WorldWideScience

Sample records for clinical multi-center study

  1. Clinical and functional outcomes of the PCCP study : a multi-center prospective study in Italy

    OpenAIRE

    Antonini, G.; Giancola, R.; D. Berruti; E. Blanchietti; Pecchia, P.; Francione, V.; Greco, P.; T.C. Russo; L. Pietrogrande

    2013-01-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proxima...

  2. Clinical and functional outcomes of the PCCP study: a multi-center prospective study in Italy.

    Science.gov (United States)

    Antonini, G; Giancola, R; Berruti, D; Blanchietti, E; Pecchia, P; Francione, V; Greco, P; Russo, T C; Pietrogrande, L

    2013-04-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proximal femoral fracture of type AO 31.A1 or 31.A2 were enrolled in eight hospitals in Italy. The primary outcome of interest was the recovery of the pre-fracture functional status at 1-year follow-up; secondary outcomes of interest included blood transfusions, surgical time, complications, and mortality. A total of 273 patients were enrolled. The ASA score was 3 or 4 in 72.5 % of patients. The mean surgical time was 44.1 min; the mean post-surgery blood transfusions was 0.9 units. At 1 year, 48 patients (17.6 %) died, 28 (10.2 %) were lost to follow-up, 4 patients (1.5 %) were excluded, hence 193 patients (70.3 %) were available for final evaluation. At the 1-year follow-up visit, 51.9 % of patients recovered or improved their pre-fracture modified Harris Hip Score, 49.1 % of patients improved or maintained their walking abilities, and 66.6 % of patients residing at home pre-surgery maintained their domicile. The overall mortality rate was 17.6 %. Major complications included two fracture collapses, one excessive sliding of the cephalic screw leading to a partial fracture collapse and one back-out of the diaphyseal screw. This study demonstrates that treatment of trochanteric fractures with PCCP gives good outcomes and significant advantages such as low blood loss, short surgical time, low risk of complications, and good functional recovery in the majority of the patients. PMID:23543403

  3. 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

  4. 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.

  5. 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...

  6. Phase III multi-center clinical study on sup 99m Tc-GSA, a new agent for functional imaging of the liver

    Energy Technology Data Exchange (ETDEWEB)

    Torizuka, Kanji (Fukui Medical School, Matsuoka (Japan)); Ha-Kawa, Sang Kil; Kudo, Masatoshi (and others)

    1992-02-01

    A multi-center clinical study was performed in patinets with hepatic disorders to evaluate the clinical usefulness of {sup 99m}Tc-DTPA-galactosyl serum albumin ({sup 99m}Tc-GSA), a new radiopharmaceutical which binds to asialoglycoprotein receptors on hepatocytes. The blood clearance and hepatic accumulation were evaluated on the basis of the dynamic data and serial hepatic images obtained for 20 min after {sup 99m}Tc-GSA injection. The blood clearance and hepatic accumulation indices of {sup 99m}Tc-GSA demonstrated the followings. In acute liver diseases, these indices reflected the clinical features of the disease and correlated with the laboratory test indices for the blood coagulation system. In chronic liver diseases, these indices changed in direct proportion to the progression of the hepatic disorder and correlated well with the conventional laboratory test results. In obstructive jaundice, these indices aided evaluation of the liver function despite the high serum bilirubin level. The indices reflected the change in the number of hepatocytes before and after hepatectomy. The scintigraphic findings with {sup 99m}Tc-GSA permitted both functional and morphological evaluations of the liver and provide additional information compared with conventional liver scintigraphy. These results suggest that {sup 99m}Tc-GSA scintigraphy may be useful for evaluating both the functional and morphology of the liver from a new viewpoint of receptor-mediated accumulation. (author).

  7. Six-month healing success rates after endodontic treatment using the novel GentleWave™ System: The pure prospective multi-center clinical study

    Science.gov (United States)

    Le, Khang T.; Woo, Stacey M.; Rassoulian, Shahriar A.; McLachlan, Kimberly; Abbassi, Farah; Garland, Randy W.

    2016-01-01

    Background This prospective multi-center (PURE) clinical study evaluated healing rates for molars after root canal treatment employing the GentleWave® System (Sonendo, Inc., Laguna Hills, CA). Material and Methods Eighty-nine patients met the inclusion criteria and consented for this clinical study after referral for a root canal treatment. All enrolled patients were treated with the GentleWave System. Five endodontists performed the clinical procedures and follow-up evaluations. Pre-operative, intra-operative, and post-operative data were collected from the consented patients. Each patient was evaluated for clinical signs and symptoms. Two trained, blinded, and independent evaluators scored the subject tooth radiographs for apical periodontitis using the periapical index (PAI). The teeth classified as healing or healed were considered as a success and composed of a cumulative success rate of healing. Statistical analysis was performed by using the Fisher’s exact test, Pearson correlation, and multivariate logistic regression analyses of the pre-operative prognostic factors at 0.05 significance level. Results Seventy-seven patients were evaluated at six months with a follow-up rate of 86.5%. The cumulative success rate of healing was 97.4%. Eleven prognostic factors were identified using bivariate analyses. Using logistic analyses, the two prognostic significant variables that were directly correlated to healing were the pre-operative presence of periapical index (p value=0.016), and single treatment visits (p value=0.024). Conclusions In this six-month PURE clinical study, the cumulative success rate of healing was 97.4% when patients were treated with the GentleWave® System. Key words:Healing rate, root canal treatment, molar, GentleWave™, Sonendo®, Multisonic Ultracleaning™ . PMID:27398180

  8. 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.

  9. 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. PMID:25924999

  10. 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.

  11. Radiologic Predictors for Clinical Stage IA Lung Adenocarcinoma with Ground Glass Components: A Multi-Center Study of Long-Term Outcomes.

    Directory of Open Access Journals (Sweden)

    Zhao Li

    Full Text Available This study was to define preoperative predictors from radiologic findings for the pathologic risk groups based on long-term surgical outcomes, in the aim to help guide individualized patient management.We retrospectively reviewed 321 consecutive patients with clinical stage IA lung adenocarcinoma with ground glass component on computed tomography (CT scanning. Pathologic diagnosis for resection specimens was based on the 2011 IASLC/ATS/ERS classification of lung adenocarcinoma. Patients were classified into different pathologic risk grading groups based on their lymph node status, local regional recurrence and overall survival. Radiologic characteristics of the pulmonary nodules were re-evaluated by reconstructed three-dimension CT (3D-CT. Univariate and multivariate analysis identifies independent radiologic predictors from tumor diameter, total volume (TV, average CT value (AVG, and solid-to-tumor (S/T ratio. Receiver operating characteristic curves (ROC studies were carried out to determine the cutoff value(s for the predictor(s. Univariate cox regression model was used to determine the clinical significance of the above findings.A total of 321 patients with clinical stage IA lung adenocarcinoma with ground glass components were included in our study. Patients were classified into two pathologic low- and high- risk groups based on their distinguished surgical outcomes. A total of 134 patients fell into the low-risk group. Univariate and multivariate analyses identified AVG (HR: 32.210, 95% CI: 3.020-79.689, P<0.001 and S/T ratio (HR: 12.212, 95% CI: 5.441-27.408, P<0.001 as independent predictors for pathologic risk grading. ROC curves studies suggested the optimal cut-off values for AVG and S/T ratio were-198 (area under the curve [AUC] 0.921, 2.9 (AUC 0.996 and 54% (AUC 0.907, respectively. The tumor diameter and TV were excluded for the low AUCs (0.778 and 0.767. Both the cutoff values of AVG and S/T ratio were correlated with pathologic

  12. Achieving lipid goals with rosuvastatin compared with simvastatin in high risk patients in real clinical practice: a randomized, open-label, parallel-group, multi-center study: the DISCOVERY-Beta study

    Directory of Open Access Journals (Sweden)

    Toivo Laks

    2008-09-01

    Full Text Available Toivo Laks1, Ester Keba2, Mariann Leiner3, Eero Merilind4, Mall Petersen5, Sirje Reinmets6, Sille Väli7, Terje Sööt8, Karin Otter81Clinic of Internal Medicine, North-Estonia Regional Hospital, Tallinn, Estonia; 2Clinic of Internal Medicine, Viljandi County Hospital, Viljandi, Estonia; 3Mustamäe Family Doctors Centre, Tallinn, Estonia; 4Nõmme Family Doctors Centre, Tallinn, Estonia; 5Saku Health Centre, Saku, Estonia; 6Kristiine Family Doctors, Tallinn, Estonia; 7Family Doctor Sille Väli, Kuressaare, Estonia; 8AstraZeneca, Tallinn, EstoniaAbstract: The aim of this multi-center, open-label, randomized, parallel-group trial was to compare the efficacy of rosuvastatin with that of simvastatin in achieving the 1998 European Atherosclerosis Society (EAS lipid treatment goals. 504 patients (≥18 years with primary hypercholesterolemia and a 10-year cardiovascular (CV risk >20% or history of coronary heart disease (CHD or other established atherosclerotic disease were randomized in a 2:1 ratio to receive rosuvastatin 10 mg or simvastatin 20 mg once daily for 12 weeks. A significantly higher proportion of patients achieved 1998 EAS low-density lipoprotein cholesterol (LDL-C goal after 12 weeks of treatment with rosuvastatin 10 mg compared to simvastatin 20 mg (64 vs 51.5%, p < 0.01. Similarly, significantly more patients achieved the 1998 EAS total cholesterol (TC goal and the 2003 EAS LDL-C and TC goals (p < 0.001 with rosuvastatin 10 mg compared with simvastatin 20 mg. The incidence of adverse events and the proportion of patients who discontinued study treatment were similar between treatment groups. In conclusion, in the DISCOVERY-Beta Study in patients with primary hypercholesterolemia greater proportion of patients in the rosuvastatin 10 mg group achieved the EAS LDL-C treatment goal compared with the simvastatin 20 mg group. Drug tolerability was similar across both treatment groups.Keywords: hypercholesterolemia, low-density lipoprotein

  13. Gnathic osteosarcomas: A 10-year multi-center demographic study

    Directory of Open Access Journals (Sweden)

    T Azizi

    2009-01-01

    Full Text Available Background: Osteosarcomas (OS of the jaws are uncommon lesions representing 6-8% of skeletal OS. We assessed the characteristics, demographics, prevalence clinical and histopathological findings and distribution of gnathic OS relative to non-gnathic OS in four major treatment centers. Materials and Methods: This study assessed 13 gnathic OS patients of 98 OS patients from four major referral centers during 1996-2007. The age distribution, gender, involved site, clinical findings, signs, symptoms, grade and sub-types were assessed. Hematoxylin-eosin, Picrosirius red, Ponceau trichrome, Masson trichrome and osteoid staining methods were used. Results: Of the 98 OS lesions, 85 (86.8% involved the skeleton, the youngest patient was 6 and the oldest 60 years old; 13 lesions (13.2% involved the jaws (seven mandibular and six maxillary and the youngest and oldest patients were 15 and 50 years-old, respectively. Non-gnathic OS was more prevalent between the ages of 11 and 20 years (avg. 15 years and was common in the distal femur and proximal tibia, presenting most frequently with pain and swelling. OS of the jaws, however, presented more than 10 years later than non-gnathic OS, being more prevalent between the ages of 20 and 30 years (avg. 27 years. OS of the jaws most frequently involved the mandibular body and the posterior maxillary alveolar ridge, presenting frequently with pain, swelling and loosening of teeth. Two patients with gnathic OS died during the 10-year follow-up period (15.3%. Conclusion: Prevalence of OS of the jaws was about twice as high as that reported in other studies and presented later than non-gnathic cases. Pain and swelling were common signs and symptoms in this disease. The mixed sub-type was the most common sub-type of gnathic OS.

  14. 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。

  15. 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.

  16. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    International Nuclear Information System (INIS)

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  17. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    Energy Technology Data Exchange (ETDEWEB)

    Zaknun, John J. [University Hospital of Innsbruck, Department of Nuclear Medicine, Innsbruck (Austria); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria); IAEA, Nuclear Medicine Section, Division of Human Health, Wagramer Strasse 5, P.O. Box 100, Wien (Austria); Bal, Chandrasekhar [All India Institute of Medical Sciences, Department of Nuclear Medicine, New Delhi (India); Maes, Alex [Katholieke Universiteit Leuven, Leuven (Belgium); AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); Tepmongkol, Supatporn [Chulalongkorn University, Nuclear Medicine Division, Department of Radiology, Bangkok (Thailand); Vazquez, Silvia [Instituto de Investigaciones Neurologicas, FLENI, Department of Radiology, Buenos Aires (Argentina); Dupont, Patrick [Katholieke Universiteit Leuven, Leuven (Belgium); Dondi, Maurizio [Ospedale Maggiore, Department of Nuclear Medicine, Bologna (Italy); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria)

    2008-01-15

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  18. Achieving lipid goals with rosuvastatin compared with simvastatin in high risk patients in real clinical practice: a randomized, open-label, parallel-group, multi-center study: the DISCOVERY-Beta study

    OpenAIRE

    Laks, Toivo

    2008-01-01

    Toivo Laks1, Ester Keba2, Mariann Leiner3, Eero Merilind4, Mall Petersen5, Sirje Reinmets6, Sille Väli7, Terje Sööt8, Karin Otter81Clinic of Internal Medicine, North-Estonia Regional Hospital, Tallinn, Estonia; 2Clinic of Internal Medicine, Viljandi County Hospital, Viljandi, Estonia; 3Mustamäe Family Doctors Centre, Tallinn, Estonia; 4Nõmme Family Doctors Centre, Tallinn, Estonia; 5Saku Health Centre, Saku, Estonia; 6Kristiine Family Doctors, Ta...

  19. Cumulative occupational lumbar load and lumbar disc disease – results of a German multi-center case-control study (EPILIFT)

    OpenAIRE

    Michaelis Martina; Luttmann Alwin; Linhardt Oliver; Hofmann Friedrich; Haerting Johannes; Grifka Joachim; Elsner Gine; Ditchen Dirk; Ellegast Rolf; Jäger Matthias; Bergmann Annekatrin; Seidler Andreas; Petereit-Haack Gabriela; Schumann Barbara; Bolm-Audorff Ulrich

    2009-01-01

    Abstract Background The to date evidence for a dose-response relationship between physical workload and the development of lumbar disc diseases is limited. We therefore investigated the possible etiologic relevance of cumulative occupational lumbar load to lumbar disc diseases in a multi-center case-control study. Methods In four study regions in Germany (Frankfurt/Main, Freiburg, Halle/Saale, Regensburg), patients seeking medical care for pain associated with clinically and radiologically ve...

  20. 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

  1. [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 long-term efficacy and safety of these devices should be established. PMID:26964398

  2. Standardization of measuring power output during wheelchair propulsion on a treadmill Pitfalls in a multi-center study

    NARCIS (Netherlands)

    de Groot, S; Zuidgeest, M; van der Woude, L H V

    2006-01-01

    OBJECTIVE: In a multi-center study the power output of wheelchair propulsion, attained by a wheelchair drag test, differed among rehabilitation centers. The purpose of this study was to investigate what causes the differences in drag force among centers. METHODS: A set of standardized drag tests was

  3. 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 (Poral) effect on sub-gingival wound healing.

  4. Vitamin D Deficiency in Healthy Male Population: Results of the Iranian Multi- Center Osteoporosis Study

    Directory of Open Access Journals (Sweden)

    Z Rahnavard

    2010-09-01

    Full Text Available "nBackground: The prevalence of vitamin D deficiency and its causative factors has been estimated more frequently in elder popula­tion, women, and patients with osteoporosis in different countries, but this issue is less defined in male population within different age groups especially in Asian countries. Therefore, we studied the role of effective factors in vitamin D defi­ciency and its prevalence in Iranian healthy men."nMethods: This study was a multi center and carried out in five metropolitans in Iran. Serum 25 Hydroxy vitamin D and other biochemical variables were determined in 2396 healthy men in late winter of 2001."nResults: 68.8% of participants suffered from vitamin D deficiency. Vitamin D levels were the highest in Bushehr (n= 111, 40.3% (P< 0.05 and between Shiraz and Tabriz, Shiraz had the better values (P< 0.05. Tehran had the highest prevalence of vitamin D deficiency (n= 380, n= 85.7%. Geographical zone independently predicted vitamin D status (P< 0.05. There was not any association among age (r= 0.035, P> 0.05, physical activity (r= 0.023, P> 0.05, and exposure of face & hands to sunlight (r= 0.022, P> 0.05 with vitamin D levels."nConclusion: Prevalence of vitamin D deficiency in Iranian male population is high, considering Iranian cultural and geographi­cal zones, food fortification and life style modification is recommended.

  5. Practice effects in a longitudinal, multi-center Alzheimer’s disease prevention clinical trial

    Directory of Open Access Journals (Sweden)

    Abner Erin L

    2012-11-01

    Full Text Available Abstract Background Practice effects are a known threat to reliability and validity in clinical trials. Few studies have investigated the potential influence of practice on repeated screening measures in longitudinal clinical trials with a focus on dementia prevention. The current study investigates whether practice effects exist on a screening measure commonly used in aging research, the Memory Impairment Screen (MIS. Methods The PREADViSE trial is a clinical intervention study evaluating the efficacy of vitamin E and selenium for Alzheimer’s disease prevention. Participants are screened annually for incident dementia with the MIS. Participants with baseline and three consecutive follow-ups who made less than a perfect score at one or more assessments were included in the current analyses (N=1,803. An additional subset of participants with four consecutive assessments but who received the same version of the MIS at baseline and first follow-up (N=301 was also assessed to determine the effects of alternate forms on mitigating practice. We hypothesized that despite efforts to mitigate practice effects with alternate versions, MIS scores would improve with repeated screening. Linear mixed models were used to estimate mean MIS scores over time. Results Among men with four visits and alternating MIS versions, although there is little evidence of a significant practice effect at the first follow-up, mean scores clearly improve at the second and third follow-ups for all but the oldest participants. Unlike those who received alternate versions, men given the same version at first follow-up show significant practice effects. Conclusion While increases in the overall means were small, they represent a significant number of men whose scores improved with repeated testing. Such improvements could bias case ascertainment if not taken into account.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. Vitamin D Deficiency in Iran: A Multi-center Study among Different Urban Areas

    Directory of Open Access Journals (Sweden)

    R Heshmat

    2008-11-01

    Full Text Available "nBackground: Recent studies have reported different prevalence of vitamin D deficiency in different sex and age groups in de­veloping countries. In the present survey, we elucidated the prevalence of vitamin D deficiency in a multi-center study among Iranian population. "nMethods: In a random cluster sample of healthy men and women (ranged 20 to 69 years old, a number of 5232 subjects from five urban metropolitans' cities (Tehran, Tabriz, Mashhad, Shiraz and Booshehr were recruited in 2001. Fasting blood sam­ple was taken from participants and sent to the laboratory for measurement of 25-hydroxy vitamin D level. Meta-analy­sis was performed using fixed effect method for estimation of vitamin D deficiency prevalence in a national level.      "nResults: Moderate to severe vitamin D deficiency was estimated in urban areas (except for Booshehr because of its heterogene­ity equal to 47.2, 45.7 and 44.2% in age groups of <50, 50-60 and 60≤ years, respectively among men and 54.2, 41.2 and 37.5 percent among women in the same age groups. The highest prevalence of moderate to severe vitamin D defi­ciency in men was observed in Tehran. Mashhad and Booshehr had also the lowest prevalence of moderate to severe vita­min D deficiency among men and women."nConclusion: Iran is a country with high prevalence of moderate to severe vitamin D deficiency and the prevalence of this defi­ciency is more evident in Tehran, capital of Iran. Therefore, consideration of main predictors for vitamin D deficiency in all age groups especially in Tehran is recommended.   

  11. 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

  12. A Randomized, Multi-Center, Single Blind, Active-Controlled, Matched Pairs Clinical Study to Evaluate Prevention of Adhesion Formation and Safety of HyFence in Patients After Endoscopic Sinus Surgery

    OpenAIRE

    Chang, Chul; Hong, Sung-Moon; Cho, Jin-Hee; Shim, Sang Yul; Cho, Jung-Sun; Lee, Heung-Man

    2014-01-01

    Objectives Recurrent mucosal disease and anatomic obstruction are commonly cited causes of failed endoscopic sinus surgery (ESS). Hyaluronic acid (HA) has been reported to reduce scarring and to promote wound healing in sinonasal surgery. HyFence is HA stabilized by 1, 4-butandiol diglycidyl ether, which makes it less-water-soluble and highly viscoelastic. The purpose of this study is to examine the anti-adhesion effect of HyFence after ESS compared to that of HA-CMC (Guardix-Sol). Methods Se...

  13. The costs in provision of haemodialysis in a developing country: A multi-centered study

    Directory of Open Access Journals (Sweden)

    Wijesinghe Aruna

    2011-09-01

    % reduction. Conclusions This multi-centered study demonstrated that the costs of haemodialysis in a developing country remained significantly lower compared to developed countries. However, it still places a significant burden on the health care sector, whilst possibility of further cost reduction exists.

  14. 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

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

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    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

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

    OpenAIRE

    Scheepers, Renée A.; Lombarts, Kiki M. J. M. H.; van Aken, Marcel A. G.; Maas Jan Heineman; 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 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 d...

  17. Pre-Transplant Cardiovascular Risk Factors Affect Kidney Allograft Survival: A Multi-Center Study in Korea

    Science.gov (United States)

    Lee, Jung Pyo; Bae, Eunjin; Kang, Eunjeong; Kim, Hack-Lyoung; Kim, Yong-Jin; Oh, Yun Kyu; Kim, Yon Su; Kim, Young Hoon; Lim, Chun Soo

    2016-01-01

    Background Pre-transplant cardiovascular (CV) risk factors affect the development of CV events even after successful kidney transplantation (KT). However, the impact of pre-transplant CV risk factors on allograft failure (GF) has not been reported. Methods and Findings We analyzed the graft outcomes of 2,902 KT recipients who were enrolled in a multi-center cohort from 1997 to 2012. We calculated the pre-transplant CV risk scores based on the Framingham risk model using age, gender, total cholesterol level, smoking status, and history of hypertension. Vascular disease (a composite of ischemic heart disease, peripheral vascular disease, and cerebrovascular disease) was noted in 6.5% of the patients. During the median follow-up of 6.4 years, 286 (9.9%) patients had developed GF. In the multivariable-adjusted Cox proportional hazard model, pre-transplant vascular disease was associated with an increased risk of GF (HR 2.51; 95% CI 1.66–3.80). The HR for GF (comparing the highest with the lowest tertile regarding the pre-transplant CV risk scores) was 1.65 (95% CI 1.22–2.23). In the competing risk model, both pre-transplant vascular disease and CV risk score were independent risk factors for GF. Moreover, the addition of the CV risk score, the pre-transplant vascular disease, or both had a better predictability for GF compared to the traditional GF risk factors. Conclusions In conclusion, both vascular disease and pre-transplant CV risk score were independently associated with GF in this multi-center study. Pre-transplant CV risk assessments could be useful in predicting GF in KT recipients. PMID:27501048

  18. 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.

  19. Radiotherapy quality assurance review in a multi-center randomized trial of limited-disease small cell lung cancer: the Japan Clinical Oncology Group (JCOG) trial 0202

    International Nuclear Information System (INIS)

    The purpose of this study was to analyze the radiotherapy (RT) quality assurance (QA) assessment in Japan Clinical Oncology Group (JCOG) 0202, which was the first trial that required on-going RT QA review in the JCOG. JCOG 0202 was a multi-center phase III trial comparing two types of consolidation chemotherapy after concurrent chemoradiotherapy for limited-disease small cell lung cancer. RT requirements included a total dose of 45 Gy/30 fx (bis in die, BID/twice a day) without heterogeneity correction; elective nodal irradiation (ENI) of 30 Gy; at least 1 cm margin around the clinical target volume (CTV); and interfraction interval of 6 hours or longer. Dose constraints were defined in regards to the spinal cord and the lung. The QA assessment was classed as per protocol (PP), deviation acceptable (DA), violation unacceptable (VU), and incomplete/not evaluable (I/NE). A total of 283 cases were accrued, of which 204 were fully evaluable, excluding 79 I/NE cases. There were 18 VU in gross tumor volume (GTV) coverage (8% of 238 evaluated); 4 VU and 23 DA in elective nodal irradiation (ENI) (2% and 9% of 243 evaluated, respectively). Some VU were observed in organs at risk (1 VU in the lung and 5 VU in the spinal cord). Overall RT compliance (PP + DA) was 92% (187 of 204 fully evaluable). Comparison between the former and latter halves of the accrued cases revealed that the number of VU and DA had decreased. The results of the RT QA assessment in JCOG 0202 seemed to be acceptable, providing reliable results

  20. 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.

  1. 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、

  2. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  4. 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

    2016-01-01

    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. PMID:27582230

  5. 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.

  6. Prevalence and variation of sesamoid bones in the hand: a multi-center radiographic study

    OpenAIRE

    Chen, Wei; Cheng, Jiaxiang; Sun, Ran; Zhang, Zekun; Zhu, Yanbin; Ipaktchi, Kyros; Zhang, Yingze

    2015-01-01

    There is rare studies with regard to sesamoid bone variations of the hand in addition to its prevalence and distribution. This study aims to assess both the prevalence and variation of sesamoid bones of the hand. A retrospective review of posteroanterior (PA) and oblique radiographs of 436 left and 414 right hands of 850 adult patients obtained from four hospitals was performed. All X-ray films were examined independently for existing sesamoid bones. The presence of sesamoid bones was confirm...

  7. Mechanical ventilation in ICUs in Poland: A multi-center point-prevalence study

    OpenAIRE

    Kübler, Andrzej; Maciejewski, Dariusz; Adamik, Barbara; Kaczorowska, Małgorzata

    2013-01-01

    Background Mechanical ventilation is the primary method of supporting organ function in patients treated in intensive care units (ICUs). Lung damage from mechanical ventilation can be avoided by using the correct ventilation modes. This study was designed to assess the epidemiology and treatment strategies of patients receiving mechanical ventilation in ICUs in Poland. Material/Methods This study was done using a point-prevalence methodology. Questionnaires requesting demographic data, indica...

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. 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

    metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called...... total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing...

  17. A multi-center randomized proof-of-concept clinical trial applying [¹⁸F]FDG-PET for evaluation of metabolic therapy with rosiglitazone XR in mild to moderate Alzheimer's disease.

    Science.gov (United States)

    Tzimopoulou, Sofia; Cunningham, Vincent J; Nichols, Thomas E; Searle, Graham; Bird, Nick P; Mistry, Prafull; Dixon, Ian J; Hallett, William A; Whitcher, Brandon; Brown, Andrew P; Zvartau-Hind, Marina; Lotay, Narinder; Lai, Robert Y K; Castiglia, Mary; Jeter, Barbara; Matthews, Julian C; Chen, Kewei; Bandy, Dan; Reiman, Eric M; Gold, Michael; Rabiner, Eugenii A; Matthews, Paul M

    2010-01-01

    Here we report the first multi-center clinical trial in Alzheimer's disease (AD) using fluorodeoxyglucose positron emission tomography ([18F]FDG-PET) measures of brain glucose metabolism as the primary outcome. We contrasted effects of 12 months treatment with the PPARγ agonist Rosiglitazone XR versus placebo in 80 mild to moderate AD patients. Secondary objectives included testing for reduction in the progression of brain atrophy and improvement in cognition. Active treatment was associated with a sustained but not statistically significant trend from the first month for higher mean values in Kiindex and CMRgluindex, novel quantitative indices related to the combined forward rate constant for [18F]FDG uptake and to the rate of cerebral glucose utilization, respectively. However, neither these nor another analytical approach recently validated using data from the Alzheimer's Disease Neuroimaging Initiative indicated that active treatment decreased the progression of decline in brain glucose metabolism. Rates of brain atrophy were similar between active and placebo groups and measures of cognition also did not suggest clear group differences. Our study demonstrates the feasibility of using [18F]FDG-PET as part of a multi-center therapeutics trial. It suggests that Rosiglitazone is associated with an early increase in whole brain glucose metabolism, but not with any biological or clinical evidence for slowing progression over a 1 year follow up in the symptomatic stages of AD. PMID:20930300

  18. 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.

  19. 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

  20. 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

  1. Apparent diffusion coefficient histogram analysis stratifies progression-free and overall survival in patients with recurrent GBM treated with bevacizumab: A multi-center study

    OpenAIRE

    Pope, WB; Qiao, XJ; Kim, HJ; Lai, A.; Nghiemphu, P; Xue, X.; Ellingson, BM; Schiff, D.; Aregawi, D; Cha, S; Puduvalli, VK; Wu, J.; Yung, WKA; Young, GS; Vredenburgh, J

    2012-01-01

    We have tested the predictive value of apparent diffusion coefficient (ADC) histogram analysis in stratifying progression-free survival (PFS) and overall survival (OS) in bevacizumab-treated patients with recurrent glioblastoma multiforme (GBM) from the multi-center BRAIN study. Available MRI's from patients enrolled in the BRAIN study (n = 97) were examined by generating ADC histograms from areas of enhancing tumor on T1 weighted post-contrast images fitted to a two normal distribution mixtu...

  2. SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World (SUGAR: a multi-center, retrospective, observational study.

    Directory of Open Access Journals (Sweden)

    Byung-Su Yoo

    Full Text Available BACKGROUND: Clinical practice guidelines have been slowly and inconsistently applied in clinical practice, and certain evidence-based, guideline-driven therapies for heart failure (HF have been significantly underused. The purpose of this study was to survey guideline compliance and its effect on clinical outcomes in the treatment of systolic HF in Korea. METHOD AND RESULTS: The SUrvey of Guideline Adherence for Treatment of Systolic Heart Failure in Real World (SUGAR trial was a multi-center, retrospective, observational study on subjects with systolic HF (ejection fraction <45% admitted to 23 university hospitals. The guideline adherence indicator (GAI was defined as a performance measure on the basis of 3 pharmacological classes: angiotensin-converting enzyme inhibitor (ACEI or angiotensin receptor II blocker (ARB, beta-blocker (BB, and aldosterone antagonist (AA. Based on the overall adherence percentage, subjects were divided into 2 groups: those with good guideline adherence (GAI ≥50% and poor guideline adherence (GAI <50%. We included 1319 regional participants as representatives of the standard population from the Korean national census in 2008. Adherence to drugs at discharge was as follows: ACEI or ARB, 89.7%; BB, 69.2%; and AA, 65.9%. Overall, 82.7% of the patients had good guideline adherence. Overall mortality and re-hospitalization rates at 1 year were 6.2% and 37.4%, respectively. Survival analysis by log-rank test showed a significant difference in event-free survival rate of mortality (94.7% vs. 89.8%, p = 0.003 and re-hospitalization (62.3% vs. 56.4%, p = 0.041 between the good and poor guideline-adherence groups. CONCLUSIONS: Among patients with systolic HF in Korea, adherence to pharmacologic treatment guidelines as determined by performance measures, including prescription of ACEI/ARB and BB at discharge, was associated with improved clinical outcomes.

  3. 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.

  4. 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

  5. Phases of non-extremal multi-centered bound states

    NARCIS (Netherlands)

    B.D. Chowdhury; D.R. Mayerson; B. Vercnocke

    2013-01-01

    We investigate the phase space of multi-centered near-extremal configurations previously studied in arXiv:​1108.​5821 [1] and arXiv:​1110.​5641 [2] in the probe limit. We confirm that in general the energetically favored ground state of the multi-center potential, which can be a single or multi-cent

  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. 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...

  8. 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.

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

    OpenAIRE

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

    2009-01-01

    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 metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measureme...

  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. 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

    PURPOSE: Clinically useful molecular markers predicting the clinical course of patients diagnosed with non-muscle-invasive bladder cancer are needed to improve treatment outcome. Here, we validated four previously reported gene expression signatures for molecular diagnosis of disease stage and ca...

  12. 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

  13. Needle-Stick Injury among Health Care Workers in Hemodialysis Units in Nigeria: A Multi-Center Study

    Directory of Open Access Journals (Sweden)

    CO Amira

    2014-01-01

    Full Text Available Background: Needle-stick and sharps injuries carry the risk of infection and are occupational hazards for all health care professionals involved in clinical care.Objective: To determine the frequency and factors contributing to needle-stick injury (NSI among health care workers of dialysis units in Lagos, Nigeria.Methods: Data were obtained by anonymous, self-reporting questionnaire from staff of 4 hemodialysis units between October and December 2011. Information on demographics, job category and duration, details of NSI in the past, kind of activity and procedure under which the NSI occurred, if injury was reported, vaccination status of staff, and post-exposure treatment received were obtained.Results: The study population included 38 (37.3% doctors, 42 nurses (41.2%, 14 (13.7% dialysis technicians and 8 (7.8% ancillary staff. There were 39 (38.2% males. The mean±SD age of the study population was 34.4±8.3 years. 25 (24.5% staff had suffered NSI in the last 12 months and 41 (40.2% in their entire working career. The most common activity leading to NSI was recapping of needles (45%, improper disposal of needles (30%, and venous cannulation and setting of drips (27.5%. NSI was significantly (p=0.016 higher among those with work experience between 6 and 10 years than others. Hollow bore needles were responsible for 82.9% of the NSIs. Only 15 (37% respondents reported their NSI to their unit head or designated officer in order to get medical advice.Conclusion: In Lagos, Nigeria, NSI is common among hemodialysis staff and is under-reported. Many NSIs can be prevented by adhering to the practice of universal precautions as well as education of staff on such precautionary methods.

  14. 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

  15. 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.

  16. 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

  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

    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...... of the flattening filter on the BSF was investigated through measurements in flattened as well as flattening filter free (FFF) beams. Furthermore, to investigate the contribution from the upper and lower jaws separately, measurements at one of the clinics also included asymmetric fields. For the iX, the obtained...

  18. Comparison of iopromide versus iohexol in aortobifemoral arteriography; A Swedish multi-center study of 446 patients

    Energy Technology Data Exchange (ETDEWEB)

    Ohlsen, H.; Albrechtsson, U.; Billstroem, Aa.; Calissendorff, B.; Gustavsson, S.; Jensen, R.; Johnsson, K.; Nyberg, P.; Strindberg, L. (Karolinska Sjukhuset, Stockholm (Sweden). Dept. of Diagnostic Radiology Lund Univ. Hospital (Sweden) Umeaa Univ. Hospital (Sweden) Huddinge Univ. Hospital (Sweden) Oestra Sjukhuset, Goeteborg (Sweden) Lasarettet Helsingborg (Sweden) Regionsjukhuset, Oerebro (Sweden) Regionsjukhuset, Linkoeping (Sweden) Lasarettet Gaevle (Sweden))

    1991-03-01

    A double-blind randomized, clinical trial was conducted in 9 hospitals comparing the use of non-ionic contrast media (CM) iopromide 300 (Ultravist) and iohexol 300 (Omnipaque) during peripheral arteriography in a total of 446 patients. After premedication with morphine-scopolamine each patient was given two consecutive injections of 50 ml CM at a rate of 12 ml/s above the aortic bifurcation. Both CM were well tolerated. There were no differences between the two substances as far as general tolerance, pulse rate, blood pressure, sensation of heat or pain after CM injection were concerned. (orig.).

  19. 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.

  20. Lifestyle factors and lumbar disc disease : results of a German multi-center case-control study (EPILIFT).

    OpenAIRE

    Schumann, Barbara; Bolm-Audorff, Ulrich; Bergmann, Annekatrin; Ellegast, Rolf; Elsner, Gine; Grifka, Joachim; Haerting, Johannes; Jäger, Matthias; Michaelis, Martina; Seidler, Andreas

    2010-01-01

    INTRODUCTION: In the large-scale case-control study EPILIFT, we investigated the dose-response relationship between lifestyle factors (weight, smoking amount, cumulative duration of different sports activities) and lumbar disc disease. METHODS: In four German study regions (Frankfurt am Main, Freiburg, Halle/Saale, Regensburg), 564 male and female patients with lumbar disc herniation and 351 patients with lumbar disc narrowing (chondrosis) aged 25 to 70 years were prospectively recruited. Fro...

  1. 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

  2. The Relationship Between Distance to Water Source and Moderate-to-Severe Diarrhea in the Global Enterics Multi-Center Study in Kenya, 2008-2011.

    Science.gov (United States)

    Nygren, Benjamin L; O'Reilly, Ciara E; Rajasingham, Anangu; Omore, Richard; Ombok, Maurice; Awuor, Alex O; Jaron, Peter; Moke, Fenny; Vulule, John; Laserson, Kayla; Farag, Tamer H; Nasrin, Dilruba; Nataro, James P; Kotloff, Karen L; Levine, Myron M; Derado, Gordana; Ayers, Tracy L; Lash, R Ryan; Breiman, Robert F; Mintz, Eric D

    2016-05-01

    In the developing world, fetching water for drinking and other household uses is a substantial burden that affects water quantity and quality in the household. We used logistic regression to examine whether reported household water fetching times were a risk factor for moderate-to-severe diarrhea (MSD) using case-control data of 3,359 households from the Global Enterics Multi-Center Study in Kenya in 2009-2011. We collected additional global positioning system (GPS) data for a subset of 254 randomly selected households and compared GPS-based straight line and actual travel path distances to fetching times reported by respondents. GPS-based data were highly correlated with respondent-provided times (Spearman correlation coefficient = 0.81, P 30 minutes was reported by 25% of cases versus 15% of controls and was significantly associated with MSD where rainwater was not used in the last 2 weeks (odds ratio = 1.97, 95% confidence interval = 1.56-2.49). These data support the United Nations definition of access to an improved water source being within 30 minutes total round-trip travel time.

  3. 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.

  4. Nomogram to Predict Insignificant Prostate Cancer at Radical Prostatectomy in Korean Men: A Multi-Center Study

    OpenAIRE

    Chung, Jae Seung; Choi, Han Yong; Song, Hae-Ryoung; Byun, Seok-Soo; Seo, Seong Il; Song, Cheryn; Cho, Jin Seon; Lee, Sang Eun; Ahn, Hanjong; Lee, Eun Sik; Hwang, Tae-Kon; Kim, Wun-Jae; Chung, Moon Kee; Jung, Tae Young; Yu, Ho Song

    2010-01-01

    Purpose Due to the availability of serum prostate specific antigen (PSA) testing, the detection rate of insignificant prostate cancer (IPC) is increasing. To ensure better treatment decisions, we developed a nomogram to predict the probability of IPC. Materials and Methods The study population consisted of 1,471 patients who were treated at multiple institutions by radical prostatectomy without neoadjuvant therapy from 1995 to 2008. We obtained nonrandom samples of n = 1,031 for nomogram deve...

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

    OpenAIRE

    Hui-Jia Lin; Li-Zhong Du; Xiao-Lu Ma; Li-Ping Shi; Jia-Hua Pan; Xiao-Mei Tong; Qiu-Ping Li; Jian-Guo Zhou; Bing Yi; Ling Liu; Yun-Bing Chen; Qiu-Fen Wei; Hui-Qing Wu; Mei Li; Cui-Qing Liu

    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...

  6. 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

  7. 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.

  8. Therapeutic cranial nerve irradiation: results from a multi-center dose response study of radiosurgery for trigeminal neuralgia

    International Nuclear Information System (INIS)

    Purpose/Objective: We performed a multi-institution study to evaluate the technique, dose-selection parameters, and results of gamma knife stereotactic radiosurgery in the management of trigeminal neuralgia. We hypothesized that MRI-stereotactic targeting of the trigeminal nerve and irradiation with a single 4 mm isocenter, 2-4 mm anterior to the brainstem, could be a safe and effective treatment for this disorder. Materials and Methods: Fifty patients at five centers had radiosurgery using a single 4 mm isocenter targeted at the root entry zone. All patients had typical trigeminal neuralgia. The mean patient age was 70 years, (range, 40-87). Thirty-two patients had undergone prior surgery, and the mean number of procedures performed was 2.8 (range, 1-7). Eighteen patients (36%) had not had prior surgery before radiosurgery. Maximum radiosurgery doses included 60 Gy (n=8), 65 Gy (n=3), 70 Gy (n=27), 75 Gy (n=2), 80 Gy (n=6) and 90 Gy (n=4). All patients were discharged within 24 hours and were studied in regard to the degree of pain relief, latency interval to pain relief, sensory loss, and the need for further therapy. Mean follow-up after radiosurgery was 9.2 months (range, 2-26 months). Results: At last follow-up, 25 patients (50%) had excellent control (pain-free), 17 (34%) had good control (50-90% relief), and 8 (16%) had failed (see Figure). The median time to pain relief was one month. We identified an actuarial response rate of 53% for complete pain relief at seven months, and 93% for pain reduction (50-100% relief). At 18 months, these results declined to 48% and 77% respectively. A significantly greater proportion of patients receiving a radiosurgery maximum dose of ≥ 70 Gy achieved complete pain relief (63% vs. 18%) and >50% pain reduction (96% vs. 80%) than those with doses <70 Gy. Patients without prior surgery had significantly better outcomes in univariate testing. Three patients (6%) developed increased facial paresthesiae after radiosurgery

  9. A multi-center, cross-sectional study on quality of life in cutaneous lupus erythematosus patients

    Science.gov (United States)

    Vasquez, R.; Wang, D.; Tran, Q.P.; Adams-Huet, B.; Chren, M.-M.; Costner, M.I.; Cohen, J.B.; Werth, V.P.; Chong, B.F.

    2012-01-01

    Background A study at the University of Pennsylvania (UPenn) Medical Center demonstrated that quality of life in cutaneous lupus erythematosus (CLE) patients is negatively impacted. Whether CLE patients in other geographic locations have similar quality of life is unknown. Objective We sought to compare quality of life indicators between CLE patients at the University of Texas Southwestern (UTSW) Medical Center at Dallas and UPenn. Methods 248 CLE patients at UTSW (N=91) and UPenn (N=157) completed the Skindex-29+3 and Short Form-36 (SF-36) surveys related to quality of life. Additional information including demographics, presence of SLE, and disease severity were collected from UTSW CLE patients. Results Most Skindex-29+3 and SF-36 sub-domain scores between UTSW and UPenn CLE patients were similar. However, UTSW CLE patients were significantly more affected in the functioning and lupus-specific Skindex-29+3 domains, and physical functioning, role-physical, and general health SF-36 subscales than UPenn CLE patients (pSkindex-29+3 and SF-36 sub-domains. Capturing data from CLE populations in different locations provides a more thorough picture of the quality of life that CLE patients experience on a daily basis with special attention to quality of life issues in select CLE patients. PMID:22708924

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. High grade anal intraepithelial neoplasia among HIV-1-infected men screening for a multi-center clinical trial of a human papillomavirus vaccine

    Science.gov (United States)

    Wilkin, Timothy; Lee, Jeannette Y.; Lensing, Shelly Y.; Stier, Elizabeth A.; Goldstone, Stephen E.; Berry, J. Michael; Jay, Naomi; Aboulafia, David M.; Einstein, Mark H.; Saah, Alfred; Mitsuyasu, Ronald T.; Palefsky, Joel M.

    2013-01-01

    Purpose High-grade anal intraepithelial neoplasia (HGAIN) is the precursor lesion to invasive anal cancer. HPV vaccination holds great promise for preventing anal cancer. Methods We examined 235 HIV-1-infected men screening for participation in a multi-site clinical trial of a quadrivalent HPV vaccine. All participants had anal swabs obtained for HPV testing and cytology, and high resolution anoscopy with biopsies of visible lesions to assess for HGAIN. Results HPV 16 and 18 were detected in 23% and 10%, respectively; abnormal anal cytology was found in 56% and HGAIN in 30%. HGAIN prevalence was significantly higher in those with HPV 16 detection compared to those without (38% vs. 17%, P=.01). Use of antiretroviral therapy, nadir and current CD4+ cell count were not associated with abnormal anal cytology or HGAIN. Conclusion HGAIN is highly prevalent in HIV-infected men. Further studies are needed on treatment and prevention of HGAIN. PMID:23611828

  15. 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. PMID:24814618

  16. 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

  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. Clinical usefulness and cost-effectiveness of FDG-PET in the staging and follow up of patients with gynecological malignancies. An analysis based on multi-center survey

    International Nuclear Information System (INIS)

    Multi-center survey has been conducted about the diagnostic ability of FDG-PET for patients with gynecological malignancies. A total of 304 cases (122 cases for staging, 182 cases for the diagnosis of recurrence) were collected from 5 institutions. FDG-PET showed high diagnostic ability in both preoperative staging and the detection of recurrence, and occasionally afforded better information than conventional morphological imaging modalities such as CT and MRI did. Furthermore, with the use of FDG-PET, unsuspected lesions were detected in 10.7% of the cases for preoperative staging and in 33.9% of the cases for diagnosing recurrence, and the therapeutic strategy was changed in 8.9% of the staging cases and 35.1% of the recurrent cases. Especially in cases where image finding was not diagnostic and also in cases where recurrence was clinically suspected but not evident by morphological imaging modalities, FDG-PET was proven to afford important information for the management of the patients and can yield cost-effectiveness by obviating unnecessary surgery and invasive procedures. (author)

  19. PRevalence of Abuse and Intimate Partner Violence Surgical Evaluation (P.R.A.I.S.E.: rationale and design of a multi-center cross-sectional study.

    Directory of Open Access Journals (Sweden)

    2010-04-01

    Full Text Available Abstract Background Intimate partner violence (IPV is described by the American Medical Association as "a pattern of coercive behaviors that may include repeated battering and injury, psychological abuse, sexual assault, progressive social isolation, deprivation, and intimidation." The long-term consequences of IPV include health risks, posttraumatic stress disorder, depression, and staggering economic costs for health care of victims. Intimate partner violence is often underreported among women who seek medical attention. The current study seeks to address the issue of possible underreporting of IPV in orthopaedic fracture clinics by establishing prevalence rates of IPV among women seeking treatment for musculoskeletal injuries. Methods/Design We propose a cross-sectional multicenter study wherein 3,600 women will complete a self-reported written questionnaire across clinical sites in North America, Europe, and Australia. Recruitment of participants will take place at orthopaedic fracture clinics at each clinical site. The questionnaire will contain a validated set of questions used to screen for IPV, as well as questions that pertain to the participant's demographic, injury characteristics, and experiences with health care utilization. Female patients presenting to the orthopaedic fracture clinics will complete two validated self-reported written questionnaires (Woman Abuse Screening Tool (WAST and the Partner Violence Screen (PVS to determine the prevalence of IPV in the past 12 months and in their lifetime. The two questionnaires were designed for rapid assessment of IPV status in emergency departments, family practice, and women's health clinics that we believe are similar to our intended setting of an orthopaedic clinic. Discussion If the prevalence of IPV among women attending orthopaedic clinics is greater than the current perceptions of orthopaedic surgeons, this study will serve to advocate for the continued education of medical

  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. Factors associated with HIV/AIDS diagnostic disclosure to HIV infected children receiving HAART: a multi-center study in Addis Ababa, Ethiopia.

    Directory of Open Access Journals (Sweden)

    Sibhatu Biadgilign

    Full Text Available BACKGROUND: Diagnostic disclosure of HIV/AIDS to a child is becoming an increasingly common issue in clinical practice. Nevertheless, some parents and health care professionals are reluctant to inform children about their HIV infection status. The objective of this study was to identify the proportion of children who have knowledge of their serostatus and factors associated with disclosure in HIV-infected children receiving HAART in Addis Ababa, Ethiopia. METHODS: A cross-sectional study was conducted in five hospitals in Addis Ababa from February 18, 2008-April 28, 2008. The study populations were parents/caretakers and children living with HIV/AIDS who were receiving Highly Active Antiretroviral Therapy (HAART in selected hospitals in Addis Ababa. Univariate and multivariate logistic regression analysis were carried out using SPSS 12.0.1 statistical software. RESULTS: A total of 390 children/caretaker pairs were included in the study. Two hundred forty three children (62.3% were between 6-9 years of age. HIV/AIDS status was known by 68 (17.4% children, 93 (29% caretakers reported knowing the child's serostatus two years prior to our survey, 180 (46.2% respondents said that the child should be told about his/her HIV/AIDS status when he/she is older than 14 years of age. Children less than 9 years of age and those living with educated caregivers are less likely to know their results than their counterparts. Children referred from hospital's in-patient ward before attending the HIV clinic and private clinic were more likely to know their results than those from community clinic. CONCLUSION: The proportion of disclosure of HIV/AIDS diagnosis to HIV-infected children is low. Strengthening referral linkage and health education tailored to educated caregivers are recommended to increase the rate of disclosure.

  2. Rationale and design of the ETN-STEP (Early administration of Tirofiban in mid to high risk patients with non-ST elevation acute coronary syndrome referred for percutaneous coronary intervention) project: A multi-center, randomized, controlled clinic trial in Chinese patients

    OpenAIRE

    Li, Jian-ping; Liu, Qun; Huo, Yong

    2012-01-01

    As a member of Glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors, Tirofiban had been shown to improve myocardial reperfusion and clinical outcomes in patients undergoing percutaneous coronary intervention (PCI), but the optimal timing of administration of Tirofiban remains unclear. In order to compare the effects of upstream versus downstream administration of Tirofiban in Chinese patients with mid to high risk, non-ST elevation acute coronary syndrome (ACS) referred for PCI, a multi-center, ran...

  3. Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID: protocol for a randomized clinical multi-center trial

    Directory of Open Access Journals (Sweden)

    Seiler Christoph

    2011-03-01

    Full Text Available Abstract Background Fractures of the distal radius represent the most common fracture in elderly patients, and often indicate the onset of symptomatic osteoporosis. A variety of treatment options is available, including closed reduction and plaster casting, K-wire-stabilization, external fixation and open reduction and internal fixation (ORIF with volar locked plating. The latter is widely promoted by clinicians and hardware manufacturers. Closed reduction and cast stabilization for six weeks is a simple, convenient, and ubiquitously available intervention. In contrast, ORIF requires hospitalization, but allows for functional rehabilitation. Given the lack of randomized controlled trials, it remains unclear whether ORIF leads to better functional outcomes one year after injury than closed reduction and casting. Methods/Design ORCHID (Open reduction and internal fixation versus casting for highly comminuted intra-articular fractures of the distal radius is a pragmatic, randomized, multi-center, clinical trial with two parallel treatment arms. It is planned to include 504 patients in 15 participating centers throughout Germany over a three-year period. Patients are allocated by a central web-based randomization tool. The primary objective is to determine differences in the Short Form 36 (SF-36 Physical Component Score (PCS between volar locked plating and closed reduction and casting of intraarticular, comminuted distal radius fractures in patients > 65 years of age one year after the fracture. Secondary outcomes include differences in other SF-36 dimensions, the EuroQol-5D questionnaire, the Disability of the Arm, Shoulder, and Hand (DASH instrument. Also, the range of motion in the affected wrist, activities of daily living, complications (including secondary ORIF and revision surgery, as well as serious adverse events will be assessed. Data obtained during the trial will be used for later health-economic evaluations. The trial architecture

  4. Phases of non-extremal multi-centered bound states

    CERN Document Server

    Chowdhury, Borun D; Vercnocke, Bert

    2013-01-01

    We investigate the phase space of multi-centered near-extremal configurations previously studied in arXiv:1108.5821 and arXiv:1110.5641 in the probe limit. We confirm that in general the energetically favored ground state of the multi-center potential, which can be a single or multi-center configuration, has the most entropy and is thus thermodynamically stable. However, we find the surprising result that for a subset of configurations, even though a single center black hole seems to be energetically favored, it is entropically not allowed (the resulting black hole would violate cosmic censorship). This disproves classical intuition that everything would just fall into the black hole if energetically favored. Along the way we highlight a shortcoming in the literature regarding the computation of the angular momentum coming from electromagnetic interaction in the probe limit and rectify it. We also demonstrate that static supertubes can exist inside ergoregions where ordinary point particles would be frame dra...

  5. 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

  6. 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

  7. Association of Relapse with Renal Outcomes under the Current Therapy Regimen for IgA Nephropathy: A Multi-Center Study.

    Directory of Open Access Journals (Sweden)

    Yanhong Yuan

    Full Text Available Renal relapse is a very common manifestation of IgA nephropathy (IgAN. The clinical characteristics and long-term outcomes of this condition have not yet been carefully explored.Patients with biopsy-proven IgAN between January 2005 and December 2010 from three medical centers in China was a primary cohort of patients. From January 2010 to April 2012, data of an independent cohort of IgAN patients from Ren Ji Hospital, Shanghai, China was collected using the same inclusion and exclusion criteria. These patients formed the validation cohort of this study.Of the patients with biopsy-proven IgAN from three medical centers, 489 patients achieved remission within 6 months following the therapy. Additionally, 76 (15.5% of these patients experienced a relapse after achieving remission. During the median follow-up period of 66 months, 6 patients (1.4% in the non-relapse group experienced renal deterioration, compared with 22 patients (29.6% in the relapse group. Our study indicated that each 1-mmHg increase in the baseline diastolic blood pressure (DBP was associated with a 4.5% increase in the risk of renal relapse; additionally, the male patients had a 3.324-fold greater risk of relapse compared with the female patients according to the adjusted multivariate Cox analysis. The nomogram was based on 489 patients achieved remission. The predictive accuracy and discriminative ability of the nomogram were determined by concordance index (C-index and calibration curve. The results were validated using bootstrap resampling on the validation cohort.This study demonstrated that renal relapse is a potential predictor of prognostic outcomes in patients under the current therapeutic regimens for IgAN. And male patients with higher diastolic blood pressure had a greater risk of experiencing relapse.

  8. 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.

  9. Deep, respiratory tract and ear infections caused by Pseudallescheria (Scedosporium) and Microascus (Scopulariopsis) in Finland. A 10-year retrospective multi-center study.

    Science.gov (United States)

    Issakainen, J; Salonen, J H; Anttila, V-J; Koukila-Kähkölä, P; Castrén, M; Liimatainen, O; Vuento, R; Ojanen, T; Koivula, I; Koskela, M; Meurman, O

    2010-05-01

    Deep, respiratory tract and ear infections due to Microascaceae (Pseudallescheria, Scedosporium, Microascus or Scopulariopsis) were studied nationwide in Finland during 1993-2002. The data were based on 52,000 fungal cultures that represented about 50% of all such specimens in Finland and included all Finnish cases of profound immunosuppression. There were 39 cases that were re-evaluated as clinically significant, i.e., three pneumonias, two deep pedal infections and five wound infections, 11 sinusitis and 18 ear infections. The pedal infections and most pneumonias occurred in immunocompromised patients. Most cases, except the ear infections, were due to Pseudallescheria boydii. Two patients had lethal P. boydii pneumonia and a deep P. boydii infection of the foot contributed to a third lethal case. Two of the patients with lethal outcomes had received an allogeneic haematopoietic stem cell transplantation (AHSCT). Two patients with haematological malignancies were cured of deep site infections by a prolonged course of itraconazole. Wound, sinus and ear infections were cured or improved by local surgery or topical therapy. There were 0.8-1.7 cases of any type of infection per million inhabitants per year (MY) and 3.4 cases/1000 AHSCT. Mortality associated with Microascaceae in any type of patient was 0.06-0.12 MY. PMID:19672782

  10. 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.

  11. A multi-center study for comparison of planar versus tomographic pulmonary ventilation/perfusion imaging for the diagnosis of pulmonary embolism

    International Nuclear Information System (INIS)

    Objective: To compare between one-day planar and tomographic pulmonary V/Q imaging for the diagnosis of PE using ROC analysis. Methods: From September 2010 to October 2011, 272 patients suspected or confirmed of acute/sub-acute PE with Wells scores ≥ 2 or blood D-Dimer values >500 μg/L were recruited into this study. Patients' data were collected from six hospitals in Beijing. All patients were followed clinically for at least six months after V/Q imaging. Based on the criteria of prospective investigation of pulmonary embolism diagnosis (PIOPED) study Ⅱ, the diagnosis by planar pulmonary V/Q scans was categorized as high-probability (definite PE), moderate or low probability (suspected PE), and very low probability or normal lung perfusion (no PE). The diagnosis by SPECT V/Q scans was also classified as definite PE, suspected PE and no PE. The final diagnosis was decided by doctors in consensus based on the results of multiple imaging modalities, laboratory tests,clinical data and a six-month follow-up. Kappa test was used to analyze the concordance between planar and tomographic V/Q scans. The difference between the two methods was tested using χ2 test. ROC analysis was used to determine the AUCs. Z test was used to calculate the statistical significance of the difference between the AUCs. Results: The uncertain diagnosis rate was 1.8% (5/272) for V/Q SPECT and 9.2% (25/272) for planar imaging. The diagnostic values for SPECT and planar V/Q scans were respectively: Se 83.6% (117/140) and 78.3% (101/129) (χ2=1.217, P>0.05); Sp 89.8%(114/127) and 94.9% (112/118) (χ2=2.269, P>0.05); PPV 90.0% (117/130) and 94.4% (101/107); NPV 83.2% (114/137) and 80.0% (112/140); Ac 86.5% (231/267) and 86.2% (213/247). There were no significant differences in Se and Sp between the two methods. The concordance between the two methods was 84.9% (231/272, Kappa=0.727, P<0.05). The AUC (95% CI) was 0.891 (0.848-0.933) and 0.865 (0.819-0.911) for SPECT and planar V

  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. Different dose combinations of bortezomib and dexamethasone in the treatment of relapsed or refractory myeloma: an open-label,observational, multi-center study in China

    Institute of Scientific and Technical Information of China (English)

    YUAN Zhen-gang; JIN Jie; HUANG Xiao-jun; LI Yan; CHEN Wen-ming; LIU Zhuo-gang; CHEN Xie-qun; SHEN Zhi-xiang; HOU Jian

    2011-01-01

    Background Although previous clinical study revealed that bortezomib combined with dexamethasone had improved the outcomes of relapsed or refractory multiple myeloma (RRMM), the optimal dose combinations of bortezomib and dexamethasone remain unknown. This trial aimed to observe the efficacy and safety of different dose combinations of bortezomib and dexamethasone in the treatment of RRMM patients in China.Methods A total of 168 patients with relapsed multiple myeloma (MM) who were refractory to at lest two prior treatments were enrolled in this multicenter, open-label, non-randomized, prospective clinical trial. Twenty patients received 1.3 mg/m2 of bortezomib twice weekly for 2 weeks of a 3-week cycle for up to 8 cycles and oral or intravenous dexamethasone 20 mg on the day of and after each bortezomib dose (group 1); 66 patients received less than 1.3 mg/m2(0.7-1.0 mg/m2) of bortezomib and dexamethasone 20 mg on the same schedule (group 2); 37 patients received 1.3 mg/m2 of bortezomib and dexamethasone 40 mg (group 3) and 45 patients received less than 1.3 mg/m2 (0.7-1.0 mg/m2)of bortezomib and dexamethasone 40 mg (group 4). The response was evaluated according to the criteria of the European Group for Blood and Marrow Transplantation and confirmed by an independent review committee. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria, version 3.0. Results The median age of groups 1 to 4 was 61,62, 56, and 60 years, respectively. Most patients were in stages Ⅱ/Ⅲ of MM and the most common subtype was IgG The rate of overall response to bortezomib and dexamethasone of group 1 to 4 was 72.2% (13/18), 73.8% (48/65), 78.8% (26/33) and 78.0% (32/41) (P=0.91), including a complete response rate of 22.2% (4/18), 20.0% (13/65), 33.3% (11/33) and 29.3% (12/41) (P=0.67), respectively. There was no statistical significance in time to progression and overall survival among these 4 groups (P >0.05). The most

  14. Design of the PROCON trial : a prospective, randomized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthroplasty

    NARCIS (Netherlands)

    Bartels, R.H.M.A.; Donk, R.; Wilt, G.J. van der; Grotenhuis, J.A.; Venderink, D.

    2006-01-01

    BACKGROUND: PROCON was designed to assess the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryan's disc prosthesis. Description of rationale and design of PROCON trial and d

  15. 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

  16. [Investigation of antibiotic resistance patterns and reduced vancomycin susceptibilities of methicillin-resistant Staphylococcus aureus isolates: a multi-center study].

    Science.gov (United States)

    Çıkman, Aytekin; Aydın, Merve; Gülhan, Barış; Parlak, Mehmet; Gültepe, Bilge; Kalaycı, Yıldız; Bayındır Bilmen, Fulya; Solmaz, Sinem; Özekinci, Tuncer

    2015-04-01

    The aims of this study were to determine the minimum inhibitory concentration (MIC) values of vancomycin, teicoplanin, daptomycin, quinupristin/dalfopristin, linezolid, tigecycline, chloramphenicol, rifampicin, ofloxacin and tetracycline and to investigate the reduced vancomycin susceptibility among methicillin-resistant Staphylococcus aureus (MRSA) strains isolated in hospitals located in different geographical regions of Turkey. A total of 100 MRSA strains isolated from patients (of which 50% were from intensive care units) hospitalized in seven centers in Turkey [Istanbul (n= 15), Ankara (n= 15), Izmir (n= 15), Adana (n= 15), Diyarbakir (n=15), Erzincan (n= 15), Van (n= 10)], between August 2013 - August 2014, were included in the study. Fourty-three strains were isolated from blood, whereas 21 were from lower respiratory tract, 17 from wounds, eight from catheters, six from urine, four from nasal swab and one from cerebrospinal fluid samples. Methicillin resistance of the isolates was determined by using cefoxitin (30 µg) disk with standard disk diffusion method, while the MIC values of other antibiotics were determined with E-test in accordance with the recommendations of Clinical and Laboratory Standards Institute (CLSI). MIC results obtained for quinupristin-dalfopristin (Q/D) were evaluated according to the CLSI criteria used for methicillin-susceptible S.aureus and for tigecycline according to the criteria recommended by the Food and Drug Administration for MRSA. Primarily, agar screening method (ASM) was used for determination of vancomycin-intermediate S.aureus (VISA) and heterogeneous VISA (hVISA) strains. Brain heart infusion agar containing 6 µg/ml vancomycin was used in ASM, and the strains with suspicion of VISA/hVISA were screened by standard E-test and macro E-test methods. All MRSA strains were susceptible to vancomycin, teicoplanin, daptomycin, Q/D and linezolid by E-test method; and their rates of susceptibility for tigecycline

  17. 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,

  18. 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-...

  19. 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.

  20. 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

  1. 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

    NARCIS (Netherlands)

    Bermejo-Sanchez, 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; Martinez-Frias, Maria-Luisa

    2011-01-01

    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 conti

  2. 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

  3. 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 pimon...... 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......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...

  4. 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

  5. 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. PMID:25338182

  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. 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

  8. 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.

  9. 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.

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

    International Nuclear Information System (INIS)

    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. 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. 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. 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

  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. 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

  13. 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)

    OpenAIRE

    Paulo Caramelli; Márcia L. F. Chaves; Eliasz Engelhardt; João Carlos B. Machado; Rodrigo R. Schultz; Francisco A.C. Vale; Helenice Charchat-Fichman

    2004-01-01

    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 ...

  14. 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...

  15. 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.

  16. 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

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. 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

  2. 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

  3. 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

  4. Inter-institution preference-based variability of ejection fraction and volumes using quantitative gated SPECT with Tc-99m tetrofosmin : A multi-center study involving 106 hospitals

    OpenAIRE

    Nakajima, Kenichi; Nishimura, Tsunehiko

    2006-01-01

    Purpose Inter-institution reproducibility of gated SPECT quantification based on institutional preferences was evaluated. This sort of variability is crucial for a multicentre study when many hospitals are involved. Methods A total of 106 institutes participated in this study and were grouped according to their use of five workstation types. Fifteen sets of 99mTc-tetrofosmin gated projection images with normal ejection fraction (EF) (70%, group A, n=5), borderline low EF (50%, group B, ...

  5. 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.

  6. Albumin versus Crystalloid Therapy in the Management of Hepatorenal Syndrome: A Model for using Meta Analysis in Cost Effectiveness Studies and the Design of Clinical Trials

    OpenAIRE

    Phillips, Kirk T.; Ohsfeldt, Robert; Voigt, Michael

    2003-01-01

    We applied traditional methods of gathering, integrating and summarizing findings of current literature, with new approaches for assessing the cost effectiveness of two treatments for hepatorenal syndrome (HRS). Findings of this cost effectiveness study are used to form a proposal for a multi-center prospective clinical trial, to assess the economic and clinical benefits of albumen versus crystalloid therapy in the care of these patients. Our initial findings suggest that albumin therapy is s...

  7. 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

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

    OpenAIRE

    Rogier Alexander Feis; Smith, Stephen M.; Nicola eFilippini; Gwenaëlle eDouaud; Dopper, Elise G. P.; Verena eHeise; 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 structur...

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

    OpenAIRE

    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 structu...

  10. 注射用牛肺表面活性物质防治新生儿呼吸窘迫综合征多中心调查%Multi-center study on effect of calf pulmonary surfactant in prevention and treatment for neonatal respiratory distress syndrome

    Institute of Scientific and Technical Information of China (English)

    李文斌; 夏世文; 王琳; 刘汉楚; 程红斌; 谢集建; 刘坚; 常立文

    2013-01-01

    Objective To investigate the efficacy and safety of calf pulmonary surfactant (made in China) in prevention and treatment for neonatal respiratory distress syndrome (NRDS).Methods A prospective,multi-center controlled clinical study was conducted.A total of 256 patients who came from 7 NICUs were enrolled in this study,with 176 cases who were treated with calf pulmonary surfactant as the observation group and 80 cases refused calf pulmonary surfactant as the control group.The clinical data were observed and compared in the 2 groups,including respiration rate,heart rate,blood pressure,transcutaneous oxygen saturation,arterial blood gas analysis,bedside X-ray of the chest at 0 h and 6 h,the use of oxygen,ventilation and nasal continuous positive airway pressure,the incidence of NRDS and complications,and the length of stay hospital and the costs.Results 1.Compared with the control group,in the observation group receiving the calf pulmonary surfactant treatment,the respiratory rate decreased at different time course (all P < 0.01) ;Pa (02) improved significantly at 1 h and 4 h(P < 0.01) ;the incidence of NRDS(26/176 cases vs 32/80 cases),receiving the ventilation (17/176 cases vs 18/80 cases) and oxygen therapy lasting [(15.6 ± 6.7) d vs (12.5 ±4.6) d] decreased significantly(all P < 0.01).2.The differences in the incidence of secondary infection,bronchopulmonary dysplasia,pneumothorax,patent ductus arteriosus closure,retinopathy of premature and brain damage (intracranial hemorrhage,hypoxic-ischemic encephalopathy,and periventricular leukomalacia) were not statistically significant between the both groups (all P > 0.05).3.Compared with the control group,in the observation group,the cases of death or the with-drawals declined significantly (20/176 cases vs 25/80 cases),P < 0.01 ; the duration of hospital stay[(35.8 ± 17.4) d vs(42.6 ± 15.7) d] and the costs[(46 568 ± 16 533) yuan vs(56 858 ± 16 334) yuan] were reduced significantly(P <0

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

    Medline Plus

    Full Text Available ... NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and ...

  12. ImTK: an open source multi-center information management toolkit

    Science.gov (United States)

    Alaoui, Adil; Ingeholm, Mary Lou; Padh, Shilpa; Dorobantu, Mihai; Desai, Mihir; Cleary, Kevin; Mun, Seong K.

    2008-03-01

    The Information Management Toolkit (ImTK) Consortium is an open source initiative to develop robust, freely available tools related to the information management needs of basic, clinical, and translational research. An open source framework and agile programming methodology can enable distributed software development while an open architecture will encourage interoperability across different environments. The ISIS Center has conceptualized a prototype data sharing network that simulates a multi-center environment based on a federated data access model. This model includes the development of software tools to enable efficient exchange, sharing, management, and analysis of multimedia medical information such as clinical information, images, and bioinformatics data from multiple data sources. The envisioned ImTK data environment will include an open architecture and data model implementation that complies with existing standards such as Digital Imaging and Communications (DICOM), Health Level 7 (HL7), and the technical framework and workflow defined by the Integrating the Healthcare Enterprise (IHE) Information Technology Infrastructure initiative, mainly the Cross Enterprise Document Sharing (XDS) specifications.

  13. Randomized,parallel-control and multi-centered research on venlafaxine sustained release tablet and pinaverium bromide in treating patients with diarrhea-predominant irritable bowel syndrome

    Institute of Scientific and Technical Information of China (English)

    2013-01-01

    Objective To observe the efficacy,adverse effects and the influence on the depression and anxiety scoringof combined venlafaxine sustained release tablet with pinaverium for treating patients with dominant-diarrhea irritable bowel syndrome (IBS-D) .Methods With randomized,parallel control,multi-center and opening study

  14. 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

  15. Efficacy of natural vitamin E on oligospermia and athenospermia: A prospective multi-centered randomized controlled study of 106 cases%天然维生素E辅助治疗特发性少弱精子症多中心前瞻性随机对照研究(附106例报告)

    Institute of Scientific and Technical Information of China (English)

    陈向锋; 李铮; 平萍; 戴继灿; 张峰彬; 商学军

    2012-01-01

    够改善精子浓度和前向运动精子比例,有助于提高女方自然受孕.%Objective: To explore the therapeutic effect of natural vitamin E (VitE) on oligospermia and athenospermia in in-fertile men. Methods; We conducted a prospective multi-centered randomized controlled study on 64 infertile men with oligospermia (31 as controls treated with Tamoxifen 10 mg bid and 33 as experimental cases treated with Tamoxifen 10 mg bid + VitE 100 mg tid) and 42 cases of athenospermia (20 as controls treated with Levocarnitine oral solution 1 bottle bid and 22 as experimental cases treated with Levocarnitine oral solution I bottle bid + VitE 100 mg tid). We compared the control and experimental groups in sperm concentration and percentage of progressively motile sperm before and 3 months after medication, as well as the rate of clinical pregnancy and adverse events. Results : Among the oligospermia patients, the average sperm concentrations in the control and experimental groups were 8.00 X lO'/ml and 10.66 X lOVml before medication (P> 0.05). After medication, the numbers of cases evaluated as with no, slight, moderate and marked improvement in sperm concentration were 10 and 9 (P>0.05) , 16 and 14 (P>0.05) , 5 and 4 (P > 0.05 ) and 0 and 0 ( P > 0.05 ) ; and the numbers of natural pregnancies were 0 and 6 in the control and experimental groups ( P 0.05 ). After medication, the numbers of cases evaluated as with no, slight, moderate and marked improvement in the percentage of progressively motile sperm were 7 and 2 (P 0. 05 ) and 1 and 1 ( P > 0.05 ) , and the numbers of natural pregnancies were 5 and 9 in the two groups ( P < 0.01) , but no adverse events were observed. Conclusion: As a safe and effective adjuvant agent for the treatment of oligospermia and athenospermia, vitamin E can improve sperm concentration, the percentage of progressively motile sperm, and finally the rate of natural pregnancy.

  16. Protective Effect of Dual-Strain Probiotics in Preterm Infants: A Multi-Center Time Series Analysis

    Science.gov (United States)

    Schwab, Frank; Garten, Lars; Geffers, Christine; Gastmeier, Petra; Piening, Brar

    2016-01-01

    Objective To determine the effect of dual-strain probiotics on the development of necrotizing enterocolitis (NEC), mortality and nosocomial bloodstream infections (BSI) in preterm infants in German neonatal intensive care units (NICUs). Design A multi-center interrupted time series analysis. Setting 44 German NICUs with routine use of dual-strain probiotics on neonatal ward level. Patients Preterm infants documented by NEO-KISS, the German surveillance system for nosocomial infections in preterm infants with birth weights below 1,500 g, between 2004 and 2014. Intervention Routine use of dual-strain probiotics containing Lactobacillus acidophilus and Bifidobacterium spp. (Infloran) on the neonatal ward level. Main outcome measures Incidences of NEC, overall mortality, mortality following NEC and nosocomial BSI. Results Data from 10,890 preterm infants in 44 neonatal wards was included in this study. Incidences of NEC and BSI were 2.5% (n = 274) and 15.0%, (n = 1631), respectively. Mortality rate was 6.1% (n = 665). The use of dual-strain probiotics significantly reduced the risk of NEC (HR = 0.48; 95% CI = 0.38–0.62), overall mortality (HR = 0.60, 95% CI = 0.44–0.83), mortality after NEC (HR = 0.51, 95% CI = 0.26–0.999) and nosocomial BSI (HR = 0.89, 95% CI = 0.81–0.98). These effects were even more pronounced in the subgroup analysis of preterm infants with birth weights below 1,000 g. Conclusion In order to reduce NEC and mortality in preterm infants, it is advisable to add routine prophylaxis with dual-strain probiotics to clinical practice in neonatal wards. PMID:27332554

  17. A multi-center prospective randomized controlled study on the effect of recovery of gastrointestinal function withHoupupaiqi mixture after the gynecological surgery%厚朴排气合剂对妇科手术后胃肠功能恢复的影响

    Institute of Scientific and Technical Information of China (English)

    姚远洋; 刘凤英; 王世军; 王悦; 周蓉; 孙秀丽; 李艺; 赵超; 崔恒; 刘毅智

    2012-01-01

    Objective To observe the effect of recovery of gastrointestinal function with Houpupaiqi mixture after the gynecological surgery, and assess the efficacy and safety. Methods Through a prospective, multi-center, randomized, double blind, controlled trial, all 96 selected gynecological patients in Peking University Peoples Hospital and the Second Xiangya Hospital of Central South University between May 2010 and July 2011 were treated with Houpupaiqi mixture (test group), or the placebo (control group) according to the test number at 6 and 10 hours after surgery. The data got from the 4-days clinical observation was analyzed. Results Compared with the control group, the time of first exhaust, first defecation, recovery of regular bowel sounds, and eating solid diet were significantly earlier in the test group (P =0. 000). There was no significant difference in the alteration of body temperature, respiration, heart rate and blood pressure before and after taking medicine between the two groups (P > 0.05 ). There was no significant difference in the number of cases with the abnormal results of blood test, renal function, and ECG after taking medicine between the two groups (P>0.05); while compared with the control group, the number of cases with the abnormal results of urine glucose and aspartate aminotransferase were significantly less in the test group (P = 0. 024, 0. 014). Conclusion Taking houpupaiqi mixture can promote the recovery of gastrointestinal function after the gynecological surgery, and it's safe to clinical application.%目的 探讨中药厚朴排气合剂对妇科手术后胃肠功能恢复的影响,评价其有效性及安全性.方法 2010年5月至2011年7月在北京大学人民医院和中南大学湘雅二医院采用前瞻性、多中心、随机双盲对照的方法,将96例妇科入选患者依照试验编号,于手术后6h及10h给予厚朴排气合剂(试验组)或模拟剂(对照组),经过4d临床观察后,对数

  18. Prolactinomas: clinical studies

    OpenAIRE

    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 increased risk of cardiac valve disease has been reported in patients treated with cabergoline for Parkinson’s disease. Stimulation of serotonin receptors on cardiac valves by dopamine agonists re...

  19. Multi-center, multi-topic heart sound databases and their applications.

    Science.gov (United States)

    Xie, Meilan; Xiao, Shouzhong; Liu, Tianhu; Yi, Qijian; You, Fengzhi; Guo, Xingming; Shao, Yong; Huo, Junmimg; Du, Deqi; Xu, Dongmei; Wu, Wenzhu; Xiao, Zifu; Yang, Yong; Guo, Weizhen

    2012-02-01

    This paper describes a large resource of multi-center and multi-topic heart sound databases, which were based on the measured data from more than 9,000 heart sound samples (saved in WAV file format). According to different research topics, these samples were respectively stored in different folders (corresponding to different research topics and distributed over various cooperative research centers), most of which as subfolds were stored in a pooled folder in the principal center. According to different research topics, the measured data from these samples were used to create different databases. Relevant data for a specific topic can be pooled in a large database for further analysis. This resource is shared by members of related centers for their own specific topic. The applications of this resource include evaluation of cardiac safety of pregnant women, evaluation of cardiac reserve for children, athletes, addicts, astronauts, and general populations, as well as studies on a bedside method for evaluating cardiac energy, reversal of S1-S2 ratio, etc.

  20. 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

  1. 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.

  2. Multi-center reproducibility of neurochemical profiles in the human brain at 7 T.

    Science.gov (United States)

    van de Bank, B L; Emir, U E; Boer, V O; van Asten, J J A; Maas, M C; Wijnen, J P; Kan, H E; Oz, G; Klomp, D W J; Scheenen, T W J

    2015-03-01

    The purpose of this work was to harmonize data acquisition and post-processing of single voxel proton MRS ((1) H-MRS) at 7 T, and to determine metabolite concentrations and the accuracy and reproducibility of metabolite levels in the adult human brain. This study was performed in compliance with local institutional human ethics committees. The same seven subjects were each examined twice using four different 7 T MR systems from two different vendors using an identical semi-localization by adiabatic selective refocusing spectroscopy sequence. Neurochemical profiles were obtained from the posterior cingulate cortex (gray matter, GM) and the corona radiata (white matter, WM). Spectra were analyzed with LCModel, and sources of variation in concentrations ('subject', 'institute' and 'random') were identified with a variance component analysis. Concentrations of 10-11 metabolites, which were corrected for T1 , T2 , magnetization transfer effects and partial volume effects, were obtained with mean Cramér-Rao lower bounds below 20%. Data variances and mean concentrations in GM and WM were comparable for all institutions. The primary source of variance for glutamate, myo-inositol, scyllo-inositol, total creatine and total choline was between subjects. Variance sources for all other metabolites were associated with within-subject and system noise, except for total N-acetylaspartate, glutamine and glutathione, which were related to differences in signal-to-noise ratio and in shimming performance between vendors. After multi-center harmonization of acquisition and post-processing protocols, metabolite concentrations and the sizes and sources of their variations were established for neurochemical profiles in the healthy brain at 7 T, which can be used as guidance in future studies quantifying metabolite and neurotransmitter concentrations with (1) H-MRS at ultra-high magnetic field. PMID:25581510

  3. 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.

  4. The Multi-Center Airborne Coherent Atmospheric Wind Sensor: Recent Measurements and Future Applications

    Science.gov (United States)

    Rothermel, Jeffry; Cutten, Dean R.; Hardesty, R. Michael; Howell, James N.; Darby, Lisa S.; Tratt, David M.; Menzies, Robert T.

    1999-01-01

    The coherent Doppler lidar, when operated from an airborne platform, offers a unique measurement capability for study of atmospheric dynamical and physical properties. This is especially true for scientific objectives requiring measurements in optically-clear air, where other remote sensing technologies such as Doppler radar are at a disadvantage in terms of spatial resolution and coverage. Recent experience suggests airborne coherent Doppler lidar can yield unique wind measurements of--and during operation within--extreme weather phenomena. This paper presents the first airborne coherent Doppler lidar measurements of hurricane wind fields. The lidar atmospheric remote sensing groups of National Aeronautics and Space Administration (NASA) Marshall Space Flight Center, National Oceanic and Atmospheric Administration (NOAA) Environmental Technology Laboratory, and Jet Propulsion Laboratory jointly developed an airborne lidar system, the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS). The centerpiece of MACAWS is the lidar transmitter from the highly successful NOAA Windvan. Other field-tested lidar components have also been used, when feasible, to reduce costs and development time. The methodology for remotely sensing atmospheric wind fields with scanning coherent Doppler lidar was demonstrated in 1981; enhancements were made and the system was reflown in 1984. MACAWS has potentially greater scientific utility, compared to the original airborne scanning lidar system, owing to a factor of approx. 60 greater energy-per-pulse from the NOAA transmitter. MACAWS development was completed and the system was first flown in 1995. Following enhancements to improve performance, the system was re-flown in 1996 and 1998. The scientific motivation for MACAWS is three-fold: obtain fundamental measurements of subgrid scale (i.e., approx. 2-200 km) processes and features which may be used to improve parameterizations in hydrological, climate, and general

  5. Clinical Studies with Epothilones

    Science.gov (United States)

    Altmann, Karl-Heinz

    As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

  6. A perspective,open-label,and multi-center phase Ⅱ study of FOLFOX 4 regimen as systemic therapy for patients with unresectable hepatocellular carcinoma%FOLFOX4方案治疗晚期肝细胞癌的多中心Ⅱ期临床研究

    Institute of Scientific and Technical Information of China (English)

    龚新雷; 秦叔逵; 王雅杰; 邢宝才; 吴晴; 曹梦苒; 华海清; 刘秀峰

    2011-01-01

    目的:在初步观察的基础上,探讨以奥沙利铂(OXA)和亚叶酸钙/5-氟尿嘧啶(LV/5-FU)组成的FOLFOX 4方案进行系统化疗,治疗无法手术切除的国人晚期肝细胞癌(HCC)患者的有效性和安全性.方法:前瞻性、单臂、开放性、多中心的Ⅱ期临床研究,采取Simon二阶段法.经病理组织学和/或细胞学检查确诊的局部晚期、无法手术或已有远处转移的HCC患者,给予FOLFOX 4方案进行全身化疗,即 OXA 85 Mg*m(-2),静滴,d1;LV200mg·m(-2),静滴2h,d1,d2;5-FU400mg·m(-2),静推,继以600 mg·m(-2),持续静脉滴注22 h,d1,d2;每2周重复;直至疾病进展或最多不超过6个周期.每2个周期(6周时间)按照RECIST标准(1.0版)评价客观疗效,观察至疾病进展时间(TTP)和生存期(OS),并动态监测血清甲胎蛋白(AFP)的变化.一般毒性,按照NCI-CTC 2.0版标准观察和判定;神经系统毒性,参照OXA专用神经病变分级标准评判.结果:4家肿瘤中心参加,共入组25例患者,其中22例可以评估疗效,结果获得完全缓解(CR)1例,部分缓解(PR)3例,稳定(SD)7例,进展11例,客观缓解率(CR + PR)为18.2%,疾病控制率(DCR = CR +PR + SD)为50.0%;中位,TTP为2.0个月(95%可信区间:1.3~4.0个月),中位OS为12.4个月.AFP反应率为28%.常见的毒性反应为粒细胞减少和轻度的周围神经毒性.结论:以奥沙利铂为主的FOLFOX 4方案进行系统化疗,对于国人晚期肝细胞癌具有良好的客观疗效和一定的生存获益,不良反应较轻,患者易于耐受,值得进一步开展大规模、随机对照的Ⅲ期临床研究.%Objective: To observe the efficacy and safety of oxaliplatin (OXA) combined with LV/5-FU ( FOLFOX 4 regimen ) in Chinese patients with unresectable hepatocellular carcinoma ( HCC ). Methods: It was a perspective, open-label, single arm, and multi-center phase II study, conducted in 4 cancer centers in China. The patients had pathologically confirmed as inoperable HCC with or without

  7. 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.

  8. 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

  9. Second trimester maternal serum screening for Down's syndrome in mainland China :a multi-center prospective study%对孕中期妇女行血清学二联指标筛查胎儿唐氏综合征的多中心前瞻性研究

    Institute of Scientific and Technical Information of China (English)

    边旭明; 朱宝生; 王和; 许争锋; 潘小英; 廖灿; 蔡艳; 王华; 王泽; 朱军; 胡娅莉; 刘俊涛; 戚庆炜; 蒋宇林; 李岩; 刘善英; 郝娜; 周京; 吕时铭

    2008-01-01

    Objective To evaluate the performance characteristics of the second trimester double-marker test for the detection of fetal Down's syndrome in mainland China. Methods This prospective national multi-centered study used alpha-fetoprotein (AFP) and free β-subunit of human chorionic gonadotrophin( free β-hCG)as the serum markers. From May 2004 to September 2006, 11 centers participated in the collection and analysis of maternal serum AFP and free β-hCG between 14 and 20+6 weeks of pregnancy. The screening results were calculated using the standard algorithm based on the standard database provided with the analytic software. Patients with an increased risk of Down's syndrome pregnancy (≥1/270) were offered genetic anmiocentesis. Outcomes of all pregnancies were obtained.Results A total of 66 132 singleton pregnancies were included in the study. The median maternal age was 27 years. At a cut-eft of 1 in 270, the detection rate (DR) based on a Caucasian database was 72% corresponding to a false positive rate (FPR) of 5%, and the DR based on the Chinese database was raised to 76% corresponding to an FPR of 5%. Conclusion The double-marker test using AFP and free β-hCG is an effective screen strategy for second-trimester detection of fetal Down's syndrome in mainland China. Ethnic variance exists between the Caucasian and Chinese populations. The accuracy of screening is increased by the use of race-specific medians.%目的 建立中国孕妇孕中期血清学二联指标筛查胎儿唐氏综合征的数据库,探讨适合中国大陆孕妇筛查胎儿唐氏综合征的策略.方法 应用有区域代表性的多中心前瞻性研究方法,收集2004年5月至2006年9月期间在北京协和医院等11家医疗单位就诊的、孕周为14~20周+6并同意接受产前筛查的66 132例妊娠单活胎孕妇(平均年龄27岁)行血清甲胎蛋白(AFP)和游离人绒毛膜促性腺激素B亚单位(freeβ-Hcg)二联指标检测,将二联指标测定值输入以高加

  10. Comparative assessment of clinical efficacy of percutaneous transhepatic metal versus plastic biliary stent implantation for malignant biliary obstruction: a multi-centered investigation%金属支架、内涵管治疗恶性胆道梗阻的临床疗效比较(多中心研究)

    Institute of Scientific and Technical Information of China (English)

    郭元星; 李彦豪; 陈勇; 俞志坚; 陈平雁; 罗鹏飞; 李勇; 单鸿; 姜在波

    2003-01-01

    Objective To compare the clinical efficacy of metal versus plastic biliary stent implantation for treatment of malignant biliary obstruction. Methods Percutaneous transhepatic implantations of self-expandable metal stent (MS, n=61) or 10F plastic stent (PS, n=34) were performed in 95 patients with malignant biliary obstruction selected from 3 hospitals of Guangdong Province. All patients were followed up until death or at least one year after the procedure. Kaplan-Meier analysis was used to compare the patients' survival and stent patency rates. Results The 30-day mortality rate was lower in MS group (6/61, 9.8%) than in PS group (9/34, 26.5%, P<0.05). The 30-day reobstruction rate and incidence of complications were 15.0%, 16.4% in MS group and 32.4%, 29.4% in PS group, respectively (P<0.01). The median patency period of the stents and median survival period of the patients were 230 d, 224 d in MS group and 90 d, 94 d in PS group, respectively (P<0.01).Conclusion Metal stent implantation is superior to plastic stent for treatment of malignant biliary obstruction.%目的比较金属支架与塑料支架(内涵管)置入术治疗恶性胆道梗阻的临床疗效.方法调查广东省3家医院95例实施经皮穿肝胆总管支架置入术的恶性胆道梗阻患者,其中61例置入自膨式金属支架(支架组),34例置入10F塑料内涵管(内涵管组).所有患者均回访至死亡或至少术后1年.用Kaplan-Meier方法分析比较两组患者的生存及支架开通率.结果支架组的30 d死亡率(6/61,9.8%)低于内涵管组(9/34,26.5%,P<0.05).支架组30d再阻塞率(15.0%)和并发症发生率(16.4%)均明显低于内涵管组(分别为32.4%和29.4%,P<0.01).支架组中位开通期(230 d)和中位生存期(224d)明显长于内涵管组(分别为90和94d,P<0.01).结论金属支架置入术治疗恶性胆道梗阻临床疗效优于内涵管.

  11. 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

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

    Medline Plus

    Full Text Available ... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ... children's health with the goal to develop treatments, drugs, and devices specific to children. Resources for a ...

  13. OBSTRUCTIVE JAUNDICE: A CLINICAL STUDY

    OpenAIRE

    Antony,; Rasool Syed

    2016-01-01

    BACKGROUND Jaundice is a frequent manifestation of biliary tract disorders and evaluation of obstructive jaundice is a common problem faced by general surgeons. Obstructive jaundice of varied aetiology is one of the main cause of hospital admissions. Hence, comprehensive study of aetiology, clinical presentation, management of obstructive jaundice is important in management of these patients. AIMS AND OBJECTIVES  Study the clinical history and presentation of obstructiv...

  14. Establishment and validation of a standard protocol for the detection of minimal residual disease in B lineage childhood acute lymphoblastic leukemia by flow cytometry in a multi-center setting;

    OpenAIRE

    Irving, Julie; Jesson, Jenny; Virgo, Paul; Case, Marian; Minto, Lynne; Eyre, Lisa; Noel, Nigel; Johansson, Ulrika; Macey, Marion; Knotts, Linda; Helliwell, Margaret; Davies, Paul; Whitby, Liam; Barnett, David; Hancock, Jeremy

    2009-01-01

    Minimal residual disease detection, used for clinical management of children with acute lymphoblastic leukemia, can be performed by molecular analysis of antigen-receptor gene rearrangements or by flow cytometric analysis of aberrant immunophenotypes. For flow minimal residual disease to be incorporated into larger national and international trials, a quality assured, standardized method is needed which can be performed in a multi-center setting. We report a four color, flow cytometric protoc...

  15. [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.

  16. Diagnostic criteria of high altitude de-acclimatization syndrome among plateau migrants after their return to the plain:a multi-center randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    Qi-quan Zhou; Yong Fan; Fu-ling Wang; Guan-song Wang; Sheng-yue Yang; Zhen-cai Yuan; Yin-hu Wang; Xue-feng Zhang; Wei Gao; Zi-fu Shi; You-li Yang; Yun-hong Wu

    2015-01-01

    Objective: The objective of this study was to investigate the diagnostic methods of high altitude de-acclimatization syndrome and to formulate diagnostic criteria. Methods: This study was conducted using epidemiological surveys and a multi-center randomized controlled clinical trial. A total of 3,011 subjects were studied, and the following indices were collected after their return to low altitude areas from the plateau: general health status, blood, urine and stool samples, myocardial enzyme levels, liver and kidney function, nerve function, sex hormone levels, microalbuminuria, electrocardiogram (ECG), echocardiography, pulmonary function, and hemorheological markers. These data were compared to those of randomized healthy subjects in the same age range who lived at the same altitude to determine the characteristics of high altitude de-acclimatization syndrome. Based on these characteristics, diagnostic criteria for high altitude de-acclimatization syndrome were formulated. Results: This study demonstrated that the incidence of high altitude de-acclimatization syndrome was 84.36%. Sixty percent of the cases were mild, 30% were medium, and 10% were severe. The incidence was higher among those who returned to a place of lower altitude, resided at a high altitude for a longer period of time, or engaged in heavy labor while at high altitude. Patients with high altitude de-acclimatization syndrome manifested hematological abnormalities and abnormal ventricular function, notably a right ventricular diastolic function, which recovered to baseline function after one to five years. Exposure to long-term hypoxia often caused obvious changes in cardiac morphology, i.e., left and right ventricular hypertrophy, particularly within the right ventricle. In addition, patients with high altitude de-acclimatization syndrome often presented with low blood pressure, low pulse pressure, and microalbuminuria. A few patients presented with occult blood in their feces. The diagnosis of

  17. CLINICAL STUDY OF ANORECTAL MALFORMATIONS

    OpenAIRE

    Umesh; Sowmya,

    2015-01-01

    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)...

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

    Medline Plus

    Full Text Available ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & ...

  19. 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

  20. 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.

  1. 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%.

  2. 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

  3. 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.

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

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  5. Clinical studies on cerebral infarction

    International Nuclear Information System (INIS)

    Hemorrhagic infarction (HI) is termed as the infarction in which a large part of the necrotic tissue is stippled with small hemorrhage. The pathogenetic mechanism of this disease still remains controversial. Cerebral infarction has long been divided into two subtypes-thrombosis and embolism-according to the pathogenetic mechanisms. Clinical studies were carried out in 31 cases of HI with cerebral thrombosis. CT findings of these cases were classified into five groups according to both size of low density area which indicates regions of infarction and distribution of arterial supply. The low density area of Type I-Type III were observed in the area of the middle cerebral artery. That of Type IV was observed in the area of the internal capsule and basal ganglia. That of Type V was observed in the area of the posterior cerebral artery. CT reveals two patterns of HI -pattern A and pattern B-. The CT finding of pattern A is appearance of high density area in the low density area. The CT finding of pattern B is appearance of iso density area in the low density area. rCBF was measured by 133Xe inhalation technique in 21 patients with CT type I, II and III. Thereafter, with regard to the various findings in CT, the clinical findings and CBF findings, a comparative study was carried out on these ten groups. From the results of present studies, it is concluded that sequential changes of CBF in cases with pattern A are different from those with pattern B, and that CBF measurement does not permit an estimation of a patient's chance for functionary recovery after a stroke in acute and subacute stage but permits estimation of functional outcome in chronic stage. (J.P.N.)

  6. 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

  7. The Procalcitonin And Survival Study (PASS – A Randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population: 1000 patients

    Directory of Open Access Journals (Sweden)

    Fjeldborg Paul

    2008-07-01

    Full Text Available Abstract Background Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein may often be influenced by other parameters than infection, and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient. Specific and rapid markers of bacterial infection have been sought for use in these patients. Methods Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC. Inclusion: 1 Age ≥ 18 years of age, 2 Admitted to the participating intensive care units, 3 Signed written informed consent. Exclusion: 1 Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2 Likely that safety is compromised by blood sampling, 3 Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1, n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients. Discussion For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival

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

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  9. A Clinical Study on Hypothyroidism

    International Nuclear Information System (INIS)

    A clinical study was made on 263 patients of hypothyroidism among the 5,970 patients of Various thyroid diseases diagnosed and treated at the Radioisotope Clinic and Laboratory, Seoul National University Hospital from May, 1960 to Aug, 1975. The results obtained with this study are as follows: 1) The etiological classification of hypothyroidism revealed 244 cases (93%) of primary hypothyroidism and 19 cases (7%) of secondary hypothyroidism. 2) The most frequent cause of the thyroprivic primary hypothyroidism was post radioiodine therapy with 109 cases (41.4%). 3) There were 37 cases (14%) of male and 226 cases (86%) of female, showing a ratio of 1 : 6. 4) The majority of patients were between the ages of 30 and 60 with the peak incidence (87 cases, 33%) in their fourth decades of lives. 5) The major symptoms and signs were weakness (97%), edema of face and extremities (92%); Decreased Achilles tendon reflex (87%), cold intolerance (82%), gain in weight (76%), constipation (58%) and cold skin (51%). 6) The cumulative incidence of hypothyroidism in patient treated with 131I (3-8 mci) was 7.2% at first year, 33.3% at tenth year and the 50% at fourteenth year and the annual increment was 2.9%. 7) The incidence of hypothyroidism related to the numbers of 131I therapy was not linear. 8) The diagnostic compatibilities of the various tests to hypothyroidism were TSH (100%), T4 (93.8%), 24-hour-RNIU (91.5%), ATR (86.7%), T3RU (66.1%) and BMR (64.9%).

  10. 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

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

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

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

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    Full Text Available ... children's health with the goal to develop treatments, drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ... and Postcards ...

  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 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.

  16. 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.

  17. 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.

  18. 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

  19. Assessment of radiofrequency ablation for lung cancer on the basis of clinical study

    International Nuclear Information System (INIS)

    Percutaneous radiofrequency ablation (RFA) for malignant lung tumors become increasingly widespread. We therefore conducted a multi-center phase I/II clinical study to evaluate its safety and efficacy. Eligibility criteria included a lesion of longer axis 1-2.5 cm with abnormal accumulation on fluorodeoxyglucose-positron emission tomography (FDG-PET) and of which was also considered to be difficult to curatively resect. Lesion of the diameters of which was difficult to measure, and close to the mediastinum, pleura or major blood vessels or bronchi larger than 5 mm is excluded. Percutaneous puncture was performed under image guidance using local anesthesia. Output power is gradually elevated from a low power. Overlapping ablation is carried out if necessary to cover the entire lesion. Safety was evaluated before and after the procedure by patient observation, CT, MRI, blood biochemical tests, respiratory function test and so on. The efficacy was evaluated by visual analysis of abnormal accumulation of FDG-PET before the procedure, 3 months later and 6 months later. Of the 30 cases (primary 6, metastasis 24) reported until now, the mean diameter was 1.53 cm. Pneumothorax was observed in 46.7% and a chest tube needed to be inserted in one case of them. There were no severe complications. The rate of efficacy evaluated by FDG-PET was 91.7%. Data should be analyzed in more detail in the future. (author)

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

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  1. Silibinin Improves the Effects of Methotrexate in Patients with Active Rheumatoid Arthritis: Pilot Clinical Study

    Science.gov (United States)

    Hussain, Saad Abdulrahman; Mortada, Ahmed Hashem; Jasim, Nazar Abdulateef; Gorial, Faiq Isho

    2016-01-01

    Objectives Our study sought to evaluate the effects of silibinin in patients with active rheumatoid arthritis (RA) treated with methotrexate (MTX). Methods We conducted a randomized multi-center, double-blind, placebo-controlled clinical trial over a 16-week treatment period at the Al-Sader and Baghdad Teaching Hospitals in Najaf and Baghdad, respectively. A total of 60 patients (30 of each sex) with active RA, already maintained on 12 mg MTX weekly for at least three consecutive months, were included in the study. Patients were randomly allocated to receive either 120 mg silibinin twice daily or a placebo, combined with their regular MTX regimen. The patients were evaluated by measuring disease activity score using the 28-joint Disease Activity Score, Simple Disease Activity Index, and Health Assessment Questionnaire–Disability Index scores at the start and end of the study. Blood samples were evaluated for the erythrocyte sedimentation rate (ESR), hemoglobin (Hb), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK), anti-cyclic citrullinated peptide (CCP), and the serum cytokine levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6, IL-8, IL-10, and IL-2. Results Silibinin significantly decreases the already elevated clinical scores compared to placebo treatment. ESR, IL-8, IL-6, TNF-α, anti-CCP, hs-CRP levels were significantly reduced. Additionally, the use of silibinin significantly increases Hb, IL-10, and IL-2 levels. Conclusion Silibinin may improve the effects of MTX on certain biochemical and clinical markers of patients with active RA. PMID:27403238

  2. 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....

  3. Multi-center MRI carotid plaque component segmentation using feature normalization and transfer learning

    DEFF Research Database (Denmark)

    van Engelen, Arna; van Dijk, Anouk C; Truijman, Martine T.B.;

    2015-01-01

    weights. Results showed that the best results were obtained for a combination of feature normalization and transfer learning. While for the other approaches significant differences in voxelwise or mean volume errors were found compared with the reference samecenter training, the proposed approach did...... not yield significant differences from that reference. We conclude that both extensive feature normalization and transfer learning can be valuable for the development of supervised methods that perform well on different types of datasets.......Automated segmentation of plaque components in carotid artery MRI is important to enable large studies on plaque vulnerability, and for incorporating plaque composition as an imaging biomarker in clinical practice. Especially supervised classification techniques, which learn from labeled examples...

  4. 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.

  5. 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.

  6. 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.

  7. Universal protocol for alopecia areata clinical studies.

    Science.gov (United States)

    Mesinkovska, Natasha A; Bergfeld, Wilma F

    2013-12-01

    Within the area of alopecia areata research, there is an obvious need for well-designed clinical trials of therapeutic agents. The National Alopecia Areata Foundation (NAAF) has created an initiative for the development of a unified protocol with guidelines for clinical studies. The NAAF universal protocol represents a joint effort of clinicians and investigators with experience in treating alopecia areata. This protocol will serve as a tremendous resource to facilitate future clinical studies. PMID:24326554

  8. Characteristics and Outcomes of Second Malignant Neoplasms after Childhood Cancer Treatment: Multi-Center Retrospective Survey.

    Science.gov (United States)

    Koh, Kyung-Nam; Yoo, Keon Hee; Im, Ho Joon; Sung, Ki Woong; Koo, Hong Hoe; Kim, Hyo Sun; Han, Jung Woo; Yoon, Jong Hyung; Park, Hyeon Jin; Park, Byung-Kiu; Baek, Hee Jo; Kook, Hoon; Lee, Jun Ah; Lee, Jae Min; Lee, Kwang Chul; Kim, Soon Ki; Park, Meerim; Lee, Young-Ho; Lyu, Chuhl Joo; Seo, Jong Jin

    2016-08-01

    This retrospective study investigated the clinical characteristics and outcomes of second malignant neoplasms (SMNs) in survivors of childhood cancer from multiple institutions in Korea. A total of 102 patients from 11 institutions who developed SMN after childhood cancer treatment between 1998 and 2011 were retrospectively enrolled. The most common primary malignant neoplasms (PMNs) were central nervous system (CNS) tumors (n = 17), followed by acute lymphoblastic leukemia (n = 16), non-Hodgkin lymphoma (n = 13), and osteosarcoma (n = 12). The most common SMNs were therapy-related myeloid neoplasms (t-MNs; acute myeloid leukemia [AML], 29 cases; myelodysplastic syndrome [MDS], 12 cases), followed by thyroid carcinomas (n = 15) and CNS tumors (n = 10). The median latency period was 4.9 years (range, 0.5-18.5 years). Among 45 patients with solid tumors defined as an SMN, 15 (33%) developed the lesion in a field previously subjected to radiation. The 5-year overall survival (OS) rate of patients with an SMN was 45% with a median follow-up time of 8.6 years. Patients with AML, MDS, and CNS tumors exhibited the poorest outcomes with 5-year OS rates of 18%, 33%, and 32%, respectively, whereas those with second osteosarcoma showed comparable outcomes (64%) to patients with primary counterpart and those with second thyroid carcinoma had a 100% OS rate. Further therapeutic efforts are recommended to improve the survival outcomes in patients with SMNs, especially in cases with t-MNs and CNS tumors. PMID:27478336

  9. Clinical studies of biomarkers in suicide prediction

    OpenAIRE

    Jokinen, Jussi

    2007-01-01

    Suicide is a major clinical problem in psychiatry and suicidal behaviours can be seen as a nosological entity per se. Predicting suicide is difficult due to its low base-rate and the limited specificity of clinical predictors. Prospective biological studies suggest that dysfunctions in the hypothalamo pituitary adrenal (HPA) axis and the serotonergic system have predictive power for suicide in mood disorders. Suicide attempt is the most robust clinical predictor making suici...

  10. HERPESE ZOSTER: A CLINICAL STUDY

    OpenAIRE

    Omprakash; Geeta; Dinesh Chandra; Kavitha; Arora; Sudheer

    2014-01-01

    The study was conducted between August 2012 and July 2013 at the dermatology department of OPD,116 cases studied with personal, present, past, family history, examined thoroughly, done all necessary investigations, taken opinion of other faculties where ever necessary . All the patients were reviewed weekly for 1 month and monthly for two more months. Patients 76 were males and 40 were females. Out of of 116 cases, 75 (64.6%) had definite history of chicken pox. In this study interesting diff...

  11. HERPESE ZOSTER: A CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Omprakash

    2014-03-01

    Full Text Available The study was conducted between August 2012 and July 2013 at the dermatology department of OPD,116 cases studied with personal, present, past, family history, examined thoroughly, done all necessary investigations, taken opinion of other faculties where ever necessary . All the patients were reviewed weekly for 1 month and monthly for two more months. Patients 76 were males and 40 were females. Out of of 116 cases, 75 (64.6% had definite history of chicken pox. In this study interesting different to previous studies some features found . Prodromal sign neuralgic pain more in below 20 years. Males more infected. Cranial nerve more involved. Thorasic PHN more. Remaining all detailed study has explained below with routine features.

  12. CLINICAL PHARMACOKINETIC STUDIES OF MIFEPRISTONE

    Institute of Scientific and Technical Information of China (English)

    XUNing; WUXi-Rui

    1989-01-01

    In ordcr to cxaminc thc pharmacokinetic charactcristics of mifcpristonc, manufactured by the Roussel-Uclaf Company, in Chincsee healthy volunteers and early pregnant womcn, the following two studies wcre carried out.

  13. [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.

  14. 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...

  15. 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

  16. Sex Differences in Clinical Features of Early, Treated Parkinson’s Disease

    OpenAIRE

    Augustine, Erika F.; Adriana Pérez; Rohit Dhall; Chizoba C Umeh; Aleksandar Videnovic; Franca Cambi; Anne-Marie A Wills; Elm, Jordan J; Zweig, Richard M.; Shulman, Lisa M.; Nance, Martha A.; Jacquelyn Bainbridge; Oksana Suchowersky

    2015-01-01

    Introduction: To improve our understanding of sex differences in the clinical characteristics of Parkinson’s Disease, we sought to examine differences in the clinical features and disease severity of men and women with early treated Parkinson’s Disease (PD) enrolled in a large-scale clinical trial. Methods: Analysis was performed of baseline data from the National Institutes of Health Exploratory Trials in Parkinson’s Disease (NET-PD) Long-term Study-1, a randomized, multi-center, double-blin...

  17. 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

  18. 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

  19. 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.

  20. PPB | What is a Clinical Study

    Science.gov (United States)

    The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

  1. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  2. Clinical studies of IGFBP-2 by radioimmunoassay

    DEFF Research Database (Denmark)

    Blum, W F; Horn, N; Kratzsch, J;

    1993-01-01

    A specific radioimmunoassay for human IGFBP-2 was developed using a polyclonal antiserum directed against a partial sequence (hIGFBP-2(176-190)). The tracer was prepared by radioiodination of a [Tyr]o-hIGFBP-2(176-190) derivative. The assay was used to study IGFBP-2 levels in numerous clinical an...

  3. Multi-center reproducibility of neurochemical profiles in the human brain at 7T

    NARCIS (Netherlands)

    van de Bank, B. L.; Emir, U. E.; Boer, VO; van Asten, J. J. A.; Maas, M. C.; Wijnen, J. P.; Kan, H. E.; Oz, G.; Klomp, D. W. J.; Scheenen, T. W. J.

    2015-01-01

    The purpose of this work was to harmonize data acquisition and post-processing of single voxel proton MRS (H-1-MRS) at 7T, and to determine metabolite concentrations and the accuracy and reproducibility of metabolite levels in the adult human brain. This study was performed in compliance with local

  4. 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.

  5. Management of Adult Chronic Immune Thrombocytopenia in Japan: Patient and Hematologist Perspectives from a Multi-center Cross-sectional Questionnaire Survey.

    Science.gov (United States)

    Tsukune, Yutaka; Komatsu, Norio

    2016-01-01

    Objective The objective of this study was to explore the perspective of hematologists and their patients regarding the management of adult chronic immune thrombocytopenia (ITP). Methods This was a multi-center, questionnaire-based, cross-sectional study conducted between 2012 and 2013 throughout Japan. Patients Hematologists, members of the Japanese Society of Hematology in 171 institutions, and their patients were invited to participate in this study. The hematologists were mainly asked about their treatment strategies, while patients were asked about their opinion of the applied treatments, treatment effect, impact on their quality of life (QOL), and treatment satisfaction. Results Questionnaires from 204 hematologists and 213 patients were collected. One hundred sixty hematologists (78.4%) started treatment based on the patient's platelet count. Corticosteroids were considered to be the most effective treatment (44.1%). Forty-six percent of hematologists responded that treatment would be started after the platelet count fell below 20×10(9)/L with bleeding symptoms, compared to 62.9% for patients with no bleeding symptoms. A platelet count of 50×10(9)/L or lower was acceptable for 94.0% of hematologists and 66.8% of patients. Fatigue was most frequently experienced by patients (44.6%). Patients also experienced psychological symptoms (feeling of anxiety or depressive mood: 29.1%, labyrinthitis: 23.5%). While 70.6% of hematologists assumed that the patient QOL was impaired to a moderate to substantial degree, the QOL was impaired in 34.3% of patients. Conclusion A substantial gap which exists between hematologists and their patients highlights a need for better understanding of potential conflicts for establishing effective strategies for ITP management. PMID:27580537

  6. 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.

  7. 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

  8. A CLINICAL STUDY OF CHRONIC DEPRESSION

    OpenAIRE

    Singhal, S; Kumar, S.; Agarwal, A K

    1991-01-01

    SUMMARY Neurological status of chronic depressive states have not been resolved as yet. Recent classificatory systems ICD-X and DSM-III-R have included chronic depression under affective disorders and have done away with the category of neurotic depression. The present study was undertaken with the aims of (a) to study clinical variables associated with major subtypes of chronic depression (chronic major depression and dysthymia) and (b) to investigate personality characteristics and life eve...

  9. 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.

  10. Multi-centered D1-D5 solutions at finite B-moduli

    International Nuclear Information System (INIS)

    We study the fate of two-centered D1-D5 systems on T4 away from the singular supergravity point in the moduli space. We do this by considering a background D1-D5 black hole with a self-dual B-field moduli turned on and treating the second center in the probe limit in this background. We find that in general marginal bound states at zero moduli become metastable at finite B-moduli, demonstrating a breaking of supersymmetry. However, we also find evidence that when the charges of both centers are comparable, the effects of supersymmetry breaking become negligible. We show that this effect is independent of string coupling and thus it should be possible to reproduce this in the CFT at weak coupling. We comment on the implications for the fuzzball proposal

  11. Controlled Blood Pressure in Iranian Patients: A Multi-Center Report.

    Science.gov (United States)

    Sadeghi, Ezzatollah; Behnood-Rod, Azin; Aerab-Sheibani, Hossein; Shobeiri, Elham; Pourzargar, Pirouz; Ormoz, Ehsan; Sadigh, Nader; Moharamzad, Yashar

    2016-01-01

    We decided to determine the percentage of hypertensive patients whose blood pressure (BP) measurements were within recommended controlled range and to identify predictive factors for controlled BP. In this study carried out in 2014, 280 patients were included consecutively through sampling from both university and private medical centers/pharmacies in four Iranian cities. Demographic data as well as information about duration of HTN and prescribed medications, admission to emergency department (ED) because of HTN crisis, comorbidities, and control of HTN during the last 6 months by a healthcare provider were gathered. Adherence to anti-hypertensives was also determined using the validated Persian version of the 8-item Morisky Medication Adherence Scale (MMAS-8). Controlled BP was defined as systolic BPpatients, 122 subjects (43.6%) had controlled BP. Among 55 diabetics, only two patients (3.6%) had controlled BP. Multiple logistic regression revealed the following variables as significant predictors of controlled BP: higher MMAS-8 score (adjusted odds ratio (OR)= 1.19, P= 0.03), fewer number of comorbid conditions (adjusted OR= 0.71, P = 0.03), having occupation as clerk/military personnel (adjusted OR= 1.03, P= 0.04), and not having history of ED admission during the last 6 months because of HTN crisis (adjusted OR= 2.11, P= 0.01). Considerable number of the studied patients had uncontrolled BP. Regarding the dramatic consequences of uncontrolled high BP in long term, it is advisable that careful attention by health care providers to the aforementioned factors could raise the likelihood of achieving controlled BP. PMID:26573037

  12. A Multi-Center Assessment of Nutrient Levels and Foods Provided by Hospital Patient Menus.

    Science.gov (United States)

    Trang, Susan; Fraser, Jackie; Wilkinson, Lori; Steckham, Katherine; Oliphant, Heather; Fletcher, Heather; Tzianetas, Roula; Arcand, JoAnne

    2015-11-01

    Diets of high nutritional quality can aid in the prevention and management of malnutrition in hospitalized patients. This study evaluated the nutritional quality of hospital patient menus. At three large acute care hospitals in Ontario, Canada, 84 standard menus were evaluated, which included regular and carbohydrate-controlled diets and 3000 mg and 2000 mg sodium diets. Mean levels of calories, macronutrients and vitamins and minerals provided were calculated. Comparisons were made with the Dietary Reference Intakes (DRI) and Canada's Food Guide (CFG) recommendations. Calorie levels ranged from 1281 to 3007 kcal, with 45% of menus below 1600 kcal. Protein ranged from 49 to 159 g (0.9-1.1 g/kg/day). Energy and protein levels were highest in carbohydrate-controlled menus. All regular and carbohydrate-controlled menus provided macronutrients within the Acceptable Macronutrient Distribution Ranges. The proportion of regular diet menus meeting the DRIs: 0% for fiber; 7% for calcium; 57% for vitamin C; and 100% for iron. Compared to CFG recommended servings, 35% met vegetables and fruit and milk and alternatives, 11% met grain products and 8% met meat and alternatives. These data support the need for frequent monitoring and evaluation of menus, food procurement and menu planning policies and for sufficient resources to ensure menu quality. PMID:26569294

  13. A Multi-Center Assessment of Nutrient Levels and Foods Provided by Hospital Patient Menus

    Directory of Open Access Journals (Sweden)

    Susan Trang

    2015-11-01

    Full Text Available Diets of high nutritional quality can aid in the prevention and management of malnutrition in hospitalized patients. This study evaluated the nutritional quality of hospital patient menus. At three large acute care hospitals in Ontario, Canada, 84 standard menus were evaluated, which included regular and carbohydrate-controlled diets and 3000 mg and 2000 mg sodium diets. Mean levels of calories, macronutrients and vitamins and minerals provided were calculated. Comparisons were made with the Dietary Reference Intakes (DRI and Canada’s Food Guide (CFG recommendations. Calorie levels ranged from 1281 to 3007 kcal, with 45% of menus below 1600 kcal. Protein ranged from 49 to 159 g (0.9–1.1 g/kg/day. Energy and protein levels were highest in carbohydrate-controlled menus. All regular and carbohydrate-controlled menus provided macronutrients within the Acceptable Macronutrient Distribution Ranges. The proportion of regular diet menus meeting the DRIs: 0% for fiber; 7% for calcium; 57% for vitamin C; and 100% for iron. Compared to CFG recommended servings, 35% met vegetables and fruit and milk and alternatives, 11% met grain products and 8% met meat and alternatives. These data support the need for frequent monitoring and evaluation of menus, food procurement and menu planning policies and for sufficient resources to ensure menu quality.

  14. 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.

  15. 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.

  16. 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. PMID:26266029

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  3. Clinical study on osteoradionecrosis of the jaws

    International Nuclear Information System (INIS)

    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.)

  4. 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.).

  5. 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...

  6. 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.

  7. 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.

  8. EMPYEMA THORACIS IN CHILDREN: A CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Narendra

    2016-01-01

    Full Text Available BACKGROUND Empyema thoracis is a disease that despite centuries of study still causes significant morbidity and mortality. AIMS To study the age-sex profile, clinical presentation, etiologic agents, management and the overall treatment outcome of empyema thoracis in children. METHODOLOGY A total of 25 patients of both the sexes aged 0-12 years diagnosed to have empyema thoracis and who underwent tube thoracostomy from March 2013 to February 2014 were studied. Detailed clinical history, physical examination, relevant routine and specific investigation were done. The pleural fluid was studied for gram staining, microscopy, cytology, pleural fluid culture and antibiotic sensitive pattern. All the patients were treated with tube thoracostomy and antibiotic therapy depending on the culture and sensitivity pattern. Complications were recorded. RESULTS Majority of patients (0.64% were seen in age group of 1-5 years. Fever (96%, breathlessness (92%, and cough (72% were the commonest presenting features. Bacteriological examination revealed staphylococcus aureus as the commonest etiologic agent (20% isolated from pleural fluid culture. Pyopneumothorax (16% was the commonest complication seen in these patients. All patients (92% were treated with antibiotics, and drainage of the empyema was effected by closed thoracostomy in (92% of the cases. There was no mortality. CONCLUSION Empyema is not rare in our practice. Early diagnosis and proper treatment of pneumonia prevent the development of empyema. Antibiotics and tube thoracostomy is an effective method of treating pyogenic empyema thoracis in children in resource poor settings.

  9. Plantago ovata: Clinical study of overuse.

    Science.gov (United States)

    Agha, Rukh-e-Nasreen; Saeed, Aftab; Nazar, Halima

    2016-03-01

    The objective of the study was to undertake evidence-base study to evaluate clinical manifestation of the over-estimated use of herbal drug Plantago ovata and to compare it with placebo for the efficacy and adverse effects. The patients of both genders were included. Blood urea, creatinine, ALT, Serum B12, CP, ESR and liver function tests were performed. The data was statistically analyzed in both groups for differential symptomatology. In anorexia test verses control results showed that Plantago ovata husk and placebo showed the affected ratio as 81 percent and 50 percent, correspondingly. Whereas in clinical performance of heart burning, pain in epigastrium, low libido, body pain, dyspepsia, fever, burning sensation in palm and sole in test drug showed affected response as adverse effect 90%, 88% and as control drug, 36%, 29%, 22%, 25%, 38%, 30%, 33%, 57%, respectively. The results were highly marked in test drug i.e. in comparison with placebo. This is clearly evident from data analysis that effect observed in test arm is far more superior hence null hypothesis was rejected clearly. Similarly serological and biochemical reports study i.e. (ALT, Vit. B1 and Vit A) revealed that there is no hepatotoxic and neurotoxic effect found in both the drugs. PMID:27087080

  10. Clinical studies of neuroinflammatory mechanisms in schizophrenia.

    Science.gov (United States)

    Watkins, Crystal C; Andrews, Sarah Ramsay

    2016-09-01

    Schizophrenia is a pervasive neurodevelopmental disorder that appears to result from genetic and environmental factors. Although the dopamine hypothesis is the driving theory behind the majority of translation research in schizophrenia, emerging evidence suggests that aberrant immune mechanisms in the peripheral and central nervous system influence the etiology of schizophrenia and the pathophysiology of psychotic symptoms that define the illness. The initial interest in inflammatory processes comes from epidemiological data and historical observations, dating back several decades. A growing body of research on developmental exposure to infection, stress-induced inflammatory response, glial cell signaling, structural and functional brain changes and therapeutic trials demonstrates the impact that inflammation has on the onset and progression of schizophrenia. Research in animal models of psychosis has helped to advance clinical and basic science investigations of the immune mechanisms disrupted in schizophrenia. However, they are limited by the inability to recapitulate the human experience of hallucinations, delusions and thought disorder that define psychosis. To date, translational studies of inflammatory mechanisms in human subjects have not been reviewed in great detail. Here, we critically review clinical studies that focus on inflammatory mechanisms in schizophrenia. Understanding the neuroinflammatory mechanisms involved in schizophrenia may be essential in identifying potential therapeutic targets to minimize the morbidity and mortality of schizophrenia by interrupting disease development. PMID:26235751

  11. Clinical and neuroradiological studies on internuclear ophthalmoplegia

    International Nuclear Information System (INIS)

    In this study 14 cases of internuclear ophthalmoplegia (INO) were analysed. The correlation of clinical symptoms with localization of the responsible lesions was studied in these patients. The subjects included 9 patients with CVD, 2 with MS, 1 with Fisher's syndrome, 1 with cranial polyneuritis and one with unknown etiology. Nine patients with unilateral INO are all associated with brainstem infarction. The other 5 patients including 2 MS had bilateral INO. CT showed abnormal findings in brain stem in 7 out of 14 patients. As for MRI an abnormality was found in 5 out of the 8 patients examined. Two of the 7 patients without any abnormality on CT had abnormal signals on MRI. We divided INO into 3 groups based on the clinical symptoms: 1) anterior type in which convergence was involved concomitantly with adduction paralysis, 2) typical type in which dissociated nystagmus was more marked in the abducting eye, and convergence was preserved, 3) posterior type in which abduction is impaired without adduction disturbance. There were 5 cases of anterior type, 9 of typical type, and none of posterior type. On MRI two patients of anterior type had abnormalities in the dorsal midbrain, and one patient had an abnormality in the pons, and two patients of typical type had abnormalities in the upper or middle dorsal pons to the dorsal midbrain. CT failed to demontrate any responsible lesions in 2 patients in whom the responsible legions were clearly identified on MRI. (J.P.N.)

  12. 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

  13. 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.

  14. Erythema infectiosumin children: A clinical study

    Directory of Open Access Journals (Sweden)

    Prćić Šonja

    2006-01-01

    Full Text Available Erythema infectiositm is a childhood illness characterized by mild constitutional symptoms and a blotchy or maculo-papular lacy rash on the cheeks (slapped - cheek spreading primarily to the extremities and trunk. The disease- is-caused by human parvovirus B19. Erythema infectiosum epidemics occur in a cyclic fashion, mostly during winter and spring months. The diagnosis of erythema infectiosum is usually based on the appearance and pattern of the rash. The aim of our study was to establish the frequency and clinical characteristics of erythema infectiosum in children, in the period between 2000 and 2004 at the Institute of Child and Youth Health Care, Department of Dermatology, Novi Sad. There were 0.23% of children with a clinical picture of infectious erythema. There was an outbreak of erythema infectiosum from December 2001 to September 2002. The highest number of cases was detected in April and May of 2002. from 2003 to 2004, no cases with infekctious erythema were diagnosed. The average age of infected children was 7.38. Female children were affected slightly more often than male (56.41%:43.58%. Pruritus was detected in 10.26% of children. The most constant clinical sign was reticular exanthema on the limbs, present in 100% of cases, followed by 89.74% of cheek exanthema, while limb and trunk exanthema was present in 7.68% of children. Adenopathies and mild constitutional symptoms were present in 5.12% of children. No complications were recorded in any of the cases. .

  15. 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

  16. 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.

  17. 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

  18. Controlled outcome studies of child clinical hypnosis.

    Science.gov (United States)

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    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. PMID:24165457

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. Outcome of Acute Upper Gastrointestinal Bleeding in Patients with Coronary Artery Disease: A Matched Case–control Study

    OpenAIRE

    Kessarin Thanapirom; Wiriyaporn Ridtitid; Rungsun Rerknimitr; Rattikorn Thungsuk; Phadet Noophun; Chatchawan Wongjitrat; Somchai Luangjaru; Padet Vedkijkul; Comson Lertkupinit; Swangphong Poonsab; Thawee Ratanachu-ek; Piyathida Hansomburana; Bubpha Pornthisarn; Thirada Thongbai; Varocha Mahachai

    2016-01-01

    Background/Aim: The risk of upper gastrointestinal bleeding (UGIB) increases in patients with coronary artery disease (CAD) due to the frequent use of antiplatelets. There is some data reporting on treatment outcomes in CAD patients presenting with UGIB. We aim to determine the clinical characteristics and outcomes of UGIB in patients with CAD, compared with non-CAD patients. Patients and Methods: We conducted a prospective multi-center cohort study (THAI UGIB-2010) that enrolled 981 consecut...

  4. Seizures after stroke : a prospective clinical study.

    Directory of Open Access Journals (Sweden)

    Dhanuka A

    2001-01-01

    Full Text Available Stroke is one of the most common causes of epilepsy in elderly. However, there have been very few prospective studies to define the incidence, pattern and outcome of seizures in stroke. Most studies are based on retrospective analysis of hospital records. Hence, we planned this prospective study to see the clinical, radiological and electroencephalographic characteristics of seizures in stroke and their outcome, from a north Indian tertiary care centre. Over a span of approximately 6 years, 269 consecutive patients with stroke were studied and followed up. Thirty-five (13% of these developed seizures, primarily related to stroke, during mean follow up period of 15.9 months. Twenty of these had infarctions while 15 had haemorrhages. Involvement of the cortical region was seen in most of the patients with seizures. In these patients, 86% of the lesions involved cortical areas exclusively or in addition to subcortical areas on CT scan of the brain. Twenty-seven (77% developed early seizures, two third of them had immediate post-stroke seizures. None of the patients with early onset seizures developed recurrent seizures or epilepsy, while 50% of late onset seizures developed epilepsy. No specific EEG pattern was found in those who later developed epilepsy. In the present study, early onset seizures after stroke were rather common and did not affect outcome and did not recur even when not treated with anti-epileptics. Late onset seizures were less common but were associated with recurrent seizures.

  5. Experimental and clinical studies with intraoperative radiotherapy

    International Nuclear Information System (INIS)

    Studies of normal tissue tolerance to intraoperative radiotherapy were done upon 65 dogs subjected to laparotomy and 11 million electron volt electron irradiation in doses ranging from zero to 5,000 rads. Results of studies indicated that intact aorta and vena cava tolerate up to 5,000 rads without loss of structural integrity. Ureteral fibrosis and stenosis develop at doses of 3,000 rads or more. Arterial anastomoses heal after doses of 4,500 rads, but fibrosis can lead to occlusion. Intestinal suture lines heal after doses of 4,500 rads. Bile duct fibrosis and stenosis develop at doses of 2,000 rads or more. Biliary-enteric anastomoses fail to heal at any dose level. A clinical trial of intraoperative radiotherapy combined with radical surgery was performed upon 20 patients with advanced malignant tumors which were considered unlikely to be cured by conventional therapies and which included carcinomas of the stomach, carcinomas of the pancreas, carcinomas involving the hilus of the liver, retroperitoneal sarcomas and osteosarcomas of the pelvis. All patients underwent resection of gross tumor, followed by intraoperative irradiation of the tumor bed and regional nodal basins. Some patients received additional postoperative external beam radiotherapy. Treatment mortality for combined operation and radiotherapy occurred in four of 20 patients. Postoperative complications occurred in four of the 16 surviving patients. Local tumor control was achieved in 11 of the 16 surviving patients, with an over-all median follow-up period of 18 months. The clinical trial suggested that intraoperative radiotherapy is a feasible adjunct to resection in locally advanced tumors, that the resulting mortality and morbidity is similar to that expected from operation alone and that local tumor control may be improved

  6. 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.

  7. 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.

  8. Uremic pruritus. Clinical and experimental studies.

    Science.gov (United States)

    Ståhle-Bäckdahl, M

    1989-01-01

    The aim of the study was to investigate clinical aspects of pruritus in maintenance hemodialysis patients and to evaluate factors of putative pathogenic importance. 60-65% of the patients in a maintenance hemodialysis program during a two-year period suffered from itching. Patients with pruritus tended to have been on dialysis treatment longer than those without pruritus (p = 0.05), otherwise there was no difference in clinical data or routine laboratory tests. Measurement of itch intensity continuously over one week in 28 patients using a computerized method showed that itching peaked at night after two days without dialysis, was relatively high during treatment and lowest during the day following dialysis. Our results suggest that the accumulation of pruritogens between dialysis sessions influences the intensity of itching. Most patients had "dry" skin. Recording of the stratum corneum water content by measurement of electrical capacitance, in 31 patients (19 with pruritus) and 12 controls, disclosed no significant difference between dialysis patients and controls, but a tendency that pruritic patients had a lower water content than the other subjects. In different body areas, there was a positive correlation in all groups between the clinical estimation of xerosis and hydration. Serum concentrations of parathyroid hormone (PTH) were significantly higher in dialysis patients with pruritus than in those without, but there was no correlation between the degree of symptoms and the PTH level. Indirect immunohistochemistry revealed no immunoreactivity for different parts of the PTH molecule in skin biopsies from uremic patients. Intradermal injections of PTH fragments did not evoke itching or other cutaneous reactions in patients or controls. Our results do not support PTH as a peripheral mediator of uremic itching. Flare reactions induced by intradermal histamine injections were significantly smaller in 26 dialysis patients (18 with pruritus) than in 9 healthy

  9. 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

  10. 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

  11. 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

  12. Content and timing of feedback and reflection: a multi-center qualitative study of experienced bedside teachers

    OpenAIRE

    Gonzalo, Jed D.; Heist, Brian S; Duffy, Briar L; Dyrbye, Liselotte; Fagan, Mark J; Ferenchick, Gary; Harrell, Heather; Hemmer, Paul A.; Kernan, Walter N.; Kogan, Jennifer R.; Rafferty, Colleen; Wong, Raymond; Elnicki, Michael D

    2014-01-01

    Background Competency-based medical education increasingly recognizes the importance of observation, feedback, and reflection for trainee development. Although bedside rounds provide opportunities for authentic workplace-based implementation of feedback and team-based reflection strategies, this relationship has not been well described. The authors sought to understand the content and timing of feedback and team-based reflection provided by bedside teachers in the context of patient-centered ...

  13. 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

  14. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

    OpenAIRE

    Prayle, A.P.; Hurley, M.N.; Smyth, Alan R

    2012-01-01

    Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...

  15. CLINICAL STUDY OF EARLY BREAST CARCINOMA

    Directory of Open Access Journals (Sweden)

    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

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

    OpenAIRE

    Andony, Louise Julia; Tay, Elaine; Allen, Karina L; Wade, Tracey D.; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia V W; Treasure, Janet; Schmidt, Ulrike H.; Fairburn, Christopher G.; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M.

    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...

  17. CLINICAL AND HISTOPATHOLOGICAL STUDY OF CUTANEOUS TUBERCULOSIS

    Directory of Open Access Journals (Sweden)

    Ashok S

    2014-09-01

    Full Text Available Extrapulmonary tuberculosis constitutes about 10% of all cases of tuberculosis, and cutaneous tuberculosis makes up only a small proportion of these cases. Despite prevention programs, tuberculosis is still progressing endemically in developing countries. Commonest clinical variant of cutaneous tuberculosis in our study was tuberculous verrucosa cutis (TBVC seen in 46.66% patients followed by Lupus vulgaris seen in 33.33% patients followed by scrofuloderma (13.33%, papulonecrotic tuberculide (6.66%. The commonest site of involvement was upper limbs seen in 46.66% patients followed by lower limb seen in 20% patients, face, neck, inguinal region, axilla, chest in 6.66% and generalized pappilary eruptions in 6.66% patients. Maximum percentage of patients (53.3% had duration of cutaneous tuberculosis between 1-3 years followed by 33.33% between 1-6 months, 6.66% had duration of cutaneous tuberculosis between 7-12 months, and rest 6.66% had duration between 4-6 years. The commonest histopathological feature in our study was tuberculoid granuloma with epithelioid and Langhans giant cells seen in 70% patients, hyperkeratosis was seen in 13.33% patients and AFB bacilli were seen in 6.66% patients.

  18. 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.

  19. [Clinical and histopathologic study of salivary mucoceles].

    Science.gov (United States)

    Kang, S K; Kim, K S

    1989-11-01

    Mucoceles are commonly occurring lesions of the oral mucous membrane and the most common lesion involving minor salivary tissue. The incidence of mucoceles is understandable since accessary salivary gland tissue is widely distributed throughout the oral mucous membrane and trauma to the mucosa, which causes their formation, occurs frequently. But only a few studies have been reported that describe its detailed features. This is a retrospective study on the salivary mucoceles in the oral mucous membrane and based on clinical chart, biopsy request and photomicroscopic finding of 112 patients treated by Dept. of Oral Surgery in Seoul National University Hospital, during the period of last 10 years. The results were as following. 1. The age range of the 112 patients was 2 to 60 years, with a peak incidence in the second decade and a gradual decline thereafter. Of the 112 patients, 49 (44%) were males and 63 (56%) were females, the male-to-female ratio being 1:1.29. 2. The majority of these lesions were located on the lower lip but occurred with lesser frequently on the buccal mucosa, floor of the mouth, tongue, retromolar region, upper lip. 3. Of the 112 patients, 107 (95%) were treated by excision and only 5 were treated by marsupialization. 18 of 112 cases had recurrence and the recurrence rate in this study was 16%. 4. Only 3 of the 112 cases revealed an epithelial lining. This incidence indicates that the mucus-extravasation by the damage of excretory duct rather than the ductal dilatation by mucus-retention may play a critical role in the production of these lesions. 5. In 81 cases (72.3%) minor salivary gland were included in the excision biopsy, specimen. Changes observed in the glandular tissue were atrophy and infiltration of chronic inflammatory cell, but the secretory function of gland was thought to be normal in most cases because the changes were mild. PMID:2489621

  20. Obstructive sleep apnea. Clinical and laboratory studies.

    Science.gov (United States)

    Paiva, T; Vasconcelos, P; Leitão, A N; Andrea, M

    1994-12-01

    Our study included 42 patients with obstructive sleep apnea (OSAS) confirmed by polysomnography. In these patients we investigated the clinical manifestations, the results of the laboratory examinations, including polysomnography, ORL observations and tests of pulmonary function, as well as the therapeutic results. Our patients presented a serious set of symptoms which included excessive daytime sleepiness, snoring, obesity, craniofacial abnormalities, systemic hypertension, cardiac arrhythmias, incapacity to work with precocious retirement, marital conflicts and high incidence of accidents, namely traffic accidents. An adequate treatment, mostly with nasal CPAP (continuous positive airway pressure), induced marked relief of the symptoms; some patients had an advantage in surgical treatment and weight reduction. OSAS is a frequent entity, affecting mostly male adults after the 5th decade. The lack of knowledge about this entity and the common social acceptance of some of its cardinal symptoms induces considerable delays in its diagnosis. The severity of the symptoms, the personal and social risks of excessive daytime sleepiness, the cardiocirculatory effects and the risk of sudden death during sleep justify an early diagnosis in order to prevent the severe evolution of the disease. Its complex physiopathology and multiple etiological factors justify a multidisciplinary approach. PMID:7653280

  1. 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)

  2. 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…

  3. CLINICAL STUDY OF FISTULA IN ANO

    Directory of Open Access Journals (Sweden)

    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.

  4. 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

  5. Ceftriaxone: in vitro studies and clinical evaluation.

    OpenAIRE

    Gnann, J. W.; Goetter, W E; Elliott, A M; Cobbs, C G

    1982-01-01

    The in vitro activity of ceftriaxone against 437 clinical isolates of gram-negative bacilli was determined. Ceftriaxone was found to have high in vitro activity against Enterobacteriaceae, with the exception of Enterobacter cloacae. Ceftriaxone was only minimally active against Pseudomonas aeruginosa and Acinetobacter calcoaceticus. We evaluated the clinical efficacy and toxicity of ceftriaxone in 55 adult patients. Bacterial infection was confirmed by the isolation of etiological bacteria in...

  6. A CLINICAL STUDY OF STROKE IN YOUNG

    Directory of Open Access Journals (Sweden)

    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

  7. [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. PMID:12085271

  8. [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.

  9. Clinical Presentation, Management and Outcome of Acute Coronary Syndrome in Yemen: Data from GULF RACE - 2 Registry

    OpenAIRE

    Al-Motarreb Ahmed; Al-Matry Abdulwahab; Al-Fakih Hesham; Wather Nawar

    2013-01-01

    Background: Acute Coronary Syndrome (ACS) is increasing in Yemen in recent years and there are no data available on its short and long-term outcome. We evaluated the clinical pictures, management, in-hospital, and long-term outcomes of the ACS patients in Yemen. Design and Setting: A 9-month prospective, multi-center study conducted in 26 hospitals from 9 governorates. The study included 30-day and 1-year mortality follow-up. Patients and Methods: One thousand seven hundred and sixty ...

  10. [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

  11. 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

  12. A clinical study of Noonan syndrome.

    OpenAIRE

    Sharland, M; Burch, M; McKenna, W M; Paton, M A

    1992-01-01

    Clinical details are presented on 151 individuals with Noonan syndrome (83 males and 68 females, mean age 12.6 years). Polyhydramnios complicated 33% of affected pregnancies. The commonest cardiac lesions were pulmonary stenosis (62%), and hypertrophic cardiomyopathy (20%), with a normal echocardiogram present in only 12.5% of all cases. Significant feeding difficulties during infancy were present in 76% of the group. Although the children were short (50% with a height less than 3rd centile),...

  13. 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.

  14. 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.

  15. 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

  16. 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.

  17. 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.

  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). PMID:24551370

  19. 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.

  20. Congenital myopathies: clinical and immunohistochemical study.

    Science.gov (United States)

    Thaha, Fazil; Gayathri, N; Nalini, A

    2011-01-01

    Congenital myopathies (CMs), a group of relatively non-progressive disorders presents with weakness and hypotonia of varying severity, morphologically recognized by specific structural abnormalities within the myofiber. This report presents the clinical and Histopathological features of 40 patients with CMs. Centronuclear myopathy was the commonest (40%) followed by congenital fiber type disproportion (37.5%). Other less common CMs included: myotubular myopathy (5%), nemaline myopathy (5%), central core disease (5%), multicore disease (2.5%) and congenital myopathy with tubular aggregate (5%). Immunolabeling to desmin corresponded to morphological changes within the myofibers while vimentin was negative in all the patients. There is no combined role of these proteins in the disease process. PMID:22234203

  1. Frontotemporal dementia; clinical-radiological study

    International Nuclear Information System (INIS)

    Frontotemporal dementia is the third most common degenerative condition (after Alzheimer Disease and Lewy Body Disease) of the brain. It occurs predominantly after the age of 40 and usually before the age of 65, with equal incidence in men and women. Unspecific behavioral symptoms often lead to misdiagnosis and FTD remains undetected. As in other degenerative dementias, there is no specific tissue marker; therefore, the diagnosis is established in vivo on the basis of clinical and radiological examinations. Structural and functional neuroimaging modalities are most useful in detection and differentiation of FTD as the findings are specific enough to be considered as criteria, based on which the diagnosis of this disorder can be established. (author)

  2. Data Management and Site-Visit Monitoring of the Multi-Center Registry in the Korean Neonatal Network

    OpenAIRE

    Choi, Chang Won; Park, Moon Sung

    2015-01-01

    The Korean Neonatal Network (KNN), a nationwide prospective registry of very-low-birth-weight (VLBW, < 1,500 g at birth) infants, was launched in April 2013. Data management (DM) and site-visit monitoring (SVM) were crucial in ensuring the quality of the data collected from 55 participating hospitals across the country on 116 clinical variables. We describe the processes and results of DM and SVM performed during the establishment stage of the registry. The DM procedure included automated pro...

  3. The clinical & neurophysiological study of leprosy

    OpenAIRE

    Cabalar, Murat; Yayla, Vildan; Ulutas, Samiye; Senadim, Songul; Oktar, Ayla Culha

    2014-01-01

    Objectives: The aim of this study was to evaluate neurological and neurophysiological features of leprosy. Methods: Seventy seven hospitalized leprosy patients (52 male, 25 female) were examined neurological and neurophysiologically between 2010 and 2012. Standard procedures were performed for evaluating sensory and motor conduction studies to all patients. Motor studies were carried out on median, ulnar, tibial and common peroneal nerves. Sensory studies were carried out on median, ulnar and...

  4. Oral mucocele: A clinical and histopathological study

    Directory of Open Access Journals (Sweden)

    Chandramani B More

    2014-01-01

    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.

  5. 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.

  6. An Overview of Clinical Studies on Fiber Post Systems

    Directory of Open Access Journals (Sweden)

    Idil Dikbas

    2013-01-01

    Full Text Available Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis.

  7. 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.

  8. 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...

  9. A Nation-Wide multicenter 10-year (1999-2008) retrospective clinical epidemiological study of female breast cancer in china

    International Nuclear Information System (INIS)

    According to the very limited cancer registry, incidence and mortality rates for female breast cancer in China are regarded to be increasing especially in the metropolitan areas. Representative data on the breast cancer profile of Chinese women and its time trend over years are relatively rare. The aims of the current study are to illustrate the breast cancer profile of Chinese women in time span and to explore the current treatment approaches to female breast cancer. This was a hospital-based nation-wide and multi-center retrospective study of female primary breast cancer cases. China was divided into 7 regions according to the geographic distribution; from each region, one tertiary hospital was selected. With the exception of January and February, one month was randomly selected to represent each year from year 1999 to 2008 at every hospital. All inpatient cases within the selected month were reviewed and related information was collected based on the designed case report form (CRF). The Cancer Hospital/Institute, Chinese Academy of Medical Sciences (CICAMS) was the leading hospital in this study. Four-thousand two-hundred and eleven cases were randomly selected from the total pool of 45,200 patients and were included in the analysis. The mean age at diagnosis was 48.7 years (s.d. = 10.5 yrs) and breast cancer peaked in age group 40-49 yrs (38.6%). The most common subtype was infiltrating ductal carcinoma (86.5%). Clinical stage I & II accounted for 60.6% of 4,211 patients. Three-thousand five-hundred and thirty-four cases had estrogen receptor (ER) and progestin receptor (PR) tests, among them, 47.9% were positive for both. Two-thousand eight-hundred and forty-nine cases had human epidermal growth factor receptor 2(HER-2) tests, 25.8% of them were HER-2 positive. Among all treatment options, surgery (96.9% (4,078/4,211)) was predominant, followed by chemotherapy (81.4% (3,428/4,211). Much less patients underwent radiotherapy (22.6% (952/4,211)) and endocrine

  10. The administration of music therapy training clinics: a descriptive study.

    Science.gov (United States)

    Abbott, Elaine A

    2006-01-01

    A two-part study was conducted to describe issues and administrative practices related to university and college affiliated music therapy training clinics. First, all 72 AMTA academic directors were surveyed in order to discover (a) which programs had a clinic, and (b) the reasons why other directors did not operate a clinic. Second, 12 survey respondents, who reported that they were involved with a training clinic, participated in in-depth interviews discussing: (a) their motivations for establishing a clinic, (b) the possible effects of a clinic on the community, (c) the individuals and groups involved in clinic operations, d) clinic space and equipment, (e) policy and procedure topics, (f) specific administrative practices related to clients and students, (g) finances, (h) research (i) quality assurance, (j) dual roles, and (k) liability issues. The administrative practices described by the interviewees varied greatly across clinics and provided a wealth of information that could be considered both useful and thought provoking for those interested in operating a music therapy clinic. PMID:16671838

  11. 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.

  12. CLINICAL STUDY OF ACUTE POISONING: A RETROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    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.

  13. 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

  14. Case Study: Learner Physiotherapists' Perceptions of Clinical Education.

    Science.gov (United States)

    Harris, Duncan; Naylor, Sandra

    1992-01-01

    Describes a study conducted in the United Kingdom to discover what processes learner physiotherapists experience in clinical education and whether their experience is comparable to that of other students in medical professions. The need for feedback is addressed, and the role of the clinical educator is discussed. A form for student assessment is…

  15. 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

  16. 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

  17. 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

  18. 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

  19. [Process of perversion. Methodological and clinical study].

    Science.gov (United States)

    Marchais, P

    1975-07-01

    Studies in classical psychiatry and psychoanalysis have reduced perversions to pathological phenomena, by lessening the moral criterion progressively. The applying of a comprehensive method of study of acquired perversions incites to consider various levels of observation. Henceforth properties common to each of these levels appears permitting thus to isolate a general process of perversion. This process, which keeps undeniable links with mental pathology, must however be differentiated, for it is not necessarily to be assimilated or reduced to the latter. Besides, it entails notable consequences on the social and cultural level. PMID:1233902

  20. Performance of the classification criteria for early rheumatoid arthritis in a multi-center cohort%早期类风湿关节炎分类标准的全国多中心临床验证

    Institute of Scientific and Technical Information of China (English)

    叶华; 苏茵; 李茹; 赵金霞; 刘湘源; 梅轶芳; 张志毅; 郭嘉隆; 毕黎琦

    2014-01-01

    目的 多中心验证并比较早期RA (ERA)分类标准与1987年ACR和2010年ACR/EULAR分类标准在病程≤1年的ERA诊断中的敏感性和特异性.方法 按照国际通用的标准验证方法,入选病程≤1年,年龄>18岁,至少有1个以上部位关节炎的患者,详细记录发病情况,包括关节肿胀部位、持续时间、对称性、晨僵时间、皮下结节以及伴随症状等,检测其血清中抗CCP抗体、RF、ESR以及CRP等指标,并记录关节影像学改变的特点,经2名风湿科专科医师进行临床诊断,未确诊的患者每3个,月随访1次,共随访1年.比较ERA标准和1987年ACR以及2010年ACR/EULAR标准在ERA分类诊断中的敏感性和特异性.组间比较采用X2检验,敏感性和特异性比较采用Mc Nemar检验,阳性预测值比较采用Score检验.结果 ①共入组患者271例,1年随访结束时确诊病例256例,其中RA 120例,非RA136例;未确诊病例15例.②ERA标准的敏感性(76.7%)略高于2010年标准(70.0%),差异无统计学意义(P=0.115);但2010年标准(70.0%)和ERA标准(76.7%)的敏感性均明显高于1987年标准(51.7%),差异有统计学意义(x2=11.524,P<0.01;x2=26.471,P<0.01).ERA标准、2010年标准和1987年标准的特异性相似,分别为83.8%、83.8%和86.8%.结论 ERA分类标准在ERA诊断中的敏感性稍高于2010年ACR/EULAR分类标准,明显高于1987年ACR分类标准;3个标准在ERA诊断中的特异性相当,但ERA标准更为简单实用,可用于ERA的临床诊断.%Objective To evaluate the classification criteria for early rheumatoid arthritis (ERA) in a multi-center cohort,and compare the specificity and sensitivity among ERA criteria,1987 ACR criteria and 2010 ACR/EULAR criteria.Methods Patients who had arthritic complaints with disease duration no more than 1 year,and age more than 18 years were enrolled.The clinical and laboratory parameters were recorded.The patients were diagnosed by 2 experienced rheumatologists based

  1. Melanocytic nevi in children: A clinical study

    Directory of Open Access Journals (Sweden)

    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.

  2. Obesity and periodontitis: A clinical study

    OpenAIRE

    Mathur, Lalit Kumar; Manohar, Balaji; Shankarapillai, Rajesh; Pandya, Dhara

    2011-01-01

    Background: The aim of the study was to evaluate the relationship between obesity and periodontitis. Materials and Methods: A total of 300 subjects aged 20 years and above suffering from generalized periodontitis were recruited from Department of Periodontics, Pacific Dental College and Hospital, Udaipur. Periodontal status of the subjects was recorded. Body mass index and waist circumference were used as measure to assess obesity. Other variables like age, gender, oral hygiene index were als...

  3. CLINICAL STUDY OF LABOUR IN TWIN PREGNANCY

    Directory of Open Access Journals (Sweden)

    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.

  4. 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

  5. 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.

  6. Ambiguous genitalia: a clinical and chromosomal study

    Directory of Open Access Journals (Sweden)

    V. Anantha Kumari

    2015-12-01

    Methods: The study is undertaken with forty cases with ages ranging from new borne to 20 yrs. Out of these 40 cases eight cases are below one year. In these cases physical examination is correlated with ultrasonography and chromosomal analysis. Results: In chromosomal analysis three persons out of forty cases were mosaics with 45, XO/46, twenty one cases who showed the chromosomal pattern as 46, XY mostly showed with no mullarian reminents. On examination palpable gonads were found in labio-scrotal sacs in seventeen cases. One of these cases was reared as girl found cytogenetically as 46, XY with the ultrasonographic impression as small uterus with no ovaries. Nineteen cases who with ambiguous genitalia showed the chromosomal pattern as 46, XX one out of these cases showed enlargement of the breast, and on examination of external genitalia found enlarged clitoris with labiamajora and minora. The child was brought up as male. Genitogram showed the absence of uterus. Conclusions: Chromosomal studies with ultrasonography can help in rearing a child male or female in young generation by surgical and Hormonal therapy. This prevents many problems in later life. This fact should be advertised openly in the public so that illiterate people should be alert. [Int J Res Med Sci 2015; 3(12.000: 3743-3748

  7. 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.

  8. 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

  9. 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....

  10. A Clinical Study of aluminium Phosphide Poisoning

    Directory of Open Access Journals (Sweden)

    S.K. Gupta,Annil Mahajan,Ajay Gupta

    2002-04-01

    Full Text Available Thc present prospectiYe study 01'56 cases ofAlwniniwn Phosphide (ALP poisoning in Gov!. MedicalCollcge Hospital Jammu. found out the prevalence of Deliberate self-poisoning self (DSP andaccidental ingestion in young population in age group of 16-30 years. Male-female ratio ",as 1.03: 1.00;ha' ing marital discord and family quarrels as prominent predisposing factors. The majority of patientshad gastrointestinal (GIT symptoms (73.2%, cardiac arrthymias (62.5% and shock (53.3%. Thccommoncst clectrocardiographic (ECG abnormalities were tachycardia (96%, atrial fibrillation(58% and venticular-ectopic (VE beats (59%. The management was supportive in the fonn ofstomach wash, intra"enous (IN fluids. dopamine, hydrocortisone, sodabicarbonate and assisted"entilation in intensiYe care unit (lCU setting

  11. 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

  12. 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.

  13. Hyperkeratosis of palms and soles : clinical study

    Directory of Open Access Journals (Sweden)

    Chopra A

    1997-01-01

    Full Text Available Typical lesions of hyperkeratosis of palms and soles do not create any problem but when slight variation is there it becomes difficult to diagnose and that changes the line of treatment. For that we have studied 300 fresh cases of hyperkeratosis of palms and soles which included 110 cases of hyperkeratotic eczema. 42 cases of hyperkeratotic tinea, 64 cases of psoriasis of palms and soles and 84 cases of pustulosis palmaris et plantaris (PPP. To reach the final diagnosis alongwith the detailed history, general physical examination and routine investigations, help was taken of special investigations like pus for culture and sensitivity, KOH smear examination of skin scrapings and nail cutting and culture on Sabouraud′s dextrose agar medium.

  14. Female Breast Cancer: Epidemiological And Clinical Study Of Some Risk Factors Among Egyptian Females- Multi Clinics Study

    OpenAIRE

    E. A. El-Moselhy; M. A. S. Ahmed*; A. M. Abdel-Fattah

    2005-01-01

    This study was conducted on 390 female breast cancer patients and an equal number of females as controls. The patients were attending some University and Teaching Hospitals in Cairo and Assuit. Ninety of them were newly operated. A retrospective, case-control, clinic based study was chosen to carry out this research. The aim of the study was to describe the sociodemographic, characteristics and clinical features of female breast cancer and to determine its risk factors among Egyptian women. A...

  15. 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.

  16. 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。

  17. The efficacy of 'Radio guided Occult Lesion Localization' (ROLL versus 'Wire-guided Localization' (WGL in breast conserving surgery for non-palpable breast cancer: A randomized clinical trial – ROLL study

    Directory of Open Access Journals (Sweden)

    Mali Willem PTHM

    2008-05-01

    Full Text Available Abstract Background With the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL is the standard of care in most countries. Radio guided occult lesion localization (ROLL is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care. The aim of this study is to compare the ROLL technique with the standard of care (WGL regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome. Methods/design The ROLL trial is a multi center randomized clinical trial. Over a period of 2–3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (discomfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure. The rationale, study design and planned analyses are described. Trial Registration (http://www.clinicaltrials.gov, study protocol number NCT00539474

  18. 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.......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....

  19. Comparative study of clinical pulmonary surfactants using atomic force microscopy

    OpenAIRE

    Zhang, Hong; Fan, Qihui; Wang, Yi E.; Neal, Charles R.; Zuo, Yi Y.

    2011-01-01

    Clinical pulmonary surfactant is routinely used to treat premature newborns with respiratory distress syndrome, and has shown great potential in alleviating a number of neonatal and adult respiratory diseases. Despite extensive study of chemical composition, surface activity, and clinical performance of various surfactant preparations, a direct comparison of surfactant films is still lacking. In this study, we use atomic force microscopy to characterize and compare four animal-derived clinica...

  20. Turning guidelines into clinical practice : Findings from an implementation study

    OpenAIRE

    Forsner, Tord

    2010-01-01

    Aim: The general aim of this thesis is to describe factors of importance when implementing clinical guidelines in psychiatry, and more specifically contribute to a better understanding of the implementation process. The specific aims are: Study I, to investigate a tailored implementation programme for implementing clinical guidelines for depression and suicidal patients, and to evaluate the compliance to guidelines after 6 months. In Study II, to further investigate complian...

  1. 多中心临床数据的快速检索系统%Efficient Multi-Center Clinical Data Retrieval System

    Institute of Scientific and Technical Information of China (English)

    王晔; 王崇; 王晓玲; 周傲英

    2010-01-01

    临床数据共享平台是我国医疗信息化发展的重要方向,在当今医疗数据呈几何级增长的环境下,多中心海量的临床数据如何管理、共享、并有效地查询和检索是一项重要的课题.该系统使用HL7 CDA XML作为描述电子病历的标准,采用关系型-XML混合数据库提供索引和XQuery查询工具.同时为了提高查询效率和并发性能,使用了BerkeleyDB作为Key-Value存储的数据层,并架设了Memcached作为查询数据的缓存层,增强了整体系统的可用性,最终形成了一个标准、通用、高效的临床数据共享平台.

  2. A clinical study of psoriatic arthropathy

    Directory of Open Access Journals (Sweden)

    Prasad PVS

    2007-01-01

    Full Text Available Background: The incidence of uncomplicated psoriasis is 1-3% in the general population. Arthritis is found in increased frequency in psoriatic patients and its incidence is estimated to be 5-7%. Aim: To assess the prevalence of arthritis in psoriatic patients. Methods: Four hundred and seventy-two psoriatic patients were enrolled in the study out of which 40 patients had (psoriatic arthropathy (PsA. Severity of psoriasis was assessed by the psoriasis area and severity index (PASI. Routine blood investigations were carried out along with radiological investigations. Results: Forty percent of the 40 PsA patients were in the age group of 51-60 years. Seven patients out of the 40 (17.5% psoriatic arthropathic (PsA patients had a family history of psoriasis. Nail involvement was observed in 37 cases (92.5%. Rheumatoid factor was present in five out of the 40 (12.5% PsA patients. Serum uric acid levels were above normal in eighteen out of the 40 (45% PsA patients. Asymmetric oligoarthropathy was the most commonly observed feature in 42.5% of the 40 PsA patients. Narrowing of joint spaces and erosions were observed in 62.5% and 45% of the 40 PsA patients. Conclusion: There is an association between the duration of skin lesions and duration of arthropathy. Similarly the PASI score is also directly related with arthropathy.

  3. 无缝气瓶多心凹底底型的设计%Design of Multi-center Concave Bottom for Seamless Cylinder

    Institute of Scientific and Technical Information of China (English)

    由宏新; 李灿; 招聪; 戴行涛; 韩冰; 胡军

    2015-01-01

    针对管制无缝气瓶凹底的设计,传统的三心凹底底型在过渡段外表面轮廓线是直线,球壳部分是等厚的球壳。将过渡段原来的直线过渡改为内外两个圆弧过渡,球壳部分设计为厚度变化的球壳,设计出多心凹底底型;运用正交设计方法,定义与设计了多心凹底底型的设计参数;用有限元分析确定各个参数对多圆心凹底底型应力的影响。结果表明,多心凹底气瓶的应力集中程度可以大幅度降低,最低应力集中系数接近于1.1,这对多心凹底气瓶底型设计和加工具有一定的参考价值。%The concave bottom of seamless cylinders has been designed for gas cylinder made from seam-less steel pipe.The contour line of outer surface is a straight line,and the thickness of spherical shell is uniform in traditional three-center geometry design for bottom end-plates of gas cylinders.In this research, a new multi-center concave bottom of gas cylinder was designed by changing the internal and external pro-file of transition section into two arcs with different centers, and using unequal thickness of spherical shell.The design parameters and relationship of the parameters about new bottom were determined by the orthogonal design method.The effects of various parameters on the multi-center concave bottom were ana-lyzed by the finite element method.The results, which are based on finite element analysis of different structure,show that the stress concentration of new bottom can be greatly reduced,and the minimum stress concentration factor is even closed to 1 .1 .It is valuable for designing and manufacturing the new type of concave bottom.

  4. 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. PMID:27332171

  5. 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

  6. Clinical implication of thiopurine methyltransferase polymorphism in children with acute lymphoblastic leukemia: A preliminary Egyptian study

    Directory of Open Access Journals (Sweden)

    Farida H El-Rashedy

    2015-01-01

    Full Text Available Background: 6-mercaptopurine (6-MP is an essential component of pediatric acute lymphoblastic leukemia (ALL maintenance therapy. Individual variability in this drug-related toxicity could be attributed in part to genetic polymorphism thiopurine methyltransferase (TPMT. Aim: To investigate the frequency of common TPMT polymorphisms in a cohort of Egyptian children with ALL and the possible relation between these polymorphisms and 6-MP with short-term complications. Materials and Methods: This study included 25 children. Data related to 6-MP toxicity during the maintenance phase were collected from the patients′ files. DNA was isolated and genotyping for TPMT G460A, and A719G mutations were performed by polymerase chain reaction-restriction fragment length polymorphism. Results: Twenty (80% of the included 25 patients had a polymorphic TPMT allele. TPMTFNx013A was the most frequent (14/25, 56%, 8 patients were homozygous and 6 were heterozygous. TPMTFNx013C mutant allele was found in 4 patients (16% in the heterozygous state while 2 patients (8% were found to be heterozygous for TPMTFNx013B mutant allele. TPMT mutant patients, especially homozygous, were at greater risk of 6-MP hematological toxicity without significant difference regarding hepatic toxicity. Conclusions: TPMT polymorphism was common among the studied group and was associated with increased risk of drug toxicity. A population-based multi-center study is required to confirm our results.

  7. Multi-center reproducibility of neurochemical profiles in the human brain at 70.167emT

    NARCIS (Netherlands)

    Bank, B.L. van de; Emir, U.E.; Boer, V.O.; Asten, J.J.A. van; Maas, M.C.; Wijnen, J.P.; Kan, H.E.; Oz, G.; Klomp, D.W.J.; Scheenen, T.W.J.

    2015-01-01

    The purpose of this work was to harmonize data acquisition and post-processing of single voxel proton MRS ((1) H-MRS) at 7nT, and to determine metabolite concentrations and the accuracy and reproducibility of metabolite levels in the adult human brain. This study was performed in compliance with loc

  8. The Development of the Multi-Center Traffic Management Advisor (MCTMA): Traffic Flow Management Research in a Multi-Facility Environment

    Science.gov (United States)

    Lee, Katharine K.; Davis, Thomas J.; Levin, Kerry M.; Rowe, Dennis W.

    2001-01-01

    The Traffic Management Advisor (TMA) is a decision-support tool for traffic managers and air traffic controllers that provides traffic flow visualization and other flow management tools. TMA creates an efficiently sequenced and safely spaced schedule for arrival traffic that meets but does not exceed specified airspace system constraints. TMA is being deployed at selected facilities throughout the National Airspace System in the US as part of the FAA's Free Flight Phase 1 program. TMA development and testing, and its current deployment, focuses on managing the arrival capacity for single major airports within single terminal areas and single en route centers. The next phase of development for this technology is the expansion of the TMA capability to complex facilities in which a terminal area or airport is fed by multiple en route centers, thus creating a multicenter TMA functionality. The focus of the multi-center TMA (McTMA) development is on the busy facilities in the Northeast comdor of the US. This paper describes the planning and development of McTMA and the challenges associated with adapting a successful traffic flow management tool for a very complex airspace.

  9. Clinical And Mycological Study Of Superficial Mycoses In Amritsar

    OpenAIRE

    Aggarwal Aruna; Arora Usha; Khanna Saroj

    2002-01-01

    A clinical and mycological study of 500 cases of superficial mycoses was conducted. Two hundred fifty two samples from various sites, viz., skin, nail and hair were positive on culture. The most prevalent clinical type was tinea corporis (36.2%) and the most prevalent aetiological agent was Trichophyton rubrum (62.3%). Nondermatophytic filamentous fungi and candida species were also isolated in 17 (6.74%) cases. It was concluded that along with dermatophytes, nondermatoph...

  10. 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.

  11. Preclinical and clinical safety studies on DNA vaccines.

    OpenAIRE

    Schalk, Johanna A C; Mooi, Frits R.; Berbers, Guy A M; Aerts, Leon A G J M van; Ovelgönne, Hans; Kimman, Tjeerd G.

    2007-01-01

    DNA vaccines are based on the transfer of genetic material, encoding an antigen, to the cells of the vaccine recipient. Despite high expectations of DNA vaccines as a result of promising preclinical data their clinical utility remains unproven. However, much data is gathered in preclinical and clinical studies about the safety of DNA vaccines. Here we review current knowledge about the safety of DNA vaccines. Safety concerns of DNA vaccines relate to genetic, immunologic, toxic, and environme...

  12. 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.

  13. Acute radiation proctitis. A clinical, histopathological and histochemical study

    International Nuclear Information System (INIS)

    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

  14. 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

  15. The Role and Interpretation of Pilot Studies in Clinical Research

    OpenAIRE

    Leon, Andrew C.; Davis, Lori L.; Kraemer, Helena C.

    2010-01-01

    Pilot studies represent a fundamental phase of the research process. The purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to be used in a larger scale study. The roles and limitations of pilot studies are described here using a clinical trial as an example. A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and implementation of the novel intervention.

  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. 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.

  18. 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.

  19. 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

  20. Preclinical studies of sex differences: a clinical perspective

    OpenAIRE

    Voskuhl, Rhonda

    2016-01-01

    The new policy from the National Institutes of Health to encourage grant applicants to consider studying both females and males in preclinical biological experiments has been met with support and opposition. Here, we will discuss implications of preclinical studies of sex differences on clinical research.

  1. Can estrogen keep you smart? Evidence from clinical studies.

    OpenAIRE

    Sherwin, B B

    1999-01-01

    OBJECTIVE: To review and critically analyze the biological plausibility of and the clinical empirical evidence concerning a link between estrogen levels and memory in women. DATA SOURCES: MEDLINE search of the literature published from 1980 to 1998. Studies published between 1952 and 1980 that were known to the author were also included. STUDY SELECTION: Sixteen prospective, placebo-controlled studies in humans. DATA SYNTHESIS: Most of the studies that used neuropsychological tests with known...

  2. Clinical skills development in student-run free clinic volunteers: a multi-trait, multi-measure study

    OpenAIRE

    Nakamura, Mio; Altshuler, David; Binienda, Juliann

    2014-01-01

    Background At Wayne State University School of Medicine (WSU SOM), the Robert R. Frank Student Run Free Clinic (SRFC) is one place preclinical students can gain clinical experience. There have been no published studies to date measuring the impact of student-run free clinic (SRFC) volunteerism on clinical skills development in preclinical medical students. Methods Surveys were given to first year medical students at WSU SOM at the beginning and end of Year 1 to assess perception of clinical s...

  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. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic.

    Science.gov (United States)

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-03-01

    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. PMID:26938553

  5. 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.

  6. Study designs in dermatology: A review for the clinical dermatologist.

    Science.gov (United States)

    Silverberg, Jonathan I

    2015-11-01

    A working knowledge of common research study designs and their advantages and disadvantages is necessary for critical reading of the literature by clinicians. However, understanding study designs and related statistical methodologies may be perceived as being complex and difficult to execute. This review aims to provide a practical foundation for basic study designs and to help physicians identify pitfalls that commonly occur in clinical studies and their level of evidence. Topics covered include the pros and cons of observational versus prospectively controlled studies, case-control, cohort, randomized controlled studies, adaptive controlled trials and metaanalyses, and the role of matching in studies. PMID:26475532

  7. Multinational observational study on clinical practices and therapeutic management of mineral and bone disorders in patients with chronic kidney disease stages 4, 5, and 5D: The OCEANOS study

    Directory of Open Access Journals (Sweden)

    Faissal A. M. Shaheen

    2016-01-01

    Full Text Available Our aim is to assess the current clinical practices in monitoring and treatment patterns of chronic kidney disease (CKD-mineral bone disorder and the degree to which these practices met the kidney disease improving global outcome (KDIGO guidelines. This was an international, multi-center, cross-sectional, observational study in adult patients diagnosed with CKD Stages 4, 5, and 5D. Patients were enrolled from Middle East, South Asia, Eurasia, and Africa; patients with estimated glomerular filtration rate ≥30 mL/min/1.73 m 2 or with any medical/surgical conditions precluding their participation were excluded. Frequency of measurements, levels of serum calcium (Ca, phosphorus and parathormone (parathyroid hormone [PTH], and presence vascular/valvular calcification were recorded. Of the 2250 patients enrolled, data on 2247 patients were evaluated. Overall, only a small percentage of patients met all three target KDIGO ranges of serum Ca, phosphorus, and PTH (13.7% [95% confidence interval: 12.0; 15.4], with a higher proportion among CKD Stage 5D patients (14.8% than CKD Stage 4 and 5 (5.6% patients. Majority (84.3% of the patients received treatment with phosphorous binders, of whom 85.5% received Ca-based phosphate binders. Overall, 57.0% of patients received Vitamin D treatment with a similar frequency among patients with CKD Stages 4, 5, and 5D. Over half (65.7% of the patients were screened for vascular/valvular calcification; of these, 58.8% had ≥1 calcification. Diabetes status, P, PTH, and low density lipoprotein-cholesterol had significant impact on the prescription pattern of phosphorous binders. The current practices for the management of bone and mineral metabolism in CKD patients in the study region fall far short of meeting the KDIGO target range.

  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. A qualitative study of constructive clinical learning experiences.

    Science.gov (United States)

    van der Hem-Stokroos, H H; Daelmans, H E M; van der Vleuten, C P M; Haarman, H J Th M; Scherpbier, A J J A

    2003-03-01

    Little is known about the effectiveness of clinical education. A more educational structure is considered to be potentially beneficial. The following structured components were added to a surgical clerkship: logbooks, an observed student-patient encounter, individual appraisals, feedback on patient notes, and (case) presentations by students. The authors organized two focus-group sessions in which 19 students participated to explore their perceptions about effective clinical learning experiences and the newly introduced structured components. The analysis of the transcripts showed that observation and constructive feedback are key features of clinical training. The structured activities were appreciated and the results show the direction to be taken for further improvement. Learning experiences depended vastly on individual clinicians' educational qualities. Students experienced being on call, assisting in theatre and time for self-study as instructive elements. Recommended clerkship components are: active involvement of students, direct observation, selection of teachers, a positive learning environment and time for self-study. PMID:12745517

  10. A clinical study of skin changes in pregnancy

    OpenAIRE

    Kumari Rashmi; Jaisankar T; Thappa Devinder

    2007-01-01

    Background: During pregnancy profound immunologic, metabolic, endocrine and vascular changes occur, that are responsible for the changes of the skin and its appendages, both physiologic and pathologic. Aims: We undertook a clinical study to find out the frequency and pattern of skin changes in pregnant women. Methods: All consecutive pregnant women were included in the study. Results: A total of 607 pregnant women were included in this study. Of these, 303(49.9%) pregnant women ...

  11. CLINICAL COMPARATIVE STUDY OF SUMATRIPTAN VERSUS ERGOTAMINE THERAPY IN MIGRAINE

    OpenAIRE

    Giriraja; Pavitra,; Bindumathi

    2015-01-01

    BACKGROUND Migraine is a common neurological problem accounting for large morbidity and disability. Ergotamine and triptans are mainly used to terminate the attack of severe migraine. To study the clinical comparison between sumatriptan and ergotamine in migraine patients. AIM This study compared the safety efficacy and pharmacoeconomics of triptans verses ergotamine therapy. MATERIALS AND METHODS Study sample included 100 patients of either gender aged 1...

  12. CORRELATION OF CLINICAL AND LABORATORY ASPIRIN RESISTANCE: A PILOT STUDY

    Directory of Open Access Journals (Sweden)

    PRASHANT C K,SUDHA,MURALIDHAR, LAXMINARAYANA,ANNAMMA KURIEN,ASHWIN KAMATH

    2013-09-01

    Full Text Available Aspirin resistance may be biochemical or clinical. Data related to the presence of aspirinresistance in the Indian population is scarce. We conducted a cross sectional study toaddress the issue of clinical aspirin non responsiveness and to assess the associationbetween inhibition of platelet aggregation, clinical risk factors and occurrence of vascularevents. We studied platelet aggregation by optical aggregometry in 20 patients on aspirin.No patient was found to be aspirin-resistant on the basis of previously defined criteria.This led us to relook at the current cut offs for resistance, and an analysis of 60 normalpatients showed lower cut off values suggesting ethnic variability. The data wasreanalyzed using these cutoffs. An association between poor clinical aspirin response,older age, male sex, smoking and dyslipidemia was found, suggesting a trend, though notsignificant. 25% of patients had vascular events on aspirin suggesting clinical aspirinresistance. A lower cut off value for aspirin resistance in normal Indians may be neededto detect true prevalence of this entity. In patients with multiple atherothrombotic riskfactors lab detection of resistance may be useful in identifying patients with high risk forrecurrent vascular events. This may help to modify antiplatelet therapy to preventvascular events.

  13. 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. PMID:25707959

  14. 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

  15. Clinical Teaching by Video-Enhanced Study Club Discussion Sessions.

    Science.gov (United States)

    Roberts, Douglass B.; And Others

    1988-01-01

    The Loma Linda University School of Dentistry's "study club" method of teaching operative dentistry involves a four-hour clinical operating session and an hour-long discussion immediately following. Videotape recordings of the operative procedures are used successfully in the discussion period to enhance observation and recall. (MSE)

  16. CLINICAL STUDY OF HYPERTENSIVE EMERGENCIES IN RURAL HOSPITAL

    Directory of Open Access Journals (Sweden)

    Srinivas

    2014-05-01

    Full Text Available BACKGROUND AND OBJECTIVES: The clinical profile of patients with hypertensive emergencies presenting to rural hospitals in a developing country like ours is unknown. The objective of the present study was to evaluate the modes of presentations, clinical profile and spectrum of target organ damage in patients with hypertensive emergencies. METHOD: This observational study was done at SRI ADICHUNCHANGIRI INSTITUTE OF MEDICAL SCIENCES AND REASEARCH CENTER over a period of one and a half years. The study population included patients admitted to this hospital with severely elevated blood pressure with clinical or laboratory evidence of acute target organ damage. The clinical and laboratory profile of 50 patients were evaluated. RESULTS: Males had higher chances of developing a hypertensive emergency compared to females, male: female ratio 2.57:1. The commonest presenting symptoms were neurological deficit (50%, dyspnea (30%, followed by chest pain (24%. Majority of the patients were known hypertensive (70%. Higher levels of blood pressure at presentation were associated with an adverse outcome. Laboratory abnormalities noticed in these patients included hyponatremia and hyperkalemia. Acute intracerebral hemorrhage was the commonest mode of target organ damage. An in hospital mortality of 24% was observed in the present study.

  17. 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

  18. The UK clinical aptitude test and clinical course performance at Nottingham: a prospective cohort study

    OpenAIRE

    Yates, Janet; James, David

    2013-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham un...

  19. Clinical And Mycological Study Of Superficial Mycoses In Amritsar

    Directory of Open Access Journals (Sweden)

    Aggarwal Aruna

    2002-01-01

    Full Text Available A clinical and mycological study of 500 cases of superficial mycoses was conducted. Two hundred fifty two samples from various sites, viz., skin, nail and hair were positive on culture. The most prevalent clinical type was tinea corporis (36.2% and the most prevalent aetiological agent was Trichophyton rubrum (62.3%. Nondermatophytic filamentous fungi and candida species were also isolated in 17 (6.74% cases. It was concluded that along with dermatophytes, nondermatophytic fungi are also emerging as important causes of superficial mycoses.

  20. CLINICAL EFFICACY OF THE DRUG STRUCTUM IN OSTEOARTHRITIS THERAPY (results of multicenlral clinical study in Russia

    Directory of Open Access Journals (Sweden)

    V A Nassonova

    2001-01-01

    Full Text Available Objective. Study of the efficacy and tolerability of Structum in pts with gonarthritis and coxarthritis during 6 months therapy. Material. Open multicentral study included off -patients of both sexes with osteoarthritis (ОЛ of knee and hip joints with obvious pain syndrome - pain in walking 30 mm and more on visual analog scale, functional Lesquene index more or equal to 4 and less or equal toll, regular NSAIDs taking for 30 days for the last 3 months, radiological I-II-III OA stage according Kellgren-Lawrence and consent of the patient for the study. Total number of pts included was 555 and 192 out of them were experimental group and 363 - controls. Pts from experimental group had Structum - three capsules in the morning and 3 capsules in the evening during meals (one capsule - 250 mg for 3 weeks, then 2 capsules in the morning and 2 in the evening for 21 weeks. Clinical examination of pts was done after the third and sixth month of the treatment. Results. During Structum therapy reliable lessening of pain syndrome in knee and hip joints, improvement of articular function, decrease of NSAIDs dosage or their full cancellation were demonstrated. It was noticed that the assessment of clinical Structum efficacy and tolerability bu physician and patient coincided. Conclusion. Structum (chondroitin sulfate is a new effective drug for treatment of osteoarthritis of knee and hip joints with high clinical efficacy and good tolerability

  1. Actual issues of clinical radiobiology and their experimental study

    International Nuclear Information System (INIS)

    Information being collector for some tens years in frame of clinical study of radiation effects in man in broad range of dose and exposure variant has been summarised and systematized. It has been formulated the questions which could be answered under only clinical observation with many difficulties: diagnostical and prognostical criteria for evaluation of therapy efficiency in non-bonemarrow syndrome of acute radiation disease choice and confirmaty of methods of bonemarrow syndrome therapy in overlethal range of dose; improving of preclinical examination of means and methods of acute radiation syndrome prophylaxis and treatment; comparative analysis of the role of various radiation factory in development of oncological and severe somatic disease and possibility of these effects modification. Some limitations in extrapolation of experimental data onto clinical practice has been discussed and optimal forms of cooperation are shown

  2. Musculoskeletal demands on flamenco dancers: a clinical and biomechanical study.

    Science.gov (United States)

    Bejjani, F J; Halpern, N; Pio, A; Dominguez, R; Voloshin, A; Frankel, V H

    1988-04-01

    The flamenco dancer acts on the floor like a drummer. The percussive footwork and vibration patterns created during dancing impose unusual demands on the musculoskeletal system. This study investigated the clinical and biomechanical aspects of this task. Using the electrodynogram and skin-mounted accelerometers, foot pressures as well as hip and knee vibrations were recorded in 10 female dancers after a thorough clinical evaluation. A health questionnaire was also distributed to 29 dancers. Foot pressures and acceleration data reveal the percussive nature of the dance. Some clinical findings, like calluses, are related to pressure distribution. Urogenital disorders, as well as back and neck pain, may be related to the vibrations generated by the flamenco dance form. The hip joint seems to absorb most of the impacts. "Vibration-pressure" diagrams are suggested as a useful tool for evaluating a dancer's biomechanical behavior, as well as the effect of floors and footwear on this behavior. PMID:3366430

  3. 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

  4. Exploring Factors Affecting Undergraduate Medical Students' Study Strategies in the Clinical Years: A Qualitative Study

    Science.gov (United States)

    Al Kadri, Hanan M. F.; Al-Moamary, Mohamed S.; Elzubair, Margaret; Magzoub, Mohi Eldien; AlMutairi, Abdulrahman; Roberts, Christopher; van der Vleuten, Cees

    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 Sciences, College of Medicine, Riyadh, Saudi…

  5. TCM Clinical Passage Study on Children Sexual Precocity%小儿性早熟的中医临床路径研究

    Institute of Scientific and Technical Information of China (English)

    陈梅; 陶敏; 董勤; 丛丽; 黄丽先

    2013-01-01

    Objective] To study TCM clinical passage of children sexual pecocity. [Method] Take multi-center and big sample clinical research, and inte-grated differentiation and treatment based on sign identification, make discussion on diagnosis and treatment of children sexual precocity. [Result] There're 50 cases in al , they take TCM decoctions for treatment, the clinical control rate is 68.00%, the improvement rate 20.00%, the course satisfying degree 88.00%, effect satisfying degree 86.00%, acceptance degree 98.00%, the diagnosis and treatment service satisfying degree 98.00%, the aspects above al get parents' affirmation. [Conclusion] TCM treating children sexual precocity is available and operationable.%  [目的]研究小儿性早熟的中医临床路径。[方法]采用多中心、大样本临床研究方法,采用整体辨证和论证施治的方法,以中药汤剂为治疗手段,对小儿性早熟的诊疗方案进行探讨。[结果]本分中心共收集病例50例,均采用中药汤剂治疗,临床控制率为68.00%,好转率为20.00%,未愈率为12.00%;治疗总费用为日均24.78元;在治疗费用满意度(80.00%)、治疗疗程满意度(88.00%)、治疗效果满意度(86.00%)、接受程度(98.00%)、诊疗服务满意度(98.00%)等方面调查均获得患者家长肯定。[结论]中药治疗小儿性早熟具有可行性和可操作性。

  6. PHARMACEUTICAL AND CLINICAL STUDIES ON COMPOUND AYURVEDIC FORMULATION, SARASWATA CHURNA

    OpenAIRE

    Tiwari Radheyshyam; Reddy K.R.C; Gupta Sanjay; Tripathi J.S.

    2011-01-01

    Saraswata Churna is a unique combination of Ayurvedic herbal drugs, containing mainly Medhya Rasayana drugs, like Vacha, Shankhpushpi, Aswagandha, Bramhi, etc. For the first time Saraswata churna is mentioned in Bhavaprakash Unmadadhikar and formula given in the same, selected for present study. The drug is prepared in the Ayurvedic Pharmacy, Institute of Medical Sciences, Banaras Hindu University and was selected for the management of Geriatric Depression. In the clinical study a series of 5...

  7. Clinical profile of forefoot eczema: A study of 42 cases

    OpenAIRE

    Brar Kamal; Shenoi S; Balachandran C; Mehta Vandana

    2005-01-01

    BACKGROUND : Forefoot eczema (FE) is characterized by dry fissured dermatitis of the plantar surface of the feet. AIM : To study the clinical profile of FE and the possible etiological factors. METHODS : Forty-two patients with FE were included in the study. A detailed history was recorded and examination done. Fungal scrapings and patch test with Indian Standard Series (ISS) were performed in all patients. RESULTS : The most common site affected was the plantar surface of the great toe in...

  8. Self-reported dietary intake of youth with recent onset of type 2 diabetes: Results from the TODAY study

    OpenAIRE

    Delahanty, Linda; Kriska, Andrea; Edelstein, Sharon; Amodei, Nancy; Chadwick, Jennifer; Copeland, Kenneth; Galvin, Bryan; El ghormli, Laure; Haymond, Morey; Kelsey, Megan; Lassiter, Chad; Milaszewski, Kerry; Syme, Amy; Mayer-Davis, Elizabeth

    2013-01-01

    Despite the widely recognized importance of diet in managing diabetes, few studies have documented usual dietary intake in youth with type 2 diabetes (T2D). The objectives of this study were to assess dietary intake among a large, ethnically diverse cohort of youth with T2D and compare intake to current recommendations. Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) is a multi-center randomized clinical trial of 699 youth aged 10-17. At baseline, following a run-in per...

  9. 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; Toner, Mehmet; Warren, H. Shaw; Schoenfeld, David A.; Rahme, Laurence; McDonald-Smith, Grace P.; Hayden, Douglas; Mason, Philip; Fagan, Shawn; Yu, Yong-Ming; Cobb, J. Perren; Remick, Daniel G.; Mannick, John A.; Lederer, James A.; Gamelli, Richard L.; Silver, Geoffrey M.; West, Michael A.; Shapiro, Michael B.; Smith, Richard; Camp, David G.; Qian, Weijun; Tibshirani, Rob; Lowry, Stephen; Calvano, Steven; Chaudry, Irshad; Cohen, Mitchell; Moore, Ernest E.; Johnson, Jeffrey; Baker, Henry V.; Efron, Philip A.; Balis, Ulysses G. J.; Billiar, Timothy R.; Ochoa, Juan B.; Sperry, Jason L.; Miller-Graziano, Carol L.; De, Asit K.; Bankey, Paul E.; Herndon, David N.; Finnerty, Celeste C.; Jeschke, Marc G.; Minei, Joseph P.; Arnoldo, Brett D.; Hunt, John L.; Horton, Jureta; Cobb, J. Perren; Brownstein, Bernard; Freeman, Bradley; Nathens, Avery B.; Cuschieri, Joseph; Gibran, Nicole; Klein, Matthew; O'Keefe, Grant

    2011-01-01

    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. PMID:21317363

  10. 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.

  11. 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.

  12. 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

  13. Clinical, radiological and imunogenectical study in patients with Reiter's Syndrome

    International Nuclear Information System (INIS)

    This study puspose was to investigate the clinical, radiological and immunogenetical parameters from a brazilian Reiter's Syndrome population. Twenty Reiter's Syndrome patients from ''Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo'' were prospectivelly studied in their demographical (sex, race, age at study, age at disease onset and disease duration), epidemiological (family history), clinical (general, articular, mucocutaneous, genitourinary, ocular and intestinal manifestations besides functional capacity at study), radiological (sacro-iliitis, spondylitis and calcaneal spur) and immunogenetical (HLA loci A, B and DR typing). The technique employed in the 61 aloantigens from loci HLA A (17), B (34) and DR (10) typing was Terasaki microlymphocitotoxicity modified by Danilovs, had being performed in the ''Laboratorio de Imunogenetica da Faculdade de Medicina da Universidade de Sao Paulo''. We concluded that the clinical, radiological and immunogenetical Reiter's Syndrome expression in the brazilian population is similar to the others north american or european already studied populations and that the probability of one brazilian HLA B27 positie individual to develop Reiter's Syndrome is 19 fold larger when compared to one brazilian HLA B27 negative individual. (author)

  14. 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.

  15. Clinical Utility of Combinatorial Pharmacogenomics-Guided Antidepressant Therapy: Evidence from Three Clinical Studies.

    Science.gov (United States)

    Altar, C Anthony; Carhart, Joseph; Allen, Josiah D; Hall-Flavin, Daniel; Winner, Joel; Dechairo, Bryan

    2015-10-01

    DNA of 258 patients with treatment-resistant depression was collected in three 8-10 week, two-arm, prospective clinical trials. Forty-four allelic variations were measured in genes for the cytochrome P450 (CYP) enzymes CYP2D6, CYPC19, and CYP1A2, the serotonin transporter (SLC6A4), and the 5-HT2A receptor (HTR2A). The combinatorial pharmacogenomic (CPGx™) GeneSight test results were provided to clinicians to support medication changes from baseline (guided arm), or they were provided at the end of each study to clinicians of unguided patients who were treated as usual (TAU). TAU subjects who at baseline were prescribed medications genetically discordant for them showed only a 12% symptom improvement, far less than the 32.5% or 28.5% improvements of the TAU subjects on yellow-category ('use with caution'; p = 0.002) or green-category medications ('use as recommended'; p = 0.02), respectively. The odds of a clinical response were increased 2.3-fold among all GeneSight-guided compared to all TAU subjects (p = 0.004), and overall, the guided group had a 53% greater improvement in depressive symptoms (p = 0.0002), a 1.7-fold relative improvement in response (p = 0.01), and a number needed to treat for one clinical response above that seen in the TAU group of 6.07. PMID:27606312

  16. Tinea Capitis In Assuit Governorate (A Clinical and Mycological Study

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    Amer Abu El ­ Enin *, Mohamed Khedr** and Alaa Abu El-Ata

    2007-12-01

    Full Text Available Tinea capitis is a common condition seen by clinician in all setting through out the world. Several investigations of the various superficial mycosewere carried out in Egypt, but they were mainly confined to urban areas. In the present work, the predominant species causing dermatophtosis in Assuit Governorate were investigated, this is represented in rural and partially suburban communities. A clinical and mycological study was done for hundred patients attending the Dermatology Out-patient Clinic in Al- Azhar University Hospital in Assuit City. The ages of patient ranged from 3 to 20 years . 60% of cases were between 6-10 years of ages. Males were affected more than females in a ratio of 3: 1 60% of cases were from rural areas. Positive history of contact with animals was present in 40%. The most common clinical variety was scaly type 55% followed by black dot 22%, kerion 20%, and lastly favus 3%. Direct microscopic examination was + ve in 80% of cases. Positive culture results were obtained in 90% of cases. The results indicated that Zoophilic dermatophytes was the predominant causative species in these regions. Five dermatophytes were identified namely: M.canis was the most frequently isolated organism from the clinical varieties of dermatophytosis (55% . followed by T. violaceum (20%. T. rubrum 12.8% , M. gypseum (10% and lastly T.soudanense (2.2%.

  17. Digital breast tomosynthesis versus digital mammography: a clinical performance study

    Energy Technology Data Exchange (ETDEWEB)

    Gennaro, Gisella; Baldan, Enrica; Bezzon, Elisabetta; Polico, Ilaria; Proietti, Alessandro; Toffoli, Aida [Venetian Oncological Institute (IOV), IRCCS, Department of Radiology, Padua (Italy); Toledano, Alicia [Statistics Collaborative Inc., Washington, DC (United States); Di Maggio, Cosimo [Padua University, Department of Oncological and Surgical Sciences, Padua (Italy); La Grassa, Manuela [Aviano Oncological Reference Center (CRO), IRCCS, Department of Radiology, Aviano (Pordenone) (Italy); Pescarini, Luigi [Venetian Oncological Institute (IOV), IRCCS, Department of Radiology, Padua (Italy); Padua University, Department of Oncological and Surgical Sciences, Padua (Italy); Muzzio, Pier Carlo [Venetian Oncological Institute (IOV), IRCCS, Department of Radiology, Padua (Italy); Padua University, Department of Medical Diagnostic Sciences, Padua (Italy)

    2010-07-15

    To compare the clinical performance of digital breast tomosynthesis (DBT) with that of full-field digital mammography (FFDM) in a diagnostic population. The study enrolled 200 consenting women who had at least one breast lesion discovered by mammography and/or ultrasound classified as doubtful or suspicious or probably malignant. They underwent tomosynthesis in one view [mediolateral oblique (MLO)] of both breasts at a dose comparable to that of standard screen-film mammography in two views [craniocaudal (CC) and MLO]. Images were rated by six breast radiologists using the BIRADS score. Ratings were compared with the truth established according to the standard of care and a multiple-reader multiple-case (MRMC) receiver-operating characteristic (ROC) analysis was performed. Clinical performance of DBT compared with that of FFDM was evaluated in terms of the difference between areas under ROC curves (AUCs) for BIRADS scores. Overall clinical performance with DBT and FFDM for malignant versus all other cases was not significantly different (AUCs 0.851 vs 0.836, p = 0.645). The lower limit of the 95% CI or the difference between DBT and FFDM AUCs was -4.9%. Clinical performance of tomosynthesis in one view at the same total dose as standard screen-film mammography is not inferior to digital mammography in two views. (orig.)

  18. Chronic actinic dermatitis - A study of clinical features

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    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.

  19. A STUDY OF OVARIAN TUMOURS : CLINICAL AND PATHOLOGICAL CORRELATION

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    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.

  20. 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. PMID:27354166

  1. Developing Medicare Competitive Bidding: A Study of Clinical Laboratories

    OpenAIRE

    Hoerger, Thomas J.; Meadow, Ann

    1997-01-01

    Competitive bidding to derive Medicare fees promises several advantages over administered fee systems. The authors show how incentives for cost savings, quality, and access can be incorporated into bidding schemes, and they report on a study of the clinical laboratory industry conducted in preparation for a bidding demonstration. The laboratory industry is marked by variable concentration across geographic markets and, among firms themselves, by social and economic heterogeneity. The authors ...

  2. Human transcriptome array for high-throughput clinical studies

    OpenAIRE

    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; Ronald V Maier; Tompkins, Ronald G.; Wong, Wing Hung

    2011-01-01

    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 ind...

  3. 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.

  4. Exploring autistic traits in anorexia: a clinical study

    OpenAIRE

    Tchanturia, Kate; Smith, Emma; Weineck, Felicitas; Fidanboylu, Eliz; Kern, Nikola; Treasure, Janet; Baron Cohen, Simon

    2013-01-01

    Background The objectives of this study were to explore associations between autistic traits and self-reported clinical symptoms in a population with anorexia nervosa (AN). Experimental and self-report evidence reveals similarities between AN and autism spectrum condition (ASC) populations in socio-emotional and cognitive domains; this includes difficulties with empathy, set-shifting and global processing. Focusing on these similarities may lead to better tailored interventions for both condi...

  5. Erythropoietin in Myocardial Infarction: Experimental Evidence and Clinical Studies

    OpenAIRE

    Andreas Stein; Ilka Ott

    2011-01-01

    Erythropoietin produced mainly in the kidney is the main regulator of erythropoiesis. Experimental studies identified additional, non-haematopoietic, protective effects during myocardial ischemia and reperfusion due to inhibition of apoptosis, stimulation of vasculogenesis and progenitor cell mobilisation. Based on these findings, five prospective, randomised, clinical trials have been performed. A short term regimen of erythropoietin was applied during PCI in patients with STEMI up to a cumu...

  6. Biotinidase deficiency: clinical and genetic studies of 38 Brazilian patients

    OpenAIRE

    Borsatto, Taciane; Sperb-Ludwig, Fernanda; Pinto, Louise LC; De Luca, Gisele R; Carvalho, Francisca L; De Souza, Carolina FM; De Medeiros, Paula FV; Charles M. Lourenço; Filho, Reinaldo LO; Neto, Eurico C.; Bernardi, Pricila; Leistner-Segal, Sandra; Schwartz, Ida VD

    2014-01-01

    Background Biotinidase deficiency (BD) is an inborn error of metabolism in which some genetic variants correlate with the level of enzyme activity. Biotinidase activity, however, may be artifactually low due to enzyme lability, premature birth, and jaundice; this hinders both phenotypic classification and the decision to implement therapy. This study sought to characterize the clinical and genetic profile of a sample of Brazilian patients exhibiting reduced biotinidase activity. Methods This ...

  7. OSSIFIED CARTILAGO THYREOIDEA AND ITS CLINICAL INSIGHT: A CADAVERIC STUDY

    OpenAIRE

    Kosuri Kalyan Chakravarthi*, Nelluri Venumadhav and Huban Thomas

    2013-01-01

    The three major cartilages of the larynx - thyroid, cricoid, and arytenoids are all hyaline cartilage. They may undergo calcification or endochondral ossification (or both), such calcified or ossified cartilage may compress the neuro vascular structures around it. Accordingly the present study was undertaken to observe the incidence of the ossified thyroid cartilages (Cartilago Thyreoidea) in the human cadavers, discuss its clinical implications and to review the literature regarding these an...

  8. Best herbs for managing diabetes: a review of clinical studies

    Directory of Open Access Journals (Sweden)

    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.

  9. Physiologic endpoints for clinical studies for cystic fibrosis.

    Science.gov (United States)

    Stanojevic, Sanja; Ratjen, Felix

    2016-07-01

    The cystic fibrosis (CF) drug development pipeline promises many exciting new treatments for patients with CF, all which will require clinical studies to prove their benefits on CF lung disease. Historically many pivotal CF studies have used the Forced Expiratory Volume in 1s (FEV1) as the primary outcome measure, and after demonstrating significant improvements in the treatment group relative to placebo have led to regulatory approval of therapies for routine clinical care. Widespread implementation of these therapies has subsequently led to significant improvements in outcomes for patients with CF. While preserving lung function has obvious benefits to CF patients, as more patients maintain FEV1 in the normal range, it has become increasingly difficult to conduct clinical trials using FEV1 as the primary outcome measure. With multiple concurrent trials competing to enroll from the same pool of patients, there is a need for novel approaches to study end points as well as new physiological outcomes for CF therapeutic trials. In this review we will discuss some of the limitations of FEV1 in the current era of CF care, describe alternative physiological endpoints and outline areas for further research. PMID:27316663

  10. 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.

  11. Epidemiology, etiology and study of clinical findings of headache

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    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

  12. Eurythmy Therapy in clinical studies: a systematic literature review

    Directory of Open Access Journals (Sweden)

    Majorek Magdalena

    2008-03-01

    Full Text Available Abstract Background We aimed to overview the current literature on eurythmy therapy (EYT which is an integral part of Anthroposophic Medicine. EYT can be described as a movement therapy in which speech movements are transposed into exercises which address the patient's capability to soul expression and strengthen his salutogenetic resources. Methods We searched several databases such as Cochrane, EMBASE, NCCAM, NLM, DIMDI, CAMbase, and Medline for case-control studies, cohort studies and randomised controlled trials on the treatment effects of EYT in a clinical setting. In a second search we included journal databases from Karger, Kluwer, Springer, Thieme, and Merkurstab archive. Results We found 8 citations which met the inclusion criterion: 4 publications referring to a prospective cohort study without control group (the AMOS study, and 4 articles referring to 2 explorative pre-post studies without control group, 1 prospective, non-randomized comparative study, and 1 descriptive study with a control group. The methodological quality of studies ranged in from poor to good, and in sample size from 5 to 898 patients. In most studies, EYT was used as an add-on, not as a mono-therapy. The studies described positive treatment effects with clinically relevant effect sizes in most cases. Conclusion Indications, study designs and the usage of additional treatments within the identified studies were quite heterogeneous. Despite of this, EYT can be regarded as a potentially relevant add-on in a therapeutic concept, although its specific relevance remains to be clarified. Well performed controlled studies on this unique treatment are highly recommended.

  13. 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.

  14. 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.

  15. Multiplex component-based allergen microarray in recent clinical studies.

    Science.gov (United States)

    Patelis, A; Borres, M P; Kober, A; Berthold, M

    2016-08-01

    During the last decades component-resolved diagnostics either as singleplex or multiplex measurements has been introduced into the field of clinical allergology, providing important information that cannot be obtained from extract-based tests. Here we review recent studies that demonstrate clinical applications of the multiplex microarray technique in the diagnosis and risk assessment of allergic patients, and its usefulness in studies of allergic diseases. The usefulness of ImmunoCAP ISAC has been validated in a wide spectrum of allergic diseases like asthma, allergic rhinoconjunctivitis, atopic dermatitis, eosinophilic esophagitis, food allergy and anaphylaxis. ISAC provides a broad picture of a patient's sensitization profile from a single test, and provides information on specific and cross-reactive sensitizations that facilitate diagnosis, risk assessment, and disease management. Furthermore, it can reveal unexpected sensitizations which may explain anaphylaxis previously categorized as idiopathic and also display for the moment clinically non-relevant sensitizations. ISAC can facilitate a better selection of relevant allergens for immunotherapy compared with extract testing. Microarray technique can visualize the allergic march and molecular spreading in the preclinical stages of allergic diseases, and may indicate that the likelihood of developing symptomatic allergy is associated with specific profiles of sensitization to allergen components. ISAC is shown to be a useful tool in routine allergy diagnostics due to its ability to improve risk assessment, to better select relevant allergens for immunotherapy as well as detecting unknown sensitization. Multiplex component testing is especially suitable for patients with complex symptomatology. PMID:27196983

  16. 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.

  17. 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

  18. 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.

  19. Clinical studies on kalmegh (andrographis paniculata nees) in infective hepatitis.

    Science.gov (United States)

    Chturvedi, G N; Tomar, G S; Tiwari, S K; Singh, K P

    1983-04-01

    Infective hepatitis ia an acute inflamatory condition of liver. It is usually manifested in the form of Jaundice. In this clinical study Kalmegh(Andrographis paniculata Nees) was given in the decoction form to the patients of infective hepitis. The results were assessed on the basis of clinical and biochemical parameters. A marked symptomatic improvement in majority of the cases was observed. A statistically highly significant decrease was noted in various liver function tests viz., serum bilirubin, thymol turbidity, alkaline phosphatase, S.G.O.T.; S.G.P.T. and serum globulin fraction of protein. Moreover it increased significantly total serum globulin fraction of protien. Moreover it increased significantly total serum protein level along with albumin fraction. On the total assessment 80% cases of this series were cured and 20% patients were relieved. Therefore, Kalmegh appears to be a useful remedy for the treatment of infective hepatitis.

  20. 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.

  1. [Clinical manifestations, complications and treatment of brucellosis: 45-patient study].

    Science.gov (United States)

    Zribi, M; Ammari, L; Masmoudi, A; Tiouiri, H; Fendri, C

    2009-07-01

    The aim of this study was to evaluate the clinical, laboratory findings and therapeutic features of patients with brucellosis. The diagnosis was made by clinical findings, automated blood culture, serology (Rose Bengal plate agglutination test, standard tube agglutination (Wright) and immunofluorerescence). The susceptibility of 13 strains was tested in vitro. The base sequence was determined for four strains. Forty-five cases were collected (31 acute and 14 sub-acute). Contamination was digestive in 62%. Symptoms of patients were fever (93%), sweating (82%), arthralgia (78%) and splenomegaly (51%). Elevated erythrocyte sedimentation rate was determined in 80%, leukopenia in 49% and anaemia in 37% of cases. Blood cultures were positives in 39% of cases. The four sequenced strains were identified as Brucella melitensis biovar abortus. Six strains were resistant to sufomethoxazol-trimetoprim (54%). In 93% of cases, the treatment was associated rifampicin and doxycyclin. One patient died. No relapse was reported. PMID:18387752

  2. 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.

  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. 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. PMID:25149866

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Efficiency of Calatonia on clinical parameters in the immediate post-surgery period: a clinical study

    Directory of Open Access Journals (Sweden)

    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.

  12. Human reporter genes: potential use in clinical studies

    International Nuclear Information System (INIS)

    The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

  13. Nasal polyps. A clinical radiological histopathological and mycological study

    International Nuclear Information System (INIS)

    Forty patients with nasal polyposis were studied. This study included clinical, haematological and mycological aspects. There were 24 females (60% of patients) and 16 males (40%). We found that all patients presented with nasal obstruction and nasal tone and the majority of them had allergic nasal symptoms such as sneezing and watery discharge. Thirty five percent of the patients were recurrent cases, being operated before for nasal polyps. Radiological investigations showed high of sinusitis and that 10% of the patients had complicated disease with orbital or intracranial extensions. Mycological studies revealed the presence of fungal infection in 4 patient (10%) and it was caused by Aspergillus flavus. Histological studies identified the allergic nature of the polyps in all patients. Surgical treatment was carried out in all patients and operations varied from simple intranasal polypectomy, intranasal ethmiodectomy, external ethmoidectomy to Caldwell-Luc operation for patients with antrochanal polyps.(Author)

  14. CLINICAL COMPARATIVE STUDY OF SUMATRIPTAN VERSUS ERGOTAMINE THERAPY IN MIGRAINE

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    Giriraja

    2015-12-01

    Full Text Available BACKGROUND Migraine is a common neurological problem accounting for large morbidity and disability. Ergotamine and triptans are mainly used to terminate the attack of severe migraine. To study the clinical comparison between sumatriptan and ergotamine in migraine patients. AIM This study compared the safety efficacy and pharmacoeconomics of triptans verses ergotamine therapy. MATERIALS AND METHODS Study sample included 100 patients of either gender aged 18 to 65 yrs reporting in Neurology OPD in Sapthagiri Institute of Medical Sciences, Bangalore. The study was conducted from January 2014 to December 2014. RESULTS Triptans was found to be more efficacious than ergotamine in curing an attack of migraine and its associated symptoms, but looking into the contraindications, side effects and cost of the triptans, there has been limitations in its prescriptions as well as use. CONCLUSION Ergotamine is more effective in sustained pain relief with less recurrence rate, less adverse effects and more economical compared to sumatriptan.

  15. A CLINICAL STUDY OF ALOPECIA AREATA IN CHILDREN

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    Vishwanath

    2014-09-01

    Full Text Available BACKGROUND: Alopecia areata (AA is an immunologically mediated disorder characterized by focal to diffuse hair loss. It accounts for roughly 2% of new dermatological outpatients. The incidence is higher in children with slightly higher incidence among female children. Onset peaks between 6 and 10 years of age. It has serious implication on a growing child’s psychological well-being at a critical time of development. AIMS: To study the epidemiology of AA, its clinical presentation, association with history of atopy, family history, and rate of recurrence among children below the age of sixteen years. MATERIAL AND METHODS: Fifty consecutively clinically diagnosed cases of AA in children less than sixteen years were enrolled in the study. A detailed clinical examination and history pertained to the aim of the study was recorded. Later the data was entered to MS Excel Spread-sheet and analyzed using SSPS software. RESULTS: Female to male sex ratio was 1.17:1, while the overall incidence in pediatric population was little over 1%. The most common presenting age group was 7-10 years. It was also noted that large majority of patients reported acute loss of hair over the patches. AA appeared earlier among the atopics than in non atopics but the patches were smaller among atopics compared to non-atopics. Almost 1 in 10 patients had significant family history. Nail changes and recurrence were positive in more than 10% of patients. CONCLUSION: Though AA is not a life threatening illness, the cosmetic disfigurement can be bear enormous amount of psychological impact on children of school going age. Most of the therapies only hasten what ultimately would be a spontaneous remission. Treatment may not be successful in many cases; here children will have to be tactfully managed with counseling.

  16. Clinical Study of 224 Patients with Hypertriglyceridemia Pancreatitis

    Institute of Scientific and Technical Information of China (English)

    Xiao-Li Zhang; Fei Li; Ya-Min Zhen; Ang Li; Yu Fang

    2015-01-01

    Background:Hypertriglyceridenia (HTG) is the most common etiology of acute pancreatitis (AP) after alcohol and gallstone-induced disease.Elevation of serum triglyceride (TG) levels to ≥ 1000 mg/dl in a patient with AP strongly indicates HTG as the cause.The absolute risk of pancreatitis based on serum TG ≤1000 mg/dl has not been clearly defined.The aims of this study were to address the role of elevated TG levels between 500 and 1000 mg/dl in the clinical course of HTG pancreatitis (HTGP);and assess the relationship between the level of serum TG and disease severity.Methods:A total of 224 HTGP patients between 2007 and 2011 were divided into two subgroups.Totally,122 patients in Group A had serum TG >1000 mg/dl;102 patients in Group B had maximal TG levels between 500 and 1000 mg/dl accompanied by lactescent serum;100 patients with biliary AP and 99 patients with alcoholic AP hospitalized during the study period were enrolled as controls.The clinical and biochemical data were analyzed.Results:The clinical presentation ofHTG-induced pancreatitis was similar to other causes.Severe form of AP in Group A was higher than Group B (x2 =4.002,P =0.045).The severity with HTGP was significantly higher as compared to biliaryAP (x2 =33.533,P =0.000) and alcoholic AP (x2 =7.179,P =0.007).Systemic complications with HTGP were significantly higher than biliary AP (x2 =58.763,P =0.000).Conclusions:The study demonstrated that TG level ≥500 mg/dl should raise a high degree of suspicion,especially if no other etiology of AP is apparent.The severity of HTGP seems to correlate directly with TG level.HTGP seems be more severe than other causes of AP.

  17. A study on the perception of students in the radiologic technology study on the clinical practices

    Energy Technology Data Exchange (ETDEWEB)

    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

  18. A study on the perception of students in the radiologic technology study on the clinical practices

    International Nuclear Information System (INIS)

    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

  19. 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.

  20. MRI Diagnosis of Intracranial Hemorrhage : Experimental and Clinical Studies

    International Nuclear Information System (INIS)

    The purpose of this work was to improve the diagnosis of intracranial hemorrhage with MRI, and add knowledge about the newer sequences increasing in use to depict intra parenchymal bleeds, especially T2*-w GE sequences. We also compared the effect of magnetic field strengths. The sequences and field strengths were tested in animals. Then, the most effective technique was applied to patients with hematomas of different ages and with hematoma residuals. Occurrence of residuals of earlier, clinically silent, haemorrhages in patients with acute spontaneous hematoma or with suspected ischemic stroke were compared. Experimental studies: The MR detectability of small experimental haematomas in the brain and of blood in the cerebrospinal fluid (CSF) spaces of 30 rabbits was evaluated. MRI examinations were performed at determined intervals using different pulse sequences at two field strengths. The last MR images were compared to the formalin fixed brain sections and, in 16 rabbits, also to the histological findings. T2*-weighted GE sequences revealed all the intra parenchymal haematomas at 1.5 T: they were strongly hypointense. Their sizes became smaller but the signal patterns remained unchanged during the follow-up. The haematoma sizes and shapes corresponded well to gross pathology at acute and subacute stages. At chronic stage, the signal changes were larger than iron deposits. Blood in the CSF spaces was best detected at 1.5T with T2*-weighted GE sequences during the first 2 days. The FLAIR sequence often revealed blood in CSF spaces but not in the brain. SE sequences were rather insensitive. Imaging at 0.5 T was less effective than at 1.5 T. Clinical studies: All MR examinations on patients were performed at 1.5T, including T1- and T2-w SE, FLAIR, T2*-w GE sequences, and, occasionally, diffusion-w sequences. Sixty-six intra parenchymal hematomas were examined in the first clinical study. The hematomas were of different sizes and the ages varied from 8 hours to 3

  1. MRI Diagnosis of Intracranial Hemorrhage : Experimental and Clinical Studies

    Energy Technology Data Exchange (ETDEWEB)

    Alemany Ripoll, Montserrat

    2003-02-01

    The purpose of this work was to improve the diagnosis of intracranial hemorrhage with MRI, and add knowledge about the newer sequences increasing in use to depict intra parenchymal bleeds, especially T2*-w GE sequences. We also compared the effect of magnetic field strengths. The sequences and field strengths were tested in animals. Then, the most effective technique was applied to patients with hematomas of different ages and with hematoma residuals. Occurrence of residuals of earlier, clinically silent, haemorrhages in patients with acute spontaneous hematoma or with suspected ischemic stroke were compared. Experimental studies: The MR detectability of small experimental haematomas in the brain and of blood in the cerebrospinal fluid (CSF) spaces of 30 rabbits was evaluated. MRI examinations were performed at determined intervals using different pulse sequences at two field strengths. The last MR images were compared to the formalin fixed brain sections and, in 16 rabbits, also to the histological findings. T2*-weighted GE sequences revealed all the intra parenchymal haematomas at 1.5 T: they were strongly hypointense. Their sizes became smaller but the signal patterns remained unchanged during the follow-up. The haematoma sizes and shapes corresponded well to gross pathology at acute and subacute stages. At chronic stage, the signal changes were larger than iron deposits. Blood in the CSF spaces was best detected at 1.5T with T2*-weighted GE sequences during the first 2 days. The FLAIR sequence often revealed blood in CSF spaces but not in the brain. SE sequences were rather insensitive. Imaging at 0.5 T was less effective than at 1.5 T. Clinical studies: All MR examinations on patients were performed at 1.5T, including T1- and T2-w SE, FLAIR, T2*-w GE sequences, and, occasionally, diffusion-w sequences. Sixty-six intra parenchymal hematomas were examined in the first clinical study. The hematomas were of different sizes and the ages varied from 8 hours to 3

  2. 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.

  3. 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.

  4. Clinical study of CT discography for the lumbar disc herniation

    Energy Technology Data Exchange (ETDEWEB)

    Sakamoto, Tadashi (Yamaguchi Univ., Ube (Japan). School of Medicine)

    1990-08-01

    The purpose of this clinical study was to introduce technique for correct positioning of the needle into the center of the disc for discography by means of CT analysis and also to clarify usefulness of CT discography for diagnosis of the lumbar disc herniation. We have taken CT analysis in order to determine correct place and the angle of inserting the needle. This measurement provides easy needle insertion. Unless the needle tip places center of disc, discogram false positive or negative will occur as a result. The materials of this study are 222 discs of 105 cases with the lumbar disc herniation. Comparative study of the findings among myelography, discography and CT discography was investigated. The results indicated that CT discography demonstrates the most clear findings and is useful in the diagnosis of lumbar disc herniation, especially in obtaining detailed observation of herniated discs. (author).

  5. [Pantethine, diabetes mellitus and atherosclerosis. Clinical study of 1045 patients].

    Science.gov (United States)

    Donati, C; Bertieri, R S; Barbi, G

    1989-03-31

    After a review of the clinical studies on the treatment of diabetic patients with pantethine, the authors discuss the results obtained in a postmarketing surveillance (PMS) study on 1045 hyperlipidemic patients receiving pantethine (900 mg/day on average). Of these patients, 57 were insulin-dependent (Type I) and 241 were non insulin-dependent (Type II) diabetics. Beyond the epidemiological considerations made possible by a PMS study, the authors show that pantethine brought about a statistically significant and comparable improvement of lipid metabolism in the three groups of patients, with very good tolerability. Pantethine should therefore be considered for the treatment of lipid abnormalities also in patients at risk such as those with diabetes mellitus. PMID:2524328

  6. Development of the clinical learning evaluation questionnaire for undergraduate clinical education: Factor structure, validity, and reliability study

    OpenAIRE

    AlHaqwi, Ali I; Kuntze, Jeroen; van der Molen, Henk

    2014-01-01

    textabstractBackground: Teaching and learning of clinical skills for undergraduate medical students usually takes place during the clinical clerkship. Therefore, it is of vital importance to ensure the effectiveness of the rotations within this clerkship. The aims of this study were to develop an instrument that measures the effectiveness of the clinical learning environment, to determine its factor structure, and to find first evidence for the reliability and validity of the total scale and ...

  7. A CLINICAL STUDY OF LOCALLY ADVANCED CARCINOMA OF BREAST

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    Mrinalini

    2015-06-01

    Full Text Available BACKGROUND : In India it is observed that most of the patients of breast cancer clinically present in late stage due to their ignorance of disease despite so much advancement in its detection and management. Locally advanced breast cancer (LABC accounts for 30 - 35% of all cases of breast cancers in India. This study aims to evaluate C linical features, Investigations, various Treatment modalities and the Clinico - pathological correlation & outcome of various treatment modalities of LABC, with special emphasis on Neo - adjuvant chemotherapy (NACT in Indian setting. MATERIAL AND METHOD : This was a non - randomised prospective observational study. We analyzed 57 patients of LABC Stage IIIB & IIIC presenting at Government Medical College, Nagpur, Maharashtra, a tertiary care C entre from September 2012 to November 2014. RESULTS : Stage IIIB comprised 84.21% patients while remaining 15.79% were having Stage IIIC disease. Skin involvement was observed in 91.23% patients. 15.79% showed supraclavicular lymph node involvement. 32 patients received NACT (2 to 6 cycles. Out of these 32, complete clinical response (cCR was 12.5%, partial response (cPR was 68.75% and pathological CR (pCR was 6.25% with Total Objective response (cCR+cPR 81.25%. Feasibility of Breast Conserving Surgery (BCS was observed in 12.5% patients. 25 patients underwent primary surgery followed by adjuvant chemotherapy. Modified Radical Mastectomy was performed in 89.48% patients. CONCLUSIONS : With overall clinical response of 81.25%, n eoadjuvant chemotherapy is the best treatment option for patients with Locally Advanced Breast Cancer with added advantage of in vivo testing the sensitivity of chemotherapeutic agents, early management of micrometastasis and down staging the primary tumour with feasibility of BCS. Patients presenting LABC constitute a diverse group for whic h a variety of treatment modalities should be instituted with co o rdinated treatment planning among surgeons

  8. 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

  9. Herpes zoster: A clinical study in 205 patients

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    E N Abdul Latheef

    2011-01-01

    Full Text Available Background: Even though herpes zoster is a common condition its incidence and pattern of occurrence in the era of HIV disease is significant. Aim: To analyze the incidence, pattern of occurrence and evolution of herpes zoster with special attention to provocative factors if any. Materials and Method s: This was an analytical study conducted for 2 years based on a preformed proforma containing preliminary information, a detailed clinical evaluation regarding the segment of involvement, morphology, pattern of lesions, complications, disseminations etc. and investigations to establish provocative factors if any. Results: Incidence of herpes zoster was mainly in the fourth and third decades of life. A definite history of chicken pox was present in only 63.4% cases. In the majority (70% herpes zoster occurred spontaneously. In 30% cases, immunosuppression due to chemotherapy, malignancy, HIV infection, diabetes mellitus were observed. The commonest segment affected was thoracic (42.4% followed by cranial (28.2% and cervical (12.1%. Majority resolved in 7-14 days except immunosuppressed. 34.6% of the patients had complications such as secondary bacterial infection, post herpetic neuralgia, and motor weakness. Ten patients had HIV infection as a provocative factor. Conclusion: The results of incidence and clinical pattern of herpes zoster is almost parallel to the previous studies. Any factors of immunosuppression should be checked, especially HIV, particularly in disseminated and long-lasting cases.

  10. Biomarkers in differentiating clinical dengue cases: A prospective cohort study

    Directory of Open Access Journals (Sweden)

    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.

  11. Retroperitoneal and pelvic hemangiopericytomas: A clinical, radiologic, pathologic correlative study

    International Nuclear Information System (INIS)

    The hemangiopericytoma (HP) is an aggressive neoplasm consisting of proliferation of endothelial-lined capillaries with intact reticulum sheaths surrounded by the pericyte. Approximately a fifth of these lesions occur in the retroperitoneum. This is the first large clinical, radiologic, pathologic study of retroperitoneal HP (17 cases). Significant clinical findings included a palpable mass (64%) and hypoglycemia in one. Approximately 40% were located in the true anatomic pelvis or near the cecum along the pelvic psoas muscle. Radiographically, a mass may be seen on plain film, IVP, or barium studies which might displace, compress, or rarely invade an adjacent organ. Most significant was the angiographic findings of an extremely vascular tumor with extensive collateralization, hypertrophy of vessels, and venous engorgement. On CT, HP appeared as a large, bulky well-defined enhancing tumor occasionally with areas of low density in a swirled or marbled pattern. Although by no means diagnostic, HP can be considered when a hypervascular retroperitoneal tumor is encountered on angiography or a large, enhancing mass with several low-density areas is recognized on CT

  12. 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

  13. A clinical study of temporomandibular joint disorders by using arthrography

    International Nuclear Information System (INIS)

    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

  14. Posterior shoulder pain and anterior instability: a preliminary clinical study.

    Science.gov (United States)

    Castagna, Alessandro; Conti, Marco; Borroni, Mario; Massazza, Giuseppe; Vinci, Enzo; Franceschi, Giorgio; Garofalo, Raffaele

    2008-02-01

    Different clinical tests have been suggested in the literature as significant indicators of anterior shoulder instability. Sometimes patients with recurrent anterior shoulder instability may show some muscular guarding thus making the evaluation of specific clinical tests very difficult. These patients may also report a medical history with posterior shoulder pain that can be also elicited during some clinical manoeuvres. From September 2005 to September 2006 we prospectively studied patients who underwent an arthroscopic anterior capsuloplasty. Shoulder clinical examination was performed including anterior shoulder instability tests (drawer, apprehension and relocation tests). Furthermore the exam was focused on the presence of scapular dyskinesia and posterior shoulder pain. The patients were also evaluated with ASES, Rowe, SST (Simple Shoulder Test), Constant and UCLA (University of California at Los Angeles) scoring system preoperatively and at the latest follow-up time. In the period of this study we observed 16 patients treated for anterior gleno-humeral arthroscopic stabilisation, who preoperatively complained also of a posterior scapular pain. The pain was referred at the level of lower trapezium and upper rhomboids tendon insertion on the medial border of the scapula. It was also reproducible upon local palpation by the examiner. Four of these patients also referred pain in the region of the insertion of the infraspinatus and teres minor. After arthroscopic stabilisation the shoulder was immobilised in a sling with the arm in the neutral rotation for a period of 4 weeks. A single physician supervised shoulder rehabilitation. After a mean time of 6.8 months of follow-up, all the shoulder scores were significantly improved and, moreover, at the same time the patients referred the disappearance of the posterior pain. Posterior scapular shoulder pain seems to be another complaint and sign that can be found in patients affected by anterior shoulder instability

  15. A prospective clinical study of patients with hypernatraemic dehydration.

    Science.gov (United States)

    Eke, F; Nte, A

    1996-09-01

    In a clinical prospective 3-year study of 158 children aged 2 weeks to 14 years with hypernatraemic dehydration (serum sodium 150 mmol/l or more), infants predominated (61.4%). The 158 children with hypernatraemia accounted for 13.7% of all children admitted with gastroenteritis over the same period, and significant aetiological factors included the use of artificial feeds, differences between the children with hypernatraemia and those with normo- or hyponatraemia, P dehydration P dehydrated. There was also a significant difference between the presence of neurological features in hyper- and normonatraemic patients P Hypernatraemic dehydration remains an important and serious complication of childhood gastroenteritis in our area of study. The use of artificial milk feeds is contributory, and well-nourished babies appear more at risk. We recommend more liberal water intake during gastroenteritis and the public should also be educated on and made more aware of this condition.

  16. A STUDY ON THORACIC VERTEBRAL SYNOSTOSIS & ITS CLINICAL IMPORTANCE

    Directory of Open Access Journals (Sweden)

    Md. Khaleel

    2015-01-01

    Full Text Available Vertebral anomalies are of interest not only to anatomist, but also to orthopedician, neurologist & neurosurgeons. Various vertebral anomalies of anatomic interest have been reported namely; occipitalisation, sacralisation, lumbarisation, absence of posterior elements of vertebral arch & vertebral s ynostosis. The fusion of vertebral column is rare anomalies usually congenital in origin. The fusion of thoracic vertebrae can present many clinical sign including congenital scoliosis. A study on 594 dry adult human vertebrae of unknown age & sex collected from the department of anatomy and phase I students of KBNIMS, Kalaburagi, Karnataka. The study was done over a period of 6 months (July to December 2014 during routine osteology classes for 1 year MBBS, we found the fusion of typical thoracic vertebrae between T 3 & T 4 . The cause could be failure of re - segmentation of somitomeres or acquired.

  17. Peer influence in clinical workplace learning : A study of medical students’ use of social comparison in clinical practice

    NARCIS (Netherlands)

    Raat, Adriana

    2015-01-01

    Undergraduate students in clinical workplace frequently compare their own experiences with those of peers. The research reported in this thesis shows that these so called social comparisons are vital to the process of learning in clinical practice. The first study confirms students’ tendency to comp

  18. Effect of hyaluronan on periodontitis: A clinical and histological study

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    Gauri Gontiya

    2012-01-01

    Full Text Available Background: Conventional, non-surgical periodontal therapy consists of supra- and subgingival tooth debridement. However, it is a technically demanding procedure and is not always efficient at eradicating all periodontal pathogens and in reducing inflammation. Therefore, local subgingival application of other chemotherapeutic agents may be used as an adjunct to non-surgical therapy. The aim of this study was to investigate the clinical and histological outcomes of local subgingival application of 0.2% hyaluronic acid gel (GENGIGEL® as an adjunct to scaling and root planing (SRP in chronic periodontitis patients. Materials and Methods: One hundred and twenty sites were chosen from 26 patients with chronic periodontitis (criteria being periodontal pockets ≥5mm. Experimental sites additionally received HA gel subgingivally at baseline, 1 st , 2 nd , and 3 rd week. Clinical parameters were re-assessed at 4 th , 6 th , and 12 th week. At 4 th week recall, a gingival biopsy was obtained from test and control site for histologic examination. Results: Intra-group analysis of all the clinical parameters at all sites from baseline to 4 th , 6 th , and 12 th week showed statistically significant changes. Experimental sites showed statistically significant improvement in Gingival index and Bleeding index at 6 th and 12 th week when compared with control sites. However, no statistically significant differences were observed in the PPD and RAL between control and experimental sites at 4 th , 6 th , and 12 th week time interval. No statistically significant association was found between the histological grading of the sites that received HA treatment. Conclusion: Subgingival placement of 0.2% HA gel along with SRP provided a significant improvement in gingival parameters. However, no additional benefit was found in periodontal parameters. Histologically, experimental sites showed reduced inflammatory infiltrate, but it was not statistically significant.

  19. Friedreich's ataxia: clinical and molecular study of 25 Brazilian cases

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    Albano Lilian M. J.

    2001-01-01

    Full Text Available INTRODUCTION: Friedreich's ataxia is a neurodegenerative disorder whose clinical diagnostic criteria for typical cases basically include: a early age of onset (< 20 or 25 years, b autosomal recessive inheritance, c progressive ataxia of limbs and gait, and d absence of lower limb tendon reflexes. METHODS: We studied the frequency and the size of expanded GAA and their influence on neurologic findings, age at onset, and disease progression in 25 Brazilian patients with clinical diagnosis of Friedreich's ataxia - 19 typical and 6 atypical - using a long-range PCR test. RESULTS: Abnormalities in cerebellar signs, in electrocardiography, and pes cavus occurred more frequently in typical cases; however, plantar response and speech were more frequently normal in this group when the both typical and atypical cases were compared. Homozygous GAA expansion repeats were detected in 17 cases (68% - all typical cases. In 8 patients (32% (6 atypical and 2 typical, no expansion was observed, ruling out the diagnosis of Friedreich's ataxia. In cases with GAA expansions, foot deformity, cardiac abnormalities, and some neurologic findings occurred more frequently; however, abnormalities in cranial nerves and in tomographic findings were detected less frequently than in patients without GAA expansions. DISCUSSION: Molecular analysis was imperative for the diagnosis of Friedreich's ataxia, not only for typical cases but also for atypical ones. There was no genotype-phenotype correlation. Diagnosis based only on clinical findings is limited; however, it aids in better screening for suspected cases that should be tested. Evaluation for vitamin E deficiency is recommended, especially in cases without GAA expansion.

  20. Urticarial vasculitis in northern Spain: clinical study of 21 cases.

    Science.gov (United States)

    Loricera, Javier; Calvo-Río, Vanesa; Mata, Cristina; Ortiz-Sanjuán, Francisco; González-López, Marcos A; Alvarez, Lino; González-Vela, M Carmen; Armesto, Susana; Fernández-Llaca, Héctor; Rueda-Gotor, Javier; González-Gay, Miguel A; Blanco, Ricardo

    2014-01-01

    Urticarial vasculitis (UV) is a subset of cutaneous vasculitis (CV), characterized clinically by urticarial skin lesions of more than 24 hours' duration and histologically by leukocytoclastic vasculitis. We assessed the frequency, clinical features, treatment, and outcome of a series of patients with UV. We conducted a retrospective study of patients with UV included in a large series of unselected patients with CV from a university hospital. Of 766 patients with CV, UV was diagnosed in 21 (2.7%; 9 male and 12 female patients; median age, 35 yr; range, 1-78 yr; interquartile range, 5-54 yr). Eight of the 21 cases were aged younger than 20 years old. Potential precipitating factors were upper respiratory tract infections and drugs (penicillin) (n = 4; in all cases in patients aged urticarial lesions, other features such as palpable purpura (n = 7), arthralgia and/or arthritis (n = 13), abdominal pain (n = 2), nephropathy (n = 2), and peripheral neuropathy (n = 1) were observed. Hypocomplementemia (low C4) with low C1q was disclosed in 2 patients. Other abnormal laboratory findings were leukocytosis (n = 7), increased erythrocyte sedimentation rate (n = 6), anemia (n = 4), and antinuclear antibody positivity (n = 2). Treatment included corticosteroids (n = 12), antihistaminic drugs (n = 6), chloroquine (n = 4), nonsteroidal antiinflammatory drugs (n = 3), colchicine (n = 2), and azathioprine (n = 1). After a median follow-up of 10 months (interquartile range, 2-38 mo) recurrences were observed in 4 patients. Apart from 1 patient who died because of an underlying malignancy, the outcome was good with full recovery in the remaining patients. In conclusion, our results indicate that UV is rare but not exceptional. In children UV is often preceded by an upper respiratory tract infection. Urticarial lesions and joint manifestations are the most frequent clinical manifestation. Low complement serum levels are observed in a minority of cases. The prognosis is generally good

  1. Clinical Study of Ursodeoxycholic Acid in Barrett's Esophagus Patients.

    Science.gov (United States)

    Banerjee, Bhaskar; Shaheen, Nicholas J; Martinez, Jessica A; Hsu, Chiu-Hsieh; Trowers, Eugene; Gibson, Blake A; Della'Zanna, Gary; Richmond, Ellen; Chow, H-H Sherry

    2016-07-01

    Prior research strongly implicates gastric acid and bile acids, two major components of the gastroesophageal refluxate, in the development of Barrett's esophagus and its pathogenesis. Ursodeoxycholic acid (UDCA), a hydrophilic bile acid, has been shown to protect esophageal cells against oxidative stress induced by cytotoxic bile acids. We conducted a pilot clinical study to evaluate the clinical activity of UDCA in patients with Barrett's esophagus. Twenty-nine patients with Barrett's esophagus received UDCA treatment at a daily dose of 13 to 15 mg/kg/day for 6 months. The clinical activity of UDCA was assessed by evaluating changes in gastric bile acid composition and markers of oxidative DNA damage (8-hydroxydeoxyguanosine), cell proliferation (Ki67), and apoptosis (cleaved caspase-3) in Barrett's esophagus epithelium. The bile acid concentrations in gastric fluid were measured by liquid chromatography/mass spectrometry. At baseline, UDCA (sum of unchanged and glycine/taurine conjugates) accounted for 18.2% of total gastric bile acids. After UDCA intervention, UDCA increased significantly to account for 93.4% of total gastric bile acids (P < 0.0001). The expression of markers of oxidative DNA damage, cell proliferation, and apoptosis was assessed in the Barrett's esophagus biopsies by IHC. The selected tissue biomarkers were unchanged after 6 months of UDCA intervention. We conclude that high-dose UDCA supplementation for 6 months resulted in favorable changes in gastric bile acid composition but did not modulate selected markers of oxidative DNA damage, cell proliferation, and apoptosis in the Barrett's esophagus epithelium. Cancer Prev Res; 9(7); 528-33. ©2016 AACRSee related article by Brian J. Reid, p. 512. PMID:26908564

  2. Non-compacted cardiomyopathy: clinical-echocardiographic study

    Directory of Open Access Journals (Sweden)

    Castellanos Luis Muñóz

    2006-09-01

    Full Text Available Abstract The aim of the present study was to describe the clinical and echocardiographic findings of ventricular noncompaction in adult patients. Fifty-three patients underwent complete clinical history, electrocardiogram, Holter and transthoracic echocardiogram. Forty patients (75% were in class I/II of the New York Heart Association, and 13 (25% in class III/IV. Ventricular and supraventricular escape beats were found in 40% and 26.4%, respectively. Holter showed premature ventricular contractions in 32% and sustained ventricular tachycardia in 7.5%. Ventricular noncompaction was an isolated finding in 74% of cases and was associated with other congenital heart disease in 26%. Noncompacted ventricular myocardium involved only left ventricle in 62% of the patients and both ventricles in 38%. The mean ratio of noncompacted to compacted myocardial layers at the site of maximal wall thickness was 3.4 ± 0.87 mm (range 2.2–7.5. The presence of ventricular noncompaction in more than three segments was associated with a functional class greater than II and ventricular arrhythmia with demonstrable statistical significance by χ2(p Conclusion a Noncompacted cardiomyopathy is a congenital pathological entity that can occur in isolated form or associated with other heart disease and often involves both ventricles. b A ratio of noncompacted to compacted myocardium greater than 3 and involvement of three or more segments are indicators of poor prognosis. c Since the clinical manifestations are not sufficient to establish diagnosis, echocardiography is the diagnostic tool that makes it possible to document ventricular noncompaction and establish prognostic factors.

  3. Statistical Use in Clinical Studies: Is There Evidence of a Methodological Shift?

    OpenAIRE

    Yi, Dali; Ma, Dihui; Li, Gaoming; Zhou, Liang; Xiao, Qin; Zhang, Yanqi; Liu, Xiaoyu; Chen, Hongru; Pettigrew, Julia Christine; Yi, Dong; Liu, Ling; Wu, Yazhou

    2015-01-01

    Background Several studies indicate that the statistical education model and level in medical training fails to meet the demands of clinicians, especially when they want to understand published clinical research. We investigated how study designs and statistical methods in clinical studies have changed in the last twenty years, and we identified the current trends in study designs and statistical methods in clinical studies. Methods We reviewed 838 eligible clinical study articles that were p...

  4. 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

  5. PVP-coated, negatively charged silver nanoparticles: A multi-center study of their physicochemical characteristics, cell culture and in vivo experiments

    Directory of Open Access Journals (Sweden)

    Sebastian Ahlberg

    2014-11-01

    Full Text Available PVP-capped silver nanoparticles with a diameter of the metallic core of 70 nm, a hydrodynamic diameter of 120 nm and a zeta potential of −20 mV were prepared and investigated with regard to their biological activity. This review summarizes the physicochemical properties (dissolution, protein adsorption, dispersability of these nanoparticles and the cellular consequences of the exposure of a broad range of biological test systems to this defined type of silver nanoparticles. Silver nanoparticles dissolve in water in the presence of oxygen. In addition, in biological media (i.e., in the presence of proteins the surface of silver nanoparticles is rapidly coated by a protein corona that influences their physicochemical and biological properties including cellular uptake. Silver nanoparticles are taken up by cell-type specific endocytosis pathways as demonstrated for hMSC, primary T-cells, primary monocytes, and astrocytes. A visualization of particles inside cells is possible by X-ray microscopy, fluorescence microscopy, and combined FIB/SEM analysis. By staining organelles, their localization inside the cell can be additionally determined. While primary brain astrocytes are shown to be fairly tolerant toward silver nanoparticles, silver nanoparticles induce the formation of DNA double-strand-breaks (DSB and lead to chromosomal aberrations and sister-chromatid exchanges in Chinese hamster fibroblast cell lines (CHO9, K1, V79B. An exposure of rats to silver nanoparticles in vivo induced a moderate pulmonary toxicity, however, only at rather high concentrations. The same was found in precision-cut lung slices of rats in which silver nanoparticles remained mainly at the tissue surface. In a human 3D triple-cell culture model consisting of three cell types (alveolar epithelial cells, macrophages, and dendritic cells, adverse effects were also only found at high silver concentrations. The silver ions that are released from silver nanoparticles may be harmful to skin with disrupted barrier (e.g., wounds and induce oxidative stress in skin cells (HaCaT. In conclusion, the data obtained on the effects of this well-defined type of silver nanoparticles on various biological systems clearly demonstrate that cell-type specific properties as well as experimental conditions determine the biocompatibility of and the cellular responses to an exposure with silver nanoparticles.

  6. PRevalence of Abuse and Intimate Partner Violence Surgical Evaluation (P.R.A.I.S.E.): rationale and design of a multi-center cross-sectional study.

    OpenAIRE

    ,

    2010-01-01

    Background Intimate partner violence (IPV) is described by the American Medical Association as "a pattern of coercive behaviors that may include repeated battering and injury, psychological abuse, sexual assault, progressive social isolation, deprivation, and intimidation." The long-term consequences of IPV include health risks, posttraumatic stress disorder, depression, and staggering economic costs for health care of victims. Intimate partner violence is often underreported among women who ...

  7. Feeling labeled, judged, lectured, and rejected by family and friends over depression: Cautionary results for primary care clinicians from a multi-centered, qualitative study

    OpenAIRE

    Y-Garcia Erik; Duberstein Paul; Paterniti Debora A; Cipri Camille S; Kravitz Richard L; Epstein Ronald M

    2012-01-01

    Abstract Background Family and friends may help patients seek out and engage in depression care. However, patients’ social networks can also undermine depression treatment and recovery. In an effort to improve depression care in primary care settings, we sought to identify, categorize, and alert primary care clinicians to depression-related messages that patients hear from friends and family that patients perceive as unhelpful or detrim...

  8. Feeling labeled, judged, lectured, and rejected by family and friends over depression: Cautionary results for primary care clinicians from a multi-centered, qualitative study

    Directory of Open Access Journals (Sweden)

    Y-Garcia Erik

    2012-06-01

    Full Text Available Abstract Background Family and friends may help patients seek out and engage in depression care. However, patients’ social networks can also undermine depression treatment and recovery. In an effort to improve depression care in primary care settings, we sought to identify, categorize, and alert primary care clinicians to depression-related messages that patients hear from friends and family that patients perceive as unhelpful or detrimental. Methods We conducted 15 focus groups in 3 cities. Participants (n = 116 with a personal history or knowledge of depression responded to open-ended questions about depression, including self-perceived barriers to care-seeking. Focus group conversations were audio-recorded and analyzed using iterative qualitative analysis. Results Four themes emerged related to negatively-received depression messages delivered by family and friends. Specifically, participants perceived these messages as making them feel labeled, judged, lectured to, and rejected by family and friends when discussing depression. Some participants also expressed their interpretation of their families’ motivations for delivering the messages and described how hearing these messages affected depression care. Conclusions The richness of our results reflects the complexity of communication within depression sufferers’ social networks around this stigmatized issue. To leverage patients’ social support networks effectively in depression care, primary care clinicians should be aware of both the potentially beneficial and detrimental aspects of social support. Specifically, clinicians should consider using open-ended queries into patients’ experiences with discussing depression with family and friends as an initial step in the process. An open-ended approach may avoid future emotional trauma or stigmatization and assist patients in overcoming self-imposed barriers to depression discussion, symptom disclosure, treatment adherence and follow-up care.

  9. Evaluation of a Minimally Invasive Cell Sampling Device Coupled with Assessment of Trefoil Factor 3 Expression for Diagnosing Barrett's Esophagus: A Multi-Center Case–Control Study

    OpenAIRE

    Ross-Innes, Caryn S.; Irene Debiram-Beecham; Maria O'Donovan; Elaine Walker; Sibu Varghese; Pierre Lao-Sirieix; Laurence Lovat; Michael Griffin; Krish Ragunath; Rehan Haidry; Sami, Sarmed S.; Philip Kaye; Marco Novelli; Babett Disep; Richard Ostler

    2015-01-01

    Editors' Summary Background Barrett's esophagus is a condition in which the cells lining the esophagus (the tube that transports food from the mouth to the stomach) change and begin to resemble the cells lining the intestines. Although some people with Barrett's esophagus complain of burning indigestion or acid reflux from the stomach into the esophagus, many people have no symptoms or do not seek medical advice, so the condition often remains undiagnosed. Long-term acid reflux (gastroesophag...

  10. 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.

  11. The knowledge, attitudes and practices of parents of children with asthma in 29 cities of China: a multi-center study

    Directory of Open Access Journals (Sweden)

    Zhao Jing

    2013-02-01

    Full Text Available Abstract Background Asthma is becoming increasingly prevalent among children in China. Poor parent knowledge and attitudes often contribute to inappropriate management practices, leading to deficiencies in the care process. We aimed to document the knowledge, attitudes and practices (KAP of parents of children with asthma and analyze how knowledge and attitudes relate to practices. Our secondary objective was to identify the factors associated with parent KAP scores. Methods A KAP questionnaire was distributed to parents caring for 2960 children (0–14 years diagnosed with asthma for at least 3 months from China’s 29 provinces. A 50-item questionnaire was devised for this cross-sectional survey based on a comprehensive review of the subject. Questionnaires were scored on 30 items regarding parent asthma-related KAP, with one point for every correct response and a possible range of 0–13 for knowledge, 0–7 for attitudes and 0–10 for practices. Higher scores indicated better KAP. Chi-squared tests and logistic regression were used to identify factors associated with practices and combined KAP scores. Results The response rate was 83.95% (2485/2960. Only 18.31% (455/2485 of parents correctly answered ≥ 60% of the knowledge questions (mean = 5.69. Most (89.85%; 2226/2485 gave positive responses to ≥ 60% of the attitude questions (mean = 5.23 while 67.89% (1687/2485 correctly answered ≥ 60% of the practices questions (mean = 6.19. Knowledge and attitudes were positively associated with pulmonary function testing, regular physician visits, monitoring with a peak flow meter and the Children’s Asthma Control Test questionnaire, avoidance of asthma triggers, using an inhaled β2 receptor agonist and adherence to medication regimen (p ≤ 0.05. Attitudes were also associated with allergen testing. In logistic regression analysis, high KAP scores (dichotomized by a cut-off score of 18 were positively associated with food allergy, rhinitis, physician visits, frequency of visits and parent education (p 1. Conclusions Generally, the parents’ KAP were poor. A gap between recommended and actual practice was observed, which may be related to inadequate knowledge about and poor attitudes toward childhood asthma. Improving knowledge and attitudes may encourage better practices among parents of children with asthma.

  12. 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

  13. 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

  14. [Clinical study of BRON-L syrup (cough suppressant) abuse].

    Science.gov (United States)

    Miyatake, Ryosuke; Doi, Tomoko; Date, Kenji; Naitoh, Tomomichi; Suwaki, Hiroshi

    2002-02-01

    In 1980s, abuse and dependence of BRON-W syrup (cough suppressant), which contains methylephedrine, dihydrocodeine, chlorpheniramine and caffeine, were prevalent in Japan. Pharmacological and clinical studies suggest that methylephedrine and dihydrocodeine cause dependence. Although BRON-L syrup, newly modified cough suppressant contains only chlorpheniramine and caffeine, there still are abuse and dependence of this drug. In this report, three cases of BRON-L syrup abuse are demonstrated. All cases started using BRON-L syrup in the late teens in their peer groups, and dropped out from school. Case 1 misused only BRON-L syrup, but case 2 and 3 were multi-drug abusers (case 2: amphetamine, cocaine, and marijuana, case 3: solvent, alcohol, bromovalerylurea), and had kept in tough with the peer groups. Case 2 and 3 hospitalized more than 2 times. Withdrawal symptoms, such as headache, insomnia, and irritability were mild and improved in a few weeks after drug use was stopped. These findings suggest that 1) psychosocial backgrounds of these cases are in common with those of BRON-W syrup abusers, but 2) the clinical course and prognosis of multi-drug abusers are different from the BRON single abuser, 3) chlorpheniramine and caffeine possibly cause dependence, 4) abusers are likely to choose BRON brand although two main dependence-producing constituents are removed from it now. Therefore, prevention and care of BRON-L abusers requires both psychosocial and pharmacological aspects. PMID:11915306

  15. Study on waste from hospital and clinics in Phitsanulok

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    Suwannee Adsavakulchai

    2002-10-01

    Full Text Available Waste generation depends on numerous factors such as established waste management methods, type of hospital establishment, hospital specialization, proportion of reusable items employed in hospital, and proportion of patients treated on a day-care basis. This study surveyed the waste from hospital and clinics in Phitsanulok and found the average daily waste generated as general, medical and hazardous waste from all hospitals in Phitsanulok Province at 1.751, 0.284 and 0.013 kg/bed respectively and at 0.323, 0.041 and 0.002 kg/bed respectively from all clinics in Phitsanulok Province. Medical waste from all hospitals consisted of needles, gloves, drain tubes, cottons and gauze, napkins, plastic syringes, swap and body parts with total daily generation at 0.452, 0.480, 0.390, 0.404, 0.018, 0.355, 0.004 and 0.382 kg/bed respectively. Information about proper waste management process is needed to improve hospital waste management. Hospital waste management is an important and necessary component of environmental health protection.

  16. Clinical and electrophysiological study of chronic inflammatory demyelinating polyneuropathy

    Institute of Scientific and Technical Information of China (English)

    秦绍森; 玛依努尔; 王湘

    2001-01-01

    Objective To investigate the clinical and electrophysiological features of chronic inflammatory demyelinating polyneuropathy (CIDP) . Methods The clinical symptoms and signs of 11 patients with CIDP were studied, motor conduction velocity( MCV), sensory con-duction velocity (SCV) and Electromyography (EMG) were also respectively carried out on 54 motor nerves, 28 sensory nerves and 21 musclesof these 11 cases. The amplitudes of compound muscle action potential(CAMP) obtained from distal and proximal ends were compared to as-certain the presence of conduction block (CB) by stimulating the segments starting from the distal ends. Results More than 3 nerves werefound involved in 10 out of 11 cases, slow MCV were found in 52%, prolongation of the distal latency in 64%, reduction of the amplitudes ofCAMP in 68%, CB in 26%, slow SCV in 85. 7%. EMG revealed neurogenic damage in 81%. Conclusion CIDP is a peripheral de- myelinating neuropathy involving not only the prox imal and distal segments but also the sensory and motor nerves. If there were no conditionsto perform nerve biopsy, testing of protein in CSF and electrophysiology mightbe of important diagnostic value for CIDP.

  17. STUDY OF RISK FACTORS AND CLINICAL PROFILE OF ACUTE STROKE

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    Tomar

    2014-05-01

    Full Text Available `INTRODUCTION: Stroke is the third leading cause of death in developed countries after cardiovascular disease and cancer. In India Community Surveys have shown a crude prevalence rate for hemiplegia 200 per 1, 00, 000 population. It accounts for nearly 1.5% of all urban admissions, 4.5 % of all medical and about 20% of neurological cases. AIMS AND OBJECTIVE: Identification of risk factors and evaluation of clinical profile of acute stroke. MATERIAL AND METHOD: INCLUSION CRITERIA: Cases of acute stoke admitted in SGMH hospital were selected for the study. EXCLUSION CRITERIA: Brain injury cases, infective, neoplastic cases producing stroke were excluded. RESULTS: Stroke was more common in male, 58 % patients were male and 42% patients were female. It was more common in 5th and 6th decade. Most common etiology was infarction. Most common risk factor was hypertension followed by smoking. In addition to limb weakness, headache and vomiting were most common presenting symptoms followed by convulsion. These symptoms were more common in hemorrhagic stroke. Right sided hemiplegia was more common than left sided. Middle cerebral artery was involved in majority of cases in atherothrombotic stroke whereas basal ganglion was most common site of bleed in hemorrhagic stroke. Coma and mortality were more in hemorrhagic stroke. CONCLUSION: The risk factors and clinical profile of acute stroke in India are similar to that of Western countries. Common risk factors are hypertension, smoking, diabetes mellitus and hyperlipidemia

  18. Onchomycosis – a clinical and mycological study of 75 cases

    Directory of Open Access Journals (Sweden)

    Neerja Puri

    2012-07-01

    Full Text Available Onychomycosis or fungal infection of the nails is a common disease, especially in older persons. A mycological study of onchomycosis was undertaken in 75 patients. The nails were judged to be infected by their clinical appearance. There were a total of 75 suspected cases of onychomycosis. Of these 75 cases 22.6% were positive by direct microscopy and 33.3% were culture positive. Of these 75 cases, 18 were males (24% and 57 (76 % were females, male to female ratio being. The commonest age group was 31-40 years followed by 21-30 years. The finger nails were more frequently involved. i.e. 45 (60 %, followed by toe nails 30 (40 % and both in 18 (24% cases. Ratio of finger nail to toe nail infection was 1.5:1. Distal and lateral subungual onychomycosis (DLSO was the commonest clinical pattern (76% followed by total dystrophic onychomycosis (18.66% and then superficial white onychomycosis (4% and proximal subungual onychomycosis (1.33%. The most common fungal isolates were dermatophytes of which 44% were Trytophyton rubrum, 4% were Trytophyton mentagrophytes. Non dermatophyte moulds constituted 16% of the fungus isolates. Onychomycosis was found to be the commonest in housewives (52%, followed by serviceman / businessman (32% followed by farmers (8% and labourer and student 4% each.

  19. Clinical study of cerebral infarction in hemodialysis patients

    International Nuclear Information System (INIS)

    Stroke is one of the leading causes of death in patients undergoing chronic dialysis. However, few clinical studies have so far examined stroke, especially brain infarction, under such conditions. We retrospectively evaluated the clinical features and risk factors for brain infarction in 33 patients undergoing hemodialysis (hemodialysis, 29 patients; continuous ambulatory peritoneal dialysis, 4 patients; male:female ratio, 25:8) between May 2003 and August 2006. The mean age was 68.5±10.9 (mean±standard deviation (SD)) years. The basal renal diseases were chronic glomerulonephritis (n=16), diabetes mellitus (n=10) and other diseases (n=7). The mean duration of maintenance dialysis before the onset of stroke was 5.6±5.2 years. All 33 patients developed brain infarction, including the atherothrombotic (n=13), lacunar (n=9) and cardioembolic (n=11) types. The complications included a high frequency of hypertension (79%) in all groups, diabetes mellitus (36%) and atrial fibrillation (21%). Four of the patients, 2 with lacunar and 2 with atherothrombotic infarction, developed brain infarction within 3 hours after hemodialysis. Hemodynamic changes might have caused the infarction in these patients. The proportion of patients with a modified Rankin Scale grade of 4-6 at discharge was 42%, and the mortality rate was high (15%). The prognosis of brain infarction was poorer in patients with hemodialysis than in those without. (author)

  20. Bedside Teaching in Australian Clinical Schools: A National Study

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    Praveen L. Indraratna

    2013-01-01

    Full Text Available Purpose. Bedside teaching (BST of medical students has become less common in recent years; however, there have been strong recommendations made in the literature to continue this teaching modality for the valued benefits it provides. The purpose of the present study is to explore the perceptions and opinions of bedside teaching among senior Australian medical students. Methods. Medical students at Australian universities were surveyed by means of an electronic questionnaire. The results were collected and analysed. Results. A total of 517 responses were received from students at 15 universities and 94 different clinical sites. The percentage of students who identified BST as very important ranged from 62.5% in psychiatry to 90.4% in internal medicine. The optimal class size was nominated as 3-4 students, and students favoured a style where one individual performs a complete examination, with the remainder allowed to elicit the key sign afterwards. Students felt 3-4 hours of BST per week to be ideal. Advantages identified to BST included provision of feedback and elicitation of clinical signs. Disadvantages included time constraints and excessive class sizes. Conclusions. The unique benefits of BST result in its high demand by students, regardless of the discipline being taught.

  1. Clinical TVA-based studies: a general review

    Directory of Open Access Journals (Sweden)

    Thomas eHabekost

    2015-03-01

    Full Text Available In combination with whole report and partial report tasks, the Theory of Visual Attention (TVA can be used to estimate individual differences in five basic attentional parameters: The visual processing speed, the storage capacity of visual short-term memory, the perceptual threshold, the efficiency of top-down selectivity, and the spatial bias of attentional weighting. TVA-based assessment has been used in about 30 studies to investigate attentional deficits in a range of neurological and psychiatric conditions: (a neglect and simultanagnosia, (b reading disturbances, (c aging and neurodegenerative diseases, and most recently (d neurodevelopmental disorders. The article introduces TVA based assessment, discusses its methodology and psychometric properties, and reviews the progress made in each of the four research fields. The empirical results demonstrate the general usefulness of TVA-based assessment for many types of clinical neuropsychological research. The method’s most important qualities are cognitive specificity and theoretical grounding, but it is also characterized by good reliability and sensitivity to minor deficits. The review concludes by pointing to promising new areas for clinical TVA-based research.

  2. Palmoplantar Dermatoses- A Clinical Study of 300 Cases

    Science.gov (United States)

    Rajashekhar, Nadiga; Gejje, Somashekar

    2016-01-01

    Introduction Dermatoses affecting palms and soles are among the most difficult of all dermatological therapeutic problems. Many previous studies have focused on the specific diseases of palmoplantar dermatoses. However, none of them have included a comprehensive study of palmoplantar dermatoses. Aims: To study the epidemiological aspects like age distribution, sex distribution, the dermatoses affecting the palms & soles and the frequency of involvement of palms, soles or both palms & soles, in patient with palmoplantar dermatoses. Materials and Methods This cross sectional study was conducted in the Department of Dermatology between October 2011 to September 2013. First 300 cases attending the department of dermatology primarily with complaints pertaining to palms and soles were enrolled in the study. After taking consent a detailed history and clinical examination pertaining to the aim of the study was recorded and analysed, which included inspection of morphology and distribution of lesions and palpation of any swelling. Direct microscopic examination of scrapings, wet mounted with 10% potassium hydroxide was done for cases with scaly lesions. Those who had a pustule, gram staining was done. Patch testing using Indian Standard Battery Series was done for those cases of eczema. A sample for biopsy was taken when diagnosis could not be arrived clinically, and subjected to histopathological examination. Results In our study of 300 patients with palmoplantar dermatoses, 164 were females and 136 were males, the ratio observed being 1.2:1. The peak incidence was found in the age group 21-30 years, with 41 females (25%) and 35 males (25.7%). Most frequently affected individuals in this study were housewives (30%). The most common five diseases of palmoplantar dermatoses were palmoplantar psoriasis (20.7%), moniliasis (19%), palmoplantar hyperhidrosis (7%), keratolysis exfoliativa (6%) and pitted keratolysis (6%). Majority of patients had involvement of both palms and

  3. Clinical, chromosomal and endocrine studies for congenital adrenal hyperplasia

    International Nuclear Information System (INIS)

    Severe forms of congenital adrenal hyperplasia are potentially fatal if unrecognized and untreated. The aim of this study was to clarify the clinical presentation together with the chromosomal and laboratory associations in this syndrome. Twenty four patients diagnosed as congenital adrenal hyperplasia were referred from Children's Hospital, Cairo University, Egypt, for hormonal and chromosomal workup. The age ranged from eight months to 19 years with mean age of 3.18 years. Twenty two patients were diagnosed as classic congenital adrenal hyperplasia (CAH) syndrome. Severe salt wasting form was present in ten patients whereas simple virilisation was the presenting manifestation in twelve patients. Two patients presented as late onset congenital adrenal hyperplasia (LOCAH). The sex of rearing was female in 18 cases and male in six cases. Genitography and sonography confirmed the presence of female internal organs in all cases. Advanced bone age was evident by radiographic studies. Although the karyotyping was 46,XX in all cases, the diagnosed correct sex was delayed in six cases. Serum concentrations of 17-hydroxyprogesterone (17.OH.P), dehydroepiandrosterone sulfate (DHEAS), delta, 4-androstenedione (D4A), testosterone (T) and 11-deoxycortisol were all elevated as compared to controls. It was found that the adrenal androgens DHEAS, D4A and T were more elevated in salt losers when compared to simple virilising patients. However, this difference was statistically non-significant. The present study demonstrates that the clinical examination and laboratory investigations are necessary for the early detection and treatment of these cases to avoid major medical and psychological problems for the patients and their parents

  4. Clinical, Chromosomal and Endocrine Studies for Congenital Adrenal Hyperplasia

    International Nuclear Information System (INIS)

    Several forms of congenital adrenal hyperplasia are potentially fatal if unrecognized and untreated. The aim of this study is to throw light on the clinical presentation together with chromosomal and laboratory associations in this syndrome. Twenty four patients diagnosed as congenital adrenal hyperplasia were referred from the Diabetic Endocrine Metabolic Pediatric Unit [DEMPU], Children's Hospital, Cairo University for hormonal and chromosomal workup. Twenty two patients were diagnosed as classic congenital adrenal hyperplasia (CAH) syndrome. Sever salt wasting form was present in ten patients whereas simple virilization was the presenting manifestation in twelve patients. Two patients presented as late onset congenital adrenal hyperplasia (LOCAH). The mean age was 3.18 years, ranging from eight months to 19 years. The sex of rearing was Female in 18 cases and male in six cases. Genitography and sonography confirmed the presence of female internal organs in all cases. Advanced bone age was evident by radiographic studies. Although the karyotyping was (46,XX) in all cases, the correct sex diagnosis was delayed in 6 cases. Serum concentrations of 17-hydroxyprogesterone (17.OH.P); Dehydroepiandrosterone sulfate (DHEAS); Delta,4-androstenedione (D 4 A); Testosterone and 11-deoxycortisol were all elevated in relation to controls. We found that the adrenal androgens DHEAS, delta 4A, and T were more elevated in salt losers when compared to simple virilizing patients. However, this difference was not of statistical significance. The present study demonstrates that clinical examination and laboratory investigations are necessary for early detection and treatment of hese cases to avoid major medical and psychological problems for the patients and their parents.

  5. A CLINICAL STUDY OF BENIGN LESIONS OF PINNA

    Directory of Open Access Journals (Sweden)

    Srirangaprasad

    2016-02-01

    Full Text Available BACKGROUND AND OBJECTIVES To study the clinical aspects of benign lesions of pinna and to evaluate aetiopathological factors, prevalence and management options. METHODS The study included 115 patients during the period from January 2013 to December 2013. The selection criteria included patients presenting with swellings of pinna which included keloids, seromas, sebaceous cyst, preauricular sinus, haemangioma, dermoid and neurofibroma. A detailed clinical history regarding onset, predisposing factors and associated conditions was documented and analysed. RESULTS Of total 115 cases in our study, 66 cases (57% presented with keloid followed by 33 cases (29% of pseudocyst of auricle, sebaceous cyst were seen in 10 cases, i.e. 9% and only 1 case of Neurofibroma, Haemangioma and Dermoid was diagnosed (<1%; 94 percent of patients presenting with Keloid were females; 88% of them had unilateral and just 12% had bilateral disease. Trauma was the factor in causation of pseudocyst of auricle in 11 cases (34%, diabetes also was seen in 3 cases (9%. Of all 33 cases of pseudocyst of auricle, 27 cases (82% were managed by window procedure and 6 cases (18% were managed with aspiration. CONCLUSION Trauma is the most important factor in causation of number of benign lesions of pinna. Other factors being high ear piercing through the cartilage. Diabetes mellitus plays a significant role and should be controlled simultaneously. Wide bore needle aspiration can be done for some of the cases of seroma patients who have recurrence and other cases can be managed by window procedure. Other lesions like keloid, sebaceous cyst, haemangioma and dermoid can be managed by complete surgical excision. A firm pressure bandage should be applied in most of the cases after surgery. Neurofibroma can be managed conservatively.

  6. Clinical analysis of hypertension in children: An urban Indian study

    Directory of Open Access Journals (Sweden)

    Sunil K Kota

    2013-01-01

    Full Text Available Hypertension in children, although an uncommon entity, is associated with end-organ damage. We tried to study the clinical profile of hypertension in children presented to our hospital. The medical records from January 1990 to December 2010 of all children aged 18 years and younger with hypertension were studied. The patients were divided into four age groups (infants, pre-school age, school age and adolescents Presenting symptoms and other clinical parameters were thoroughly evaluated. The results were compared with previous studies on hypertension in children. A total of 135 patients were selected (male:female 103:32, with mean age of 0.4 ± 2.1 years (range: six months to 17 years. The most common age group affected was the adolescents group (42.9%. The most common clinical feature at presentation was dizziness (30.3%, followed by headache and chest discomfort (22.9%. Transient hypertension was detected in 34 patients (25.2%, and was most common in the adolescent age group, whereas sustained hypertension was noticed in 101 patients (74.8% and was the most common in the school age group (36/45, 80%. Forty-two patients (31.1% presented with hypertensive crisis. Nine patients were considered to have essential hypertension. The chief causes included chronic glomerulonephritis in 56 (41.5%, endocrine disorders in 21 (15.5%, obstructive uropathy in 16 (11.8%, reflux nephropathy in 12 (8.8% and renovascular disease in 5 (3.7%. Takayasu′s disease was the most common cause of renovascular hypertension. Coarctation of aorta was the most common cause of hypertension in infancy, being present in 40% of the cases. Hypertension in children may be easily underestimated but is a potentially life-threatening problem. Most of them are asymptomatic and a large chunk has an underlying etiology. Primary care clinicians should promptly identify patients with hypertension and treat them immediately and appropriately to prevent damage to the cardiovascular organs.

  7. A clinical study of oral mucous membrane pemphigoid.

    Science.gov (United States)

    Alkan, A; Günhan, O; Alkan, A; Otan, F

    2003-01-01

    We present 13 cases of oral mucous membrane pemphigoid (MMP) and review the literature. The cases were retrieved from the archives of Ondokuz Mayis University and Gülhane Military Medical Academy, Turkey, between 1997 and 2002. Inclusion criteria were clinical findings of oral MMP verified by histological and immunofluorescent examination. Thirteen patients (two males and 11 females), aged 16-72 years, were identified. Involvement was confined to the mouth in all cases except one, in which the conjunctiva was also affected. Two individuals in the study were < 20 years old, an age group rarely affected. The oral mucosa is often the initial site of MMP