WorldWideScience

Sample records for clinical multi-center study

  1. 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......) 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...... Leukoaraiosis And Disability (LADIS). Semi-manually delineated WMC were used for validating the segmentation produced by the neural networks. The neural network segmentation demonstrated high consistency between subjects and centers, making it a promising technique for large studies. For WMC volumes less than...

  2. 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)

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    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. PMID:20703765

  3. Multi-centered Clinical Study on Effects of Nano-Amomi Paste in Treating Children's Anorexia

    Institute of Scientific and Technical Information of China (English)

    WU Min; LI Zhan; YU Jian-er; LU Wei-wei; NI Ju-xiu; XIA Yi-lin

    2007-01-01

    Objective:To assess the effect and safety of nano-Amoni Paste (nmAP) in the treatment of children's anorexia (AR).Methods:One hundred and eighty patients of AR were assigned accordlng to the randomized,double-blinded,double-simulated and parallel controlled principle to three groups,the treated group (TG),the positive control group (PCG) and the negative control group (NCG),60 in each group.The patients in TG were treated by sticking 1.5 ml of nmAP on the acupoint of Shenque (Ren 8) once a day and orally taking placebo liquid 10 ml twice a day;those in PCG and NGG treated with sticking paste of placebo on Ren 8,and oral taking of Shanmai Jianpi Oral Liquid (山麦健脾口服液) and placebo liquid respectively,10 ml each time twice per day.The course of treatment for all was 10 days,all patients were treated for 2 courses.Results:The total effective rate and the effective rate on cardinal symptom in TG was 85.0% and 95.0% respectively,that in PCG 86.2% and 96.55% and in NCG 45.5% and 65.45%,respectively,showing significant difference between groups (P<0.05).Comparison of the clinical manifestation before and after treatment showed significant improvement in volume of food intake,appetite,complexion and reduction of restlessness symptom (P<0.05) in all three groups,and there was no adverse reaction found in them.Conclusion:nmAP is an effective and safe remedy for treatment of Children's anorexia.

  4. 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.

  5. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    Science.gov (United States)

    Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton

    2015-01-01

    Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome.

  6. Treatment of hereditary angioedema with nanofiltered C1-esterase inhibitor concentrate (Cetor (R)) : Multi-center phase II and III studies to assess pharmacokinetics, clinical efficacy and safety

    NARCIS (Netherlands)

    Hofstra, J. J.; Budde, I. Kleine; van Twuyver, E.; Choi, G.; Levi, M.; Leebeek, F. W. G.; de Monchy, J. G. R.; Ypma, P. F.; Keizer, R. J.; Huitema, A. D. R.; Strengers, P. F. W.

    2012-01-01

    From 1997, plasma-derived C1-inhibitor concentrate (Cetor (R)) has been available to HAE and AAE patients. Recently, a virus reducing 15 nm nanofiltration step has been introduced in the production process. A randomized, double-blind controlled cross-over study was performed to compare the pharmacok

  7. 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 study...... of consecutive subjects with at least one swollen joint who conceivably may have gout. All subjects underwent arthrocentesis; cases were subjects with MSU crystal confirmation. Rheumatologists or radiologists, blinded to the results of the MSU crystal analysis, performed ultrasound on one or more clinically...... with positive ultrasound results among subjects with gout. RESULTS: Ultrasound was performed in 824 subjects (416 cases and 408 controls). The sensitivity, specificity, PPV and NPV for the presence of any one of the features were 76.9%, 84.3%, 83.3% and 78.1% respectively. Sensitivity was higher among subjects...

  8. 紫草油纱治疗糖尿病足溃疡的临床研究%A Multi-center,Randomized,Double-blind,Placebo-controlled Clinical Studies on the Efficiency of ZICAOYOUSHA in Treating Diabetic Foot Ulcers

    Institute of Scientific and Technical Information of China (English)

    姚明; 葛晓东

    2013-01-01

    [Objective] To observe the clinical efficacy of ZICAOYOUSHA in treating diabetic foot ulcers.[Method] A multi-center ,randomized,double-blind,placebo-control ed study was conducted. A total of 232 patients with diabetic foot ulcers were randomly assigned the treatment group and control group,in foundation treatment at the same time,the therapy group which was treated by External Application ZICAOYOUSHA had 174 patients,the contrast group which was treated by External Application Gentamicin Emery cloth had 58 patients. Observe the aspect improvement situation in two groups separately in accordance with Wagner grading,carry out statistics processing.[Results] Two groups of curative effect indices had significant differ-ence. [Conclusion] ZICAOYOUSHA is an effective drug for external use in treating diabetic foot ulcers.%  [目的]观察紫草油纱治疗糖尿病足溃疡(diabetic foot ulcers,DFU)的临床疗效。[方法]根据患者就诊顺序依照随机法将232例DFU患者分为治疗组及对照组,在常规治疗基础上,根据溃疡面大小,治疗组选用紫草油纱覆盖溃疡面外加消毒纱布重叠包扎,对照组选用庆大霉素纱条覆盖溃疡面外加消毒纱布重叠包扎,每2d换药1次,观察两组在Wagner分级方面的改善情况。[结果]治疗组、对照组总有效率分别为89.88%、74.07%,两组比较,差异有统计学意义(P<0.05)。[结论]紫草油纱治疗DFU有良好的疗效。

  9. A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion.

    Science.gov (United States)

    Kanter, Adam S; Gandhoke, Gurpreet S; Welch, William C; Arnold, Paul M; Cheng, Joseph S; Okonkwo, David O

    2016-03-01

    This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.

  10. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result A prospective, historically controlled, multi-center clinical study

    Institute of Scientific and Technical Information of China (English)

    ZHANG Qi; HONG Tao; CHEN Ji-lin; HUO Yong; SHEN Wei-feng; GAO Run-lin; XU Bo; YANG Yue-jin; ZHANG Rui-yan; LI Jian-ping; QIAO Shu-bin; ZHANG Jian-sheng; HU Jian; QIN Xue-wen

    2007-01-01

    Background The emergence of drug-eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis.This study was conducted to evaluate the safetyand efficacy of sirolimus-eluting cobalt-chrome stents (Firebird 2) for treating patients with coronary artery disease.Methods Sixty-seven patients with de novo or non-stented restenostic coronary lesions were chosen to receive the Firebird 2 stent as the final treatment (Firebird 2 group). Another 49 consecutive patients were implanted with bare cobalt alloyed stents (Driver, Medtronic) withit the previous six months and served as historical controls (control group).Baseline clinical characteristics, angiographic features, procedural results, 30-day, 6-month and 12-month clinical follow-up regarding the occurrence of major adverse cardiac events (MACE), as well as the primary endpoint of late lumen loss at 6-month angiographic follow-up were compared between the two groups.Results The demographic characteristics were similar between the two groups despite more patients in the Firebird 2group who underwent previous percutaneous coronary intervention (22.4% vs 8.2%, P=0.0418) and who had diabetes mellitus (29.9% vs 12.2%, P=0.0253). In the Firebird 2 group, the mean diameter of the reference vessel was smaller((2.79±0.46) mm vs (2.98±0.49) mm, P=0.0175) and more stents were implanted for each lesion (1.28±0.52 vs 1.10±0.30, P=0.0060). Other angiographic, procedural results and the device success rate were similar between the two groups. The MACE rate at 30-day and 3-month was the same, but significantly fewer MACE occurred in the Firebird 2group at 6- and 12-month follow-up (1.5% vs 12.2% at 6 month, P=0.0168; 1.5% vs 26.5% at 12 month, P<0.0001). The primary endpoint of late lumen loss at 6-month angiographic follow-up was significantly reduced in the Firebird 2 group (in-stent: (0.05±0.09) mm vs (0.98±0.61) mm; in-segment: (0.05±0.18) mm vs (0.72±0.59) mm; P<0.0001) than the control group

  11. Management of venous thromboembolism in patients with acute leukemia at high bleeding risk: a multi-center study.

    Science.gov (United States)

    Napolitano, Mariasanta; Valore, Luca; Malato, Alessandra; Saccullo, Giorgia; Vetro, Calogero; Mitra, Maria Enza; Fabbiano, Francesco; Mannina, Donato; Casuccio, Alessandra; Lucchesi, Alessandro; Del Principe, Maria Ilaria; Candoni, Anna; Di Raimondo, Francesco; Siragusa, Sergio

    2016-01-01

    In the last decades, evaluation of clinically relevant thrombotic complications in patients with acute leukemia (AL) has been poorly investigated. The authors performed a multi-center study to evaluate the management of symptomatic venous thromboembolism (VTE) in adult patients with AL. The intention was to find as clinically relevant the following: symptomatic Venous Thrombosis (VT) occurred in typical (lower limbs) and atypical (cerebral, upper limbs, abdominal, etc) sites with or without pulmonary embolism (PE). Over a population of 1461 patients with AL, 22 cases of symptomatic VTE were recorded in hospitalized patients with a mean age of 54.6 years. The absolute incidence of VTE was 1.5%. VTE occurred during chemotherapy in 17/22 (77.2%) cases, mainly (14/17, 82.3%) during the induction phase. Treatment of acute VTE was based on Low Molecular Weight Heparin (LMWH) at full dosage for the first month from diagnosis and reduced dosage (75%) for the following months.

  12. A multi-center study of hemodynamic characteristics exhibited by children with unexplained syncope

    Institute of Scientific and Technical Information of China (English)

    CHEN Li; TANG Chao-shu; DU Jun-bao; YANG Yuan-yuan; WANG Cheng; WANG Hong-wei; TIAN Hong; ZHANG Qing-you; CHEN Jian-jun; WANG Yu-li; KANG Yi-long

    2006-01-01

    Background Syncope is common in children and adolescents, with 15% estimated to have had at least one syncopal episode by age 18. In recent years, an increasing number of children, especially girls at their school age,have developed unexplained syncope. The mechanism of an unexplained syncope exhibited by children is incompletely studied; the association between different hemodynamic patterns and clinical features is also not clear. The aim of the study was to investigate the hemodynamic patterns of children with unexplained syncope and to examine the clinical relevance.Methods Two hundred and eight children [87 boys, 121 girls, aged 3-19 years, mean (11.66±2.72) years]were selectively recruited from May 2000 to April 2006 when they presented syncope as their main complaint at the Multi-center Network for Childhood Syncope in Beijing, Hunan Province, Hubei Province, and Shanghai of China. All of the patients underwent head-up tilt tests; data were analyzed using SPSS version 10.0 for Windows.Continuous variables were expressed as the mean±standard deviation. Dichotomous variables were compared through a χ2 test. A value of P<0.05 (two sided) was regarded as statistically significant.Results The age distribution of children with syncope was approximately normal. Head-up tilt tests was positive in 155 children, and the incidence of positive response of the baseline head-up tilt test for diagnosing unexplained syncope was 50.48%. The sensitivity value and diagnostic value of sublingual nitroglycerin head-up tilt test were both 74.52%. The hemodynamic pattern was normal in 53 children. The 155 children, who were positive in head-up tilt tests, showed signs of postural orthostatic tachycardia syndrome (60, 28.8%), the vasoinhibitory pattern (72, 34.6%), the cardioinhibitory pattern (5, 2.4%), and the mixed pattern (18, 8.7%). The gender distribution between the two age groups (age < 12 years vs age ≥ 12 years) was not different (P>0.05).The distribution of

  13. [Evaluation of the Effectiveness and Safety in a Multi-center Clinical Trial of VIBRANT SOUNDBRIDGE in Japan].

    Science.gov (United States)

    Doi, Katsumi; Kanzaki, Sho; Kumakawa, Kozo; Usami, Shin-ichi; Iwasaki, Satoshi; Yamanaka, Noboru; Naito, Yasushi; Gyo, Kiyofumi; Tono, Tetsuya; Takahashi, Haruo; Kanda, Yukihiko

    2015-12-01

    Middle ear implants (MEIs) such as the Vibrant Soundbridge (VSB) are attractive and alternative treatments for patients with conductive, sensorineural, and mixed hearing loss who do not benefit from, or who choose not to wear, conventional hearing aids (HAs). Recent studies suggest that MEIs can provide better improvements in functional gain, speech perception, and quality of life than HAs, although there are certain risks associated with the surgery which should be taken into consideration, including facial nerve or chorda tympanic nerve damage, dysfunctions of the middle and inner ears, and future device failure/explantation. In Japan, a multi-center clinical trial of VSB was conducted between 2011-2014. A round window vibroplasty via the transmastoid approach was adopted in the protocol. The bony lip overhanging the round window membrane (RWM) was extensively but very carefully drilled to introduce the Floating Mass Transducer (FMT). Perichondrium sheets were used to stabilize the FMT onto the RWM. According to the audiological criteria, the upper limit of bone conduction should be 45 dB, 50 dB, and 65 dB from 500 Hz to 4, 000 Hz. Twenty-five patients underwent the surgery so far at 13 different medical centers. The age at the surgery was between 26-79 years old, and there were 15 males and 10 females. The cause of conductive or mixed hearing loss was middle ear diseases in 23 cases and congenital aural atresia in two cases. The data concerning on the effectiveness and safety of VSB was collected before the surgery and 20 weeks after the surgery. Significant improvements of free-field Pure Tone Audiogram (PTA) from 250 Hz to 8, 000 Hz were confirmed (p VSB. However, the long-term efficacy and safety of these devices should be established.

  14. The impact of nutritional status, nutritional risk, and nutritional treatment on clinical outcome of 2248 hospitalized cancer patients: a multi-center, prospective cohort study in Chinese teaching hospitals.

    Science.gov (United States)

    Pan, Hongming; Cai, Sanjun; Ji, Jiafu; Jiang, Zhiwei; Liang, Houjie; Lin, Feng; Liu, Xiyong

    2013-01-01

    To better understand the impact of undernutrition, nutritional risk, and nutritional treatment on the clinical outcomes of hospitalized cancer patients in China, the authors conducted a multicenter, cross-sectional study with 2248 cancer patients from 20 hospitals from January to June 2010. The authors defined 19.7% and 26.8% patients as undernourished at baseline and reassessment, respectively. Patients with gastrointestinal malignancies had a higher rate of undernutrition than other patients. The nutritional risk rate was 24.6% and 40.2% at baseline and reassessment, respectively. For patients with nutritional risk, the relative risk (RR) of adverse events (AEs) significantly increased with and without nutritional treatment. In comparison with the nonnutritional treatment subgroup, patients who received enteral nutrition (EN) or total parenteral nutrition (TPN) significantly reduced the RR of AE development. The RR of AEs for EN and TPN were 0.08 (95% CI: 0.01-0.62) and 0.56 (95% CI: 0.33-0.96), respectively. Separated nutrient infusion increased the risk of AEs. The authors concluded that undernutrition and nutritional risk are general problems that impact the outcomes of hospitalized cancer patients in China. Higher NRS2002 scores are related to AE risk but not weight loss. In nutritional treatment, EN and TPN can significantly reduce the risk of AEs.

  15. China collaborative study on dialysis: a multi-centers cohort study on cardiovascular diseases in patients on maintenance dialysis

    Directory of Open Access Journals (Sweden)

    Hou Fanfan

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the main cause of death in patients on chronic dialysis. The question whether dialysis modality impacts cardiovascular risk remains to be addressed. China Collaborative Study on Dialysis, a multi-centers cohort study, was performed to evaluate cardiovascular morbidity during maintenance hemodialysis (HD and peritoneal dialysis (PD. Method The cohort consisted of chronic dialysis patients from the database of 9 of the largest dialysis facilities around China. The inclusion period was between January 1, 2005, and December 1, 2010. Cardiovascular morbidity was defined as the presence of clinically diagnosed ischemic heart disease, heart failure, peripheral vascular disease, and/or stroke. The patients who had cardiovascular morbidity before initiation of dialysis were excluded. Data collection was based on review of medical record. Result A total of 2,388 adult patients (1,775 on HD and 613 on PD were enrolled. Cardiovascular morbidity affected 57% patients and was comparable between HD and PD patients. However, clinically diagnosed ischemic heart disease and stroke was more prevalent in PD than HD patients. When the patients were stratified by age or dialysis vintage, the cardiovascular morbidity was significantly higher in PD than HD among those aged 50 years or older, or those receiving dialysis over 36 months. Multivariate analysis revealed that the risk factors for cardiovascular morbidity had different pattern in PD and HD patients. Hyperglycemia was the strongest risk factor for cardiovascular morbidity in PD, but not in HD patients. Hypertriglyceridemia and hypoalbuminemia were independently associated with CVD only in PD patients. Conclusions Cardiovascular morbidity during chronic dialysis was more prevalent in PD than HD patients among those with old age and long-term dialysis. Metabolic disturbance-related risk factors were independently associated with CVD only in PD patients

  16. Electronic data capture and DICOM data management in multi-center clinical trials

    Science.gov (United States)

    Haak, Daniel; Page, Charles-E.; Deserno, Thomas M.

    2016-03-01

    Providing eligibility, efficacy and security evaluation by quantitative and qualitative disease findings, medical imaging has become increasingly important in clinical trials. Here, subject's data is today captured in electronic case reports forms (eCRFs), which are offered by electronic data capture (EDC) systems. However, integration of subject's medical image data into eCRFs is insufficiently supported. Neither integration of subject's digital imaging and communications in medicine (DICOM) data, nor communication with picture archiving and communication systems (PACS), is possible. This aggravates the workflow of the study personnel, in special regarding studies with distributed data capture in multiple sites. Hence, in this work, a system architecture is presented, which connects an EDC system, a PACS and a DICOM viewer via the web access to DICOM objects (WADO) protocol. The architecture is implemented using the open source tools OpenClinica, DCM4CHEE and Weasis. The eCRF forms the primary endpoint for the study personnel, where subject's image data is stored and retrieved. Background communication with the PACS is completely hidden for the users. Data privacy and consistency is ensured by automatic de-identification and re-labelling of DICOM data with context information (e.g. study and subject identifiers), respectively. The system is exemplarily demonstrated in a clinical trial, where computer tomography (CT) data is de-centrally captured from the subjects and centrally read by a chief radiologists to decide on inclusion of the subjects in the trial. Errors, latency and costs in the EDC workflow are reduced, while, a research database is implicitly built up in the background.

  17. Appreciating the broad clinical features of SMAD4 mutation carriers: a multi-center chart review

    Science.gov (United States)

    Wain, K.E.; Ellingson, M.S.; McDonald, J.; Gammon, A.; Roberts, M.; Pichurin, P.; Winship, I.; Riegert-Johnson, D.; Weitzel, J. N.; Lindor, N.M.

    2014-01-01

    Heterozygous loss-of-function (LOF) SMAD4 mutations are associated with juvenile polyposis syndrome (JP) and hereditary hemorrhagic telangiectasia (HHT). Some carriers exhibit symptoms of both conditions, leading to the name JP-HHT syndrome. Three families have been reported with connective tissue abnormalities. In order to better understand the spectrum and extent of clinical findings in SMAD4 carriers, medical records of 34 patients (20 families) from five clinical practices were reviewed. Twenty-one percent (7/34) had features suggesting a connective tissue defect: enlarged aortic root (n=3), aortic and mitral insufficiency (n=2), aortic dissection (n=1), retinal detachment (n=1), brain aneurysms (n=1), lax skin and joints (n=1). JP-specific findings were almost uniformly present but variable. Ninety-seven percent had colon polyps that were generally pan-colonic and of variable histology and number. Forty-eight percent (15/31) had extensive gastric polyposis. HHT features were documented in 76% including epistaxis (19/31, 61%), mucocutaneous telangiectases (15/31, 48%), liver arteriovenous malformation (AVM) (6/16, 38%), brain AVM (1/26, 4%), pulmonary AVM (9/17, 53%), and intrapulmonary shunting (14/23, 61%). SMAD4 carriers should be managed for JP and HHT, since symptoms of both are likely yet unpredictable. Connective tissue abnormalities are an emerging component of JP-HHT syndrome, and larger studies are needed to understand these manifestations. PMID:24525918

  18. 中国突发性聋分型治疗的多中心临床研究%Prospective clinical multi-center study on the treatment of sudden deafness with different typings in china

    Institute of Scientific and Technical Information of China (English)

    中国突发性聋多中心临床研究协作组

    2013-01-01

    目的 探讨突发性聋分型治疗的必要性.方法 采用国际通用的标准化临床研究方法,统一设计、统一方案进行前瞻性临床多中心研究.收集年龄在18 ~ 65周岁之间,病程在2周以内,未经任何相关医疗处理的突发性聋患者,按照听力曲线分为低中频下降型,中高频下降型;平坦型和全聋型四种类型.每种类型有四种不同治疗方案,根据统一设计的随机表,随机选取其中一种方案进行治疗.其中低中频下降型为银杏叶提取物(金纳多)、泼尼松、巴曲酶(东菱迪芙)及其组合;中高频下降型为利多卡因、泼尼松、金纳多及其组合;平坦型或全聋型为东菱迪芙、金纳多、泼尼松及其组合.结果 2007年8月至2011年10月全国33家医院共收集符合入组条件的单侧突发性聋患者1024例,其中男性492例(48.05%),女性532例(51.95%).年龄为19~65岁,平均(41.2±12.8)岁.按照听力曲线分型,低中频下降型205例(20.02%),高频下降型141例(13.77%),平坦型402例(39.26%),全聋型276例(26.95%).各种类型的总有效率:低中频下降型最高,为90.73%;平坦型次之,为82.59%;全聋型为70.29%;中高频下降型为65.96%;各型之间总有效率比较,差异具有统计学意义(x2 =231.58,P =0.000).1024病例中,痊愈378例(36.91%),显效229例(22.36%),有效198例(19.34%),无效219例(21.39%);总有效率为78.61%.糖皮质激素对各型突聋均有效,联合用药优于单独用药.结论 不同听力曲线类型的突发性聋患者预后差异很大,根据听力曲线进行分型选择不同的治疗方案具有重要意义.低中频下降型疗效最好,平坦型次之,中高频下降型和全聋型效果不佳.%Objective To investigate the necessity of subtyping for the treatment of sudden deafness.Methods The international standardized clinical research methods,the unified design and program were used in the study.The sudden deafness

  19. Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study

    Directory of Open Access Journals (Sweden)

    Enger Shelley M

    2007-06-01

    Full Text Available Abstract Background The choice between paper data collection methods and electronic data collection (EDC methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study. Methods A computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859, at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR system was developed using a modified version of the EDC. Results Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites. Conclusion Automated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved.

  20. Evaluation of a Teleform-based data collection system: A multi-center obesity research case study

    Science.gov (United States)

    Jenkins, Todd M.; Boyce, Tawny Wilson; Akers, Rachel; Andringa, Jennifer; Liu, Yanhong; Miller, Rosemary; Powers, Carolyn; Buncher, C. Ralph

    2016-01-01

    Utilizing electronic data capture (EDC) systems in data collection and management allows automated validation programs to preemptively identify and correct data errors. For our multi-center, prospective study we chose to use TeleForm, a paper-based data capture software that uses recognition technology to create case report forms (CRFs) with similar functionality to EDC, including custom scripts to identify entry errors. We quantified the accuracy of the optimized system through a data audit of CRFs and the study database, examining selected critical variables for all subjects in the study, as well as an audit of all variables for 25 randomly selected subjects. Overall we found 6.7 errors per 10,000 fields, with similar estimates for critical (6.9/10,000) and non-critical (6.5/10,000) variables – values that fall below the acceptable quality threshold of 50 errors per 10,000 established by the Society for Clinical Data Management. However, error rates were found to widely vary by type of data field, with the highest rate observed with open text fields. PMID:24709056

  1. A Study on the Minimized Randomization Network System in Multi-Center Clinical Trials%多中心临床试验中的最小化随机网络系统研究

    Institute of Scientific and Technical Information of China (English)

    刘志臻; 郑国华; 曹治云; 陈旭征; 余宗阳; 杜建; 欧阳学农

    2011-01-01

    In order to improve the efficiency and guarantee the quality of the research of cross-regional multicenter clinical trials, with the combination of WIN 2003 Server IIS, SQL Server 2005 database and ASP.Net programming techniques, the Pocock and Simon minimized randomization system model facing the network was put forward, and this system based on that model was developed. The two sides in this system can achieve cooperation process from screening subjects, random allocation and drug management to filling electronic case report form. Moreover, the customers of this system can also publish official documents, exchange information and take full use of other available assistant functions through the office automation platform.%在跨地域的多中心临床试验中,为提高试验效率、保障试验质量,结合Win 2003 Server的II S服务、SQLServer 2005数据库,使用ASP.Net编程技术,开发了面向网络的Pocock and Simon最小化随机化算法模型,并在此模型上开发出多中心临床试验网络管理系统.该系统中双方用户实现了从受试者筛选、随机化、药物管理到电子病例报告表填写的协调过程;该系统用户还可以通过内部邮件办公信息平台,实现公文公示、信息交流等众多实用辅助功能.

  2. 儿童原发性免疫性血小板减少症颅内出血的多中心临床研究%Multi-center clinical study on intracranial hemorrhage in children with primary immune thrombocytopenia

    Institute of Scientific and Technical Information of China (English)

    胡群; 刘爱国; 金润铭; 徐云云; 李建新; 李晖; 朱斌

    2013-01-01

    To explore the incidence,relevant clinical risk factors and prognosis of intracranial hemorrhage in children with primary immune thrombocytopenia (ITP) . Method:Retrospective analysis was conducted on 17 cases of ITP with intracranial hemorrhage admitted in four children hematologic diseases centers during 2001 to 2011. Result:The incidence of intracranial hemorrhage in children with ITP was 0. 46%. There were some risk factors for intracranial hemorrhage,such as disease course within 1 month for acute patients and longer than 1 year for chronic patients; concurrent-infection; strenuous exercise; trauma and platelet count less than 10 × 109/L. The motality of ITP with intracranial hemorrhage was 11.7% and the prognosis was fine after active treatment. Conclusion: Intracranial hemorrhage in children with ITP was a disease which could be effectively cured through active treatment. The majority of survivors did not have severe neurological sequelae.%目的:探讨我国儿童免疫性血小板减少症(ITP)颅内出血的发生率、相关临床因素及预后.方法:对四大儿童血液病中心2001-2011年收治的儿童ITP并发颅内出血者17例进行回顾性分析.结果:①ITP患儿颅内出血的发生率为0.46%.②颅内出血高危因素为急性患儿起病1个月内,慢性患儿病程1年后;并发感染、剧烈运动和外伤;血小板计数小于10×109/L.③并发颅内出血者病死率为11.7%.④积极治疗后预后良好.结论:ITP患儿的颅内出血是一种可以通过积极治疗而达到有效治愈的疾病,幸存下来的患儿多数无严重的神经系统后遗症.

  3. 全国多中心慢性便秘患者情绪和睡眠状况的调查%Multi-centered stratified clinical studies for psychological and sleeping status in patients with chronic constipation in China

    Institute of Scientific and Technical Information of China (English)

    朱丽明; 方秀才; 刘诗; 张军; 李兆申; 胡品津; 高峻; 辛海威; 柯美云

    2012-01-01

    constipated symptoms,emotional and sleeping status,previous treatments and self-reported impact of constipation on health status,etc.Questionnaires were completed by well-trained physicians or investigators during face-to-face interviews.CC was diagnosed in accordance with the Rome Ⅲ criteria.Results A total of 909 valid questionnaires analyzed. There were 258 males and 651 females with a mean age of (49 ± 19) years.41.5% (377 cases)reported " tense feelings" and 38.3% (348 cases) "felt downcast" over the past 3 months.The patients feeling tense and (or) downcast "frequently" and "most of time" were around 11.3 % ( 103 cases) and 9.4% ( 85 cases).And 43.8% ( 398 cases) patients reported sleeping disorders over the past 3 months.Regional differences existed in the comorbidities of psychological and sleeping disorders in CC patients,especially in those from tertiary hospitals.And it was the highest in Beijing area for tense feelings and downcast. The sleeping disorders were the most common in the patients from secondary hospitals,of which 66.1% ( 37/56 ) and 65.0% ( 39/60 ) were from Wuhan and Xi' an respectively.They were higher than Beijing and Guangzhou (39.7% (23/58),29.0% (9/31),all P =0.001 ).The patients from rural primary clinics suffered more sleeping disorders than those from urban primary cares (P =0.026).About 35.0% (318 cases)and 28.4% (258 cases)patients reported their constipation was related with emotional and sleeping disorders.The comorbidities of psychological and sleeping disorders were more common in severe constipated patients than mild and moderate counterparts and resulted in more hospital visits( both P =0.000).Conclusions The CC patients often have the comorbidities of psychological and sleeping disorders with regional differences. The patients from the hospitals at various levels may present different spectrums of comorbidities of psychological and sleeping disorders. And the severity of CC influences the moods,sleeps and

  4. Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT Study.

    Directory of Open Access Journals (Sweden)

    Sara E Moore

    Full Text Available Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated. We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating

  5. Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

    Science.gov (United States)

    Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

    2014-02-01

    Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

  6. Risk factors for tuberculosis in dialysis patients: a prospective multi-center clinical trial

    Directory of Open Access Journals (Sweden)

    Goumenos Demetrios S

    2009-11-01

    Full Text Available Abstract Background Profound alterations in immune responses associated with uraemia and exacerbated by dialysis increase the risk of developing active tuberculosis (TB in chronic haemodialysis patients (HDPs. In the current study, was determined the impact of various risk factors on TB development. Our aim was to identify which HDPs need anti-TB preventive therapy. Methods Prospective study of 272 HDPs admitted, through a 36-month period, to our institutions. Specific Relative Risk (RR for TB was estimated, considering age matched subjects from the general population as reference group. Entering the study all patients were tested with tuberculin (TST. Using Cox's proportional hazard model the independent effect of various risk factors associated with TB development was estimated. Results History of TB, dialysis efficiency, use of Vitamin D supplements, serum albumin and zinc levels were not proved to influence significantly the risk for TB, in contrast to: advanced age (>65 years, BMI, diabetes mellitus, tuberculin reactivity, healed TB lesions on chest X-ray and time on dialysis. Elderly (>70 years old HDPs (Adjusted RR 25.3, 95%CI 20.4-28.4, P Conclusion The above mentioned factors have to be considered by the clinicians, evaluating for TB in HDPs. Positive TST, the existence of predisposing risk factors and/or old TB lesions on chest X-ray, will guide the diagnosis of latent TB infection and the selection of those HDPs who need preventive chemoprophylaxis.

  7. Confirmed adult dengue deaths in Singapore: 5-year multi-center retrospective study

    Directory of Open Access Journals (Sweden)

    Narayanan Rajmohan L

    2011-05-01

    Full Text Available Abstract Background Dengue re-emerges in Singapore despite decades of effective vector control; the infection predominantly afflicts adults. Severe dengue not fulfilling dengue hemorrhagic fever (DHF criteria according to World Health Organization (WHO 1997 guideline was increasingly reported. A new WHO 2009 guideline emphasized warning signs and a wider range of severe dengue manifestations. We aim to evaluate the utility of these two guidelines in confirmed adult dengue fatalities. Methods We conducted a multi-center retrospective chart review of all confirmed adult dengue deaths in Singapore from 1 January 2004 to 31 December 2008. Results Of 28 adult dengue deaths, median age was 59 years. Male gender comprised 67.9% and co-morbidities existed in 75%. From illness onset, patients presented for admission at a median of 4 days and death occurred at a median of 12 days. Intensive care admission was required in 71.4%. Probable dengue was diagnosed in 32.1% by WHO 1997 criteria and 78.6% by WHO 2009. The earliest warning sign was persistent vomiting at a median of 1.5 days. Hematocrit change ≥20% concurrent with platelet count Conclusions In our adult fatal dengue cohort, WHO 2009 criteria had higher sensitivity in diagnosing probable dengue and severe dengue compared with WHO 1997. As warning signs, persistent vomiting occurred early and hematocrit change ≥20% concurrent with platelet count

  8. National down syndrome patient database: Insights from the development of a multi-center registry study.

    Science.gov (United States)

    Lavigne, Jenifer; Sharr, Christianne; Ozonoff, Al; Prock, Lisa Albers; Baumer, Nicole; Brasington, Campbell; Cannon, Sheila; Crissman, Blythe; Davidson, Emily; Florez, Jose C; Kishnani, Priya; Lombardo, Angela; Lyerly, Jordan; McCannon, Jessica B; McDonough, Mary Ellen; Schwartz, Alison; Berrier, Kathryn L; Sparks, Susan; Stock-Guild, Kara; Toler, Tomi L; Vellody, Kishore; Voelz, Lauren; Skotko, Brian G

    2015-11-01

    The Down Syndrome Study Group (DSSG) was founded in 2012 as a voluntary, collaborative effort with the goal of supporting evidenced-based health care guidelines for individuals with Down syndrome (DS). Since then, 5 DS specialty clinics have collected prospective, longitudinal data on medical conditions that co-occur with DS. Data were entered by clinical staff or trained designees into the National Down Syndrome Patient Database, which we created using REDCap software. In our pilot year, we enrolled 663 participants across the U.S., ages 36 days to 70 years, from multiple racial and ethnic backgrounds. Here we report: (i) the demographic distribution of participants enrolled, (ii) a detailed account of our database infrastructure, and (iii) lessons learned during our pilot year to assist future researchers with similar goals for other patient populations.

  9. Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China

    OpenAIRE

    Jia, Zhen-Yi; Yang, Jun; XIA, Yang; Tong, Da-Nian; Gary P. Zaloga; Qin, Huan-Long; ,

    2015-01-01

    Background Small studies suggest differences in efficacy and safety exist between olive oil-based (OLIVE) and soybean oil-based (SOYBEAN) parenteral nutrition regimens in hospitalized adult patients. This large, prospective, randomized (1:1), open-label, multi-center, noninferiority study compared the delivery, efficacy, and safety of OLIVE (N = 226) with SOYBEAN (N = 232) in Chinese adults (≥18 years) admitted to a surgical service for whom parenteral nutrition was required. Methods Treatmen...

  10. Proton pump inhibitor step-down therapy for GERD: A multi-center study in Japan

    Institute of Scientific and Technical Information of China (English)

    Takao Tsuzuki; Hiroyuki Okada; Yoshiro Kawahara; Ryuta Takenaka; Junichiro Nasu; Hidehiko Ishioka; Akiko Fujiwara; Fumiya Yoshinaga; Kazuhide Yamamoto

    2011-01-01

    AIM: To investigate the predictors of success in stepdown of proton pump inhibitor and to assess the quality of life (QOL). METHODS: Patients who had heartburn twice a week or more were treated with 20 mg omeprazole (OPZ) once daily for 8 wk as an initial therapy (study 1). Patients whose heartburn decreased to once a week or less at the end of the initial therapy were enrolled in study 2 and treated with 10 mg OPZ as maintenance therapy for an additional 6 mo (study 2). QOL was investigated using the gastrointestinal symptom rating scale (GSRS) before initial therapy, after both 4 and 8 wk of initial therapy, and at 1, 2, 3, and 6 mo after starting maintenance therapy. RESULTS: In study 1, 108 patients were analyzed. Their characteristics were as follows; median age: 63 (range: 20-88) years, sex: 46 women and 62 men. The success rate of the initial therapy was 76%. In the patients with successful initial therapy, abdominal pain, indigestion and reflux GSRS scores were improved. In study 2, 83 patients were analyzed. Seventy of 83 patients completed the study 2 protocol. In the per-protocol analysis, 80% of 70 patients were successful for stepdown. On multivariate analysis of baseline demographic data and clinical information, no previous treatment for gastroesophageal reflux disease (GERD) [odds ratio (OR) 0.255, 95% CI: 0.06-0.98] and a lower indigestion score in GSRS at the beginning of step-down therapy (OR 0.214, 95% CI: 0.06-0.73) were found to be the predictors of successful step-down therapy. The improved GSRS scores by initial therapy were maintained through the step-down therapy. CONCLUSION: OPZ was effective for most GERD patients. However, those who have had previous treatment for GERD and experience dyspepsia before stepdown require particular monitoring for relapse.

  11. The clinical application of cardiovascular implantable electronic devices in China:a multi-center regis-try study%家庭监测功能的心血管植入型电子器械的临床应用--多中心注册研究结果

    Institute of Scientific and Technical Information of China (English)

    陈柯萍; 于波汤; 宝鹏; 张澍; 华伟; 刘欣; 杨杰孚; 宿燕岗; 梁兆光; 汪芳; 陈泗林; 梁延春

    2016-01-01

    Objective To investigate the clinical application of cardiovascular implantable electronic devices(CIED)with home monitoring(HM) function in China. Methods This study was a multi-center, pro-spective, registry study to enroll patients who underwent implantion of a pacemaker or an implantable cardioverter debrillator (including cardiac resynchronization therapy devices) with HM function. HM function was activated in all patients to allow daily remote monitoring.The third party was authorized to monitor HM data. Results From February 2009 to October 2014,a total of 5 378 patients were implanted with HM devices. Pacemaker was the most common type among HM device implantations, accounting for 68. 0%.The number of HM implantation was increasing with year, but was stable after 2012. The majority of HM devices were implanted in Beijing. Patients who lived in Beijing were also underwent insertion of the majority HM devices. 40% patients with HM devices lived in remote areas. Over a follow-up period of (711. 6 ± 486. 0) days, 445 patients were died. The mortality of all causes was 8. 3%. Conclusion CIED with HM have been widely used in domestic clinical, but still with obvi-ous regional differences. Pacemaker was the most common type among HM device implant. A new model of HM data management has been established by authorizing a third party, which can improve the information transmission ratio.%目的:了解具有家庭监测功能的心血管植入型电子器械(CIED)在国内的临床应用现状。方法本研究为前瞻性、多中心的注册研究,连续入选植入具有家庭监测功能的起搏器、植入型心律转复除颤器以及心脏再同步治疗起搏器和除颤器患者。所有患者均程控打开远程监测功能,每日收集其远程监测信息。由第三方公司负责数据收集和监测。结果2009年2月10日至2014年12月31日,323家医院参与注册研究,共5378例患者植入了具有家庭监测功能的 CIED

  12. Nosocomial Rotavirus Gastroenteritis in pediatric patients: a multi-center prospective cohort study

    Directory of Open Access Journals (Sweden)

    Festini Filippo

    2010-08-01

    Full Text Available Abstract Background Few data are available on the incidence of nosocomial Rotavirus infections (NRVI in pediatric hospitals and on their economic impact. The goals of this study were: to evaluate the incidence of NRVI in various Italian pediatric wards during the course of two peak RV seasons; to investigate possible risk factors for NRVI; to estimate the costs caused by NRVI. Methods prospective cohort study. Population: all the children under 30 months of age who were admitted without any symptom or diagnosis of gastroenteritis in the pediatric hospitals of Florence, Naples, Brescia and Ancona, Italy, during the winter-spring periods 2006-2007 and 2007-2008. Serial RV rapid tests and clinical monitoring were carried out on the cohort. Telephone interviews were performed from 3 to 5 days after discharge. Results 520 out of 608 children completed the study (85.6%. The overall incidence of NRVI was 5.3% (CI95% 3.6-7.5, (7.9 per 1,000 days of hospital stay, CI 95% 5.3-11.3. The average duration of hospital stay was significantly longer for children who had NRVI (8.1 days, SD 5.4 than for non-infected children (6.4 days, SD 5.8, difference 1.7 days, p = 0.004. The risk of contracting NRVI increased significantly if the child stayed in hospital more than 5 days, RR = 2.8 (CI95% 1.3-6, p = 0.006. In Italy the costs caused by NRVI can be estimated at 8,019,155.44 Euro per year. 2.7% of the children hospitalized with no gastroenteritis symptoms tested positive for RV. Conclusions Our study showed a relevant incidence of NRVI, which can increase the length of the children's stay in hospital. Limiting the number of nosocomial RV infections is important to improve patients' safety as well as to avoid additional health costs.

  13. Characterization of Complex Fractionated Atrial Electrograms by Sample Entropy: An International Multi-Center Study

    Directory of Open Access Journals (Sweden)

    Eva Cirugeda–Roldán

    2015-10-01

    Full Text Available Atrial fibrillation (AF is the most commonly clinically-encountered arrhythmia. Catheter ablation of AF is mainly based on trigger elimination and modification of the AF substrate. Substrate mapping ablation of complex fractionated atrial electrograms (CFAEs has emerged to be a promising technique. To improve substrate mapping based on CFAE analysis, automatic detection algorithms need to be developed in order to simplify and accelerate the ablation procedures. According to the latest studies, the level of fractionation has been shown to be promisingly well estimated from CFAE measured during radio frequency (RF ablation of AF. The nature of CFAE is generally nonlinear and nonstationary, so the use of complexity measures is considered to be the appropriate technique for the analysis of AF records. This work proposes the use of sample entropy (SampEn, not only as a way to discern between non-fractionated and fractionated atrial electrograms (A-EGM, Entropy 2015, 17 7494 but also as a tool for characterizing the degree of A-EGM regularity, which is linked to changes in the AF substrate and to heart tissue damage. The use of SampEn combined with a blind parameter estimation optimization process enables the classification between CFAE and non-CFAE with statistical significance (p < 0:001, 0.89 area under the ROC, 86% specificity and 77% sensitivity over a mixed database of A-EGM combined from two independent CFAE signal databases, recorded during RF ablation of AF in two EU countries (542 signals in total. On the basis of the results obtained in this study, it can be suggested that the use of SampEn is suitable for real-time support during navigation of RF ablation of AF, as only 1.5 seconds of signal segments need to be analyzed.

  14. A multi-center study to define sarcopenia in patients with end-stage liver disease.

    Science.gov (United States)

    Carey, Elizabeth J; Lai, Jennifer C; Wang, Connie W; Dasarathy, Srinivasan; Lobach, Iryna; Montano-Loza, Aldo J; Dunn, Michael A

    2017-02-27

    Sarcopenia is associated with increased waitlist mortality, but a standard definition is lacking. In this retrospective study, we sought to determine the optimal definition of sarcopenia in end-stage liver disease (ESLD) patients awaiting LT. Included were 396 patients newly listed for LT in 2012 at five North American transplant centers. All CT scans were read by two individuals with inter-observer correlation of 98%. Using image analysis software, the total cross-sectional area (cm(2) ) of abdominal skeletal muscle at L3 was measured. The skeletal muscle index (SMI), which normalizes muscle area to patient height, was then calculated. The primary outcome was waitlist mortality, defined as death on the waitlist or removal from the waitlist for reasons of clinical deterioration. Sex-specific potential cut-off values to define sarcopenia were determined with a grid search guided by log-rank test statistics. Optimal search method identified potential cutoffs to detect survival differences between groups. The overall median SMI was 47.6 cm(2) /m(2) : 50.0 in men and 42.0 in women. At a median of 8.8 months follow-up, mortality was 25% in men and 36% in women. Patients who died had lower SMI than those who survived (45.6 vs 48.5 cm(2) /m(2) , p<0.001) and SMI was associated with waitlist mortality (HR 0.95, p<0.001). Optimal search method yielded SMI cut-offs of 50 cm(2) /m(2) for men and 39 cm(2) /m(2) for women; these cutoff values best combined statistical significance with a sufficient number of events to detect survival differences between groups. In conclusion, we recommend that an SMI < 50 cm(2) /m(2) for men and < 39 cm(2) /m(2) for women be used to define sarcopenia in patients with ESLD awaiting LT. This article is protected by copyright. All rights reserved.

  15. Transplant Nurses' Work Environment: A Cross-Sectional Multi-Center Study.

    Science.gov (United States)

    Kugler, Christiane; Akca, Selda; Einhorn, Ina; Rebafka, Anne; Russell, Cynthia L

    2016-09-01

    BACKGROUND Numerically, nurses represent the largest healthcare profession, thus setting norms for the quality and safety of direct patient care. Evidence of a global shortage of nurses in all clinical practice settings across different healthcare systems and countries has been documented. The aims of the present study were: (1) to assess work environments in a sample of German transplant nurses, and (2) to compare their statements with a US-based sample. MATERIAL AND METHODS In a cross-sectional study, 181 transplant nurses from 16 German transplant centers provided information on their work environments. The translated version of the Job Design (JD) and Job Satisfaction (JS) survey showed satisfactory internal consistency for the JD (0.78) and JS (0.93) subscales. German nurses' work environments were compared with 331 transplant nurses from the US. RESULTS The majority of transplant nurses were female (81.8%), 55.4% were age 21-40 years, and 78.1% were employed full-time. German (versus US) transplant nurses reported their job design to be best for 'skill varieties' (p≤0.0002), and worst for 'autonomy' (p≤0.01). Job satisfaction was best with 'opportunities for autonomy and growth' (p≤0.0001), and 'pay and benefits' (p≤0.0001) was lowest. A higher professional degree (OR 1.57; p≤0.03; 95% CI 1.19-2.86), and longer time in transplant (OR 1.24; p≤0.001; 95% CI 1.11-1.38) showed a positive impact on German transplant nurses' perceptions of 'job satisfaction'. Nurses with time-dependent working contracts perceived more stress negatively affecting job satisfaction (OR 1.13; p≤0.009; 95% CI 1.02-12.82). CONCLUSIONS German specialty nurses working in the field of solid organ transplantation rate their work environments with respect to job design and job satisfaction as satisfactory. Institutions' investment into satisfactory nurse work environments and specializing nurses might increase the quality of care, thus improving patient outcomes.

  16. Personality traits affect teaching performance of attending physicians: results of a multi-center observational study.

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    Renée A Scheepers

    Full Text Available BACKGROUND: Worldwide, attending physicians train residents to become competent providers of patient care. To assess adequate training, attending physicians are increasingly evaluated on their teaching performance. Research suggests that personality traits affect teaching performance, consistent with studied effects of personality traits on job performance and academic performance in medicine. However, up till date, research in clinical teaching practice did not use quantitative methods and did not account for specialty differences. We empirically studied the relationship of attending physicians' personality traits with their teaching performance across surgical and non-surgical specialties. METHOD: We conducted a survey across surgical and non-surgical specialties in eighteen medical centers in the Netherlands. Residents evaluated attending physicians' overall teaching performance, as well as the specific domains learning climate, professional attitude, communication, evaluation, and feedback, using the validated 21-item System for Evaluation of Teaching Qualities (SETQ. Attending physicians self-evaluated their personality traits on a 5-point scale using the validated 10-item Big Five Inventory (BFI, yielding the Five Factor model: extraversion, conscientiousness, neuroticism, agreeableness and openness. RESULTS: Overall, 622 (77% attending physicians and 549 (68% residents participated. Extraversion positively related to overall teaching performance (regression coefficient, B: 0.05, 95% CI: 0.01 to 0.10, P = 0.02. Openness was negatively associated with scores on feedback for surgical specialties only (B: -0.10, 95% CI: -0.15 to -0.05, P<0.001 and conscientiousness was positively related to evaluation of residents for non-surgical specialties only (B: 0.13, 95% CI: 0.03 to 0.22, p = 0.01. CONCLUSIONS: Extraverted attending physicians were consistently evaluated as better supervisors. Surgical attending physicians who display high levels of

  17. 金草口服液治疗小儿急性支气管炎痰热壅肺证的多中心临床研究%Multi-center Clinical Study on Jincao Oral Liquid in the Treatment of Phlegm-heat Obstructing Lung Syndrome in Children with Acute Bronchitis

    Institute of Scientific and Technical Information of China (English)

    陈曦; 马融; 胡思源; 刘虹; 黄文玉; 李荣辉; 向希雄; 闫慧敏

    2013-01-01

    OBJECTIVE: To evaluate the effectiveness and safety of Jincao oral liquid in the treatment of phlegm-heat obstructing lung syndrome in children with acute bronchitis. METHODS: Stratified random, double-blind, parallel control of positive drug and multi-center clinical study were applied. Trial group and control group were given Jincao oral liquid and Jizhi syrup respectively, 5 ml per time for children aged 1-2 years old, 10 ml children aged 3-6 years old, 15 ml children aged 7-14 years old, 3 times a day for 5 days. RESULTS: The effectiveness of Jincao oral liquid for cough, expectoration and physical signs of phlegm-heat obstructing lung syndrome in children with acute bronchitis reached 87.20% , 81.71% , 80.37% (full data analysis set) respectively, which was similar to control group. Results of full data analysis set were in line with that of program data set. There was no significant difference between therapeutic efficacies of main symptoms and therapeutic efficacies of secondary symptoms, disease, syndrome and thoracic roentgenoscopy(P>0.05). No ADR related to drug use was found. CONCLUSION: Jincao oral liquid possesses obvious effectiveness for cough, expectoration and physical signs of mild and moderate pediatric acute bronchitis, which is similar to Jizhi syrup.%目的:评价金草口服液治疗小儿急性支气管炎痰热壅肺证的有效性与安全性.方法:采用分层区组随机、双盲、阳性药平行对照、多中心临床研究的方法.试验组与对照组患者分别服用金草口服液和急支糖浆,两药的用量均为1~2岁每次5 ml;3~6岁每次10 ml;7~14岁每次15 ml.每日3次,疗程均为5d.结果:金草口服液对轻、中度小儿急性支气管炎痰热壅肺证之咳嗽、咯痰、肺部体征疗效分别达到87.20%、81.71%、80.37%(全分析数据集),与对照组相当,且全分析数据集和符合方案数据集分析结论一致.两组患儿主要症状疗效、次要症状疗效、疾病疗效、

  18. A Multi-Center Prospective Derivation and Validation of a Clinical Prediction Tool for Severe Clostridium difficile Infection.

    LENUS (Irish Health Repository)

    Na, Xi

    2015-04-23

    Prediction of severe clinical outcomes in Clostridium difficile infection (CDI) is important to inform management decisions for optimum patient care. Currently, treatment recommendations for CDI vary based on disease severity but validated methods to predict severe disease are lacking. The aim of the study was to derive and validate a clinical prediction tool for severe outcomes in CDI.

  19. Stability of R2* and quantitative susceptibility mapping of the brain tissue in a large scale multi-center study

    Science.gov (United States)

    Wang, Rongpin; Xie, Guangyou; Zhai, Maoxiong; Zhang, Zhongping; Wu, Bing; Zheng, Dandan; Hong, Nan; Jiang, Tao; Wen, Baohong; Cheng, Jingliang

    2017-01-01

    Multi-center studies are advantageous for enrolling participants of varying pathological and demographical conditions, and especially in neurological studies. Hence stability of the obtained quantitative R2* and susceptibility in multicenter studies is a key issue for their widespread applications. In this work, the stabilities of simultaneously obtained R2* and susceptibility are investigated and compared across 10 sites that are equipped with the same scanner and receiver coil, the same post-processing process was used to achieve consistent experiment setup. Two healthy adult volunteers (one male and female) participated in this study. High intraclass correlation coefficient was obtained for both susceptibility (0.94) and R2* (0.96). The coefficients of variance for all measurements obtained were smaller than 0.1, the largest variations of measurements in all the chosen ROIs fall within ±20% from the median value. Higher level of stability was obtained in R2* as compared to susceptibility at 1 mm resolution (P < 0.05) and at 1.5 mm (P < 0.01). PMID:28349957

  20. Patient-reported adverse effects of high-dose intravenous methylprednisolone treatment : a prospective web-based multi-center study in multiple sclerosis patients with a relapse

    NARCIS (Netherlands)

    Jongen, Peter Joseph; Stavrakaki, Ioanna; Voet, Bernard; Hoogervorst, Erwin; van Munster, Erik; Linssen, Wim H.; Sinnige, Ludovicus G.; Verhagen, Wim I.; Visser, Leo H.; van der Kruijk, Ruud; Verheul, Freek; Boringa, Jan; Heerings, Marco; Gladdines, Werner; Lonnqvist, Fredrik; Gaillard, Pieter

    2016-01-01

    In a prospective multi-center observational study, we evaluated the frequency, severity, and impact on activities of daily living (ADL) of adverse effects (AEs) of high-dose intravenous methylprednisolone (IVMP) in relapsing remitting multiple sclerosis (MS) patients with a relapse. Online self-repo

  1. Mifepristone in Combination with Misoprostol vs. Low Dose Mifepristone Alone in Emergency Contraception: a Multi-center Double-blind Randomized Clinical Trial

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    Objective To compare the effectiveness and side effects of various low dose ofMi fepristone in combination with Misoprostol and low doses Mi fepristone alone in emer-gency contraceptionMaterials & Methods This is a multi-center double-blind randomized controlled clini-cal trial. A total of 899 healthy women were allocated into this study and were ran-domly divided into 3 groups. They were orally administrated with different emergen-cy contraceptives with 120 h after unprotected intercourse. Group Ⅰ (n = 300) was giv-en 25 mg Mifepristone plus 0. 2 mg Misoprostol after 24 h. Group Ⅱ (n = 299) wasgiven 10 mg Mifepristone plus 0. 2 mg Misoprostol after 24 h. Group Ⅲ (n = 300)was administrated with 10 mg Mifepristone alone. The effective rates in differentgroups were calculated with Dixon method.Results Altogether 11 pregnancies occurred, among which 2 cases were in Group Ⅰ, 2cases in Group Ⅱ, and 7 cases were in Grout Ⅲ. After correction with method fail-ure, there was only one case in Group Ⅰ, 0 case in Group Ⅱ, and 5 cases in Group Ⅲ.The contraceptive effectiveness in these groups was 95. 5%, 100% and 76. 9% respec-tively. The pregnancy rate was significantly lower in Group Ⅰ and Group Ⅱ than thatof Group Ⅲ (P< 0. 01). The side effects were slight and tolerable, and there was nosignificant difference between di fferent groups (P> 0. 05).Conclusion Use of low dose Mi fepristone (25 mg or 10 mg ) in combination with 0. 2mg Misoprostol was an effective, low side effects and safe treatment regimen foremergency contraception.

  2. Paediatric Early Warning Score - A multi-center randomized controlled intervention study

    DEFF Research Database (Denmark)

    Jensen, Claus Sixtus; Aagaard, Hanne; Olesen, Hanne Vebert;

    and implementation of PEWS is expected to contribute to reduce the number of children developing acute critical illness, number of admissions to intensive care. PEWS is also expected to contribute to increase professional skills and competences in health professionals. It is expected that this study will contribute...... is critically ill are related to the child’s symptoms of serious illness often being uncharacteristic. Children can seem relatively unaffected until a short time before circulatory insufficiency and cardiac arrest. Thus, there is a need for developing and investigating if an Paediatric Early Warning System...... (PEWS) model for ill children has a significant influence on children’s development of acute conditions. Objective: The purpose of this study is to investigate if PEWS optimises identification of acute and critically ill children and prevents life-threatening situations. Moreover, the study investigated...

  3. Intestinal fungal and parasitic infections in kidney transplant recipients: A multi-center study

    Directory of Open Access Journals (Sweden)

    Afsoon Emami Naeini

    2012-01-01

    Full Text Available Kidney transplant recipients are susceptible to various infections due to the use of immunosuppressive drugs. The present study was performed as studies on the prevalence of intes-tinal fungal and parasitic infections in kidney transplant recipients are limited. A total of 150 kidney transplant recipients and 225 matched immunocompetent outpatients, who were referred to the laboratory of Noor Hospital, Isfahan, were studied. After recording demographic characte-ristics, direct test and specific laboratory cultures were carried out on the stool specimens. Patients were instructed on sanitary rules and, during each medical visit, they were reminded of the same. The overall prevalence of intestinal parasitic and fungal infections was 33.3% and 58.7%, respec-tively, in transplant recipients and 20% and 51%, respectively, in the control group; the difference was not statistically significant. The most prevalent intestinal parasite was Entameba coli, which was seen in 9.3% of the study patients and 6.7% of the controls. The most prevalent fungus was Candida sp., which was seen in 22% of the study patients and 24.4% of the control group. Co-existing infection with two or more fungi was seen in 14.8% and 3.4% in the case and control groups, respectively; P <0.001. Interestingly, there was no significant difference in the prevalence of infection by a single organism between the two groups. However, co-existing infection with two or more species was more prevalent in transplant recipients. We conclude that further investigations are needed to evaluate the pathogenesis of infection with these microorganisms.

  4. Randomized Multi-center Study of Baofuxin for Treatment of Bleeding Side-effect Induced by IUD

    Institute of Scientific and Technical Information of China (English)

    吴尚纯; 王翠萍; 程渭玉; 韩学军; 王素贞; 戚娟芳; 刘莹; 付伟

    2000-01-01

    Objective To observe the efficacy of Baofuxin for treatment of bleeding side effect induced by IUD.Method The study is a multi-center trial. The subjects were randomly allocated into two groups, Baofuxin group ( 90 cases) and Indomethacin group ( 90 cases). In the Baofuxin group, the subjects took the medicine on the first day of menses, once a bag,twice a day for 10 days. In the Indomethacin group, only one capsule was taken once a time, twice a day for 7 days. The treatment was given for three menstrual cycles.The subjects were asked to record their bleeding~spotting by using menstrual diary card not only during the treatment cycles but also during the three months previous and after the treatment cycles. The menstrual profile was analyzed by using MDSv2. 3 program that was provided by WHO.Results Within each 90-day reference period of treatment and post-treatment cycles,the number of bleeding/spotting days decreased obviously and bleeding/spotting free days were greatly increased. Both medicines have little effect on number of episode of bleeding/spotting. The subjects who thought the treatment were highly effective were 81. 1% in the Baofuxin group and 56. 2% in the Indomethacin group respectively (P< 0.01).Conclusion Both Baofuxin and indomethacin are highly effective on treatment of bleeding side effect induced by IUD, but Baofuxin had longer effects and was more acceptable.

  5. A multi-center study of Restylane for treatment of nasolabial folds in China

    Institute of Scientific and Technical Information of China (English)

    YAN Xiao-qing; CHEN Li-yang; HUANG Lü-ping; YOU Lei; MA Yong-guang; L(U) Chang-sheng; LI Wei; XU Jun

    2010-01-01

    Background Restylane, a hyaluronic acid gel, has been widely used as a dermal filler in USA and European countries. This study was designed to study the safety and efficacy of Restylane as a non-permanent dermal filler for facial augmentation therapy in China for the correction of nasolabial folds during a follow-up period of 6 months. Methods The study consisted of a screening visit, a baseline visit during which injection with Restylane was given, and follow-up visits after four weeks, three months and six months. The efficacy was subjectively assessed by comparing the treatment results between pre-treatment and post-treatment. Adverse events were analyzed by severity and duration. Results At six months post-baseline, the subjects and the investigators' independent assessment score of Wrinkle Severity Rating Scale was decreased. Global Aesthetic Improvement Scale was considered to have improved by over 90% in some cases. Adverse events related to product and injection was reported in 21.5% of the injections. A vast majority of the post-treatment reactions were mild. Conclusions The efficacy of Restylane for nasolabial fold in a Chinese population was excellent. Restylane was well tolerated and no systemic reactions or other safety concerns were raised.

  6. Assessment of gynecologic malignancies: A multi-center study in Tehran (1995-2005

    Directory of Open Access Journals (Sweden)

    S Momtahen

    2009-01-01

    Full Text Available Objective: The observed differences in cancer incidence are mainly due to different individuals and social risk factors. This study aims to demonstrate the characteristics of female genital malignancies according to the pathological records in Tehran, Iran. Materials and Methods: In this cross-sectional study, all records of pathological specimens categorized as ovarian, uterine corpus or uterine cervix cancers from 1995 to 2005, in five teaching hospitals in Tehran, were studied. Age, marriage, parity, menopausal status, smoking, oral contraceptive usage, pathological staging, and histological grading were reviewed by a trained general practitioner. SPSS 14 was used for statistical analysis. Result: Mean age (SD at the time of diagnosis was 50 (15. Fifty-nine percent of ovarian, 33.9 and 47.7% of uterine corpus and uterine cervix malignant patients were premenopausal. About 90% of all were nonsmokers and 82.7% were multiparae. Various types of gynecologic malignancies included ovarian (55.5%, uterine corpus (24.9%, and uterine cervical cancers (19.6% were diagnosed. In tumors of the uterine corpus and uterus cervix, the most frequent stage of diagnosis was stage IIA. Conclusion: Ovarian cancer was the most frequently occurring gynecologic tumor. Although distribution of age in ovarian cancer was similar to that mentioned in the literature, occurrence of the cancer was more frequent in the premenopausal state.

  7. Iron status and Helicobacter pylori infection in symptomatic children: an international multi-centered study.

    Directory of Open Access Journals (Sweden)

    Dulciene Maria Magalhaes Queiroz

    Full Text Available OBJECTIVE: Iron deficiency (ID and iron deficiency anaemia (IDA are global major public health problems, particularly in developing countries. Whilst an association between H. pylori infection and ID/IDA has been proposed in the literature, currently there is no consensus. We studied the effects of H. pylori infection on ID/IDA in a cohort of children undergoing upper gastrointestinal endoscopy for upper abdominal pain in two developing and one developed country. METHODS: In total 311 children (mean age 10.7±3.2 years from Latin America--Belo Horizonte/Brazil (n = 125, Santiago/Chile (n = 105--and London/UK (n = 81, were studied. Gastric and duodenal biopsies were obtained for evaluation of histology and H. pylori status and blood samples for parameters of ID/IDA. RESULTS: The prevalence of H. pylori infection was 27.7% being significantly higher (p<0.001 in Latin America (35% than in UK (7%. Multiple linear regression models revealed H. pylori infection as a significant predictor of low ferritin and haemoglobin concentrations in children from Latin-America. A negative correlation was observed between MCV (r = -0.26; p = 0.01 and MCH (r = -0.27; p = 0.01 values and the degree of antral chronic inflammation, and between MCH and the degree of corpus chronic (r = -0.29, p = 0.008 and active (r = -0.27, p = 0.002 inflammation. CONCLUSIONS: This study demonstrates that H. pylori infection in children influences the serum ferritin and haemoglobin concentrations, markers of early depletion of iron stores and anaemia respectively.

  8. Pooling fMRI data: meta-analysis, mega-analysis and multi-center studies

    Directory of Open Access Journals (Sweden)

    Sergi G Costafreda

    2009-09-01

    Full Text Available The quantitative analysis of pooled data from related fMRI experiments has the potential to significantly accelerate progress in brain mapping. Such data-pooling can be achieved through meta-analysis (the pooled analysis of published results, mega-analysis (the pooled analysis of raw data or multi-site studies which can be seen as designed mega-analyses. Current limitations in function-location brain mapping and how data-pooling can be used to remediate them are reviewed, with particular attention to power aggregation and mitigation of false positive results. Some recently developed analysis tools for meta- and mega-analysis are also presented, and recommendations for the conduct of valid fMRI data pooling are formulated.

  9. Prevalence estimates for primary brain tumors in China: a multi-center cross-sectional study

    Institute of Scientific and Technical Information of China (English)

    JIANG Tao; WU Nai-feng; CHEN Xiao-jun; XING Hou-xun; SU Tong-yong; WANG Zhong-cheng; TANG Gen-fu; LIN Yi; PENG Xiao-xia; ZHANG Xiao; ZHAI Xiu-wei; PENG Xiang; YANG Jin-qing; HUANG Hong-er

    2011-01-01

    Background Although the first leading cause of death in China was malignant neoplasms (mortality,374.1 per 100000 person-years),the full impact of primary brain tumors (PBT) on the healthcare system is not completely described because there are a few well documented reports about the epidemiologic features of brain tumors.This study aimed to report a comprehensive assessment on the prevalence of PBT.Methods A multicenter cross-sectional study on brain tumor (MCSBT) in China was initiated in five regional centers:Daqing (northeast),Puyang (north of China),Shiyan (center of China),Ma'anshan (center of China) and Shanghai (southeast).Prevalence rate was calculated by counting the number of people living with a PBT between October 1,2005 and September 30,2006 and dividing by the total population of the five communities at January 1,2006.Estimates of prevalence were expressed as percentages and grouped according to gender and to age in fifteen-year categories.Within these strata,the rates were estimated with 95% confidence intervals (C/) using the accurate calculation of CI for Poisson distribution.A chi-square test was used to compare the various frequencies with α<0.05.Age-standardized prevalence with the direct method was calculated with the ten-year age-specific prevalence and the age distribution of the Chinese population in 2010,obtained from Worldpopulation prospects:the 2008 revision.Results We estimated that the overall prevalence of PBT was 24.56 per 100 000 (95% CI,14.85 to 34.27),and the overall prevalence of PBT in female population (30.57 per 100 000 and its 95% CI ranged from 19.73 to 41.41 ) was higher than that in male population (18.84 per 100 000 and its 95% CI ranged from 10.33 to 27.35).However,the discrepancy between genders was not statistically significant because the 95% CI overlapped.Of 272 cases of newly diagnosed PBT,the proportion of histological subtypes by age groups,gender was statistically different (χ2=52.6510,P <0.0001).More than

  10. Effect of Helicobacter pylori Eradication on Reflux Esophagitis Therapy: A Multi-center Randomized Control Study

    Institute of Scientific and Technical Information of China (English)

    Yan Xue; Li-Ya Zhou; San-Ren Lin; Xiao-Hua Hou; Zhao-Shen Li; Min-Hu Chen; Xiu-E Yan

    2015-01-01

    Background:Helicobacterpylori (H.pylori) frequently colonizes the stomach.Gastroesophageal reflux disease (GERD) is a common and costly disease.But the relationship ofH.pylori and GERD is still unclear.This study aimed to explore the effect ofH.pylori and its eradication on reflux esophagitis therapy.Methods:Patients diagnosed with reflux esophagitis by endoscopy were enrolled;based on rapid urease test and Warth-Starry stain,they were divided into H.pylori positive and negative groups.H.pylori positive patients were randomly given H.pylori eradication treatment for 1 0 days,then esomeprazole 20 mg bid for 46 days.The other patients received esomeprazole 20 mg bid therapy for 8 weeks.After treatment,three patient groups were obtained:H.pylori positive eradicated,H.pylori positive uneradicated,and H.pylori negative.Before and after therapy,reflux symptoms were scored and compared.Healing rates were compared among groups.The x2 test and t-test were used,respectively,for enumeration and measurement data.Results:There were 176 H.pylori positive (with 92 eradication cases) and 180 negative cases.Healing rates in the H.pylori positive eradicated and H.pylori positive uneradicated groups reached 80.4% and 79.8% (P =0.911),with reflux symptom scores of 0.22 and 0.14 (P =0.588).Healing rates of esophagitis in the H.pylori positive uneradicated and H.pylori negative groups were,respectively,79.8% and 82.2% (P =0.848);reflux symptom scores were 0.14 and 0.21 (P =0.546).Conclusions:Based on esomeprazole therapy,H.pylori infection and eradication have no significant effect on reflux esophagitis therapy.

  11. Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: a Multi-Center, Randomized, Controlled Study

    Science.gov (United States)

    Talley, Nicholas J.; Locke, G. Richard; Saito, Yuri A.; Almazar, Ann E.; Bouras, Ernest P.; Howden, Colin W.; Lacy, Brian E.; DiBaise, John K.; Prather, Charlene M.; Abraham, Bincy P.; El-Serag, Hashem B.; Moayyedi, Paul; Herrick, Linda M.; Szarka, Lawrence A.; Camilleri, Michael; Hamilton, Frank A.; Schleck, Cathy D.; Tilkes, Katherine E.; Zinsmeister, Alan R.

    2015-01-01

    Background & Aims Anti-depressants are frequently prescribed to treat functional dyspepsia (FD), a common disorder characterized by upper abdominal symptoms, including discomfort or post-prandial fullness. However, there is little evidence for the efficacy of these drugs in patients with FD. We performed a randomized, double-blind, placebo-controlled trial to evaluate the effects of anti-depressant therapy effects on symptoms, gastric emptying (GE), and mealinduced satiety in patients with FD. Methods We performed a study at 8 North American sites of patients who met the Rome II criteria for FD and did not have depression or use anti-depressants. Subjects (n=292; 44±15 y old, 75% female, 70% with dysmotility-like FD, and 30% with ulcer-like FD) were randomly assigned to groups given placebo, 50 mg amitriptyline, or 10 mg escitalopram for 10 weeks. The primary endpoint was adequate relief of FD symptoms for ≥5 weeks of the last 10 weeks (out of 12). Secondary endpoints included GE time, maximum tolerated volume in a nutrient drink test, and FD-related quality of life. Results An adequate relief response was reported by 39 subjects given placebo (40%), 51 given amitriptyline (53%), and 37 given escitalopram (38%) (P=.05, following treatment, adjusted for baseline balancing factors including all subjects). Subjects with ulcer-like FD given amitriptyline were more than 3-fold more likely to report adequate relief than those given placebo (odds ratio=3.1; 95% confidence interval, 1.1–9.0). Neither amitriptyline nor escitalopram appeared to affect GE or meal-induced satiety after the 10 week period in any group. Subjects with delayed GE were less likely to report adequate relief than subjects with normal GE (odds ratio=0.4; 95% confidence interval, 0.2–0.8). Both anti-depressants improved overall quality-of-life. Conclusions Amitriptyline, but not escitalopram, appears to benefit some patients with FD— particularly those with ulcer-like (painful) FD. Patients

  12. 格列吡嗪控释片治疗2型糖尿病有效性和安全性的多中心临床研究%Effect and safety of glipizide GITS in the therapy of type 2 diabetes: a multi-center clinical study

    Institute of Scientific and Technical Information of China (English)

    瑞易宁临床研究协作组

    2011-01-01

    目的 评价格列吡嗪控释片(瑞易宁)治疗2型糖尿病的有效性、安全性.方法 为多中心、开放性临床观察性研究.675例患者完成了本研究.对单纯生活方式干预(n=134)或已用非胰岛素促泌剂(n=305)治疗,但血糖控制不佳的患者,加用瑞易宁;对已用其他磺脲类或格列奈类促泌剂(n=236)治疗,但血糖控制不佳、安全性不好或生活质量受影响的患者,停用原促泌剂,改用瑞易宁.瑞易宁治疗12周后,评价其有效性、安全性和对生活质量的影响.结果 应用瑞易宁治疗后,糖化血红蛋白(Hb)A1c下降(1.48±1.20)%,空腹血糖下降(2.47±1.38)mmol/L,餐后血糖下降(3.64±2.63)mmol/L(P值均为0.0000);52.21%的患者HbA1c<6.5%,83.21%的患者HbA1c<7.0%.治疗期间轻度低血糖发生率为4.59%,严重低血糖发生率为0.15%.原促泌剂治疗组改用瑞易宁后低血糖显著减少,99%以上的患者认为瑞易宁较其他促泌剂更为简单易行,生活质量提高,更愿意选用瑞易宁治疗.结论 在2型糖尿病治疗中,瑞易宁为一疗效显著、安全性好、能提高患者生活质量的口服降糖药,可广泛用于临床.%Objective To investigate the effect and safety of glipizide GITS in the therapy of type 2diabetes. Methods A total of 675 type 2 diabetic patients were included in this multi-center, open-labeled and self-controlled clinical study. Patients with inadequate glycemic control by life style intervention (n=134)or non-insulin secretagogues(n=305) were added glipizide GITS therapy for 12 weeks. Patients with inadequate glycemic control,poor safety or low life quality by other secretagogues(n =236)were changed to glipizide GITS therapy for 12 weeks. Results After treatment by glipizide GITS,HbA1c of these patients decreased (1.48 ±1.20) % ( P = 0. 0000 ), fasting blood glucose decreased ( 2.47 ± 1.38 ) mmol/L ( P= 0. 0000 ), postprandial blood glucose decreased (3.64 ±2.63)mmol/L(P = 0.0000).52. 21% patients

  13. 聚苯乙烯磺酸钙治疗慢性肾脏病高钾血症患者的多中心临床研究%Calcium polystyrene sulfonate in treating hyperkalemia patients with chronic kidney disease: a multi-center clinical study

    Institute of Scientific and Technical Information of China (English)

    李晓; 徐钢; 林洪丽; 胡昭; 余学清; 邢昌赢; 梅长林; 左力; 倪兆慧

    2013-01-01

    potassium levels in all visits during the treatment and after discontinuation of calcium polystyrene sulfonate were all significantly decreased comparing to the baseline level (all P < 0.01).At the same time,serum levels of sodium,phosphorus,calcium showed no significant changes during the treatment.Constipation (9.2%) was the commonest side effect.There was no treatment-related serious adverse effect.Conclusions This single-arm,open,multi-center clinical study shows that calcium polystyrene sulfonate is effective and safe in treating hyperkalemia due to chronic kidney disease.

  14. Multi-link Vision and MiniVision stent registry in Asian patients with coronary artery disease: a prospective, multi-center study

    Institute of Scientific and Technical Information of China (English)

    XU Ya-wei; HOU Yu-qing; Ashok Jain; Parvez Grant; Gudapati Ramesh; Basavappa Ramesh; Chumpol Piamsomboon; Srun Kuanprasert; Hyeon-Cheol Gwon; Yoon Haeng Cho; Haizal Haroon Kamar; WEI Yi-dong; HUANG Cong-xin; TANG Kai; CHEN Yan-qing; LI Wei-ming; YU Xue-jing; QIN Yong-wen; QI Guo-xian; QU Peng

    2007-01-01

    Background Recent studies have showed that the fine mesh stents are associated with a significant reduction in both clinical and angiographic re-stenosis of the coronary arteries. To maintain a very satisfactory radio-opacity using the stents, Guidant of the USA has designed a new type of bare metal stents (BMS)-Multi-link (ML) Vision / ML MiniVision stents. The clinical outcomes of Asian patients with coronary artery disease (CAD) after implanting the Multi-link Vision or MiniVision stent were investigated in this study.Methods An observational, prospective, multi-center, non-randomized post marketing registry was conducted to demonstrate the efficacy of the BMS- ML Vision / ML MiniVision stents. The primary end point of the registry was clinical target lesion revascularization (TLR) at a 6-month follow-up. The major secondary end points included the rate of major adverse cardiac events (MACE) and serious adverse events (SAE) in hospital and at 6 months; and the rate of clinical TLR as a function of the type of angina. A total of 429 Asian people with 449 lesions from 14 centers were selected for this study. The average reference diameter of the lesions was (3.0±0.5) mm, and the mean length was (15.7±5.0) mm.Results The successful rate of the procedure was 99.3%. Twenty-five percent of the lesions were treated by direct stenting without pre-dilation. Eighty-six percent of the lesions were implanted with ML Vision stent. After the 6-month follow-up, the rate of clinical TLR was 1.4%. The MACE, SAE and target vessel revascularization (TVR) were 6.8%, 3.5%and 1.4% respectively.Conclusion The current registry showed the excellent 6-month clinical outcomes of ML Vision/ML MiniVision stents in Asian patients with CAD.

  15. Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized,multi-center,double-blind,placebo-controlled clinical study%雌二醇屈螺酮片治疗绝经后妇女绝经相关症状的多中心临床研究

    Institute of Scientific and Technical Information of China (English)

    周远征; 林守清; 孙丽洲; 林金芳; 杨欣; 张莉嘉; 乔杰; 王泽华; 许燕雪; 熊正爱

    2011-01-01

    .Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned for 16 weeks in this randomized multi-center double-blind placebo-controlled study.During the trial.the follow-up visits were conducted at week 4,8,12,16 of treatment and 2 weeks after treatment respectively.Height,weight,vital signs,hot flushes,other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit,while the clinical global impression scale Was assessed at 16 weeks as well.Results It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P<0.01 ), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by - 0. 6± 0. 5 in observation group and - 0. 4 ± 0. 4 in placebo group from baseline respectively, which reached significant difference ( P < 0. 05 ). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by - 0. 6± 0. 8 in observation group and -0. 3± 0.6 in placebo group from baseline respectively, which had no significant difference (P > 0. 05 ).After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P <0. 01 ).During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48. 9% (87/178) in observation group and 10. 7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183 ). The level of serum potassium

  16. 阿达木单抗联合甲氨蝶呤治疗类风湿关节炎的多中心、随机、双盲、安慰剂对照临床研究%Adalimumab plus methotrexate for the treatment of rheumatoid arthritis: a multi-center randomized, double-blind, placebo-controlled clinical study

    Institute of Scientific and Technical Information of China (English)

    黄烽; 赵东宝; 吴东海; 张奉春; 鲍春德; 陶怡; 古洁若; 徐建华; 朱平; 徐沪济; 张志毅

    2009-01-01

    现结核病.在双盲期,有3例(1.2%)受试者出现了严重不良事件,但研究者判定与药物无关或可能无关.在开放期,有8例(2.7%)受试者出现了严重不良事件,其中3例判定与药物无关或可能无关.结论 阿达木单抗联合MTX治疗RA的疗效优于单用MTX,可显著提高治疗有效率并持续改善症状、体征、实验室炎性活动指标,减少功能障碍并提高整体生活质量,同时具有良好的安全性与耐受性.%Obiective To investigate the efficacy and safety of adalimumab plus methotrexate (MTX)for the treatment of rheumatoid arthritis(RA).Methods This is a multi-center,randomized,doable-blind, parallel-group, and placebo-controlled clinical study, included a total of 302 cases of active rheumatoid arthritis, randomized into three groups of observation: 40 mg adalimumab (121 cases), 80 mg adalimumab ( 121 cases), or placebo (60 cases). Upon enrollment, all subjects had been previously treated with MTX for at least 3 months, and their doses of drug had remained stable for at least 28 days. The double-blind phase lasted for 12 weeks, during which the subjects were administered with adalimumab or placebo subcutaneously every other week. Then the subjects entered into another 12 weeks of open-label study, which included subcutaneous injection of 40 mg adalimumab every other week. In both the double-blind and the open-label periods, all subjects were maintained concomitantly with MTX that had already been used before this study. The primary efficacy variables were evaluated on basis of American College of Rheumatology (ACR)20 response rate at week 12. The secondary efficacy variables included: ACR20 response rate at week 24; ACR50 and ACR70 response rates at weeks 12 and 24 ; and changes at weeks 12 and 24 compared with baseline observations for tender and swollen joint counts, as well as the assessment of pain with visual analog scale (VAS), the physician's and the patient's global assessment of disease activity (VAS), and the

  17. Hepatitis B Virus Vaccination Coverage in Medical, Nursing, and Paramedical Students: A Cross-Sectional, Multi-Centered Study in Greece.

    Science.gov (United States)

    Papagiannis, Dimitrios; Tsimtsiou, Zoi; Chatzichristodoulou, Ioanna; Adamopoulou, Maria; Kallistratos, Ilias; Pournaras, Spyros; Arvanitidou, Malamatenia; Rachiotis, George

    2016-03-15

    Students of health professions are at high risk of hepatitis B Virus (HBV) infection during their clinical training. The aim of this cross-sectional, multi-centered study was to investigate the HBV vaccination coverage in Greek medical, nursing, and paramedical students, to look into their attitudes towards the importance of vaccines and to reveal reasons associated with not being vaccinated. A self-completed, anonymous questionnaire was distributed to 2119 students of health professions in Greece, during the academic year 2013-2014. The HBV vaccination coverage of students was high (83%), being higher among medical students (88.1%, vs. 81.4% among nursing and 80.1% among paramedical students; p vaccinated during childhood. In addition, 30% of the unvaccinated students declared fear over HBV safety. Our results indicate that the healthcare students achieved higher reported immunization rates compared to the currently serving healthcare workers, but also to the students of the last decade. The fact that nursing and paramedical students have lower coverage figures underlines the importance of targeted interventions for the different subgroups of healthcare students in terms of educational programs and screening for HBV markers in order to increase HBV vaccination uptake.

  18. A Multi-Center Controlled Study of the Acute and Chronic Effects of Cooling Therapy for MS

    Science.gov (United States)

    Luna, Bernadette; Schwid, Steven W.; Cutter, Gary; Murray, Ronald; Bowen, James; Pellegrino, Richard; Guisado, Raul; Webbon, Bruce W.; DeVincenzi, Donald (Technical Monitor)

    2000-01-01

    To determine the acute and chronic effects of cooling therapy on patients with MS using objective functional performance measures and self-assessed measures of fatigue. Cooling demyelinated nerves can reduce conduction block, potentially improving symptoms of MS. Significant acute and chronic effects of cooling have not been demonstrated in a multi-center, controlled, blinded study using objective measures of neurologic function. Patients (N=84) with definite MS, mild to moderate disability (EDSS less than 6.0), and self-reported heat sensitivity were enrolled at 5 study sites. Acute effects of cooling were assessed by randomly assigning subjects to high-dose or low-dose cooling for one hour using an active cooling vest and cap (Life Enhancement Technologies, Santa Clara, CA). Settings were individualized to maintain the cooling garments at 55 F for the high-dose treatment and 70 F for the low-dose treatment. Both patients and examining investigators were blinded to treatment assignments. The MSFC and visual acuity/contrast sensitivity were assessed before and 30 minutes after treatment. The following week, subjects had an identical visit with the alternate cooling treatment. Chronic effects of cooling were assessed by randomly assigning the same subjects to unblinded daily home cooling or observation for 4 weeks. All subjects completed the Rochester Fatigue Diary (RFD) twice weekly and subjective measures of strength, cognition, and energy level daily. At the end of the period, subjects completed the Modified Fatigue Impact Scale (MFIS) and underwent another high-dose cooling session with assessment of the MSFC and vision. After a one-week washout period, subjects crossed over to the alternate 4-week treatment. Oral temperatures were reduced with both acute treatments (0.8 +/- .06 F, high and 0.5 +/- .06 F, low). While mean MSFC did not change significantly during individual cooling sessions, post hoc analysis pooling the 3 high-dose cooling sessions revealed an

  19. A multi-center blinded study on the efficiency of phenotypic screening methods to detect glycopeptide intermediately susceptible Staphylococcus aureus (GISA and heterogeneous GISA (h-GISA

    Directory of Open Access Journals (Sweden)

    Sloos Jacobus H

    2007-09-01

    Full Text Available Abstract Backgrounds To determine the true incidence of hGISA/GISA and its consequent clinical impact, methods must be defined that will reliably and reproducibly discriminate these resistant phenotypes from vancomycin susceptible S. aureus (VSSA. Methods This study assessed and compared the ability of eight Dutch laboratories under blinded conditions to discriminate VSSA from hGISA/GISA phenotypes and the intra- and inter-laboratory reproducibility of agar screening plates and the Etest method. A total of 25 blinded and unique strains (10 VSSA, 9 hGISA and 6 GISA were categorized by the PAP-AUC method and PFGE typed to eliminate clonal duplication. All strains were deliberately added in quadruplets to evaluate intra-laboratory variability and reproducibility of the methods. Strains were tested using three agar screening methods, Brain Heart Infusion agar (BHI + 6 μg/ml vancomycin, Mueller Hinton agar (MH + 5 μg/ml vancomycin and MH + 5 μg/ml teicoplanin and the Etest macromethod using a 2 McFarland inoculum. Results and Discussion The ability to detect the hGISA/GISA phenotypes varied significantly between methods and phenotypes. BHI vancomycin and MH vancomycin agar screens lacked the ability to detect hGISA. The MH teicoplanin agar screen was more sensitive but still inferior to Etest that had a sensitivity of 98.5% and 99.5%, for hGISA and GISA, respectively. Intra- and inter-laboratory reproducibility varied between methods with poorest performance seen with BHI vancomycin. Conclusion This is the first multi-center blinded study to be undertaken evaluating various methods to detect GISA and hGISA. These data showed that the ability of clinical laboratories to detect GISA and hGISA varied considerably, and that screening plates with vancomycin have a poor performance in detecting hGISA.

  20. A Prospective Multi-Center Clinical Trial to Compare Efficiency, Accuracy and Safety Of the VisionScope Imaging System Compared to MRI and Diagnostic Arthroscopy

    Science.gov (United States)

    Xerogeanes, John W.; Safran, Marc R.; Huber, Bryan; Mandelbaum, Bert R.; Robertson, William; Gambardella, Ralph A.

    2014-01-01

    Objectives: Until now, arthroscopic surgery has been the gold standard for the diagnosis of intra-articular pathology. When a patient presents with ongoing pain and/or disability despite non-operative care, MRI is commonly used as a diagnostic modality. To date, there is not a minimally-invasive option that can provide detailed information about the intra-articular pathology of a joint. VisionScope Imaging (VSI) is an office-based diagnostic modality that provides comprehensive real-time images and video of a joint with higher accuracy and reliability compared to static MR images. The purpose of this study was to compare the efficacy, accuracy and safety of VSI compared to MRI and surgical diagnostic arthroscopy. Methods: A prospective, blinded, multi-centered study was performed of all patients who had a routine surgical arthroscopy at one of the six participating clinical sites between July 2012 and May 2013. Patients were consented by the physician investigator at each site. Study inclusion criteria consisted of: suspected meniscal tears or articular cartilage damage. Patients were excluded from the study if they had (1) acute traumatic hemarthoses, (2) concomitant ligament injury, (3) active systemic infection, (4) allergy to silicone or any medication used during the procedure,. All patients had a MRI and a comprehensive physical exam prior to their surgical arthroscopy. Each patient underwent a MRI, VSI exam and surgical diagnostic arthroscopy. The attending physician completed standard forms comparing the VSI exam findings to the diagnostic arthroscopy findings on each patient. Two blinded experts unaffiliated with the study reviewed the VSI and MRI images. The arthroscopy served as the “control” comparison between the VSI and MRI findings. Results: There were 110 patients included in this study. The accuracy, sensitivity and specificity of VSI was equivalent to surgical diagnostic arthroscopy and more accurate than MRI (Table 1). When comparing VSI to

  1. Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy

    Science.gov (United States)

    Schicho, Andreas; Pereira, Philippe L.; Pützler, Manfred; Michalik, Katharina; Albrecht, Thomas; Nolte-Ernsting, Claus; Stroszczynski, Christian; Wiggermann, Philipp

    2017-01-01

    Background The aim of this study was to evaluate the safety and efficacy of DSM (degradable starch microspheres) as an embolic agent in transarterial chemoembolization in the treatment of intrahepatic cholangiocellular carcinoma (ICC). Material/Methods This was a national, multi-center observational cohort study on the safety and efficacy of DSM-TACE using mitomycin, gemcitabine, cisplatin, doxorubicin, and carboplatin in palliative treatment of ICC. Recruitment period for the study was from January 2010 to June 2014. Primary endpoints were toxicity, safety, and response according to mRECIST criteria. Results Twenty-five DSM-TACE procedures in cases of advanced ICC were performed in seven patients. Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87.5%) associated with the use of gemcitabine. In 11 out of 25 treatments (44%) moderate, transient epigastric pain was registered as an adverse event (AE) within 24 hours of DSM-TACE. One case (1/25) of severe AE (4%) with thrombocytopenia led to discontinuation of the DSM-TACE-treatment. A total of 25 DSM-TACE procedures with complete clinical and imaging follow-up over a two-year-period were analyzed: objective response (OR) was achieved in three of 25 treatments (12%) Disease control (DC) was achieved in 44% (11/25) of treatments; progress was registered in 4% (1/25). Conclusions The use of DSM as an embolic agent for TACE is safe in the treatment of ICC. A standardized anti-emetic medication should be established, especially when using gemcitabine. Further prospective studies need to be conducted to find the most suitable, standardized DSM-TACE treatment regime. PMID:28192388

  2. Degradable Starch Microspheres Transcatheter Arterial Chemoembolization (DSM-TACE) in Intrahepatic Cholangiocellular Carcinoma (ICC): Results from a National Multi-Center Study on Safety and Efficacy.

    Science.gov (United States)

    Schicho, Andreas; Pereira, Philippe L; Pützler, Manfred; Michalik, Katharina; Albrecht, Thomas; Nolte-Ernsting, Claus; Stroszczynski, Christian; Wiggermann, Philipp

    2017-02-13

    BACKGROUND The aim of this study was to evaluate the safety and efficacy of DSM (degradable starch microspheres) as an embolic agent in transarterial chemoembolization in the treatment of intrahepatic cholangiocellular carcinoma (ICC). MATERIAL AND METHODS This was a national, multi-center observational cohort study on the safety and efficacy of DSM-TACE using mitomycin, gemcitabine, cisplatin, doxorubicin, and carboplatin in palliative treatment of ICC. Recruitment period for the study was from January 2010 to June 2014. Primary endpoints were toxicity, safety, and response according to mRECIST criteria. RESULTS Twenty-five DSM-TACE procedures in cases of advanced ICC were performed in seven patients. Nausea and vomiting occurred as adverse event (AE) in eight out of 25 treatments (32%), with seven of eight events (87.5%) associated with the use of gemcitabine. In 11 out of 25 treatments (44%) moderate, transient epigastric pain was registered as an adverse event (AE) within 24 hours of DSM-TACE. One case (1/25) of severe AE (4%) with thrombocytopenia led to discontinuation of the DSM-TACE-treatment. A total of 25 DSM-TACE procedures with complete clinical and imaging follow-up over a two-year-period were analyzed: objective response (OR) was achieved in three of 25 treatments (12%) Disease control (DC) was achieved in 44% (11/25) of treatments; progress was registered in 4% (1/25). CONCLUSIONS The use of DSM as an embolic agent for TACE is safe in the treatment of ICC. A standardized anti-emetic medication should be established, especially when using gemcitabine. Further prospective studies need to be conducted to find the most suitable, standardized DSM-TACE treatment regime.

  3. A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease

    Energy Technology Data Exchange (ETDEWEB)

    McGregor, Robert [St. Boniface General Hospital, Winnipeg, Manitoba (Canada); Vymazal, Josef [Hospital Na Homolce, Prague (Czech Republic); Martinez-Lopez, Manuel [Hospital Medica Sur, Mexico City (Mexico); Neuwirth, Jiri [Faculty Hospital Motol, Prague (Czech Republic); Salgado, Perla [American British Cowdray Medical Center, Mexico City (Mexico); Beregi, Jean-Paul [Hopital Cardiologique, Lille (France); Peduto, Anthony [Westmead Hospital, Westmead New South Wales (Australia); Pena-Almaguer, Erasmo de la [Christus-Muguerza Medical Center, Monterrey, Nuevo Leon (Mexico); Slater, Greg J. [Greenslopes Private Hospital, Greenslopes, Queensland (Australia); Shamsi, Kohkan [Berlex Laboratories, Montville, NJ (United States); Parsons, Edward C. [EPIX Pharmaceuticals, Inc., Lexington, MA (United States)], E-mail: eparsons@epixpharma.com

    2008-02-15

    Purpose: To determine prospectively the safety and efficacy of the blood-pool contrast agent gadofosveset trisodium in renal artery magnetic resonance angiography (MRA). Materials and methods: Gadofosveset (0.03 mmol/kg) was administered to adult patients with known or suspected renal arterial disease in a multi-center phase 3 single dose study. The drug binds reversibly to albumin, prolonging the blood residence time, and allowing collection of images in the first-pass and steady-state phases. The combination of these images was compared to non-contrast MRA, using catheter X-ray angiography (XRA) as the standard of reference (SOR). All MRA images were collected at 1.5 T in one imaging session for direct comparison, and XRA within 30 days. Sensitivity, specificity, and accuracy for diagnosing significant disease (stenosis {>=}50%) were calculated for MRA using three independent blinded readers. Patient safety was monitored for 72-96 h. Results: A total of 145 patients at 18 centers were enrolled and received gadofosveset; the 127 with complete efficacy data entered the primary efficacy analysis. Gadofosveset-enhanced MRA led to significant improvement (p < 0.01) in sensitivity (+25%, +26%, +42%), specificity (+23%, +25%, +29%), and accuracy (+23%, +28%, +29%) over non-enhanced MRA for the three readers. The rate of uninterpretable examinations decreased from 30% to less than 2%. There were no serious adverse events, and the most common adverse events were nausea, pruritis, and headache (8% each). No significant trends in clinical chemistry parameters, nor significant changes in serum creatinine, were found following administration of gadofosveset. Conclusion: In patients with known or suspected renal arterial disease, multi-phase gadofosveset-enhanced MRA significantly improves sensitivity, specificity, and accuracy versus non-enhanced MRA. Gadofosveset was safe and well tolerated in this patient population.

  4. Immunogenicity and safety of trivalent inactivated influenza vaccine: a randomized, double-blind, multi-center, phase 3 clinical trial in a vaccine-limited country.

    Science.gov (United States)

    Song, Joon Young; Cheong, Hee Jin; Woo, Heung Jeong; Wie, Seong-Heon; Lee, Jin-Soo; Chung, Moon-Hyun; Kim, Yang Ree; Jung, Sook In; Park, Kyung-Hwa; Kim, Tae Hyong; Uh, Soo-Taek; Kim, Woo Joo

    2011-02-01

    Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multi-center trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with ≥ 80% of subjects achieving post-vaccination titers ≥ 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile in both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.

  5. 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......), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin...... provided significantly better pain relief (p=0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p=0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p=0.0016). Both the Patient (p=0...

  6. 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...

  7. Anti-HMGCR antibodies as a biomarker for immune-mediated necrotizing myopathies: A history of statins and experience from a large international multi-center study.

    Science.gov (United States)

    Musset, Lucile; Allenbach, Yves; Benveniste, Olivier; Boyer, Olivier; Bossuyt, Xavier; Bentow, Chelsea; Phillips, Joe; Mammen, Andrew; Van Damme, Philip; Westhovens, René; Ghirardello, Anna; Doria, Andrea; Choi, May Y; Fritzler, Marvin J; Schmeling, Heinrike; Muro, Yoshinao; García-De La Torre, Ignacio; Ortiz-Villalvazo, Miguel A; Bizzaro, Nicola; Infantino, Maria; Imbastaro, Tiziana; Peng, Qinglin; Wang, Guochun; Vencovský, Jiří; Klein, Martin; Krystufkova, Olga; Franceschini, Franco; Fredi, Micaela; Hue, Sophie; Belmondo, Thibaut; Danko, Katalin; Mahler, Michael

    2016-10-01

    In an effort to find naturally occurring substances that reduce cholesterol by inhibiting 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR), statins were first discovered by Endo in 1972. With the widespread prescription and use of statins to decrease morbidity from myocardial infarction and stroke, it was noted that approximately 5% of all statin users experienced muscle pain and weakness during treatment. In a smaller proportion of patients, the myopathy progressed to severe morbidity marked by proximal weakness and severe muscle wasting. Remarkably, Mammen and colleagues were the first to discover that the molecular target of statins, 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGCR), is an autoantibody target in patients that develop an immune-mediated necrotizing myopathy (IMNM). These observations have been confirmed in a number of studies but, until today, a multi-center, international study of IMNM, related idiopathic inflammatory myopathies (IIM), other auto-inflammatory conditions and controls has not been published. Accordingly, an international, multi-center study investigated the utility of anti-HMGCR antibodies in the diagnosis of statin-associated IMNM in comparison to different forms of IIM and controls. This study included samples from patients with different forms of IIM (n=1250) and patients with other diseases (n=656) that were collected from twelve sites and tested for anti-HMGCR antibodies by ELISA. This study confirmed that anti-HMGCR autoantibodies, when found in conjunction with statin use, characterize a subset of IIM who are older and have necrosis on muscle biopsy. Taken together, the data to date indicates that testing for anti-HMGCR antibodies is important in the differential diagnosis of IIM and might be considered for future classification criteria.

  8. A Prospective Multi-Center Observational Study of Children Hospitalized with Diarrhea in Ho Chi Minh City, Vietnam.

    OpenAIRE

    Thompson, CN; Phan, MV; Hoang, NV; Minh, PV; Vinh, NT; Thuy, CT; Nga, TT; Rabaa, MA; Duy, PT; Dung, TT; Phat, VV; Nga, TV; Tu, leTP; Tuyen, HT; K. Yoshihara

    2015-01-01

    : We performed a prospective multicenter study to address the lack of data on the etiology, clinical and demographic features of hospitalized pediatric diarrhea in Ho Chi Minh City (HCMC), Vietnam. Over 2,000 (1,419 symptomatic and 609 non-diarrheal control) children were enrolled in three hospitals over a 1-year period in 2009-2010. Aiming to detect a panel of pathogens, we identified a known diarrheal pathogen in stool samples from 1,067/1,419 (75.2%) children with diarrhea and from 81/609 ...

  9. 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

    Arterial Spin Labeling (ASL) is a method to measure perfusion using magnetically labeled blood water as an endogenous tracer. Being fully non-invasive, this technique is attractive for longitudinal studies of cerebral blood flow in healthy and diseased individuals, or as a surrogate marker of met...

  10. Clinicopathologic characteristics and prognostic factors of ovarian fibrosarcoma: the results of a multi-center retrospective study

    Directory of Open Access Journals (Sweden)

    Liao Ling-Min

    2010-10-01

    Full Text Available Abstract Background Ovarian fibrosarcomas are very rare tumors, and therefore, few case studies have evaluated the prognostic factors of this disease. To our knowledge, this study represents the largest study to evaluate the clinical and pathologic factors associated with ovarian fibrosarcoma patients. Methods Thirty-one cases of ovarian fibrosarcoma were retrospectively reviewed, which included medical records for eight patients, and 23 published case reports from 1995 through 2009. Patient treatment regimens included total hysterectomy with bilateral adnexectomy and an omentectomy (BAO (n = 9, oophorectomy (OR (n = 8, chemotherapy (CT (n = 1, BAO followed by chemotherapy (BAO+CT (n = 11, BAO followed by radiotherapy (BAO+RT (n = 1, and oophorectomy followed by radiotherapy (OR + RT (n = 1. Results The patients of this cohort were staged according to the guidelines of the Federation of Gynecology and Obstetrics (FIGO, with 15, 6, 9, and 1 stage I-IV cases identified, respectively. Mitotic count values were also evaluated from 10 high-power fields (HPFs, and 3 cases had an average mitotic count P = 0.007 and treatment (P = 0.008 were predictive of poor prognosis. Furthermore, patients with stage I tumors that received BAO+CT were associated with a better prognosis. Conclusions Mitotic activity, and cells positive for Ki-67 were identified as important factors in the diagnosis of ovarian fibrosarcoma. Furthermore, FIGO stage and treatment modalities have the potential to be prognostic factors of survival, with BAO followed by adjuvant chemotherapy associated with an improved treatment outcome.

  11. Mortality and Morbidity of Extremely Low Birth Weight Infants in the Mainland of China: A Multi-center Study

    Science.gov (United States)

    Lin, Hui-Jia; Du, Li-Zhong; Ma, Xiao-Lu; Shi, Li-Ping; Pan, Jia-Hua; Tong, Xiao-Mei; Li, Qiu-Ping; Zhou, Jian-Guo; Yi, Bing; Liu, Ling; Chen, Yun-Bing; Wei, Qiu-Fen; Wu, Hui-Qing; Li, Mei; Liu, Cui-Qing; Gao, Xi-Rong; Xia, Shi-Wen; Li, Wen-Bin; Yan, Chao-Ying; He, Ling; Liang, Kun; Zhou, Xiao-Yu; Han, Shu-Ping; Lyu, Qin; Qiu, Yin-Ping; Li, Wen; Chen, Dong-Mei; Lu, Hong-Ru; Liu, Xiao-Hong; Liu, Hong; Lin, Zhen-Lang; Liu, Li; Zhu, Jia-Jun; Xiong, Hong; Yue, Shao-Jie; Zhuang, Si-Qi

    2015-01-01

    Background: With the progress of perinatal medicine and neonatal technology, more and more extremely low birth weight (ELBW) survived all over the world. This study was designed to investigate the short-term outcomes of ELBW infants during their Neonatal Intensive Care Unit (NICU) stay in the mainland of China. Methods: All infants admitted to 26 NICUs with a birth weight (BW) < l000 g were included between January l, 2011 and December 31, 2011. All the data were collected retrospectively from clinical records by a prospectively designed questionnaire. The data collected from each NICU transmitted to the main institution where the results were aggregated and analyzed. Categorical variables were performed with Pearson Chi-square test. Binary Logistic regression analysis was used to detect risk factors. Results: A total of 258 ELBW infants were admitted to 26 NICUs, of whom the mean gestational age (GA) was 28.1 ± 2.2 weeks, and the mean BW was 868 ± 97 g. The overall survival rate at discharge was 50.0%. Despite aggressive treatment 60 infants (23.3%) died and another 69 infants (26.7%) died after medical care withdrawal. Furthermore, the survival rate was significantly higher in coastal areas than inland areas (53.6% vs. 35.3%, P = 0.019). BW < 750 g and GA < 28 weeks were the largest risk factors, and being small for gestational age was a protective factor related to mortality. Respiratory distress syndrome was the most common complication. The incidence of patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, retinopathy of prematurity was 26.2%, 33.7%, 6.7%, 48.1%, and 41.4%, respectively. Ventilator associated pneumonia was the most common hospital acquired infection during hospitalization. Conclusions: Our study was the first survey that revealed the present status of ELBW infants in the mainland of China. The mortality and morbidity of ELBW infants remained high as compared to other developed

  12. YMDD motif mutations in chronic hepatitis B antiviral treatment naïve patients: a multi-center study

    Directory of Open Access Journals (Sweden)

    You-Wen Tan

    2012-06-01

    Full Text Available OBJECTIVE: This study aimed to determine the natural prevalence of variants of tyrosine-methionine-aspartic acid-aspartic acid (YMDD motif in patients with chronic hepatitis B (CHB, and to explore its relation with demographic and clinical features, hepatitis B virus (HBV genotypes, and HBV DNA levels. METHODS: A total of 1,042 antiviral treatment naïve CHB patients (including with lamivudine [LAM] in the past year were recruited from outpatient and inpatient departments of six centers from December 2008 to June 2010. YMDD variants were analyzed using the HBV drug resistance line probe assay (Inno-Lipa HBV-DR. HBV genotypes were detected with polymerase chain reaction (PCR microcosmic nucleic acid cross-ELISA, and HBV deoxyribonucleic acid (DNA was quantitated with real-time PCR. All serum samples underwent tests for HBV, HCV, and HDV with ELISA. RESULTS: YMDD variants were detected in 23.3% (243/1042 of CHB patients. YMDD mutation was accompanied by L180M mutation in 154 (76.9% patients. Both wild-type HBV and YMDD variant HBV were present in 231 of 243 patients. Interestingly, 12 patients had only YIDD and/or YVDD variants without wild YMDD motif. In addition, 27.2% (98/359 of HbeAg-positive patients had YMDD mutations, which was higher than that in HbeAg-negative patients (21.2%, 145/683. The incidence of YMDD varied among patients with different HBV genotypes, but the difference was not significant. Moreover, the incidence of YMDD in patients with high HBV DNA level was significantly higher than that in those with low HBV DNA level. CONCLUSION: Mutation of YMDD motif was detectable at a high rate in CHB patients in this study. The incidence of YMDD may be correlated with HBeAg and HBV DNA level.

  13. Epidemiology of respiratory distress and the illness severity in late preterm or term infants: a prospective multi-center study

    Institute of Scientific and Technical Information of China (English)

    MA Xiao-lu; YI Bin; SHI Jing-yun; DU Li-zhong; XU Xue-feng; CHEN Chao; YAN Chao-ying; LIU Ya-ming; LIU Ling; XIONG Hong; SUN Hui-qing; LAI Jian-pu

    2010-01-01

    Background The severity of respiratory distress was associated with neonatal prognosis. This study aimed to explore the clinical characteristics, therapeutic interventions and short-term outcomes of late preterm or term infants who required respiratory support, and compare the usage of different illness severity assessment tools.Methods Seven neonatal intensive care units in tertiary hospitals were recruited. From November 2008 to October 2009, neonates born at ≥34 weeks' gestational age, admitted at <72 hours of age, requiring continuous positive airway pressure (CPAP) or mechanical ventilation for respiratory support were enrolled. Clinical data including demographic variables, underlying disease, complications, therapeutic interventions and short-term outcomes were collected. All infants were divided into three groups by Acute care of at-risk newborns (ACoRN) Respiratory Score <5, 5-8, and >8.Results During the study period, 503 newborn late preterm or term infants required respiratory support. The mean gestational age was (36.8±2.2) weeks, mean birth weight was (2734.5±603.5) g. The majority of the neonates were male (69.4%), late preterm (63.3%), delivered by cesarean section (74.8%), admitted in the first day of life (89.3%) and outborn (born at other hospitals, 76.9%). Of the cesarean section, 51.1% were performed electively. Infants in the severe group were more mature, had the highest rate of elective cesarean section, Apgar score <7 at 5 minutes and resuscitated with intubation, the in-hospital mortality increased significantly. In total, 58.1% of the patients were supported with mechanical ventilation and 17.3% received high frequency oscillation. Adjunctive therapies were commonly needed.Higher rate of infants in severe group needed mechanical ventilation or high frequency oscillation, volume expansion,bicarbonate infusion or vasopressors therapy (P <0.05). The incidence of complications was also increased significantly in severe group (P

  14. Prevalence of mental disorders, psychosocial distress and need for psychosocial support in cancer patients – study protocol of an epidemiological multi-center study

    Directory of Open Access Journals (Sweden)

    Mehnert Anja

    2012-07-01

    Full Text Available Abstract Background Empirical studies investigating the prevalence of mental disorders and psychological distress in cancer patients have gained increasing importance during recent years, particularly with the objective to develop and implement psychosocial interventions within the cancer care system. Primary purpose of this epidemiological cross-sectional multi-center study is to detect the 4-week-, 12-month-, and lifetime prevalence rates of comorbid mental disorders and to further assess psychological distress and psychosocial support needs in cancer patients across all major tumor entities within the in- and outpatient oncological health care and rehabilitation settings in Germany. Methods/Design In this multicenter, epidemiological cross-sectional study, cancer patients across all major tumor entities will be enrolled from acute care hospitals, outpatient cancer care facilities, and rehabilitation centers in five major study centers in Germany: Freiburg, Hamburg, Heidelberg, Leipzig and Würzburg. A proportional stratified random sample based on the nationwide incidence of all cancer diagnoses in Germany is used. Patients are consecutively recruited in all centers. On the basis of a depression screener (PHQ-9 50% of the participants that score below the cutoff point of 9 and all patients scoring above are assessed using the Composite International Diagnostic Interview for Oncology (CIDI-O. In addition, all patients complete validated questionnaires measuring emotional distress, information and psychosocial support needs as well as quality of life. Discussion Epidemiological data on the prevalence of mental disorders and distress provide detailed and valid information for the estimation of the demands for the type and extent of psychosocial support interventions. The data will provide information about specific demographic, functional, cancer- and treatment-related risk factors for mental comorbidity and psychosocial distress, specific

  15. Mortality and Morbidity of Extremely Low Birth Weight Infants in the Mainland of China: A Multi-center Study

    Directory of Open Access Journals (Sweden)

    Hui-Jia Lin

    2015-01-01

    Full Text Available Background: With the progress of perinatal medicine and neonatal technology, more and more extremely low birth weight (ELBW survived all over the world. This study was designed to investigate the short-term outcomes of ELBW infants during their Neonatal Intensive Care Unit (NICU stay in the mainland of China. Methods: All infants admitted to 26 NICUs with a birth weight (BW < l000 g were included between January l, 2011 and December 31, 2011. All the data were collected retrospectively from clinical records by a prospectively designed questionnaire. The data collected from each NICU transmitted to the main institution where the results were aggregated and analyzed. Categorical variables were performed with Pearson Chi-square test. Binary Logistic regression analysis was used to detect risk factors. Results: A total of 258 ELBW infants were admitted to 26 NICUs, of whom the mean gestational age (GA was 28.1 ± 2.2 weeks, and the mean BW was 868 ± 97 g. The overall survival rate at discharge was 50.0%. Despite aggressive treatment 60 infants (23.3% died and another 69 infants (26.7% died after medical care withdrawal. Furthermore, the survival rate was significantly higher in coastal areas than inland areas (53.6% vs. 35.3%, P = 0.019. BW < 750 g and GA < 28 weeks were the largest risk factors, and being small for gestational age was a protective factor related to mortality. Respiratory distress syndrome was the most common complication. The incidence of patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, retinopathy of prematurity was 26.2%, 33.7%, 6.7%, 48.1%, and 41.4%, respectively. Ventilator associated pneumonia was the most common hospital acquired infection during hospitalization. Conclusions: Our study was the first survey that revealed the present status of ELBW infants in the mainland of China. The mortality and morbidity of ELBW infants remained high as compared to other

  16. Mortality and Morbidity of Extremely Low Birth Weight Infants in the Mainland of China: A Multi-center Study

    Institute of Scientific and Technical Information of China (English)

    Hui-Jia Lin; Li-Zhong Du; Xiao-Lu Ma; Li-Ping Shi; Jia-Hua Pan; Xiao-Mei Tong; Qiu-Ping Li

    2015-01-01

    Background:With the progress ofperinatal medicine and neonatal technology,more and more extremely low birth weight (ELBW) survived all over the world.This study was designed to investigate the short-term outcomes of ELBW infants during their Neonatal Intensive Care Unit (NICU) stay in the mainland of China.Methods:All infants admitted to 26 NICUs with a birth weight (BW) <1000 g were included between January 1,2011 and December 3 1,201 1.All the data were collected retrospectively from clinical records by a prospectively designed questionnaire.The data collected from each NICU transmitted to the main institution where the results were aggregated and analyzed.Categorical variables were performed with Pearson Chi-square test.Binary Logistic regression analysis was used to detect risk factors.Results:A total of 258 ELBW infants were admitted to 26 NICUs,of whom the mean gestational age (GA) was 28.1 ± 2.2 weeks,and the mean BW was 868 ± 97 g.The overall survival rate at discharge was 50.0%.Despite aggressive treatment 60 infants (23.3%) died and another 69 infants (26.7%) died after medical care withdrawal.Furthermore,the survival rate was significantly higher in coastal areas than inland areas (53.6% vs.35.3%,P =0.019).BW <750 g and GA <28 weeks were the largest risk factors,and being small for gestational age was a protective factor related to mortality.Respiratory distress syndrome was the most common complication.The incidence of patent ductus arteriosus,intraventricular hemorrhage,periventricular leukomalacia,bronchopulmonary dysplasia,retinopathy of prematurity was 26.2%,33.7%,6.7%,48.1%,and 41.4%,respectively.Ventilator associated pneumonia was the most common hospital acquired infection during hospitalization.Conclusions:Our study was the first survey that revealed the present status of ELBW infants in the mainland of China.The mortality and morbidity of ELBW infants remained high as compared to other developed countries.

  17. Measurements of the relative backscatter contribution to the monitor chamber for modern medical linear accelerators; A multi-center study

    DEFF Research Database (Denmark)

    Sibolt, Patrik; Cronholm, Rickard O.; Beierholm, Anders Ravnsborg

    2015-01-01

    Conversion to absolute dose in Monte Carlo (MC) simulations of MV radiotherapy beams needs correct modeling of backscatter (BS) to the linear accelerator (linac) monitor chamber. For some linacs the BS depends largely on jaw settings. The backscattered fraction (BSF) of radiation can be determined...... experimentally by measuring ratios of target charge for a given number of monitor units as a function of jaw settings. This was done using the in-house developed ME40 dosimetry system, which is able to determine the target charge for each radiation pulse from the linac. The BSF measurements were performed...... for different linac models at five Danish radiotherapy clinics. The investigated linacs were four Varian TrueBeams (TB), one Varian iX (iX) and one Elekta Synergy (ES). BSF measurements were performed for square field side lengths ranging from 1 to 40 cm, using the 10 × 10 cm2 field as reference. The impact...

  18. Dento-alveolar and maxillofacial injuries: a 5-year multi-center study. Part 1: general vs facial and dental trauma.

    Science.gov (United States)

    Lin, Shaul; Levin, Liran; Goldman, Sharon; Peleg, Kobi

    2008-02-01

    Maxillofacial injuries are a significant cause of morbidity and demand meticulously planned treatment. The aim of this present multi-center study was to evaluate the occurrence of dento-alveolar and maxillofacial injuries over a 5-year period. A retrospective cohort study of data from the Israel Trauma Registry was conducted for the years 2000-2004. The registry includes all trauma patients admitted and hospitalized due to an injury. Of the 111,010 hospitalized trauma patients, 5886 (5.3%) were diagnosed with maxillofacial or dental injuries. The main causes of injuries for hospitalized trauma patients were falls (48.1%) and motor vehicle accidents (25.2%), while the major causes of facial and dental injuries were vehicle accidents (39.6%, 56.8%, respectively) and falls (32.1%, 26.7%, respectively). High-risk age groups for dental and facial trauma were 10-18 years and 19-28 years, respectively, while for other trauma, ages for the greatest risk ranged from 0 to 9 years and over 59 years. Males were injured two to three times more frequently than females. A better understanding of the etiology of maxillofacial and dental injuries and identifying the high-risk groups should lead to appropriate prevention programs and treatment methods.

  19. Predicting sickness impact profile at six months after stroke: further results from the European multi-center CERISE study

    NARCIS (Netherlands)

    Stummer, C.A.; Verheyden, G.; Putman, K.; Jenni, W.; Schupp, W.; Wit, L. De

    2015-01-01

    PURPOSE: To develop prognostic models and equations for predicting participation at six months after stroke. METHODS: This European prospective cohort study recruited 532 consecutive patients from four rehabilitation centers. Participation was assessed at six months after stroke with the Sickness Im

  20. Improvement of left ventricular hypertrophy and arrhythmias after lanreotide-induced GH and IGF-I decrease in acromegaly. A prospective multi-center study.

    Science.gov (United States)

    Lombardi, G; Colao, A; Marzullo, P; Biondi, B; Palmieri, E; Fazio, S

    2002-12-01

    We report the results of a prospective Italian multi-center study of the effects of lanreotide, a slow-release somatostatin analog, on left ventricular morphology and function and on the prevalence of ventricular arrhythmic events in 19 patients with active, newly diagnosed, uncomplicated acromegaly. Cardiac features were evaluated with Doppler-echocardiography and 24-h Holter ECG monitoring at baseline and after 6 months of lanreotide therapy. Fifteen patients (78.9%) had left ventricular hypertrophy. Lanreotide treatment significantly decreased the left ventricular mass (127.8+/-6.9 vs 140.7+/-7.1 g/m2, paffect systolic function, whereas it increased the Doppler-derived early-to-late mitral flow velocity, (E/A) ratio, of early-to-late trans-mitral flow velocity (1.34+/-0.1 vs 1.09+/-0.06, p=0.001). Stroke volume was slightly but not significantly increased after treatment, whereas systolic BP was significantly higher (134+/-14 vs 129+/-13 mmHg, p50/24 h) occurred in 16.6% of patients and were unaffected by treatment. Differently, ventricular premature beats (>50/24 h) occurred in 33.3% of patients before treatment vs 16.5%, after treatment. In conclusion, lanreotide reduced the left ventricular mass, and improved ventricular filling and ventricular arrhythmic profile.

  1. Dento-alveolar and maxillofacial injuries: a 5-year multi-center study. Part 2: severity and location.

    Science.gov (United States)

    Lin, Shaul; Levin, Liran; Goldman, Sharon; Sela, Galit

    2008-02-01

    Maxillofacial and dental injuries are not uncommon. These injuries may cause morbidity and demand meticulously planned treatment. Part 1 of this study focused on the incidence of general trauma injuries, as well as facial or dental trauma. The aim of part 2 is to evaluate the severity and location of the dento-alveolar and maxillofacial injuries over 5 years. A retrospective cohort study was conducted based on data from the Israel National Trauma Registry. Patients admitted and hospitalized due to trauma injuries during the years 2000-2004, totaled 111,010 in which 5886 (5.3%) were maxillofacial or dental injuries. Most of these injuries were traffic-related (54.5%), followed by events at home (18.7%). Facial injuries combined with injuries to other organs involved occurred in 3721 (63.2%) of the patients. Most minor injuries were noted when no other organs were involved, while severe injuries were more common when multiple organs were involved. More than 25% of facial injuries required surgery. Meticulous epidemiologic studies are needed to support the leading role, extent, and severity of maxillofacial trauma.

  2. Anticoagulation therapy in Chinese patients with non-valvular atrial fibrillation: a prospective, multi-center, randomized,controlled study

    Institute of Scientific and Technical Information of China (English)

    CHEN Ke-ping; HUANG Cong-xin; HUANG De-jia; CAO Ke-jiang; MA Chang-sheng; WANG Fang-zheng; ZHANG Shu

    2012-01-01

    Background Non-valvular atrial fibrillation is associated with an increased risk of ischemic stroke; however,the appropriate intensity of anticoagulation therapy for Chinese patients has not been determined.The purpose of this study was to compare the safety and the efficacy of standard-intensity warfarin therapy,low-intensity warfarin therapy,and aspirin therapy for the prevention of ischemic events in Chinese patients with non-valvular atrial fibrillation (NVAF).Methods A total of 786 patients from 75 Chinese hospitals were enrolled in this study and randomized into three therapy groups:standard-intensity warfarin (international normalized ratio (INR) 2.1 to 2.5) group,low-intensity warfarin (INR 1.6 to 2.0) group and aspirin (200 mg per day) group.All patients were evaluated by physicians at 1,3,6,9,12,15,18,21 and 24 months after randomization to obtain a patient questionnaire,physical examination and related laboratory tests.Results The annual event rates of ischemic stroke,transient ischemic attack (TIA) or systemic thromboembolism were 2.6%,3.1% and 6.9% in the standard-intensity warfarin,low-intensity warfarin and aspirin groups,respectively (P=0.027).Thromboembolic event rates in both warfarin groups were significantly lower than that in the aspirin group (P=0.018,P=0.044),and there was no significant difference between the two warfarin groups.Severe hemorrhagic events occurred in 15 patients,7 (2.6%) in the standard-intensity warfarin group,7 (2.4%) in the low-intensity warfarin group and 1 (0.4%)in the aspirin group.The severe hemorrhagic event rates in the warfarin groups were higher than that in the aspirin group,but the difference did not reach statistical significance (P=0.101).The mild hemorrhagic and total hemorrhagic event rates in the warfarin groups (whether in the standard-intensity warfarin group or low-intensity warfarin group) were much higher than that in the aspirin group with the annual event rates of total hemorrhages of 10

  3. Awareness of general public towards cancer prostate and screening practice in Arabic communities: a comparative multi-center study.

    Science.gov (United States)

    Arafa, Mostafa A; Rabah, Danny M; Wahdan, Iman H

    2012-01-01

    The current study aimed at exploring the knowledge and beliefs of men aged forty years and over towards prostate cancer screening and early detection in three Arab countries. The field work was conducted in three countries; Saudi Arabia, Egypt and Jordan, during the period February through December 2011. Our target population were men aged 40 years and over. It was a population-based cross sectional study comprising 400 subjects at each site. In addition to socio-demographic data, history of the present and past medical illness, practice history of prostatic cancer examination, family history of cancer prostate; participants were inquired about their knowledge and attitude towards prostate cancer and screening behavior using two different likert scales. The percentage of participants who practiced regular prostate check up ranged from 8-30%. They had poor knowledge and fair attitude towards prostate cancer screening behavior, where the mean total knowledge score was 10.25±2.5, 10.76±3.39 and 11.24±3.39 whereas the mean total attitude score was 18.3±4.08, 20.68±6.4 and 17.96±5.3 for Saudi Arabia, Egypt and Jordan respectively. The respondents identified the physicians as the main sources of this information (62.4%), though they were not the main motives for regular checkup. Knowledge was the only significant predictor for participants' attitude in the multiple regression models. Participants' attitudes depends mainly on level of knowledge and quantity of information provided to the patients and their families. Such attitudes should rely on a solid background of proper information and motivation from physicians to enhance and empower behaviors towards prostate cancer screening practices.

  4. Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in Chinese postmenopausal women with osteoporosis:a multi-center, randomized, placebo-controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    LIU Jian-li刘建立; LIU Hui刘慧; CHEN Xiao-ping陈小平; LIU Yu-juan刘玉娟; Abie Ekangaki; ZHENG Yi-man郑以漫; Adolfo Diez-Perez; Kristine Harper; ZHU Han-min朱汉民; HUANG Qi-ren黄琪仁; ZHANG Zhong-lan张忠兰; LI Hui-lin李慧林; QIN Yue-juan秦跃娟; ZHANG Ying张颖; WEI Dao-lin魏道林; LU Jing-hui陆敬辉

    2004-01-01

    Background Raloxifene has been approved for prevention and treatment of postmenopausal osteoporosis in Caucasian women. It also has some positive effects on serum lipids in Caucasians. The objective of this study was to determine the effect of raloxifene hydrochloride on lumbar spine and total hip bone mineral density (BMD), bone metabolism, and serum lipids in Chinese postmenopausal women with osteoporosis.Methods This was a multi-center, randomized, double-blind, placebo-controlled clinical trial in which 204 postmenopausal Chinese women with osteoporosis were assigned to receive raloxifene (60 mg) or placebo treatment daily for 12 months. BMD, serum bone metabolism markers, and serum lipids were measured before and after drug administration. BMD was measured by Dual-Energy X-Ray Absorptiometry (DEXA) and bone metabolism markers were analyzed by one-step enzyme-linked immunosorbent assay. Serum lipids were measured by enzymatic analysis.Results At the end of the 12-month study, lumbar spine BMD increased in both groups with a mean increase of (3.3±4.8) % in the raloxifene group and (1.0±4.9) % in the placebo group (P0.05). In the raloxifene group, the median decreases in the biochemical markers of bone metabolism serum osteocalcin and C-telopeptide were 41.7% and 61.5%, respectively. These changes were statistically significant compared with those in the placebo group (10.6% and 35.6%, P<0.001, respectively). Both total cholesterol and low-density lipoprotein cholesterol decreased significantly in the raloxifene group compared with those in the placebo group (P<0.001, respectively) and there was no significant effect of raloxifene on high-density lipoprotein cholesterol and triglycerides compared with placebo. Conclusions Raloxifene 60 mg/d for 12 months significantly increases lumbar spine and total hip BMD, significantly decreases bone turnover, and has favourable effects on serum lipids in Chinese postmenopausal women with osteoporosis.

  5. A Multi-centered Cross-sectional Study of Disease Burden of Pain of Inpatients in Southwest China

    Institute of Scientific and Technical Information of China (English)

    Li-Hua Peng; Ju-Yin Jing; Pei-Pei Qin; Min Su

    2016-01-01

    Background:Pain is a common burden of disease globally;yet,it is not systematically investigated in China,especially in hospitalized patients.This study was aimed at clarifying the epidemiological characteristics of pain and related factors in hospitalized patients in Southwest China.Methods:A cross-sectional study was conducted to investigate the prevalence,severity,and influencing factors of pain and modes of postoperative analgesia in hospitalized patients from 17 hospitals in Southwest China.A prevalidated questionnaire was employed to calibrate all of these items within 3 days from March 18,2015 to March 20,2015.Results:A total of 2293 patients were surveyed,the incidence of pain was 57.4% in all hospitalized patients at rest,of which 62.1% were with acute pain and 37.9% had persistent to chronic pain.Among surgical patients,90.8% of them complained of acute postoperative pain at rest and 97.1% in motion.The incidence of acute postoperative moderate-to-severe pain was 28.8% at rest and 45.1% in motion.Surgical patients reported higher incidences of pain,especially acute and persistent pain compared with nonsurgical patients (P < 0.05).Postoperative pain occurred predominately at surgical sites (95.2%) as compared with nonsurgical sites (4.8%).Agedness,lower education level,surgery,and history of smoking were factors associated with increased duration and severity of postoperative pain and nonsurgical pain (P < 0.05).Conclusions:Pain is a common burden of disease in China,of which surgical pain constituted an important component.Surgical patients complained more severe pain than those who did not undergo surgery.Postoperative analgesia still needs to be improved to control pain after surgery.Patients' perception might influence the efficacy of pain management,which should be implemented with a multidisciplinary approach.

  6. Concomitant pulmonary tuberculosis in hospitalized healthcare-associated pneumonia in a tuberculosis endemic area: a multi-center retrospective study.

    Directory of Open Access Journals (Sweden)

    Jia-Yih Feng

    Full Text Available BACKGROUND: In tuberculosis (TB endemic areas, Mycobacterium tuberculosis is an important but easily misdiagnosed pathogen in community-acquired pneumonia (CAP. However, the occurrence of concomitant pulmonary tuberculosis (PTB in hospitalized healthcare-associated pneumonia (HCAP has never been investigated. METHODS AND FINDINGS: Seven hundred and one hospitalized HCAP and 934 hospitalized CAP patients from six medical centers in Taiwan were included in this nationwide retrospective study. Concomitant PTB was defined as active PTB diagnosed within 60 days of admission due to HCAP or CAP. The predictors for concomitant PTB and the impact of PTB on the outcomes of pneumonia were investigated. Among the enrolled subjects, 21/701 (3% of the HCAP patients and 25/934 (2.7% of the CAP patients were documented to have concomitant PTB. In multivariate analysis, a history of previous anti-TB treatment (OR = 5.84, 95% CI: 2.29-20.37 in HCAP; OR = 3.33, 95% CI: 1.09-10.22 in CAP and escalated pneumonia severity index (PSI scores (OR = 1.014, 95% CI: 1.002-1.026, in HCAP; OR = 1.013, 95% CI: 1.001-1.026, in CAP were independent predictors for concomitant PTB in both CAP and HCAP patients. Regarding treatment outcomes, HCAP patients with concomitant PTB were associated with more acute respiratory failure within 48 hours of admission (47.6% vs. 22.6%, p = 0.008, higher intensive care unit admission rate (61.9% vs. 35.7%, p = 0.014, longer hospitalization (39.6±34.1 vs. 23.7±27 days, p = 0.009, and higher in-hospital mortality (47.6% vs. 26.3%, p = 0.03 than those without concomitant PTB. Exposure to certain groups of antibiotics for the treatment of pneumonia was not associated with the occurrence of concomitant PTB. CONCLUSIONS: In HCAP patients, the occurrence of concomitant PTB is comparable with that in CAP patients and associated with higher PSI scores, more acute respiratory failure, and higher in-hospital mortality.

  7. Prospective multi-center study of female patients with ST-elevation myocardial infarction in Liaoning province, China

    Institute of Scientific and Technical Information of China (English)

    ZHANG Bo; LI Yu-ze; SHI Jing-pu; QI Guo-xian; JIANG Da-ming; ZHOU Xu-chen; LIU Jun; ZHANG Wei; SUN Yu-jiao; REN Li-na; ZHANG Zhi-hong; GAO Yuan

    2012-01-01

    Background In cardiology,it is controversial whether gender influences prognosis after acute myocardial infarction (MI).We examined the 30-day and 1-year prognosis for female patients with ST-elevation myocardial infarction (STEMI)in Liaoning province,and we analyzed factors that influenced these outcomes.Methods This was a prospective,multicenter,observational study in which patient data were collected by questionnaire at the time of diagnosis and at approximately 30 days and 1 year later by telephone inquiries.Patients were diagnosed with STEMI between June 1,2009 and June 1,2010 at any of the 20 hospitals that gave treatment representative of current STEMI treatment in Liaoning Province.Unified follow-up questionnaire was used to visit the STEMI patients.Results We analyzed data from a total of 1429 consecutive patients with STEMI in Liaoning province.Female patients were older (70.0 vs.60.3,P <0.001) and were less likely to receive emergency reperfusion therapy than male ones (39.2% vs.58.0%,P <0.001).Female gender was associated with higher unadjusted 30-day mortality rates (HR=2.118,95%C/:1.572-2.854,P <0.001) and higher unadjusted 1-year mortality rates (HR=2.174,95%C/:1.659-2.848,P <0.001).Multivariate Cox regression analysis showed that female gender was not an independent predictor of 30-day mortality rates (HR=1.273,95%C/:0.929-1.745,P=0.133) nor of 1-year mortality rates (HR=1.112,95%C/:0.831-1.487,P=0.475).Conclusions Women with STEMI appear to be at increased risk of 30-day and 1-year mortality compared with male STEMI patients,but this difference may be explained by older age and less frequent receipt of reperfusion therapy among the women.

  8. The concordance of care for age related macular degeneration with the chronic care model: a multi-centered cross-sectional study.

    Directory of Open Access Journals (Sweden)

    Stefan Markun

    Full Text Available AIMS: The aim of the study was to assess the concordance of care for age related macular degeneration with the evidence-based framework for care for chronic medical conditions known as the chronic care model. Furthermore we aimed to identify factors associated with the concordance of care with the chronic care model. METHODS: Multi-centered cross-sectional study. 169 patients beginning medical treatment for age related macular degeneration were recruited and analyzed. Patients completed the Patient Assessment of Chronic Illness Care (PACIC questionnaire, reflecting accordance to the chronic care model from a patient's perspective, the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25 and Patient Health Questionnaire (PHQ-9. Visual acuity and chronic medical conditions were assessed. Nonparametric tests and correlation analyses were performed, also multivariable regression analysis. RESULTS: The median PACIC summary score was 2.4 (interquartile range 1.75 to 3.25, the lowest PACIC subscale score was "follow-up/coordination" with a median of 1.8 (interquartile range 1.00 to 2.60. In multivariable regression analysis the presence of diabetes type 2 was strongly associated with low PACIC scores (coefficient = -0.85, p = 0.007. CONCLUSION: Generally, care for patients with age related macular degeneration by ophthalmologists is in moderate concordance with the chronic care model. Concerning follow-up and coordination of health service, large improvements are possible. Future research should answer the question how healthcare delivery can be improved effecting relevant benefits to patients with AMD.

  9. The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749

    Directory of Open Access Journals (Sweden)

    Bärthel Erik

    2013-01-01

    Full Text Available Abstract Background Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. Methods/Design A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level > 2000 IU/ml within the first 7 postoperative days, bilirubine ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. Discussion A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. Trial Registration German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749.

  10. A multi-center study of a modified open trocar first-puncture approach in 17 350 patients for laparoscopic entry

    Institute of Scientific and Technical Information of China (English)

    LIU Hai-fang; CHEN Xu; LIU Yan

    2009-01-01

    Background Laparoscopic entry is of primary importance in laparoscopic surgery because of its potential association with serious complications such as visceral and vascular injuries. There are several approaches now available for laparoscopic entry. The present study reported a modified open trocar first-puncture approach (Yan's open technique) and validated its safety and practicability in a multi-center research.Methods The study was performed in seven gynecological endoscopy centers for 8 successive years from September 1998 to March 2006 involving 17 350 patients, who received the modified open trocar first-puncture approach developed by Dr. LIU Yan as the study group (MOT group). The "Yan's open technique" is the umbilical incision with a scalpel and then a 10-mm trocar entry into the abdominal cavity through direct trocar puncture or insertion of the cannula sheath via the opened umbilicus under no resistance. Another 4570 patients received the traditional Veress needle puncture as the control (VN group). The first puncture procedures of both groups were performed by 28 experienced gynecologic laparoscopists and 170 learners.Results In MOT group, the successful achievement rate (AR) of first puncture was 99.99% (17 348/17 350), including smooth manipulation in 17326 cases and unsmooth manipulation in 22 cases. The remaining two cases failed.First-puncture associated complications occurred in two cases (0.01%). In VN group, the successful AR of first puncture was 99.89% (4565/4570), including smooth manipulation in 4542 cases and unsmooth manipulation in 23 cases. The remaining five cases failed. First-puncture associated complications occurred in four cases (0.09%). There was no significant difference in the successful AR between the experienced gynecologic laparoscopists of the two groups (100% vs 100%, P >0.05), but the difference was significant between the learners of the two groups (99.98% vs 99.81%, P <0.05). The complication rate of VN group was

  11. Deferiprone versus deferoxamine in sickle cell disease: results from a 5-year long-term Italian multi-center randomized clinical trial.

    Science.gov (United States)

    Calvaruso, Giusi; Vitrano, Angela; Di Maggio, Rosario; Ballas, Samir; Steinberg, Martin H; Rigano, Paolo; Sacco, Massimiliano; Telfer, Paul; Renda, Disma; Barone, Rita; Maggio, Aurelio

    2014-12-01

    Blood transfusion and iron chelation currently represent a supportive therapy to manage anemia, vasculopathy and vaso-occlusion crises in Sickle-Cell-Disease. Here we describe the first 5-year long-term randomized clinical trial comparing Deferiprone versus Deferoxamine in patients with Sickle-Cell-Disease. The results of this study show that Deferiprone has the same effectiveness as Deferoxamine in decreasing body iron burden, measured as repeated measurements of serum ferritin concentrations on the same patient over 5-years and analyzed according to the linear mixed-effects model (LMM) (p=0.822). Both chelators are able to decrease, significantly, serum ferritin concentrations, during 5-years, without any effect on safety (p=0.005). Moreover, although the basal serum ferritin levels were higher in transfused compared with non-transfused group (p=0.031), the changes over time in serum ferritin levels were not statistically significantly different between transfused and non-transfused cohort of patients (p=0.389). Kaplan-Meier curve, during 5-years of study, suggests that Deferiprone does not alter survival in comparison with Deferoxamine (p=0.38). In conclusion, long-term iron chelation therapy with Deferiprone was associated with efficacy and safety similar to that of Deferoxamine. Therefore, in patients with Sickle-Cell-Disease, Deferiprone may represent an effective long-term treatment option.

  12. Euclidean supergravity and multi-centered solutions

    Science.gov (United States)

    Sabra, W. A.

    2017-04-01

    In ungauged supergravity theories, the no-force condition for BPS states implies the existence of stable static multi-centered solutions. The first solutions to Einstein-Maxwell theory with a positive cosmological constant describing an arbitrary number of charged black holes were found by Kastor and Traschen. Generalisations to five and higher dimensional theories were obtained by London. Multi-centered solutions in gauged supergravity, even with time-dependence allowed, have yet to be constructed. In this letter we construct supersymmetry-preserving multi-centered solutions for the case of D = 5, N = 2 Euclidean gauged supergravity coupled to an arbitrary number of vector multiplets. Higher dimensional Einstein-Maxwell multi-centered solutions are also presented.

  13. Euclidean supergravity and multi-centered solutions

    Directory of Open Access Journals (Sweden)

    W.A. Sabra

    2017-04-01

    Full Text Available In ungauged supergravity theories, the no-force condition for BPS states implies the existence of stable static multi-centered solutions. The first solutions to Einstein–Maxwell theory with a positive cosmological constant describing an arbitrary number of charged black holes were found by Kastor and Traschen. Generalisations to five and higher dimensional theories were obtained by London. Multi-centered solutions in gauged supergravity, even with time-dependence allowed, have yet to be constructed. In this letter we construct supersymmetry-preserving multi-centered solutions for the case of D=5, N=2 Euclidean gauged supergravity coupled to an arbitrary number of vector multiplets. Higher dimensional Einstein–Maxwell multi-centered solutions are also presented.

  14. EFFICACY OF ADDING FENTANYL TO LIGNOCAINE – ADRENALINE COMBINATION IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERIES A MULTI - CENTER STUDY

    Directory of Open Access Journals (Sweden)

    Anish M

    2015-06-01

    Full Text Available BACKGROUND: Brachial plexus block is a suitable alternative to general anesthesia for surgeries of upper limb and it can be performed even in patients who are not adequately fit for general anesthesia. The significance of brachial plexus block has increased in recent years due to renewed interest in day care surgery. Lignocaine hydrochloride has been used extensively for brachial plexus block and it has the disadvantage of having short duration of action. Opioids when added to anesthetic mixtures may improve and prolo ng the action of local anesthetics during peripheral nerve blocks. Such postoperative pain control can reduce both narcotic requirements and narcotic induced side effects. Studies have shown the efficacy of opioids as analgesic adjuvants in prolonging the duration of brachial plexus block. With this background in mind, this study was conducted to compare the onset and duration of sensory and motor block produced by a mixture of lignocaine and adrenaline with that produced by a mixture of fentanyl, lignocain e and adrenaline. Aims: To assess the effectiveness of addition of fentanyl to a mixture of lignocaine and adrenaline in prolonging the duration of analgesia and motor block for upper limb orthopedic surgeries. MATERIALS AND METHODS: This multi - center rand omized control study was conducted in two tertiary care centers in 80 patients underwent elective upper limb orthopedic surgeries and they were allocated into two groups of 40 each group L and group F. the classical approach of supraclavicular brachial ple xus block. Drug used were 30 ml of lignocaine 1.5%+adrenaline 5mcg/ml + 0.5ml normal saline in group L and 30ml of lignocaine 1.5% + adrenaline 5mcg/ml + fentanyl 50 mcg in group F. Adequacy of block was assessed by the pin prick test and temperature test. Motor power was assessed by the modified Lowett scale. Sedation was monitored using the modified Ramsay scale. An assessment was made for onset of analgesia, onset of

  15. Microscopic examination of intracellular organisms in bronchoalveolar lavage fluid for the diagnosis of ventilator-associated pneumonia:a prospective multi-center study

    Institute of Scientific and Technical Information of China (English)

    Liu Chang; Du Zhaohui; Zhou Qing; Hu Bo; Li Zhifeng; Yu Li; Xu Tao

    2014-01-01

    Background The presence of intracellular organisms (ICOs) in polymorphonuclear leukocytes obtained from bronchoalveolar lavage fluid (BALF) is a possible method for rapid diagnosis of ventilator-associated pneumonia (VAP).However,the validity of this diagnostic method remains controversial and the diagnostic thresholds reported by investigators were different.Our objective was to evaluate the accuracy of quantification of ICOs in BALF for the diagnosis of VAP,and to detect the best cutoff percentage of PMNs containing ICOs (PIC) in the microscopic examination of BALF for the diagnosis of VAP.Methods This was a prospective multi-center study conducted in 4 ICUs in Wuhan,China,which involved 181 patients suspected of first episode of VAP.BALF was obtained from all enrolled patients.The BALF samples underwent quantitative culture,cytological and bacteriological analysis to detect the culture results,PIC values and the morphological features of microorganisms.Definite diagnosis of VAP was based on pre-set criteria.The receiver-operating characteristic curve was used to detect the best cutoff point for PIG to diagnose VAP,and the diagnostic accuracy was calculated.Moreover,quantitative culture and Gram's stain of BALF were adopted to diagnose VAP,and their diagnostic accuracy was evaluated as well.Results There were 102 patients definitely diagnosed with VAP (VAP group),and 60 patients definitely diagnosed without VAP (no VAP group).We found that ICOs were present in 96.08% (98 out of 102) of VAP patients and 20.00% (12 out of 60) of no VAP patients.The PICs were significantly higher ((9.53±6.65)% vs.(0.52±1.33)%,P<0.01) in VAP group.In our study,the best cutoff point for PIC to diagnose VAP was 1.5%,which had a sensitivity of 94.12%,a specificity of 88.33%,a positive predictive value (PPV) of 93.20% and a negative predictive value (NPV) of 89.83%.The area under the receiveroperating characteristic curve was 0.956 (95% confidence interval,0

  16. Phase 3 study of. beta. -methyl-p-( sup 123 I)-iodophenyl-pentadecanoic acid, a myocardial imaging agent for evaluating fatty acid metabolism; A multi-center trial

    Energy Technology Data Exchange (ETDEWEB)

    Torizuka, Kanji (Fukui Medical School, Matsuoka (Japan)); Yonekura, Yoshiharu; Nishimura, Tsunehiko; Ohtake, Tohru; Bunko, Hisashi; Tamaki, Nagara; Uehara, Toshiisa

    1992-04-01

    A multi-center trial of {beta}-methyl-p-({sup 123}I)-iodophenyl-pentadecanoic acid ({sup 123}I-BMIPP) was performed to assess its clinical usefulness in the evaluation of myocardial fatty acid metabolism in 587 patients with various heart diseases. {sup 123}I-BMIPP showed relatively decreased uptake compared with {sup 201}Tl in the myocardial lesions of 62% of patients with ischemic heart disease (IHD), 39% of those with cardiomyopathy and 32% of those with other heart diseases. In case of myocardial infarction, less uptake of {sup 123}I-BMIPP (Type B) than {sup 201}Tl was more frequently seen in patients with successful recanalization than in those without recanalization. The patients with matched distribution of the two tracers (Type E) increased in the direct proportion to the interval between the onset of myocardial infarction and the radionuclide studies. The uptake of {sup 123}I-BMIPP correlated well with myocardial viability evaluated by {sup 201}Tl exercise-redistribution studies. Type B was frequently seen in the areas with {sup 201}Tl redistribution, while Type E was seen in the fixed defect areas. In the other heart diseases studied, Type E was observed in approximately 60% of patients with dilated or secondary cardiomyopathies. Type B was seen in about 45% of patients with valvular heart diseases and myocarditis. Various types of mismatch between the two tracers were demonstrated in hypertrophic cardiomyopathy and hypertensive heart disease. It is concluded that {sup 123}I-BMIPP is a safe and useful agent for the diagnosis of various heart diseases, since it reflects myocardial fatty acid metabolism. (author)

  17. 经鼻持续气道正压给氧多中心临床试验研究%A multi-center clinical trial of oxygen administration with nasal continuous positive airway pressure

    Institute of Scientific and Technical Information of China (English)

    持续气道正压给氧临床试验协作组

    2008-01-01

    目的 评价经鼻持续气道正压(CPAP)给氧的效果.方法 2003年1月至2007年12月首都儿科研究所(牵头)和北京市9家郊区县医院对107例因肺部疾患导致低氧血症新生儿和婴幼儿进行多中心临床试验,通过脉搏血氧仪并结合临床观察对国产的CPAP氧疗仪和普通给氧方法 (面罩、头罩)在改善血氧饱和度的效果方面进行评价.结果 CPAP治疗组46例,普通给氧组61例.应用CPAP后新生儿组在给氧后0.5 h及2 h血氧饱和度为(88.6±7.9)%及(94.4±5.0)%,普通给氧组为(82.4±5.7)%及(90.3±4.5)%,两组间差异有显著性(P<0.05).婴幼儿组在CPAP给氧后1 h血氧饱和度为(95.7±2.6)%,普通给氧组为(87.3±15.8)%,两组间差异有显著性(P<0.05).给氧后紫绀和呼吸困难程度的改善,CPAP组优于普通给氧组.结论 经鼻CPAP氧疗仪是适用于基层、安全、有效、效果优于普通给氧方法 的给氧工具.%Objective To evaluate the effect of nasal continuous positive airway pressure (CPAP).Methods A randomized controlled multi-center clinical trial was conducted during January 2003 to December 2007 in 107 newborns and infants with hypoxemia due to pulmonary diseases.These patients were hospitalized in Capital Institute of Pediatrics and 9 local hospitals.The changes of arterial oxygen saturation and clinical signs were studied after CPAP treatment and conventional oxygen therapy.Results CPAP group recruited 46 cases,conventional oxygen therapy group included 61 cases.After CPAP treatment,oxygen saturation values in newborns at 0.5 and 2 hour were (88.6±7.9)% and (94.4±5.0)%,and there was significant difference as compared with those in conventional oxygen therapy group [(82.4±5.7)% and (90.3±4.5)%].Oxygen saturation value of infants with CPAP at 1 hour was (95.7±2.6)%,and there was significant difference as compared with that in conventional oxygen therapy group[(87.3±15.8)%].Oxygen therapy alleviated the severity of cyanosis and dyspnea

  18. A MULTI-CENTER CLUSTER-RANDOMIZED TRIAL OF A MULTI-FACTORIAL INTERVENTION TO IMPROVE ANTIHYPERTENSIVE MEDICATION ADHERENCE AND BLOOD PRESSURE CONTROL AMONG PATIENTS AT HIGH CARDIOVASCULAR RISK (The COM99 study)*

    Science.gov (United States)

    Pladevall, Manel; Brotons, Carlos; Gabriel, Rafael; Arnau, Anna; Suarez, Carmen; de la Figuera, Mariano; Marquez, Emilio; Coca, Antonio; Sobrino, Javier; Divine, George; Heisler, Michele; Williams, L Keoki

    2010-01-01

    Background Medication non-adherence is common and results in preventable disease complications. This study assesses the effectiveness of a multifactorial intervention to improve both medication adherence and blood pressure control and to reduce cardiovascular events. Methods and Results In this multi-center, cluster-randomized trial, physicians from hospital-based hypertension clinics and primary care centers across Spain were randomized to receive and provide the intervention to their high-risk patients. Eligible patients were ≥50 years of age, had uncontrolled hypertension, and had an estimated 10-year cardiovascular risk greater than 30%. Physicians randomized to the intervention group counted patients’ pills, designated a family member to support adherence behavior, and provided educational information to patients. The primary outcome was blood pressure control at 6 months. Secondary outcomes included both medication adherence and a composite end-point of all cause mortality and cardiovascular-related hospitalizations. Seventy-nine physicians and 877 patients participated in the trial. The mean duration of follow-up was 39 months. Intervention patients were less likely to have an uncontrolled systolic blood pressure (odds ratio 0.62; 95% confidence interval [CI] 0.50–0.78) and were more likely to be adherent (OR 1.91; 95% CI 1.19–3.05) when compared with control group patients at 6 months. After five years 16% of the patients in the intervention group and 19% in the control group met the composite end-point (hazard ratio 0.97; 95% CI 0.67–1.39). Conclusions A multifactorial intervention to improve adherence to antihypertensive medication was effective in improving both adherence and blood pressure control, but it did not appear to improve long-term cardiovascular events. PMID:20823391

  19. 全聋型突发性聋药物治疗的多中心研究%Multi-center study on the treatment of sudden total deafness

    Institute of Scientific and Technical Information of China (English)

    郑虹; 戴晴晴; 周莲; 冯宁宇; 邱建华; 陈阳; 温立婷; 韩宇; 陈俊

    2013-01-01

    目的 探讨全聋型突发性聋的药物治疗.方法 采用前瞻性临床多中心、随机、单盲法研究,纳入年龄18 ~ 65周岁,病程2周内,未经任何相关医疗处理的全聋型突发性聋患者(纯音测听全部频率听阈升高,500、1000、2000、4000 Hz平均听阈≥81 dB HL).按各分中心随机数字表,随机选取四种治疗方案(巴曲酶,巴曲酶+银杏叶提取物,巴曲酶+银杏叶提取物+糖皮质激素和银杏叶提取物+糖皮质激素)中的一种对患者进行治疗.结果 2007年8月至2011年10月,全国33家医院按标准共纳入符合条件的单侧全聋型突发性聋276例,其中男135例(48.91%),女141例(51.09%);平均年龄(41.7±13.3)岁.治疗后,听力痊愈40例(14.49%),显效78例(28.26%),有效76例(27.54%),无效82例(29.71%),总有效率为70.29%.四种治疗方案中,总有效率分别为73.33%、61.43%、78.31%和67.95%,组间比较差异无统计学意义(x2=9.97,P=0.62).四组中耳聋痊愈率分别为11.11%、12.86%、16.87%和15.38%,使用激素的两组好于未使用者.全聋型突发性聋患者中耳鸣伴发率为92.39%,晕(头晕或眩晕)伴发率为44.93%,耳闷伴发率为50.36%;这些伴发症状的疗效在四种治疗方案中,组间差异无统计学意义(P值均>0.05).结论 全聋型突发性聋患者听力损失重,治疗有效率达70%,值得积极治疗;但痊愈率仅14%,医患对此应有合理预期.激素对提高耳聋痊愈率可能有一定作用,推荐使用.%Objective To assess the results of drug therapy in patients with severe idiopathic sudden sensorineural hearing loss (ISSHL) with total frequency hearing loss.Methods A prospective randomized,single blind,multi-center clinical trial was designed.The untreated patients with ISSHL were included,who had severe hearing loss (pure tone audiometry showed patients had total frequency hearing loss,and their mean auditory threshold of 500,1000,2000,4000 Hz was

  20. 第23次"营养风险、不良、支持、结局与成本效益比"及"鱼油干预对结局与成本效益比的影响"工作坊纪要%The 23rd "Nutritional risk, malnutrition, nutritional support, outcome and cost/effective cohort study"and "Impact of fish oil for postoperative patients on outcome and cost/effectiveness: multi-center randomized clinical trial" workshop report

    Institute of Scientific and Technical Information of China (English)

    于康; 蒋朱明; 许静涌; 李海龙

    2010-01-01

    中华医学会肠外肠内营养学分会的"营养风险、不良、支持、结局与费用"协作组第23次工作坊于2010年8月6日至8日在北京举行.本次工作坊由来自北京、天津、重庆、成都、昆明、贵阳、广州、松原、潍坊、桂林、乌鲁木齐、青岛、岳阳和秦皇岛14个中心的共30名代表参加.工作坊的内容主要分为两大部分.第一部分:学习与本协作组研究内容有关的已发表的3篇SCI论文,以及"如何评价论文质量"和"临床医学研究设计"专题报告;第二部分:研讨本协作组目前正进行的两个研究计划,并分别领取工作任务,其中"营养风险、不良、支持、结局与成本效益比"研究计划继续目前的炎症性肠病方面的研究,"鱼油干预对结局与成本效益比"研究计划从随机对照临床试验开始进行.工作坊是高度互动和交流的平台,收效显著.第24次工作坊定于2010年12月17至19日在北京举行.%From August 6 to 8, 2010, the 23 rd "Nutritional risk, malnutrition, nutritional support, outcome, and cost-effective" workshop was held in Beijing. There were 30 participants from Beijing, Tianjin,Chongqing, Chengdu, Kunming, Guiyang, Guangzhou, Songyuan, Weifang, Guilin, Urumqi, Qingdao, Yueyang, and Qinhuangdao. The workshop has 2 sections. Section 1: Learn the published papers from ( 1 ) Jie B,Jiang ZM, Nolan MT, et al. Impact of nutritional support on clinical outcome in patients at nutritional risk: a multicenter, prospective cohort study in Baltimore and Beijing teaching hospitals. Nutrition, 2010, (9); (2)Braga M, Gianotti L. Preoperative immunonutrition: cost-benefit analysis. JPEN J Parenter Enteral Nutr,2005, 29 ( 1 Suppl): S57-S61; and ( 3 ) Jiang ZM, Wilmore DW, Wang XR, et al. Randomized clinical trial of intravenous soybean oil alone versus soybean oil plus fish oil emulsion after gastrointestinal cancer surgery. Br J Surg, 2010, 97 (6): 804-809. Section 2: Discuss two protocols for

  1. A multi-center study on low-frequency rTMS combined with intensive occupational therapy for upper limb hemiparesis in post-stroke patients

    Directory of Open Access Journals (Sweden)

    Kakuda Wataru

    2012-01-01

    Full Text Available Abstract Background Both low-frequency repetitive transcranial magnetic stimulation (rTMS and intensive occupational therapy (OT have been recently reported to be clinically beneficial for post-stroke patients with upper limb hemiparesis. Based on these reports, we developed an inpatient combination protocol of these two modalities for the treatment of such patients. The aims of this pilot study were to confirm the safety and feasibility of the protocol in a large number of patients from different institutions, and identify predictors of the clinical response to the treatment. Methods The study subjects were 204 post-stroke patients with upper limb hemiparesis (mean age at admission 58.5 ± 13.4 years, mean time after stroke 5.0 ± 4.5 years, ± SD from five institutions in Japan. During 15-day hospitalization, each patient received 22 treatment sessions of 20-min low-frequency rTMS and 120-min intensive OT daily. Low-frequency rTMS of 1 Hz was applied to the contralesional hemisphere over the primary motor area. The intensive OT, consisting of 60-min one-to-one training and 60-min self-exercise, was provided after the application of low-frequency rTMS. Fugl-Meyer Assessment (FMA and Wolf Motor Function Test (WMFT were performed serially. The physiatrists and occupational therapists involved in this study received training prior to the study to standardize the therapeutic protocol. Results All patients completed the protocol without any adverse effects. The FMA score increased and WMFT log performance time decreased significantly at discharge, relative to the respective values at admission (change in FMA score: median at admission, 47 points; median at discharge, 51 points; p Conclusions The 15-day inpatient rTMS plus OT protocol is a safe, feasible, and clinically useful neurorehabilitative intervention for post-stroke patients with upper limb hemiparesis. The response to the treatment was not influenced by age or time after stroke onset. The

  2. A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder.

    Science.gov (United States)

    Woelk, H; Schläfke, S

    2010-02-01

    Generalized and persistent anxiety, accompanied by nervousness and other symptoms (Generalised Anxiety Disorder, GAD) is frequent in the general population and leads to benzodiazepine usage. Unfortunately, these substances induce sedation and have a high potential for drug abuse, and there is thus a need for alternatives. As the anxiolytic properties of lavender have already been demonstrated in pharmacological studies and small-scale clinical trials, it was postulated that lavender has a positive effect in GAD. A controlled clinical study was then performed to evaluate the efficacy of silexan, a new oral lavender oil capsule preparation, versus a benzodiazepine. In this study, the efficacy of a 6-week-intake of silexan compared to lorazepam was investigated in adults with GAD. The primary target variable was the change in the Hamilton Anxiety Rating Scale (HAM-A-total score) as an objective measurement of the severity of anxiety between baseline and week 6. The results suggest that silexan effectively ameliorates generalized anxiety comparable to a common benzodiazepine (lorazepam). The mean of the HAM-A-total score decreased clearly and to a similar extent in both groups (by 11.3+/-6.7 points (45%) in the silexan group and by 11.6+/-6.6 points (46%) in the lorazepam group, from 25+/-4 points at baseline in both groups). During the active treatment period, the two HAM-A subscores "somatic anxiety" (HAM-A subscore I) and "psychic anxiety" (HAM-A subscore II) also decreased clearly and to a similar extent in both groups. The changes in other subscores measured during the study, such as the SAS (Self-rating Anxiety Scale), PSWQ-PW (Penn State Worry Questionnaire), SF 36 Health survey Questionnaire and Clinical Global Impressions of severity of disorder (CGI item 1, CGI item 2, CGI item 3), and the results of the sleep diary demonstrated comparable positive effects of the two compounds. In conclusion, our results demonstrate that silexan is as effective as lorazepam

  3. The effectiveness of cognitive behavioral therapy on the quality of life of patients with inflammatory bowel disease: multi-center design and study protocol (KL!C- study

    Directory of Open Access Journals (Sweden)

    Evertsz’ Floor Bennebroek

    2012-12-01

    Full Text Available Abstract Background Inflammatory Bowel Disease (IBD patients report poorer quality of life (QoL and more anxiety and depressive symptoms than controls from the general population. Cognitive behavioral therapy (CBT is effective for anxiety and depression, but questionable in case of co-morbidity with IBD. Therefore, an adapted new CBT specifically designed for IBD patients was developed. The objective of this study is to evaluate the effectiveness of adapted CBT on QoL. Methods/design IBD patients with a poor level of mental QoL (score less than or equal to 23 on the mental health scale of SF-36 will be randomly assigned to the experimental (n = 40 or waiting-list control condition (n = 40. The experimental condition will then immediately start CBT. The waiting-list control condition will wait 3,5 months before CBT begins with pre- and post assessments. Both conditions will complete a baseline and follow-up assessment following CBT and a mid-treatment assessment. The primary outcome is IBD-specific QoL (IBDQ. Secondary outcomes are generic QoL (SF-36 and anxiety and depression complaints (HADS, CES-D. Additionally, we will examine the working mechanism of the psychological intervention by investigating the impact of the intervention on illness-related cognitions, attitudes, coping styles and their associations with outcome. Data will be analysed on an intention to treat (ITT as well as treatment completer basis (greater than or equal to five sessions followed. Discussion If found effective, this IBD-specific CBT is a first step to enhance poor QoL in IBD patients and possibly, other gastroenterological diseases. By enhancing IBD patients’ QoL, we may also improve their mental and physical health, and lower unnecessary health care consumption. Trial registration number NTR (TC = 1869

  4. Cognitive dysfunction in patients with multiple sclerosis treated with first-line disease-modifying therapy: a multi-center, controlled study using the BICAMS battery.

    Science.gov (United States)

    Cinar, Bilge Piri; Kösehasanoğulları, Görkem; Yigit, Pinar; Ozakbas, Serkan

    2017-02-01

    Multiple sclerosis (MS) can impair cognitive functions even in the early stages. The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery is very short and highly sensitive and can be used to evaluate cognitive status in the disease. Several clinical trials have shown beneficial effects of disease-modifying drugs (DMDs) on long-term cognitive measures which may even reduce cognitive deficits in MS patients. Relapsing remitting MS patients using DMDs were enrolled in the study and monitored for 12 months. BICAMS and the Expanded Disability Status Scale were applied to the study group. We evaluated and monitored 161 newly diagnosed cases of definite MS by the end of the trial. 110 patients (68.2%) were female. One hundred and two healthy subjects (female to male ratio 68:34) were enrolled into the study. MS patients were categorized into three DMT groups: IFNB1-a SC, IFNB1-b, and GA. Mean scores of all three cognitive tests (SDMT, BVMT-R, and CVLT-II) were significantly higher in the control group than in the MS patients. The number of cognitively impaired patients decreased from 31.7 to 21.7% on the basis of CVLT (p = 0.024), and 42 (26.1%) to 30 (18.6%) on the basis of BVMT-R at month 12. A significant difference was determined in terms of cognitive status between MS patients using both IFNB and GA and the healthy control group. Ours is the first study to compare IFNB and GA in terms of evaluating cognitive involvement and to use the BICAMS battery in monitoring treatment.

  5. Erectile Dysfunction in Chronic Prostatitis/Chronic Pelvic Pain Syndrome: Outcomes from a Multi-Center Study and Risk Factor Analysis in a Single Center.

    Directory of Open Access Journals (Sweden)

    Yadong Zhang

    Full Text Available The aim of this study was to investigate the prevalence of erectile dysfunction (ED in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS and explore the influence of UPOINT domains, National Institutes of Health-CP symptom index (NIH-CPSI and other factors on ED prevalence. This was a prospective study of consecutive patients with CP/CPPS seen at 11 tertiary hospitals during January-July 2014. ED was diagnosed as a score of<21 on the International Index of Erectile Function (IIEF-5. Patients from one center were evaluated by the UPOINT system and NIH-CPSI. Each patient was assessed using clinical examination, asocio-demographic questionnaire, the Patient Health Questionnaire (PHQ, the Pain Catastrophizing Scale (PCS, NIH-CPSI and IIEF-5.1406 patients from 11 centers (mean age, 32.18 years; range 18-60 years were enrolled. ED was found in 638/1406 patients (45.4%, and was categorized as mild in 291(45.6%, moderate in 297(46.6% and severe in50(7.7%. 192 patients from one center(mean age,31.3 years; range 18-57 years were further studied.IIEF-5 score correlated negatively with NIH-CPSI(r = 0.251, PHQ (r = 0.355 and PCS (r = 0.322scores (P<0.001.PHQ score correlated positively with NIH-CPSI (r = 0.586 and PCS(r = 0.662 scores (P<0.001.NIH-CPSI, PHQ, PCS and IIEF-5 scores did not differ significantly between class IIIA and IIIB CP/CPPS. Multivariate logistic regression showed that UPOINT psychological (P domain and NIH-CPSI symptom severity were independent risk factors for ED in CP/CPPS. It is concluded that psychological factors and symptom severity are independent risk factors for ED in CP/CPPS.

  6. Risk of bladder cancer among patients with diabetes treated with a 15 mg pioglitazone dose in Korea: a multi-center retrospective cohort study.

    Science.gov (United States)

    Jin, Sang-Man; Song, Sun Ok; Jung, Chang Hee; Chang, Jin-Sun; Suh, Sunghwan; Kang, Seung Min; Jung, Inkyung; Park, Cheol-Young; Kim, Jae Hyeon; Cho, Jae Hyoung; Lee, Byung-Wan

    2014-02-01

    It has not yet been determined whether chronic exposure to relatively low doses of pioglitazone increases risk of bladder cancer. We aimed to assess the risk of bladder cancer associated with pioglitazone in Korean patients. This was a retrospective cohort study of diabetic patients who had ≥ 2 clinic visits between November 2005 and June 2011 at one of four tertiary referral hospitals in Korea. A prevalent case-control analysis nested within the cohort was conducted to further adjust confounders. A total of 101,953 control patients and 11,240 pioglitazone-treated patients were included, in which there were 237 and 30 cases of incidental bladder cancer (64.9 and 54.9 per 100,000 person-years; age, sex-adjusted HR 1.135, 95% confidence interval [CI] 0.769-1.677), respectively. In the prevalent case-control analysis nested within the cohort, use of pioglitazone for a duration of > 6 months, but not ever use of pioglitazone, was associated with an increased rate of bladder cancer as compared to never use of pioglitazone. In conclusion, we failed to exclude the possible association between use of pioglitazone for a duration of > 6 months and bladder cancer.

  7. Short-Term Outcomes and Safety of Computed Tomography-Guided Percutaneous Microwave Ablation of Solitary Adrenal Metastasis from Lung Cancer: A Multi-Center Retrospective Study

    Science.gov (United States)

    Men, Min; Fan, Weijun; Zhang, Kaixian; Bi, Jingwang; Yang, Xia; Zheng, Aimin; Huang, Guanghui; Wei, Zhigang

    2016-01-01

    Objective 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. Materials and Methods 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. Results 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). Conclusion CT-guided percutaneous MWA may be fairly safe and effective for treating solitary adrenal metastasis from lung cancer. PMID:27833402

  8. Remission of rheumatoid arthritis and potential determinants: a national multi-center cross-sectional survey.

    Science.gov (United States)

    Wang, Guan-Ying; Zhang, Sa-Li; Wang, Xiu-Ru; Feng, Min; Li, Chun; An, Yuan; Li, Xiao-Feng; Wang, Li-Zhi; Wang, Cai-Hong; Wang, Yong-Fu; Yang, Rong; Yan, Hui-Ming; Wang, Guo-Chun; Lu, Xin; Liu, Xia; Zhu, Ping; Chen, Li-Na; Jin, Hong-Tao; Liu, Jin-Ting; Guo, Hui-Fang; Chen, Hai-Ying; Xie, Jian-Li; Wei, Ping; Wang, Jun-Xiang; Liu, Xiang-Yuan; Sun, Lin; Cui, Liu-Fu; Shu, Rong; Liu, Bai-Lu; Yu, Ping; Zhang, Zhuo-Li; Li, Guang-Tao; Li, Zhen-Bin; Yang, Jing; Li, Jun-Fang; Jia, Bin; Zhang, Feng-Xiao; Tao, Jie-Mei; Lin, Jin-Ying; Wei, Mei-Qiu; Liu, Xiao-Min; Ke, Dan; Hu, Shao-Xian; Ye, Cong; Han, Shu-Ling; Yang, Xiu-Yan; Li, Hao; Huang, Ci-Bo; Gao, Ming; Lai, Bei; Cheng, Yong-Jing; Li, Xing-Fu; Song, Li-Jun; Yu, Xiao-Xia; Wang, Ai-Xue; Wu, Li-Jun; Wang, Yan-Hua; He, Lan; Sun, Wen-Wen; Gong, Lu; Wang, Xiao-Yuan; Wang, Yi; Zhao, Yi; Li, Xiao-Xia; Wang, Yan; Zhang, Yan; Su, Yin; Zhang, Chun-Fang; Mu, Rong; Li, Zhan-Guo

    2015-02-01

    The aim of this study is to investigate the remission rate of rheumatoid arthritis (RA) in China and identify its potential determinants. A multi-center cross-sectional study was conducted from July 2009 to January 2012. Data were collected by face-to-face interviews of the rheumatology outpatients in 28 tertiary hospitals in China. The remission rates were calculated in 486 RA patients according to different definitions of remission: the Disease Activity Score in 28 joints (DAS28), the Simplified Disease Activity Index (SDAI), the Clinical Disease Activity Index (CDAI), and the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definition. Potential determinants of RA remission were assessed by univariate and multivariate analyses. The remission rates of RA from this multi-center cohort were 8.6% (DAS28), 8.4% (SDAI), 8.2% (CDAI), and 6.8% (Boolean), respectively. Favorable factors associated with remission were: low Health Assessment Questionnaire (HAQ) score, absence of rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP), and treatment of methotrexate (MTX) and hydroxychloroquine (HCQ). Younger age was also predictive for the DAS28 and the Boolean remission. Multivariate analyses revealed a low HAQ score, the absence of anti-CCP, and the treatment with HCQ as independent determinants of remission. The clinical remission rate of RA patients was low in China. A low HAQ score, the absence of anti-CCP, and HCQ were significant independent determinants for RA remission.

  9. A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury.

    Directory of Open Access Journals (Sweden)

    James A Tumlin

    Full Text Available Acute kidney injury (AKI is a highly morbid condition in critically ill patients that is associated with high mortality. Previous clinical studies have demonstrated the safety and efficacy of the Selective Cytopheretic Device (SCD in the treatment of AKI requiring continuous renal replacement therapy in the intensive care unit (ICU.A randomized, controlled trial of 134 ICU patients with AKI, 69 received continuous renal replacement therapy (CRRT alone and 65 received SCD therapy.No significant difference in 60-day mortality was observed between the treated (27/69; 39% and control patients (21/59; 36%, with six patients lost to follow up in the intention to treat (ITT analysis. Of the 19 SCD subjects (CRRT+SCD and 31 control subjects (CRRT alone who maintained a post-filter ionized calcium (iCa level in the protocol's recommended range (≤ 0.4 mmol/L for greater or equal to 90% of the therapy time, 60-day mortality was 16% (3/19 in the SCD group compared to 41% (11/27 in the CRRT alone group (p = 0.11. Dialysis dependency showed a borderline statistically significant difference between the SCD treated versus control CRRT alone patients maintained for ≥ 90% of the treatment in the protocol's recommended (r iCa target range of ≤ 0.4 mmol/L with values of, 0% (0/16 and 25% (4/16, respectively (P = 0.10. When the riCa treated and control subgroups were compared for a composite index of 60 day mortality and dialysis dependency, the percentage of SCD treated subjects was 16% versus 58% in the control subjects (p<0.01. The incidence of serious adverse events did not differ between the treated (45/69; 65% and control groups (40/65; 63%; p = 0·86.SCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.ClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.

  10. Early and very early hepatocellular carcinoma: when and how much do staging and choice of treatment really matter? A multi-center study

    Directory of Open Access Journals (Sweden)

    Zoli Marco

    2009-01-01

    Full Text Available Abstract Background A consensus on the most reliable staging system for hepatocellular carcinoma (HCC is still lacking but the most used is a revised Barcelona Clinic Liver Cancer (BCLC system, adopted by the American Association for the Study of Liver Diseases (AASLD. We investigated how many patients are diagnosed in "very early" and "early" stage, follow the AASLD guidelines for treatment and whether their survival depends on treatment. Methods Data were collected in 530 "very early" and "early" HCC patients recruited by a multicentric Italian collaborative group (ITA.LI.CA. The Kaplan-Meier method was used to estimate overall survival and the log rank to test the statistical significance of difference between groups. Cox's multivariate stepwise regression analysis was used to pinpoint independent prognostic factors and the adjusted relative risks (hazard ratios were calculated as well. A statistical analysis based on the chi-square test was used to identify significant differences in clinical or pathological features between patients. A P-value Results "Very early" HCC were 3%; Cox multivariate analysis did not identify variables independently associated with survival. The patients following AASLD recommendations (20% did not show longer survival. In "early" HCC patients (25%, treatment significantly modulated survival (p = 0.0001; the 28% patients treated according to the AASLD criteria survived longer (p = 0,004. The Cox analysis however identified only age, gender, number of lesions and Child class as independent predictors of survival. Conclusion patients with very early" HCC were very few in this analysis. In most instances they were not treated with the treatment suggested as the most appropriate by the AASLD guidelines and the type of treatment had no impact on survival, even though the number of patients was relatively low and part of the patients were diagnosed before the introduction of the guidelines: this analysis, therefore

  11. Neuropathologic assessment of participants in two multi-center longitudinal observational studies: the Alzheimer Disease Neuroimaging Initiative (ADNI) and the Dominantly Inherited Alzheimer Network (DIAN).

    Science.gov (United States)

    Cairns, Nigel J; Perrin, Richard J; Franklin, Erin E; Carter, Deborah; Vincent, Benjamin; Xie, Mingqiang; Bateman, Randall J; Benzinger, Tammie; Friedrichsen, Karl; Brooks, William S; Halliday, Glenda M; McLean, Catriona; Ghetti, Bernardino; Morris, John C

    2015-08-01

    It has been hypothesized that the relatively rare autosomal dominant Alzheimer disease (ADAD) may be a useful model of the more frequent, sporadic, late-onset AD (LOAD). Individuals with ADAD have a predictable age at onset and the biomarker profile of ADAD participants in the preclinical stage may be used to predict disease progression and clinical onset. However, the extent to which the pathogenesis and neuropathology of ADAD overlaps with that of LOAD is equivocal. To address this uncertainty, two multicenter longitudinal observational studies, the Alzheimer Disease Neuroimaging Initiative (ADNI) and the Dominantly Inherited Alzheimer Network (DIAN), leveraged the expertise and resources of the existing Knight Alzheimer Disease Research Center (ADRC) at Washington University School of Medicine, St. Louis, Missouri, USA, to establish a Neuropathology Core (NPC). The ADNI/DIAN-NPC is systematically examining the brains of all participants who come to autopsy at the 59 ADNI sites in the USA and Canada and the 14 DIAN sites in the USA (eight), Australia (three), UK (one) and Germany (two). By 2014, 41 ADNI and 24 DIAN autopsies (involving nine participants and 15 family members) had been performed. The autopsy rate in the ADNI cohort in the most recent year was 93% (total since NPC inception: 70%). In summary, the ADNI/DIAN NPC has implemented a standard protocol for all sites to solicit permission for brain autopsy and to send brain tissue to the NPC for a standardized, uniform and state-of-the-art neuropathologic assessment. The benefit to ADNI and DIAN of the implementation of the NPC is very clear. The NPC provides final "gold standard" neuropathological diagnoses and data against which the antecedent observations and measurements of ADNI and DIAN can be compared.

  12. Amelia: A Multi-Center Descriptive Epidemiologic Study in a Large Dataset from the International Clearinghouse for Birth Defects Surveillance and Research, and Overview of the Literature

    Science.gov (United States)

    BERMEJO-SÁNCHEZ, EVA; CUEVAS, LOURDES; AMAR, EMMANUELLE; BAKKER, MARIAN K.; BIANCA, SEBASTIANO; BIANCHI, FABRIZIO; CANFIELD, MARK A.; CASTILLA, EDUARDO E.; CLEMENTI, MAURIZIO; COCCHI, GUIDO; FELDKAMP, MARCIA L.; LANDAU, DANIELLE; LEONCINI, EMANUELE; LI, ZHU; LOWRY, R. BRIAN; MASTROIACOVO, PIERPAOLO; MUTCHINICK, OSVALDO M.; RISSMANN, ANKE; RITVANEN, ANNUKKA; SCARANO, GIOACCHINO; SIFFEL, CSABA; SZABOVA, ELENA; MARTÍNEZ-FRÍAS, MARÍA-LUISA

    2015-01-01

    This study describes the epidemiology of congenital amelia (absence of limb/s), using the largest series of cases known to date. Data were gathered by 20 surveillance programs on congenital anomalies, all International Clearinghouse for Birth Defects Surveillance and Research members, from all continents but Africa, from 1968 to 2006, depending on the program. Reported clinical information on cases was thoroughly reviewed to identify those strictly meeting the definition of amelia. Those with amniotic bands or limb-body wall complex were excluded. The primary epidemiological analyses focused on isolated cases and those with multiple congenital anomalies (MCA). A total of 326 amelia cases were ascertained among 23,110,591 live births, stillbirths and (for some programs) elective terminations of pregnancy for fetal anomalies. The overall total prevalence was 1.41 per 100,000 (95% confidence interval: 1.26–1.57). Only China Beijing and Mexico RYVEMCE had total prevalences, which were significantly higher than this overall total prevalence. Some under-registration could influence the total prevalence in some programs. Liveborn cases represented 54.6% of total. Among monomelic cases (representing 65.2% of nonsyndromic amelia cases), both sides were equally involved, and the upper limbs (53.9%) were slightly more frequently affected. One of the most interesting findings was a higher prevalence of amelia among offspring of mothers younger than 20 years. Sixty-nine percent of the cases had MCA or syndromes. The most frequent defects associated with amelia were other types of musculoskeletal defects, intestinal, some renal and genital defects, oral clefts, defects of cardiac septa, and anencephaly. PMID:22002956

  13. Risk factors for interstitial cystitis/painful bladder syndrome in patients with lower urinary tract symptoms: a Chinese multi-center study

    Institute of Scientific and Technical Information of China (English)

    LI Gui-zhong; DAI Yi; ZHANG Ning; DU Peng; YANG Yong; WU Shi-liang; XIAO Yun-xiang; JIN Rui; LIU Lei; SHEN Hong

    2010-01-01

    Background Despite 100 years of research, the continued absence of well-established risk factors impedes the diagnosis and treatment of interstitial cystitis/painful bladder syndrome (IC/PBS). We aimed to identify risk factors in patients with lower urinary tract symptoms (LUTS) without urinary tract infection or benign prostate hyperplasia in China.Methods A total of 397 outpatients with LUTS presenting for care to urology clinics in several hospitals throughout China were surveyed using a standardized questionnaire and validated outcome measures. The definitions for painful bladder syndrome based on the O‘Leary-Sant interstitial cystitis symptom and problem indices were used. The prevalence of possible risk factors was analyzed using the Fisher's exact test and Pearson chi-square test, and multivariate predictive models were developed using binary Logistic regression methods.Results Of those multi-centre patients surveyed, including 174 women and 223 men, 41% (162/397) met criteria for painful bladder syndrome. There was a significant difference between women and men (55% (95/174) vs. 30% (67/223),P <0.001). Women with IC/PBS were more likely than those without IC/PBS to report a history of gynecological infections (odds ratio (OR): 2.85; 95% confidence interval (CI): 1.32-6.16, P=0.007), intake of stimulatory foods (OR: 3.52; 95% CI:1.50-8.30; P=0.004), irritable bowel (OR: 3.46; 95% CI: 1.22-9.80; P=0.014) and/or anorectal disease (OR: 2.68; 95% CI:1.12-6.40, P=0.023). After adjusting for confounding factors, bladder pain was significantly associated with stimulatory foods (OR: 3.85; 95% CI: 1.58-9.36, P=0.003) and anorectal disease (OR: 2.76; 95% CI: 1.09-7.04, P=0.03) in women.Caffeine beverage intake (OR: 3.54; 95% CI: 1.54-8.12, P=0.003) was identified the only modifiable association noted in multivariate analysis of men.Conclusions We found that stimutatory foods, anorectal disease and caffeine beverages are potential risk factors for IC/PBS. Further

  14. Investigating the efficacy of an individualized metacognitive therapy program (MCT+) for psychosis: study protocol of a multi-center randomized controlled trial

    OpenAIRE

    2016-01-01

    Background Psychological interventions are increasingly recommended as adjunctive treatments for psychosis, but their implementation in clinical practice is still insufficient. The individualized metacognitive therapy program (MCT+; www.uke.de/mct_plus) represents a low-threshold psychotherapeutic approach that synthesizes group metacognitive training (MCT) and cognitive behavioral therapy for psychosis, and addresses specific cognitive biases that are involved in the onset and maintenance of...

  15. Effect of Marvelon on Medical Abortion: a Randomized, Double-blind and Multi-center Control Study%妈富隆提高药物流产效果的随机双盲对照研究

    Institute of Scientific and Technical Information of China (English)

    陈勤芳; 黄紫蓉; 范晓芳; 方爱华; 黄咏梅; 庄留琪

    2011-01-01

    Objective: To evaluate the clinical effect of Marvelon on the abortion induced by mifepristone and misoprostol. Methods: This was a randomized, double-blind, multi-center control study. Pregnant women meeting the criteria of medical abortion were enrolled in different outpatient centers (3 hospital) of Shanghai,China. After the gestational sac was discharged, all subjects were randomly assigned into two groups: group A based on that the subjects were administered medicine A and group B based on that the subjects was administered medicine B for the next continual 21 d. The complete abortion rate and the time of vaginal bleeding and menstruation recovery were followed up. Results: Total 414 subjects were recruited: group A——Marvelon (desogestrel ethinyl estradiol tablets) group, included 209 cases, and group B——the placebo (only starch) group, included 205 cases. Group A had significant high rate of complete abortion, short time of vaginal bleeding and menstruation recovery compared with group B (P<0.05). Conclusion: Oral administration of Marvelon for continual 21 d just after medical abortion significantly enhances the rate of complete abortion and shortens the time of vaginal bleeding and menstruation recovery.%目的:观察药物流产后及时服用妈富隆的临床效果.方法:在上海市区3个临床中心共招纳600例因非意愿妊娠要求药物流产的早孕(<49 d)健康妇女,采用随机双盲对照的多中心临床研究.各中心门诊按药物流产常规接纳对象,口服米非司酮配伍米索前列醇,孕囊排出后随机分为A组和B组,于当日起每晚加服A或B药(外包装相似)1片,连服21d,定期随访完全流产率、阴道出血时间、月经恢复情况等.结果:完全按医嘱执行并纳入资料分析的共414例,统计后揭秘A药为妈富隆(去氧孕烯炔雌醇片),209例,B药为安慰剂(不含任何药物的淀粉剂),205例,妈富隆组完全流产率高、月经恢复时间和经期出血时间短,

  16. 突发性聋患者伴发耳鸣的疗效分析%Multi-center study on the treatment of sudden deafness accompanied with tinnitus

    Institute of Scientific and Technical Information of China (English)

    赵晖; 董红; 程岩; 马元煦; 林鹏; 钟时勋; 康厚墉; 钱怡; 胡国华

    2015-01-01

    伴发的耳鸣均有效.%Objective To investigate the clinical characteristics and the effects of different drug therapies in patients of sudden deafness accompanied with tinnitus.Methods The international standardized clinical research methods,the unified design and program were used in the study.The patients of sudden deafness accompanied with tinnitus,aged between 18 to 65 years old,were recruited,whose duration was less than two weeks with no medication.The patients were divided into four types according to the hearing curve:type A was acute sensorineural hearing loss in low tone frequencies,type B was acute sensorineural hearing loss in high tone frequencies,type C was acute sensorineural hearing loss in all frequencies and type D was total deafness.Each type had four different treatment programs,based on the unified designed randomized table.Results A total of 1024 cases with single side sudden deafness were recruited in the study by 33 hospitals in China from August 2007 to October 2011.Among the 1024 cases,922 cases were accompanied with tinnitus (90.04%).By classification of audiogram,among the 922 cases,169 cases were type A(82.44%),127 cases were type B(90.07%),370 cases were type C(92.04%),and 256 cases were type D (92.75%).The tinnitus mostly was persistent and low tone tinnitus.The degree of the tinnitus was mostly 2-3 grade.The curative effects of different types were analyzed,type A had the highest rate of 96.18%,type C was 87.75%,type B was 81.51%,and type D had the lowest rate of 75.32%.Significant difference of curative rate between different types was detected (x2 =125.33,P =0.000).There had no significant difference between the four different treatment groups (all P > 0.05).Conclusions In the cases with single side sudden deafness accompanied with tinnitus,the type in low tone frequencies has the best curative effect,followed by the type in all frequencies.The type in high tone frequencies and the total deafness type have poor curative results.The steroid plays

  17. 77 FR 9665 - Submission for OMB Emergency Review; Comment Request: A Multi-Center International Hospital-Based...

    Science.gov (United States)

    2012-02-17

    ... Multi- Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI... Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and... currently valid OMB control number. Proposed Collection: Title: A Multi-Center International Hospital-...

  18. The effect of water fluoride concentration on dental caries and fluorosis in five Iran provinces: A multi-center two-phase study

    Directory of Open Access Journals (Sweden)

    Gholamhossein Ramezani

    2015-01-01

    Conclusion: Extremely low fluoride levels in Iran cities are an alarming finding and need attention. Higher fluoride is likely to reduce dental caries while increasing fluorosis. This finding was not confirmed in all the areas studied.

  19. Multi-center feasibility study evaluating recruitment, variability in risk factors and biomarkers for a diet and cancer cohort in India

    Directory of Open Access Journals (Sweden)

    McAdams Mary J

    2011-05-01

    Full Text Available Abstract Background India's population exhibits diverse dietary habits and chronic disease patterns. Nutritional epidemiologic studies in India are primarily of cross-sectional or case-control design and subject to biases, including differential recall of past diet. The aim of this feasibility study was to evaluate whether a diet-focused cohort study of cancer could be established in India, providing insight into potentially unique diet and lifestyle exposures. Methods Field staff contacted 7,064 households within three regions of India (New Delhi, Mumbai, and Trivandrum and found 4,671 eligible adults aged 35-69 years. Participants completed interviewer-administered questionnaires (demographic, diet history, physical activity, medical/reproductive history, tobacco/alcohol use, and occupational history, and staff collected biological samples (blood, urine, and toenail clippings, anthropometric measurements (weight, standing and sitting height; waist, hip, and thigh circumference; triceps, sub-scapula and supra-patella skin fold, and blood pressure measurements. Results Eighty-eight percent of eligible subjects completed all questionnaires and 67% provided biological samples. Unique protein sources by region were fish in Trivandrum, dairy in New Delhi, and pulses (legumes in Mumbai. Consumption of meat, alcohol, fast food, and soft drinks was scarce in all three regions. A large percentage of the participants were centrally obese and had elevated blood glucose levels. New Delhi participants were also the least physically active and had elevated lipids levels, suggesting a high prevalence of metabolic syndrome. Conclusions A high percentage of participants complied with study procedures including biological sample collection. Epidemiologic expertise and sufficient infrastructure exists at these three sites in India to successfully carry out a modest sized population-based study; however, we identified some potential problems in conducting a cohort

  20. The effect of water fluoride concentration on dental caries and fluorosis in five Iran provinces: A multi-center two-phase study

    Science.gov (United States)

    Ramezani, Gholamhossein; Valaie, Nasser; Rakhshan, Vahid

    2015-01-01

    Background: Water fluoride level is unknown in many regions of Iran. Besides, only few non-controlled studies world-wide have assessed the effect of water fluoride on dental fluorosis and caries. We aimed to measure the fluoride level of 76 water supplies in 54 cities and evaluate the effect of fluoride on dental caries and fluorosis in a large multi-project study. Materials and Methods: In the first phase (cross-sectional), fluoride levels of 76 water tanks in 54 cities/villages in five provinces of Iran were randomly evaluated in five subprojects. In the second phase (retrospective cohort), 1127 middle school children (563 cohort and 564 control subjects) in the high and low ends of fluoride concentration in each subproject were visited. Their decayed, missing and filled teeth (DMFT) and fluorosis states were assessed. The data were analyzed using Chi-square, Mann-Whitney U and independent-samples t-test (α = 0.05). Results: Mean fluoride level was 0.298 ± 0.340 mg/L in 54 cities/villages. Only eight water tanks had fluoride levels within the normal range and only one was higher than normal and the rest (67 tanks) were all at low levels. Overall, a significant association was observed between fluoride level and fluorosis. However, this was not the case in all areas, as in 2 of 5 provinces, the effect of fluoride on fluorosis was not confirmed. In 4 of the 5 areas studied, there was a significant link between fluoride level and DMFT. Conclusion: Extremely low fluoride levels in Iran cities are an alarming finding and need attention. Higher fluoride is likely to reduce dental caries while increasing fluorosis. This finding was not confirmed in all the areas studied. PMID:25709672

  1. The prognostic value of pimonidazole and tumour pO2 in human cervix carcinomas after radiation therapy: a prospective international multi-center study

    DEFF Research Database (Denmark)

    Nordsmark, Marianne; Loncaster, Julie; Aquino-Parsons, Christina

    2006-01-01

    BACKGROUND AND PURPOSE: Hypoxia adversely affects treatment outcome in human uterine cervical cancer. Here, we present the results of a prospective international multi-centre study evaluating the prognostic value of pre-treatment tumour oxygen partial pressure (pO(2)) and the hypoxia marker...... pimonidazole (pimo). MATERIALS AND METHODS: One hundred and twenty-seven patients with primary cervix cancer were entered. Pre-treatment tumour pO(2) measurements were obtained, and reported by the median tumour pO(2), the fraction of pO(2) values...

  2. Prognostic and Predictive Factors in Patients with Advanced Penile Cancer Receiving Salvage (2nd or Later Line) Systemic Treatment: A Retrospective, Multi-Center Study

    Science.gov (United States)

    Buonerba, Carlo; Di Lorenzo, Giuseppe; Pond, Gregory; Cartenì, Giacomo; Scagliarini, Sarah; Rozzi, Antonio; Quevedo, Fernando J.; Dorff, Tanya; Nappi, Lucia; Lanzetta, Gaetano; Pagliaro, Lance; Eigl, Bernhard J.; Naik, Gurudatta; Ferro, Matteo; Galdiero, Mariano; De Placido, Sabino; Sonpavde, Guru

    2016-01-01

    Introduction and objectives: Metastatic penile squamous cell carcinoma (PSCC) is associated with dismal outcomes with median overall survival (OS) of 6–12 months in the first-line and <6 months in the salvage setting. Given the rarity of this disease, randomized trials are difficult. Prognostic risk models may assist in rational drug development by comparing observed outcomes in nonrandomized phase II studies and retrospective data vs. predicted outcomes based on baseline prognostic factors in the context of historically used agents. In this retrospective study, we constructed a prognostic model in the salvage setting of PSCC patients receiving second or later line systemic treatment, and also explored differences in outcomes based on type of treatment. Materials and methods: We performed a chart review to identify patients with locally advanced unresectable or metastatic PSCC who received second or later line systemic treatment in centers from North America and Europe. The primary outcome was OS from initiation of treatment, with secondary outcomes being progression-free survival (PFS) and response rate (RR). OS was estimated using the Kaplan-Meier method. Cox proportional hazards regression was used to identify prognostic factors for outcomes using univariable and multivariable models. Results: Sixty-five patients were eligible. Seventeen of 63 evaluable patients had a response (27.0%, 95% confidence interval [CI] = 16.6–39.7%) and median OS and PFS were 20 (95% CI = 20–21) and 12 (95% CI = 12, 16) weeks, respectively. Visceral metastasis (VM) and hemoglobin (Hb) ≤ 10 gm/dl were consistently significant poor prognostic factors for both OS and PFS, and Hb was also prognostic for response. The 28 patients with neither risk factor had a median OS (95% CI) of 24 (20–40) weeks and 1-year (95% CI) OS of 13.7% (4.4–42.7%), while the 37 patients with 1 or 2 risk factors had median OS (95% CI) of 20 (16–20) weeks and 1-year (95% CI) OS of 6.7% (1.8–24

  3. Effects of heat and moisture exchangers on tracheal mucociliary clearance in laryngectomized patients: a multi-center case-control study.

    Science.gov (United States)

    van den Boer, C; Muller, S H; van der Noort, V; Olmos, R A Valdés; Minni, A; Parrilla, C; Hilgers, F J M; van den Brekel, M W M; van der Baan, S

    2015-11-01

    After total laryngectomy, inspired air is no longer optimally conditioned by the upper airways. Impaired mucociliary clearance and histological changes of respiratory epithelium, such as loss of ciliated cells, have been described in laryngectomized patients. Heat and moisture exchangers (HMEs) are passive humidifiers that re-condition the inspired air. Aim of this study was to assess the effect of HMEs on tracheal epithelium and tracheal mucus transport velocity (TMV). Tracheal brush biopsies were collected in three groups of TLE patients: 21 long-term HME users, 10 non-HME users, and 16 non-HME users before and after 4-9 months HME use. Tracheal epithelium biopsies were assessed using a digital high-speed camera mounted onto a light microscope. TMV was determined by scintigraphy in the first two patient groups. Significantly more ciliated cells were found in HME users compared to non-HME users (p = 0.05). TMV was higher in HME users (median 2 mm/min; 0-7.9) compared to non-HME users (median 0.8 mm/min; 0-12.3), but this difference was not significant (p = 0.37). One-hour breathing without HME in long-term HME users did not measurably decrease TMV (p = 0.13). The long-term use of an HME restores/prevents the loss of tracheal ciliated cells. A significant improvement in TMV was not found. Short-term (one hour) detachment of an HME has no measurable effect on TMV.

  4. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients

    Directory of Open Access Journals (Sweden)

    Villafranca Alex

    2009-11-01

    Full Text Available Abstract Background Awareness with explicit recall of intra-operative events is a rare and distressing complication that may lead to severe psychological symptoms. Candidate depth of anesthesia monitors have been developed, partly with the aim of preventing this complication. Despite conflicting results from clinical trials and the lack of incisive validation, such monitors have enjoyed widespread clinical adoption, in particular the bispectral index. The American Society of Anesthesiologists has called for adequately powered and rigorously designed clinical trials to determine whether the use of such monitors decreases the incidence of awareness in various settings. The aim of this study is to determine with increased precision whether incorporating the bispectral index into a structured general anesthesia protocol decreases the incidence of awareness with explicit recall among a subset of surgical patients at increased risk for awareness and scheduled to receive an inhalation gas-based general anesthetic. Methods/Design BAG-RECALL is a multi-center, randomized, controlled clinical trial, in which 6,000 patients are being assigned to bispectral index-guided anesthesia (target range, 40 to 60 or end-tidal anesthetic gas-guided anesthesia (target range, 0.7 to 1.3 age-adjusted minimum alveolar concentration. Postoperatively, patients are being assessed for explicit recall at two intervals (0 to 72 hours, and 30 days after extubation. The primary outcome of the trial is awareness with explicit recall. Secondary outcomes include postoperative mortality, psychological symptoms, intensive care and hospital length of stay, average anesthetic gas administration, postoperative pain and nausea and vomiting, duration of stay in the recovery area, intra-operative dreaming, and postoperative delirium. Discussion This trial has been designed to complement two other clinical trials: B-Unaware and MACS (ClinicalTrials.gov numbers, NCT00281489 and NCT00689091

  5. A Retrospective, Multi-Center, Post-Marketing Observational Study to Evaluate the Effectiveness of Ademetionine 1,4-Butanedisulfonate Injection (Transmetil®) Treatment in Chinese Patients with Intrahepatic Cholestasis Caused by Viral Hepatitis

    Institute of Scientific and Technical Information of China (English)

    Wen Xie; Ming-sheng Chen; Cun-jin Mei; Xiao-lin Guo; Xiao-hu Zhao; Jiang-bin Wang; Zheng-qin Fan; Jian-he Gan; Qing Xie; Jun Cheng; Hong Zhao; Yu Chen; Qin Zhang; Wei Lu; Wei Liu; Ai-rong Hu; Han-wei Li; Ping Feng

    2013-01-01

    Obejective Ademetionine 1,4-butanedisulfonate [S-adenosyl-L-methionine (SAMe)/Transmetil®, Abbott] has been available in China for more than 15 years, and it has been shown to reduce serum bilirubin and transaminase levels in patients with viral hepatitis (VH). However, no large-scale studies have focused on the impact of SAMe treatment regimen on reducing the serum total bilirubin (TBil) in VH patients with intrahepatic cholestasis (IHC). The main objective of this study was to evaluate the effectiveness of intravenous SAMe (Transmetil®) treatment in reducing the serum TBil by 50%. Methods This retrospective, multi-center, cross-sectional medical record review involved patients aged≥18 years. Records of 1 280 hospitalized VH patients at 16 sites diagnosed with IHC who had received intravenous SAMe 1 000 mg or 2 000 mg q.d. for at least 7 days from January 1, 2006 to June 30, 2009, were screened and 905 records were randomly selected. Results The safety set (SS) included 834 patients and the full analysis set included 826 patients. TBil levels after 14 days injection treatment were available for 763 patients. TBil decreased≥ 50%versus baseline after 14 days treatment in 288 (37.7%) patients (95%CI 34.3%, 41.2%). Twenty-nine non-serious adverse events (non-SAEs) were reported in 19 (2.3%) patients, and 29 SAEs were reported in 10 patients (1.2%). All adverse events (AEs) were considered unrelated to the drug. Conclusions This retrospective study shows that intravenous SAMe administration in VH patients with IHC is associated with signiifcant reduction of TBil levels in more than 30%of patients 14 days after treatment initiation.

  6. A Retrospective, Multi-Center, Post-Marketing Observational Study to Evaluate the Effectiveness of Ademetionine 1,4-Butanedisulfonate Injection (Transmetil?) Treatment in Chinese Patients with Intrahepatic Cholestasis Caused by Viral Hepatitis

    Institute of Scientific and Technical Information of China (English)

    2013-01-01

    Obejective Ademetionine 1,4-butanedisulfonate [S-adenosyl-L-methionine (SAMe)/Transmetil?, Abbott] has been available in China for more than 15 years, and it has been shown to reduce serum bilirubin and transaminase levels in patients with viral hepatitis (VH). However, no large-scale studies have focused on the impact of SAMe treatment regimen on reducing the serum total bilirubin (TBil) in VH patients with intrahepatic cholestasis (IHC). The main objective of this study was to evaluate the effectiveness of intravenous SAMe (Transmetil?) treatment in reducing the serum TBil by 50%. Methods This retrospective, multi-center, cross-sectional medical record review involved patients aged≥18 years. Records of 1 280 hospitalized VH patients at 16 sites diagnosed with IHC who had received intravenous SAMe 1 000 mg or 2 000 mg q.d. for at least 7 days from January 1, 2006 to June 30, 2009, were screened and 905 records were randomly selected. Results The safety set (SS) included 834 patients and the full analysis set included 826 patients. TBil levels after 14 days injection treatment were available for 763 patients. TBil decreased≥ 50%versus baseline after 14 days treatment in 288 (37.7%) patients (95%CI 34.3%, 41.2%). Twenty-nine non-serious adverse events (non-SAEs) were reported in 19 (2.3%) patients, and 29 SAEs were reported in 10 patients (1.2%). All adverse events (AEs) were considered unrelated to the drug. Conclusions This retrospective study shows that intravenous SAMe administration in VH patients with IHC is associated with signiifcant reduction of TBil levels in more than 30%of patients 14 days after treatment initiation.

  7. Multi-Center Vector Field Methods for Wave Equations

    Science.gov (United States)

    Soffer, Avy; Xiao, Jianguo

    2016-12-01

    We develop the method of vector-fields to further study Dispersive Wave Equations. Radial vector fields are used to get a-priori estimates such as the Morawetz estimate on solutions of Dispersive Wave Equations. A key to such estimates is the repulsiveness or nontrapping conditions on the flow corresponding to the wave equation. Thus this method is limited to potential perturbations which are repulsive, that is the radial derivative pointing away from the origin. In this work, we generalize this method to include potentials which are repulsive relative to a line in space (in three or higher dimensions), among other cases. This method is based on constructing multi-centered vector fields as multipliers, cancellation lemmas and energy localization.

  8. 蔗糖凝胶治疗细菌性阴道病的多中心、随机、双盲、平行对照Ⅲ期临床试验%Sucrose gel for treatment of bacterial vaginosis:a randomized, double-blind, multi-center, parallel-group, phase Ⅲ clinical trial

    Institute of Scientific and Technical Information of China (English)

    肖冰冰; 张岱; 陈锐; 史惠蓉; 辛晓燕; 王惠兰; 庞义存; 朱赛楠; 姚晨

    2015-01-01

    目的:通过多中心、随机、双盲、平行对照的临床研究,进一步评价蔗糖凝胶治疗细菌性阴道病的有效性及安全性. 方法:选择5个研究中心的533例细菌性阴道病患者作为研究对象,依据随机表按对照组与试验组为2:3比例随机入组,甲硝唑凝胶5. 0 g组(对照组)214例,蔗糖凝胶5. 0 g组(实验组)319例,两组均采取每日早晚各一次阴道上药,连用5 d的疗程进行治疗. 分别于治疗第7~10天、第21~30天进行疗效观察及安全性评价.结果:治疗第7~10天,甲硝唑凝胶组和蔗糖凝胶组的临床综合疗效治愈率分别为70. 53%和80. 83%,阴道分泌物涂片Nugent积分痊愈率分别为71. 50%和81. 15%,差异均有统计学意义(P0. 05). 结论:蔗糖凝胶治疗细菌性阴道病的临床综合疗效近期(治疗第7~10天)及恢复阴道菌群方面明显优于甲硝唑凝胶,远期治愈率(治疗第21~30天)与甲硝唑凝胶相当,可成为治疗细菌性阴道病的新策略.%Objective:To evaluate the cure effectiveness and safety of sucrose gel in the treatment of bacterial vaginosis through a multi-center, randomized, double-blind, parallel controlled clinical study. Methods:A clinical research method of multi-center, randomly double-blind, and dose group parallel comparison was adopted. In the study, 533 patients with bacterial vaginosis were randomly divided into two groups, which included 214 cases in the control group (5. 0 g metronidazole gel) and 319 cases in the trial group (5. 0 g sucrose gel ). The patients were treated with different medication according to the group where they were. All the cases in these two groups were treated with drugs vaginally twice in a day, morning and evening separately, for 5 days. The curative effect and safety evaluation were assessed from 7 to 10 days and 21 to 30 days after treatment respectively. Results: The efficacy of the comprehensive clinical treatment showed that the cure rate of metronidazole gel group

  9. Efficacy and Safety of Vitamin E Capsules in the Treatment of Chloasma: A Multi-Center, Randomized and Open Clinical Trial%天然维生素E胶丸治疗黄褐斑有效性与安全性的多中心随机开放临床观察

    Institute of Scientific and Technical Information of China (English)

    余土根; 郑敏; 方红; 郑益志; 刘伦飞; 丁颖果

    2012-01-01

    Objective To evaluate the efficacy and safety of vitamin E for the treatment of chloasma. Methods A multi-center,randomized and open clinical study was conducted. Seventy-nine patients with chloasma were treated with oral vitamin E 100mg,3 times daily for 12 weeks. In the treatment of 4 weeks,8 weeks and 12 weeks respectively, the subside and efficacy of skin lesions in patients were evaluated by MASI (melasma area and severity index) evaluation standard. Results Before and after treatment for 4 weeks,8 weeks and 12 weeks, the difference of MASI score were significant (P< 0.001). The total effective rate was 81.01%, about 1/5 of patients improved in the fourth weeks of treatment, and more than half of the patients obtained apparent effect in the treatment of eighth week. No serious adverse effect was foud during the observation. Conclusion The treatment for melasma with vitamin E is safe and effective.%目的 探讨天然维生素E胶丸治疗黄褐斑的有效性,并观察其安全性.方法 采用多中心、随机、开放临床研究的方法,对79例黄褐斑患者应用天然维生素E胶丸100mg,3次/d,口服治疗,疗程12周,并在治疗第4周,8周和12周随访,按照MASI评判标准评价皮损消退情况.结果 治疗前、治疗后4周、8周与12周MASI评分比较差异均有统计学意义(P均<0.001),有效率为81.01%,约1/5的患者在治疗第4周皮损出现改善,且半数以上的患者在治疗第8周取得明显治疗效果,临床观察期间未发现任何明显的不良反应.结论 使用天然维生素E胶丸治疗黄褐斑是安全有效的方法.

  10. Clinical Effect of Antioxidant Glasses Containing Extracts of Medicinal Plants in Patients with Dry Eye Disease: A Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Won Choi

    Full Text Available To investigate the clinical efficacy and safety of wearable antioxidant glasses containing extracts of medicinal plants in patients with mild dry eye disease (DED.Fifty patients with mild DED were randomly assigned to wear either extracts of antioxidant medicinal plants containing (N = 25 or placebo glasses (N = 25. Patients wore the glasses for 15 min three times daily. The ocular surface disease index (OSDI score, tear film break up time (BUT, and Schirmer's test were evaluated and compared within the group and between the groups at baseline, 4 weeks, and 8 weeks after treatment.OSDI score and tear film BUT were significantly improved in the treatment group at 4 and 8 weeks after wearing glasses (all P < 0.001. Compared to the placebo group, the OSDI scores were significantly lower in the treatment group at 8 weeks (P = 0.007. The results of the Schirmer's test showed significant improvement in the treatment group at 4 weeks (P = 0.035, however there were no significant differences between the other groups or within the groups. No adverse events were reported during the study.Antioxidant glasses containing extracts of medicinal plants were effective in improving in DED both subjectively and objectively. Wearing antioxidants glasses might be a safe and adjunctive therapeutic option for DED.ISRCTN registry 71217488.

  11. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer

    Directory of Open Access Journals (Sweden)

    Thropay John P

    2010-07-01

    Full Text Available Abstract Background A modified form of high dose rate (HDR brachytherapy has been developed called Axxent Electronic Brachytherapy (EBT. EBT uses a kilovolt X-ray source and does not require treatment in a shielded vault or a HDR afterloader unit. A multi-center clinical study was carried out to evaluate the success of treatment delivery, safety and toxicity of EBT in patients with endometrial cancer. Methods A total of 15 patients with stage I or II endometrial cancer were enrolled at 5 sites. Patients were treated with vaginal EBT alone or in combination with external beam radiation. Results The prescribed doses of EBT were successfully delivered in all 15 patients. From the first fraction through 3 months follow-up, there were 4 CTC Grade 1 adverse events and 2 CTC Grade II adverse events reported that were EBT related. The mild events reported were dysuria, vaginal dryness, mucosal atrophy, and rectal bleeding. The moderate treatment related adverse events included dysuria, and vaginal pain. No Grade III or IV adverse events were reported. The EBT system performed well and was associated with limited acute toxicities. Conclusions EBT shows acute results similar to HDR brachytherapy. Additional research is needed to further assess the clinical efficacy and safety of EBT in the treatment of endometrial cancer.

  12. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    and repair? Have new materials improved longevity? Are there still clinical and material problems to be solved? And what has the highest impact on longevity of posterior resin restorations – the material, the dentist, the patient or the tooth? These matters will be discussed on the basis of the literature......Within the last 25 years composite resin materials have in many countries successively replaced amalgam as a restorative for posterior teeth. Resin materials and bonding systems are continuously being improved by the manufactures, adhesive procedures are now included in the curriculum of most...... universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...

  13. 45.2 THE EFFECTIVENESS OF PARENT TRAINING AS A TREATMENT FOR PRESCHOOL ATTENTION-DEFICIT/HYPERACTIVITY DISORDER: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL OF THE NEW FOREST PARENTING PROGRAM IN EVERYDAY CLINICAL PRACTICE

    DEFF Research Database (Denmark)

    Lange, Anne-Mette

    2016-01-01

    to investigate whether the NFPP can be delivered effectively for children who are referred through official community pathways in everyday clinical practice. Methods A multicenter randomized controlled parallel arm trial design was incorporated. There were two treatment arms, NFPP and treatment as usual. NFPP...... ADHD-Rating Scale (Preschool ADHD-RS) by T2. Secondary outcome measures included the following: effects on this measure at T3; T2 and T3 measures of teacher-reported preschool ADHD-RS scores; parent- and teacher-rated scores on the Strength and Difficulties Questionnaire; direct observation of ADHD...... behaviors during child’s solo play; observation of parent–child interaction; parent sense of competence; and family stress. Conclusions This trial will provide evidence on whether NFPP is a more effective treatment for preschool ADHD than the treatment usually offered in everyday clinical practice....

  14. Clinical and multi-center research on hepatitis C infection in hemodialysis patients%血液透析人群丙型肝炎病毒感染的多中心临床研究

    Institute of Scientific and Technical Information of China (English)

    张小丽; 朱蓓; 喻荣彬; 赵卫红

    2011-01-01

    目的 探讨多中心维持性血液透析(maintenance hemodialysis,MHD)人群丙型肝炎病毒(hepatitis C virus,HCV)感染的发生率、危险因素以及血清转氨酶水平的变化.方法采集多中心MHD 患者病史、输血史、肾移植史等临床资料,检测丙氨酸氨基转移酶(alanine transaminase,ALT)、天冬氨酸氨基转移酶(aspartate transaminase,AST)、抗HCV 抗体及HCV-RNA.结果 796 例透析患者抗HCV 抗体阳性176 例(22.1%),其中HCV-RNA 阳性142 例(80.7%).单因素分析表明,MHD 患者的HCV感染与透析时间、输血率、透析器复用率及肾移植有关(均P < 0.05).多因素logistic 回归分析提示透析时间(OR=1.38,95%CI=1.24~1.53,P<0.05)和透析器复用史(OR=10.91,95%CI =5.52~21.55,P<0.05)是HCV感染的独立危险因素.HCV感染组和HCV 未感染组的ALT 水平分别为(25±30)U/L 和(12±13)U/L,AST 水平分别为(24 ± 20)U/L 和(16 ± 14)U/L,差异均有统计学意义(均P < 0.05).HCV 感染组和HCV 未感染组的ALT 异常增高率分别为17.0%(30/176)和2.4%(15/620),AST 异常增高率分别为10.5%(18/171)和4.8%(29/608),差异均有统计学意义(均P < 0.05).结论抗HCV 抗体阳性的透析患者可进一步检测HCV-RNA 以判断其活动性;监测血清转氨酶水平虽不宜作为判断血液透析患者HCV 感染的敏感指标,但可作为了解肝损害的指标;针对MHD 患者应当采取综合措施,控制HCV 的传播,降低感染率.%Objective The aim of this study was to investigate the incidence of hepatitis C virus (HCV)infection and the risk factors for the infection in maintenance hemodialysis (HD) patients from multiple centers in Jiangsu province.We also measured serum aminotransferase level in these patients.Methods Clinical data of these patients, including demographical information, history of blood transfusion and kidney transplantation,were recorded.Liver biochemistry tests including alanine aminotransferase (ALT) and aspartate

  15. Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center,Randomized, Parallel, Open-label, Phase Ⅱ Clinical Trial

    Institute of Scientific and Technical Information of China (English)

    Ying Mao; Yu Yao; Li-Wei Zhang; Yi-Cheng Lu; Zhong-Ping Chen; Jian-Min Zhang; Song-Tao Qi

    2015-01-01

    Background:The radiochemotherapy regimen concomitantly employing temozolomide (TMZ) chemotherapy and radiotherapy (RT) 4 weeks after surgery,followed by 6 cycles of TMZ is a common treatment for glioblastoma (GBM).However,its median overall survival (OS) is only 14.6 months.This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.Methods:A randomized,parallel group,open-label study of 99 newly diagnosed GBM patients was conducted at 1 0 independent Chinese neurosurgical departments from June 2008 to June 2012.Patients were treated with concomitant radiochemotherapy regimen plus early postsurgical temozolomide (early TMZ group) or standard concomitant radiochemotherapy regimen (control group).Overall response was assessed based on objective tumor assessments,administration ofcorticosteroid and neurological status test.Hematological,biochemical,laboratory,adverse event (AE),and neurological condition were measured for 24 months of follow-up.The primary efficacy endpoint of this study was overall survival (OS).The secondary endpoint was progression free survival (PFS).Results:The median OS time in the early TMZ group was 17.6 months,compared with 13.2 months in the control group (log-rank test P =0.021).In addition,the OS rate in the early TMZ group was higher at 6,12,and 18 months than in the control group,respectively (P <0.05).The median PFS time was 8.7 months in the early TMZ group and 10.4 months in the control group (log-rank test P =0.695).AEs occurred in 29 (55.8%) and 31(73.8%) patients respectively in early and control groups,including nausea (15.4% vs.33.3%),vomiting (7.7% vs.28.6%),fever (7.7% vs.11.9%),and headache (3.8% vs.23.8%).Only 30.8% and 33.3% were drug-related,respectively.Conclusions:Addition of TMZ chemotherapy in the early break of the standard concomitant radiochemotherapy regimen was well tolerated

  16. Effects of recombinant human brain natriuretic peptide on the prognosis of patients with acute anterior myocardial infarction undergoing primary percutaneous coronary intervention: a prospective, multi-center, randomized clinical trial

    Science.gov (United States)

    Hou, Ai-Jie; Zang, Hong-Yun; Huang, Ru-Gang; Zheng, Xiao-Qun; Lin, Hai-Long; Wang, Wei; Hou, Ping; Xia, Fei; Li, Zhan-Quan

    2017-01-01

    Background This study aims to investigate the effects of recombinant human brain natriuretic peptide (rhBNP) on serum enzyme data, cardiac function parameters and cardiovascular events in patients with acute anterior myocardial infarction (MI). Methods A total of 421 patients with acute anterior or extensive anterior MI were collected from 20 hospitals. These patients were randomly divided into two groups: rhBNP and control groups. Both groups of patients received primary percutaneous coronary intervention (PCI) within the effective time window. In the rhBNP group, rhBNP administration (0.01 µg/kg/min, 48–72 successive hours) was performed as early as possible after hospital admission. Prior to and one or seven days after PCI, serum concentrations of cardiac troponin (cTnT), creatine kinase-MB (CK-MB) and N-terminal pro-brain natriuretic peptide (NT-proBNP) were measured. At seven days and 6 months after PCI, left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDd) and stroke volume (SV) were measured using 2D Doppler echocardiography. MACEs that occurred during hospitalization and within 6 months after PCI were recorded. Results At postoperative days one and seven, serum concentrations of cTnT were significantly lower in the rhBNP group than in the control group. At postoperative day one, serum concentrations of CK-MB were significantly lower in the rhBNP group than in the control group. At postoperative day seven, serum concentrations of NT-proBNP were significantly lower in the rhBNP group than in the control group, and LVEF was significantly greater in the rhBNP group than in the control group. At postoperative 6 months, LVEDd was significantly lower in the rhBNP group compared with the control group. In addition, SV and LVEF were significantly greater in the rhBNP group than in the control group. By postoperative month 6, the incidence of composite cardiovascular events (16.0% vs. 26.0%, P=0.012), cardiac death (7.0% vs.13

  17. 77 FR 11136 - Proposed Collection; Comment Request; a Multi-Center International Hospital-Based Case-Control...

    Science.gov (United States)

    2012-02-24

    ... International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) SUMMARY: In compliance... the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: A Multi-Center International Hospital- Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI). Type...

  18. 慢性便秘伴发肛门直肠疼痛的全国多中心分层调查研究%Multi-centered stratified study of chronic constipation with anorectal pain in China

    Institute of Scientific and Technical Information of China (English)

    辛海威; 方秀才; 高峻; 刘诗; 肖英莲; 张军; 朱丽明; 王智凤; 柯美云

    2011-01-01

    Objective To investigate the prevalence of anorectal pain in chronic constipation (CO patients. Methods With multi-centered stratified questionnaires investigation,the face to face questionnaires investigation was carried out on the symptoms of constipation and intensity,frequency and duration of anorectal pain in CC patients. CC and anorectal pain was diagnosed according to Rome Ⅲ criteria. Results Total 921 CC patients were investigated,and 909 questionnaires were valid. Of those,there were 258 male cases and 651 female cases,the mean age was(48. 9±18. 7)years. About 15. 1%(137/909)CC patients reported anorectal pain in last six months;of those 26 cases(2. 9%)with chronic proctalgia(CP),111 cases(12. 2%)with proctalgia fugax(PF). The percentage of pain occurred frequently or regularly in CP and PF patients was 88. 5%(23/26)and 73. 9%(82/111)respectively. The pain of PF patients was milder than that of CP patients. The detection rate of CP was higher in tertiary hospitals than in primary cares(3. 6% vs 0. 6%,P= 0. 04). There was no significant difference of PF detection rate between different hospitals(P= 0. 09). The occurrence of pain was associated with anorectal symptoms,sleeping and psychosocial condition. Conclusions CC patients are frequently with anorectal pain and more common in female,which should cause extensive concern by physicians.If necessary,the prevalence of anorectal pain in general population as well as the mechanism of the symptom need further investigation.%目的 调查慢性便秘患者伴发肛门直肠疼痛情况.方法 采用全国多中心分层问卷调查,纳入慢性便秘患者后就便秘症状、肛门直肠疼痛程度、频率及持续时间等进行面对面问卷调查.慢性便秘与肛门直肠疼痛的判断均参考罗马Ⅲ诊断标准.结果 共凋查921例慢性便秘患者,有效问卷909份,其中男性258例、女性651例,平均年龄(48.9±18.7)岁.15.1%(137/909)的慢性便秘患者最近6个月有肛门直肠

  19. Efficacy and safety of ecabet sodium on functional dyspepsia :A prospective, double-blinded, randomized, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    Jun Haeng Lee; Soo Teik Lee; Eun Hyun Lee; Jong Chul Rhee; Jae J Kim; Ki-Baik Hahm; Dong Ho Lee; Nayoung Kim; Sung Kook Kim; Jong Jae Park; Seok Reyol Choi; Jong Hun Lee

    2006-01-01

    AIM: To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia.METHODS: We performed a multi-center, prospective,randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-Ⅱ criteria were enrolled from 7 centers. In the study group (115 patients), 1.5 g ecabet sodium was given twice a day. In the control group (121 patients),400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3,14, and 28 d after initiating the treatment.RESULTS: Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment,the rates of improvement in patients with dyspeptic symptoms were not different between two groups (77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P > 0.05). Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups.There was no clinically significant adverse event in both groups.CONCLUSION: In patients with functional dyspepsia,ecabet sodium has similar clinical efficacy with cimetidine.

  20. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI

    NARCIS (Netherlands)

    R.A. Feis (Rogier A.); S.M. Smith (Stephen); N. Filippini (Nicola); G. Douaud (Gwenaëlle); E.G.P. Dopper (Elise); V. Heise (Verena); A.J. Trachtenberg (Aaron J.); J.C. van Swieten (John); M.A. van Buchem (Mark); S.A.R.B. Rombouts (Serge); C.E. Mackay (Clare E.)

    2015-01-01

    textabstractResting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acqui

  1. 77 FR 56854 - Submission for OMB Review; Comment Request: A Multi-Center International Hospital-Based Case...

    Science.gov (United States)

    2012-09-14

    ... recent decades. Specifically, environmental exposures to industrial emissions, genetic susceptibility... International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) SUMMARY: Under the... currently valid OMB control number. Proposed Collection: Title: A Multi-Center International Hospital-...

  2. Toward quality assurance for metaphase FISH: A multi-center experience

    Energy Technology Data Exchange (ETDEWEB)

    Dewald, G. [Mayo Clinic, Rochester, NY (United States); Higgins, R. [Abbott Northwestern Hospital, Minneapolis, MN (United States); Hirsch, B. [Univ. Minnesota Hospitals and Clinics, Minneapolis, MN (United States)] [and others

    1996-09-06

    Although fluorescent in situ hybridization (FISH) is rapidly becoming a part of clinical cytogenetics, no organization sponsors multi-center determinations of the efficacy of probes. We report on 23 laboratories that volunteered to provide slides and to use a probe for SNRPN and a control locus. Experiences with FISH for these laboratories during 1994 ranged from 0 to 645 utilizations (median = 84) involving blood, amniotic fluid and bone marrow. In an initial study of hybridization efficiency, the median percentage of metaphases from normal individuals showing two SNRPN and 2 control signals for slides prepared at each site was 97.0 (range = 74-100); for slides prepared by a central laboratory, it was 97.8 (range = 81.6-100). In a subsequent blind study, each laboratory attempted to score 5 metaphases from each of 23 specimens [8 with del(15)(q11.2{r_arrow}q12) and 15 with normal 15 chromosomes]. Of 529 challenges, the correct SNRPN pattern was found in 5 of 5 metaphases in 457 (86%) and in 4 of 5 in 33 (6%). Ambiguous, incomplete or no results were reported for 32 (6%) challenges. Seven (1%) diagnostic errors were made including 6 false positives and 1 false negative: 1 laboratory made 3 errors, 1 made 2, and 2 made 1 each. Most errors and inconsistencies seemed due to inexperience with FISH. The working time to process and analyze slides singly averaged 49.5 minutes; slides processed in batches of 4 and analyzed singly required 36.9 minutes. We conclude that proficiency testing for FISH using an extensive array of challenges is possible and that multiple centers can collaborate to test probes and to evaluate costs. 10 refs., 1 fig., 4 tabs.

  3. The efficacy and safety of bupropion sustained-release formulation for the treatment of major depressive disorder: a multi-center, randomized, double-blind, placebo-controlled study in Asian patients

    Directory of Open Access Journals (Sweden)

    Koshino Y

    2013-08-01

    Full Text Available Yoshifumi Koshino,1 Won-Myong Bahk,2 Hideaki Sakai,3 Takayuki Kobayashi4 1Iris Medical Clinic, Kanazawa University, Ishikawa, Japan; 2Yeouido St Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea; 3Meguro Station East Mental Clinic, Shinagawa, Tokyo, Japan; 4Medicines Development (Neurosciences, Development and Medical Affairs, GlaxoSmithKline, Shibuya, Tokyo, Japan Abstract: This study was conducted to compare the efficacy and safety of bupropion sustained-release (SR formulation orally administered at daily doses of 150 mg/day (once daily and 300 mg/day (150 mg twice daily for 8 weeks versus placebo in Asian patients with major depressive disorder. The mean change from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS total score at week 8 was compared between each of the bupropion SR dose groups and the placebo group using an analysis of covariance with the multiplicity adjustment by Dunnett’s step-down procedure. A total of 569 subjects met all of the inclusion criteria and proceeded to the treatment phase. The subjects proceeding to the treatment phase included 454 Japanese patients and 115 Korean patients. There was no statistically significant difference between each of the bupropion SR dose groups and the placebo group in the primary efficacy endpoint of change from baseline in MADRS total score at week 8. Similar results were generally obtained for all of the secondary efficacy endpoints. The secondary analysis and the other subgroup analysis did not show a statistically significant difference in efficacy. There was no substantial difference in the type, severity, and incidence of adverse events (AEs between the bupropion SR dose groups and the placebo group, which indicates a favorable safety profile for bupropion SR. There were no significant findings in subjects treated with bupropion SR in regard to sexual dysfunction, weight change, and withdrawal syndrome, which are frequently recognized as

  4. A multi-center, double-blind, randomized, parallel group study to evaluate the effects of two different doses of losartan on morbidity and mortality in Chinese patients with symptomatic heart failure intolerant of angiotensin converting enzyme inhibitor t%A multi-center, double-blind, randomized, parallel group study to evaluate the effects of two different doses of losartan on morbidity and mortality in Chinese patients with symptomatic heart failure intolerant of angiotensin converting enzyme inhibitor treatment

    Institute of Scientific and Technical Information of China (English)

    HU Da-yi; HUANG Jun; CAI Nai-sheng; ZHU Wen-ling; LI Yi-shi; Rachid Massaad; Mary E.Hanson; Kenneth Dickstein

    2012-01-01

    Background There have been no mortality/morbidity endpoint studies with losartan in Chinese heart failure patients.The objective was to evaluate the effects of high-dose vs.low-dose losartan on clinical outcomes in Chinese subjects with heart failure.Methods This study was a post hoc analysis of the Heart failure Endpoint evaluation of Angiotensin Ⅱ Antagonist losartan (HEAAL)trial (n=545).Chinese adults with symptomatic heart failure (New York Heart Association (NYHA) Ⅱ-Ⅳ)intolerant of treatment with angiotensin converting enzyme (ACE) inhibitors were randomized to losartan 150 mg or 50 mg daily.The primary endpoint was the composite event rate of all-cause death or hospitalization for heart failure.Safety and tolerability were assessed.Results Median follow-up was 4.8 years.Baseline characteristics were generally similar to the overall HEAAL cohort.Overall,120 (44.1%) subjects in the losartan 150 mg group and 137 (50.2%) subjects in the losartan 50 mg group died (any cause) or were hospitalized for heart failure (hazard ratio (OR) 0.807,95% CI0.631-1.031).There were no notable differences between treatment groups in the proportion of subjects with adverse experiences.Conclusion The results of this post hoc analysis in Chinese subjects,although not powered to show significance,were generally consistent with the main study results,which demonstrated a significantly reduced risk of all cause death or hospitalization for heart failure with daily losartan 150 mg vs.losartan 50 mg in subjects with symptomatic heart failure and intolerance to ACE inhibitors,supporting the use of the higher dose for optimum clinical benefit.

  5. Open, Prospective, Multi-Center, Two-Part Study of Patient Preference with Monthly Ibandronate Therapy in Women with Postmenopausal Osteoporosis Switched From Daily or Weekly Alendronate or Risendronate-BONCURE: Results of Turkish Sub-Study

    Directory of Open Access Journals (Sweden)

    Nurten Eskiyurt

    2012-04-01

    Full Text Available Aim: BONCURE (Bonviva for Current Bisphosphonate Users Regional European Trial, aimed to evaluate patient preference with monthly ibandronate in women with postmenopausal osteoporosis who previously received daily or weekly alendronate or risendronate. Materials and Methods: This prospective, open-label study consisted of two sequential stages, Part A (screening and Part B (treatment. Patients enrolled into Part A completed the Candidate Identification Questionnaire (CIQ. In Part B, after completing the Osteoporosis Patient Satisfaction Questionnaire (OPSATQ, patients received monthly oral ibandronate 150 mg for 6 months. Following treatment, patients completed the OPSAT-Q and Preference Questionnaire. Results: A total of 223 patients (mean age, 63.7±9.51 years were enrolled in Part A from Turkey. Among them, 103 (46.2% answered “YES” to at least one CIQ question. The mean composite OPSAT-Q domain scores increased for convenience (mean change, 15.3±17.7 points, quality of life (10.4±20.4 points, overall satisfaction (11.9±22.7 points, and side effects (3.3±18.8 points. At month 6, 177 subjects (92.7% preferred once-monthly dosing schedule and 99.0% were compliant (≥80% with study treatment. Thirty (15.6% subjects experienced mild to moderate adverse events, mostly gastrointestinal. Conclusion: Postmenopausal women with osteoporosis prefer and are more satisfied and compliant with monthly dosing of ibandronate than daily or weekly bisphosphonate treatment. (Turkish Journal of Osteoporosis 2012;18:1-7

  6. Should I stay or should I go? Understanding families’ decisions regarding initiating, continuing, and terminating health services for managing pediatric obesity: the protocol for a multi-center, qualitative study

    Directory of Open Access Journals (Sweden)

    Ball Geoff DC

    2012-12-01

    initiation, continuation, and termination of care. Demographic and anthropometric/clinical data will also be collected. Discussion A better understanding of family involvement in pediatric weight management care will help to improve existing health services in this area. Study data will be used in future research to develop a validated survey that clinicians working in pediatric obesity management can use to understand and enhance their own health services delivery.

  7. 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)

    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

    Background 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. Methods Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125mg 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. Results 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). Conclusions 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. Trial Registration ClinicalTrials.gov NCT02486354 PMID:26599904

  8. White matter hyperintensities and medial temporal lobe atrophy in clinical subtypes of mild cognitive impairment: the DESCRIPA study

    OpenAIRE

    Pol, van de, Jaco; Verhey, F.; Frisoni, G.B.; Tsolaki, M; Papapostolou, P.; Nobili, F.; Wahlund, L. O.; Minthon, L.; Frolich, L.; Hampel, H.; Soininen, H.; Knol, D.L.; Barkhof, F; Scheltens, P.; Visser, P.J.

    2009-01-01

    Abstract Clinical subtypes of mild cognitive impairment (MCI) may represent different underlying aetiologies. In a European, multi-center, memory-clinic based study (DESCRIPA) of non-demented subjects we investigated whether MCI subtypes have different brain correlates on MRI and whether the relation between subtypes and brain pathology is modified by age. Using visual rating scales medial temporal lobe atrophy (MTA) (0-4) and white matter hyperintensities (WMH) (0-30) were assesse...

  9. 慢性肾脏病3~5期中西医结合临床路径多中心实施的效果研究%Multi-Center Implementation of Integrative Medicine-Based Clinical Pathway for Stage 3-5 Chronic Kidney Disease

    Institute of Scientific and Technical Information of China (English)

    张蕾; 刘旭生; 蔡寸; 苏国彬

    2012-01-01

    目的 探索及评估慢性肾脏病3~5期中西医结合临床路径多中心实施的效益.方法 采用非同期历史对照,评估5家医院实施临床路径规范化管理后,患者住院天数、住院费用的改善情况.结果 路径组的平均住院天数较回顾性病案组略有缩短,存在中心效应(P=0.000),经校正后平均住院天数间差异无统计学意义(P=0.621).住院总费用较回顾性病案组稍有升高,不存在中心效应(P=0.126),组间比较差异无统计学意义(P=0.381).费用明细支出,中药费、西药费、检查费和放射费较回顾性病案组降低,中成药费、治疗费和化验费较回顾性病案组明显升高,其中中药费、放射费、化验费组间比较差异有统计学意义(P<0.05).结论 在保证临床路径执行率的情况下,慢性肾脏病3~5期临床路径能缩短住院天数.虽未能降低住院总费用水平,但费用明细支出的改变在一定程度上体现了该路径的实施目的.%Objective To explore and evaluate the benefits of the multi - center implementation of integrative medicine - based clinical pathway for stage 3-5 chronic kidney disease ( CKD ). Methods Using the historical data as the control group, we compared the improvements in the duration of hospital stay and hospital expenses were evaluated in five centers after the implementation of integrative medicine - based clinical pathways ( pathway group ). Results The duration of hospital stay was a little shortened after the implementation of the clinical pathways, showing a center effect ( P = 0. 000 ); after adjustment, no statistical significance was found between the pathway group and control group ( P =0. 621 ). The total hospital expenses in the pathway group were little higher, but was not statistically significant ( P =0. 381 ) and without center effect ( P =0. 126 ). More specifically, the costs for traditional Chinese drugs, modern drugs, examinations, and radiology were lower in the pathway

  10. A Snapshot on the On-Label and Off-Label Use of the Interleukin-1 Inhibitors in Italy among Rheumatologists and Pediatric Rheumatologists: A Nationwide Multi-Center Retrospective Observational Study

    Science.gov (United States)

    Vitale, Antonio; Insalaco, Antonella; Sfriso, Paolo; Lopalco, Giuseppe; Emmi, Giacomo; Cattalini, Marco; Manna, Raffaele; Cimaz, Rolando; Priori, Roberta; Talarico, Rosaria; Gentileschi, Stefano; de Marchi, Ginevra; Frassi, Micol; Gallizzi, Romina; Soriano, Alessandra; Alessio, Maria; Cammelli, Daniele; Maggio, Maria C.; Marcolongo, Renzo; La Torre, Francesco; Fabiani, Claudia; Colafrancesco, Serena; Ricci, Francesca; Galozzi, Paola; Viapiana, Ombretta; Verrecchia, Elena; Pardeo, Manuela; Cerrito, Lucia; Cavallaro, Elena; Olivieri, Alma N.; Paolazzi, Giuseppe; Vitiello, Gianfranco; Maier, Armin; Silvestri, Elena; Stagnaro, Chiara; Valesini, Guido; Mosca, Marta; de Vita, Salvatore; Tincani, Angela; Lapadula, Giovanni; Frediani, Bruno; De Benedetti, Fabrizio; Iannone, Florenzo; Punzi, Leonardo; Salvarani, Carlo; Galeazzi, Mauro; Rigante, Donato; Cantarini, Luca

    2016-01-01

    Background: Interleukin (IL)-1 inhibitors have been suggested as possible therapeutic options in a large number of old and new clinical entities characterized by an IL-1 driven pathogenesis. Objectives: To perform a nationwide snapshot of the on-label and off-label use of anakinra (ANA) and canakinumab (CAN) for different conditions both in children and adults. Methods: We retrospectively collected demographic, clinical, and therapeutic data from both adult and pediatric patients treated with IL-1 inhibitors from January 2008 to July 2016. Results: Five hundred and twenty-six treatment courses given to 475 patients (195 males, 280 females; 111 children and 364 adults) were evaluated. ANA was administered in 421 (80.04%) courses, CAN in 105 (19.96%). Sixty-two (32.1%) patients had been treated with both agents. IL-1 inhibitors were employed in 38 different indications (37 with ANA, 16 with CAN). Off-label use was more frequent for ANA than CAN (p < 0.0001). ANA was employed as first-line biologic approach in 323 (76.7%) cases, while CAN in 37 cases (35.2%). IL-1 inhibitors were associated with corticosteroids in 285 (54.18%) courses and disease modifying anti-rheumatic drugs (DMARDs) in 156 (29.65%). ANA dosage ranged from 30 to 200 mg/day (or 1.0–2.0 mg/kg/day) among adults and 2–4 mg/kg/day among children; regarding CAN, the most frequently used posologies were 150mg every 8 weeks, 150mg every 4 weeks and 150mg every 6 weeks. The frequency of failure was higher among patients treated with ANA at a dosage of 100 mg/day than those treated with 2 mg/kg/day (p = 0.03). Seventy-six patients (14.4%) reported an adverse event (AE) and 10 (1.9%) a severe AE. AEs occurred more frequently after the age of 65 compared to both children and patients aged between 16 and 65 (p = 0.003 and p = 0.03, respectively). Conclusions: IL-1 inhibitors are mostly used off-label, especially ANA, during adulthood. The high frequency of good clinical responses suggests that IL-1

  11. Efficacy and safety of Changfu peritoneal dialysis solution:a multi-center prospective randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    ZHOU Jian-hui; NI Zhao-hui; MEI Chang-lin; YU Xue-qing; LIU Fu-you; MIAO Li-ning; LIU Zhi-hong

    2013-01-01

    Background A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions.Some researchers believe that 6 L/d is enough for adequate dialysis,but there is no multi-center prospective study on Chinese population to confirm this.In this study,we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage.Methods Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages,i.e.,6 L dose with Changfu dialysis solution,6 L dose with Baxter dialysis solution,8 L dose with Changfu dialysis solution,and 8 L dose with Baxter dialysis solution.After 48 weeks,the changes of primary and secondary efficacy indices were compared between different types and different dosages.We also analyzed the changes of safety indices.Results Changes of KW from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr).Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR).Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR.The decline of KW from baseline to 48 weeks in 6 L group was more than that in 8 L group.Change of Ccr was similar.During the 48-week period,the mean Kt/V was above 1.7/w,and mean Ccr was above 50 L·1.73 m-2·w-1.More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization,and the statistical differences disappeared after that.Conclusions The domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution.During 48-week period,a dosage of 6 L/d was enough for

  12. A multi-center open-labeled study of recombinant erythropoietin-beta in the treatment of anemic patients with multiple myeloma, low-grade non-Hodgkin's lymphoma, or chronic lymphocytic leukemia in Chinese population.

    Science.gov (United States)

    Yang, Shen; Jun, Ma; Hong-Li, Zhu; Jian-Min, Wang; Chun, Wang; Lu-Gui, Qiu; Yong-Qiang, Zhao; Jun, Zhu; Jian, Hou; Zhi-Xiang, Shen

    2008-09-01

    The purpose of this study is to investigate the efficacy and safety of recombinant erythropoietin-beta in the treatment of anemic patients with multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), and chronic lymphocytic leukemia (CLL). From December 2005 to November 2006, the patients with MM, low-grade NHL, and CLL were enrolled in this study, male or female, aged > or = 18 years, transfusion-dependant, and receiving anti-neoplasia chemotherapy. Recombinant human erythropoietin-beta was used in this study with the dose initiated at 150 IU/kg, thrice a week, subcutaneously. The total treatment duration was 12 weeks. The primary endpoint of the study is response rate (RR), which is defined as hemoglobin increasing > or = 2 g/dL comparing to baseline level, or returning to normal range, without any transfusion within 6 weeks of evaluation. Fifty out of 82 (64.6%) patients enrolled in this study responded to the treatment and 29 patients had no response. Hypertension (12.2%) is the most common adverse effect; however, all the adverse events were mild, categorized in NCI grade I or II. We conclude that recombinant erythropoietin-beta was effective in the treatment of anemia of the patients with MM, NHL, and CLL, as well as it is well-tolerated.

  13. Variability in the prevalence of adult ADHD in treatment seeking substance use disorder patients : Results from an international multi-center study exploring DSM-IV and DSM-5 criteria

    NARCIS (Netherlands)

    van de Glind, Geurt; Konstenius, Maija; Koeter, Maarten W. J.; van Emmerik-van Oortmerssen, Katelijne; Carpentier, Pieter-Jan; Kaye, Sharlene; Degenhardt, Louisa; Skutle, Arvid; Franck, Johan; Bu, Eli-Torild; Moggi, Franz; Dom, Geert; Verspreet, Sofie; Demetrovics, Zsolt; Kapitany-Foveny, Mate; Fatseas, Melina; Auriacombe, Marc; Schillinger, Arild; Moller, Merete; Johnson, Brian; Farone, Stephen V.; Antoni Ramos-Quiroga, J.; Casas, Miguel; Allsop, Steve; Carruthers, Susan; Schoevers, Robert A.; Wallhed, Sara; Barta, Csaba; Alleman, Peter; Levin, Frances R.; van den Brink, Wim

    2014-01-01

    Background: Available studies vary in their estimated prevalence of attention deficit/hyperactivity disorder (ADHD) in substance use disorder (SUD) patients, ranging from 2 to 83%. A better understanding of the possible reasons for this variability and the effect of the change from DSM-IV to DSM-5 i

  14. Multi-center study on treatment for intermediate and high-frequency sudden sensorineural hearing loss%中高频下降型突发性聋药物治疗的多中心研究

    Institute of Scientific and Technical Information of China (English)

    王明明; 樊兆民; 罗建芬; 侯志强; 艾毓; 王海波; 许珉; 祝康; 侯瑾

    2013-01-01

    Objective To analyze the therapeutic effect of treatment for intermediate and highfrequency sudden sensorineural hearing loss (SSNHL).Methods A prospective clinical multicentre research was conducted using international standardized approach of clinical research.SSNHL Cases with intermediate and high-frequency hearing loss,that accepted no medicationfrom onset of hearing loss withintwo weeks duration and ages ranged between 18 and 65,were collected.All patients were treated by one of four treatments plans chosen by unified random table.Results 141 patients with intermediate and high-frequency SSNHL were recruited in the research.Twenty subjects were treated with lidocaine,21 cases with lidocaine and hormone,40 cases with Ginaton,and 60 cases with Ginaton and hormone.42 out of 141 (29.79%) patients were total recovery,24 (17.02%)achieved excellent recovery,27 (19.15%)achieved partial recovery,and 48 (34.04%) were ineffective.Thc total effective rate was 65.96%.In lidocaine group,the total effective rate was 55.00%,66.67% in lidocaine and hormone group,67.50% in Ginaton group,and 68.33% in Ginaton and hormone group.Considering the total effective rate,there was no statistical difference between four groups (P > 0.05).However,the recovery rate in Ginaton group was significant difference comparing with that in lidocaine group (P =0.0496).119 had concomitant symptom of tinnitus,and the tinnitus was improved in patients of 81.51%.With regard to total effective ratc of tinnitus in four treatment groups,it was 57.89% (11/19) in lidocaine group,100.00% (18/18) in lidocaine and hormone group,88.57% (31/35) in Ginaton group,78.72% (37/47) in Ginaton and hormone group.There was significant ascendency in lidocaine and hormone group versus that in lidocaine group (P =0.002) and Ginaton and hormone group (P =0.029).And the difference between lidocaine and Ginaton groups was statistical significance (x2 =6.705,P < 0.05).In 43 patients with muffled

  15. Ethics review of pediatric multi-center drug trials.

    Science.gov (United States)

    Needham, Allison C; Kapadia, Mufiza Z; Offringa, Martin

    2015-02-01

    The assessment of safety and efficacy of therapeutics for children and adolescents requires the use of multi-centered designs. However, the need to obtain ethical approval from multiple independent research ethics boards (REBs) presents as a challenge to investigators and sponsors who must consider local requirements while ensuring that the protection of human subjects is consistent across sites. In pediatrics, this requirement is complicated by pediatric-specific ethical concerns such as the acquisition of assent and consent and the need for pediatric expertise to assess the scholarly merit of the proposed research. Efforts to tackle these challenges have focused on the process of ethics review, which will improve efficiency. In addition to improving process, we suggest further research to fill gaps in the evidence base for recommendations and decisions made by REBs, specifically their effectiveness to protect human subjects. Evidence gathered will contribute to the successful development, adoption and implementation of harmonized guidance to apply ethics principles in order to protect children through research rather than from research.

  16. Efficacy of a dopamine-somatostatin chimeric molecule, BIM-23A760, in the control of cell growth from primary cultures of human non-functioning pituitary adenomas: a multi-center study.

    Science.gov (United States)

    Florio, Tullio; Barbieri, Federica; Spaziante, Renato; Zona, Gianluigi; Hofland, Leo J; van Koetsveld, Peter M; Feelders, Richard A; Stalla, Günter K; Theodoropoulou, Marily; Culler, Michael D; Dong, Jesse; Taylor, John E; Moreau, Jacques-Pierre; Saveanu, Alexandru; Gunz, Ginette; Dufour, Henry; Jaquet, Philippe

    2008-06-01

    Dopamine D2 and somatostatin receptors (sstrs) were reported to affect non-functioning pituitary adenoma (NFPA) proliferation in vitro. However, the reported results differ according to the experimental conditions used. We established an experimental protocol allowing reproducible evaluation of NFPA cell proliferation in vitro, to test and compare the antiproliferative effects of dopamine and somatostatin analogs (alone or in combination) with the activity of the dopamine-somatostatin chimeric molecule BIM-23A760. The protocol was utilized by four independent laboratories, studying 38 fibroblast-deprived NFPA cell cultures. Cells were characterized for GH, POMC, sstr1-sstr5, total dopamine D2 receptor (D2R) (in all cases), and D2 receptor long and short isoforms (in 15 out of 38 cases) mRNA expression and for alpha-subunit, LH, and FSH release. D2R, sstr3, and sstr2 mRNAs were consistently observed, with the dominant expression of D2R (2.9+/-2.6 copy/copy beta-glucuronidase; mean+/-s.e.m.), when compared with sstr3 and sstr2 (0.6+/-1.0 and 0.3+/-0.6 respectively). BIM-23A760, a molecule with high affinity for D2R and sstr2, significantly inhibited [3H]thymidine incorporation in 23 out of 38 (60%) NFPA cultures (EC50=1.2 pM and Emax=-33.6+/-3.7%). BIM-23A760 effects were similar to those induced by the selective D2R agonist cabergoline that showed a statistically significant inhibition in 18 out of 27 tumors (compared with a significant inhibition obtained in 17 out of 27 tumors using BIM-23A760, in the same subgroup of adenomas analyzed), while octreotide was effective in 13 out of 27 cases. In conclusion, superimposable data generated in four independent laboratories using a standardized protocol demonstrate that, in vitro, chimeric dopamine/sstr agonists are effective in inhibiting cell proliferation in two-thirds of NFPAs.

  17. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI

    OpenAIRE

    2015-01-01

    Resting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acquisition and analysis, as fMRI data is particularly sensitive to structured noise resulting from hardware, software, and environmental differences. Here, we investigated whether a novel clean up tool for structu...

  18. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI.

    OpenAIRE

    2015-01-01

    Resting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acquisition and analysis, as fMRI data is particularly sensitive to structured noise resulting from hardware, software and environmental differences. Here, we investigated whether a novel clean up tool for structur...

  19. Qingdou Xiufu Jinghua Ye for the improvement of acne vulgaris: a multi-center study%清痘修复精华液改善寻常痤疮皮损的多中心研究

    Institute of Scientific and Technical Information of China (English)

    徐良恒; 李娜; 程波; 李惠; 林新瑜; 范文葛; 黄一锦; 曹萍; 孙东杰

    2013-01-01

    目的 探讨含重楼、马齿苋提取物、透明质酸钠的清痘修复精华液改善寻常痤疮的安全性.方法 多中心、随机、开放对照研究,分为观察组及对照组各80例.每天早晚各1次,在使用薇诺娜洁面泡沫清洁面部后,观察组在痤疮皮损处使用含重楼、马齿苋提取物、透明质酸钠的清痘修复精华液,对照组在皮损处外用含木瓜蛋白酶活性成分、维生素B3、马齿苋提取液、水杨酸衍生物的薇诺娜清痘修复精华液.分别观察观察组和对照组使用前后皮损改善情况.结果 共完成149例,脱落11例,完成实验中,观察组73例,对照组76例.使用受试品14 d,28 d,使用前后炎性皮损及总皮损数较首诊日均有明显改善(P<0.05),观察组与对照组有效率比较,差异无统计学意义.结论 含重楼、马齿苋提取物、透明质酸钠的清痘修复精华液能辅助改善痤疮皮损.%Objective To evaluate the safety of Qingdou Xiufu Jinghua Ye,a skin care product containing the extract of Chinese manyleaf paris rhizome,purslane and sodium hyaluronate,in the improvement of acne vulgaris.Methods A multicenter,randomized,open-label,controlled study was conducted.Totally,160 patients with acne vulgaris were equally classified into two groups to topically apply the modified Qingdou Xiufu Jinghua Ye containing the extract of Chinese manyleaf paris rhizome,purslane and sodium hyaluronate (experiment group) or the original Qingdou Xiufu Jinghua Ye containing papain,vitamin B3,extract of purslane,and salicylic acid derivate (control group),twice a day after face washing with a commercial foaming face wash.The number of acne lesions was calculated at the baseline,on day 7,14 and 28 after the start of intervention.Results Finally,11 patients were lost to follow-up,and 149 patients completed the trial,including 73 patients in the experiment group and 76 patients in the control group.The number of inflammatory lesions and total lesions

  20. Multi-Center Electronic Structure Calculations for Plasma Equation of State

    Energy Technology Data Exchange (ETDEWEB)

    Wilson, B G; Johnson, D D; Alam, A

    2010-12-14

    We report on an approach for computing electronic structure utilizing solid-state multi-center scattering techniques, but generalized to finite temperatures to model plasmas. This approach has the advantage of handling mixtures at a fundamental level without the imposition of ad hoc continuum lowering models, and incorporates bonding and charge exchange, as well as multi-center effects in the calculation of the continuum density of states.

  1. Regional Gray Matter Atrophy in Relapsing Remitting Multiple Sclerosis: Baseline Analysis of Multi-Center Data

    Science.gov (United States)

    Datta, Sushmita; Staewen, Terrell D.; Cofield, Stacy S.; Cutter, Gary R.; Lublin, Fred D.; Wolinsky, Jerry S.; Narayana, Ponnada A.

    2015-01-01

    Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison. Using the analysis of covariance, atrophy differences between MS patients and healthy controls were assessed on a voxel-by-voxel analysis. Regional GM atrophy was observed in a number of deep GM structures that included thalamus, caudate nucleus, putamen, and cortical GM regions. General linear regression analysis was performed to analyze the effects of age, gender, and scanner field strength, and imaging sequence on the regional atrophy. Correlations between regional GM volumes and expanded disability status scale (EDSS) scores, disease duration (DD), T2 lesion load (T2 LL), T1 lesion load (T1 LL), and normalized cerebrospinal fluid (nCSF) were analyzed using Pearson’s correlation coefficient. Thalamic atrophy observed in MS patients compared to healthy controls remained consistent within subgroups based on gender and scanner field strength. Weak correlations between thalamic volume and EDSS (r = −0.133; p < 0.001) and DD (r = −0.098; p = 0.003) were observed. Of all the structures, thalamic volume moderately correlated with T2 LL (r = −0.492; p-value < 0.001), T1 LL (r = −0.473; p-value < 0.001) and nCSF (r = −0.367; p-value < 0.001). PMID:25787188

  2. Regional gray matter atrophy in relapsing remitting multiple sclerosis: baseline analysis of multi-center data.

    Science.gov (United States)

    Datta, Sushmita; Staewen, Terrell D; Cofield, Stacy S; Cutter, Gary R; Lublin, Fred D; Wolinsky, Jerry S; Narayana, Ponnada A

    2015-03-01

    Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison. Using the analysis of covariance, atrophy differences between MS patients and healthy controls were assessed on a voxel-by-voxel analysis. Regional GM atrophy was observed in a number of deep GM structures that included thalamus, caudate nucleus, putamen, and cortical GM regions. General linear regression analysis was performed to analyze the effects of age, gender, and scanner field strength, and imaging sequence on the regional atrophy. Correlations between regional GM volumes and expanded disability status scale (EDSS) scores, disease duration (DD), T2 lesion load (T2 LL), T1 lesion load (T1 LL), and normalized cerebrospinal fluid (nCSF) were analyzed using Pearson׳s correlation coefficient. Thalamic atrophy observed in MS patients compared to healthy controls remained consistent within subgroups based on gender and scanner field strength. Weak correlations between thalamic volume and EDSS (r=-0.133; p<0.001) and DD (r=-0.098; p=0.003) were observed. Of all the structures, thalamic volume moderately correlated with T2 LL (r=-0.492; P-value<0.001), T1 LL (r=-0.473; P-value<0.001) and nCSF (r=-0.367; P-value<0.001).

  3. The C-seal trial: colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler, a multi-center randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bakker Ilsalien S

    2012-11-01

    Full Text Available Abstract Background Anastomotic leakage is a major complication in colorectal surgery and with an incidence of 11% the most common cause of morbidity and mortality. In order to reduce the incidence of anastomotic leakage the C-seal is developed. This intraluminal biodegradable drain is stapled to the anastomosis with a circular stapler and prevents extravasation of intracolonic content in case of an anastomotic dehiscence. The aim of this study is to evaluate the efficacy of the C-seal in reducing anastomotic leakage in stapled colorectal anastomoses, as assessed by anastomotic leakage leading to invasive treatment within 30 days postoperative. Methods The C-seal trial is a prospective multi-center randomized controlled trial with primary endpoint, anastomotic leakage leading to re-intervention within 30 days after operation. In this trial 616 patients will be randomized to the C-seal or control group (1:1, stratified by center, anastomotic height (proximal or distal of peritoneal reflection and the intention to create a temporary deviating ostomy. Interim analyses are planned after 50% and 75% of patient inclusion. Eligible patients are at least 18 years of age, have any colorectal disease requiring a colorectal anastomosis to be made with a circular stapler in an elective setting, with an ASA-classification Discussion This Randomized Clinical trial is designed to evaluate the effectiveness of the C-seal in preventing clinical anastomotic leakage. Trial registration NTR3080

  4. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  5. L-谷氨酰胺和左旋肉碱改善维持性血液透析患者营养状况的多中心、随机临床研究%L-Glutamine and L-Carnitine in Maintenance Hemodialysis Patients to Improve Nutritional Status of the Multi-center Randomized Clinical Approach

    Institute of Scientific and Technical Information of China (English)

    张琥; 何晓峰; 汪汉东

    2011-01-01

    目的:观察L-谷氨酰胺和左旋肉碱(L-肉碱)在维持性血液透析(maintain hemodialysis,MHD)患者营养不良治疗中的作用.方法:采用多中心、随机的方法将78例MHD患者随机分成A组、B组、C组,3组患者均皮下注射重组人促红细胞生成素(erythropoietinin,EPO)6 000 U,2次/周;A组每次血液透析结束时静脉注射L-肉碱2 g,3次/周;B组每日口服L-谷氨酰胺胶囊1.5 g(分3次口服);C组联合使用L-肉碱和L-谷氨酰胺,用法不变.观察时间3个月.结果:C组患者血细胞比容(haematocrit,HCT)、血红蛋白(haemoglobin,Hb)、血浆总蛋白(plasma total protein,Tp)、血浆白蛋白(serum albumin,Alb)上升幅度明显高于A组和B组(P<0.05或P<0.01),C组血C反应蛋白(C-reactive protein,CRP)水平明显低于A组和B组(P<0.01),免疫球蛋白(IgA、IgG、IgM)水平明显高于A组及B组(P<0.01).结论:MHD患者联合使用L-谷氨酰胺和L-肉碱可显著改善患者的营养状况及免疫功能;减轻体内微炎症反应;改善对EPO的敏感性,减少用量,提高疗效;安全性较好.%Objective: To assess the efficacy of L - glutamine and L - carnitine in the treatment of maintenance hemodialysis patients with malnutrition. Methods: A multi - center approach of seventy - eight on malnutrition maintenance hemodialysis patients were randomly divided in to 3 groups: group A,group B and group C. Three groups were treated by EPO ( 6 000 u,two times each week by subcutaneous injection ). In addition,2 g of L - carnitine was infused after each hemodialysis is treatment, three times each week in group A;oral L - glutamine administration( 1.5 g,three times each day )in group B;and L - glutamine and L - carnitine coad-ministration in group C. The patients were observed for three months. Results: Compared with group A and group B, haematocrit( Hct ) and plasma total protein( Tp )and serum albumin( Alb ) and haemoglobin( Hb ) were all significantly increased( P < 0. 05 or P < 0.01 ),but the

  6. Variation of Community Consultation and Public Disclosure for a Pediatric Multi-centered “Exception from Informed Consent” Trial

    Science.gov (United States)

    Holsti, Maija; Zemek, Roger; Baren, Jill; Stanley, Rachel M.; Prashant, Mahajan; Vance, Cheryl; Brown, Kathleen M.; Gonzalez, Victor; King, Denise; Jacobsen, Kammy; Shreve, Kate; van de Bruinhorst, Katrina; Jones, Anne Marie; Chamberlain, James M.

    2014-01-01

    Background The U.S. federal regulation “Exception from Informed Consent (EFIC) for Emergency Research,” 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards (IRBs) determine the adequacy of these activities at a local level. Thus there is potential for broad interpretation and practice variation. Aim To describe the variation of community consultation and public disclosure activities approved by IRBs, and the effectiveness of this process for a multi-center, EFIC, pediatric status epilepticus clinical research trial. Methods: Community consultation and public disclosure activities were analyzed for each of 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment. Results Every IRB, among the 15 participating sites, had a varied interpretation of EFIC regulations for community consultation and public disclosure activities. IRBs required various combinations of focus groups, interviews, surveys, and meetings for community consultation; news releases, mailings, and public service announcements for public disclosure. At least 4,335 patients received information about the study from these efforts. 158 chose to be included in the “Opt Out” list. Of the 304 participants who were enrolled under EFIC, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for

  7. Multimodal Cognitive Enhancement Therapy for Patients with Mild Cognitive Impairment and Mild Dementia: A Multi- Center, Randomized, Controlled, Double-Blind, Crossover Trial.

    Science.gov (United States)

    Han, Ji Won; Lee, Hyeonggon; Hong, Jong Woo; Kim, Kayoung; Kim, Taehyun; Byun, Hye Jin; Ko, Ji Won; Youn, Jong Chul; Ryu, Seung-Ho; Lee, Nam-Jin; Pae, Chi-Un; Kim, Ki Woong

    2017-01-01

    We developed and evaluated the effect of Multimodal Cognitive Enhancement Therapy (MCET) consisting of cognitive training, cognitive stimulations, reality orientation, physical therapy, reminiscence therapy, and music therapy in combination in older people with mild cognitive impairment (MCI) or mild dementia. This study was a multi-center, double-blind, randomized, placebo-controlled, two-period cross-over study (two 8-week treatment phases separated by a 4-week wash-out period). Sixty-four participants with MCI or dementia whose Clinical Dementia Rating was 0.5 or 1 were randomized to the MCET group or the mock-therapy (placebo) group. Outcomes were measured at baseline, week 9, and week 21. Fifty-five patients completed the study. Mini-Mental State Examination (effect size = 0.47, p = 0.013) and Alzheimer's Disease Assessment Scale-Cognitive Subscale (effect size = 0.35, p = 0.045) scores were significantly improved in the MCET compared with mock-therapy group. Revised Memory and Behavior Problems Checklist frequency (effect size = 0.38, p = 0.046) and self-rated Quality of Life - Alzheimer's Disease (effect size = 0.39, p = 0.047) scores were significantly improved in the MCET compared with mock-therapy. MCET improved cognition, behavior, and quality of life in people with MCI or mild dementia more effectively than conventional cognitive enhancing activities did.

  8. Line Defects, Tropicalization, and Multi-Centered Quiver Quantum Mechanics

    CERN Document Server

    Cordova, Clay

    2013-01-01

    We study BPS line defects in N=2 supersymmetric four-dimensional field theories. We focus on theories of "quiver type," those for which the BPS particle spectrum can be computed using quiver quantum mechanics. For a wide class of models, the renormalization group flow between defects defined in the ultraviolet and in the infrared is bijective. Using this fact, we propose a way to compute the BPS Hilbert space of a defect defined in the ultraviolet, using only infrared data. In some cases our proposal reduces to studying representations of a "framed" quiver, with one extra node representing the defect. In general, though, it is different. As applications, we derive a formula for the discontinuities in the defect renormalization group map under variations of moduli, and show that the operator product algebra of line defects contains distinguished subalgebras with universal multiplication rules. We illustrate our results in several explicit examples.

  9. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept ... treatments based on what is known to work in adults. To improve clinical care of children, more ...

  10. Quantitative multi-parameter mapping of R1, PD*, MT and R2* at 3T: a multi-center validation

    Directory of Open Access Journals (Sweden)

    Nikolaus eWeiskopf

    2013-06-01

    Full Text Available Multi-center studies using magnetic resonance imaging facilitate studying small effect sizes, global population variance and rare diseases. The reliability and sensitivity of these multi-center studies crucially depend on the comparability of the data generated at different sites and time points. The level of inter-site comparability is still controversial for conventional anatomical T1-weighted MRI data. Quantitative multi-parameter mapping (MPM was designed to provide MR parameter measures that are comparable across sites and time points, i.e., 1mm high-resolution maps of the longitudinal relaxation rate (R1=1/T1, effective proton density (PD*, magnetization transfer saturation (MT and effective transverse relaxation rate (R2*=1/T2*. MPM was validated at 3T for use in multi-center studies by scanning five volunteers at three different sites. We determined the inter-site bias, inter-site and intra-site coefficient of variation (CoV for typical morphometric measures (i.e., gray matter probability maps used in voxel-based morphometry and the four quantitative parameters. The inter-site bias and CoV were smaller than 3.1% and 8%, respectively, except for the inter-site CoV of R2* (< 20%. The gray matter probability maps based on the MT parameter maps had a 14% higher inter-site reproducibility than maps based on conventional T1-weighted images. The low inter-site bias and variance in the parameters and derived gray matter probability maps confirm the high comparability of the quantitative maps across sites and time points. The reliability, short acquisition time, high resolution and the detailed insights into the brain microstructure provided by MPM makes it an efficient tool for multi-center imaging studies.

  11. Solution of multi-center molecular integrals of Slater-type orbitals

    Science.gov (United States)

    Tai, H.

    1989-01-01

    The troublesome multi-center molecular integrals of Slater-type orbitals (STO) in molecular physics calculations can be evaluated by using the Fourier transform and proper coupling of the two center exchange integrals. A numerical integration procedure is then readily rendered to the final expression in which the integrand consists of well known special functions of arguments containing the geometrical arrangement of the nuclear centers and the exponents of the atomic orbitals. A practical procedure was devised for the calculation of a general multi-center molecular integrals coupling arbitrary Slater-type orbitals. Symmetry relations and asymptotic conditions are discussed. Explicit expressions of three-center one-electron nuclear-attraction integrals and four-center two-electron repulsion integrals for STO of principal quantum number n=2 are listed. A few numerical results are given for the purpose of comparison.

  12. Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

    Science.gov (United States)

    Ando, Kenji; Ishii, Katsuhisa; Tada, Eiji; Kataoka, Kazuaki; Hirohata, Atsushi; Goto, Kenji; Kobayashi, Katsuyuki; Tsutsui, Hiroshi; Nakahama, Makoto; Nakashima, Hitoshi; Uchikawa, Shinichiroh; Kanda, Junji; Yasuda, Satoshi; Yajima, Junji; Kitabayashi, Hiroshi; Sakurai, Shumpei; Nakanishi, Keita; Inoue, Naoto; Noike, Hirofumi; Hasebe, Terumitsu; Sato, Tetsuya; Yamasaki, Masao; Kimura, Takeshi

    2016-07-22

    The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION(®)). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION(®) (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION(®). All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

  13. Expanding the Use of Time-Based Metering: Multi-Center Traffic Management Advisor

    Science.gov (United States)

    Landry, Steven J.; Farley, Todd; Hoang, Ty

    2005-01-01

    Time-based metering is an efficient air traffic management alternative to the more common practice of distance-based metering (or "miles-in-trail spacing"). Despite having demonstrated significant operational benefit to airspace users and service providers, time-based metering is used in the United States for arrivals to just nine airports and is not used at all for non-arrival traffic flows. The Multi-Center Traffic Management Advisor promises to bring time-based metering into the mainstream of air traffic management techniques. Not constrained to operate solely on arrival traffic, Multi-Center Traffic Management Advisor is flexible enough to work in highly congested or heavily partitioned airspace for any and all traffic flows in a region. This broader and more general application of time-based metering is expected to bring the operational benefits of time-based metering to a much wider pool of beneficiaries than is possible with existing technology. It also promises to facilitate more collaborative traffic management on a regional basis. This paper focuses on the operational concept of the Multi-Center Traffic Management Advisor, touching also on its system architecture, field test results, and prospects for near-term deployment to the United States National Airspace System.

  14. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI.

    Directory of Open Access Journals (Sweden)

    Rogier Alexander Feis

    2015-10-01

    Full Text Available Resting-state fMRI (R-fMRI has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acquisition and analysis, as fMRI data is particularly sensitive to structured noise resulting from hardware, software and environmental differences. Here, we investigated whether a novel clean up tool for structured noise was capable of reducing center-related R-fMRI differences between healthy subjects.We analyzed 3 Tesla R-fMRI data from 72 subjects, half of whom were scanned with eyes closed in a Philips Achieva system in The Netherlands, and half of whom were scanned with eyes open in a Siemens Trio system in the UK. After pre-statistical processing and individual Independent Component Analysis (ICA, FMRIB’s ICA-based X-noiseifier (FIX was used to remove noise components from the data. GICA and dual regression were run and non-parametric statistics were used to compare spatial maps between groups before and after applying FIX.Large significant differences were found in all resting-state networks between study sites before using FIX, most of which were reduced to non-significant after applying FIX. The between-center difference in the medial/primary visual network, presumably reflecting a between-center difference in protocol, remained statistically different.FIX helps facilitate multi-center R-fMRI research by diminishing structured noise from R-fMRI data. In doing so, it improves combination of existing data from different centers in new settings and comparison of rare diseases and risk genes for which adequate sample size remains a challenge.

  15. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI

    Science.gov (United States)

    Feis, Rogier A.; Smith, Stephen M.; Filippini, Nicola; Douaud, Gwenaëlle; Dopper, Elise G. P.; Heise, Verena; Trachtenberg, Aaron J.; van Swieten, John C.; van Buchem, Mark A.; Rombouts, Serge A. R. B.; Mackay, Clare E.

    2015-01-01

    Resting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acquisition and analysis, as fMRI data is particularly sensitive to structured noise resulting from hardware, software, and environmental differences. Here, we investigated whether a novel clean up tool for structured noise was capable of reducing center-related R-fMRI differences between healthy subjects. We analyzed three Tesla R-fMRI data from 72 subjects, half of whom were scanned with eyes closed in a Philips Achieva system in The Netherlands, and half of whom were scanned with eyes open in a Siemens Trio system in the UK. After pre-statistical processing and individual Independent Component Analysis (ICA), FMRIB's ICA-based X-noiseifier (FIX) was used to remove noise components from the data. GICA and dual regression were run and non-parametric statistics were used to compare spatial maps between groups before and after applying FIX. Large significant differences were found in all resting-state networks between study sites before using FIX, most of which were reduced to non-significant after applying FIX. The between-center difference in the medial/primary visual network, presumably reflecting a between-center difference in protocol, remained statistically significant. FIX helps facilitate multi-center R-fMRI research by diminishing structured noise from R-fMRI data. In doing so, it improves combination of existing data from different centers in new settings and comparison of rare diseases and risk genes for which adequate sample size remains a challenge. PMID:26578859

  16. 地拉罗司对伴有铁过载的再生障碍性贫血患者的祛铁疗效及安全性--一项单臂、多中心、前瞻性临床研究%Efficacy and safety of deferasirox in aplastic anemia patients with iron overload:a single arm, multi-center, prospective study in China

    Institute of Scientific and Technical Information of China (English)

    施均; 全日成; 郑春梅; 肖海燕; 胡明辉; 胡令彦; 刘锋; 周永明; 郑以州; 张凤奎; 常红; 张莉; 邵英起; 聂能; 张静; 黄金波; 张丽; 唐旭东

    2016-01-01

    Objective To explore the efficacy and safety of deferasirox in aplastic anemia(AA) patients with iron overload. Methods A single arm, multi-center, prospective, open-label study was conducted to evaluate absolute change in serum ferritin(SF)from baseline to 12 months of deferasirox administration, initially at a dose of 20 mg · kg-1 · d-1, and the safety in 64 AA patients with iron overload. Results All patients started their deferasirox treatment with a daily dose of 20 mg · kg-1 · d-1. The mean actual dose was(18.6 ± 3.60)mg · kg-1 · d-1. The median SF decreased from 4 924(2 718-6 765)μg/L at baseline (n=64) to 3 036(1 474-5 551)μg/L at 12 months (n=23) with the percentage change from baseline as 38%. A median SF decrease of 651(126-2 125)μg/L was observed at the end of study in 23 patients who completed 12 months’treatment, the median SF level decreased by 1 167(580-4 806)μg/L[5 271(3 420-8 278)μg/L at baseline;3 036(1 474-5 551)μg/L after 12 months’treatment;the percentage change from baseline as 42%]after 12 months of deferasirox treatment. The most common adverse events (AEs)were increased serum creatinine levels(40.98%), gastrointestinal discomfort(40.98%), elevated liver transaminase(ALT:21.31%;AST:13.11%)and proteinuria(24.59%). The increased serum creatinine levels were reversible and non-progressive. Of 38 patients with concomitant cyclosporine use, 12(31.8%) patients had two consecutive values>ULN, 10(26.3%)patients had two consecutive values>1.33 baseline values, but only 1(2.6%)patient’s serum creatinine increased more than 1.33 baseline values and exceeded ULN. For both AST and ALT, no patients experienced two post-baseline values >5 × ULN or >10 × ULN during the whole study. In AA patients with low baseline PLT count(less than 50 × 109/L), there was no decrease for median PLT level during 12 months’treatment period. Conclusions AA patients with iron overload could achieve satisfactory efficacy of iron chelation by deferasirox

  17. 吸烟对急性ST段抬高型心肌梗死接受紧急冠状动脉介入治疗患者预后影响的前瞻性多中心队列研究%Impact of Smoking Status on Prognosis in Patients with Acute ST-segment Elevation Myocardial Infarction after Emergency Percutaneous Coronary Intervention,A Prospective,Multi-center Cohort Study

    Institute of Scientific and Technical Information of China (English)

    孙宇姣; 姜大明; 张波; 孙洋; 高远; 李玉泽; 于海杰; 齐国先

    2012-01-01

    Objective To evaluate the impact of smoking status on the prognosis of patients with acute ST - segment elevation myocardial infarction ( ASTEMI ) after percutaneous coronary intervention ( PCI ). Methods In this prospective, multi - center cohort study, the consecutive ASTEMI patients who were admitted to 20 hospitals between May 2009 and May 2010 in Liaoning Province were enrolled. Patients were divided into smoker group and non - smoker group on admission. The baseline demographic data, treatment and clinical outcomes were compared between these two groups. The survival curves, log - rank test, and Cox proportional hazard analysis were applied. Results Totally 402 patients were enrolled, among whom 228 patients were in the smoker group and 174 patients in non - smoker group, yielding a smoking rate of 56. 7% ( n = 228 ). The smoker group was significantly younger than the non - smoker group [ ( 56. 47 ± 10. 90 ) y vs. ( 64. 86 ± 11. 97 ) y, P < 0. 001 ]. There was significantly more men in the smoker group than in non - smoker group ( 94. 7% vs 61. 5% , P <0. 001 ). The non -smoker group had significantly higher incidences of myocardial infarction, hypertension and diabetes than the smoker group ( P < 0. 05 ). The non - smoker group had significantly higher rate of multi - vessels disease than smoker group but lower rate of single vessel disease ( P <0. 05 ). The mortality ( both in - hospital and follow - up: P =0. 19 ) and the cumulative survival rate ( in -hospital: P =0. 53 ; follow - up: P = 0. 08 ) showed no significant difference between these two groups. The mortality was sig- nificantly correlated with age [ HR = 1. 118, 95% CI (1.069, 1.168), P<0. 001], body mass index [ HR = 1. 113, 95% CI ( 1.107, 1.219), P=0. 02), and smoking status [ HR =3. 549, 95% CI ( 1.305, 9.650), P = 0. 01]. Conclusion Among patients with ASTEMI after PCI, smokers are younger, with lower comorbiditiess and simpler lesions. Although the short - and long - term prognosis of

  18. Clinical studies involving probiotics

    OpenAIRE

    Degnan, Fred H

    2012-01-01

    Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of “probiotics.” Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the “investigational new drug” (IND) rubric administered and enforced by the US Food and Drug Administration. In determining whether a...

  19. Clinical Nursing Records Study

    Science.gov (United States)

    1991-08-01

    for Sam Houston, Texas MAJ Joanne Burton , AN, Clinical Head Nurse, Psychiatry MAJ Shelby Christian, AN, Clinical Head Nurse, OB/GYN MAJ Melissa Opio...Specify Level) Parenting, Potential Alteration In Decubitus Ulcer Self-Care Deficit, Total (Specify Level) Social Isolation Fluid Volume Deficit. Potential...METABOLIC PATTERN Self-Care Dieficit. Total (Specify Level) SiX alizaticni Alterations ifl Decubitus ulcer S-If-Batingrla.v~qene Oeticit 601?Cif Levet

  20. 布洛伪麻那敏胶囊治疗成人普通感冒的多中心随机双盲对照临床研究%Multi center randomized double-blind clinical comparison of ibuprofen and pseudoephedrine chlorphenira-mine capsule in the treatment of adult common cold

    Institute of Scientific and Technical Information of China (English)

    邓俊; 王宋平; 张睢扬; 孙圣华; 肖贞良; 崔社怀

    2016-01-01

    Objective To evaluate the efficacy and safety of ibuprofen pseudoephedrine hydrochloride and chlorpheniramine maleate cpasules in the treatment of adult common cold. Methods A multicenter, randomized, double-blind, double-dummy, and positive drug parallel-controlled clinical trial was conducted. The trial group and the control group were administered with ibuprofen pseudoephedrine hydrochloride and chlorpheniramine maleate cpa-sules and paracetamol pseudoephedrine hydrochloride and chlorphenamine maleate tablets, respectively. The medi-cine was taken orally one cpasule (tablet), three times a day for 3 to 5days for each group. Results The total effec-tive rate and control rate of the trial group (n=119) and the control group (n=119) enrolled in the full analysis set (FAS) were 98. 32% vs. 97. 48% and 86. 55% vs. 93. 28%, respectively, while those of the trial group (n=117) and the control group (n=115) enrolled in the per protocol set (PPS) were 98. 29% vs. 98. 26% and 86. 32% vs. 93. 91%, respectively (P>0. 05). After the treatment, the effective rate and control rate of the individual symptom (fever, headache, limb ache, stuffy nose, sneezing, runny nose) showed no significant difference between the two groups ( P>0. 05 ) . The incidence of adverse drug reactions ( including mild drowsiness, dizziness, fatigue, and thirsty) in the trial group and the control group was 13. 45% and 11. 76%, respectively, with no statistical signifi-cant difference between the two groups ( P >0. 05 ) . Conclusion Ibuprofen pseudoephedrine hydrochloride and chlorpheniramine maleate cpasules is safe and effective in treating adult common cold. Its therapeufic efficacy and safety are similar to paracetamol pseudoephedrine hydrochloride and chlorphenamine maleate tablets.%目的:评价天圣制药集团股份有限公司研制生产的布洛伪麻那敏胶囊治疗成人普通感冒的疗效和安全性。方法采用多中心、随机、双盲、双模拟、阳性药物平行对照

  1. 中国汉族人群慢性丙型肝炎病毒基因型分布规律研究%Genotypes distribution of hepatitis C virus through multi-center, large sample studies among chronic hepatitis C patients in Chinese Han population

    Institute of Scientific and Technical Information of China (English)

    聂红明; 陈建杰; 汪蓉; 王成宝; 董慧琳; 陈逸云

    2012-01-01

    Objective To understand the distribution of hepatitis C virus (HCV) genotypes in China.Methods A national multi-center,large sample epidemiological survey was carried out and certified by an international third-party testing organization.Internationally accepted method for sequencing analysis of viral genotype was used.Results Patients were those suffered from the 4 major genotypes of chronic hepatitis C,including nine subtypes,which were dominated by genotype 1 (69.6%),with type lb in particular (accounting for 68.38% ).Among the rare gene-6,we saw more subtypes of 6a.In the south,central,and north areas,there was no significant difference seen between the south and the north areas in the distribution of the genotype 1.However,the rate of gene type 2a increased gradually from south to north.In terms of less common type of gene 3b and gene-6,they were seen mainly in the southern provinces.Conclusion In China,Patients with chronic hepatitis C had 4 HCV genotypes,with 9 subtypes.The rarely seen genotypes 3b and 6 were mainly distributed in the southern provinces.%目的 了解中国汉族人群慢性丙型肝炎病毒(HCV)基因型分布规律.方法 通过多中心、大样本流行病学调查,经具有国际认证资质的第三方检测机构,采用国际通用的测序方法分析病毒基因型.结果 共采集全国不同地区18个研究中心764例(男性384例,女性380例)患者血标本,患者平均年龄(44.9±14.3)岁,平均病程(7.7±7.3)年.最终对740例患者的病毒基因分型进行结果分析.中国慢性丙型肝炎患者共有4种主要基因型和9种亚型,其中以基因1型为主(69.6%),尤其是1b型(68.38%).在较少见的基因6型中,以6a亚型较多.以南、中、北地区划分,基因l型在南北地区的分布差异无统计学意义,基因2a型分布的比例由南向北逐渐增高;较少见的基因3b型、6型主要分布在南方省份.结论 中国汉族人群慢性丙型肝炎患者共有4

  2. Cross-sectional Multi-center Analysis of Portal Hypertension in 163 Children and Young Adults with Biliary Atresia

    Science.gov (United States)

    Shneider, Benjamin L.; Abel, Bob; Haber, Barbara; Karpen, Saul J.; Magee, John C.; Romero, Rene; Schwarz, Kathleen; Bass, Lee M.; Kerkar, Nanda; Miethke, Alexander G.; Rosenthal, Philip; Turmelle, Yumirle; Robuck, Patricia R.; Sokol, Ronald J.

    2012-01-01

    Objectives Biliary atresia (BA) frequently results in portal hypertension (PHT), complications of which lead to significant morbidity and mortality. The Childhood Liver Disease Research and Education Network (ChiLDREN) was utilized to perform a cross-sectional multi-centered analysis of PHT in children with BA. Methods BA subjects receiving medical management at a ChiLDREN site were enrolled. A priori, clinically evident PHT was defined as “definite” when there was either 1) history of a complication of PHT or 2) clinical findings consistent with PHT (both splenomegaly and thrombocytopenia). PHT was denoted as “possible” if one of the findings was present in the absence of a complication, while PHT was “absent” if none of the criteria were met. Results 163 subjects were enrolled between May 2006 and December 2009. At baseline, definite PHT was present in 49%, possible in 17% and absent in 34% of subjects. Demographics, growth and anthropometrics were similar amongst the 3 PHT categories. ALT, GGTP, and sodium levels were similar, while there were significant differences in AST, AST/ALT, albumin, total bilirubin, PT, WBC, platelet count and AST/platelet between definite and absent PHT. Thirty-four percent of those with definite PHT had either PT > 15s or albumin < 3 g/L. Conclusions Clinically definable PHT is present in two thirds of North American long-term BA survivors with their native livers. The presence of PHT is associated with measures of hepatic injury and dysfunction, although in this selected cohort the degree of hepatic dysfunction is relatively mild and growth is preserved. PMID:22903006

  3. [Significance of Multi-center Obstetrics Perioperative Team Training Including Various Medical Staffs].

    Science.gov (United States)

    Komasawa, Nobuyasu; Fujita, Daisuke; Nakayama, Mai; Fujiwara, Shunsuke; Mihara, Ryosuke; Okada, Daisuke; Omoto, Haruka; Tanaka, Motoshige; Nishihara, Isao; Minami, Toshiaki

    2016-02-01

    We report the development of a multi-center/multispecialist obstetrics perioperative team training program. Participants were members of the team, including anesthesiologists, obstetricians, and operation nurses. A questionnaire survey was conducted prior to course participation to clarify any questions team members had. The courses included a lecture and simulation training with scenario-based discussions or the use of a simulator. Scenarios included massive bleeding during cesarean section, massive bleeding after vaginal delivery, and emergency cesarean section for premature placental abruption. After each course, participants discussed problems associated with obstetrics medical safety in the context of each theme. Simulation-based perioperative team training with anesthesiologists, obstetricians, and operation nurses may serve as a vehicle to promote perioperative obstetrics patient safety.

  4. Learn about Clinical Studies

    Science.gov (United States)

    ... is to make sure that the study is ethical and that the rights and welfare of participants ... trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  5. Multi-center study of carbachol on the treatment of grastrointestinal dysfunction in patients with sepsis%卡巴胆碱对脓毒症患者胃肠功能障碍治疗的多中心临床研究

    Institute of Scientific and Technical Information of China (English)

    程爱斌; 陈辉; 刁增利; 王瑞刚

    2011-01-01

    目的 研究卡巴胆碱对脓毒症患者胃肠功能障碍的治疗价值.方法 通过前瞻性、多中心、随机对照临床试验,将入选患者随机分为两组:莫沙必利组(178例)和卡巴胆碱组(286例),分别于入组0 h及用药后24 h、48 h、72 h、7 d或死亡前取血行血浆D-乳酸、内毒素的测定.临床动态监测肠鸣音恢复情况、腹胀、排便、肠管积气积液情况,在上述各时点评定两组患者的胃肠功能评分.结果 与莫沙必利组比较,卡巴胆碱组血浆D-乳酸、内毒素及胃肠功能评分均有显著变化(P<0.05).结论卡巴胆碱能有效改善脓毒症患者的肠道功能,减轻其炎症反应.%Objective To study therapeutical value of carbachol on gastrointestinal dysfunction in patients with sepsis. Methods By a prospective, multicenter, randomized controlled clinical trials, 464 cases will be selected randomly and were divided into two groups respectively. In the group of 0 h, and 24 h, 48 h, 72 h, 7 d after treatment or before death, we test blood plasma endotoxin, plasma D -lactate. At the same time, in order to assess the score of two groups at each time point about gastrointestinal function, we monitored dynamically clinical recovery of bowel sounds, abdominal distension, defecation, intestinal pneumatosis, fluid situation, jvesults Compared with mosapride treatment group, in carbachol treatment group, plasma D - lactate, endotoxin and gastrointestinal function scores changed significantly (P<0.05). Conclusion Carbachol can improve bowel function and reduce the inflammatory response of sepsis patients.

  6. Clinical Microfluidics for Neutrophil Genomics and Proteomics

    OpenAIRE

    2010-01-01

    Neutrophils play critical roles in modulating the immune response. We present a robust methodology for rapidly isolating neutrophils directly from whole blood and develop ‘on-chip’ processing for mRNA and protein isolation for genomics and proteomics. We validate this device with an ex vivo stimulation experiment and by comparison with standard bulk isolation methodologies. Lastly, we implement this tool as part of a near patient blood processing system within a multi-center clinical study of...

  7. Effects of galantamine on attention and memory in Alzheimer's disease measured by computerized neuropsychological tests: results of the Brazilian Multi-Center Galantamine Study (GAL-BRA-01 Efeitos da galantamina sobre a memória e a atenção na doença de Alzheimer medidos por testes neuropsicológicos computadorizados: resultados do Estudo Multicêntrico com Galantamina (GAL-BRA-01

    Directory of Open Access Journals (Sweden)

    Paulo Caramelli

    2004-06-01

    Full Text Available OBJECTIVE: To investigate the effects of galantamine on the performance of patients with mild to moderate Alzheimer's disease (AD in a computerized neuropsychological test battery (CNTB. METHOD: Thirty-three patients with probable AD were treated with galantamine for three months and evaluated in a prospective, open-label, multi-center study. The CNTB and the ADAS-Cog were administered at baseline and after 12 weeks. The CNTB includes reaction time tests to evaluate attention, implicit and episodic memory for faces and words. Statistical comparisons were performed between the results in week 12 versus baseline. Patients who did not reach the therapeutic doses were excluded from the efficacy analysis. RESULTS: Four patients (12.1% were excluded from the analysis either because of treatment discontinuation (n=3 or because a therapeutic dose was not reached (n=1. The remaining 29 patients were treated with doses of 24 mg/day (n=22 and 16 mg/day (n=7. After 12 weeks, significant reductions in reaction time were seen in the test of episodic memory for faces (p=0.023 and in the test of two-choice reaction time (p=0.039 of the CNTB. CONCLUSION: Treatment with galantamine produced improvement in computerized tests of attention and episodic memory after 12 weeks, leading to statistically significant reduction in the reaction times.OBJETIVO: Investigar os efeitos da galantamina no desempenho de pacientes portadores de doença de Alzheimer (DA leve a moderada em uma bateria de testes neuropsicológicos computadorizados (BTNC. MÉTODO: Trinta e três pacientes com DA provável receberam tratamento com galantamina por três meses em ensaio clínico multicêntrico aberto e prospectivo. A escala BTNC e a ADAS-Cog foram administradas no início e ao final de 12 semanas. A BTNC incluiu testes de tempo de reação avaliando atenção, memória implícita e memória episódica para palavras e faces. Comparações estatísticas foram realizadas entre os resultados

  8. Effectiveness of fentanyl transdermal patch (fentanyl-TTS, durogegic) for radiotherapy induced pain and cancer pain: multi-center trial

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Seong Soo; Choi, Eun Kyung [University of Ulsan College of Medicine, Seoul (Korea, Republic of); Huh, Seung Jae [Sungkyunkwan University College of Medicine, Seoul (Korea, Republic of)] (and others)

    2006-12-15

    To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. Our study was open labelled prospective phase IV multi-center study, the study population included patients with more 4 numeric rating scale (NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups: patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief: second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, {rho} = 0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There wa no major side effect.

  9. Distributed Scheduling Architecture for Multi-Center Time-Based Metering

    Science.gov (United States)

    Landry, Steven; Farley, Todd; Foster, John; Green, Steve; Hoang, Ty; Wong, Gregory L.

    2003-01-01

    The Traffic Management Advisor (TMA) is an air traffic control automation system currently in use in seven Air Route Traffic Control Centers (ARTCCs) to enable time based metering to busy airports within their airspace. However, this system is limited to operation within a single ARTCC, within about a 200 nautical mile radius of the airport, and on relatively simple streams of traffic. The need for coordinated metering within a greater (300+ nautical mile) radius of an airport, on streams of traffic with significant branching, and across ARTCC boundaries, has been identified. Early tests revealed that TMA could not simply be scaled up to handle such a problem. Instead, a loosely coupled hierarchy of schedules, in which constraints from downstream schedules are passed upstream, is required. Such an architecture reduces the reliance on distant projections of arrival times, making schedules robust to changes in sequence and to additions of aircraft (such as aircraft departing inside the system s scheduling horizon). This architecture is also scaleable, easily reconfigurable, and can be networked together. As such, it can be adapted for use in any size or configuration of airspace and with any number of airports delivering restrictions. An implementation of this distributed scheduling architecture is currently undergoing testing in the TMA-Multi Center system. This paper describes the architecture and its motivation.

  10. An analysis of 181 cases with blood stream infection caused by Streptococcus agalactiae in children from 2011 to 2015: a multi-center retrospective study%2011至2015年181例儿童无乳链球菌血流感染多中心研究

    Institute of Scientific and Technical Information of China (English)

    华春珍; 俞蕙; 庄捷秋; 李小露; 许红梅; 罗巧二; 卢洪萍; 俞惠民; 曹云

    2016-01-01

    ,2011 to December 31,2015 were enrolled by checking the laboratory information system (LIS) from 7 Class 3 Grade A hospitals (4 in Zhejiang,2 in Shanghai and 1 in Chongqing).Clinical data were collected for analysis.x2 test,t test and non parametric test were used in the study.Result One hundred and eighty-one pediatric cases of blood stream infection caused by Streptococcus agalactiae were included in current study.Eighty-six cases (47.5%) were male,and with age range from one day to 9 years (media 13 days).Thirty cases (16.6%) were premature infants and 127 cases (70.2%) were born via vaginal delivery.Seventy-one cases (39.2%) had early onset (< 7 d) infections,and 106 cases (58.6%) had late onset (7-89 d) infections.Seventy-eight cases (43.1%) were complicated with purulent meningitis.Incidences of vaginal delivery(81.7% (58/71) vs.62.3% (66/106)),shortness of breath moaning (43.7% (31/71) vs.15.1% (16/106)) and preterm premature rupture of membranes (25.4% (18/71) vs.3.8% (4/106)) were higher in the early onset infection group compared with the late onset group(P all < 0.05).However,the number of cases who had fever(25.4% (18/71) vs.85.8% (91/106)) and complicated with purulent meningitis (29.6% (21/71) vs.53.8% (57/106)) in early onset infections group was less than that in the late onset group(P both <0.05).The blood cultures of most patients (87.8%) were performed before the use of antibiotics.Drug-resistant tests showed that the sensitive rates to penicillin G,ceftriaxone and cefotaxime were 98.9%,99.0% and 99.0% respectively.All strains were sensitive to vancomucine.The rates of resistance to clindamycin and erythromycin were 68.0% and 34.0%,respectively.Only 39 cases (22.0%) were treated with single antibiotics of either penicillins or cephalosporins,80 cases (45.2%) were treated with antibiotics containing β lactamase inhibitor,61 cases (34.5%) were treated with either meropenem or cefoperazone

  11. A multi-center survey of childhood asthma in Turke--I: the cost and its determinants.

    Science.gov (United States)

    Beyhun, Nazim E; Soyer, Ozge U; Kuyucu, Semanur; Sapan, Nihat; Altintaş, Derya U; Yüksel, Hasan; Anlar, Fehmi Y; Orhan, Fazil; Cevit, Omer; Cokuğras, Haluk; Boz, Ayşen B; Yazicioğlu, Mehtap; Tanaç, Remziye; Sekerel, Bülent E

    2009-02-01

    Successful management of childhood asthma requires a thorough idea of the economic impact of asthma and its determinants, as policy makers and physicians inevitably influence the outcome. The aim of this study was to define the cost of childhood asthma in Turkey and its determinants. In April 2006, a multi-center, national study was performed where data regarding cost and control levels were collected. Asthmatic children (6-18 yr) with at least a 1-yr follow-up seen during a 1-month period with scheduled or unscheduled visits were included. The survey included a questionnaire-guided interview and retrospective evaluation of files. Cost and its determinants during the last year were analyzed. A total of 618 children from 12 asthma centers were surveyed. The total annual cost of childhood asthma was US$1597.4 +/- 236.2 and there was a significant variation in costs between study centers (p < 0.05). Frequent physician visits [odds ratio (95% confidence intervals)] [2.3 (1.6-3.4)], hospitalization [1.9 (1.1-3.3)], asthma severity [1.6 (1.1-2.8)], and school absenteeism due to asthma [1.5 (1.1-2.1)] were major predictors of total annual costs (p < 0.05 for each). The comparable cost of asthma among Turkish children with that reported in developed countries suggests that interventions to decrease the economic burden of pediatric asthma should focus on the cost-effectiveness of anti-allergic household measures and on improving the control levels of asthma.

  12. 术前放化疗并手术治疗局部晚期食管鳞癌的多中心随机对照临床研究%A multi-centered randomized controlled study of neo-adjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of esophagus:an interim analysis

    Institute of Scientific and Technical Information of China (English)

    杨弘; 毛伟敏; 郑晓; 朱成楚; 孔敏; 韩泳涛; 李涛; 傅剑华; 刘孟忠; 方文涛; 王家明; 陈于平; 陈志坚; 相加庆; 杨焕军

    2012-01-01

    significantly different.The incidence of pulmonary infection in arm A was slightly higher than that in arm B (8.2% vs 1.4%,P=0.094).No perioperative deaths occurred in either group.There were no significant differences in overall survivals at 1,2 years between arms A and B(85.6%/75.5% vs 79.1%/66.1%,P =0.207).The disease-free survivals at 1,2 years in arm A were slightly higher than in arm B (86.6%/83.2% vs 70.9%/61.8%,P =0.075 ).Conclusion Neo-adjuvant chemoradiation followed by surgery may achieve a high clinical response rate and pathologic complete tumor regression rate.It significantly increases the RO resection rate and downstage the esophageal cancer patients.But its ultimate efficacy awaits further follow-up studies.%目的 评价术前放化疗并手术治疗局部晚期食管癌的安全性与近期疗效.方法 开展多中心前瞻性随机对照临床研究,入组ⅡB、Ⅲ期胸段食管鳞癌患者,随机分组为试验组(术前放化疗组)与对照组(单纯手术组).试验组术前放化疗方案:去甲长春花碱联合顺铂化疗,同期采用常规分割放疗2.0 Gy/d,每周5d,总量40 Gy.放化疗结束4~6周后,施行三切口食管癌切除术.对照组患者直接接受手术.主要终点观测指标是总生存.结果 2007年7月1日至2011年6月1日,7个试验中心共入组患者123例,随机分组为试验组54例,对照组69例.试验组术前放化疗的临床有效率90.7%,49例进一步接受手术.试验组的RO切除率高于对照组(96.0%比85.5%,P=0.015),病理完全缓解率为29.6%.术前放化疗引起的3度以上急性毒性反应最常见是白细胞减少,达33例(61.1%),食管炎与呕吐也比较常见,多为1~2度,无术前放化疗的毒副反应导致无法手术或死亡.试验组与对照组的手术时间、术中出血量、胸管留置时间、术后住院时间差异无统计学意义.主要术后并发症,包括心功能不全、吻合口漏、声嘶、肺部感染发生率的发生

  13. Interaction of iron deficiency anemia and hemoglobinopathies among college students and pregnant women: a multi center evaluation in India.

    Science.gov (United States)

    Mohanty, Dipika; Gorakshakar, Ajit C; Colah, Roshan B; Patel, Ramesh Z; Master, Dilip C; Mahanta, J; Sharma, Santanu K; Chaudhari, Utpal; Ghosh, Malay; Das, Sheila; Britt, Reitt P; Singh, Shawinder; Ross, Cecil; Jagannathan, Lata; Kaul, Rajni; Shukla, Deepak K; Muthuswamy, Vasantha

    2014-01-01

    Although iron deficiency anemia is very common in India, systematic large studies on the prevalence and hematological consequences of iron deficiency among carriers of β-thalassemia (β-thal) and other hemoglobinopathies are lacking. A multi center project was undertaken to screen college/university students and pregnant women for iron deficiency anemia and various hemoglobinopathies. Fifty-six thousand, seven hundred and seventy-two subjects from six states, Maharashtra, Gujarat, Karnataka, West Bengal, Assam and Punjab, were studied. Iron deficiency anemia was evaluated by measuring zinc protoporphyrin (ZPP) and hemoglobin (Hb) levels, while β-thal and other hemoglobinopathies were detected by measuring the red cell indices and by Hb analysis using high performance liquid chromatography (HPLC). College boys (2.2%), college girls (14.3%) and antenatal women (27.0%) without any hemoglobinopathies had iron deficiency anemia. Among the β-thal carriers, the prevalence of iron deficiency anemia was 17.3% in college boys, 38.1% in college girls and 55.9% in pregnant women, while in the Hb E [β26(B8)Glu→Lys; HBB: c.79G>A] carriers, it was 7.3% in college boys, 25.4% in college girls and 78.0% in antenatal women. In individuals with Hb E disease, the prevalence of iron deficiency anemia varied from 31.2-77.3% in the three groups. A significant reduction in Hb levels was seen when iron deficiency anemia was associated with hemoglobinopathies. However, the Hb A2 levels in β-thal carriers were not greatly reduced in the presence of iron deficiency anemia.

  14. A Chinese multi-center study on the significance of monitoring imatinib plasma concentration in patients with gastrointestinal stromal tumor before and after administration%胃肠间质瘤患者服药前后监测伊马替尼血浆浓度意义的中国多中心研究

    Institute of Scientific and Technical Information of China (English)

    徐皓; 于吉人; 王永庆; 孙鲁宁; 杨力; 张殿彩; 李沣员; 支小飞; 王吉伟; 徐江浩; 徐泽宽; 马利林; 徐为; 管文贤; 汪宝林; 李国立; 苗永昌; 李乐平; 陈环球

    2016-01-01

    显示,每日剂量为400 mg的患者伊马替尼血浆浓度与白细胞计数呈负相关(R2=0.103,P=0.013),与血浆丙氨酸转移酶(ALT)浓度呈正相关(R2=0.076, P=0.033)。结论体表面积较大、行胃大部切除术或全胃切除术的患者伊马替尼血浆浓度可能较低,对该类患者可考虑适量加大伊马替尼的给药剂量,以达到有效的血浆浓度。而患者伊马替尼的血浆浓度过高会造成白细胞计数降低和肝功能损伤等不良反应。因此,监测伊马替尼血浆水平,适时调整伊马替尼剂量,将伊马替尼血浆浓度稳定维持在有效且安全的范围对临床获得最佳的治疗效果有重要意义。%Objective To investigate the factors which may influence the imatinib plasma concentration in Chinese patients with gastrointestinal stromal tumor (GIST), and to illuminate the significance of monitoring imatinib plasma concentration in adjuvant therapy for patients with GIST. Methods A cross-sectional study with 60 GIST patients who accepted the imatinib therapy after surgery was conducted. They were respectively administrated in 10 domestic hospitals from December 2014 to April 2016, including The First Affiliated Hospital of Nanjing Medical University (n = 28), The Affiliated Hospital of Nantong University(n=9), The Affiliated Hospital of Xuzhou Medical College(n=6), Nanjing Drum Tower Hospital (n = 5), The Second Affiliated Hospital of Nanjing Medical University (n=2), Jingling Hospital (n=2), The Second People′s Hospital of Lianyungang (n=2), Shandong Provincial Hospital(n=2), Jiangsu Province Tumor Hospital(n=2), and The First Affiliated Hospital of Zhejiang University (n=2). Some specific time points for collecting blood sample before and after taking imatinib were determined, then liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used for monitoring imatinib plasma concentration in patients with GIST. Linear regression analysis was used for the

  15. [Clinical studies on pramipexol retard].

    Science.gov (United States)

    Klivényi, Péter; Vécsei, László

    2010-05-30

    Pramipexol retard is the newest drug for the treatment of Parkinson's disease. The prolonged release of the agent in this preparation allows a more continuous dopaminergic stimulation than previous preparations, without reducing the agent's already known and proven clinical efficiency. In addition, it has a more favourable adverse effect profile than previous preparations, and patient compliance can also be better as it needs to be taken only once daily. These benefits have been proven in recent clinical studies, of which the most important ones are reviewed here.

  16. Multi-center retrospective study of single-port and multi-port video-assisted thoracoscopic anatomic lobectomy and segmentectomy%单孔和多孔胸腔镜肺叶、肺段切除术多中心回顾性分析

    Institute of Scientific and Technical Information of China (English)

    吉春宇; 项杨威; 章雪飞; 王喆歆; 冯键; 方文涛

    2016-01-01

    Objective To assess the feasibility and perioperative outcomes of single-port and multi-port video-assisted thoracoscopic anatomic lobectomy and segmentectomy.Methods The clinical data of 458 patients undergoing video-assisted thoracoscopic anatomic lobectomy or segmentectomy in Shanghai Chest Hospital affiliated to Shanghai Jiaotong University, Affiliated Hospital of National Taiwan University, University of HongKong Queen Mary Hospital,Shenzhen Hospital and Korea University Guro Hospital between 2013 and 2014 were retrospectively analyzed.Patients were divided into single-port thoracoscopic group and multi-port(including 2-port, 3-port and 4-port) thoracoscopic group according to surgical approaches.The parameters of duration of operation,volume of blood loss during operation,conversion of surgical approach,number and stations of lymph nodes harvested,postoperative chest tube drainage time, volume of chest tube drainage, postoperative hospitalization time, incidence of hospital readmission, perioperative morbidity and mortality,and pain score within 3 days after operation were compared between two groups.Results There was no significant difference in the number and stations of lymph nodes harvested, incidence of hospital readmission,postoperative morbidity and mortality,and pain score on the third day after operation between two group(P>0.05).The duration of operation and volume of blood loss during operation in single-port group were significantly longer or larger than those in multi-port group(t=2.039,P =0.042;χ2 =23.534,P <0.001) The pain scores on the first day and second day after operation in single-port group were significantly lower than those in multi-port group(χ2 =9.959,P =0.002;χ2 =11.971,P <0.0001)5). Conclusions Single-port video-assisted thoracoscopic anatomic lobectomy and segmentectomy is a safe and feasible approach,which has less surgical trauma and postoperative pain than the traditional multiple-port approach.%目的:分析和比较单

  17. 一步核酸扩增仪术中诊断乳腺癌前哨淋巴结转移的前瞻性、多中心临床观察%Prospective multi-center study of one-step nucleic acid amplification assay for the detection of sentinel lymph nodes metastases in breast cancer patients

    Institute of Scientific and Technical Information of China (English)

    王永胜; 欧阳涛; 吴炅; 刘艳辉; 曹旭晨; 孙晓; 付丽; 廖宁; 杨文涛

    2013-01-01

    Objective To evaluate the roles of Sysmex RD100i one-step nucleic acid amplification (OSNA) assay in the intraoperative assessments of breast cancer sentinel lymph nodes (SLNs).Methods A total of 552 consecutive prospective patients were enrolled from five centers nationwide from February to December 2010.And SLNs were sliced into alternating 2 mm blocks.The odd blocks were tested by the OSNA assay intraoperatively and the even ones assessed by postoperative histology.In addition,intraoperative histological assessments were performed on the even blocks of 211 patients by frozen section and all blocks by touch imprint cytology.Results A total of 1188 SLNs were removed.The mean turnaround time of the assay was 37.3 min.Thcrc was no significant difference of turnaround time at each center (P =0.074).As compared to postoperative histology,the overall performance of the assay had an accuracy of 91.4% (1086/1188),a sensitivity of 83.7% (159/190) and a specificity of 92.9% (927/998).The sensitivity of the assay was higher than frozen section (77.6% (59/76) vs 69.7% (53/76),P =0.286) and was significantly higher than touch imprint cytology (83.6% (158/189) vs 76.2% (144/189),P =0.044).For nodes with micro-metastases,the sensitivity of the assay was higher than frozen section (8/17 vs 4/17,P =0.289) and was significantly higher than touch imprint cytology (62.5% (30/48) vs 35.4% (17/48),P = 0.007).Conclusion As an accurate and rapid intraoperative assay for assessing breast SLNs,the OSNA assay may replace frozen section and touch imprint cytology for clinical applications.%目的 评估应用一步核酸扩增(OSNA)技术进行乳腺癌前哨淋巴结(SLN)术中检测诊断的价值.方法 共入组2010年2至12月全国5个乳腺病中心的552例原发性乳腺癌患者,术中将SLN根据其质量及短轴长度进行切分后,行OSNA检测和印片细胞学检测,术后行逐层切片病理检测.另外,211例患者术中同时行快速冰

  18. A multi-center retrospective study of organ involvement in adult patients with polymyositis or dermatomyositis%成人多发性肌炎和(或)皮肌炎多器官损害多中心回顾性研究

    Institute of Scientific and Technical Information of China (English)

    赵千子; 王国春; 刘湘源; 张江林; 穆荣; 左晓霞; 李小峰; 武丽君; 巩路

    2014-01-01

    Objective To explore the prevalence and characteristics of main organ involvement in adult patients with polymyositis (PM) or dermatomyositis (DM) and determine their specific relative factors.Methods Using unified questionnaire,we retrospectively collected the medical records of 1 387 confirmed adult PM/DM patients from 2007 to 2012 at 22 rheumatology centers in China.Statistical analyses were performed with chi-square or Fisher exact test and multivariate analyses with logistic regression.Results A total of 1 387 patients were collected with 460 (33.2%) PM and 927 (66.8%) DM.The female:male ratio was 2.4∶ 1.Their onset age was(47 ± 14) years.A total of 1 031 (74.3%) patients had organ involvement.The prevalence of pulmonary involvement,arthritis,gastrointestinal and cardiac involvement were 44.6%,32.3%,21.9% and 20.3% respectively.The multivariate analysis indicated that older onset age (P < 0.01) was positively associated with pulmonary involvement while myalgia (P <0.05) was negatively associated.Fever (P < 0.05),weight loss (P < 0.05) and Raynaud's phenomenon (P < 0.01) were positively associated with arthritis while muscle weakness (P < 0.05) negatively associated.Weight loss (P <0.05),Raynaud's phenomenon (P <0.01) and muscle weakness (P <0.05)were positively associated with gastrointestinal involvement.Weight loss (P < 0.05) and swollen limbs (P <0.05) were positively associated with cardiac involvement.Conclusion The prevalence of organ involvement is high in adult PM/DM patients.Our study may aid the diagnosis of organ damage in PM/DM patients.%目的 分析成人多发性肌炎(PM)和(或)皮肌炎(DM)主要器官损害的发生率和特点,并确定与其相关的特异性因素.方法 使用统一的调查表,回顾性收集2007至2012年在全国22个三级甲等医院风湿免疫科住院的符合纳入排除标准的1 387例成人PM和(或)DM患者的病例资料,并进行统计分析.结果 共收集1 387

  19. 广西地区中年打鼾者简单三参数筛查OSAHS的多中心研究%Simple three-variable screening tool for identification of patients with obstructive sleep apnea-hypopnea syndrome in middle-aged male snorers from Guangxi region: a multi-center study

    Institute of Scientific and Technical Information of China (English)

    潘凤锦; 刘建红; 谢宇萍; 雷志坚; 梁碧芳; 伍光腾; 周燕; 凌月福; 梁宪梅

    2015-01-01

    Objective To evaluate the correlation between three variables of neck circumference,body mass index (BMI) and Epworth sleepiness scale (ESS) and obstructive sleep apnea-hypopnea syndrome (OSAHS) and the value of three-variable screening tool among snorers in Guangxi region.Methods From May 2009 to June 2014,2 955 middle-aged consecutive patients with snoring were recruited from four hospitals of Guangxi Province.All subjects underwent polysomnography (PSG) and physical examinations including neck circumference,BMI and ESS.The diffrences of neck circumference,BMI and ESS were compared between OSAHS and non-OSAHS groups; the correlation between apnea-hypopnea index (AHI) and neck circumference,BMI and ESS were analyzed.The optimal cutoff point of three variables was selected by SPSS's Optimal Binning methods and screening score was assigned according to the Logistic regression coefficient.The recommended cutoff points were neck circumference ≥ 38.5 cm (3 points),BMI ≥ 25.7 kg/m2 (5 points),ESS ≥ 9 points (1 point) for males and neck circumference ≥ 34.5 cm (5 points),BMI ≥ 24.5 kg/m2 (2 points),ESS ≥ 7 points (1 points) for females.The best integral value was obtained through the receiver operating characteristic (ROC) curve.Results A total of 2 803 subjects fulfilled the study criteria.There were 2 366 males and 437 females.The average values of neck circumference,BMI and ESS were (38.7 ± 3.5) cm,(27.3 ± 3.6) kg/m2 and (8.6 ± 5.4) score respectively.Both males and females had a positive association between AHI and neck circumference,BMI and ESS (r =0.389,0.485,0.293,0.386,0.439 and 0.291 respectively,all P < 0.001).For males,at an integral value ≥6,the sensitivity was 71.4% in the diagnosis of OSAHS,specificity 65.5% and positive predictive value 91.1%.For females,at an integral value ≥3,the sensitivity was 73.3% in the diagnosis of OSAHS,specificity 63.6% and positive predictive value 66.3%.Conclusions In middle-aged snorers in

  20. CLINICAL STUDY OF ACUTE POISONING

    Directory of Open Access Journals (Sweden)

    Panduranga

    2014-09-01

    Full Text Available BACKGROUND AND OBJECTIVE: Acute poisoning is an important medical emergency. Studies of this nature will be useful tool in planning, early diagnosis and management of acute poisoning cases. The objective of the study are to study the clinical features, diagnosis and management, morbidity and mortality of various acute poisoning. METHODOLOGY: This study comprises of 350 patients of acute poisoning admitted to Chigateri General Hospital and Bapuji Hospital attached to J. J. M. Medical College, Davangere, between 1st March 2011 to 31st October 2011. REUSLTS: Out of 350 cases of acute poisoning studied, there were 268 males and 82 females. Males comprised 76.57%and females 23.42% of the total, in this series, Organophosphorous compounds were the commonest (30%, majority of the patients hailed from rural area 70%. Mortality is 10.57%.

  1. Heart rate awareness in patients with chronic stable heart failure. A multi-center observational study.

    LENUS (Irish Health Repository)

    Moran, D

    2014-08-23

    We assessed adherence to European Society of Cardiology heart rate guidelines (i.e. heart rates less than 70bpm) in patients with chronic stable heart failure. We also investigated the percent of patients on target doses of rate controlling drugs.

  2. Methods for identifying Neisseria meningitidis carriers: a multi-center study in the African meningitis belt.

    Directory of Open Access Journals (Sweden)

    Nicole E Basta

    Full Text Available Detection of meningococcal carriers is key to understanding the epidemiology of Neisseria meningitidis, yet no gold standard has been established. Here, we directly compare two methods for collecting pharyngeal swabs to identify meningococcal carriers.We conducted cross-sectional surveys of schoolchildren at multiple sites in Africa to compare swabbing the posterior pharynx behind the uvula (U to swabbing the posterior pharynx behind the uvula plus one tonsil (T. Swabs were cultured immediately and analyzed using molecular methods.One thousand and six paired swab samples collected from schoolchildren in four countries were analyzed. Prevalence of meningococcal carriage was 6.9% (95% CI: 5.4-8.6% based on the results from both swabs, but the observed prevalence was lower based on one swab type alone. Prevalence based on the T swab or the U swab alone was similar (5.2% (95% CI: 3.8-6.7% versus 4.9% (95% CI: 3.6-6.4% respectively (p=0.6. The concordance between the two methods was 96.3% and the kappa was 0.61 (95% CI: 0.50-0.73, indicating good agreement.These two commonly used methods for collecting pharyngeal swabs provide consistent estimates of the prevalence of carriage, but both methods misclassified carriers to some degree, leading to underestimates of the prevalence.

  3. Intravenous ketamine for the treatment of refractory status epilepticus: a retrospective multi-center study

    Science.gov (United States)

    Gaspard, Nicolas; Foreman, Brandon; Judd, Lilith M.; Brenton, James N.; Nathan, Barnett R.; McCoy, Blathnaid M.; Al-Otaibi, Ali; Kilbride, Ronan; Fernández, Ivan Sánchez; Mendoza, Lucy; Samuel, Sophie; Zakaria, Asma; Kalamangalam, Giridhar P.; Legros, Benjamin; Szaflarski, Jerzy P.; Loddenkemper, Tobias; Hahn, Cecil D.; Goodkin, Howard P.; Claassen, Jan; Hirsch, Lawrence J.; LaRoche, Suzette M.

    2013-01-01

    Summary Purpose To examine patterns of use, efficacy and safety of intravenous ketamine for the treatment of refractory status epilepticus (RSE). Methods Multicenter retrospective review of medical records and EEG reports in ten academic medical centers in North America and Europe, including 58 subjects, representing 60 episodes of RSE were identified between 1999 and 2012. Seven episodes occurred after anoxic brain injury. Key findings Permanent control of RSE was achieved in 57% (34/60) of episodes. Ketamine was felt to have contributed to permanent control (“possible” or “likely” responses) in 32% (19/60) including seven (12%) in which ketamine was the last drug added (likely responses). Four of the seven likely responses, but none of the 12 possible ones, occurred in patients with post-anoxic brain injury. No likely responses were observed when infusion rates were lower than 0.9mg/kg/h; when ketamine was introduced at least eight days after SE onset; or after failure of seven or more drugs. Ketamine was discontinued due to possible adverse events in five patients. Complications were mostly attributed to concurrent drugs, especially other anesthetics. Mortality rate was 43% (26/60), but was lower when SE was controlled within 24h of ketamine initiation (16% vs. 56%, p=0.0047). Significance Ketamine appears to be a relatively effective and safe drug for the treatment of RSE. This retrospective series provides preliminary data on effective dose and appropriate time of intervention to aid in the design of a prospective trial to further define the role of ketamine in the treatment of RSE. PMID:23758557

  4. Personality traits affect teaching performance of attending physicians : Results of a multi-center observational study

    NARCIS (Netherlands)

    Scheepers, Renée A.; Lombarts, Kiki M J M H; Van Aken, Marcel A G; Heineman, Maas Jan; Arah, Onyebuchi A.

    2014-01-01

    Background: Worldwide, attending physicians train residents to become competent providers of patient care. To assess adequate training, attending physicians are increasingly evaluated on their teaching performance. Research suggests that personality traits affect teaching performance, consistent wit

  5. Economic consequences incurred by living kidney donors: a Canadian multi-center prospective study.

    Science.gov (United States)

    Klarenbach, S; Gill, J S; Knoll, G; Caulfield, T; Boudville, N; Prasad, G V R; Karpinski, M; Storsley, L; Treleaven, D; Arnold, J; Cuerden, M; Jacobs, P; Garg, A X

    2014-04-01

    Some living kidney donors incur economic consequences as a result of donation; however, these costs are poorly quantified. We developed a framework to comprehensively assess economic consequences from the donor perspective including out-of-pocket cost, lost wages and home productivity loss. We prospectively enrolled 100 living kidney donors from seven Canadian centers between 2004 and 2008 and collected and valued economic consequences ($CAD 2008) at 3 months and 1 year after donation. Almost all (96%) donors experienced economic consequences, with 94% reporting travel costs and 47% reporting lost pay. The average and median costs of lost pay were $2144 (SD 4167) and $0 (25th-75th percentile 0, 2794), respectively. For other expenses (travel, accommodation, medication and medical), mean and median costs were $1780 (SD 2504) and $821 (25th-75th percentile 242, 2271), respectively. From the donor perspective, mean cost was $3268 (SD 4704); one-third of donors incurred cost >$3000, and 15% >$8000. The majority of donors (83%) reported inability to perform usual household activities for an average duration of 33 days; 8% reported out-of-pocket costs for assistance with these activities. The economic impact of living kidney donation for some individuals is large. We advocate for programs to reimburse living donors for their legitimate costs.

  6. [Shared web-based data center for multi-institutional clinical trials: evaluation of UMIN-INDICE (university hospital medical information network-internet data and information center for medical research)in clinical trials of JIVROSG (Japan interventional radiology in oncology study group)].

    Science.gov (United States)

    Sone, Miyuki; Arai, Yasuaki; Kiuchi, Takahiro; Ishikawa, Hirono; Aoki, Noriaki; Inaba, Yoshitaka; Yoshioka, Tetsuya; Aramaki, Takeshi; Kobayashi, Takeshi; Matsuoka, Toshiyuki; Anai, Hiroshi; Tanigawa, Noboru; Osuga, Keigo; Takeuchi, Yoshito; Okusaka, Takushi; Kanazawa, Susumu; Matsui, Osamu; Endo, Keigo

    2012-04-01

    A patient registration system is mandatory for establishing the scientific credibility of the multi-center clinical trials. The Japan Interventional Radiology in Oncology Study Group (JIVROSG) was organized in 2002 to establish evidence supporting the procedures used in interventional radiology. The Internet Data and Information Center for Medical Research (INDICE), provided by the University Hospital Medical Information Network(UMIN), has been utilized for patient registration in the clinical trials of JIVROSG. In this study, the safety and efficacy of UMIN-INDICE were evaluated. From 2002 to 2010, 18 clinical trials, including one international trial, were conducted. A total of 736 patients were enrolled from 51 institutions. No significant trouble was encountered during this period. A questionnaire survey demonstrated that 90% of participating researchers could use this system without difficulties. UMIN-INDICE may contribute to promoting clinical trials as an infrastructure of multicenter studies.

  7. CLINICAL STUDY OF ECTOPIC PREGNANCY

    Directory of Open Access Journals (Sweden)

    Swami

    2015-10-01

    Full Text Available An ectopic pregnancy is one in which fertilized ovum is implanted at the site other than normal uterine cavity.[1] Incidence of ectopic pregnancy is 1:160 deliveries.[2] Clinical presentation is variable from acute to chronic type. Due to its varied clinical presentation ectopic pregnancy poses great diagnostic difficulty both to obstetrician, physician and surgeons.[3] OBJECTIVE: To find out incidence in our study population and to evaluate symptomatically and clinical presentation in these patients. MATERIALS AND METHODS: Retrospective study of 34 ectopic pregnancies admitted and treated in Medical College hospital, Ujjain from 2010 to 2015 are included in the study. RESULTS: The incidence of ectopic pregnancy is more between the age group of 21-30years (73.52% and in Multigravida 64.71%. Infertility and previous tubal surgery are the high risk factors for tubal pregnancy. Pain in abdomen was present in all 34 cases, amenorrhea in 97.05% and bleeding per vagina in 76.47% cases. Syncopal attacks, vomiting were detected in 14.70% cases. Acute ectopic pregnancy was detected in 14.71% and chronic in 85.29% cases. 82.35% cases presented with adnexal mass, 79.41% with cervical motion tenderness, 50% with pallor, 32.35% with abdominal lump and tenderness and 11.76% with fullness in POD. CONCLUSION: Ectopic pregnancy is leading cause of maternal mortality in first trimester. In spite of advanced diagnostic techniques. It poses great diagnostic difficulties due to varied signs and symptoms. Previous tubal surgery pelvic inflammatory disease and infertility are the risk factors of tubal pregnancy.

  8. CLINICAL STUDY ON ACUTE PANCREATITIS

    Directory of Open Access Journals (Sweden)

    Suhaib Rehaman

    2015-07-01

    Full Text Available INTRODUCTION : Early diagnosis and severity evaluation on patients with acute pancreatitis are very important due to its potential morbidity and mortality. Given the wide spectrum of disease seen, the care of patients with pancreatitis must be highly individualized. Sev eral clinical, laboratory and radiologic factors and many scoring systems have been proposed for outcome prediction. AIMS AND OBJECTIVES: To study the symptomatology, clinical presentation and management in pancreatitis . To study the severity of acute panc reatitis according to Glasgow Scale . METHODS: Present study includes consecutive 38 patients hospitalized in CSI Holdsworth Memorial Hospital over the period of 2 years. All patients were thoroughly investigated and were stratified according to the Glasgow criteria. Data was collected on complications, investigations and interventions undertaken, outcome, duration of stay in hospital and ICU. STATISTICAL ANALYSIS USED: Descriptive, Chi square tests, Crosstabs (Contingency coefficient analysis . RESULTS : Mean age of presentation in our study was 43.1 years. There was a male predominance accounting for 68.4% compared to 31.6% females. Alcohol was the main etiological factor in about 50% of the patients. Sensitivity to S. amylase was about 100%. Accuracy of USG abdomen in diagnosing pancreatitis was about 88.5%. Ascitis was the commonest complication seen in 13.2%. Mean duration of hospital stay was 6.2 days. The patient were stratified according to Glasgow scoring system into mild (0 - 3 and severe (>3 panc reatitis. In our study 32 people were graded with mild pancreatitis, all improved and in 6 people who were graded with severe pancreatitis, 83.3 % improved and 2.6% expired because of complications. Test statistics showed Contingency coefficient 0.355 and P 0.019 (NS. CONCLUSION : Glasgow scoring system remains a valid predicting system for the outcome in patients with acute pancreatitis. It is simple easy to apply with

  9. Clinical study: assessing the performance and skin environments of two reusable underpads.

    Science.gov (United States)

    Leiby, D M; Shanahan, N

    1994-10-01

    The authors wanted to compare the performance and skin environment provided by a recently introduced reusable underpad (Test Group underpad) to an underpad already well established in the absorbent products market (Reference Group underpad). A controlled, prospective, randomized multi-centered clinical trial was conducted in 18 facilities (6 hospitals, 7 home health agencies, and 5 skilled nursing facilities) and completed by 107 patients. The majority of the patients had a Braden score near 13, were 70 to 80 years of age, and weighed 130 to 138 lbs. The Test Group underpad ranked more favorably overall and in all eight categories of daily assessment. These differences were statistically significant (p Skin Dry, Keeping Clothing Dry, No Pooling of Fluid, and Patient Comfort. The Test Group underpad also ranked more favorably with statistical significance (p assessment categories at the conclusion of the study: Pad Absorbency, Pad's Ability to Wick Moisture, and Pad's Ability to Keep Skin Dry. Investigators also noted that 57 patients (53%) exhibited some measure of improvement by the end of the study. Of these, 45 (79%) had been assigned to the Test Group. The Test Group underpad demonstrated better absorbency, kept patients' skin, clothing and bed linens drier, exhibited less pooling of fluid and resulted in higher patient comfort. As a result, it may have contributed to a more beneficial skin environment, allowing for prevention of preexisting skin integrity problems and enhancement of healing.

  10. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development ...

  11. CLINICAL STUDY OF ANORECTAL MALFORMATIONS

    Directory of Open Access Journals (Sweden)

    Umesh

    2015-01-01

    Full Text Available BACKGROUND: A norectal malformations are relatively encountered anomalies. Presentations may vary from mild to severe and bowel control is t he main concern. AIM: To study the modes of presentation , types of anomalies , associated anomalies , reliability of clinical signs and radiological investigations in the diagnosis and the prognosis and continence in the post - operative in relation to type of anomaly and associated anomaly (s. MATERIAL AND METHODS: 50 cases of anorectal malformations admit ted to Department of Paediatric Surgery , in Medical Coll ege and Research Institute , were included in the study. Data related to the objectives of the study were collected. RESULTS: Commonest mode of presentation was failure to pass meconium 50%. 59% of mal es had high anomalies , while 53% females had intermediate anomalies. The diagnosis of low anomaly was made clinically , while high and intermediate anomalies needed further investigations. Associated anomalies were noted in 46.6% of the cases. 71.42% of the se patients had either a high or intermediate ARM. All patients with high anomalies underwent a 3 stage procedure , while low anomalies underwent a single stage procedure followed by anal dilatations. Rectal mucosal prolapse (2 cases , wound infection (4 ca ses , stenosis (3 cases , retraction of neo anus (1 case was seen. All the patients with low anomalies had a good functional result post operatively , while 57% and 28% of patients with intermediate and high anomalies had good results. CONCLUSION : Anorectal malformations are common congenital anomalies. Males are more commonly affected (1.3:1. Low anomalies are the commonest lesions noted in both the sexes (36.67%. High anomalies are more frequent in males. Invertogram offer an accurate diagnosis for planning management in patients with anorectal malformations. Low anomalies have a better outcome following surgery. For intermediate and high anomalies a staged repair offers better results

  12. A clinical study of vitiligo

    Directory of Open Access Journals (Sweden)

    Martis Jacintha

    2002-01-01

    Full Text Available A clinical study of one hundred patients having vitiligo revealed the incidence among new patients to be 1.84%. The male/female ratio was 1:1.22. Family history of vitiligo was available in 8% of our patients. The different morphological pattern consisted of vitiligo vulgaris (39 cases, focal vitiligo (27 cases, acrofacial vitiligo (18 cases, lip - tip vitiligo (7 cases, lip vitiligo (5 cases, segmental vitiligo (3 cases and universal vitiligo (1 case. Associated diseases include atopic dermatitis (2 cases, Hansen s disease (2 cases, alopecia areata (1 case, halo naevus (1 case, chronic urticaria (1 case, lichen planus (1 case, diabetes mellitus (9 cases, hypertension (4 cases, hypothyroidism (2 cases, epilepsy (1 case and IHD (1 case.

  13. New developments in the conduct and management of multi-center trials

    DEFF Research Database (Denmark)

    Gluud, C; Sørensen, T I

    1995-01-01

    There is an urgent need for the performance of more, better designed, and better managed randomized clinical trials. After visits to 43 leading organizations and units involved in clinical trials in Europe and North America during 1993, the way of conducting randomized clinical trials was analyze...... and data management systems). By employing such developments, randomized clinical trials can run much more efficiently. This facilitates faster and better answers to the questions addressed by randomized clinical trials, thereby also making them more ethical.......There is an urgent need for the performance of more, better designed, and better managed randomized clinical trials. After visits to 43 leading organizations and units involved in clinical trials in Europe and North America during 1993, the way of conducting randomized clinical trials was analyzed....... By using a structured questionnaire, information on recent improvements in the way randomized clinical trials are performed was identified. These developments encompass human aspects (better information, collaboration, and communication) as well as non-human aspects (press button phone randomization...

  14. Clinical study of ectopic pregnancy.

    Science.gov (United States)

    Chhabra, S; Aher, K; Jaiswal, M

    1992-01-01

    Ectopic pregnancy remains a leading cause of maternal mortality and accounts for a sizeable proportion of infertility and ectopic recurrence. The possibility that a woman is experiencing an ectopic pregnancy must be considered when evaluating a woman, especially a sterilized woman, who has a possible pregnancy, amenorrhea, abdominal pain, or abnormal bleeding; studies have found that one in six pregnancies occurring after tubal sterilization are ectopic. The authors present a clinical study of 82 cases of ectopic pregnancy admitted to the department of Obstetrics and Gynecology of Mahatma Gandhi Institute of Medical Sciences, Sevagram. Cases of ectopic pregnancy represent 0.99% of total obstetric admissions, of whom 69.51% were diagnosed as such on admission. 40.24% of the women were older than 30 years, while 34.14% were elderly beyond third parity. 70.73% of the women presented before missing their second period. Patients presented with multiple complaints, but the most common was abdominal pain reported by 61.70%. 78.04% were admitted with an acute abdomen, but shock was present in only 7.14% of cases. The main surgical treatment modality was salpingectomy among 59.75%. There was no maternal mortality through postoperative morbidity in the form of paralytic ileus, although fever did occur in some women.

  15. A Randomized, Double-blind, Placebo-controlled, Multi-center, Extension Trial Evaluating the Efficacy of a New Oral Supplement in Women with Self-perceived Thinning Hair

    OpenAIRE

    Ablon, Glynis; Dayan, Steven

    2015-01-01

    Objective: The purpose of this six-month, randomized, double-blind, multi-center, placebo-controlled study was to determine if the administration of a new oral supplement will promote terminal hair growth. Design: A randomized, double-blind study. Setting: Two private practices (dermatology and facial plastics). Participants: Women 21 to 75 years of age with self-perceived thinning hair. Measurements: The primary efficacy endpoint was the change in terminal and vellus hairs in a 4cm2 target a...

  16. A clinical study of retinoblastoma

    Directory of Open Access Journals (Sweden)

    L Subha

    2015-01-01

    Full Text Available Aim: The aim was to analyze general incidence, age incidence, laterality, common mode of presentation, staging of the tumor, radiological evidence, histopathological confirmation, management and follow-up of cases, which were diagnosed as retinoblastoma. Design: Interventional case series study from April 1997 to March 2000. Materials and Methods: Detailed history regarding the symptoms such as white reflex, watering, pain, redness, protrusion of eyeball, squint, hyphema, and defective vision were obtained. Family history regarding consanguinity between parents, health of the siblings and other relatives were recorded. Ocular examination included vision, pupillary reaction, detailed fundus examination, ocular tension, and corneal diameter. Investigations included X-ray orbit and skull, computed tomography scan orbit and brain, B-scan orbit, serum and aqueous lactate dehydrogenase; enucleated eyes were subjected to holoprosencephaly (HPE. Enucleation, radiotherapy, cryotherapy and chemotherapy were modalities of treatment. The empty socket and the other apparently normal eye were examined carefully at each visit. Results: The incidence of retinoblastoma is less when compared to other diseases of the eye. There was no sex predilection. Most of the cases diagnosed were sporadic and unilateral. Age of onset is earlier for bilateral cases than unilateral cases. Consanguinity bears close relationship with bilateral involvement. Predominant clinical sign is white reflex in the pupillary area. Majority of cases presented in the second stage of the disease. Enucleation plays a greater role in the management of retinoblastoma. HPE should include several sections of the optic nerve to find out skip lesions.

  17. Our experience and commentaries on improving clinical laboratory services in China%有关提高我国临床分子医学检验水平的探索和感想

    Institute of Scientific and Technical Information of China (English)

    包黎明

    2006-01-01

    @@ The Sino-US Joint Clinical and Molecular Laboratory (JCML) is a comprehensive clinical research laboratory with main focus on study of hematopoetic diseases including myelodysplastic syndrome, leukemias and lymphomas. The JCML is located in the Shanghai Medical College of Fudan University (formerly Shanghai Medical University) in Shanghai, China and was established as part of a large multi-center, international study of benzene health effect in China that is sponsored by the international consortium on benzene health effect.

  18. Innovative measures to combat rare diseases in China: The national rare diseases registry system, larger-scale clinical cohort studies, and studies in combination with precision medicine research

    Science.gov (United States)

    Song, Peipei; He, Jiangjiang; Li, Fen; Jin, Chunlin

    2017-01-01

    Summary China is facing the great challenge of treating the world's largest rare disease population, an estimated 16 million patients with rare diseases. One effort offering promise has been a pilot national project that was launched in 2013 and that focused on 20 representative rare diseases. Another government-supported special research program on rare diseases – the “Rare Diseases Clinical Cohort Study” – was launched in December 2016. According to the plan for this research project, the unified National Rare Diseases Registry System of China will be established as of 2020, and a large-scale cohort study will be conducted from 2016 to 2020. The project plans to develop 109 technical standards, to establish and improve 2 national databases of rare diseases – a multi-center clinical database and a biological sample library, and to conduct studies on more than 50,000 registered cases of 50 different rare diseases. More importantly, this study will be combined with the concept of precision medicine. Chinese population-specific basic information on rare diseases, clinical information, and genomic information will be integrated to create a comprehensive predictive model with a follow-up database system and a model to evaluate prognosis. This will provide the evidence for accurate classification, diagnosis, treatment, and estimation of prognosis for rare diseases in China. Numerous challenges including data standardization, protecting patient privacy, big data processing, and interpretation of genetic information still need to be overcome, but research prospects offer great promise.

  19. Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: the SMILE study.

    Science.gov (United States)

    Weisbord, Steven D; Shields, Anne Marie; Mor, Maria K; Sevick, Mary Ann; Homer, Marcia; Peternel, Janet; Porter, Patricia; Rollman, Bruce L; Palevsky, Paul M; Arnold, Robert M; Fine, Michael J

    2010-09-01

    Despite the high prevalence of pain, sexual dysfunction, and depression in patients on chronic hemodialysis, these symptoms are often unrecognized and under-treated by renal providers. This report describes the rationale and methodology of the SMILE study (Symptom Management Involving End-Stage Renal Disease), a multi-center, randomized clinical trial comparing the effectiveness of two strategies for implementing treatment for these symptoms in patients receiving chronic hemodialysis. Approximately 250 patients from nine outpatient dialysis units will participate. Over a 2-12 month observational phase, participants complete monthly surveys characterizing their pain, sexual dysfunction, and depression. Following this observational period, subjects are randomized to one of two study arms to receive a 12-month intervention. In one study arm (feedback intervention), patients continue to complete the same three symptom surveys, and the presence and severity of the symptoms reported on these surveys is mailed to the patient's renal provider along with evidence-based algorithms outlining treatment options for these symptoms. Decisions on treatment are left at the discretion of the provider. Patients randomized to the other study arm (management intervention) also continue to complete the same monthly symptom surveys and are evaluated by a symptom management nurse trained in the management of these symptoms. This nurse then discusses the patient's symptoms with the renal provider, provides specific recommendations for treatment, and facilitates the implementation of treatment. The primary endpoints are changes in scores on pain, erectile dysfunction, and depression surveys. This report describes the rationale and methodology of this clinical trial.

  20. Current State of Clinical Studies on Diagnosis and Treatment of Sudden Deafness in China

    Institute of Scientific and Technical Information of China (English)

    YU Yaping; YANG Shiming; GUO Wei; YANG Weiyan; GU Rui

    2006-01-01

    Objective To evaluate the current status of clinical studies on diagnosis and treatment of sudden deafness (SD) in China by retrospective reviewing articles on SD published in Chinese journals in the past 5 years.Special attention is given to whether the diagnosis and treatment standards established in 1996 by the otolaryngology branch of Chinese Medical Association (the"1996 standard") were followed. Methods The terms of "Sudden deafness" and "treatment" were used as the keywords in searching articles published between 2000 and 2004 in the Chinese biomedicine literature database and Chinese journal network. Principles of evidence-based medicine were applied in reviewing the articles. Results Two hundreds and thirty- four articles were identified, including 176 between 2000 and 2002 and 58 between 2003 and 2004. Among the 176 articles published between 2000 and 2002,effects of medications were studies in 126 articles, of which only 26 (20.6%) followed the"1996 standards".Eighty-nine (70.6%) were reported based on controlled clinical trials (CCT) and 36 (28.5%) met the criteria of randomized controlled trails (RCT). Of the 58 articles published between 2003 and 2004, drug effects were evaluated in 25 articles, which were all based on the "1996 standards". However, there lacked placebo control, follow-up data or statistical analysis in these papers. Only 6 articles reported side-effects from pharmacological treatment. Conclusions While a significant number of articles on SD were published in the past 5 years, the "1996 standards" were followed only in a small number of them. The standards may not be appropriate in guiding research and need to be modified for improved guidance to SD management. Multi-center, RCTs should be a crucial part in studies on SD.

  1. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial

    OpenAIRE

    Lewis Stephanie; Badlani Sameer; Dalapathi Vijay; Harris Vanessa; Ridge Alana; Bilderback Andrew; Hatipoğlu Umur; Diette Gregory B; Mahajan Amit K; Charbeneau Jeff T; Naureckas Edward T; Krishnan Jerry A

    2011-01-01

    Abstract Background High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD). Methods Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients receiv...

  2. Safety and effectiveness of minimally invasive sacroiliac joint fusion in women with persistent post-partum posterior pelvic girdle pain: 12-month outcomes from a prospective, multi-center trial.

    Science.gov (United States)

    Capobianco, Robyn; Cher, Daniel

    2015-01-01

    Postpartum posterior pelvic girdle pain (PPGP) affects nearly 20 % of women who experience back pain in the peripartum period. The sacroiliac joint is a source of this pain in 75 % of women with persistent PPGP. A subset of women will fail to obtain acceptable pain relief from the current array of non-surgical treatment options. The purpose of this study is to assess the safety and effectiveness of minimally invasive sacroiliac (SI) joint fusion in women with chronic SI joint dysfunction whose pain began in the peri-partum period whose symptoms were recalcitrant to non-surgical management. A sub-group analysis of subjects with sacroiliac joint disruption and/or degenerative sacroiliitis enrolled in a prospective, multi-center trial of SI joint fusion was performed. Subjects with PPGP were identified and compared with women without PPGP and with men. Of 172 enrolled subjects, 52 were male, 100 were females without PPGP and 20 females had PPGP. PPGP subjects were significantly younger (43.3 years, vs. 52.8 for females without PPGP and 50.5 for men, p = 0.002). There were no differences in any other demographic or baseline clinical measure. Women with PPGP experienced a significant improvement in pain (-51 mm on VAS), function (-20.6 pts on ODI) and quality of life (SF-36 PCS +10.4, MCS +7.2, EQ-5D +0.31) at 12 months after surgery. These improvements were characteristic of the overall study results; no difference was detected between sub-groups. The sacroiliac joint can be a source of pain in women with persistent PPGP and should be investigated as a pain generator. In this study, women with carefully diagnosed chronic SI joint pain from PPGP recalcitrant to conservative therapies experienced clinically beneficially improvements in pain, disability and quality of life after minimally invasive SI joint fusion using a series of triangular porous plasma spray coated implants.

  3. Gastric leptomeningeal carcinomatosis: Multi-center retrospective analysis of 54 cases

    Institute of Scientific and Technical Information of China (English)

    Sung Yong Oh; Su-Jin Lee; Jeeyun Lee; Suee Lee; Sung-Hyun Kim; Hyuk-Chan Kwon; Gyeong-Won Lee; Jung Hun Kang; In Gyu Hwang; Joung-Soon Jang; Ho Yeong Lim; Young Suk Park; Won Ki Kang; Hyo-Jin Kim

    2009-01-01

    AIM: To identify the clinical features and outcomes of infrequently reported leptomeningeal carcinomatosis (LMC) of gastric cancer.METHODS: We analyzed 54 cases of cytologically con- firmed gastric LMC at four institutions from 1994 to 2007.RESULTS: The male-to-female ratio was 32:22, and the patients ranged in age from 28 to 78 years (median,48.5 years). The majority of patients had advanced disease at initial diagnosis of gastric cancer. The clinical or pathologic tumor, node and metastasis stage of the primary gastric cancer was Ⅳ in 38 patients (70%).The median interval from diagnosis of the primary malignancy to the diagnosis of LMC was 6.3 mo, ranging between 0 and 73.1 mo. Of the initial endoscopic findings for the 45 available patients, 23 (51%) of the patients were Bormann type Ⅲ and 15 (33%) patients were Bormann type Ⅳ. Pathologically, 94% of cases proved to be poorly differentiated adenocarcinomas.Signet ring cell component was also observed in 40% of patients. Headache (85%) and nausea/vomiting (58%) were the most common presenting symptoms of LMC. A gadolinium-enhanced magnetic resonance imaging was conducted in 51 patients. Leptomeningeal enhancement was noted in 45 cases (82%). Intrathecal (IT) chemotherapy was administered to 36 patientsprimarily methotrexate alone (61%), but also in combination with hydrocortisone/± Ara-C (39%). The median number of IT treatments was 7 (range, 1-18). Concomitant radiotherapy was administered to 18 patients,and concomitant chemotherapy to seven patients. Seventeen patients (46%) achieved cytological negative conversion. Median overall survival duration from the diagnosis of LMC was 6.7 wk (95% CI: 4.3-9.1 wk). In the univariate analysis of survival duration, hemoglobin,IT chemotherapy, and cytological negative conversion showed superior survival duration ( P = 0.038, P = 0.010, and P = 0.002, respectively). However, in our multivariate analysis, only cytological negative conversion was predictive of

  4. A multiple correlation factors analysis of avascular necrosis after closed reduction and cannulated compression screws fixation of intra-capsular femoral neck fracture.A multi-center retrospective study%股骨颈骨折闭合复位加压螺纹钉内固定术后股骨头坏死多中心多因素相关分析

    Institute of Scientific and Technical Information of China (English)

    周锦春; 郭敦明; 王青; 陈哲峰; 崔维顶; 范卫民; 刘锋

    2013-01-01

    Objective To determine the incidence of avascular necrosis after closed reduction and cannulated compression screws fixation of intra-capsular femoral neck fracture and to investigate the multiple factors correlated to avascular femoral head necrosis.Methods All the patients of intra-capsular femoral neck fracture who accepted closed reduction and cannulated compression screws fixation between 2001 and 2010 in Jiangsu Province were reviewed in multi-centers retrospectively.The multiple factors were analyzed including age,gender,affected side,mechanism of injury,fracture classification,procedure delay,quality of reduction,time of full-weight-bearing,configuration of the screws and removal of the screws.Multiple correlation factors were analyzed with SPSS 13.0 statistic system.Results Complete case records were documented in 1849 cases who were followed up for an average 6.5±2.7 years (range,2-10 years).Avascular necrosis occurred in 246 cases (13.3%).The average time of diagnosis of avascular necrosis was 17±4.6months (range,8-72 months) after injury.The average Harris score of the hips which didn't develop to avascular necrosis was 93.8±8.9 (range,78~100) at the last follow up.Multiple correlation factors analysis indicated that displacement degrees of fracture and the quality of reduction were significantly correlated to the incidence of avascular necrosis (OR=2.078,3.423).Conclusion Closed reduction and cannulated compression screws fixation after the intra-capsular femoral neck fracture can get satisfactory results.Displacement degrees of fracture and the quality of reduction are significantly correlated to the incidence of avascular femoral head necrosis.%目的 调查股骨颈骨折闭合复位加压螺纹钉内固定术后股骨头坏死的发生率,探讨各影响因素与股骨头坏死的相关性.方法 对江苏地区2001至2010年期间接受闭合复位加压螺纹钉内固定治疗的股骨颈骨折患者进行回顾性调查.以股骨头坏

  5. Managing Multi-Center Recruitment in the PLCO Cancer Screening Trial.

    Science.gov (United States)

    Gohagan, John K; Broski, Karen; Gren, Lisa H; Fouad, Mona N; Higgins, Darlene; Lappe, Karen; Ogden, Sheryl; Shambaugh, Vicki; Pinsky, Paul F; O'Brien, Barbara; Yurgalevich, Susan; Riley, Tom; Wright, Patrick; Prorok, Philip C

    2015-01-01

    There were significant recruitment challenges specific to the PLCO Cancer Screening Trial. Large numbers of participants were to be randomized from ten catchment areas nationwide within time and budgetary constraints. The eligible population was elderly and had to meet health and behavioral thresholds. Informed consent was required to participate and be randomized to screening for three cancers at periodic clinic visits or to a usual care arm that included no clinical visits. Consenting required special efforts to fully explain the trial and its potential scientific benefit to future patients with potentially no benefits but possible harms to PLCO participants. Participation would include continued follow-up for at least 13 years after randomization. Strong collaborative investments were required by the NCI and screening centers (SCs) to assure timely recruitment and appropriate racial participation. A trial-wide pilot phase tested recruitment and protocol follow through at SCs and produced a vanguard population of 11,406 participants. NCI announced the trial nationally in advance of the pilot and followed with an even more intense collaborative role with SCs for the main phase to facilitate trial-wide efficient and timely recruitment. Special efforts to enhance recruitment in the main phase included centralized and local monitoring of progress, cross-linking SCs to share experiences in problem solving, centralized training, substantial additional funding dedicated to recruitment and retention, including specialized programs for minority recruitment, obtaining national endorsement by the American Cancer Society, launching satellite recruitment and screening centers, including minority focused satellites, and adding a new SC dedicated to minority recruitment.

  6. Asymptomatic moyamoya disease: literature review and ongoing AMORE study.

    Science.gov (United States)

    Kuroda, Satoshi

    2015-01-01

    Recent development of a non-invasive magnetic resonance examination has increased the opportunity to identify asymptomatic patients with moyamoya disease who have experienced no cerebrovascular events. However, their clinical features, prognosis, and treatment strategy are still unclear because of small number of subjects and short follow-up periods. Therefore, we have designed Asymptomatic Moyamoya Registry (AMORE) study in Japan. The objectives of this nation-wide, multi-center prospective study are to clarify long-term prognosis of asymptomatic patients with moyamoya disease and to determine the risk factors that cause ischemic and hemorrhagic stroke in them. In this article, we review the published data on asymptomatic moyamoya disease and report the on-going multi-center prospective cohort study, AMORE study. We would like to emphasize the importance to determine the clinical features, prognosis, and treatment strategies of asymptomatic moyamoya disease in very near future.

  7. [Adaptive clinical study methodologies in drug development].

    Science.gov (United States)

    Antal, János

    2015-11-29

    The evolution of drug development in human, clinical phase studies triggers the overview of those technologies and procedures which are labelled as adaptive clinical trials. The most relevant procedural and operational aspects will be discussed in this overview from points of view of clinico-methodological aspect.

  8. Multi-center MRI prediction models : Predicting sex and illness course in first episode psychosis patients

    NARCIS (Netherlands)

    Nieuwenhuis, Mireille; Schnack, Hugo G.; van Haren, Neeltje E.; Kahn, René S.; Lappin, Julia; Dazzan, Paola; Morgan, Craig; Reinders, Antje A.; Gutierrez-Tordesillas, Diana; Gutierrez-Tordesillas, Diana; Roiz-Santiañez, Roberto; Crespo-Facorro, Benedicto; Schaufelberger, Maristela S.; Rosa, Pedro G.; Zanetti, Marcus V.; Busatto, Geraldo F.; McGorry, Patrick D.; Velakoulis, Dennis; Pantelis, Christos; Wood, Stephen J.; Mourao-Miranda, Janaina; Mourao-Miranda, Janaina; Dazzan, Paola; Crespo-Facorro, Benedicto

    2017-01-01

    Structural Magnetic Resonance Imaging (MRI) studies have attempted to use brain measures obtained at the first-episode of psychosis to predict subsequent outcome, with inconsistent results. Thus, there is a real need to validate the utility of brain measures in the prediction of outcome using large

  9. [Clinical research III. The causality studies].

    Science.gov (United States)

    Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo

    2011-01-01

    The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.

  10. CLINICAL STUDY OF DUODENAL PERFORATION

    Directory of Open Access Journals (Sweden)

    Sambasiva Rao

    2016-04-01

    Full Text Available BACKGROUND The duodenal injury can pose a formidable challenge to the surgeon and failure to manage it properly may have devastating results. Over the centuries, there was little to offer the patient of acute abdomen beyond cupping, purgation and enemas, all of which did more harm than good. It was not until 1884 that Mikulicz made an attempt to repair a perforation. Recent statistics indicate roughly 10% of population develop gastric or duodenal ulcer in life time. Roughly 1-3% of population above the age of 20 years have some degree of peptic ulcer activity during any annual period. A detailed history with regards to the signs and symptoms of the patient, a meticulous examination, radiological and biochemical investigations help to arrive at a correct preoperative diagnosis. In this study, a sincere effort has been put to understand the demographic patterns, to understand the underlying aetiology and to understand the effectiveness of the standard methods of investigation and treatment in use today. METHODS This is a 24 months prospective study i.e., from September 2011 to September 2013 carried out at Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation. The study included the patients presenting to Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation to emergency ward with signs and symptoms of hollow viscus perforation. The sample size included 30 cases of duodenal perforation. RESULTS Duodenal ulcer perforation commonly occurs in the age group of 30-60 years, but it can occur in any age group. Majority of the patients were male. Smoking and alcohol consumption were risk factors in most cases (53.3% for the causation of duodenal ulcer perforation. Sudden onset of abdominal pain, situated at epigastrium and right hypochondrium was a constant symptom (100%. Vomiting, constipation and fever were not so common. CONCLUSION The emergency surgical management for perforated duodenal ulcer is by

  11. Dynamical symmetries of generalized Taub-NUT and multi-center metrics

    CERN Document Server

    Ngome, J -P

    2013-01-01

    Hidden symmetries of generalized Kaluza-Klein-type metrics are studied using van Holten's systematic analysis \\cite{vH} based on Killing tensors. Applied to generalized Taub-NUT metrics, Kepler-type symmetries with associated Runge-Lenz-type conserved quantities are constructed. In the multicenter case, the subclass of two-center metrics gives rise to a conserved Runge-Lenz-type scalar, while no Kepler-type constant of the motion does exist for non aligned $(N\\geq3)$-centers. We also investigated the diatomic molecule system of Wilczek et al. where "truly" non-Abelian gauge fields mimicking monopole-like fields arised. From the latter system we deduced a new conserved charge.

  12. Coping Strategies and Locus of Control in Childhood Leukemia: A Multi-Center Research.

    Science.gov (United States)

    Polizzi, Concetta; Fontana, Valentina; Perricone, Giovanna; D'Angelo, Paolo; Jankovic, Momcilo; Taormina, Calogero; Nichelli, Francesca; Burgio, Sofia

    2015-05-25

    Acute lymphoblastic leukemia (ALL) is a very distressing experience for children and requires a special effort of adjustment. Therefore, it seems to be crucial to explore coping resources for the experienced risk condition. In this sense, the study focuses on coping strategies and locus of control in children with ALL during the treatment phase, and on their possible relation. The correlation between children and maternal coping strategies is also investigated. The participants involved were an experimental group of 40 children with ALL and their mothers, and 30 healthy children as the control group. The tools used were: the Child Behavioral Style Scale and the Monitor-Blunter Style Scale to assess the coping strategies of children and mothers; the locus of Control Scale for Children to analyze the children's perception of controlling the events. Both children with ALL and their mothers resorted to monitoring coping strategies with a statistically significant rate of occurrence (children: M=17.8, SD=3.8; mothers: M=10.48, SD=3.4). The data concerning the locus of control show this tendency towards internal causes (M=53.1, SD=4.7). There were statistically significant correlations between monitoring coping strategies and external locus of control (r=0.400, P<0.05). The results gained from the control group are almost equivalent. The outcomes show several interesting resources of the psychological functioning of children as well as of their mothers.

  13. Coping strategies and locus of control in childhood leukemia: a multi-center research

    Directory of Open Access Journals (Sweden)

    Concetta Polizzi

    2015-06-01

    Full Text Available Acute lymphoblastic leukemia (ALL is a very distressing experience for children and requires a special effort of adjustment. Therefore, it seems to be crucial to explore coping resources for the experienced risk condition. In this sense, the study focuses on coping strategies and locus of control in children with ALL during the treatment phase, and on their possible relation. The correlation between children and maternal coping strategies is also investigated. The participants involved were an experimental group of 40 children with ALL and their mothers, and 30 healthy children as the control group. The tools used were: the Child Behavioral Style Scale and the Monitor-Blunter Style Scale to assess the coping strategies of children and mothers; the locus of Control Scale for Children to analyze the children’s perception of controlling the events. Both children with ALL and their mothers resorted to monitoring coping strategies with a statistically significant rate of occurrence (children: M=17.8, SD=3.8; mothers: M=10.48, SD=3.4. The data concerning the locus of control show this tendency towards internal causes (M=53.1, SD=4.7. There were statistically significant correlations between monitoring coping strategies and external locus of control (r=0.400, P<0.05. The results gained from the control group are almost equivalent. The outcomes show several interesting resources of the psychological functioning of children as well as of their mothers.

  14. Superior efficacy of St John's wort extract WS® 5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial [ISRCTN77277298

    Directory of Open Access Journals (Sweden)

    Dienel Angelika

    2006-06-01

    Full Text Available Abstract Background The aim of the current study was to assess the antidepressant efficacy and safety of Hypericum perforatum (St. John's wort extract WS® 5570 at doses of 600 mg/day in a single dose and 1200 mg/day in two doses. Methods The participants in this double-blind, randomized, placebo-controlled, multi-center clinical trial were male and female adult out-patients with an episode of mild or moderate major depressive episode (single or recurrent episode, DSM-IV criteria. As specified by the relevant guideline, the study was preceded by a medication-free run-in phase. For the 6-week treatment, 332 patients were randomized: 123 to WS® 5570 600 mg/day, 127 to WS® 5570 1200 mg/day, and 82 to placebo. The primary outcome measure was the change in total score on the Hamilton Rating Scale for Depression (HAM-D, 17-item version between baseline and endpoint. Additional measures included the number of responders, the number of patients in remission, and several other standard rating scales. Efficacy and safety were assessed after 2 and 6 weeks. The design included an interim analysis performed after randomization with the option of early termination. Results After 6 weeks of treatment, mean ± standard deviation decreases in HAM-D total scores of 11.6 ± 6.4, 10.8 ± 7.3, and 6.0 ± 8.1 points were observed for the WS® 5570 600 mg/day, 1200 mg/day and placebo groups, respectively (endpoint analysis. Secondary measures of treatment efficacy also showed that both WS® 5570 groups were statistically superior to placebo. Significantly more patients in the WS® 5570 treatment groups than in the placebo group showed treatment response and remission. WS® 5570 was consistently more effective than placebo in patients with either less severe or more severe baseline impairment. The number of patients who experienced remission was higher in the WS® 5570 1200 mg/day group than the WS® 5570 600 mg/day group. The incidence of adverse events was low in

  15. Treatment of Patients with Erectile Dysfunction by Shugan Yiyang Capsule(疏肝益阳胶囊):A Multi-Centered Randomized Controlled Trial

    Institute of Scientific and Technical Information of China (English)

    王琦; 杨吉相; 李国信; 夏仲元; 王斌; 李贤初; 胡海翔; 毕焕洲; 徐福松; 何映; 林天东

    2004-01-01

    Objective: To evaluate the efficacy and safety of Shugan Yiyang Capsule (SGYY, 疏肝益阳ficiency Syndrome type with or without blood stasis. Methods: A multi-centered, randomized, double-blinded, placebo-controlled trial in 304 patients was conducted by dividing them into 3 groups, who received re101), 1.0g taken three times a day for 4 weeks. Besides, 205 patients were arranged in an open-label studyand treated with SGYY 1.0 g taken three times a day for 4 weeks. The total effective rate, total remarkablyeffective rate, erection recovery rate tested by penis hardness test ring, time taken for improving erection among groups, as well as therapeutic effect between psychogenic ED group and mild arteriogenic ED group were compared. Adverse reactions related to SGYY were recorded. And a 3-month follow-up study was conducted on 105 cured patients. Results: The trial was completed in 500 patients. The total effective rate and total remarkably effective rate in the SGYY treated double-blinded group were 88.0% and 64.0% respectively, and those in the open-label group 90.5% and 65.0%, respectively, all significantly higher th an thosein the placebo (21.0%, 6.0%) and SYBS groups (60.0%, 29.0%), P<0.01. At the same time, the e rection recovery rate and improving time in SGYY group were significantly better than those in other groups ( P<0.01). No adverse reactions related to SGYY were found. The successful rate of potency to have intercourse within 3 months was over 80% (100 patients out of the 105 cured patients). Conclusion: SGYY was an effective and safe treatment for patients with psychogenic and mild arteriogenic ED of Gan stagnation and Shen deficiency Syndrome type with or without blood stasis, especially for psychogenic ED patients.

  16. Multi-center evaluation of the novel fully-automated PCR-based Idylla™ BRAF Mutation Test on formalin-fixed paraffin-embedded tissue of malignant melanoma.

    Science.gov (United States)

    Melchior, Linea; Grauslund, Morten; Bellosillo, Beatriz; Montagut, Clara; Torres, Erica; Moragón, Ester; Micalessi, Isabel; Frans, Johan; Noten, Veerle; Bourgain, Claire; Vriesema, Renske; van der Geize, Robert; Cokelaere, Kristof; Vercooren, Nancy; Crul, Katrien; Rüdiger, Thomas; Buchmüller, Diana; Reijans, Martin; Jans, Caroline

    2015-12-01

    The advent of BRAF-targeted therapies led to increased survival in patients with metastatic melanomas harboring a BRAF V600 mutation (implicated in 46-48% of malignant melanomas). The Idylla(™) System (Idylla(™)), i.e., the real-time-PCR-based Idylla(™) BRAF Mutation Test performed on the fully-automated Idylla(™) platform, enables detection of the most frequent BRAF V600 mutations (V600E/E2/D, V600K/R/M) in tumor material within approximately 90 min and with 1% detection limit. Idylla(™) performance was determined in a multi-center study by analyzing BRAF mutational status of 148 archival formalin-fixed paraffin-embedded (FFPE) tumor samples from malignant melanoma patients, and comparing Idylla(™) results with assessments made by commercial or in-house routine diagnostic methods. Of the 148 samples analyzed, Idylla(™) initially recorded 7 insufficient DNA input calls and 15 results discordant with routine method results. Further analysis learned that the quality of 8 samples was insufficient for Idylla(™) testing, 1 sample had an invalid routine test result, and Idylla(™) results were confirmed in 10 samples. Hence, Idylla(™) identified all mutations present, including 7 not identified by routine methods. Idylla(™) enables fully automated BRAF V600 testing directly on FFPE tumor tissue with increased sensitivity, ease-of-use, and much shorter turnaround time compared to existing diagnostic tests, making it a tool for rapid, simple and highly reliable analysis of therapeutically relevant BRAF mutations, in particular for diagnostic units without molecular expertise and infrastructure.

  17. Multi-center Superstrata

    CERN Document Server

    Tian, Wukongjiaozi

    2016-01-01

    We construct a new class of superstrata, the regular supergravity solutions describing the microstates of D1-D5-P black holes. Our solutions are obtained by adding momentum charge to the D1-D5 geometries based on multiple concentric Kaluza-Klein monopoles.

  18. Comparison of Biodegradable and Titanium Fixation Systems in Maxillofacial Surgery : A Two-year Multi-center Randomized Controlled Trial

    NARCIS (Netherlands)

    van Bakelen, N. B.; Buijs, G. J.; Jansma, J.; de Visscher, J. G. A. M.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; Stegenga, B.; Bos, R. R. M.

    2013-01-01

    Biodegradable osteosynthesis could reduce/delete the problems associated with titanium plate removal. The aim of the present study was to compare the clinical performance in the first 2 post-operative years between a biodegradable and a titanium system in oral and maxillofacial surgery. The multicen

  19. Treatment of Idiopathic Parkinson's Disease with Traditional Chinese Herbal Medicine: A Randomized Placebo-Controlled Pilot Clinical Study

    Directory of Open Access Journals (Sweden)

    Wan Fung Kum

    2011-01-01

    Full Text Available The objective of this clinical study is to examine the effects of a Chinese herbal medicine formula (Jia Wei Liu Jun Zi Tang: JWLJZT on motor and non-motor symptoms, and on complications of conventional therapy in idiopathic Parkinson's disease (PD, using an add-on design. Fifty-five patients with PD were randomly allocated to receive either Chinese herbal medicine or placebo for 24 weeks. Primary outcome measure was the 39-item Parkinson's Disease Questionnaire (PDQ-39. Secondary outcome measures included the Unified Parkinson's Disease Rating Scale (UPDRS, Short-Form-36 Health Survey (SF-36, Geriatric Depression Scale (GDS, home diaries, and a range of category rating scales. JWLJZT resulted in a significant improvement in the UPDRS IVC when compared with placebo at 12 weeks (P = .039 and 24 weeks (P = .034. In addition, patients in the Chinese herbal medicine group also showed significant improvement in PDQ-39 communication scores at 12 weeks (P = .024 and 24 weeks (P = .047 when compared with the placebo group. There were no significant differences between treatment and control groups for SF-36 variables, GDS score or the mean daily “on-off” time. One case of mild diarrhea was noted in the treatment group. The findings suggest that JWLJZT can relieve some non-motor complications of conventional therapy and improve the communication ability in patients with PD. The results of this pilot study warrant larger multi-center clinical studies to assess long-term efficacy and tolerability of JWLJZT, and to elucidate the mechanisms by which it affects PD function.

  20. Good clinical practices in phase I studies.

    Science.gov (United States)

    Decousus, H; Perpoint, B; Mismetti, P; Ollagnier, M; Queneau, P

    1990-01-01

    In France, official guidelines for good clinical practices in clinical trials were issued in 1987. In December 1988, a law was passed that fixed the requirements for carrying out experiments in healthy subjects. It will be completed by official guidelines for the structures in which experiments on healthy subjects (and patients as well, when the investigation would not benefit the health of the patients) may be conducted. Hence a battery of recent legal instructions precisely state what good clinical practices are in the setting of phase I studies. Of particular importance are: subject recruitment and selection methods and procedures; specific competence of the investigator, in particular to interpret the pre-trial data; necessary and sufficient facilities to guarantee the subjects' safety; careful quality control to check all laboratory procedures; necessity of written standard operating procedures.

  1. Left ventricular noncompaction: Clinical-echocardiographic study

    Directory of Open Access Journals (Sweden)

    Nikolić Aleksandra

    2012-01-01

    Full Text Available Background/Aim. Left ventricular noncompaction (LVNC is a disorder in endomyocardial morphogenesis, seen either isolated (in the absence of other cardiac anomalies or in association with congenital heart disease and some neuromuscular diseases. Intrauterine arrest of the compaction of myocardial fibers is postulated to be the reason of LVNC. Recognition of this condition is extremely important due to its high mortality and morbidity that lead to progressive heart failure, ventricular arrhythmias and thromboembolic events. The aim of this study was to determine the prevalence and clinical presentation of LVNC among consecutive outpatients according to clinical and echocardiographyic findings. Methode. A total of 3,854 consecutive patients examined at the Institute for Cardiovascular Diseases within a period January 2006 - January 2007 were included in the study. All the patients underwent echocardiographic examination using the same equipment (Vivid 7, GE Medical System. Echocardiographic parameters and clinical presentation in patients with echocardiographic criteria for LVNC were analyzed. Results. Analyzing 3,854 consecutive outpatients, using two-dimensional Color Doppler echocardiography from January 2006 to January 2007, 12 patients met the criteria for LVNC. Seven of them were male. The mean age at diagnosis was 45 ± 15 years. Analyzing clinical manifestation of LVNC it was found that seven patients had signs of heart failure, six had arrhythmias with no embolic events. Conclusion. Our results suggest that the real prevalence of LVNC may be higher than expected. New studies have to be done to solve this problem.

  2. 奥硝唑片治疗急性厌氧菌感染性疾病及阴道毛滴虫病的临床试验%The multi-center clinical study of the efficacy of ornidazole against acute anaerobic infections and vaginalis trichomoniasis

    Institute of Scientific and Technical Information of China (English)

    汤慧芳; 龚培力; 周际安; 李英茜; 郑启昌; 戴立人; 闵洁; 李兴睿; 彭志翔; 陈茹; 丁俊清; 罗新; 王培良; 蒲子敬; 杨恒

    2001-01-01

    目的:评价奥硝唑片治疗由厌氧菌所致的感染及滴虫所致阴道炎的临床疗效及其安全性.方法:采用多中心随机双盲双模拟平行对照研究方法,试验组口服奥硝唑,对照组口服替硝唑,共观察厌氧菌感染121例(外科60例,口腔科61例),妇科阴道毛滴虫感染80例,奥硝唑500mg,bid;口腔科奥硝唑500mg,qd,首剂加倍.疗程3~10d.结果:奥硝唑与替硝唑治疗急性厌氧菌感染总有效率分别为98.4%及85%(P<0.05),细菌清除率分别为96 2%及90.7%(P>0.05);治疗滴虫性阴道炎的总有效率均为100%.奥硝唑和替硝唑的不良反应发生率分别为¨.5%及28.3%(P<0.05).结论:奥硝唑片治疗急性厌氧菌感染和滴虫性阴道炎安全有效,不良反应少,优于同类药物替硝唑.

  3. 疾病严重程度与ICU清醒危重患者心理状态关系的多中心研究%Relationship between severity of illness and mental status in ICU conscious patients:a nationwide multi-center clinical study

    Institute of Scientific and Technical Information of China (English)

    王宇; 马朋林; 刘京涛; 苏瑾文; 李秦; 曾琳

    2008-01-01

    Objective To survey the incidence of psychological adverse events in critical conscious Patients dunng their ICU stay and analyze the relationship between the incidence and the sevetitu of illness.Methods 234 conscious patients,133 males and 101 females,aged(55.4±19.6).80 with internal medicine diseases and 154 with surgical diseases,were treated in the ICUs of 31 grade 3 A hospitals over the country consecutively during the period of 2 months and then successfully transferred to other departments.The patients were interviewed with specific questionnaire within the 2 days after transfer to investigate the incldence of anxiety and depression and the tolerance of invasive medical and nursing procedures of the patients.Results The overall incidence of psychological adverse events(PAE)was 69.6%.Multi.variate Logistic analysis showed that acute physiology and chronic health evaluation(APACHE) Ⅱscore was an independent high risk factor of PAE(OR=1.07,95%CI:1.02.1.13,P20 were 1.29.2.53.and 4.85respectively.The higher the APACHE Ⅱ score,the more invasive interventions received(P20的3个不同区间内,发生心理不良事件的相对危险度(RR)分别为1.29、2.53和4.85(P<0.05).APACHE Ⅱ评分越高,接受有创监测和治疗项目数越多(P<0.01,),耐受噪音以及医疗护理操作的阈值越低,发生心理不良事件的危险度越高(P<0.01).结论 APACHE Ⅱ评分是诱发不良心理事件的独立危险因素.APACHE Ⅱ评分高的ICU清醒患者接受有创监测和治疗项目数多,以及心理应激阈值降低是诱发心理不良事件的重要原因.

  4. A Controlled Study on Clinic Results of Active Intrauterine Device Preserving in Later - puerperium and Post - men- opause Samples in Multi-centers%晚产褥期与经后放置活性宫内节育器多中心临床比较性研究

    Institute of Scientific and Technical Information of China (English)

    任灿晴; 郑淑云

    2003-01-01

    目的:总结分析浙江省晚产褥期与经后放置活性宫内节育器(IUD)多中心临床效果比较性研究3年的结果.方法:接受晚产褥组放置对象818例,其中活性γ型IUD 204例,TCu 220C IUD 210例,宫Cu IUD 193例,药铜165 IUD211例;经后组763例,其中活性γ型IUD 195例,TCu 220C IUD 194例,宫Cu及药铜165 IUD各为187例.观察3年使用效果,3年中失访7例,随访率99%以上.结果:晚产褥组3年继续存放率活性γ型IUD92.07/100妇女,TCu220C IUD 86.73/100妇女,官CuIUD 84.05/100妇女,药铜165 IUD 81.62/100妇女;经后组3年继续存放率活性γ型IUD 87.18/100妇女,TCu 220C IUD 83.38/100妇女,宫Cu IUD 89.77/100妇女,药铜165 IUD 79.13%,两组的带器妊娠率、脱落率、因症取出率均无统计学差异(P>0.05).而四种IUD相比较,3年继续存放率活性γ型IUD最高,药铜最低,两种IUD之间有极显著性的差异(P<0.01),因症取出率以TCu 220C IUD最高,其余依次为宫Cu IUD,活性γ型IUD和药铜165IUD.结论:四种活性IUD均适合于晚产褥期与经后妇女放置.经对晚产褥组观察,放置活性IUD不增加产科并发症,不增加副反应的发生率.对于今后及时落实避孕措施,减少哺乳期妇女妊娠,保障妇女身心健康,将有极为重要的意义.

  5. 踝臂指数评价高危患者下肢外周动脉病多中心临床研究%Prevalence of peripheral arterial disease in high-risk Chinese patients--A Multi-center Clinical Study

    Institute of Scientific and Technical Information of China (English)

    胡大一; 王领军; 余金明; 布艾加尔; 仝其广; 王锦纹; 魏毅东; 吴琛

    2005-01-01

    目的通过测量踝臂指数(ankle-brachial index, ABI)评价我国高危患者下肢外周动脉病(peripheral arterial disease, PAD)的患病情况.方法对入院的691例多家研究中心的高危患者进行踝臂指数测定,并进行资料收集和统计学处理.结果 691例高危患者中PAD患病率为34.3%,在≤59岁高危患者中PAD患病率为12.5%,而在≥60岁老年高危患者中为40.0%.冠心病(coronary heart disease, CHD)患者PAD患病率为35.8%,缺血性卒中(ischemic stroke, IS)患者PAD患病率为35.9%.10.7%的高危患者同时合并CHD、IS和PAD.同一年龄组内,不同性别的PAD患病率之间差别无统计学意义.PAD患者只有6.3%既往有PAD史记录,而绝大多数患者(93.7%)的PAD没有得到明确诊断.结论动脉粥样硬化是多血管疾病;PAD在高危患者中常见,在≥60岁老年高危患者中更常见;PAD患病率与性别无关联.

  6. Clinical and histopathological study of palmoplantar keratoderma

    Directory of Open Access Journals (Sweden)

    Mahajan P

    1994-01-01

    Full Text Available Study of palmo-plantar keratoderma in eighty-two cases showed that twenty different diseases, both hereditary and acquired were responsible for palmoplantar keratoderma. Maximum number of cases were of hereditary variety of palmoplantar keratoderma (Unna-Thost syndrome (28.05%. Whereas psoriasis was the leading cause among the acquired conditions (17.07%. Two histopathological types of Unna-Thost syndrome and their correlation with clinical features are reported.

  7. Nail disorders in children, a clinical study

    Directory of Open Access Journals (Sweden)

    Ayşe Akbaş

    2016-04-01

    Full Text Available Introduction: Aims of the study to investigate the frequency and the nature ofnail disorders in children significant clinical data is available. Nail disorders although common in children in some parts of our country. This study was carried out to document the clinical and demographic pattern of nail disorders in a dermatology outpatient clinic of a pediatric hospital in Ankara, Turkey. Material and Methods: All consecutive patients a total of 3000 children from age 0-16 were admitted to dermatology outpatient clinic of Ankara Pediatric Hematology and Oncology Education and Research Hospital during January 2011 to December 2011 were studied and retrospectively evaluated for age, gender, drug use, diseases, systemic or genetic disorders and demographic features. Diagnostic evaluation results were noted and patients were categorized for demographic features and diagnosis. Results: These 133 patients (M: F 58:75, %44 vs 56, respectively were under 16 years of age and have 17 different dermatological disorders related with nail symptoms. Fifty three of (39,8% these patient were under 2 years of age, 31 (23.3% were between 3-5 years, 30 (22.5% were between 6-11 years old, 19 of 133 (14%, 2 were between 11-16 years of age. Through all of ages and independent of gender the most etiologies of nail disorders were, onychomadesis, paronychia, onycholysis, onychomycosis and systemic nail presentation of systemic dermatosis. Conclusion: Nail disorders are different in children than in adults. In our study, the first 5 years of age was found in 53% of nail disorders. Nail disorders are uncommon but may be seen as a part of a systemic disease and may be associated with cosmetic and psychologic problem.

  8. Effect of levothyroxine on live birth rate in euthyroid women with recurrent miscarriage and TPO antibodies (T4-LIFE study)

    DEFF Research Database (Denmark)

    Vissenberg, R; van Dijk, M M; Fliers, E;

    2015-01-01

    BACKGROUND: Thyroid peroxidase antibodies (TPO-Ab) in euthyroid women are associated with recurrent miscarriage (RM) and other pregnancy complications such as preterm birth. It is unclear if treatment with levothyroxine improves pregnancy outcome. Aim To determine the effect of levothyroxine admi...... we discuss the rationale and design of the T4-LIFE study, an international multi-center randomized, double blind placebo controlled, clinical trial aimed to assess the effectiveness of levothyroxine in women with recurrent miscarriage and TPO-Ab....

  9. REFLEX, a social-cognitive group treatment to improve insight in schizophrenia: study protocol of a multi-center RCT

    Directory of Open Access Journals (Sweden)

    Pijnenborg GHM

    2011-10-01

    Full Text Available Abstract Background Insight is impaired in a majority of people with schizophrenia. Impaired insight is associated with poorer outcomes of the disorder. Based on existing literature, we developed a model that explains which processes may possibly play a role in impaired insight. This model was the starting point of the development of REFLEX: a brief psychosocial intervention to improve insight in schizophrenia. REFLEX is a 12-sessions group training, consisting of three modules of four sessions each. Modules in this intervention are: "coping with stigma", "you and your personal narrative", and "you in the present". Methods/Design REFLEX is currently evaluated in a multicenter randomized controlled trial. Eight mental health institutions in the Netherlands participate in this evaluation. Patients are randomly assigned to either REFLEX or an active control condition, existing of cognitive remediation exercises in a group. In a subgroup of patients, fMRI scans are made before and after training in order to assess potential haemodynamic changes associated with the effects of the training. Discussion REFLEX is one of the few interventions aiming specifically to improving insight in schizophrenia and has potential value for improving insight. Targeting insight in schizophrenia is a complex task, that comes with several methodological issues. These issues are addressed in the discussion of this paper. Trial registration Current Controlled Trials: ISRCTN50247539

  10. Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial

    NARCIS (Netherlands)

    Radonic, T.; Witte, P.; Baars, M.J.H.; Zwinderman, A.H.; Mulder, B.J.M.; Groenink, M.

    2010-01-01

    BACKGROUND: Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatation and dissection is the main cause of morbidity and mortality of Marfan patie

  11. Psychometric qualities of the Dutch version of the Pediatric Inventory for Parents (PIP) : a multi-center study

    NARCIS (Netherlands)

    Vrijmoet-Wiersma, C. M. Jantien; Hoekstra-Weebers, Josette E. H. M.; de Peinder, W. M. G. Margreet; Koopman, Hendrik M.; Tissing, Wim J. E.; Treffers, Philip D. A.; Bierings, Marc B.; Jansen, Nathalie C. A.; Grootenhuis, Martha A.; Egeler, R. Maarten

    2010-01-01

    Objectives: Diagnosis and treatment of childhood cancer are continuous stressors in the lives of the entire family involved. Disease-related tools for the assessment of parental stress and adaptation are scarce. For that reason, the Pediatric Inventory for Parents (PIP), a disease-related measure, w

  12. 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...

  13. Psychometric qualities of the Dutch version of the Pediatric Inventory for Parents (PIP): a multi-center study

    NARCIS (Netherlands)

    C.M.J. Vrijmoet-Wiersma; J.E.H.M. Hoekstra-Weebers; W.M.G.M. de Peinder; H.M. Koopman; W.J.E. Tissing; P.D.A. Treffers; M.B. Bierings; N.C.A. Jansen; M.A. Grootenhuis; R.M. Egeler

    2010-01-01

    Objectives: Diagnosis and treatment of childhood cancer are continuous stressors in the lives of the entire family involved. Disease-related tools for the assessment of parental stress and adaptation are scarce. For that reason, the Pediatric Inventory for Parents (PIP), a disease-related measure, w

  14. REFLEX, a social-cognitive group treatment to improve insight in schizophrenia : Study protocol of a multi-center RCT

    NARCIS (Netherlands)

    Pijnenborg, G H M; Van der Gaag, Mark; Bockting, Claudi L H; Van der Meer, Lisette; Aleman, André

    2011-01-01

    BACKGROUND: Insight is impaired in a majority of people with schizophrenia. Impaired insight is associated with poorer outcomes of the disorder. Based on existing literature, we developed a model that explains which processes may possibly play a role in impaired insight. This model was the starting

  15. Leveraging a clinical research information system to assist biospecimen data and workflow management: a hybrid approach

    Science.gov (United States)

    2011-01-01

    Background Large multi-center clinical studies often involve the collection and analysis of biological samples. It is necessary to ensure timely, complete and accurate recording of analytical results and associated phenotypic and clinical information. The TRIBE-AKI Consortium http://www.yale.edu/tribeaki supports a network of multiple related studies and sample biorepository, thus allowing researchers to take advantage of a larger specimen collection than they might have at an individual institution. Description We describe a biospecimen data management system (BDMS) that supports TRIBE-AKI and is intended for multi-center collaborative clinical studies that involve shipment of biospecimens between sites. This system works in conjunction with a clinical research information system (CRIS) that stores the clinical data associated with the biospecimens, along with other patient-related parameters. Inter-operation between the two systems is mediated by an interactively invoked suite of Web Services, as well as by batch code. We discuss various challenges involved in integration. Conclusions Our experience indicates that an approach that emphasizes inter-operability is reasonably optimal in allowing each system to be utilized for the tasks for which it is best suited. PMID:21884570

  16. Clinical study on osteoradionecrosis of the jaws

    Energy Technology Data Exchange (ETDEWEB)

    Okano, Atsuo; Kato, Joji

    1988-07-01

    In the present study osteoradionecrosis which had developed after radiotherapy for malignant tumor was studied clinically and therapeutically and the following results were obtained. 1. The subjects were 28 patients with squamous cell carcinoma and 2 patients with adenoid cystic carcinoma aged 38 to 72. The ratio of male: female was 3.3 : 1. The time of manifestation was 1 month-14 years after irradiation. The main symptoms were pain and exposed bone mainly in the region of mandibular molar tooth. 2. Osteoradionecrosis was observed in 10 cases supposed to be induced by tooth extraction but also in 5 edentulous cases. 3. When the osteoradionecrosis cases were classified into limited area type and wide range type on the basis of clinical findings. X-ray of the jaws showed the presence of bone resorption and induration together in many wide range type cases. 4. Scintigram of bone showed widespread accumulation of radiation even in clinically limited area type, and the picture of some loss of bone and the intensity of the accumulation were considered to be extremely useful as an index in making therapeutical plans and decisions on the prognosis of tumor of the jaws. 5. As the method of treatment, sequestrectomy was performed in 14 of 19 cases of the limited area type and 4 of 11 cases of the wide range type and excision of the jaws in 4 cases. 6. Hyperbaric oxygen therapy was carried out in 3 cases and had good effect. (J.P.N.).

  17. CLINICAL STATISTICAL STUDIES ON HEMATURIA IN OUTPATIENTS

    OpenAIRE

    青木, 正治; 熊本, 悦明

    1982-01-01

    Clinical statistical studies on hematuria were performed in outpatients who were seen at our Department, during the 7-year period from 1974 through 1980. Of the 11,574 outpatients studied, the total number of outpatients with hematuria 1,705; macroscopic hematuria was found in 446 cases (3.9%) and microscopic hematuria was in 1,259 cases (10.9%). The most frequent cause of macroscopic hematuria was malignant urinary tumors and that of microscopic hematuria was urinary tract infections. Macros...

  18. Clinical Study on Ocular Trauma in Children

    Institute of Scientific and Technical Information of China (English)

    Zicai Huang; Hongni Li; Yixia Huang; Zhongxia Zhou

    2002-01-01

    Purpose: To investigate the clinical characteristics of ocular trauma in children and put forward the major treatment and prevention of ocular trauma in children.Methods: To analyze the clinical data by 77 eyes in 77 cases of ocular trauma in children from April 1999 to February 2002. Results: The male and female were in the ratio of 2.21: 1. Right eye ocular traumas were more than left ones. Ocular penetrating trauma was 83.12% and blunt trauma 12.99%. 41 cases (53.25%) were injured by themselves while 33 cases by others. 90.91% patients came from the countryside.Conclusion: The rate of blindness of children with ocular trauma could be reduced by prompt treatment. The study indicated that ocular trauma preventive publicity should be faced in the countryside in order to improve the understanding of the severity of ocular trauma and treat it as a social problem.

  19. Cryogenic Thermophysical Studies for Clinical Medicine

    Institute of Scientific and Technical Information of China (English)

    华泽钊

    2002-01-01

    Cryogenic technology has been widely used in clinical medicine and in pharmaceutics, so thermophysical studies are extremely important to solve problems during freezing and thawing. This paper reports some recent research in clinical medicine, including cryo-injury, cryosurgery, and cryopreservation of some important cells and tissues. Microscopic images of the freezing process with a cryomicroscope system show that the dendritic ice growth is affected by the solution concentration, the cooling rate, and the number of embryos. An enthalpy method is used for the freeze-thaw analysis of the cryosurgery with a program developed to predict the temperature profile and the interface motion, which compares well with experimental results. A very rapid cooling technique is developed by quenching the samples into subcooled liquid nitrogen for vitrification of cells and tissues. An analytical method developed to prevent the fracture of arteries during freezing has been verified by the electronic microscopic investigation.

  20. Robust diffusion imaging framework for clinical studies

    CERN Document Server

    Maximov, Ivan I; Neuner, Irene; Shah, N Jon

    2015-01-01

    Clinical diffusion imaging requires short acquisition times and good image quality to permit its use in various medical applications. In turn, these demands require the development of a robust and efficient post-processing framework in order to guarantee useful and reliable results. However, multiple artefacts abound in in vivo measurements; from either subject such as cardiac pulsation, bulk head motion, respiratory motion and involuntary tics and tremor, or imaging hardware related problems, such as table vibrations, etc. These artefacts can severely degrade the resulting images and render diffusion analysis difficult or impossible. In order to overcome these problems, we developed a robust and efficient framework enabling the use of initially corrupted images from a clinical study. At the heart of this framework is an improved least trimmed squares diffusion tensor estimation algorithm that works well with severely degraded datasets with low signal-to-noise ratio. This approach has been compared with other...

  1. Clinical microfluidics for neutrophil genomics and proteomics.

    Science.gov (United States)

    Kotz, Kenneth T; Xiao, Wenzong; Miller-Graziano, Carol; Qian, Wei-Jun; Russom, Aman; Warner, Elizabeth A; Moldawer, Lyle L; De, Asit; Bankey, Paul E; Petritis, Brianne O; Camp, David G; Rosenbach, Alan E; Goverman, Jeremy; Fagan, Shawn P; Brownstein, Bernard H; Irimia, Daniel; Xu, Weihong; Wilhelmy, Julie; Mindrinos, Michael N; Smith, Richard D; Davis, Ronald W; Tompkins, Ronald G; Toner, Mehmet

    2010-09-01

    Neutrophils have key roles in modulating the immune response. We present a robust methodology for rapidly isolating neutrophils directly from whole blood with 'on-chip' processing for mRNA and protein isolation for genomics and proteomics. We validate this device with an ex vivo stimulation experiment and by comparison with standard bulk isolation methodologies. Last, we implement this tool as part of a near-patient blood processing system within a multi-center clinical study of the immune response to severe trauma and burn injury. The preliminary results from a small cohort of subjects in our study and healthy controls show a unique time-dependent gene expression pattern clearly demonstrating the ability of this tool to discriminate temporal transcriptional events of neutrophils within a clinical setting.

  2. [Depression and dementia: perspectives from clinical studies].

    Science.gov (United States)

    Nozaki, Shoko; Yoshimura, Kimio; Mimura, Masaru

    2012-12-01

    In this review, we present an overview of clinical studies that addressed the relationship between depression and dementia or cognitive decline. Cross-sectional studies and meta-analyses have repeatedly shown an association between late-life depression (LLD) and dementia, particularly Alzheimer's disease (AD) and vascular dementia; however, the findings of cohort studies have been inconsistent. Furthermore, studies on the association between depression with a younger age of onset and dementia have yielded inconsistent results. Regarding cognitive decline associated with LLD, several studies have reported an association between LLD and mild cognitive impairment, suggesting that depression itself can cause persistent cognitive impairment. Other studies have compared the cognitive profile between LLD and depression with a younger age of onset, but their results have been inconclusive, especially regarding the association between memory impairment and the age of onset of depression. LLD is associated with vascular change and white matter degeneration of the brain, as shown by magnetic resonance imaging (MRI). Recently, several studies reported an association between gray matter change and LLD. Studies currently in progress employ functional brain imaging methods such as single-photon emission computed tomography, functional MRI, and positron emission tomography. Clinically, it is important to understand how subtypes of depression can be defined in terms of risk of developing dementia, and to devise effective treatments. One paper explored the possibility of detecting depression associated with AD by measuring the blood Aβ40/Aβ42 levels, and other studies have suggested that symptoms of apathy and loss of interest are associated with conversion of depression to AD. Unfortunately, current antidepressants may have limited efficacy on depression with dementia; therefore, further investigation for devising methods of predicting conversion of depression to dementia and

  3. The Clinical Efficacy of Mometasone Furoate in Multi-Lamellar Emulsion for Eczema: A Double-blinded Crossover Study

    Science.gov (United States)

    Kim, Duk Han; Lee, Hyun Jong; Park, Chun Wook; Kim, Kyu Han; Lee, Kwang Hoon; Ro, Byung In

    2013-01-01

    Background Topical application of corticosteroids also has an influence on skin barrier impairment. Physiological lipid mixtures, such as multi-lamellar emulsion (MLE) containing a natural lipid component leads to effective recovery of the barrier function. Objective The purpose of this study was to conduct an evaluation of the therapeutic efficacy and skin barrier protection of topical mometasone furoate in MLE. Methods A multi-center randomized, double-blind, controlled study was performed to assess the efficacy and safety of mometasone furoate cream in MLE for Korean patients with eczema. The study group included 175 patients with eczema, who applied either mometasone furoate in MLE cream or methylprednisolone aceponate cream for 2 weeks. Treatment efficacy was evaluated using the physician's global assessment of clinical response (PGA), trans-epidermal water loss (TEWL), and visual analogue scale (VAS) for pruritus. Patients were evaluated using these indices at days 4, 8, and 15. Results Comparison of PGA score, TEWL, and VAS score at baseline with those at days 4, 8, and 15 of treatment showed a significant improvement in both groups. Patients who applied mometasone furoate in MLE (74.8%) showed better results (p<0.05) than those who applied methylprednisolone aceponate (47.8%). The TEWL improvement ratio was higher in the mometasone furoate in MLE group than that in the methylprednisolone aceponate group, and VAS improvement was also better in the mometasone furoate in MLE group. Conclusion Mometasone furoate in MLE has a better therapeutic efficacy as well as less skin barrier impairment than methylprednisolone aceponate. PMID:23467551

  4. Evidence-based review of clinical studies on pulpotomy.

    Science.gov (United States)

    2009-08-01

    Although pulpotomy procedures have a long history of clinical application, comparatively few dental clinical trials have evaluated this treatment approach. In this section, we provide an analysis of recent clinical studies evaluating pulpotomy procedures in dental patients.

  5. Therapist adherence in the strong without anorexia nervosa (SWAN) study:A randomized controlled trial of three treatments for adults with anorexia nervosa

    OpenAIRE

    2015-01-01

    Objective To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). Method The SWAN Psychother...

  6. A multi-center, randomized controlled trial of a group psychological intervention for psychosis with comorbid cannabis dependence over the early course of illness.

    LENUS (Irish Health Repository)

    Madigan, Kevin

    2013-01-01

    Patients who experience the onset of psychotic illness with a comorbid diagnosis of cannabis dependence experience poor clinical outcomes. Few studies have identified interventions that reduce cannabis use and improve clinical outcome in this population.

  7. MULTI-CENTER RANDOMIZED CONTROLLED TRIALS OF COMBINED TREATMENT OF VERTEBRAL ARTERY TYPE CERVICAL SPONDYLOSIS WITH ACUPUNCTURE AND MASSAGE

    Institute of Scientific and Technical Information of China (English)

    ZHOU Jian-wei; WANG Cheng-wei; HU Ling-xiang; LI Ning; ZHANG Fan; LI Chun-yu; ZHAO Jing-jing; LI Ji; HU Yun-guang; ZHANG Yan

    2005-01-01

    Objective:To evaluate the clinical value of synthetical therapy of acupuncture and massage for treating vertebral artery type cervical spondylosis (VACS). Methods: In the present study, triple-center, single-blind, randomized and control methods were adopted. Qualified subjects were randomly assigned to three groups: acupuncture-massage (acu-mas) group, acupuncture group, and massage group (60 subjects in each group). Bilateral Fengchi (风池GB 20), Jiaji (夹脊EX-B 2, C4-7) and Baihui (百会GV 20) were punctured in combination with massage at the neck-shoulder and back region. The treatment was conducted once daily, 14 times altogether. Results: After treatment, of the 60 cases in each of acu-mas, acupuncture and massage groups, 28, 11 and 13 were cured, 13, 20 and 17 markedly effective, 12, 14 and 16 effective, and 7, 15 and 14 ineffective, with the total effective rates being 88.3%, 75.0% and 76.7% respectively. The therapeutic effect of acu-mas group was significantly superior to that of simple acupuncture and massage groups (P0.05). The time for producing therapeutic effects in acu-mas group was significantly shorter than those of acupuncture and massage groups (P<0.01, 0.05), meaning a faster of acu-mas group in producing clinical effect. No adverse events were found in all the 3 groups. Conclusion: Acupuncture and massage are effective and safe in the treatment of VACS, and the therapeutic effect of acupuncture combined with massage is superior to that of simple acupuncture and simple massage therapy.

  8. Angular cheilitis: a clinical and microbial study.

    Science.gov (United States)

    Ohman, S C; Dahlén, G; Möller, A; Ohman, A

    1986-04-01

    The purpose of this prospective study was to re-examine the relative importance of various factors in the pathogenesis of angular cheilitis. Sixty-four patients with cheilitis were examined clinically and microbiologically. In addition, a subsample of 23 patients was examined for serum iron and transferrin. The clinical appearance of the lip lesions fell into 4 categories. A ground rhagad at the corner of the mouth involving adjacent skin, was the most frequent type among dentate patients, whereas among denture wearers a deep lesion following the labial marginal sulcus was frequently observed. Dentate patients and denture wearers with cheilitis often had atopic constitution or cutaneous diseases. Pathogenic microorganisms were cultured from the lesions in all 64 patients; Staphylococcus aureus in 40 patients and Candida albicans in 45. The results of this study indicate a correlation between angular cheilitis and pathogenic microorganisms. Furthermore, among dentate patients, a correlation exists between cutaneous discomfort and angular cheilitis. Other etiological factors suggested for this disorder were found to be of subordinate importance.

  9. A CLINICAL STUDY ON BLUNT INJURY ABDOMEN

    Directory of Open Access Journals (Sweden)

    G. Kishore Babu

    2016-10-01

    Full Text Available BACKGROUND Abdominal trauma continues to account for a large number of trauma-related injuries and deaths. Motor vehicle accidents and urban violence, respectively, are the leading causes of blunt and penetrating trauma to this area of the body. Unnecessary deaths and complications can be minimized by improved resuscitation, evaluation and treatment. The new techniques and diagnostic tools available are important in the management of abdominal trauma. These improved methods, however, still depend on experience and clinical judgment for application and determination of the best care for the injured patient. The aim of the study is to 1. Analyse the incidence, clinical characteristics, diagnosis, indications for laparotomy, therapeutic methods and morbidity & mortality rates. 2. To study nature of blunt abdominal trauma. 3. To assess patient for surgical intervention and to avoid negative laparotomy. 4. To assess morbidity rate in different organs injury. 5. To evaluate modalities of treatment, complications and prognosis. MATERIALS AND METHODS This study is a prospective study on 97 patients with Blunt injuries to the abdomen admitted in S.V.R.R.G.G. Hospital, Tirupati during October 2013-15. Inclusion Criteria Patients > 13 years, with Blunt injury to abdomen either by RTA, fall, object contact, assault giving written informed consent. Exclusion Criteria Patients <13 yrs. Blunt injuries due to blasts, patients with severe cardiothoracic and head injuries who are hemodynamically unstable. CONCLUSION Blunt Trauma to abdomen is on rise due to excessive use of motor vehicles. It poses a therapeutic and diagnostic dilemma for the attending surgeon due to wide range of clinical manifestations ranging from no early physical findings to progression to shock. So, the Trauma surgeon should rely on his physical findings in association with use of modalities like x-ray abdomen, USG abdomen and abdominal paracentesis. Hollow viscus perforations are

  10. Korean Clinic Based Outcome Measure Studies

    Directory of Open Access Journals (Sweden)

    Jongbae Park

    2003-02-01

    Full Text Available Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here including 1 Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2 Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP; and 3 Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures

  11. Clinical studies on mercury poisoning in cattle

    Energy Technology Data Exchange (ETDEWEB)

    Sonoda, M.; Nakamura, R.; Too, K.; Matsuhashi, A.; Ishimoto, H.; Sasaki, R.; Ishida, K.; Takahashi, M.

    1956-01-01

    A sporadic outbreak of an unknown disease occurred among dairy cattle, from early February to late May 1955, in Japan. The characteristic symptoms of this disease were dyspnea and depilation; out of 29 cases, 8 died while 2 were slaughtered. Clinical studies have disclosed that the symptoms were similar to those found in cases of mercury poisoning as described by others. So the animals' feed was suspected of being the cause of the sickness. It was confirmed that the incident was due to poisoning resulting from ingestion of linseed meal treated with a mercurial fungicide. From the results of the testing anamnesis, it was found that 171 cattle were fed with the meal and 29 cases were affected. In veiw of the wide use of mercurial preparations for treating seed grains against fungi infection, a further experimental study was made on the effects of the feed and fungicide upon calves.

  12. A CLINICAL STUDY ON SLIDING INGUINAL HERNIAS

    Directory of Open Access Journals (Sweden)

    Sobha Rani

    2015-09-01

    Full Text Available INTRODUCTION: A sliding hernia is a type of hernia in which posterior wall of the sac is not only formed by the parietal peritoneum, but also by sigmoid colon with its mesentery on its left side; caecum on right side and often with portion of bladder in both sides. During surgery care is taken not t o separate the content from the sac as the posterior wall of the sac is formed by the sliding component itself and attempts to dissect it from wall results in vascular injury to the structure and end in ischemic insult of the sliding component. Thus slidin g hernia is important for the special surgical technique and care during intraoperative period which decreases the morbidity. AIMS AND OBJECTIVE S : To study the incidence of sliding hernia in S.V.R.R.G. General Hospital Tirupati . To know the presentation, o rgan involved in the sliding, post - operative complications in the management of sliding hernias. METHODOLOGY : STUDY DESIGN: Prospective Clinical Study , STUDY AREA: Sri Venka teswara Medical College Tirupat i . SOURCE OF DATA: This study is an observational study in which 600 patients with hernia were studied and 40 patients with sliding component during intra operative period were studied in a period of 12 months. S AMPLE SIZE: 40 patients fulfilling the inclusion criteria . METHOD OF COLLECTION OF DATA: Detai led history taking , Complete clinical examination , Appropriate Investigations Blood & Urine Examination, USG , Surgery is performed & Operative findings were recorded. INCLUSION CRITERIA: Patients more than 13 years, with inguinal hernia giving written inform ed consent. EXCLUSION C RITERIA: Patients less than 13 yrs. Patients with comorbid conditions like heart diseases, liver and renal diseases. SOFTWARE: Statistical software mainly SPSS 11.0 and Systat 8.00 was used for the analysis of the data and Microsoft word and excel have been used to generate graphs tables etc. CONCLUSION: In the observational study done on 40 ca ses of

  13. Efficacy and Safety of Zhuanggu Joint Capsules in Combination with Celecoxib in Knee Osteoarthritis: A Multi-center, Randomized, Double-blind, Double-dummy, and Parallel Controlled Trial

    Institute of Scientific and Technical Information of China (English)

    Xian-Long Zhang; Jing Yang; Liu Yang; Jian-Guo Liu; Xin-Yu Cai; Wei-Ming Fan; Xue-Qing Yun

    2016-01-01

    Background:Knee osteoarthritis (KOA) is a chronic joint disease that manifests as knee pain as well as different degrees of lower limb swelling,stiffness,and movement disorders.The therapeutic goal is to alleviate or eliminate pain,correct deformities,improve or restore joint functions,and improve the quality of life.This study aimed to evaluate the efficacy and safety of Zhuanggu joint capsules combined with celecoxib and the benefit of treatment with Zhuanggu alone for KOA.Methods:This multi-center,randomized,double-blind,double-dummy,parallel controlled trial,started from December 2011 to May 2014,was carried out in 6 cities,including Beijing,Shanghai,Chongqing,Changchun,Chengdu,and Nanjing.A total of 432 patients with KOA were divided into three groups (144 cases in each group).The groups were treated,respectively,with Zhuanggu joint capsules combined with celecoxib capsule simulants,Zhuanggu joint capsules combined with celecoxib capsules,and celecoxib capsules combined with Zhuanggu joint capsule simulants for 4 weeks consecutively.The improvement of Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index and the decreased rates in each dimension of WOMAC were evaluated before and after the treatment.Intergroup and intragroup comparisons of quantitative indices were performed.Statistically significant differences were evaluated with pairwise comparisons using Chi-square test (or Fisher's exact test) and an inspection level ofα =0.0167.Results:Four weeks after treatment,the total efficacies of Zhuanggu group,combination group,and celecoxib group were 65%,80%,and 64%,respectively,with statistically significant differences among the three groups (P =0.005).Intergroup pairwise comparisons showed that the total efficacy of the combination group was significantly higher than that of the Zhuanggu (P =0.005) and celecoxib (P =0.003)groups.The difference between the latter two groups was not statistically significant (P > 0.0167).Four weeks

  14. Evidence Based Studies in Clinical Transfusion Medicine

    NARCIS (Netherlands)

    A.J.G. Jansen (Gerard)

    2007-01-01

    textabstractAfter the introduction of blood component therapy in the 1960s, more and more attention is given to clinical transfusion medicine. Although blood transfusion is an important treatment in different clinical settings, there are still lack of much randomized clinical trials. Nowadays bloo

  15. [Purine metabolism in ankylosing spondylitis: clinical study].

    Science.gov (United States)

    Jiménez Balderas, F J; Robles, E J; Juan, L; Badui, E; Arellano, H; Espinosa Said, L; Mintz Spiro, G

    1989-01-01

    We undertook a prospective study of 23 male patients with Ankylosing Spondylitis (AS) (New York Criteria), 18 HLA-B27 positive and 5 HLA-B27 negative, five of them had hyperuricemia. The following data of evolution were taken into consideration: age at onset of disease, time course of the disease, presence of urolithiasis, heart disease, flares of uveitis. Clinical activity and degree of disability were evaluated every one to 3 months; on each visit, every patient had determinations of serum and urinary uric acid levels, serum and phosphorus, erythrocyte sedimentation rate (ESR), serum protein electrophoresis, as well as X-ray films of the vertebral spine and pelvis. Three groups of patients were detected, all of them with equal age at onset, duration of disease, frequency of B27, peripheral arthritis, and leukocytosis. One group had hyperuricemia (5 of 23 patients, 80% of them HLA-B27 positive) and a lesser degree of clinical activity of the disease (p less than .001, a higher frequency of uveitis (40%, lower levels of serum gammaglobulins (p less than 0.05) and ESR (p less than 0.05), a lesser degree of ankylosis of the spine, and a better functional prognosis than the other groups. Another group (8 of 23 patients, 75% of them were HLA-B27 positive) had normouricemia and hyperuricosuria, and showed a higher frequency of fever (50%), an abnormal urinalysis, and urolithiasis (25%).

  16. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  17. A CLINICAL STUDY OF OCULAR TRAUMA

    Directory of Open Access Journals (Sweden)

    Bharat Kumar

    2015-12-01

    Full Text Available AIM This study is designed to enumerate various causes of ocular trauma, clinical spectrum of presentation and to evaluate the visual outcome after appropriate management. MATERIALS AND METHODS A prospective study was conducted on total of 136 patients from the places in and around Kakinada, East Godavari District of Andhra Pradesh, India. A detailed work up of all patients including slit lamp biomicroscopy, direct, indirect ophthalmoscopy and ultra sonography B scan was done. RESULTS Observations from the study were analyzed, discussed and compared with the existing studies in the literature. Mean age group of patients belong to young adults between 20-30 years (57.9%, males (81% affected more than females. Illiterates, Agricultural labourers, Industrial workers affected more. Road Traffic Accidents (25.73%, industrial injuries (22.05% and agricultural hazards (19.11% being the major cause of unilateral eye injury. Closed globe injuries (80.88% more common than Open globe injuries (19.12. CONCLUTIONS Ophthalmic injuries due to innumerable causes results in various types of ocular trauma, leading to untold misery, visual impairment and economic burden to the family, society and country as a whole. Health education regarding use of preventive measures, seeking early treatment and appropriate rehabilitation are very much recommended to reduce the burden of morbidity due to ocular trauma.

  18. Bioavailability studies and the clinical pharmacologist: correlation of drug distribution with clinical effects.

    Science.gov (United States)

    Ogilvie, R I

    1975-06-01

    Bioavailability studies can be interpreted only when clinical information is available which correlates drug distribution with both efficacious and toxic clinical effects. The clinical pharmacologist should be instrumental in the development of safe and effective drug therapy by the systematic application of well designed clinical trials, the clear definition of therapeutically desirable clinical responses, and the development and application of improved techniques of measuring these effects.

  19. Oxymatrine therapy for chronic hepatitis B: A randomized double-blind and placebo- controlled multi- center trial

    Institute of Scientific and Technical Information of China (English)

    Lun-Gen Lu; Wei-Min She; Xiong Cai; Jun Ye; Xia-Qiu Zhou; Hui Wang; Sham-Ming Wu; Mei-Fang Tang; Jin-Shui Zhu; Wei-Xiong Chen; Hui-Quan Zhang; Min-De Zeng; Yi-Min Mao; Ji-Qiang Li; Mo-Bin Wan; Cheng-Zhong Li; Cheng-Wei Chen; Qing-Chun Fu; Ji-Yao Wang

    2003-01-01

    AIM: To evaluate the efficacy and safety of capsule oxymatrine in the treatment of chronic hepatitis B.METHODS: A randomised double-blind and placebocontrolled multicenter trial was conducted. Injection of oxymatrine was used as positive-control drug. A total of 216 patients with chronic hepatitis B entered the study for 24 weeks, of them 108 received capsule oxymatrine, 36 received injection of oxymatrine, and 72 received placebo.After and before the treatment, clinical symptoms, liver function, serum hepatitis B virus markers, and adverse drug reaction were observed.RESULTS: Among the 216 patients, six were dropped off,and 11 inconsistent with the standard were excluded.Therefore, the efficacy and safety of oxymatrine in patients were analysed. In the capsule treated patients, 76.47 % became normal in ALT level, 38.61% and 31.91% became negative both in HBV DNA and in HBeAg. In the injection treated patients, 83.33 % became normal in ALT level,43.33 % and 39.29 % became negative both in HBV DNA and in HBeAg. In the placebo treated patients, 40.00 % became normal in ALT level, 7.46 % and 6.45 % became negative both in HBV DNA and in HBeAg. The rates of complete response and partial response were 24.51% and 57.84 % in the capsule treated patients, and 33.33 % and 50.00 % in the injection treated patients, and 2.99 % and 41.79 % in the placebo treated patients, respectively.There was no significance between the two groups of patients, but both were significantly higher than the placebo. The adverse drug reaction rates of the capsule,injection and placebo were 7.77 %, 6.67 % and 8.82 %,respectively. There was no statistically significant difference among them.CONCLUSION: Oxymatrine is an effective and safe agent for the treatment of chronic hepatitis B.

  20. Statistical Issues in TBI Clinical Studies

    Directory of Open Access Journals (Sweden)

    Paul eRapp

    2013-11-01

    Full Text Available The identification and longitudinal assessment of traumatic brain injury presents several challenges. Because these injuries can have subtle effects, efforts to find quantitative physiological measures that can be used to characterize traumatic brain injury are receiving increased attention. The results of this research must be considered with care. Six reasons for cautious assessment are outlined in this paper. None of the issues raised here are new. They are standard elements in the technical literature that describes the mathematical analysis of clinical data. The purpose of this paper is to draw attention to these issues because they need to be considered when clinicians evaluate the usefulness of this research. In some instances these points are demonstrated by simulation studies of diagnostic processes. We take as an additional objective the explicit presentation of the mathematical methods used to reach these conclusions. This material is in the appendices. The following points are made:1. A statistically significant separation of a clinical population from a control population does not ensure a successful diagnostic procedure.2. Adding more variables to a diagnostic discrimination can, in some instances, actually reduce classification accuracy.3. A high sensitivity and specificity in a TBI versus control population classification does not ensure diagnostic successes when the method is applied in a more general neuropsychiatric population. 4. Evaluation of treatment effectiveness must recognize that high variability is a pronounced characteristic of an injured central nervous system and that results can be confounded by either disease progression or spontaneous recovery. A large pre-treatment versus post-treatment effect size does not, of itself, establish a successful treatment.5. A procedure for discriminating between treatment responders and nonresponders requires, minimally, a two phase investigation. This procedure must include a

  1. Comparing the effectiveness of a clinical registry and a clinical data warehouse for supporting clinical trial recruitment: a case study.

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-11-13

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost.

  2. CLINICAL STUDY OF EARLY BREAST CARCINOMA

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    Kiran Kumar

    2016-01-01

    Full Text Available Carcinoma of the breast is one of the commonest cancers occurring in female and accounts for 1/3rd of all the malignant diseases occurring in them. It is mainly a disease of the developed countries and accounts for 1,00,000 deaths annually. Breast carcinoma is classified as Early breast cancer, Locally advanced breast cancer and Metastatic breast cancer. By definition early stage breast cancer constitutes breast tumors of clinical stages I, IIa and T2N1M0. Early breast cancer is the one diagnosed by mammography. Women when approaches at this stage, they can go for breast conservation surgery. Not all women are candidates for this approach, and some require mastectomy as part of their treatment. AIM To observe the incidence of early breast carcinoma with particular reference to the time taken by the patients to seek medical advice after the symptoms have developed i.e. the average time taken by the patients to seek medical advice, their appropriate management and prognosis. MATERIALS AND METHODS This prospective study was conducted over a period of 2 years from Oct-2012 to Oct-2014 in 30 female patients aged between 25-65 years who were presented with lump in breast of size ≤5cms with or without pain, with or without lymph nodes to the outpatient department. All the patients were thoroughly asked about history, examined clinically, investigated, staged and managed by surgery either Breast Conservation Surgery or Modified Radical Mastectomy. Postoperative complications were recorded and followed up regularly. RESULTS The incidence of early breast cancer in this study was 0.98% with peak age incidence between 40-60 years and duration of symptoms <6 months in 18 patients. Breast Conservation Surgery + axillary dissection + Radiotherapy was done in 23%. Prognosis was good in these patients with no local recurrence and death. CONCLUSION The prognosis of early stage breast carcinoma patients in this study was good. To have long term tumor free and

  3. CLINICAL STUDY OF HEART DISEASE COMPLICATING PREGNANCY

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    Richa

    2014-07-01

    Full Text Available Introduction-Heart disease complicating pregnancy is considered as a high risk situation. Increased cardiac demands during the course of pregnancy potentially increase morbidity and mortality in women with underlying heart disease. AIM: To determine maternal and fetal outcome in women with heart disease complicating pregnancy, To emphasize on proper protocol for managing pregnancy complicated by heart disease, To correlate the time of booking & NYHA grading with maternal & fetal outcome. Risk of adverse outcome is more in rural population as compared to its urban counterpart. METHOD: A prospective clinical study of 25 cases of pregnancy complicated by heart disease, reporting to tertiary care hospital for delivery, was carried out to find out the incidence and maternal and fetal outcome. RESULTS: The incidence of heart disease in pregnancy in the present study was 0.6%. Most of the women (91% belonged to low socioeconomic class in the rural population. Rheumatic heart lesions constituted 77% of the cases. Mitral stenosis was the commonest lesion in 40% of cases. Ten (40% women delivered spontaneously vaginally at term. Cesarean section was performed in 14 cases (56%. There were 5 maternal deaths. There were no perinatal deaths. CONCLUSION: Early diagnosis of heart disease, regular antenatal check-up, institutional delivery, limiting family size can reduce the maternal and perinatal mortality and morbidity associated with heart disease

  4. A CLINICAL STUDY ON GASTRIC OUTLET OBSTRUCTION

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    Latchu

    2015-11-01

    Full Text Available INTRODUCTION Gastric outlet obstruction (GOO is obstruction in the first part of duodenum secondary to cicatrised duodenal ulcer or proximally where the diagnosis of carcinoma is most probable. GOO can be a diagnostic and treatment dilemma. Once a mechanical obstruction is confirmed, differentiate between benign and malignant processes. Cicatrized duodenal ulcer was the most common cause of GOO. But with increased awareness, change in the dietary habits and availability of H2 receptor blockers and Proton Pump Inhibitors and H pylori kits all have resulted in decreased incidence of patients requiring surgery and also the complications like pyloric stenosis have reduced. At the same time the incidence of antral carcinoma of stomach producing GOO has comparatively increased, which may be due to increased early diagnosis of the condition with the help of flexible fibro optic endoscope. AIMS & OBJECTIVES To study and identify the cause of cases of GOO with respect to benign peptic ulcer and malignancy of stomach. MATERIALS AND METHODS An observational study comparing of 30 cases of GOO. An elaborate study of the cases with regard to history, clinical features, routine and special investigation, pre operative treatment, operative findings, post operative management and complications in the post operative period is done. Apart from routine surgical profile special investigations like serum electrolytes, barium meal study, Upper GI Endoscopy and ultrasound abdomen and pelvis will be carried. For peptic ulcer disease truncal vagotomy with posterior gastrojejunostomy was done and for carcinoma partial gastrectomy with Billroth II reconstruction or anterior GJ or palliative resection with anterior GJ were done. INCLUSION CRITERIA 1. Peptic ulcer disease 2. Carcinoma pyloric antrum, 3. Benign neoplasm of stomach. EXCLUSION CRITERIA 1. Carcinoma stomach with liver metastasis, ascites, peritoneal implantation, 2. Gastro duodenal tuberculosis. ETHICAL ISSUES

  5. Assessment effect of central venous pressure in fluid resuscitation in the patients with shock: a multi-center retrospective research

    Institute of Scientific and Technical Information of China (English)

    HU Bo; XIANG Hu; LIANG Hui; YU Li; XU Tao; YANG Jun-hui; DU Zhao-hui

    2013-01-01

    Background Central venous pressure (CVP) and intrathoracic blood volume index (ITBVI) were used to assess the fluid status.It has previously been shown that CVP is not as accurate as ITBVI for all the shock patients.We therefore hypothesized that the change of CVP has the ability to predict fluid responsiveness in some clinical cases of shock.Methods From September 1st 2009 to September 1st 2011,sixty-three patients with shock from different Intensive Care Unit (ICU) were collected into this retrospective study.All the patients received fluid challenge strategy (infusing 300 ml hydroxyethyl starch in 20 minutes),were monitored with CVP and pulse-indicated continuous cardiac output (PICCO).The correlation between changes in cardiac index (△CI),CVP (△CVP) and ITBVI (△ITBVI) were analyzed.Fluid responsiveness was defined as an increase in CI≥10%.Receiver operating characteristic (ROC) curves were generated for △CVP and △ITBVI.Results For all the patients,there was no correlation between △CI and △CVP (P=0.073),but in the subgroup analysis,the correlation between △CI and △CVP was significant in those younger than 60 years old (P=-0.018) and those with hypovolemic shock (P=0.001).The difference of areas under the ROC curves of △CVP and △ITBVI were not statistically significant in the group younger than 60 years old or hypovolemic shock group (P >0.05,respectively).However,no similar results can be found in the group older than 60 years old and the other two shock type groups from ROC curves of △CVP and △ITBVI.Conclusions △CVP is not suitable for evaluating the volume status of the shock patients with fluid resuscitation regardless of their condition.However,in some ways,△CVP have the ability to predict fluid responsiveness in the younger shock patients or in the hypovolemic shock patients.

  6. CLINICAL STUDY AND MANAGEMENT OF CHOLEDOCHOLITHIASIS

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    Suresh

    2014-10-01

    Full Text Available BACKGROUND AND OBJECTIVES: Choledocholithiasis complicates the working and management of cholelithiasis necessitating additional diagnostic procedures, increasing morbidity and mortality. CBD stone generally remain asymptomatic but when symptoms start appearing, cause a lot of suffering. There are various treatment modalities available presently. The objective of our study was to study the incidence, various modes of clinical presentations and different modalities of treatment in common bile duct stones. MATERIALS AND METHODS: 35 Patients were prospectively studied from July 2012 to June 2014 as in-patients in Victoria Hospital. RESULTS: CBD stones occurred predominantly in elderly females and presented from subclinical jaundice to complications in the form of biliary pancreatitis and cholangitis. USG abdomen with LFT was able to diagnose majority of the CBD stones preoperatively. Per operative cholangiogram was used selectively in case USG was inconclusive, ERCP was used in patients presenting with severe obstructive jaundice, pancreatitis, cholangitis, minimal CBD ductal dilation. Open exploration was the main focus with a wide variety of procedures performed according to specific indications. CONCLUSION: CBD was more common in elderly female patients probably due to neglected gall bladder stones. CBD stones can occur from occult asymptomatic stones only with altered LFT to symptomatic presentation in the form of cholangitis, pancreatitis. USG abdomen was inexpensive and easily available imaging modality to diagnose CBD stones with per operative cholangiogram being needed in minority of the cases. While ERCP was good in treating complications of CBD stones and early stages of the disease; the more advanced stage of the disease with gross CBD ductal dilation and multiple stones open CBD exploration were more productive.

  7. FETAL ECHOCARDIOGRAPHY: A STUDY OF CLINICAL OUTCOME

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    Rajanish

    2014-01-01

    Full Text Available BACKGROUND : S tructural abnormalities of the heart and great vessels are fairly common congenital lab normalities with the incidenceof8 in 1000 live births. With the advent of real time scanners fetal cardia can atomy can be analyze d echocardiographically. The earlier diagnosis will make an impact on clinical management of fetus with congenital heart disease. It helps intimely triage and optimal management of specific congenital heart disease either structural , functional orarrhythmia . OBJECTIVES : This study was conducted to note the spectrum of congenital heart diseases detected on fetal echo in pregnant mothers referred with high risk for CHD sand to assess the outcome of prenatally detected congenital heart diseases. MATERIAL S AND METHODS : T he study is aprospective descriptive study conducted in a tertiary care pediatric hospital in Mumbai over period of one year . P regnant mothers were referred for fetal echo , where pregnancy was considered as high risk for CHDs due to maternal , fetalfactorsorabnormallevel 1 scan.Fetal echowas performed by a trained pediatric cardiologistat 18 to 20 week of gestation using HP sonos 2000 echocardiographicmachinewith3/3.5 Hz transducer. Cardiac lesionsandoutcome of pregnancy was noted by postnatal follow - up of patients. RESULTS : A total of 170 patients underwent fetal echo , 13 patients have not delivered and 48 were lost to follow - up. Fetal echo was normal in 130(76.4% and abnormalities were detected in 40(23.5%.Structural anomalies were seen in 24(14.1% , arrhythmia in 5(2.9% and functional abnormalities in 11(6.4%.On outcome analysis84 (77.1% arealive , IUD /terminationof pregnancyoccurred in 18(16.5% , neonatal death in 6 (5.5% , infant death in 1 (0.9%. CONCLUSIONS : All ranges of CHDs can be diagnosed by fetal echocardiography . O utcome of prenatally detected complex congenital heart disease is poor ; nonetheless earlier detection provides a n opportunity for early interventions and

  8. Primary pontine hemorrhage. A clinical study

    Energy Technology Data Exchange (ETDEWEB)

    Saito, Jun; Kagimoto, Hiroshi; Maeda, Masanobu; Soda, Takao [Shimane Prefectural Central Hospital, Izumo (Japan)

    2002-07-01

    We studied the relationship between outcome and clinical symptoms or CT findings of 34 cases with primary pontine hemorrhage diagnosed by CT scan from April 1994 to March 1999. This series comprised 19 males and 15 females ranging in age from 45 to 89 years with a mean of 67.1 years. According to their outcome at discharge, the cases were divided into 6 groups. Sixteen cases died within 2 weeks after onset (group AD), 4 cases died with complication in the chronic phase (group D), 3 cases were severely disabled to bed-ridden state (group C), 2 cases recovered to a daily life with wheelchair (group B), 4 cases recovered to a daily life with partial assistance (group A), and 5 cases showed a full recovery (group J). The factors significantly correlated with bed outcome are as follows: young age, consciousness disturbance, respiratory disturbance, tachycardia over 90 beats per minute, hyperthermia over 39 deg C, abnormal pupils, loss of oculocephalic reflex, tetraplegia, decerebrate rigidity, bilateral extension or over 30 mm transverse diameter of the hematoma. (author)

  9. Nail alterations during pregnancy: a clinical study.

    Science.gov (United States)

    Erpolat, Seval; Eser, Ayla; Kaygusuz, Ikbal; Balci, Hatice; Kosus, Aydin; Kosus, Nermin

    2016-10-01

    During pregnancy, cutaneous and appendageal alterations manifest and may cause concern in the subject. The nails may be affected by pregnancy. This study investigated the frequency and nature of nail changes occurring during pregnancy in 312 healthy, 18-40-year-old pregnant women in gestation weeks 16-40. After a routine obstetric examination at the obstetrics and gynecology clinic at the study institution, all subjects submitted to an examination of all fingernails and toenails. Only nail alterations that had developed during pregnancy were recorded. Any nail changes that had occurred before the start of gestation were not considered. Data were presented as percentages. The Shapiro-Wilk and chi-squared tests were used to make categorical comparisons. A P-value of nail pathologies were detected in 116 (37.2%) of the 312 subjects. The most commonly found nail change was leukonychia (24.4%). Ingrown toenail (9.0%) and onychoschizia (9.0%) represented the second most common nail changes. Rapid nail growth and subungual hyperkeratosis were observed in 6.7% and 4.2%, respectively, of subjects. When the alterations were evaluated according to gestational age, the most common nail pathology was leukonychia at both 14-28 weeks (16.3%) and 29-42 weeks (27.4%) of pregnancy. Leukonychia, onychoschizia, onycholysis, and brittle nail pathologies were frequently observed at 29-42 weeks of pregnancy (P = 0.047). A large proportion of nail changes that occur during pregnancy are benign and do not require treatment. However, these changes may cause significant cosmetic stress in women.

  10. CLINICAL STUDY OF FISTULA IN ANO

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    Raj

    2015-10-01

    Full Text Available Fistula in Ano is a benign treatable lesion of the rectum and the anal canal. Cryptoglandular infection accounts for about 90% of these cases. Majority of the infections are Acute and a minority contributed by chronic low grade infection hence pointing to varying etiologies. The pathogenesis has been attributed to the bursting open of an acute or inadequately treated Anorectal abscess into the peri anal skin. Diagnosis of the condition can be made easily with a good source of light, a proctoscope and a meticulous digital examination. Establishing a cure in this condition is difficult owing to two reasons. Firstly, the site of the infection makes the patient reluctant to subject themselves to examination. Secondly, a significant percent of these diseases persist or recur when appropriate surgery is not done or when the post op care is inadequate. Mostly it affects the young and the middle age group thus affecting productive man hours and quality of life. MATERIALS AND METHODS: All cases of clinically diagnosed Fistulae-in-ano above the age of 12 years, admitted in various surgical units in K.R. Hospital (attached to Government Medical College, Mysore during the study period December 1, 2008 to May 31, 2010. REUSLTS: Age Incidence, Sex Incidence, Socio Economic Status, Modes of Presentation, No. of External Openings, Situation of External Openings, Level of Fistulae, Type of surgical treatment, Associated with Fissure in Ano, Postoperative complication and Results were studied. CONCLUSION: Commonest age of presentation in our series is 30-40 years – 40%. Males are more commonly affected. Ratio Male: Female::3:1, Disease is more commonly seen in people with lower socio economic status group. 80% High socio economic class 20%. Discharging sinus is the commonest mode of presentation 72% and pain 72% and 84% pass history of perianal abscess was the presenting symptoms.

  11. Clinical studies on inferior right hepatic veins

    Institute of Scientific and Technical Information of China (English)

    Xue Xing; Hong Li; Wei-Guo Liu

    2007-01-01

    BACKGROUND:Many small veins are called accessory, short hepatic veins in addition to the right, middle and left hepatic veins. The size of these veins varied from a pinhole to 1 cm; the size of inferior right hepatic veins (IRHVs) is thicker than that of short hepatic veins or more than 1 cm occasionally. Adults have a higher incidence rate of the IRHV. DATA SOURCES:A literature search of the PubMed database was conducted and research articles were reviewed. RESULTS:The size of IRHVs is related to the size of the right hepatic vein, i.e. the larger the diameter of the right hepatic vein, the smaller the diameter of the IRHVs, and vice versa. The IRHVs are divided into superior, medial and inferior groups, separately named the superior, medial and inferior right hepatic veins according to the position of the IRHV entering the inferior vena cava. The superior right hepatic vein mainly drains the superior part of segmentⅦ, and the medial right hepatic vein drains the middle part of segmentⅦ. A thicker IRHV mainly drains segmentⅥ and the inferior part of segmentⅦ and a thinner IRHV drains the inferior part of segmentⅤ. CONCLUSIONS:The clinical signiifcance of these studies on IRHVs is varied: (1) Hepatic caudate lobe resection could be introduced after study on the veins of that lobe. (2) It is very important to identify the draining region of the IRHV for guiding hepatic segmentectomy. The postero-inferior area of the right lobe can be preserved along with the hypertrophic IRHV even if the entire main right hepatic vein is resected during segmentectomy ofⅦ andⅧwith right hepatic vein resection for patients with primary liver cancer. (3) The ligation of the major hepatic vein for the treatment of juxtahepatic vein injury is recommended because of severe hemorrhagic shock and dififculty in

  12. Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

    Science.gov (United States)

    Chester, Victoria

    2011-01-01

    Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

  13. Reliability of PET/CT shape and heterogeneity features in functional and morphological components of Non-Small Cell Lung Cancer tumors: a repeatability analysis in a prospective multi-center cohort

    CERN Document Server

    Desseroit, Marie-Charlotte; Weber, Wolfgang; Siegel, Barry A; Rest, Catherine Cheze Le; Visvikis, Dimitris; Hatt, Mathieu

    2016-01-01

    Purpose: The main purpose of this study was to assess the reliability of shape and heterogeneity features in both Positron Emission Tomography (PET) and low-dose Computed Tomography (CT) components of PET/CT. A secondary objective was to investigate the impact of image quantization.Material and methods: A Health Insurance Portability and Accountability Act -compliant secondary analysis of deidentified prospectively acquired PET/CT test-retest datasets of 74 patients from multi-center Merck and ACRIN trials was performed. Metabolically active volumes were automatically delineated on PET with Fuzzy Locally Adaptive Bayesian algorithm. 3DSlicerTM was used to semi-automatically delineate the anatomical volumes on low-dose CT components. Two quantization methods were considered: a quantization into a set number of bins (quantizationB) and an alternative quantization with bins of fixed width (quantizationW). Four shape descriptors, ten first-order metrics and 26 textural features were computed. Bland-Altman analysi...

  14. A hybrid framework of first principles molecular orbital calculations and a three-dimensional integral equation theory for molecular liquids: Multi-center molecular Ornstein–Zernike self-consistent field approach

    Energy Technology Data Exchange (ETDEWEB)

    Kido, Kentaro, E-mail: kido.kentaro@jaea.go.jp [Nuclear Safety Research Center, Japan Atomic Energy Agency, 2-4 Shirane, Shirakata, Tokai-mura, Naka-gun, Ibaraki 319-1195 (Japan); Kasahara, Kento [Department of Molecular Engineering, Graduate School of Engineering, Kyoto University, Nishikyo-ku, Kyoto 615-8510 (Japan); Yokogawa, Daisuke [Department of Chemistry, Graduate School of Science, Nagoya University, Chikusa, Nagoya 464-8602 (Japan); Institute of Transformative Bio-Molecules (WPI-ITbM), Nagoya University, Chikusa, Nagoya 464-8062 (Japan); Sato, Hirofumi [Department of Molecular Engineering, Graduate School of Engineering, Kyoto University, Nishikyo-ku, Kyoto 615-8510 (Japan); Elements Strategy Institute for Catalysts and Batteries (ESICB), Kyoto University, Katsura, Kyoto 615-8520 (Japan)

    2015-07-07

    In this study, we reported the development of a new quantum mechanics/molecular mechanics (QM/MM)-type framework to describe chemical processes in solution by combining standard molecular-orbital calculations with a three-dimensional formalism of integral equation theory for molecular liquids (multi-center molecular Ornstein–Zernike (MC-MOZ) method). The theoretical procedure is very similar to the 3D-reference interaction site model self-consistent field (RISM-SCF) approach. Since the MC-MOZ method is highly parallelized for computation, the present approach has the potential to be one of the most efficient procedures to treat chemical processes in solution. Benchmark tests to check the validity of this approach were performed for two solute (solute water and formaldehyde) systems and a simple S{sub N}2 reaction (Cl{sup −} + CH{sub 3}Cl → ClCH{sub 3} + Cl{sup −}) in aqueous solution. The results for solute molecular properties and solvation structures obtained by the present approach were in reasonable agreement with those obtained by other hybrid frameworks and experiments. In particular, the results of the proposed approach are in excellent agreements with those of 3D-RISM-SCF.

  15. A CLINICAL STUDY OF STROKE IN YOUNG

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    Kumbha Thulasi Ram

    2015-02-01

    Full Text Available NTRIDUCTION : Stroke is one of the important causes of morbidity and mortality all over the world. Incidence of stroke steadily increases with age. Experts are concerned of the emerging stroke epidemic in India. Stroke affecting the young has potentially devastating consequence son the individual and his family. Certain risk factors are unique to the young. I t needs more studies for identification and modification of risk factors. The study aims to evaluate clinical features, risk factors, etiology and mortality of stroke in young patients. METHODS : 74 young patients satisfying the inclusion criteria were included in this study. A detailed history was taken from young stroke patients, systemic examination and required investigations were done. Data was collected in standardized proforma and analysed. RESULTS: Stroke in young accounts for 7.95% of stroke cases of all age groups. The mean age of the patients was 34.66 ± 7.48 years. Among 74 patients, 47(63.51% were male and 27(36.49% were female. Seizures, decreased consciousness, speech involvement and motor deficit were observed in 33.78%, 44.59%, 22.97% and 100% of cases respectively. 82.43% patients had ischemic and 17.57% patients had hemorrhagic stroke. Among ischemic stroke, large artery atherosclerosis was 16.21%, tuberculous meningoencephalitis with vasculitis was 16.21%, lacunar stroke was 10.81%, CVT was 10.81% and cardio embolic stroke was 6.76%. Smoking (59.45%, alcoholism (58.10%, hypertension (43.24%, coronary artery disease (8.10%, diabetes mellitus (10.81%, elevated total cholesterol (25.67%, elevated low density lipo proteins (22.97%, elevated triglycerides (27.02% and low HDL (22.97% were important risk factors. Carotid doppler was abnormal in 9.45% of patients. 6.76% patients had mitral stenosis in echocardiogram. Low protein C and protein S were found in 1.35% of patients. Eight (10.81% patients died during the hospital stay. INTERPRETATION AND CONCLUSIONS: The major risk

  16. Efficacy of extended cefquinome treatment of clinical Staphylococcus aureus mastitis

    NARCIS (Netherlands)

    Swinkels, J. M.; Cox, P.; Schukken, Y. H.; Lam, T. J G M

    2013-01-01

    Clinical Staphylococcus aureus mastitis is difficult to cure. Extended antimicrobial treatment is often advocated as a practical approach to improve cure rates; however, scientific evidence of this hypothesis is lacking. A multi-centered, nonblinded, randomized, positive-controlled clinical trial wa

  17. [Changing surgical therapy because of clinical studies?].

    Science.gov (United States)

    Schwenk, W; Haase, O; Müller, J M

    2002-04-01

    The randomised controlled clinical trial (RCT) is a powerful instrument to evaluate different therapeutic regimens. In a survey among 115 physicians visiting the 25th annual meeting of the Surgical Society of Berlin and Brandenburg, the RCT was judged to be very important when changes of therapeutic strategies are discussed. 90 % of all participants claimed to use data from RCTs in the clinical routine and 89 % would participate in such a trial. In official (e. g. discussions during coffee breaks at scientific meetings) or non-medical (e. g. non-scientific press or media) sources of information were assessed as irrelevant for decisions regarding therapeutic strategies. However, in contrast to this view laparoscopic cholecystectomy was introduced into clinical practice rapidly because patients informed by external (non-medical) sources preferred to be operated on with the "modern" technique. Clinical trials with a high level of evidence had no relevant influence on the rapid distribution of laparoscopic cholecystectomy. Controversial discussions concerning the extent of lymphadenectomy with gastric resection for carcinoma demonstrate that the value of excellent clinical RCTs is low if their results challenge a stable paradigma of the surgical scientific society. To allow a rational judgement, new surgical technologies should undergo a scientific gradual evaluation in agreement with the principles of evidence based medicine.

  18. Cloudwave: distributed processing of "big data" from electrophysiological recordings for epilepsy clinical research using Hadoop.

    Science.gov (United States)

    Jayapandian, Catherine P; Chen, Chien-Hung; Bozorgi, Alireza; Lhatoo, Samden D; Zhang, Guo-Qiang; Sahoo, Satya S

    2013-01-01

    Epilepsy is the most common serious neurological disorder affecting 50-60 million persons worldwide. Multi-modal electrophysiological data, such as electroencephalography (EEG) and electrocardiography (EKG), are central to effective patient care and clinical research in epilepsy. Electrophysiological data is an example of clinical "big data" consisting of more than 100 multi-channel signals with recordings from each patient generating 5-10GB of data. Current approaches to store and analyze signal data using standalone tools, such as Nihon Kohden neurology software, are inadequate to meet the growing volume of data and the need for supporting multi-center collaborative studies with real time and interactive access. We introduce the Cloudwave platform in this paper that features a Web-based intuitive signal analysis interface integrated with a Hadoop-based data processing module implemented on clinical data stored in a "private cloud". Cloudwave has been developed as part of the National Institute of Neurological Disorders and Strokes (NINDS) funded multi-center Prevention and Risk Identification of SUDEP Mortality (PRISM) project. The Cloudwave visualization interface provides real-time rendering of multi-modal signals with "montages" for EEG feature characterization over 2TB of patient data generated at the Case University Hospital Epilepsy Monitoring Unit. Results from performance evaluation of the Cloudwave Hadoop data processing module demonstrate one order of magnitude improvement in performance over 77GB of patient data. (Cloudwave project: http://prism.case.edu/prism/index.php/Cloudwave).

  19. [Clinical studies of pediatric malabsorption syndromes].

    Science.gov (United States)

    Hosoyamada, Takashi

    2006-11-01

    Multiple cases with various types of pediatric malabsorption syndromes were evaluated. The clinical manifestations, laboratory findings, pathophysiology, and histopathological descriptions of each patient were analyzed in an effort to clear the pathogenesis of the malabsorption syndromes and the treatments were undertaken. The cases studied, included one patient with cystic fibrosis, two with lactose intolerance with lactosuria (Durand type), one with primary intestinal lymphangiectasia, two with familial hypobetalipoproteinemia, one with Hartnup disease, one with congenital chroride diarrhea, one with acrodermatitis enteropathica, one with intestinal nodular lymphoid hyperplasia (NLH), five with intractable diarrhea of early infancy and four with glycogenosis type Ia. Each case description and outcome is described below: 1. A 15-year-old Japanese boy with cystic fibrosis presented with severe symptoms, including pancreatic insufficiency, bronchiectasis, pneumothorax and hemoptysis. His prognosis was poor. Analysis of the CFTR genes of this patient revealed a homozygous large deletion from intron 16 to 17b. 2. In the sibling case of Durand type lactose intolerance, the subjects'disaccaridase activity of the small bowel, including lactase, were within normal limits. The results of per oral and per intraduodenal lactose tolerance tests confirmed lactosuria in both. These observations suggested, not only an abnormal gastric condition, but also duodenal and intestinal mucosal abnormal permeability of lactose. 3. In the case of primary intestinal lymphangiectasia, the subject had a lymphedematous right arm and hand, a grossly coarsened mucosal pattern of the upper gastrointestinal tract (identified via radiologic examination) and the presence of lymphangiectasia (confirmed via duodenal mucosal biopsy). The major laboratory findings were hypoalbuminemia, decreased immunoglobulin levels and lymphopenia resulting from loss of lymph fluid and protein into the gastro

  20. A CLINICAL AND MICROBIAL STUDY OF OTOMYCOSIS: AN ORIGINAL STUDY

    Directory of Open Access Journals (Sweden)

    Prakash

    2015-09-01

    Full Text Available Otomycosis or “Otitis externa myotica” refers to a fungal or yeast infection of the external auditory meatus. Fungi can be isolated in up to 40 percent of all cases of external otitis, especially “Aspergillus niger and Candida albicans”. It has a worldwide distribution with higher prev alence in the hot, humid and dusty climate of the tropical and subtropical regions and sometimes in association with immunosuppression and poor hygienic conditions. The purpose of this study is to analyse the etiology, clinical manifestations, microbial pa ttern of otomycosis and treatment.

  1. Clinical study to evaluate the safety and effectiveness of the Aesculap Activ-L™ artificial disc in the treatment of degenerative disc disease

    Directory of Open Access Journals (Sweden)

    Mo Fred F

    2010-04-01

    Full Text Available Abstract Background The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The hypothesis of the study is that the Activ-L Disc is non-inferior to the control (the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes Spine] with respect to the rate of individual subject success at 24 months. Individual subject success is a composite of effectiveness and safety. Methods/Design The study proposed is a prospective, randomized, single-masked, controlled, multi-center clinical trial consisting of an estimated 414 subjects with single-level DDD of the lumbar spine (L4/L5, or L5/S1 who have failed to improve with conservative treatment for at least six months prior to enrollment. After enrollment, subjects will be randomized in a 2:1 ratio to either the Activ-L Disc (investigational device or the control (Charité or ProDisc-L. Radiographic endpoints will be evaluated by an independent reviewer at an imaging core laboratory. Each subject will be followed for 5 years post-treatment. Discussion The safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine will be equivalent to Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes Spine] at 24 months. Trial Registration Current Controlled Trials NCT00589797.

  2. New graduate nurses' clinical competence, clinical stress, and intention to leave: a longitudinal study in Taiwan.

    Science.gov (United States)

    Cheng, Ching-Yu; Tsai, Hsiu-Min; Chang, Chia-Hao; Liou, Shwu-Ru

    2014-01-01

    This longitudinal research study aimed to develop a pregraduation clinical training program for nursing students before graduation and evaluate its effect on students' self-perceived clinical competence, clinical stress, and intention to leave current job. A sample of 198 students returned the questionnaires before and after the program. They were followed up at 3, 6, and 12 months after graduation. Results showed that posttest clinical competence was significantly higher than pretest competence, positively related to clinical competence at 3 and 12 months, and negatively related to clinical stress at 3 months. The clinical competence at 3 months was positively related to clinical competence at 6 and 12 months, and clinical competence at 6 months was related to intention to leave at 12 months. Intention to leave at 6 months was positively related to intention to leave at 3 and 12 months. Clinical stress at 3 months was positively related to clinical stress at 6 and 12 months, but not related to intention to leave at any time points. The training program improved students' clinical competence. The stressful time that was correlated with new graduate nurses' intention to leave their job was between the sixth and twelfth months after employment.

  3. A Multi-Center, Qualitative Assessment of Pediatrician and Maternal Perspectives on Rotavirus Vaccines and the Detection of Porcine circovirus

    Directory of Open Access Journals (Sweden)

    Locke David

    2011-09-01

    Full Text Available Abstract Background In 2010, researchers using novel laboratory techniques found that US-licensed rotavirus vaccines contain DNA or DNA fragments from Porcine circovirus (PCV, a virus common among pigs but not believed to cause illness in humans. We sought to understand pediatricians' and mothers' perspectives on this finding. Methods We conducted three iterations of focus groups for pediatricians and non-vaccine hesitant mothers in Seattle, WA, Cincinnati, OH, and Rochester, NY. Focus groups explored perceptions of rotavirus disease, rotavirus vaccination, and attitudes about the detection of PCV material in rotavirus vaccines. Results Pediatricians understood firsthand the success of rotavirus vaccines in preventing severe acute gastroenteritis among infants and young children. They measured this benefit against the theoretical risk of DNA material from PCV in rotavirus vaccines, determining overall that the PCV finding was of no clinical significance. Particularly influential was the realization that the large, randomized clinical trials that found both vaccines to be highly effective and safe were conducted with DNA material from PCV already in the vaccines. Most mothers supported the ideal of full disclosure regarding vaccination risks and benefits. However, with a scientific topic of this complexity, simplified information regarding PCV material in rotavirus vaccines seemed frightening and suspicious, and detailed information was frequently overwhelming. Mothers often remarked that if they did not understand a medical or technical topic regarding their child's health, they relied on their pediatrician's guidance. Many mothers and pediatricians were also concerned that persons who abstain from pork consumption for religious or personal reasons may have unsubstantiated fears of the PCV finding. Conclusions Pediatricians considered the detection of DNA material from PCV in rotavirus vaccines a "non-issue" and reported little hesitation in

  4. Treosulfan-Based Conditioning and Hematopoietic Cell Transplantation for Nonmalignant Diseases: A Prospective Multi-Center Trial

    Science.gov (United States)

    Burroughs, Lauri M.; Nemecek, Eneida R.; Torgerson, Troy R.; Storer, Barry E.; Talano, Julie-An; Domm, Jennifer; Giller, Roger H.; Shimamura, Akiko; Delaney, Colleen; Skoda-Smith, Suzanne; Thakar, Monica S.; Baker, K. Scott; Rawlings, David J.; Englund, Janet A.; Flowers, Mary E. D.; Deeg, H. Joachim; Storb, Rainer; Woolfrey, Ann E.

    2015-01-01

    Hematopoietic cell transplantation (HCT) is effective in the treatment of patients with nonmalignant diseases and for many is the only known cure. Conventional myeloablative regimens have been associated with unacceptably high early transplant-related mortality (TRM) particularly in patients with co-morbid conditions. This prospective multicenter trial was designed to determine the safety and engraftment efficacy of treosulfan-based conditioning in patients with nonmalignant diseases. Thirty-one patients received HLA-matched related (n=4) or unrelated (n=27) grafts following conditioning with treosulfan (total dose: 42 g/m2), fludarabine (total dose: 150 mg/m2), ± thymoglobulin (6 mg/kg; n=22). Graft-versus-host disease (GVHD) prophylaxis consisted of tacrolimus and methotrexate. All patients engrafted. Day-100 TRM was 0%. With a median follow-up of 2 years, the 2-year survival was 90%. Three patients died of GVHD, recurrent hemophagocytic lymphohistiocytosis, and a surgical complication, respectively. The cumulative incidences of grades II–IV and III–IV acute GVHD at day 100 and chronic GVHD at 2 years were 62%, 10% and 21%, respectively. Patients who received thymoglobulin had a significantly lower incidence of grade III-IV acute GVHD (0% versus 33%; P = 0.005). These results indicate that the combination of treosulfan, fludarabine, and thymoglobulin is effective at establishing donor engraftment with low toxicity and improved survival in patients with nonmalignant diseases, and support the need for future disease-specific clinical trials. PMID:25196857

  5. Cryptogenic Polyneuropathy : Clinical, Environmental, And Genetic Studies

    OpenAIRE

    Lindh, Jonas

    2011-01-01

    Objectives: The purpose of this medical thesis was to describe the clinical and neurophysiological features and to evaluate the health related quality of life (HR-QoL) in patients with cryptogenic polyneuropathy. We also wanted to investigate different occupational, and leisure time exposures as determinants for cryptogenic polyneuropathy, and to analyze whether polymorphisms for the null alleles of Glutathione S-Transferase Mu-1 (GSTM1), and Theta-1 (GSTT1), and a low activity genetic variat...

  6. [Limitations and pitfalls of clinical studies in oncology].

    Science.gov (United States)

    Cerny, Thomas

    2008-01-01

    Nowadays results of clinical studies in oncology are often first found and commented in the news media because of their high relevance to the pharmaceutical market. The limits and pitfalls of clinical studies are manifold and not always appreciated even by specialists as well as journalists and politicians. The planning of a study is a most crucial phase, and most deficits are due to inappropriate design and conduct of a study. Adequate and skilful interpretation of a study is often hampered by many known but mostly overlooked variable pitfalls. Today there is an overrepresentation of pharmaceutically sponsored studies and a painful lack of well-designed academic studies with really meaningful endpoints for patient care. This paper touches several important aspects of today's shortcomings of clinical studies in oncology and highlights the importance of strengthening the academic clinical research. Evidence-based medicine needs to be more clinically relevant, and therefore we need well-designed, and critically interpreted studies in the future.

  7. Passenger Transportation in Multi-Center City Shenzhen%深圳市多中心空间结构下的客运交通组织

    Institute of Scientific and Technical Information of China (English)

    邓琪; 郭莉; 杨涛

    2015-01-01

    Urban area in Shenzhen has gradually transformed from a belt shape within the original Special Economic Zone into an outward radial-shaped city in the past three decades, which, to some extent, devi-ates the original urban development plan that calls for a multi-center development pattern. By summarizing the experience and lessons-learned from the interactive urban land use and transportation infrastructure de-velopment in Shenzhen, this paper proposes transportation system for a multi-center spatial development. Focusing on national, regional and urban passenger terminals, the paper emphasizes that context-sensitive concept should be introduced to the distribution of passenger terminals, which can match the intended ur-ban functional designs. Transportation arterial corridors should be developed to fit the urban structure of“three axis and two belt”, providing flexibility for future urban development. Based on the multi-center development plan and travel demand forecasting, the paper outlines the six transportation zones with differ-ent population and employment measures, public transit development goal, travel demand management strategy, and etc.%过去30年,深圳城市空间逐渐由原特区内的带状组团拓展至现阶段的全境轴带梯度推进,并出现与城市规划期望的多中心组团化相背离的发展趋势。总结深圳市城市空间拓展与交通设施布局互动发展历程中的经验及教训,提出多中心组团化空间结构下的交通组织模式。强调结合城市不同功能中心布局客运枢纽,重点关注全国性、区域性、全市性三个层级的客运枢纽。依托城市“三轴两带”形成骨干交通走廊,为未来空间发展预留弹性空间。基于多中心组团化空间发展愿景以及规划预测出行分析,划分六大交通政策分区,并给出不同分区的居住人口、就业岗位等指标,公共交通发展目标,以及需求管理措施等发展指引。

  8. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  9. CLINICAL AND INVESTIGATIONAL STUDY OF DIABETIC KETOACIDOSIS

    Directory of Open Access Journals (Sweden)

    Narasimham

    2015-06-01

    Full Text Available BACKGROUND AND OBJECTIVES: To compare the clinical features and biochemical profile in DKA. To assess the response in the patients with standard treatment of DKA. Clinical descriptions of polyuric states resembling diabetes mellitus have been described in the Ebers papyrus of Egypt in 15th century BC . 1,2 A yurvedic literature from the times of Charaka and Sushrutha, the ancient Indian physicians identified two forms of “MadhuMeha” ( H oneyed Urine in 400 BC . 3 John Rolo of England in 1797 was one of 1st who coined the term diabetes mellitus. William Prout of E ngland described diabetic coma during 1810 – 20. In 1886, Dreschfeld8 described DKA and HHNS (Hyper osmolar Hyperglycemic Non - ketotic Syndrome. In 1922 Banting , Best, Collip and Macleod isolated and clinically used insulin and later won Nobel prize for that memorable invention. SETTING: Inpatients of king George Hospital attached to Andhra Medical College, Visakhapatnam . METHODS: Diagnosis of diabetic ketoacidosis was made according to the inclusion criteria. Hyperglycemia >250 mg/dl, acidosis with blood pH <7.3, serum bicarbonate <15 mEq/l, urine positive for ketones. RESULTS: Of the 100 patients admitted for diabetic ketoacidosis; 84 had type 2 diabetes (84% and 16(16% were type I diabetes. Average age at the time of presentation was 42.9±12.9 years. Th e commonest precipitating factor was infection (56% followed by other factors (28% and irregular treatment (16%. The most common clinical features at the time of presentation were vomiting, abdominal pain, acidotic breathing and dehydration. The values for RBS, HCO3, and pH were 355.3±69.1, 14.9±3.4 and 7.2±0.1 respectively. INTERPRETATION AND CONCLUSION: Most common precipitating factors are infection and omission of insulin or irregular treatment. Most common clinical features at the time of presentati on are vomiting, abdominal pain, dehydration, acidotic breathing and tachycardia. Mortality rate in diabetic

  10. Neuroimaging, Genetics, and Clinical Data Sharing in Python Using the CubicWeb Framework

    Science.gov (United States)

    Grigis, Antoine; Goyard, David; Cherbonnier, Robin; Gareau, Thomas; Papadopoulos Orfanos, Dimitri; Chauvat, Nicolas; Di Mascio, Adrien; Schumann, Gunter; Spooren, Will; Murphy, Declan; Frouin, Vincent

    2017-01-01

    In neurosciences or psychiatry, the emergence of large multi-center population imaging studies raises numerous technological challenges. From distributed data collection, across different institutions and countries, to final data publication service, one must handle the massive, heterogeneous, and complex data from genetics, imaging, demographics, or clinical scores. These data must be both efficiently obtained and downloadable. We present a Python solution, based on the CubicWeb open-source semantic framework, aimed at building population imaging study repositories. In addition, we focus on the tools developed around this framework to overcome the challenges associated with data sharing and collaborative requirements. We describe a set of three highly adaptive web services that transform the CubicWeb framework into a (1) multi-center upload platform, (2) collaborative quality assessment platform, and (3) publication platform endowed with massive-download capabilities. Two major European projects, IMAGEN and EU-AIMS, are currently supported by the described framework. We also present a Python package that enables end users to remotely query neuroimaging, genetics, and clinical data from scripts. PMID:28360851

  11. Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multi-center survey

    Science.gov (United States)

    Zeiser, Robert; Burchert, Andreas; Lengerke, Claudia; Verbeek, Mareike; Maas-Bauer, Kristina; Metzelder, Stephan K.; Spoerl, Silvia; Ditschkowski, Markus; Ecsedi, Matyas; Sockel, Katja; Ayuk, Francis; Ajib, Salem; de Fontbrune, Flore Sicre; Na, Il-Kang; Penter, Livius; Holtick, Udo; Wolf, Dominik; Schuler, Esther; Meyer, Everett; Apostolova, Petya; Bertz, Hartmut; Marks, Reinhard; Lübbert, Michael; Wäsch, Ralph; Scheid, Christof; Stölzel, Friedrich; Ordemann, Rainer; Bug, Gesine; Kobbe, Guido; Negrin, Robert; Brune, Mats; Spyridonidis, Alexandros; Schmitt-Gräff, Annette; van der Velden, Walter; Huls, Gerwin; Mielke, Stephan; Grigoleit, Götz Ulrich; Kuball, Jürgen; Flynn, Ryan; Ihorst, Gabriele; Du, Jing; Blazar, Bruce R; Arnold, Renate; Kröger, Nicolaus; Passweg, Jakob; Halter, Jörg; Socié, Gerard; Beelen, Dietrich; Peschel, Christian; Neubauer, Andreas; Finke, Jürgen; Duyster, Justus; von Bubnoff, Nikolas

    2016-01-01

    Despite major improvements in allogeneic hematopoietic cell transplantation over the last decades, corticosteroid-refractory (SR) acute (a) and chronic (c) graft-versus-host disease (GVHD) cause high mortality. Pre-clinical evidence indicates the potent anti-inflammatory properties of the JAK1/2 inhibitor ruxolitinib. In this retrospective survey, 19 stem cell transplant centers in Europe and the United States reported outcome data from 95 patients who had received ruxolitinib as salvage-therapy for SR-GVHD. Patients were classified as having SR-aGVHD (n=54, all grade III or IV) or SR-cGVHD (n=41, all moderate or severe). The median number of previous GVHD-therapies was 3 for both SR-aGVHD (1–7) and SR-cGVHD (1–10). The ORR was 81.5% (44/54) in SR-aGVHD including 25 CRs (46.3%), while for SR-cGVHD the ORR was 85.4% (35/41). Of those patients responding to ruxolitinib, the rate of GVHD-relapse was 6.8% (3/44) and 5.7% (2/35) for SR-aGVHD and SR-cGVHD, respectively. The 6-month-survival was 79% (67.3%–90.7%,95% CI) and 97.4% (92.3%–100%,95% CI) for SR-aGVHD and SR-cGVHD, respectively. Cytopenia and CMV-reactivation were observed during ruxolitinib-treatment in both SR-aGVHD (30/54, 55.6% and 18/54, 33.3%) and SR-cGVHD (7/41, 17.1% and 6/41, 14.6%) patients. Ruxolitinib may constitute a promising new treatment option for SR-aGVHD and SR-cGVHD that should be validated in a prospective trial. PMID:26228813

  12. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    Science.gov (United States)

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2016-03-01

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy.

  13. Design and Anticipated Outcomes of the eMERGE-PGx Project: A Multi-Center Pilot for Pre-Emptive Pharmacogenomics in Electronic Health Record Systems

    Science.gov (United States)

    Rasmussen-Torvik, Laura J.; Stallings, Sarah C.; Gordon, Adam S.; Almoguera, Berta; Basford, Melissa A.; Bielinski, Suzette J.; Brautbar, Ariel; Brilliant, Murray; Carrell, David S.; Connolly, John; Crosslin, David R.; Doheny, Kimberly F.; Gallego, Carlos J.; Gottesman, Omri; Kim, Daniel Seung; Leppig, Kathleen A.; Li, Rongling; Lin, Simon; Manzi, Shannon; Mejia, Ana R.; Pacheco, Jennifer A.; Pan, Vivian; Pathak, Jyotishman; Perry, Cassandra L.; Peterson, Josh F.; Prows, Cynthia A.; Ralston, James; Rasmussen, Luke V.; Ritchie, Marylyn D.; Sadhasivam, Senthilkumar; Scott, Stuart A.; Smith, Maureen; Vega, Aida; Vinks, Alexander A.; Volpi, Simona; Wolf, Wendy A.; Bottinger, Erwin; Chisholm, Rex L.; Chute, Christopher G.; Haines, Jonathan L.; Harley, John B.; Keating, Brendan; Holm, Ingrid A.; Kullo, Iftikhar J.; Jarvik, Gail P.; Larson, Eric B.; Manolio, Teri; McCarty, Catherine A.; Nickerson, Deborah A.; Scherer, Steven E.; Williams, Marc S.; Roden, Dan M.; Denny, Joshua C.

    2014-01-01

    We describe here the design and initial implementation of the eMERGE-PGx project. eMERGE-PGx, a partnership of the eMERGE and PGRN consortia, has three objectives : 1) Deploy PGRNseq, a next-generation sequencing platform assessing sequence variation in 84 proposed pharmacogenes, in nearly 9,000 patients likely to be prescribed drugs of interest in a 1–3 year timeframe across several clinical sites; 2) Integrate well-established clinically-validated pharmacogenetic genotypes into the electronic health record with associated clinical decision support and assess process and clinical outcomes of implementation; and 3) Develop a repository of pharmacogenetic variants of unknown significance linked to a repository of EHR-based clinical phenotype data for ongoing pharmacogenomics discovery. We describe site-specific project implementation and anticipated products, including genetic variant and phenotype data repositories, novel variant association studies, clinical decision support modules, clinical and process outcomes, approaches to manage incidental findings, and patient and clinician education methods. PMID:24960519

  14. Oral mucocele: A clinical and histopathological study

    Science.gov (United States)

    More, Chandramani B; Bhavsar, Khushbu; Varma, Saurabh; Tailor, Mansi

    2014-01-01

    Background: Oral mucocele is the most common benign minor (accessory) salivary gland lesion, caused due to mechanical trauma to the excretory duct of the gland. Clinically they are characterized by single or multiple, soft, fluctuant nodule, ranging from the normal color of the oral mucosa to deep blue. It affects at any age and is equally present in both sexes with highest incidence in second decade of life. They are classified as extravasation or retention type. Objectives: To analyze the data between 2010 and 2011 of, clinically and histopathologically diagnosed 58 oral mucoceles for age, gender, type, site, color, cause, symptoms and dimension. Results: Oral mucoceles were highly prevalent in the age group of 15-24 years, were seen in 51.72% of males and 48.28% of females, with a ratio of 1.07:1. The extravasation type (84.48%) was more common than the retention type (15.52%). The most common affected site was lower lip (36.20%) followed by ventral surface of the tongue (25.86%). The lowest frequency was observed in floor of mouth, upper lip and palate. The maximum numbers of mucoceles were asymptomatic (58.62%), and the color of the overlying mucosa had color of adjacent normal mucosa (48.28%). It was also observed that most of the mucoceles had diameter ranging from 5 to 14 mm. The causative factors of the lesion were lip biting (22.41%), trauma (5.18%) and numerous lesions (72.41%). Conclusion: Oral Mucoceles are frequently seen in an oral medicine service, mainly affecting young people and lower lip, measuring around 5 to 14 mm and the extravasation type being the most common. PMID:25364184

  15. Relationship of daytime blood pressure and severity of obstructive sleep apnea among Chinese: a multi-center investigation in China

    Institute of Scientific and Technical Information of China (English)

    HE Quan-ying; WANG Bei; LIN Qi-chang; ZHANG Jing-nong; LIU Hui-guo; LUO Yuan-ming; LIU Jian-hong; WANG Shi; XIAO Gao-hui; LU Gan; ZHANG Jin; FENG Jing; FENG Xue-wei; CHEN Bao-yuan; ZHANG Xi-long; LIANG Zong-an; HUANG Shao-guang; KANG Jian; WANG Guang-fa; ZHANG Li-qiang; MA Li-jun

    2010-01-01

    Background Epidemiologic studies have shown an independent and definite association between obstructive sleep apnea (OSA) and hypertension. This study aimed to define the association between daytime blood pressure and severity of OSA in Chinese population in mainland of China. Methods Twenty university hospital sleep centers in mainland of China were invited by the Chinese Medical Association (CMA) to participate in this epidemiologic study and 2297 consecutive patients (aged 18-85 years; 1981 males and 316 females) referred to these twenty sleep centers for evaluation of OSA between January 2004 and April 2006 were prospectively enrolled. Nocturnal polysomnography was performed in each patient, and disease severity was assessed based on the apnea-hypopnea index (AHI). These patients were classfied into four groups: non-apneic control (control, n=257) with AHI ≤5 episodes/hour; mild sleep apnea (mild, n=402) with AHI >5 and ≤15 episodes/hour; moderate sleep apnea (moderate, n=460) with AHI >15 and ≤30 episodes/hour and severe sleep apnea (severe, n=1178) with AHI >30 episodes/hour. Daytime blood pressure measurements were performed under standardized conditions in each patient at 10 a.m. in office on the day of referring to sleep centers for getting average value. All the patients were requested to quit medications related to blood pressure for three days before the day of assessing.Results Both daytime systolic blood pressure and diastolic blood pressure values were significantly related to AHI positively (r = 0.201 and 0.276, respectively; both P values <0.001) and to nadir nocturnal oxygen saturation negatively (r= -0.215 and -0.277, respectively; both Pvalues <0.001), which were the parameters of OSA severity. In two special designed mean plots, means of daytime systolic and diastolic blood pressure increased gradually with increasing AHI. Beyond AHI of 61-65, this increasing trend reached a plateau.Conclusions The results showed that OSA severity was

  16. The Effect of Trimosan© Gel on Pessary-Associated Bacterial Vaginosis: A Multi-Center, Randomized, Controlled Trial

    Science.gov (United States)

    Meriwether, Kate V.; Rogers, Rebecca G.; Craig, Ellen; Peterson, Sean D.; Gutman, Robert E.; Iglesia, Cheryl B.

    2015-01-01

    Objectives Pessaries are important options for women with pelvic floor disorders, but many pessary users experience bacterial vaginosis (BV). The aim of this study was to evaluate the effect of TrimoSan© gel on BV prevalence among pessary users. Study Design Women presenting for a pessary fitting completed questionnaires on vaginal symptoms and hormone therapy (HT) use and underwent a BV® BLUE test and slide collection for BV analysis by Nugent's criteria. Following pessary fitting, women were randomized to either standard pessary care with the use of TrimoSan© placed vaginally twice weekly or to standard pessary care without TrimoSan© gel. Women returned 2 weeks and 3 months later for repeat slide collection for Gram stain, BV® BLUE testing, and completion of questionnaires on vaginal symptoms and desire to continue the pessary. Results There were 184 women randomized after successful fitting (92 to the TrimoSan© group), and 147 (79%) presented for 3 month follow up. Mean age was 56 ± 16 years; patients were mostly Caucasian (57%) or Hispanic (23%) and 36% were using HT. The groups did not differ in the prevalence of BV by Nugent's criteria at 2 weeks (20% TrimoSan© vs 26% no gel, p=0.46) or 3 months (24% TrimoSan© vs 23% no gel, p=0.82), nor did they differ in BV by BV® BLUE testing at 2 weeks (0%TrimoSan©vs 4% no gel, p=0.12) or 3 months (3% TrimoSan© vs 0% no gel, p=0.15). The prevalence of at least one vaginal symptom did not differ between groups at 2 weeks (44% TrimoSan© vs 45% no gel, p=0.98) or 3 months (42% TrimoSan© vs 32% no gel, p=0.30). The TrimoSan© group was equally likely to want to continue their pessary use compared to the standard care group at 2 weeks (90% vs 86%, p=0.64) and 3 months (63% vs 60%, p=0.76). Conclusions TrimoSan© gel in the first 3 months of pessary use does not decrease the prevalence of BV or vaginal symptoms and does not alter the likelihood of a woman desiring to continue pessary use. PMID:25935783

  17. Identification and Antifungal Susceptibility Profiles of Candida nivariensis and Candida bracarensis in a Multi-Center Chinese Collection of Yeasts

    Science.gov (United States)

    Hou, Xin; Xiao, Meng; Chen, Sharon C.-A.; Wang, He; Yu, Shu-Ying; Fan, Xin; Kong, Fanrong; Xu, Ying-Chun

    2017-01-01

    Candida nivariensis and C. bracarensis are two emerging cryptic species within the C. glabrata complex. Thirteen of these isolates from 10 hospitals in China were studied for their species identification and antifungal susceptibilities. Phenotypic and molecular [rDNA ITS sequencing, D1/D2 sequencing and ITS sequencer-based capillary gel electrophoresis (SCGE)] and matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS identification methods were compared for their performance in species identification. Twelve of 13 (92.3%) isolates were identified as C. nivariensis and one as C. bracarensis using ITS sequencing as the reference method. Results obtained by D1/D2 sequencing and ITS SCGE were concordant with ITS sequencing results for all (100%) isolates. SCGE was able to subtype 12 C. nivariensis into four ITS SCGE length types. All isolates failed to be identified by the Vitek MALDI-TOF MS system (bioMérieux), whilst the Bruker MS system (Bruker Daltoniks) correctly identified all C. nivariensis isolates but using a lowered (≥1.700) cut-off score for species assignment; the C. bracarensis isolate was identified but with score MALDI-TOF may be improved by adding mass spectral profiles (MSPs) into the current databases. The antifungal susceptibility profile of isolates should be monitored. PMID:28154553

  18. Multi-center evaluation of post-operative morbidity and mortality after optimal cytoreductive surgery for advanced ovarian cancer.

    Directory of Open Access Journals (Sweden)

    Arash Rafii

    Full Text Available PURPOSE: While optimal cytoreduction is the standard of care for advanced ovarian cancer, the related post-operative morbidity has not been clearly documented outside pioneering centers. Indeed most of the studies are monocentric with inclusions over several years inducing heterogeneity in techniques and goals of surgery. We assessed the morbidity of optimal cytoreduction surgery for advanced ovarian cancer within a short inclusion period in 6 referral centers dedicated to achieve complete cytoreduction. PATIENTS AND METHODS: The 30 last optimal debulking surgeries of 6 cancer centers were included. Inclusion criteria included: stage IIIc- IV ovarian cancer and optimal surgery performed at the site of inclusion. All post-operative complications within 30 days of surgery were recorded and graded using the Memorial secondary events grading system. Student-t, Chi2 and non-parametric statistical tests were performed. RESULTS: 180 patients were included. There was no demographic differences between the centers. 63 patients underwent surgery including intestinal resections (58 recto-sigmoid resection, 24 diaphragmatic resections, 17 splenectomies. 61 patients presented complications; One patient died post-operatively. Major (grade 3-5 complications requiring subsequent surgeries occurred in 21 patients (11.5%. 76% of patients with a major complication had undergone an ultraradical surgery (P = 0.004. CONCLUSION: While ultraradical surgery may result in complete resection of peritoneal disease in advanced ovarian cancer, the associated complication rate is not negligible. Patients should be carefully evaluated and the timing of their surgery optimized in order to avoid major complications.

  19. Corticosteroid myopathy: a clinical and pathological study.

    Science.gov (United States)

    Khaleeli, A A; Edwards, R H; Gohil, K; McPhail, G; Rennie, M J; Round, J; Ross, E J

    1983-02-01

    In six patients with Cushing's syndrome and three with steroid myopathy, the clinical, functional, biochemical and structural characteristics of myopathy are described. Proximal muscle weakness occurred in all the patients, preferentially affected the lower limbs and was accompanied by muscle wasting in all but one patient. Force measurements confirmed quadriceps weakness in every patient. Vastus lateralis muscle biopsies showed light microscopic abnormalities in two of three patients with steroid myopathy and one of five patients with Cushing's syndrome. Type II fibre atrophy was the commonest abnormality. Reduced type II mean fibre areas occurred in all the patients with steroid myopathy and were common in Cushing's syndrome patients. Type I mean fibre areas were also reduced in two of the former group and one of the latter group and two further patients in this group had areas at the lower end of the normal range. Abnormalities in electron microscopy, mitochondrial function tests and chemical content of skeletal muscle were frequent and are described and discussed. A plasma creatine kinase activity (CK) at the lower end of the normal range, a myopathic electromyogram (EMG) and a raised 24-h urinary 3-methylhistidine/creatinine ratio on a creatine free diet were other characteristic findings in both groups of patients.

  20. Clinical Study on Treatment of Infantile Rotaviral

    Institute of Scientific and Technical Information of China (English)

    魏连波; 李智军; 陈宝田; 栾图; 高云飞; 李吉来; 孙升云

    2001-01-01

    Objective: To observe the clinical effect of guava leaf (GL) in treating infantile rotaviral enteritis.Methods: Sixty-two patients of rotaviral enteritis were randomly divided into the treated group treated with GL and the control group treated with Gegen Qinlian Decoction. The time for ceasing diarrhea, content of Na+ in blood, content of Na+ and glucose in stool, and the rate of negative conversion of human rotavirus antigen (HRVA) were observed.Results: The 3-day recovery rate in the treated group (87.1%) was significantly higher than that in the control group (58.1%, P<0.05). The time of ceasing diarrhea in the treated group (25.1±9.5 hrs) was significantly shorter than that in the control group (38.7±15.2 hrs, P<0.01). Moreover, content of Na+ and glucose in stool were reduced obviously in the treated group but not in the control group; and negative conversion rate of HRVA in the former group also got better than that in the latter group (87.1% vs 58.1%, P<0.05). Consequently, the effect of GL was superior to that of the control significantly.Conclusion: GL has good curative effect on infantile rotaviral enteritis.

  1. Competence of novice nurses: role of clinical work during studying.

    Science.gov (United States)

    Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

    2015-01-01

    Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period.

  2. Bispectral index monitoring prevent awareness during total intravenous anesthesia: a prospective, randomized,double-blinded, multi-center controlled trial

    Institute of Scientific and Technical Information of China (English)

    ZHANG Chen; GUO Jian-rong; JIN Yao-jun; WU Gang; YUAN Wei; YUAN Zhi-guo; YUE Yun; XU Liang; MA Ya-qun; SUN Yan-xia; LI Yan-hong; ZHANG Liang; FENG Chun-sheng; LUO Bing; ZHAO Zhen-long

    2011-01-01

    Background Awareness is a serious complication of general anesthesia.In China,the incidence of intraoperative awareness was 1% in patients undergoing total intravenous anesthesia (TIVA).In this study,we compared the incidence of awareness between Bispectral index (BIS)-guided and routine TIVA protocol and evaluated the effect of BIS on preventing awareness.Methods A prospective,randomized,double-blinded,multicenter controlled trial was performed.Patients (≥18 years of age) undergoing TIVA were randomly divided into BIS-guided group (Group A,BIS was monitored and recommended to maintain between 40-60) and control group (Group B,BIS was monitored but the screen was covered).The intraoperative BIS values were downloaded and the BIS trends of confirmed awareness cases were analyzed to determine whether light anesthesia existed.Results Of the total 5228 patients,2919 patients were assigned to Group A and 2309 to Group B.Four cases of confirmed awareness (0.14%) were reported in the BIS-guided group and 15 (0.65%) in the control group (P=0.002,OR=0.21,95% confidence intervals:0.07-0.63).The incidence of possible awareness (0.14% vs.0.26%,P=0.485) and dreaming (3.1% vs.3.1%,P=0.986) was comparable between BIS-guided group and the control group.Among the 19 confirmed awareness cases,intraoperative BIS trends of six cases were downloaded and identified.Five of them showed signs of light anesthesia as BIS >60 and lasted 19-106 minutes,whereas one case had a stable BIS trend and the values were within 60 during the operation.Another five awareness cases were reviewed for anesthesia procedures,of which improper light anesthesia were confirmed.Conclusions BIS-guided TIVA (BIS was recommended to maintain between 40-60) decreased the risk of awareness compared with routine TIVA.The main reason for awareness was light anesthesia.

  3. Towards Data Value-Level Metadata for Clinical Studies.

    Science.gov (United States)

    Zozus, Meredith Nahm; Bonner, Joseph

    2017-01-01

    While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.

  4. Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

    Science.gov (United States)

    Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

    2017-01-01

    Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing

  5. Clinical Study of Tuina for Stiff Neck

    Institute of Scientific and Technical Information of China (English)

    吴耀持; 张峻峰; 汪崇淼; 王健雄; 张沈煜

    2009-01-01

    Objective: To observe the clinical effect of Tuina for stiffneck. Methods: All of 216 cases with stiff neck were randomly allocated into a tuina group (110 cases) and a control group (106 cases). The patients in the tuina group were treated with "Three Parts, Four Points,Five Manipulation" tuina therapy, while those in the control group were treated with pucturing Wailaogong (Ex-UE 8), Houxi (SI 3), Jianjing (GB 21) and Ashi points in the affected side,Once a day, and 3 times constitute one treatment course. The effect was observed after 2-course treatments. Result: The effective rate in the tuina group and the control group was 93.64% and 83.02%, respectively, and there was statistical difference between the two groups (P < 0.05).Conclusion: The tuina therapy of "Three Parts, Four Points, Five Manipulations" is better than simple acupuncture therapy in treating stiff neck.%目的:观察推拿治疗落枕的临床疗效.方法:将216例落枕患者随机分为推拿组110例和对照组106例,推拿组用"三部四穴五法"推拿法治疗,对照组针刺患侧外劳宫、后溪、肩井和阿是穴.每日1次,3次为1个疗程;治疗2个疗程后观察疗效. 结果:推拿组有效率为93.64%,对照组为83.02%,两者比较有统计学意义(P<0.05)结论:"三部四穴五法"推拿法治疗落枕明显优于单纯针刺疗法.

  6. CLINICAL STUDY OF ACUTE POISONING: A RETROSPECTIVE STUDY

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    Praveen

    2014-11-01

    Full Text Available : OBJECTIVES: To determine the common agents, clinical features and outcomes of acute poisoning. MATERIALS AND METHODS: A retrospective study of patients of acute poisoning of more than 14 years age admitted through emergency with a history of intentional, self-inflicted and suicidal poisoning in SRMS-IMS from Jan 2010 to Dec 2012. RESULTS: A total of 58 cases were included with a common age of affection 16 to 25 years and male to female ratio 1.63: 1. Poisoning cases occur throughout the year with maximum prevalence in May and minimum in June. Organophosphorus was the most common poison followed by aluminium phosphide. Vomiting was the most common symptoms followed by altered sensorium. 70.68% patients were discharged, 20.68% expired and 8.62% left against medical advice. Aluminium phosphide was the most common toxin consumed by dead patients. CONCLUSION: Acute poisoning is commonly affecting young population and is caused by variety of toxin. High mortality is associated with aluminum phosphide.

  7. CLINICAL AND EPIDEMIOLOGICAL STUDIES ON VASECTOMY

    Institute of Scientific and Technical Information of China (English)

    TANGGuang-Hua

    1989-01-01

    In order to ascertain whether vasectomy presented any increased risk of diseases or long-term sequelae, we conducted from 1981 to 82 a large scale cross sectional prevalence study on coronary heart disease, hypertension and other diseases following

  8. Best practices for clinical pathology testing in carcinogenicity studies.

    Science.gov (United States)

    Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

    2011-02-01

    The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

  9. Dutch transmural nurse clinics for chronic patients: a descriptive study.

    NARCIS (Netherlands)

    Temmink, D.; Francke, A.L.; Kerkstra, A.; Huyer Abu-Saad, H.

    2000-01-01

    'Transmural care' can be defined as patient-tailored care provided on the basis of close collaboration and joint responsibility between hospitals and home care organizations. One form of transmural care is transmural nurse clinics for chronically ill. This study describes 62 transmural nurse clinics

  10. Clinical rehabilitation of the amputee : A retrospective study

    NARCIS (Netherlands)

    Rommers, GM; Vos, LDW; Groothoff, JW; Eisma, WH

    1996-01-01

    The aim of this study was to determine the rehabilitation outcome of lower limb amputee patients after clinical rehabilitation. Altogether 183 amputee patients admitted for clinical rehabilitation in the years 1987-1991 were reviewed by retrospective analysis of medical record data. Three groups of

  11. Clinical and molecular studies on differentiated thyroid carcinoma management

    NARCIS (Netherlands)

    Abdulrahman Hareedy, Randa Mostafa

    2015-01-01

    This thesis describes clinical and fundamental studies addressing clinical challenges in patients with differentiated thyroid carcinoma (DTC). The diagnosis of DTC is hampered by the fact that although the incidence is low thyroid nodules are prevalent. In this thesis, the diagnostic value of a pote

  12. Regional enteritis and gluten-free diet. A clinical study

    NARCIS (Netherlands)

    Merwe, Christiaan Frederik van der

    1974-01-01

    The purpose of this clinical study was to determine whether the use of a gluten-free diet influenced the course and prognosis of regional enteritis. Following a few clinical communications in the Dutch medical literature reporting favourable results obtained with the gluten-free diet in the treatmen

  13. Incisional Hernia: An Experimental and Clinical Study

    NARCIS (Netherlands)

    M. van 't Riet (Martijne)

    2004-01-01

    markdownabstract__Abstract__ Incisional hernia is one of the most common long-term complications of abdominal surgery. In prospective studies with sufficient follow-up, incidences of incisional hernia after laparotomy up to 20% are reported. Incisional hernia can be defined as an internal abdominal

  14. Melanocytic nevi in children: A clinical study

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    Senthilkumar M

    2006-01-01

    Full Text Available BACKGROUND: Melanocytic nevi show different presentations in children which have not much studied in India. PURPOSES: To document the incidence and pattern of melanocytic nevi in children. METHODS: A total of 4,256 paediatric cases attending the dermatology OPD, JIPMER during the study period from August 2002 to August 2004 were screened for melanocytic nevi. FINDINGS: Out of these, 41 (0.96% cases were found to have melanocytic nevi. The mean age of these cases was 1.4 years (range of 3 days to 14 years. Fourteen (34.1% of them were males and 27 (65.9% were females with male to female ratio of 1:1.9. Majority of these cases (32 cases, 78% were in the age group of 0-1 year. Thirty-seven (90.2% cases had single lesion and 4 (9.8% cases had multiple lesions. The size of the nevi varied from 1.5 cm to 20 cm in 40 (97.6% cases and more than 20 cm in 1 (2.4% case. The most common site of involvement was the back (32 cases, 78% followed by head and neck (6 cases, 14.6%. Out of the total of 41 cases, 30 (73.2% were Mongolian spots, 8 (19.5% were congenital melanocytic nevi, one case (2.4% each had giant congenital melanocytic nevus, nevus spilus and nevus of Ota. Four cases had other associated cutaneous disorders. These included ashleaf macules in 2 cases, epidermolysis bullosa simplex in 1 case and a solitary case had both cafι-au-lait macule and mixed hemangioma. The systemic associations included seizures (suspected neurocutaneous melanosis in a solitary case of congenital melanocytic nevi. CONCLUSIONS: The spectrum of melanocytic nevi seen in children in this study partially differs from this of abroad studies. LIMITATION: Unicentre hospital-based study which cannot be generalized.

  15. CLINICAL STUDY OF PENETRATING INJURIES OF ABDOMEN

    OpenAIRE

    Raghu; Santhosh Babu; Devender

    2016-01-01

    Penetrating trauma forms an important component of surgical emergencies. The importance of this category becomes further apparent when one realises that most of such trauma victims are essentially healthy people and in the prime of their life. Over the past century, great advances were made in the management of such wounds. The operative management replaced the expectant therapy and reduced mortality rates. So this study is being done to evaluate the various indications for early ...

  16. CLINICAL STUDY OF LABOUR IN TWIN PREGNANCY

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    Amudha

    2015-07-01

    Full Text Available OBJECTIVES: The objective of the present study is to analyse the incidence of preterm labour, intrapartum complications, incidence of operative delivery both vaginal and cesarean and indications for such interventions. METHODOLOGY: A total of 150 cases of twin pregnancy were analyzed between the period of September 2012 to February 2014. These cases were stud ied with respect to period of gestation at the onset of labour, fetal presentations at the onset of labour, route and mode of delivery, indications in cases of cesarean delivery, intrapartum complications and delivery interval between twins. OBSERVATIONS A ND RESULTS: In the present study there was increased incidence of preterm labour (52.6%, fetal malpresentations (43.3%, operative vaginal delivery (29.5%, cesarean delivery (17.3%. CONCLUSION: In this study it is observed that above mentioned labour ev ents and complications double up in the event of a twin pregnancy. Regular antenatal visits, planned delivery and anticipation and identification of complications will help for better pregnancy outcome.

  17. Clinical study of nail changes in vitiligo.

    Science.gov (United States)

    Anbar, Tag; Hay, Rania Abdel; Abdel-Rahman, Amal T; Moftah, Noha H; Al-Khayyat, Mohamed A

    2013-03-01

    Both vitiligo and alopecia areata (AA) are associated together, associated with other autoimmune diseases, and autoimmunity is one of the important theories in their etiology. Nail changes are a known association with AA, thus we hypothesized that nail changes can be found in vitiligo patients. On revising the literature, only two types of nail changes were described in association with vitiligo. Our aim was to study the frequency and types of nail changes among vitiligo patients in comparison with normal healthy volunteers. This multi-centric study was carried on 91 patients with vitiligo, as well as 91 normal healthy control subjects who were age- and sex-matched. Nails were examined for changes in nail plates as regards striations, texture, curvature, dystrophy, and pigmentation. The presence or absence of the thumb lunula was also reported. Nail changes were observed in 62 patients (68.1%) and 46 (50.5%) control subjects with a statistically significant difference (P = 0.016). Longitudinal ridging and absent lunula were significantly higher in patients than in the controls (P = 0.001 and 0.037, respectively). Other reported nail abnormalities in the current study included punctate leukonychia, pitting, flag sign, and Terry's nails. Awareness of this association will widen the clinician's perspective to carefully examine the nail changes in vitiligo patients and conversely examine patients with nail changes for vitiligo.

  18. Clinical study of histologically proven conjunctival cysts

    Science.gov (United States)

    Thatte, Shreya; Jain, Jagriti; Kinger, Mallika; Palod, Sapan; Wadhva, Jatin; Vishnoi, Avijit

    2014-01-01

    Purpose This is a clinco-histopathological study of different varieties of conjunctival cysts where modification of surgical technique was done as per requirement for intact removal of cysts to minimise recurrence rate. Materials and methods Retrospective study of 40 cases of conjunctival cysts. A thorough ocular examination and basic haematological work up was done for all patients. B-scan USG and MRI was done wherever required to see the posterior extent. All patients underwent surgical excision of cyst followed by histo-pathological examination. Results The various types of conjunctival cysts found in our study were primary inclusion cyst 12 (30%), secondary inclusion cyst 6 (15%), pterygium with cysts 15 (37.5%), parasitic cyst 4 (10%), lymphatic cyst 2 (5%), and orbital cyst with rudimentary eye 1 (2.5%). The common symptoms noted were progressive increase in size of cyst (39.45%), cosmetic disfigurement (26.23%), foreign body sensations (27.86%), proptosis (1.6%), ocular motility restrictions (3.2%) and decreased visual acuity (1.6%). The patients were followed till one year after surgical excision for any recurrence and complications and no recurrence was seen. Conclusion Careful and intact removal of conjunctival cyst is important to prevent recurrence. Minor modifications in surgical technique according to the size, site and nature of cyst help in intact removal and prevent recurrence. PMID:25892928

  19. Clinical pearls: factors affecting reported contraceptive efficacy rates in clinical studies.

    Science.gov (United States)

    Burkman, Ronald T

    2002-01-01

    Current combination oral contraceptives (OCs) are among the most popular, safe, and effective methods of reversible contraception. There are, however, many factors that can affect contraceptive failure rates as reported in clinical trials, including subject characteristics, factors related to study methodology and data analysis, and publication biases. The variability of these factors among clinical trials makes meaningful comparisons of contraceptive efficacy data across studies difficult, if not misleading or erroneous. It is even more difficult to reconcile the differences between clinical trial efficacy rates and everyday use rates; for instance, the National Survey of Family Growth reported that the rate of OC failure is close to 8% in the United States, which is higher than rates reported in clinical trials. Thus, it is important for the clinician to consider the many factors that can influence reporting of contraceptive failure rates in clinical trials and be aware of the limitations in differentiating OCs on the basis of contraceptive efficacy derived from clinical trial data. Furthermore, clinical trial data may not accurately predict contraceptive efficacy in everyday use.

  20. Review of clinical studies on clobazam.

    Science.gov (United States)

    Koeppen, D

    1979-01-01

    1 Clobazam was compared with placebo and diazepam in 45 double-blind studies. 2 Clobazam dosage ranged from 5 mg daily (paediatric patients) to 120 mg daily (psychiatric in-patients). Usual daily dosage in out-patient therapy ranged from 20-30 mg clobazam. 3 Treatment duration varied from a few days up to 3.5 years. The usual duration of treatment was 2-4 weeks. 4 Clobazam was shown to be an efficacious and well tolerated anxiolytic agent in various neurotic and psychosomatic disorders. 5 Dosages showing distinct anxiolytic effects in out-patient therapy did not impair psychomotor performance.

  1. A CLINICAL STUDY OF ABDOMINAL WOUND DEHISCENCE

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    Zahir Hussain

    2016-10-01

    Full Text Available BACKGROUND Abdominal wound dehiscence is a preventable complication, but is still seen. When present, it poses problem in the management of the case, increases the morbidity and mortality of the patient. The present study is a prospective study done from January 2010-May 2016 with an objective to find out the incidence of wound dehiscence, the most common pathologies associated with dehiscence and to find out the statistical significance of the difference risk factors causing wound dehiscence and to evaluate the role of tension sutures in prevention of wound dehiscence. MATERIALS AND METHODS 291 major laparotomies were followed from January 2010-September 2016. There were 21 cases of dehiscence and from the remaining 270 cases, 58 patients were chosen as controls who underwent the same procedure, but without dehiscence. 15 factors were analysed and compared between the dehiscence and control groups. RESULTS The incidence was found to be 7.2%. Peritonitis was the most common pathology. The significant factors were age more than 50, wound infection. Tension suture application has shown to reduce the incidence of wound dehiscence. CONCLUSIONS  Intra-abdominal sepsis (peritonitis increases the incidence of wound dehiscence.  Age >50, Uraemic, Jaundiced, Obesity, Malnutrition increases the incidence of wound dehiscence.  Wound infection was a highly significant factor having 8 times more risk of dehiscence.

  2. Clinical cosmobiology: The Lithuanian study 1990 1992

    Science.gov (United States)

    Stoupel, Eliyahu; Petrauskiene, Jadviga; Kalediene, Ramune; Abramson, Evgeny; Sulkes, Jacqueline

    1995-12-01

    The numbers of deaths from ischaemic heart disease (IHD), stroke (CVA), all accidents except vehicular, vehicular accidents and suicide (overall total, totals for men and women) per month for 36 months (1990 1992) in Lithuania were analysed in relation to: (1) month of the year (1 12); (2) geomagnetic activity; and (3) solar activity. A total of 122227 deaths (64490 men and 57737 women) was studied, and the results compared with those obtained in an earlier study in Israel, differing geographically and climatically from Lithuania. It was shown that the time of year, solar activity, and geomagnetic activity were related to the monthly death distribution, especially regarding death from IHD and suicide. Age and gender differences were apparent in the relationship between death distribution and physical environmental factors. At age >70 years, many of these relationships change. The monthly distribution of deaths from IHD and suicide are adversely correlated with solar activity and with each other. Differences are presumed in serotoninergic effects as caused by environmental influences.

  3. [Anatomo-clinical study of arterioventricular disorders].

    Science.gov (United States)

    Attié, F; Bassotti, R; Arteaga, M; Kuri, J; Zamora, C

    1976-01-01

    The relationship of the great arteries with their respective ventricles in the three toncoconal morphologies depends on the orientation and rotation of the septum of the trunk and cone. In this work we study a case of crossed great arteries and another of partial distortion of the great arteries and one of transposition of the great arteries, all with arterioventricular concordance. In the anatomic and angiocardiographic examples an analysis is made of the arterioventricular relation in each type of arterial pedicle. We say that arterioventricular concordance exists with crossed great arteries when the pulmonary originated from the anterior infundibulum and its direction of right to left or from left to right in the frontal plane shows the spacial position of the anatomically right ventricle. In the transposition of the great arteries or in the partial distortion of the great arteries with arterioventricular concordance the aorta in the frontal plane shows the spacial position of the anatomically right ventricle. In the first group the aorta originates from the anterior infundibulum while in the second, from the posterior infundibulum. We review the examples of arterioventricular discordance diagnosed by necropsy or by laboratory studies. We study 5 cases; 1 with crossed great arteries, 3 with transposition of great arteries and the last with partial distortion of the great arteries. In the arterioventricular discordances with crossed great arteries in the lateral position, we observe that the pulmonary artery originates from the anterior infudnibulum whereas in the transposition, the aorta emerges from the anterior infundibulum. In the partial distortion of the great arteries the vessels are side by side or the aorta a little bit anterior to the pulmonary which is connected with the anterior infundibulum. In the posteroanterior incidence when there exists an arterioventricular discordance with crossed great arteries, the direction of the pulmonary does not

  4. A clinical study of annular cyclitis

    Directory of Open Access Journals (Sweden)

    Marilita Michael Moschos

    2009-02-01

    Full Text Available Marilita Michael Moschos1, Yan Guex-Crosier2, Ioannis Margetis1, Leonidas Zografos21Department of Ophthalmology, University of Athens, Greece; 2Jules Gonin Eye Hospital, University of Lausanne, SwitzerlandPurpose: To investigate six cases of annular cyclitis.Methods: All patients with impairment of visual acuity underwent complete ophthalmologic examination, color fundus photography, laboratory tests and fluorescein angiography. Indocyanine green (ICG angiography and B-scan ultrasonography were also performed in three cases in order to diagnose the disease.Results: All patients presented a unilateral or bilateral granulomatous uveitis, associated with inflammatory annular cyclitis. They had a shallow anterior chamber, a mildly elevated intraocular pressure (under 25 mm Hg and an annular serous retinal detachment. A resolution was observed after specific therapy associated with systemic prednisolone therapy and antiglaucomatous drops.Conclusion: This is the first description of an observational study of six patients with inflammatory annular cyclitis.Keywords: cyclitis, uveitis, malignant glaucoma

  5. TRACHEOSTOMY IN CHILDREN: A CLINICAL STUDY

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    Shankar

    2015-11-01

    Full Text Available : A trachestomy is a small, surgical opening from the skin to the anterior wall of the trachea, pediatric patients for whom tracheostomy is more hazardous than adults, consideration have different anatomy, medical conditions, and prognoses than adults, even the tracheostomy tubes are different in size, the indications for tracheostomy in children include, bypassing airway obstruction (Laryngo- tracheobronchitis, epiglottitis, providing access for prolong ventilation, and facilitating tracheo-bronchial toilet, to day prime indication for pediatrics tracheostomy is subglottic stenosis. We have reviewed experience with 84 tracheostomies under 13 years of age in our hospital. We are here discussing the common indications and complications, difficulty in decannulation in pediatric patients, in our study the common indication is the foreign body bronchus followed by other conditions.

  6. CLINICAL STUDY OF THIAZIDE DIURETIC INDUCED HYPONATREMIA

    Directory of Open Access Journals (Sweden)

    Siddappa

    2015-12-01

    Full Text Available AIMS AND OBJECTIVES The importance of Thiazide-Induced Hyponatremia (TIH is reemerging because thiazide diuretic prescription seems to be increasing after the guidelines recommending thiazides as first-line treatment of essential hypertension have been introduced. Hyponatremia is a common complication comes across with thiazide diuretics. Aim is to determine the prevalence and vulnerability of symptoms from thiazide-induced hyponatremia. MATERIALS AND METHOD Study included 100 patients attending outpatient department/admitted in S. S. Hospital, Davangere fulfilling the inclusion and exclusion criteria. Patients received 6.25mg to 25mg hydrochlorothiazide with or without combination of other anti-hypertensives. Patients were followed up every day with estimation of serum electrolytes after hospitalization. RESULTS Female patients presented with lower serum sodium levels than male counterparts (114±8 versus 117±8 mmol/L, P=0.02, although the frequency of central nervous system manifestation was comparable between both gender groups. The most frequent symptoms were malaise and lethargy (49%, followed by dizzy spells (47% and vomiting (35%. Degree of hyponatremia depend upon presentation predicted the development of confusion and vomiting symptoms. Serum sodium concentration <115 mmol/L was significantly associated with the development of confusion (odds ratio 2.6, 95% confidence interval 1.3 to 5.1, P=0.004. Our results show that symptoms from thiazide-induced hyponatremia primarily reflect osmotic water shift into brain cells rather than extracellular fluid volume depletion. CONCLUSION In our study hyponatremia is common and serious side effect of thiazide diuretics. Timely detection and intervention is very essential and improves the outcomes in patients with thiazide diuretics.

  7. Clinical waste incinerators in Cameroon--a case study

    DEFF Research Database (Denmark)

    Mochungong, Peter Ikome Kuwoh; Gulis, Gabriel; Sodemann, Morten

    2012-01-01

    Incinerators are widely used to treat clinical waste in Cameroon's Northwest Region. These incinerators cause public apprehension owing to purported risks to operators, communities and the environment. This article aims to summarize findings from an April 2008 case study....

  8. Genome-wide association study of clinical dimensions of schizophrenia

    DEFF Research Database (Denmark)

    Fanous, Ayman H; Zhou, Baiyu; Aggen, Steven H;

    2012-01-01

    Multiple sources of evidence suggest that genetic factors influence variation in clinical features of schizophrenia. The authors present the first genome-wide association study (GWAS) of dimensional symptom scores among individuals with schizophrenia....

  9. A multichannel time-domain brain oximeter for clinical studies

    Science.gov (United States)

    Contini, Davide; Spinelli, Lorenzo; Caffini, Matteo; Cubeddu, Rinaldo; Torricelli, Alessandro

    2009-07-01

    We developed and optimized a multichannel dual-wavelength time-domain brain oximeter for functional studies in the clinical environment. The system, mounted on a 19"-rack, is interfaced with instrumentation for monitoring physiological parameters and for stimuli presentation.

  10. Facilitating case studies in massage therapy clinical education.

    Science.gov (United States)

    Baskwill, Amanda

    2013-01-01

    The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience.

  11. Chronic urticaria. Clinical and pathogenetic studies in 141 patients

    NARCIS (Netherlands)

    Doeglas, Hendrik Maarten George

    1975-01-01

    This study describes a combined clinical, laboratory and experimental approach of the problems of 141 patients with chronic urticaria, collected over a three-year period in a Dermatology department. ... Zie: Summary

  12. Case Study: Caregiver Perception of Pediatric Multidisciplinary Feeding Outpatient Clinic

    Directory of Open Access Journals (Sweden)

    Thomas F. Fisher PhD, OT, FAOTA

    2014-01-01

    Full Text Available This study explores the perception of satisfaction of caregivers who attended a feeding clinic at a large pediatric hospital in the midwest. The clinic is designed for a multidisciplinary team to meet with the child and the caregiver. Thirty-five participants were involved in the study. Results indicated that most participants were satisfied with the clinic experience. However, there were areas of care not covered by the members of the feeding team, which indicates a need. It is suggested that this need could be filled by occupational therapists.

  13. CLINICAL STUDY AND MANAGEMENT OF INCISIONAL HERNIA

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    Jyothirmayi

    2016-05-01

    Full Text Available Incisional hernia follows operations on the anterolateral abdominal wall. It is a diffuse extrusion of peritoneum and abdominal contents through a weak scar due to the failure of the lines of closure of the abdominal wall following laparotomy. The incidence of incisional hernia varies widely in different series published and is at least 10% as shown in longterm follow-up studies. Clarification regarding the type of mesh and its positioning and operative methods of open surgery and laparoscopic repair needs to be addressed. In addition to surgical closure techniques, patient's risk factors also influence surgical outcome following wound closure. RESULTS Age, gender and risk factors such as diabetes, Hypertension, Anaemia, Obesity, COPD and Type of previous incision contribute to the development of primary and recurrent incisional hernia. Although complete prevention of development of incisional hernia is not possible, repair of hernia by replacement of simple suture technique with that of mesh reinforcement has shown better longterm results and patient satisfaction. CONCLUSION For management of incisional hernia, the available evidence has been favourable for good quality long term results with mesh repair techniques.

  14. Microneedle delivery: clinical studies and emerging medical applications.

    Science.gov (United States)

    Pettis, Ronald J; Harvey, Alfred J

    2012-03-01

    The concept of microneedle drug delivery was described three decades ago; however, effective clinical demonstration has only occurred within the past 10-15 years. Substantial progress in microneedle design and fabrication including extensive in vitro, ex vivo, and in vivo preclinical evaluation with various drugs, vaccines and other agents has transpired over the last decade. In contrast with this large volume of preclinical data, there are relatively few published microneedle clinical studies. To date, the clinical investigative focus has included testing to reduce dermal barrier properties and enhance transdermal delivery; evaluation of enhanced vaccine antigenicity, including development of the first commercial microneedle product for intradermal influenza vaccination; evaluation of altered microneedle protein pharmacokinetics and pharmacodynamics, especially for insulin; and evaluation of the pain and other perceptions associated with microneedle usage. This review summarizes the various aspects of microneedle clinical evaluation to date and identifies areas requiring further clinical evaluation.

  15. Enhancing Patient Safety Using Clinical Nursing Data: A Pilot Study.

    Science.gov (United States)

    Choi, Jeeyae; Choi, Jeungok E

    2016-01-01

    To enhance patient safety from falls, many hospital information systems have been implemented to collect clinical data from the bedside and have used the information to improve fall prevention care. However, most of them use administrative data not clinical nursing data. This necessitated the development of a web-based Nursing Practice and Research Information Management System (NPRIMS) that processes clinical nursing data to measure nurses' delivery of fall prevention care and its impact on patient outcomes. This pilot study developed computer algorithms based on a falls prevention protocol and programmed the prototype NPRIMS. It successfully measured the performance of nursing care delivered and its impact on patient outcomes using clinical nursing data from the study site. Results of the study revealed that NPRIMS has the potential to pinpoint components of nursing processes that are in need of improvement for preventing patient from falls.

  16. Nursing Students' Clinical Experience With Death: A Pilot Study.

    Science.gov (United States)

    Heise, Barbara A; Gilpin, Laura C

    2016-01-01

    Although debriefing in simulation settings is routine in nursing education, debriefing does not routinely take place in clinical settings with nursing students after a patient has died. This pilot study sought to explore nursing students' perceptions of their first experience with the death of a patient. Students reported emotional distress and feelings of inadequacy with regard to communicating with and supporting the family of the dying patient. Only half the students sampled reported debriefing by their clinical instructor or staff. Nurse educators must include debriefing and student support following a patient death in the clinical setting.

  17. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis – the membrane study

    Directory of Open Access Journals (Sweden)

    Dorsch Oliver

    2012-06-01

    Full Text Available Abstract Background Adequate anticoagulation is prerequisite for effective hemodialysis to prevent clotting in the extracorporeal circuit. We aimed providing first data on the efficacy and safety of the low-molecular-weight heparin certoparin in this setting. Methods Multicenter, open-label, 8-week trial. Patients received a single dose of 3,000 IU certoparin i.v. with additional titration steps of 600 IU and/or continuous infusion if necessary. Results 120 patients were screened, 109 enrolled (median age 71; range 26–90 years and 106 available for efficacy analyses. The percentage of unsatisfactory dialysis results at 8 weeks due to clotting or bleeding, was 1.9% (n = 2/106; 95% confidence interval [CI] 0.23–6.65%; no major bleeding. 1.9% had moderate/severe clotting in the lines/bubble catcher and 2.8% in the dialyser at week 8. 15.7 ± 14.3% of the dialysis filters’ visual surface area was showing redness. In subgroups of patients receiving median doses of 3000 ± 0, 3000 (2400–6000 and 4200 (3000–6600 IU, plasma aXa levels at baseline, 4 and 8 weeks were 0.24 [95%CI 0.21–0.27], 0.33 [0.27–0.40] and 0.38 [0.33–0.45] aXa IU/ml at 2 h. C48h was 0.01 [0.01–0.02] aXa IU at all visits. At baseline and 4 weeks AUC0-48h was 2.66 [2.19–3.24] and 3.66 [3.00–4.45] aXa IU*h/ml. In 3.0% of dialyses (n = 83/2724 prolonged fistula compression times were documented. Eight patients (7.34% had at least one episode of minor bleeding. 4 85.3% of patients had any adverse event, 9.2% were serious without suspected drug relation; and in 32 patients a drug-relation was suspected. Conclusions Certoparin appears effective and safe for anticoagulation in patients undergoing maintenance hemodialysis.

  18. Primary gout in Shantou: a clinical and epidemiological study

    Institute of Scientific and Technical Information of China (English)

    曾庆馀; 王庆文; 陈韧; 肖征宇; 黄少弼; 许敬才

    2003-01-01

    Objective To evaluate the prevalence of primary gout in the Shantou area, China, and to understand its clinical features. Methods Samples from three surveys of the Chenghai across ten years were studied. Clinical, laboratory and radiology data of 419 cases of primary gout were collected and analyzed. Conclusions The prevalence of primary gout in Shantou area has been increasing in the last ten years. Changes in diet and lifestyle may be responsible for this rapid increase.

  19. Acute radiation proctitis. A clinical, histopathological and histochemical study

    Energy Technology Data Exchange (ETDEWEB)

    Hovdenak, Nils

    2004-07-01

    The aim of the study is: 1) A sequential description of the clinical course of acute radiation proctitis during pelvic RT. 2) A sequential description of the rectal mucosal histopathology during pelvic RT as a possible substrate for clinical toxicity. 3) To assess the mucosal protease activity during RT as a possible explanation of the observed tissue changes. 4) To assess the efficacy of prophylactic sucralfate in acute radiation proctitis a randomised study was initiated and carried out together with a meta-analysis of previously available data. 5) Most studies on clinical acute toxicity in pelvic RT use either the RTOG/EORTC score system or focus on diarrhoea/stool frequency. A more differentiated and sensitive recording was developed and tested to pick up symptoms escaping the commonly used scores. 6) Study the relation between histopathological findings and the clinical picture. 4 papers presenting various studies are included. The titles are: 1) Acute radiation proctitis: a sequential clinicopathologic study during pelvic radiotherapy. 2) Clinical significance of increased gelatinolytic activity in the rectal mucosa during external beam radiation therapy of prostate cancer. 3) Profiles and time course of acute radiation toxicity symptoms during conformal radiotherapy for cancer of the prostate. 4) Sucralfate does not ameliorate acute radiation proctitis. Some future prospects are discussed.

  20. A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin - Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam

    Directory of Open Access Journals (Sweden)

    Gazzotti Filippo

    2011-04-01

    Full Text Available Abstract Background The recommendations outlined in the latest guidelines published by the Surgical Infection Society (SIS and the Infectious Disease Society of America (IDSA regarding the proper duration of antibiotic therapy in patients with intra-abdominal infections are limited and non-specific. This ambiguity is due mainly to the lack of clinical trials on the topic of optimal duration of therapy. It is well known that the overuse of antibiotics has several important consequences such as increased treatment costs, reduced clinical efficacy, and above all, the increased emergence of antibiotic-resistant pathogens. Ampicillin-Sulbactam is a commonly used "first line" antibiotic for intra-abdominal infections. Ertapenem and Ampicillin-sulbactam are recommended as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines. Methods/Design This study is a prospective multi-center randomized investigation. The study will be performed in the Departments of General, Emergency, and Transplant Surgery of Sant'Orsola-Malpighi University Hospital in Bologna, Italy, in the General Surgery Department of the Ospedali Riuniti of Bergamo, Italy, and in the Trauma and Emergency Surgery Department of Maggiore Hospital in Bologna, Italy, and will be conducted by all surgeons willing to participate in the study. The inclusion period of the study will take approximately two years before the planned number of 142 enrolled patients is reached. Discussion Ertapenem and Ampicillin-sulbactam are recommended both as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines. As one of the discussed topic is the optimal duration of the antibiotic therapy and this ambiguity is due mainly to the lack of clinical trials on the topic, the present study aims for obtain precise data. Trial Registration ClinicalTrials.gov: NCT00630513

  1. Infections in orthopaedic surgery : clinical and experimental studies

    NARCIS (Netherlands)

    Vogely, Henri Charles

    2001-01-01

    The diagnostic difficulties, variability in outcome and the heterogeinity of the problem of orthopaedic infections stimulated the author to a study of the literature, and several clinical and experimental studies. The diagnosis prosthesis-related infection can only be reached with an acceptable d

  2. Rethinking clinical governance: healthcare professionals’ views: a Delphi study

    Science.gov (United States)

    Veenstra, Gepke L; Ahaus, Kees; Welker, Gera A; Heineman, Erik; van der Laan, Maarten J; Muntinghe, Friso L H

    2017-01-01

    Objective Although the guiding principle of clinical governance states that healthcare professionals are the leading contributors to quality and safety in healthcare, little is known about what healthcare professionals perceive as important for clinical governance. The aim of this study is to clarify this by exploring healthcare professionals' views on clinical governance. Design Based on a literature search, a list of 99 elements related to clinical governance was constructed. This list was refined, extended and restricted during a three-round Delphi study. Setting and participants The panel of experts was formed of 24 healthcare professionals from an academic hospital that is seen as a leader in terms of its clinical governance expertise in the Netherlands. Main outcome measures Rated importance of each element on a four-point scale. Results The 50 elements that the panel perceived as most important related to adopting a bottom-up approach to clinical governance, ownership, teamwork, learning from mistakes and feedback. The panel did not reach a consensus concerning elements that referred to patient involvement. Elements that referred to a managerial approach to clinical governance and standardisation of work were rejected by the panel. Conclusions In the views of the panel of experts, clinical governance is a practice-based, value-driven approach that has the goal of delivering the highest possible quality care and ensuring the safety of patients. Bottom-up approaches and effective teamwork are seen as crucial for high quality and safe healthcare. Striving for high quality and safe healthcare is underpinned by continuous learning, shared responsibility and good relationships and collaboration between healthcare professionals, managers and patients. PMID:28082364

  3. Muscle pain: animal and human experimental and clinical studies.

    Science.gov (United States)

    Marchettini, P

    1993-10-01

    The search for the identification of the sensory apparatus encoding muscle pain sensation in humans is recounted. Basic neurophysiologic animal studies, leading to a description of slowly conducting afferent from muscle and definition of high threshold polymodal muscle nociceptors, and pioneer psychophysic human studies together with recent microneurographic experiments in humans are described. The phenomena of muscle pain broad localization and distant referral are discussed, and clinical implications are extrapolated to interpret muscle pain as a localizing sign of mononeuropathy or radiculopathy. The identification of human muscle nociceptors has defined the scientific standard to test emerging clinical descriptions having muscle pain as a symptom.

  4. Noonan syndrome: a clinical and genetic study of 31 patients

    Directory of Open Access Journals (Sweden)

    Bertola Débora Romeo

    1999-01-01

    Full Text Available Noonan syndrome is a multiple congenital anomaly syndrome, inherited in an autosomal dominant pattern. We studied 31 patients (18 males and 13 females affected by this disorder regarding their clinical and genetic characteristics. The most frequent clinical findings were short stature (71%; craniofacial dysmorphisms, especially hypertelorism, ptosis, downslanting of the palpebral fissures; short or webbed neck (87%; cardiac anomalies (65%, and fetal pads in fingers and toes (70%. After studying the probands' first-degree relatives, we made the diagnosis of Noonan syndrome in more than one family member in three families. Therefore, the majority of our cases were sporadic.

  5. Clinical value of acoustic voice measures: a retrospective study.

    Science.gov (United States)

    Werth, Katrin; Voigt, Daniel; Döllinger, Michael; Eysholdt, Ulrich; Lohscheller, Jörg

    2010-08-01

    Within this study a retrospective analysis of clinical voice perturbation measures, Dysphonia Severity Index and subjective perceived hoarseness was performed to determine their value under clinical aspects. The study included the data of 580 healthy and 1,700 pathologic voices, which were investigated under the following aspects. The relevant parameters were identified and their interrelation determined. Group differences between healthy and pathologic voices were figured out and investigated if voice quality measures allowed an automatic diagnosis of voice disorders. The analysis revealed significant changes between the clinical groups, which indicate the diagnostic relevance of voice quality measures. However, an individual diagnosis of the underlying voice disorder failed due to a vast spread of the parameter values within the respective groups. Classification accuracies of 75-90% were achieved. The high misclassification rate of up to 25% implied that in voice disorder diagnosis, the individual interpretation of the parameter values has to be done carefully.

  6. Clinical and histopathological study of primary cutaneous macular amyloidosis

    Directory of Open Access Journals (Sweden)

    Fatima Razvi

    2013-02-01

    Full Text Available Primary cutaneous amyloidosis often presents with pigmentary dystonias of the skin in the form of asymptomatic reticulate hyper-pigmentation or pruritic lichenoid papular lesions. The aim of this study was to evaluate the incidence of primary cutaneous macular amyloidosis and also to find out the possible etiological agents, to correlate their clinical disease with histopathological positivity for amyloid deposition, and to find out the percentage of positive cas-es by special stains. A total of 24 patients attending dermatology out-patient clinic of Princess Esra Hospital, Hyderabad over a pe-riod of 1 year presenting with hyperpigmented skin lesions and clinically diagnosed as macular amyloidosis were taken up for this study.

  7. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    Directory of Open Access Journals (Sweden)

    Oguzhan Sıtkı Dizdar

    2016-02-01

    Full Text Available Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002 and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40, 46.6% (n = 29, 39.7% (n = 27, 35.3% (n = 24, 14.1% (n = 9, respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission.

  8. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies.

    Science.gov (United States)

    O'Donnell, Lauren A; Perry, Michael W; Doup, Dane't R

    2015-12-01

    For many students in the health sciences, including doctor of pharmacy (PharmD) students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions), and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course.

  9. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies

    Directory of Open Access Journals (Sweden)

    Lauren A. O'Donnell

    2015-08-01

    Full Text Available For many students in the health sciences, including doctor of pharmacy (PharmD students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions, and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course.

  10. Clinical study on IgG4-related autoimmune pancreatitis

    Institute of Scientific and Technical Information of China (English)

    吴庆军

    2013-01-01

    Objective To investigate the clinical features of IgG4-related autoimmune pancreatitis(IgG4-related AIP). Methods A prospective cohort study on IgG4 related disease(IgG4-RD) was carried out in Peking Union Medical College Hospital during December 2010 to June

  11. Considerations for clinical pharmacology studies for biologics in emerging markets.

    Science.gov (United States)

    Damle, Bharat; White, Robert; Wang, Huifen Faye

    2015-03-01

    Registration of innovative biologics in Emerging Markets (EMs) poses many opportunities and challenges. The BRIC-MT countries (Brazil, Russia, India, China, Mexico, and Turkey) that are the fastest growing markets and regulators in these countries have imposed certain requirements, including the need for local clinical studies, for registration of biologics. The regulatory landscape in these countries is rapidly evolving, which necessitates an up-to-date understanding of such requirements. There is growing evidence which suggests that race, after accounting for body weight differences, may not influence the pharmacokinetics of biologics to the same extent that it does for small molecules. Thus, the requirements for clinical pharmacology trials in EMs are driven mainly by regulatory needs set forth by local Ministry of Health. In addition to the clinical Phase I to III studies done in the global program that supports registration in large geographies, countries such as China require local single and multiple dose Phase I studies. Participating in global studies with clinical sites within their country may be sufficient for some markets, while other regulators may be satisfied with a Certificate of Pharmaceutical Product. This paper discusses the current requirements for registration of innovative biologics in key EMs.

  12. Risk factors for acute kidney injury (AKI) in infants with melamine-associated urolithiasis and follow-up: a multi-center retrospective analysis.

    Science.gov (United States)

    He, Qiqi; Yue, Zhongjin; Tang, XiaoShuang; Chang, Hong; Wang, Wei; Shi, Wei; Wang, Zhiping; Shang, Panfeng

    2014-10-01

    Abstract An epidemic of urinary tract stones was noted among infants in China, 2008. This event was believed to be associated with consumption melamine-contaminated powdered formula. The patients with symptoms and clinical manifests had already been analyzed in our previous studies. In this study, our aim is to investigate the risk factors of melamine-associated acute kidney injury (AKI) and the potential relationship toward children growth in our five years follow-up. A total of 619 infants with melamine-associated urolithiasis were admitted into 20 different hospitals in the Gansu province, China. All clinical data were divided into AKI and control groups according to the occurrence of AKI. Univariate and multivariate analyses were performed with a logistic regression model to assess the independent risk factors of AKI. Logistic regression analysis revealed that the odds ratio (OR) of AKI was 19.62 in the group of infants who consumed Sanlu® milk powdered infant milk formula. A higher prevalence of AKI was observed in infants age of 6-11 months (OR: 9.59, p melamine infant formula (Sanlu® milk powdered infant formula), age (6-17 months) and symptoms of URTI, diarrhea, dehydration or fever were risk factors of AKI in infants with melamine-associated urolithiasis.

  13. Subcutaneous immunoglobulin in CIDP and MMN: a short-term nationwide study.

    Science.gov (United States)

    Cocito, Dario; Merola, Aristide; Peci, Erdita; Mazzeo, Anna; Fazio, Raffaella; Francia, Ada; Valentino, Paola; Liguori, Rocco; Filosto, Massimiliano; Siciliano, Gabriele; Clerici, Angelo Maurizio; Lelli, Stefania; Marfia, Girolama Alessandra; Antonini, Giovanni; Cecconi, Ilaria; Nobile-Orazio, Eduardo; Lopiano, Leonardo

    2014-11-01

    This multi-center Italian prospective observational study reports the 4 months follow-up data of 87 patients affected by chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) shifted from intravenous to subcutaneous immunoglobulin treatment. A therapeutic shift from intravenous to subcutaneous immunoglobulin was performed in 87 patients (66 CIDP; 21 MMN) affected by immune-mediated peripheral neuropathies with evidence of a sustained clinical response to intravenous immunoglobulin. Patients were evaluated by means of the Overall Neuropathy Limitation Scale, Medical Research Council Scale and Life Quality Index questionnaire, both at the time of therapeutic shift and after 4 months of subcutaneous immunoglobulin treatment. A sustained clinical efficacy was observed after the switch to subcutaneous immunoglobulin: the Overall Neuropathy Limitation Scale score improved in the group of 66 CIDP patients (P = 0.018), with only one subject reporting a worsening of 1 point, and remained stable in the group of 21 MMN patients (P = 0.841), with one subject reporting a worsening of two points. An improvement in the patient's perception of therapeutic setting was reported in both groups. This large multi-center study confirms the short-term clinical equivalence of subcutaneous versus intravenous immunoglobulin and a possible improvement in the patient's perception of therapeutic setting with the subcutaneous administration. However, further studies are required to extend the results to a longer observational period.

  14. Scoring clinical competencies of learners: A quantitative descriptive study

    Directory of Open Access Journals (Sweden)

    Ann Müller

    2011-02-01

    Full Text Available This article reports the correlation between different clinical assessors’ scoring of learners’ clinical competencies in order to exclude any possible extraneous variables with regard to reasons for poor clinical competencies of learners. A university in Gauteng, South Africa provides a learning programme that equips learners with clinical knowledge, skills and values in the assessment, diagnosis, treatment and care of patients presenting at primary health care (PHC facilities. The researcher observed that, despite additional clinical teaching and guidance, learners still obtained low scores in clinical assessments at completion of the programme. This study sought to determine possible reason(s for this observation. The objectives were to explore and describe the demographic profile of learners and the correlation between different clinical assessors’ scoring of learners. A purposive convenience sample consisted of learners (n = 34 and clinical assessors (n = 6. Data were collected from learners using a self-administered questionnaire and analysed using a nominal and ordinal scale measurement. Data from clinical assessors were collected using a checklist, which was statistically analysed using a software package. The variables were correlated to determine the nature of the relationship between the different clinical assessors’ scores on the checklist to ensure inter-rater reliability. Findings showed that there was no significant difference in the mean of the scoring of marks between clinical assessors after correlation (p < 0.05. Thus, scoring of marks did not contribute to poor clinical competencies exhibited by learners.

    Opsomming

    Hierdie artikel beskryf die ondersoek na die korrelasie tussen verskillende kliniese assesseerders se puntetoekenning tydens assessering van leerders se kliniese vaardighede ten einde enige moontlike vreemde veranderlikes met betrekking tot redes vir swak

  15. [Clinical studies with cefmenoxime in the field of pediatrics].

    Science.gov (United States)

    Takimoto, M; Yoshioka, H; Maruyama, S; Sanae, N; Nagamatsu, I

    1982-10-01

    The present study was performed to evaluate the clinical effectiveness and safety of cefmenoxime (CMX), a new cephalosporin antibiotic for injection in the field of pediatrics. Thirty-one cases, including 2 cases with sepsis, 18 cases with respiratory tract infections and 7 cases with urinary tract infections, were given CMX at daily doses of 30 mg/kg to 125 mg/kg divided into 3 or 4 for 3 days to 13 days. Clinical responses were excellent in 16 cases, good in 9 cases and poor in 6 cases, the satisfactory response being 80.6%. No side effects and no abnormal laboratory findings relating to the drug were observed.

  16. Cockayne syndrome - A Clinical, Radiological, Audiological And Chromosomal Study

    Directory of Open Access Journals (Sweden)

    Ashraff V V

    2004-01-01

    Full Text Available We report two brothers of Cockayne syndrome (CS with progressive growth retardation, microcephaly, bird headed facies with sunken eyes, cutaneous photosensitivity, retinits pigmentosa, sensorineural deafness, spasticity ataxia, neuropathy and intracranial calcifiactions. These clinical with radiological features of cortical and cerebellar atrophy with basal ganglionic calcification and presence of consanguinity in parents and chromosome studies showing sister chromatid exchange in less than 6% strongly supported the diagnosis of Cockyne syndrome and differentiated it from Bloom′s syndrome and xeroderma pigmentosa. Without genetic analysis or tests for defective DNA repair, the diagnosis is mostly clinical.

  17. Exploring factors affecting undergraduate medical students' study strategies in the clinical years: a qualitative study.

    NARCIS (Netherlands)

    Al Kadri, H.M.; Al-Moamary, M.S.; Elzubair, M.; Magzoub, M.E.; AlMutairi, A.; Roberts, C.; Vleuten, C.P.M. van der

    2011-01-01

    The aim of this study is to explore the effects of clinical supervision, and assessment characteristics on the study strategies used by undergraduate medical students during their clinical rotations. We conducted a qualitative phenomenological study at King Saud Bin Abdulaziz University for Health S

  18. A STUDY OF INTERFACE DERMATITIS WITH CLINICAL CORRELATION

    Directory of Open Access Journals (Sweden)

    Suja Ajoy

    2015-05-01

    Full Text Available BACKGROUND : Interface dermatitis ( ID is defined as an inflammatory skin disease in which the junction between the papillary dermis and the epidermis is obscured . They are so named because they are cell mediated immune reactions whose targets are basal keratinocytes that reside above the dermo - epidermal junction . Interface dermatitis enco mpasses multiple clinical entities with diverse histological features . This study is aimed at understanding the various associated histological features with clinical correlation of conditions in which Interface Dermatitis is the most important histopathol ogic finding . This will help us in arriving at a more specific diagnosis by light microscopy . MATERIALS AND METHODS : The study was conducted over a period of two and a half years . Skin biopsies showing interface dermatitis as a major histological finding w ere studied in detail and classified according to Le Boit’s classification . PAS staining was done to highlight pathology of basement membrane . Normal skin biopsies & biopsies with an unrelated condition were taken as control . Correlation between clinical f eatures , clinical diagnosis and histological diagnosis was assessed . RESULTS : 71 cases showing interface dermatitis were studied . The most common age range was between 50 - 59 years with a female preponderance . Majority of the cases belonged to type I interf ace dermatitis with lichen planus being representative of this type . PAS staining revealed basement membrane disruption in many of the cases . CONCLUSION : Interface dermatitis includes diverse e ntities which have overlapping f eatures at the clinical and his topathological level . Hence , a detailed light microscopic examination aided further by special tests such as immunofluorescence will help at arriving at a definitive diagnosis . More studies are also needed in order to identify specific features to redefine each of the entities

  19. [Study and prospects for clinical diseases treated with scraping therapy].

    Science.gov (United States)

    Wang, Ying-ying; Yang, Jin-sheng

    2009-02-01

    In order to explore characteristics of clinical diseases treated by scraping therapy, summarize laws of clinical application of scraping therapy, and prospect for research direction of scraping therapy in future, collect 437 articles about scraping therapy between 1994-2007 and analyze and summarize the treated diseases and methods of scraping therapy. Results indicate that scraping therapy has been widely applied to commonly encountered diseases and frequently encountered diseases in departments of internal medicine, surgery, gynecology and pediatrics, etc. with more obvious therapeutic effects. Clinically, it can combine with acupuncture and moxibustion, cupping, massage, blood-letting puncture and other methods. In future, the studies on standardization of manipulation and standards for assessment of therapeutic effect, suitable diseases and the mechanisms of scraping therapy, and development of tools and media, etc. of scraping therapy should be strengthened.

  20. Equine pastern vasculitis: a clinical and histopathological study.

    Science.gov (United States)

    Psalla, Dimitra; Rüfenacht, Silvia; Stoffel, Michael H; Chiers, Koen; Gaschen, Véronique; Doherr, Marcus G; Gerber, Vincent; Welle, Monika M

    2013-11-01

    Equine pastern vasculitis is clinically challenging and the underlying aetiopathogenesis is unclear. The aims of this retrospective study were to establish histopathological criteria for pastern vasculitis, to look for an underlying cause, to investigate whether the histopathological lesions are associated with a distinct clinical picture, to assess if and how the clinical picture varies, and to determine the treatment response. Skin biopsies and clinical data from 20 horses with a diagnosis of vasculitis of the distal extremities were investigated and histology was compared to biopsies from healthy horses. It was concluded that intramural inflammatory cells, leukocytoclasia with nuclear dust, thickening and oedema of the vessel walls, and microhaemorrhages are highly specific histological findings in equine pastern vasculitis. Based on the feedback from the clinicians, the lesions were mostly seen on the lateral and medial aspects of un-pigmented legs. Lesions in white skin were characterised by exudation and crusts, whereas those in pigmented skin were alopecic and characterised by scaling. The response to treatment was poor and the prognosis guarded. No association was found between any of the histopathological findings and a distinct clinical picture. An underlying cause of equine pastern vasculitis could not be identified. Considering the large number of confounding factors, the causative agents are difficult to identify, but may involve drugs or a hypersensitivity reactions to yet unknown antigens.

  1. Parasitological and clinical studies on human scabies in Cairo.

    Science.gov (United States)

    Sarwat, M A; el Okbi, L M; el Sayed, M M; el Okbi, S M; el Deeb, H K

    1993-12-01

    This study is a parasitological and clinical study on human scabies. This study was carried out on 100 patients attending the Dermatology Outpatient Clinic at Ain Shams University Hospitals, including 54 males and 46 females. All patients were subjected to detailed history taking, complete dermatological examination including Skin Scraping Test and Burrow Ink Test. Younger patients attended the dermatology clinic earlier than older patients, who usually delayed their visits until complications occurred. Scratching, erythematous papules and secondary infected lesions were the commonest lesions. The hands, wrist and external genitalia were the most frequently affected sites while the feet, ankles, knees and back were the least affected. Burrows could only be detected in 40% of patients. The most frequent sites were the web spaces, external genitalia, and finger sides. Burrow Ink Test was positive among 85% of patients with burrows while mites could be identified by Skin Scraping Test in 55% of patients. The most frequent clinical manifestations in the parasitologically positive patients were itching, burrows, and papules, and the most frequent sites were the web spaces, and the finger sides. Multiple sites affection was the characteristic feature among the preschool age children who represented 14% of cases.

  2. The SAPHO syndrome: a clinical and imaging study.

    Science.gov (United States)

    Sallés, Meritxell; Olivé, Alejandro; Perez-Andres, Ricard; Holgado, Susana; Mateo, Lourdes; Riera, Elena; Tena, Xavier

    2011-02-01

    The purpose of this study is to describe the clinical and radiological manifestations of patients with the synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome. Retrospective study (1984-2007) was performed in a single center. All patients with the SAPHO syndrome were included. Fifty-two patients were included: 26 male, mean age at diagnosis is 42±12 years. Ostearticular involvement was present before cutaneous involvement in 59.6% of patients and concomitantly in 23.5%. Anterior chest pain was the commonest clinical manifestation, it was present in 38 patients (73%), followed by peripheral arthritis in 17 patients (32%), and sacroliliac pain in 14 patients (26.9%). Cutaneous involvement was present in 33 patients (63.5%). HLA B27 antigen was present in eight patients (17.7%). Bone scintigraphy showed an increased uptake in 42 patients (93.3%). The location of the uptake was mainly in sternoclavicular and manubriosternal joints. CT scan was performed in all "hot joints" showing sclerosis, erosions, hyperostosis, and soft tissue involvement. Refractory patients were treated mainly with pamidronate. Although SAPHO syndrome is an entity that share features that fit into a variety of established disease categories, the present study has a homogenous clinical and radiological pattern that gives support to believe that the SAPHO syndrome is an isolated clinical entity.

  3. A CLINICAL AND HISTOPATHOLOGICAL STUDY OF LICHEN PLANUS

    OpenAIRE

    Ch. Madhu Babu; Padmaja, P.; M. Roopa Shree

    2016-01-01

    BACKGROUND Lichen planus is an idiopathic subacute or chronic inflammatory disease of the skin, mucous membranes, and nails. We studied the clinicopathological profile of 50 cases of Lichen planus in Osmania General Hospital from September 2010-April 2012. METHODS A total of 50 cases Lichen planus attending DVL OPD at OGH were studied. Clinical features like age, sex, type of Lichen planus, location were recorded in the case record form. Histological features of Lichen planus...

  4. Clinical Laboratory Stressors Used to Study Alcohol–Stress Relationships

    OpenAIRE

    Thomas, Suzanne; Bacon, Amy K.; Sinha, Rajita; Uhart, Magdalena; Adinoff, Bryon

    2012-01-01

    Understanding the biologic systems that underlie the relationship between stress and alcohol consumption may lead to better prevention efforts and more effective treatments for alcoholism. Clinical laboratory studies offer a unique opportunity to examine these relationships by using a controlled environment to study how an acute stressor affects alcohol drinking and alcohol craving, how individuals in recovery or those at risk for alcoholism may respond differently to stressors relative to co...

  5. Human transcriptome array for high-throughput clinical studies.

    Science.gov (United States)

    Xu, Weihong; Seok, Junhee; Mindrinos, Michael N; Schweitzer, Anthony C; Jiang, Hui; Wilhelmy, Julie; Clark, Tyson A; Kapur, Karen; Xing, Yi; Faham, Malek; Storey, John D; Moldawer, Lyle L; Maier, Ronald V; Tompkins, Ronald G; Wong, Wing Hung; Davis, Ronald W; Xiao, Wenzhong

    2011-03-01

    A 6.9 million-feature oligonucleotide array of the human transcriptome [Glue Grant human transcriptome (GG-H array)] has been developed for high-throughput and cost-effective analyses in clinical studies. This array allows comprehensive examination of gene expression and genome-wide identification of alternative splicing as well as detection of coding SNPs and noncoding transcripts. The performance of the array was examined and compared with mRNA sequencing (RNA-Seq) results over multiple independent replicates of liver and muscle samples. Compared with RNA-Seq of 46 million uniquely mappable reads per replicate, the GG-H array is highly reproducible in estimating gene and exon abundance. Although both platforms detect similar expression changes at the gene level, the GG-H array is more sensitive at the exon level. Deeper sequencing is required to adequately cover low-abundance transcripts. The array has been implemented in a multicenter clinical program and has generated high-quality, reproducible data. Considering the clinical trial requirements of cost, sample availability, and throughput, the GG-H array has a wide range of applications. An emerging approach for large-scale clinical genomic studies is to first use RNA-Seq to the sufficient depth for the discovery of transcriptome elements relevant to the disease process followed by high-throughput and reliable screening of these elements on thousands of patient samples using custom-designed arrays.

  6. Clinical and microbiologic studies of genital ulcers in Kenyan women.

    Science.gov (United States)

    Plummer, F A; D'Costa, L J; Nsanze, H; Karasira, P; MacLean, I W; Piot, P; Ronald, A R

    1985-01-01

    The etiology of genital ulcers in women in tropical regions is poorly understood. Eighty-nine women, presenting to a sexually transmitted disease clinic in Nairobi (Kenya) with a primary complaint of genital ulcers, were evaluated prospectively in a clinical and laboratory study. A final etiologic diagnosis was possible for 60 (67%) of the women. Culture for Haemophilus ducreyi was positive for 43 women, eight had secondary syphilis with ulcerated condyloma latum, three had primary syphilis, one had both chancroid and syphilis, two had moniliasis, two had herpetic ulceration, and one had a traumatic ulcer. The clinical characteristics that best distinguished chancroid from secondary syphilis were ulcer excavation and a rough ulcer base. No etiologic diagnosis was established for 29 patients. However, the clinical and epidemiologic features of these patients suggested that they were similar if not identical to the patients with H. ducreyi culture-positive chancroid. Further studies are necessary to determine the etiology of ulcers in females in whom no pathogen was identified.

  7. A clinical and histolopathological study of pityriasis lichenoides

    Directory of Open Access Journals (Sweden)

    Nair Pradeep

    2007-01-01

    Full Text Available Background: Pityriasis lichenoides is a papulosquamous disorder of unknown etiology with remissions and exacerbations. Histopathology helps greatly in the diagnosis of this condition. Aim: We studied clinical and histopathological features of pityriasis lichenoides in our patients. Methods: This is a 3-year retrospective and prospective, descriptive study of all patients clinically diagnosed as pityriasis lichenoides and confirmed by histopathology. All patients were studied clinically and histopathologically. Results: There were 51 (30 males and 21 females cases of pityriasis lichenoides in the study period. The maximum number of cases, 14 (27.45% were in their second decade of life. Pityriasis lichenoides chronica was diagnosed in 39 cases (76.47% and pityriasis lichenoides et varioliformis acuta (PLEVA in 12 cases (23.53%. Histopathologically, basal cell vacuolation and perivascular infiltrate were seen in all the cases. Exocytosis was seen in 45.1% of the cases. All the cases of PLEVA showed lymphocytic vasculitis albeit without fibrinoid deposition in the vessel walls. Conclusion: Pityriasis lichenoides is not a rare disorder. and is not a true lymphocytic vasculitis as blood vessel damage and fibrinoid deposition in the blood vessel walls were not seen in this study.

  8. Clinical risk factors for the development of consecutive exotropia: a comparative clinical study

    Science.gov (United States)

    Taylan Sekeroglu, Hande; Erkan Turan, Kadriye; Karakaya, Jale; Sener, Emin Cumhur; Sanac, Ali Sefik

    2016-01-01

    AIM To compare a group of patients with consecutive exotropia with patients who had ≤10 prism diopters (PD) esotropia or no deviation postoperatively in terms of probable clinical risk factors for the development of consecutive exotropia. METHODS The study recruited fourteen patients who developed consecutive exodeviation during follow-up period after the correction of esotropia who were categorized as group 1 and thirty-one patients who had still ≤10 PD esotropia or no deviation at the final visit that were considered as group 2. Clinical risk factors leading the development of consecutive deviation were analyzed as the main outcome measures. RESULTS The mean age of patients was 4.57±3.11y in group 1 and 5.10±3.52y in group 2 (P=0.634). There was no significant difference of preoperative near and distant deviations among two groups (P=0.835, 0.928 respectively). The mean amount of medial rectus recession and lateral rectus resection was similar in both groups (P=0.412, 0.648 respectively). Convergence insufficiency and neurological diseases were more frequent in group 1 (P=0.007, 0.045). Accompanying neurological disease was found to be as a significant factor increasing the risk of the development of consecutive exotropia significantly [odds ratios (OR): 5.75 (1.04-31.93)]. CONCLUSION Accompanying neurological disease appears to be a significant clinical risk factor for the development of consecutive exodeviation during postoperative follow-up after the correction of esotropia. However, larger studies are needed in order to interpret the results to the clinical practice and to ascertain other concurrent risk factors. PMID:27366693

  9. Standardization of Data for Clinical Use and Research in Spinal Cord Injury

    DEFF Research Database (Denmark)

    Biering-Sørensen, Fin; Noonan, Vanessa K

    2016-01-01

    for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged...... to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures...... to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements...

  10. Evaluation of quality of life in PKU before and after introducing tetrahydrobiopterin (BH4) : A prospective multi-center cohort study

    NARCIS (Netherlands)

    Demirdas, Serwet; Maurice-Stam, Heleen; Boelen, Carolien C. A.; Hofstede, Floris C.; Janssen, Mirian C. H.; Langendonk, Janneke G.; Mulder, Margot F.; Rubio-Gozalbo, M. Estela; van Spronsen, FrancJan; de Vries, Maaike; Grootenhuis, Martha A.; Bosch, Annet M.

    2013-01-01

    Background: Phenylketonuria (PKU) is a rare inborn error of metabolism caused by phenylalanine hydroxylase enzyme (PAH) deficiency. Treatment constitutes a strict Phe restricted diet with unpalatable amino acid supplements. Residual PAH activity enhancement with its cofactor tetrahydrobiopterin (BH4

  11. 儿童不明原因晕厥诊断的多中心研究%Diagnosis of unexplained syncope in children: a multi-center study

    Institute of Scientific and Technical Information of China (English)

    陈丽; 王瑜丽; 张清友; 杜军保; 王成; 金红芳; 田宏; 汪立; 胡秀芬; 王宏伟; 李万镇; 杜忠东

    2009-01-01

    Objective To examine the diagnostic value of head-up tilt test in children with unexplained syncope (UPS). Methods A total of 379 children (171 males, 208 females) aged 3 -18 years, mean age(12±3) years with unexplained syncope from Beijing, Hunan, Hubei and Shanghai and undergoing baseline head-up tilt tests (BHUTY) or head-up tilt tests potentiated with nitroglycerine (SNHUTT) under a quiet circumstance were selected as the syncope group. Ten healthy children (5 males, 5 females) aged 9 -15 years with a mean age of (11.4±2.1) years,were recruited as the control group. SPSS 10.0 software was used for data analysis. Results In 379 children with unexplained syncope, 67 (17.7%) were of postural orthostatic tachycardia syndrome (POTS), 157 (41.4%) of vasovagal syncope vasoinhibitory pattern, 14 (3.7%) of vasovagal syncope cardioinhibitory pattern, 47 (12.4%) of vasovagal syncope mixed pattern, 1 (0.3%) of orthostatic hypotension (OH) and 93 children (24.5%) of UPS. In syncope group and control group, the positive rate of BHUTT was 55.9% and 0 respectively and it was 75.5% and 20.0% respectively for SNHUTT. During BHUTT, the mean time of positive response occurrence was (16±12) minutes, and the posture when positive response appeared was at a tilt angle of 60 degrees. For SNHUTT, the mean time of positive response occurrence was (6±4) minutes and the posture was at a tilt angle of 60 degrees when potentiated with nitroglycerine. Conclusion HuTr is an objective diagnostic tool of UPS. With a high diagnostic positive rate, SNHUTT can improve the diagnostic positive rate of BHUTT. Meanwhile the time of positive response occurrence during SNHUTT is markedly shorter than BHUTT.%目的 探讨直立倾斜试验(HUTT)对儿童不明原因晕厥的诊断价值.方法 晕厥组为2002年1月至2008年4月在北京、湖南、湖北、上海四地晕厥门诊就诊或住院的379例不明原因晕厥患儿,其中男171例,女208例;年龄3~18岁,平均(12±3)岁.所有患儿通过常规检查仍不能明确患儿晕厥的原因时,进行基础直立倾斜试验(BHUTT)或舌下含化硝酸甘油激发的倾斜试验(SNHUTT)检查.对照组为10名身体健康、无晕厥及晕厥先兆病史的正常儿童,其中男5名,女5名;年龄9~15岁,平均(11.4±2.1)岁,其心血管、神经系统、心电图、超声心动图及X线胸片检查均正常;所有正常儿童均进行BHUTT或SNHUTT.结果 在379例患儿中,286例患儿为自主神经介导性晕厥(75.5%).晕厥患儿中67例为体位性心动过速综合征(17.7%);157例为血管迷走性晕厥血管抑制型(41.4%);14例为血管迷走性晕厥心脏抑制型(3.7%);47例为血管迷走性晕厥混合型(12.4%);1例患儿为直立性低血压(0.3%);93例患儿仍为不明原因晕厥(24.5%).在晕厥组和对照组中,BHUTr的诊断阳性率分别为55.9%和0,SNHUTT的诊断阳性率分别为75.5%和20.0%.BHUTT阳性患者在BHUTT过程中出现阳性反应的时间平均为(16±12)min,阳性反应出现时的体位均为倾斜60°体位;SNHUTT阳性患儿在SNHUTT过程中出现阳性反应的时间平均为(6±4)min,阳性反应出现时的体位均为倾斜60°体位并舌下含化硝酸甘油.结论 应用HUTT可较好地、客观地对儿童自主神经介导性晕厥进行诊断,SNHUTT具有较高的诊断阳性率,明显提高了BHUTT的诊断阳性率,且阳性反应时间明显低于BHUTT.

  12. Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study

    DEFF Research Database (Denmark)

    Ankjærgaard, Kasper Linde; Tønnesen, Philip; Laursen, Lars Christian;

    2016-01-01

    BACKGROUND: In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respirator...

  13. Comparison between Total Parenteral Nutrition Vs. Partial Parenteral Nutrition on Serum Lipids Among Chronic Ventilator Dependent Patients; A Multi Center Study

    OpenAIRE

    Radpay, Rojan; Poor Zamany Nejat Kermany, Mahtab; Radpay, Badiozaman

    2016-01-01

    Background: Malnutrition is very common among chronically hospitalized patients, especially those in the intensive care unit (ICU). Identifying the patients at risk and providing suitable nutritional support can prevent and/or overcome malnutrition in them. Total parenteral nutrition (TPN) and partial parenteral nutrition (PPN) are two common routes to deliver nutrition to hospitalized patients. We conducted a multicenter, prospective double blind randomized controlled trial to evaluate the b...

  14. BEATVIC, a body-oriented resilience training with elements of kickboxing for individuals with a psychotic disorder : study protocol of a multi-center RCT

    NARCIS (Netherlands)

    Stouwe, van der Elisabeth C.D.; de Vries, Bertine; Aleman, André; Arends, Johan; Waarheid, Clement; Meerdink, Aniek; van der Helm, Erwin; van Busschbach, Jooske T; Pijnenborg, Gerdina H M

    2016-01-01

    BACKGROUND: Individuals with a psychotic disorder are at an increased risk of becoming victim of a crime or other forms of aggression. Research has revealed several possible risk factors (e.g. impaired social cognition, aggression regulation problems, assertiveness, self-stigma, self-esteem) for vic

  15. BEATVIC, a body-oriented resilience training with elements of kickboxing for individuals with a psychotic disorder: study protocol of a multi-center RCT

    OpenAIRE

    Stouwe, van der, Elisabeth C.D.; de Vries, Bertine; Aleman, André; Arends, Johan; Waarheid, Clement; Meerdink, Aniek; van der Helm, Erwin; van Busschbach, Jooske T.; Pijnenborg, Gerdina H. M.

    2016-01-01

    BACKGROUND: Individuals with a psychotic disorder are at an increased risk of becoming victim of a crime or other forms of aggression. Research has revealed several possible risk factors (e.g. impaired social cognition, aggression regulation problems, assertiveness, self-stigma, self-esteem) for victimization in patients with a psychotic disorder. To address these risk factors and prevent victimization, we developed a body-oriented resilience training with elements of kickboxing: BEATVIC. The...

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

    NARCIS (Netherlands)

    Olde Rikkert, M.G.M.; Verhey, F.R.J.; Blesa, R.; Arnim, C.A. von; Bongers, A.; Harrison, J.; Sijben, J.; Scarpini, E.; Vandewoude, M.F.; Vellas, B.; Witkamp, R.; Kamphuis, P.J.; Scheltens, P.

    2015-01-01

    BACKGROUND: 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 (Souve

  17. Occurrence of infection following prostate biopsy procedures in Japan: Japanese Research Group for Urinary Tract Infection (JRGU) - a multi-center retrospective study.

    Science.gov (United States)

    Togo, Yoshikazu; Kubo, Tatsuhiko; Taoka, Rikiya; Hiyama, Yoshiki; Uehara, Teruhisa; Hashimoto, Jiroh; Kurimura, Yuichiro; Takahashi, Satoshi; Tsukamoto, Taiji; Miyazaki, Jun; Nishiyama, Hiroyuki; Kira, Shinichiro; Kiyota, Hiroshi; Yazawa, Satoshi; Niwa, Naoya; Hongo, Hiroshi; Oya, Mototsugu; Kato, Taku; Yasuda, Mitsuru; Deguchi, Takashi; Ishikawa, Kiyohito; Hoshinaga, Kiyotaka; Matsumoto, Minori; Shigemura, Katsumi; Tanaka, Kazushi; Arakawa, Soichi; Fujisawa, Masato; Wada, Koichiro; Uehara, Shinya; Watanabe, Toyohiko; Kumon, Hiromi; Kobayashi, Kanao; Matsubara, Akio; Matsumoto, Masahiro; Sho, Takehiko; Hamasuna, Ryoichi; Matsumoto, Tetsuro; Hayami, Hiroshi; Nakagawa, Masayuki; Yamamoto, Shingo

    2014-04-01

    We retrospectively investigated the incidence of genitourinary tract infection in 5895 patients who underwent transrectal and/or transperineal prostate biopsy procedure between January and December 2011 at 46 institutions belonging to Japanese Research Group for Urinary Tract Infection (JRGU). The total rate of genitourinary tract infection after prostate biopsy was 0.76%, while that following transrectal procedure was 0.83% and following transperineal procedure was 0.57%, which were not significantly different. In contrast, febrile infection associated with a fever (≥38 °C) occurred significantly more frequently after transrectal (0.71%) than transperineal (0.16%) approach (P = 0.04). Notably, in infectious cases, Escherichia coli was most frequently isolated. Of the 9 E. coli strains isolated by urine culture, 6 (66.7%) produced extended spectrum β-lactamase (ESBL) and 7 (77.8%) showed levofloxacin resistance. Similarly, of 6 E. coli strains isolated by blood culture, 4 (66.7%) produced ESBL and 6 (100%) showed levofloxacin resistance. When the efficacy of antimicrobial prophylaxis (AMP) with levofloxacin for the patients undergoing transrectal or transperineal biopsy was compared between a single dose (500 mg) and that given for 2 or more days, no significant difference was observed for the rate of infection (transrectal: 0.82% vs. 1.04%, p = 0.94; transperineal: 0.30% vs. 0.46%, p = 0.68). Although a single dose of levofloxacin for AMP is sufficient to prevent genitourinary infection after transrectal or transperineal prostate biopsy, and recommended in this era of increased multi-drug resistant pathogens, the increase in fluoroquinolone-resistant E. coli and ESBL-producing E. coli has emerged as a profound problem for surveillance.

  18. The incidence of low venous oxygen saturation on admission to the intensive care unit : a multi-center observational study in The Netherlands

    NARCIS (Netherlands)

    van Beest, P. A.; Hofstra, J. J.; Schultz, M. J.; Boerma, E. C.; Spronk, P. E.; Kuiper, M. A.

    2008-01-01

    Background Low mixed or central venous saturation (S(c)vO(2)) can reveal global tissue hypoxia and therefore can predict poor prognosis in critically ill patients. Early goal directed therapy (EGDT), aiming at an ScvO(2) >= 70%, has been shown to be a valuable strategy in patients with sepsis or sep

  19. Clinical and neuroimaging study of spinocerebellar ataxia type 2

    Directory of Open Access Journals (Sweden)

    JIN Miao

    2013-06-01

    Full Text Available Background Spinocerebellar ataxia type 2 (SCA2 is an autosomal dominant genetic disease characterized by cerebellar ataxia, ophthalmoplegia, slow saccade, hyporeflexia, action tremor, cognitive decline and peripheral neuropathy. The brain MRI shows obvious atrophy of cerebellum and brainstem, indicating typical change of olivopontocerebellar atrophy. SCA2 is caused by an expanded cytosine-adenine-guanine (CAG trinucleotide repeat in the encoding region of ATXN2. The normal CAG repeats range from 13 to 31, and ataxic phenotype occurs when the repeats are more than 34. This study focused on the clinical and imaging features of 5 SCA2 families confirmed by genetic testing. The correlation between phenotype and genotype was analyzed. Methods The pathological CAG triplet repeat expansions of SCA1-3, 6, 7, 17 and dentatorubral-pallidoluysian atrophy (DRPLA genes were analyzed in the probands of 708 autosomal dominant SCA families and 119 sporadic SCA cases. The CAG repeat of ATXN2 gene was amplified by polymerase chain reaction (PCR and agarose gel electrophoresis. Fragment analysis based on CEQ8000 sequencer were applied to analyze expanded alleles. Results Expanded CAG repeats of ATXN2 gene were detected in 45 probands of SCA2 families. Most of the patients manifested with the typical clinical features of SCA2 such as cerebellar ataxia, ophthalmoplegia, slow saccade and hyporeflexia. Some of them also associated with action tremor. The brain MRI showed obvious atrophy of cerebellum and brainstem. The correlation between clinical features and CAG repeat of ATXN2 gene was studied carefully in 5 families. Conclusion Genetic analysis provides the basis for the diagnosis of SCA2. Clinical and neuroimaging features are very helpful in the diagnosis and differential diagnosis of this disease. For the identification of cases carrying intermediate allele, it is important to combine clinical, imaging features with dynamic mutation analysis in the affected

  20. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

    Science.gov (United States)

    Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.

  1. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes

    Science.gov (United States)

    Sharma, Deepak K.; Solbrig, Harold R.; Prud’hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary’s metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration. PMID:28269909

  2. A STUDY OF OVARIAN TUMOURS : CLINICAL AND PATHOLOGICAL CORRELATION

    Directory of Open Access Journals (Sweden)

    Uma Devi

    2015-10-01

    Full Text Available OBJECTIVE: To study incidence age distribution of benign and malignant ovarian tu mours in general population. METHODS AND MATERIAL : To study 120 patients with ovarian tumours in Govt . general hospital during June 2003 and June 2005. RESULTS: Clinical and pathological evaluation of all ovarian tumours was done and incidence, age distrib ution of various benign and malignant ovarian neoplasms were tabulated and compared with other studies. CONCLUSIONS: Most common ovarian tumours are benign tumours and serous cystadenoma is the commonest benign tumour and S erous cystadeno carcinoma is the most common malignant tumour.

  3. Examining an ethical dilemma: a case study in clinical practice.

    Science.gov (United States)

    Narrigan, Deborah

    2004-01-01

    When clients and health care providers differ in their understanding of what is right or wrong, an ethical dilemma may arise. Such dilemmas occur in everyday clinical practice. Health care providers have the professional responsibility to analyze these dilemmas. A clinical case study of an ethical dilemma that occurred in a cross-cultural context is examined. The language of the client and provider differed, and no interpreter service was available. Given these conditions, the provider's ethical dilemma was whether, and if so how, to give safe, satisfying care that respected the needs of a client with limited English proficiency. Measuring the morality of the provider's decisions and actions using Rawls' ethical theory of social justice finds deficits. A 10-step Bioethical Decision-Making Model by Thompson is used to demonstrate one method for analyzing the moral dimension of a clinical scenario focusing on the decisions and actions taken by a midwife. Scrutinizing ethically challenging clinical encounters will result in better understanding of the moral dimensions of practice.

  4. Chronic actinic dermatitis - A study of clinical features

    Directory of Open Access Journals (Sweden)

    Somani Vijay

    2005-01-01

    Full Text Available Background: Chronic actinic dermatitis (CAD, one of the immune mediated photo-dermatoses, comprises a spectrum of conditions including persistent light reactivity, photosensitive eczema and actinic reticuloid. Diagnostic criteria were laid down about 20 years back, but clinical features are the mainstay in diagnosis. In addition to extreme sensitivity to UVB, UVA and/or visible light, about three quarters of patients exhibit contact sensitivity to several allergens, which may contribute to the etiopathogenesis of CAD. This study was undertaken to examine the clinical features of CAD in India and to evaluate the relevance of patch testing and photo-aggravation testing in the diagnosis of CAD. Methods: The clinical data of nine patients with CAD were analyzed. Histopathology, patch testing and photo-aggravation testing were also performed. Results: All the patients were males. The average age of onset was 57 years. The first episode was usually noticed in the beginning of summer. Later the disease gradually tended to be perennial, without any seasonal variations. The areas affected were mainly the photo-exposed areas in all patients, and the back in three patients. Erythroderma was the presenting feature in two patients. The palms and soles were involved in five patients. Patch testing was positive in seven of nine patients. Conclusions: The diagnosis of CAD mainly depended upon the history and clinical features. The incidence of erythroderma and palmoplantar eczema was high in our series. Occupation seems to play a role in the etiopathogenesis of CAD.

  5. Alflutop clinical efficacy assessment in osteoarthritis (two-years study)

    OpenAIRE

    V. N. Chodyrev; N I Znaisheva; G M Lobanova; L M Ridnyak

    2003-01-01

    Objective. To assess alflutop clinical efficacy and safety during long-term course treatment of knee osteoarthritis. Methods. 51 pts with definite knee osteoarthritis of I-III stage according to Kellgren-Lawrence classification were included in an open controlled study. 20 pts received 6 intra-articular injections of alflutop 2 ml with subsequent intramuscular treatment during 3 months. Such courses were repeated 6 months apart for 2 years. 31 pts of control group received nonsteroidal anti-i...

  6. Evidence of clinical competence by simulation, a hermeneutical observational study.

    Science.gov (United States)

    Lejonqvist, Gun-Britt; Eriksson, Katie; Meretoja, Riitta

    2016-03-01

    Making the transition from theory to practise easier in nursing education through simulation is widely implemented all over the world, and there is research evidence of the positive effects of simulation. The pre-understanding for this study is based on a definition of clinical competence as encountering, knowing, performing, maturing and developing, and the hypothesis is that these categories should appear in simulated situations. The aim of the study was to explore the forms and expressions of clinical competence in simulated situations and furthermore to explore if and how clinical competence could be developed by simulation. An observational hermeneutic study with a hypothetic-deductive approach was used in 18 simulated situations with 39 bachelor degree nursing students. In the situations, the scenarios, the actors and the plots were described. The story told was "the way from suffering to health" in which three main plots emerged. The first was, doing as performing and knowing, which took the shape of knowing what to do, acting responsibly, using evidence and equipment, appearing confident and feeling comfortable, and sharing work and information with others. The second was, being as encountering the patient, which took the shape of being there for him/her and confirming by listening and answering. The third plot was becoming as maturing and developing which took the shape of learning in co-operation with other students. All the deductive categories, shapes and expressions appeared as dialectic patterns having their negative counterparts. The study showed that clinical competence can be made evident and developed by simulation and that the challenge is in encountering the patient and his/her suffering.

  7. Neurophysiology versus clinical genetics in Rett syndrome: A multicenter study.

    Science.gov (United States)

    Halbach, Nicky; Smeets, Eric E; Julu, Peter; Witt-Engerström, Ingegerd; Pini, Giorgio; Bigoni, Stefania; Hansen, Stig; Apartopoulos, Flora; Delamont, Robert; van Roozendaal, Kees; Scusa, Maria F; Borelli, Paolo; Candel, Math; Curfs, Leopold

    2016-09-01

    Many studies have attempted to establish the genotype-phenotype correlation in Rett syndrome (RTT). Cardiorespiratory measurements provide robust objective data, to correlate with each of the different clinical phenotypes. It has important implications for the management and treatment of this syndrome. The aim of this study was to correlate the genotype with the quantitative cardiorespiratory data obtained by neurophysiological measurement combined with a clinical severity score. This international multicenter study was conducted in four European countries from 1999 to 2012. The study cohort consisted of a group of 132 well-defined RTT females aged between 2 and 43 years with extended clinical, molecular, and neurophysiological assessments. Diagnosis of RTT was based on the consensus criteria for RTT and molecular confirmation. Genotype-phenotype analyses of clinical features and cardiorespiratory data were performed after grouping mutations by the same type and localization or having the same putative biological effect on the MeCP2 protein, and subsequently on eight single recurrent mutations. A less severe phenotype was seen in females with CTS, p.R133C, and p.R294X mutations. Autonomic disturbances were present in all females, and not restricted to nor influenced by one specific group or any single recurrent mutation. The objective information from non-invasive neurophysiological evaluation of the disturbed central autonomic control is of great importance in helping to organize the lifelong care for females with RTT. Further research is needed to provide insights into the pathogenesis of autonomic dysfunction, and to develop evidence-based management in RTT. © 2016 Wiley Periodicals, Inc.

  8. Antiasthmatic activity of Moringa oleifera Lam: A clinical study

    OpenAIRE

    2008-01-01

    The present study was carried out to investigate the efficacy and safety of seed kernels of Moringa oleifera in the treatment of bronchial asthma. Twenty patients of either sex with mild-to-moderate asthma were given finely powdered dried seed kernels in dose of 3 g for 3 weeks. The clinical efficacy with respect to symptoms and respiratory functions were assessed using a spirometer prior to and at the end of the treatment. Hematological parameters were not changed markedly by treatment with ...

  9. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    Science.gov (United States)

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  10. First metatarsophalangeal arthrodesis: a clinical, pedobarographic and gait analysis study.

    Science.gov (United States)

    DeFrino, Paul Francis; Brodsky, James White; Pollo, Fabian E; Crenshaw, Stephanie J; Beischer, Andrew D

    2002-06-01

    This study investigated the results of first metatarsophalangeal (MTP) arthrodesis in terms of clinical outcome measures, plantar pressure distribution, and gait patterns. Ten feet in nine patients with severe hallux rigidus (HR) who underwent first MTP arthrodesis were studied. The preoperative evaluation included a subjective questionnaire, physical exam, AOFAS hallux score, radiographs and dynamic pedobarography (EMED). At follow-up (average 34 months) these were repeated, and gait analysis studies were obtained. Patients showed significant clinical improvement based on the subjective criteria. The mean AOFAS score improved from 38 preoperatively to 90 postoperatively. Postoperative EMED analysis showed restoration of the weightbearing function of the first ray, with greater maximum force carried by the distal hallux at toe-off. Kinematic and kinetic gait analysis from each patient's operative limb were compared to the unaffected contralateral limb and to age- and sex-matched healthy subjects. The kinematic data indicated a significantly shorter step length with some loss in ankle plantar flexion at toe-off on the fused side. The kinetic data indicated a reduction in both ankle torque and ankle power at push-off. Clinical results indicated effective pain relief and a high level of patient satisfaction, consistent with previous reports in patients with symptomatic Hallux Rigidus.

  11. Best herbs for managing diabetes: a review of clinical studies

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    Ahmad Ghorbani

    2013-09-01

    Full Text Available Diabetes mellitus is a public health problem which leads to serious complications over time. Experimentally, many herbs have been recommended for treating diabetes. In most cases, however, the recommendations are based on animal studies and limited pieces of evidence exist about their clinical usefulness. This review focused on the herbs, the hypoglycemic actions of which have been supported by three or more clinical studies. The search was done in Google Scholar, Medline and Science Direct databases using the key terms diabetes, plants, herbs, glucose and patients. According to the clinical studies, Aegle marmelos, Allium cepa, Gymnema sylvestre, Momordica charantia, Ocimum sanctum, Nigella sativa, Ocimum sanctum, Panax quinquefolius, Salacia reticulate, Silybum marianum and Trigonella foenum-graecum have shown hypoglycemic and, in some cases, hypolipidemic activities in diabetic patients. Among them, Gymnema sylvestre, Momordica charantia, Silybum marianum and Trigonella foenum-graecum have acquired enough reputation for managing diabetes. Thus, it seems that physicians can rely on these herbs and advise for the patients to improve management of diabetes.

  12. Recombinant human thrombopoietin: basic biology and evaluation of clinical studies.

    Science.gov (United States)

    Kuter, David J; Begley, C Glenn

    2002-11-15

    Thrombocytopenia is a common medical problem for which the main treatment is platelet transfusion. Given the increasing use of platelets and the declining donor population, identification of a safe and effective platelet growth factor could improve the management of thrombocytopenia. Thrombopoietin (TPO), the c-Mpl ligand, is the primary physiologic regulator of megakaryocyte and platelet development. Since the purification of TPO in 1994, 2 recombinant forms of the c-Mpl ligand--recombinant human thrombopoietin (rhTPO) and pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF)--have undergone extensive clinical investigation. Both have been shown to be potent stimulators of megakaryocyte growth and platelet production and are biologically active in reducing the thrombocytopenia of nonmyeloablative chemotherapy. However, neither TPO has demonstrated benefit in stem cell transplantation or leukemia chemotherapy. Other clinical studies have investigated the use of TPO in treating chronic nonchemotherapy-induced thrombocytopenia associated with myelodysplastic syndromes, idiopathic thrombocytopenic purpura, thrombocytopenia due to human immunodeficiency virus, and liver disease. Based solely on animal studies, TPO may be effective in reducing surgical thrombocytopenia and bleeding, ex vivo expansion of pluripotent stem cells, and as a radioprotectant. Ongoing and future studies will help define the clinical role of recombinant TPO and TPO mimetics in the treatment of chemotherapy- and nonchemotherapy-induced thrombocytopenia.

  13. Phase I clinical and pharmacokinetic study of LY 195448.

    Science.gov (United States)

    Cassidy, J; Lewis, C; Adams, L; Setanoians, A; Bayssas, M; Boder, G G; Rankin, E M; Kaye, S B

    1989-01-01

    LY 195448 is a phenethanolamine that has shown anti-tumour activity in a range of murine tumour models, although its mechanism of action is unknown. Pre-clinical studies have indicated the absence of "standard" side effects such as myelosuppression and gastrointestinal toxicity. The present phase I trial was carried out in nine patients at doses ranging up to 133 mg/m2. The major toxicities up to that dose were mild, reversible hypotension, tachycardia and tremor. No haematological or biochemical toxicity was observed. Murine pharmacokinetics were assessed at a dose level that was effective in experimental tumours and compared with human pharmacokinetic parameters derived from this study. The results indicated the clinical possibility of reaching peak drug levels associated with experimental activity. However, no responses were seen at the doses used. This study was terminated prior to its completion due to an unexplained loss of activity against murine tumours since September 1987. No significant loss of the in vitro anti-mitotic activity originally reported by Boder et al. [3] was observed. Possible reasons for the apparent loss of in vivo activity have been intensively investigated, but no cause has been determined. Therefore, clinical trials with LY 195448 have been discontinued.

  14. A Clinical Study of Safflower Yellow Injection in Treating Coronary Heart Disease Angina Pectoris with Xin-Blood Stagnation Syndrome

    Institute of Scientific and Technical Information of China (English)

    2005-01-01

    Objective: To evaluate the clinical effect and safety of Safflower Yellow injection (SYI) in treating coronary heart disease angina pectoris (CHD-AP) with Xin-blood stagnation syndrome (XBSS).Methods: Adopted was the multi-centered, randomized, positive parallel controlled method, 448 patients with CHD-AP-XBSS were enrolled and divided into two groups, 336 in the tested group treated with SYI and112 in the control group treated with Salvia injection by intravenous dripping once a day for 14 days, so as to observe the conditions of angina, electrocardiogram, and therapeutic effect on traditinal Chinese medicine(TCM) symptoms as well as the safety of the treatment. Results: The significantly effective rate and total effective rate in the tested group were 60.06% (194/323) and 91.02% (294/323) respectively; those in improvement of TCM symptoms were 40.18% (129/321) and 75.23% (243/323) respectively, which were better than those in the control group (P<0.01). Conclusion: SYI Injection is effective and safe in treating CHD-AP-XBSS.

  15. Analysis of ventilator associated pneumonia (VAP studies in Egyptian University Hospitals

    Directory of Open Access Journals (Sweden)

    Amal Fathy

    2013-01-01

    Conclusion: It is important to establish large-scale multi center national studies to explore incidence of VAP, all possible risk factors (whether preventable or non preventable, causative organisms, and mortality due to VAP and its economic aspect.

  16. Xanthelasma palpebrarum with arcus cornea: A clinical and biochemical study

    Directory of Open Access Journals (Sweden)

    Pragya Ashok Nair

    2016-01-01

    Full Text Available Background: Xanthelasma palpebrarum (XP is characterized by sharply demarcated yellowish flat plaques on upper and lower eyelids. It is commonly seen in women with a peak incidence at 30–50 years. It is also considered as the cutaneous marker of underlying atherosclerosis along with the disturbed lipid metabolism. XP and corneal arcus are associated with increased levels of serum cholesterol and low-density lipoprotein (LDL cholesterol. Aims and Objectives: To study the clinical pattern of XP, its relationship with lipid profile and association with arcus cornea. Materials and Methods: This study was conducted at Department of Dermatology and Opthalmology, between August 2013 and January 2015. Patients with clinical diagnosis of XP who visited skin outpatient department and willing to undergo lipid profile test and eye examination were included in the study. Data regarding demographics, clinical findings, family history, and past history were noted along with the lipid profile details. Data of age-matched healthy controls were taken for comparison. The clinical profile of the participants was presented using frequency and proportions. Gender wise analysis comparing the lipid profile in cases with XP and without XP was done using independent sample t-test. Results: Total 49 patients of XP, 81.6% were females. Maximum, 35% patients were among 50–60 years of age and 69.4% were homemakers by occupation. The average lipid values were-cholesterol 210.57 mg%, triglyceride 123.06 mg%. LDL 142.79 mg% and VLDL 30.95 mg% among patients of XP. Arcus cornea was found in 20% cases of XP. Conclusions: Patients of XP requires proper investigation at the onset and regular follow-up thereafter for any altered lipid profile and early diagnosis of coronary artery disease.

  17. Epidemiology, etiology and study of clinical findings of headache

    Directory of Open Access Journals (Sweden)

    Ghaffarpoor M

    1998-09-01

    Full Text Available In a cross-sectional epidemiological study of headache disorders in neurology clinic of Fatemieh hospital of Semnan (August 22-November 20.1996, information on types of headaches, quality, severity, location, duration, frequency, precipitating factors, age of onset, influence of menstruation and pregnancy, positive familial history, use of oral contraceptive pills and other epidemiological factors including socioeconomic and age/sex composition was collected. The presence of any types of headaches was ascertained by a clinical interview and examination using the operational diagnostic criteria of the International Headaches Society. The prevalence of migraine and tension type headache was also analysed in relation to variables of life style (physical activity and sleep pattern and associated signs and symptoms (nausea, vomiting, photophobia and phonophobia. In this study migraine and tension headache were also compared in variable aspects with each other. 1 Headache was more prevalent in women than men (F/M=3/1. 2 The most common types of headache included: tension type headache (41.4%, migraine (31.2% and unclassified headaches (17.2%. 3 Migraine and T.T.H were more prevalent in early adult life and middle ages. 4 In both migraine and tension type headache the time profiles (duration, frequency, age of onset, quality and location were like that noted in textbook and previous studies. 5 In both migraine and tension type headache the most conspicuous precipitating factor was stress and mental tension and frequent headaches were accompanied with psychiatric problems (e.g depression and or anxiety. 6 Nausea, vomiting, phonophobia and photophobia were the most common associated symptoms in both of them. 7 Positive familial history and aggravation of headache in perimenstual period were more commonly seen in patients with migraine than tension type headache. In conclusion using the operational diagnostic criteria of International Headache Society in

  18. Studies on clinical standard. Studies on the standardization of clinical application of novel radiopharmaceuticals for circulation

    Energy Technology Data Exchange (ETDEWEB)

    Sugishita, Yasuro [Tsukuba Univ., Ibaraki (Japan). Inst. of Clinical Medicine; Kanbara, Hirofumi; Konishi, Junji [and others

    1998-08-01

    This paper is a summary guideline for the use of recent radiopharmaceuticals for circulation in various disease states, which is based on the studies to recognize the actual status of the use of radiopharmaceuticals by questionnaire, then to make the guideline for their use by authors and finally to evaluate its usefulness. The questionnaire to 339 facilities was performed in 1995 to obtained answers from 200 facilities, of which 96% had used at least one of the novel radiopharmaceuticals. Planar and SPECT imaging had been done under various conditions in those facilities. This guideline consists of three chapters. In the chapter for the tracer, use of radiopharmaceuticals, theory, apparatuses, technique, diagnostic criteria and notes for diagnosis were guided for {sup 123}I-BMIPP (myocardial imaging), {sup 123}I-MIBG (myocardial imaging) and {sup 99m}Tc-MIBI and -TF (blood flow imaging). In the chapter for disease states, pathophysiology of following diseases and significance of nuclear medicine in their diagnosis, therapy and prognosis were described: acute coronary diseases, myocardial infarction, angina pectoris, cardiomyopathy and others. In the additional chapter, {sup 111}In-labeled anti-myosin antibody was described for imaging of impaired myocardium. The present guideline was hoped to be useful. (K.H.). 315 refs.

  19. Genetic studies in chronic kidney disease: interpretation and clinical applicability.

    Science.gov (United States)

    Witasp, Anna; Nordfors, Louise; Carrero, Juan Jesus; Luttropp, Karin; Lindholm, Bengt; Schalling, Martin; Stenvinkel, Peter

    2012-01-01

    The tools of modern molecular biology are evolving rapidly, resulting in vastly more efficient approaches to illuminating human genetic variations and their effects on common multifactorial disorders such as chronic kidney disease (CKD). Indeed, candidate gene association studies and genome-wide association studies (GWASs) have generated novel genetic variants in previously unrecognized biological pathways, highlighting disease mechanisms with a potential role in CKD etiology, morbidity and mortality. Nephrologists now need to find ways to make use of these advancements and meet the increasingly stringent requirements for valid study design, data handling and interpretation of genetic studies. Adding to our prior article in this journal, which introduced the basics of genotype-phenotype association studies in CKD, this second article focuses on how to ascertain robust and reproducible findings by applying adequate methodological and statistical approaches to genotype-phenotype studies in CKD populations. Moreover, this review will briefly discuss genotype-based risk prediction, pharmacotherapy, drug target identification and individualized treatment solutions, specifically highlighting potentially important findings in CKD patients. This increased knowledge will hopefully facilitate the exciting transition from conventional clinical medicine to gene-based medicine. However, before this can be accomplished, unsolved issues regarding the complex human genetic architecture as well technical and clinically oriented obstacles will have to be overcome. Additionally, new policies and standardized risk evaluations for genetic testing in the clinical setting will have to be established to guarantee that CKD patients are provided with high-quality genotype-guided counseling that will help to improve their poor outcomes.

  20. Patient advocacy from the clinical nurses' viewpoint: a qualitative study

    Science.gov (United States)

    Davoodvand, Shirmohammad; Abbaszadeh, Abbas; Ahmadi, Fazlollah

    2016-01-01

    One of the advanced nursing care procedures emphasized by nursing organizations around the world is patient or nursing advocacy. In addition to illustrating the professional power of nursing, it helps to provide effective nursing care. The aim of the present study was to explain the concept of patient advocacy from the perspective of Iranian clinical nurses. This was a qualitative study that examined the viewpoint and experiences of 15 clinical nurses regarding patient advocacy in nursing. The nurses worked in intensive care units (ICUs), coronary care units (CCUs), and emergency units. The study participants were selected via purposeful sampling. The data was collected through semi-structured interviews and analyzed using content analysis. Data analysis showed that patient advocacy consisted of the two themes of empathy with the patient (including understanding, being sympathetic with, and feeling close to the patient) and protecting the patients (including patient care, prioritization of patients’ health, commitment to the completion of the care process, and protection of patients' rights). The results of this study suggest that nurses must be empathetic toward and protective of their patients. The results of the present study can be used in health care delivery, nursing education, and nursing management and planning systems to help nurses accomplish their important role as patient advocates. It is necessary to further study the connections between patient advocacy and empathy. PMID:27471588

  1. Patient advocacy from the clinical nurses' viewpoint: a qualitative study.

    Science.gov (United States)

    Davoodvand, Shirmohammad; Abbaszadeh, Abbas; Ahmadi, Fazlollah

    2016-01-01

    One of the advanced nursing care procedures emphasized by nursing organizations around the world is patient or nursing advocacy. In addition to illustrating the professional power of nursing, it helps to provide effective nursing care. The aim of the present study was to explain the concept of patient advocacy from the perspective of Iranian clinical nurses. This was a qualitative study that examined the viewpoint and experiences of 15 clinical nurses regarding patient advocacy in nursing. The nurses worked in intensive care units (ICUs), coronary care units (CCUs), and emergency units. The study participants were selected via purposeful sampling. The data was collected through semi-structured interviews and analyzed using content analysis. Data analysis showed that patient advocacy consisted of the two themes of empathy with the patient (including understanding, being sympathetic with, and feeling close to the patient) and protecting the patients (including patient care, prioritization of patients' health, commitment to the completion of the care process, and protection of patients' rights). The results of this study suggest that nurses must be empathetic toward and protective of their patients. The results of the present study can be used in health care delivery, nursing education, and nursing management and planning systems to help nurses accomplish their important role as patient advocates. It is necessary to further study the connections between patient advocacy and empathy.

  2. Cancer therapy with phytochemicals: evidence from clinical studies

    Directory of Open Access Journals (Sweden)

    Ahmad Ghorbani

    2015-02-01

    Full Text Available Cancer is still one of the major causes of mortality in both developing and developed countries. At this time, in spite of intensive interventions, a large number of patients have poor prognosis. Therefore, the effort for finding new anticancer agents with better efficacy and lesser side effects has continued. According to the traditional recommendations and experimental studies, numerous medicinal plants have been reported to have anticancer effect. Also antiproliferative, proapoptotic, antimetastatic and antiangiogenic effects of several phytochemicals have been shown with in vitro experiments or animal studies. However, only a small number of them were tested in cancerous patients and limited evidence exists on their clinical effectiveness. Also, regarding some phytochemicals, only beneficial effects on cancer-related symptoms or on quality of life have been reported and no positive results exist on their antitumor actions. In this review we focus on phytochemicals that their beneficial effects on various types of cancer are supported by clinical trials. Based our literature search, curcumin, green tea, resveratrol and Viscum album had satisfactory instances of clinical evidence for supporting their anticancer effects. The main findings on these phytochemicals are summarized and discussed.

  3. Photodynamic therapy of port wine stain: preliminary clinical studies

    Science.gov (United States)

    Nelson, J. Stuart

    1993-07-01

    The broad, long term objective of this work is the development of Photodynamic Therapy (PDT) for application in the clinical management of patients with port wine stain (PWS). PDT involves the use of an exogenous drug which is concentrated in a targeted tissue. When irradiated at wavelengths specifically absorbed by the drug, selective destruction of the targeted tissue, without the production of heat, occurs. The results of this preliminary study demonstrate in human PWS patients that a photosensitizer, such as PHOTOFRINR, activated by red light at the appropriate therapeutic wavelength, can cause destruction of subsurface blood vessels in the skin with a high degree of specificity, and further study appears warranted.

  4. Cytokine-induced killer (CIK) cells:from basic research to clinical translation

    Institute of Scientific and Technical Information of China (English)

    Yelei Guo; Weidong Han

    2015-01-01

    The accumulation of basic researches and clinical studies related to cytokine-induced killer (CIK) cells has confirmed their safety and feasibility in treating malignant diseases. This review summarizes the available published literature related to the biological characteristics and clinical applications of CIK cells in recent years. A number of clinical trials with CIK cells have been implemented during the progressive phases of cancer, presenting potential widespread applications of CIK cells for the future. Furthermore, this review briefly compares clinical applications of CIK cells with those of other adoptive immunotherapeutic cells. However, at present, there are no uniform criteria or large-scale preparations of CIK cells. The overall clinical response is difficult to evaluate because of the use of autologous CIK cells. Based on these observations, several suggestions regarding uniform criteria and universal sources for CIK cell preparations and the use of CIK cells either combined with chemotherapy or alone as a primary strategy are briefly proposed in this review. Large-scale, controlled, grouped, and multi-center clinical trials on CIK cell-based immunotherapy should be conducted under strict supervision. These interventions might help to improve future clinical applications and increase the clinical curative effects of CIK cells for a broad range of malignancies in the future.

  5. Root coverage with free gingival autografts--a clinical study.

    Directory of Open Access Journals (Sweden)

    Deepalakshmi D

    2006-01-01

    Full Text Available AIM: To assess the percentage of root coverage with autogenous free gingival grafts. MATERIALS & METHODS: Ten non-smoking patients with Miller′s class I or class II recessions were included in the study. The clinical parameters such as recession depth, recession width, probing pocket depth, clinical attachment level and width of the keratinized gingiva were recorded at the baseline, at the end of 1 month, 3 months, and 6 months after the surgical procedure. Autogenous free gingival grafts harvested from the palatal mucosa were used to cover the denuded roots. RESULTS: Four out of ten sites showed 100% root coverage. A mean percentage of 80.3% of root coverage was achieved.

  6. Study Of Clinical Profile of Allergic Contact Dermatitis In Pune

    Directory of Open Access Journals (Sweden)

    Sayal S K

    1999-01-01

    Full Text Available One hundred and twenty five cases of clinically diagnosed allergic contact dermatitis were studied. All patients were subjected to patch test with standard test allergens and also with suspected test allergens based on history and clinical profile. Allergic contact dermatitis due to Parthenium hysterophorus was commonest and found in 64% cases, followed by wearing apparel and jewellery in 16.8%, topical medicaments in 8% and cosmetics and occupational contactants in 5.6% cases each. The common individual allergens other than parthenium, were nickel in 8.8%, leather, hair dye and cement in 3.2% each, nitrofurazone and petrol, oil, lubricant (POL in 2.4% each. Patch test with suspected allergens was positive in 72% of cases.

  7. Chronic liver disease in Kuala Lumpur, Malaysia: a clinical study.

    Science.gov (United States)

    Kudva, M V; Zawawi, M M

    1990-08-01

    This study was undertaken to analyse the clinical spectrum of chronic liver disease (cirrhosis, and others with portal hypertension) in Kuala Lumpur. Eighty patients were diagnosed over a 6-year period. Twenty-two had biopsy proven cirrhosis while 58 others had portal hypertension with clinical and biochemical evidence of chronic liver disease. The commonest aetiology was alcohol (36%), followed by the idiopathic variety and hepatitis B. The male to female ratio was 4.4:1. Indians had a high prevalence of alcohol-associated chronic liver disease. Overall, ascites was the commonest presentation. Eight patients presented with hepatocellular carcinoma. Spontaneous bacterial peritonitis was diagnosed in 13% of patients undergoing abdominal paracentesis. Gallstones were detected in 37% of patients who underwent ultrasonography. Diabetes mellitus and peptic ulcer disease were noted in 22% and 31% of patients respectively.

  8. Clinical and microbiological study of otitis externa in sheep

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    M. I. Al-Farwachi

    2008-01-01

    Full Text Available In this study one hundred Awassi sheep were examined clinically and bacteriologically for isolation and identification of the bacterial agents of otitis externa in sheep. The main clinical signs appeared included weakness, pale mucus membrane, auricular discharge, cough, anorexia, emaciation, and nasal discharge. Results revealed isolation of bacteria from (45% examined swabs. The most being from right ear. Younger animals were more frequently infected than older animals. Pseudomonas aeruginosa, Staphylococcus aureus, Mannheimia haemolytica, Staph. epidermidis, Pasteurella multocida, Streptococcus spp., Acintobacter spp., Escherichia coli and Klebsiella pneumonia were isolated. The results revealed that the most bacterial isolates were resistance to the bactericidal effect of the normal serum included Streptococcus pneumonia, Staphylococcus aureus, Mannheimia haemolytica. While the most bacterial isolates were produced hydroxymate siderophore included Staphylococcus aureus, Mannheimia haemolytica, Streptococcus pneumonia. The obtained results indicated to the importance of determination of serum resistance as a bacterial virulence factor in otitis externa in sheep.

  9. CLINICAL STUDY OF HASHIMOTO’S THYROIDITIS & ITS MANAGEMENT

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    Purnaiah

    2016-03-01

    Full Text Available INTRODUCTION Hashimoto’s Thyroiditis is a well-known clinical condition affecting the thyroid gland predominantly in women during 4 th decade & is often under diagnosed due its wide spectrum of clinical features. It could present as a multinodular goitre, diffuse goitre, or as a solitary nodule with features of Hypothyroidism, Hyperthyroidism or Euthyroid state. AIMS 1. To detect HT by FNAC, Antibody titers finally by Histopathology of excised Thyroid gland. 2. To know its various clinical features. 3. To study Sex ratio & Age it affects. 4. Management i.e. by conservative or surgical. 5. Complications & malignant transformation including Lymphomas. MATERIALS & METHODS 60 patients were taken for 2 years’ period from March 2014 to Feb 2016 attending Government General Hospital-Nizamabad; Telangana State. OBSERVATIONS  56 case are females, 4 cases are males; common age is 30-39 yrs., >50 yrs.-2 cases.  All cases presented with swelling in front of neck, only 5 had toxicity, 2 had obstructive symptoms. None had voice change.  36 Cases- 60% had MNG, 18 Cases- 30% diffuse goitre and 6 cases- 10%- solitary nodule.  The Hypothyroid, Euthyroid & Hyperthyroid state here are 48%, 44% & 8% comparative to Fenn et al -44%, 47% and 7%,  FNAC- was positive 90% here where as Lakshman Rao et al study has 77%.  We had 80% Anti Thyroid Antibodies positivity, others shown 63% and 84%. MANAGEMENT All are put on Hormone-Thyroxine replacement or suppression therapy and all patients found to be clinically Euthyroid during follow up. All patients showed decrease in size of gland except those with MNG. 8 patients underwent surgery- Subtotal Thyroidectomy. Of these 6 were Colloid goiters, later on diagnosed as HT by final HPE. One case was operated for cosmetic reason and the other for obstructive symptoms which was noticed to be lymphoma after HPE.

  10. Clinical studies in orthodontics--an overview of NIDR-sponsored clinical orthodontic studies in the US.

    Science.gov (United States)

    Baumrind, S

    1998-11-01

    A number of clinical trials sponsored by the National Institutes of Health (NIH) use rigorous methods of data acquisition and analysis previously developed in fundamental biology and the physical sciences. The naive expectation that these trials would lead relatively rapidly to definitive answers concerning the therapeutic strategies and techniques under study is dispelled. This presentation focuses on delineating differences between the study of central tendencies and individual variation, more specifically on the strategy to study this variation: measure additional sources of variance within each patient at more timepoints and perhaps with greater precision. As rigorous orthodontic research is still in its infancy, the problem of defining the proper mix between prospective and retrospective trials is discussed. In view of the high costs of prospective clinical trials, many of the questions germane to orthodontics can be answered by well-conducted retrospective trials, assuming that properly randomized sampling procedures are employed. Definitive clinical trials are likely to require better theoretical constructs, better instrumentation, and better measures than now available. Reasons for concern are the restricted resources available and the fact that current mensurational approaches may not detect many of the individual differences. The task of constructing sharable databases and record bases stored in digital form and available either remotely from servers, or locally from CD-ROMs or optical disks, is crucial to the optimization of future investigations.

  11. A multi-center randomised controlled trial of gatifloxacin versus azithromycin for the treatment of uncomplicated typhoid fever in children and adults in Vietnam.

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    Christiane Dolecek

    Full Text Available BACKGROUND: Drug resistant typhoid fever is a major clinical problem globally. Many of the first line antibiotics, including the older generation fluoroquinolones, ciprofloxacin and ofloxacin, are failing. OBJECTIVES: We performed a randomised controlled trial to compare the efficacy and safety of gatifloxacin (10 mg/kg/day versus azithromycin (20 mg/kg/day as a once daily oral dose for 7 days for the treatment of uncomplicated typhoid fever in children and adults in Vietnam. METHODS: An open-label multi-centre randomised trial with pre-specified per protocol analysis and intention to treat analysis was conducted. The primary outcome was fever clearance time, the secondary outcome was overall treatment failure (clinical or microbiological failure, development of typhoid fever-related complications, relapse or faecal carriage of S. typhi. PRINCIPAL FINDINGS: We enrolled 358 children and adults with suspected typhoid fever. There was no death in the study. 287 patients had blood culture confirmed typhoid fever, 145 patients received gatifloxacin and 142 patients received azithromycin. The median FCT was 106 hours in both treatment arms (95% Confidence Interval [CI]; 94-118 hours for gatifloxacin versus 88-112 hours for azithromycin, (logrank test p = 0.984, HR [95% CI] = 1.0 [0.80-1.26]. Overall treatment failure occurred in 13/145 (9% patients in the gatifloxacin group and 13/140 (9.3% patients in the azithromycin group, (logrank test p = 0.854, HR [95% CI] = 0.93 [0.43-2.0]. 96% (254/263 of the Salmonella enterica serovar Typhi isolates were resistant to nalidixic acid and 58% (153/263 were multidrug resistant. CONCLUSIONS: Both antibiotics showed an excellent efficacy and safety profile. Both gatifloxacin and azithromycin can be recommended for the treatment of typhoid fever particularly in regions with high rates of multidrug and nalidixic acid resistance. The cost of a 7-day treatment course of gatifloxacin is approximately one third of the

  12. Topical alprostadil (PGE1) for the treatment of female sexual arousal disorder: in-clinic evaluation of safety and efficacy.

    Science.gov (United States)

    Heiman, Julia R; Gittelman, Marc; Costabile, Raymond; Guay, Andre; Friedman, Alice; Heard-Davison, Amy; Peterson, Craig; Dietrich, John; Stephens, Darby

    2006-03-01

    This multi-center, randomized, placebo-controlled, crossover design study evaluated the effects of a topical alprostadil solution for the treatment of female sexual arousal disorder (FSAD). A total of 79 naturally or surgically post menopausal women with FSAD were treated with either 100 or 400 micrograms of alprostadil solution and placebo, delivered on separate clinic visits in random order. Study drug was applied to the external genitalia and was followed by 30 minutes of visual sexual stimulation. Study evaluations included investigator assessments of genital vasocongestion and patient assessments of physical and emotional sexual arousal, and sexual satisfaction. Genital vasocongestion in response to PGE1 was significantly greater than placebo (p alprostadil. Topical alprostadil was well tolerated with no reports of significant systemic side effects. The most common adverse event was mild, transient genital burning typically alprostadil should be further researched as a potentially appropriate on-demand therapeutic choice for women experiencing FSAD.

  13. Alflutop clinical efficacy assessment in osteoarthritis (two-years study

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    V. N. Chodyrev

    2003-01-01

    Full Text Available Objective. To assess alflutop clinical efficacy and safety during long-term course treatment of knee osteoarthritis. Methods. 51 pts with definite knee osteoarthritis of I-III stage according to Kellgren-Lawrence classification were included in an open controlled study. 20 pts received 6 intra-articular injections of alflutop 2 ml with subsequent intramuscular treatment during 3 months. Such courses were repeated 6 months apart for 2 years. 31 pts of control group received nonsteroidal anti-inflammatory drugs (NSAID only. Pain on visual analog scale, Leken functional score, changes of NSAID treatment and radiological picture were used for assessment of efficacy. Clinical examination was performed before and after every treatment course and 3 months after the last course. Results. Every alflutop treatment course provided significant stepwise decrease of pain with improvement of mobility, reduction of NSAID requirement and absence of osteoarthritis radiological progression. Doctor and pts clinical efficacy and safety assessment coincided. Conclusion. Alflutop is an effective drug for knee osteoarthritis treatment. It has anti-inflammatory and probably chondroprotective activity with good safety.

  14. Therapeutic horticulture in clinical depression: a prospective study.

    Science.gov (United States)

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2009-01-01

    Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

  15. Safety of amisulpride (Solian): a review of 11 clinical studies.

    Science.gov (United States)

    Coulouvrat, C; Dondey-Nouvel, L

    1999-07-01

    We assessed the overall safety profile of amisulpride based on the results from 11 clinical studies performed in patients suffering from schizophrenia with predominance of positive or negative symptoms. A total of 1933 patients were randomly assigned to treatment with amisulpride (n = 1247) or haloperidol (n = 309), risperidone (n = 113), flupentixol (n = 62) and placebo (n = 202). Safety data collection was performed using open reporting, UKU scales or specific extrapyramidal side-effect scales; electrocardiogram recording and vital signs examination; laboratory data collection. Amisulpride demonstrated a satisfactory global safety profile in the range of doses usually prescribed. The number of patients having at least one extrapyramidal side-effect was higher in haloperidol patients compared with both amisulpride and risperidone patients (50% versus 30% in the two latter groups). For endocrine events, a similar rate was observed between amisulpride and risperidone groups (4% versus 6%, respectively) versus 1% in the haloperidol group. Electrocardiogram results were satisfactory, confirmed by the absence of cardiovascular events. The overall laboratory safety profile of amisulpride did not show clinically relevant abnormalities in liver function tests nor haematological abnormalities. Our extensive clinical data confirm the satisfactory safety profile of amisulpride which is superior to standard reference compounds.

  16. 3D ultrasound computer tomography: update from a clinical study

    Science.gov (United States)

    Hopp, T.; Zapf, M.; Kretzek, E.; Henrich, J.; Tukalo, A.; Gemmeke, H.; Kaiser, C.; Knaudt, J.; Ruiter, N. V.

    2016-04-01

    Ultrasound Computer Tomography (USCT) is a promising new imaging method for breast cancer diagnosis. We developed a 3D USCT system and tested it in a pilot study with encouraging results: 3D USCT was able to depict two carcinomas, which were present in contrast enhanced MRI volumes serving as ground truth. To overcome severe differences in the breast shape, an image registration was applied. We analyzed the correlation between average sound speed in the breast and the breast density estimated from segmented MRIs and found a positive correlation with R=0.70. Based on the results of the pilot study we now carry out a successive clinical study with 200 patients. For this we integrated our reconstruction methods and image post-processing into a comprehensive workflow. It includes a dedicated DICOM viewer for interactive assessment of fused USCT images. A new preview mode now allows intuitive and faster patient positioning. We updated the USCT system to decrease the data acquisition time by approximately factor two and to increase the penetration depth of the breast into the USCT aperture by 1 cm. Furthermore the compute-intensive reflectivity reconstruction was considerably accelerated, now allowing a sub-millimeter volume reconstruction in approximately 16 minutes. The updates made it possible to successfully image first patients in our ongoing clinical study.

  17. CLINICAL AND BACTERIOLOGICAL STUDY OF ACUTE DIARRHOEA IN CHILDREN

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    Haricharan

    2013-06-01

    Full Text Available ABSTRACT : OBJECTIVES: To know the hospital prevalence and clinical features of acute diarrhoea and describe the common bacterial pathogens isolated in these cases of diarrhoea in children. MATERIALS AND METHODS: A cross sectional study was carried out in children with acute dia rrhea between 1month to 12 years of age at Shree Siddhartha Medical College Hospital, Tumkur from November 2007 to August 2009.After detailed history and examination, stool samples were collected and subjected to microscopic examination and culture and sen sitivity. The data thus collected was analysed . RESULTS AND CONCLUSION: Acute diarrhea accounted for 10.12 % (95% CI 8.98, 11.26 percent of total admissions to pediatric ward. The prevalence of diarrhea peaks in children aged 7 - 24 months (the usual weani ng period and then decreases with increasing age. The analysis of clinical presentation revealed that vomiting and fever were frequent accompaniments of diarrhoea. Artificially fed children were affected more often than exclusively breast - fed ones. Varyin g grades of PEM was present in majority of the study cases. Most of the cases had some dehydration. In majority of study cases enteropathogenic bacteria were isolated; among which E. coli was the commonest. Most of the isolates were sensitive to Gentam i cin and Amikacin. Bacteriological study and sensitivity pattern helps us to identify the most prevalent organism in the locality and to select the most appropriate drug and thus reducing the cost of treatment. Appropriate fluid and antibiotic management resul ted in prompt recovery.

  18. Clinical Case Studies in Psychoanalytic and Psychodynamic Treatment

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    Willemsen, Jochem; Della Rosa, Elena; Kegerreis, Sue

    2017-01-01

    This manuscript provides a review of the clinical case study within the field of psychoanalytic and psychodynamic treatment. The method has been contested for methodological reasons and because it would contribute to theoretical pluralism in the field. We summarize how the case study method is being applied in different schools of psychoanalysis, and we clarify the unique strengths of this method and areas for improvement. Finally, based on the literature and on our own experience with case study research, we come to formulate nine guidelines for future case study authors: (1) basic information to include, (2) clarification of the motivation to select a particular patient, (3) information about informed consent and disguise, (4) patient background and context of referral or self-referral, (5) patient's narrative, therapist's observations and interpretations, (6) interpretative heuristics, (7) reflexivity and counter-transference, (8) leaving room for interpretation, and (9) answering the research question, and comparison with other cases. PMID:28210235

  19. A study on the perception of students in the radiologic technology study on the clinical practices

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    Lee, Byung Ryul; Kim, Hyun Gil; Yoon, Myeong Kwan; Lee, Gi Jong; Cha, Sang Young [Dept. of Diagnostic Radiology, Inha University Hospital, Incheon (Korea, Republic of); Lim, Cheong Hwan [Dept. of Radiological Science, Hanseo University, Seosan (Korea, Republic of)

    2014-09-15

    The clinical practices provide the students with a good opportunity to study the practical experiences in their field through the clinical training education in hospital. Now, in this study, comparing the perceptions of the clinic teachers with those of students at the clinical site. The study was conducted to the students attending universities located in Seoul and who finished the clinical practices in 2013. The questionnaires were distributed to the student and collected from them. The study were conducted to 275 questionnaires with frequency analysis, crosstabs, chi-square test and McNemar test. The major motivation was of the select radiography course was high employment rate(44.0%) and the satisfaction of radiography course was general(53.1%). 51.3% of the study answered 8 weeks current duration of clinical practices is proper. The 3-year course students answered that the period of clinical practices would be proper if it is performed in the winter vacation in their second year in college(47.3%). The 4-year course students answered that the first semester in their third years is proper for clinical practices(27.7%). The students answered that they felt the lack in their knowledge on the professional field(32.4%) during the clinical practices and some of the practical training is different from the education performed at school(68.4%). Most of answered that they were satisfied with the clinical practices and among them they recognized the importance of the clinical practices (3.94 ± 0.89). After the clinical practices, their desire for getting job as a radiography has changed from 84.1% to 82.9%. The reason why they want the job related to the radiation is because the job is stable (changed from 49.0% to 46.0% after the clinical practice) while the reason why they do not want be a radigrapher because that job is not proper for them (changed from 37.0% to 40.7% after the clinical practice) The effort should be made to enhance the position of radiation

  20. Efficiency of Calatonia on clinical parameters in the immediate post-surgery period: a clinical study

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    Elaine Ferreira Lasaponari

    2013-09-01

    Full Text Available OBJECTIVE: to assess the efficiency of the Calatonia technique about clinical parameters and pain in the immediate post-surgical phase. METHOD: a randomised study was carried out with 116 patients subjected to a cholecystectomy, by laparoscopy, divided into an experimental group (58 patients and a placebo group (58 patients. The experimental group received the Calatonia technique, while the placebo was only subjected to non-intentional touches. RESULTS: The placebo group and the experimental group were considered homogeneous in terms of the variables: sex, age, physical status classification, duration of surgical procedures and also the time spent recovering in the Post-Anaesthetic Recovery Room. The only variable to show a statistically significant difference was the axillary temperature of the body. In relation to pain, the experimental group showed significant results, and hence it is possible to deduce that the relaxation caused by the Calatonia technique brought some relief of the general situation of pain. CONCLUSION: The application of Calatonia can take up the function of a resource complementary to assistance in the period immediately after surgery. Brazilian Register of Clinical Trials, UTN U1111-1129-9629.

  1. Clinical and economic studies of eptifibatide in coronary stenting

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    Pasala T

    2014-08-01

    Full Text Available Tilak Pasala, Prasongchai Sattayaprasert, Pradeep K Bhat, Ganesh Athappan, Sanjay Gandhi The Heart and Vascular Center, Case Western Reserve University/MetroHealth, Cleveland, OH, USA Abstract: Platelet adhesion and aggregation at the site of coronary stenting can have catastrophic clinical and economic consequences. Therefore, effective platelet inhibition is vital during and after percutaneous coronary intervention. Eptifibatide is an intravenous antiplatelet agent that blocks the final common pathway of platelet aggregation and thrombus formation by binding to glycoprotein IIb/IIIa receptors on the surface of platelets. In clinical studies, eptifibatide was associated with a significant reduction of mortality, myocardial infarction, or target vessel revascularization in patients with acute coronary syndrome undergoing percutaneous coronary intervention. However, recent trials conducted in the era of dual antiplatelet therapy and newer anticoagulants failed to demonstrate similar results. The previously seen favorable benefit of eptifibatide was mainly offset by the increased risk of bleeding. Current American College of Cardiology/American Heart Association guidelines recommend its use as an adjunct in high-risk patients who are undergoing percutaneous coronary intervention with traditional anticoagulants (heparin or enoxaparin, who are not otherwise at high risk of bleeding. In patients receiving bivalirudin (a newer safer anticoagulant, routine use of eptifibatide is discouraged except in select situations (eg, angiographic complications. Although older pharmacoeconomic studies favor eptifibatide, in the current era of P2Y12 inhibitors and newer safer anticoagulants, the increased costs associated with bleeding make the routine use of eptifibatide an economically nonviable option. The cost-effectiveness of eptifibatide with the use of strategies that decrease the bleeding risk (eg, transradial access is unknown. This review provides an

  2. A CLINICAL STUDY OF PULMONARY TUBERCULOSIS AMONG DIABETES MELLITUS PATIENTS

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    Mojjada Dhanunjaya

    2015-09-01

    Full Text Available Of all the non - tuberculosis complications associated with disease, Diabetes Mellitus exerts, the most adverse influence on the course of pulmonary tuberculosis. The combined diagnosis was invariably fatal before Specific anti tuberculous and anti - diabetic drugs were available. As per new diabetes guidelines, every diabetic patient should be under gone screening for Pulmonary Tuberculosis. We conducted a clinical study of 60 Patients with Diabetes and Pulmonary Tuberculosis. For establishment of Diagnosis Ch est X – ray and Sputum for AFB were done for pulmonary tuberculosis and both blood & Urine Sugar were done for Diabetes Mellitus.

  3. Study on the Clinical Effectiveness of Thymectomy for Myasthenia Gravis

    Institute of Scientific and Technical Information of China (English)

    PANTiecheng; YANHua; ZHANGNi; PANYouming; TANGYingxiong; WENXiang; SONGDingwei; HUMing; LIULigang; LIUZixiong; YANGMingshan; XUJinzhi; PUBitao; GAOBoting

    2002-01-01

    Objectiv:To investigate the theoretical basis and clinical significance of thymectomy in the treatment of myasthenia gravis (MG). Methods:Analyze the changes in the contents of serum AchRab and sIL-2R, lymphocyte subtypes in Peripheral blood lymphocytes before and after thymectomy in 69 patients. Results:In the study group significant changes were found in serum contents of AchRab and sIL-2R before and after operation and there was also remarkable change in the number and constitution of peripheral blood lymphocyte subtypes. Conclusion:Thymectomy is an effective therapy for MG.

  4. Preliminary Clinical Study of Intra-vas Device

    Institute of Scientific and Technical Information of China (English)

    吴伟雄; 袁石锦; 陈振文; 谷翊群; 李世勤

    1994-01-01

    Fifty-one volunteers with implanted intravas device (IVD ) in comparison with 40 volunteers undergone no-scalpel vasectomy have been recruited for 1 to 3 years clinical follow-up study, The results demonstrate that efficacy rates of contraception in both the IVD group and the vasectomy group are 100%, Sixteen out of thirty - one volunteers (51.6% ) in the IVD group were found to have glucosidase activity in their seminal plasma 1 to 3 years after the operation. Only 12 subjects in the IVD

  5. Study on clinical symptoms in canine cardiac diseases

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    F. Karlette Anne

    Full Text Available Cardiac diseases in canines are an extensively studied phenomenon all over the world but meagre information has been reported in India. Certain problems, including historical, physical, and laboratory abnormalities, are associated with cardiovascular or pulmonary disease. In India however, the recognition of canine cardiac diseases has been delayed, and ignored on account of lack of awareness and knowledge by the owner and inadequate diagnostic facility to a field veterinarian. Considering the above facts, the present study was undertaken in Gujarat to survey the prevalence of common cardiac diseases in hospital population of dogs along with the clinical symptoms which often goes undetected due to lack of proper diagnostic techniques to be implied and the most forms of heart disease may be present for many years before any evidence of failure develops. In the present study most of the clinical cases of cardiac diseases were presented with a history of nocturnal coughing (seven cases; 2.55%, exercise intolerance (five cases; 1.82%, partial or complete anorexia (five cases; 1.82%, swelling in abdominal area (four cases; 1.45%, dullness and depression (two cases; 0.72%, cachexia and hepatojugular pulsation (one case each; 0.36% each at times. [Vet World 2009; 2(8.000: 307-309

  6. Insights into restrictive cardiomyopathy from clinical and animal studies

    Institute of Scientific and Technical Information of China (English)

    Pierre-Yves Jean-Charles; Yue-Jin Li; Chang-Long Nan; Xu-Pei Huang

    2011-01-01

    Catdiomyopathies are diseases that primarily affect the myocardium,leading to serious cardiac dysfimction and heart failure.Out of the three major categories of candiomyopathies(hypertrophic,dilated and restrictive),restrictive cardiomyopathy(RCM)is less common and also the least studied However,the prognosis for RCM is poor as some patients dying in their childhood The molecular mechanisms behind the disease development and progression are not very clear and the treatment of RCM is very difficult and often ineffective.In this article,we reviewed the recent progress in RCM research from the clinical studies and the translational studies done on diseased transgenic animal models.This will help for a better understanding of tare mechanisms underlying the etiology and development of RCM and for the design of better treatments for the disease.

  7. Clinical laboratory stressors used to study alcohol-stress relationships.

    Science.gov (United States)

    Thomas, Suzanne; Bacon, Amy K; Sinha, Rajita; Uhart, Magdalena; Adinoff, Bryon

    2012-01-01

    Understanding the biologic systems that underlie the relationship between stress and alcohol consumption may lead to better prevention efforts and more effective treatments for alcoholism. Clinical laboratory studies offer a unique opportunity to examine these relationships by using a controlled environment to study how an acute stressor affects alcohol drinking and alcohol craving, how individuals in recovery or those at risk for alcoholism may respond differently to stressors relative to control subjects, and how alcohol differentially affects stress reactivity in these groups. This article reviews some of the most common physical, psychological, and pharmacological stressors used in stress-induction studies designed to reveal details about the relationship between stress reactivity and alcohol use and abuse.

  8. A multi-center randomized trial to assess the efficacy of gatifloxacin versus ciprofloxacin for the treatment of shigellosis in Vietnamese children.

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    Ha Vinh

    2011-08-01

    Full Text Available BACKGROUND: The bacterial genus Shigella is the leading cause of dysentery. There have been significant increases in the proportion of Shigella isolated that demonstrate resistance to nalidixic acid. While nalidixic acid is no longer considered as a therapeutic agent for shigellosis, the fluoroquinolone ciprofloxacin is the current recommendation of the World Health Organization. Resistance to nalidixic acid is a marker of reduced susceptibility to older generation fluoroquinolones, such as ciprofloxacin. We aimed to assess the efficacy of gatifloxacin versus ciprofloxacin in the treatment of uncomplicated shigellosis in children. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a randomized, open-label, controlled trial with two parallel arms at two hospitals in southern Vietnam. The study was designed as a superiority trial and children with dysentery meeting the inclusion criteria were invited to participate. Participants received either gatifloxacin (10 mg/kg/day in a single daily dose for 3 days or ciprofloxacin (30 mg/kg/day in two divided doses for 3 days. The primary outcome measure was treatment failure; secondary outcome measures were time to the cessation of individual symptoms. Four hundred and ninety four patients were randomized to receive either gatifloxacin (n=249 or ciprofloxacin (n=245, of which 107 had a positive Shigella stool culture. We could not demonstrate superiority of gatifloxacin and observed similar clinical failure rate in both groups (gatifloxacin; 12.0% and ciprofloxacin; 11.0%, p=0.72. The median (inter-quartile range time from illness onset to cessation of all symptoms was 95 (66-126 hours for gatifloxacin recipients and 93 (68-120 hours for the ciprofloxacin recipients (Hazard Ratio [95%CI]=0.98 [0.82-1.17], p=0.83. CONCLUSIONS: We conclude that in Vietnam, where nalidixic acid resistant Shigellae are highly prevalent, ciprofloxacin and gatifloxacin are similarly effective for the treatment of acute shigellosis.

  9. Incidence and clinical outcome of renal amyloidosis: A retrospective study

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    Emad Abdallah

    2013-01-01

    Full Text Available The kidneys are affected in almost all patients with amyloid A in secondary amyloidosis (AA amyloidosis but less frequently in immunoglobulin light chains in primary systemic amyloidosis (AL amyloidosis. In this study, we present the incidence, etiology, clinical manifestations, biochemical features and clinical course of renal amyloidosis. We conducted a retrospective study on a group of 40 cases with renal biopsy-proven amyloidosis. They constituted 2.5% of the total cases of renal biopsies performed in the Theodor Bilharz Research Institute, Cairo, Egypt, during the period from February 2003 to May 2009. The mean age (30 males, ten females was 36.51 ± 10.32 years. Thirty-two of the cases had secondary AA amyloidosis and eight cases had primary AL amyloidosis. The causes of secondary amyloidosis were as follows: 12 (30% familial Mediterranean fever (FMF, eight (20% pulmonary tuberculosis, four (10% chronic osteomyelitis, four (10% bronchiectasis, three (7% rheumatoid arthritis and one (2% rheumatic heart disease. The eight cases of primary AL amyloidosis comprised of five cases that were associated with myloma (13% and three (8% cases that were idiopathic. Among the 23 patients with AA amyloidosis, after six months of treatment with colchicine, the proteinuria improved, serum albumin level increased and edema disappeared in 13 patients. In four cases of AA amyloidosis who were clinically and biochemically normal after cholchicine therapy, a second renal biopsy disclosed decreased amyloid deposition compared with the first biopsy. In the three renal transplanted patients who had amyloidosis secondary to FMF and were treated with colchicines, AA amyloidosis did not recur in the transplanted kidney. It might be possible that in AL amyloidosis, treatment with methotrexate, melphalan and prednisolone may improve survival. The incidence of renal amyloidosis is increasing and colchicine can be used in secondary amyloidosis as it may have an effect

  10. A prospective clinical study of polycarboxylate cement in periapical surgery

    Science.gov (United States)

    Ortega-Sánchez, Bárbara; García-Mira, Berta; Maestre-Ferrín, Laura; Peñarrocha-Oltra, David; Gay-Escoda, Cosme

    2012-01-01

    Objective: To evaluate the clinical efficacy of polycarboxylate cement as retrograde filling material. Design: A prospective clinical study was made of 25 patients subjected to periapical surgery with ultrasound and magnifying loupes, in which polycarboxylate cement was used as retrograde filling material. Measurements were made of the area and diameter of the lesions pre- and postoperatively, and 6 and 12 months after the operation. The apical resection and retrograde filling areas were also measured, and the prognosis following surgery was recorded. Results: A total of 23 patients with 31 apicoectomized teeth were studied (2 patients being lost to follow-up). The mean area of the periapical lesions before surgery was 52.25 mm2, with a mean major diameter of 6.1 mm and a mean lesser diameter of 4.8 mm. The success rate after 12 months was 54.7%, according to the criteria of Von Arx and Kurt. The prognosis was poorer in females, in larger lesions, and in cases with larger retrograde filling areas. Conclusions: Polycarboxylate cement offers good results, with important bone regeneration after periapical surgery. Key words: Periapical surgery, endodontic treatment, polycarboxylate cement. PMID:22143701

  11. Biomarkers in differentiating clinical dengue cases: A prospective cohort study

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    Gary Kim Kuan Low

    2015-12-01

    Full Text Available Objective: To evaluate five biomarkers (neopterin, vascular endothelial growth factor-A, thrombomodulin, soluble vascular cell adhesion molecule 1 and pentraxin 3 in differentiating clinical dengue cases. Methods: A prospective cohort study was conducted whereby the blood samples were obtained at day of presentation and the final diagnosis were obtained at the end of patients’ follow-up. All patients included in the study were 15 years old or older, not pregnant, not infected by dengue previously and did not have cancer, autoimmune or haematological disorder. Median test was performed to compare the biomarker levels. A subgroup Mann-Whitney U test was analysed between severe dengue and non-severe dengue cases. Monte Carlo method was used to estimate the 2-tailed probability (P value for independent variables with unequal number of patients. Results: All biomarkers except thrombomodulin has P value < 0.001 in differentiating among the healthy subjects, non-dengue fever, dengue without warning signs and dengue with warning signs/severe dengue. Subgroup analysis for all the biomarkers between severe dengue and non-severe dengue cases was not statistically significant except vascular endothelial growth factor-A (P < 0.05. Conclusions: Certain biomarkers were able to differentiate the clinical dengue cases. This could be potentially useful in classifying and determining the severity of dengue infected patients in the hospital.

  12. A clinical study of temporomandibular joint disorders by using arthrography

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    Lee, Seung Hyun; Hwang, Eui Hwan; Lee, Sang Rae [Dept. of Oral and Maxillofacial Radiology, College of Dentistry, Kyunghee University, (Korea, Republic of)

    1998-02-15

    The purpose of this study was to prove the relationship between arthrographic and clinical features in temporomandibular joint disorders. In order to carry out this study, ninety-eight arthrographic examinations of temporomandibular joints were performed in eighty-two patients who had the temporomandibular joint disorders. As the arthrographic examination, the cases were classified in three groups, disk displacement with reduction, disk displacement without reduction, within normal limit. After this, the cases were clinically examined, and the results were compared and analyzed in each other group. The obtained results were as follows: 1. As the classification by arthrographic examination, three groups (disc displacement with reduction, disc displacement without reduction, within normal limit) were 41%, 54%, 5% of total cases in this study, respectively. 2. The third decade (65%) was most frequent in this study. The average age of each group (disc displacement with reduction, disc displacement without reduction, within normal limit) was 24, 28, 21, and disc displacement without reduction group was higher than any other group. 3. In the chief complaint, pain was the most frequent in all three groups. Joint sound was also frequent in disc displacement with reduction group, but in disc displacement without reduction group, limitation of mouth opening was more frequent. 4. Of the various pain, the movement pain was most frequent (61%) in this study. In joint sound, click (63%) was the most frequent in disc displacement with reduction group, but sound history (42%) and no sound (31%) were more frequent in disc displacement without reduction group. 5. The average maximum opening of each group (disc displacement with reduction, disc displacement without reduction, within normal limit) was 44 mm, 32.9 mm, 44 mm, and disc displacement without reduction group was less than any other group. 6. The masticatory disturbance of each group (disc displacement with reduction, disc

  13. Statins in oncological research: from experimental studies to clinical practice.