, the risk of RLNP after cervical spine surgery ranged from 0.6% to 2.9% between centers. Though rare, it was found that 16% of patients may experience partial resolution with residual effects, and 74% resolve completely.

  10. Mass Spectrometry Imaging of Biological Tissue: An Approach for Multicenter Studies

    Energy Technology Data Exchange (ETDEWEB)

    Rompp, Andreas; Both, Jean-Pierre; Brunelle, Alain; Heeren, Ronald M.; Laprevote, Olivier; Prideaux, Brendan; Seyer, Alexandre; Spengler, Bernhard; Stoeckli, Markus; Smith, Donald F.

    2015-03-01

    Mass spectrometry imaging has become a popular tool for probing the chemical complexity of biological surfaces. This led to the development of a wide range of instrumentation and preparation protocols. It is thus desirable to evaluate and compare the data output from different methodologies and mass spectrometers. Here, we present an approach for the comparison of mass spectrometry imaging data from different laboratories (often referred to as multicenter studies). This is exemplified by the analysis of mouse brain sections in five laboratories in Europe and the USA. The instrumentation includes matrix-assisted laser desorption/ionization (MALDI)-time-of-flight (TOF), MALDI-QTOF, MALDIFourier transform ion cyclotron resonance (FTICR), atmospheric-pressure (AP)-MALDI-Orbitrap, and cluster TOF-secondary ion mass spectrometry (SIMS). Experimental parameters such as measurement speed, imaging bin width, and mass spectrometric parameters are discussed. All datasets were converted to the standard data format imzML and displayed in a common open-source software with identical parameters for visualization, which facilitates direct comparison of MS images. The imzML conversion also allowed exchange of fully functional MS imaging datasets between the different laboratories. The experiments ranged from overview measurements of the full mouse brain to detailed analysis of smaller features (depending on spatial resolution settings), but common histological features such as the corpus callosum were visible in all measurements. High spatial resolution measurements of AP-MALDI-Orbitrap and TOF-SIMS showed comparable structures in the low-micrometer range. We discuss general considerations for planning and performing multicenter studies in mass spectrometry imaging. This includes details on the selection, distribution, and preparation of tissue samples as well as on data handling. Such multicenter studies in combination with ongoing activities for reporting guidelines, a common

  11. Dopamine serotonin stabilizer RP5063: A randomized, double-blind, placebo-controlled multicenter trial of safety and efficacy in exacerbation of schizophrenia or schizoaffective disorder.

    Science.gov (United States)

    Cantillon, Marc; Prakash, Arul; Alexander, Ajay; Ings, Robert; Sweitzer, Dennis; Bhat, Laxminarayan

    2017-11-01

    The study objectives were to evaluate the efficacy, safety, tolerability, and pharmacokinetics of RP5063 versus placebo. The study was conducted in adults with acute exacerbation of schizophrenia or schizoaffective disorder. This 28-day, multicenter, placebo-controlled, double-blind study randomized 234 subjects to RP5063 15, 30, or 50mg; aripiprazole; or placebo (3:3:3:1:2) once daily. The aripiprazole arm was included solely to show assay sensitivity and was not powered to show efficacy. The primary endpoint was change from baseline to Day 28/EOT (End-of-Treatment) in Positive and Negative Syndrome Scale (PANSS) total score; secondary endpoints included PANSS subscales, improvement ≥1 point on the Clinical Global Impressions-Severity (CGI-S), depression and cognition scales. The primary analysis of PANSS Total showed improvement by a mean (SE) of -20.23 (2.65), -15.42 (2.04), and -19.21 (2.39) in the RP5063 15, 30, and 50mg arms, versus -11.41 (3.45) in the placebo arm. The difference between treatment and placebo reached statistical significance for the 15mg (p=0.021) and 50mg (p=0.016) arms. Improvement with RP5063 was also seen for multiple secondary efficacy outcomes. Discontinuation for any reason was much lower for RP5063 (14%, 25%, 12%) versus placebo (26%) and aripiprazole (35%). The most common treatment-emergent adverse events (TEAE) in the RP5063 groups were insomnia and agitation. There were no significant changes in body weight, electrocardiogram, or incidence of orthostatic hypotension; there was a decrease in blood glucose, lipid profiles, and prolactin levels. In conclusion, the novel dopamine serotonin stabilizer, RP5063 is an efficacious and well-tolerated treatment for acute exacerbation of schizophrenia or schizoaffective disorder. Copyright © 2017. Published by Elsevier B.V.

  12. Serious gaming and voluntary laparoscopic skills training : A multicenter study

    NARCIS (Netherlands)

    Verdaasdonk, E.; Dankelman, J.; Schijven, M.P.; Lange, J.F.; Wentink, M.; Stassen, L.P.S.

    2009-01-01

    This study assesses the issue of voluntary training of a standardized online competition (serious gaming) between surgical residents. Surgical residents were invited to join a competition on a virtual reality (VR) simulator for laparoscopic motor skills. A final score was calculated based on the

  13. Serious gaming and voluntary laparoscopic skills training: a multicenter study

    NARCIS (Netherlands)

    Verdaasdonk, E. G. G.; Dankelman, J.; Schijven, M. P.; Lange, J. F.; Wentink, M.; Stassen, L. P. S.

    2009-01-01

    This study assesses the issue of voluntary training of a standardized online competition (serious gaming) between surgical residents. Surgical residents were invited to join a competition on a virtual reality (VR) simulator for laparoscopic motor skills. A final score was calculated based on the

  14. Sexual functioning of people with rheumatoid arthritis: a multicenter study

    NARCIS (Netherlands)

    van Berlo, Willy T.M.; van de Wiel, Harry B.M.; Taal, Erik; Rasker, Johannes J.; Weijmar Schultz, Willibrord C.M.; van Rijswijk, Martin H.

    2007-01-01

    The objective of this study is to compare men and women with rheumatoid arthritis (RA) to controls regarding sexual motivation, activity, satisfaction, and specific sexual problems, and to determine the correlation of physical aspects of the disease with sexual functioning. Questionnaire for

  15. Sexual functioning of people with rheumatoid arthritis : a multicenter study

    NARCIS (Netherlands)

    van Berlo, W.T.M.; van de Wiel, H.B.M.; Taal, E.; Rasker, J.J.; Schultz, W.C.M.W.; van Rijswijk, M.H.

    The objective of this study is to compare men and women with rheumatoid arthritis (RA) to controls regarding sexual motivation, activity, satisfaction, and specific sexual problems, and to determine the correlation of physical aspects of the disease with sexual functioning. Questionnaire for

  16. Efficiency and safety of leflunomide in rheumatoid arthritis: Results of a Russian observational multicenter of trial

    Directory of Open Access Journals (Sweden)

    R. M. Balabanova

    2015-01-01

    CRP from 27.8 to 12.35 mg/l. By 6 months of therapy, low and moderate RA activities estimated by DAS28 were noted in 70.9% of cases and those by CDAI in 61.2%. No serious ARs were detected during the study.Conclusion. The findings suggest that leflunomide shows a good clinical efficacy and tolerability.

  17. [International multicenter studies of treatment of severe traumatic brain injury].

    Science.gov (United States)

    Talypov, A E; Kordonsky, A Yu; Krylov, V V

    2016-01-01

    Despite the introduction of new diagnostic and therapeutic methods, traumatic brain injury (TBI) remains one of the leading cause of death and disability worldwide. Standards and recommendations on conservative and surgical treatment of TBI patients should be based on concepts and methods with proven efficacy. The authors present a review of studies of the treatment and surgery of severe TBI: DECRA, RESCUEicp, STITCH(TRAUMA), CRASH, CRASH-2, CAPTAIN, NABIS: H ll, Eurotherm 3235. Important recommendations of the international group IMPACT are considered.

  18. Fall predictors in older cancer patients: a multicenter prospective study

    OpenAIRE

    Vande Walle, Nathalie; Kenis, Cindy; Heeren, Pieter; Van Puyvelde, Katrien; Decoster, Lore; Beyer, Ingo; Conings, Godelieve; Flamaing, Johan; Lobelle, Jean-Pierre; Wildiers, Hans; Milisen, Koen

    2014-01-01

    Background In the older population falls are a common problem and a major cause of morbidity, mortality and functional decline. The etiology is often multifactorial making the identification of fall predictors essential for preventive measures. Despite this knowledge, data on falls within the older cancer population are limited. The objective of this study was to evaluate the occurrence of falls within 2 to 3?months after cancer treatment decision and to identify predictors of falls (?1 fall)...

  19. Insomnia in hemodialysis patients: A multicenter study from morocco

    Directory of Open Access Journals (Sweden)

    Mohamed Amine Hamzi

    2017-01-01

    Full Text Available Previous studies have shown that insomnia is a common sleep disorder in patients with end-stage renal disease. This study aims to determine the prevalence and risk factors of insomnia in our chronic hemodialysis (HD patients. This is a cross-sectional study conducted in three HD units in Morocco. To assess the prevalence of insomnia, we used a specific questionnaire. Patients complaining of difficulty in falling asleep and/or nocturnal awakenings occurring seven nights a week during the last month were included in the group “insomnia;” the other patients were used as controls. Clinical, biological, and dialysis data were recorded for each patient. Sleep disorders and their subjective causes were also identified. Eighty-nine percent of questioned patients admitted to having sleep disturbances of different degrees. Insomnia was significantly associated with female gender and time of dialysis. Age, body mass index, inter-dialytic weight gain, and blood pressure were similar between the two groups, as well as dialytic parameters and drug use. There was no significant difference in the values of plasma creatinine, urea, hemoglobin, parathyroid hormone, calcium, phosphorus, C-reactive protein, and albumin between the groups. Disorders most frequently encountered in patients with insomnia were waking up at night (90%, difficulty falling asleep (60%, and daytime sleepiness (60%. The restless legs syndrome was seen in half of these patients. The main reported causes of insomnia were anxiety and/or depression (70% and bone pain (67%. Insomnia is common in HD patients and is frequently associated with other disorders of sleep. Female sex and duration on dialysis are the two risk factors found in our study. Insomnia does not appear related to any biochemical or dialysis parameters. Increased attention should be given to the management of dialysis patients regarding the diagnosis and management of insomnia and associated sleep disorders.

  20. Prognostic Factors of Uterine Serous Carcinoma-A Multicenter Study.

    Science.gov (United States)

    Zhong, Xiaozhu; Wang, Jianliu; Kaku, Tengen; Wang, Zhiqi; Li, Xiaoping; Wei, Lihui

    2018-04-04

    The prognostic factors of uterine serous carcinoma (USC) vary among studies, and there is no report of Chinese USC patients. The aim of this study was to investigate the clinicopathological characteristics and prognostic factors in Chinese patients with USC. Patients with USC from 13 authoritative university hospitals in China and treated between 2004 and 2014 were retrospectively reviewed. Three-year disease-free survival rate (DFSR), cumulative recurrence, and cumulative mortality were estimated by Kaplan-Meier analyses and log-rank tests. Multivariate Cox regression analysis was used to model the association of potential prognostic factors with clinical outcomes. Data of a total of 241 patients were reviewed. The median follow-up was 26 months (range, 1-128 months). Median age was 60 years (range, 39-84 years), and 58.0% had stages I-II disease. The 3-year DFSR and cumulative recurrence were 46.8% and 27.7%. Advanced stage (III and IV) (P = 0.004), myometrial invasion (P = 0.001), adnexal involvement (P USC. Prospective studies are needed to confirm these results.

  1. A Multicenter Study of the Presentation, Treatment, and Outcomes of Cervical Dural Tears.

    Science.gov (United States)

    O'Neill, Kevin R; Fehlings, Michael G; Mroz, Thomas E; Smith, Zachary A; Hsu, Wellington K; Kanter, Adam S; Steinmetz, Michael P; Arnold, Paul M; Mummaneni, Praveen V; Chou, Dean; Nassr, Ahmad; Qureshi, Sheeraz A; Cho, Samuel K; Baird, Evan O; Smith, Justin S; Shaffrey, Christopher; Tannoury, Chadi A; Tannoury, Tony; Gokaslan, Ziya L; Gum, Jeffrey L; Hart, Robert A; Isaacs, Robert E; Sasso, Rick C; Bumpass, David B; Bydon, Mohamad; Corriveau, Mark; De Giacomo, Anthony F; Derakhshan, Adeeb; Jobse, Bruce C; Lubelski, Daniel; Lee, Sungho; Massicotte, Eric M; Pace, Jonathan R; Smith, Gabriel A; Than, Khoi D; Riew, K Daniel

    2017-04-01

    Retrospective multicenter case series study. Because cervical dural tears are rare, most surgeons have limited experience with this complication. A multicenter study was performed to better understand the presentation, treatment, and outcomes following cervical dural tears. Multiple surgeons from 23 institutions retrospectively identified 21 rare complications that occurred between 2005 and 2011, including unintentional cervical dural tears. Demographic data and surgical history were obtained. Clinical outcomes following surgery were assessed, and any reoperations were recorded. Neck Disability Index (NDI), modified Japanese Orthopaedic Association (mJOA), Nurick classification (NuC), and Short-Form 36 (SF36) scores were recorded at baseline and final follow-up at certain centers. All data were collected, collated, and analyzed by a private research organization. There were 109 cases of cervical dural tears among 18 463 surgeries performed. In 101 cases (93%) there was no clinical sequelae following successful dural tear repair. There were statistical improvements ( P < .05) in mJOA and NuC scores, but not NDI or SF36 scores. No specific baseline or operative factors were found to be associated with the occurrence of dural tears. In most cases, no further postoperative treatments of the dural tear were required, while there were 13 patients (12%) that required subsequent treatment of cerebrospinal fluid drainage. Analysis of those requiring further treatments did not identify an optimum treatment strategy for cervical dural tears. In this multicenter study, we report our findings on the largest reported series (n = 109) of cervical dural tears. In a vast majority of cases, no subsequent interventions were required and no clinical sequelae were observed.

  2. Diagnostic performance of computed tomography coronary angiography (from the Prospective National Multicenter Multivendor EVASCAN Study).

    Science.gov (United States)

    Gueret, Pascal; Deux, Jean-François; Bonello, Laurent; Sarran, Anthony; Tron, Christophe; Christiaens, Luc; Dacher, Jean-Nicolas; Bertrand, David; Leborgne, Laurent; Renard, Cedric; Caussin, Christophe; Cluzel, Philippe; Helft, Gerard; Crochet, Dominique; Vernhet-Kovacsik, Hélène; Chabbert, Valérie; Ferrari, Emile; Gilard, Martine; Willoteaux, Serge; Furber, Alain; Barone-Rochette, Gilles; Jankowski, Adrien; Douek, Philippe; Mousseaux, Elie; Sirol, Marc; Niarra, Ralph; Chatellier, Gilles; Laissy, Jean-Pierre

    2013-02-15

    Computed tomographic coronary angiography (CTCA) has been proposed as a noninvasive test for significant coronary artery disease (CAD), but only limited data are available from prospective multicenter trials. The goal of this study was to establish the diagnostic accuracy of CTCA compared to coronary angiography (CA) in a large population of symptomatic patients with clinical indications for coronary imaging. This national, multicenter study was designed to prospectively evaluate stable patients able to undergo CTCA followed by conventional CA. Data from CTCA and CA were analyzed in a blinded fashion at central core laboratories. The main outcome was the evaluation of patient-, vessel-, and segment-based diagnostic performance of CTCA to detect or rule out significant CAD (≥50% luminal diameter reduction). Of 757 patients enrolled, 746 (mean age 61 ± 12 years, 71% men) were analyzed. They underwent CTCA followed by CA 1.7 ± 0.8 days later using a 64-detector scanner. The prevalence of significant CAD in native coronary vessels by CA was 54%. The rate of nonassessable segments by CTCA was 6%. In a patient-based analysis, sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios of CTCA were 91%, 50%, 68%, 83%, 1.82, and 0.18, respectively. The strongest predictors of false-negative results on CTCA were high estimated pretest probability of CAD (odds ratio [OR] 1.97, p <0.001), male gender (OR 1.5, p <0.002), diabetes (OR 1.5, p <0.0001), and age (OR 1.2, p <0.0001). In conclusion, in this large multicenter study, CTCA identified significant CAD with high sensitivity. However, in routine clinical practice, each patient should be individually evaluated, and the pretest probability of obstructive CAD should be taken into account when deciding which method, CTCA or CA, to use to diagnose its presence and severity. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile.

    Directory of Open Access Journals (Sweden)

    Hayfaa Wahabi

    Full Text Available To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant.A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated.The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%.Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world.

  4. Pediatric neurofibromatosis 1 and parental stress: a multicenter study

    Directory of Open Access Journals (Sweden)

    Esposito M

    2014-01-01

    Full Text Available Maria Esposito,1 Rosa Marotta,2 Michele Roccella,3 Beatrice Gallai,4 Lucia Parisi,3 Serena Marianna Lavano,2 Marco Carotenuto1 1Clinic of Child and Adolescent Neuropsychiatry, Department of Mental Health, Physical and Preventive Medicine, Second University of Naples, Naples, Italy; 2Department of Psychiatry, "Magna Graecia" University of Catanzaro, Catanzaro, Italy; 3Child Neuropsychiatry, Department of Psychology, University of Palermo, Palermo, Italy; 4Unit of Child and Adolescent Neuropsychiatry, University of Perugia, Perugia, Italy Background: Neurofibromatosis 1 (NF1 is a complex and multifaceted neurocutaneous syndrome with many and varied comorbidities. The literature about the prevalence and degree of maternal stress and the impact of NF1 in the parent–child interaction is still scant. The aim of this study was to evaluate the prevalence of maternal stress in a large pediatric sample of individuals affected by NF1. Methods: Thirty-seven children (19 boys, 18 girls of mean age 7.86±2.94 (range 5–11 years affected by typical NF1 and a control group comprising 405 typically developing children (207 boys, 198 girls; mean age 8.54±2.47 years were included in this study. To assess parental stress, the mothers of all individuals (NF1 and comparisons filled out the Parenting Stress Index-Short Form test. Results: The two study groups were comparable for age (P=0.116, gender (P=0.886, and body mass index adjusted for age (P=0.305. Mothers of children affected by NF1 reported higher mean Parenting Stress Index-Short Form scores on the Parental Distress domain (P<0.001, Difficult Child domain (P<0.001, and Total Stress domain than the mothers of typically developing children (controls (P<0.001. No significant differences between the two groups were found for the Parent-Child Dysfunctional Interaction domain (P=0.566 or Defensive Responding domain scores (P=0.160. Conclusion: NF1 is considered a multisystemic and complex disease, with many

  5. Giant cell arteritis: a multicenter observational study in Brazil

    Directory of Open Access Journals (Sweden)

    Alexandre Wagner Silva de Souza

    2013-01-01

    Full Text Available OBJECTIVE: To describe demographic features, disease manifestations and therapy in patients with giant cell arteritis from referral centers in Brazil. METHODS: A retrospective cohort study was performed on 45 giant cell arteritis patients from three university hospitals in Brazil. Diagnoses were based on the American College of Rheumatology classification criteria for giant cell arteritis or temporal artery biopsy findings. RESULTS: Most patients were Caucasian, and females were slightly more predominant. The frequencies of disease manifestations were as follows: temporal headache in 82.2%, neuro-ophthalmologic manifestations in 68.9%, jaw claudication in 48.9%, systemic symptoms in 44.4%, polymyalgia rheumatica in 35.6% and extra-cranial vessel involvement in 17.8% of cases. Aortic aneurysms were observed in 6.6% of patients. A comparison between patients with biopsy-proven giant cell arteritis and those without temporal artery biopsies did not yield significant differences in disease manifestations. All patients were treated with oral prednisone, and intravenous methylprednisolone was administered to nearly half of the patients. Methotrexate was the most commonly used immunosuppressive agent, and low-dose aspirin was prescribed to the majority of patients. Relapses occurred in 28.9% of patients, and aspirin had a protective effect against relapses. Females had higher prevalences of polymyalgia rheumatica, systemic manifestations and jaw claudication, while permanent visual loss was more prevalent in men. CONCLUSIONS: Most of the clinical features of Brazilian giant cell arteritis patients were similar to those found in other studies, except for the high prevalence of neuro-ophthalmic manifestations and permanent blindness in the Brazilian patients. Aspirin had a protective effect on relapses.

  6. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Pascal H Colson

    Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  7. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Science.gov (United States)

    Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

    2016-01-01

    To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  8. Pigmented villonodular synovitis: a retrospective multicenter study of 237 cases.

    Directory of Open Access Journals (Sweden)

    Guo-ping Xie

    Full Text Available To review clinical characteristics of pigmented villonodular synovitis (PVNS in China.Electronic medical records (EMR of four Chinese institutes were queried for patients with histologically proven PVNS between January 2005 and February 2014. Their data were collected including gender, age at diagnosis, clinical presentation, affected site, symptom duration, comorbidities, treatment strategy, recurrence and routine laboratories.A total of 237 patients with biopsy-proven PVNS were investigated. The gender ratio was 1.35 for a female predominance (101 males and 136 females. The average age was 36 years (range, 2 to 83 years. The median delay from initial clinical symptom to diagnosis was 18 months. Main affected areas were the knee (73.84% and the hip (18.14%. Forty patients had a clear history of joint trauma. Six patients were concurrently diagnosed with PVNS and avascular necrosis (AVN. Five patients suffered from PVNS following implantation of orthopaedic devices including artificial prosthesis, plate and wire. One hundred and twenty-nine patients underwent arthroscopic synovectomy and 108 open synovectomy. Altogether 48 patients (26 males and 22 females had recurrence of disease. The relapse rate was 24% (knee and 6.98% (hip, 20.93% (open surgery and 19.44% (arthroscopy, respectively. Erythrocyte sedimentation rate (ESR and C-reactive protein (CRP rate were elevated in 45.83% and 38.41% of the patients respectively.To our knowledge, this study is the largest sample size of PVNS patients reported as well as the largest sample of PVNS with concurrent AVN reported to date. Our outcomes suggest that PVNS shows a female predominance, occurs mostly between 20-40 years and favors the knee and hip. Recurrence is frequent, particularly in the knee. Serum ESR and CRP may be elevated in some patients. Additionally, the present study supports the theory of an association between PVNS and orthopedic surgery, which is not limited to joint replacement.

  9. Diagnostic imaging and interventional radiology of hepatocellular carcinoma: A multicenter study on 290 cases

    International Nuclear Information System (INIS)

    Dalla Palma, Ludovico; Puzzi Mucelli, Roberto; Sponza, Massimo; De Santis, Mario; Gandini, Giovanni; Matricardi, Luigi; Rossi, Cristina

    1997-01-01

    The authors report of a multicenter study on the diagnosis and interventional therapy of hepatocellular carcinoma (HCC).The first aim -diagnostic - was to evaluate the sensitivity of 4 imaging techniques, namely ultrasonography (US), Computed Tomography (CT), digital arteriography (DSA) and Lipiodol CT (LCT), in hepatocellular carcinoma detection. The accuracy of these techniques was also investigated in tumor staging, which is important for treatment planning.The second aim - treatment - consisted in assessing the therapeutic efficacy of intraarterial chemoembolization (CEAT) versus percutaneous ethanol injection (PEI) in non advanced hepatocellular carcinoma and of intraarterial chemoembolization versus no treatment (NT) in advanced hepatocellular carcinoma. Treatment efficacy was evaluated with the following randomized protocols

  10. A multicenter prospective study of surgical audit systems.

    Science.gov (United States)

    Haga, Yoshio; Ikejiri, Koji; Wada, Yasuo; Takahashi, Tadateru; Ikenaga, Masakazu; Akiyama, Noriyoshi; Koike, Shoichiro; Koseki, Masato; Saitoh, Toshihiro

    2011-01-01

    This study was undertaken to evaluate a modified form of Estimation of Physiologic Ability and Surgical Stress (E-PASS) for surgical audit comparing with other existing models. Although several scoring systems have been devised for surgical audit, no nation-wide survey has been performed yet. We modified our previous E-PASS surgical audit system by computing the weights of 41 procedures, using data from 4925 patients who underwent elective digestive surgery, designated it as mE-PASS. Subsequently, a prospective cohort study was conducted in 43 national hospitals in Japan from April 1, 2005, to April 8, 2007. Variables for the E-PASS and American Society of Anesthesiologists (ASA) status-based model were collected for 5272 surgically treated patients. Of the 5272 patients, we also collected data for the Portsmouth modification of Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM) in 3128 patients. The area under the receiver operative characteristic curve (AUC) was used to evaluate discrimination performance to detect in-hospital mortality. The ratio of observed to estimated in-hospital mortality rates (OE ratio) was defined as a measure of quality. The numbers of variables required were 10 for E-PASS, 7 for mE-PASS, 20 for P-POSSUM, and 4 for the ASA status-based model. The AUC (95% confidence interval) values were 0.86 (0.79-0.93) for E-PASS, 0.86 (0.79-0.92) for mE-PASS, 0.81 (0.75-0.88) for P-POSSUM, and 0.73 (0.63-0.83) for the ASA status-based model. The OE ratios for mE-PASS among large-volume hospitals significantly correlated with those for E-PASS (R = 0.93, N = 9, P = 0.00026), P-POSSUM (R = 0.96, N = 6, P = 0.0021), and ASA status-based model (R = 0.83, N = 9, P = 0.0051). Because of its features of easy use, accuracy, and generalizability, mE-PASS is a candidate for a nation-wide survey.

  11. Secured web-based video repository for multicenter studies.

    Science.gov (United States)

    Yan, Ling; Hicks, Matt; Winslow, Korey; Comella, Cynthia; Ludlow, Christy; Jinnah, H A; Rosen, Ami R; Wright, Laura; Galpern, Wendy R; Perlmutter, Joel S

    2015-04-01

    We developed a novel secured web-based dystonia video repository for the Dystonia Coalition, part of the Rare Disease Clinical Research network funded by the Office of Rare Diseases Research and the National Institute of Neurological Disorders and Stroke. A critical component of phenotypic data collection for all projects of the Dystonia Coalition includes a standardized video of each participant. We now describe our method for collecting, serving and securing these videos that is widely applicable to other studies. Each recruiting site uploads standardized videos to a centralized secured server for processing to permit website posting. The streaming technology used to view the videos from the website does not allow downloading of video files. With appropriate institutional review board approval and agreement with the hosting institution, users can search and view selected videos on the website using customizable, permissions-based access that maintains security yet facilitates research and quality control. This approach provides a convenient platform for researchers across institutions to evaluate and analyze shared video data. We have applied this methodology for quality control, confirmation of diagnoses, validation of rating scales, and implementation of new research projects. We believe our system can be a model for similar projects that require access to common video resources. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. [Magnet ingestions in children: a French multicenter study].

    Science.gov (United States)

    Talvard, M; Mouttalib, S; Flaum, V; Viala, J; Galinier, P; Olives, J-P; Mas, E

    2015-01-01

    Digestive complications related to the ingestion of magnetic foreign bodies in children are increasing, especially in Asia and North America. In France, several case reports have been reported since 2008. We conducted a retrospective multicentric study to evaluate the frequency of ingestion of magnet foreign bodies and to describe the complicated cases that have occurred in France over the last 5 years. We report 40 cases of which 60% were multiple magnet ingestions. Eighty-eight percent of the children of the group who had swallowed multiple magnets needed interventional management by endoscopy (33%) or surgery (58%). Only two children (12.5%) of the group who swallowed one magnet required removal. This problem is not uncommon in France (2% of the 1132 foreign bodies investigated in the Toulouse center over 5 years), which justifies clear information for healthcare professionals and caregivers in order to avoid potential intestinal complications. We suggest interventional management or very close monitoring in the cases of multiple magnet ingestion. Meanwhile, in the majority of confirmed cases of simple magnet ingestions, we propose home monitoring. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  13. PR Interval Prolongation and Cryptogenic Stroke: A Multicenter Retrospective Study.

    Science.gov (United States)

    Montalvo, Mayra; Tadi, Prasanna; Merkler, Alexander; Gialdini, Gino; Martin-Schild, Sheryl; Navalkele, Digvijaya; Samai, Alyana; Nouh, Amre; Hussain, Mohammad; Goldblatt, Steven; Hemendinger, Morgan; Chu, Antony; Song, Christopher; Kamel, Hooman; Furie, Karen L; Yaghi, Shadi

    2017-10-01

    Atrial dysfunction or "cardiopathy" has been recently proposed as a mechanism in cryptogenic stroke. A prolonged PR interval may reflect impaired atrial conduction and thus may be a biomarker of atrial cardiopathy. We aim to compare the prevalence of PR interval prolongation in patients with cryptogenic stroke (CS) when compared with known non-cryptogenic non-cardioembolic stroke (NCNCS) subtypes. We used prospective ischemic stroke databases of 3 comprehensive stroke centers to identify patients 18 years or older with a discharge diagnosis of ischemic non-cardioembolic stroke between December 1, 2013 and August 31, 2015. The main outcome was ischemic stroke subtype (CS versus NCNCS). We compared PR intervals as a continuous and categorical variable (PR interval prolongation and CS. We identified 644 patients with ischemic non-cardioembolic stroke (224 CS and 420 NCNCS). Patients with CS were more likely to have a PR of 200 milliseconds or greater when compared with those with NCNCS (23.2% versus 13.8%, P = .009). After adjusting for factors that were significant in univariate analyses, a PR of 200 milliseconds or greater was independently associated with CS (odds ratio [OR] 1.70, 95% CI 1.08-2.70). The association was more pronounced when excluding patients on atrioventricular nodal blocking agents (OR 2.64, 95% CI 1.44-4.83). A PR of 200 milliseconds or greater is associated with CS and may be a biomarker of atrial cardiopathy in the absence of atrial fibrillation. Prospective studies are needed to confirm this association. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  14. Recognition of Delirium in Postoperative Elderly Patients: A Multicenter Study.

    Science.gov (United States)

    Numan, Tianne; van den Boogaard, Mark; Kamper, Adriaan M; Rood, Paul J T; Peelen, Linda M; Slooter, Arjen J C

    2017-09-01

    To evaluate to what extent delirium experts agree on the diagnosis of delirium when independently assessing exactly the same information and to evaluate the sensitivity of delirium screening tools in routine daily practice of clinical nurses. Prospective observational longitudinal study. Three medical centers in the Netherlands. Elderly postoperative adults (n = 167). A researcher examined participants daily (Postoperative Day 1-3) for delirium using a standardized cognitive assessment and interview including the Delirium Rating Scale Revised-98 as global impression without any cut-off values that was recorded on video. Two delirium experts independently evaluated the videos and clinical information from the last 24 hours in the participants' record and classified each assessment as delirious, possibly delirious, or not delirious. Interrater agreement between the delirium experts was determined using weighted Cohen's kappa. When there was no consensus, a third expert was consulted. Final classification was based on median score and compared with the results of the Confusion Assessment Method for Intensive Care Unit and Delirium Observation Scale that clinical nurses administered. Four hundred twenty-four postoperative assessments of 167 participants were included. The overall kappa was 0.61 (95% confidence interval = 0.53-0.68). There was no agreement between the experts for 89 (21.0%) assessments and a third delirium expert was needed for the final classification. Delirium screening that nurses performed detected 32% of the assessments that the experts diagnosed as (possibly) delirious. There was considerable disagreement in classification of delirium by experts who independently assessed exactly the same information, showing the difficulty of delirium diagnosis. Furthermore, the sensitivity of daily delirium screening by clinical nurses was poor. Future research should focus on development of objective instruments to diagnose delirium. © 2017, Copyright the

  15. Delayed Diagnoses in Children with Constipation: Multicenter Retrospective Cohort Study.

    Science.gov (United States)

    Freedman, Stephen B; Rodean, Jonathan; Hall, Matthew; Alpern, Elizabeth R; Aronson, Paul L; Simon, Harold K; Shah, Samir S; Marin, Jennifer R; Cohen, Eyal; Morse, Rustin B; Katsogridakis, Yiannis; Berry, Jay G; Neuman, Mark I

    2017-07-01

    The use of abdominal radiographs contributes to increased healthcare costs, radiation exposure, and potentially to misdiagnoses. We evaluated the association between abdominal radiograph performance and emergency department (ED) revisits with important alternate diagnosis among children with constipation. Retrospective cohort study of children aged constipation at one of 23 EDs from 2004 to 2015. The primary exposure was abdominal radiograph performance. The primary outcome was a 3-day ED revisit with a clinically important alternate diagnosis. RAND/University of California, Los Angeles methodology was used to define whether the revisit was related to the index visit and due to a clinically important condition other than constipation. Regression analysis was performed to identify exposures independently related to the primary outcome. A total of 65.7% (185 439/282 225) of children with constipation had an index ED visit abdominal radiograph performed. Three-day revisits occurred in 3.7% (10 566/282 225) of children, and 0.28% (784/282 225) returned with a clinically important alternate related diagnosis. Appendicitis was the most common such revisit, accounting for 34.1% of all 3-day clinically important related revisits. Children who had an abdominal radiograph performed were more likely to have a 3-day revisit with a clinically important alternate related diagnosis (0.33% vs 0.17%; difference 0.17%; 95% CI 0.13-0.20). Following adjustment for covariates, abdominal radiograph performance was associated with a 3-day revisit with a clinically important alternate diagnosis (aOR: 1.39; 95% CI 1.15-1.67). Additional characteristics associated with the primary outcome included narcotic (aOR: 2.63) and antiemetic (aOR: 2.35) administration and underlying comorbidities (aOR: 2.52). Among children diagnosed with constipation, abdominal radiograph performance is associated with an increased risk of a revisit with a clinically important alternate related diagnosis

  16. Fall predictors in older cancer patients: a multicenter prospective study.

    Science.gov (United States)

    Vande Walle, Nathalie; Kenis, Cindy; Heeren, Pieter; Van Puyvelde, Katrien; Decoster, Lore; Beyer, Ingo; Conings, Godelieve; Flamaing, Johan; Lobelle, Jean-Pierre; Wildiers, Hans; Milisen, Koen

    2014-12-15

    In the older population falls are a common problem and a major cause of morbidity, mortality and functional decline. The etiology is often multifactorial making the identification of fall predictors essential for preventive measures. Despite this knowledge, data on falls within the older cancer population are limited. The objective of this study was to evaluate the occurrence of falls within 2 to 3 months after cancer treatment decision and to identify predictors of falls (≥1 fall) during follow-up. Older patients (70 years or more) with a cancer treatment decision were included. At baseline, all patients underwent geriatric screening (G8 and Flemish Triage Risk Screening Tool), followed by a geriatric assessment including living situation, activities of daily living (ADL), instrumental activities of daily living (IADL), fall history in the past 12 months, fatigue, cognition, depression, nutrition, comorbidities and polypharmacy. Questionnaires were used to collect follow-up (2-3 months) data. Univariate and multivariate analyses were performed to identify predictors for falls (≥1 fall) during follow-up. At baseline, 295 (31.5%) of 937 included patients reported at least one fall in the past 12 months with 88 patients (29.5%) sustaining a major injury. During follow-up (2-3 months), 142 (17.6%) patients fell, of whom 51.4% fell recurrently and 17.6% reported a major injury. Baseline fall history in the past 12 months (OR = 3.926), fatigue (OR = 0.380), ADL dependency (OR = 0.492), geriatric risk profile by G8 (OR = 0.471) and living alone (OR = 1.631) were independent predictors of falls (≥1 fall) within 2-3 months after cancer treatment decision. Falls are a serious problem among older cancer patients. Geriatric screening and assessment data can identify patients at risk for a fall. A patient with risk factors associated with falls should undergo further evaluation and intervention to prevent potentially injurious fall incidents.

  17. Subjective perception of safety in healthy individuals working with 7 T MRI scanners: a retrospective multicenter survey.

    Science.gov (United States)

    Fatahi, Mahsa; Demenescu, Liliana Ramona; Speck, Oliver

    2016-06-01

    To retrospectively assess perception of safety of healthy individuals working with human 7 Tesla (T) magnetic resonance imaging (MRI) scanners. A total of 66 healthy individuals with a mean age of 31 ± 7 years participated in this retrospective multicentre survey study. Nonparametric correlation analysis was conducted to evaluate the relation between self-reported perception of safety and prevalence of sensory effects while working with 7 T MRI scanners for an average 47 months. The results indicated that 98.5 % of the study participants had a neutral or positive feeling about safety aspects at 7 T MRI scanners. 45.5 % reported that they feel very safe and none of the participants stated that they feel moderately or very unsafe while working with 7 T MRI scanners. Perception of safety was not affected by the number of hours per week spent in the vicinity of the 7 T MRI scanner or the duration of experience with 7 T MRI. More than 50 % of individuals experienced vertigo and metallic taste while working with 7 T MRI scanners. However, participants' perceptions of safety were not affected by the prevalence of MR-related symptoms. The overall data indicated an average perception of a moderately safe work environment. To our knowledge, this study delineates the first attempt to assess the subjective safety perception among 7 T MRI workers and suggests further investigations are indicated.

  18. Safety and Efficacy of a Flexible Dosing Regimen of Ranibizumab in Neovascular Age-Related Macular Degeneration: The SUSTAIN Study

    NARCIS (Netherlands)

    Holz, Frank G.; Amoaku, Winfried; Donate, Juan; Guymer, Robyn H.; Kellner, Ulrich; Schlingemann, Reinier O.; Weichselberger, Andreas; Staurenghi, Giovanni

    2011-01-01

    Objective: To evaluate the safety and efficacy of individualized ranibizumab treatment in patients with neovascular age-related macular degeneration. Design: Twelve-month, phase III, multicenter, open-label, single-arm study. Participants: A total of 513 ranibizumab-naive SUSTAIN patients.

  19. Test-retest and between-site reliability in a multicenter fMRI study.

    Science.gov (United States)

    Friedman, Lee; Stern, Hal; Brown, Gregory G; Mathalon, Daniel H; Turner, Jessica; Glover, Gary H; Gollub, Randy L; Lauriello, John; Lim, Kelvin O; Cannon, Tyrone; Greve, Douglas N; Bockholt, Henry Jeremy; Belger, Aysenil; Mueller, Bryon; Doty, Michael J; He, Jianchun; Wells, William; Smyth, Padhraic; Pieper, Steve; Kim, Seyoung; Kubicki, Marek; Vangel, Mark; Potkin, Steven G

    2008-08-01

    In the present report, estimates of test-retest and between-site reliability of fMRI assessments were produced in the context of a multicenter fMRI reliability study (FBIRN Phase 1, www.nbirn.net). Five subjects were scanned on 10 MRI scanners on two occasions. The fMRI task was a simple block design sensorimotor task. The impulse response functions to the stimulation block were derived using an FIR-deconvolution analysis with FMRISTAT. Six functionally-derived ROIs covering the visual, auditory and motor cortices, created from a prior analysis, were used. Two dependent variables were compared: percent signal change and contrast-to-noise-ratio. Reliability was assessed with intraclass correlation coefficients derived from a variance components analysis. Test-retest reliability was high, but initially, between-site reliability was low, indicating a strong contribution from site and site-by-subject variance. However, a number of factors that can markedly improve between-site reliability were uncovered, including increasing the size of the ROIs, adjusting for smoothness differences, and inclusion of additional runs. By employing multiple steps, between-site reliability for 3T scanners was increased by 123%. Dropping one site at a time and assessing reliability can be a useful method of assessing the sensitivity of the results to particular sites. These findings should provide guidance toothers on the best practices for future multicenter studies.

  20. Efficacy of liquid nitrogen cryotherapy for Barrett's esophagus after endoscopic resection of intramucosal cancer: A multicenter study.

    Science.gov (United States)

    Trindade, Arvind J; Pleskow, Douglas K; Sengupta, Neil; Kothari, Shivangi; Inamdar, Sumant; Berkowitz, Joshua; Kaul, Vivek

    2018-02-01

    Liquid nitrogen cryotherapy (LNC) allows increased depth of ablation compared with radiofrequency ablation in Barrett's esophagus (BE). Expert centers may use LNC over radiofrequency ablation to ablate Barrett's esophagus after endoscopic resection of intramucosal cancer (IMCA). The aim of our study was to (1) evaluate the safety and efficacy of LNC ablation in patients with BE and IMCA and (2) to evaluate the progression to invasive disease despite therapy. This was a multicenter, retrospective study of consecutive patients with BE who received LNC following endoscopic mucosal resection (EMR) of IMCA. The outcomes evaluated were complete eradication of dysplasia and intestinal metaplasia and development of invasive cancer during follow up. The follow-up period was at least 1 year from initial LNC. Twenty-seven patients were identified. The median Prague score was C3M5 (range C0M1-C14M14). After EMR+LNC, the median Prague score was C0M1 (range C0M0-C9M10); 22/27 patients (82%) achieved complete eradication of dysplasia after cryotherapy, and 19/27 patients (70%) achieved complete eradication of intestinal metaplasia. One out of 27 patients (4%) developed invasive cancer (disease beyond IMCA) over the study period. Cryotherapy is an effective endoscopic tool for eradication of BE dysplasia after EMR for IMCA. Development of invasive cancer is low for this high-risk group. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  1. Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial.

    Science.gov (United States)

    Shin, Seungwon; Lee, Jiwon; Yoo, Junghee; Lim, Sung Min; Lee, Euiju

    2016-04-12

    This study protocol evaluates the effectiveness of adjuvant electroacupuncture (EA) for urinary retention in poststroke patients undergoing conventional treatments, in comparison with that of a sham control. A multicenter, blinded, randomized controlled trial will be conducted in three hospitals in the Republic of Korea. We are recruiting 54 stroke survivors (aged >19 years), who were diagnosed with urinary retention based on the results of two consecutive post-void residual (PVR) tests, and dividing them randomly into two arms: the EA and Park-sham control groups. They will receive ten sessions of EA or sham treatment for 2 weeks. The participants will be blinded with non-penetrating needles and fake sounds of EA stimulators. The daily PVR ratio will be primarily measured at baseline and at the end of the study to statistically test the effectiveness of EA for poststroke urinary retention. Then, the Korean version of the Qualiveen Questionnaire, the Korean version of the International Prostate Symptom Score, and the blinding index will be assessed. After each EA session or sham EA, adverse events will be reported to evaluate the safety of EA. Results will be analyzed by using the independent t-test or Mann-Whitney U test, based on both intention-to-treat and per-protocol principles. The findings will provide clinical evidence for the effectiveness of EA treatment to improve urinary retention in stroke survivors. This study protocol was registered in ClinicalTrials.gov (NCT02472288) on 10 June 2015.

  2. Effectiveness of intra-articular injections of sodium hyaluronate-chondroitin sulfate in knee osteoarthritis: a multicenter prospective study.

    Science.gov (United States)

    Rivera, Fabrizio; Bertignone, Luca; Grandi, Giancarlo; Camisassa, Roberto; Comaschi, Guido; Trentini, Diego; Zanone, Marco; Teppex, Giuseppe; Vasario, Gabriele; Fortina, Giorgio

    2016-03-01

    Intra-articular injection of hyaluronic acid is a well-established therapy for the treatment of knee osteoarthritis. The aim of the study was to assess the effectiveness and safety of the use of Arthrum HCS(®) (40 mg hyaluronic acid and 40 mg chondroitin sulfate in 2 mL). This was an open, multicenter, prospective study. Men or women over 40 years of age with documented knee osteoarthritis and WOMAC subscore A (severity of pain) ≥25 were enrolled. They received three weekly intra-articular injections of sodium hyaluronate 2 % and chondroitin sulfate 2 % in combination. WOMAC subscore A was assessed at 1, 3 and 6 months after the last injection. One hundred and twelve patients were included (women, 66 %). The mean (SD) WOMAC subscore A decreased from 52.1 (15.2) at inclusion to 20.5 (19.7) at month 6 (P chondroitin sulfate in reducing pain (77 %), improving mobility (78 %) and reducing the consumption of analgesics (74 %). Only one adverse effect was reported by one patient (knee tumefaction). These results suggest that intra-articular injections of Arthrum HCS(®) (sodium hyaluronate plus chondroitin sulfate) in patients with knee osteoarthritis are efficient and safe. These results should be confirmed in a randomized controlled study. IV.

  3. Model quality and safety studies

    DEFF Research Database (Denmark)

    Petersen, K.E.

    1997-01-01

    The paper describes the EC initiative on model quality assessment and emphasizes some of the problems encountered in the selection of data from field tests used in the evaluation process. Further, it discusses the impact of model uncertainties in safety studies of industrial plants. The model...... that most of these have never been through a procedure of evaluation, but nonetheless are used to assist in making decisions that may directly affect the safety of the public and the environment. As a major funder of European research on major industrial hazards, DGXII is conscious of the importance......-tain model is appropriate for use in solving a given problem. Further, the findings from the REDIPHEM project related to dense gas dispersion will be highlighted. Finally, the paper will discuss the need for model quality assessment in safety studies....

  4. Rapid virological response of telaprevir and boceprevir in a Brazilian cohort of HCV genotype 1 patients: a multicenter longitudinal study

    Directory of Open Access Journals (Sweden)

    Borba HHL

    2017-01-01

    Full Text Available Helena HL Borba,1 Astrid Wiens,1 Laiza M Steimbach,1 Fernanda S Tonin,1 Maria LA Pedroso,2 Cláudia AP Ivantes,3 Fernando Fernandez-Llimos,4 Roberto Pontarolo1 1Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy, 2Gastroenterology Service, Hospital de Clínicas, Federal University of Paraná, 3Guidance and Counseling Center, Curitiba City Hall, Curitiba, Paraná, Brazil; 4Department of Social Pharmacy, Faculty of Pharmacy, Research Institute for Medicines, University of Lisboa, Lisbon, Portugal Background: Chronic hepatitis C is a major public health issue, but there is a gap in the literature regarding the effectiveness and safety of direct-acting antiviral agents in the Brazilian population. The main aim of this study was to describe the effectiveness of boceprevir and telaprevir in patients treated at public health care institutions in Brazil.Materials and methods: A prospective longitudinal and multicenter study was conducted in five centers in the State of Paraná between September 2014 and June 2016. Data regarding effectiveness and safety were collected from medical records of patients treated with boceprevir or telaprevir. The effectiveness outcome comprised the rapid virological response (RVR. Multivariate analysis was performed to verify the influence of independent variables (ie, age, gender, baseline viral load on RVR achievement.Results: Data were collected from 117 patients with chronic hepatitis C virus (HCV genotype 1 infection. Fifteen patients received treatment with boceprevir and 102 received telaprevir. The mean age was 51.6 years, 64.1% were male, 44.4% were infected with HCV subtype 1a, 62.4% had a high baseline viral load (≥800,000 IU/mL and 33% were cirrhotic. Furthermore, 79.5% of patients achieved RVR (26.7% in the boceprevir group and 87.3% in the telaprevir group. Multivariate analysis demonstrated that the type of protease inhibitor (boceprevir or telaprevir and the baseline viral load

  5. Prospective validation of a prognostic model for respiratory syncytial virus bronchiolitis in late preterm infants: a multicenter birth cohort study

    NARCIS (Netherlands)

    Blanken, M.O.; Koffijberg, H.; Nibbelke, E.E.; Rovers, M.M.; Bont, L.; Liem, K.D.; et al.,

    2013-01-01

    OBJECTIVES: This study aimed to update and validate a prediction rule for respiratory syncytial virus (RSV) hospitalization in preterm infants 33-35 weeks gestational age (WGA). STUDY DESIGN: The RISK study consisted of 2 multicenter prospective birth cohorts in 41 hospitals. Risk factors were

  6. LAP-BAND for BMI 30-40: 5-year health outcomes from the multicenter pivotal study.

    Science.gov (United States)

    Dixon, J B; Eaton, L L; Vincent, V; Michaelson, R

    2016-02-01

    We performed a 5-year multicenter study to evaluate the safety and effectiveness of the LAP-BAND System surgery (LBS) in patients with obesity with a body mass index (BMI) of 30-39.9 kg m(-)(2). This pivotal study was designed to support LBS application to the US Food and Drug Administration for broadening the indications for surgery and the lower BMI indication was approved with 1-year data in 2011, with the intention to complete the 5-year evaluation. To present broad health outcome data including weight change, patient reported outcomes, comorbidity change and complications during the 5-year study. The study was conducted at seven US private practice clinical trial sites. We enrolled 149 BMI 30-39.9 subjects into a 5-year, multicenter, longitudinal, prospective post-approval study. Data for those completing each time point are presented. The predefined target of at least 30% excess weight loss was achieved by more than 76% of subjects by 1-year and at every year thereafter during the 5-year study. Mean percentage weight loss at 5 years was 15.9±12.4%. Sustained weight loss was accompanied by sustained improvement in generic and weight-specific quality of life, symptoms of depression and the prevalence of binge-eating disorder. The number of subjects with normal fasting triglyceride, high-density lipoprotein cholesterol, plasma glucose and HbA1c increased significantly between baseline and 5 years. Fifty-four months after LBS implantation, the rate of device explants without replacement was 5.4%; however, the rate of explants increased to 12.1% by month 60 owing to no cost-elective band removals offered to subjects at study exit. No deaths or unanticipated adverse device effects were reported. The LBS is safe and effective for people with BMI 30-39.9 with demonstrated improvements in weight loss, comorbidities and quality of life, and with a low explant rate through 5 years following treatment.

  7. Center for Maritime Safety and Health Studies

    Data.gov (United States)

    Federal Laboratory Consortium — Established in November 2015, the Center for Maritime Safety and Health Studies (CMSHS) promotes safety and health for all maritime workers, including those employed...

  8. Safety analysis and related studies

    International Nuclear Information System (INIS)

    Lelievre, J.

    1979-12-01

    Several examples of reactor safety studies are given. For light water reactors, the consequences of loss of coolant, the disposition of the fuel elements and the behaviour under irradiation of the steels used for containment are described. For fast reactors, the disposition of fuel elements in the case of cooling accidents and sodium fies are described. Examples given of studies not specific to a particular reactor type include studies of non-destructive testing and those of reliability

  9. Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale.

    Science.gov (United States)

    Furlan, Anthony J; Reisman, Mark; Massaro, Joseph; Mauri, Laura; Adams, Harold; Albers, Gregory W; Felberg, Robert; Herrmann, Howard; Kar, Saibal; Landzberg, Michael; Raizner, Albert; Wechsler, Lawrence

    2010-12-01

    Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke. This prospective, multicenter, randomized, controlled trial has finished enrollment. Two-year follow-up for all 910 patients is required. The primary end point is the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurologic mortality from ≥ 31 days of follow-up, as adjudicated by a panel of physicians who are unaware of treatment allocation. This article describes the rationale and study design of CLOSURE I. This trial should provide information as to whether the STARFlex septal closure system is safe and more effective than best medical therapy alone in preventing recurrent stroke/TIA and mortality in patients with PFO and whether the STARFlex septal closure device can demonstrate superiority compared with best medical therapy alone. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00201461.

  10. FEMIC (Fibromes Embolises aux MICrospheres calibrees): Uterine Fibroid Embolization using Tris-acryl Microspheres. A French Multicenter Study

    International Nuclear Information System (INIS)

    Joffre, Francis; Tubiana, Jean-Michel; Pelage, Jean-Pierre

    2004-01-01

    Purpose: A French multicenter registry was set up to confirm the safety and efficacy of large calibrated tris-acryl gelatin microspheres for embolization of symptomatic fibroids. Methods: Technical recommendations included embolization using large microspheres (>500 μm) with no secondary embolization agent. Postprocedural pain, clinical improvement and adverse events were prospectively evaluated during a follow-up period of at least 6 months.Results: Eighty-five women complaining of fibroid-related symptoms entered the study. In seven women, a secondary embolization agent was used in addition to microspheres. Complete resolution of menorrhagia was achieved in 84% of women at 24 months and significant uterine and fibroid volume reductions were noted after 6 months (37% and 73%, respectively). Three women experienced definitive amenorrhea (4%) and two women required hysteroscopic resection of a fibroid. Eight women were treated by hysterectomy because of treatment failure. In seven of these women, treatment failure was explained by an additional cause of symptoms including diffuse adenomyosis, endometrial hyperplasia or ovarian artery supply to the fibroids.Conclusion: Limited uterine artery embolization using large microspheres has good clinical success rate with low postprocedural pain and complications. Women can expect excellent midterm results with a high level of symptom control and significant fibroid volume reduction. Confidence in the end-point recommended here may require the experience of several cases

  11. A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry.

    Science.gov (United States)

    Mustapha, Jihad A; Lansky, Alexandra; Shishehbor, Mehdi; Miles McClure, John; Johnson, Sarah; Davis, Thomas; Makam, Prakash; Crowder, William; Konstantino, Eitan; Attaran, Robert R

    2018-05-01

    The Chocolate BAR study is a prospective multicenter post-market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow-limiting dissection); secondary long-term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12-months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all-cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an "all-comers" population achieved excellent procedural outcomes with low dissection rates and bailout stent use. © 2018 Wiley Periodicals, Inc.

  12. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  13. Endoscopic management of unresectable malignant gastroduodenal obstruction with a nitinol uncovered metal stent: A prospective Japanese multicenter study

    Science.gov (United States)

    Sasaki, Reina; Sakai, Yuji; Tsuyuguchi, Toshio; Nishikawa, Takao; Fujimoto, Tatsuya; Mikami, Shigeru; Sugiyama, Harutoshi; Yokosuka, Osamu

    2016-01-01

    AIM: To determine the safety and efficacy of endoscopic duodenal stent placement in patients with malignant gastric outlet obstruction. METHODS: This prospective, observational, multicenter study included 39 consecutive patients with malignant gastric outlet obstruction. All patients underwent endoscopic placement of a nitinol, uncovered, self-expandable metal stent. The primary outcome was clinical success at 2 wk after stent placement that was defined as improvement in the Gastric Outlet Obstruction Scoring System score relative to the baseline. RESULTS: Technical success was achieved in all duodenal stent procedures. Procedure-related complications occurred in 4 patients (10.3%) in the form of mild pneumonitis. No other morbidities or mortalities were observed. The clinical success rate was 92.3%. The mean survival period after stent placement was 103 d. The mean period of stent patency was 149 d and the patency remained acceptable for the survival period. Stent dysfunction occurred in 3 patients (7.7%) on account of tumor growth. CONCLUSION: Endoscopic management using duodenal stents for patients with incurable malignant gastric outlet obstruction is safe and improved patients’ quality of life. PMID:27076769

  14. A multicenter study of routine versus selective intraoperative leak testing for sleeve gastrectomy.

    Science.gov (United States)

    Bingham, Jason; Kaufman, Jedediah; Hata, Kai; Dickerson, James; Beekley, Alec; Wisbach, Gordon; Swann, Jacob; Ahnfeldt, Eric; Hawkins, Devon; Choi, Yong; Lim, Robert; Martin, Matthew

    2017-09-01

    Staple line leaks after sleeve gastrectomy are dreaded complications. Many surgeons routinely perform an intraoperative leak test (IOLT) despite little evidence to validate the reliability, clinical benefit, and safety of this procedure. To determine the efficacy of IOLT and if routine use has any benefit over selective use. Eight teaching hospitals, including private, university, and military facilities. A multicenter, retrospective analysis over a 5-year period. The efficacy of the IOLT for identifying unsuspected staple line defects and for predicting postoperative leaks was evaluated. An anonymous survey was also collected reflecting surgeons' practices and beliefs regarding IOLT. From January 2010 through December 2014, 4284 patients underwent sleeve gastrectomy. Of these, 37 patients (.9%) developed a postoperative leak, and 2376 patients (55%) received an IOLT. Only 2 patients (0.08%) had a positive finding. Subsequently, 21 patients with a negative IOLT developed a leak. IOLT demonstrated a sensitivity of only 8.7%. There was a nonsignificant trend toward increased leak rates when an IOLT was performed versus when IOLT was not performed. Leak rates were not statistically different between centers that routinely perform IOLT versus those that selectively perform IOLT. Routine IOLT had very poor sensitivity and was negative in 91% of patients who later developed postoperative leaks. The use of IOLT was not associated with a decrease in the incidence of postoperative leaks, and routine IOLT had no benefit over selective leak testing. IOLT should not be used as a quality indicator or "best practice" for bariatric surgery. Published by Elsevier Inc.

  15. Screening for primary aldosteronism in an argentinian population: a multicenter prospective study.

    Science.gov (United States)

    Leal Reyna, Mariela; Gómez, Reynaldo M; Lupi, Susana N; Belli, Susana H; Fenili, Cecilia A; Martínez, Marcela S; Ruibal, Gabriela F; Rossi, María A; Chervin, Raúl A; Cornaló, Dora; Contreras, Liliana N; Costa, Liliana; Nofal, María T; Damilano, Sergio A; Pardes, Ester M

    2015-10-01

    Primary aldosteronism (PA) is characterized by the autonomous overproduction of aldosterone. Its prevalence has increased since the use of the aldosterone (ALD)/plasma renin activity (PRA) ratio (ARR). The objective of this study is to determine ARR and ARC (ALD/plasma renin concentration ratio) cut-off values (COV) and their diagnostic concordance (DC%) in the screening for PA in an Argentinian population.Design multicenter prospective study. We studied 353 subjects (104 controls and 249 hypertensive patients). Serum aldosterone, PRA and ARR were determined. In 220 randomly selected subjects, 160 hypertensive patients and 60 controls, plasma renin concentration (PRC) was simultaneously measured and ARC was determined. According to the 95th percentile of controls, we determined a COV of 36 for ARR and 2.39 for ARC, with ALD ≥ 15 ng/dL. In 31/249 hypertensive patients, ARR was ≥ 36. PA diagnosis was established in 8/31 patients (23/31 patients did not complete confirmatory tests). DC% between ARR and ARC was calculated. A significant correlation between ARR and ARC (r = 0.742; p 0.3 ng/mL/h and PRC > 5 pg/mL. DC% for ARR and ARC above or below 36 and 2.39 was 79.1%, respectively. This first Argentinian multicenter study determined a COV of 36 for ARR and 2.39 for ARC. Applying an ARR ≥ 36 in the hypertensive group, we confirmed PA in a higher percentage of patients than the previously reported one in our population. As for ARC, further studies are needed for its clinical application, since DC% is acceptable only for medium range renin values.

  16. Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Tomusiak A

    2015-09-01

    Full Text Available Anna Tomusiak,1 Magdalena Strus,1 Piotr B Heczko,1 Paweł Adamski,2 Grzegorz Stefański,3 Aleksandra Mikołajczyk-Cichońska,3 Magdalena Suda-Szczurek3 1Department of Microbiology, Jagiellonian University Medical College, 2Institute of Nature Conservation, Polish Academy of Sciences, 3IBSS BIOMED SA, Kraków, Poland Objective: The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. Patients and methods: The study was a multicenter, randomized, double-blind, and placebo-controlled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4–6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag®, or a placebo (one capsule for seven consecutive days vaginally. The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Results: Administration of inVag contributed to a significant decrease (between visits in both vaginal pH (P<0.05 and Nugent score (P<0.05, and a significant increase in the abundance of Lactobacillus between visit I and visits III and IV (P<0.05. Molecular typing revealed the presence of Lactobacillus strains originating from inVag in 82% of women taking the drug at

  17. Effect of women's age on embryo morphology, cleavage rate and competence-A multicenter cohort study

    DEFF Research Database (Denmark)

    Grøndahl, Marie Louise; Christiansen, Sofie Lindgren; Kesmodel, Ulrik Schiøler

    2017-01-01

    This multicenter cohort study on embryo assessment and outcome data from 11,744 IVF/ICSI cycles with 104,830 oocytes and 42,074 embryos, presents the effect of women's age on oocyte, zygote, embryo morphology and cleavage parameters, as well as cycle outcome measures corrected for confounding.......0001) with increasing age. Maternal age had no effect on cleavage parameters or on the morphology of the embryo day 2 post insemination. Interestingly, initial hCG value after single embryo transfer followed by ongoing pregnancy was increased with age in both IVF (p = 0.007) and ICSI (p = 0.001) cycles. For the first...... time, we show that a woman's age does impose a significant footprint on early embryo morphological development (3PN). In addition, the developmentally competent embryos were associated with increased initial hCG values as the age of the women increased. Further studies are needed to elucidate...

  18. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study

    DEFF Research Database (Denmark)

    Giovannini, Marc; Thomas, Botelberge; Erwan, Bories

    2009-01-01

    AIM: To evaluate the ability of endoscopic ultrasound (EUS) elastography to distinguish benign from malignant pancreatic masses and lymph nodes. METHODS: A multicenter study was conducted and included 222 patients who underwent EUS examination with assessment of a pancreatic mass (n = 121) or lymph...... node (n = 101). The classification as benign or malignant, based on the real time elastography pattern, was compared with the classification based on the B-mode EUS images and with the final diagnosis obtained by EUS-guided fine needle aspiration (EUS-FNA) and/or by surgical pathology. An interobserver...... study was performed. RESULTS: The sensitivity and specificity of EUS elastography to differentiate benign from malignant pancreatic lesions are 92.3% and 80.0%, respectively, compared to 92.3% and 68.9%, respectively, for the conventional B-mode images. The sensitivity and specificity of EUS...

  19. Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD

    DEFF Research Database (Denmark)

    Miravitlles, Marc; Sliwinski, Pawel; Rhee, Chin Kook

    2018-01-01

    BACKGROUND: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHOD: This international, multicenter, prospective study aimed to validate the concept of control in COPD [control = stability (no...... exacerbations or impairment in CAT scores) + low impact (low level of symptoms)]. Data from the screening visit was used to: investigate the level of control, compare characteristics of patients according to the control status, and perform a sensitivity analysis of the levels of control using either clinical...... criteria or questionnaires (COPD Assessment Test -CAT- or Clinical COPD Questionnaire -CCQ-). RESULTS: A total of 314 patients were analysed, mean age was 68.5 years and mean FEV1 was 52.6% of predicted. According to the prespecified criteria 21% of patients were classified as controlled, all of them...

  20. Multicenter Study of the Clinical Presentation of Staphylococcus lugdunensis Bacteremia in Japan.

    Science.gov (United States)

    Ainoda, Yusuke; Takeshita, Nozomi; Hase, Ryota; Mikawa, Takahiro; Hosokawa, Naoto; Kawamura, Ichiro; Kurai, Hanako; Abe, Masahiro; Kimura, Muneyoshi; Araoka, Hideki; Fujita, Takahiro; Totsuka, Kyoichi; Mezaki, Kazuhisa; Sekiya, Noritaka; Ohmagari, Norio

    2017-07-24

    Staphylococcus lugdunensis (SL) is a bacterium with a highly pathogenicity than most other coagulase-negative Staphylococcus spp. (CoNS). In Japan, data on this pathogen are sparse, and the current prevalence of SL bacteremia is unknown. Therefore, we investigated the prevalence of SL in blood culture specimens in a prospective multicenter study across 5 facilities. A total of 3,284 patients had positive blood cultures, and 2,478 patients had bacteremia. Among the patients with bacteremia, 7 patients (0.28%) had SL bacteremia. A total of 281 patients had CoNS bacteremia, with SL accounting for 2.49% of these cases. Of the 7 patients with SL bacteremia, 1 patient (14.3%) had infective endocarditis, and 1 patient (14.3%) died within 30 days. In this study, SL resulted in the development of bacteremia in select patients. Clinicians in Japan should be aware of the prevalence of SL and the complications of SL bacteremia.

  1. Surgical outcomes of robot-assisted rectal cancer surgery using the da Vinci Surgical System: a multi-center pilot Phase II study.

    Science.gov (United States)

    Tsukamoto, Shunsuke; Nishizawa, Yuji; Ochiai, Hiroki; Tsukada, Yuichiro; Sasaki, Takeshi; Shida, Dai; Ito, Masaaki; Kanemitsu, Yukihide

    2017-12-01

    We conducted a multi-center pilot Phase II study to examine the safety of robotic rectal cancer surgery performed using the da Vinci Surgical System during the introduction period of robotic rectal surgery at two institutes based on surgical outcomes. This study was conducted with a prospective, multi-center, single-arm, open-label design to assess the safety and feasibility of robotic surgery for rectal cancer (da Vinci Surgical System). The primary endpoint was the rate of adverse events during and after robotic surgery. The secondary endpoint was the completion rate of robotic surgery. Between April 2014 and July 2016, 50 patients were enrolled in this study. Of these, 10 (20%) had rectosigmoid cancer, 17 (34%) had upper rectal cancer, and 23 (46%) had lower rectal cancer; six underwent high anterior resection, 32 underwent low anterior resection, 11 underwent intersphincteric resection, and one underwent abdominoperineal resection. Pathological stages were Stage 0 in 1 patient, Stage I in 28 patients, Stage II in 7 patients and Stage III in 14 patients. Pathologically complete resection was achieved in all patients. There was no intraoperative organ damage or postoperative mortality. Eight (16%) patients developed complications of all grades, of which 2 (4%) were Grade 3 or higher, including anastomotic leakage (2%) and conversion to open surgery (2%). The present study demonstrates the feasibility and safety of robotic rectal cancer surgery, as reflected by low morbidity and low conversion rates, during the introduction period. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  2. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study).

    Science.gov (United States)

    Starling, Amaal J; Tepper, Stewart J; Marmura, Michael J; Shamim, Ejaz A; Robbins, Matthew S; Hindiyeh, Nada; Charles, Andrew C; Goadsby, Peter J; Lipton, Richard B; Silberstein, Stephen D; Gelfand, Amy A; Chiacchierini, Richard P; Dodick, David W

    2018-05-01

    Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a -2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (-0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of -2

  3. MRI, PET/CT and ultrasound in the preoperative staging of endometrial cancer - A multicenter prospective comparative study

    DEFF Research Database (Denmark)

    Antonsen, Sofie Leisby; Jensen, Lisa Neerup; Loft, Annika

    2012-01-01

    OBJECTIVES: The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC). METHODS: 318 consecutive women with EC were included when...

  4. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects

    NARCIS (Netherlands)

    Tack, C.J.; Pohlmeier, H.; Behnke, T.; Schmid, V.; Grenningloh, M.; Forst, T.; Pfutzner, A.

    2012-01-01

    BACKGROUND: This multicenter study was conducted to evaluate the performance of five recently introduced blood glucose (BG) monitoring (BGM) devices under daily routine conditions in comparison with the YSI (Yellow Springs, OH) 2300 Stat Plus glucose analyzer. METHODS: Five hundred one diabetes

  5. Early Stage Blood Purification for Paraquat Poisoning: A Multicenter Retrospective Study.

    Science.gov (United States)

    Li, An; Li, Wenxiong; Hao, Fengtong; Wang, Haishi

    2016-01-01

    To evaluate the efficacy of conservative treatment vs. hemoperfusion (HP) vs. HP + continuous veno-venous hemofiltration (CVVH) for acute Paraquat (PQ) poisoning. This was a multicenter retrospective study of patients with PQ poisoning between January 2013 and June 2014. Clinical data and PQ serum levels were collected at baseline and after 24, 48, and 72 h of treatment. Seventy-five, 65, and 43 underwent conservative treatment only (conservative treatment group), conservative treatment + HP (HP group), and conservative treatment + HP + CVVH (HP + CVVH group), respectively. PQ serum levels decreased in all groups after 72 h of treatment (p treatment group. More importantly, PQ blood levels were significantly lower in the HP + CVVH group compared with the HP group at 24 h (p treatment group (p poisoning could decrease PQ blood levels, alleviate organ damage, and increase survival. © 2016 S. Karger AG, Basel.

  6. Prevalence of genital Chlamydia trachomatis infections in Russia: systematic literature review and multicenter study.

    Science.gov (United States)

    Smelov, Vitaly; Thomas, Pierre; Ouburg, Sander; Morré, Servaas A

    2017-09-29

    A reliable overview of data on the prevalence of Chlamydia trachomatis (CT) in Russia is lacking and needed. All the available data on CT prevalence were analyzed in a systematic literature review on CT prevalence in Russia, strengthened with data from the multicenter study among 1263 people in the second-largest Russian megalopolis, St. Petersburg, testing for CT DNA in urethral, anal, cervical and prostate samples. A total of 10 articles met the inclusion criteria. The overall average prevalence of genital CT infections in Russian populations ranged from 2.9% to 33%. Risk factors included being symptomatic (P = 0.004; in men P Russia should be considered. © FEMS 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  7. Nanotechnology Safety Self-Study

    Energy Technology Data Exchange (ETDEWEB)

    Grogin, Phillip W. [Los Alamos National Laboratory

    2016-03-29

    Nanoparticles are near-atomic scale structures between 1 and 100 nanometers (one billionth of a meter). Engineered nanoparticles are intentionally created and are used in research and development at Sandia National Laboratories (SNL) and Los Alamos National Laboratory (LANL). This course, Nanotechnology Safety Self-Study, presents an overview of the hazards, controls, and uncertainties associated with the use of unbound engineered nanoscale particles (UNP) in a laboratory environment.

  8. CT perfusion-guided patient selection for endovascular recanalization in acute ischemic stroke: a multicenter study.

    Science.gov (United States)

    Turk, Aquilla S; Magarick, Jordan Asher; Frei, Don; Fargen, Kyle Michael; Chaudry, Imran; Holmstedt, Christine A; Nicholas, Joyce; Mocco, J; Turner, Raymond D; Huddle, Daniel; Loy, David; Bellon, Richard; Dooley, Gwendolyn; Adams, Robert; Whaley, Michelle; Fanale, Chris; Jauch, Edward

    2013-11-01

    The treatment of acute ischemic stroke is traditionally centered on time criteria, although recent evidence suggests that physiologic neuroimaging may be useful. In a multicenter study we evaluated the use of CT perfusion, regardless of time from symptom onset, in patients selected for intra-arterial treatment of ischemic stroke. Three medical centers retrospectively assessed stroke patients with a National Institute of Health Stroke Scale of ≥ 8, regardless of time from symptom onset. CT perfusion maps were qualitatively assessed. Patients with defined salvageable penumbra underwent intra-arterial revascularization of their occlusion. Functional outcome using the modified Rankin Score (mRS) was recorded. Two hundred and forty-seven patients were selected to undergo intra-arterial treatment based on CT perfusion imaging. The median time from symptom onset to procedure was 6 h. Patients were divided into two groups for analysis: ≤ 8 h and >8 h from symptom onset to endovascular procedure. We found no difference in functional outcome between the two groups (42.8% and 41.9% achieved 90-day mRS ≤ 2, respectively (p=1.0), and 54.9% vs 55.4% (p=1.0) achieved 90-day mRS ≤ 3, respectively). Overall, 48 patients (19.4%) had hemorrhages, of which 20 (8.0%) were symptomatic, with no difference between the groups (p=1.0). In a multicenter study, we demonstrated similar rates of good functional outcome and intracranial hemorrhage in patients with ischemic stroke when endovascular treatment was performed based on CT perfusion selection rather than time-guided selection. Our findings suggest that physiologic imaging-guided patient selection rather than time for endovascular reperfusion in ischemic stroke may be effective and safe.

  9. Profile of Nigerians with diabetes mellitus - Diabcare Nigeria study group (2008: Results of a multicenter study

    Directory of Open Access Journals (Sweden)

    Sunday Chinenye

    2012-01-01

    Full Text Available Background: Diabetes Mellitus is the commonest endocrine-metabolic disorder in Nigeria similar to the experience in other parts of the world. The aim was to assess the clinical and laboratory profile, and evaluate the quality of care of Nigerian diabetics with a view to planning improved diabetes care. Materials and Methods: In a multicenter study across seven tertiary health centers in Nigeria, the clinical and laboratory parameters of diabetic out-patients were evaluated. Clinical parameters studied include type of diabetes, anthropometry, and blood pressure (BP status, chronic complications of diabetes, and treatment types. Laboratory data assessed included fasting plasma glucose (FPG, 2-h post-prandial (2-HrPP glucose, glycated hemoglobin (HbA1c, urinalysis, serum lipids, electrolytes, urea, and creatinine. Results: A total of 531 patients, 209 (39.4% males and 322 (60.6% females enrolled. The mean age of the patients was 57.1 ± 12.3 years with the mean duration of diabetes of 8.8 ± 6.6 years. Majority (95.4% had type 2 diabetes mellitus (DM compared to type 1 DM (4.6%, with P < 0.001. The mean FPG, 2-HrPP glucose, and HbA1c were 8.1 ± 3.9 mmol/L, 10.6 ± 4.6 mmol/L, and 8.3 ± 2.2%, respectively. Only 170 (32.4% and 100 (20.4% patients achieved the ADA and IDF glycemic targets, respectively. Most patients (72.8% did not practice self-monitoring of blood glucose. Hypertension was found in 322 (60.9%, with mean systolic BP 142.0 ± 23.7 mmHg, and mean diastolic BP 80.7 ± 12.7 mmHg. Diabetic complications found were peripheral neuropathy (59.2%, retinopathy (35.5%, cataracts (25.2%, cerebrovascular disease (4.7%, diabetic foot ulcers (16.0%, and nephropathy (3.2%. Conclusion: Most Nigerian diabetics have suboptimal glycemic control, are hypertensives, and have chronic complications of DM. Improved quality of care and treatment to target is recommended to reduce diabetes-related morbidity and mortality.

  10. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study

    DEFF Research Database (Denmark)

    Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier

    2010-01-01

    Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated...... and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing...

  11. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study

    DEFF Research Database (Denmark)

    Petersen, Esben; Mouridsen, Kim; Golay, Xavier

    2009-01-01

    Quantitative STAR labeling of Arterial Regions or QUASAR), a method providing user independent quantification of CBF in a large test-retest study across sites from around the world, dubbed "The QUASAR reproducibility study". Altogether, 28 sites located in Asia, Europe and North America participated...... and a total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing...

  12. The Use of Neuraxial Catheters for Postoperative Analgesia in Neonates: A Multicenter Safety Analysis from the Pediatric Regional Anesthesia Network.

    Science.gov (United States)

    Long, Justin B; Joselyn, Anita S; Bhalla, Tarun; Tobias, Joseph D; De Oliveira, Gildasio S; Suresh, Santhanam

    2016-06-01

    Currently, there is limited evidence to support the safety of neuraxial catheters in neonates. Safety concerns have been cited as a major barrier to performing large randomized trials in this population. The main objective of this study is to examine the safety of neuraxial catheters in neonates across multiple institutions. Specifically, we sought to determine the incidence of overall and individual complications encountered when neuraxial catheters were used for postoperative analgesia in neonates. This was an observational study that used the Pediatric Regional Anesthesia Network database. Complications and adverse events were defined by the presence of at least 1 of the following intraoperative and/or postoperative factors: catheter malfunction (dislodgment/occlusion), infection, block abandoned (unable to place), block failure (no evidence of block), vascular (blood aspiration/hematoma), local anesthetic systemic toxicity, excessive motor block, paresthesia, persistent neurologic deficit, and other (e.g., intra-abdominal misplacement, tremors). Additional analyses were performed to identify the use of potentially toxic doses of local anesthetics. The study cohort included 307 neonates with a neuraxial catheter. There were 41 adverse events and complications recorded, resulting in an overall incidence of complications of 13.3% (95% confidence interval, 9.8%-17.4%). Among the complications, catheter malfunction, catheter contamination, and vascular puncture were common. None of the complications resulted in long-term complications and/or sequelae, resulting in an estimated incidence of any serious complications of 0.3% (95% confidence interval, 0.08%-1.8%). There were 120 of 307 patients who received intraoperative and/or postoperative infusions consistent with a potentially toxic local anesthetic dose in neonates. The incidence of potentially toxic local anesthetic infusion rates increased over time (P = 0.008). Neuraxial catheter techniques for intraoperative

  13. A Phase 3, Randomized, Double-Blind, Multicenter Study To Evaluate the Safety and Efficacy of Intravenous Iclaprim versus Vancomycin for Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed To Be Due to Gram-Positive Pathogens (REVIVE-2 Study).

    Science.gov (United States)

    Holland, Thomas L; O'Riordan, William; McManus, Alison; Shin, Elliot; Borghei, Ali; File, Thomas M; Wilcox, Mark H; Torres, Antoni; Dryden, Matthew; Lodise, Thomas; Oguri, Toyoko; Corey, G Ralph; McLeroth, Patrick; Shukla, Rajesh; Huang, David B

    2018-05-01

    Iclaprim is a novel diaminopyrimidine antibiotic that may be an effective and safe treatment for serious skin infections. The safety and effectiveness of iclaprim were assessed in a global phase 3, double-blind, randomized, active-controlled trial. Six hundred thirteen adults with acute bacterial skin and skin structure infections (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens were randomized to iclaprim (80 mg) or vancomycin (15 mg/kg of body weight), both of which were administered intravenously every 12 h for 5 to 14 days. The primary endpoint was a ≥20% reduction in lesion size compared with that at the baseline at 48 to 72 h after the start of administration of study drug in the intent-to-treat population. Among patients randomized to iclaprim, 78.3% (231 of 295) met this primary endpoint, whereas 76.7% (234 of 305) of those receiving vancomycin met this primary endpoint (difference, 1.58%; 95% confidence interval, -5.10% to 8.26%). This met the prespecified 10% noninferiority margin. Iclaprim was well tolerated, with most adverse events being categorized as mild. In conclusion, iclaprim was noninferior to vancomycin in this phase 3 clinical trial for the treatment of acute bacterial skin and skin structure infections. On the basis of these results, iclaprim may be an efficacious and safe treatment for skin infections suspected or confirmed to be due to Gram-positive pathogens. (This trial has been registered at ClinicalTrials.gov under identifier NCT02607618.). Copyright © 2018 American Society for Microbiology.

  14. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

    Directory of Open Access Journals (Sweden)

    Pandina Gahan

    2012-06-01

    Full Text Available Abstract Background Data on the long-term efficacy, safety, and tolerability of risperidone in adolescents with schizophrenia are limited. The objective of this study was to evaluate the efficacy and safety of maintenance risperidone treatment in adolescents with schizophrenia. Methods This open-label study of adolescents aged 13 to 17 years with schizophrenia was a single extension study of two short-term double-blind risperidone studies and also enrolled subjects directly in open-label risperidone treatment. The risperidone dose was flexible and ranged from 2 to 6 mg/day. Most subjects enrolled for 6 months; a subset enrolled for 12 months. Assessment tools included the Positive and Negative Syndrome Scale total and factor scores, Clinical Global Impressions, Children’s Global Assessment Scale, adverse event (AE monitoring, vital signs, laboratory testing, and extrapyramidal symptom rating scales. Results A total of 390 subjects were enrolled; 48 subjects had received placebo in a previous double-blind study; 292 subjects had received risperidone as part of their participation in one of two previous controlled studies; and 50 subjects were enrolled directly for this study. A total of 279 subjects enrolled for 6 months of treatment, and 111 subjects enrolled for 12 months of treatment. Overall, 264 (67.7% subjects completed this study: 209 of the 279 subjects (75% in the 6-month group and 55 of the 111 subjects (50% in the 12-month group. The median mode dose was 3.8 mg/day. At 6 months, all three groups experienced improvement from open-label baseline in symptoms of schizophrenia as well as general assessments of global functioning. Improvements were generally maintained for the duration of treatment. The most common AEs (≥10% of subjects were somnolence, headache, weight increase, hypertonia, insomnia, tremor, and psychosis. Potentially prolactin-related AEs (PPAEs were reported by 36 (9% subjects. The AE profile in this study was

  15. A Multicenter Phase I/II Study of the BCNU Implant (Gliadel ® Wafer) for Japanese Patients with Malignant Gliomas

    Science.gov (United States)

    AOKI, Tomokazu; NISHIKAWA, Ryo; SUGIYAMA, Kazuhiko; NONOGUCHI, Naosuke; KAWABATA, Noriyuki; MISHIMA, Kazuhiko; ADACHI, Jun-ichi; KURISU, Kaoru; YAMASAKI, Fumiyuki; TOMINAGA, Teiji; KUMABE, Toshihiro; UEKI, Keisuke; HIGUCHI, Fumi; YAMAMOTO, Tetsuya; ISHIKAWA, Eiichi; TAKESHIMA, Hideo; YAMASHITA, Shinji; ARITA, Kazunori; HIRANO, Hirofumi; YAMADA, Shinobu; MATSUTANI, Masao

    2014-01-01

    Carmustine (BCNU) implants (Gliadel® Wafer, Eisai Inc., New Jersey, USA) for the treatment of malignant gliomas (MGs) were shown to enhance overall survival in comparison to placebo in controlled clinical trials in the United States and Europe. A prospective, multicenter phase I/II study involving Japanese patients with MGs was performed to evaluate the efficacy, safety, and pharmacokinetics of BCNU implants. The study enrolled 16 patients with newly diagnosed MGs and 8 patients with recurrent MGs. After the insertion of BCNU implants (8 sheets maximum, 61.6 mg BCNU) into the removal cavity, various chemotherapies (including temozolomide) and radiotherapies were applied. After placement, overall and progression-free survival rates and whole blood BCNU levels were evaluated. In patients with newly diagnosed MGs, the overall survival rates at 12 months and 24 months were 100.0% and 68.8%, and the progression-free survival rate at 12 months was 62.5%. In patients with recurrent MGs, the progression-free survival rate at 6 months was 37.5%. There were no grade 4 or higher adverse events noted due to BCNU implants, and grade 3 events were observed in 5 of 24 patients (20.8%). Whole blood BCNU levels reached a peak of 19.4 ng/mL approximately 3 hours after insertion, which was lower than 1/600 of the peak BCNU level recorded after intravenous injections. These levels decreased to less than the detection limit (2.00 ng/mL) after 24 hours. The results of this study involving Japanese patients are comparable to those of previous studies in the United States and Europe. PMID:24739422

  16. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1.

    Science.gov (United States)

    Huang, David B; O'Riordan, William; Overcash, J Scott; Heller, Barry; Amin, Faisal; File, Thomas M; Wilcox, Mark H; Torres, Antoni; Dryden, Matthew; Holland, Thomas L; McLeroth, Patrick; Shukla, Rajesh; Corey, G Ralph

    2018-04-03

    Our objective in this study was to demonstrate the safety and efficacy of iclaprim compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). REVIVE-1 was a phase 3, 600-patient, double-blinded, randomized (1:1), active-controlled trial among patients with ABSSSI that compared the safety and efficacy of iclaprim 80 mg fixed dose with vancomycin 15 mg/kg, both administered intravenously every 12 hours for 5-14 days. The primary endpoint of this study was a ≥20% reduction in lesion size (early clinical response [ECR]) compared with baseline among patients randomized to iclaprim or vancomycin at the early time point (ETP), 48 to 72 hours after the start of administration of study drug in the intent-to-treat population. ECR among patients who received iclaprim and vancomycin at the ETP was 80.9% (241 of 298) of patients receiving iclaprim compared with 81.0% (243 of 300) of those receiving vancomycin (treatment difference, -0.13%; 95% confidence interval, -6.42%-6.17%). Iclaprim was well tolerated in the study, with most adverse events categorized as mild. Iclaprim achieved noninferiority (10% margin) at ETP compared with vancomycin and was well tolerated in this phase 3 clinical trial for the treatment of ABSSSI. Based on these results, iclaprim appears to be an efficacious and safe treatment for ABSSSI suspected or confirmed to be due to gram-positive pathogens. NCT02600611.

  17. Study of industry safety management

    International Nuclear Information System (INIS)

    Park, Pil Su

    1987-06-01

    This book deals with general remarks, industrial accidents, statistics of industrial accidents, unsafe actions, making machinery and facilities safe, safe activities, having working environment safe, survey of industrial accidents and analysis of causes, system of safety management and operations, safety management planning, safety education, human engineering such as human-machines system, system safety, and costs of disaster losses. It lastly adds individual protective equipment and working clothes including protect equipment for eyes, face, hands, arms and feet.

  18. Systemic hydrocortisone to prevent bronchopulmonary dysplasia in preterm infants (the SToP-BPD study; a multicenter randomized placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Onland Wes

    2011-11-01

    Full Text Available Abstract Background Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD. However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants. Methods/Design The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age Discussion This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants. Trial registration number Netherlands Trial Register (NTR: NTR2768

  19. Multicenter transversal two-phase study to determine a national prevalence of epilepsy in Algeria.

    Science.gov (United States)

    Moualek, Dalila; Pacha, Lamia Ali; Abrouk, Samira; Kediha, Mohamed Islam; Nouioua, Sonia; Aissa, Leila Ait; Bellatache, Mounia; Belarbi, Soreya; Slimani, Saddek; Khennouf, Houria; Fellahi, Lynda; El Amine Hamimed, Mohamed; Benali, Nadia; Chekkour, Mohamed Chahine; Maamoun, Ramdane; Dameche, Rachida; Assami, Salima; Tazir, Meriem

    2012-01-01

    The prevalence of epilepsy in Algeria is unknown. The aims of this multicenter transversal study were to determine the national prevalence and clinical characteristics of epilepsy in the Algerian population. This two-phase study was conducted in 5 circumscriptions and included 8,046 subjects aged over 2 months who attended the randomly selected public and private primary care clinics. In the phase 1 study, a questionnaire was submitted to the sample of patients. In the phase 2 study, all potentially epileptic people were examined by neurologists and a second questionnaire was submitted, eventually assessed by appropriate investigations. Sixty-seven patients were identified as having active epilepsy, giving a crude prevalence ratio of 8.32 per 1,000 (95% CI, 6.34-10.3) and an age-adjusted prevalence ratio of 8.9 per 1,000. The highest age-specific ratio was found in patients aged 10-19 years (16.92 per 1,000). Generalized seizures (68.7%) were more common than partial seizures (29.8%). Perinatal injuries were the major leading putative causes (11.9%). The prevalence of epilepsy of 8.32 determined in this study is relatively high. These results provide new epidemiological data and suggest that epilepsy remains an important public health issue to consider in Algeria. Copyright © 2012 S. Karger AG, Basel.

  20. Study on the KALIMER safety approach

    International Nuclear Information System (INIS)

    Kim, Eui Kwang; Han, Do Hee; Kim, Young Cheol.

    1997-01-01

    This study describes KALIMER's safety approach, how to establish the safety criteria and temperature limit, how to define safety evaluation events, and some safety research and development needs items. It is recommended that the KALIMER's approach to safety use seven levels of safety design and a defense-in-depth design approach with particular emphasis on inherent passive features. In order to establish as set DBEs for KALIMER safety evaluation, the procedure is explained how to define safety evaluation events. Final selection is to be determined later with the final establishment of design concepts. On the basis of preliminary studies and evaluation of the plant safety related areas, the KALIMER and PRISM have following three main difference that may require special research and development for KALIMER. (author). 7 refs., 6 tabs., 6 figs

  1. The Effectiveness of Silodosin for Nocturnal Polyuria in Elderly Men With Benign Prostatic Hyperplasia: A Multicenter Study

    OpenAIRE

    Kim, Young Won; Park, Jinsung; Chung, Hong; Kim, Hong-Wook; Kim, Hyung Joon; Jung, Jae Hung; Kim, Won Tae

    2015-01-01

    Purpose: To investigate improvement in nocturia and nocturnal polyuria in nocturnal polyuria patients after silodosin administration by using a 3-day frequency volume chart. Methods: This was a prospective multicenter study. We enrolled nocturnal polyuria patients (nocturnal polyuria index [NPi]>0.33), aged ≥60 years, diagnosed with the 3-day frequency volume charts of patients with benign prostatic hyperplasia taking α-blockers. Of the 54 patients, 30 (55.6%) completed the study according to...

  2. Carotid Artery Injury in Anterior Cervical Spine Surgery: Multicenter Cohort Study and Literature Review.

    Science.gov (United States)

    Härtl, Roger; Alimi, Marjan; Abdelatif Boukebir, Mohamed; Berlin, Connor D; Navarro-Ramirez, Rodrigo; Arnold, Paul M; Fehlings, Michael G; Mroz, Thomas E; Riew, K Daniel

    2017-04-01

    Retrospective study and literature review. To provide more comprehensive data about carotid artery injury (CAI) or cerebrovascular accident (CVA) related to anterior cervical spine surgery. We conducted a retrospective, multicenter, case series study involving 21 high-volume surgical centers from the AOSpine North America Clinical Research Network. Medical records of 17 625 patients who went through cervical spine surgery (levels from C2 to C7) between January 1, 2005, and December 31, 2011, were analyzed. Also, we performed a literature review using Medline and PubMed databases. The following terms were used alone, and in combination, to search for relevant articles: cervical, spine, surgery, complication, iatrogenic, carotid artery, injury, cerebrovascular accident, CVA, and carotid stenosis. Among 17 625 patients that were analyzed, no cases were reported to experienced CAI or CVA after cervical spine surgery. Nevertheless, in our PubMed search we found 157 articles, but only 5 articles matched our study objective criteria; 2 cases were reported to present CAI and 3 cases presented CVA. CAI and CVA related to anterior cervical spine surgeries are extremely rare. We were not able to find neither in our retrospective study nor in our literature research a correlation between the type or length of anterior cervical spine procedure with CVA or CAI complications. However, surgeons should be aware of the possibility of vascular complications and minimize intraoperative direct vascular manipulations or retraction. Preoperative screening for underlying vascular pathology and risk factors is also important.

  3. "Burnout in Medical Oncology Fellows: a Prospective Multicenter Cohort Study in Brazilian Institutions".

    Science.gov (United States)

    Cubero, Daniel I G; Fumis, Renata Rego Lins; de Sá, Thiago Hérick; Dettino, Aldo; Costa, Felipe Osório; Van Eyll, Brigitte M R H Adam; Beato, Carlos; Peria, Fernanda Maris; Mota, Augusto; Altino, José; Azevedo, Sérgio Jobim; da Rocha Filho, Duílio Reis; Moura, Melba; Lessa, Álvaro Edson Ramos; Del Giglio, Auro

    2016-09-01

    Burnout syndrome is a common occurrence among oncologists. Doctors enrolled in residency programs in clinical oncology are exposed to similar risk factors; however, few data are available in this population. This study assessed the occurrence of burnout and associated factors among first-year residents at Brazilian institutions. The present prospective, multicenter, cohort study was conducted with doctors enrolled in residency programs in clinical oncology at Brazilian institutions affiliated with the public health system. The participants answered a sociodemographic questionnaire, the Maslach Burnout Inventory (MBI), Lipp's Stress Inventory, and the Beck Depression Inventory (BDI), upon admission to the program and 6 and 12 months later. Of 37 eligible residency programs in 2009, 11 (30.6 %) agreed to participate in the study. Fifty-four residents, representing 100 % of new admissions to the participating institutions, were included. Most of the participants met the criteria for severe burnout upon admission to the residency programs (emotional exhaustion in 49.0 % and depersonalization in 64.7 %). The scores on MBI domains emotional exhaustion and depersonalization increased significantly (p burnout increased to 88 % at the end of that first year. The present study found a high prevalence of burnout among doctors enrolled in residency programs in clinical oncology at Brazilian institutions. A large fraction of the participants met the criteria for burnout syndrome upon admission to the program, which suggests that the problem began during the course of the previous residency program in internal medicine.

  4. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  5. Ultrasound therapy for recalcitrant diabetic foot ulcers: results of a randomized, double-blind, controlled, multicenter study.

    Science.gov (United States)

    Ennis, William J; Foremann, Phil; Mozen, Neal; Massey, Joi; Conner-Kerr, Teresa; Meneses, Patricio

    2005-08-01

    An estimated 15% of patients with diabetes will develop a foot ulcer sometime in their life, making them 30 to 40 times more likely to undergo amputation due to a non-healing foot ulcer than the non-diabetic population. To determine the safety and efficacy of a new, non-contact, kilohertz ultrasound therapy for the healing of recalcitrant diabetic foot ulcers - as well as to evaluate the impact on total closure and quantitative bacterial cultures and the effect on healing of various levels of sharp/surgical debridement - a randomized, double-blinded, sham-controlled, multicenter study was conducted in hospital-based and private wound care clinics. Patients (55 met criteria for efficacy analysis) received standard of care, which included products that provide a moist environment, offloading diabetic shoes and socks, debridement, wound evaluation, and measurement. The "therapy" was either active 40 KHz ultrasound delivered by a saline mist or a "sham device" which delivered a saline mist without the use of ultrasound. After 12 weeks of care, the proportion of wounds healed (defined as complete epithelialization without drainage) in the active ultrasound therapy device group was significantly higher than that in the sham control group (40.7% versus 14.3%, P = 0.0366, Fisher's exact test). The ultrasound treatment was easy to use and no difference in the number and type of adverse events between the two treatment groups was noted. Of interest, wounds were debrided at baseline followed by a quantitative culture biopsy. The results of these cultures demonstrated a significant bioburden (greater than 10(5)) in the majority of cases, despite a lack of clinical signs of infection. Compared to control, this therapeutic modality was found to increase the healing rate of recalcitrant, diabetic foot ulcers.

  6. Nationwide, Multicenter, Retrospective Study on High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Yoshioka, Yasuo, E-mail: yoshioka@radonc.med.osaka-u.ac.jp [Department of Radiation Oncology, Osaka University Graduate School of Medicine, Osaka (Japan); Kotsuma, Tadayuki [Department of Radiation Oncology, Osaka National Hospital, Osaka (Japan); Komiya, Akira [Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama (Japan); Department of Urology, Chiba University Hospital, Chiba (Japan); Kariya, Shinji [Department of Radiology, Kochi Medical School, Kochi (Japan); Konishi, Koji [Department of Radiation Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka (Japan); Nonomura, Norio [Department of Urology, Osaka University Graduate School of Medicine, Osaka (Japan); Ogawa, Kazuhiko [Department of Radiation Oncology, Osaka University Graduate School of Medicine, Osaka (Japan); Tanaka, Eiichi [Department of Radiation Oncology, Osaka National Hospital, Osaka (Japan); Nishimura, Kensaku [Department of Urology, Osaka National Hospital, Osaka (Japan); Fujiuchi, Yasuyoshi; Kitamura, Hiroshi [Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama (Japan); Yamagami, Takuji [Department of Radiology, Kochi Medical School, Kochi (Japan); Yamasaki, Ichiro [Department of Urology, Kochi Medical School, Kochi (Japan); Nishimura, Kazuo [Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka (Japan); Teshima, Teruki [Department of Radiation Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka (Japan); Nakamura, Katsumasa [Department of Radiation Oncology, Hamamatsu University School of Medicine, Shizuoka (Japan); Itami, Jun [Department of Radiation Oncology, National Cancer Center Hospital, Tokyo (Japan)

    2017-04-01

    Purpose: To present, analyze, and discuss results of a nationwide, multicenter, retrospective study on high-dose-rate brachytherapy (HDR-BT) as monotherapy for low-, intermediate-, and high-risk prostate cancer. Methods and Materials: From 1995 through 2013, 524 patients, 73 (14%) with low-risk, 207 (40%) with intermediate-risk, and 244 (47%) with high-risk prostate cancer, were treated with HDR-BT as monotherapy at 5 institutions in Japan. Dose fractionations were 27 Gy/2 fractions for 69 patients (13%), 45.5 Gy/7 fractions for 168 (32%), 49 Gy/7 fractions for 149 (28%), 54 Gy/9 fractions for 130 (25%), and others for 8 (2%). Of these patients, 156 (30%) did not receive androgen deprivation therapy, and 202 patients (39%) did receive androgen deprivation therapy <1 year, 112 (21%) for 1-3 years, and 54 (10%) for >3 years. Median follow-up time was 5.9 years (range, 0.4-18.1 years), with a minimum of 2 years for surviving patients. Results: After 5 years, respective actuarial rates of no biochemical evidence of disease, overall survival, cause-specific survival, and metastasis-free survival for all patients were 92%, 97%, 99%, and 94%. For low/intermediate/high-risk patients, the 5-year no biochemical evidence of disease rates were 95%/94%/89%, the 5-year overall survival rates were 98%/98%/94%, the 5-year cause-specific survival rates were 98%/100%/98%, and the 5-year metastasis-free survival rates were 98%/95%/90%, respectively. The cumulative incidence of late grade 2 to 3 genitourinary toxicity at 5 years was 19%, and that of late grade 3 was 1%. The corresponding incidences of gastrointestinal toxicity were 3% and 0% (0.2%). No grade 4 or 5 of either type of toxicity was detected. Conclusions: The findings of this nationwide, multicenter, retrospective study demonstrate that HDR-BT as monotherapy was safe and effective for all patients with low-, intermediate-, and high-risk prostate cancer.

  7. Nationwide, Multicenter, Retrospective Study on High-Dose-Rate Brachytherapy as Monotherapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Yoshioka, Yasuo; Kotsuma, Tadayuki; Komiya, Akira; Kariya, Shinji; Konishi, Koji; Nonomura, Norio; Ogawa, Kazuhiko; Tanaka, Eiichi; Nishimura, Kensaku; Fujiuchi, Yasuyoshi; Kitamura, Hiroshi; Yamagami, Takuji; Yamasaki, Ichiro; Nishimura, Kazuo; Teshima, Teruki; Nakamura, Katsumasa; Itami, Jun

    2017-01-01

    Purpose: To present, analyze, and discuss results of a nationwide, multicenter, retrospective study on high-dose-rate brachytherapy (HDR-BT) as monotherapy for low-, intermediate-, and high-risk prostate cancer. Methods and Materials: From 1995 through 2013, 524 patients, 73 (14%) with low-risk, 207 (40%) with intermediate-risk, and 244 (47%) with high-risk prostate cancer, were treated with HDR-BT as monotherapy at 5 institutions in Japan. Dose fractionations were 27 Gy/2 fractions for 69 patients (13%), 45.5 Gy/7 fractions for 168 (32%), 49 Gy/7 fractions for 149 (28%), 54 Gy/9 fractions for 130 (25%), and others for 8 (2%). Of these patients, 156 (30%) did not receive androgen deprivation therapy, and 202 patients (39%) did receive androgen deprivation therapy 3 years. Median follow-up time was 5.9 years (range, 0.4-18.1 years), with a minimum of 2 years for surviving patients. Results: After 5 years, respective actuarial rates of no biochemical evidence of disease, overall survival, cause-specific survival, and metastasis-free survival for all patients were 92%, 97%, 99%, and 94%. For low/intermediate/high-risk patients, the 5-year no biochemical evidence of disease rates were 95%/94%/89%, the 5-year overall survival rates were 98%/98%/94%, the 5-year cause-specific survival rates were 98%/100%/98%, and the 5-year metastasis-free survival rates were 98%/95%/90%, respectively. The cumulative incidence of late grade 2 to 3 genitourinary toxicity at 5 years was 19%, and that of late grade 3 was 1%. The corresponding incidences of gastrointestinal toxicity were 3% and 0% (0.2%). No grade 4 or 5 of either type of toxicity was detected. Conclusions: The findings of this nationwide, multicenter, retrospective study demonstrate that HDR-BT as monotherapy was safe and effective for all patients with low-, intermediate-, and high-risk prostate cancer.

  8. Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance registered)

    International Nuclear Information System (INIS)

    Herborn, Christoph U.; Jaeger-Booth, I.; Goyen, M.; Lodemann, K.P.; Spinazzi, A.

    2009-01-01

    Purpose: Retrospective analysis of the occurrence of adverse events and the diagnostic efficacy of a paramagnetic contrast agent with weak intermittent protein binding and high relaxivity. Materials end methods: Postmarketing surveillance studies for gadobenate dimeglumine (MultiHance, BRACCO Altana Pharma, Constance) were conducted in Germany between 1998 and 2006 and then retrospectively analyzed. Demographic data, relevant comorbidities, and allergies were recorded. The safety and tolerability of MultiHance were logged on a standardized data sheet. Results: A total of 38568 patients were included in the study. 829 patients (2.1%) had a known intolerance against contrast media. The examined regions included the central nervous system, the liver, and the vascular bed. The injection rate with automated injectors (n = 10456) varied between 1.0 und 3.0 ml/sec in 86.5% of patients. Adverse events totaled 1.2%. 11 patients (0.03%) experienced serious adverse events. The most frequent findings were nausea, vomiting and a feeling of warmth. Conclusion: MultiHance is a safe and very well tolerated contrast agent for magnetic resonance imaging (MRI) with a profile and frequency of adverse events similar to other extracellular MR contrast materials. (orig.)

  9. Fibromyalgia as a cause of uncontrolled asthma: a case-control multicenter study.

    Science.gov (United States)

    Martinez-Moragon, Eva; Plaza, Vicente; Torres, Isabel; Rosado, Ana; Urrutia, Isabel; Casas, Xavier; Hinojosa, Belen; Blanco-Aparicio, Marina; Delgado, Julio; Quirce, Santiago; Sabadell, Carles; Cebollero, Pilar; Muñoz-Fernández, Ana

    2017-12-01

    Fibromyalgia can affect the control of asthma when both diseases are present in a single patient. To characterize asthma in patients with concomitant fibromyalgia to assess whether fibromyalgia is an independent factor of asthma severity that influences poor asthma control. We also evaluated how dyspnea is perceived by patients in order to demonstrate that alterations in the perception of airway obstruction may be responsible for poor asthma control. This was a cross-sectional case-control multicenter study, in which 56 patients in the asthma and fibromyalgia group were matched to 36 asthmatics by sex, approximate age, and asthma severity level. All patients were women. Study variables included the Asthma Control Test (ACT), the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), the Nijmegen hyperventilation syndrome questionnaire, the Hospital Anxiety and Depression Scale, and perception of dyspnea after acute bronchoconstriction. Although patients in both study groups showed similar asthma severity and use of anti-asthmatic drugs, patients in the asthma and fibromyalgia group showed lower scores on the ACT and MiniAQLQ questionnaires, and higher scores of anxiety and depression as well as hyperventilation compared to asthma patients without fibromyalgia. All these differences were statistically significant. Fibromyalgia in patients with asthma influences poor control of the respiratory disease and is associated with altered perception of dyspnea, hyperventilation syndrome, high prevalence of depression and anxiety, and impaired quality of life. Fibromyalgia may be considered a risk factor for uncontrolled asthma in patients suffering from asthma and fibromyalgia concomitantly.

  10. Neonatal outcome following new assisted reproductive technology regulations in Turkey - a nationwide multicenter point prevalence study.

    Science.gov (United States)

    Kultursay, Nilgun; Yalaz, Mehmet; Koroglu, Ozge Altun

    2015-01-01

    In March 2010, a new legislation about assisted reproductive technology (ART) activities, favoring single embryo transfer, was introduced in Turkey. Consequences of new regulations on neonatal outcome have not been evaluated in multicenter studies yet. In this study, our aim was to evaluate neonatal outcome of infants from medically assisted reproduction (MAR) pregnancies in the post-legislation era. A point prevalence study was conducted at 51 centers in Turkey on 1 April 2013. Data about fertility treatments and neonatal characteristics were evaluated for "live births" (Group 1) and "patients being cared in the NICU" (Group 2). Seventeen (4%) of 420 infants in group 1, and 89 (8.1%) of 1094 infants in group 2 were born after MAR pregnancies. The ratio of multiple births in MAR pregnancies was still very high as 47.1% for group 1, 69.1% for group 2 infants. MAR babies constituted 9.9% of infants in Level 3 NICUs and 7.6% infants in Level 2 NICUs. MAR was associated with increased risk of multiple births and prematurity. After the new legislation, multiple birth rates are still high in MAR pregnancies, resulting in unfavorable neonatal outcomes. Efforts to decrease multiple birth rates should be encouraged.

  11. The Anti-Osteoporotic Drug Preferences of Physiatrists: A Multicenter Descriptive Study

    Directory of Open Access Journals (Sweden)

    Yeşim Gökçe Kutsal

    2012-08-01

    Full Text Available Aim: The purpose of this multicenter descriptive study is to determine the preferences of physiatrists in our country for anti-osteoporotic drugs in patients with primary and secondary osteoporosis. Materials and Methods: This study was carried out in 10 provinces of Turkey. The diagnosis of osteoporosis was based on World Health Organization criteria using dual-energy x-ray absorptiometry. Patients with a spine and/or hip T-score ≤-2.5 were considered as osteoporotic. 714 patients over 18 years old with primary or secondary osteoporosis were included in the study. In addition to socio-demographic characteristics and chronic use of medications and/or additional systemic diseases that cause secondary osteoporosis were questioned and antiosteoporotic drugs that are recommended by their physicians were recorded.Results: The physicians’ preferred vitamin D and calcium as the prior treatment both in primary and secondary osteoporosis. The most commonly used anti-osteoporotic agent was alendronate from the biphosphonate group. It was followed by ibandronate, risedronate, strontium ranelate, calcitonin, zoledronate, raloxifene, parathyroid hormone (PTH and hormone replacement therapy (HRT in the primary osteoporosis and risedronate, ibandronate, calcitonin, strontium ranelate, zoledronate, PTH, HRT and raloxifene in the secondary osteoporosis, respectively. Conclusion: The physician should choose the most suitable treatment for the patient based on fracture risk, medical history, previous treatments for osteoporosis, concomitant diseases, treatment-induced risks and benefits, and the relation between financial cost and potential benefit. (Turkish Journal of Osteoporosis 2012;18: 42-6

  12. Factors associated with nursing students' academic success or failure: a retrospective Italian multicenter study.

    Science.gov (United States)

    Dante, A; Valoppi, G; Saiani, L; Palese, A

    2011-01-01

    With the increasing standardization of nursing education in Europe under the Bologna Process Declaration (1999), there is a growing interest in defining a common concept of academic success and/or failure, measuring associated factors and comparing differences and similarities between different countries. While there is literature available on these issues from other countries, the phenomenon has not been studied in Italy. The aim of this study was to define the factors associated with academic success or failure in an Italian cohort of nursing students on a bachelor's degree course. A retrospective multicenter study design was adopted. All students enrolling in the academic year 2004-05 on two different bachelor's courses in the north of Italy were interviewed. Only 81 of the 117 students considered (69.2%) concluded their course in three years. Multivariate analysis identified two factors determining academic success/failure: good results in the entry examination for the bachelor's degree in nursing sciences were associated with academic success (OR 4.217, IC(95%) 1.501-11.84), while family commitments, e.g. caring for children or elderly people were associated with academic failure (OR 0.120, IC(95%) 0.03-0.471). Academic failure has a strong impact on students, their families, the teaching faculties and the community, and its prevention is a challenge in the countries with a shortage of nurses. Copyright © 2010 Elsevier Ltd. All rights reserved.

  13. Determinants of Severity in Acute Pancreatitis: A Nation-wide Multicenter Prospective Cohort Study.

    Science.gov (United States)

    Sternby, Hanna; Bolado, Federico; Canaval-Zuleta, Héctor J; Marra-López, Carlos; Hernando-Alonso, Ana I; Del-Val-Antoñana, Adolfo; García-Rayado, Guillermo; Rivera-Irigoin, Robin; Grau-García, Francisco J; Oms, Lluís; Millastre-Bocos, Judith; Pascual-Moreno, Isabel; Martínez-Ares, David; Rodríguez-Oballe, Juan A; López-Serrano, Antonio; Ruiz-Rebollo, María L; Viejo-Almanzor, Alejandro; González-de-la-Higuera, Belén; Orive-Calzada, Aitor; Gómez-Anta, Ignacio; Pamies-Guilabert, José; Fernández-Gutiérrez-Del-Álamo, Fátima; Iranzo-González-Cruz, Isabel; Pérez-Muñante, Mónica E; Esteba, María D; Pardillos-Tomé, Ana; Zapater, Pedro; de-Madaria, Enrique

    2018-04-18

    The aim of this study was to compare and validate the different classifications of severity in acute pancreatitis (AP) and to investigate which characteristics of the disease are associated with worse outcomes. AP is a heterogeneous disease, ranging from uneventful cases to patients with considerable morbidity and high mortality rates. Severity classifications based on legitimate determinants of severity are important to correctly describe the course of disease. A prospective multicenter cohort study involving patients with AP from 23 hospitals in Spain. The Atlanta Classification (AC), Revised Atlanta Classification (RAC), and Determinant-based Classification (DBC) were compared. Binary logistic multivariate analysis was performed to investigate independent determinants of severity. A total of 1655 patients were included; 70 patients (4.2%) died. RAC and DBC were equally superior to AC for describing the clinical course of AP. Although any kind of organ failure was associated with increased morbidity and mortality, persistent organ failure (POF) was the most significant determinant of severity. All local complications were associated with worse outcomes. Infected pancreatic necrosis correlated with high morbidity, but in the presence of POF, it was not associated to higher mortality when compared with sterile necrotizing pancreatitis. Exacerbation of previous comorbidity was associated with increased morbidity and mortality. The RAC and DBC both signify an advance in the description and differentiation of AP patients. Herein, we describe the complications of the disease independently associated to morbidity and mortality. Our findings are valuable not only when designing future studies on AP but also for the improvement of current classifications.

  14. [Immunodiagnosis of endemic mycoses and bronchopulmonary aspergillosis: a multicenter study in Argentina].

    Science.gov (United States)

    Canteros, C E; Rivas, M C; Soria, M; Lee, W; Perrotta, D; Rodero, L; Davel, G

    2004-01-01

    In order to contribute to the knowledge of the relative frequency of chronic fungal diseases and assess the performance of diagnostic laboratories in Argentina, a multicenter study was performed with the participation of 25 medical centers located in 12 different provinces and Buenos Aires City. Between 04-01-2000 and 03-30-2001, 965 serum specimens from patients clinically suspected of having histoplasmosis (HP), paracoccidioidomycosis (PCM), coccidioidomycosis (CM) or aspergilosis were analyzed. Agar immunodiffusion tests (IDD) were done locally. All positive and 35% of negative sera were retested in the reference center. Results of laboratories of origin showed 98.8% concordance with those of reference center. Antibodies against any of the etiological agents were detected in 120 specimens from 98 patients. Endemic mycoses (HP, PCM and CM) were diagnosed in 70 patients (71.4%) and aspergilosis in 28 (28.6%). The frequencies of the different mycoses in decreasing order were PCM 47 patients (47.9%), aspergilosis 28 patients (28.6%), HP 13 patients (13.3%) and CM 10 patients (10.2%). The study was carried out on a voluntary basis and some areas of the country were not represented. However, the frequencies were in range with the expected rates in the population under study.

  15. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence

    DEFF Research Database (Denmark)

    Toozs-Hobson, Philip; Al-Singary, Waleed; Fynes, Michelle

    2012-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence....

  16. Hysteroscopic Essure Inserts for Permanent Contraception: Extended Follow-Up Results of a Phase III Multicenter International Study.

    Science.gov (United States)

    Chudnoff, Scott G; Nichols, John E; Levie, Mark

    2015-01-01

    To describe safety, tolerability, and effectiveness results through 5 years of follow-up of a Phase III trial with Essure inserts. Multicenter, nonrandomized, single-arm international study (Canadian Task Force classification II-3). Thirteen clinical study centers in the United States, Europe, and Australia. A total of 518 previously fertile women seeking permanent contraception. The objective of the hysteroscopic sterilization procedure was bilateral Essure insert placement (ESS205 model) and tubal occlusion. Women with satisfactory device location and tube occlusion (based on modified hysterosalpingography [HSG]) were instructed to discontinue alternative contraception and to rely on Essure inserts for permanent contraception. The primary endpoint for the Phase III study was the rate of pregnancies occurring during the first year of relying (i.e., HSG-confirmed occlusion) on the Essure inserts for permanent contraception (i.e., 12 months after HSG). For the full 5 years of follow-up (5 years total of relying on the Essure inserts for contraception), the endpoints of interest were safety, prevention of pregnancy, and satisfaction. No pregnancies were reported among women relying on the Essure inserts who completed the full 5 years of follow-up. As of December 5, 2007, 449 women with successful bilateral placement relying on the Essure inserts contributed a total 24 942 woman-months of follow-up for assessing effectiveness. Overall, the Essure inserts were generally well tolerated, with participant comfort rated as "good" to "excellent" by 99% of women (382 of 385) after 5 years of use. Similarly, overall satisfaction was rated as "somewhat" to "very satisfied" by 98% of women (376 of 384) after 5 years of use. The majority of adverse events reported during the 5 years of follow-up were rated as either "mild" or "moderate" in severity. Three severe events (abdominal pain with very heavy periods and irregular menstrual bleeding) were reported in 2 subjects during

  17. Establishment of an Italian chronic migraine database: a multicenter pilot study.

    Science.gov (United States)

    Barbanti, Piero; Fofi, L; Cevoli, S; Torelli, P; Aurilia, C; Egeo, G; Grazzi, L; D'Amico, D; Manzoni, G C; Cortelli, P; Infarinato, F; Vanacore, N

    2018-05-01

    To optimize chronic migraine (CM) ascertainment and phenotype definition, provide adequate clinical management and health care procedures, and rationalize economic resources allocation, we performed an exploratory multicenter pilot study aimed at establishing a CM database, the first step for developing a future Italian CM registry. We enrolled 63 consecutive CM patients in four tertiary headache centers screened with face-to-face interviews using an ad hoc dedicated semi-structured questionnaire gathering detailed information on life-style, behavioral and socio-demographic factors, comorbidities, and migraine features before and after chronicization and healthcare resource use. Our pilot study provided useful insights revealing that CM patients (1) presented in most cases symptoms of peripheral trigeminal sensitization, a relatively unexpected feature which could be useful to unravel different CM endophenotypes and to predict trigeminal-targeted treatments' responsiveness; (2) had been frequently admitted to emergency departments; (3) had undergone, sometime repeatedly, unnecessary or inappropriate investigations; (4) got rarely illness benefit exemption or disability allowance only. We deem that the expansion of the database-shortly including many other Italian headache centers-will contribute to more precisely outline CM endophenotypes, hence improving management, treatment, and economic resource allocation, ultimately reducing CM burden on both patients and health system.

  18. A Multicenter Comparative Study of Impulse Control Disorder in Latin American Patients With Parkinson Disease.

    Science.gov (United States)

    Ramírez Gómez, Carolina Candelaria; Serrano Dueñas, Marcos; Bernal, Oscar; Araoz, Natalia; Sáenz Farret, Michel; Aldinio, Victoria; Montilla, Verónica; Micheli, Federico

    Impulse control disorder (ICD) is a common adverse effect in patients with Parkinson disease who receive dopamine agonists; however, other factors are involved in its manifestations. To study the frequency and factors involved in the development of this adverse effect in a Latin American population, we conducted a cross-sectional multicenter study. Two hundred fifty-five patients in 3 Latin American centers were evaluated by examination and application of scales (Unified Parkinson's Disease Rating Scale, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale, Hoehn and Yahr, Clinical Impression of Severity Index for Parkinson's Disease). Of the patients, 27.4% had ICD, most of whom were on dopamine agonists. Other associated risk factors included a younger age at onset of Parkinson disease, moderate symptoms, a shorter evolution of the clinical manifestations, rapid eye movement (REM) sleep disorder behavior, and the consumption of tea, mate, and alcohol. The frequency of ICD is higher in Latin America than in Anglo-Saxon populations. Consuming tea and mate, in addition to the use of dopamine agonists, is a factor that may demonstrate a genetic link that predisposes patients to the establishment of an ICD.

  19. Recurrent peptic ulcers in patients following successful Helicobacter pylori eradication: a multicenter study of 4940 patients.

    Science.gov (United States)

    Miwa, Hiroto; Sakaki, Nobuhiro; Sugano, Kentaro; Sekine, Hitoshi; Higuchi, Kazuhide; Uemura, Naomi; Kato, Mototsugu; Murakami, Kazunari; Kato, Chieko; Shiotani, Akiko; Ohkusa, Toshifumi; Takagi, Atsushi; Aoyama, Nobuo; Haruma, Ken; Okazaki, Kazuichi; Kusugami, Kazuo; Suzuki, Masayuki; Joh, Takashi; Azuma, Takeshi; Yanaka, Akinori; Suzuki, Hidekazu; Hashimoto, Hiroshi; Kawai, Takashi; Sugiyama, Toshiro

    2004-02-01

    Although curative treatment of Helicobacter pylori infection markedly reduces the relapse of peptic ulcers, the details of the ulcers that do recur is not well characterized. The aim of this study is to describe the recurrence rate and specific features of peptic ulcers after cure of H. pylori infection. This was a multicenter study involving 4940 peptic ulcer patients who were H. pylori negative after successful eradication treatment and were followed for up to 48 months. The annual incidence of ulcer relapse in H. pylori-cured patients, background of patients with relapsed ulcers, time to relapse, ulcer size, and site of relapsed ulcers were investigated. Crude peptic ulcer recurrence rate was 3.02% (149/4940). The annual recurrence rates of gastric, duodenal and gastroduodenal ulcer were 2.3%, 1.6%, and 1.6%, respectively. Exclusion of patients who took NSAIDs led annual recurrence rates to 1.9%, 1.5% and 1.3%, respectively. The recurrence rate was significantly higher in gastric ulcer. Recurrence rates of patients who smoked, consumed alcohol, and used NSAIDs were significantly higher in those with gastric ulcer recurrence compared to duodenal ulcer recurrence (e.g. 125 of 149 [83.9%] relapsed ulcers recurred at the same or adjacent sites as the previous ulcers). Curative treatment of H. pylori infection is useful in preventing ulcer recurrence. Gastric ulcer is more likely to relapse than duodenal ulcer. Recurrent ulcer tended to recur at the site of the original ulcers.

  20. Normative data for Aδ contact heat evoked potentials in adult population: a multicenter study.

    Science.gov (United States)

    Granovsky, Yelena; Anand, Praveen; Nakae, Aya; Nascimento, Osvaldo; Smith, Benn; Sprecher, Elliot; Valls-Solé, Josep

    2016-05-01

    There has been a significant increase over recent years in the use of contact heat evoked potentials (CHEPs) for the evaluation of small nerve fiber function. Measuring CHEP amplitude and latency has clinical utility for the diagnosis and assessment of conditions with neuropathic pain. This international multicenter study aimed to provide reference values for CHEPs to stimuli at 5 commonly examined body sites. Contact heat evoked potentials were recorded from 226 subjects (114 females), distributed per age decade between 20 and 79 years. Temperature stimuli were delivered by a thermode (32°C-51°C at a rate of 70°C/s). In phase I of the study, we investigated side-to-side differences and reported the maximum normal side-to-side difference in Aδ CHEP peak latency and amplitude for leg, forearm, and face. In phase II, we obtained normative data for 3 CHEP parameters (N2P2 amplitude, N2 latency, and P2 latency), stratified for gender and age decades from face, upper and lower limbs, and overlying cervical and lumbar spine. In general, larger CHEP amplitudes were associated with higher evoked pain scores. Females had CHEPs of larger amplitude and shorter latency than males. This substantive data set of normative values will facilitate the clinical use of CHEPs as a rapid, noninvasive, and objective technique for the assessment of patients presenting with neuropathic pain.

  1. Recovery, relapse, or else? Treatment outcomes in gambling disorder from a multicenter follow-up study.

    Science.gov (United States)

    Müller, K W; Wölfling, K; Dickenhorst, U; Beutel, M E; Medenwaldt, J; Koch, A

    2017-06-01

    Gambling disorder is associated with various adverse effects. While data on the immediate effectiveness of treatment programs are available, follow-up studies examining long-term effects are scarce and factors contributing to a stable therapy outcome versus relapse are under-researched. Patients (n=270) finishing inpatient treatment for gambling disorder regularly participated in a prospective multicenter follow-up study (pre-treatment, post-treatment, 12-month follow-up). Criteria for gambling disorder, psychopathology, functional impairment were defined as endpoints. Changes in personality were defined as an additional parameter. At follow-up, three groups were identified: subjects maintaining full abstinence (41.6%), patients still meeting criteria for gambling disorder (29.2%), and subjects still participating in gambling without meeting the diagnostic criteria for gambling disorder (29.2%). Every group had improvements in functional impairment, abstinent subjects showed the lowest psychopathology. Significant decreases in neuroticism and increases in both extraversion and conscientiousness were found among abstinent subjects but not in patients still meeting criteria for gambling disorder. One year after treatment, a considerable percentage of patients kept on gambling but not all of them were classified with gambling disorder leading to the question if abstinence is a necessary goal for every patient. The changes of personality in abstinent patients indicate that after surmounting gambling disorder a subsequent maturing of personality might be a protective factor against relapse. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  2. Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

    Directory of Open Access Journals (Sweden)

    Rocco Totaro

    2015-01-01

    Full Text Available Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting. Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months. The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity. Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%. Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

  3. Combined therapy with peritoneal dialysis and hemodialysis: a multicenter retrospective observational cohort study in Japan.

    Science.gov (United States)

    Maruyama, Yukio; Yokoyama, Keitaro; Nakayama, Masaaki; Higuchi, Chieko; Sanaka, Tsutomu; Tanaka, Yoshihide; Sakai, Ken; Mizuiri, Sonoo; Otsuka, Yasushi; Kuriyama, Satoru; Maeba, Teruhiko; Iwasawa, Hideaki; Nakao, Toshiyuki; Hosoya, Tatsuo

    2014-01-01

    Combining peritoneal dialysis (PD) and hemodialysis (HD) has been common treatment option in Japan. In this retrospective, multicenter, observational study, the clinical characteristics and outcomes of 104 patients (57 ± 11 years, males 72%) who had switched from PD alone to combined therapy with PD and HD were studied. Clinical parameters were measured at baseline and after 3 months of combined therapy. At baseline, urine volume, dialysate-to-plasma ratio of creatinine (D/P Cr), and total Kt/V were 150 ml/day (range: 0-2,000 ml/day), 0.67 ± 0.11, and 1.8 ± 0.4, respectively. During the first 3 months of combined therapy, body weight, urine volume, serum creatinine level, and D/P Cr decreased, whereas hemoglobin levels increased. In patients where PD does not result in acceptable outcomes, combined therapy with PD and HD may have potential benefits in terms of dialysis adequacy and hydration status. Video Journal Club “Cappuccino with Claudio Ronco” at http://www.karger.com/?doi=368389 © 2014 S. Karger AG, Basel.

  4. Pediatric Patients Receiving Specialized Palliative Home Care According to German Law: A Prospective Multicenter Cohort Study

    Directory of Open Access Journals (Sweden)

    Silke Nolte-Buchholtz

    2018-05-01

    Full Text Available In Germany, every child with a life-limiting condition suffering from symptoms that cannot sufficiently be controlled is eligible by law for specialized pediatric palliative home care (SPPHC. It is the aim of this study to describe the demographic and clinical characteristics of children referred to SPPHC and to compare patients with cancer and non-cancer conditions. The prospective multicenter study includes data on 75 children (median age 7.7 years, 50.7% male. The majority had non-cancer conditions (72%. The most common symptoms were cognitive impairment, somatic pain, impairment in communication or swallowing difficulties. Swallowing difficulties, seizures, and spasticity occurred significantly more often in non-cancer patients (p < 0.01. Cancer patients received antiemetics significantly more often (permanent and on demand than non-cancer patients (p < 0.01. Significantly more non-cancer patients had some type of feeding tube (57.3% or received oxygen (33.3% (p < 0.01. Central venous catheters had been fitted in 20% of the patients, mostly in cancer patients (p < 0.001. Tracheostomy tubes (9.3% or ventilation (14.7% were only used in non-cancer patients. In conclusion, patients referred to SPPHC are a diverse cohort with complex conditions including a large range of neurologically originating symptoms. The care of pediatric palliative care patients with cancer is different to the care of non-cancer patients.

  5. Risk Factors for Malnutrition among Older Adults in the Emergency Department: A Multicenter Study.

    Science.gov (United States)

    Burks, Collin E; Jones, Christopher W; Braz, Valerie A; Swor, Robert A; Richmond, Natalie L; Hwang, Kay S; Hollowell, Allison G; Weaver, Mark A; Platts-Mills, Timothy F

    2017-08-01

    Among older adults, malnutrition is common, often missed by healthcare providers, and influences recovery from illness or injury. To identify modifiable risk factors associated with malnutrition in older patients. Prospective cross-sectional multicenter study. 3 EDs in the South, Northeast, and Midwest. Non-critically ill, English-speaking adults aged ≥65 years. Random time block sampling was used to enroll patients. The ED interview assessed malnutrition using the Mini Nutritional Assessment Short-Form. Food insecurity and poor oral health were assessed using validated measures. Other risk factors examined included depressive symptoms, limited mobility, lack of transportation, loneliness, and medication side effects, qualified by whether the patient reported the risk factor affected their diet. The population attributable risk proportion (PARP) for malnutrition was estimated for each risk factor. In our sample (n = 252), the prevalence of malnutrition was 12%. Patient characteristics associated with malnutrition included not having a college degree, being admitted to the hospital, and residence in an assisted living facility. Of the risk factors examined, the PARPs for malnutrition were highest for poor oral health (54%; 95% CI 16%, 78%), food insecurity (14%; 95% CI 3%, 31%), and lack of transportation affecting diet (12%; 95% CI 3%, 28%). Results of this observational study identify multiple modifiable factors associated with the problem of malnutrition in older adults. © 2017, Copyright the Authors Journal compilation © 2017, The American Geriatrics Society.

  6. Multicenter study of antimicrobial susceptibility of anaerobic bacteria in Korea in 2012.

    Science.gov (United States)

    Lee, Yangsoon; Park, Yeon Joon; Kim, Mi Na; Uh, Young; Kim, Myung Sook; Lee, Kyungwon

    2015-09-01

    Periodic monitoring of regional or institutional resistance trends of clinically important anaerobic bacteria is recommended, because the resistance of anaerobic pathogens to antimicrobial drugs and inappropriate therapy are associated with poor clinical outcomes. There has been no multicenter study of clinical anaerobic isolates in Korea. We aimed to determine the antimicrobial resistance patterns of clinically important anaerobes at multiple centers in Korea. A total of 268 non-duplicated clinical isolates of anaerobic bacteria were collected from four large medical centers in Korea in 2012. Antimicrobial susceptibility was tested by the agar dilution method according to the CLSI guidelines. The following antimicrobials were tested: piperacillin, piperacillin-tazobactam, cefoxitin, cefotetan, imipenem, meropenem, clindamycin, moxifloxacin, chloramphenicol, metronidazole, and tigecycline. Organisms of the Bacteroides fragilis group were highly susceptible to piperacillin-tazobactam, imipenem, and meropenem, as their resistance rates to these three antimicrobials were lower than 6%. For B. fragilis group isolates and anaerobic gram-positive cocci, the resistance rates to moxifloxacin were 12-25% and 11-13%, respectively. Among B. fragilis group organisms, the resistance rates to tigecycline were 16-17%. Two isolates of Finegoldia magna were non-susceptible to chloramphenicol (minimum inhibitory concentrations of 16-32 mg/L). Resistance patterns were different among the different hospitals. Piperacillin-tazobactam, cefoxitin, and carbapemems are highly active beta-lactam agents against most of the anaerobes. The resistance rates to moxifloxacin and tigecycline are slightly higher than those in the previous study.

  7. Undernutrition, risk of malnutrition and obesity in gastroenterological patients: A multicenter study

    Institute of Scientific and Technical Information of China (English)

    Massimiliano Rizzi; Silvia Mazzuoli; Nunzia Regano; Rosa Inguaggiato; Margherita Bianco; Gioacchino Leandro; Elisabetta Bugianesi; Donatella Noè; Nicoletta Orzes; Paolo Pallini; Maria Letizia Petroni; Gianni Testino; Francesco William Guglielmi

    2016-01-01

    AIM: To investigate the prevalence of undernutrition, risk of malnutrition and obesity in the Italian gastroenterological population. METHODS: The Italian Hospital Gastroenterology Association conducted an observational, cross-sectional multicenter study. Weight, weight loss, and body mass index were evaluated. Undernutrition was defined as unintentional weight loss > 10% in the last threesix months. Values of Malnutrition Universal Screening Tool(MUST) > 2, NRS-2002 > 3, and Mini Nutritional Assessment(MNA) from 17 to 25 identified risk of malnutrition in outpatients, inpatients and elderly patients, respectively. A body mass index ≥ 30 indicated obesity. Gastrointestinal pathologies were categorized into acute, chronic and neoplastic diseases. RESULTS: A total of 513 patients participated in the study. The prevalence of undernutrition was 4.6% in outpatients and 19.6% in inpatients. Moreover, undernutrition was present in 4.3% of the gastrointestinal patients with chronic disease, 11.0% of those with acute disease, and 17.6% of those with cancer. The risk of malnutrition increased progressively and significantly in chronic, acute and neoplastic gastrointestinal diseases in inpatients and the elderly population. Logistical regression analysis confirmed that cancer was a risk factor for undernutrition(OR = 2.7; 95%CI: 1.2-6.44, P = 0.02). Obesity and overweight were more frequent in outpatients. CONCLUSION: More than 63% of outpatients and 80% of inpatients in gastroenterological centers suffered from significant changes in body composition and required specific nutritional competence and treatment.

  8. Reliability of Semiautomated Computational Methods for Estimating Tibiofemoral Contact Stress in the Multicenter Osteoarthritis Study

    Directory of Open Access Journals (Sweden)

    Donald D. Anderson

    2012-01-01

    Full Text Available Recent findings suggest that contact stress is a potent predictor of subsequent symptomatic osteoarthritis development in the knee. However, much larger numbers of knees (likely on the order of hundreds, if not thousands need to be reliably analyzed to achieve the statistical power necessary to clarify this relationship. This study assessed the reliability of new semiautomated computational methods for estimating contact stress in knees from large population-based cohorts. Ten knees of subjects from the Multicenter Osteoarthritis Study were included. Bone surfaces were manually segmented from sequential 1.0 Tesla magnetic resonance imaging slices by three individuals on two nonconsecutive days. Four individuals then registered the resulting bone surfaces to corresponding bone edges on weight-bearing radiographs, using a semi-automated algorithm. Discrete element analysis methods were used to estimate contact stress distributions for each knee. Segmentation and registration reliabilities (day-to-day and interrater for peak and mean medial and lateral tibiofemoral contact stress were assessed with Shrout-Fleiss intraclass correlation coefficients (ICCs. The segmentation and registration steps of the modeling approach were found to have excellent day-to-day (ICC 0.93–0.99 and good inter-rater reliability (0.84–0.97. This approach for estimating compartment-specific tibiofemoral contact stress appears to be sufficiently reliable for use in large population-based cohorts.

  9. Multicenter Study of Brain Volume Abnormalities in Children and Adolescent-Onset Psychosis

    Science.gov (United States)

    Reig, Santiago; Parellada, Mara; Castro-Fornieles, Josefina; Janssen, Joost; Moreno, Dolores; Baeza, Inmaculada; Bargalló, Nuria; González-Pinto, Ana; Graell, Montserrat; Ortuño, Felipe; Otero, Soraya; Arango, Celso; Desco, Manuel

    2011-01-01

    The goal of the study is to determine the extent of structural brain abnormalities in a multicenter sample of children and adolescents with a recent-onset first episode of psychosis (FEP), compared with a sample of healthy controls. Total brain and lobar volumes and those of gray matter (GM), white matter, and cerebrospinal fluid (CSF) were measured in 92 patients with a FEP and in 94 controls, matched for age, gender, and years of education. Male patients (n = 64) showed several significant differences when compared with controls (n = 61). GM volume in male patients was reduced in the whole brain and in frontal and parietal lobes compared with controls. Total CSF volume and frontal, temporal, and right parietal CSF volumes were also increased in male patients. Within patients, those with a further diagnosis of “schizophrenia” or “other psychosis” showed a pattern similar to the group of all patients relative to controls. However, bipolar patients showed fewer differences relative to controls. In female patients, only the schizophrenia group showed differences relative to controls, in frontal CSF. GM deficit in male patients with a first episode correlated with negative symptoms. Our study suggests that at least part of the GM deficit in children and adolescent-onset schizophrenia and in other psychosis occurs before onset of the first positive symptoms and that, contrary to what has been shown in children-onset schizophrenia, frontal GM deficits are probably present from the first appearance of positive symptoms in children and adolescents. PMID:20478821

  10. Prevalence of hospital malnutrition in Latin America: the multicenter ELAN study.

    Science.gov (United States)

    Correia, M Isabel T D; Campos, Antonio Carlos L

    2003-10-01

    We determined the nutrition status and prevalence of malnutrition as determined by the Subjective Global Assessment in Latin America, investigated the awareness of the health team with regard to nutrition status, evaluated the use of nutritional therapy, and assessed the governmental policies regulating the practice of nutritional therapy in each country. This cross-sectional, multicenter epidemiologic study enrolled 9348 hospitalized patients older than 18 y in Latin America. Student's t test and chi-square tests were used to analyze univariate analysis and multiple logistic regression analysis, respectively. Malnutrition was present in 50.2% of the patients studied. Severe malnutrition was present in 11.2% of the entire group. Malnutrition correlated with age (>60 y), presence of cancer and infection, and longer length of hospital stay (P policies ruling the practice of nutritional therapy exist only in Brazil and Costa Rica. Hospital malnutrition in Latin America is highly prevalent. Despite this prevalence, physicians' awareness of malnutrition is weak, nutritional therapy is not used routinely, and governmental policies for nutritional therapy are scarce.

  11. IgM myeloma: A multicenter retrospective study of 134 patients.

    Science.gov (United States)

    Castillo, Jorge J; Jurczyszyn, Artur; Brozova, Lucie; Crusoe, Edvan; Czepiel, Jacek; Davila, Julio; Dispenzieri, Angela; Eveillard, Marion; Fiala, Mark A; Ghobrial, Irene M; Gozzetti, Alessandro; Gustine, Joshua N; Hajek, Roman; Hungria, Vania; Jarkovsky, Jiri; Jayabalan, David; Laubach, Jacob P; Lewicka, Barbara; Maisnar, Vladimir; Manasanch, Elisabet E; Moreau, Philippe; Morgan, Elizabeth A; Nahi, Hareth; Niesvizky, Ruben; Paba-Prada, Claudia; Pika, Tomas; Pour, Ludek; Reagan, John L; Richardson, Paul G; Shah, Jatin; Spicka, Ivan; Vij, Ravi; Waszczuk-Gajda, Anna; Gertz, Morie A

    2017-08-01

    IgM myeloma is a rare hematologic malignancy for which the clinicopathological features and patient outcomes have not been extensively studied. We carried out a multicenter retrospective study in patients with diagnosis of IgM myeloma defined by >10% marrow involvement by monoclonal plasma cells, presence of an IgM monoclonal paraproteinemia of any size, and anemia, renal dysfunction, hypercalcemia, lytic lesions and/or t(11;14) identified by FISH. A total of 134 patients from 20 centers were included in this analysis. The median age at diagnosis was 65.5 years with a male predominance (68%). Anemia, renal dysfunction, elevated calcium and skeletal lytic lesions were found in 37, 43, 19, and 70%, respectively. The median serum IgM level was 2,895 mg dL -1 with 19% of patients presenting with levels >6,000 mg dL -1 . International Staging System (ISS) stages 1, 2, and 3 were seen in 40 (33%), 54 (44%), and 29 (24%) of patients, respectively. The malignant cells expressed CD20 (58%) and cyclin D1 (67%), and t(11;14) was the most common cytogenetic finding (39%). The median overall survival (OS) was 61 months. Higher ISS score was associated with worse survival (P = 0.02). Patients with IgM myeloma present with similar characteristics and outcomes as patients with more common myeloma subtypes. © 2017 Wiley Periodicals, Inc.

  12. Detection of multidrug-resistant tuberculosis from stored DNA Samples: A multicenter study

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    Marie Sylvianne Rabodoarivelo

    2018-01-01

    Full Text Available Background: In low-income countries, rapid detection of tuberculosis (TB drug resistance is often restricted by the difficulties of transporting and storing sputum samples from remote health centers to the reference laboratories where molecular tests are available. The aim of this study was to evaluate the performance of four transport and storage systems for molecular detection of rifampicin (RIF and isoniazid (INH resistance. Methods: This was a multicenter study. Molecular detection of RIF and INH resistance was performed directly from smear-positive TB sputa spotted on a slide, FTA card, GenoCard, and ethanol using the Genotype MTBDRplus assay. The performance of the DNA extraction method from each storage support to detect drug resistance was assessed by calculating their sensitivity and specificity compared to the phenotypic method. Results: From all sites, the overall sensitivity and specificity for RIF-resistance detection was 88% and 85%, respectively, for slides, 86% and 92%, respectively, for GenoCard, 87% and 89%, respectively, for FTA card, and 88% and 92%, respectively, for ethanol. For INH-resistance detection, the overall sensitivity and specificity was 82% and 90%, respectively, for slides, 85% and 96%, respectively, for GenoCard, 86% and 92%, respectively, for FTA card, and 86% and 94%, respectively, for ethanol. Conclusion: Smear slides and filter cards showed to be very useful tools to facilitate DNA extraction from sputum samples with the potential to accelerate the detection of drug resistance in remote areas.

  13. Detection of multidrug-resistant tuberculosis from stored DNA Samples: A multicenter study.

    Science.gov (United States)

    Rabodoarivelo, Marie Sylvianne; Brandao, A; Cergole Novella, M C; C Bombonatte, A G; Imperiale, B; Rakotosamimanana, N; Morcillo, N; Rasolofo, V; Palomino, J C; Martin, A

    2018-01-01

    In low-income countries, rapid detection of tuberculosis (TB) drug resistance is often restricted by the difficulties of transporting and storing sputum samples from remote health centers to the reference laboratories where molecular tests are available. The aim of this study was to evaluate the performance of four transport and storage systems for molecular detection of rifampicin (RIF) and isoniazid (INH) resistance. This was a multicenter study. Molecular detection of RIF and INH resistance was performed directly from smear-positive TB sputa spotted on a slide, FTA card, GenoCard, and ethanol using the Genotype MTBDRplus assay. The performance of the DNA extraction method from each storage support to detect drug resistance was assessed by calculating their sensitivity and specificity compared to the phenotypic method. From all sites, the overall sensitivity and specificity for RIF-resistance detection was 88% and 85%, respectively, for slides, 86% and 92%, respectively, for GenoCard, 87% and 89%, respectively, for FTA card, and 88% and 92%, respectively, for ethanol. For INH-resistance detection, the overall sensitivity and specificity was 82% and 90%, respectively, for slides, 85% and 96%, respectively, for GenoCard, 86% and 92%, respectively, for FTA card, and 86% and 94%, respectively, for ethanol. Smear slides and filter cards showed to be very useful tools to facilitate DNA extraction from sputum samples with the potential to accelerate the detection of drug resistance in remote areas.

  14. Kinetic and Related Determinants of Plasma Triglyceride Concentration in Abdominal Obesity: Multicenter Tracer Kinetic Study.

    Science.gov (United States)

    Borén, Jan; Watts, Gerald F; Adiels, Martin; Söderlund, Sanni; Chan, Dick C; Hakkarainen, Antti; Lundbom, Nina; Matikainen, Niina; Kahri, Juhani; Vergès, Bruno; Barrett, P Hugh R; Taskinen, Marja-Riitta

    2015-10-01

    Patients with obesity and diabetes mellitus have increased risk of cardiovascular disease. A major cause is an atherogenic dyslipidemia related primarily to elevated plasma concentrations of triglyceride-rich lipoproteins. The aim of this study was to clarify determinants of plasma triglyceride concentration. We focused on factors that predict the kinetics of very-low density lipoprotein 1 (VLDL1) triglycerides. A multicenter study using dual stable isotopes (deuterated leucine and glycerol) and multicompartmental modeling was performed to elucidate the kinetics of triglycerides and apoB in VLDL1 in 46 subjects with abdominal obesity and additional cardiometabolic risk factors. Results showed that plasma triglyceride concentrations were dependent on both the secretion rate (r=0.44, Ptriglycerides and VLDL1-apoB. Liver fat mass was independently and directly associated with secretion rates of VLDL1-triglycerides (r=0.56, Ptriglycerides (r=0.48, Ptriglyceride concentrations in abdominal obesity are determined by the kinetics of VLDL1 subspecies, catabolism being mainly dependent on apoC-III concentration and secretion on liver fat content. Reduction in liver fat and targeting apoC-III may be an effective approach for correcting triglyceride metabolism atherogenic dyslipidemia in obesity. © 2015 American Heart Association, Inc.

  15. A Phase 3, multicenter, open-label, switchover trial to assess the safety and efficacy of taliglucerase alfa, a plant cell-expressed recombinant human glucocerebrosidase, in adult and pediatric patients with Gaucher disease previously treated with imiglucerase.

    Science.gov (United States)

    Pastores, Gregory M; Petakov, Milan; Giraldo, Pilar; Rosenbaum, Hanna; Szer, Jeffrey; Deegan, Patrick B; Amato, Dominick J; Mengel, Eugen; Tan, Ee Shien; Chertkoff, Raul; Brill-Almon, Einat; Zimran, Ari

    2014-12-01

    Taliglucerase alfa is a β-glucosidase enzyme replacement therapy (ERT) approved in the US and other countries for the treatment of Gaucher disease (GD) in adults and is approved in pediatric and adult patients in Australia and Canada. It is the first approved plant cell-expressed recombinant human protein. A Phase 3, multicenter, open-label, 9-month study assessed safety and efficacy of switching to taliglucerase alfa in adult and pediatric patients with GD treated with imiglucerase for at least the previous 2years. Patients with stable disease were offered taliglucerase alfa treatment using the same dose (9-60U/kg body weight) and regimen of administration (every 2weeks) as imiglucerase. This report summarizes results from 26 adult and 5 pediatric patients who participated in the trial. Disease parameters (spleen and liver volumes, hemoglobin concentration, platelet count, and biomarker levels) remained stable through 9months of treatment in adults and children following the switch from imiglucerase. All treatment-related adverse events were mild or moderate in severity and transient in nature. Exploratory parameters of linear growth and development showed positive outcomes in pediatric patients. These findings provide evidence of the efficacy and safety profile of taliglucerase alfa as an ERT for GD in patients previously treated with imiglucerase. This trial was registered at www.clinicaltrials.gov as # NCT00712348. Copyright © 2014 Elsevier Inc. All rights reserved.

  16. Investigation of the current situation of massive blood transfusion in different surgical departments: a large multicenter study in China

    OpenAIRE

    Sun, Yang; Jin, Zhan-Kui; Xu, Cui-Xiang; Dang, Qian-Li; Zhang, Li-Jie; Chen, Hong-Nan; Song, Yao-Jun; Yang, Jiang-Cun

    2015-01-01

    Objective: This study aims to learn about the current situation of surgical massive blood transfusion of different surgical departments in China’s Tertiary hospitals, which could provide the basis for the formulation of guidelines on massive blood transfusion. Method: A multicenter retrospective research on the application status of blood constituents during massive blood transfusion was conducted and a comparative analyses of survival and length of hospitalization in patients from different ...

  17. Gene expression signatures predict outcome in non-muscle invasive bladder carcinoma - a multi-center validation study

    DEFF Research Database (Denmark)

    Andersen, Lars Dyrskjøt; Zieger, Karsten; Real, Francisco X.

    2007-01-01

    and carcinoma in situ (CIS) and for predicting disease recurrence and progression. EXPERIMENTAL DESIGN: We analyzed tumors from 404 patients diagnosed with bladder cancer in hospitals in Denmark, Sweden, England, Spain, and France using custom microarrays. Molecular classifications were compared with pathologic....... CONCLUSION: This multicenter validation study confirms in an independent series the clinical utility of molecular classifiers to predict the outcome of patients initially diagnosed with non-muscle-invasive bladder cancer. This information may be useful to better guide patient treatment....

  18. Dermatology Medical Education: A Multicenter Survey Study of the Undergraduate Perspective of the Dermatology Clinical Clerkship.

    Science.gov (United States)

    Davari, Parastoo; Millsop, Jillian W; Johnson, Mary Ann N; Takahashi, Stefani R; Peng, David H; Badger, Joanna; Bahr, Brooks A; Shinkai, Kanade; Li, Chin-Shang; Fazel, Nasim

    2017-12-15

    Limited data are available regarding the undergraduate dermatology clinical clerkship curriculum in the United States. Our primaryaim is to assess medical students' perspectives of the dermatology clinical clerkship. A multicenter survey study was conducted, which included four California dermatology academic programs. A 17-item questionnaire was designed to investigate medical student perception with regard tothe overall educational value of the various teaching aspects of the dermatology clinical clerkship. A total of 152 medical student surveys were completed. Over half of the medical students felt proficient in diagnosing the most commondermatologic conditions. Eighty-seven percent of medical students were very satisfied with the dermatology clerkship. Ninety-one percent of students felt the length of the clerkship was appropriate. The vast majority of medical students reported a high level of proficiency in the treatment and diagnosis of common skin disorders. In contrast, our findings suggest that medical students may not begaining sufficient hands-on experience in conducting certain dermatologic procedures following the dermatology clerkship. Overall, medical studentperception of the dermatology clinical clerkship was mostly positive.

  19. Neuropsychological outcomes after Gamma Knife radiosurgery for mesial temporal lobe epilepsy: a prospective multicenter study.

    Science.gov (United States)

    Quigg, Mark; Broshek, Donna K; Barbaro, Nicholas M; Ward, Mariann M; Laxer, Kenneth D; Yan, Guofen; Lamborn, Kathleen

    2011-05-01

    To assess outcomes of language, verbal memory, cognitive efficiency and mental flexibility, mood, and quality of life (QOL) in a prospective, multicenter pilot study of Gamma Knife radiosurgery (RS) for mesial temporal lobe epilepsy (MTLE). RS, randomized to 20 Gy or 24 Gy comprising 5.5-7.5 ml at the 50% isodose volume, was performed on mesial temporal structures of patients with unilateral MTLE. Neuropsychological evaluations were performed at preoperative baseline, and mean change scores were described at 12 and 24 months postoperatively. QOL data were also available at 36 months. Thirty patients were treated and 26 were available for the final 24-month neuropsychological evaluation. Language (Boston Naming Test), verbal memory (California Verbal Learning Test and Logical Memory subtest of the Wechsler Memory Scale-Revised), cognitive efficiency and mental flexibility (Trail Making Test), and mood (Beck Depression Inventory) did not differ from baseline. QOL scores improved at 24 and 36 months, with those patients attaining seizure remission by month 24s accounting for the majority of the improvement. The serial changes in cognitive outcomes, mood, and QOL are unremarkable following RS for MTLE. RS may provide an alternative to open surgery, especially in those patients at risk of cognitive impairment or who desire a noninvasive alternative to open surgery. Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.

  20. Multicenter Study of Staging and Therapeutic Predictors of Hepatocellular Carcinoma Recurrence following Transplantation.

    Science.gov (United States)

    Welling, Theodore H; Eddinger, Kevin; Carrier, Kristen; Zhu, Danting; Kleaveland, Tyler; Moore, Derek E; Schaubel, Douglas E; Abt, Peter L

    2018-05-05

    Orthotopic liver transplantation (OLT) and resection are effective treatments for hepatocellular carcinoma (HCC). However, optimizing OLT and limiting HCC recurrence remains a vexing problem. New HCC MELD and allocation algorithms provide greater observation of HCC patients, many while receiving local-regional treatments. Potential benefits of local-regional treatment for limiting HCC recurrence post-OLT remain incompletely understood. Therefore we aimed to define HCC specific prognostic factors affecting recurrence in a contemporary, multi-center cohort of HCC patients undergoing OLT and specifically whether local-regional therapies limited recurrence. We identified 441 patients undergoing OLT for HCC at three major transplant centers from 2008-2013. Cox regression was used to analyze covariate-adjusted recurrence and mortality rates post-OLT. "Bridging" or "down-staging" therapy was used in 238 patients (54%) with transarterial chemoembolization (TACE) being used in 170 (71%) of treated patients. The survival rate post-OLT was 88% and 78% at 1 and 3 years, respectively, with HCC recurrence (28% of deaths) significantly increasing mortality rate (HR=19.87, pOLT. Local-regional therapy to achieve a pathologic response (decreasing tumor size) can limit HCC recurrences post-OLT. This article is protected by copyright. All rights reserved. © 2018 by the American Association for the Study of Liver Diseases.

  1. Inpatient glycemic management in internal medicine: an observational multicenter study in Nanjing, China.

    Science.gov (United States)

    Hao, Shujie; Zhang, Ning; Fish, Anne Folta; Yuan, Xiaodan; Liu, Lin; Li, Fan; Fang, Zhaohui; Lou, Qingqing

    2017-08-01

    To evaluate the prevalence of hyperglycemia among inpatients in internal medicine, and specifically, to assess the glycemic management of inpatients in non-endocrinology departments in three large urban hospitals in China. A multicenter observational study was conducted using electronic health records, and a survey of 1939 patients who were admitted to internal medicine units and followed until discharge. Those with previously diagnosed diabetes, newly diagnosed diabetes, or impaired fasting glucose were included. Aspects of glycemic management examined were (a) hyperglycemia, (b) endocrinology consultation for hyperglycemia and (c) hypoglycemia. The prevalence of hyperglycemia in internal medicine was 45.7% (886 out of 1939). A total of 741 (83.6%) patients were treated by non-endocrinology departments; of those, 230 (31.1%) were in poor glycemic control and needed an endocrinology consultation. Yet only 57 (24.8%) received one. In 4 cases, the physician did not follow the consultants' advice. Among the remaining 53 consulted patients, 35 (66.1%) were still in poor glycemic control, yet only about half received a second consultation. Finally, among patients treated in non-endocrinology departments, 58 (7.8%) had hypoglycemia; less than half retested their blood glucose after treatment. The majority of patients with hyperglycemia were in non-endocrinology departments. Their glycemic management was poor; the endocrinology consultation rate was low and the result was suboptimal. Also, the management of hypoglycemia was not ideal. Therefore, improving glycemic management is urgently needed in Chinese hospitals.

  2. Effectiveness of Psychosocial Interventions in Complex Palliative Care Patients: A Quasi-Experimental, Prospective Multicenter Study.

    Science.gov (United States)

    Mateo-Ortega, Dolors; Gómez-Batiste, Xavier; Maté, Jorge; Beas, Elba; Ela, Sara; Lasmarias, Cristina; Limonero, Joaquín T

    2018-03-13

    To determine whether specific psychosocial interventions can ease discomfort in palliative care (PC) patients, particularly in those with high levels of pain or emotional distress. Changes in the psychological parameters of 8333 patients were assessed in a quasi-experimental, prospective, multicenter, single group pretest/post-test study. Psychosocial care was delivered by 29 psychosocial care teams (PSTs; 137 professionals). Pre- and post-intervention changes in these variables were assessed: mood, anxiety, and emotional distress. Patients were classified as complex, when presented with high levels of anxiety, mood, suffering (or perception of time as slow), and distress (or unease, or discomfort), or noncomplex. These groups were compared to assess changes in suffering-related parameters from baseline. Psychosocial interventions reduced patients' suffering. These interventions were more effective in complex patients. After successive psychosocial interventions, the level of suffering in complex patients decreased until close to parity with noncomplex patients, suggesting that patients with major complexity could benefit most from specific psychosocial treatment. These findings support the importance of assessing and treating patients' psychosocial needs.

  3. An Angiopoietin-2 gene polymorphism in unexplained intrauterine fetal death: a multi-center study.

    Science.gov (United States)

    Huber, Ambros; Grimm, Christoph; Pietrowski, Detlef; Zeillinger, Robert; Bettendorf, Hertha; Husslein, Peter; Hefler, Lukas

    2005-02-01

    Angiopoietin-2 (Ang-2) is a potent regulator of angiogenesis and vascular tone. As vascular processes have been proposed to be involved in the pathogenesis of pregnancy associated complications such as late unexplained intrauterine fetal death (IUFD), we determined whether a common G/A polymorphism of the Ang-2 gene (ANGPT2) is associated with this condition. In a multicenter case-control study, we evaluated the common G/A polymorphism within exon 4 of the ANGPT2 gene using PCR in 90 women with IUFD and 90 healthy women with at least one uncomplicated full term pregnancy and no history of IUFD. Genotype (p=0.2; OR=1.4 [0.8-2.6]) and allele frequencies (p=0.1; OR=1.4 [0.9-2.1]) of the ANGPT2 polymorphism did not differ between women with IUFD and healthy women. A multivariate regression analysis with smoking habits and preexisting diabetes as covariates did not change the results. We are the first to report on a common polymorphism of the ANGPT2 gene in patients with late IUFD. The investigated ANGPT2 poylmorphism does not seem to be a candidate gene for IUFD in Caucasian women.

  4. Prevalence of pilomatricoma in Turner syndrome: findings from a multicenter study.

    Science.gov (United States)

    Handler, Marc Z; Derrick, Kristina M; Lutz, Richard E; Morrell, Dean S; Davenport, Marsha L; Armstrong, April W

    2013-05-01

    The absence of data on the prevalence of pilomatricoma among patients with Turner syndrome served as the catalyst for this multicenter investigation. To ascertain the prevalence of pilomatricoma among patients with Turner syndrome and to determine any association between the development of pilomatricomas and the use of exogenous hormones in patients with Turner syndrome. A retrospective medical record review from January 1, 2000, through January 1, 2010, was performed of all patients with Turner syndrome. Data on pilomatricomas and the use of hormone therapy were collected. University of California-Davis Medical Center, University of Nebraska Medical Center, and The University of North Carolina at Chapel Hill. Patients with a diagnosis of Turner syndrome. Prevalence of concomitant pilomatricoma and diagnosis of Turner syndrome. Secondary outcome measures included the use of the exogenous hormones estrogen or recombinant human growth hormone (rhGH). In total, 311 patients with Turner syndrome were identified from these 3 institutions. Among them, 8 patients (2.6%) were diagnosed as having pilomatricomas. Before the development of pilomatricomas, 5 patients had been treated with rhGH but not estrogen, 1 patient had received estrogen but not rhGH, and 2 patients did not receive either therapy. Although the prevalence of pilomatricoma among the general population is unknown, this study demonstrates a high prevalence (2.6%) of pilomatricomas among patients with Turner syndrome. No apparent relationship was noted among our patients or in the literature between the use of rhGH and the development of pilomatricomas.

  5. Factors Associated With Domestic Violence Against Women in Iran: An Exploratory Multicenter Community-Based Study.

    Science.gov (United States)

    Saffari, Mohsen; Arslan, Syed Asadullah; Yekaninejad, Mir Saeid; Pakpour, Amir H; Zaben, Faten Al; Koenig, Harold G

    2017-06-01

    Domestic violence against women committed by intimate partners is a worldwide concern especially in developing countries. The aim of this study was to assess the problem among Iranian women and identify associated risk factors. Using a cross-sectional multicenter design, 1,600 women in six different areas of Iran were surveyed. A measure of domestic violence against women was administered and demographic information collected. Logistic regression models were used to identify factors associated with domestic violence. The prevalence of domestic violence among participants were emotional (64%), physical (28%), and sexual (18%). Higher education (both women and their partners), employment status of partner (being employed), and lower number of children lowered the risk, whereas history of previous marriage (for either women or their partners), unstable marriage, substance abuse, crowded family situation, and lower socioeconomic status increased the risk of domestic violence. There is a high prevalence of domestic violence, particularly emotional, against women by their partners. Preventive measures are recommended such as increasing public awareness, improving in socioeconomic status of families, educating women about what they can do, and encouraging counseling for the couple or the woman alone.

  6. [Participatory education and the development of critical reading in teachers theoretical texts. Multicenter study].

    Science.gov (United States)

    Leyva-González, Félix Arturo; Leo-Amador, Guillermo Enrique; Viniegra-Velázquez, Leonardo; Degollado-Bardales, Lilia; Zavala-Arenas, Jesús Arturo; González-Cobos, Roberto Palemón; Valencia-Sánchez, Jesús Salvador; Leyva-Salas, César Arturo; Angulo-Bernal, Sonia Elizabeth; Gómez-Arteaga, Gress Marissell

    2010-01-01

    Determine what the relationship between participation in classroom of students attending courses at the Educational Research and Teacher Education (CIEFD's) and the development of proficiency in critical reading of theoretical texts in education. Intervention study, multicenter students (medical specialist) level Diploma in teaching methodology (DMDN) 1 and 2 (n=46 n=29) of the six CIEFD's (DF Siglo XXI, Mexico City La Raza, Nuevo Leon, Sonora, Puebla and Veracruz), period: March to August 2007 and a Masters in education (n=9, generation 2007-2008). Two instruments were constructed that evaluated the participation variables and critical reading of theoretical texts in education, conceptual validity; content and reliability were assessed by experts in education research. The educational intervention was in the form of seminars (three times a week in DMDN 1 and twice weekly in DMDN 2 and Masters). Participation was assessed halfway through the course and on completion, critical reading at the beginning as well as the end. Statistically significant associations were observed in DMDN 1 (four Centers) and the Masters, but not DMDN 2. In this investigation some of the theoretical proposals of the participatory education were recreated, starting from the analysis of our results. In some centers and in the masters, strengthening participation in this educational intervention is related to the development of critical reading of theoretical texts in education.

  7. Alveolar Ridge Reconstruction with Titanium Meshes and Simultaneous Implant Placement: A Retrospective, Multicenter Clinical Study

    Directory of Open Access Journals (Sweden)

    Raquel Zita Gomes

    2016-01-01

    Full Text Available Objective. To evaluate horizontal bone gain and implant survival and complication rates in patients treated with titanium meshes placed simultaneously with dental implants and fixed over them. Methods. Twenty-five patients treated with 40 implants and simultaneous guided bone regeneration with titanium meshes (i–Gen®, MegaGen, Gyeongbuk, Republic of Korea were selected for inclusion in the present retrospective multicenter study. Primary outcomes were horizontal bone gain and implant survival; secondary outcomes were biological and prosthetic complications. Results. After the removal of titanium meshes, the CBCT evaluation revealed a mean horizontal bone gain of 3.67 mm (±0.89. The most frequent complications were mild postoperative edema (12/25 patients: 48% and discomfort after surgery (10/25 patients: 40%; these complications were resolved within one week. Titanium mesh exposure occurred in 6 patients (6/25 : 24%: one of these suffered partial loss of the graft and another experienced complete graft loss and implant failure. An implant survival rate of 97.5% (implant-based and a peri-implant marginal bone loss of 0.43 mm (±0.15 were recorded after 1 year. Conclusions. The horizontal ridge reconstruction with titanium meshes placed simultaneously with dental implants achieved predictable satisfactory results. Prospective randomized controlled trials on a larger sample of patients are required to validate these positive outcomes.

  8. Infliximab Versus Adalimumab in the Treatment of Refractory Inflammatory Uveitis: A Multicenter Study From the French Uveitis Network.

    Science.gov (United States)

    Vallet, Hélène; Seve, Pascal; Biard, Lucie; Baptiste Fraison, Jean; Bielefeld, Philip; Perard, Laurent; Bienvenu, Boris; Abad, Sébastien; Rigolet, Aude; Deroux, Alban; Sene, Damien; Perlat, Antoinette; Marie, Isabelle; Feurer, Elodie; Hachulla, Eric; Fain, Olivier; Clavel, Gaëlle; Riviere, Sophie; Bouche, Pierre-Alban; Gueudry, Julie; Pugnet, Gregory; Le Hoang, Phuc; Resche Rigon, Matthieu; Cacoub, Patrice; Bodaghi, Bahram; Saadoun, David

    2016-06-01

    To analyze the factors associated with response to anti-tumor necrosis factor (anti-TNF) treatment and compare the efficacy and safety of infliximab (IFX) and adalimumab (ADA) in patients with refractory noninfectious uveitis. This was a multicenter observational study of 160 patients (39% men and 61% women; median age 31 years [interquartile range 21-42]) with uveitis that had been refractory to other therapies, who were treated with anti-TNF (IFX 5 mg/kg at weeks 0, 2, 6, and then every 5-6 weeks [n = 98] or ADA 40 mg every 2 weeks [n = 62]). Factors associated with complete response were assessed by multivariate analysis. Efficacy and safety of IFX versus ADA were compared using a propensity score approach with baseline characteristics taken into account. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (95% CIs) were calculated. The main etiologies of uveitis included Behçet's disease (BD) (36%), juvenile idiopathic arthritis (22%), spondyloarthropathy (10%), and sarcoidosis (6%). The overall response rate at 6 and 12 months was 87% (26% with complete response) and 93% (28% with complete response), respectively. The median time to complete response was 2 months. In multivariate analysis, BD and occurrence of >5 uveitis flares before anti-TNF initiation were associated with complete response to anti-TNF (SHR 2.52 [95% CI 1.35-4.71], P = 0.004 and SHR 1.97 [95% CI 1.02-3.84], P = 0.045, respectively). Side effects were reported in 28% of patients, including serious adverse events in 13%. IFX and ADA did not differ significantly in terms of occurrence of complete response (SHR 0.65 [95% CI 0.25-1.71], P = 0.39), serious side effects (SHR 0.22 [95% CI 0.04-1.25], P = 0.089), or event-free survival (SHR 0.55 [95% CI 0.28-1.08], P = 0.083). Anti-TNF treatment is highly effective in refractory inflammatory uveitis. BD is associated with increased odds of response. IFX and ADA appear to be equivalent in terms of efficacy.

  9. Validation of the Spanish version of the Hip Outcome Score: a multicenter study.

    Science.gov (United States)

    Seijas, Roberto; Sallent, Andrea; Ruiz-Ibán, Miguel Angel; Ares, Oscar; Marín-Peña, Oliver; Cuéllar, Ricardo; Muriel, Alfonso

    2014-05-13

    The Hip Outcome Score (HOS) is a self-reported questionnaire evaluating the outcomes of treatment interventions for hip pathologies, divided in 19 items of activities of daily life (ADL) and 9 sports' items. The aim of the present study is to translate and validate HOS into Spanish. A prospective and multicenter study with 100 patients undergoing hip arthroscopy was performed between June 2012 and January 2013. Crosscultural adaptation was used to translate HOS into Spanish. Patients completed the questionnaire before and after surgery. Feasibility, reliability, internal consistency, construct validity (correlation with Western Ontario and McMaster Universities Osteoarthritis Index), ceiling and floor effects and sensitivity to change were assessed for the present study. Mean age was 45.05 years old. 36 women and 64 men were included. Feasibility: 13% had at least one missing item within the ADL subscale and 17% within the sport subscale. Reliability: the translated version of HOS was highly reproducible with intraclass correlation coefficient of 0.95 for ADL and 0.94 for the sports subscale. Internal consistency was confirmed with Cronbach's alpha >0.90 in both subscales. Construct validity showed statistically significant correlation with WOMAC. Ceiling effect was observed in 6% and 12% for ADL and sports subscale, respectively. Floor effect was found in 3% and 37% ADL and sports subscale, respectively. Large sensitivity to change was shown in both subscales. The translated version of HOS into Spanish has shown to be feasible, reliable and sensible to changes for patients undergoing hip arthroscopy. This validated translation of HOS allows for comparisons between studies involving either Spanish- or English-speaking patients. Prognostic study, Level I.

  10. Health care utilization in patients with gout: a prospective multicenter cohort study.

    Science.gov (United States)

    Singh, Jasvinder A; Bharat, Aseem; Khanna, Dinesh; Aquino-Beaton, Cleopatra; Persselin, Jay E; Duffy, Erin; Elashoff, David; Khanna, Puja P

    2017-05-31

    All published studies of health care utilization in gout have been cross-sectional to date, and most used a patient-reported diagnosis of gout. Our objective was to assess health care utilization and its predictors in patients with physician-confirmed gout in a prospective cohort study. In a multi-center prospective cohort study of U.S. veterans with rheumatologist-confirmed gout (N = 186; two centers), we assessed patient self-reported overall and gout-specific health care utilization with the Gout Assessment Questionnaire (GAQ) every 3-months for a 9-month period. Comparisons were made using the student's t test or the chi-square, Wilcoxon rank sum test or Fisher exact test, as appropriate. Mixed effects Poisson regression was used to assess potential correlates of gout-related health care utilization. Mean age was 64.6 years, 98% were men, 13% Hispanic or Latino, 32% were African-American, 6% did not graduate high school, mean serum urate was 8.3 and mean Deyo-Charlson score was 3.1. During the past year, mean gout-related visits were as follows: rheumatologist, 1.5; primary care physician, 2 visits; ≥1 inpatient visits, 7%; ≥1 ER visits, 26%; and urgent care/walk-in visit, 33%. In longitudinal analyses, African-American race and gout flares in the last 3 months were associated with significantly higher rate ratio of gout-related outpatient visits. African-American race and lack of college education were associated with significantly higher rate ratio for gout-related urgent visits and overnight stays. African-American race and recent gout flares were associated with higher outpatient utilization and African-American race and no college education with higher urgent or inpatient utilization. Future studies should examine whether modifiable predictors of utilization can be targeted to reduce healthcare utilization in patients with gout.

  11. Clinical Features Associated with Delirium Motor Subtypes in Older Inpatients: Results of a Multicenter Study.

    Science.gov (United States)

    Morandi, Alessandro; Di Santo, Simona G; Cherubini, Antonio; Mossello, Enrico; Meagher, David; Mazzone, Andrea; Bianchetti, Angelo; Ferrara, Nicola; Ferrari, Alberto; Musicco, Massimo; Trabucchi, Marco; Bellelli, Giuseppe

    2017-10-01

    To date motor subtypes of delirium have been evaluated in single-center studies with a limited examination of the relationship between predisposing factors and motor profile of delirium. We sought to report the prevalence and clinical profile of subtypes of delirium in a multicenter study. This is a point prevalence study nested in the "Delirium Day 2015", which included 108 acute and 12 rehabilitation wards in Italy. Delirium was detected using the 4-AT and motor subtypes were measured with the Delirium Motor Subtype Scale (DMSS). A multinomial logistic regression was used to determine the factors associated with delirium subtypes. Of 429 patients with delirium, the DMSS was completed in 275 (64%), classifying 21.5% of the patients with hyperactive delirium, 38.5% with hypoactive, 27.3% with mixed and 12.7% with the non-motor subtype. The 4-AT score was higher in the hyperactive subtype, similar in the hypoactive, mixed subtypes, while it was lowest in the non-motor subtype. Dementia was associated with all three delirium motor subtypes (hyperactive, OR 3.3, 95% CI: 1.2-8.7; hypoactive, OR 2.8, 95% CI: 1.2-6.5; mixed OR 2.6, 95% CI: 1.1-6.2). Atypical antipsychotics were associated with hypoactive delirium (OR 0.23, 95% CI: 0.1-0.7), while intravenous lines were associated with mixed delirium (OR 2.9, 95% CI: 1.2-6.9). The study shows that hypoactive delirium is the most common subtype among hospitalized older patients. Specific clinical features were associated with different delirium subtypes. The use of standardized instruments can help to characterize the phenomenology of different motor subtypes of delirium. Copyright © 2017 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  12. Evaluation of clinical safety and beneficial effects of a fish oil containing lipid emulsion (Lipoplus, MLF541): data from a prospective, randomized, multicenter trial.

    Science.gov (United States)

    Wichmann, Matthias W; Thul, Paul; Czarnetzki, Hans-Dieter; Morlion, Bart J; Kemen, Matthias; Jauch, Karl-Walter

    2007-03-01

    To prove safety and effectiveness of a lipid emulsion enriched with n-3 fatty acids from fish oil (Lipoplus) within the setting of parenteral nutrition of patients after major abdominal surgery and to determine whether there are effects on outcome parameters. Prospective, randomized, double-blind, multicenter trial. University and surgical teaching hospitals. After obtaining informed consent, 256 patients undergoing major abdominal surgery were randomized. Parameters of safety, effectiveness, and outcome were routine laboratory parameters, complication rates, length of stay in the intensive care unit, and length of hospital stay. In addition we determined in patient subgroups of 30 patients each, the changes of the content of selected long-chain polyunsaturated fatty acids, the leukotriene synthetic capacity and the antioxidant alpha-tocopherol. Participating patients were randomized to receive either Lipoplus (group I; n = 127 patients) or Intralipid (group II; n = 129 patients). Parenteral nutrition was initiated immediately after surgery and ended on day 5 after surgery. No significant differences between groups I and II were observed when comparing routine laboratory parameters during the perioperative period. Plasma levels of eicosapentaenoic acid, leukotriene B5, and antioxidant content were significantly increased in group I. Furthermore, there was a significantly shorter length of hospital stay of approximately 21% (17.2 vs. 21.9 days; p = .0061) in group I. Our findings indicate that the administration of Lipoplus in the postoperative period after major abdominal surgery is safe and results in a significantly shorter length of hospital stay. Administration of n-3 polyunsaturated fatty acids in the postoperative period can be considered a valuable choice for patients requiring parenteral nutrition after major abdominal surgery.

  13. Who Donates Their Body to Science? An International, Multicenter, Prospective Study

    Science.gov (United States)

    Cornwall, Jon; Perry, Gary F.; Louw, Graham; Stringer, Mark D.

    2012-01-01

    The altruistic act of body donation provides a precious resource for both teaching and researching human anatomy. However, relatively little is known about individuals who donate their bodies to science (donors), and in particular whether donors in different geographical locations share similar characteristics. A multicenter prospective survey of…

  14. A global multicenter study on reference values: 2. Exploration of sources of variation across the countries.

    Science.gov (United States)

    Ichihara, Kiyoshi; Ozarda, Yesim; Barth, Julian H; Klee, George; Shimizu, Yoshihisa; Xia, Liangyu; Hoffmann, Mariza; Shah, Swarup; Matsha, Tandi; Wassung, Janette; Smit, Francois; Ruzhanskaya, Anna; Straseski, Joely; Bustos, Daniel N; Kimura, Shogo; Takahashi, Aki

    2017-04-01

    The intent of this study, based on a global multicenter study of reference values (RVs) for serum analytes was to explore biological sources of variation (SVs) of the RVs among 12 countries around the world. As described in the first part of this paper, RVs of 50 major serum analytes from 13,396 healthy individuals living in 12 countries were obtained. Analyzed in this study were 23 clinical chemistry analytes and 8 analytes measured by immunoturbidimetry. Multiple regression analysis was performed for each gender, country by country, analyte by analyte, by setting four major SVs (age, BMI, and levels of drinking and smoking) as a fixed set of explanatory variables. For analytes with skewed distributions, log-transformation was applied. The association of each source of variation with RVs was expressed as the partial correlation coefficient (r p ). Obvious gender and age-related changes in the RVs were observed in many analytes, almost consistently between countries. Compilation of age-related variations of RVs after adjusting for between-country differences revealed peculiar patterns specific to each analyte. Judged fromthe r p , BMI related changes were observed for many nutritional and inflammatory markers in almost all countries. However, the slope of linear regression of BMI vs. RV differed greatly among countries for some analytes. Alcohol and smoking-related changes were observed less conspicuously in a limited number of analytes. The features of sex, age, alcohol, and smoking-related changes in RVs of the analytes were largely comparable worldwide. The finding of differences in BMI-related changes among countries in some analytes is quite relevant to understanding ethnic differences in susceptibility to nutritionally related diseases. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

  15. Hours of television viewing and sleep duration in children: a multicenter birth cohort study.

    Science.gov (United States)

    Marinelli, Marcella; Sunyer, Jordi; Alvarez-Pedrerol, Mar; Iñiguez, Carmen; Torrent, Maties; Vioque, Jesús; Turner, Michelle C; Julvez, Jordi

    2014-05-01

    This study used longitudinal data to examine potential associations between hours of television viewing and sleep duration in children. To examine the association between hours of television viewing and sleep duration in preschool and school-aged children. Longitudinal, multicenter study among birth cohorts in Menorca, Sabadell, and Valencia from the Spanish Infancia y Medio Ambiente (environment and childhood) project. The study sample included 1713 children (468 from Menorca, 560 from Sabadell, and 685 from Valencia). Parent-reported child television viewing duration measured in hours per day at 2 and 4 years of age in Sabadell and Valencia and at 6 and 9 years of age in Menorca. Parent-reported child sleep duration measured in hours per day at 2 and 4 years of age in Sabadell and Valencia and at 6 and 9 years of age in Menorca. In cross-sectional analysis, children with longer periods of television viewing reported at baseline (≥ 1.5 hours per day) had shorter sleep duration. Longitudinally, children with reported increases in television viewing duration over time (from <1.5 to ≥ 1.5 hours per day) had a reduction in sleep duration at follow-up visits. Results were similar when examining television viewing duration as a continuous variable, with each 1 hour per day of increased viewing decreasing sleep duration at follow-up visits (β = -0.11; 95% CI, -0.18 to -0.05). Associations were similar when television viewing duration was assessed during weekends and after adjusting for potential intermediate factors (child executive function and attention-deficit/hyperactivity disorder symptoms) and confounders (child physical activity level, parental mental health status, maternal IQ, and maternal marital status). Children spending longer periods watching television had shorter sleep duration. Changes in television viewing duration were inversely associated with changes in sleep duration in longitudinal analysis. Parents should consider avoiding long periods of

  16. Multicenter study of environmental contamination with cyclophosphamide, ifosfamide, and methotrexate in 48 Canadian hospitals.

    Science.gov (United States)

    Poupeau, Céline; Tanguay, Cynthia; Caron, Nicolas J; Bussières, Jean-François

    2018-01-01

    Context Oncology workers are occupationally exposed to antineoplastic drugs. This exposure can induce adverse health effects. In order to reduce their exposure, contamination on surfaces should be kept as low as possible. Objectives To monitor environmental contamination with cyclophosphamide, ifosfamide, and methotrexate in oncology pharmacy and patient care areas in Canadian hospitals. To describe the impact of some factors that may limit contamination. Methods This is a descriptive study. Twelve standardized sites were sampled in each participating center (six in the pharmacy and six in patient care areas). Samples were analyzed for the presence of cyclophosphamide, ifosfamide, and methotrexate by ultra-performance liquid chromatography tandem mass spectrometry technology. Descriptive statistical analyses were done and results were compared with a Kolmogorov-Smirnov test for independent samples. Results In 2015, 48 hospitals participated in this study (48/202, 24%). Overall, 34% (181/525) of the samples were positive for cyclophosphamide, 8% (41/525) for ifosfamide, and 6% (31/525) for methotrexate. The 75th percentile value of cyclophosphamide surface concentration was 6.9 pg/cm 2 . For ifosfamide and methotrexate, they were lower than the limit of detection. Centers who prepared more antineoplastic drugs per year and centers who used more cyclophosphamide per year showed significantly higher surface contamination ( p contamination. Conclusion In comparison with other multicenter studies that were conducted in Canada, the concentration of antineoplastic drugs measured on surfaces is decreasing. Regular environmental monitoring is a good practice in order to maintain contamination as low as reasonably achievable.

  17. Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

    Directory of Open Access Journals (Sweden)

    Frank Ana

    2006-04-01

    Full Text Available Abstract Background Available screening tests for dementia are of limited usefulness because they are influenced by the patient's culture and educational level. The Eurotest, an instrument based on the knowledge and handling of money, was designed to overcome these limitations. The objective of this study was to evaluate the diagnostic accuracy of the Eurotest in identifying dementia in customary clinical practice. Methods A cross-sectional, multi-center, naturalistic phase II study was conducted. The Eurotest was administered to consecutive patients, older than 60 years, in general neurology clinics. The patients' condition was classified as dementia or no dementia according to DSM-IV diagnostic criteria. We calculated sensitivity (Sn, specificity (Sp and area under the ROC curves (aROC with 95% confidence intervals. The influence of social and educational factors on scores was evaluated with multiple linear regression analysis, and the influence of these factors on diagnostic accuracy was evaluated with logistic regression. Results Sixteen neurologists recruited a total of 516 participants: 101 with dementia, 380 without dementia, and 35 who were excluded. Of the 481 participants who took the Eurotest, 38.7% were totally or functionally illiterate and 45.5% had received no formal education. Mean time needed to administer the test was 8.2+/-2.0 minutes. The best cut-off point was 20/21, with Sn = 0.91 (0.84–0.96, Sp = 0.82 (0.77–0.85, and aROC = 0.93 (0.91–0.95. Neither the scores on the Eurotest nor its diagnostic accuracy were influenced by social or educational factors. Conclusion This naturalistic and pragmatic study shows that the Eurotest is a rapid, simple and useful screening instrument, which is free from educational influences, and has appropriate internal and external validity.

  18. A multicenter study of using carbon nanoparticles to show sentinel lymph nodes in early gastric cancer.

    Science.gov (United States)

    Yan, Jun; Zheng, Xiaoling; Liu, Zhangyuanzhu; Yu, Jiang; Deng, Zhenwei; Xue, Fangqing; Zheng, Yu; Chen, Feng; Shi, Hong; Chen, Gang; Lu, Jianping; Cai, Lisheng; Cai, Mingzhi; Xiang, Gao; Hong, Yunfeng; Chen, Wenbo; Li, Guoxin

    2016-04-01

    Lymph node metastasis occurs in approximately 10% of early gastric cancer. Preoperative or intra-operative identification of lymph node metastasis in early gastric cancer is crucial for surgical planning. The purpose of this study was to evaluate the feasibility of using carbon nanoparticles to show sentinel lymph nodes (SLNs) in early gastric cancer. A multicenter study was performed between July 2012 and November 2014. Ninety-one patients with early gastric cancer identified by preoperative endoscopic ultrasonography were recruited. One milliliter carbon nanoparticles suspension, which is approved by Chinese Food and Drug Administration, was endoscopically injected into the submucosal layer at four points around the site of the primary tumor 6-12 h before surgery. Laparoscopic radical resection with D2 lymphadenectomy was performed. SLNs were defined as nodes that were black-dyed by carbon nanoparticles in greater omentum and lesser omentum near gastric cancer. Lymph node status and SLNs accuracy were confirmed by pathological analysis. All patients had black-dyed SLNs lying in greater omentum and/or lesser omentum. SLNs were easily found under laparoscopy. The mean number of SLNs was 4 (range 1-9). Carbon nanoparticles were around cancer in specimen. After pathological analysis, 10 patients (10.99%) had lymph node metastasis in 91 patients with early gastric cancer. SLNs were positive in 9 cases and negative in 82 cases. In pathology, carbon nanoparticles were seen in lymphatic vessels, lymphoid sinus, and macrophages in SLNs. When SLNs were positive, cancer cells were seen in lymph nodes. The sensitivity, specificity, and accuracy of black-dyed SLNs in early gastric cancers were 90, 100, and 98.9 %, respectively. No patient had any side effects of carbon nanoparticles in this study. It is feasible to use carbon nanoparticles to show SLNs in early gastric cancer. Carbon nanoparticles suspension is safe for submucosal injection.

  19. The impact of skin diseases on quality of life: A multicenter study.

    Science.gov (United States)

    Sanclemente, G; Burgos, C; Nova, J; Hernández, F; González, C; Reyes, M I; Córdoba, N; Arévalo, Á; Meléndez, E; Colmenares, J; Ariza, S; Hernández, G

    2017-04-01

    To date, no formal study has been published regarding how Colombian patients with skin disorders could be affected according to their perception of disease. To determine the impact in quality of life of skin diseases in a Colombian population. This multicenter study included patients with skin disease from almost the whole country. Individuals >18 years old; of any gender; with any skin disease and who signed informed consent, were included. We applied the Colombian validated version of the Skindex-29 instrument. A total of 1896 questionnaires had sufficient information for the analyses. No significant differences in sociodemographic characteristics of patients who returned the questionnaire incomplete vs. complete, were found. Participants mean age was 41.5 years. There were no statistical differences in men vs. women regarding the global (p=0.37), symptoms (p=0.71) and emotions (p=0.32) domains, whereas statistical differences were found in the function domain (p=0.04; Mann-Whitney U test). Psoriasis, contact dermatitis, atopic dermatitis, urticaria, hair disorders, Hansen's disease, scars, hyperhidrosis and genital human papillomavirus disease scored the highest. Skindex-29 score variability as a result of differences in the location of the skin lesions, their inflammatory or non-inflammatory nature, and the start of therapy. Even the most localized or asymptomatic skin lesion in our population leads to a disruption at some level of patient's wellness. This study adds well supported scientific data of the burden of skin diseases worldwide. Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Association of Fetal Abdominal–Head Circumference Size Difference With Shoulder Dystocia: A Multicenter Study

    Science.gov (United States)

    Endres, Loraine; DeFranco, Emily; Conyac, Theresa; Adams, Marci; Zhou, Ying; Magner, Kristin; O'Rourke, Luke; Bernhard, Kiley A.; Siddiqui, Danish; McCormick, Anna; Abramowicz, Jacques; Merkel, Ronald; Jawish, Rana; Habli, Mounira; Floman, Alissa; Magann, Everett F.; Chauhan, Suneet P.

    2015-01-01

    Objective This study aims to determine if shoulder dystocia is associated with a difference in the fetal abdominal (AC) to head circumference (HC) of 50 mm or more noted on antenatal ultrasound. Study Design A multicenter matched case–control study was performed comparing women who had shoulder dystocia to controls who did not. Women with vaginal births of live born nonanomalous singletons ≥ 36 weeks of gestation with an antenatal ultrasound within 4 weeks of delivery were included. Controls were matched for gestational age, route of delivery, and diabetes status. Results We identified 181 matched pairs. Only 5% of the fetuses had an AC to HC of ≥ 50 mm. The proportion of AC to HC difference of ≥ 50 mm was significantly higher in shoulder dystocia cases (8%) than controls (1%, p = 0.002). With multivariate regression, the three significant factors associated with shoulder dystocia were AC to HC ≥ 50 mm (odds ratio [OR], 7.3; confidence interval [CI], 1.6–33.3; p = 0.010), femur length (OR, 1.1; CI, 1.0–1.2; p = 0.002), and induced labor (OR, 1.8; CI, 1.1–3.1; p = 0.027). Conclusion A prenatal ultrasound finding of a difference in AC to HC of ≥ 50 mm while uncommon is associated with shoulder dystocia. PMID:26495163

  1. Air contamination for predicting wound contamination in clean surgery: A large multicenter study.

    Science.gov (United States)

    Birgand, Gabriel; Toupet, Gaëlle; Rukly, Stephane; Antoniotti, Gilles; Deschamps, Marie-Noelle; Lepelletier, Didier; Pornet, Carole; Stern, Jean Baptiste; Vandamme, Yves-Marie; van der Mee-Marquet, Nathalie; Timsit, Jean-François; Lucet, Jean-Christophe

    2015-05-01

    The best method to quantify air contamination in the operating room (OR) is debated, and studies in the field are controversial. We assessed the correlation between 2 types of air sampling and wound contaminations before closing and the factors affecting air contamination. This multicenter observational study included 13 ORs of cardiac and orthopedic surgery in 10 health care facilities. For each surgical procedure, 3 microbiologic air counts, 3 particles counts of 0.3, 0.5, and 5 μm particles, and 1 bacteriologic sample of the wound before skin closure were performed. We collected data on surgical procedures and environmental characteristics. Of 180 particle counts during 60 procedures, the median log10 of 0.3, 0.5, and 5 μm particles was 7 (interquartile range [IQR], 6.2-7.9), 6.1 (IQR, 5.4-7), and 4.6 (IQR, 0-5.2), respectively. Of 180 air samples, 50 (28%) were sterile, 90 (50%) had 1-10 colony forming units (CFU)/m(3) and 40 (22%) >10 CFU/m(3). In orthopedic and cardiac surgery, wound cultures at closure were sterile for 24 and 9 patients, 10 and 11 had 1-10 CFU/100 cm(2), and 0 and 6 had >10 CFU/100 cm(2), respectively (P air microbial counts (P contamination (P = .22). This study suggests that particle counting is a good surrogate of airborne microbiologic contamination in the OR. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  2. A prospective, multicenter study of pharmacist activities resulting in medication error interception in the emergency department.

    Science.gov (United States)

    Patanwala, Asad E; Sanders, Arthur B; Thomas, Michael C; Acquisto, Nicole M; Weant, Kyle A; Baker, Stephanie N; Merritt, Erica M; Erstad, Brian L

    2012-05-01

    The primary objective of this study is to determine the activities of pharmacists that lead to medication error interception in the emergency department (ED). This was a prospective, multicenter cohort study conducted in 4 geographically diverse academic and community EDs in the United States. Each site had clinical pharmacy services. Pharmacists at each site recorded their medication error interceptions for 250 hours of cumulative time when present in the ED (1,000 hours total for all 4 sites). Items recorded included the activities of the pharmacist that led to medication error interception, type of orders, phase of medication use process, and type of error. Independent evaluators reviewed all medication errors. Descriptive analyses were performed for all variables. A total of 16,446 patients presented to the EDs during the study, resulting in 364 confirmed medication error interceptions by pharmacists. The pharmacists' activities that led to medication error interception were as follows: involvement in consultative activities (n=187; 51.4%), review of medication orders (n=127; 34.9%), and other (n=50; 13.7%). The types of orders resulting in medication error interceptions were written or computerized orders (n=198; 54.4%), verbal orders (n=119; 32.7%), and other (n=47; 12.9%). Most medication error interceptions occurred during the prescribing phase of the medication use process (n=300; 82.4%) and the most common type of error was wrong dose (n=161; 44.2%). Pharmacists' review of written or computerized medication orders accounts for only a third of medication error interceptions. Most medication error interceptions occur during consultative activities. Copyright © 2011. Published by Mosby, Inc.

  3. Evaluation of depressive symptoms in mid-aged women: report of a multicenter South American study.

    Science.gov (United States)

    Salazar-Pousada, Danny; Monterrosa-Castro, Alvaro; Ojeda, Eliana; Sánchez, Sandra C; Morales-Luna, Ingrid F; Pérez-López, Faustino R; Chedraui, Peter

    2017-11-01

    To evaluate depressive symptoms and related factors among mid-aged women using the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10). This was a cross-sectional multicenter study in which women aged 40 to 65 from various South American countries were surveyed with the CESD-10 and a general questionnaire containing personal and partner data. In all, 864 women were interviewed from Colombia (Afro-Colombian, n = 215), Ecuador (Mestizo, n = 202), Perú (Quechua at high altitude, n = 231), and Paraguay (Mestizo, n = 216). Mean age of the whole sample was 49.1 ± 6.0 years. Although the rate of postmenopausal status was similar among studied sites, differences were observed in relation to age, parity, hormone therapy use, hot flush rate, sedentary lifestyle, chronic medical conditions, habits, and partner aspects. Median total CESD-10 score for all sites was 7.0, with a 36.0% (n = 311) having scores equal to 10 or more (suggestive of depressed mood). Higher scores were observed for Afro-Colombian and Quechua women, and also for postmenopausal and perimenopausal ones. Multivariate linear regression analysis found that depressed mood (higher CESD-10 total scores) was significantly associated with ethnicity (Afro-Colombian), hot flush severity, hormone therapy use, sedentary lifestyle, postmenopause, perceived unhealthy status, and lower education. Higher monthly coital frequency and having a healthy partner without premature ejaculation was related to lower scores, hence less depressed mood. In this mid-aged female South American sample, depressive symptoms correlated to menopausal status and related aspects, ethnicity, and personal and partner issues. All these features require further research.

  4. Clinical evaluation of the use of a multifunctional remotely controlled insulin pump: multicenter observational study.

    Science.gov (United States)

    Boizel, Robert; Pinget, Michel; Lachgar, Karim; Parkin, Christopher G; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-11-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system's advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. © 2014 Diabetes Technology Society.

  5. Efficacy of a ketogenic diet in resistant myoclono-astatic epilepsy: A French multicenter retrospective study.

    Science.gov (United States)

    Stenger, Elodie; Schaeffer, Mickael; Cances, Claude; Motte, Jacques; Auvin, Stéphane; Ville, Dorothée; Maurey, Hélène; Nabbout, Rima; de Saint-Martin, Anne

    2017-03-01

    Recent studies have suggested that the early introduction of a ketogenic diet (KD) could improve seizure control in myoclono-astatic epilepsy (MAE). This multicenter study sought to identify the benefits of KD use on seizure control and epilepsy and on developmental outcomes in children with resistant MAE. Fifty children who were diagnosed with severe MAE in the French network of Reference Centers for Rare Epilepsies and who were treated with KD between 2000 and 2013 were included in this study. The seizure frequency and EEG recordings were assessed two weeks before KD introduction, 2 and 6 months after, and during the last follow-up, which also included an assessment of developmental outcome. Patients had a median follow up of 52 months (range 13-136) and received 4.3 antiepileptic drugs [2-9] before KD introduction. Fifty-four percent (54%) of our patients were seizure-free after 6 months of KD or more, and 86% experienced more than a 70% seizure reduction after 2 months of KD. Forty-four percent (44%) of them had a clear benefit of early KD treatment (after four AEDs failed). Early KD treatment did not result in a greater seizure reduction (p=0.055), but significantly resulted in remission (p<0.028). Fifty percent of patients with resistant MAE had normal development outcomes. Earlier KD treatment, after three AEDs failed, was correlated with a better cognitive outcome (p<0.01). Early introduction of KD treatment in resistant MAE has a strong, persistent anticonvulsant effect with long-term remission and better cognitive outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Appropriateness guidelines and predictive rules to select patients for upper endoscopy: a nationwide multicenter study.

    Science.gov (United States)

    Buri, Luigi; Hassan, Cesare; Bersani, Gianluca; Anti, Marcello; Bianco, Maria Antonietta; Cipolletta, Livio; Di Giulio, Emilio; Di Matteo, Giovanni; Familiari, Luigi; Ficano, Leonardo; Loriga, Pietro; Morini, Sergio; Pietropaolo, Vincenzo; Zambelli, Alessandro; Grossi, Enzo; Intraligi, Marco; Buscema, Massimo

    2010-06-01

    Selecting patients appropriately for upper endoscopy (EGD) is crucial for efficient use of endoscopy. The objective of this study was to compare different clinical strategies and statistical methods to select patients for EGD, namely appropriateness guidelines, age and/or alarm features, and multivariate and artificial neural network (ANN) models. A nationwide, multicenter, prospective study was undertaken in which consecutive patients referred for EGD during a 1-month period were enrolled. Before EGD, the endoscopist assessed referral appropriateness according to the American Society for Gastrointestinal Endoscopy (ASGE) guidelines, also collecting clinical and demographic variables. Outcomes of the study were detection of relevant findings and new diagnosis of malignancy at EGD. The accuracy of the following clinical strategies and predictive rules was compared: (i) ASGE appropriateness guidelines (indicated vs. not indicated), (ii) simplified rule (>or=45 years or alarm features vs. <45 years without alarm features), (iii) logistic regression model, and (iv) ANN models. A total of 8,252 patients were enrolled in 57 centers. Overall, 3,803 (46%) relevant findings and 132 (1.6%) new malignancies were detected. Sensitivity, specificity, and area under the receiver-operating characteristic curve (AUC) of the simplified rule were similar to that of the ASGE guidelines for both relevant findings (82%/26%/0.55 vs. 88%/27%/0.52) and cancer (97%/22%/0.58 vs. 98%/20%/0.58). Both logistic regression and ANN models seemed to be substantially more accurate in predicting new cases of malignancy, with an AUC of 0.82 and 0.87, respectively. A simple predictive rule based on age and alarm features is similarly effective to the more complex ASGE guidelines in selecting patients for EGD. Regression and ANN models may be useful in identifying a relatively small subgroup of patients at higher risk of cancer.

  7. Assessment of thromboprophylaxis in medical patients hospitalized in Andalusia. A multicenter study.

    Science.gov (United States)

    Navarro Puerto, M A; Medrano Ortega, F J; Izquierdo Guerrero, R; Calderón Sandubete, E; Buzón-Barrera, M L; Marín-León, I

    2015-04-01

    Hospitalized patients are a population at risk for venous thromboembolism (VTE). The PRETEMED-2007 clinical practice guidelines help identify high-risk medical patients who are suited to thromboprophylaxis. These guidelines therefore provide a standard for prophylaxis in such patients. We evaluated the risk of VTE and the adjustment of thromboprophylaxis to the standards of the PRETEMED-2007 guidelines in patients hospitalized in internal medicine departments. An observational, cross-sectional multicenter study was performed in 2010 in 16 hospitals in Andalusia and included 20 consecutive patients per center. The study variables were age, sex, risk factors for VTE and hemorrhage, the risk-adjusted PRETEMED of VTE, adjustment of thromboembolic prophylaxis at admission and at discharge and hospital mortality. The study included 293 patients (57.8% men) with a mean age of 69 (±15) years. The most common triggers for VTE were acute severe infection (27.3%) and neoplasia (16.4%). Some 43.4% of the patients presented a risk of hemorrhage. The risk of VTE at admission and discharge was high in 47.8% and 31% and moderate in 8.2% and 10.6%, respectively. A total of 91.7% and 17.3% of the patients underwent prophylaxis with low-molecular-weight heparin on admission and at discharge, respectively. The prescription was appropriate for 59.9% of the patients at admission (overutilization 38.4%, underutilization 1.7%) and for 74.7% at discharge (overutilization 5.4%, underutilization 19.9%). The adjustment was greater in patients older than 60 years and with greater hemorrhagic risk. For 60% of the patients admitted to the departments of internal medicine in Andalusia, the thromboprophylaxis was appropriate. The inadequacy of thromboprophylaxis (40%) is mostly due to overutilization. These results suggest significant space for improvement. Copyright © 2014 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  8. Medical students and controversial ethical issues: results from the multicenter study SBRAME.

    Science.gov (United States)

    Lucchetti, Giancarlo; de Oliveira, Leandro Romani; Leite, José Roberto; Lucchetti, Alessandra Lamas Granero

    2014-12-15

    Medical students(MS) will face ethical issues throughout their lives as doctors. The present study aims to investigate medical students' opinions on controversial ethical issues and factors associated with these opinions. SBRAME (Spirituality and Brazilian Medical Education) is a multicenter study involving 12 Brazilian medical schools with 5950 MS. Participants completed a questionnaire that collected information on socio-demographic data, medical schools characteristics, religious beliefs and opinions on controversial ethical issues. Of all MS, 3630 participated in the survey (61.0%). The sample was 53.8% women and the mean age was 22.5 years. In general, most MS have no objections to prescription of birth control (90.8%), adult stem cell use (87.5%), embryonic stem cell use (82.0%) and abortion for genetic reasons (51.2%). Approximately half of students have no objections to human cloning (47.3%), 45.7% to withdrawal of artificial life support, 41.4% to euthanasia and 23.3% to abortion for failed contraception. Socio-demographic data such as age, gender and income had little influence on MS opinions. On the other hand, medical schools characteristics (number of medical students in the university, year of medical school foundation, location of the university and type of university) and religious aspects (religious affiliation, religious attendance, non-organizational religiousness and intrinsic religiousness) were highly correlated with their opinions. In general, MS with more supportive opinions on controversial ethical issues were less religious and from non-traditional (newer), urban, public and bigger universities. The current study reveals MS have different opinions regarding controversial ethical issues. Noteworthy, these opinions seem to be shaped more by university characteristics and religious beliefs than socio-demographic data.

  9. Change in Care Dependency of Stroke Patients: A Longitudinal and Multicenter Study.

    Science.gov (United States)

    Nursiswati, Nursiswati; Halfens, Ruud J G; Lohrmann, Christa

    2017-06-01

    The study was conducted to investigate the change of care dependency in stroke patients from inpatient wards and outpatient units in Indonesia. This study is longitudinal and multicentered. One hundred and nine patients were included from four hospitals on the island of Java. Care dependency was assessed using the Indonesian version of the 15-item Care Dependency Scale (CDS) at five points in time: at inpatient wards for admission and discharge and at outpatient units after discharge in the 1st week, the 5th week, and the 13th week. Most of the patients were male (65.1%), and diagnosed with ischemic stroke (71.5%). The results showed that care dependency in stroke patients decreased significantly from admission to discharge, as well as from the 5th to the 13th week as measured by the CDS. At admission, 23.0% of the patients were completely dependent on care, and at the 13th week about 1.0% were. Patients' care dependency decreased significantly in all care dependency items of the CDS in the inpatient ward, but five care dependency items of the CDS did not significantly decrease in the outpatient unit. Based on the findings of this study, we recommend that hospital-based and community-based services should include continual care dependence monitoring using this comprehensive instrument. Care dependency is subject to change over time, therefore nurses have to plan and tailor adequate nursing care measures to patient needs in the different stages, especially with respect to the aspect of mobility. Copyright © 2017. Published by Elsevier B.V.

  10. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  11. THE EFFICACY AND SAFETY OF CARMOLIS GEL IN THE COMBINATION THERAPY OF KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    I. N. Denisov

    2015-01-01

    Full Text Available Osteoarthritis (OA is one of the most common rheumatic diseases. Knee OA is particularly frequently encountered among all forms of OA, the prevalence of knee OA being about 25% in the general population. Despite multiple guidelines for the management of knee OA, which have been prepared by the European League Against Rheumatism (EULAR, the American College of Rheumatology (ACR, and the Osteoarthritis Research Society International (OARSI, many problems of its treatment policy remain to be solved. The same holds true for not only the symptomatic and disease-modifying effects of chondroprotectors, but also topical therapy options.Objective: to evaluate the clinical efficacy and safety of Carmolis gel in patients with knee OA.Subjects and methods.The trial included 280 patients with knee OA (a study group consisted of 190 patents; a control group comprised 90 patients. The mean age was 58.3±9.3 years in the study group and 59±10.5 years in the control group. The disease duration was 10.3±5.5 and 10.1±4.1 years, respectively. Carmolis gel was applied to the region of the most painful knee joint up to 4–5 times daily, followed by massage of this skin area. The treatment cycle lasted for 2 weeks. No therapy was performed in the control patients. The clinical efficacy was determined by the changes in joint pains at rest or on movement and palpation, according to a visual analogue scale (VAS, WOMAC questionnaire, the synovitis intensity (assessed by ultrasonography, patient and physician global assessments of disease activity (Likert scale, and the possibility of reducing the daily dosage of nonsteroidal anti-inflammatory drugs (NSAIDs. The onset the therapeutic effect of the gel and the duration of its action were recorded.Results and discussion. The topical application of Carmolis gel caused a statistically significant reduction in joint pain at rest and on movement from 57.7±6.8 to 12±1.8 mm (р < 0.01 and from 52±5.3 to 17±2.7 mm

  12. Effect and safety of deep needling and shallow needling for functional constipation: a multicenter, randomized controlled trial.

    Science.gov (United States)

    Wu, Jiani; Liu, Baoyan; Li, Ning; Sun, Jianhua; Wang, Lingling; Wang, Liping; Cai, Yuying; Ye, Yongming; Liu, Jun; Wang, Yang; Liu, Zhishun

    2014-12-01

    Aupuncture is widely used for functional constipation. Effect of acupuncture might be related to the depth of needling; however, the evidence is limited. This trial aimed to evaluate the effect and safety of deep needling and shallow needling for functional constipation, and to assess if the deep needling and shallow needling are superior to lactulose. We conducted a prospective, superiority-design, 5-center, 3-arm randomized controlled trial. A total of 475 patients with functional constipation were randomized to the deep needling group (237), shallow needling group (119), and lactulose-controlled group (119) in a ratio of 2:1:1. Sessions lasted 30 minutes each time and took place 5 times a week for 4 weeks in 2 acupuncture groups. Participants in the lactulose group took lactulose orally for 16 continuous weeks. The primary outcome was the change from baseline of mean weekly spontaneous bowel movements (SBMs) during week 1 to 4 (changes from the baselines of the weekly SBMs at week 8 and week 16 in follow-up period were also assessed simultaneously). Secondary outcomes were the weekly SBMs of each assessing week, the mean score change from the baseline of constipation-related symptoms over week 1 to 4, and the time to the first SBM. Emergency drug usage and adverse effects were monitored throughout the study.SBMs and constipation-related symptoms were all improved in the 3 groups compared with baseline at each time frame (Pdeep needling group, 2 (1.75) in the shallow needling group, and 2 (2) in the lactulose group (P>0.05, both compared with the lactulose group). The changes of mean weekly SBMs at week 8 and week 16 in the follow-up period were 2 (2), 2 (2.5) in the deep needling group, 2 (3), 1.5 (2.5) in the shallow needling group, and 1 (2), 1 (2) in the lactulose group (Pdeep or shallow needling group. Deep and shallow needling at Tianshu (ST25) can improve intestinal function remarkably and safely. Therapeutic effects of deep and shallow needling are not

  13. Incidence of transfusion reactions: a multi-center study utilizing systematic active surveillance and expert adjudication

    Science.gov (United States)

    Hendrickson, Jeanne E.; Roubinian, Nareg H.; Chowdhury, Dhuly; Brambilla, Don; Murphy, Edward L.; Wu, Yanyun; Ness, Paul M.; Gehrie, Eric A.; Snyder, Edward L.; Hauser, R. George; Gottschall, Jerome L.; Kleinman, Steve; Kakaiya, Ram; Strauss, Ronald G.

    2017-01-01

    Background Prevalence estimates of serious hazards of transfusion vary widely. We hypothesized that the current reporting infrastructure in the United States fails to capture many transfusion reactions, and undertook a multi-center study utilizing active surveillance, data review, and adjudication to test this hypothesis. Study Design and Methods A retrospective record review was completed for a random sample of 17% of all inpatient transfusion episodes over 6 months at 4 academic tertiary care hospitals, with an episode defined as all blood products released to a patient in 6 hours. Data were recorded by trained clinical research nurses, and serious reactions were adjudicated by a panel of transfusion medicine experts. Results Of 4857 transfusion episodes investigated, 1.1% were associated with a serious reaction. Transfusion associated circulatory overload (TACO) was the most frequent serious reaction noted, being identified in 1% of transfusion episodes. Despite clinical notes describing a potential transfusion association in 59% of these cases, only 5.1% were reported to the transfusion service. Suspected transfusion related acute lung injury (TRALI/possible TRALI), anaphylactic, and hypotensive reactions were noted in 0.08%, 0.02%, and 0.02% of transfusion episodes. Minor reactions, including febrile non-hemolytic and allergic, were noted in 0.62% and 0.29% of transfusion episodes, with 30–50% reported to the transfusion service. Conclusion Underreporting of cardiopulmonary transfusion reactions is striking among academic, tertiary care hospitals. Complete and accurate reporting is essential to identify, define, establish pathogenesis, and mitigate/treat transfusion reactions. A better understanding of the failure to report may improve the accuracy of passive reporting systems. PMID:27460200

  14. Timing of renal replacement therapy after cardiac surgery: a retrospective multicenter Spanish cohort study.

    Science.gov (United States)

    García-Fernández, Nuria; Pérez-Valdivieso, José Ramón; Bes-Rastrollo, Maira; Vives, Marc; Lavilla, Javier; Herreros, Jesús; Monedero, Pablo

    2011-01-01

    The optimal time to initiate renal replacement therapy (RRT) in cardiac surgery-associated acute kidney injury (CSA-AKI) is unknown. Evidence suggests that the early use of RRT in critically ill patients is associated with improved outcomes. We studied the effects of time to initiation of RRT on outcome in patients with CSA-AKI. This was a retrospective observational multicenter study (24 Spanish hospitals). We analyzed data on 203 patients who required RRT after cardiac surgery in 2007. The cohort was divided into 2 groups based on the time at which RRT was initiated: in the early RRT group, therapy was initiated within the first 3 days after cardiac surgery; in the late group, RRT was begun after the 3rd day. Multivariate nonconditional logistic and linear regression models were used to adjust for potential confounders. In-hospital mortality was significantly higher in the late RRT group compared with early RRT patients (80.4 vs. 53.2%; p < 0.001; adjusted odds ratio of 4.1, 95% CI: 1.6-10.0). Also, patients in the late RRT group had longer adjusted hospital stays by 11.6 days (95% CI: 1.4-21.9) and higher adjusted percentage increases in creatinine at discharge compared with baseline by 67.7% (95% CI: 28.5-106.4). Patients who undergo early initiation of RRT after CSA-AKI have improved survival rates and renal function at discharge and decreased lengths of hospital stay. Copyright © 2011 S. Karger AG, Basel.

  15. Mechanical Ventilation and ARDS in the ED: A Multicenter, Observational, Prospective, Cross-sectional Study.

    Science.gov (United States)

    Fuller, Brian M; Mohr, Nicholas M; Miller, Christopher N; Deitchman, Andrew R; Levine, Brian J; Castagno, Nicole; Hassebroek, Elizabeth C; Dhedhi, Adam; Scott-Wittenborn, Nicholas; Grace, Edward; Lehew, Courtney; Kollef, Marin H

    2015-08-01

    There are few data regarding mechanical ventilation and ARDS in the ED. This could be a vital arena for prevention and treatment. This study was a multicenter, observational, prospective, cohort study aimed at analyzing ventilation practices in the ED. The primary outcome was the incidence of ARDS after admission. Multivariable logistic regression was used to determine the predictors of ARDS. We analyzed 219 patients receiving mechanical ventilation to assess ED ventilation practices. Median tidal volume was 7.6 mL/kg predicted body weight (PBW) (interquartile range, 6.9-8.9), with a range of 4.3 to 12.2 mL/kg PBW. Lung-protective ventilation was used in 122 patients (55.7%). The incidence of ARDS after admission from the ED was 14.7%, with a mean onset of 2.3 days. Progression to ARDS was associated with higher illness severity and intubation in the prehospital environment or transferring facility. Of the 15 patients with ARDS in the ED (6.8%), lung-protective ventilation was used in seven (46.7%). Patients who progressed to ARDS experienced greater duration in organ failure and ICU length of stay and higher mortality. Lung-protective ventilation is infrequent in patients receiving mechanical ventilation in the ED, regardless of ARDS status. Progression to ARDS is common after admission, occurs early, and worsens outcome. Patient- and treatment-related factors present in the ED are associated with ARDS. Given the limited treatment options for ARDS, and the early onset after admission from the ED, measures to prevent onset and to mitigate severity should be instituted in the ED. ClinicalTrials.gov; No.: NCT01628523; URL: www.clinicaltrials.gov.

  16. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study.

    Science.gov (United States)

    Giovannini, Marc; Thomas, Botelberge; Erwan, Bories; Christian, Pesenti; Fabrice, Caillol; Benjamin, Esterni; Geneviève, Monges; Paolo, Arcidiacono; Pierre, Deprez; Robert, Yeung; Walter, Schimdt; Hanz, Schrader; Carl, Szymanski; Christoph, Dietrich; Pierre, Eisendrath; Jean-Luc, Van Laethem; Jacques, Devière; Peter, Vilmann; Andrian, Saftoiu

    2009-04-07

    To evaluate the ability of endoscopic ultrasound (EUS) elastography to distinguish benign from malignant pancreatic masses and lymph nodes. A multicenter study was conducted and included 222 patients who underwent EUS examination with assessment of a pancreatic mass (n = 121) or lymph node (n = 101). The classification as benign or malignant, based on the real time elastography pattern, was compared with the classification based on the B-mode EUS images and with the final diagnosis obtained by EUS-guided fine needle aspiration (EUS-FNA) and/or by surgical pathology. An interobserver study was performed. The sensitivity and specificity of EUS elastography to differentiate benign from malignant pancreatic lesions are 92.3% and 80.0%, respectively, compared to 92.3% and 68.9%, respectively, for the conventional B-mode images. The sensitivity and specificity of EUS elastography to differentiate benign from malignant lymph nodes was 91.8% and 82.5%, respectively, compared to 78.6% and 50.0%, respectively, for the B-mode images. The kappa coefficient was 0.785 for the pancreatic masses and 0.657 for the lymph nodes. EUS elastography is superior compared to conventional B-mode imaging and appears to be able to distinguish benign from malignant pancreatic masses and lymph nodes with a high sensitivity, specificity and accuracy. It might be reserved as a second line examination to help characterise pancreatic masses after negative EUS-FNA and might increase the yield of EUS-FNA for lymph nodes.

  17. Sarcopenia in patients with hip fracture: A multicenter cross-sectional study.

    Science.gov (United States)

    Steihaug, Ole Martin; Gjesdal, Clara Gram; Bogen, Bård; Kristoffersen, Målfrid Holen; Lien, Gunhild; Ranhoff, Anette Hylen

    2017-01-01

    Sarcopenia is prevalent in older persons and is a risk factor for falls, fractures, and mortality. The aim of this study was to determine a) the feasibility of determining sarcopenia in patients with acute hip fracture, b) the prevalence of sarcopenia and c) associations of sarcopenia with nutritional status and comorbidities. A multicenter cross-sectional study on sarcopenia in male and female patients with acute hip fracture. Participants were previously ambulatory and living in the community. Sarcopenia was assessed postoperatively with muscle mass estimated by anthropometry using triceps skinfold, arm circumference, height, weight and sex. Grip strength was measured by Jamar dynamometer and pre-fracture mobility was by self-report using the New Mobility Score. Out of 282 patients, 202 were assessed for sarcopenia of whom 74 (37%) were diagnosed as sarcopenic. Sarcopenia was associated with age, odds ratio (OR) 1.4 per 5 years, 95% confidence interval (CI) [1.1, 1.8], ASA Physical Status Classification System score, OR 2.3 per point, 95% CI [1.3, 4.3] and number of medications at discharge, OR 1.2 per medication, 95% CI [1.0, 1.3] and inversely associated with BMI, OR 0.8, 95% CI [0.7, 0.9] and serum albumin, OR 0.9, 95% CI [0.8,1.0]. Thirty-seven percent of assessed subjects were diagnosed with sarcopenia. Our data demonstrates that the prevalence of sarcopenia is associated with older age, malnutrition and comorbidities. Determining sarcopenia at the bedside was feasible in postoperative hip fracture patients by using grip strength, estimation of muscle mass by anthropometry and self-reported mobility.

  18. Sarcopenia in patients with hip fracture: A multicenter cross-sectional study.

    Directory of Open Access Journals (Sweden)

    Ole Martin Steihaug

    Full Text Available Sarcopenia is prevalent in older persons and is a risk factor for falls, fractures, and mortality. The aim of this study was to determine a the feasibility of determining sarcopenia in patients with acute hip fracture, b the prevalence of sarcopenia and c associations of sarcopenia with nutritional status and comorbidities.A multicenter cross-sectional study on sarcopenia in male and female patients with acute hip fracture. Participants were previously ambulatory and living in the community. Sarcopenia was assessed postoperatively with muscle mass estimated by anthropometry using triceps skinfold, arm circumference, height, weight and sex. Grip strength was measured by Jamar dynamometer and pre-fracture mobility was by self-report using the New Mobility Score.Out of 282 patients, 202 were assessed for sarcopenia of whom 74 (37% were diagnosed as sarcopenic. Sarcopenia was associated with age, odds ratio (OR 1.4 per 5 years, 95% confidence interval (CI [1.1, 1.8], ASA Physical Status Classification System score, OR 2.3 per point, 95% CI [1.3, 4.3] and number of medications at discharge, OR 1.2 per medication, 95% CI [1.0, 1.3] and inversely associated with BMI, OR 0.8, 95% CI [0.7, 0.9] and serum albumin, OR 0.9, 95% CI [0.8,1.0].Thirty-seven percent of assessed subjects were diagnosed with sarcopenia. Our data demonstrates that the prevalence of sarcopenia is associated with older age, malnutrition and comorbidities. Determining sarcopenia at the bedside was feasible in postoperative hip fracture patients by using grip strength, estimation of muscle mass by anthropometry and self-reported mobility.

  19. Nationwide Multicenter Reference Interval Study for 28 Common Biochemical Analytes in China.

    Science.gov (United States)

    Xia, Liangyu; Chen, Ming; Liu, Min; Tao, Zhihua; Li, Shijun; Wang, Liang; Cheng, Xinqi; Qin, Xuzhen; Han, Jianhua; Li, Pengchang; Hou, Li'an; Yu, Songlin; Ichihara, Kiyoshi; Qiu, Ling

    2016-03-01

    A nationwide multicenter study was conducted in the China to explore sources of variation of reference values and establish reference intervals for 28 common biochemical analytes, as a part of the International Federation of Clinical Chemistry and Laboratory Medicine, Committee on Reference Intervals and Decision Limits (IFCC/C-RIDL) global study on reference values. A total of 3148 apparently healthy volunteers were recruited in 6 cities covering a wide area in China. Blood samples were tested in 2 central laboratories using Beckman Coulter AU5800 chemistry analyzers. Certified reference materials and value-assigned serum panel were used for standardization of test results. Multiple regression analysis was performed to explore sources of variation. Need for partition of reference intervals was evaluated based on 3-level nested ANOVA. After secondary exclusion using the latent abnormal values exclusion method, reference intervals were derived by a parametric method using the modified Box-Cox formula. Test results of 20 analytes were made traceable to reference measurement procedures. By the ANOVA, significant sex-related and age-related differences were observed in 12 and 12 analytes, respectively. A small regional difference was observed in the results for albumin, glucose, and sodium. Multiple regression analysis revealed BMI-related changes in results of 9 analytes for man and 6 for woman. Reference intervals of 28 analytes were computed with 17 analytes partitioned by sex and/or age. In conclusion, reference intervals of 28 common chemistry analytes applicable to Chinese Han population were established by use of the latest methodology. Reference intervals of 20 analytes traceable to reference measurement procedures can be used as common reference intervals, whereas others can be used as the assay system-specific reference intervals in China.

  20. Deep Learning for Prediction of Obstructive Disease From Fast Myocardial Perfusion SPECT: A Multicenter Study.

    Science.gov (United States)

    Betancur, Julian; Commandeur, Frederic; Motlagh, Mahsaw; Sharir, Tali; Einstein, Andrew J; Bokhari, Sabahat; Fish, Mathews B; Ruddy, Terrence D; Kaufmann, Philipp; Sinusas, Albert J; Miller, Edward J; Bateman, Timothy M; Dorbala, Sharmila; Di Carli, Marcelo; Germano, Guido; Otaki, Yuka; Tamarappoo, Balaji K; Dey, Damini; Berman, Daniel S; Slomka, Piotr J

    2018-03-12

    The study evaluated the automatic prediction of obstructive disease from myocardial perfusion imaging (MPI) by deep learning as compared with total perfusion deficit (TPD). Deep convolutional neural networks trained with a large multicenter population may provide improved prediction of per-patient and per-vessel coronary artery disease from single-photon emission computed tomography MPI. A total of 1,638 patients (67% men) without known coronary artery disease, undergoing stress 99m Tc-sestamibi or tetrofosmin MPI with new generation solid-state scanners in 9 different sites, with invasive coronary angiography performed within 6 months of MPI, were studied. Obstructive disease was defined as ≥70% narrowing of coronary arteries (≥50% for left main artery). Left ventricular myocardium was segmented using clinical nuclear cardiology software and verified by an expert reader. Stress TPD was computed using sex- and camera-specific normal limits. Deep learning was trained using raw and quantitative polar maps and evaluated for prediction of obstructive stenosis in a stratified 10-fold cross-validation procedure. A total of 1,018 (62%) patients and 1,797 of 4,914 (37%) arteries had obstructive disease. Area under the receiver-operating characteristic curve for disease prediction by deep learning was higher than for TPD (per patient: 0.80 vs. 0.78; per vessel: 0.76 vs. 0.73: p deep learning threshold set to the same specificity as TPD, per-patient sensitivity improved from 79.8% (TPD) to 82.3% (deep learning) (p deep learning) (p Deep learning has the potential to improve automatic interpretation of MPI as compared with current clinical methods. Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  1. The effects of thoracic surgery operations on quality of life: a multicenter study.

    Science.gov (United States)

    Öz, Gürhan; Solak, Okan; Metin, Muzaffer; Esme, Hıdır; Sayar, Adnan

    2015-10-01

    Some treatment modalities may cause losses in patients' life comfort because of the treatment process. Our aim is to determine the effects of thoracic surgery operations on patients' quality of life. This is a multicenter and prospective study. A hundred patients, who had undergone posterolateral thoracotomy (PLT) and/or lateral thoracotomy (LT), were included in the study. A quality of life questionnaire (SF-36) was used to determine the changes in life comfort. SF-36 was performed before the operation, on the first month, third month, sixth month and twelfth month after the operation. Seventy-two percent (n = 72) of the patients were male. PLT was performed in 66% (n = 66) of the patients, and LT was performed in 34% (n = 34) of the patients. The types of resections in patients were pneumonectomy in four patients, lobectomy in 59 patients and wedge resection in 11 patients. No resection was performed in 26 patients. Thoracotomy caused deteriorations in physical function (PF), physical role (RP), bodily pain (BP), health, vitality and social function scores. The deteriorations observed in the third month improved in the sixth and twelfth months. The PF, RP, BP and MH scores of the patients with lung resection were much more worsened compared with the patients who did not undergo lung resection. Thoracic surgery operations caused substantial dissatisfaction in life comfort especially in the third month postoperatively. The worsening in physical function, physical role, pain and mental health is much more in patients with resection compared with the patients who did not undergo resection. © 2014 John Wiley & Sons Ltd.

  2. Hemorrhoids and matrix metalloproteinases: A multicenter study on the predictive role of biomarkers.

    Science.gov (United States)

    Serra, Raffaele; Gallelli, Luca; Grande, Raffaele; Amato, Bruno; De Caridi, Giovanni; Sammarco, Giuseppe; Ferrari, Francesco; Butrico, Lucia; Gallo, Gaetano; Rizzuto, Antonia; de Franciscis, Stefano; Sacco, Rosario

    2016-02-01

    An association between hemorrhoidal disease and matrix metalloproteinases (MMPs) has been described previously. MMPs regulate extracellular structural proteins and tissue remodeling. Neutrophil gelatinase-associated lipocalin (NGAL) is involved in the regulation of MMP activity. The aim of this work was to study the relationship between tissue immunoreactive levels of MMPs and NGAL and different stages of hemorrhoids. In a multicenter, open-label, prospective study, the population under investigation consisted of 2 groups: group I (with symptomatic hemorrhoids; Goligher grade I-IV) and group II (healthy volunteers). We enrolled 97 patients with hemorrhoids: 21 with grade I hemorrhoids, 37 with grade II, 14 with grade III, and 25 with grade IV. Finally, 90 healthy volunteers (53 males and 37 females; age range, 19-70 years; median, 56) were enrolled in group II. Enzyme-linked immunosorbent assay and Western blot analysis revealed greater levels of immunoreactive MMPs and NGAL in all patients with hemorrhoids. We recorded significantly greater levels of MMP-1 and MMP-3 in grade I and II patients compared with control, and greater levels of MMP-3, MMP-7, MMP-8, and MMP-9 in grade III compared with grade II. MMP-9 and NGAL were particularly increased in patients with grade IV especially in case of thrombosed hemorrhoids. These results provide potentially important insights into the understanding of the natural history of hemorrhoids. MMPs and NGAL play a role in development of disease and may represent molecular markers for the complications such as hemorrhoidal thrombosis. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Surgical volume and conversion rate in laparoscopic hysterectomy: does volume matter? A multicenter retrospective cohort study.

    Science.gov (United States)

    Keurentjes, José H M; Briët, Justine M; de Bock, Geertruida H; Mourits, Marian J E

    2018-02-01

    A multicenter, retrospective, cohort study was conducted in the Netherlands. The aim was to evaluate whether surgical volume of laparoscopic hysterectomies (LHs) performed by proven skilled gynecologists had an impact on the conversion rate from laparoscopy to laparotomy. In 14 hospitals, all LHs performed by 19 proven skilled gynecologists between 2007 and 2010 were included in the analysis. Surgical volume, conversion rate and type of conversion (reactive or strategic) were retrospectively assessed. To estimate the impact of surgical volume on the conversion rate, logistic regressions were performed. These regressions were adjusted for patient's age, Body Mass Index (BMI), ASA classification, previous abdominal surgery and the indication (malignant versus benign) for the LH. During the study period, 19 proven skilled gynecologists performed a total of 1051 LHs. Forty percent of the gynecologists performed over 20 LHs per year (median 17.3, range 5.4-49.5). Conversion to laparotomy occurred in 5.0% of all LHs (53 of 1051); 38 (3.6%) were strategic and 15 (1.4%) were reactive conversions. Performing over 20 LHs per year was significantly associated with a lower overall conversion rate (OR adjusted 0.43, 95% CI 0.24-0.77), a lower strategic conversion rate (OR adjusted 0.32, 95% CI 0.16-0.65), but not with a lower reactive conversion rate (OR adjusted 0.96, 95% CI 0.33-2.79). A higher annual surgical volume of LHs by proven skilled gynecologists is inversely related to the conversion rate to laparotomy, and results in a lower strategic conversion rate.

  4. Sarcopenia in patients with hip fracture: A multicenter cross-sectional study

    Science.gov (United States)

    Gjesdal, Clara Gram; Bogen, Bård; Kristoffersen, Målfrid Holen; Lien, Gunhild; Ranhoff, Anette Hylen

    2017-01-01

    Background Sarcopenia is prevalent in older persons and is a risk factor for falls, fractures, and mortality. The aim of this study was to determine a) the feasibility of determining sarcopenia in patients with acute hip fracture, b) the prevalence of sarcopenia and c) associations of sarcopenia with nutritional status and comorbidities. Methods A multicenter cross-sectional study on sarcopenia in male and female patients with acute hip fracture. Participants were previously ambulatory and living in the community. Sarcopenia was assessed postoperatively with muscle mass estimated by anthropometry using triceps skinfold, arm circumference, height, weight and sex. Grip strength was measured by Jamar dynamometer and pre-fracture mobility was by self-report using the New Mobility Score. Results Out of 282 patients, 202 were assessed for sarcopenia of whom 74 (37%) were diagnosed as sarcopenic. Sarcopenia was associated with age, odds ratio (OR) 1.4 per 5 years, 95% confidence interval (CI) [1.1, 1.8], ASA Physical Status Classification System score, OR 2.3 per point, 95% CI [1.3, 4.3] and number of medications at discharge, OR 1.2 per medication, 95% CI [1.0, 1.3] and inversely associated with BMI, OR 0.8, 95% CI [0.7, 0.9] and serum albumin, OR 0.9, 95% CI [0.8,1.0]. Conclusions Thirty-seven percent of assessed subjects were diagnosed with sarcopenia. Our data demonstrates that the prevalence of sarcopenia is associated with older age, malnutrition and comorbidities. Determining sarcopenia at the bedside was feasible in postoperative hip fracture patients by using grip strength, estimation of muscle mass by anthropometry and self-reported mobility. PMID:28902873

  5. Factors contributing to disability in rheumatoid arthritis patients: An Egyptian multicenter study.

    Science.gov (United States)

    Hammad, Marwa; Eissa, Mervat; Dawa, Ghada A

    2018-04-30

    Minimizing disability and enhancing physical function to its optimal levels is still a challenge in management of rheumatoid arthritis (RA). The aim is to identify factors leading to disability in RA. This is a cross-sectional Egyptian multicenter study carried out on 215 RA patients attending to our inpatient and outpatient rheumatology clinics during 4 months starting from April to July 2017 who agreed to participate in the study; 170 patients were from Cairo University hospitals and 45 from Zagazig University hospitals. We recorded a number of possible risk factors including demographic, clinical, serological and therapeutic factors. The assessment of patients' disability was done using Modified HAQ (MHAQ). A significant positive correlation was found between MHAQ and different markers of activity in addition to age and depression score (P<0.001). Illiteracy accounted for higher MHAQ scores (P=0.001). A higher MHAQ was found in patients with ischemic heart disease (P<0.05). Patients with erosions on X-rays had significantly higher MHAQ scores. Subluxations also accounted for higher MHAQ scores (P=0.000). Aging, illiteracy, disease activity, erosions, subluxations, depression and ischemic heart disease were all related to higher disability. Good control of disease activity which in turn reduces erosions and subluxations is mandatory. Screening for depression and proper use of anti-depressants is of great value. Proper screening and prophylaxis is recommended against ischemic heart disease by controlling modifiable risk factors like obesity, dyslipidaemia, hypertension, smoking and sedentary lifestyle. Copyright © 2018 Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. Publicado por Elsevier España, S.L.U. All rights reserved.

  6. Association between 24-h urinary sodium excretion and obesity in Korean adults: A multicenter study.

    Science.gov (United States)

    Nam, Ga Eun; Kim, Seon Mee; Choi, Mi-Kyeong; Heo, Young-Ran; Hyun, Tai-Sun; Lyu, Eun-Soon; Oh, Se-Young; Park, Hae-Ryun; Ro, Hee-Kyong; Han, Kyungdo; Lee, Yeon Kyung

    2017-09-01

    The aim of this study was to explore the association between sodium intake, as assessed by 24-h urinary sodium excretion, and various obesity parameters among South Korean adults. The associations of 24-h urinary sodium excretion and sodium intake calculated from the dietary questionnaire with obesity parameters also were compared. This multicenter, cross-sectional study analyzed data of 640 healthy adults from eight provinces in South Korea. Obesity was assessed by body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR). Mean 24-h urinary sodium excretion was calculated from repeatedly collected 24-h urine samples. Participants' dietary intake was assessed by 24-h dietary recall interview on the days before 24-h urine collection. In both sexes, the means of all anthropometric measurements tended to increase proportionally with 24-h urinary sodium excretion quartiles, regardless of adjustment. Men in the highest quartile (Q4) of 24-h urinary sodium excretion had increased odds of obesity (as assessed by BMI, WC, WHR, and WHtR) compared with men in the three lower quartiles (Q1-Q3) of 24-h urinary sodium excretion. Women in Q4 of 24-h urinary sodium excretion exhibited a higher chance of general obesity and abdominal obesity. Sodium intake calculated from the dietary questionnaire was not significantly associated with obesity in either sex. In Korean adults, there was a positive association between higher sodium intake as assessed by 24-h urinary sodium excretion and obesity independent of energy intake. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Factors associated to depression and anxiety in medical students: a multicenter study

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    Fernanda Brenneisen Mayer

    2016-10-01

    Full Text Available Abstract Background To evaluate personal and institutional factors related to depression and anxiety prevalence of students from 22 Brazilian medical schools. Methods The authors performed a multicenter study (August 2011 to August 2012, examining personal factors (age, sex, housing, tuition scholarship and institutional factors (year of the medical training, school legal status, location and support service in association with scores of Beck Depression Inventory (BDI and State Trait Anxiety Inventory (STAI. Results Of 1,650 randomly selected students, 1,350 (81.8 % completed the study. The depressive symptoms prevalence was 41 % (BDI > 9, state-anxiety 81.7 % and trait-anxiety in 85.6 % (STAI > 33. There was a positive relationship between levels of state (r = 0,591, p < 0.001 and trait (r = 0,718, p < 0.001 anxiety and depression scores. All three symptoms were positively associated with female sex and students from medical schools located in capital cities of both sexes. Tuition scholarship students had higher state-anxiety but not trait-anxiety or depression scores. Medical students with higher levels of depression and anxiety symptoms disagree more than their peers with the statements “I have adequate access to psychological support” and “There is a good support system for students who get stressed”. Conclusions The factors associated with the increase of medical students’ depression and anxiety symptoms were female sex, school location and tuition scholarship. It is interesting that tuition scholarship students showed state-anxiety, but not depression and trait-anxiety symptoms.

  8. A multicenter nationwide reference intervals study for common biochemical analytes in Turkey using Abbott analyzers.

    Science.gov (United States)

    Ozarda, Yesim; Ichihara, Kiyoshi; Aslan, Diler; Aybek, Hulya; Ari, Zeki; Taneli, Fatma; Coker, Canan; Akan, Pinar; Sisman, Ali Riza; Bahceci, Onur; Sezgin, Nurzen; Demir, Meltem; Yucel, Gultekin; Akbas, Halide; Ozdem, Sebahat; Polat, Gurbuz; Erbagci, Ayse Binnur; Orkmez, Mustafa; Mete, Nuriye; Evliyaoglu, Osman; Kiyici, Aysel; Vatansev, Husamettin; Ozturk, Bahadir; Yucel, Dogan; Kayaalp, Damla; Dogan, Kubra; Pinar, Asli; Gurbilek, Mehmet; Cetinkaya, Cigdem Damla; Akin, Okhan; Serdar, Muhittin; Kurt, Ismail; Erdinc, Selda; Kadicesme, Ozgur; Ilhan, Necip; Atali, Dilek Sadak; Bakan, Ebubekir; Polat, Harun; Noyan, Tevfik; Can, Murat; Bedir, Abdulkerim; Okuyucu, Ali; Deger, Orhan; Agac, Suret; Ademoglu, Evin; Kaya, Ayşem; Nogay, Turkan; Eren, Nezaket; Dirican, Melahat; Tuncer, GulOzlem; Aykus, Mehmet; Gunes, Yeliz; Ozmen, Sevda Unalli; Kawano, Reo; Tezcan, Sehavet; Demirpence, Ozlem; Degirmen, Elif

    2014-12-01

    A nationwide multicenter study was organized to establish reference intervals (RIs) in the Turkish population for 25 commonly tested biochemical analytes and to explore sources of variation in reference values, including regionality. Blood samples were collected nationwide in 28 laboratories from the seven regions (≥400 samples/region, 3066 in all). The sera were collectively analyzed in Uludag University in Bursa using Abbott reagents and analyzer. Reference materials were used for standardization of test results. After secondary exclusion using the latent abnormal values exclusion method, RIs were derived by a parametric method employing the modified Box-Cox formula and compared with the RIs by the non-parametric method. Three-level nested ANOVA was used to evaluate variations among sexes, ages and regions. Associations between test results and age, body mass index (BMI) and region were determined by multiple regression analysis (MRA). By ANOVA, differences of reference values among seven regions were significant in none of the 25 analytes. Significant sex-related and age-related differences were observed for 10 and seven analytes, respectively. MRA revealed BMI-related changes in results for uric acid, glucose, triglycerides, high-density lipoprotein (HDL)-cholesterol, alanine aminotransferase, and γ-glutamyltransferase. Their RIs were thus derived by applying stricter criteria excluding individuals with BMI >28 kg/m2. Ranges of RIs by non-parametric method were wider than those by parametric method especially for those analytes affected by BMI. With the lack of regional differences and the well-standardized status of test results, the RIs derived from this nationwide study can be used for the entire Turkish population.

  9. Efficacy of Mesoglycan in Pain Control after Excisional Hemorrhoidectomy: A Pilot Comparative Prospective Multicenter Study

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    Gaetano Gallo

    2018-01-01

    Full Text Available Introduction. Various pain management strategies for patients undergoing open excisional hemorrhoidectomy have been proposed, yet postoperative pain remains a frequent complaint. Objective. To determine whether mesoglycan (30 mg two vials i.m. once/day for the first 5 days postoperative, followed by 50 mg 1 oral tablet twice/day for 30 days would reduce the edema of the mucocutaneous bridges and thus improve postoperative pain symptoms. Patients and Methods. For this prospective observational multicenter study, 101 patients undergoing excisional diathermy hemorrhoidectomy for III-IV degree hemorrhoidal disease were enrolled at 5 colorectal referral centers. Patients were assigned to receive either mesoglycan (study group SG or a recommended oral dose of ketorolac tromethamine of 10 mg every 4–6 hours, not exceeding 40 mg per day and not exceeding 5 postoperative days according to the indications for short-term management of moderate/severe acute postoperative pain, plus stool softeners (control group CG. Results. Postoperative thrombosis (SG 1/48 versus CG 5/45 (p<0.001 and pain after rectal examination (p<0.001 were significantly reduced at 7–10 days after surgery in the mesoglycan-treated group, permitting a faster return to work (p<0.001; however, in the same group, the incidence of postoperative bleeding, considered relevant when needing a readmission or an unexpected outpatient visit, was higher, possibly owing to the drug’s antithrombotic properties. Conclusions. The administration of mesoglycan after an open diathermy excisional hemorrhoidectomy can reduce postoperative thrombosis and pain at 7–10 days after surgery, permitting a faster return to normal activities.

  10. Multicenter prospective study of magnetic resonance imaging prior to breast-conserving surgery for breast cancer.

    Science.gov (United States)

    Liu, Qian; Liu, Yinhua; Xu, Ling; Duan, Xuening; Li, Ting; Qin, Naishan; Kang, Hua; Jiang, Hongchuan; Yang, Deqi; Qu, Xiang; Jiang, Zefei; Yu, Chengze

    2014-01-01

    This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer. The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012. The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group). Enhanced MRI was used to measure breast volume, longest diameter of tumor and tumor volume. The correlations between these measurements and those derived from histopathologic findings were assessed. The relationships between the success rate of breast-conserving surgery and MRI- and pathology-based measurement results were statistically analyzed in the breast-conserving group. The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group. Allocation to these groups was based on clinical indications and patient preferences. The cut-off for concurrence between MRI- and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm. In the total mastectomy group, the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%. Correlation coefficients for MRI and histopathology-based measurements of breast volume, tumor volume and tumor volume/breast volume ratio were r = 0.861, 0.569, and 0.600, respectively (all P surgery were 100% and 88.54%, respectively. There were significant correlations between dynamic enhanced MRI- and histopathology-based measurements of the longest diameter of breast lesions, breast and tumor volumes, and breast volume/tumor volume ratios. Preoperative MRI examination improves the success rate of breast-conserving surgery.

  11. Transverse tripolar spinal cord stimulation: results of an international multicenter study

    NARCIS (Netherlands)

    Oakley, John C.; Espinosa, Francisco; Burchiel, Kim; Bothe, Hans; McKean, John; Allen, Peter; Quarty, Gilbert; Spincemaille, Geert; Nuttin, Bart; Gielen, Frans; King, Gary; Holsheimer, J.

    Experienced neurosurgeons at eight spinal cord stimulation centers in the United States, Canada, and Europe participated in a study from 1997 to 2000 investigating the safety, performance, and efficacy of a Transverse Tripolar Stimulation (TTS) system invented at the University of Twente, The

  12. Clinical features of tic-related obsessive-compulsive disorder: results from a large multicenter study.

    Science.gov (United States)

    Gomes de Alvarenga, Pedro; de Mathis, Maria Alice; Dominguez Alves, Anna Claudia; do Rosário, Maria Conceição; Fossaluza, Victor; Hounie, Ana Gabriela; Miguel, Euripedes Constantino; Rodrigues Torres, Albina

    2012-06-01

    To evaluate the clinical features of obsessive-compulsive disorder (OCD) patients with comorbid tic disorders (TD) in a large, multicenter, clinical sample. A cross-sectional study was conducted that included 813 consecutive OCD outpatients from the Brazilian OCD Research Consortium and used several instruments of assessment, including the Yale-Brown Obsessive-Compulsive Scale, the Dimensional Yale-Brown Obsessive-Compulsive Scale, the Yale Global Tic Severity Scale (YGTSS), the USP Sensory Phenomena Scale, and the Structured Clinical Interview for DSM-IV Axis I Disorders. The sample mean current age was 34.9 years old (SE 0.54), and the mean age at obsessive-compulsive symptoms (OCS) onset was 12.8 years old (SE 0.27). Sensory phenomena were reported by 585 individuals (72% of the sample). The general lifetime prevalence of TD was 29.0% (n = 236), with 8.9% (n = 72) presenting Tourette syndrome, 17.3% (n = 141) chronic motor tic disorder, and 2.8% (n = 23) chronic vocal tic disorder. The mean tic severity score, according to the YGTSS, was 27.2 (SE 1.4) in the OCD + TD group. Compared to OCD patients without comorbid TD, those with TD (OCD + TD group, n = 236) were more likely to be males (49.2% vs. 38.5%, p disorders in general: separation anxiety disorder, social phobia, specific phobia, generalized anxiety disorder, post-traumatic stress disorder, attention-deficit hyperactivity disorder, impulse control disorders in general, and skin picking. Also, the "aggressive," "sexual/religious," and "hoarding" symptom dimensions were more severe in the OCD + TD group. Tic-related OCD may constitute a particular subgroup of the disorder with specific phenotypical characteristics, but its neurobiological underpinnings remain to be fully disentangled.

  13. Portuguese Version of the Pain Beliefs and Perceptions Inventory: A Multicenter Validation Study.

    Science.gov (United States)

    Azevedo, Luís Filipe; Sampaio, Rute; Camila Dias, Cláudia; Romão, José; Lemos, Laurinda; Agualusa, Luís; Vaz-Serra, Sílvia; Patto, Teresa; Costa-Pereira, Altamiro; Castro-Lopes, José Manuel

    2017-07-01

    We aimed to perform the translation, cultural adaptation, and validation of the Pain Beliefs and Perceptions Inventory (PBPI) for the European Portuguese language and chronic pain population. This is a longitudinal multicenter validation study. A Portuguese version of the PBPI (PBPI-P) was created through a process of translation, back translation, and expert panel evaluation. The PBPI-P was administered to a total of 122 patients from 13 chronic pain clinics in Portugal, at baseline and after 7 days. Internal consistency and test-retest reliability were assessed by Cronbach's alpha (α) and intraclass correlation coefficient (ICC). Construct (convergent and discriminant) validity was assessed based on a set of previously developed theoretical hypotheses about interrelations between the PBPI-P and other measures. Exploratory and confirmatory factor analyses were performed to test the theoretical structure of the PBPI-P. The internal consistency and test-retest reliability coefficients for each respective subscale were α = 0.620 and ICC = 0.801 for mystery; α = 0.744 and ICC = 0.841 for permanence; α = 0.778 and ICC = 0.791 for constancy; and α = 0.764 and ICC = 0.881 for self-blame. Exploratory and confirmatory factor analysis revealed a four-factor structure (performance, constancy, self-blame, and mystery) that explained 63% of the variance. The construct validity of the PBPI-P was shown to be adequate, with more than 90% of the previously defined hypotheses regarding interrelations with other measures confirmed. The PBPI-P has been shown to be adequate and to have excellent reliability, internal consistency, and validity. It may contribute to a better pain assessment and is suitable for research and clinical use. © 2016 World Institute of Pain.

  14. Factors influencing survival outcome for radiotherapy for biliary tract cancer: A multicenter retrospective study

    International Nuclear Information System (INIS)

    Yoshioka, Yasuo; Ogawa, Kazuhiko; Oikawa, Hirobumi; Onishi, Hiroshi; Uchida, Nobue; Maebayashi, Toshiya; Kanesaka, Naoto; Tamamoto, Tetsuro; Asakura, Hirofumi; Kosugi, Takashi; Hatano, Kazuo; Yoshimura, Michio; Yamada, Kazunari; Tokumaru, Sunao; Sekiguchi, Kenji; Kobayashi, Masao; Soejima, Toshinori; Isohashi, Fumiaki; Nemoto, Kenji; Nishimura, Yasumasa

    2014-01-01

    Purpose: To seek for the possible factors influencing overall survival (OS) with radiotherapy (RT) for biliary tract cancer. Materials and methods: Data were collected retrospectively from RT database of 31 institutions in Japan. All patients underwent at least external beam RT. The factors influencing OS were investigated. Results: Data of 498 patients were analyzed. Median OS of the 212 patients who underwent surgery was significantly better than that of the 286 patients without surgery (31 vs. 15 months, p < 0.001). The OS for the R0 or R1 resection group was significantly longer than that for the R2 or non-surgery group, as well as for n0 compared to n1 (all p < 0.001). Chemoradiotherapy (CRT), both sequential and concurrent, resulted in a better OS than RT alone for the n1 group (31 vs. 13 months, p < 0.001), and marginally better for the R0/R1 group (p = 0.065; p = 0.054 for concurrent CRT). However, no such benefit was observed for the R2/non-surgical patients. Multivariate analysis identified performance status, clinical stage, and surgery as significant factors. Conclusion: Surgery, especially R0/R1 resection, seemed as the gold standard for treatment of biliary tract cancer including RT, even in the highly heterogeneous population obtained from the multicenter retrospective study. The possibility was shown that CRT yielded better survival benefit especially for n1 patients. We recommend that future prospective trials include an arm of adjuvant CRT at least for n1 and possibly R0/R1 patients

  15. Disease-Specific Mortality of Differentiated Thyroid Cancer Patients in Korea: A Multicenter Cohort Study

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    Min Ji Jeon

    2017-11-01

    Full Text Available BackgroundLittle is known regarding disease-specific mortality of differentiated thyroid cancer (DTC patients and its risk factors in Korea.MethodsWe retrospectively reviewed a large multi-center cohort of thyroid cancer from six Korean hospitals and included 8,058 DTC patients who underwent initial surgery between 1996 and 2005.ResultsMean age of patients at diagnosis was 46.2±12.3 years; 87% were females. Most patients had papillary thyroid cancer (PTC; 97% and underwent total thyroidectomy (85%. Mean size of the primary tumor was 1.6±1.0 cm. Approximately 40% of patients had cervical lymph node (LN metastases and 1.3% had synchronous distant metastases. During 11.3 years of follow-up, 150 disease-specific mortalities (1.9% occurred; the 10-year disease-specific survival (DSS rate was 98%. According to the year of diagnosis, the number of disease-specific mortality was not different. However, the rate of disease-specific mortality decreased during the study period (from 7.7% to 0.7%. Older age (≥45 years at diagnosis, male, follicular thyroid cancer (FTC versus PTC, larger tumor size (>2 cm, presence of extrathyroidal extension (ETE, lateral cervical LN metastasis, distant metastasis and tumor node metastasis (TNM stage were independent risk factors of disease-specific mortality of DTC patients.ConclusionThe rate of disease-specific mortality of Korean DTC patients was 1.9%; the 10-year DSS rate was 98% during 1996 to 2005. Older age at diagnosis, male, FTC, larger tumor size, presence of ETE, lateral cervical LN metastasis, distant metastasis, and TNM stages were significant risk factors of disease-specific mortality of Korean DTC patients.

  16. Estimating cardiovascular risk in patients with type 2 diabetes: a national multicenter study in Brazil

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    Gomes Marilia B

    2009-10-01

    Full Text Available Abstract According to Brazilian National Data Survey diabetes is the fifth cause for hospitalization and is one of the ten major causes of mortality in this country. Aims to stratify the estimated cardiovascular risk (eCVR in a population of type 2 diabetics (T2DM according to the Framingham prediction equations as well as to determine the association between eCVR with metabolic and clinical control of the disease. Methods From 2000 to 2001 a cross-sectional multicenter study was conducted in 13 public out-patients diabetes/endocrinology clinics from 8 Brazilian cities. The 10-year risk of developing coronary heart disease (CHD was estimated by the prediction equations described by Wilson et al (Circulation 1998. LDL equations were preferably used; when patients missed LDL data we used total cholesterol equations instead. Results Data from 1382 patients (59.0% female were analyzed. Median and inter-quartile range (IQ of age and duration of diabetes were 57.4 (51-65 and 8.8 (3-13 years, respectively without differences according to the gender. Forty-two percent of these patients were overweight and 35.4% were obese (the prevalence of higher BMI and obesity in this T2DM group was significantly higher in women than in men; p 20% in 738 (53.4%, intermediate in 202 (14.6% and low in 442 (32% patients. Men [25.1(15.4-37.3] showed a higher eCVR than women [18.8 (12.4-27.9 p

  17. Acute renal failure according to the RIFLE and AKIN criteria: a multicenter study.

    Science.gov (United States)

    Salgado, G; Landa, M; Masevicius, D; Gianassi, S; San-Román, J E; Silva, L; Gimenez, M; Tejerina, O; Díaz-Cisneros, P; Ciccioli, F; do Pico, J L

    2014-01-01

    To determine the incidence of acute renal failure (ARF) in critically ill patients using the RIFLE and AKIN criteria. A prospective, multicenter observational study with a duration of one year from February 2010 was carried out. RIFLE and AKIN were employed using the urinary (UC) and creatinine criteria (CC) jointly and separately. Nine polyvalent Critical Care Units (CCUs) in Argentina. A total of 627 critical patients over 18 years of age were admitted to the CCU for more than 48h. inability to quantify diuresis, surgical instrumentation of the urinary tract, and need for renal support therapy (RST). Calculated hourly diuresis (CHD) was used to apply the UC. The incidence of ARF was 69.4% and 51.8% according to RIFLE and AKIN, respectively. UC detected ARF in 59.5% of cases, while CC identified ARF in 34.7% (RIFLE) and 25.3% (AKIN). The mortality rate was 40.9% and 44.6% according to RIFLE and AKIN respectively, was significantly higher than in patients without ARF, and increased with disease severity (Data processing: Excel, SQL and SPSS. Levene test, comparison of means with Student t and chi-squared, with 95% confidence interval). RIFLE identified more cases of ARF. UC proved more effective than CC. The presence of ARF and severity levels were correlated to mortality but not to days of stay in the CCU. Implementation of the unified CHD was useful for implementing UC and achieving comparable results. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

  18. Statistical considerations for harmonization of the global multicenter study on reference values.

    Science.gov (United States)

    Ichihara, Kiyoshi

    2014-05-15

    The global multicenter study on reference values coordinated by the Committee on Reference Intervals and Decision Limits (C-RIDL) of the IFCC was launched in December 2011, targeting 45 commonly tested analytes with the following objectives: 1) to derive reference intervals (RIs) country by country using a common protocol, and 2) to explore regionality/ethnicity of reference values by aligning test results among the countries. To achieve these objectives, it is crucial to harmonize 1) the protocol for recruitment and sampling, 2) statistical procedures for deriving the RI, and 3) test results through measurement of a panel of sera in common. For harmonized recruitment, very lenient inclusion/exclusion criteria were adopted in view of differences in interpretation of what constitutes healthiness by different cultures and investigators. This policy may require secondary exclusion of individuals according to the standard of each country at the time of deriving RIs. An iterative optimization procedure, called the latent abnormal values exclusion (LAVE) method, can be applied to automate the process of refining the choice of reference individuals. For global comparison of reference values, test results must be harmonized, based on the among-country, pair-wise linear relationships of test values for the panel. Traceability of reference values can be ensured based on values assigned indirectly to the panel through collaborative measurement of certified reference materials. The validity of the adopted strategies is discussed in this article, based on interim results obtained to date from five countries. Special considerations are made for dissociation of RIs by parametric and nonparametric methods and between-country difference in the effect of body mass index on reference values. Copyright © 2014 Elsevier B.V. All rights reserved.

  19. Multicenter study evaluating the Vitek MS system for identification of medically important yeasts.

    Science.gov (United States)

    Westblade, Lars F; Jennemann, Rebecca; Branda, John A; Bythrow, Maureen; Ferraro, Mary Jane; Garner, Omai B; Ginocchio, Christine C; Lewinski, Michael A; Manji, Ryhana; Mochon, A Brian; Procop, Gary W; Richter, Sandra S; Rychert, Jenna A; Sercia, Linda; Burnham, Carey-Ann D

    2013-07-01

    The optimal management of fungal infections is correlated with timely organism identification. Matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry (MS) is revolutionizing the identification of yeasts isolated from clinical specimens. We present a multicenter study assessing the performance of the Vitek MS system (bioMérieux) in identifying medically important yeasts. A collection of 852 isolates was tested, including 20 Candida species (626 isolates, including 58 C. albicans, 62 C. glabrata, and 53 C. krusei isolates), 35 Cryptococcus neoformans isolates, and 191 other clinically relevant yeast isolates; in total, 31 different species were evaluated. Isolates were directly applied to a target plate, followed by a formic acid overlay. Mass spectra were acquired using the Vitek MS system and were analyzed using the Vitek MS v2.0 database. The gold standard for identification was sequence analysis of the D2 region of the 26S rRNA gene. In total, 823 isolates (96.6%) were identified to the genus level and 819 isolates (96.1%) were identified to the species level. Twenty-four isolates (2.8%) were not identified, and five isolates (0.6%) were misidentified. Misidentified isolates included one isolate of C. albicans (n = 58) identified as Candida dubliniensis, one isolate of Candida parapsilosis (n = 73) identified as Candida pelliculosa, and three isolates of Geotrichum klebahnii (n = 6) identified as Geotrichum candidum. The identification of clinically relevant yeasts using MS is superior to the phenotypic identification systems currently employed in clinical microbiology laboratories.

  20. The Effectiveness and Efficiency of Inpatient Rehabilitation Services in Thailand: A Prospective Multicenter Study

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    Vilai Kuptniratsaikul

    2016-01-01

    Full Text Available Objective To investigate the effectiveness and efficiency of inpatient rehabilitation. Methods A total of 2,081 patients across 14 hospitals were recruited in this prospective, multicenter cohort study. Data on the diagnoses, types of admission, length of stay (LOS, and functional ability score based on a modified Barthel index (BI at admission (BIa and at discharge (BId were collected. Effectiveness was defined as the difference of BI (ΔBI and efficiency as ΔBI divided by LOS. Results The majority of patients were diagnosed with spinal cord injury and stroke (41.8% and 37.5%, respectively. The mean age was 52.4 ± 18.6 years with a mean LOS of 23.9 ± 19.9 days, BIa of 9.4 ± 6.1, and BId of 12.3 ± 5.7. The overall effectiveness and efficiency were 2.9 ± 3.4 and 0.16 ± 0.30 scores/day, respectively; stroke rehabilitation provided the most effective and efficient BI improvement compared with rehabilitation for other diseases. Most patients (54.5% received intensive functional rehabilitation, which was the most effective and efficient program (4.4 ± 3.6 and 0.23 ± 0.32 scores/day, respectively; the efficiency of the intensive program was not different among various diseases (P = 0.726. Conclusion Stroke rehabilitation had the highest efficiency compared with rehabilitation for other neurological diseases. The most efficient type of admission was intensive rehabilitation, regardless of the disease being treated.

  1. Shigella isolates from the global enteric multicenter study inform vaccine development.

    Science.gov (United States)

    Livio, Sofie; Strockbine, Nancy A; Panchalingam, Sandra; Tennant, Sharon M; Barry, Eileen M; Marohn, Mark E; Antonio, Martin; Hossain, Anowar; Mandomando, Inacio; Ochieng, John B; Oundo, Joseph O; Qureshi, Shahida; Ramamurthy, Thandavarayan; Tamboura, Boubou; Adegbola, Richard A; Hossain, Mohammed Jahangir; Saha, Debasish; Sen, Sunil; Faruque, Abu Syed Golam; Alonso, Pedro L; Breiman, Robert F; Zaidi, Anita K M; Sur, Dipika; Sow, Samba O; Berkeley, Lynette Y; O'Reilly, Ciara E; Mintz, Eric D; Biswas, Kousick; Cohen, Dani; Farag, Tamer H; Nasrin, Dilruba; Wu, Yukun; Blackwelder, William C; Kotloff, Karen L; Nataro, James P; Levine, Myron M

    2014-10-01

    Shigella, a major diarrheal disease pathogen worldwide, is the target of vaccine development. The Global Enteric Multicenter Study (GEMS) investigated burden and etiology of moderate-to-severe diarrheal disease in children aged Shigella was 1 of the 4 most common pathogens across sites and age strata. GEMS Shigella serotypes are reviewed to guide vaccine development. Subjects' stool specimens/rectal swabs were transported to site laboratories in transport media and plated onto xylose lysine desoxycholate and MacConkey agar. Suspect Shigella colonies were identified by biochemical tests and agglutination with antisera. Shigella isolates were shipped to the GEMS Reference Laboratory (Baltimore, MD) for confirmation and serotyping of S. flexneri; one-third of isolates were sent to the Centers for Disease Control and Prevention for quality control. Shigella dysenteriae and S. boydii accounted for 5.0% and 5.4%, respectively, of 1130 Shigella case isolates; S. flexneri comprised 65.9% and S. sonnei 23.7%. Five serotypes/subserotypes comprised 89.4% of S. flexneri, including S. flexneri 2a, S. flexneri 6, S. flexneri 3a, S. flexneri 2b, and S. flexneri 1b. A broad-spectrum Shigella vaccine must protect against S. sonnei and 15 S. flexneri serotypes/subserotypes. A quadrivalent vaccine with O antigens from S. sonnei, S. flexneri 2a, S. flexneri 3a, and S. flexneri 6 can provide broad direct coverage against these most common serotypes and indirect coverage against all but 1 (rare) remaining subserotype through shared S. flexneri group antigens. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America.

  2. Office gel sonovaginography for the prediction of posterior deep infiltrating endometriosis: a multicenter prospective observational study.

    Science.gov (United States)

    Reid, S; Lu, C; Hardy, N; Casikar, I; Reid, G; Cario, G; Chou, D; Almashat, D; Condous, G

    2014-12-01

    To use office gel sonovaginography (SVG) to predict posterior deep infiltrating endometriosis (DIE) in women undergoing laparoscopy. This was a multicenter prospective observational study carried out between January 2009 and February 2013. All women were of reproductive age, had a history of chronic pelvic pain and underwent office gel SVG assessment for the prediction of posterior compartment DIE prior to laparoscopic endometriosis surgery. Gel SVG findings were compared with laparoscopic findings to determine the diagnostic accuracy of office gel SVG for the prediction of posterior compartment DIE. In total, 189 women underwent preoperative gel SVG and laparoscopy for endometriosis. At laparoscopy, 57 (30%) women had posterior DIE and 43 (23%) had rectosigmoid/anterior rectal DIE. For the prediction of rectosigmoid/anterior rectal (i.e. bowel) DIE, gel SVG had an accuracy of 92%, sensitivity of 88%, specificity of 93%, positive predictive value (PPV) of 79%, negative predictive value (NPV) of 97%, positive likelihood ratio (LR+) of 12.9 and negative likelihood ratio (LR-) of 0.12 (P = 3.98E-25); for posterior vaginal wall and rectovaginal septum (RVS) DIE, respectively, the accuracy was 95% and 95%, sensitivity was 18% and 18%, specificity was 99% and 100%, PPV was 67% and 100%, NPV was 95% and 95%, LR+ was 32.4 and infinity and LR- was 0.82 and 0.82 (P = 0.009 and P = 0.003). Office gel SVG appears to be an effective outpatient imaging technique for the prediction of bowel DIE, with a higher accuracy for the prediction of rectosigmoid compared with anterior rectal DIE. Although the sensitivity for vaginal and RVS DIE was limited, gel SVG had a high specificity and NPV for all forms of posterior DIE, indicating that a negative gel SVG examination is highly suggestive of the absence of DIE at laparoscopy. Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd.

  3. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries.

    Science.gov (United States)

    Nnoaham, Kelechi E; Hummelshoj, Lone; Webster, Premila; d'Hooghe, Thomas; de Cicco Nardone, Fiorenzo; de Cicco Nardone, Carlo; Jenkinson, Crispin; Kennedy, Stephen H; Zondervan, Krina T

    2011-08-01

    To assess the impact of endometriosis on health-related quality of life (HRQoL) and work productivity. Multicenter cross-sectional study with prospective recruitment. Sixteen clinical centers in ten countries. A total of 1,418 premenopausal women, aged 18-45 years, without a previous surgical diagnosis of endometriosis, having laparoscopy to investigate symptoms or to be sterilized. None. Diagnostic delay, HRQoL, and work productivity. There was a delay of 6.7 years, principally in primary care, between onset of symptoms and a surgical diagnosis of endometriosis, which was longer in centers where women received predominantly state-funded health care (8.3 vs. 5.5 years). Delay was positively associated with the number of pelvic symptoms (chronic pelvic pain, dysmenorrhoea, dyspareunia, and heavy periods) and a higher body mass index. Physical HRQoL was significantly reduced in affected women compared with those with similar symptoms and no endometriosis. Each affected woman lost on average 10.8 hours (SD 12.2) of work weekly, mainly owing to reduced effectiveness while working. Loss of work productivity translated into significant costs per woman/week, from US$4 in Nigeria to US$456 in Italy. Endometriosis impairs HRQoL and work productivity across countries and ethnicities, yet women continue to experience diagnostic delays in primary care. A higher index of suspicion is needed to expedite specialist assessment of symptomatic women. Future research should seek to clarify pain mechanisms in relation to endometriosis severity. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  4. Software-based evaluation of toric IOL orientation in a multicenter clinical study.

    Science.gov (United States)

    Kasthurirangan, Sanjeev; Feuchter, Lucas; Smith, Pamela; Nixon, Donald

    2014-12-01

    To evaluate the rotational stability of a new one-piece hydrophobic acrylic toric intraocular lens (IOL) using a custom-developed software for analysis of slit-lamp photographs. In a prospective, multicenter study, 174 eyes were implanted with the TECNIS Toric IOL (Abbott Medical Optics, Inc., Santa Ana, CA). A custom-developed software was used to analyze high-resolution slit-lamp photographs of 156 eyes taken at day 1 (baseline) and 1, 3, and 6 months postoperatively. The software uses iris and sclera landmarks to align the baseline image and later images for comparison. Validation of software was performed through repeated analyses of protractor images rotated from 0.1° to 10.0° and randomly selected photographs of 20 eyes. Software validation showed precision (repeatability plus reproducibility variation) of 0.02° using protractor images and 2.22° using slit-lamp photographs. Good quality slit-lamp images and clear landmarks were necessary for precise measurements. At 6 months, 94.2% of eyes had 5° or less change in IOL orientation versus baseline; only 2 eyes (1.4%) had axis shift greater than 30°. Most eyes were within 5° or less of rotation between 1 and 3 months (92.9%) and 3 and 6 months (94.1%). Mean absolute axis change (± standard deviation) from 1 day to 6 months was 2.70° ± 5.51°. The new custom software was precise and quick in analyzing slit-lamp photographs to determine postoperative toric IOL rotation. Copyright 2014, SLACK Incorporated.

  5. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries

    Science.gov (United States)

    Nnoaham, Kelechi E.; Hummelshoj, Lone; Webster, Premila; d’Hooghe, Thomas; Nardone, Fiorenzo de Cicco; Nardone, Carlo de Cicco; Jenkinson, Crispin; Kennedy, Stephen H.; Zondervan, Krina T.

    2013-01-01

    Objective To assess the impact of endometriosis on health-related quality of life (HRQoL) and work productivity. Design Multicenter cross-sectional study with prospective recruitment. Setting Sixteen clinical centers in ten countries. Patient(s) A total of 1,418 premenopausal women, aged 18–45 years, without a previous surgical diagnosis of endometriosis, having laparoscopy to investigate symptoms or to be sterilized. Intervention(s) None. Main Outcome Measure(s) Diagnostic delay, HRQoL, and work productivity. Result(s) There was a delay of 6.7 years, principally in primary care, between onset of symptoms and a surgical diagnosis of endometriosis, which was longer in centers where women received predominantly state-funded health care (8.3 vs. 5.5 years). Delay was positively associated with the number of pelvic symptoms (chronic pelvic pain, dysmenorrhoea, dyspareunia, and heavy periods) and a higher body mass index. Physical HRQoL was significantly reduced in affected women compared with those with similar symptoms and no endometriosis. Each affected woman lost on average 10.8 hours (SD 12.2) of work weekly, mainly owing to reduced effectiveness while working. Loss of work productivity translated into significant costs per woman/week, from US$4 in Nigeria to US$456 in Italy. Conclusion(s) Endometriosis impairs HRQoL and work productivity across countries and ethnicities, yet women continue to experience diagnostic delays in primary care. A higher index of suspicion is needed to expedite specialist assessment of symptomatic women. Future research should seek to clarify pain mechanisms in relation to endometriosis severity. PMID:21718982

  6. Gemcitabine-Based Chemotherapy in Adrenocortical Carcinoma: A Multicenter Study of Efficacy and Predictive Factors.

    Science.gov (United States)

    Henning, Judith E K; Deutschbein, Timo; Altieri, Barbara; Steinhauer, Sonja; Kircher, Stefan; Sbiera, Silviu; Wild, Vanessa; Schlötelburg, Wiebke; Kroiss, Matthias; Perotti, Paola; Rosenwald, Andreas; Berruti, Alfredo; Fassnacht, Martin; Ronchi, Cristina L

    2017-11-01

    Adrenocortical carcinoma (ACC) is rare and confers an unfavorable prognosis in advanced stages. Other than combination chemotherapy with cisplatin, etoposide, doxorubicin, and mitotane, the second- and third-line regimens are not well-established. Gemcitabine (GEM)-based chemotherapy was suggested in a phase 2 clinical trial with 28 patients. In other solid tumors, human equilibrative nucleoside transporter type 1 (hENT1) and/or ribonucleotide reductase catalytic subunit M1 (RRM1) expression have been associated with resistance to GEM. To assess the efficacy of GEM-based chemotherapy in ACC in a real-world setting and the predictive role of molecular parameters. Retrospective multicenter study. Referral centers of university hospitals. A total of 145 patients with advanced ACC were treated with GEM-based chemotherapy (132 with concomitant capecitabine). Formalin-fixed paraffin-embedded tumor material was available for 70 patients for immunohistochemistry. The main outcome measures were progression-free survival (PFS) and an objective response to GEM-based chemotherapy. The secondary objective was the predictive role of hENT1 and RRM1. The median PFS for the patient population was 12 weeks (range, 1 to 94). A partial response or stable disease was achieved in 4.9% and 25.0% of cases, with a median duration of 26.8 weeks. Treatment was generally well tolerated, with adverse events of grade 3 or 4 occurring in 11.0% of cases. No substantial effect of hENT1 and/or RRM1 expression was observed in response to GEM-based chemotherapy. GEM-based chemotherapy is a well-tolerated, but modestly active, regimen against advanced ACC. No reliable molecular predictive factors could be identified. Owing to the scarce alternative therapeutic options, GEM-based chemotherapy remains an important option for salvage treatment for advanced ACC. Copyright © 2017 Endocrine Society

  7. Initiation of nutritional support is delayed in critically ill obese patients: a multicenter cohort study.

    Science.gov (United States)

    Borel, Anne-Laure; Schwebel, Carole; Planquette, Benjamin; Vésin, Aurélien; Garrouste-Orgeas, Maité; Adrie, Christophe; Clec'h, Christophe; Azoulay, Elie; Souweine, Bertrand; Allaouchiche, Bernard; Goldgran-Toledano, Dany; Jamali, Samir; Darmon, Michael; Timsit, Jean-François

    2014-09-01

    A high catabolic rate characterizes the acute phase of critical illness. Guidelines recommend an early nutritional support, regardless of the previous nutritional status. We aimed to assess whether the nutritional status of patients, which was defined by the body mass index (BMI) at admission in an intensive care unit (ICU), affected the time of nutritional support initiation. We conducted a cohort study that reported a retrospective analysis of a multicenter ICU database (OUTCOMEREA) by using data prospectively entered from January 1997 to October 2012. Patients who needed orotracheal intubation within the first 72 h and >3 d were included. Data from 3257 ICU stays were analyzed. The delay before feeding was different according to BMI groups (P = 0.035). The delay was longer in obese patients [BMI (in kg/m²) ≥30; n = 663] than in other patients with either low weight (BMI nutritional status and a delay in nutrition initiation was independent of potential confounding factors such as age, sex, and diabetes or other chronic diseases. In comparison with normal weight, the adjusted RR (95% CI) associated with a delayed nutrition initiation was 0.92 (0.86, 0.98) for patients with low weight, 1.00 (0.94, 1.05) for overweight patients, and 1.06 (1.00, 1.12) for obese patients (P = 0.004). The initiation of nutritional support was delayed in obese ICU patients. Randomized controlled trials that address consequences of early compared with delayed beginnings of nutritional support in critically ill obese patients are needed. © 2014 American Society for Nutrition.

  8. [Critical reading of reports of educational research in teachers of IMSS. Multicenter study].

    Science.gov (United States)

    Leyva-González, Félix Arturo; Cacho-Salazar, Julio M; Degollado-Bardales, Lilia; Zavala-Arenas, Jesús Arturo; Angulo-Bernal, Sonia Elizabeth; Leyva-Salas, César Arturo; Orozco-Bisson, Gisele Victorine

    2011-01-01

    To determine the effect of an educational strategy promoting participation in the development of critical reading of educational research reports on professors of Educational Research and Teacher Education (CIEFD's). We performed an intervention study, multicenter professors (medical specialists) who enrolled in the courses: Diploma in teaching methodological level 1 and 2 (n = 46, n = 29, respectively) in the six CIEFD's (D.F. Siglo XXI, DF. La Raza, Nuevo León, Sonora, Puebla and Jalisco), in the period March to August 2007. A tool was built that assessed the variables critical appraisal of educational research reports, the construct validity, content and reliability was assessed by experts in education research. The educational strategy developed in the form of seminars, which were held three times a week in the Certification in teaching methodological level 1 and twice per week in the Certification Level 2 in teaching methodology duration per session: 6 h. The instrument was applied at the beginning and end of the course. In the two Graduates it was observed in the total group, an advance in the three indicators of critical reading, which was expressed with statistically significant differences; in the global score of the Diploma level 1 (final vs. initial measurement) the following mediums were observed: 36-67 (p = 0.0001); in the Diploma level 2, it was observed in its overall rating: 42-78 (p = 0.0001). This inquiry from the results observed some of theoretical approaches to mainstreaming participatory. An educational strategy promoting participation produced a breakthrough in the three indicators (to interpret, to judge and to formulate proposals) for critical reading of educational research reports.

  9. Aggressive Surgical Management of Congenital Diaphragmatic Hernia: Worth the Effort?: A Multicenter, Prospective, Cohort Study.

    Science.gov (United States)

    Harting, Matthew T; Hollinger, Laura; Tsao, Kuojen; Putnam, Luke R; Wilson, Jay M; Hirschl, Ronald B; Skarsgard, Erik D; Tibboel, Dick; Brindle, Mary E; Lally, Pamela A; Miller, Charles C; Lally, Kevin P

    2018-05-01

    The objectives of this study were (i) to evaluate infants with congenital diaphragmatic hernia (CDH) that do not undergo repair, (ii) to identify nonrepair rate by institution, and (iii) to compare institutional outcomes based on nonrepair rate. Approximately 20% of infants with CDH go unrepaired and the threshold to offer surgical repair is variable. Data were abstracted from a multicenter, prospectively collected database. Standard clinical variables, including repair (or nonrepair), and outcome were analyzed. Institutions were grouped based on volume and rate of nonrepair. Preoperative mortality predictors were identified using logistic regression, expected mortality for each center was calculated, and observed /expected (O/E) ratios were computed for center groups and compared by Kruskal-Wallis ANOVA. A total of 3965 infants with CDH were identified and 691 infants (17.5%) were not repaired. Nonrepaired patients had lower Apgar scores (P HiLo = 5.1-16.7% and HiHi = 17.6-38.5%), leaving 3 groups: HiLo, HiHi, and Lo. Predictors of mortality were lower birth weight, lower Apgar scores, prenatal diagnosis, and presence of congenital anomalies. O/E ratios for mortality in the HiLo, HiHi, and Lo groups were 0.81, 0.94, and 1.21, respectively (P HiLo centers have 2.73 (2.4-3.1, 95% confidence interval) survivors beyond expectation. There are significant differences between repaired and nonrepaired CDH infants and significant center variation in rate of nonrepair exists. Aggressive surgical management, leading to a low rate of nonrepair, is associated with improved risk-adjusted mortality.

  10. Results of a multicenter study of the retrievable Tulip vena cava filter: Early clinical experience

    International Nuclear Information System (INIS)

    Neuerburg, Joerg M.; Guenther, Rolf W.; Vorwerk, Dierk; Dondelinger, Robert F.; Jaeger, Horst; Lackner, Klaus J.; Schild, Hans H.; Plant, Graham R.; Joffre, Francis G.; Schneider, Pierre A.; Janssen, Johan H. A.

    1997-01-01

    Purpose. To evaluate clinically a new, retrievable vena caval filter in a multicenter study. Methods. The Tulip filter is a stainless steel half-basket that is suitable for antegrade or retrograde insertion via an 8.5 Fr introducer sheath. The filter can be retrieved via the jugular approach using an 11 Fr coaxial retrieval system. Forty-eight filters were implanted via the femoral approach and 38 via the jugular approach in 83 patients. Follow-up examinations (plain films, colorcoded duplex sonography) were performed up to 3 years after filter insertion (mean 136 days) in 75 patients. Twenty-seven patients were screened by colorcoded duplex sonography for insertion site thrombosis. Results. An appropriate filter position was achieved in all cases. Insertion problems occurred in 3 cases; these were not due to the filter design but to an imperfect prototype insertion mechanism that has now been modified (n=2) or a manipulation error (n=1). In 2 of these cases the filters were replaced percutaneously; 1 patient required venotomy for filter removal. No further complications due to filter insertion occurred. Two filters were used as temporary devices and were successfully removed after 6 and 11 days, respectively. There was 1 fatal recurrent pulmonary embolism (PE) and 2 non-fatal PE, 5 complete and 3 partial caval occlusions, and 3 caudal migrations of the filter. Insertion site venous thrombosis was not seen in the 27 patients monitored for this complication. Conclusion. Precise placement of the Tulip filter is feasible by either access route and the device appears mechanically stable. Further observations are needed to confirm that safe filter removal is practical up to 10 days after its insertion

  11. Role of Experience, Leadership and Individual Protection in the Cath Lab--A Multicenter Questionnaire and Workshop on Radiation Safety.

    Science.gov (United States)

    Kuon, E; Weitmann, K; Hoffmann, W; Dörr, M; Hummel, A; Busch, M C; Felix, S B; Empen, K

    2015-10-01

    Radiation exposure in invasive cardiology remains considerable. We evaluated the acceptance of radiation protective devices and the role of operator experience, team leadership, and technical equipment in radiation safety efforts in the clinical routine. Cardiologists (115 from 27 centers) answered a questionnaire and documented radiation parameters for 10 coronary angiographies (CA), before and 3.1 months after a 90-min. mini-course in radiation-reducing techniques. Mini-course participants achieved significant median decreases in patient dose area products (DAP: from 26.6 to 13.0 Gy × cm(2)), number of radiographic frames (-29%) and runs (-8%), radiographic DAP/frame (-2%), fluoroscopic DAP/s (-39%), and fluoroscopy time (-16%). Multilevel analysis revealed lower DAPs with decreasing body mass index (-1.4 Gy × cm(2) per kg/m(2)), age (-1.2 Gy × cm(2)/decade), female sex (-5.9 Gy × cm(2)), participation of the team leader (-9.4 Gy × cm(2)), the mini-course itself (-16.1 Gy × cm(2)), experience (-0.7 Gy × cm(2)/1000 CAs throughout the interventionalist's professional life), and use of older catheterization systems (-6.6 Gy × cm(2)). Lead protection included apron (100%), glass sheet (95%), lengthwise (94%) and crosswise (69%) undercouch sheet, collar (89%), glasses (28%), cover around the patients' thighs (19%), foot switch shield (7%), gloves (3%), and cap (1%). Radiation-protection devices are employed less than optimally in the clinical routine. Cardiologists with a great variety of interventional experience profited from our radiation safety workshop - to an even greater extent if the interventional team leader also participated. Radiation protection devices are employed less than optimally in invasive cardiology. The presented radiation-safety mini-course was highly efficient. Cardiologists at all levels of experience profited from the mini-course - considerably more so if the team leader also took part. Interventional experience was less relevant for

  12. Clinical manifestations of colorectal cancer patients from a large multicenter study in Colombia.

    Science.gov (United States)

    Bohorquez, Mabel; Sahasrabudhe, Ruta; Criollo, Angel; Sanabria-Salas, María Carolina; Vélez, Alejandro; Castro, Jorge Mario; Marquez, Juan Ricardo; Mateus, Gilbert; Bolaños, Fernando; Panqueva, Cesar; Restrepo, Jose Ignacio; Puerta, Juan Dario; Murillo, Raul; Bravo, María Mercedes; Hernández, Gustavo; Rios, Angela; Prieto, Rodrigo; Tomlinson, Ian; Echeverry, Magdalena; Carvajal-Carmona, Luis G

    2016-10-01

    Colorectal cancer (CRC) is a major public health problem, and its incidence is rising in developing countries. However, studies characterizing CRC clinicopathological features in cases from developing countries are still lacking. The goal of this study was to evaluate clinicopathological and demographic features in one of the largest CRC studies in Latin America.The study involved over 1525 CRC cases recruited in a multicenter study in Colombia between 2005 and 2014 as part of ongoing genetic and epidemiological studies. We gathered clinicopathological data such as age at diagnosis, sex, body mass index, tobacco and alcohol consumption, family history of cancer, and tumor features including location, histological type, and stage. Statistical analyses were performed to test the association between age of onset, sex, and clinical manifestations.The average age at CRC diagnosis was 57.4 years, with 26.5% of cases having early-onset CRC (diagnosed by age 50 years). Most cases were women (53.2%; P = 0.009), 49.2% were overweight or obese, 49.1% were regular alcohol drinkers, 52% were smokers/former smokers, and 12.2% reported relatives with cancer. Most tumors in the study were located in the rectum (42.7%), were adenocarcinomas (91.5%), and had advanced stage (T3-T4, 79.8%). Comparisons by sex found that male cases were more likely to be obese (36.5% vs 31.1%; P = 0.001), less likely to have a family history of cancer (9.7% vs 15.3%; P = 0.016), and more likely to have advanced-stage tumors (83.9% vs 76.1%; P = 0.036). Comparisons by age of onset found that early-onset cases were more likely to be women (59.3% vs 51.0%; P = 0.005) and report a family history of cancer (17.4% vs 10.2%; P = 0.001).To our knowledge, our study is the largest report of clinicopathological characterization of Hispanic CRC cases, and we suggest that further studies are needed to understand CRC etiology in diverse Hispanic populations.

  13. Socio-demographic and clinical profiles of paranoid and nonparanoid schizophrenia: a prospective, multicenter study in China.

    Science.gov (United States)

    Xiang, Yu-Tao; Wang, Chuan-Yue; Chiu, Helen F K; Weng, Yong-Zhen; Bo, Qi-Jing; Chan, Sandra S M; Lee, Edwin H M; Ungvari, Gabor S

    2011-07-01

    This study aimed to explore the socio-demographic and clinical characteristics of paranoid and nonparanoid subtypes of schizophrenia. In a multicenter, randomized, controlled, longitudinal study, 374 clinically stable schizophrenia patients were interviewed at entry with standardized assessment instruments and followed for 12-26 months. In the multivariate analysis, male sex, married marital status, urban abode, and more frequent relapse over the study period were independently associated with paranoid schizophrenia. The socio-demographic and clinical characteristics of Chinese patients with the paranoid subtype of schizophrenia are different from those of their Caucasian counterparts who are more likely to be women and have a better outcome. © 2010 Wiley Periodicals, Inc.

  14. The oncologic outcome and immediate surgical complications of lipofilling in breast cancer patients: a multicenter study--Milan-Paris-Lyon experience of 646 lipofilling procedures.

    Science.gov (United States)

    Petit, Jean Yves; Lohsiriwat, Visnu; Clough, Krishna B; Sarfati, Isabelle; Ihrai, Tarik; Rietjens, Mario; Veronesi, Paolo; Rossetto, Fabio; Scevola, Anna; Delay, Emmanuel

    2011-08-01

    Lipofilling is now performed to improve the breast contour, after both breast-conserving surgery and breast reconstruction. However, injection of fat into a previous tumor site may create a new environment for cancer and adjacent cells. There is also no international agreement regarding lipofilling after breast cancer treatment. The authors included three institutions specializing in both breast cancer treatment and breast reconstruction (European Institute of Oncology, Milan, Italy; Paris Breast Center, Paris, France; and Leon Berard Centre, Lyon, France) for a multicenter study. A collective chart review of all lipofilling procedures after breast cancer treatment was performed. From 2000 to 2010, the authors reviewed 646 lipofilling procedures from 513 patients. There were 370 mastectomy patients and 143 breast-conserving surgery patients. There were 405 patients (78.9 percent) with invasive carcinoma and 108 (21.1 percent) with carcinoma in situ. The average interval between oncologic surgical interventions and lipofilling was 39.7 months. Average follow-up after lipofilling was 19.2 months. The authors observed a complication rate of 2.8 percent (liponecrosis, 2.0 percent). Twelve radiologic images appeared after lipofilling in 119 breast-conserving surgery cases (10.1 percent). The overall oncologic event rate was 5.6 percent (3.6 percent per year). The locoregional event rate was 2.4 percent (1.5 percent per year). Lipofilling after breast cancer treatment leads to a low complication rate and does not affect radiologic follow-up after breast-conserving surgery. A prospective clinical registry including high-volume multicenter data with a long follow-up is warranted to demonstrate the oncologic safety. Until then, lipofilling should be performed in experienced hands, and a cautious oncologic follow-up protocol is advised. Therapeutic, IV [corrected].

  15. Accuracy of cotinine serum test to detect the smoking habit and its association with periodontal disease in a multicenter study.

    Science.gov (United States)

    Duque, A; Martínez, P-J; Giraldo, A; Gualtero, D-F; Ardila, C-M; Contreras, A; Duarte, S; Lafaurie, G-I

    2017-07-01

    The validity of the surveys on self-reported smoking status is often questioned because smokers underestimate cigarette use and deny the habit. It has been suggested that self-report should be accompanied by cotinine test. This report evaluates the usefulness of serum cotinine test to assess the association between smoking and periodontal status in a study with a large sample population to be used in studies with other serum markers in epidemiologic and periodontal medicine researches. 578 patients who were part of a multicenter study on blood biomarkers were evaluated about smoking and its relation to periodontal disease. Severity of periodontal disease was determinate using clinical attachment loss (CAL). Smoking was assessed by a questionnaire and a blood sample drawn for serum cotinine determination. The optimal cut-off point for serum cotinine was 10 ng/ml. Serum cotinine showed greater association with severity of CAL than self-report for mild-moderate CAL [OR 2.03 (CI95% 1.16-3.53) vs. OR 1.08 (CI95% 0.62-1.87) ] advanced periodontitis [OR 2.36 (CI95% 1.30- 4.31) vs. OR 2.06 (CI95% 0.97-4.38) ] and extension of CAL > 3 mm [ OR 1.78 (CI95% 1.16-1.71) vs. 1.37 (CI95% 0.89-2.11)]. When the two tests were evaluated together were not shown to be better than serum cotinine test. Self-reported smoking and serum cotinine test ≥ 10ng/ml are accurate ,complementary and more reliable methods to assess the patient's smoking status and could be used in studies evaluating serum samples in large population and multicenter studies. The serum cotinine level is more reliable to make associations with the patient's periodontal status than self-report questionnaire and could be used in multicenter and periodontal medicine studies.

  16. A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain

    NARCIS (Netherlands)

    A.L. Liem (Liong); M. Russo (Marc); F.J.P.M. Huygen (Frank); J.P. Van Buyten (Jean-Pierre); I. Smets (Ilse); P. Verrills (Paul); M. Cousins (Michael); C. Brooker (Charles); R. Levy (Richard); T. Deer (Timothy); J. Kramer (Jeffery)

    2013-01-01

    textabstractObjectives: This multicenter prospective trial was conducted to evaluate the clinical performance of a new neurostimulation system designed to treat chronic pain through the electrical neuromodulation of the dorsal root ganglia (DRG) neurophysiologically associated with painful regions

  17. A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry.

    Science.gov (United States)

    Salvatori, Roberto; Gordon, Murray B; Woodmansee, Whitney W; Ioachimescu, Adriana G; Carver, Don W; Mirakhur, Beloo; Cox, David; Molitch, Mark E

    2017-12-01

    This analysis evaluates the 2-year effectiveness and safety of lanreotide depot/autogel (LAN), as well as treatment convenience and acromegaly symptom relief, from the Somatuline ® Depot for Acromegaly (SODA) registry, a post-marketing, open-label, observational, multicenter, United States registry study. Patients with acromegaly treated with LAN were eligible for enrollment. Demographics, LAN dose, extended dosing interval (EDI) (interval of injections ≥42 days), insulin-like growth factor 1 (IGF-1), growth hormone (GH), glycated hemoglobin, adverse events (AEs), injection convenience, and symptom data were collected. As of September 29, 2014, 241 patients were enrolled in SODA. IGF-1 levels below age- and gender-adjusted upper normal limit (ULN) were achieved in 71.2% at month (M) 12 and 74.4% at M24; GH ≤2.5 µg/L in 83.3% at M12 and 80.0% at M24; GH convenient. SODA indicates 2-year biochemical control with majority of patients achieving both IGF-1 < ULN and GH ≤2.5 µg/L. LAN was generally well tolerated with no new or unexpected safety signals reported during the observation period. clinicaltrials.gov Clinical Trial Identifier: NCT00686348.

  18. Effect of Kangfuxin Solution on Chemo/Radiotherapy-Induced Mucositis in Nasopharyngeal Carcinoma Patients: A Multicenter, Prospective Randomized Phase III Clinical Study

    Directory of Open Access Journals (Sweden)

    Yangkun Luo

    2016-01-01

    Full Text Available Objective. To evaluate the efficacy and safety of Kangfuxin Solution, a pure Chinese herbal medicine, on mucositis induced by chemoradiotherapy in nasopharyngeal carcinoma patients. Methods. A randomized, parallel-group, multicenter clinical study was performed. A total of 240 patients were randomized to receive either Kangfuxin Solution (test group or compound borax gargle (control group during chemoradiotherapy. Oral mucositis, upper gastrointestinal mucositis, and oral pain were evaluated by Common Terminology Criteria for Adverse Events (CTCAE v3.0 and the Verbal Rating Scale (VRS. Results. Of 240 patients enrolled, 215 were eligible for efficacy analysis. Compared with the control group, the incidence and severity of oral mucositis in the test group were significantly reduced (P=0.01. The time to different grade of oral mucositis occurrence (grade 1, 2, or 3 was longer in test group (P<0.01, and the accumulated radiation dose was also higher in test group comparing to the control group (P<0.05. The test group showed lower incidence of oral pain and gastrointestinal mucositis than the control group (P<0.01. No significant adverse events were observed. Conclusion. Kangfuxin Solution demonstrated its superiority to compound borax gargle on mucositis induced by chemoradiotherapy. Its safety is acceptable for clinical application.

  19. Role of experience, leadership and individual protection in cath lab. A multicenter questionnaire and workshop on radiation safety

    International Nuclear Information System (INIS)

    Kuon, E.; Weitmann, K.; Hoffmann, W.; Doerr, M.; Hummel, A.; Busch, M.C.; Felix, S.B.; Empen, K.

    2015-01-01

    Radiation exposure in invasive cardiology remains considerable. We evaluated the acceptance of radiation protective devices and the role of operator experience, team leadership, and technical equipment in radiation safety efforts in the clinical routine. Cardiologists (115 from 27 centers) answered a questionnaire and documented radiation parameters for 10 coronary angiographies (CA), before and 3.1 months after a 90-min. mini-course in radiation-reducing techniques. Mini-course participants achieved significant median decreases in patient dose area products (DAP: from 26.6 to 13.0 Gy x cm 2 ), number of radiographic frames (- 29 %) and runs (- 18 %), radiographic DAP/frame (- 32 %), fluoroscopic DAP/s (- 39 %), and fluoroscopy time (- 16 %). Multilevel analysis revealed lower DAPs with decreasing body mass index (- 1.4 Gy x cm 2 per kg/m2), age (- 1.2 Gy x cm 2 /decade), female sex (- 5.9 Gy x cm 2 ), participation of the team leader (- 9.4 Gy x cm 2 ), the mini-course itself (- 16.1 Gy x cm 2 ), experience (- 0.7 Gy x cm 2 /1000 CAs throughout the interventionalist's professional life), and use of older catheterization systems (- 6.6 Gy x cm 2 ). Lead protection included apron (100 %), glass sheet (95 %), lengthwise (94 %) and crosswise (69 %) undercouch sheet, collar (89 %), glasses (28 %), cover around the patients' thighs (19 %), foot switch shield (7 %), gloves (3 %), and cap (1 %). Radiation-protection devices are employed less than optimally in the clinical routine. Cardiologists with a great variety of interventional experience profited from our radiation safety workshop - to an even greater extent if the interventional team leader also participated.

  20. Role of experience, leadership and individual protection in cath lab. A multicenter questionnaire and workshop on radiation safety

    Energy Technology Data Exchange (ETDEWEB)

    Kuon, E. [Klinik Fraenkische Schweiz, Ebermannstadt (Germany). Div. of Cardiology; Weitmann, K.; Hoffmann, W. [University Medicine, Greifswald (Germany). Inst. for Community Medicine; Doerr, M.; Hummel, A.; Busch, M.C.; Felix, S.B.; Empen, K. [University Medicine, Greifswald (Germany). Div. of Internal Medicine

    2015-10-15

    Radiation exposure in invasive cardiology remains considerable. We evaluated the acceptance of radiation protective devices and the role of operator experience, team leadership, and technical equipment in radiation safety efforts in the clinical routine. Cardiologists (115 from 27 centers) answered a questionnaire and documented radiation parameters for 10 coronary angiographies (CA), before and 3.1 months after a 90-min. mini-course in radiation-reducing techniques. Mini-course participants achieved significant median decreases in patient dose area products (DAP: from 26.6 to 13.0 Gy x cm{sup 2}), number of radiographic frames (- 29 %) and runs (- 18 %), radiographic DAP/frame (- 32 %), fluoroscopic DAP/s (- 39 %), and fluoroscopy time (- 16 %). Multilevel analysis revealed lower DAPs with decreasing body mass index (- 1.4 Gy x cm{sup 2} per kg/m2), age (- 1.2 Gy x cm{sup 2}/decade), female sex (- 5.9 Gy x cm{sup 2}), participation of the team leader (- 9.4 Gy x cm{sup 2}), the mini-course itself (- 16.1 Gy x cm{sup 2}), experience (- 0.7 Gy x cm{sup 2}/1000 CAs throughout the interventionalist's professional life), and use of older catheterization systems (- 6.6 Gy x cm{sup 2}). Lead protection included apron (100 %), glass sheet (95 %), lengthwise (94 %) and crosswise (69 %) undercouch sheet, collar (89 %), glasses (28 %), cover around the patients' thighs (19 %), foot switch shield (7 %), gloves (3 %), and cap (1 %). Radiation-protection devices are employed less than optimally in the clinical routine. Cardiologists with a great variety of interventional experience profited from our radiation safety workshop - to an even greater extent if the interventional team leader also participated.

  1. Fusion reactor safety studies, FY 1977

    International Nuclear Information System (INIS)

    Darby, J.B. Jr.

    1978-04-01

    This report reviews the technical progress in the fusion reactor safety studies performed during FY 1977 in the Fusion Power Program at the Argonne National Laboratory. The subjects reported on include safety considerations of the vacuum vessel and first-wall design for the ANL/EPR, the thermal responses of a tokamak reactor first wall, the vacuum wall electrical resistive requirements in relationship to magnet safety, and a major effort is reported on considerations and experiments on air detritiation

  2. Multicenter, randomized, placebo-controlled study of the nitric oxide scavenger pyridoxalated hemoglobin polyoxyethylene in distributive shock.

    Science.gov (United States)

    Kinasewitz, Gary T; Privalle, Christopher T; Imm, Amy; Steingrub, Jay S; Malcynski, John T; Balk, Robert A; DeAngelo, Joseph

    2008-07-01

    To assess the safety and efficacy of the hemoglobin-based nitric oxide scavenger, pyridoxalated hemoglobin polyoxyethylene (PHP), in patients with distributive shock. Phase II multicenter, randomized (1:1), placebo-controlled study. Fifteen intensive care units in North America. Sixty-two patients with distributive shock, > or = 2 systemic inflammatory response syndrome criteria, and persistent catecholamine dependence despite adequate fluid resuscitation (pulmonary capillary wedge pressure > or = 12). Patients were randomized to PHP at 0.25 mL/kg/hr (20 mg/kg/hr), or an equal volume of placebo, infused for up to 100 hrs, in addition to conventional vasopressor therapy. Because treatment could not be blinded, vasopressors and ventilatory support were weaned by protocol. Sixty-two patients were randomized to PHP (n = 33) or placebo (n = 29). Age, sex, etiology of shock (sepsis in 94%), and Acute Physiology and Chronic Health Evaluation II scores (33.1 +/- 8.3 vs. 30 +/- 7) were similar in PHP and placebo patients, respectively. Baseline plasma nitrite and nitrate levels were markedly elevated in both groups. PHP infusion increased systemic blood pressure within minutes. Overall 28-day mortality was similar (58% PHP vs. 59% placebo), but PHP survivors were weaned off vasopressors faster (13.7 +/- 8.2 vs. 26.3 +/- 21.4 hrs; p = .07) and spent less time on mechanical ventilation (10.4 +/- 10.2 vs. 17.4 +/- 9.9 days; p = .21). The risk ratio (PHP/placebo) for mortality was .79 (95% confidence interval, .39-1.59) when adjusted for age, sex, Acute Physiology and Chronic Health Evaluation II score, and etiology of sepsis. No excess medical interventions were noted with PHP use. PHP survivors left the intensive care unit earlier (13.6 +/- 8.6 vs. 17.9 +/- 8.2 days; p = .21) and more were discharged by day 28 (57.1 vs. 41.7%). PHP is a hemodynamically active nitric oxide scavenger. The role of PHP in distributive shock remains to be determined.

  3. Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: rationale and design of a prospective, randomized, multicenter study.

    Science.gov (United States)

    Tejani, Furqan H; Thompson, Randall C; Iskandrian, Ami E; McNutt, Bruce E; Franks, Billy

    2011-02-01

    Caffeine attenuates the coronary hyperemic response to adenosine by competitive A₂(A) receptor blockade. This study aims to determine whether oral caffeine administration compromises diagnostic accuracy in patients undergoing vasodilator stress myocardial perfusion imaging (MPI) with regadenoson, a selective adenosine A(2A) agonist. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study includes patients with suspected coronary artery disease who regularly consume caffeine. Each participant undergoes three SPECT MPI studies: a rest study on day 1 (MPI-1); a regadenoson stress study on day 3 (MPI-2), and a regadenoson stress study on day 5 with double-blind administration of oral caffeine 200 or 400 mg or placebo capsules (MPI-3; n = 90 per arm). Only participants with ≥ 1 reversible defect on the second MPI study undergo the subsequent stress MPI test. The primary endpoint is the difference in the number of reversible defects on the two stress tests using a 17-segment model. Pharmacokinetic/pharmacodynamic analyses will evaluate the effect of caffeine on the regadenoson exposure-response relationship. Safety will also be assessed. The results of this study will show whether the consumption of caffeine equivalent to 2-4 cups of coffee prior to an MPI study with regadenoson affects the diagnostic validity of stress testing (ClinicalTrials.gov number, NCT00826280).

  4. A Prospective, Multicentered Study to Assess Social Adjustment in Patients With an Intestinal Stoma in Turkey.

    Science.gov (United States)

    Karadağ, Ayişe; Karabulut, Hatice; Baykara, Zehra G; Harputlu, Deniz; Toyluk, Eylem; Ulusoy, Birgül; Karadağ, Sercan; Kahraman, Aysel; Hin, Aysel Ören; Altinsoy, Meral; Akıl, Yasemin; Leventoğlu, Sezai

    2015-10-01

    with planned stoma operations and persons with permanent stomas increased significantly (P less than 0.05) between assessments. Significant increases in OAI-23 scores also were noted among persons who did not receive information before the operation, patients whose stoma site was not marked, and patients who had experienced a complication (P less than 0.05). Postoperatively, it is important to consider sociodemographic and stoma characteristics as well as preoperative variables that may influence adaptation to stoma. Additional larger, multicentered studies with extended patient follow-up are warranted.

  5. Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

    Directory of Open Access Journals (Sweden)

    Bockelbrink Angelina

    2010-07-01

    Full Text Available Abstract Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female were included. The most frequent diagnoses were hypertension (11.1%, breast cancer (3.5%, and heart failure (3.0%. In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic. The adjusted odds ratio (AOR for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79, treatment by an internist (AOR = 1.49; CI: 1.40-1.58, female patients (AOR = 1.35; CI: 1.27-1.43, cancer (AOR = 4.54; CI: 4.12-4.99, arthropathies (AOR = 1.36; CI: 1.19-1.55, or dorsopathies (AOR = 1.34; CI: 1.16-1.55 and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98. The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39, diabetes mellitus (AOR = 0.17; CI: 0

  6. Occupation and skin cancer: the results of the HELIOS-I multicenter case-control study

    Directory of Open Access Journals (Sweden)

    Gafà Lorenzo

    2007-07-01

    Full Text Available Abstract Background Non-melanoma skin cancer (NMSC is the most frequent tumour among Caucasian populations worldwide. Among the risk factors associated with this tumour, there are host-related factors and several environmental agents. A greater likelihood of high exposure to physical agents (with the exception of solar radiation and chemical agents depends on the work setting. Our objective is to evaluate the role of occupational exposures in NMSC, with special emphasis on risk factors other than solar radiation and skin type. Methods We analysed 1585 cases (1333 basal cell carcinoma (BCC and 183 squamous cell carcinoma (SCC and 1507 controls drawn from the Helios-I multicenter study. Odds ratios (OR and 95% confidence intervals (CI were estimated using logistic regression mixed models. Results For NMSC as a whole (both histological types, miners and quarrymen, secondary education teachers, and masons registered excess risk, regardless of exposure to solar radiation and skin type (OR 7.04, 95% CI 2.44–20.31; OR 1.75, 95% CI 1.05–2.89 and OR 1.54, 95% CI 1.04–2.27, respectively. Frequency of BCC proved higher among railway engine drivers and firemen (OR 4.55; 95% CI 0.96–21.57, specialised farmers (OR 1.65; 95% CI 1.05–2.59 and salesmen (OR 3.02; 95% CI 1.05–2.86, in addition to miners and quarrymen and secondary education teachers (OR 7.96; 95% CI 2.72–23.23 and OR 1.76; 95% CI 1.05–2.94 respectively. The occupations that registered a higher risk of SCC (though not of BCC were those involving direct contact with livestock, construction workers not elsewhere classified (OR 2.95, 95% CI 1.12–7.74, stationary engine and related equipment operators not elsewhere classified (OR 5.31, 95% CI 1.13–21.04 and masons (OR 2.55, 95% CI 1.36–4.78. Conclusion Exposure to hazardous air pollutants, arsenic, ionizing radiations and burns may explain a good part of the associations observed in this study. The Helios study affords an

  7. [Efficacy and safety of reduced osmolarity oral rehydration salts in treatment of dehydration in children with acute diarrhea--a multicenter, randomized, double blind clinical trial].

    Science.gov (United States)

    Yang, Dao-Feng; Guo, Wei; Tian, De-Ying; Luo, Xiao-Ping; He, Yong-Wen; Dai, Yong-An; Xu, Hua-Lin

    2007-04-01

    To assess the efficacy and safety of reduced osmolarity oral rehydration salts (ROORS) in treatment of mild to moderate dehydration caused by acute diarrhea in children. A multicenter, randomized, double-blind, positive drug controlled clinical trial was conducted in 125 cases aged 1 to 17 years. These children with acute diarrhea and signs of dehydration were randomly assigned to receive either ROORS (trial group, n = 62) or oral rehydration salts II (ORS II) (control group, n = 63). The volume of intravenous infusion were recorded. The improvements of systemic symtoms and signs, diarrhea, dehydration and total scores were compared between the two groups. The adverse events and changes of electrolyte and other laboratory tests during treatment were also observed and analyzed. The overall effective rates in trial group and control group were 96.8% and 96.8%, respectively. The recovery of systemic symptoms, dehydration signs and diarrhea occurred in 96%, 97% and 78% patients in trial groups, and 96%, 98% and 85% patients in control group. The scores of symptoms and signs in both groups decreased significantly after treatment. All the above parameters and the number of cases who needed intravenous infusion (41 vs. 39) were not statistically different between two groups. However, the average volume of intravenously infused fluids in trial group was (450.98 +/- 183.07) ml, 24.5% less than that in the control group (597.30 +/- 343.37) ml (P 0.05). A case in trial group had mild abdominal distention and recovered spontaneously. ROORS was shown to be effective and safe in the treatment of mild and moderate dehydration induced by acute diarrhea. Compared to ORS II, ROORS could decrease the intravenous supplement of fluid and lower the risk of hypernatremia.

  8. Antecedents of organizational citizenship behavior among Iranian nurses: a multicenter study.

    Science.gov (United States)

    Taghinezhad, Fakhredin; Safavi, Mahboobe; Raiesifar, Afsaneh; Yahyavi, Sayed Hossein

    2015-10-08

    Organizational citizenship behavior (OCB) improves efficiency and employees' participation and generally provides a good ambiance. This study was conducted to determine the role of job satisfaction (JS), organizational commitment (OC) and procedural justice (PJ) in explaining OCB among nurses working in fifteen educational-treatment centers in Tehran-Iran, to provide guidelines for health care managers' further understanding of how to encourage citizenship behavior among nurses. In this multi-center descriptive-correlational study 373 nurses were evaluated through a Multi-stage cluster sampling method after obtaining approval from the Ethics Committee of Islamic Azad University, Tehran Medical Branch and Tehran University of Medical Sciences Research Deputy. Nurses who signed the informed consent and holding a bachelor or master degree, having a minimum one year of job experience and not having organizational management position during the questionnaire distribution were included in the study. In order to collect data, Demographic questionnaire, Podsakoff et al. (Leadersh Q 1(2):107-142, 1990) OCB questionnaire, OC questionnaire, Aelterman et al. (Educ Stud 33(3):285-297, 2007) JS questionnaire and PJ questionnaire were used. These questionnaires were translated into Persian and content validity was confirmed by an expert group; their reliability was calculated by the internal consistency Cronbach alpha coefficient and it was satisfied. Data were analyzed by descriptive statistics, Comparative mean tests, correlation coefficient and multiple-regression in the SPSS software version 11. The general mean and all five aspects of OCB that ranked higher than 3 were evaluated in a "quite desired" state. The mean for perceived procedural justice, the general mean for JS and the mean of general grade for OC from the nurses' was in "quite desired" state. Finding from multiple regression indicated that OC and PJ exhibit about 19 % of OCB variance totally which is

  9. Refractory obstetrical antiphospholipid syndrome: Features, treatment and outcome in a European multicenter retrospective study.

    Science.gov (United States)

    Mekinian, Arsène; Alijotas-Reig, Jaume; Carrat, Fabrice; Costedoat-Chalumeau, Nathalie; Ruffatti, Amelia; Lazzaroni, Maria Grazia; Tabacco, Sara; Maina, Aldo; Masseau, Agathe; Morel, Nathalie; Esteve-Valverde, Enrique Esteve; Ferrer-Oliveras, Raquel; Andreoli, Laura; De Carolis, Sara; Josselin-Mahr, Laurence; Abisror, Noémie; Nicaise-Roland, Pascale; Tincani, Angela; Fain, Olivier

    2017-07-01

    To describe the consecutive pregnancy outcome and treatment in refractory obstetrical antiphospholipid syndrome (APS). Retrospective multicenter open-labelled study from December 2015 to June 2016. We analyzed the outcome of pregnancies in patients with obstetrical APS (Sydney criteria) and previous adverse obstetrical event despite low-dose aspirin and low-molecular weight heparin LMWH (LMWH) conventional treatment who experienced at least one subsequent pregnancy. Forty nine patients with median age 27years (23-32) were included from 8 European centers. Obstetrical APS was present in 71%, while 26% had obstetrical and thrombotic APS. Lupus anticoagulant was present in 76% and triple antiphospholipid antibody (APL) positivity in 45% of patients. Pregnancy loss was noted in 71% with a median age of gestation of 11 (8-21) weeks. The presence of APS non-criteria features (35% vs 17% in pregnancies without adverse obstetrical event; p=0.09), previous intrauterine death (65% vs 38%; p=0.06), of LA (90% vs 65%; p=0.05) were more frequent in pregnancies with adverse pregnancy outcome, whereas isolated recurrent miscarriage profile was more frequent in pregnancies without any adverse pregnancy outcome (15% vs 41%; p=0.04). In univariate analysis considering all pregnancies (index and subsequent ones), an history of previous intrauterine death was associated with pregnancy loss (odds-ratio 2.51 (95% CI 1.274.96); p=0.008), whereas previous history of prematurity related to APS (odds-ratio 0.13 95%CI 0.04 0.41, P=0.006), steroids use during the pregnancy (odds-ratio 0.30 95% CI 0.11-0.82, p=0.019) and anticardiolipids isolated profile (odds-ratio 0.51 95% CI 0.26-1.03, p=0.0588) were associated with favorable outcome. In multivariate analysis, only previous history of prematurity, steroids use and anticardiolipids isolated profiles were associated with live-birth pregnancy. The main features of refractory obstetrical APS were the high rates of LA and triple APL positivity

  10. Evaluation of coronary features of HIV patients presenting with ACS: The CUORE, a multicenter study.

    Science.gov (United States)

    Peyracchia, Mattia; De Lio, Giulia; Montrucchio, Chiara; Omedè, Pierluigi; d'Ettore, Gabriella; Calcagno, Andrea; Vullo, Vincenzo; Cerrato, Enrico; Pennacchi, Mauro; Sardella, Gennaro; Manga, Pravin; GrossoMarra, Walter; Vullo, Francesco; Fedele, Francesco; Biondi-Zoccai, Giuseppe; Moretti, Claudio; Vachiat, Ahmed; Bonora, Stefano; Rinaldi, Mauro; Mancone, Massimo; D'Ascenzo, Fabrizio

    2018-05-05

    The risk of recurrence of myocardial infarction (MI) in HIV patients presenting with acute coronary syndrome (ACS) is well known, but there is limited evidence about potential differences in coronary plaques compared to non-HIV patients. In this multicenter case-control study, HIV patients presenting with ACS, with intravascular-ultrasound (IVUS) data, enrolled between February 2015 and June 2017, and undergoing highly active antiretroviral therapy (HAART), were retrospectively compared to non-HIV patients presenting with ACS, before and after propensity score with matching, randomly selected from included centers. Primary end-point was the prevalence of multivessel disease. Secondary end-points were the prevalence of abnormal features at IVUS, the incidence of major-acute-cardiovascular-events (MACE), a composite end point of cardiovascular death, MI, target lesion revascularization (TLR), stent thrombosis (ST), non-cardiac death and target vessel revascularization (TVR). For each end-point, a subgroup analysis was conducted in HIV patients with CD4 cell count <200/mm 3 . Before propensity score, 66 HIV patients and 120 non-HIV patients were selected, resulting in 20 and 40 after propensity score. Patients with multivessel disease were 11 and 17, respectively (p = 0.56). IVUS showed a lower plaque burden (71% vs. 75%, p < 0.001) and a higher prevalence of hyperechoic non-calcified plaques (100% vs. 35%, p < 0.05) in HIV patients; a higher prevalence of hypoechoic plaques (7% vs. 0%, p < 0.05), a higher incidence of MACE (17.4% vs. 9.1% vs. l'8.0%, p < 0.05), MI recurrence (17.2% vs. 0.0% vs. 2.3%, p < 0.05), and ST (6.7% vs. 0.3% vs. 03%, p < 0.05) in HIV patients with CD4 < 200/mm 3 . Our study may provide a part of the pathophysiological basis of the differences in coronary arteries between HIV-positive and HIV-negative patients, suggesting that the former present with peculiar morphological features at IVUS, even after adjustment for clinical variables

  11. Risk Factors for De Novo Malignancies in Women After Kidney Transplantation: A Multicenter Transversal Study.

    Science.gov (United States)

    Helmy, Samir; Marschalek, Julian; Bader, Yvonne; Koch, Marianne; Schmidt, Alice; Kanzler, Marina; Gyoeri, Georg; Polterauer, Stephan; Reinthaller, Alexander; Grimm, Christoph

    2016-06-01

    Transplantation results in a 5-time elevated risk for a variety of malignancies (Kaposi sarcoma, skin, liver, lung, gastrointestinal cancer). A patient's risk for malignancies could be of particular interest for the follow-up programs of patients and risk adaption after kidney transplantation. The aim of this study was to identify independent risk factors for de novo malignancies in women after renal transplantation. This is a multicenter transversal study, conducted at the Medical University of Vienna and Hospital Rudolfstiftung, Vienna, Austria. We included female kidney graft recipients who were transplanted between 1980 and 2012 and followed-up at our institutions (N = 280). Clinical data of patients were extracted from hospital charts and electronic patient files. Patients were interviewed using a standardized questionnaire regarding their medical history, history of transplantation, and malignant diseases. Detailed information about present and past immunosuppressive regimens, rejection episodes and therapies, renal graft function, and information about primary disease was obtained. Diagnostic work-up and/or surgical exploration was performed if any presence of malignancy was suspected during routine follow-up. Histological specimens were obtained from all patients. the presence of de novo malignancy after kidney transplantation. Two hundred sixty-two women were included for statistical analysis. Median (interquartile range) follow-up period after transplantation was 101.1 (27.3-190.7) months. Thirty-two patients (12.2%) developed a malignancy: dermatologic malignancies (5.7%), breast cancer (3.4%), cervical cancer (0.8%), lung cancer (0.4%), gastrointestinal malignancies (1.5%), vulvar cancer (0.4%), and unclassified malignancies (1.9%). Median (interquartile range) time to malignancy after transplantation was 185.9 (92.0-257.6) months. Cumulative cancer rates were 4.9% (1 year), 14.4% (3 years), 16.4% (5 years), and 21.8% (10 years). Second transplantations

  12. Long-term outcome of renal transplantation from octogenarian donors: A multicenter controlled study.

    Science.gov (United States)

    Ruggenenti, Piero; Silvestre, Cristina; Boschiero, Luigino; Rota, Giovanni; Furian, Lucrezia; Perna, Annalisa; Rossini, Giuseppe; Remuzzi, Giuseppe; Rigotti, Paolo

    2017-12-01

    To assess whether biopsy-guided selection of kidneys from very old brain-dead donors enables more successful transplantations, the authors of this multicenter, observational study compared graft survival between 37 recipients of 1 or 2 histologically evaluated kidneys from donors older than 80 years and 198 reference-recipients of non-histologically evaluated single grafts from donors aged 60 years and younger (transplantation period: 2006-2013 at 3 Italian centers). During a median (interquartile range) of 25 (13-42) months, 2 recipients (5.4%) and 10 reference-recipients (5.1%) required dialysis (crude and donor age- and sex-adjusted hazard ratio [95% confidence interval] 1.55 [0.34-7.12], P = .576 and 1.41 [0.10-19.54], P = .798, respectively). Shared frailty analyses confirmed similar outcomes in a 1:2 propensity score study comparing recipients with 74 reference-recipients matched by center, year, donor, and recipient sex and age. Serum creatinine was similar across groups during 84-month follow-up. Recipients had remarkably shorter waiting times than did reference-recipients and matched reference-recipients (7.5 [4.0-19.5] vs 36 [19-56] and 40 [24-56] months, respectively, P < .0001 for both comparisons). Mean (± SD) kidney donor risk index was 2.57 ± 0.32 in recipients vs 1.09 ± 0.24 and 1.14 ± 0.24 in reference-recipients and matched reference-recipients (P < .0001 for both comparisons). Adverse events were similar across groups. Biopsy-guided allocation of kidneys from octogenarian donors permits further expansion of the donor organ pool and faster access to a kidney transplant, without increasing the risk of premature graft failure. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

  13. Integrating a Patient-Controlled Admission Program Into Mental Health Hospital Service: A Multicenter Grounded Theory Study

    DEFF Research Database (Denmark)

    Ellegaard, Trine; Bliksted, Vibeke Fuglsang; Mehlsen, Mimi Yung

    2018-01-01

    Patient-controlled admissions (PCAs) enable mental health patients by means of a contract to initiate an admission at a mental health hospital unit without using traditional admission procedures. This study was part of a 3-year Danish multicenter project, and we explored how mental health...... the mental health professionals strived to integrate PCA into clinical practice. The process was motivated by the idea of establishing a partnership with patients and involved two interrelated strategies to manage (a) the patient-related duties and (b) the admission contracts. The professionals moved from...

  14. Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial.

    Science.gov (United States)

    Solish, Nowell; Rivers, Jason K; Humphrey, Shannon; Muhn, Channy; Somogyi, Chris; Lei, Xiaofang; Bhogal, Meetu; Caulkins, Carrie

    2016-03-01

    Various onabotulinumtoxinA doses are effective in treating forehead lines (FHL), with a trend toward lower doses. To evaluate efficacy and safety of onabotulinumtoxinA dose-ranging treatment of FHL when the frontalis area and glabellar complex are treated together. Adults with moderate-to-severe FHL received onabotulinumtoxinA 40 U (FHL, 20 U; glabellar lines [GL], 20 U), 30 U (FHL, 10 U; GL, 20 U), or placebo. Response was assessed at weeks 1, 2, day 30, and monthly to day 180. Coprimary efficacy end points were investigator- and subject-assessed Facial Wrinkle Scale scores of none or mild (day 30). Patient-reported outcomes, onset/duration of effect, and adverse events (AEs) were evaluated. Responder rates (investigator/subject, respectively) were 40-U group, 91.2%/89.5%; 30-U group, 86.4%/81.4%; placebo, 1.7%/5.1%. OnabotulinumtoxinA resulted in significantly greater responder rates than placebo (p < .001). Adverse events were mild to moderate and similar between groups (most common AEs: nasopharyngitis [4.6%] and headache [4.0%]). Treatment of FHL with onabotulinumtoxinA 40 and 30 U (in frontalis and glabellar complex muscles) was tolerable, effective, and sustained. Both doses significantly reduced FHL severity; however, the 40-U dose demonstrated a trend toward greater sustained benefit and longer duration of effect versus the 30-U dose, with similar AE rates.

  15. BIOCHEMICAL CONTROL DURING LONG-TERM FOLLOW-UP OF 230 ADULT PATIENTS WITH CUSHING DISEASE: A MULTICENTER RETROSPECTIVE STUDY.

    Science.gov (United States)

    Geer, Eliza B; Shafiq, Ismat; Gordon, Murray B; Bonert, Vivien; Ayala, Alejandro; Swerdloff, Ronald S; Katznelson, Laurence; Lalazar, Yelena; Manuylova, Ekaterina; Pulaski-Liebert, Karen J; Carmichael, John D; Hannoush, Zeina; Surampudi, Vijaya; Broder, Michael S; Cherepanov, Dasha; Eagan, Marianne; Lee, Jackie; Said, Qayyim; Neary, Maureen P; Biller, Beverly M K

    2017-08-01

    Cushing disease (CD) results from excessive exposure to glucocorticoids caused by an adrenocorticotropic hormone-secreting pituitary tumor. Inadequately treated CD is associated with significant morbidity and elevated mortality. Multicenter data on CD patients treated in routine clinical practice are needed to assess treatment outcomes in this rare disorder. The study purpose was to describe the burden of illness and treatment outcomes for CD patients. Eight pituitary centers in four U.S. regions participated in this multicenter retrospective chart review study. Subjects were CD patients diagnosed at ≥18 years of age within the past 20 years. Descriptive statistical analyses were conducted to examine presenting signs, symptoms, comorbidities, and treatment outcomes. Of 230 patients, 79% were female (median age at diagnosis, 39 years; range, 18 to 78 years). Length of follow-up was 0 to 27.5 years (median, 1.9 years). Pituitary adenomas were 0 to 51 mm. The most common presenting comorbidities included hypertension (67.3%), polycystic ovary syndrome (43.5%), and hyperlipidemia (41.5%). Biochemical control was achieved with initial pituitary surgery in 41.4% patients (91 of 220), not achieved in 50.0% of patients (110 of 220), and undetermined in 8.6% of patients (19 of 220). At the end of follow-up, control had been achieved with a variety of treatment methods in 49.1% of patients (110 of 224), not achieved in 29.9% of patients (67 of 224), and undetermined in 21.0% of patients (47 of 224). Despite multiple treatments, at the end of follow-up, biochemical control was still not achieved in up to 30% of patients. These multicenter data demonstrate that in routine clinical practice, initial and long-term control is not achieved in a substantial number of patients with CD. BLA = bilateral adrenalectomy CD = Cushing disease CS = Cushing syndrome eCRF = electronic case report form MRI = magnetic resonance imaging PCOS = polycystic ovary syndrome.

  16. Probabilistic studies for a safety assurance program

    International Nuclear Information System (INIS)

    Iyer, S.S.; Davis, J.F.

    1985-01-01

    The adequate supply of energy is always a matter of concern for any country. Nuclear power has played, and will continue to play an important role in supplying this energy. However, safety in nuclear power production is a fundamental prerequisite in fulfilling this role. This paper outlines a program to ensure safe operation of a nuclear power plant utilizing the Probabilistic Safety Studies

  17. Accidente bothrópico en Colombia: estudio multicéntrico de la eficacia y seguridad de Antivipmyn-Tri®, un antiveneno polivalente producido en México Bothrops bites in Colombia: a multicenter study on the efficacy and safety of Antivipmyn-Tri®, a polyvalent antivenom produced in Mexico

    Directory of Open Access Journals (Sweden)

    Oscar Fernando Jaramillo Delgado

    2007-08-01

    Full Text Available Introducción: Colombia es un país con dos productores de antivenenos de IgG, pero hay un mercado insatisfecho por diferentes razones técnicas. Objetivos: evaluar la eficacia y la seguridad de un antiveneno F(ab´2 polivalente (Antivipmyn-Tri® producido en México, y un nuevo esquema de dosis en accidente bothrópico en Colombia. Métodos: se realizaron durante 9 meses un ensayo clínico-terapéutico y cuantificaciones de veneno y antiveneno sérico (ELISA en 53 pacientes. Resultados: cuarenta y cuatro pacientes fueron mordidos por Bothrops asper en Antioquia y Chocó y 9 por B. atrox en Amazonas; todos tenían sangre incoagulable al ingreso, 30 (56,6% con sangrado local y 24 (45,3% con sangrado sistémico. El grado final de envenenamiento fue leve en 13 (24,5%, moderado en 30 (56,6% y grave en 10 pacientes (18,9%. A las dosis recomendadas de 5 frascos para los casos leves o moderados y 10 para los graves, Antivipmyn-Tri® fue 100% eficaz para disminuir significativamente las concentraciones séricas de veneno en la primera hora de tratamiento y para detener el sangrado en las primeras 6-12 horas, 96,2% eficaz para normalizar la coagulación en 24 horas y 100% en 48 horas. Hubo 2 casos (3,8% de recurrencia de coagulopatía sin sangrado y 12 recurrencias de antigenemia sin implicaciones clínicas. Diez pacientes (18,9% presentaron reacciones tempranas adversas (leves a la faboterapia. No hubo muertes, y cuatro pacientes (7,5% tuvieron secuelas. Conclusión: a las dosis utilizadas en este estudio, Antivipmyn-Tri® fue eficaz y seguro para el tratamiento del envenenamiento bothrópico en Colombia. Introduction: Colombia is a country with two whole IgG antivenom producers, but the expectancy of all the market are not fulfilled by different technical reasons. Objectives: To evaluate the efficacy and safety of a F(ab´2 polyvalent antivenom produced in Mexico and of a new dosage regimen for Bothrops bites in Colombia. Methods: A clinical trial

  18. Contribution of subtraction ictal SPECT coregistered to MRI to epilepsy surgery. A multicenter study

    International Nuclear Information System (INIS)

    Matsuda, Hiroshi; Matsuda, Kazumi; Nakamura, Fumihiro

    2009-01-01

    A multicenter prospective study was performed to assess the additional value of a subtraction ictal single photon emission computed tomography (SPECT) coregistered to MRI (SISCOM) technique to traditional side-by-side comparison of ictal- and interictal SPECT images in epilepsy surgery. One hundred and twenty-three patients with temporal and extratemporal lobe epilepsy who had undergone epilepsy surgery after evaluation of scalp ictal and interictal electroencephalogram (EEG), MRI, and ictal and interictal SPECT scans were followed up in terms of postsurgical outcome for a period of at least 1 year. Three reviewers localized the epileptogenic focus using ictal and interictal SPECT images first by side-by-side comparison and subsequently by SISCOM. Concordance of the localization of the epileptogenic focus by SPECT diagnosis with the surgical site and inter-observer agreement between reviewers was compared between side-by-side comparison and SISCOM. Logistic regression analysis was performed in predicting the surgical outcome with the dependent variable being the achievement of a good postsurgical outcome and the independent variables using the SISCOM, side-by-side comparison of ictal and interictal SPECT images, MRI, and scalp ictal EEG. The SISCOM presented better concordance in extratemporal lobe epilepsy and less concordance in temporal lobe epilepsy than side-by-side comparison. Inter-observer concordance was higher in SISCOM than in side-by-side comparison. Much higher concordance of the epileptogenic focus by SPECT diagnosis with the surgical site was obtained in patients with good surgical outcome than in those with poor surgical outcome. These differences in concordance between good and poor surgical outcomes were greater in SISCOM than in side-by-side comparison. Logistic regression analysis showed the highest odds ratio of 12.391 (95% confidence interval; 3.319, 46.254) by SISCOM evaluation for concordance of the epileptogenic focus with the surgical site

  19. Clinical presentation and visual status of retinitis pigmentosa patients: a multicenter study in southwestern Nigeria

    Directory of Open Access Journals (Sweden)

    Onakpoya OH

    2016-08-01

    Full Text Available Oluwatoyin Helen Onakpoya,1 Caroline Olufunlayo Adeoti,2 Tunji Sunday Oluleye,3 Iyiade Adeseye Ajayi,4 Timothy Majengbasan,4,5 Olayemi Kolawole Olorundare1 1Department of Ophthalmology, Obafemi Awolowo University Teaching Hospital, Ile-Ife, 2Department of Ophthalmology, Ladoke Akintola University of Technology Teaching Hospital, Osogbo, 3Department of Ophthalmology, University College Hospital, Ibadan, 4Department of Ophthalmology, University Teaching Hospital, Ado-Ekiti, 5Department of Ophthalmology, Federal Medical Centre, Ido-Ekiti, Nigeria Background: To review the visual status and clinical presentation of patients with retinitis pigmentosa (RP.Methodology: Multicenter, retrospective, and analytical review was conducted of the visual status and clinical characteristics of patients with RP at first presentation from January 2007 to December 2011. Main outcome measure was the World Health Organization’s visual status classification in relation to sex and age at presentation. Data analysis by SPSS (version 15 and statistical significance was assumed at P<0.05.Results: One hundred and ninety-two eyes of 96 patients with mean age of 39.08±18.5 years and mode of 25 years constituted the study population; 55 (57.3% were males and 41 (42.7% females. Loss of vision 67 (69.8% and night blindness 56 (58.3% were the leading symptoms. Twenty-one (21.9% patients had a positive family history, with RP present in their siblings 15 (71.4%, grandparents 11 (52.3%, and parents 4 (19.4%. Forty (41.7% were blind at presentation and 23 (24% were visually impaired. Blindness in six (15% patients was secondary to glaucoma. Retinal vascular narrowing and retinal pigmentary changes of varying severity were present in all patients. Thirty-five (36.5% had maculopathy, 36 (37.5% refractive error, 19 (20% lenticular opacities, and eleven (11.5% had glaucoma. RP was typical in 85 patients (88.5%. Older patients had higher rates of blindness at presentation (P=0

  20. Improvement in Visual Symptomatology after Endovascular Treatment of Cavernous Carotid Aneurysms: A Multicenter Study.

    Science.gov (United States)

    Drazin, Doniel; Choulakian, Armen; Nuño, Miriam; Gandhi, Ravi; Edgell, Randall C; Alexander, Michael J

    2013-06-01

    Aneurysms arising from the cavernous internal carotid artery (CCAs) pose technical challenges for surgical management and such patients are frequently referred for endovascular treatment. These aneurysms often produce a variety of neurological deficits, primarily those related to oculoparesis. Our purpose was to determine the visual and neurological outcome of patients with treated CCAs. We reviewed the medical records and angiograms for patients who underwent endovascular treatment for CCAs at three academic medical centers. The following outcomes were analyzed: angiographic assessment, visual improvement and outcome at 3 months using Glasgow Outcome Scale (GOS). Thirty-four patients (mean age 54.7 years) were treated for CCAs. The mean aneurysm size was 14.2 mm (range: 3-45 mm), and fourteen patients (41.2%) required stent assistance. Twenty-one aneurysms (61.8%) were completely occluded; nine aneurysms (26.6%) had near-complete occlusion; 4 aneurysms (11.8%) had partial occlusion. Seven patients (20.6%) required retreatment. Fifteen of the 34 patients (44.1%) presented with visual symptoms, while only eight patients had residual visual symptomatology at follow-up (44.1% vs. 23.5%; p=0.02). Patients that presented with visual symptoms (N=15) had a mean aneurysm size of 24.5 mm, while those without visual symptoms (N=19) had a size of 7.5 mm (p=0.001). Follow-up GOS was good (4-5) in 29 patients (90.6%). No thromboembolic complications were observed. One patient died (3.1%) of an unrelated cause. Most patients in this multicenter series improved or remained stable after treatment. The results of this study indicate that endovascular treatment may improve the outcome of visual symptoms in patients with large cavernous aneurysms with low periprocedural morbidity. MJA is a consultant for Stryker and Codman. AC receives a Cordis Endovascular Fellowship Training Grant and a Stryker Endovascular Neurosurgery Post-graduate Fellow Grant. Dr. Drazin: Conception and Design

  1. A phase III multicenter trail of radiosensitizing effect and safety of sodium glycididazole in thoracic esophageal squamous carcinoma

    International Nuclear Information System (INIS)

    Qin Shangbin; Wang Yadi; Yang Junquan; Wang Xiaohu; Li Haibin; Yang Zhiyong; Yu Hong; Li Xueying; Gao Xianshu

    2012-01-01

    Objective: To evaluate the efficacy and clinical safety glycididazole (CMNa) in thoracic esophageal squamous carcinoma. Methods: From June 1, 2008 to October 13, 2009, 66 pathologically proved thoracic esophageal squamous carcinoma (stage II a -III, stage IV with metastases only in supraclavicular lymph nodes, by AJCC 6 th ed) were randomized into radiotherapy plus CMNa (A) or radiotherapy plus placebo (B) group. Radiotherapy was given by conventional schedule: 1.8-2.0 Gy per fraction, 5 times per week to a total dose of 66 Gy/6.6-7.2 w. CMNa was given intravenously 800 mg/m 2 3 times a week in solution of 100 ml saline within 30 minutes. Radiotherapy was started 30-60 minutes after completion of infusion. Patients of Group B received placebo in saline solution. A total of 66 patients were enrolled (Group A: 32; Group B: 34), and four patients were unanalyzable, remaining 31 patients in each Group. Baseline factors were balanced. Results: Follow-up rate was 97%. Group A vs. Group B: the overall response rate was 93.5% vs. 67.7% (χ 2 =6.61, P=0.01), 2-year overall survival was 39.9% vs. 29.9% (χ 2 = 0.62, P=0.433), 2-year cancer specific survival was 43.1% vs. 26.8% (χ 2 = 0.30, P=0.878), and 2-year progression-free survival was 30.1% vs. 27.9% (χ 2 = 0.02, P=0.586). No severe side effects observed. All patients tolerated CMNa infusion well. Conclusions: CMNa is tolerable and effective as a hypoxic radiosensitizer, and its combination with radiotherapy can improve short term effect. However, survival is not improved within our follow-up period. (authors)

  2. Response to methylphenidate by adult and pediatric patients with attention-deficit/hyperactivity disorder: the Spanish multicenter DIHANA study

    Directory of Open Access Journals (Sweden)

    Valdizán-Usón JR

    2013-02-01

    Full Text Available JR Valdizán-Usón,1 A Cánovas-Martínez,2 MT De Lucas-Taracena,3 F Díaz-Atienza,4 LS Eddy-Ives,5 A Fernández-Jaén,6 M Fernández-Pérez,7 M García-Giral,8 P García-Magán,9 M Garraus-Oneca,10 MA Idiazábal-Alecha,11 M López-Benito,12 G Lorenzo-Sanz,13 J Martínez-Antón,14 MA Martínez-Granero,15 F Montañés-Rada,16 F Mulas-Delgado,17 G Ochando-Perales,18 E Ortega-García,19 A Pelaz-Antolín,20 JA Ramos-Quiroga,21 FC Ruiz-Sanz,22 J Vaquerizo-Madrid,23 A Yusta-Izquierdo241Unidad Trastornos Neurofuncionales, Clínica Montpellier, Zaragoza, 2Hospital Dr Peset, Valencia, 3Hospital 12 de Octubre, Madrid, 4Hospital Virgen de las Nieves, Granada, 5Centre Mèdic Sant Ramon, Santa Coloma de Gramenet, Barcelona, 6Hospital Universitario Quirón, Madrid, 7Centro de Salud La Felguera, Langreo, Asturias, 8Hospital Clínic, Barcelona, 9Unidad Salud Mental, Talavera de la Reina, 10Clínica Universitaria de Navarra, Pamplona, 11Hospital Ntra. Sra. del Pilar, Barcelona, 12Centro Salud Contrueces, Gijón, 13Hospital Ramón y Cajal, Madrid, 14Complejo Hospitalario Carlos Haya, Málaga, 15Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, 16Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, 17Hospital Universitario La Fe, Valencia, 18Hospital Universitario La Fe, Valencia, 19Complejo Asistencial Universitario de León, 20Centro Salud Mental, Alcalá de Henares, 21Hospital Universitari Vall d'Hebron. CIBERSAM. Department of Psychiatry and Legal Medicine. Universitat Autònoma de Barcelona, 22Hospital General Rio Carrión, Palencia, 23Hospital Materno-Infantil, Badajoz, 24Hospital Universitario, Guadalajara, SpainBackground: The purpose of this multicenter Spanish study was to evaluate the response to immediate-release methylphenidate by children and adults diagnosed with attention-deficit/hyperactivity disorder (ADHD, as well as to obtain information on current therapy patterns and safety characteristics.Methods: This multicenter

  3. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study.

    Science.gov (United States)

    Gory, Benjamin; Blanc, Raphaël; Turjman, Francis; Berge, Jérôme; Piotin, Michel

    2018-02-02

    The Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up. The Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond-Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months. Twenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19). This prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms. REGISTERED CLINICAL TRIAL: NCT02125097;Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. [Pharmacotherapy of attention deficit hyperactivity disorder in children: the results of a multicenter double-blind placebo-controlled study of hopantenic acid].

    Science.gov (United States)

    Zavadenko, N N; Suvorinova, N Yu; Vakula, I N; Malinina, E V; Kuzenkova, L M

    To assess the efficacy and safety of hopantenic acid (pantogam) compared to placebo in the treatment of attention deficit hyperactivity disorder (ADHD) in children, aged from 6 to 12 years, during 4 month in the prospective multicenter comparative double-blind placebo-controlled study in parallel groups. One hundred patients enrolled in the safety assessment population were stratified into two equal pantogam and placebo groups. Eighty-nine patients who completed the study in according to the protocol were included in the efficacy assessment group: 45 in the pantogam group and 44 in the placebo group. Pantogam was administered in tablets (250 mg) in the therapeutic dose 30 mg/kg of body mass, divided into 2 doses, during 4 month. Patient's state was assessed by the total score on ADHD-DSM-IV, CGI-S WFIRS-P and results of the Toulouse-Piéron test for sustained attention. There was a trend towards an increase in the percentage of patients with positive changes (a decrease in the total ADHD-DSM-IV by ≥25%) in the end of the 3rd and 4th month in the pantogam group (treatment response was 66.7 and 68.9%, respectively) compared to the placebo group (treatment response was 52.3 and 61.4%, respectively). A significant decrease in disease severity assessed by the CGI-S was noted in the pantogam group compared to the placebo group. After 4 month of treatment with pantogam, the severity of functional disturbances was reduced by 4 out of 6 WFIRS-P domains: Family, School and learning, Child's self-concept and Risky activities. Pantogam improved the measures of sustained attention (accuracy and speed) in the Toulouse-Piéron test. The drug used in mean daily dose 30 mg/kg during 4 month had a favorable safety profile which did not differ from that of placebo.

  5. Prediction of functional recovery after revascularization using quantitative gated myocardial perfusion SPECT: a multi-center cohort study in Japan

    International Nuclear Information System (INIS)

    Nakajima, Kenichi; Tamaki, Nagara; Kuwabara, Yoichi; Kawano, Masaya; Matsunari, Ichiro; Taki, Junichi; Nishimura, Shigeyuki; Yamashina, Akira; Ishida, Yoshio; Tomoike, Hitonobu

    2008-01-01

    Prediction of left ventricular functional recovery is important after myocardial infarction. The impact of quantitative perfusion and motion analyses with gated single-photon emission computed tomography (SPECT) on predictive ability has not been clearly defined in multi-center studies. A total of 252 patients with recent myocardial infarction (n = 74) and old myocardial infarction (n = 175) were registered from 25 institutions. All patients underwent resting gated SPECT using 99m Tc-hexakis-2-methoxy-isobutyl isonitrile (MIBI) and repeated the study after revascularization after an average follow-up period of 132 ± 81 days. Visual and quantitative assessment of perfusion and wall motion were performed in 5,040 segments. Non-gated segmental percent uptake and end-systolic (ES) percent uptake were good predictors of wall motion recovery and significantly differed between improved and non-improved groups (66 ± 17% and 55 ± 18%, p 99m Tc-MIBI uptake provided a useful predictor of wall motion improvement. Application of quantitative approach with non-gated and ES percent uptake enhanced predictive accuracy over visual analysis particularly in a multi-center study. (orig.)

  6. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    Energy Technology Data Exchange (ETDEWEB)

    Zaknun, John J. [University Hospital of Innsbruck, Department of Nuclear Medicine, Innsbruck (Austria); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria); IAEA, Nuclear Medicine Section, Division of Human Health, Wagramer Strasse 5, P.O. Box 100, Wien (Austria); Bal, Chandrasekhar [All India Institute of Medical Sciences, Department of Nuclear Medicine, New Delhi (India); Maes, Alex [Katholieke Universiteit Leuven, Leuven (Belgium); AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); Tepmongkol, Supatporn [Chulalongkorn University, Nuclear Medicine Division, Department of Radiology, Bangkok (Thailand); Vazquez, Silvia [Instituto de Investigaciones Neurologicas, FLENI, Department of Radiology, Buenos Aires (Argentina); Dupont, Patrick [Katholieke Universiteit Leuven, Leuven (Belgium); Dondi, Maurizio [Ospedale Maggiore, Department of Nuclear Medicine, Bologna (Italy); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria)

    2008-01-15

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  7. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    International Nuclear Information System (INIS)

    Zaknun, John J.; Bal, Chandrasekhar; Maes, Alex; Tepmongkol, Supatporn; Vazquez, Silvia; Dupont, Patrick; Dondi, Maurizio

    2008-01-01

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  8. Effectiveness and predictors of success of noninvasive ventilation during H1N1 pandemics: a multicenter study.

    Science.gov (United States)

    Nicolini, A; Tonveronachi, E; Navalesi, P; Antonelli, M; Valentini, I; Melotti, R M; Pigna, A; Carrassi, A; Righini, P; Ferrari Bravo, M; Pelosi, P; Nicoli, F; Cosentini, R; Vaschetto, R; Faenza, S; Nava, S

    2012-12-01

    The use of non-invasive ventilation (NIV) in acute hypoxemic respiratory failure (AHRF) due to H1N1 virus infection is controversial. In this multicenter study we aimed to assess the efficacy of NIV in avoiding endotracheal intubation (ETI) and to identify predictors of success or failure. In this prospective multicenter study, 98 patients with new pulmonary infiltrate(s) sustained by H1N1 virus and a PaO(2)/FiO229 and a PaO(2)/FIO(2)≤127 at admission and PaO2/FIO(2)≤149 after 1 hr of NIV were independently associated with the need for ETI. The early application of NIV, with the aim to avoid invasive ventilation, during the H1N1 pandemics was associated with an overall success rate of 47/98 (48%). Patients presenting at admission with an high SAPS II score and a low PaO(2)/FiO(2) ratio and/or unable to promptly correct gas exchange are at high risk of intubation and mortality.

  9. A multicenter study of preventable contact burns from glass fronted gas fireplaces.

    Science.gov (United States)

    Wibbenmeyer, Lucy; Gittelman, Michael A; Kluesner, Karen; Liao, Junlin; Xing, Yunfan; Faraklas, Iris; Anyan, Walter; Gamero, Chelsea; Moulton, Steven; Nederveld, Cindy; Banks, Ashley; Ryan, Colleen M; Conway, Jennifer A; Reilly, Debra A; Fish, Joel; Kelly, Charis; Peltier, George; Schwantke, Emily; Conrad, Peggie F; Caruso, Daniel M; Richey, Karen J; McCrory, Kristine; Elfar, Mohamed S A; Pittinger, Timothy; Sadie, Christine; Greenhalgh, David; Palmieri, Tina; Grossman, Peter H; Richards, Kurt M; Joyce, Teresa; Pozez, Andrea L; Savetamal, Alisa; Harrington, David T; Duncan, Kimberley; Pomerantz, Wendy J; Dillard, B Daniel

    2015-01-01

    Glass fronted gas fireplaces (GFGFs) have exterior surfaces that can reach extremely high temperatures. Burn injuries from contact with the glass front can be severe with long-term sequelae. The Consumer Product Safety Commission reported that these injuries are uncommon, whereas single-center studies indicate a much higher frequency. The purpose of this multi-institutional study was to determine the magnitude and severity of GFGF injuries in North America. Seventeen burn centers elected to participate in this retrospective chart review. Chart review identified 402 children ≤10 years of age who sustained contact burns from contact with GFGF, who were seen or admitted to the study hospitals from January 2006 to December 2010. Demographic, burn, treatment, and financial data were collected. The mean age of the study group was 16.8 ± 13.3 months. The majority suffered burns to their hands (396, 98.5%), with burns to the face being the second, much less common site (14, 3.5%). Two hundred and sixty-nine required rehabilitation therapy (66.9%). The number of GFGF injuries reported was 20 times greater than the approximately 30 injuries estimated by the Consumer Product Safety Commission's 10-year review. For the affected children, these injuries are painful, often costly and occasionally can lead to long-term sequelae. Given that less than a quarter of burn centers contributed data, the injury numbers reported herein support a need for broader safety guidelines for gas fireplaces in order to have a significant impact on future injuries.

  10. To dimension safety valves. Probabilist study

    International Nuclear Information System (INIS)

    Noel, Robert; Couvreur, Denis

    1982-01-01

    The gauge of safety valves of a steam pressure apparatus is usually determined according to an operating situation envelope which it is admitted covers all that can happen in reality. For the safety of the dryer-superheaters of turbines in nuclear power stations, Electricite de France and Alsthom-Atlantique made a reliability study; its method is exposed and the results are discussed. Such a study is heavy going and complex, but in return it permits a better quantitative understanding of the various dimension and operating parameters of an installation which condition its safety. It is therefore a source of progress [fr

  11. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

    Science.gov (United States)

    Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

    2011-12-01

    New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

  12. The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation.

    Science.gov (United States)

    Deuse, Tobias; Bara, Christoph; Barten, Markus J; Hirt, Stephan W; Doesch, Andreas O; Knosalla, Christoph; Grinninger, Carola; Stypmann, Jörg; Garbade, Jens; Wimmer, Peter; May, Christoph; Porstner, Martina; Schulz, Uwe

    2015-11-01

    In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Flammable Gas Safety Self-Study 52827

    Energy Technology Data Exchange (ETDEWEB)

    Glass, George [Los Alamos National Laboratory

    2016-03-17

    This course, Flammable Gas Safety Self-Study (COURSE 52827), presents an overview of the hazards and controls associated with commonly used, compressed flammable gases at Los Alamos National Laboratory (LANL).

  14. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series

    DEFF Research Database (Denmark)

    Pierot, Laurent; Moret, Jacques; Barreau, Xavier

    2018-01-01

    BACKGROUND: Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. PURPOSE: To report clinical and anatomical results of the WEB treatment in the cumulative popula...

  15. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM)

    NARCIS (Netherlands)

    Kemp, Samuel V.; Slebos, Dirk-Jan; Kirk, Alan; Kornaszewska, Malgorzata; Carron, Kris; Ek, Lars; Broman, Gustav; Hillerdal, Gunnar; Mal, Herve; Pison, Christophe; Briault, Amandine; Downer, Nicola; Darwiche, Kaid; Rao, Jagan; Huebner, Ralf-Harto; Ruwwe-Glosenkamp, Christof; Trosini-Desert, Valery; Eberhardt, Ralf; Herth, Felix J.; Derom, Eric; Malfait, Thomas; Shah, Pallav L.; Garner, Justin L.; ten Hacken, Nick H.; Fallouh, Hazem; Leroy, Sylvie; Marquette, Charles H.

    2017-01-01

    Rationale: Single-center randomized controlled trials of the Zephyr endobronchial valve (EBV) treatment have demonstrated benefit in severe heterogeneous emphysema. This is the first multicenter study evaluating this treatment approach. Objectives: To evaluate the efficacy and safety of Zephyr EBVs

  16. Therapy response evaluation of malignant lymphoma in a multicenter study. Comparison of manual and semiautomatic measurements in CT

    International Nuclear Information System (INIS)

    Wessling, J.; Schuelke, C.; Koch, R.

    2014-01-01

    Purpose: Comparison of manual one-/bi-dimensional measurements versus semi-automatically derived one-/bi-dimensional and volumetric measurements for therapy response evaluation of malignant lymphoma during CT follow-up examinations in a multicenter setting. Materials and Methods: MSCT data sets of patients with malignant lymphoma were evaluated before (baseline) and after two cycles of chemotherapy (follow-up) at radiological centers of five university hospitals. The long axis diameter (LAD), the short axis diameter (SAD) and the bi-dimensional WHO of 307 target lymph nodes were measured manually and semi-automatically using dedicated software. Lymph node volumetry was performed semi-automatically only. The therapeutic response was evaluated according to lymphoma-adapted RECIST. Results: Based on a single lymph node, semi-automatically derived multidimensional parameters allowed for significantly more accurate therapy response classification than the manual or the semi-automatic unidimensional parameters. Incorrect classifications were reduced by up to 9.6%. Compared to the manual approach, the influence of the study center on correct therapy classification is significantly less relevant when using semi-automatic measurements. Conclusion: Semi-automatic volumetry and bi-dimensional WHO significantly reduce the number of incorrectly classified lymphoma patients by approximately 9.6% in the multicenter setting in comparison to linear parameters. Semi-automatic quantitative software tools may help to significantly reduce wrong classifications that are associated with the manual assessment approach. (orig.)

  17. Therapy response evaluation of malignant lymphoma in a multicenter study. Comparison of manual and semiautomatic measurements in CT

    Energy Technology Data Exchange (ETDEWEB)

    Wessling, J.; Schuelke, C. [Muenster Univ. (Germany). Dept. of Clinical Radiology; Koch, R. [Muenster Univ. (Germany). Dept. of Medical Informatics and Biomathematics; and others

    2014-08-15

    Purpose: Comparison of manual one-/bi-dimensional measurements versus semi-automatically derived one-/bi-dimensional and volumetric measurements for therapy response evaluation of malignant lymphoma during CT follow-up examinations in a multicenter setting. Materials and Methods: MSCT data sets of patients with malignant lymphoma were evaluated before (baseline) and after two cycles of chemotherapy (follow-up) at radiological centers of five university hospitals. The long axis diameter (LAD), the short axis diameter (SAD) and the bi-dimensional WHO of 307 target lymph nodes were measured manually and semi-automatically using dedicated software. Lymph node volumetry was performed semi-automatically only. The therapeutic response was evaluated according to lymphoma-adapted RECIST. Results: Based on a single lymph node, semi-automatically derived multidimensional parameters allowed for significantly more accurate therapy response classification than the manual or the semi-automatic unidimensional parameters. Incorrect classifications were reduced by up to 9.6%. Compared to the manual approach, the influence of the study center on correct therapy classification is significantly less relevant when using semi-automatic measurements. Conclusion: Semi-automatic volumetry and bi-dimensional WHO significantly reduce the number of incorrectly classified lymphoma patients by approximately 9.6% in the multicenter setting in comparison to linear parameters. Semi-automatic quantitative software tools may help to significantly reduce wrong classifications that are associated with the manual assessment approach. (orig.)

  18. Multicenter phase II study of sequential radioembolization-sorafenib therapy for inoperable hepatocellular carcinoma.

    Directory of Open Access Journals (Sweden)

    Pierce K H Chow

    Full Text Available The safety and tolerability of sequential radioembolization-sorafenib therapy is unknown. An open-label, single arm, investigator-initiated Phase II study (NCT0071279 was conducted at four Asia-Pacific centers to evaluate the safety and efficacy of sequential radioembolization-sorafenib in patients with hepatocellular carcinoma (HCC not amenable to curative therapies.Sorafenib (400 mg twice-daily was initiated 14 days post-radioembolization with yttrium-90 (90Y resin microspheres given as a single procedure. The primary endpoints were safety and tolerability and best overall response rate (ORR using RECIST v1.0.Secondary endpoints included: disease control rate (complete [CR] plus partial responses [PR] and stable disease [SD] and overall survival (OS.Twenty-nine patients with Barcelona Clinic Liver Cancer (BCLC stage B (38% or C (62% HCC received a median of 3.0 GBq (interquartile range, 1.0 90Y-microspheres followed by sorafenib (median dose/day, 600.0 mg; median duration, 4.1 months. Twenty eight patients experienced ≥1 toxicity; 15 (52% grade ≥3. Best ORR was 25%, including 2 (7% CR and 5 (18% PR, and 15 (54% SD. Disease control was 100% and 65% in BCLC stage B and C, respectively. Two patients (7% had sufficient response to enable radical therapy. Median survivals for BCLC stage B and C were 20.3 and 8.6 months, respectively.This study shows the potential efficacy and manageable toxicity of sequential radioembolization-sorafenib.ClinicalTrials.gov NCT00712790.

  19. A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss.

    Science.gov (United States)

    Bergfeld, Wilma; Washenik, Ken; Callender, Valerie; Zhang, Paul; Quiza, Carlos; Doshi, Uday; Blume-Peytavi, Ulrike

    2016-07-01

    BACKGROUND Female pattern hair loss (FPHL) is a common hair disorder that affects millions of women. A new 5% minoxidil topical foam (MTF) formulation, which does not contain propylene glycol, has been developed. To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL. This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm2) at weeks 12 and 24. A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm2 and 9.1 hairs/cm2 more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm2 and 644 μm/cm2 more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups. Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. ClinicalTrials.gov identifier: nCT01226459J Drugs Dermatol. 2016;15(7):874-881.

  20. Multicenter evaluation of efficacy and safety of low-dose versus high-dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients.

    Science.gov (United States)

    Heldenbrand, Seth; Li, Chenghui; Cross, Rosemary P; DePiero, Kelly A; Dick, Travis B; Ferguson, Kara; Kim, Miae; Newkirk, Erin; Park, Jeong M; Sudaria-Kerr, Janice; Tichy, Eric M; Ueda, Kimi R; Weng, Renee; Wisniewski, Jesse; Gabardi, Steven

    2016-12-01

    The cytomegalovirus (CMV) donor-positive/recipient-positive (D+/R+) population is the largest proportion of renal transplant recipients (RTR). Guidelines for prevention of CMV in the intermediate-risk D+/R+ population include prophylaxis with valganciclovir (VGCV) 900 mg/day for 3 months. This study is the first head-to-head analysis, to our knowledge, comparing the efficacy and safety CMV prophylaxis of VGCV 450 vs 900 mg/day for 3 months in D+/R+ RTR. A multicenter, retrospective analysis evaluated 478 adult RTR between January 2008 and October 2011. Study participants received VGCV 450 mg/day (Group 1; n=398) or 900 mg/day (Group 2; n=89)×3 months for CMV prophylaxis. All VGCV was adjusted for renal function. All groups included in this study received study-approved induction and maintenance immunosuppression regimens. The primary endpoint was incidence of CMV disease at 12 months. The rates of graft loss, patient survival, T-cell and/or antibody-mediated rejection, hematological adverse events, opportunistic infections, and early VGCV discontinuation were evaluated. Patient demographics were comparable, but had significant differences in ethnicity and donor type between the groups. The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939). © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  1. FTY720 and everolimus in de novo renal transplant patients at risk for delayed graft function: results of an exploratory one-yr multicenter study.

    Science.gov (United States)

    Tedesco-Silva, H; Lorber, M I; Foster, C E; Sollinger, H W; Mendez, R; Carvalho, D B; Shapiro, R; Rajagopalan, P R; Mayer, H; Slade, J; Kahan, B D

    2009-01-01

    This exploratory, multicenter, open-label study evaluated the efficacy and safety of FTY720, as a part of an immunosuppressive regimen, in combination with everolimus and steroids in de novo renal transplant recipients at increased risk of delayed graft function (DGF). Patients received FTY720 (5 mg) and everolimus (4 mg) 2-12 h pre-transplantation, followed by 2.5 mg/d FTY720 and concentration-controlled everolimus (4-8 ng/mL) post-transplant for 12 months. Induction therapy was prohibited. After enrollment of 56 of the planned 200 patients between 2000 and 2002, the recruitment was terminated. The primary endpoint, rate of graft loss, or death at three months was 15.4% and the biopsy-confirmed acute rejection was 42.3%. Death or graft loss at 12 months in the DGF and non-DGF arms was 36.0% and 25.9%, respectively. The mean estimated creatinine clearance at three months was 63 and 55 mL/min in the non-DGF and DGF groups, respectively, while at 12 months it was 56 mL/min in both the groups. Although there was no comparator arm, the results from this exploratory study (compared with data from other phases II and III trials) indicated no apparent benefits of FTY720-based regimens for prevention of acute rejection and preservation of renal function in renal transplant recipients at high risk of DGF.

  2. Criticality safety basics, a study guide

    Energy Technology Data Exchange (ETDEWEB)

    V. L. Putman

    1999-09-01

    This document is a self-study and classroom guide, for criticality safety of activities with fissile materials outside nuclear reactors. This guide provides a basic overview of criticality safety and criticality accident prevention methods divided into three parts: theory, application, and history. Except for topic emphasis, theory and history information is general, while application information is specific to the Idaho National Engineering and Environmental Laboratory (INEEL). Information presented here should be useful to personnel who must know criticality safety basics to perform their assignments safely or to design critically safe equipment or operations. However, the guide's primary target audience is fissile material handler candidates.

  3. Criticality safety basics, a study guide

    International Nuclear Information System (INIS)

    Putman, V.L.

    1999-01-01

    This document is a self-study and classroom guide, for criticality safety of activities with fissile materials outside nuclear reactors. This guide provides a basic overview of criticality safety and criticality accident prevention methods divided into three parts: theory, application, and history. Except for topic emphasis, theory and history information is general, while application information is specific to the Idaho National Engineering and Environmental Laboratory (INEEL). Information presented here should be useful to personnel who must know criticality safety basics to perform their assignments safely or to design critically safe equipment or operations. However, the guide's primary target audience is fissile material handler candidates

  4. Contraceptive Use and the Risk of Ectopic Pregnancy: A Multi-Center Case-Control Study.

    Science.gov (United States)

    Li, Cheng; Zhao, Wei-Hong; Meng, Chun-Xia; Ping, Hua; Qin, Guo-Juan; Cao, Shu-Jun; Xi, Xiaowei; Zhu, Qian; Li, Xiao-Cui; Zhang, Jian

    2014-01-01

    To evaluate the association between the risk of ectopic pregnancy (EP) and the use of common contraceptives during the previous and current conception/menstrual cycle. A multi-center case-control study was conducted in Shanghai. Women diagnosed with EP were recruited as the case group (n = 2,411). Women with intrauterine pregnancy (IUP) (n = 2,416) and non-pregnant women (n = 2,419) were matched as controls at a ratio of 1∶1. Information regarding the previous and current use of contraceptives was collected. Multivariate logistic regression analyses were performed to calculate odds ratios (ORs) and the corresponding 95% confidential intervals (CIs). Previous use of intrauterine devices (IUDs) was associated with a slight risk of ectopic pregnancy (AOR1 = 1.87 [95% CI: 1.48-2.37]; AOR2 = 1.84 [1.49-2.27]), and the risk increased with the duration of previous use (P1 for trend contraceptives reduced the risk of both unwanted IUP (condom: AOR = 0.04 [0.03-0.05]; withdrawal method: AOR = 0.10 [0.07-0.13]; calendar rhythm method: AOR = 0.54 [0.40-0.73]; oral contraceptive pills [OCPs]: AOR = 0.03 [0.02-0.08]; levonorgestrel emergency contraception [LNG-EC]: AOR = 0.22 [0.16-0.30]; IUDs: AOR = 0.01 [0.005-0.012]; tubal sterilization: AOR = 0.01 [0.001-0.022]) and unwanted EP (condom: AOR1 = 0.05 [0.04-0.06]; withdrawal method: AOR1 = 0.13 [0.09-0.19]; calendar rhythm method: AOR1 = 0.66 [0.48-0.91]; OCPs: AOR1 = 0.14 [0.07-0.26]; IUDs: AOR1 = 0.17 [0.13-0.22]; tubal sterilization: AOR1 = 0.04 [0.02-0.08]). However, when contraception failed and pregnancy occurred, current use of OCPs (AOR2 = 4.06 [1.64-10.07]), LNG-EC (AOR2 = 4.87 [3.88-6.10]), IUDs (AOR2 = 21.08 [13.44-33.07]), and tubal sterilization (AOR2 = 7.68 [1.69-34.80]) increased the risk of EP compared with the non-use of contraceptives. Current use of most contraceptives reduce the risk of both IUP and EP. However, if the

  5. Contraceptive Use and the Risk of Ectopic Pregnancy: A Multi-Center Case-Control Study.

    Directory of Open Access Journals (Sweden)

    Cheng Li

    Full Text Available To evaluate the association between the risk of ectopic pregnancy (EP and the use of common contraceptives during the previous and current conception/menstrual cycle.A multi-center case-control study was conducted in Shanghai. Women diagnosed with EP were recruited as the case group (n = 2,411. Women with intrauterine pregnancy (IUP (n = 2,416 and non-pregnant women (n = 2,419 were matched as controls at a ratio of 1∶1. Information regarding the previous and current use of contraceptives was collected. Multivariate logistic regression analyses were performed to calculate odds ratios (ORs and the corresponding 95% confidential intervals (CIs.Previous use of intrauterine devices (IUDs was associated with a slight risk of ectopic pregnancy (AOR1 = 1.87 [95% CI: 1.48-2.37]; AOR2 = 1.84 [1.49-2.27], and the risk increased with the duration of previous use (P1 for trend <10-4, P2 for trend <10-4. The current use of most contraceptives reduced the risk of both unwanted IUP (condom: AOR = 0.04 [0.03-0.05]; withdrawal method: AOR = 0.10 [0.07-0.13]; calendar rhythm method: AOR = 0.54 [0.40-0.73]; oral contraceptive pills [OCPs]: AOR = 0.03 [0.02-0.08]; levonorgestrel emergency contraception [LNG-EC]: AOR = 0.22 [0.16-0.30]; IUDs: AOR = 0.01 [0.005-0.012]; tubal sterilization: AOR = 0.01 [0.001-0.022] and unwanted EP (condom: AOR1 = 0.05 [0.04-0.06]; withdrawal method: AOR1 = 0.13 [0.09-0.19]; calendar rhythm method: AOR1 = 0.66 [0.48-0.91]; OCPs: AOR1 = 0.14 [0.07-0.26]; IUDs: AOR1 = 0.17 [0.13-0.22]; tubal sterilization: AOR1 = 0.04 [0.02-0.08]. However, when contraception failed and pregnancy occurred, current use of OCPs (AOR2 = 4.06 [1.64-10.07], LNG-EC (AOR2 = 4.87 [3.88-6.10], IUDs (AOR2 = 21.08 [13.44-33.07], and tubal sterilization (AOR2 = 7.68 [1.69-34.80] increased the risk of EP compared with the non-use of contraceptives.Current use of most

  6. Prognostic factors in urothelial renal pelvis and ureter tumors: a multicenter rare cancer network study