WorldWideScience

Sample records for clinical investigator inspection

  1. Good clinical practice regulatory inspections: Lessons for Indian investigator sites

    Directory of Open Access Journals (Sweden)

    R Marwah

    2010-01-01

    Full Text Available Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs, protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15-30 days with effective Corrective and Preventive Action Plan (CAPA. Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective.

  2. Clinical Investigator Inspector List (CLIIL)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who...

  3. Clinical Investigations

    Science.gov (United States)

    1977-09-30

    conducted at WBAV’S is categorized as t basic experimental medicine or trials and testing of clinical medicine pro- cedures using the indigenous population...Unit No. 77/20 (FY77, 0) An Analysis of Ameloblastic Fibro-odontoma ....................... 27 Department of Medicine Nork Unit No, 69/338 (FY69, T...Unit No. 71/38 (FY71, T) Injected Marihuana : Effects of Cannabinol ....................... 71 Department of Pediatrics Wfork Unit No. 74/23 (FY74, T

  4. Clinical Investigation.

    Science.gov (United States)

    1979-09-30

    Zbylski, LaRossa, Cullington: A Simple Method of Rapid Assessment of Malar Depression . Annals of Plastic Surgery, Aug 79. Urology Service Fauver, H.E...J.R.: ST Depression Suggesting Subendocardial Ischemia in Neonates with PDA. Presented: Eighth Annual Army Association of Cardiok yy tt,eting, Tacoma...79/100 Investigation of the Tumor Reduction Effect of Combined Sodium-L-Ascorbate and 5FU Chemotherapy in Transplanted B16 Melanoma of Mice. (O

  5. Getting ready for inspection of investigational site at short notice

    Directory of Open Access Journals (Sweden)

    Rajendra Talele

    2010-01-01

    Full Text Available India is becoming an attractive destination for drug development and clinical research. This is evidenced by the three fold increment in clinical trial applications in last four years to the office of Drugs Controller General of India (DCGI. This upward trend is collaborative efforts of all stake holders and the quality of Indian data. Therefore to sustain this trend, it is important that stake holders such as Regulators, Sponsor, CRO, Monitor, Investigators and trial subjects required maintaining high standards of data and conduct of clinical trials. Indian regulations and the role of DCGI in quality check for Indian clinical trials is always a topic of discussion in various forums. A recent move by DCGI for conducting random inspections of investigational sites and companies at short notice, checking their compliance in accordance with the guidelines, and taking action against non-complier is welcomed. This will certainly increase over quality of the clinical trials. Quality of clinical trial conduct is measured on essential documents for their appropriateness and its correctness. It is observed that the stakeholders engaged in multitasking often overlook the requirements or appropriateness of the document due to their focused approach on a specific activity which is on priority. This can lead to serious quality problem and issues. Understanding of the process and documents reviewed by auditor is important to maintain such high quality. The proper planning and time management working on essential documents can minimize the quality issues, and we can be always ready for any type of inspection, announced or unannounced, or "short notice".

  6. Future requirements. Clinical investigations

    DEFF Research Database (Denmark)

    Qvist, V.

    2002-01-01

    Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics......Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics...

  7. Clinical relevance of studies on the accuracy of visual inspection for detecting caries lesions

    DEFF Research Database (Denmark)

    Gimenez, Thais; Piovesan, Chaiana; Braga, Mariana M

    2015-01-01

    Although visual inspection is the most commonly used method for caries detection, and consequently the most investigated, studies have not been concerned about the clinical relevance of this procedure. Therefore, we conducted a systematic review in order to perform a critical evaluation considering...... the clinical relevance and methodological quality of studies on the accuracy of visual inspection for assessing caries lesions. Two independent reviewers searched several databases through July 2013 to identify papers/articles published in English. Other sources were checked to identify unpublished literature...... to clinical relevance and the methodological quality of the studies were evaluated. 96 of the 5,578 articles initially identified met the inclusion criteria. In general, most studies failed in considering some clinically relevant aspects: only 1 included study validated activity status of lesions, no study...

  8. Clinical Investigation Program.

    Science.gov (United States)

    1985-10-01

    Tracheoesophageal Fistula: Diagnosis with CT. Pediatr Radiol 15:134-135, 1985 Sueoka BL, Johnson JF, Enzenauer RW, Kolina JS: Infantile Infectious Sacroiliitis...C) Stokes WS: Spontaneous Diabetes Mellitus in a Baboon (Papio anubis). 35th Annual Session, American Association for Laboratory Animal Science...Summary Sheet Prot No: 21H/85 Status: Ongoing TITLE: Efficacy of Cholestyramine in Acute Infantile Diarrhea Principal Investigator: CPT George M. Maher

  9. IAEA inspection team conducting investigation in South Korea

    International Nuclear Information System (INIS)

    2004-01-01

    Full text: On 23 August 2004, during discussions about the initial declarations of the Republic of Korea (ROK) under the Additional Protocol to its Safeguards Agreement, the ROK informed the IAEA that it had enriched nuclear material in the course of atomic vapour laser isotope separation (AVLIS) experiments that had not been declared to the IAEA. The ROK informed the IAEA that these experiments had been on a laboratory scale and involved the production of only milligram quantities of enriched uranium. According to the ROK, these activities were carried out without the Government's knowledge at a nuclear site in Korea in 2000, and that the activities had been terminated. Following receipt of this information, the IAEA dispatched a team of inspectors, headed by the Director of the Safeguards Operations Division responsible for the ROK, to investigate further all relevant aspects of this matter. The inspectors will report to the Director General upon their return to Vienna early next week. The Director General will be informing the Board of Governors of the IAEA's initial findings at the next meeting of the Board of Governors beginning on 13 September 2004. (IAEA)

  10. The clinical course of asymptomatic esophageal candidiasis incidentally diagnosed in general health inspection.

    Science.gov (United States)

    Lee, Sang Pyo; Sung, In-Kyung; Kim, Jeong Hwan; Lee, Sun-Young; Park, Hyung Seok; Shim, Chan Sup

    2015-01-01

    Esophageal candidiasis mostly occurs in the immunocompromised host. However, it may also affect healthy people and is frequently asymptomatic. The clinical significance of asymptomatic esophageal candidiasis (AEC) is still unclear. The aims of the study were to investigate the prevalence of AEC during health inspection and to identify its predisposing factors and clinical significance. A total of 49,497 subjects who underwent a health inspection that included upper endoscopy were enrolled. We retrospectively reviewed the subject's self-reporting questionnaires, medical records and endoscopic findings. We considered "long-term" follow-up to be >6 months with at least one more follow-up endoscopy. One hundred and seventy (0.4%) subjects were endoscopically diagnosed as esophageal candidiasis and 141 subjects were AEC. Multivariate analysis revealed that old age (≥60 years) was an independent risk factor for AEC (OR, 1.862, p = 0.005). The number of subjects with long-term follow-up was 79 (195.3 person-years). Among these, AEC of 64 subjects (81.0%) had disappeared on the follow-up endoscopy and was not recurrent. The other 15 subjects had AEC diagnosed more than once on the follow-up endoscopy, and 5 of them were spontaneously healed during the follow-up period. The remaining 10 subjects whose candidiasis was sustained up to the last endoscopy did not complain of symptoms during the follow-up period, and their endoscopic findings did not worsen. AEC is rare and old age is the only risk factor. AEC does not require medical care because it is a self-limited disease.

  11. 77 FR 60440 - Clinical Investigator Training Course

    Science.gov (United States)

    2012-10-03

    ... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... with knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine...

  12. 76 FR 45577 - Clinical Investigator Training Course

    Science.gov (United States)

    2011-07-29

    ... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine; and Improve...

  13. A Missing Piece in Clinical Trial Inspections in Latin America: Interviews With Research Subjects in Peru.

    Science.gov (United States)

    Minaya, Gabriela E; Fuentes-Delgado, Duilio J; Ugalde, Antonio; Homedes, Núria

    2017-10-01

    Most regulatory agencies conduct clinical trial (CT) site inspections, but the experiences and behaviors of research subjects and their knowledge of the rights and obligations that ensue from participating in a CT are seldom explored. The authors assessed the technical feasibility of incorporating interviews with participants in CT inspections. This article analyzes the responses of 13 CT participants, 14% ( n = 96) of those included in three tuberculosis (TB) CTs. Participants did not object to being interviewed and provided information not obtained during regular inspections. Participants were appreciative of the agency's concern for the integrity of the CT process. Most interviewees did not understand the consent form and were unaware that they were participating in an experiment with unapproved new drugs. Participants' decision to enroll in CT related to undue inducement and therapeutic misconception. Some patients' behaviors, undisclosed to researchers, could have compromised the integrity of the data collected.

  14. Clinical investigation of thyroid disorders

    International Nuclear Information System (INIS)

    Miller, J.L.

    1981-01-01

    Current investigations of thyroid dysfunction available to the clinician are reviewed and correlated with disease processes. The aim is to provide a simplified guide to the investigation of thyroid disorders

  15. Clinical investigation in Wilson's disease

    International Nuclear Information System (INIS)

    Mizutani, Naoki; Maehara, Mitsuo; Negoro, Tamiko; Watanabe, Kazuyoshi

    1983-01-01

    Wilson's disease of cerebral type with a chief complaint of tremor occurred in 3 brothers and sisters of a certain family line. Treatment with D-penicillamine produced remarkable clinical improvement as shown by the disappearance of tremor and Kayser-Fleischer ring. Cranial CT scans made before the treatment revealed abnormal findings such as low density areas in the (bilateral) thalamus and the lenticular nucleus, atrophy of the cerebral cortex, and enlargement of the ventricles. After the treatment, cranial CT revealed that the low density areas in the thalamus and the lenticular nucleus disappeared corresponding to the clinical improvement. However, the atrophy of the cerebral cortex and the enlargement of the ventricles were not ameliorated. (Ueda, J.)

  16. 78 FR 63988 - Clinical Investigator Training Course

    Science.gov (United States)

    2013-10-25

    ... communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1214... support regulatory decisions. This course is intended to assist clinical investigators in understanding...

  17. Supplemental site inspection for Air Force Plant 59, Johnson City, New York, Volume 1: Investigation report

    Energy Technology Data Exchange (ETDEWEB)

    Nashold, B.; Rosenblatt, D.; Hau, J. [and others

    1995-08-01

    This summary describes a Supplemental Site Inspection (SSI) conducted by Argonne National Laboratory (ANL) at Air Force Plant 59 (AFP 59) in Johnson City, New York. All required data pertaining to this project were entered by ANL into the Air Force-wide Installation Restoration Program Information System (IRPIMS) computer format and submitted to an appropriate authority. The work was sponsored by the United States Air Force as part of its Installation Restoration Program (IRP). Previous studies had revealed the presence of contaminants at the site and identified several potential contaminant sources. Argonne`s study was conducted to answer questions raised by earlier investigations.

  18. Investigation with automatic ultrasonic equipment to trace flaws in a large test piece, and experience gained in carrying out inspections

    International Nuclear Information System (INIS)

    Lindner, J.P.

    1975-01-01

    Based on the FRG codes providing guide lines for the Reactor Safety Commission regarding the size and location of flaws to be detected during in-service inspections, investigations were carried out into the possibility of detecting defects in thick-walled reactor pressure vessel components with the aid of ultrasonic inspection systems. A large test rig was used and, in a similar manner to the in-service inspections on a reactor, the tests were carried out with remote-controlled, automatically guided inspection equipment. For this purpose, a test specimen weighing about 10 tons was produced and provided with two weld seams having a large number of artificial defects. Essential parameters for the various reflectors in the test specimen were the size, location, angle and roughness or structure of the reflecting surfaces. As it is known that austenitic cladding has a considerable influence on flaw detection, the tests were undertaken first without cladding and then with cladding. A manipulator was designed for automatic remote-controlled inspection with which the inspection system travels on a meandering route over the area to be inspected. The inspection system employed was of the same type as the one used for baseline tests during external inspections of reactor vessel walls with parallel surfaces. Digital data collection was by a magnetic tape recorder designed to store both the data of the ultrasonic inspection system as well as the allied position data. The data stored on the tape are evaluated with electronic data processing programmes especially developed for this purpose. These programmes allow locally coherent indication patterns to be prepared, thus simplifying the interpretation of the data obtained. The author initially describes the equipment with the aid of which the studies were undertaken. A detailed discussion is then presented on the design of the test specimen and the inspection systems employed. Following this, the results obtained are explained and

  19. 75 FR 57472 - Clinical Investigator Training Course

    Science.gov (United States)

    2010-09-21

    ... days in advance. SUPPLEMENTARY INFORMATION: Clinical trial investigators play a critical role in the... toxicological, pharmacological, and manufacturing data to support investigational use in humans; Fundamental issues in the design and conduct of clinical trials; Statistical and analytic considerations in the...

  20. [Clinical symptoms and immunology inspection characteristics of nasal cavity local allergy].

    Science.gov (United States)

    Yin, Z X; Zhu, Y; Zhai, X; Zhang, J L; Liu, G

    2017-08-05

    Objective: To investigate the clinical symptoms and immunology inspection characteristics of nasal cavity local allergy. Method: Selected 60 patients as observation group, who had only nasal local allergy symptoms, allergen skin prick test and serum allergen specific IgE (SIgE) test were negative, 40 allergic rhinitis (AR) patients and 40 healthy volunteers as control groups. To detect Symptom scores and VAS scores, and eosinophilia counts in venous blood, allergen skin prick test (SPT), serum allergen SIgE test, nasal secretions allergen SIgE test, nasal mucous membrane excitation test in both observation group and AR group, eosinophilia counts in nasal secretion, taked the data for statistical analysis. Result: There was no difference ( P > 0.05) in the symptom scores and VAS scores of observation group and the AR group. The eosinophilia counts in venous blood in the AR group were higher than in the observation group ( P 0.05) in the eosinophilia percentages in nasal secretion in the observation group and the AR group. There was significant difference ( P < 0.05) in the eosinophilia percentages in nasal secretion in the observation group and the healthy volunteers group. There were 6 patients in observation group whose nasal secretions allergen SIgE test and nasal mucous membrane excitation test were both negative, could be diagnosised as non-allergic rhinitis (NAR). According to eosinophilia counts in venous blood and nasal secretions, 4 patients were diagnosised as vasomotor rhinitis and 2 patients were diagnosised as NAR with eosinophilia syndrome. There were 54 patients in observation group whose nasal secretions allergen SIgE test and (or) nasal mucous membrane excitation test were positive, could be diagnosised as local allergic rhinitis. After three years, all of the observation group patients were detected with SPT and serum allergen SIgE test. Five patients diagnosed as local allergic rhinitis before three years were positive. Six patients diagnosed as

  1. Conduct of inspections for plant modifications, event investigations and operability decisions. Proceedings of an International Workshop

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-07-01

    Preliminary planning started following the approval given by the CNRA. Formal planning for the Workshop was started at the Fifth Meeting of the WGIP in April 1993, in Lyon. Planning included taking into consideration comments made and lessons learned at the first Workshop. The first organising committee meeting for the Workshop was held in London preceding the Sixth WGIP meeting in October 1993. It was decided to remain with the same format: discussion groups with facilitators. It was also decided to have a three day programme with three Discussion Group sessions. The Announcement and Call for Participation was issued in December 1993. As part of the Announcement and Call for Participation, registrants were requested to transmit questions or issues of particular interest within the selected topics, they wanted to be addressed at the Workshop. A compilation of the these is included as Appendix H. Additionally, participants were requested to provide a short paper of one or two pages, describing the practices within their own countries related to the topics, for utilisation during the discussion sessions. These papers are attached as Appendix I. A training session was held for all facilitators on the afternoon of 22 May, to introduce methods in leading small group discussions and to complete final preparations. The Workshop programme (Appendix B) consisted of an opening plenary session, 3 discussion group sessions and a closing plenary session to review conclusions and an open question period. Following completion of the Workshop, facilitators met to evaluate and formulate final reports on the various topics. The main objectives of the Workshop were the following: To meet with inspectors from other organisations, To exchange information regarding regulatory inspections practices, To discuss the major topics: plant modifications, event investigation, and operability decisions, To discuss current issues, To develop conclusions on the topics discussed. Six discussion

  2. Conduct of inspections for plant modifications, event investigations and operability decisions. Proceedings of an International Workshop

    International Nuclear Information System (INIS)

    1995-01-01

    Preliminary planning started following the approval given by the CNRA. Formal planning for the Workshop was started at the Fifth Meeting of the WGIP in April 1993, in Lyon. Planning included taking into consideration comments made and lessons learned at the first Workshop. The first organising committee meeting for the Workshop was held in London preceding the Sixth WGIP meeting in October 1993. It was decided to remain with the same format: discussion groups with facilitators. It was also decided to have a three day programme with three Discussion Group sessions. The Announcement and Call for Participation was issued in December 1993. As part of the Announcement and Call for Participation, registrants were requested to transmit questions or issues of particular interest within the selected topics, they wanted to be addressed at the Workshop. A compilation of the these is included as Appendix H. Additionally, participants were requested to provide a short paper of one or two pages, describing the practices within their own countries related to the topics, for utilisation during the discussion sessions. These papers are attached as Appendix I. A training session was held for all facilitators on the afternoon of 22 May, to introduce methods in leading small group discussions and to complete final preparations. The Workshop programme (Appendix B) consisted of an opening plenary session, 3 discussion group sessions and a closing plenary session to review conclusions and an open question period. Following completion of the Workshop, facilitators met to evaluate and formulate final reports on the various topics. The main objectives of the Workshop were the following: To meet with inspectors from other organisations, To exchange information regarding regulatory inspections practices, To discuss the major topics: plant modifications, event investigation, and operability decisions, To discuss current issues, To develop conclusions on the topics discussed. Six discussion

  3. Clinical Investigation Program, RCS MED-300 (RI).

    Science.gov (United States)

    1984-10-01

    protocol is a clinical validation study uti - lizing the BIOTRONIK DIPLOS 04 Dual Chamber Pulse Generator. This study is being conducted under an...recurrence-rates, survival-rates, and pattern of recurrence for patients receiving therapy uti - lizing surgery and postoperative radiation vs combined...placed in the treatment qroup or control aroup by the pharmacist . Progress: Terminate. Both the principal and associate investigators have ETS d. 7

  4. Pipe degradation investigations for optimization of flow-accelerated corrosion inspection location selection

    International Nuclear Information System (INIS)

    Chandra, S.; Habicht, P.; Chexal, B.; Mahini, R.; McBrine, W.; Esselman, T.; Horowitz, J.

    1995-01-01

    A large amount of piping in a typical nuclear power plant is susceptible to Flow-Accelerated Corrosion (FAC) wall thinning to varying degrees. A typical PAC monitoring program includes the wall thickness measurement of a select number of components in order to judge the structural integrity of entire systems. In order to appropriately allocate resources and maintain an adequate FAC program, it is necessary to optimize the selection of components for inspection by focusing on those components which provide the best indication of system susceptibility to FAC. A better understanding of system FAC predictability and the types of FAC damage encountered can provide some of the insight needed to better focus and optimize the inspection plan for an upcoming refueling outage. Laboratory examination of FAC damaged components removed from service at Northeast Utilities' (NU) nuclear power plants provides a better understanding of the damage mechanisms involved and contributing causes. Selected results of this ongoing study are presented with specific conclusions which will help NU to better focus inspections and thus optimize the ongoing FAC inspection program

  5. Investigate existing non-intrusive (NII) technologies for port cargo inspections.

    Science.gov (United States)

    2011-09-01

    "The quantity of cargo handled by United States ports has increased significantly in recent years. Based on : 2004 data, almost 2.7 billion tons of cargo passed through the ports in one year. To protect the U.S., all of this : cargo must be inspected...

  6. Clinical investigation of radioallergosorbent test (RAST)

    International Nuclear Information System (INIS)

    Okuda, Minoru; Usami, Atsushi

    1974-01-01

    Relationship of radioallergosorbent test (RAST), intracutaneous reaction, serum IgE determination and RMCD (Rat Mast Cell Degranulation Test) in subjects with tick allergy was compared in order to investigate clinical application for nasal allergy. 1. RAST is suitable for clinical examinations as determination of IgE. Because it is simple in technique, a technical expert can treat many subjects within a short time, and the result can be decleared within 2 days. 2. RAST was high in specificity and was consistent with clinical findings. RAST positive was thought to be allergy by the antigen, but RAST negative could not deny allergy by the antigen. 3. Correlation of some degree was found to exist between RAST and intracutaneous reaction or degree of induced reaction or threshold value of antigen intracutaneous reaction. But degree of intracutaneous reaction and induced reaction and threshold value of intracutaneous reaction could not be determined from the result of RAST. 4. Determination of IgE antibody by RAST was more useful in clinical study than that of IgE or IgE antibody by RMCD. (Oyama, S.)

  7. A clinical and investigational study of donovanosis

    Directory of Open Access Journals (Sweden)

    Veeranna S

    2003-03-01

    Full Text Available A clinical and investigational study of 25 cases of Donovanosis was undertaken. The incidence was found to be 1.53% of all STD cases and 2.9% of GUD. M:F ratio was 2.12:1. Incidence was more in unmarried people. Fleshy exuberant type was seen in 88% of cases. Two patients (8% had extragenital ulcers. Donovan bodies were found in 88%. Pseudo elephantiasis was seen in 8 patients. Biopsy was done in 8 cases and showed ocanthosis, plasma cell infiltration and pseudo epitheliomatous hyperplasia. One patient developed squamous cell carcinoma of vulva.

  8. Investigation of in service inspection for pressure vessel of the 200 MW nuclear heating reactor

    International Nuclear Information System (INIS)

    He Shuyan; Yin Ming; Liu Junjie; Chang Huanjian; Zhou Ningning

    1997-01-01

    The Nuclear District Heating Reactor (NHR) is a new type of reactor. There are some differences in the arrangement of the primary circuit components and in safety features between NHR and PWR or other reactors. In this paper the safety features of the 200 MW NHR are described. The failure probability, the LBB property and the in-service inspection requirement for the 200 MW NHR pressure vessel are also discussed. (author). 16 refs, 6 figs, 4 tabs

  9. Investigation of in service inspection for pressure vessel of the 200 MW nuclear heating reactor

    Energy Technology Data Exchange (ETDEWEB)

    Shuyan, He; Ming, Yin; Junjie, Liu; Huanjian, Chang; Ningning, Zhou [Institute of Nuclear Energy and Technology, Tsingua Univ., Beijing (China)

    1997-09-01

    The Nuclear District Heating Reactor (NHR) is a new type of reactor. There are some differences in the arrangement of the primary circuit components and in safety features between NHR and PWR or other reactors. In this paper the safety features of the 200 MW NHR are described. The failure probability, the LBB property and the in-service inspection requirement for the 200 MW NHR pressure vessel are also discussed. (author). 16 refs, 6 figs, 4 tabs.

  10. Preliminary investigation of ultrasonic shear wave holography with a view to the inspection of pressure vessels

    International Nuclear Information System (INIS)

    Aldridge, E.E.; Clare, A.B.; Shepherd, D.A.

    1975-01-01

    The manner in which holography would fit into the general scheme of pressure vessel inspection is discussed. Compared to conventional A, B and C presentations holography requires a different processing of the ultrasonic signal and a mechanical scan which may be more demanding than that normally provided for a C display. Preliminary results are presented of the examination of artificial defects in steel plate using shear wave holography. (author)

  11. Transcranial magnetic stimulation techniques in clinical investigation.

    Science.gov (United States)

    Currà, A; Modugno, N; Inghilleri, M; Manfredi, M; Hallett, M; Berardelli, A

    2002-12-24

    Transcranial magnetic stimulation (TMS) is a technique that can activate cortical motor areas and the corticospinal tract without causing the subject discomfort. Since TMS was introduced, numerous applications of the technique have been developed for the evaluation of neurologic diseases. Standard TMS applications (central motor conduction time, threshold and amplitude of motor evoked potentials) allow the evaluation of motor conduction in the CNS. Conduction studies provide specific information in neurologic conditions characterized by clinical and subclinical upper motor neuron involvement. In addition, they have proved useful in monitoring motor abnormalities and the recovery of motor function. TMS also gives information on the pathophysiology of the processes underlying the various clinical conditions. More complex TMS applications (paired-pulse stimulation, silent period, ipsilateral silent period, input-output curve, and evaluation of central fatigue) allow investigation into the mechanisms of diseases causing changes in the excitability of cortical motor areas. These techniques are also useful in monitoring the effects of neurotrophic drugs on cortical activity. TMS applications have an important place among the investigative tools to study patients with motor disorders.

  12. Investigation of reliability of EC method for inspection of VVER steam generator tubes

    International Nuclear Information System (INIS)

    Corak, Z.

    2004-01-01

    Complete and accurate non-destructive examinations (NDE) data provides the basis for performing mitigating actions and corrective repairs. It is important that detection and characterization of flaws are done properly at an early stage. EPRI Document PWR Steam Generator Examination Guidelines recommends an approach that is intended to provide the following: Ensure accurate assessment of steam generator tube integrity; Extend the reliable, cost effective, operating life of the steam generators, and Maximize the availability of the unit. Steam Generator Eddy Current Data Analysis Performance Demonstration represents the culmination of the intense two-year industry effort in the development of a performance demonstration program for eddy current testing (ECT) of steam generator tubing. It is referred to as the Industry Database (IDB) and provides a capability for individual organizations to implement SG ECT performance demonstration programs in accordance with the requirements specified in Appendices G and H of the ISI Guidelines. The Appendix G of EPRI Document PWR Steam Generator Examination Guidelines specifies personnel training and qualification requirements for NDE personnel who analyze NDE data for PWR steam generator tubing. Its purpose is to insure a continuing uniform knowledge base and skill level for data analysis. The European methodology document is intended to provide a general framework for development of qualifications for the inspection of specific components to ensure they are developed in a consistent way throughout Europe while still allowing qualification to be tailored in detail to meet different nation requirements. In the European methodology document one will not find a detailed description of how the inspection of a specific component should be qualified. A recommended practice is a document produced by ENIQ to support the production of detailed qualification procedures by individual countries. VVER SG tubes are inspected by EC method but a

  13. Clinical investigation of proximate exposed group, 1

    International Nuclear Information System (INIS)

    Ito, Chikako; Hasegawa, Kazuyo; Kato, Masafumi; Kumasawa, Toshihiko

    1984-01-01

    In order to investigate effects of the A-bombing on prevalence of diabetes mellitus, follow-up studies were made on 5907 A-bomb survivors who received glucose tolerance test (GTT) during 20 years between 1963 and 1983. The A-bomb survivors were divided into the group A (1899 men and 1165 women exposed within 1.9 km from the hypocenter) and the group B (1725 men and 1118 women exposed 3.0 km or farther from it). Among non-obese survivors, 21.9% and 21.8% were being treated for diabetes mellitus or were evaluated as having diabetic type on GTT in the group A and the group B, respectively; while this was seen in 52.1% of obese survivors in the group A and 49.9% in the group B. There was no difference between the groups. In non-obese survivors, the annual development rate from the normal type to the diabetic type was 0.89% in the group A and 0.65% in the group B; the annual development rate from the borderline type to the diabetic type was 5.73% in the group A and 5.49% in the group B, showing no differences between the groups. The annual development rate from the normal or borderline type to the diabetic type was two times or higher in obese survivors than in non-obese survivors irrespective of exposure status. Regarding the number of diabetic survivors who became non-diabetic type in spite of having no treatment, and prevalence of diabetic complications, no difference was seen between the groups. These results suggest that the A-bombing has scarcely influenced the prevalence of diabetes mellitus and clinical course. (Namekawa, K.)

  14. A novel optical investigation technique for railroad track inspection and assessment

    Science.gov (United States)

    Sabato, Alessandro; Beale, Christopher H.; Niezrecki, Christopher

    2017-04-01

    Track failures due to cross tie degradation or loss in ballast support may result in a number of problems ranging from simple service interruptions to derailments. Structural Health Monitoring (SHM) of railway track is important for safety reasons and to reduce downtime and maintenance costs. For this reason, novel and cost-effective track inspection technologies for assessing tracks' health are currently insufficient and needed. Advancements achieved in recent years in cameras technology, optical sensors, and image-processing algorithms have made machine vision, Structure from Motion (SfM), and three-dimensional (3D) Digital Image Correlation (DIC) systems extremely appealing techniques for extracting structural deformations and geometry profiles. Therefore, optically based, non-contact measurement techniques may be used for assessing surface defects, rail and tie deflection profiles, and ballast condition. In this study, the design of two camera-based measurement systems is proposed for crossties-ballast condition assessment and track examination purposes. The first one consists of four pairs of cameras installed on the underside of a rail car to detect the induced deformation and displacement on the whole length of the track's cross tie using 3D DIC measurement techniques. The second consists of another set of cameras using SfM techniques for obtaining a 3D rendering of the infrastructure from a series of two-dimensional (2D) images to evaluate the state of the track qualitatively. The feasibility of the proposed optical systems is evaluated through extensive laboratory tests, demonstrating their ability to measure parameters of interest (e.g. crosstie's full-field displacement, vertical deflection, shape, etc.) for assessment and SHM of railroad track.

  15. Clinical Investigation of Benign Asbestos Pleural Effusion

    Directory of Open Access Journals (Sweden)

    Nobukazu Fujimoto

    2015-01-01

    Full Text Available There is no detailed information about benign asbestos pleural effusion (BAPE. The aim of the study was to clarify the clinical features of BAPE. The criteria of enrolled patients were as follows: (1 history of asbestos exposure; (2 presence of pleural effusion determined by chest X-ray, CT, and thoracentesis; and (3 the absence of other causes of effusion. Clinical information was retrospectively analysed and the radiological images were reviewed. There were 110 BAPE patients between 1991 and 2012. All were males and the median age at diagnosis was 74 years. The median duration of asbestos exposure and period of latency for disease onset of BAPE were 31 and 48 years, respectively. Mean values of hyaluronic acid, adenosine deaminase, and carcinoembryonic antigen in the pleural fluid were 39,840 ng/mL, 23.9 IU/L, and 1.8 ng/mL, respectively. Pleural plaques were detected in 98 cases (89.1%. Asbestosis was present in 6 (5.5% cases, rounded atelectasis was detected in 41 (37.3% cases, and diffuse pleural thickening (DPT was detected in 30 (27.3% cases. One case developed lung cancer (LC before and after BAPE. None of the cases developed malignant pleural mesothelioma (MPM during the follow-up.

  16. Clinical Investigation Program: Annual Progress Report

    Science.gov (United States)

    1992-09-30

    Diamminedichloroplatinum (II), Methotrexate and Bleomycin in the Treatment of Advanced Epidermoid Carcinoma of the Penis , Phase II...II), Methotrexate and Bleomycin in the Treatment of Advanced Epidermoid Carcinoma of the Penis , Phase II (5) Start Date: (6) Est Compl Date: (7...Associate Investigators (11) Key Words: constitutional delay delayed puberty (12) Accumulative MEDCASE:* (13) Est Accum OKA Cost:* *Refer to Unit Summary

  17. Clinical significance of nuclide renal dynamic imaging and urine microalbumin inspection of type II diabetic patients

    International Nuclear Information System (INIS)

    Wang Ying; Jin Yaoge; Shi Xueying; Gao Yong

    2011-01-01

    To investigate clinical value of glomerular filtration rate (GFR) and urine microalbumin in early diagnosis of diabetic nephropathy, GFR in 60 patients with type II diabetes mellitus and a control group of 20 were determined using 99 Tc m DTPA renal dynamic imaging and urine microalbumin. The following results were obtained.Among the 60 patients with diabetes, 5 patients had increased GFRs of, 142.0±13.6 mg/min, which was 35% higher than that of controls and differed significantly from the control (P<0.01); 20 patients had GFRs of 102.2±10.2 mg/min, which differed little from the control; and 35 patients had declined GFRs of 57.2±18.0 mg/min, which was 54.3% lowered than the control and differed significantly from the control (P<0.01). The urine microalbumin in diabetes patients was significantly higher than the control. In conclusion, the GFR is a good index of the early kidney injury in diabetic patients. The combined detection of GFR and urine microalbumin can improve the early diagnosis of diabetic nephropathy, and may help to monitor the treatment response and assess prognosis. (authors)

  18. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1993-09-30

    The assigned staff of the Molecular Biology Service are Dr. Anthony G. Gutierrez , Chef , GSl3, Ph. D. in Molecular Genetics, and Ms. Judith O’Brien...Node-Negative Breast Cancer Patients Using a Panel of Prognostic Factors. A Companion Protocol to SWOG 8897 ................................ . 103 91...of Prog- nostic Factors. A companion protocol to 8897 (5) Start Date: 1991 (6) Est Compl Date: (7) Principal Investigator: (8) Facility: FAMC Thomas

  19. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1988-10-20

    Presented: Interna- tional Symposium on Orthopedics, Mexico , September 1987. Publications: In preparation. 147 FAMC A.P.R. (RCS MED 300) Detail Summary...Infection: A Prospective Study. Presented: 2nd Annual Symposium of the Rocky Moun- tain Flow Cytometry Users Group, Albuquerque, New Mexico , 10-11...Podgore, COL, MC (9) Dept/ISvc: Pediatrics (10) Associate Investigators (11) Key Words: Myron J. Levin, M.D. varicella vaccine U Co. HSC (12

  20. Measurements of body protein for clinical investigation

    International Nuclear Information System (INIS)

    Mernagh, J.R.; Harrison, J.E.; McNeill, M.G.; Jeejeebhoy, K.N.; Krishnan, S.S.

    1986-01-01

    Body protein (nitrogen) is determined by bilaterally irradiating the body with neutrons using Pu-Be sources and measuring the resultant 10.8 MeV gamma rays from the reaction 14 N(n,8) 15 N. In the authors lab the whole body can be scanned or separate segments of the body can be measured independently. A nitrogen index has been developed based on body size and is used as a predictor of normal total body nitrogen (TBN). They have found that TBN, when normalized to body size in this way, provides a reliable index of protein status which cannot be accurately determined by body weight, anthropometry, or body potassium measurements. Changes in body composition with age were studied by measuring the composition of 56 healthy female volunteers aged 20-80. Measurements were made for K( 40 K), Ca and N. It was shown that protein and bone mineral decrease with age but that this is not reflected in K or anthropometry measurements. Results of other studies to be presented include: body protein measurements pre and post TPN (total parenteral nutrition), nutritional status of patients on long term CAPD (continuous ambulatory peritoneal dialysis) and changes in body composition as a result of TPN in patients with small cell lung cancer receiving chemotherapy. Clinical results show that indirect measurements of body protein based on weight, potassium, or anthropometry, do not give an accurate measure of body protein. For an accurate measurement, direct measurement of body protein is necessary

  1. [Support Team for Investigator-Initiated Clinical Research].

    Science.gov (United States)

    Fujii, Hisako

    2017-07-01

    Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

  2. Clinical investigation of fatty liver by CT

    International Nuclear Information System (INIS)

    Kato, Katsumoto; Takayama, Tetsuo; Sano, Hiroshi; Katada, Naoyuki; Takeichi, Masayuki

    1984-01-01

    CT findings of 56 cases of diffuse fatty infiltration comfirmed by liver biopsy were investigated and compared with those of chronic hepatitis and liver cirrhosis. We found that the diagnosis of severe fatty infiltration (fatty liver) can be specifically possible when the ratios of CT values of liver to those of spleen are less than 0.85 and it is reasonable criterion for diagnosis of fatty liver by CT. This criterion was satisfied by 197 studies (2.9%), 169 cases with fatty liver (diffuse: 141 cases, focal: 28 cases) of 6800 CT studies of liver. Obesity, diabetes and alcohol abuse were main causative factors in both diffuse and focal fatty liver. The percentage of cases showing no abnormal results in blood chemistry tests was great compared with the previous report based on liver biopsy. The changes of CT values of liver faithfully reflected the improvement of each causal factor and reciprocal changes were observed between diffuse and focal fatty liver in repeated CT examination. So, CT is useful in estimating the effect of treatment as well as in diagnosis of fatty liver. Focal fatty liver is temporary manifestation during the proscess of development or improvement of fatty liver. (author)

  3. Investigation into the March 28, 1979 Three Mile Island accident by Office of Inspection and Enforcement (Investigative Report No. 50-320/79-10)

    International Nuclear Information System (INIS)

    1979-07-01

    On March 28, 1979, the Three Mile Island Unit 2 Nuclear Power Plant experienced the most severe accident in U.S. commercial nuclear power plant operating history. This report sets forth the facts concerning the events of the accident determined as a result of an investigation by the NRC Office of Inspection and Enforcement. The IE investigation is limited to two aspects of the accident: (1) Those related operational actions by the licensee during the period from before the initiating event until approximately 8:00 p.m., March 28, when primary coolant flow was re-established by starting a reactor coolant pump, and (2) Those steps taken by the licensee to control the release of radioactive material to the off-site environs, and to implement his emergency plan during the period from the initiation of the event to midnight, March 30. These investigation periods were selected because they include the licensee actions which most significantly affected the accident sequence and its results

  4. Project inspection using mobile technology - phase I : an investigation into existing business processes and areas for improvement using mobile technology.

    Science.gov (United States)

    2013-08-01

    As mobile technology becomes widely available and affordable, transportation agencies can use this technology to : streamline operations involved within project inspection. This research, conducted in two phases, identified : opportunities for proces...

  5. Notification: Background Investigation Services EPA’s Efforts to Incorporate Environmental Justice Into Clean Air Act Inspections for Air Toxics

    Science.gov (United States)

    Project #OPE-FY14-0017, March 7, 2014. The OIG plans to begin the preliminary research phase of an evaluation of the EPA's efforts to incorporate environmental justice into Clean Air Act (CAA) inspections for air toxics.

  6. Acceptability of cervical cancer screening using visual inspection among women attending a childhood immunization clinic in Uganda

    Directory of Open Access Journals (Sweden)

    Meng Li

    2017-12-01

    Full Text Available Objective: To evaluate the acceptability and performance of cervical cancer (CC screening using visual inspection with acetic acid (VIA integrated into a rural immunization clinic in Uganda. Methods/materials: We conducted a cross-sectional pilot study in rural Uganda. We explored associations between women's characteristics and acceptance of VIA testing. We collected samples for Papanicolaou (Pap smear testing in a random subset of women and used results from this test as a comparator for assessing VIA performance. Results: We enrolled 625 women of whom 571 (91.4% accepted and 54 (8.6% refused CC screening. In the univariate model, age (Odds Ratio (OR=1.10; p-value<0.001 and employment status (OR 2.00; p-value=0.019 were significantly associated with acceptance of VIA screening. In the multivariate model, no characteristic was independently associated with acceptance of VIA screening after adjusting for other factors. Compared to reference Pap smear, CC screening with VIA had a sensitivity of 50% and a specificity of 97.7%. Conclusions: CC screening with VIA is highly acceptable in the setting of rural immunization clinics in Uganda. Studies to assess which screening method would be the most effective and cost-effective are needed before stakeholders can consider adopting screening programs at scale.

  7. Inspection Database

    Data.gov (United States)

    U.S. Department of Health & Human Services — FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not...

  8. Clinical Investigation of Treatment Failure in Type 2 Diabetic ...

    African Journals Online (AJOL)

    Clinical Investigation of Treatment Failure in Type 2 Diabetic Patients ... Purpose: To examine body mass index (BMI), occupation, sex, age, and ... development of secondary failure in type 2 diabetics receiving metformin and glibenclamide.

  9. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  10. Inspection planning

    International Nuclear Information System (INIS)

    Korosec, D.; Levstek, M.F.

    2001-01-01

    Slovenian Nuclear Safety Administration (SNSA) division of nuclear and radiological safety inspection has developed systematic approach to their inspections. To be efficient in their efforts regarding regular and other types of inspections, in past years, the inspection plan has been developed. It is yearly based and organized on a such systematic way, that all areas of nuclear safety important activities of the licensee are covered. The inspection plan assures appropriate preparation for conducting the inspections, allows the overview of the progress regarding the areas to be covered during the year. Depending on the licensee activities and nature of facility (nuclear power plant, research reactor, radioactive waste storage, others), the plan has different levels of intensity of inspections and also their frequency. One of the basic approaches of the plan is to cover all nuclear and radiological important activities on such way, that all regulatory requests are fulfilled. In addition, the inspection plan is a good tool to improve inspection effectiveness based on previous experience and allows to have the oversight of the current status of fulfillment of planned inspections. Future improvement of the plan is necessary in the light of newest achievements on this field in the nuclear world, that means, new types of inspections are planned and will be incorporated into plan in next year.(author)

  11. Clinical investigations for SUS, the Brazilian public health system.

    Science.gov (United States)

    Paula, Ana Patrícia de; Giozza, Silvana Pereira; Pereira, Michelle Zanon; Boaventura, Patrícia Souza; Santos, Leonor Maria Pacheco; Sachetti, Camile Giaretta; Tamayo, César Omar Carranza; Kowalski, Clarissa Campos Guaragna; Elias, Flavia Tavares Silva; Serruya, Suzanne Jacob; Guimarães, Reinaldo

    2012-01-01

    Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

  12. Investigating antibiotic resistance in non-clinical environments

    Directory of Open Access Journals (Sweden)

    Fiona eWalsh

    2013-02-01

    Full Text Available There have been many calls for more information about the natural resistome and these have also highlighted the importance of understanding the soil resistome in the preservation of antibiotics for the treatment of infections. However, to date there have been few studies which have investigated the culturable soil resistome, which highlights the difficulties faced by microbiologists in designing these experiments to produce meaningful data. The World Health Organization definition of resistance is the most fitting to non-clinical environmental studies: Antimicrobial resistance is resistance of a microorganism to an antimicrobial medicine to which it was previously sensitive. The ideal investigation of non-clinical environments for antibiotic resistance of clinical relevance would be using standardized guidelines and breakpoints. This review outlines different definitions and methodologies used to understand antibiotic resistance and suggests how this can be performed outside of the clinical environment.

  13. 59th Medical Wing Clinical Research Division Clinical Investigations Program Pathology Poster

    Science.gov (United States)

    2017-04-28

    59 MDW/SGVU SUBJECT: Professional Presentation Approval 1. Your paper, entitled 59th Medical Wing Clinical Research Division Clinical Investigations...Program Pathology Poster presented at/published to For hanging in a hallway of the 591h Medical Wing Clinical Research Division, Bldg 4430 in...Graduate Health Sciences Education student and your department has told you they cannot fund your publication, the 59th Clinical Research Division may

  14. Inspection vehicle

    International Nuclear Information System (INIS)

    Takahashi, Masaki; Omote, Tatsuyuki; Yoneya, Yutaka; Tanaka, Keiji; Waki, Tetsuro; Yoshida, Tomiji; Kido, Tsuyoshi.

    1993-01-01

    An inspection vehicle comprises a small-sized battery directly connected with a power motor or a direct power source from trolly lines and a switching circuit operated by external signals. The switch judges advance or retreat by two kinds of signals and the inspection vehicle is recovered by self-running. In order to recover the abnormally stopped inspection vehicle to the targeted place, the inspection vehicle is made in a free-running state by using a clutch mechanism and is pushed by an other vehicle. (T.M.)

  15. 76 FR 20575 - Disqualification of a Clinical Investigator

    Science.gov (United States)

    2011-04-13

    ... research or marketing permit for products regulated by FDA. This proposal is based in part upon.... SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Background III. Description of the Proposed.... References I. Introduction Under current regulations, a clinical investigator disqualified by the...

  16. Clinical Investigation Program. Annual Progress Report. Volume 1

    Science.gov (United States)

    1994-01-20

    Components Surgical Day, Bethesda, MD, in April 1993. 2. Planned for FY-94 The Department of Clinical Investigation hopes to maintain the essence of the...sclerosing cholangitis after choledochojejun- ostomy : radiographic and biochemical improvement with antibiotic therapN. Am J Gastroenterol 1993;88:1635

  17. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    Science.gov (United States)

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

  18. Clinical investigations for SUS, the Brazilian public health system

    Directory of Open Access Journals (Sweden)

    Ana Patrícia de Paula

    Full Text Available CONTEXT AND OBJECTIVE: Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. DESIGN AND SETTING: Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. METHODS: The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. RESULTS: The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa, especially with regard to establishing a National Clinical Research Network. CONCLUSION: The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

  19. Ultrasonic inspection

    International Nuclear Information System (INIS)

    Satittada, Gannaga

    1984-01-01

    Ultrasonic inspection is one of the most widely used methods for nondestructive inspection. The beam of high-frequency sound wave, ultrasonic wave, is introduced into the material. It travels through the material with some attendant loss of energy and can be reflected at interfaces. The reflected beam is detected and analyzed. Ultrasonic inspection is used to detect flaws in metal parts as well as in welded, brazed and bonded joints during research work and developing production and service. It is also used to detect and locate porosity, pipe, and flakes. In addition, it can be used for the measurement of metal thickness. Ultrasonic inspection is therefore used for quality control and material inspection in all major industries

  20. Comparative clinical and haematological investigations in lactating cows with subclinical and clinical ketosis

    Directory of Open Access Journals (Sweden)

    Vania Marutsova

    2015-10-01

    Full Text Available Ketosis of lactating cows is among the most common metabolic diseases in modern dairy farms. The economic importance of the disease is caused by the reduced milk yield and body weight loss, poor feed conversion, lower conception rates, culling and increased mortality of affected animals. In the present study, a total of 47 high-yielding dairy cows up to 45 days in milk (DIM are included. All animals were submitted to physical examination wich included checking the rectal body temperature, heart rate, respiratory and rumen contraction rates, and inspection of visible mucous coats. The body condition was scored, and blood β-hydroxybutyrate (BHBA concentrations were assayed. The cows were divided into 3 groups: first group (control (n=24 with blood β-hydroxybutyrate level 2.6 mmol/l (clinical ketosis. Whole blood samples were obtained and analyzed for Red Blood Cell (RBC, 1012/l, Hemoglobin (HGB, g/l, Hematocrit (HCT, %, Mean Corpuscular Volume (MCV, fl, Mean Corpuscular Hemoglobin (MCH, pg, Mean Corpuscular Hemoglobin Concentration (MCHC, g/l, White Blood Cell (WBC, 109/l, Lymphocytes (LYM, 109/l, Monocytes (MON, 109/l, Granulocytes (GRA, 109/l, Red Blood Distribution Width (RDW, %, Red Blood Cell Distribution Width Absolute (RDWa, fl, Platelets (PLT, 109/l and Mean Platelet Volume (MPV, fl. In this study, deviations in the clinical parameters in the control group and in those with subclinical ketosis were not identified. The cows from the third group (clinical ketosis exhibited hypotonia, anorexia and body weight loss vs. control group. Hematological analysis showed leukocytosis and lymphocytosis in cows with subclinical ketosis vs. control group. In cows with clinical ketosis WBC counts decreased (leukopenia, while hemoglobin content and hematocrit values are higher vs. control group. Blood BHBA values are higher in both groups of ketotic cows vs. the control group. The other analyzed parameters (RBC, MCH, MCHC, MCV, RDW, RDWa, MON, GRA, PLT

  1. A history of the American Society for Clinical Investigation

    Science.gov (United States)

    Howell, Joel D.

    2009-01-01

    One hundred years ago, in 1909, the American Society for Clinical Investigation (ASCI) held its first annual meeting. The founding members based this new society on a revolutionary approach to research that emphasized newer physiological methods. In 1924 the ASCI started a new journal, the Journal of Clinical Investigation. The ASCI has also held an annual meeting almost every year. The society has long debated who could be a member, with discussions about whether members must be physicians, what sorts of research they could do, and the role of women within the society. The ASCI has also grappled with what else the society should do, especially whether it ought to take a stand on policy issues. ASCI history has reflected changing social, political, and economic contexts, including several wars, concerns about the ethics of biomedical research, massive increases in federal research funding, and an increasingly large and specialized medical environment. PMID:19348041

  2. Comparative clinical, roentgenological, scintigraphic and thermographic investigations in psoriasis arthropathica

    International Nuclear Information System (INIS)

    Loreck, D.; Lips, H.; Schulze, P.

    1988-01-01

    20 patients with psoriasis arthropatica and different duration of the articular symptoms were examined. Besides clinical investigation radiographs of both hands and feet (central and phalanges), scintigraphy of hands, feet and the sacroiliac joints as well as liquid crystal thermograhy of both hands were performed and the results are compared. The conclusions drawn characterize the diagnostic value of the methods. Scintigraphy as well as thermography are very good means for the early detection of psoriasis arthropathica. (author)

  3. An Investigation into the Clinical Reasoning Development of Veterinary Students.

    Science.gov (United States)

    Vinten, Claire E K; Cobb, Kate A; Freeman, Sarah L; Mossop, Liz H

    Clinical reasoning is a fundamental skill for veterinary clinicians and a competency required of graduates by the Royal College of Veterinary Surgeons. However, it is unknown how veterinary students develop reasoning skills and where strengths and shortcomings of curricula lie. This research aimed to use the University of Nottingham School of Veterinary Medicine and Science (SVMS) as a case study to investigate the development of clinical reasoning among veterinary students. The analysis was framed in consideration of the taught, learned, and declared curricula. Sixteen staff and sixteen students from the SVMS participated separately in a total of four focus groups. In addition, five interviews were conducted with recent SVMS graduates. Audio transcriptions were used to conduct a thematic analysis. A content analysis was performed on all curriculum documentation. It was found that SVMS graduates feel they have a good level of reasoning ability, but they still experience a deficit in their reasoning capabilities when starting their first job. Overarching themes arising from the data suggest that a lack of responsibility for clinical decisions during the program and the embedded nature of the clinical reasoning skill within the curriculum could be restricting development. In addition, SVMS students would benefit from clinical reasoning training where factors influencing "real life" decisions (e.g., finances) are explored in more depth. Integrating these factors into the curriculum could lead to improved decision-making ability among SVMS graduates and better prepare students for the stressful transition to practice. These findings are likely to have implications for other veterinary curricula.

  4. Hospital Inspections

    Data.gov (United States)

    U.S. Department of Health & Human Services — Welcome to hospitalinspections.org, a website run by the Association of Health Care Journalists (AHCJ) that aims to make federal hospital inspection reports easier...

  5. Clinical investigation on RBE estimation for heavy particle radiotherapy

    International Nuclear Information System (INIS)

    Tsuji, Hiroshi; Kamada, Tadashi; Yanagi, Takeshi; Mizoe, Junetsu; Tsujii, Hirohiko

    2004-01-01

    Analysis of the clinical updated data of the prostate cancer patients treated with carbon-ions was performed for the purpose of investigating the clinical relative biological effectiveness (RBE) values of carbon ion beams. Most of the patients received the carbon ion radiotherapy (C-ion RT) with the dose of 66.0 GyE/20 fractions. Probabilities of the late urethral morbidity and biochemical tumor control with this dose fractionation were calculated using the actual updated clinical data. The linear energy transfer (LET) values and physical carbon ion doses of urethra were obtained from treatment planning data. RBE values were calculated from the ratio of average carbon physical doses and photon doses which cause the same grade of urethra reaction with the same probabilities. Obtained RBE values were compared with the values that are being used in actual carbon ion radiotherapy in National Institute of Radiological Sciences (NIRS). In addition, relative RBE of carbon ion beams for biochemical tumor control was calculated using the data from the literature. As a result, the RBE values being used for the treatment were thought to be proper enough for both the urethra reaction and tumor control. (author)

  6. An interactive data management and analysis system for clinical investigators.

    Science.gov (United States)

    Groner, G F; Hopwood, M D; Palley, N A; Sibley, W L; Baker, W R; Christopher, T G; Thompson, H K

    1978-09-01

    An interactive minicomputer-based system has been developed that enables the clinical research investigator to personally explore and analyze his research data and, as a consequence of these explorations, to acquire more information. This system, which does not require extensive training or computer programming, enables the investigator to describe his data interactively in his own terms, enter data values while having them checked for validity, store time-oriented patient data in a carefully controlled on-line data base, retrieve data by patient, variable, and time, create subsets of patients with common characteristics, perform statistical analyses, and produce tables and graphs. It also permits data to be transferred to and from other computers. The system is well accepted and is being used by a variety of medical specialists at the three clinical research centers where it is operational. Reported benefits include less elapsed and nonproductive time, more thorough analysis of more data, greater and earlier insight into the meaning of research data, and increased publishable results.

  7. Clinical trials in orthopaedics and the future direction of clinical investigations for femoroacetabular impingement

    DEFF Research Database (Denmark)

    Clohisy, John C; Kim, Young-Jo; Lurie, Jon

    2013-01-01

    to be further defined. To date, clinical research reports have included primarily surgical case series. Future clinical investigations are needed to establish improved clinical evidence to guide patient care. Most urgent is the need to better understand the potential role of standardized nonsurgical treatment......Femoroacetabular impingement (FAI) represents a heterogeneous group of disorders that affect a diverse patient population. The natural history of the disease, the role of nonsurgical management, the indications for surgery, optimal surgical techniques, and the predictors of treatment outcomes need...... options for FAI and to define the predictors of surgical and nonsurgical outcomes. Future randomized controlled trials and large observational cohort studies targeted at these clinical research deficiencies will strengthen the evidence and improve informed decision making regarding the management...

  8. Operational inspections

    International Nuclear Information System (INIS)

    Bystersky, M.

    1997-01-01

    Special equipment is described, designed for inspection of reactor pressure vessels performed from the inside. Central shaft manipulator ZMM-5 is available for crack detection control using ultrasound and eddy currents, for visual check of surfaces, repair works at the reactor pressure vessel, and hardness measurements. The manipulator consists of the manipulator bridge, a cable container, shaft segments, a control mechanism and auxiliary parts. Eight inspections were performed at the Bohunice nuclear power plant and two at the Paks nuclear power plant. (M.D.)

  9. Sesame seed allergy: Clinical manifestations and laboratory investigations

    Directory of Open Access Journals (Sweden)

    Fazlollahi MR.

    2007-10-01

    Full Text Available Background: Plant-origin foods are among the most important sources of food allergic reactions. An increase in the incidence of sesame seed allergy among children and adults has been reported in recent years. The aim of this preliminary study was to investigate the prevalence, importance and clinical manifestations of sesame allergy among Iranian patients.Methods: In a cross-sectional survey, 250 patients with suspected IgE-mediated food allergies completed a questionnaire and underwent skin prick tests with sesame extract as well as cross-reacting foods (walnut, soya and peanut. Total IgE and sesame-specific IgE levels were measured. Patients with positive skin test reactions and/or IgE specific for sesame without clinical symptoms were considered sensitive to sesame. The patients who also had clinical symptoms with sesame consumption were diagnosed as allergic to sesame.Results: Of the 250 patients enrolled in this study, 129 were male and 121 female, with a mean age of 11.7 years. The most common food allergens were cow's milk, egg, curry, tomato and sesame. Sesame sensitivity was found in 35 patients (14.1%. Only five patients (2% had sesame allergy. Sesame-sensitive patients had a significantly higher frequency of positive prick test to cross-reacting foods when compared to non-sensitized patients (p=0.00. The type of symptom was independent of gender and age of the patients, but urticaria and dermatitis-eczema were significantly more frequent in sensitized patients (p=0.008.Conclusions: This is the first study addressing the prevalence of sesame seed allergy in Iranian population. We found sesame to be a common and important cause of food allergy. The panel of foods recommended for use in diagnostic allergy tests should be adjusted.

  10. [Clinical investigation of the positioning accuracy of acute pulpitis pain].

    Science.gov (United States)

    Wang, Jin; Sun, Wei; Ji, Aiping

    2013-10-01

    This study aims to investigate the positioning accuracy of acute pulpitis pain and its possible factors. The clinical symptoms and physical signs of 3 432 cases of acute pulpitis were recorded and analyzed by using questionnaire forms, which included age, gender, tooth position, infection origin, pain history, time of acute attack, duration and nature of pain, pain frequency, referred pain areas, percussion examination, temperature pulp test, pulp bleeding, and positioning accuracy. Univariate analysis and multivariate stepwise regression analysis were used for data processing. Pain location was accurately identified by 39.1% of the patients with acute pulpitis. Referred pain could reduce the positioning accuracy of pain (P 0.05). Some cases of acute pulpitis pain can be located accurately. Referred pain and periodontium infection origin are related to the positioning accuracy of acute pulpitis pain. The exact cause of this correlation needs further study.

  11. Clinical Investigation of Radiation Retinopathy Fundus and Fluorescein Angiographic Features

    Institute of Scientific and Technical Information of China (English)

    LiMei; QiuGT

    1999-01-01

    Purpose:To investigate the fundus and fluorescein angiographic features in the patients with radiation retinopathy.Clinical Materials:Color fundus photography and/or fluorescein angiography from 13 patients with nasopharyngeal carcinomas received external beam radiation were retrospectively analyzed.Reslts:In this study,26 damaged eyes of 13 patients eveloped some degree of radiation retinopathy.The earliest and most common finding was macular microvascular changes (microaneurysms and/or telangiectasia),which was observed in 100%(26/26)of the eyes.Intraretinal hemorrhages,macular capillary nonperfusion,and macular edema were noted in 84%,50%,and 42% of the eyes,respectively.Conclusions:Radiation retinopathy is common after external beam radiation of nasopharyngeal carcinomas.The prominent changes include maular microvascular changes,intraretinal hemorrhages and macular capillary nonperfusion.

  12. [The role of gonadal peptides in clinical investigation].

    Science.gov (United States)

    Lahlou, N; Bouvattier, C; Linglart, A; Rodrigue, D; Teinturier, C

    2009-01-01

    Inhibins, activins, and anti-Mullerian hormone (AMH) are gonadal dimeric peptides produced in ovaries and testes by homologous cells, granulosa cells and Sertoli cells, respectively. The production of inhibins is driven by FSH, that of AMH may indirectly depends on FSH, while it is down regulated, at least in the male, by testosterone. In the past decade, measurements of serum inhibin and AMH have provided useful tools for clinical investigation in gonadal disorders: pseudohermaphroditism, androgen insensitivity, anorchidism, gonadal dysgenesis, disorders of pubertal developpement. Inhibins, activins, and AMH are also reliable markers of gonadal tumors. They are extensively used as indexes of fertility: in the male the production of inhibin B reflects the spermatogenetic activity, in women both inhibin B and AMH levels are correlated with the number of preantral and early antral follicles and reflect the ovarian reserve of follicles available for recruitment.

  13. Clinical investigation of 14C-urea breath test

    International Nuclear Information System (INIS)

    Yu Yongli; Zhu Ruisen; Ji Hong; Luo Quanyong

    2000-01-01

    To investigate clinical value of 14 C-urea breath test ( 14 C-UBT) for the diagnosis of Helicobacter pylori(Hp), 70 patients were both performed gastroscopy (taking gastric mucosae biopsy for rapid urease test and histology) and 14 C-UBT (some patients by Hp-IgG or DNAHp test also) within two days. The positive cases of both rapid urease test and histology was defined as 'gold standard' of Hp-positive, whereas the negative cases of both rapid urease test and histology as 'gold standard' of Hp-negative. The sensitivity of 14 C-UBT was 93.2%, the specificity 73.1%, and the diagnostic accuracy 85.7%. The difference (comparing with 'gold standard') was not marked (x 2 = 0.9 0.05(1) 2 = 3.84, P>0.05). But the diagnostic accuracy of 14 C-UBT (85.7%) and Hp-IgG (50%) had a marked difference (x 2 13.80>x 0.01(1) 2 = 6.64, P 14 C-UBT was easy to operate, reliable and suitable for clinical application

  14. Basic and clinical investigation of T3 immunoassay kit

    International Nuclear Information System (INIS)

    Konishi, Junji; Nakajima, Akiko; Morita, Rikushi; Endo, Keigo; Ikekubo, Katsuji

    1976-01-01

    T 3 immunoassay kit was investigated basically and clinically. A good result was obtained at the prescribed incubation temperature and for 16 hours of incubation time. Moreover, it was thought to be possible that incubation time could be shortened to 1 - 4 hours at 37 0 C. Specificity of antibody was good. Recovery of added T 3 was 100+-5 (S.D.) % on an average and parallel of dilution curve of high T 3 serum was also good. Variation coefficient of accuracy of this kit was 1.5 - 2.1 % and that of reproducibility was 1.3 - 6.6 %. Mild hemolysis did not affect measurement value. Serum T 3 level in normals, untreated patients with Basedow's disease and patients with primary hypothyroidism was 142+-21 ng/100 ml, 452+-156 ng/100 ml and 67+-17 ng/100 ml, respectively. Serum T 3 level in patients with Hashimoto's disease was distributed to a wide extent, but that of patients with goiter and simple goiter ranged within normal range. On the other side, serum T 3 level of normal pregnant woman was high and that of patients with anorexia nervosa showed low level. From the above mentioned results, it was concluded that this kit was simple in method and good in sensitivity, specificity and reproducibility and it was also useful for clinical applications. (M. Tsunoda)

  15. Factors associated with regulatory action involving investigation of illnesses associated with Shiga toxin-producing Escherichia coli in products regulated by the Food Safety and Inspection Service.

    Science.gov (United States)

    Green, Alice L; Seys, Scott; Douris, Aphrodite; Levine, Jeoff; Robertson, Kis

    2014-07-01

    We described characteristics of the Escherichia coli O157 and Escherichia coli non-O157 illness investigations conducted by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) during the 5-year period from 2006 through 2010. We created a multivariable logistic regression model to determine characteristics of these investigations that were associated with FSIS regulatory action, which was defined as having occurred if a product recall occurred or if FSIS personnel performed an environmental health assessment (Food Safety Assessment) at the implicated establishment. During this period, FSIS took regulatory action in 38 of 88 (43%) investigations. Illness investigations in which FoodNet states were involved were more likely to result in regulatory action. Illness investigations in which state and local traceback, or FSIS traceback occurred were more likely to result in regulatory action. Reasons for lack of action included evidence of cross-contamination after the product left a regulated establishment, delayed notification, lack of epidemiological information, and insufficient product information.

  16. Atomoxetine for hoarding disorder: A pre-clinical and clinical investigation.

    Science.gov (United States)

    Grassi, Giacomo; Micheli, Laura; Di Cesare Mannelli, Lorenzo; Compagno, Elisa; Righi, Lorenzo; Ghelardini, Carla; Pallanti, Stefano

    2016-12-01

    Despite several studies suggested that inattention and impulsivity-compulsivity could represent two core dimensions of hoarding disorder (HD), only a small case series study investigated the effectiveness of attention-deficit-hyperactivity-disorder (ADHD) medications in HD. The aim of the present study was to target attentional and inhibitory control networks in HD patients through the ADHD medication atomoxetine, moving from a preclinical investigation on an animal model of compulsive-like behavior (marble burying test) to a clinical investigation on both medicated and unmedicated patients with a primary diagnosis of HD without ADHD. Our preclinical investigation showed that acute administration of atomoxetine significantly reduced the compulsive-like behaviours of mice in the marble burying test without affecting neither locomotor activity and coordination nor exploration behaviours. When compared, atomoxetine and fluoxetine showed similar effects on the marble burying test. However, fluoxetine impaired both locomotor and exploratory activity. In our clinical investigation 12 patients were enrolled and 11 patients completed an open trial with atomoxetine at flexible dose (40-80 mg) for 12 weeks. At the endpoint the mean UCLA Hoarding Severity Scale score decreased by 41.3% for the whole group (p = 0003). Six patients were classified as full responders (mean symptom reduction of 57.2%) and three patients as partial responders (mean symptom reduction of 27.3%). Inattentive and impulsivity symptoms showed a significant mean score reduction of 18.5% from baseline to the endpoint (F (1,9) = 20.9, p = 0.0013). Hoarding symptoms improvement was correlated to reduction of patients' disability and increased in their global functioning. These preclinical and clinical data suggest that atomoxetine may be effective for HD and therefore should be considered for future controlled trials. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Dosimetry investigation of MOSFET for clinical IMRT dose verification.

    Science.gov (United States)

    Deshpande, Sudesh; Kumar, Rajesh; Ghadi, Yogesh; Neharu, R M; Kannan, V

    2013-06-01

    In IMRT, patient-specific dose verification is followed regularly at each centre. Simple and efficient dosimetry techniques play a very important role in routine clinical dosimetry QA. The MOSFET dosimeter offers several advantages over the conventional dosimeters such as its small detector size, immediate readout, immediate reuse, multiple point dose measurements. To use the MOSFET as routine clinical dosimetry system for pre-treatment dose verification in IMRT, a comprehensive set of experiments has been conducted, to investigate its linearity, reproducibility, dose rate effect and angular dependence for 6 MV x-ray beam. The MOSFETs shows a linear response with linearity coefficient of 0.992 for a dose range of 35 cGy to 427 cGy. The reproducibility of the MOSFET was measured by irradiating the MOSFET for ten consecutive irradiations in the dose range of 35 cGy to 427 cGy. The measured reproducibility of MOSFET was found to be within 4% up to 70 cGy and within 1.4% above 70 cGy. The dose rate effect on the MOSFET was investigated in the dose rate range 100 MU/min to 600 MU/min. The response of the MOSFET varies from -1.7% to 2.1%. The angular responses of the MOSFETs were measured at 10 degrees intervals from 90 to 270 degrees in an anticlockwise direction and normalized at gantry angle zero and it was found to be in the range of 0.98 ± 0.014 to 1.01 ± 0.014. The MOSFETs were calibrated in a phantom which was later used for IMRT verification. The measured calibration coefficients were found to be 1 mV/cGy and 2.995 mV/cGy in standard and high sensitivity mode respectively. The MOSFETs were used for pre-treatment dose verification in IMRT. Nine dosimeters were used for each patient to measure the dose in different plane. The average variation between calculated and measured dose at any location was within 3%. Dose verification using MOSFET and IMRT phantom was found to quick and efficient and well suited for a busy radiotherapy

  18. Clinical dosimetry in photon radiotherapy. A Monte Carlo based investigation

    International Nuclear Information System (INIS)

    Wulff, Joerg

    2010-01-01

    Practical clinical dosimetry is a fundamental step within the radiation therapy process and aims at quantifying the absorbed radiation dose within a 1-2% uncertainty. To achieve this level of accuracy, corrections are needed for calibrated and air-filled ionization chambers, which are used for dose measurement. The procedures of correction are based on cavity theory of Spencer-Attix and are defined in current dosimetry protocols. Energy dependent corrections for deviations from calibration beams account for changed ionization chamber response in the treatment beam. The corrections applied are usually based on semi-analytical models or measurements and are generally hard to determine due to their magnitude of only a few percents or even less. Furthermore the corrections are defined for fixed geometrical reference-conditions and do not apply to non-reference conditions in modern radiotherapy applications. The stochastic Monte Carlo method for the simulation of radiation transport is becoming a valuable tool in the field of Medical Physics. As a suitable tool for calculation of these corrections with high accuracy the simulations enable the investigation of ionization chambers under various conditions. The aim of this work is the consistent investigation of ionization chamber dosimetry in photon radiation therapy with the use of Monte Carlo methods. Nowadays Monte Carlo systems exist, which enable the accurate calculation of ionization chamber response in principle. Still, their bare use for studies of this type is limited due to the long calculation times needed for a meaningful result with a small statistical uncertainty, inherent to every result of a Monte Carlo simulation. Besides heavy use of computer hardware, techniques methods of variance reduction to reduce the needed calculation time can be applied. Methods for increasing the efficiency in the results of simulation were developed and incorporated in a modern and established Monte Carlo simulation environment

  19. Airplane tire inspection by image processing techniques

    OpenAIRE

    Jovancevic , Igor; Arafat , Al; Orteu , Jean-José; Sentenac , Thierry

    2016-01-01

    International audience; In this paper, we propose a new approach to detect and inspect airplane tires. We use normalized correlation based template matching to detect tires and GrabCut segmentation method to extract them from the background. We inspect the tires condition by investigating the tire treads. Ridge based intensity profiling gives satisfying inspection results.

  20. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Science.gov (United States)

    2013-02-26

    ... marketing applications, (2) what is meant by ``due diligence'' in obtaining financial disclosures from...: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

  1. Clinical Investigations and Management of Refractive Changes in ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    Pregnancy: A Case Report ... condition therefore requires clinical observation and monitoring until the resolution of the serous detachment is ... bilateral involvement in 40% cases of CSCR. .... edema, acute hypertensive retinopathy, retinal.

  2. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates

    KAUST Repository

    Heunis, Tiaan; Dippenaar, Anzaan; Warren, Robin M.; van Helden, Paul D.; van der Merwe, Ruben G.; Gey van Pittius, Nicolaas C.; Pain, Arnab; Sampson, Samantha L.; Tabb, David L.

    2017-01-01

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach we identified 59 peptides containing single amino acid variants, which covered ~9% of all total coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e. large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  3. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates

    KAUST Repository

    Heunis, Tiaan

    2017-08-18

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach we identified 59 peptides containing single amino acid variants, which covered ~9% of all total coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e. large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  4. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates.

    Science.gov (United States)

    Heunis, Tiaan; Dippenaar, Anzaan; Warren, Robin M; van Helden, Paul D; van der Merwe, Ruben G; Gey van Pittius, Nicolaas C; Pain, Arnab; Sampson, Samantha L; Tabb, David L

    2017-10-06

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of the utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study, we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach, we identified 59 peptides containing single amino acid variants, which covered ∼9% of all coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here, we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e., large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  5. Beyond Readability: Investigating Coherence of Clinical Text for Consumers

    Science.gov (United States)

    Hetzel, Scott; Dalrymple, Prudence; Keselman, Alla

    2011-01-01

    Background A basic tenet of consumer health informatics is that understandable health resources empower the public. Text comprehension holds great promise for helping to characterize consumer problems in understanding health texts. The need for efficient ways to assess consumer-oriented health texts and the availability of computationally supported tools led us to explore the effect of various text characteristics on readers’ understanding of health texts, as well as to develop novel approaches to assessing these characteristics. Objective The goal of this study was to compare the impact of two different approaches to enhancing readability, and three interventions, on individuals’ comprehension of short, complex passages of health text. Methods Participants were 80 university staff, faculty, or students. Each participant was asked to “retell” the content of two health texts: one a clinical trial in the domain of diabetes mellitus, and the other typical Visit Notes. These texts were transformed for the intervention arms of the study. Two interventions provided terminology support via (1) standard dictionary or (2) contextualized vocabulary definitions. The third intervention provided coherence improvement. We assessed participants’ comprehension of the clinical texts through propositional analysis, an open-ended questionnaire, and analysis of the number of errors made. Results For the clinical trial text, the effect of text condition was not significant in any of the comparisons, suggesting no differences in recall, despite the varying levels of support (P = .84). For the Visit Note, however, the difference in the median total propositions recalled between the Coherent and the (Original + Dictionary) conditions was significant (P = .04). This suggests that participants in the Coherent condition recalled more of the original Visit Notes content than did participants in the Original and the Dictionary conditions combined. However, no difference was seen

  6. Detailed simulation of ultrasonic inspections

    International Nuclear Information System (INIS)

    Chaplin, K.R.; Douglas, S.R.; Dunford, D.

    1997-01-01

    Simulation of ultrasonic inspection of engineering components have been performed at the Chalk River Laboratories of AECL for over 10 years. The computer model, called EWE for Elastic Wave Equations, solves the Elastic Wave Equations using a novel finite difference scheme. It simulates the propagation of an ultrasonic wave from the transducer to a flaw, the scatter of waves from the flaw, and measurement of signals at a receive transducer. Regions of different materials, water and steel for example, can be simulated. In addition, regions with slightly different material properties from the parent material can be investigated. The two major types of output are displays of the ultrasonic waves inside the component and the corresponding A-scans. EPRI and other organizations have used ultrasonic models for: defining acceptable ultrasonic inspection procedures, designing and evaluating inspection techniques, and for quantifying inspection reliability. The EWE model has been applied to the inspection of large pipes in a nuclear plant, gas pipeline welds and steam generator tubes. Most recent work has dealt with the ultrasonic inspection of pressure tubes in CANDU reactors. Pressure tube inspections can reliably detect and size defects; however, there are improvements that can be made. For example, knowing the sharpness of a flaw-tip is crucial for fitness for service assessments. Computer modelling of the ultrasonic inspection of flaws with different root radius has suggested inspection techniques that provide flaw tip radius information. A preliminary investigation of these methods has been made in the laboratory. The basis for the model will be reviewed at the presentation. Then the results of computer simulations will be displayed on a PC using an interactive program that analyzes simulated A-scans. This software tool gives inspection staff direct access to the results of computer simulations. (author)

  7. 77 FR 25353 - Disqualification of a Clinical Investigator

    Science.gov (United States)

    2012-04-30

    .... * * * * * Sec. 312.70, relating to whether an investigator is eligible to receive test articles under part 312... ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also... marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon...

  8. Department of Clinical Investigation Annual Research Progress Report, FY 1992

    Science.gov (United States)

    1992-09-30

    parameters in a group of residents over the course of their first year Graduate Medical Education training to follow changes in diet and exercise habits... hypocaloric state. This study would analyze the serum from these nine men collected before and after their training to correlate declines in body...ideal body weight, and % usual body weight. A clinical assessment (history and physical exam) will be done and a diet history taken. Patients will be

  9. Clinical Investigation Program Report, RCS MED-300 (R1).

    Science.gov (United States)

    1986-10-31

    handpieces . Technical Approach: The study will be conducted in vitro using the palatal roots of human maxillary molar teeth which previously extracted due...109 1985 Histoplasmosis Seroconversion Study. (T) 110 1986 A Comparative Study of Fetal Movement Perceptions in the Third Trimester of Multiparous and...Hartwell G, Portell FR: Clinical management of middle mesial root canals in mandibular molars : Two case reports. Submitted to J Am Dent Assn. DeFiore

  10. Clinical investigation of set-shifting subtypes in anorexia nervosa.

    Science.gov (United States)

    Abbate-Daga, Giovanni; Buzzichelli, Sara; Marzola, Enrica; Amianto, Federico; Fassino, Secondo

    2014-11-30

    While evidence continues to accumulate on the relevance of cognitive inflexibility in anorexia nervosa (AN), its clinical correlates remain unclear. We aimed at examining the relationship between set-shifting and clinical variables (i.e., eating psychopathology, depression, and personality) in AN. Ninety-four individuals affected by AN and 59 healthy controls (HC) were recruited. All participants were assessed using: Eating Disorders Inventory-2 (EDI-2), Temperament and Character Inventory (TCI), Beck Depression Inventory (BDI), and Wisconsin Card Sorting Test (WCST). The AN group scored worse than HCs on set-shifting. According to their neuropsychological performances, AN patients were split into two groups corresponding to poor (N=30) and intact (N=64) set-shifting subtypes. Interoceptive awareness, impulse regulation, and maturity fears on the EDI-2 and depression on the BDI differed across all groups (HC, intact, and poor set-shifting subtype). Self-directedness on the TCI differed significantly among all groups. Cooperativeness and reward dependence differed instead only between HC and AN poor set-shifting subtype. After controlling for depression, only interoceptive awareness remained significant with reward dependence showing a trend towards statistical significance. These findings suggest that multiple clinical variables may be correlated with set-shifting performances in AN. The factors contributing to impaired cognitive inflexibility could be more complex than heretofore generally considered. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  11. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

  12. Preliminary clinical pharmacological investigations of tylosin and tiamulin in chickens.

    Science.gov (United States)

    Ziv, G

    1980-10-15

    The minimal inhibitory concentrations (MIC) of tiamulin and tylosin for mycoplasma, Gram-positive, and Gram-negative micro-organisms isolated from chickens were determinated by the agar dilution method. Median MIC values for tiamulin against Mycoplasma gallisepticum (0.05 microgram/ml) and Mycoplasma synoviae (0.10 microgram/ml) were 2 to 4 times lower than the corresponding values for tylosin. Tiamulin was also slightly more effective in vitro in inhibiting Escherichia coli, Pasteurella multocida, and beta-haemolytic streptococci than was tylosin. Groups of chicken were offered tiamulin medicated drinking water at rates of 125 and 250 mg/litre for 48 hours. Average serum tiamulin concentrations were 0.38 and 0.78 microgram/ml, respectively. When tylosin tartrate was added to the drinking water at 500 and 700 mg/litre, average serum drug levels were 0.12 and 0.17 microgram/ml, respectively. Tiamulin was 45% bound in chicken serum, as against 30% serum protein binding for tylosin. Correlations were made between free (non protein bound) serum drug levels and the MIC values of the two drugs. Such comparisons suggest that when tiamulin is given in the drinking water at rates of 125 to 250 mg/litre, better antimycoplasmal activity is to be expected in vivo than by giving tylosin tartrate in the drinking water at 500 to 700 mg/litre. Based on these data, no clinical efficacy of these dose rates can be expected in flocks infected by gram-negative micro-organisms such as E. coli or P. multocida. The tylosin tartrate rate of 500 to 700 mg/litre, may be clinical ineffective the treatment of Staphylococcus aureus infections.

  13. Clinical Investigation Program RCS-MED-300 (R1)

    Science.gov (United States)

    1988-09-30

    deprivation noted in the history or physical. Subjects agree to participate in the study. The independent variable is touch which if present is administered...INVESTIGATORS: MAJ Lynn Whittington , MC KEY WORDS: Intubation, pediatric training Study Objective: This training is designed to teach physicians and other health...with a high stress job are medical interns. Interns are sleep deprived , eat poorly, and have a high degree of emotional stress due to the novelty of

  14. 10 CFR 19.15 - Consultation with workers during inspections.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Consultation with workers during inspections. 19.15...: INSPECTION AND INVESTIGATIONS § 19.15 Consultation with workers during inspections. (a) Commission inspectors... inspectors deem necessary for the conduct of an effective and thorough inspection. (b) During the course of...

  15. Clinical investigations of receptive and expressive musical functions after stroke

    Directory of Open Access Journals (Sweden)

    Ken eRosslau

    2015-06-01

    Full Text Available There is a long tradition of investigating various disorders of musical abilities after stroke. These impairments, associated with acquired amusia, can be highly selective, affecting only music perception (i.e., receptive abilities/functions or expression (music production abilities, and some patients report that these may dramatically influence their emotional state. The aim of this study was to systematically test both the melodic and rhythmic domains of music perception and expression in left- and right-sided stroke patients compared to healthy subjects. Music perception was assessed using rhythmic and melodic discrimination tasks, while tests of expressive function involved the vocal or instrumental reproduction of rhythms and melodies. Our approach revealed deficits in receptive and expressive functions in stroke patients, mediated by musical expertise. Those patients who had experienced a short period of musical training in childhood and adolescence performed better in the receptive and expressive subtests compared to those without any previous musical training. While discrimination of specific musical patterns was unimpaired after a right-sided stroke, patients with a left-sided stroke had worse results for fine melodic and rhythmic analysis. In terms of expressive testing, the most consistent results were obtained from a test that required patients to reproduce sung melodies. This implies that the means of investigating production abilities can impact the identification of deficits.

  16. Clinical investigations of receptive and expressive musical functions after stroke.

    Science.gov (United States)

    Rosslau, Ken; Steinwede, Daniel; Schröder, C; Herholz, Sibylle C; Lappe, Claudia; Dobel, Christian; Altenmüller, Eckart

    2015-01-01

    There is a long tradition of investigating various disorders of musical abilities after stroke. These impairments, associated with acquired amusia, can be highly selective, affecting only music perception (i.e., receptive abilities/functions) or expression (music production abilities), and some patients report that these may dramatically influence their emotional state. The aim of this study was to systematically test both the melodic and rhythmic domains of music perception and expression in left- and right-sided stroke patients compared to healthy subjects. Music perception was assessed using rhythmic and melodic discrimination tasks, while tests of expressive function involved the vocal or instrumental reproduction of rhythms and melodies. Our approach revealed deficits in receptive and expressive functions in stroke patients, mediated by musical expertise. Those patients who had experienced a short period of musical training in childhood and adolescence performed better in the receptive and expressive subtests compared to those without any previous musical training. While discrimination of specific musical patterns was unimpaired after a left-sided stroke, patients with a right-sided stroke had worse results for fine melodic and rhythmic analysis. In terms of expressive testing, the most consistent results were obtained from a test that required patients to reproduce sung melodies. This implies that the means of investigating production abilities can impact the identification of deficits.

  17. Annual Progress Report FY 93 (Walter Reed Army Medical Center, Department of Clinical Investigation). Clinical Investigation Program. Volume 2

    Science.gov (United States)

    1993-01-01

    129 REPORT DATE: 03/04/93 WORK UNIT a 1332-91 DETAIL SUMMARY SHEET TITLE: Thermogenic Agent Promotion of Weight Loss in Obese Soldiers KEYWORDS...thermogenic, promotion, obese PRINCIPAL INVESTIGATOR: Solomon, Barbara DNSc DEPARTMENT: Department of Medicine STATUS: Completed SERVICE: Endocrine...are: possible variance between adult and chilhood forms of HD, patterns of previous infectious disease exposure, socioeconomic patterns, familial

  18. Notification: Background Investigation Services New Assignment Notification: EPA’s Efforts to Incorporate Environmental Justice Into Clean Air Act Inspections for Air Toxics

    Science.gov (United States)

    The purpose of this memorandum is to notify you that the EPA OIG plans to begin the preliminary research phase of an evaluation of the U.S. EPA's efforts to incorporate environmental justice into Clean Air Act inspections for air toxics.

  19. Patient engagement: an investigation at a primary care clinic

    Science.gov (United States)

    Gill, Preetinder Singh

    2013-01-01

    Background Engaged employees are an asset to any organization. They are instrumental in ensuring good commercial outcomes through continuous innovation and incremental improvement. A health care facility is similar to a regular work setting in many ways. A health care provider and a patient have roles akin to a team leader and a team member/stakeholder, respectively. Hence it can be argued that the concept of employee engagement can be applied to patients in health care settings in order to improve health outcomes. Methods Patient engagement data were collected using a survey instrument from a primary care clinic in the northern Indian state of Punjab. Canonical correlation equations were formulated to identify combinations which were strongly related to each other. In addition, the cause-effect relationship between patient engagement and patient-perceived health outcomes was described using structural equation modeling. Results Canonical correlation analysis showed that the first set of canonical variables had a fairly strong relationship, ie, a magnitude > 0.80 at the 95% confidence interval, for five dimensions of patient engagement. Structural equation modeling analysis yielded a β ≥ 0.10 and a Student’s t statistic ≥ 2.96 for these five dimensions. The threshold Student’s t statistic was 1.99. Hence it was found the β values were significant at the 95% confidence interval for all census regions. Conclusion A scaled reliable survey instrument was developed to measured patient engagement. Better patient engagement is associated with better patient-perceived health outcomes. This study provides preliminary evidence that patient engagement has a causal relationship with patient-perceived health outcomes. PMID:23515133

  20. Clinical investigation on application of water swallowing to MR esophagography

    Energy Technology Data Exchange (ETDEWEB)

    Zhang, Jinping, E-mail: zjpmri@163.com [Department of Radiology, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China); Hu, Weijian; Zang, Lin [Department of Cardiothoracic Surgery, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China); Yao, Yibin; Tang, Yongxiang; Qian, Zhen; Gao, Ping; Wu, Xiaoyan; Li, Shijian [Department of Radiology, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China); Xie, Zhenlan; Yuan, Xiaoqing [Department of Pathology, Tongling People' s Hospital, Bijiashan Road 468, Tongling 244000, Anhui (China)

    2012-09-15

    Objective: To verify the clinical outcomes of applying water swallowing to MR esophagography. Methods: Thirty patients confirmed postoperatively or histopathologically with thoracic esophageal carcinoma by endoscopic biopsy and 10 healthy volunteers with normal esophagus underwent respectively conventional magnetic resonance imaging (MRI) detection and water swallowing MR esophagography. Of those patients, 4 underwent second examination after radiotherapy. Assessment on imaging effects of MR esophagography was performed. Assessment on definition on MR esophagography of the tumor in both upper and lower ends, specific localization, tumor size finally measured, coincidence with the gross pathologic types and tumor staging were respectively performed by comparison with conventional MRI. Additionally, we evaluated the outcomes of radiotherapy by comparing the previous MR esophagography with the second one with interventional technique. Results: Of the total 44 images of MR esophagography, 97.7% (43/44) were in high resolution by sagittal view and 81.8% (36/44) by cross-section. 93.3% (56/60) of the MR esophagography were clearly defined with the neoplastic lesion ends in the 30 patients with thoracic esophageal carcinoma, compared with 11.7% (7/60) by conventional MRI. The results were totally different in statistics (P < 0.005). Preoperative conventional MRI detection of the 22 cases in 25 undergone radical resection suggested vague diameter of the primary tumor and impossibly identified it at middle-lower thoracic esophagus in 5, and even failed to confirm gross pathologic types in 19 cases. Yet, MR esophagography with water swallowing represented accurate tumor length (graded as excellent) in 88% (22/25), localization in 100% (25/25), exact gross pathologic types in 88% (22/25), and accuracy for tumor staging in 80.8% (21/26) compared to 92.3% (24/26) by conventional MRI. Therapeutic effects achieved in 4 patients with radiotherapy. Conclusions: MR esophagography

  1. Additive Manufacturing Infrared Inspection

    Science.gov (United States)

    Gaddy, Darrell; Nettles, Mindy

    2015-01-01

    The Additive Manufacturing Infrared Inspection Task started the development of a real-time dimensional inspection technique and digital quality record for the additive manufacturing process using infrared camera imaging and processing techniques. This project will benefit additive manufacturing by providing real-time inspection of internal geometry that is not currently possible and reduce the time and cost of additive manufactured parts with automated real-time dimensional inspections which deletes post-production inspections.

  2. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  3. Clinical trials using a radiopharmaceutical investigational drug: What legal environment and what authorizations required?

    International Nuclear Information System (INIS)

    El-Deeb, G.; Nguon, B.; Tibi, A.; Rizzo-Padoin, N.

    2009-01-01

    Recent revision of the legal environment for clinical research in France provided an opportunity to review what a hospital needs to carry out clinical trials using a radiopharmaceutical investigational drug. Legal measures concerning radiopharmaceutical investigational drugs are indeed more complex than those of classical clinical trials because of the additional legal provisions governing the use of ionizing radiation. Thus, requirements by the concerned staff (sponsor, pharmacist, person in charge of the nuclear activity) are described here. (authors) [fr

  4. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  5. Acoustic inspection device

    Energy Technology Data Exchange (ETDEWEB)

    Diaz, Aaron A.; Burghard, Brion J.; Skorpik, James R.; Pappas, Richard A.; Mullen, O. Dennis; Samuel, Todd J.; Reid, Larry D.; Harris, Joe C.; Valencia, Juan D.; Smalley, Jonathan T.; Shepard, Chester L.; Taylor, Theodore T.

    2005-09-06

    An ultrasound inspection apparatus particularly adapted to examine containers (sealed or unsealed) containing a liquid or solid bulk material. The apparatus has an overall configuration of a hand held pistol with a front transducer contact surface that is positioned against a front wall of the container. An ultrasound pulse is transmitted from the apparatus to be reflected from a back wall of a container being investigated. The received echo pulse is converted to a digital waveform. The waveform is analyzed relative to temperature, travel distance of the pulse(s), and time of travel to ascertain characteristics of the liquid or other materials and to provide identification of the same.

  6. Pre-Clinical and Clinical Investigation of the Impact of Obesity on Ovarian Cancer Pathogenesis

    Science.gov (United States)

    2015-12-01

    clinical cancer drug discovery , including 10 years as a Research Assistant Professor in the Department of Surgery at Duke University Medical Center...cancer therapy. Nature chemical biology . 2015;11(1):9-15. Epub 2014/12/18. doi: 10.1038/nchembio.1712. PubMed PMID: 25517383; PubMed Central PMCID...Assistant Professor of Nutrition, a member of the Nutrition Obesity Research Center, Center for Gastrointestinal Biology and Disease, McCallister Heart

  7. Automated Inspection of Aircraft

    Science.gov (United States)

    1998-04-01

    This report summarizes the development of a robotic system designed to assist aircraft inspectors by remotely deploying non-destructive inspection (NDI) sensors and acquiring, processing, and storing inspection data. Carnegie Mellon University studie...

  8. Optimising import phytosanitary inspection

    NARCIS (Netherlands)

    Surkov, I.

    2007-01-01

    Keywords: quarantine pest, plant health policy, optimization, import phytosanitary inspection, ‘reduced checks’, optimal allocation of resources, multinomial logistic regression, the Netherlands World trade is a major vector of spread of quarantine plant pests. Border phytosanitary inspection

  9. NRC program of inspection and enforcement

    International Nuclear Information System (INIS)

    LeDoux, J.C.; Rehfuss, C.

    1978-01-01

    The Nuclear Regulatory Commission (NRC) regulates civilian uses of nuclear materials to ensure the protection of the public health and safety and the environment. The Office of Inspection and Enforcement (IE) develops and implements the inspection, investigation, and enforcement programs for the NRC. The IE conducts inspection programs for reactors under construction and in operation, nuclear industry vendors, fuel facilities and users of nuclear materials, and all aspects of the safeguarding of facilities and materials. Recently the IE began implementing a program that will place inspectors on site at nuclear power reactors and will provide for national appraisal of licensee performance and for an evaluation of the effectiveness of the inspection programs

  10. [Methods of investigation in clinical cardiology. VIII. Socioeconomic evaluation of clinical cardiology practice].

    Science.gov (United States)

    Lázaro de Mercado, P

    1997-06-01

    Health services are systems whose mission is to improve the health status of both individuals and society in general. In recent decades, these systems have faced challenges such as their increasing complexity, limited resources, rapid innovation and diffusion of medical technologies, pressures on demand from society and professionals, and the lack of knowledge of the effects of these factors on costs and society's health. In addition, health care expenditures have grown twice as fast as wealth in industrialized countries during the last 25 years. These problems have prompted cost containment as a key issue in health policy and, at the same time, have promoted the development of socioeconomic evaluation as a scientific activity in the frame of health services research. Socioeconomic evaluation tries to determine if the sacrifice made by society, which devotes part of its limited resources to health care, maximizes the outcomes for population. This article describes basic concepts and methods of economic appraisal in health services which are illustrated with examples of clinical practice in cardiology. Common methods of evaluation are described; the relation between the clinical outcome of a procedure and its associated costs is emphasized in explaining the types of efficiency analysis (cost-efficacy, cost-effectiveness, cost-utility, and cost-benefit); and finally a guide for socioeconomic evaluation is provided.

  11. Applicable or non-applicable: investigations of clinical heterogeneity in systematic reviews

    Directory of Open Access Journals (Sweden)

    Laura E. Chess

    2016-02-01

    Full Text Available Abstract Background Clinical heterogeneity can be defined as differences in participant characteristics, types or timing of outcome measurements and intervention characteristics. Clinical heterogeneity in systematic reviews has the possibility to significantly affect statistical heterogeneity leading to inaccurate conclusions and misled decision making. The aim of this study is to identify to what extent investigators are assessing clinical heterogeneity in both Cochrane and non-Cochrane systematic reviews. Methods The most recent 100 systematic reviews from the top five journals in medicine—JAMA, Archives of Internal Medicine, British Medical Journal, The Lancet, and PLOS Medicine—and the 100 most recently published and/or updated systematic reviews from Cochrane were collected. Various defined items of clinical heterogeneity were extracted from the included reviews. Investigators used chi-squared tests, logarithmic modeling and linear regressions to determine if the presence of such items served as a predictor for clinical heterogeneity when comparing Cochrane to non-Cochrane reviews. Extracted variables include number of studies, number of participants, presence of quantitative synthesis, exploration of clinical heterogeneity, heterogeneous characteristics explored, basis and methods used for investigating clinical heterogeneity, plotting/visual aids, author contact, inferences from clinical heterogeneity investigation, reporting assessment, and the presence of a priori or post-hoc analysis. Results A total of 317 systematic reviews were considered, of which 199 were in the final analysis. A total of 81 % of Cochrane reviews and 90 % of non-Cochrane reviews explored characteristics that are considered aspects of clinical heterogeneity and also described the methods they planned to use to investigate the influence of those characteristics. Only 1 % of non-Cochrane reviews and 8 % of Cochrane reviews explored the clinical

  12. Investigators' viewpoint of clinical trials in India: Past, present and future

    Directory of Open Access Journals (Sweden)

    Mohandas K Mallath

    2017-01-01

    Full Text Available India's success in producing food and milk for its population (Green Revolution and White Revolution happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

  13. Technical objectives of inspection

    International Nuclear Information System (INIS)

    Sorenson, R.J.; Stewart, K.B.; Schneider, R.A.

    1976-01-01

    The various technical objectives of inspection are discussed in a very general manner. The discussion includes how the inspection function is related to the assumed threat, the various degrees of assurance and reliance on criteria, and the hierarchy of assurance which is obtained from the various types or levels of inspection

  14. Software Formal Inspections Guidebook

    Science.gov (United States)

    1993-01-01

    The Software Formal Inspections Guidebook is designed to support the inspection process of software developed by and for NASA. This document provides information on how to implement a recommended and proven method for conducting formal inspections of NASA software. This Guidebook is a companion document to NASA Standard 2202-93, Software Formal Inspections Standard, approved April 1993, which provides the rules, procedures, and specific requirements for conducting software formal inspections. Application of the Formal Inspections Standard is optional to NASA program or project management. In cases where program or project management decide to use the formal inspections method, this Guidebook provides additional information on how to establish and implement the process. The goal of the formal inspections process as documented in the above-mentioned Standard and this Guidebook is to provide a framework and model for an inspection process that will enable the detection and elimination of defects as early as possible in the software life cycle. An ancillary aspect of the formal inspection process incorporates the collection and analysis of inspection data to effect continual improvement in the inspection process and the quality of the software subjected to the process.

  15. 59th Medical Wing Clinical Research Division Clinical Investigations Program Posters (Count: 2)

    Science.gov (United States)

    2017-05-08

    Investigations Program Posters (Count: 2) presented at/published to Graduate School Faculty Development and Research Symposium, Gateway Club, JBSA...copy of your abstract, paper. poster and other supporting documentation. 5. Save and forward, via email, the processing form and all supporting...you a final letter of approval or disapproval. g, Once your manuscript, poster or presentation has been approved for a one-lime public release, you may

  16. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

    .... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

  17. Clinical investigation of CT-guided ozone-blowing and fumigation ...

    African Journals Online (AJOL)

    Clinical investigation of CT-guided ozone-blowing and fumigation therapy for the chronic ... African Journal of Biotechnology ... In control group, seven patients were completely cured in 45 days after being treated by traditional surgery.

  18. Randomization of inspections

    International Nuclear Information System (INIS)

    Markin, J.T.

    1989-01-01

    As the numbers and complexity of nuclear facilities increase, limitations on resources for international safeguards may restrict attainment of safeguards goals. One option for improving the efficiency of limited resources is to expand the current inspection regime to include random allocation of the amount and frequency of inspection effort to material strata or to facilities. This paper identifies the changes in safeguards policy, administrative procedures, and operational procedures that would be necessary to accommodate randomized inspections and identifies those situations where randomization can improve inspection efficiency and those situations where the current nonrandom inspections should be maintained. 9 refs., 1 tab

  19. Defense Treaty Inspection Readiness Program

    International Nuclear Information System (INIS)

    Cronin, J.J.; Kohen, M.D.; Rivers, J.D.

    1996-01-01

    The Defense Treaty Inspection Readiness Program (DTIRP) was established by the Department of Defense in 1990 to assist defense facilities in preparing for treaty verification activities. Led by the On-Site Inspection Agency (OSIA), an element of the Department of Defense, DTIRP''s membership includes representatives from other Department of Defense agencies, the Department of Energy (DOE), the Central Intelligence Agency, the Federal Bureau of Investigation, the Department of Commerce, and others. The Office of Safeguards and Security has a significant interest in this program, due to the number of national defense facilities within its purview that are candidates for future inspections. As a result, the Office of Safeguards and Security has taken a very active role in DTIRP. This paper discusses the Office of Safeguards and Security''s increasing involvement in various elements of the DTIRP, ranging from facility assessments to training development and implementation

  20. A clinical scoring system to prioritise investigation for tuberculosis among adults attending HIV clinics in South Africa.

    Directory of Open Access Journals (Sweden)

    Yasmeen Hanifa

    Full Text Available The World Health Organization (WHO recommendation for regular tuberculosis (TB screening of HIV-positive individuals with Xpert MTB/RIF as the first diagnostic test has major resource implications.To develop a diagnostic prediction model for TB, for symptomatic adults attending for routine HIV care, to prioritise TB investigation.Cohort study exploring a TB testing algorithm.HIV clinics, South Africa.Representative sample of adult HIV clinic attendees; data from participants reporting ≥1 symptom on the WHO screening tool were split 50:50 to derive, then internally validate, a prediction model.TB, defined as "confirmed" if Xpert MTB/RIF, line probe assay or M. tuberculosis culture were positive; and "clinical" if TB treatment started without microbiological confirmation, within six months of enrolment.Overall, 79/2602 (3.0% participants on ART fulfilled TB case definitions, compared to 65/906 (7.2% pre-ART. Among 1133/3508 (32.3% participants screening positive on the WHO tool, 1048 met inclusion criteria for this analysis: 52/515 (10.1% in the derivation and 58/533 (10.9% in the validation dataset had TB. Our final model comprised ART status (on ART > 3 months vs. pre-ART or ART 1 symptom. We converted this to a clinical score, using clinically-relevant CD4 and BMI categories. A cut-off score of ≥3 identified those with TB with sensitivity and specificity of 91.8% and 34.3% respectively. If investigation was prioritised for individuals with score of ≥3, 68% (717/1048 symptomatic individuals would be tested, among whom the prevalence of TB would be 14.1% (101/717; 32% (331/1048 of tests would be avoided, but 3% (9/331 with TB would be missed amongst those not tested.Our clinical score may help prioritise TB investigation among symptomatic individuals.

  1. [THE RESULTS OF CLINICAL AND PSYCHOPATHOLOGICAL AND PSYCHOLOGICAL DIAGNOSTIC INVESTIGATIONS EMPLOYEES OF FINANCIAL INSTITUTIONS WHICH WERE IDENTIFIED NEUROTIC DISORDERS].

    Science.gov (United States)

    Solovyova, M

    2014-12-01

    The article presents the results of the clinical and psychopathological and psychological diagnostic, investigations mental health employees of financial institutions, description and analysis of clinical forms identified disorders.

  2. Diagnostic investigation of patients with chronic polyneuropathy: evaluation of a clinical guideline

    NARCIS (Netherlands)

    Rosenberg, N. R.; Portegies, P.; de Visser, M.; Vermeulen, M.

    2001-01-01

    OBJECTIVE: (1) To evaluate a clinical guideline for the diagnostic investigation of patients presenting with signs and symptoms (present for longer than 6 weeks) suggesting a chronic polyneuropathy. (2) To investigate the contribution of electrophysiological studies to a focused search for aetiology

  3. GCP inspections in Germany and Europe following the implementation of the Directive 2001/20/EC

    Directory of Open Access Journals (Sweden)

    Hundt, Ferdinand

    2009-03-01

    Full Text Available Background: The implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections – which affect study sites, laboratories, sponsors and contract research organizations (CRO alike – make up an important part of these regulations. A common understanding of how these regulations apply in daily life is however not always ensured. Methods: A working group of the Clinical Research/Quality Assurance subcommittee of the German Association of Research-Based Pharmaceutical Companies (VFA was established to outline the regulatory requirements, the experience gathered with inspections by means of a survey and to set up guidance on how to manage an inspection. Results and conclusions: The survey, conducted with the help of 15 pharmaceutical companies within the VFA, included a total of 224 inspections (74 inspections in Germany, 150 from other European countries. Most frequent findings in and outside Germany were related to “documentation” (40.5% vs. 21.3%, “investigational new drugs” (16.2% vs. 14.7%, “drug safety” (13.5% vs. 8% and “application for a clinical trial authorization” (5.4% vs. 12%. From a German perspective, key findings of this working group were the necessity for a clear differentiation of responsibilities between national and federal as well as international authorities, a harmonization of inspection procedures and topics, and a clarification of whether pre-study/on-study and pre-approval/post-approval GCP inspections of the federal higher authority are included in the “Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten” (ZLG requirements. The survey illustrated, that inspections usually are conducted at the investigational site, and that most of the findings are well known and thus could be prevented by communicating and discussing

  4. Optical fiber inspection system

    Science.gov (United States)

    Moore, Francis W.

    1987-01-01

    A remote optical inspection system including an inspection head. The inspection head has a passageway through which pellets or other objects are passed. A window is provided along the passageway through which light is beamed against the objects being inspected. A plurality of lens assemblies are arranged about the window so that reflected light can be gathered and transferred to a plurality of coherent optical fiber light guides. The light guides transfer the light images to a television or other image transducer which converts the optical images into a representative electronic signal. The electronic signal can then be displayed on a signal viewer such as a television monitor for inspection by a person. A staging means can be used to support the objects for viewing through the window. Routing means can be used to direct inspected objects into appropriate exit passages for accepted or rejected objects. The inspected objects are advantageously fed in a singular manner to the staging means and routing means. The inspection system is advantageously used in an enclosure when toxic or hazardous materials are being inspected.

  5. On automatic visual inspection of reflective surfaces

    DEFF Research Database (Denmark)

    Kulmann, Lionel

    1995-01-01

    surfaces, providing new and exciting applications subject to automated visual inspection. Several contextual features have been surveyed along with introduction of novel methods to perform data-dependent enhancement of local surface appearance . Morphological methods have been described and utilized......This thesis descrbes different methods to perform automatic visual inspection of reflective manufactured products, with the aim of increasing productivity, reduce cost and improve the quality level of the production. We investigate two different systems performing automatic visual inspection....... The first is the inspection of highly reflective aluminum sheets, used by the Danish company Bang & Olufsen, as a part of the exterior design and general appearance of their audio and video products. The second is the inspection of IBM hard disk read/write heads for defects during manufacturing. We have...

  6. 46 CFR 153.812 - Inspection for Certificate of Inspection.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 5 2010-10-01 2010-10-01 false Inspection for Certificate of Inspection. 153.812... CARGOES SHIPS CARRYING BULK LIQUID, LIQUEFIED GAS, OR COMPRESSED GAS HAZARDOUS MATERIALS Design and Equipment Testing and Inspection § 153.812 Inspection for Certificate of Inspection. The rules governing the...

  7. A short version of the revised 'experience of close relationships questionnaire': investigating non-clinical and clinical samples.

    Science.gov (United States)

    Wongpakaran, Tinakon; Wongpakaran, Nahathai

    2012-01-01

    This study seeks to investigate the psychometric properties of the short version of the revised 'Experience of Close Relationships' questionnaire, comparing non-clinical and clinical samples. In total 702 subjects participated in this study, of whom 531 were non-clinical participants and 171 were psychiatric patients. They completed the short version of the revised 'Experience of Close Relationships' questionnaire (ECR-R-18), the Perceived Stress Scale-10(PSS-10), the Rosenberg Self-Esteem Scale (RSES) and the UCLA Loneliness scale. A retest of the ECR-R-18 was then performed at four-week intervals. Then, confirmatory factor analyses were performed to test the validity of the new scale. The ECR-R-18 showed a fair to good internal consistency (α 0.77 to 0.87) for both samples, and the test-retest reliability was found to be satisfactory (ICC = 0.75). The anxiety sub-scale demonstrated concurrent validity with PSS-10 and RSES, while the avoidance sub-scale showed concurrent validity with the UCLA Loneliness Scale. Confirmatory factor analysis using method factors yielded two factors with an acceptable model fit for both groups. An invariance test revealed that the ECR-R-18 when used on the clinical group differed from when used with the non-clinical group. The ECR-R-18 questionnaire revealed an overall better level of fit than the original 36 item questionnaire, indicating its suitability for use with a broader group of samples, including clinical samples. The reliability of the ECR-R- 18 might be increased if a modified scoring system is used and if our suggestions with regard to future studies are followed up.

  8. System of automated processing of radionuclide investigations (SAPRI-01) in clinical practice

    International Nuclear Information System (INIS)

    Sivachenko, T.P.; Mechev, D.S.; Krupka, I.N.

    1988-01-01

    The author described the results of clinical testing of a system SAPRI-01 designed for automated collection, storage and processing of data on radionuclide investigations. He gave examples of automated processing of RCG and the results of positive scintigraphy of tumors of different sites using 67 Ga-citrate and 99m Tc pertechnetate in statistical and dynamic investigations. Short-comings and ways for updating 4 the system during its serial production were pointed out. The introduction of the system into clinical practice on a wide scale was shown to hold promise

  9. Software inspections at Fermilab -- Use and experience

    International Nuclear Information System (INIS)

    Berman, E.F.

    1998-01-01

    Because of the critical nature of DA/Online software it is important to commission software which is correct, usable, reliable, and maintainable, i.e., has the highest quality possible. In order to help meet these goals Fermi National Accelerator Laboratory (Fermilab) has begun implementing a formal software inspection process. Formal Inspections are used to reduce the number of defects in software at as early a stage as possible. These Inspections, in use at a wide variety of institutions (e.g., NASA, Motorola), implement a well-defined procedure that can be used to improve the quality of many different types of deliverables. The inspection process, initially designed by Michael Fagan, will be described as it was developed and as it is currently implemented at Fermilab where it has been used to improve the quality of a variety of different experiment DA/Online software. Benefits of applying inspections at many points in the software life-cycle and benefits to the people involved will be investigated. Experience with many different types of Inspections and the lessons learned about the inspection process itself will be detailed. Finally, the future of Inspections at Fermilab will be given

  10. Technical regulation of nondestructive inspection

    International Nuclear Information System (INIS)

    1995-01-01

    It starts with the explanation of definition of nondestructive inspection and qualifications for a inspection. It lists the technical regulations of nondestructive inspections which are radiographic testing, ultrasonic flaw detecting test, liquid penetrant test, magnetic particle inspection, eddy current test visual inspection and leakage test.

  11. EM-GE-5 Regulation. Standard for the first-rate application clinical practices in the execution of the clinical investigations for medical teams' evaluation

    International Nuclear Information System (INIS)

    2015-01-01

    This guide has the following objectives: a) To guide methodologically the implementation of Good Clinical Practice for the execution of clinical research with medical devices that need to be evaluated, in addition to the Regulation E R-6. Requirements for the Conduct of Clinical Trials for Medical Devices , b) Provide the fundamental aspects to be taken into count for quality control to clinical investigations.

  12. Detecting accuracy of flaws by manual and automatic ultrasonic inspections

    International Nuclear Information System (INIS)

    Iida, K.

    1988-01-01

    As the final stage work in the nine year project on proving tests of the ultrasonic inspection technique applied to the ISI of LWR plants, automatic ultrasonic inspection tests were carried out on EDM notches, surface fatigue cracks, weld defects and stress corrosion cracks, which were deliberately introduced in full size structural components simulating a 1,100 MWe BWR. Investigated items are the performance of a newly assembled automatic inspection apparatus, detection limit of flaws, detection resolution of adjacent collinear or parallel EDM notches, detection reproducibility and detection accuracy. The manual ultrasonic inspection of the same flaws as inspected by the automatic ultrasonic inspection was also carried out in order to have comparative data. This paper reports how it was confirmed that the automatic ultrasonic inspection is much superior to the manual inspection in the flaw detection rate and in the detection reproducibility

  13. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Science.gov (United States)

    2010-01-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0605... clinical investigators and sponsors better understand their responsibilities related to continuing review...-463-6332 or 301-796-3400); or the Office of Communication, Outreach and Development (HFM-40), Center...

  14. Naa Technique for Clinical Investigation of Mice Immunized with BOTHROP Venom

    Science.gov (United States)

    Zamboni, C. B.; Aguiar, R. O.; Kovacs, L.; Suzuki, M.; Sant'Anna, O. A.

    2009-06-01

    In the present study Neutron Activation Analysis (NAA) technique was used to determine sodium concentration in whole blood of mice immunized with Bothrops venom. With this value it was possible to perform clinical investigation in this animal model using whole blood.

  15. Using Hermeneutic Phenomenology to Investigate How Experienced Practitioners Learn to Communicate Clinical Reasoning

    Science.gov (United States)

    Ajjawi, Rola; Higgs, Joy

    2007-01-01

    This paper is primarily targeted at doctoral students and other researchers considering using hermeneutic phenomenology as a research strategy. We present interpretive paradigm research designed to investigate how experienced practitioners learn to communicate their clinical reasoning in professional practice. Twelve experienced physiotherapy…

  16. 21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

    Science.gov (United States)

    2010-04-01

    ... that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health... opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children... clinical investigation presents a reasonable opportunity to further the understanding, prevention, or...

  17. 77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Science.gov (United States)

    2012-02-27

    ..., Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the Agencies... criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of... review to assure the protection of the rights and welfare of subjects in clinical investigations. The...

  18. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Science.gov (United States)

    2011-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...

  19. Health products inspection

    International Nuclear Information System (INIS)

    Stoltz, M.

    2009-01-01

    To protect public health, the Health Products Inspection is a public service mission where the application of regulations concerning activities on human health products and cosmetic products is verified. This mission permits a global approach to assess the health products risk-based benefit and, in monitoring by laboratory testing and by on site inspections, to verify their compliance with appropriate regulations. The seventy five inspectors perform about eight hundred inspections per year, in France and abroad. These inspections are related to data provided in the health products assessment and also to manufacturing and delivery practices. The French inspection body is also involved in the training of foreign inspectors and in the harmonization of national, European and international practices either for operators than for the competent authorities. (author)

  20. Genomic investigation of Staphylococcus aureus isolates from bulk tank milk and dairy cows with clinical mastitis.

    Science.gov (United States)

    Ronco, Troels; Klaas, Ilka C; Stegger, Marc; Svennesen, Line; Astrup, Lærke B; Farre, Michael; Pedersen, Karl

    2018-02-01

    Staphylococcus aureus is one of the most common pathogens that cause mastitis in dairy cows. Various subtypes, virulence genes and mobile genetic elements have been associated with isolates from bulk tank milk and clinical mastitis. So far, no Danish cattle associated S. aureus isolates have been whole-genome sequenced and further analyzed. Thus, the main objective was to investigate the population structure and genomic content of isolates from bulk tank milk and clinical mastitis, using whole-genome sequencing. This may reveal the origin of strains that cause clinical mastitis. S. aureus isolates from bulk tank milk (n = 94) and clinical mastitis (n = 63) were collected from 91 and 24 different farms, respectively and whole-genome sequenced. The genomic content was analyzed and a phylogenetic tree based on single nucleotide polymorphisms was constructed. In general, the isolates from both bulk tank milk and clinical mastitis were of similar genetic background. This suggests that dairy cows are natural carriers of the S. aureus subtypes that cause clinical mastitis if the right conditions are present and that a broad range of subtypes cause mastitis. A phylogenetic cluster that mostly consisted of ST151 isolates carried three mobile genetic elements that were primarily found in this group. The prevalence of resistance genes was generally low. However, the first ST398 methicillin resistant S. aureus isolate from a Danish dairy cow with clinical mastitis was detected. Copyright © 2018 Elsevier B.V. All rights reserved.

  1. Investigation Clinical Competence and Its Relationship with Professional Ethics and Spiritual Health in Nurses

    Directory of Open Access Journals (Sweden)

    Elahe Ramezanzade Tabriz

    2017-03-01

    Full Text Available Abstract Background and Objectives: Study of clinical competence in nursing helps determine the quality of health care delivered to patients. Given the priority of observance of principles over caretaking and necessity of spirituality existence at the core of health care provision, this study was conducted to investigate clinical competence and its relationship with professional ethics and spiritual health in nurses. Methods: In this cross-sectional, descriptive, and correlational study, 281 nurses were enrolled by consensus sampling. Sampling was conducted from February, 2016 till June, 2016. The data were gathered by a demographics questionnaire, a self-assessment scale of clinical competence, a nursing ethics questionnaire, and a spiritual health questionnaire, and analyzed by descriptive statistics and t-test, Pearson's correlation coefficient, ANOVA, and linear regression analysis in SPSS 21. Results: The total scores for self-assessment scale of nurses' clinical competence, professional ethics, and spiritual health were moderate. In the light of the results of Spearman's correlation coefficient, there was a significant and positive correlation between clinical competence and spiritual health. Moreover, a significant positive correlation was observed between professional ethics and spiritual health but there was no correlation between professional ethics and clinical competence. Conclusion: Managers' and personnel's Knowledge about the level of nurses clinical competence, professional ethics, and spiritual health in teaching health care centers provides valuable information to develop in-service and efficacious education programs and ultimately to improve the quality of nursing services.

  2. The relationship between senior management team culture and clinical governance: Empirical investigation and managerial implications.

    Science.gov (United States)

    Prenestini, Anna; Calciolari, Stefano; Lega, Federico; Grilli, Roberto

    2015-01-01

    Health care organizations are pressured to improve the cost-effectiveness of service delivery. Clinical governance is an important trigger to improve care quality and safety and rank high in the reform agenda of health systems. The senior management team culture plays a major role in establishing clinical governance practices, because it strongly influences the values, attitudes, and behaviors of the members of an organization. The aim of this study was to investigate the relationship between senior management team culture and clinical governance in the public health care organizations of three Italian regions. The assessment of senior management culture was conducted using the Competing Values Framework and a corresponding instrument adapted for the Italian context. Clinical governance was assessed using an ad hoc instrument focused on the senior management team's perception and attitude toward clinical governance. The survey achieved a 54% response rate. The results of four different models demonstrate that organizations characterized by different dominant cultures are associated with significant differences in attitudes toward clinical governance. In particular, on average, dominant cultures with a prevailing external focus are associated with a more positive attitude toward clinical governance. The selection and appointments of top managers should consider the style of leadership that is most apt to facilitate the growth of rational and developmental cultures. Furthermore, the training of top managers and leading doctors should reinforce leadership aptitude and approaches that are consistent with the desired organizational cultures.

  3. An investigation of nurse educator's perceptions and experiences of undertaking clinical practice.

    Science.gov (United States)

    Williams, Angela; Taylor, Cathy

    2008-11-01

    Educational policy (DOH, 1999. Making a difference: strengthening the nursing, midwifery and health visiting contribution to health and healthcare. Department of Health, London; UKCC, 1999. Fitness for Practice. United Kingdom Central Council for Nursing, Midwifery and Health Visiting, London; Nursing and Midwifery Council, 2006. Standards to support learning and assessment in practice. Nursing and Midwifery Council, London) and current nursing literature (Griscti, O., Jacono, B., Jacono, J., 2005. The nurse educator's clinical role. Journal of Advanced Nursing 50 (1), 84-92; Owen, S., Ferguson, K., Baguley, I., 2005. The clinical activity of mental health nurse lecturers. Journal of Psychiatric and Mental Health Nursing 12, 310-316), place increasing emphasis on nurse educators undertaking clinical practice to facilitate their clinical confidence and competence. This study investigated nurse educators' perceptions and experiences of undertaking clinical practice. A qualitative design and descriptive, exploratory approach were used. A purposive sample of 11 nurse educators in one nursing department, took part in two focus group interviews, one with 5 and the other with 6 respondents, to identify and discuss their perceptions and experiences of undertaking clinical practice. A process of thematic content analysis revealed three broad themes relating to the meaning and importance of clinical practice, perceived benefits and barriers which are examined and discussed. The paper concludes that despite policy recommendations, barriers highlighted in this study such as insufficient time, heavy workload and a lack of valuing of the clinical role have been raised over the past few decades. The effect of undertaking clinical practice, particularly on the quality of teaching is argued to be valuable armoury in the battle to secure sufficient resources to support engagement in clinical practice. Financial and organisational commitment; valuing of clinical practice and research

  4. Compare the Clinical Significance of the Biochemical Markers of Myocardial Damage Inspection%对比不同心肌损伤生化标记物检验的临床意义

    Institute of Scientific and Technical Information of China (English)

    王博; 马昉

    2015-01-01

    目的:对比不同心肌损伤生化标记物检验的临床意义。方法随机选自2011年10月~2012年10月我院收治的80例心肌损伤患者,采用 AU640全自动型的生化仪对其心肌钙蛋白、肌红蛋白 I、血同型半胱氨酸、脑利钠肽前体、肌酸激酶同工酶水平进行相应的检测,对检验过程中不同标记物的应用价值及特点进行分析。结果80例心肌损伤患者经过相应的检测之后,灵敏度最高的是脑利钠肽前体,最低的是血同型半胱氨酸。结论在五种不同的心肌损伤生化标记物的检验过程中,各种标记物均可发挥明显的指导意义,对不同的标记物进行联合检测可以使诊治效果得到提升。%Objective To compare the clinical significance of the biochemical markers of myocardial damage inspection. Methods Randomly selected from October 2011 to October 2012,our hospital 80 cases of patients with myocardial injury,using type AU640 automatic biochemical instrument on the myocardial calcium,protein,myoglobin I,blood homocysteine,brain natriuretic peptide precursor,creatine kinase isoenzyme level corresponding detection,in the process of inspection application value and characteristics of different markers were analyzed. Results 80 cases of patients with myocardial injury after the corresponding detection,sensitivity is the highest brain natriuretic peptide precursor,blood homocysteine are the lowest. Conclusion In five different biochemical markers of myocardial injury during the process of inspection,al kinds of markers can play a significant guiding significance,for different markers for joint detection can make make a diagnosis and give treatment effect is improved.

  5. Runway Inspection by RPAS

    Directory of Open Access Journals (Sweden)

    Stanislav Absolon

    2015-10-01

    Full Text Available This article discusses the use of the RPAS for the inspection of the airport operating areas. The paper compares the current process of the inspection of the airport operating areas by the airport staff with the possibilities which are offered by the use of the modern technology RPAS. The following text also describes how to inspect airport operating areas by the RPAS, specific technical possibilities and the applicable technical solutions. Furthermore there are variants of piloting the RPAS, comparing usable equipment, equipment for video recording and the possibility of using thermal imaging camera in the article.

  6. Magnetic rubber inspection (MRI)

    International Nuclear Information System (INIS)

    Carro, L.

    1997-01-01

    Magnetic Rubber Inspection (MRI) was developed to inspect for small cracks and flaws encountered in high performance aircraft. A formula of very fine magnetic particles immersed in a room temperature curing rubber is catalysed and poured into dams (retainers) on the surface of the part to be inspected. Inducing a magnetic field then causes the particles to be drawn to discontinuities in the component under test. These indicating particles are held to the discontinuity by magnetic attraction, as the rubber cures. The solid rubber cast (Replica) is then removed and examined under a microscope for indicating lines of particle concentrations. 3 refs., 6 figs

  7. Automated PCB Inspection System

    Directory of Open Access Journals (Sweden)

    Syed Usama BUKHARI

    2017-05-01

    Full Text Available Development of an automated PCB inspection system as per the need of industry is a challenging task. In this paper a case study is presented, to exhibit, a proposed system for an immigration process of a manual PCB inspection system to an automated PCB inspection system, with a minimal intervention on the existing production flow, for a leading automotive manufacturing company. A detailed design of the system, based on computer vision followed by testing and analysis was proposed, in order to aid the manufacturer in the process of automation.

  8. Clinical association between teeth malocclusions, wrong posture and ocular convergence disorders: an epidemiological investigation on primary school children

    Directory of Open Access Journals (Sweden)

    Silvestrini-Biavati Armando

    2013-01-01

    Full Text Available Abstract Background As the various systems in the body are inter-connected to form a single structural unit, a pathological condition in one area can also affect other areas. There are many known correlations between the visual and motor system. The importance of visual function, particularly the paracentral peripheral field of view, in motor coordination, ambulation and the maintenance of balance has been amply demonstrated. In line with current medical principles, which are moving towards a more holistic view of the human body, this study aims to investigate, in an interdisciplinary manner, the incidence of dental malocclusions together with posture and eye convergence disorders. Methods Six hundred and five children attending at the 3rd, 4th and 5th years of seven Genoa primary schools were examined. Each child underwent the following examinations: (i dental/occlusal; (ii orthoptic; and (iii postural. Occlusal data concerned the presence of cross-bite, midline deviation with a mandibular shift, bad habits and deep or open bite. Postural assessment involved frontal and lateral inspection, investigation during trunk flexion and ambulation, and note of any asymmetry in the lower limbs. The recorded orthoptic data included those pertaining to ocular dominance, a cover test, convergence and the Brock string test. Results A prevalence of cases with an unphysiological gait was found in patients with overjet (14.70% or overbite (14.87%, while the percentage of patients with normal occlusion that showed an unphysiological gait was 13.08%. Also, about 93.8%–94.2% of children showed normal legs without dysmetry, with no difference in respect to the type of occlusion. Subjects with an open bite or deep bite showed a slightly different distribution of right or left dominant eyes. Conclusion About 13% of children showed a pathological gait and, among them, vertical anomalies of occlusion (deep bite or open bite were prevalent with respect to the other

  9. Wall Painting Investigation by Means of Non-invasive Terahertz Time-Domain Imaging (THz-TDI): Inspection of Subsurface Structures Buried in Historical Plasters

    DEFF Research Database (Denmark)

    Dandolo, Corinna Ludovica Koch; Jepsen, Peter Uhd

    2016-01-01

    Characterization of subsurface features of wall paintings is important in conservation and technical art history as well as in building archaeology and architecture fields. In this study, an area of the apsidal wall painting of Nebbelunde Church (Rødby, Denmark) has been investigated by means of ...

  10. Anatomical-clinical investigations of variations of the human coronary arteries

    OpenAIRE

    Aida Hasanović; Faruk Dilberović; Fehim Ovčina

    2003-01-01

    Variations of the human coronary arteries have always attracted the attention of many researchers. A review of the literature shows that variations can cause ischemic heart disease or sudden cardiac death. The aim of the investigations was to examine the existence and clinical significance of variations of the human coronary arteries. Special attention has been focused on myocardial bridging of the coronary arteries and coronary arteriovenous fistula. Our investigations were carried out on th...

  11. Wheel inspection system environment.

    Science.gov (United States)

    2008-11-18

    International Electronic Machines Corporation (IEM) has developed and is now marketing a state-of-the-art Wheel Inspection System Environment (WISE). WISE provides wheel profile and dimensional measurements, i.e. rim thickness, flange height, flange ...

  12. Department of Clinical Investigation: Annual Research Progress Report for Fiscal Year 1992. Volume 2

    Science.gov (United States)

    1993-01-01

    A-5-90 Production of Mouse Positive and Negative Control Slides for 295 Use in Rabies FRA Test. (0) A-7-90 Clinical Investigation on the...Dose Intensification of Methotrexate and 519 6- Mercaptopurine for ALL in Childhood. (0) POG 9006 ALinC 15: Up-Front 6-MP/MTX vs. Up-Front Alternating 520...for the mouse bioassay as a means for detecting Clostridium botulinum toxin in cultures, food products , serum and fecal specimens. Technical Approach

  13. Information-Driven Inspections

    International Nuclear Information System (INIS)

    Laughter, Mark D.; Whitaker, J. Michael; Lockwood, Dunbar

    2010-01-01

    New uranium enrichment capacity is being built worldwide in response to perceived shortfalls in future supply. To meet increasing safeguards responsibilities with limited resources, the nonproliferation community is exploring next-generation concepts to increase the effectiveness and efficiency of safeguards, such as advanced technologies to enable unattended monitoring of nuclear material. These include attribute measurement technologies, data authentication tools, and transmission and security methods. However, there are several conceptual issues with how such data would be used to improve the ability of a safeguards inspectorate such as the International Atomic Energy Agency (IAEA) to reach better safeguards conclusions regarding the activities of a State. The IAEA is pursuing the implementation of information-driven safeguards, whereby all available sources of information are used to make the application of safeguards more effective and efficient. Data from continuous, unattended monitoring systems can be used to optimize on-site inspection scheduling and activities at declared facilities, resulting in fewer, better inspections. Such information-driven inspections are the logical evolution of inspection planning - making use of all available information to enhance scheduled and randomized inspections. Data collection and analysis approaches for unattended monitoring systems can be designed to protect sensitive information while enabling information-driven inspections. A number of such inspections within a predetermined range could reduce inspection frequency while providing an equal or greater level of deterrence against illicit activity, all while meeting operator and technology holder requirements and reducing inspector and operator burden. Three options for using unattended monitoring data to determine an information-driven inspection schedule are to (1) send all unattended monitoring data off-site, which will require advances in data analysis techniques to

  14. Electrochemical impedance spectroscopy investigation on the clinical lifetime of ProTaper rotary file system.

    Science.gov (United States)

    Penta, Virgil; Pirvu, Cristian; Demetrescu, Ioana

    2014-01-01

    The main objective of the current paper is to show that electrochemical impedance spectroscopy (EIS) could be a method for evaluating and predicting of ProTaper rotary file system clinical lifespan. This particular aspect of everyday use of the endodontic files is of great importance in each dental practice and has profound clinical implications. The method used for quantification resides in the electrochemical impedance spectroscopy theory and has in its main focus the characteristics of the surface titanium oxide layer. This electrochemical technique has been adapted successfully to identify the quality of the Ni-Ti files oxide layer. The modification of this protective layer induces changes in corrosion behavior of the alloy modifying the impedance value of the file. In order to assess the method, 14 ProTaper sets utilized on different patients in a dental clinic have been submitted for testing using EIS. The information obtained in regard to the surface oxide layer has offered an indication of use and proves that the said layer evolves with each clinical application. The novelty of this research is related to an electrochemical technique successfully adapted for Ni-Ti file investigation and correlation with surface and clinical aspects.

  15. [ISO 9001certification of a quality management system in a clinical investigation center].

    Science.gov (United States)

    Chesnais, Jimmy; Fougerou-Leurent, Claire; Laforest, Claire; Renault, Alain; Bellissant, Eric; Laviolle, Bruno

    2018-05-03

    Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  16. Estimation of inspection effort

    International Nuclear Information System (INIS)

    Mullen, M.F.; Wincek, M.A.

    1979-06-01

    An overview of IAEA inspection activities is presented, and the problem of evaluating the effectiveness of an inspection is discussed. Two models are described - an effort model and an effectiveness model. The effort model breaks the IAEA's inspection effort into components; the amount of effort required for each component is estimated; and the total effort is determined by summing the effort for each component. The effectiveness model quantifies the effectiveness of inspections in terms of probabilities of detection and quantities of material to be detected, if diverted over a specific period. The method is applied to a 200 metric ton per year low-enriched uranium fuel fabrication facility. A description of the model plant is presented, a safeguards approach is outlined, and sampling plans are calculated. The required inspection effort is estimated and the results are compared to IAEA estimates. Some other applications of the method are discussed briefly. Examples are presented which demonstrate how the method might be useful in formulating guidelines for inspection planning and in establishing technical criteria for safeguards implementation

  17. Packaging supplier inspection guide

    International Nuclear Information System (INIS)

    Stromberg, H.M.; Gregg, R.E.; Kido, C.; Boyle, C.D.

    1991-05-01

    This is document is a guide for conducting quality assurance inspections of transportations packaging suppliers, where suppliers are defined as designers, fabricators, distributors, users, or owners of transportation packaging. This document can be used during an inspection to determine regulatory compliance within the requirements of 10 Code of Federal Regulations, Part 71, Subpart H (10 CFR 71.101--71.135). The guidance described in this document provides a framework for an inspection. It provides the inspector with the flexibility to adapt the methods and concepts presented here to meet the needs of the particular facility being inspected. The guide was developed to ensure a structured and consistent approach for inspections. The method treats each activity at a supplier facility as a separate entity (or functional element), and combines the activities within the framework of an ''inspection tree.'' The method separates each functional element into several areas of performance and then identifies guidelines, based on regulatory requirements, to be used to qualitatively rate each area. This document was developed to serve as a field manual to facilitate the work of inspectors. 1 ref., 1 fig., 5 tabs

  18. Fuel inspection device

    International Nuclear Information System (INIS)

    Tsuji, Tadashi.

    1990-01-01

    The fuel inspection device of the present invention has a feature of obtaining an optimum illumination upon fuel rod interval inspection operation in a fuel pool. That is, an illumination main body used underwater is connected to a cable which is led out on a floor. A light control device is attached to the other end of the cable and an electric power cable is connected to the light control device. A light source (for example, incandescent lamp) is incorporated in the casing of the illumination main body, and a diffusion plate is disposed at the front to provide a plane light source. The light control device has a light control knob capable of remote-controlling the brightness of the light of the illumination main body. In the fuel inspection device thus constituted, halation is scarcely caused on the image screen upon inspection of fuels by a submerged type television camera to facilitate control upon inspection. Accordingly, efficiency of the fuel inspection can be improved to shorten the operation time. (I.S.)

  19. Wall Painting Investigation by Means of Non-invasive Terahertz Time-Domain Imaging (THz-TDI): Inspection of Subsurface Structures Buried in Historical Plasters

    Science.gov (United States)

    Dandolo, Corinna Ludovica Koch; Jepsen, Peter Uhd

    2016-02-01

    Characterization of subsurface features of wall paintings is important in conservation and technical art history as well as in building archaeology and architecture fields. In this study, an area of the apsidal wall painting of Nebbelunde Church (Rødby, Denmark) has been investigated by means of terahertz time-domain imaging (THz-TDI). Subsurface structures have been detected at different depths inside the lime-based plaster of the wall painting until approximately 1 cm from the surface. The surface morphology of the buried structures has been 3D imaged in detail, providing a substantial contribution in their characterization.

  20. An Exploratory Study Investigating the Non-Clinical Benefits of Evidence-Based Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    Elizabeth Jackson

    2017-05-01

    Full Text Available Objective: As little prior research exists about the non-clinical benefits of evidence-based veterinary medicine (EBVM, this exploratory study was conducted to identify non-clinical benefits of EBVM to veterinary practices, as well as highlighting the barriers to further implementation, and ways to overcome them.Background: A PICO-based literature review (Hauser and Jackson, 2016 was conducted to establish current knowledge about the non-clinical benefits of EBVM. It found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction and client retention, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted.Evidentiary value: This exploratory study provides a solid basis for the further development of a confirmatory study of the themes identified in the interviews. The impact on practice from our findings is significant as it details the key areas where the use of EBVM can yield commercial benefits from the perspective of a group of EBVM experts via interview. It is entirely possible that international veterinary environments which mirror that of the UK will find this research beneficial.Methods: Due to the paucity of data about the non-clinical benefits of EBVM, an exploratory, qualitative approach was taken to this research in order to build a platform for further confirmatory, quantitative investigation (Zikmund, 2003. In February and March 2016 interviews with 16 RCVS Knowledge Group chairs[1] were conducted. The interview guide contained broad, open-ended questions to explore existing tacit knowledge about the non-commercial benefits of EBVM. The interviews were audio recorded and transcribed verbatim and subsequently analysed using NVivo 11 software.Results: This qualitative enquiry showed that the key areas where the use of EBVM can yield non-clinical benefits are through increased client satisfaction and retention, improved

  1. Clinical neurophysiology and quantitative sensory testing in the investigation of orofacial pain and sensory function.

    Science.gov (United States)

    Jääskeläinen, Satu K

    2004-01-01

    Chronic orofacial pain represents a diagnostic and treatment challenge for the clinician. Some conditions, such as atypical facial pain, still lack proper diagnostic criteria, and their etiology is not known. The recent development of neurophysiological methods and quantitative sensory testing for the examination of the trigeminal somatosensory system offers several tools for diagnostic and etiological investigation of orofacial pain. This review presents some of these techniques and the results of their application in studies on orofacial pain and sensory dysfunction. Clinical neurophysiological investigation has greater diagnostic accuracy and sensitivity than clinical examination in the detection of the neurogenic abnormalities of either peripheral or central origin that may underlie symptoms of orofacial pain and sensory dysfunction. Neurophysiological testing may also reveal trigeminal pathology when magnetic resonance imaging has failed to detect it, so these methods should be considered complementary to each other in the investigation of orofacial pain patients. The blink reflex, corneal reflex, jaw jerk, sensory neurography of the inferior alveolar nerve, and the recording of trigeminal somatosensory-evoked potentials with near-nerve stimulation have all proved to be sensitive and reliable in the detection of dysfunction of the myelinated sensory fibers of the trigeminal nerve or its central connections within the brainstem. With appropriately small thermodes, thermal quantitative sensory testing is useful for the detection of trigeminal small-fiber dysfunction (Adelta and C). In neuropathic conditions, it is most sensitive to lesions causing axonal injury. By combining different techniques for investigation of the trigeminal system, an accurate topographical diagnosis and profile of sensory fiber pathology can be determined. Neurophysiological and quantitative sensory tests have already highlighted some similarities among various orofacial pain conditions

  2. Incore inspection device

    International Nuclear Information System (INIS)

    Ogisu, Tatsuki; Taguchi, Kosei.

    1995-01-01

    The device of the present invention can inspect surfaces of equipments in reactor water in a nuclear reactor in a state of atmospheric air. Namely, an inspection device is movable forwardly and backwardly in a water-proof vessel. An annular sucker with pleats is disposed to the outer side of a lid of the water-proof vessel. A television camera for an under water monitoring is disposed to the inner side of the lid of the water-proof vessel by way of a partitioning wall with lid. Transferring screws are disposed at the back and on the side of the water-proof vessel. In the device having such a constitution, (1) the inside of the water-proof vessel is at first made water-tight by closing the partitioning wall with lid, (2) the back and the side screws are operated by the guide of the underwater monitoring television camera, to transfer the water-proof vessel to the surface of the reactor core to be inspected, (3) the annular sucker with pleats is urged on the surface to be inspected by the back screw, to fix the water-proof vessel, (4) reactor water in a space of the annular sucker with pleats is discharged and replaced with air, and (5) the lid of the partition wall with lid is opened and the inspection device is disposed at a position of the underwater monitoring television camera, to inspect the surface to be inspected in a state of atmospheric air. (I.S.)

  3. An empirical investigation of incompleteness in a large clinical sample of obsessive compulsive disorder.

    Science.gov (United States)

    Sibrava, Nicholas J; Boisseau, Christina L; Eisen, Jane L; Mancebo, Maria C; Rasmussen, Steven A

    2016-08-01

    Obsessive Compulsive Disorder (OCD) is a disorder with heterogeneous clinical presentations. To advance our understanding of this heterogeneity we investigated the prevalence and clinical features associated with incompleteness (INC), a putative underlying core feature of OCD. We predicted INC would be prominent in individuals with OCD and associated with greater severity and impairment. We examined the impact of INC in 307 adults with primary OCD. Participants with clinically significant INC (22.8% of the sample) had significantly greater OCD severity, greater rates of comorbidity, poorer ratings of functioning, lower quality of life, and higher rates of unemployment and disability. Participants with clinically significant INC were also more likely to be diagnosed with OCPD and to endorse symmetry/exactness obsessions and ordering/arranging compulsions than those who reported low INC. Our findings provide evidence that INC is associated with greater severity, comorbidity, and impairment, highlighting the need for improved assessment and treatment of INC in OCD. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. [Clinical investigation of basophil activation test as a complementary test for house dust mite allergen].

    Science.gov (United States)

    Ren, H L; Li, J D; Miao, Y H; Xu, T

    2018-03-01

    Objective: To investigate the clinical application of glass micro fiber basophil activation test (BAT) used as a complementary test for house dust mite allergen. Method: Forty patients with clinical diagnosed allergic rhinitis was test by three methods for house dust mite allergen, skin prick test(SPT),Immuno CAP sIgE, and BAT in vitro. The sensitivity and specificity of glass micro fiber were accessed, and the consistency between BAT, SPT, and Immuno sIgE was analyzed. As in vivo provocation was not performed, gold standard is regarded as the combination of medical history and positive reports of SPT and/or ImmunoCAP sIgE test. Result: Twentythree patients are diagnosed as house dust mite allergic rhinitis by gold standard. The sensitivity and specificity of glass micro fiber BAT were 60.9% and 88.2%, the sensitivity of SPT and sIgE was 87.0% and sIgE 73.9%. The correlation rates between BAT with SPT is 0.67( P house dust mite allergic rhinitis, BAT have a good consistency with SPT and sIgE, while as it has only moderate consistency with "gold standard", further studies are needed to prove its clinical significance. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

  5. [What role for paraclinical investigations within clinical trials conducted in psychiatric patients?

    Science.gov (United States)

    Kaladjian, A; Adida, M; Simon, N; Belzeaux, R; Blin, O; Fakra, E; Azorin, J-M

    2016-12-01

    As in the usual care of patients, paraclinical investigations have today only a very modest role in clinical trials in psychiatry, mainly to complete the pre-therapeutical assessments prior to inclusion of subjects or to monitor treatment tolerance. Yet, the accumulation of data in neurosciences suggests the next emergence of biomarkers, whose interest is that they are closely associated to the biological disturbances underlying psychiatric illnesses, and that they are accessible by means of technological tools such as imaging devices. These tools allow to explore the effects on brain of psychotropic medications, such as antidepressants, antipsychotics, or mood stabilizers, in relation to their therapeutic action. The obtained results allow to consider the use of such biomarkers in clinical trials in addition to more conventional approaches. In particular, they could be used as targets to measure brain response to treatment in association with clinical response, to predict a therapeutic response from the neurofunctional characteristics of patients, or to establish the safety profile of drugs on the nervous system. The use of such biomarkers in clinical trials would help to better define the explored populations and their characteristics, as well as the variables to assess, and to better measure the impact of the treatments and their potential harmful effects on the nervous system. © L’Encéphale, Paris, 2016.

  6. Inspection Strategies for Concrete Bridges

    DEFF Research Database (Denmark)

    Sørensen, John Dalsgaard; Thoft-Christensen, Palle

    1989-01-01

    In this paper an optimal inspection strategy for concrete bridges based on periodic routine and detailed inspections is presented. The failure mode considered is corrosion of the reinforcement due to chlorides. A simple modelling of the corrosion and of the inspection strategy is presented....... The optimal inspection strategy is determined from an optimization problem, where the design variables are time intervals between detailed inspections and the concrete cover. The strategy is illustrated on a simple structure, namely a reinforced concrete beam....

  7. Using thermographic cameras to investigate eye temperature and clinical severity in depression

    Science.gov (United States)

    Maller, Jerome J.; George, Shefin Sam; Viswanathan, Rekha Puzhavakkathumadom; Fitzgerald, Paul B.; Junor, Paul

    2016-02-01

    Previous studies suggest that altered corneal temperature may be a feature of schizophrenia, but the association between major depressive disorder (MDD) and corneal temperature has yet to be assessed. The aim of this study is to investigate whether eye temperature is different among MDD patients than among healthy individuals. We used a thermographic camera to measure and compare the temperature profile across the corneas of 16 patients with MDD and 16 age- and sex-matched healthy subjects. We found that the average corneal temperature between the two groups did not differ statistically, although clinical severity correlated positively with right corneal temperature. Corneal temperature may be an indicator of clinical severity in psychiatric disorders, including depression.

  8. Clinical investigation of large perfusion defect cases with 201Tl exercise myocardial scintigraphy

    International Nuclear Information System (INIS)

    Morota, Motoi; Kobayashi, Yasuhiko

    1999-01-01

    We investigated retrospectively the clinical significance of large perfusion defect on 201 Thallium myocardial scintigraphy from the records of 833 patients during the past 3 years from 1991 to 1994. The patients were divided into 3 groups according to the extent of perfusion defect; cases with normal perfusion (n=561), with small perfusion defect (n=211) and with large perfusion defect (n=61). We found that the proportions of cases with large perfusion defect was significantly larger than that of cases with small perfusion defect in myocardial disease (MD; hypertrophic cardiomyopathy, dilated cardiomyopathy, and post myocarditis combined) (P 201 Thallium myocardial scintigraphy and that complication of diabetes mellitus and clinical symptoms may be useful in differentiating IHD from MD. (author)

  9. Investigating the connections between health lean management and clinical risk management.

    Science.gov (United States)

    Crema, Maria; Verbano, Chiara

    2015-01-01

    The purpose of this paper is to investigate connections and overlaps between health lean management (HLM) and clinical risk management (CRM) understanding whether and how these two approaches can be combined together to pursue efficiency and patient safety improvements simultaneously. A systematic literature review has been carried out. Searching in academic databases, papers that focus not only on HLM, but also on clinical errors and risk reduction, were included. The general characteristics of the selected papers were analysed and a content analysis was conducted. In most of the papers, pursing objectives of HLM and CRM and adopting tools and practices of both approaches, results of quality and, particularly, of safety improvements were obtained. A two-way arrow between HLM and CRM emerged but so far, none of the studies has been focused on the relationship between HLM and CRM. Results highlight an emerging research stream, with many useful theoretical and practical implications and opportunities for further research.

  10. Research Capacity at Traditional Chinese Medicine (TCM) Centers in China: A Survey of Clinical Investigators.

    Science.gov (United States)

    Feng, Shuo; Han, Mei; Lai, Lily; Wang, Si-Cheng; Liu, Jian-Ping

    2017-01-01

    Background. The development of an evidence-based approach to traditional Chinese medicine (TCM), which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82%) were qualified to at least a Master's degree, whilst a smaller proportion (40.24%) held a senior professional title. We found that academic outputs were low with the majority (62.16%) authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43%) and identification of research questions (86.81%), whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%), and time (37.15%). Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators' research capacity and the development of an evidence-based approach of TCM.

  11. Piping inspection round robin

    International Nuclear Information System (INIS)

    Heasler, P.G.; Doctor, S.R.

    1996-04-01

    The piping inspection round robin was conducted in 1981 at the Pacific Northwest National Laboratory (PNNL) to quantify the capability of ultrasonics for inservice inspection and to address some aspects of reliability for this type of nondestructive evaluation (NDE). The round robin measured the crack detection capabilities of seven field inspection teams who employed procedures that met or exceeded the 1977 edition through the 1978 addenda of the American Society of Mechanical Engineers (ASME) Section 11 Code requirements. Three different types of materials were employed in the study (cast stainless steel, clad ferritic, and wrought stainless steel), and two different types of flaws were implanted into the specimens (intergranular stress corrosion cracks (IGSCCs) and thermal fatigue cracks (TFCs)). When considering near-side inspection, far-side inspection, and false call rate, the overall performance was found to be best in clad ferritic, less effective in wrought stainless steel and the worst in cast stainless steel. Depth sizing performance showed little correlation with the true crack depths

  12. Inspection device in liquid

    International Nuclear Information System (INIS)

    Nagaoka, Etsuo.

    1996-01-01

    The present invention provides an inspection device in PWR reactor core in which inspection operations are made efficient by stabilizing a posture of the device in front-to-back, vertical and left-to-right directions by a simple structure. When the device conducts inspection while running in liquid, the front and the back directions of the device main body are inspected using a visual device while changing the posture by operating a front-to-back direction propulsion device and a right-to-left direction propulsion device, and a vertical direction propulsion device against to rolling, pitching and yawing of the device main body. In this case, a spherical magnet moves freely in the gravitational direction in a vibration-damping fluid in a non-magnetic spherical shell following the change of the posture of the device main body, in which the vibrations due to the movement of the spherical magnet is settled by the vibration-damping fluid thereby stabilizing the posture of the device main body. At a typical inspection posture, the settling effect is enhanced by the attraction force between the spherical magnets in the spherical shell and each of magnetic force-attracted magnetic members disposed to the outer circumference of the shell, and the posture of the device main body can be confirmed in front-to-back, right-to-left and vertical directions by each of the posture confirming magnetic sensors. (N.H.)

  13. Sustaining the Clinical and Translational Research Workforce: Training and Empowering the Next Generation of Investigators.

    Science.gov (United States)

    Yin, Helen L; Gabrilove, Janice; Jackson, Rebecca; Sweeney, Carol; Fair, Alecia M; Toto, Robert

    2015-07-01

    There is mounting concern that clinician-scientists are a vanishing species and that the pipeline for clinical and translational research (CTR) investigators is in jeopardy. For the majority of current junior CTR investigators, the career path involves first obtaining a National Institutes of Health (NIH)-funded K-type career development award, particularly K08 and K23, and subsequently an NIH R01. This transition, popularly referred to as K2R, is a major hurdle with a low success rate and gaps in funding. In this Perspective, the authors identify factors that facilitate K2R transition and important aspects of increasing and sustaining the pipeline of CTR investigators. They also highlight significant differences in success rates of women and those underrepresented in biomedical research. Early career exposure to research methodology, protected time, multidisciplinary mentoring, and institutional "culture shift" are important for fostering and rewarding team science. Mentoring is the single most important contributor to K2R success, and emerging evidence suggests that formal mentor training and team mentoring are effective. Leadership training can empower junior investigators to thrive as independent CTR investigators. Future research should focus on delineating the difference between essential and supplemental factors to achieve this transition, and mentoring methods that foster success, including those that promote K2R transition of women and those underrepresented in biomedical research. The Clinical and Translational Science Awards National Consortium is well positioned to test existing models aimed at shortening the time frame, increasing the rate of K2R transition, and identifying strategies that improve success.

  14. Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

    Science.gov (United States)

    McKenna, Dennis J

    2004-05-01

    Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

  15. Duplex investigations in children: Are clinical signs in children with venous disorders relevant?

    Science.gov (United States)

    Birgitte Maessen-Visch, M; Smeets, L; van Vleuten, C

    2015-12-01

    Ultra sound colored duplex sonography is the preferred method in diagnosing chronic venous disease. Data in children on incidence, indications, and results are lacking. From the total of 9180 duplex investigations performed in our hospital from 2009 to 2012, data on indication and results of the investigation as well as patient characteristics were evaluated retrospectively for the proportion of pediatric patients. Duplex investigations were performed 49 times in 38 children (6-18 years), with an average of 1.3 times (1-6 times) per child. Forty percent showed abnormalities: 17 times deep venous thrombosis was suspected; deep venous thrombosis was objectified in 18%. In the 21 investigations performed for varicosis-related complaints, varicose veins or venous malformations were objectified in 57%. Edema was never a symptom of chronic venous disease. Duplex investigation is not often performed in children. In children with established deep venous thrombosis, a family history with deep venous thrombosis is common. In general, edema was not seen in children with varicose veins and, therefore, does not seem a reliable clinical sign at young age. © The Author(s) 2014.

  16. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    Science.gov (United States)

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  17. 29 CFR 1903.7 - Conduct of inspections.

    Science.gov (United States)

    2010-07-01

    ... of § 1903.3, inspections shall take place at such times and in such places of employment as the Area... photographs related to the purpose of the inspection, employ other reasonable investigative techniques, and... trade secrets.) As used herein, the term employ other reasonable investigative techniques includes, but...

  18. The relationship between school inspections, school characteristics and school improvement.

    NARCIS (Netherlands)

    Ehren, Melanie Catharina Margaretha; Visscher, Arend J.

    2008-01-01

    The effects of school inspections on school improvement have been investigated only to a limited degree. The investigation reported on in this article is meant to expand our knowledge base regarding the impact of school inspections on school improvement. The theoretical framework for this research

  19. A descriptive survey investigating pre-registration student nurses' perceptions of clinical skill development in clinical placements.

    Science.gov (United States)

    Stayt, Louise C; Merriman, Clair

    2013-04-01

    Clinical skill development is essential to nurse education. Clinical skills are frequently taught in higher education institutions using clinical simulation. It is unclear if clinical skills are subsequently consolidated and developed in clinical placements. The aim of this survey was to evaluate pre-registration student nurses perceptions of the frequency of opportunities to practise, the level of supervision and assessment of, clinical skills in their clinical placements. This was a cross-sectional survey design using an online, self-report questionnaire including a Likert-type scale and open ended comments. Four hundred and twenty one students, from all year groups, from a university in the south of England on a wide variety of clinical placements participated. Participants evaluated the frequency of opportunity to practise, level of supervision and assessment of and feedback on performance of specific clinical skills. Clinical skills evaluated were measurement of vital signs, aseptic non-touch technique, assisting with eating and drinking, and assisting with comfort and hygiene. Data were analysed utilising Statistical Package for the Social Sciences Version 19. The frequency of opportunities to practise skills in clinical placement was variable with some participants reporting that they never had opportunity to practise essential skills. Similarly the level of supervision and assessment was also inconsistent suggesting that participants frequently practised clinical skills unsupervised without being assessed as competent. Inconsistencies in clinical skill development may lead to graduates who are not work ready and as a result, insufficient clinical competence potentially leads to unsafe practice and poor patient care. This calls for stronger partnerships between educators and clinical areas and the prioritisation of mentor preparation and education as well as organisational support in terms of mentor workload planning. Copyright © 2012 Elsevier Ltd. All

  20. Clinical and ECG investigations in subjects with acute carbon monoxide poisoning

    Energy Technology Data Exchange (ETDEWEB)

    Capellini, A; Tomasini, M; Limonta, A

    1974-01-01

    Research carried out on more than 100 workers hospitalized for acute CO poisoning at the Milan Clinica del Lavoro and some 50 subjects undergoing treatment at the Milan polyclinic. The purpose of the research was to investigate the incidence and frequency of myocardial and coronary impairment in cases of acute CO poisoning. The authors concluded from their clinical and ECG findings that myocardial and coronary impairment in subjects suffering from acute CO poisoning was rarely serious or irreversible unless there was preexistent coronary disease. (CIS Abstr. Vol. 2)

  1. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1993. Volume 2

    Science.gov (United States)

    1993-10-01

    A-5-90 Production of Mouse Positive and Negative Control Slides for 382 Use in Rabies FRA Test. (0) A-7-90 Clinical Investigation on the...Possible 402 Diagnostic and Therapeutic Manuever as Tested in a Mouse Model Utilizing PET Scanning. (0) A-93-04 Production of Monoclonal Antibodies to...xlv Project Page Number POG 9005 ALinC 15: Dose Intensification of Methotrexate and 583 6- Mercaptopurine for ALL in Childhood. (0) P00 9006 ALinC 15

  2. Hysterosalpingographic picture encountered during the investigation of female infertility clinic has Lemba of Saint Raphael

    International Nuclear Information System (INIS)

    Kitenge, N.; Nzeza, N.; Mbanzulu, P.; Ndaye, B.

    2010-01-01

    A cross-sectional study was conducted at the St Raphael Lemba Clinic on a sample of 115 patients suspected of infertility during the period from june 1 1997 in 1 march 2003 (6 years). The technique of hysterosalpingography has allowed the identification of female infertility presents images that can diagnose one or more causes utero-tubal. Men also carry a significant responsibility in the genesis of the sterility of the couple: thus, they must also undergo exploration. Hormonal factors also have an important contribution in the investigation of infertility in women and must be taken in addition to hysterosalpingography

  3. Plant abnormality inspection device

    International Nuclear Information System (INIS)

    Takenaka, Toshio.

    1990-01-01

    The present invention concerns a plant abnormality inspection device for conducting remote or automatic patrolling inspection in a plant and, more particularly, relates to such a device as capable of detecting abnormal odors. That is, the device comprises a moving device for moving to a predetermined position in the plant, a plurality of gas sensors for different kind of gases to be inspected mounted thereon, a comparator for comparing the concentration of a gas detected by the gas sensor with the normal gas concentration at the predetermined position and a judging means for judging the absence or presence of abnormality depending on the combination of the result of the comparison and deliverying a signal if the state is abnormal. As a result, a slight amount of gas responsible to odors released upon abnormality of the plant can be detected by a plurality of gas sensors for different kinds gases to rapidly and easily find abnormal portions in the plant. (I.S.)

  4. Magnetic particle inspection

    Science.gov (United States)

    Sastri, Sankar

    1990-01-01

    The purpose of this experiment is to familiarize the student with magnetic particle inspection and relate it to classification of various defects. Magnetic particle inspection is a method of detecting the presence of cracks, laps, tears, inclusions, and similar discontinuities in ferromagnetic materials such as iron and steel. This method will most clearly show defects that are perpendicular to the magnetic field. The Magnaglo method uses a liquid which is sprayed on the workpiece to be inspected, and the part is magnetized at the same time. The workpiece is then viewed under a black light, and the presence of discontinuity is shown by the formation of a bright indication formed by the magnetic particles over the discontinuity. The equipment and experimental procedures are described.

  5. Visual Inspection for Caries Detection

    DEFF Research Database (Denmark)

    Gimenez, T; Piovesan, C; Braga, M M

    2015-01-01

    July 2014 to identify published and nonpublished studies in English. Studies of visual inspection were included that 1) assessed accuracy of the method in detecting caries lesions; 2) were performed on occlusal, proximal, or free smooth surfaces in primary or permanent teeth; 3) had a reference...... (from 5,808 articles initially identified) and 1 abstract (from 168) met the inclusion criteria. In general, the analysis demonstrated that the visual method had good accuracy for detecting caries lesions. Although laboratory and clinical studies have presented similar accuracy, clinically obtained...... caries detection method has good overall performance. Furthermore, although the identified studies had high heterogeneity and risk of bias, the use of detailed and validated indices seems to improve the accuracy of the method....

  6. Federal environmental inspections handbook

    International Nuclear Information System (INIS)

    1991-10-01

    This Federal Environmental Inspection Handbook has been prepared by the Department of Energy (DOE), Office of Environmental Guidance, RCRA/CERCLA Division (EH-231). It is designed to provide DOE personnel with an easily accessible compilation of the environmental inspection requirements under Federal environmental statutes which may impact DOE operations and activities. DOE personnel are reminded that this Handbook is intended to be used in concert with, and not as a substitute for, the Code of Federal Regulations (CFR). Federal Register (FR), and other applicable regulatory documents

  7. Subsea Infrastructure Inspection

    DEFF Research Database (Denmark)

    Mai, Christian; Pedersen, Simon; Hansen, Leif

    2016-01-01

    Due to the increasing energy demands, the offshore energy business has boomed in recent decades. Sub-sea pipeline and power transmission cable installations are commonly applied worldwide. Any potential breakages can cause equipment damage and also damage the environment. The majority...... (S-AUVs) can significantly change the inspections of infrastructure, as these vehicles could be much cheaper to deploy. S-AUVs can potentially conduct faster data collection and provide higher inspection data quality. However, there are still some technical challenges related to: underwater wireless...

  8. Inspection and test planning

    International Nuclear Information System (INIS)

    Miller, T.

    1980-01-01

    Purpose of Quality Plan - arrangement of all necessary tests or inspections as far as possible filted to certain components or systems. Subject of Quality Plan - precise determination of tests or inspections and - according to the actual safety significance - the certificates to be done. Disposition of Quality Plan - accommodation of tests to the actual state of fabrication. Application of Quality Plan - to any component or system that is regarded. Supervision of Employment - by authorized personnel of manufacturer, customer or authority providing exact employment of quality plan. Overservance of Instructions - certificates given by authorized personnel. (orig./RW)

  9. Effect modification, interaction and mediation: an overview of theoretical insights for clinical investigators

    Directory of Open Access Journals (Sweden)

    Corraini P

    2017-06-01

    Full Text Available Priscila Corraini,1 Morten Olsen,1 Lars Pedersen,1 Olaf M Dekkers,1,2 Jan P Vandenbroucke1–3 1Department of Clinical Epidemiology, Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark; 2Leiden University Medical Center, Leiden, the Netherlands; 3Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK Abstract: We revisited the three interrelated epidemiological concepts of effect modification, interaction and mediation for clinical investigators and examined their applicability when using research databases. The standard methods that are available to assess interaction, effect modification and mediation are explained and exemplified. For each concept, we first give a simple “best-case” example from a randomized controlled trial, followed by a structurally similar example from an observational study using research databases. Our explanation of the examples is based on recent theoretical developments and insights in the context of large health care databases. Terminology is sometimes ambiguous for what constitutes effect modification and interaction. The strong assumptions underlying the assessment of interaction, and particularly mediation, require clinicians and epidemiologists to take extra care when conducting observational studies in the context of health care databases. These strong assumptions may limit the applicability of interaction and mediation assessments, at least until the biases and limitations of these assessments when using large research databases are clarified. Keywords: methods, epidemiology, effect modifiers, stratified analyses, health care administrative claims

  10. Investigation of clinical pharmacokinetic variability of an opioid antagonist through physiologically based absorption modeling.

    Science.gov (United States)

    Ding, Xuan; He, Minxia; Kulkarni, Rajesh; Patel, Nita; Zhang, Xiaoyu

    2013-08-01

    Identifying the source of inter- and/or intrasubject variability in pharmacokinetics (PK) provides fundamental information in understanding the pharmacokinetics-pharmacodynamics relationship of a drug and project its efficacy and safety in clinical populations. This identification process can be challenging given that a large number of potential causes could lead to PK variability. Here we present an integrated approach of physiologically based absorption modeling to investigate the root cause of unexpectedly high PK variability of a Phase I clinical trial drug. LY2196044 exhibited high intersubject variability in the absorption phase of plasma concentration-time profiles in humans. This could not be explained by in vitro measurements of drug properties and excellent bioavailability with low variability observed in preclinical species. GastroPlus™ modeling suggested that the compound's optimal solubility and permeability characteristics would enable rapid and complete absorption in preclinical species and in humans. However, simulations of human plasma concentration-time profiles indicated that despite sufficient solubility and rapid dissolution of LY2196044 in humans, permeability and/or transit in the gastrointestinal (GI) tract may have been negatively affected. It was concluded that clinical PK variability was potentially due to the drug's antagonism on opioid receptors that affected its transit and absorption in the GI tract. Copyright © 2013 Wiley Periodicals, Inc.

  11. Research Capacity at Traditional Chinese Medicine (TCM Centers in China: A Survey of Clinical Investigators

    Directory of Open Access Journals (Sweden)

    Shuo Feng

    2017-01-01

    Full Text Available Background. The development of an evidence-based approach to traditional Chinese medicine (TCM, which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82% were qualified to at least a Master’s degree, whilst a smaller proportion (40.24% held a senior professional title. We found that academic outputs were low with the majority (62.16% authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43% and identification of research questions (86.81%, whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%, and time (37.15%. Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators’ research capacity and the development of an evidence-based approach of TCM.

  12. Electron probe microanalysis for clinical investigations: Microdrop and soft tissue analysis

    International Nuclear Information System (INIS)

    Ingram, M.J.; Ingram, F.D.

    1984-01-01

    The most important advantage offered by electron probe microanalysis (EPA) for clinical investigations is the ability to analyze smaller volumes of tissue than is possible with conventional techniques. The sample can be a biological soft tissue specimen, which involves subcellular localization, or a picoliter fluid droplet. In either case, the analysis can be nondestructive and permit multiple analyses for a number of elements in a given sample. The most highly developed electron microprobe analytical technique is fluid drop analysis, popularly referred to as microdrop analysis. This method provides the investigator with an analytic capability that has an accuracy of measurement often 1% or better on 20 to 30 picoliter fluid droplets. Electron microprobe techniques have been used for studies of animal hard tissue and for studies that involve insoluble inclusions. However, the development of techniques for studies of labile constituents in animal soft tissue has been much slower. It has been necessary not only to develop appropriate methods of tissue preparation, but also to establish sound techniques for tissue collection. Although there are adequate methods for collection of most types of tissue from laboratory animals, many of these methods are not suitable for human subjects. In order to provide the reader with a better understanding of the capabilities and potential for the application of electron microprobe methodology to problems in clinical medicine, the authors discuss some of their experiences with liquid droplet analysis and quantitative electrolyte distribution measurements in animal soft tissue

  13. Methods to reduce medication errors in a clinical trial of an investigational parenteral medication

    Directory of Open Access Journals (Sweden)

    Gillian L. Fell

    2016-12-01

    Full Text Available There are few evidence-based guidelines to inform optimal design of complex clinical trials, such as those assessing the safety and efficacy of intravenous drugs administered daily with infusion times over many hours per day and treatment durations that may span years. This study is a retrospective review of inpatient administration deviation reports for an investigational drug that is administered daily with infusion times of 8–24 h, and variable treatment durations for each patient. We report study design modifications made in 2007–2008 aimed at minimizing deviations from an investigational drug infusion protocol approved by an institutional review board and the United States Food and Drug Administration. Modifications were specifically aimed at minimizing errors of infusion rate, incorrect dose, incorrect patient, or wrong drug administered. We found that the rate of these types of administration errors of the study drug was significantly decreased following adoption of the specific study design changes. This report provides guidance in the design of clinical trials testing the safety and efficacy of study drugs administered via intravenous infusion in an inpatient setting so as to minimize drug administration protocol deviations and optimize patient safety.

  14. [Etiological, clinical and neuroradiological investigation of deaf children with additional neuropsychiatric disabilities].

    Science.gov (United States)

    Chilosi, A M; Scusa, M F; Comparini, A; Genovese, E; Forli, F; Berrettini, S; Cipriani, P

    2012-04-01

    Sensorineural hearing loss (SNHL) is complicated by additional disabilities in about 30% of cases, but the epidemiology of associated disorders, in terms of type, frequency and aetiology is still not clearly defined. Additional disabilities in a deaf child have important consequences in assessing and choosing a therapeutic treatment, in particular when considering cochlear implantation (CI) or hearing aids (HA). The aim of this paper was to evaluate frequency, type and severity of additional neurodevelopmental disabilities in children with profound bilateral sensorineural hearing loss and to investigate the relationship between disability and the etiology of deafness. Eighty children with profound bilateral sensorineural hearing loss (mean age 5.4 years) were investigated by means of a diagnostic protocol including clinical, neurodevelopmental, and audiological procedures together with genetic and neurometabolic tests and neuroradiological investigation by brain MRI. Fifty-five percent of the sample exhibited one or more disabilities in addition to deafness, with cognitive, behavioural-emotional and motor disorders being the most frequent. The risk of additional disabilities varied according to aetiology, with a higher incidence in hereditary syndromic deafness, in cases due to pre-perinatal pathology (in comparison to unknown and hereditary non syndromic forms) and in the presence of major brain abnormalities at MRI. Our results suggest that the aetiology of deafness may be a significant risk indicator for the presence of neuropsychiatric disorders. A multidimensional evaluation, including aetiological, neurodevelopmental and MRI investigation is needed for formulating prognosis and for planning therapeutic intervention, especially in those children candidated to cochlear implant.

  15. Investigation of paramedics' compliance with clinical practice guidelines for the management of chest pain.

    LENUS (Irish Health Repository)

    Figgis, Ken

    2012-01-31

    BACKGROUND: Acute coronary syndromes remain a leading cause of preventable early deaths. However, previous studies have indicated that paramedics\\' compliance with chest pain protocols is suboptimal and that many patients do not receive the benefits of appropriate prehospital treatment. AIMS: To evaluate paramedics\\' level of compliance with national clinical practice guidelines and to investigate why, in certain circumstances, they may deviate from the clinical guidelines. SETTING: The Health Service Executive Mid-Western Regional Ambulance Service which serves a mixed urban and rural population across three counties in the west of Ireland. METHOD: A retrospective review of completed ambulance Patient Care Report Forms was conducted for all adult patients with non-traumatic chest pain treated between 1 December 2007 and 31 March 2008. During the same study period, paramedics were asked to complete a prospective questionnaire survey investigating the rationale behind their treatment decisions, their estimation of patient risk and their attitudes towards the clinical practice guidelines and training. RESULTS: 382 completed Patient Care Report Forms were identified for patients with chest pain, of whom 84.8% received ECG monitoring, 75.9% were given oxygen, 44.8% were treated with sublingual glyceryl trinitrate (GTN) and 50.8% were treated with aspirin. Only 20.4% of patients had a prehospital 12-lead ECG recorded. 58 completed questionnaires were returned (response rate 15%); 64% of respondents said they had received insufficient training to identify ECG abnormalities. CONCLUSIONS: Prehospital treatment with oxygen, aspirin, sublingual GTN and ECG monitoring remains underused by paramedics, even though only a small number of patients had documented contraindications to their use. The small number of patients who received a prehospital 12-lead ECG is a cause of particular concern and suggests that incomplete patient assessment may contribute to undertreatment

  16. Understanding Career Success and Its Contributing Factors for Clinical and Translational Investigators

    Science.gov (United States)

    Robinson, Georgeanna F.W.B.; Schwartz, Lisa S.; DiMeglio, Linda A.; Ahluwalia, Jasjit S.; Gabrilove, Janice L.

    2015-01-01

    Purpose To understand the factors that facilitate career success for career development awardees in clinical and translational science and to reconceptualize understanding of career success for this population. Method In 2013–2014, the authors conducted semi-structured interviews with former NIH KL2 or K12 scholars from nine Clinical and Translational Science Award-funded institutions. Participants either had or had not secured independent funding at least two years after the end of their last K award. Questions covered the factors that facilitate or hinder junior investigators’ transition to independent funding. Interviews were recorded and transcribed and the transcripts analyzed thematically. Results Forty individuals participated, with equal representation by men and women and by independently and not independently funded investigators. Personal factors that facilitated success included: networks, persistence and resilience, initiative, autonomy, and personal and professional balance. Organizational factors included: appropriate mentorship, protected research time, and institutional resources and support. Even independently funded participants described challenges regarding career direction. Five participants without independent funding modeled a broad spectrum of successful career paths, having assumed leadership positions not reliant on grant funding. Alternative definitions of career success included: improving public health, enjoying work, seeing mentees succeed, and receiving external acknowledgement of successes. Conclusions Awareness of the factors that facilitate or hinder career success can help junior faculty, mentors, and institutional leaders support career development in clinical and translational science. New definitions of career success are needed, as are career paths for faculty who want to engage in research in roles other than principal investigator. PMID:26509600

  17. Inspection of Emergency Arrangements

    International Nuclear Information System (INIS)

    2013-01-01

    The Working Group on Inspection Practices (WGIP) was tasked by the NEA CNRA to examine and evaluate the extent to which emergency arrangements are inspected and to identify areas of importance for the development of good inspection practices. WGIP members shared their approaches to the inspection of emergency arrangements by the use of questionnaires, which were developed from the requirements set out in IAEA Safety Standards. Detailed responses to the questionnaires from WGIP member countries have been compiled and are presented in the appendix to this report. The following commendable practices have been drawn from the completed questionnaires and views provided by WGIP members: - RBs and their Inspectors have sufficient knowledge and information regarding operator's arrangements for the preparedness and response to nuclear emergencies, to enable authoritative advice to be given to the national coordinating authority, where necessary. - Inspectors check that the operator's response to a nuclear emergency is adequately integrated with relevant response organisations. - Inspectors pay attention to consider the integration of the operator's response to safety and security threats. - The efficiency of international relations is checked in depth during some exercises (e.g. early warning, assistance and technical information), especially for near-border facilities that could lead to an emergency response abroad. - RB inspection programmes consider the adequacy of arrangements for emergency preparedness and response to multi-unit accidents. - RBs assess the adequacy of arrangements to respond to accidents in other countries. - The RB's role is adequately documented and communicated to all agencies taking part in the response to a nuclear or radiological emergency. - Inspectors check that threat assessments for NPPs have been undertaken in accordance with national requirements and that up-to-date assessments have been used as the basis for developing emergency plans for

  18. [Clinical and genetic investigation of families with Waardenburg syndrome type 2].

    Science.gov (United States)

    Chen, H S; Liao, X B; Liu, Y L; He, C F; Zhang, H; Jiang, L; Feng, Y; Mei, L Y

    2016-12-01

    Objective: To investigate the clinical chacteration and molecular pathology of Waardenburg syndrome type 2 in seven families, and provide genetic diagnosis and hereditary counseling for family members. Method: Clinical data of seven families with WS2(14 patients)were collected. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of microphthalmia associated transcription factor (MITF), sex-determining region Y-box 10(SOX10), snail family zinc finger 2 (SNAI2) and endothelin receptor type B(EDNRB)were analyzed by polymerase chain reaction and DNA sequencing. Then the raw data was analyzed. Result: The most common manifestations of WS2 are sensorineural hearing loss(10/14,71.4%), freckle(7/14, 50.0%),heterochromia iridis(6/14, 42.9%) and premature greying(5/14,35.7%). All the deafness phenotype is congenital, bilateral profound sensorineural hearing loss. Freckles phenotype is different from cutaneous pigment abnormalities of WS in Westerners. The heterozygous mutation, c.328C>T in exon 3 of the MITF gene was detected in the proband and all patients of pedigree 2. However, no pathological mutation of the relevant genes (SOX10,SNAI2 and EDNRB) was detected in other pedigrees. Conclusion: There are obvious variations in clinical features of WS, while freckles may be a special subtype of cutaneous pigment disturbances. The MITF gene mutation, R110X,is therefore considered the disease causing mutation in pedigree WS02.However, there are novel disease causing genes or copy number variations in Waardenburg syndrome type 2, which require further research. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

  19. Risk-Informed Decisions Optimization in Inspection and Maintenance

    International Nuclear Information System (INIS)

    Robertas Alzbutas

    2002-01-01

    The Risk-Informed Approach (RIA) used to support decisions related to inspection and maintenance program is considered. The use of risk-informed methods can help focus the adequate in-service inspections and control on the more important locations of complex dynamic systems. The focus is set on the highest risk measured as conditional core damage frequency, which is produced by the frequencies of degradation and final failure at different locations combined with the conditional failure consequence probability. The probabilities of different degradation states per year and consequences are estimated quantitatively. The investigation of inspection and maintenance process is presented as the combination of deterministic and probabilistic analysis based on general risk-informed model, which includes the inspection and maintenance program features. Such RIA allows an optimization of inspection program while maintaining probabilistic and fundamental deterministic safety requirements. The failure statistics analysis is used as well as the evaluation of reliability of inspections. The assumptions regarding the effectiveness of the inspection methods are based on a classification of the accessibility of the welds during the inspection and on the different techniques used for inspection. The probability of defect detection is assumed to depend on the parameters either through logarithmic or logit transformation. As example the modeling of the pipe systems inspection process is analyzed. The means to reduce a number of inspection sites and the cumulative radiation exposure to the NPP inspection personnel with a reduction of overall risk is presented together with used and developed software. The developed software can perform and administrate all the risk evaluations and ensure the possibilities to compare different options and perform sensitivity analysis. The approaches to define an acceptable level of risk are discussed. These approaches with appropriate software in

  20. Inspective investigation on Atlantic pomfret (Brama raji

    Directory of Open Access Journals (Sweden)

    Antonio Panebianco

    2013-02-01

    Full Text Available The present study was carried out on 21 specimens of Brama raji collected at fish markets of Sicily and Calabria between april 2011 and march 2012. The detection of total Enterobacteriaceae, Vibrio spp. and Specific Spoilage Bacteria from gills, intestine, skin and muscle during storage (336h was carried out. 34 Vibrio spp. (rpoA+ strains were isolated from gills and skin. The subsequent identification of species by multiplex PCR (gene collagenase allowed to establish that 33 strains were V. alginolyticus and one was V. parahaemolyticus. The anatomopathological examination of muscle tissue showed that 15 specimens (71.x4% were positive for the presence of larvae of Gymnorhynchus gigas. The determination of TVB-N and TMA-N was made on muscle portions around the parasite, on larvae of G. gigas and on muscle portions parasite-free. The TVB-N and TMA-N contents of each sample were measured using the Conway microdiffusion method. The higher values of TVB-N (31.6 mg/100g and TMA-N (8.5 mg/100g were observed at 336 hours of storage. No statistically significant differences between muscle parasite-free and muscle around the parasite for TVB-N and TMA-N were observed during storage. Parasites of genus Koellikeria filicollis, Sphiriocephalus tergestinus and Anisakis spp. were also observed.

  1. Investigation of Factors Affecting Body Temperature Changes During Routine Clinical Head Magnetic Resonance Imaging

    Science.gov (United States)

    Kim, Myeong Seong

    2016-01-01

    Background Pulsed radiofrequency (RF) magnetic fields, required to produce magnetic resonance imaging (MRI) signals from tissue during the MRI procedure have been shown to heat tissues. Objectives To investigate the relationship between body temperature rise and the RF power deposited during routine clinical MRI procedures, and to determine the correlation between this effect and the body’s physiological response. Patients and Methods We investigated 69 patients from the Korean national cancer center to identify the main factors that contribute to an increase in body temperature (external factors and the body’s response) during a clinical brain MRI. A routine protocol sequence of MRI scans (1.5 T and 3.0 T) was performed. The patient’s tympanic temperature was recorded before and immediately after the MRI procedure and compared with changes in variables related to the body’s physiological response to heat. Results Our investigation of the physiological response to RF heating indicated a link between increasing age and body temperature. A higher increase in body temperature was observed in older patients after a 3.0-T MRI (r = 0.07, P = 0.29 for 1.5-T MRI; r = 0.45, P = 0.002 for 3.0-T MRI). The relationship between age and body heat was related to the heart rate (HR) and changes in HR during the MRI procedure; a higher RF power combined with a reduction in HR resulted in an increase in body temperature. Conclusion A higher magnetic field strength and a decrease in the HR resulted in an increase in body temperature during the MRI procedure. PMID:27895872

  2. Pipework inspection apparatus

    International Nuclear Information System (INIS)

    Wrigglesworth, K.J.; Knowles, J.F.

    1987-01-01

    The patent concerns a pipework inspection apparatus, which is capable of negotiating bends in pipework. The apparatus comprises a TV camera system, which contains an optical section and an electronics section, which are connected by a flexible coupling. The system can be pulled or pushed along the bore of the pipework. (U.K.)

  3. Fuel assembly inspection device

    International Nuclear Information System (INIS)

    Yaginuma, Yoshitaka

    1998-01-01

    The present invention provides a device suitable to inspect appearance of fuel assemblies by photographing the appearance of fuel assemblies. Namely, the inspection device of the present invention measures bowing of fuel assembly or each of fuel rods or both of them based on the partially photographed images of fuel assembly. In this case, there is disposed a means which flashily projects images in the form of horizontal line from a direction intersecting obliquely relative to a horizontal cross section of the fuel assembly. A first image processing means separates the projected image pictures including projected images and calculates bowing. A second image processing means replaces the projected image pictures of the projected images based on projected images just before and after the photographing. Then, images for the measurement of bowing and images for inspection can be obtained simultaneously. As a result, the time required for the photographing can be shortened, the time for inspection can be shortened and an effect of preventing deterioration of photographing means by radiation rays can be provided. (I.S.)

  4. Inspection qualification and implementation of ENIQ in Sweden

    International Nuclear Information System (INIS)

    Zettervall, Tommy

    2013-01-01

    Many countries are currently considering their approaches to inspection qualification and risk-informed in-service inspection (RI-ISI) and are carefully assessing experience data. In Europe most of the utilities operating nuclear power plants have joined together to form the European Network for Inspection Qualification ENIQ. In practice, qualification can be performed with varying degrees of complexity and cost, varying from capability statement based on existing evidence, through to an extensive qualification consisting of a detailed Technical Justification (TJ) together with open and blind trials on full-scale test blocks. An Inspection Qualification is an investigation and demonstration, which confirm that an inspection system has the ability to solve its specific tasks. The qualification is a Quality Assurance of an inspection system based on documents and practical trials. A reliable inspection system, based on a reliable qualification and correct prerequisites, will reduce total costs for Licensees and increase the credibility of the inspection result. To get such inspection system, which could be valid for many years, it's of necessity to fulfil all included parts in the process. It begins with the Technical Specification from Licensee, where input data and requirements about the actual component are specified. To get an inspection system that could live over time, the Technical Justification is of importance. Finally the test blocks and used simulation techniques play an important part of the final result, and these test blocks together with TJ form the basis for qualification body's decision. (author)

  5. Adapting Cognitive Task Analysis to Investigate Clinical Decision Making and Medication Safety Incidents.

    Science.gov (United States)

    Russ, Alissa L; Militello, Laura G; Glassman, Peter A; Arthur, Karen J; Zillich, Alan J; Weiner, Michael

    2017-05-03

    Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare. We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews. We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection. The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

  6. 16 CFR 1605.2 - Conduct and scope of inspections.

    Science.gov (United States)

    2010-01-01

    ... Section 1605.2 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS INVESTIGATIONS, INSPECTIONS AND INQUIRIES PURSUANT TO THE FLAMMABLE FABRICS ACT Procedures for Investigations... any product, fabric, or related material and all pertinent equipment, materials, substances, products...

  7. Idiopathic Canalicular Inflammatory Disease: New Disease Description of Clinical Patterns, Investigations, Management, and Outcomes.

    Science.gov (United States)

    Ali, Mohammad Javed

    2018-01-25

    The objective of this perspective is to present a separate disease description of "idiopathic canalicular inflammatory disease" and outline the diagnostic criteria and early experiences with its investigations and management. Retrospective case series of 44 canaliculi of 22 eyes of 11 patients presenting at a tertiary care Dacryology service over a period of 2 years with typical clinical patterns of inflammatory canaliculitis and its outcomes were studied. All the patients underwent microbiological work-up with culture and sensitivity, dacryoendoscopy imaging, serial Fourier domain ocular coherence tomography, and collagen vascular profiles. Stages in the evolution of the disease were studied. All patients were treated initially with topical steroids followed by punctal dilatation and placement of mini-monoka stents. Five patients in addition had a small biopsy from the inflamed portion of the vertical canaliculus. Stents were extubated at 6 weeks. Forty-four canaliculi were diagnosed to have idiopathic canalicular inflammatory disease during the study period. There was a female preponderance (81.8%, 9/11) and the mean age at presentation was 57 years. All patients presented with unilateral epiphora without any discharge, pain, or swelling. Collagen vascular profiles and screening for autoimmune diseases were negative. Clinical picture ranged from stages 1 to 5, consisting of edema, progressive centripetal vascularization, pouting of vascularized mucosa, membrane formation, and progressive scarring. The presentation begins in 1 eye and usually involves the other eye at a mean of 6 months. Ocular coherence tomography and dacryoendoscopy were of adjunctive value in the diagnosis. Histopathological examination was suggestive of a chronic inflammation. All patients had relentless progression to end-stage disease, although delayed significantly by steroids and monoka intubation. Idiopathic canalicular inflammatory disease has a distinct and typical clinical behavior and

  8. An Investigation of Factors Influencing Nurses' Clinical Decision-Making Skills.

    Science.gov (United States)

    Wu, Min; Yang, Jinqiu; Liu, Lingying; Ye, Benlan

    2016-08-01

    This study aims to investigate the influencing factors on nurses' clinical decision-making (CDM) skills. A cross-sectional nonexperimental research design was conducted in the medical, surgical, and emergency departments of two university hospitals, between May and June 2014. We used a quantile regression method to identify the influencing factors across different quantiles of the CDM skills distribution and compared the results with the corresponding ordinary least squares (OLS) estimates. Our findings revealed that nurses were best at the skills of managing oneself. Educational level, experience, and the total structural empowerment had significant positive impacts on nurses' CDM skills, while the nurse-patient relationship, patient care and interaction, formal empowerment, and information empowerment were negatively correlated with nurses' CDM skills. These variables explained no more than 30% of the variance in nurses' CDM skills and mainly explained the lower quantiles of nurses' CDM skills distribution. © The Author(s) 2016.

  9. Inspections in veterinary medicine 2005; Veterinaerinspektioner 2005

    Energy Technology Data Exchange (ETDEWEB)

    Joensson, Helene

    2006-11-15

    In Sweden 300 veterinary clinics have a license for x-ray diagnostics. Six of them also have a license for nuclear medicine. During 2005 eight clinics were inspected and the results show that the radiation protection in veterinary medicine can be improved. No clinic fulfilled the regulations of categorization of workplaces and workers (SSI FS 1998:3). Half of the clinics had no Swedish manual to the x-ray equipment and just as many had not performed the annual function check. Obviously, there is a need for more information to staff in veterinary medicine.

  10. Investigation of Clinical Characteristics and Etiological Factors in Children with Molar Incisor Hypomineralization

    Directory of Open Access Journals (Sweden)

    Maria Rita Giuca

    2018-01-01

    Full Text Available Aim. The purpose of the present study was to evaluate the clinical defects and etiological factors potentially involved in the onset of MIH in a pediatric sample. Methods. 120 children, selected from the university dental clinic, were included: 60 children (25 boys and 35 girls; average age: 9.8 ± 1.8 years with MIH formed the test group and 60 children (27 boys and 33 girls; average age: 10.1 ± 2 years without MIH constituted the control group. Distribution and severity of MIH defects were evaluated, and a questionnaire was used to investigate the etiological variables; chi-square, univariate, and multivariate statistical tests were performed (significance level set at p<0.05. Results. A total of 186 molars and 98 incisors exhibited MIH defects: 55 molars and 75 incisors showed mild defects, 91 molars and 20 incisors had moderate lesions, and 40 molars and 3 incisors showed severe lesions. Univariate and multivariate statistical analysis showed a significant association (p<0.05 between MIH and ear, nose, and throat (ENT disorders and the antibiotics used during pregnancy (0.019. Conclusions. Moderate defects were more frequent in the molars, while mild lesions were more frequent in the incisors. Antibiotics used during pregnancy and ENT may be directly involved in the etiology of MIH in children.

  11. Investigation of Clinical Characteristics and Etiological Factors in Children with Molar Incisor Hypomineralization

    Science.gov (United States)

    Giuca, Maria Rita; Cappè, Maria; Carli, Elisabetta; Lardani, Lisa

    2018-01-01

    Aim The purpose of the present study was to evaluate the clinical defects and etiological factors potentially involved in the onset of MIH in a pediatric sample. Methods 120 children, selected from the university dental clinic, were included: 60 children (25 boys and 35 girls; average age: 9.8 ± 1.8 years) with MIH formed the test group and 60 children (27 boys and 33 girls; average age: 10.1 ± 2 years) without MIH constituted the control group. Distribution and severity of MIH defects were evaluated, and a questionnaire was used to investigate the etiological variables; chi-square, univariate, and multivariate statistical tests were performed (significance level set at p MIH defects: 55 molars and 75 incisors showed mild defects, 91 molars and 20 incisors had moderate lesions, and 40 molars and 3 incisors showed severe lesions. Univariate and multivariate statistical analysis showed a significant association (p MIH and ear, nose, and throat (ENT) disorders and the antibiotics used during pregnancy (0.019). Conclusions Moderate defects were more frequent in the molars, while mild lesions were more frequent in the incisors. Antibiotics used during pregnancy and ENT may be directly involved in the etiology of MIH in children. PMID:29861729

  12. Phase II drugs under clinical investigation for the treatment of chronic constipation.

    Science.gov (United States)

    Mozaffari, Shilan; Didari, Tina; Nikfar, Shekoufeh; Abdollahi, Mohammad

    2014-11-01

    Chronic constipation (CC) is a common gastrointestinal (GI) motility disorder that significantly impairs the quality of life in affected subjects. As almost half of the patients suffering from CC are not satisfied with currently available medicines, there is a need to develop new molecules with better effectiveness and tolerability. The authors include all experimental and clinical trials (up to Phase II) about new investigational drugs for the treatment of CC. The article identifies nine new agents: mitemcinal, TD-8954, YKP10811, itopride, RM-131, KWA-0711, elobixibat, velusetrag, and naronapride. All nine agents have shown prokinetic effects in different stages of the development. The mechanisms of new developing drugs include: the activation of 5-hydroxytryptamine type-4 (5-HT4), ghrelin and motilin receptors, antagonizing dopamine type-2 (D2) receptors, inhibition of ileal bile acid reabsorption and acetylcholine esterase, as well as water absorption from the GI tract. At this current point in time, new generations of 5-HT4 receptor agonists (velusetrag, noranopride and YKP10811) are hoped to progress, further in the future, due to better efficiency and safety. However, it is not possible to make a concise conclusion at this current time due to a lack of evidence. Further clinical trials with a longer duration and a larger sample size are warranted.

  13. Driving Organizational Change From the Bedside: The AACN Clinical Scene Investigator Academy.

    Science.gov (United States)

    Lacey, Susan R; Goodyear-Bruch, Caryl; Olney, Adrienne; Hanson, Dave; Altman, Marian S; Varn-Davis, Natasha S; Brinker, Debbie; Lavandero, Ramón; Cox, Karen S

    2017-08-01

    Staff nurses are pivotal in leading change related to quality improvement efforts, although many lack skills to steer change from the bedside. The American Association of Critical-Care Nurses (AACN) staff nurse leadership program, Clinical Scene Investigator (CSI) Academy, teaches and empowers staff nurses in leadership skills and change concepts to translate evidence into practice affecting patient outcomes. To describe the curriculum of the AACN CSI Academy that provides staff nurses with the leadership skills required to create unit-based change projects that positively impact patient/family outcomes. The curriculum of the Academy included leadership topics, communication, change concepts, quality improvement methods, project management, and data management and analysis. Each team of participants collected project data to show improvements in patient care. The program evaluation used many data sources to assess the program effectiveness, relating to the professional growth of the participant nurses. The participants assessed project patient outcomes, sustainability, and spread. The first cohort of CSI participants included 164 direct care nurses from 42 hospitals in 6 cities. They rated the Academy highly in the program evaluation, and they reported that the Academy contributed to their professional development. The individual hospital quality improvement projects resulted in positive patient and estimated fiscal outcomes that were generally sustained 1 year after the program. With the skills, tools, and support obtained from participation in the CSI Academy, staff nurses can make substantial contributions to their organizations in clinical and possibly fiscal outcomes. ©2017 American Association of Critical-Care Nurses.

  14. Optimal inspection planning for onshore pipelines subject to external corrosion

    International Nuclear Information System (INIS)

    Gomes, Wellison J.S.; Beck, André T.; Haukaas, Terje

    2013-01-01

    Continuous operation of pipeline systems involves significant expenditures in inspection and maintenance activities. The cost-effective safety management of such systems involves allocating the optimal amount of resources to inspection and maintenance activities, in order to control risks (expected costs of failure). In this context, this article addresses the optimal inspection planning for onshore pipelines subject to external corrosion. The investigation addresses a challenging problem of practical relevance, and strives for using the best available models to describe random corrosion growth and the relevant limit state functions. A single pipeline segment is considered in this paper. Expected numbers of failures and repairs are evaluated by Monte Carlo sampling, and a novel procedure is employed to evaluate sensitivities of the objective function with respect to design parameters. This procedure is shown to be accurate and more efficient than finite differences. The optimum inspection interval is found for an example problem, and the robustness of this optimum to the assumed inspection and failure costs is investigated. It is shown that optimum total expected costs found herein are not highly sensitive to the assumed costs of inspection and failure. -- Highlights: • Inspection, repair and failure costs of pipeline systems considered. • Optimum inspection schedule (OIS) obtained by minimizing total expected life-cycle costs. • Robustness of OIS evaluated w.r.t. estimated costs of inspection and failure. • Accurate non-conservative models of corrosion growth employed

  15. Study on the inspection item and inspection method of HTGR fuel

    International Nuclear Information System (INIS)

    Na, Sang Ho; Kim, Y. K.; Jeong, K. C.; Oh, S. C.; Cho, M. S.; Kim, Y. M.; Lee, Y. W.

    2006-01-01

    The type of HTGR(High Temperature Gas-cooled Reactor) fuel is different according to the reactor type. Generally the HTGR fuel has two types. One is a block type, which is manufactured in Japan or America. And the other is a pebble type, which is manufactured in China. Regardless of the fuel type, the fuel manufacturing process started from the coated particle, which is consisted of fuel kernel and the 4 coating layers. Korea has a plan to fabricate a HTGR fuel in near future. The appropriate quality inspection standards are requested to produce a sound and reliable coated particle for HTGR fuel. Therefore, the inspection items and the inspection methods of HTGR fuel between Japan and China, which countries have the manufacturing process, are investigated to establish a proper inspection standards of our product characteristics

  16. Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

    Science.gov (United States)

    Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

    New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified

  17. Investigating Clinically and Scientifically Useful Cut Points on the Compulsive Sexual Behavior Inventory.

    Science.gov (United States)

    Miner, Michael H; Raymond, Nancy; Coleman, Eli; Swinburne Romine, Rebecca

    2017-05-01

    clinical screening tool and the other, more conservative measurement that is useful for etiologic and epidemiologic research. Miner MH, Raymond N, Coleman E, Swinburne Romine R. Investigating Clinically and Scientifically Useful Cut Points on the Compulsive Sexual Behavior Inventory. J Sex Med 2017;14:715-720. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  18. Advanced inspection technology for non intrusive inspection (NII) program

    International Nuclear Information System (INIS)

    Zamir Mohamed Daud

    2003-01-01

    In the current economic environment, plants and facilities are under pressure to introduced cost saving as well as profit maximising measures. Among the many changes in the way things are run is a move towards Risk Based Inspection (RBI), with an emphasis on longer operating periods between shutdowns as well as to utilise components to their maximum capability. Underpinning and RBI program requires good data from an effective online inspections program, which would not require the shutdown of critical components. One methodology of online inspection is known as Non Intrusive Inspection (NII), an inspection philosophy with the objective of replacing internal inspection of a vessel by doing Non Destructive Testing (NDT) and inspections externally. To this end, a variety of advanced NDT techniques are needed to provide accurate online measurements. (Author)

  19. Clinical investigation of TROP-2 as an independent biomarker and potential therapeutic target in colon cancer.

    Science.gov (United States)

    Zhao, Peng; Yu, Hai-Zheng; Cai, Jian-Hui

    2015-09-01

    Colon cancer is associated with a severe demographic and economic burden worldwide. The pathogenesis of colon cancer is highly complex and involves sequential genetic and epigenetic mechanisms. Despite extensive investigation, the pathogenesis of colon cancer remains to be elucidated. As the third most common type of cancer worldwide, the treatment options for colon cancer are currently limited. Human trophoblast cell‑surface marker (TROP‑2), is a cell‑surface transmembrane glycoprotein overexpressed by several types of epithelial carcinoma. In addition, TROP‑2 has been demonstrated to be associated with tumorigenesis and invasiveness in solid types of tumor. The aim of the present study was to investigate the protein expression of TROP‑2 in colon cancer tissues, and further explore the association between the expression of TROP‑2 and clinicopathological features of patients with colon cancer. The expression and localization of the TROP‑2 protein was examined using western blot analysis and immunofluorescence staining. Finally, the expression of TROP‑2 expression was correlated to conventional clinicopathological features of colon cancer using a χ2 test. The results revealed that TROP‑2 protein was expressed at high levels in the colon cancer tissues, which was associated with the development and pathological process of colon cancer. Therefore, TROP‑2 may be used as a biomarker to determine the clinical prognosis, and as a potential therapeutic target in colon cancer.

  20. Investigations with FDG-PET Scanning in Prostate Cancer Show Limited Value for Clinical Practice

    Energy Technology Data Exchange (ETDEWEB)

    Salminen, Eeva [Univ. of Turku (Finland). Department of Oncology and Radiotherapy; Hogg, Annette; Binns, David; Hicks, Rodney [The Peter MacCallum Cancer Institute, East Melbourne, Vic (Australia). Dept. of Diagnostic Imaging; Frydenberg, Mark [Monash Medical Centre, Clayton, Vic (Australia)

    2002-09-01

    The aim of this study was to investigate FDG-PET (fluorodeoxyglucose positron emission tomography) imaging in the management of prostate cancer. Twenty-two patients were studied during different disease phases of prostate cancer, for staging or restaging to clarify specific clinical questions. FDG-PET was performed encompassing the thorax, abdomen and pelvis using the Penn PET 300H scanner. Scanning was begun 60 min after {sup 18}F fluorodeoxyglucose marker. Patients were catheterized and administered diuretics to minimize urinary activity. Information obtained with FDG-PET was concordant with findings from other investigations in 7/22 (32%) patients, discordant in 15/22 (68%) patients and equivalent in one patient (4%). PET indicated progressive disease in five patients with prostate-specific antigen (PSA) <4 ng/L. The impact on management of the patients was high in 46% of cases, low in 41% and for 14% there was no impact on management. The accuracy of FDG-PET was 72% (95% CI 50-89) as confirmed by invasive diagnostics/follow-up. FDG-PET can provide useful information and improve the clinician's decision on further management procedures in selected patients with low PSA and bone or lymph node changes. A negative PET scan in prostate cancer should be interpreted with caution.

  1. Methodology optimization and diversification for the investigation of virulence potential in Haemophilus influenzae clinical strains.

    Science.gov (United States)

    Giucă, Mihaela Cristina; Străuţ, Monica; Surdeanu, Maria; Nica, Maria; Ungureanu, Vasilica; Mihăescu, Grigore

    2011-01-01

    Ten Haemophilus influenzae strains were isolated from patients aged between 1.6 - 24 years, with various diagnoses (acute meningitis, acute upper respiratory infection, otitis media and acute sinusitis). Identification was based on phenotypic and molecular characteristics; antibiotic susceptibility testing was performed by diffusion method according to CLSI standards 2011 for seven antibiotics. The results of molecular testing showed that all the studied strains produced an amplicon of 1000 bp with ompP2 primers indicating that all strains were H. influenzae. For six strains, the PCR amplicon obtained with bexA specific primers, proving that the strains were capsulated. The results of phenotypic testing showed that four strains were ampicillin nonsusceptible and (beta-lactamase-positive. The virulence potential of H. influenzae clinical strains was investigated by phenotypic methods, including the assessment of the soluble virulence factors on specific media containing the biochemical substratum for the investigated enzymatic factor, as well as the adherence and invasion capacity to HeLa cells monolayer using Cravioto modified method. The studied strains exhibited mainly a diffuse adherence pattern and different adherence indexes. Interestingly, two strains isolated from the same pacient (blood and CSF) showed a different degree of invasiveness, the strain isolated from blood being 20 times more invasive than the one isolated from CSF.

  2. Standard Ship Test and Inspection Plan, Procedures and Database

    National Research Council Canada - National Science Library

    1999-01-01

    ... construction schedules and increased cost is the area of test and inspection. This project investigates existing rules and regulations for testing and inspection of commercial ships and identifies differences and similarities within the requirements. The results include comparison matrices, a standard test plan, a set of standard test procedures, and a sample test database developed for a typical commercial ship.

  3. Hygiene inspections on passenger ships in Europe - an overview

    Science.gov (United States)

    2010-01-01

    Background Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU) countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS) and European Free Trade Association countries. Methods Two questionnaires were composed and disseminated to 28 countries. A total of 92 questionnaires were completed by competent authorities responsible for hygiene inspections (n = 48) and the creation of legislation (n = 44); response rates were 96%, and 75.9%, respectively. Results Out of the 48 responding authorities responsible for hygiene inspections, a routine programme was used by 19 (39.6%) of these to conduct inspections of ships on national voyages and by 26 (54.2%) for ships on international voyages. Standardised inspection forms are used by 59.1% of the authorities. A scoring inspection system is applied by five (11.6%) of the 43 responding authorities. Environmental sampling is conducted by 84.1% of the authorities (37 out of 44). The inspection results are collected and analysed by 54.5% (24 out of 44) of the authorities, while 9 authorities (20.5%) declared that they publish the results. Inspections are conducted during outbreak investigations by 75% and 70.8% of the authorities, on ships on national and international voyages, respectively. A total of 31 (64.6%) and 39 (81.3%) authorities conducted inspections during complaint investigations on ships on international and on national voyages, respectively. Port-to-port communication between the national port authorities was reported by 35.4% (17 out of 48) of the responding authorities and 20.8% (10 out

  4. Hygiene inspections on passenger ships in Europe - an overview.

    Science.gov (United States)

    Mouchtouri, Varvara A; Westacott, Sandra; Nichols, Gordon; Riemer, Tobias; Skipp, Mel; Bartlett, Christopher L R; Kremastinou, Jenny; Hadjichristodoulou, Christos

    2010-03-10

    Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU) countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS) and European Free Trade Association countries. Two questionnaires were composed and disseminated to 28 countries. A total of 92 questionnaires were completed by competent authorities responsible for hygiene inspections (n = 48) and the creation of legislation (n = 44); response rates were 96%, and 75.9%, respectively. Out of the 48 responding authorities responsible for hygiene inspections, a routine programme was used by 19 (39.6%) of these to conduct inspections of ships on national voyages and by 26 (54.2%) for ships on international voyages. Standardised inspection forms are used by 59.1% of the authorities. A scoring inspection system is applied by five (11.6%) of the 43 responding authorities. Environmental sampling is conducted by 84.1% of the authorities (37 out of 44). The inspection results are collected and analysed by 54.5% (24 out of 44) of the authorities, while 9 authorities (20.5%) declared that they publish the results. Inspections are conducted during outbreak investigations by 75% and 70.8% of the authorities, on ships on national and international voyages, respectively. A total of 31 (64.6%) and 39 (81.3%) authorities conducted inspections during complaint investigations on ships on international and on national voyages, respectively. Port-to-port communication between the national port authorities was reported by 35.4% (17 out of 48) of the responding authorities and 20.8% (10 out of 48) of the port

  5. Hygiene inspections on passenger ships in Europe - an overview

    Directory of Open Access Journals (Sweden)

    Bartlett Christopher LR

    2010-03-01

    Full Text Available Abstract Background Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS and European Free Trade Association countries. Methods Two questionnaires were composed and disseminated to 28 countries. A total of 92 questionnaires were completed by competent authorities responsible for hygiene inspections (n = 48 and the creation of legislation (n = 44; response rates were 96%, and 75.9%, respectively. Results Out of the 48 responding authorities responsible for hygiene inspections, a routine programme was used by 19 (39.6% of these to conduct inspections of ships on national voyages and by 26 (54.2% for ships on international voyages. Standardised inspection forms are used by 59.1% of the authorities. A scoring inspection system is applied by five (11.6% of the 43 responding authorities. Environmental sampling is conducted by 84.1% of the authorities (37 out of 44. The inspection results are collected and analysed by 54.5% (24 out of 44 of the authorities, while 9 authorities (20.5% declared that they publish the results. Inspections are conducted during outbreak investigations by 75% and 70.8% of the authorities, on ships on national and international voyages, respectively. A total of 31 (64.6% and 39 (81.3% authorities conducted inspections during complaint investigations on ships on international and on national voyages, respectively. Port-to-port communication between the national port authorities was reported by 35.4% (17 out of 48 of the responding authorities

  6. Investigations of portable cadmium telluride (CdTe(Cl)) detectors for clinical studies with radioactive indicators

    International Nuclear Information System (INIS)

    Bojsen, J.

    1985-01-01

    The combination of small, portable γ-radiation-sensitive Cadmium Telluride (CdTE(Cl)) crystal detectors and portable solid state data storage memories makes it feasible to extend the measuring period in a number of clinical investigations based on the use of various radioisotopes and external detection. Blood sampling can be avoided in some cases. Continuous ambulatory monitoring of relevant physiological parameters is practicable, e.g. kidney function (GFR), left ventricular ejection fraction, subcutaneous blood flow, muscle blood flow and insulin absorption in diabetic patients. In the present methodological study the applicability of the 133-Xe washout technique to subcutaneous (s.c.) adipose tissue blood flow (SBF) has been investigated and adapted to the use of CdTe(Cl) detectors attached to the skin surface for the measurement of local 133-Xe-disappearance rate constants (k). Physical characterization of CdTe(Cl) detectors as γ-sensitive devices has been performed, and adequate counting sensitivities were found without detector energy-resolution properties. The CdTe(Cl) detectors are therefore suitable for single indicator studies. The measuring geometry of CdTe(Cl) detectors was studied and compared with that of stationary Sodium Iodide (NaI(Tl)) detectors in both phantom and in vivo investigations. The spatial properties of CdTe(Cl) detectors could to some extent be adjusted by pulse height discrimination and lead collimation. When long-term measurements were complicated by for instance physical activity of the patients, the small CdTe(Cl) detectors in general showed equal or better performance than the heavy and voluminous NaI(Tl) detectors. The free movement of the ambulatory patient and the avoidance of cable connections to stationary data-collecting systems gave improved possibilities for measurements of the relevant parameters. From this point of view, portable CdTe(Cl) detectors must be considered an important advance for radioactivity studies in

  7. Overview of the software inspection process

    Energy Technology Data Exchange (ETDEWEB)

    Lane, G.L.; Dabbs, R. [Sandia National Labs., Albuquerque, NM (United States)

    1997-11-01

    This tutorial introduces attendees to the Inspection Process and teaches them how to organize and participate in a software inspection. The tutorial advocates the benefits of inspections and encourages attendees to socialize the inspection process in their organizations.

  8. Inspecting fuel pellets for nuclear reactor

    International Nuclear Information System (INIS)

    Wilks, R.S.; Sternheim, E.; Breakey, G.A.; Sturges, R.H.; Taleff, A.; Castner, R.P.

    1982-01-01

    An improved method of controlling the inspection, sorting and classifying of nuclear reactor fuel pellets, including a mechanical handling system and a computer controlled data processing system, is described. Having investigated the diameter, length, surface flaws and weights of the pellets, they are sorted accordingly and the relevant data are stored. (U.K.)

  9. Guidance for performing site inspections under CERCLA

    Energy Technology Data Exchange (ETDEWEB)

    1992-09-01

    This guidance presents EPA`s site inspection (SI) strategy. The strategy discusses procedural guidelines to investigate potential Superfund (CERCLA) sites for evaluation pursuant to the Hazard Ranking System (HRS), revised in accordance with the Superfund Amendments and Reauthorization Act of 1986. The HRS is the primary means by which EPA evaluates sites for superfund`s National Priorities List (NPL).

  10. Intelligence, Inspection Time, and Decision Time.

    Science.gov (United States)

    Bates, Timothy C.; Eysenck, Hans J.

    1993-01-01

    Relationships among Multidimensional Aptitude Battery scores, inspection time, choice reaction time, and the odd-man procedure were investigated for 63 female and 25 male adults. No significant relationships were found for these mental speed measures and the Eysenck Personality Questionnaire-Revised dimensions of extraversion, neuroticism, and…

  11. Waste Inspection Tomography (WIT)

    International Nuclear Information System (INIS)

    Bernardi, R.T.

    1995-01-01

    Waste Inspection Tomography (WIT) provides mobile semi-trailer mounted nondestructive examination (NDE) and assay (NDA) for nuclear waste drum characterization. WIT uses various computed tomography (CT) methods for both NDE and NDA of nuclear waste drums. Low level waste (LLW), transuranic (TRU), and mixed radioactive waste can be inspected and characterized without opening the drums. With externally transmitted x-ray NDE techniques, WIT has the ability to identify high density waste materials like heavy metals, define drum contents in two- and three-dimensional space, quantify free liquid volumes through density and x-ray attenuation coefficient discrimination, and measure drum wall thickness. With waste emitting gamma-ray NDA techniques, WIT can locate gamma emitting radioactive sources in two- and three-dimensional space, identify gamma emitting isotopic species, identify the external activity levels of emitting gamma-ray sources, correct for waste matrix attenuation, provide internal activity approximations, and provide the data needed for waste classification as LLW or TRU. The mobile feature of WIT allows inspection technologies to be brought to the nuclear waste drum storage site without the need to relocate drums for safe, rapid, and cost-effective characterization of regulated nuclear waste. The combination of these WIT characterization modalities provides the inspector with an unprecedented ability to non-invasively characterize the regulated contents of waste drums as large as 110 gallons, weighing up to 1,600 pounds. Any objects that fit within these size and weight restrictions can also be inspected on WIT, such as smaller waste bags and drums that are five and thirty-five gallons

  12. Recurrent inspection of tubes

    International Nuclear Information System (INIS)

    Andersson, S.

    1984-01-01

    Recommendations concerning the selection of areas for the inspection of tubes have been outlined. The aim is to focus the control on the regions which are important for the safety and where damage is supposed to take place. The number of zones will depend on the risk factors as judged by experts. The localizing will be based upon probable damaging mechanisms. A certain number of areas should be chosen at random. (G.B.)

  13. Regulatory inspection in Spain

    International Nuclear Information System (INIS)

    Alvarez de Buergo, L.

    1977-01-01

    The 1964 Act on Nuclear Energy lays down that the Junta de Energia Nuclear is responsible for assessing the hazards of and inspecting nuclear power plants as well as for the transport of nuclear fuel for these plants. The Junta de Energia Nuclear has a specialised service, the Nuclear Safety Department in charge of performing these duties. Experience acquired from work in this field is analysed in this paper. (NEA) [fr

  14. Infrared microscope inspection apparatus

    Science.gov (United States)

    Forman, Steven E.; Caunt, James W.

    1985-02-26

    Apparatus and system for inspecting infrared transparents, such as an array of photovoltaic modules containing silicon solar cells, includes an infrared microscope, at least three sources of infrared light placed around and having their axes intersect the center of the object field and means for sending the reflected light through the microscope. The apparatus is adapted to be mounted on an X-Y translator positioned adjacent the object surface.

  15. OSE inspections: A different perspective

    International Nuclear Information System (INIS)

    Ware, J.H.

    1987-01-01

    The Office of Security Evaluation (OSE) is a staff activity of the Assistant Secretary for Defense Programs (ASDP) and is responsible for the conduct of an inspection and evaluation program. The OSE Inspection Division conducts assessments of the effectiveness of Department of Energy (DOE) Safeguards and Security policies and protection programs. The inspections are conducted by OSE Inspectors and Support Specialists. Prior to the author's participation in the inspection of the San Francisco Operations Office, a DOE Field Office employee had never played an active role in an OSE Inspection of another field office. This paper discloses his experience as an OSE Inspector

  16. Terahertz Radome Inspection

    Directory of Open Access Journals (Sweden)

    Fabian Friederich

    2018-01-01

    Full Text Available Radomes protecting sensitive radar, navigational, and communications equipment of, e.g., aircraft, are strongly exposed to the environment and have to withstand harsh weather conditions and potential impacts. Besides their significance to the structural integrity of the radomes, it is often crucial to optimize the composite structures for best possible radio performance. Hence, there exists a significant interest in non-destructive testing techniques, which can be used for defect inspection of radomes in field use as well as for quality inspection during the manufacturing process. Contactless millimeter-wave and terahertz imaging techniques provide millimeter resolution and have the potential to address both application scenarios. We report on our development of a three-dimensional (3D terahertz imaging system for radome inspection during industrial manufacturing processes. The system was designed for operation within a machining center for radome manufacturing. It simultaneously gathers terahertz depth information in adjacent frequency ranges, from 70 to 110 GHz and from 110 to 170 GHz by combining two frequency modulated continuous-wave terahertz sensing units into a single measurement device. Results from spiraliform image acquisition of a radome test sample demonstrate the successful integration of the measurement system.

  17. Inspections Report 2002 - 2003; Tillsynsrapport 2002 - 2003

    Energy Technology Data Exchange (ETDEWEB)

    Viidas, Josefin

    2004-10-01

    The report summarises primarily the supervision of waste management and environmental protection at the nuclear facilities that was carried out by the Swedish Radiation Protection Authority in 2002 and 2003. A summary of the inspections and a description of important issues connected with the supervision of nuclear facilities are given. The inspections during 2002 focused on the investigation and coverage of the mishap related to the transport of iridium from Studsvik. The Studsvik project was initiated and the remaining supervision was temporarily given lower priority. In 2003 SSI performed two theme inspections. One focused on the handling of waste management and the other on the limitation of the effluent. Extensive supervision efforts concentrated also on Ranstad Mineral inc.

  18. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

    DEFF Research Database (Denmark)

    Gluud, Christian; Kubiak, Christine; Whitfield, Kate

    2012-01-01

    In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.......In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe....

  19. Pressurized water reactor inspection procedures

    International Nuclear Information System (INIS)

    Heinrich, D.; Mueller, G.; Otte, H.J.; Roth, W.

    1998-01-01

    Inspections of the reactor pressure vessels of pressurized water reactors (PWR) so far used to be carried out with different central mast manipulators. For technical reasons, parallel inspections of two manipulators alongside work on the refueling cavity, so as to reduce the time spent on the critical path in a revision outage, are not possible. Efforts made to minimize the inspection time required with one manipulator have been successful, but their effects are limited. Major reductions in inspection time can be achieved only if inspections are run with two manipulators in parallel. The decentralized manipulator built by GEC Alsthom Energie and so far emmployed in boiling water reactors in the USA, Spain, Switzerland and Japan allows two systems to be used in parallel, thus reducing the time required for standard inspection of a pressure vessel from some six days to three days. These savings of approximately three days are made possible without any compromises in terms of positioning by rail-bound systems. During inspection, the reactor refueling cavity is available for other revision work without any restrictions. The manipulator can be used equally well for inspecting standard PWR, PWR with a thermal shield, for inspecting the land between in-core instrumentation nozzles, BWR with and without jet pumps (complementary inspection), and for inspecting core support shrouds. (orig.) [de

  20. Elucidation of salvage laryngectomy pathologic and clinical variables to guide further treatment intensification investigation.

    Science.gov (United States)

    Scharpf, Joseph; Ward, Matthew; Adelstein, David; Koyfman, Shlomo; Li, Mingsi

    2018-04-01

    There are limited treatment options beyond surgical salvage for patients who fail nonoperative treatment for laryngeal squamous cell carcinoma. In this study, we examine the failure patterns after surgical salvage and the potential pathologic and clinical prognostic variables that might guide further postoperative intensification investigation. Retrospective analysis at a tertiary academic referral center. From an institutional review board-approved institutional head and neck cancer registry, a consecutive series of 147 patients who underwent salvage laryngectomy for squamous cell cancer recurrence or persistence after radiotherapy with or without chemotherapy between May 1995 and May 2016 were identified. Variables potentially associated with oncologic outcome after surgical salvage were then collected and retrospectively evaluated. The projected 2-year locoregional failure rate was 21.8% (95% confidence interval [CI], 14.6%-29.0%]), and the overall survival 65% (95% CI, 57.5%-74.3%) for the entire cohort after salvage laryngectomy. On multivariable analysis, sarcomatoid/spindle cell pathology (hazard ratio [HR], 3.147; 95% CI, 1.181-8.386; P = 0.022), lymphovascular space invasion (LVSI) (positive vs. negative; HR, 2.31; 95% CI, 1.21-4.42; P = 0.011), and advanced initial American Joint Committee on Cancer 7th Edition grouped stage (stages III-IVB vs. stages I-II; HR, 1.64; 95% CI, 1.04-2.6; P = 0.035) were found to be independently associated with inferior disease-free survival. No other clinical or pathologic variables predicted failure. Salvage laryngectomy after nonoperative treatment failure results in successful locoregional control rates and survival in the majority of patients failing initial therapy. This should temper enthusiasm for routine treatment intensification with postoperative re-irradiation and/or other systemic treatments for the vast majority of patients. Sarcomatoid pathology, LVSI, and an advanced initial stage are associated with inferior

  1. Investigating the congruence of crowdsourced information with official government data: the case of pediatric clinics.

    Science.gov (United States)

    Kim, Minki; Jung, Yuchul; Jung, Dain; Hur, Cinyoung

    2014-02-03

    Health 2.0 is a benefit to society by helping patients acquire knowledge about health care by harnessing collective intelligence. However, any misleading information can directly affect patients' choices of hospitals and drugs, and potentially exacerbate their health condition. This study investigates the congruence between crowdsourced information and official government data in the health care domain and identifies the determinants of low congruence where it exists. In-line with infodemiology, we suggest measures to help the patients in the regions vulnerable to inaccurate health information. We text-mined multiple online health communities in South Korea to construct the data for crowdsourced information on public health services (173,748 messages). Kendall tau and Spearman rank order correlation coefficients were used to compute the differences in 2 ranking systems of health care quality: actual government evaluations of 779 hospitals and mining results of geospecific online health communities. Then we estimated the effect of sociodemographic characteristics on the level of congruence by using an ordinary least squares regression. The regression results indicated that the standard deviation of married women's education (P=.046), population density (P=.01), number of doctors per pediatric clinic (P=.048), and birthrate (P=.002) have a significant effect on the congruence of crowdsourced data (adjusted R²=.33). Specifically, (1) the higher the birthrate in a given region, (2) the larger the variance in educational attainment, (3) the higher the population density, and (4) the greater the number of doctors per clinic, the more likely that crowdsourced information from online communities is congruent with official government data. To investigate the cause of the spread of misleading health information in the online world, we adopted a unique approach by associating mining results on hospitals from geospecific online health communities with the sociodemographic

  2. On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs).

    Science.gov (United States)

    Méthot, Julie; Brisson, Diane; Gaudet, Daniel

    2012-04-01

    Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.

  3. Non-inflammatory destructive periodontal disease: a clinical, microbiological, immunological and genetic investigation

    Directory of Open Access Journals (Sweden)

    Carlos Eduardo Repeke

    2012-02-01

    Full Text Available Periodontitis comprises a group of multifactorial diseases in which periodontopathogens accumulate in dental plaque and trigger host chronic inflammatory and immune responses against periodontal structures, which are determinant to the disease outcome. Although unusual cases of non-inflammatory destructive periodontal disease (NIDPD are described, their pathogenesis remains unknown. A unique NIDPD case was investigated by clinical, microbiological, immunological and genetic tools. The patient, a non-smoking dental surgeon with excessive oral hygiene practice, presented a generalized bone resorption and tooth mobility, but not gingival inflammation or occlusion problems. No hematological, immunological or endocrine alterations were found. No periodontopathogens (A. actinomycetemcomitans, P. gingivalis, F. nucleatum and T. denticola or viruses (HCMV, EBV-1 and HSV-1 were detected, along with levels of IL-1β and TNF-a in GCF compatible with healthy tissues. Conversely ALP, ACP and RANKL GCF levels were similar to diseased periodontal sites. Genetic investigation demonstrated that the patient carried some SNPs, as well HLA-DR4 (*0404 and HLA-B27 alleles, considered risk factors for bone loss. Then, a less vigorous and diminished frequency of toothbrushing was recommended to the patient, resulting in the arrest of alveolar bone loss, associated with the return of ALP, ACP and RANKL in GCF to normality levels. In conclusion, the unusual case presented here is compatible with the previous description of NIDPD, and the results that a possible combination of excessive force and frequency of mechanical stimulation with a potentially bone loss prone genotype could result in the alveolar bone loss seen in NIDPD.

  4. A study on improvements of inspection efficiency with remote transmission of inspection data

    International Nuclear Information System (INIS)

    Kikuchi, Masahiro

    2010-01-01

    Current information networks technology brought secure and convenient condition of information transmission, so that inspectorates intend to apply such technology to optimize current inspection efforts. IAEA established the Remote Monitoring Project (RMP) in 1996 and started to draft safeguards concepts, and approaches to refer the implementation of remote monitoring technology and to compromise with relationship between current inspection activities and the remote monitoring technologies. Although communications costs and conditions of secured communication should be further investigated, the technologies would have a possibility to reduce current inspection efforts. We would face at the step to study on the several issues such as what measures could be candidate to use, how much cost we needs, what kind of technical risks would be concerned, further improvements could be achieved by comparison with current inspection costs and effectiveness. This paper reports on the expectation points and relevant technical attention points which are related to apply unattended inspection system with remote data transmission to the flows and inventory verification of item and bulk facility, respectively, in order to improve inspection efforts. (author)

  5. Clinical and genetic investigation of families with type II Waardenburg syndrome.

    Science.gov (United States)

    Chen, Yong; Yang, Fuwei; Zheng, Hexin; Zhou, Jianda; Zhu, Ganghua; Hu, Peng; Wu, Weijing

    2016-03-01

    The present study aimed to investigate the molecular pathology of Waardenburg syndrome type II in three families, in order to provide genetic diagnosis and hereditary counseling for family members. Relevant clinical examinations were conducted on the probands of the three pedigrees. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of paired box 3 (PAX3), microphthalmia‑associated transcription factor (MITF), sex‑determining region Y‑box 10 (SOX10) and snail family zinc finger 2 (SNAI2) were analyzed by polymerase chain reaction and DNA sequencing. The heterozygous mutation, c.649_651delAGA in exon 7 of the MITF gene was detected in the proband and all patients of pedigree 1; however, no pathological mutation of the relevant genes (MITF, SNAI2, SOX10 or PAX3) was detected in pedigrees 2 and 3. The heterozygous mutation c.649_651delAGA in exon 7 of the MITF gene is therefore considered the disease‑causing mutation in pedigree 1. However, there are novel disease‑causing genes in Waardenburg syndrome type II, which require further research.

  6. Ischaemic memory imaging using metabolic radiopharmaceuticals: overview of clinical settings and ongoing investigations

    Energy Technology Data Exchange (ETDEWEB)

    Yoshinaga, Keiichiro [Hokkaido University Graduate School of Medicine, Department of Molecular Imaging, Sapporo (Japan); Naya, Masanao [Hokkaido University Graduate School of Medicine, Department of Cardiology, Sapporo (Japan); Shiga, Tohru; Suzuki, Eriko; Tamaki, Nagara [Hokkaido University Graduate School of Medicine, Department of Nuclear Medicine, Sapporo (Japan)

    2014-02-15

    ''Ischaemic memory'' is defined as a prolonged functional and/or biochemical alteration remaining after a particular episode of severe myocardial ischaemia. The biochemical alteration has been reported as metabolic stunning. Metabolic imaging has been used to detect the footprint left by previous ischaemic episodes evident due to delayed recovery of myocardial metabolism (persistent dominant glucose utilization with suppression of fatty acid oxidation). β-Methyl-p-[{sup 123}I]iodophenylpentadecanoic acid (BMIPP) is a single-photon emission computed tomography (SPECT) radiotracer widely used for metabolic imaging in clinical settings in Japan. In patients with suspected coronary artery disease but no previous myocardial infarction, BMIPP has shown acceptable diagnostic accuracy. In particular, BMIPP plays an important role in the identification of prior ischaemic insult in patients arriving at emergency departments with acute chest pain syndrome. Recent data also show the usefulness of {sup 123}I-BMIPP SPECT for predicting cardiovascular events in patients undergoing haemodialysis. Similarly, SPECT or PET imaging with {sup 18}F-FDG injected during peak exercise or after exercise under fasting conditions shows an increase in FDG uptake in postischaemic areas. This article will overview the roles of ischaemic memory imaging both under established indications and in ongoing investigations. (orig.)

  7. Variability of intraductal papillomas of the mammary gland: Clinical, roentgenologic and morphologic investigations

    International Nuclear Information System (INIS)

    Rummel, W.

    1974-01-01

    The radiodiagnostical method of choice is the galactographic technique. However, a specific X-ray image of the papilloma does not exist. The galactographic technique has to be adapted to the surgical and histologic one. Only by combining these three techniques good results can be achieved. It is not possible to draw conclusions from the colour of the pathologic discharge about the type and character of the pathologic process. Contrary to the findings documented in the literature, we were able to diagnose with our technique not only small tumours, but also tumours situated in the periphery of the lactiferous duct. Because of our investigations it is no longer possible to maintain and keep the strict division of the proliferative changes occurring at the lactiferous duct walls. In this study, the most significant morphologic results are described in detail. In all patients with pathologic discharge of the mammary gland, the so-called papillo-carcinoma was found only in one case. As clinical consequence it has therefore to be demanded that in all women with the symptom of pathologic mamillary discharge first of all the origin of this discharge has to be localised by means of galactography. Only the individual morphologic picture of a proliferative change of the lactiferous duct provides some prognostic value. The prerequisites for such an individual assessment are differentiated roentgenologic, surgical and histological techniques. (orig./MG) [de

  8. Clinical investigation of 131I therapy combined with low-dose lithium carbonate for Graves disease

    International Nuclear Information System (INIS)

    Xu Haiqing; Wu Bian

    2006-01-01

    Objective: To investigate the clinical curative effects of 131 I therapy combined with low-dose lithium carbonate for Graves disease. Methods: Patients with Graves disease took lithium carbonate (250 mg, once per day) orally for 5 weeks. Then they were treated with 131 I (doses=3.15 MBq(80 uCi)/g, based on 60%-70% of the thyroid size). We kept track from 6 to 24 months (averaging 14 months) and classified the results into three: cured, improved or no effect. Results: After a single cycle of 131 I therapy combined with low-dose lithium carbonate, 106 patients with Graves disease were cured, 28 were improved and 8 saw no effects, respectively 74.6%, 19.7% and 5.6% among the 142 patients. We then treated 23 of them with another 131 I therapy (without lithium carbonate). 10 of such were cured (43.5%), 8 were improved (34.8%) and the other 5 saw no effects. Among all patients, hypothyroidism was observed from 25(17.6%), 6 months after the first 131 I therapy. Conclusions: Notable curative results were observed from 131 I therapy combined with low-dose lithium carbonate for Graves disease. Moreover, the dosage of 131 I was therefore decreased, which also lowered the toxicity response. (authors)

  9. Investigation of Exon 1 in FXN Gene in Patients with Clinical Symptomatic of Friedreich Ataxia

    Directory of Open Access Journals (Sweden)

    Naseroleslami M

    2013-01-01

    Full Text Available Background and Objectives: Friedreich’s ataxia (FRDA is an autosomal recessive disorder that is typically associated with dysarthria, muscle weakness, spasticity in the lower limbs, scoliosis, bladder dysfunction, absent lower limb reflexes, and loss of position and vibration sense. Approximately two-thirds of these patients suffer from cardiomyopathy and more than 30% have diabetes mellitus. Individuals with FRDA have identifiable mutations in the FXN gene. The most common type of mutation which is observed on both alleles in more than 98% of patients is an expansion of a GAA triplet-repeat in intron of FXN gene. Approximately 2% of individuals with FRDA are compound heterozygotes, who have a GAA expansion in the disease-causing range in one FXN allele and an inactivating FXN mutation in another allele. Aim of the present study was to investigate exon 1 in FRDA gene in patients with clinical symptoms of Friedreich’s Ataxia that have not GAA triplet-repeat expansion in intron 1 of FXN gene.Methods: In this study, exon 1 in 5 patients suspected of FRDA analyzed using PCR and sequencing. Results: An A to G transition at nucleotide number 815284, in exon 1 was observed in all patients. Conclusion: The results of this study showed that disease-causing homozygous mutations could be because of consanguinity marriage in Iran. Therefore, sequencing of all exons of the gene is necessary.

  10. Clinical distinctions between selective mutism and social phobia: an investigation of childhood psychopathology.

    Science.gov (United States)

    Yeganeh, Robin; Beidel, Deborah C; Turner, Samuel M; Pina, Armando A; Silverman, Wendy K

    2003-09-01

    To investigate the hypothesis that children with selective mutism are more socially anxious than children with social anxiety disorder but who are not selectively mute. Twenty-three children with comorbid selective mutism and social phobia and 23 age-matched controls with social phobia alone and their parents participated in a comprehensive assessment of social anxiety and related aspects of psychopathology. The results do not uniformly support previous suggestions that children with selective mutism refuse speech because they are "frozen with fear." Although clinician and observer ratings for children with selective mutism revealed higher ratings of social distress than for children with social phobia alone, self-report data do not support this conclusion. Furthermore, although there were no group differences on measures of trait anxiety, general fears, or scores on the Child Behavior Checklist broadband Internalizing or Externalizing scales, children with selective mutism scored higher than children with social phobia alone on the Child Behavior Checklist Delinquency subscale, suggesting the presence of a broader clinical syndrome. It remains unclear whether children with selective mutism have extreme levels of social anxiety. Potential areas that might shed further light on this interesting disorder are discussed.

  11. Ischaemic memory imaging using metabolic radiopharmaceuticals: overview of clinical settings and ongoing investigations

    International Nuclear Information System (INIS)

    Yoshinaga, Keiichiro; Naya, Masanao; Shiga, Tohru; Suzuki, Eriko; Tamaki, Nagara

    2014-01-01

    ''Ischaemic memory'' is defined as a prolonged functional and/or biochemical alteration remaining after a particular episode of severe myocardial ischaemia. The biochemical alteration has been reported as metabolic stunning. Metabolic imaging has been used to detect the footprint left by previous ischaemic episodes evident due to delayed recovery of myocardial metabolism (persistent dominant glucose utilization with suppression of fatty acid oxidation). β-Methyl-p-[ 123 I]iodophenylpentadecanoic acid (BMIPP) is a single-photon emission computed tomography (SPECT) radiotracer widely used for metabolic imaging in clinical settings in Japan. In patients with suspected coronary artery disease but no previous myocardial infarction, BMIPP has shown acceptable diagnostic accuracy. In particular, BMIPP plays an important role in the identification of prior ischaemic insult in patients arriving at emergency departments with acute chest pain syndrome. Recent data also show the usefulness of 123 I-BMIPP SPECT for predicting cardiovascular events in patients undergoing haemodialysis. Similarly, SPECT or PET imaging with 18 F-FDG injected during peak exercise or after exercise under fasting conditions shows an increase in FDG uptake in postischaemic areas. This article will overview the roles of ischaemic memory imaging both under established indications and in ongoing investigations. (orig.)

  12. Clinical Investigation of the Dopaminergic System with PET and FLUORINE-18-FLUORO-L-DOPA.

    Science.gov (United States)

    Oakes, Terrence Rayford

    1995-01-01

    Positron Emission Tomography (PET) is a tool that provides quantitative physiological information. It is valuable both in a clinical environment, where information is sought for an individual, and in a research environment, to answer more fundamental questions about physiology and disease states. PET is particularly attractive compared to other nuclear medicine imaging techniques in cases where the anatomical regions of interest are small or when true metabolic rate constants are required. One example with both of these requirements is the investigation of Parkinson's Disease, which is characterized as a presynaptic motor function deficit affecting the striatum. As dopaminergic neurons die, the ability of the striatum to affect motor function decreases. The extent of functional neuronal damage in the small sub-structures may be ascertained by measuring the ability of the caudate and putamen to trap and store dopamine, a neurotransmitter. PET is able to utilize a tracer of dopamine activity, ^ {18}F- scL-DOPA, to quantitate the viability of the striatum. This thesis work deals with implementing and optimizing the many different elements that compose a PET study of the dopaminergic system, including: radioisotope production; conversion of aqueous ^{18}F ^-into [^ {18}F]-F2; synthesis of ^{18}F- scL -DOPA; details of the PET scan itself; measurements to estimate the radiation dosimetry; accurate measurement of a plasma input function; and the quantitation of dopaminergic activity in normal human subjects as well as in Parkinson's Disease patients.

  13. The investigation of genetic and clinical features in Chinese patients with juvenile amyotrophic lateral sclerosis.

    Science.gov (United States)

    Liu, Z-J; Lin, H-X; Liu, G-L; Tao, Q-Q; Ni, W; Xiao, B-G; Wu, Z-Y

    2017-09-01

    Juvenile amyotrophic lateral sclerosis (JALS) occurs at an age of onset below 25 years with a heterogeneous disease onset location, variable progression and survival time. To investigate whether an ALS gene profile could resolve any aspects of clinical symptom heterogeneity, we have used targeted sequencing technology in a cohort of 12 JALS patients of Chinese descent. We detected 5 likely pathogenic mutations, 2 in familial probands and 3 in sporadic patients. One was a known TARDBP mutation (p.G348V) and 4 were FUS frameshift mutations including a known p.Gln519Ilefs*9 mutation and 3 novel mutations, p.Gly515Valfs*14, p.Gly486Profs*30, and p.Arg498Alafs*32. Of the 4 FUS mutations, 2 were able to be confirmed as de novo mutations. The TARDBP mutation carrier showed a classic ALS phenotype. All patients with FUS mutations experienced limb weakness at an early age and developed bulbar symptoms during the disease course. FUS mutations have previously been associated with increased JALS disease progression, however, we found a large range 12 to 84 months in disease survival (mean 58.2 months). Our results justify future screening for variants in FUS as it remains the most frequent genetic determinant of early onset, JALS (found in 30% of our patients). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Ischaemic memory imaging using metabolic radiopharmaceuticals: overview of clinical settings and ongoing investigations.

    Science.gov (United States)

    Yoshinaga, Keiichiro; Naya, Masanao; Shiga, Tohru; Suzuki, Eriko; Tamaki, Nagara

    2014-02-01

    "Ischaemic memory" is defined as a prolonged functional and/or biochemical alteration remaining after a particular episode of severe myocardial ischaemia. The biochemical alteration has been reported as metabolic stunning. Metabolic imaging has been used to detect the footprint left by previous ischaemic episodes evident due to delayed recovery of myocardial metabolism (persistent dominant glucose utilization with suppression of fatty acid oxidation). β-Methyl-p-[(123)I]iodophenylpentadecanoic acid (BMIPP) is a single-photon emission computed tomography (SPECT) radiotracer widely used for metabolic imaging in clinical settings in Japan. In patients with suspected coronary artery disease but no previous myocardial infarction, BMIPP has shown acceptable diagnostic accuracy. In particular, BMIPP plays an important role in the identification of prior ischaemic insult in patients arriving at emergency departments with acute chest pain syndrome. Recent data also show the usefulness of (123)I-BMIPP SPECT for predicting cardiovascular events in patients undergoing haemodialysis. Similarly, SPECT or PET imaging with (18)F-FDG injected during peak exercise or after exercise under fasting conditions shows an increase in FDG uptake in postischaemic areas. This article will overview the roles of ischaemic memory imaging both under established indications and in ongoing investigations.

  15. New approaches to chemotherapy-induced nausea and vomiting: from neuropharmacology to clinical investigations.

    Science.gov (United States)

    Rubenstein, Edward B; Slusher, Barbara S; Rojas, Camilo; Navari, Rudolph M

    2006-01-01

    Nausea and vomiting are considered to be among the most distressing consequences of cytotoxic chemotherapies. Currently, there are several novel 5-HT(3) receptor antagonists for the treatment of chemotherapy-induced nausea and vomiting (CINV), including ondansetron, granisetron, and dolasetron. These agents provide significant improvement in the management of acute emesis but are ineffective at preventing delayed emesis. In 2003, a new 5-HT(3) receptor antagonist, palonosetron HCL (Aloxi), was introduced to the U.S. market. Palonosetron was found to be effective in preventing delayed CINV. Indeed, palonosetron was the first and only 5-HT(3) receptor antagonist approved by the FDA for the prevention of both acute and delayed CINV. More recently, studies on the role of substance P in the emetic process led to the development of aprepitant (Emend) for the prevention of delayed emesis in combination with 5-HT(3) receptor antagonists. Despite these major advances, CINV remains uncontrolled in some patients. Current efforts are focused on treating refractory emesis and include both the clinical evaluation of compounds marketed for other indications and the preclinical evaluation of novel molecules targeting other transmitters in the emetic pathway. Ongoing work in pharmacogenomics has postulated several candidate genes that could be involved in emetic sensitivity and responsiveness to antiemetic therapy. Investigations into the pharmacogenomics of CINV may someday be able to aid in the identification of high risk patients and patients unlikely to respond to conventional therapies.

  16. Investigating Treatment Outcomes Across OCD Symptom Dimensions in a Clinical Sample of OCD Patients.

    Science.gov (United States)

    Chase, Tannah; Wetterneck, Chad T; Bartsch, Robert A; Leonard, Rachel C; Riemann, Bradley C

    2015-01-01

    Despite the heterogeneous nature of obsessive-compulsive disorder (OCD), many self-report assessments do not adequately capture the clinical picture presenting within each symptom dimension, particularly unacceptable thoughts (UTs). In addition, obsessions and ordering/arranging compulsions are often underrepresented in samples of treatment outcome studies for OCD. Such methodological discrepancies may obscure research findings comparing treatment outcomes across OCD symptom dimensions. This study aimed to improve upon previous research by investigating treatment outcomes across OCD symptom dimensions using the Dimensional Obsessive-Compulsive Scale, which offers a more comprehensive assessment of UTs. The study included a primarily residential sample of 134 OCD patients. Results indicated that there were no significant differences in treatment outcomes across symptom dimensions. However, the severity of UTs remained significantly greater than other symptom dimensions at both admission and discharge. Thus, it is possible that UTs may exhibit uniquely impairing features, compared with other symptom dimensions. It is also possible that these findings may reflect the characteristics of the residential OCD samples. These speculations as well as implications for OCD treatment and future research are discussed.

  17. Recognition of food-allergic patients and their allergens by RAST technique and clinical investigation

    International Nuclear Information System (INIS)

    Wraith, D.G.; Merrett, J.; Roth, A.; Yman, L.; Merrett, T.G.

    1979-01-01

    Sera from 119 patients with possible food allergies were tested against a panel of thirteen food allergens by the RAST method. The results were compared with in vivo tests. 79% of foods causing symptoms gave a positive RAST to the specific food. Symptoms were grouped according to their time of appearance after taking the food 'immediate' up to 1 hr and 'non-immediate' more than 1 hr afterwards. Almost all those with 'immediate' symptoms were already aware of the foods causing them and there was a 100% correlation of the RAST results with these. Only a few of those with 'non-immediate' symptoms were previously aware that these foods were responsible, and 64% of these gave a positive RAST. The majority of patients with a positive RAST result had total IgE in excess of 300 u/ml, had specific IgE antibodies against one or more common inhalant allergens, were under the age of 30 years and had a combination of asthma and eczema. The RAST method was found to be a useful and safe guide upon which to base a clinical investigation of food allergy, especially for patients whose symptoms appeared more than 1 hr after the food and in whom the relationship between their symptoms and food was not apparent. The RAST technique was surprisingly successful in identifying the foods which caused these 'non-immediate' symptoms. (author)

  18. SmartInspect: Smart Contract Inspection Technical Report

    OpenAIRE

    Bragagnolo , Santiago; Rocha , Henrique ,; Denker , Marcus; Ducasse , Stéphane

    2017-01-01

    Smart contracts are embedded procedures stored with the data they act upon. Debugging deployed Smart Contracts is a difficult task since once deployed, the code cannot be reexecuted and inspecting a simple attribute is not easily possible because data is encoded. In this technical report, we present SmartInspect to address the lack of inspectability of a deployed contract. Our solution analyses the contract state by using decompilation techniques and a mirror-based architecture to represent t...

  19. Shell Inspection History and Current CMM Inspection Efforts

    Energy Technology Data Exchange (ETDEWEB)

    Montano, Joshua Daniel [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-01-26

    The following report provides a review of past and current CMM Shell Inspection efforts. Calibration of the Sheffield rotary contour gauge has expired and the primary inspector, Matthew Naranjo, has retired. Efforts within the Inspection team are transitioning from maintaining and training new inspectors on Sheffield to off-the-shelf CMM technology. Although inspection of a shell has many requirements, the scope of the data presented in this report focuses on the inner contour, outer contour, radial wall thickness and mass comparisons.

  20. Safeguards management inspection procedures

    International Nuclear Information System (INIS)

    Barth, M.J.; Dunn, D.R.

    1984-08-01

    The objective of this inspection module is to independently assess the contributions of licensee management to overall safeguards systems performance. The inspector accomplishes this objective by comparing the licensee's safeguards management to both the 10 CFR, parts 70 and 73, requirements and to generally accepted management practices. The vehicle by which this comparison is to be made consists of assessment questions and key issues which point the inspector to areas of primary concern to the NRC and which raise additional issues for the purpose of exposing management ineffectiveness. Further insight into management effectiveness is obtained through those assessment questions specifically directed toward the licensee's safeguards system performance. If the quality of the safeguards is poor, then the inspector should strongly suspect that management's role is ineffective and should attempt to determine management's influence (or lack thereof) on the underlying safeguards deficiencies. (The converse is not necessarily true, however.) The assessment questions in essence provide an opportunity for the inspector to identify, to single out, and to probe further, questionable management practices. Specific issues, circumstances, and concerns which point to questionable or inappropriate practices should be explicitly identified and referenced against the CFR and the assessment questions. The inspection report should also explain why the inspector feels certain management practices are poor, counter to the CFR, and/or point to ineffecive management. Concurrent with documenting the inspection results, the inspector should provide recommendations for alleviating observed management practices that are detrimental to effective safeguards. The recommendations could include: specific changes in the practices of the licensee, followup procedures on the part of NRC, and proposed license changes

  1. Laser Safety Inspection Criteria

    International Nuclear Information System (INIS)

    Barat, K.

    2005-01-01

    A responsibility of the Laser Safety Officer (LSO) is to perform laser audits. The American National Standard Z136.1 Safe Use of Lasers references this requirement through several sections. One such reference is Section 1.3.2.8, Safety Features Audits, ''The LSO shall ensure that the safety features of the laser installation facilities and laser equipment are audited periodically to assure proper operation''. The composition, frequency and rigor of that inspection/audit rests in the hands of the LSO. A common practice for institutions is to develop laser audit checklists or survey forms It is common for audit findings from one inspector or inspection to the next to vary even when reviewing the same material. How often has one heard a comment, ''well this area has been inspected several times over the years and no one ever said this or that was a problem before''. A great number of audit items, and therefore findings, are subjective because they are based on the experience and interest of the auditor to particular items on the checklist. Beam block usage, to one set of eyes might be completely adequate, while to another, inadequate. In order to provide consistency, the Laser Safety Office of the National Ignition Facility Directorate has established criteria for a number of items found on the typical laser safety audit form. The criteria are distributed to laser users. It serves two broad purposes; first, it gives the user an expectation of what will be reviewed by an auditor. Second, it is an opportunity to explain audit items to the laser user and thus the reasons for some of these items, such as labelling of beam blocks

  2. Molecular typing and epidemiological investigation of clinical populations of Pseudomonas aeruginosa using an oligonucleotide-microarray

    Directory of Open Access Journals (Sweden)

    Ballarini Annalisa

    2012-07-01

    Full Text Available Abstract Background Pseudomonas aeruginosa is an opportunistic pathogen which has the potential to become extremely harmful in the nosocomial environment, especially for cystic fibrosis (CF patients, who are easily affected by chronic lung infections. For epidemiological purposes, discriminating P.aeruginosa isolates is a critical step, to define distribution of clones among hospital departments, to predict occurring microevolution events and to correlate clones to their source. A collection of 182 P. aeruginosa clinical strains isolated within Italian hospitals from patients with chronic infections, i.e. cystic fibrosis (CF patients, and with acute infections were genotyped. Molecular typing was performed with the ArrayTube (AT multimarker microarray (Alere Technologies GmbH, Jena, Germany, a cost-effective, time-saving and standardized method, which addresses genes from both the core and accessory P.aeruginosa genome. Pulsed-field gel electrophoresis (PFGE and multilocus sequence typing (MLST were employed as reference genotyping techniques to estimate the ArrayTube resolution power. Results 41 AT-genotypes were identified within our collection, among which 14 were novel and 27 had been previously described in publicly available AT-databases. Almost 30% of the genotypes belonged to a main cluster of clones. 4B9A, EC2A, 3C2A were mostly associated to CF-patients whereas F469, 2C1A, 6C22 to non CF. An investigation on co-infections events revealed that almost 40% of CF patients were colonized by more than one genotype, whereas less than 4% were observed in non CF patients. The presence of the exoU gene correlated with non-CF patients within the intensive care unit (ICU whereas the pKLC102-like island appeared to be prevalent in the CF centre. The congruence between the ArrayTube typing and PFGE or MLST was 0.077 and 0.559 (Adjusted Rand coefficient, respectively. AT typing of this Italian collection could be easily integrated with the global P

  3. A clinical investigation of force delivery systems for orthodontic space closure.

    Science.gov (United States)

    Nightingale, C; Jones, S P

    2003-09-01

    To investigate the force retention, and rates of space closure achieved by elastomeric chain and nickel titanium coil springs. Randomized clinical trial. Eastman Dental Hospital, London and Queen Mary's University Hospital, Roehampton, 1998-2000. Twenty-two orthodontic patients, wearing the pre-adjusted edgewise appliance undergoing space closure in opposing quadrants, using sliding mechanics on 0.019 x 0.025-inch posted stainless steel archwires. Medium-spaced elastomeric chain [Durachain, OrthoCare (UK) Ltd., Bradford, UK] and 9-mm nickel titanium coil springs [OrthoCare (UK) Ltd.] were placed in opposing quadrants for 15 patients. Elastomeric chain only was used in a further seven patients. The initial forces on placement and residual forces at the subsequent visit were measured with a dial push-pull gauge [Orthocare (UK) Ltd]. Study models of eight patients were taken before and after space closure, from which measurements were made to establish mean space closure. The forces were measured in grammes and space closure in millimetres. Fifty-nine per cent (31/53) of the elastomeric sample maintained at least 50 per cent of the initial force over a time period of 1-15 weeks. No sample lost all its force, and the mean loss was 47 per cent (range: 0-76 per cent). Nickel titanium coil springs lost force rapidly over 6 weeks, following that force levels plateaued. Forty-six per cent (12/26) maintained at least 50 per cent of their initial force over a time period of 1-22 weeks, and mean force loss was 48 per cent (range: 12-68 per cent). The rate of mean weekly space closure for elastomeric chain was 0.21 mm and for nickel titanium coil springs 0.26 mm. There was no relationship between the initial force applied and rate of space closure. None of the sample failed during the study period giving a 100 per cent response rate. In clinical use, the force retention of elastomeric chain was better than previously concluded. High initial forces resulted in high force decay

  4. Investigating the role of feedback and motivation in clinical reaction time assessment.

    Science.gov (United States)

    Eckner, James T; Chandran, Srikrishna; Richardson, James K

    2011-12-01

    To investigate the influence of performance feedback and motivation during 2 tests of simple visuomotor reaction time (RT). Cross-sectional, observational study. Outpatient academic physiatry clinic. Thirty-one healthy adults (mean [SD], 54 ± 15 years). Participants completed a clinical test of RT (RT(clin)) and a computerized test of RT with and without performance feedback (RT(compFB) and RT(compNoFB), respectively) in randomly assigned order. They then ranked their degree of motivation during each test. RT(clin) measured the time required to catch a suspended vertical shaft by hand closure after release of the shaft by the examiner. RT(compFB) and RT(compNoFB) both measured the time required to press a computer key in response to a visual cue displayed on a computer monitor. Performance feedback (visual display of the previous trial and summary results) was provided for RT(compFB), but not for RT(compNoFB). Means and standard deviations of RT(clin), RT(compFB), and RT(compNoFB) and participants' self-reported motivation on a 5-point Likert scale for each test. There were significant differences in both the means and standard deviations of RT(clin), RT(compFB), and RT(compNoFB) (F(2,60) = 81.66, P motivation between RT(clin) and RT(compFB), both of which were reported to be more motivating than RT(compNoFB). The stronger correlation between RT(clin) and RT(compFB) as well as the higher reported motivation during RT(clin) and RT(compFB) testing suggest that performance feedback is a positive motivating factor that is inherent to RT(clin) testing. RT(clin) is a simple, inexpensive technique for measuring RT and appears to be an intrinsically motivating task. This motivation may promote faster, more consistent RT performance compared with currently available computerized programs, which do not typically provide performance feedback. Copyright © 2011 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  5. Inspection of internal tank welds using the ACFM inspection method

    International Nuclear Information System (INIS)

    Topp, D.A.; Lugg, M.C.

    2009-01-01

    The paper describes recent developments of the ACFM technique and describes several case studies where ACFM has been used to inspect the internal plate welds on large steel storage tanks in refineries. For weld inspection, conventional methods such as magnetic particle inspection or vacuum box testing are generally used. This paper presents comparisons of the results from ACFM with those from the conventional methods, from which conclusions are drawn as to the benefits this technique offers in terms of cost, time savings and inspection reliability. (author)

  6. INSPECT: a package of computer programs for planning safeguards inspections

    International Nuclear Information System (INIS)

    Wincek, M.A.; Mullen, M.F.

    1979-04-01

    As part of the U.S. program to provide technical assistance to the International Atomic Energy Agency, a package of computer programs was developed for use in planning safeguards inspections of various types of nuclear facilities. The INSPECT software package is a set of five interactive FORTRAN programs which can be used to calculate the variance components of the MUF (Material Unaccounted For) statistic, the variance components of the D (difference) statistic, attribute and variables sampling plans, a measure of the effectiveness of the inspection, and a measurement of the cost of implementing the inspection plan. This report describes the programs and explains how to use them

  7. "There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

    Science.gov (United States)

    Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

    2012-01-01

    We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

  8. “There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

    Science.gov (United States)

    Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak

    2012-01-01

    Background We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Materials and Methods Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Results Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. Conclusions There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined. PMID:22937106

  9. Model for investigating the benefits of clinical supervision in psychiatric nursing

    DEFF Research Database (Denmark)

    Gonge, Henrik; Buus, Niels

    2011-01-01

    with the effectiveness of clinical supervision, as measured by the Manchester Clinical Supervision Scale (MCSS). Furthermore, MCSS scores were associated with benefits, such as increased job satisfaction, vitality, rational coping and less stress, emotional exhaustion, and depersonalization. Multivariate analyses......The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sample...

  10. Endoscopic inspection of steam turbines

    International Nuclear Information System (INIS)

    Maliniemi, H.; Muukka, E.

    1990-01-01

    For over ten years, Imatran Voima Oy (IVO) has developed, complementary inspection methods for steam turbine condition monitoring, which can be applied both during operation and shutdown. One important method used periodically during outages is endoscopic inspection. The inspection is based on the method where the internal parts of the turbine is inspected through access borings with endoscope and where the magnified figures of the internal parts is seen on video screen. To improve inspection assurance, an image-processing based pattern recognition method for cracks has been developed for the endoscopic inspection of turbine blades. It is based on the deduction conditions derived from the crack shape. The computer gives an alarm of a crack detection and prints a simulated image of the crack, which is then checked manually

  11. Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study

    Science.gov (United States)

    Peng, Kun; Xu, Keyang; Liu, Luna; Hendricks, Robert; Delarosa, Reginald; Erickson, Rich; Budha, Nageshwar; Leabman, Maya; Song, An; Kaur, Surinder; Fischer, Saloumeh K

    2014-01-01

    RG7652 is a human immunoglobulin 1 (IgG1) monoclonal antibody (mAb) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) and is designed for the treatment of hypercholesterolemia. A target-binding enzyme-linked immunosorbent assay (ELISA) was developed to measure RG7652 levels in human serum in a Phase I study. Although target-binding assay formats are generally used to quantify free therapeutic, the actual therapeutic species being measured are affected by assay conditions, such as sample dilution and incubation time, and levels of soluble target in the samples. Therefore, in the presence of high concentrations of circulating target, the choice of reagents and assay conditions can have a significant effect on the observed pharmacokinetic (PK) profiles. Phase I RG7652 PK analysis using the ELISA data resulted in a nonlinear dose normalized exposure. An investigation was conducted to characterize the ELISA to determine whether the assay format and reagents may have contributed to the PK observation. In addition, to confirm the ELISA results, a second orthogonal method, liquid chromatography tandem mass spectrometry (LC-MS/MS) using a signature peptide as surrogate, was developed and implemented. A subset of PK samples, randomly selected from half of the subjects in the 6 single ascending dose (SAD) cohorts in the Phase I clinical study, was analyzed with the LC-MS/MS assay, and the data were found to be comparable to the ELISA data. This paper illustrates the importance of reagent characterization, as well as the benefits of using an orthogonal approach to eliminate bioanalytical contributions when encountering unexpected observations. PMID:25484037

  12. Clinical prediction in defined populations: a simulation study investigating when and how to aggregate existing models

    Directory of Open Access Journals (Sweden)

    Glen P. Martin

    2017-01-01

    Full Text Available Abstract Background Clinical prediction models (CPMs are increasingly deployed to support healthcare decisions but they are derived inconsistently, in part due to limited data. An emerging alternative is to aggregate existing CPMs developed for similar settings and outcomes. This simulation study aimed to investigate the impact of between-population-heterogeneity and sample size on aggregating existing CPMs in a defined population, compared with developing a model de novo. Methods Simulations were designed to mimic a scenario in which multiple CPMs for a binary outcome had been derived in distinct, heterogeneous populations, with potentially different predictors available in each. We then generated a new ‘local’ population and compared the performance of CPMs developed for this population by aggregation, using stacked regression, principal component analysis or partial least squares, with redevelopment from scratch using backwards selection and penalised regression. Results While redevelopment approaches resulted in models that were miscalibrated for local datasets of less than 500 observations, model aggregation methods were well calibrated across all simulation scenarios. When the size of local data was less than 1000 observations and between-population-heterogeneity was small, aggregating existing CPMs gave better discrimination and had the lowest mean square error in the predicted risks compared with deriving a new model. Conversely, given greater than 1000 observations and significant between-population-heterogeneity, then redevelopment outperformed the aggregation approaches. In all other scenarios, both aggregation and de novo derivation resulted in similar predictive performance. Conclusion This study demonstrates a pragmatic approach to contextualising CPMs to defined populations. When aiming to develop models in defined populations, modellers should consider existing CPMs, with aggregation approaches being a suitable modelling

  13. Intradiscal electrothermal treatment for discogenic back pain: experimental investigation and preliminary clinical application

    International Nuclear Information System (INIS)

    Fang Wen; Teng Gaojun; He Shicheng; Guo Jinhe; Deng Gang; Zhu Guangyu; Li Guozhao; Ding Huijuan; Shen Zhiping

    2005-01-01

    Objective: To assess the effectiveness and the safety of IDET for chronic discogenic low back pain. Methods: Standard intradiscal electrothermal treatment were performed in two adjacent disc levels (L3-4, L4-5) of two domestic pigs. MRI were available at pretreatment, posttreatment of 1,2 weeks, and then the two animals were killed respectively at 1,2 weeks after the procedure. The specimens were then undergone thin sectioned and subjected to humatoxylin and eosin staining for histological investigation. 23 patients (totally 29 discs, including L2-3 to L5-S1) with chronic symptoms underwent IDET for clinical study. VAS (Visual Analog Scale) pain scores were collected before the treatment, 1 week and 3 months after the procedure. One way ANOVA was used for statistical analysis. Results: 4 discs of standard IDET models have been set up in two pigs showing normal MRI T2W1 signal of nucleus pulposus immediately after the procedure, but the high signal extent of the central part of the nucleo pulposus shrinked with conspicuous peripheral low signal changes during the following 1-2 W. Degeneration and shrinkage of nucleo-pulposus with lecolized fibrous ring thickening were found pathologically but without damage to nurve roots and epidural sac. 29 discs in 23 patients were performed successfully, without complication. The follow-up evaluation of 1 week and 3 months after the treatment showing significant differences with those before the treatment on was scores 65.3% and 78.9% respectively (P<0.0001). Conclusions: IDET is safe and effective for chronic discogenic low back pain. (authors)

  14. Clinical investigation of proximate exposed group. 1. A study for prevalence rate of diabetes mellitus

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Chikako; Hasegawa, Kazuyo; Kato, Masafumi; Kumasawa, Toshihiko

    1984-11-01

    In order to investigate effects of the A-bombing on prevalence of diabetes mellitus, follow-up studies were made on 5907 A-bomb survivors who received glucose tolerance test (GTT) during 20 years between 1963 and 1983. The A-bomb survivors were divided into the group A (1899 men and 1165 women exposed within 1.9 km from the hypocenter) and the group B (1725 men and 1118 women exposed 3.0 km or farther from it). Among non-obese survivors, 21.9% and 21.8% were being treated for diabetes mellitus or were evaluated as having diabetic type on GTT in the group A and the group B, respectively; while this was seen in 52.1% of obese survivors in the group A and 49.9% in the group B. There was no difference between the groups. In non-obese survivors, the annual development rate from the normal type to the diabetic type was 0.89% in the group A and 0.65% in the group B; the annual development rate from the borderline type to the diabetic type was 5.73% in the group A and 5.49% in the group B, showing no differences between the groups. The annual development rate from the normal or borderline type to the diabetic type was two times or higher in obese survivors than in non-obese survivors irrespective of exposure status. Regarding the number of diabetic survivors who became non-diabetic type in spite of having no treatment, and prevalence of diabetic complications, no difference was seen between the groups. These results suggest that the A-bombing has scarcely influenced the prevalence of diabetes mellitus and clinical course.

  15. [Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

    Science.gov (United States)

    Benninger-Döring, G; Boos, J

    2006-07-01

    Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.

  16. Central site monitoring: results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection.

    Science.gov (United States)

    Lindblad, Anne S; Manukyan, Zorayr; Purohit-Sheth, Tejashri; Gensler, Gary; Okwesili, Paul; Meeker-O'Connell, Ann; Ball, Leslie; Marler, John R

    2014-04-01

    Site monitoring and source document verification account for 15%-30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification. To determine whether a central review by statisticians using data submitted to the Food and Drug Administration (FDA) by clinical trial sponsors can identify problem sites and trials that failed FDA site inspections. An independent Analysis Center (AC) analyzed data from four anonymous new drug applications (NDAs) where FDA had performed site inspections overseen by FDA's Office of Scientific Investigations (OSI). FDA team members in the OSI chose the four NDAs from among all NDAs with data in Study Data Tabulation Model (SDTM) format. Two of the NDAs had data that OSI had deemed unreliable in support of the application after FDA site inspections identified serious data integrity problems. The other two NDAs had clinical data that OSI deemed reliable after site inspections. At the outset, the AC knew only that the experimental design specified two NDAs with significant problems. FDA gave the AC no information about which NDAs had problems, how many sites were inspected, or how many were found to have problems until after the AC analysis was complete. The AC evaluated randomization balance, enrollment patterns, study visit scheduling, variability of reported data, and last digit reference. The AC classified sites as 'High Concern', 'Moderate Concern', 'Mild Concern', or 'No Concern'. The AC correctly identified the two NDAs with data deemed unreliable by OSI. In addition, central data analysis correctly identified 5 of 6 (83%) sites for which FDA recommended rejection of data and 13 of 15 sites (87%) for which any regulatory deviations were

  17. Waste inspection tomography (WIT)

    Energy Technology Data Exchange (ETDEWEB)

    Bernardi, R.T. [Bio-Imaging Research, Inc., Lincolnshire, IL (United States)

    1995-10-01

    Waste Inspection Tomography (WIT) provides mobile semi-trailer mounted nondestructive examination (NDE) and assay (NDA) for nuclear waste drum characterization. WIT uses various computed tomography (CT) methods for both NDE and NDA of nuclear waste drums. Low level waste (LLW), transuranic (TRU), and mixed radioactive waste can be inspected and characterized without opening the drums. With externally transmitted x-ray NDE techniques, WIT has the ability to identify high density waste materials like heavy metals, define drum contents in two- and three-dimensional space, quantify free liquid volumes through density and x-ray attenuation coefficient discrimination, and measure drum wall thickness. With waste emitting gamma-ray NDA techniques, WIT can locate gamma emitting radioactive sources in two- and three-dimensional space, identify gamma emitting, isotopic species, identify the external activity levels of emitting gamma-ray sources, correct for waste matrix attenuation, provide internal activity approximations, and provide the data needed for waste classification as LLW or TRU.

  18. Waste inspection tomography (WIT)

    International Nuclear Information System (INIS)

    Bernardi, R.T.

    1995-01-01

    Waste Inspection Tomography (WIT) provides mobile semi-trailer mounted nondestructive examination (NDE) and assay (NDA) for nuclear waste drum characterization. WIT uses various computed tomography (CT) methods for both NDE and NDA of nuclear waste drums. Low level waste (LLW), transuranic (TRU), and mixed radioactive waste can be inspected and characterized without opening the drums. With externally transmitted x-ray NDE techniques, WIT has the ability to identify high density waste materials like heavy metals, define drum contents in two- and three-dimensional space, quantify free liquid volumes through density and x-ray attenuation coefficient discrimination, and measure drum wall thickness. With waste emitting gamma-ray NDA techniques, WIT can locate gamma emitting radioactive sources in two- and three-dimensional space, identify gamma emitting, isotopic species, identify the external activity levels of emitting gamma-ray sources, correct for waste matrix attenuation, provide internal activity approximations, and provide the data needed for waste classification as LLW or TRU

  19. Inspections - a cost effective approach

    International Nuclear Information System (INIS)

    Joseph, C.

    1981-01-01

    This paper describes a cost effective approach for inspections of Computerized Nuclear Materials Control and Accounting Systems (CNMCAS). Highlighted is the capability to conduct an inspection program via portable telephone terminals from off-site locations. The program can be applied to various materials management functions including materials control, quality assurance, and materials accounting. The system is designed to facilitate inspections by both external and internal groups

  20. Radiochemical studies, pre-clinical investigation and preliminary clinical evaluation of "1"7"0Tm-EDTMP prepared using in-house freeze-dried EDTMP kit

    International Nuclear Information System (INIS)

    Das, Tapas; Shinto, Ajit; Kamaleshwaran, Koramadai K.; Sarma, Haladhar D.; Mohammed, Sahiralam Khan; Mitra, Arpit; Lad, Sangita; Rajan, M.G.R.; Banerjee, Sharmila

    2017-01-01

    The objective of the present work is to formulate "1"7"0Tm-EDTMP using an in-house freeze-dried EDTMP kit and evaluate its potential as a bone pain palliation agent. Patient dose of "1"7"0Tm-EDTMP was prepared with high radiochemical purity using the lyophilized kit at room temperature within 15 min. Pre-clinical evaluation in normal Wistar rats revealed selective skeletal accumulation with extended retention. Preliminary clinical investigation in 8 patients with disseminated skeletal metastases exhibited selective uptake in the bone and retention therein for a long duration. - Highlights: • Formulation of patient dose of "1"7"0Tm-EDTMP using freeze-dried EDTMP kit. • Radiochemical studies and pre-clinical evaluation of the agent in animal model. • Clinical evaluation in eight cancer patients with disseminated skeletal metastases.

  1. The role of Clinical Trial Units in investigator- and industry-initiated research projects.

    Science.gov (United States)

    von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane

    2015-01-01

    Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.

  2. Clinical impact of diagnostic SPET investigations with a dopamine re-uptake ligand

    DEFF Research Database (Denmark)

    Løkkegaard, Annemette; Werdelin, Lene M; Friberg, Lars

    2002-01-01

    The diagnosis of Parkinson's disease is based on clinical features with pathological verification. However, autopsy has been found to confirm a specialist diagnosis in only about 75% of cases. Especially early in the course of the disease, the clinical diagnosis can be difficult. Imaging of presy...

  3. Inspection system performance test procedure

    International Nuclear Information System (INIS)

    Jensen, C.E.

    1995-01-01

    This procedure establishes requirements to administer a performance demonstration test. The test is to demonstrate that the double-shell tank inspection system (DSTIS) supplied by the contractor performs in accordance with the WHC-S-4108, Double-Shell Tank Ultrasonic Inspection Performance Specification, Rev. 2-A, January, 1995. The inspection system is intended to provide ultrasonic (UT) and visual data to determine integrity of the Westinghouse Hanford Company (WHC) site underground waste tanks. The robotic inspection system consists of the following major sub-systems (modules) and components: Mobile control center; Deployment module; Cable management assembly; Robot mechanism; Ultrasonic testing system; Visual testing system; Pneumatic system; Electrical system; and Control system

  4. Experience on inspection at PFPF

    International Nuclear Information System (INIS)

    Aoki, I.; Yamamoto, Y.; Takahashi, Saburo; Ooshima, Hirofumi; Kuniyasu, Kazufusa.

    1993-01-01

    In order to reduce a personal radiation exposure, Plutonium Fuel Production Facility (PFPF) introduced an automated MOX fabrication technology. Safeguards system for the PFPF was designed and installed so as to be compatible with automated process operation as much as possible. Introduction of these system in PFPF made possible to do the inspection measurements with unattended mode and Near Real Time Material Accountancy (NRTA), consequently inspection has been carrying out effectively and efficiently. This paper describes the new Inspection activities as a comparison with old Inspection activities based on our experience. (author)

  5. PWR vessel inspection performance improvements

    International Nuclear Information System (INIS)

    Blair Fairbrother, D.; Bodson, Francis

    1998-01-01

    A compact robot for ultrasonic inspection of reactor vessels has been developed that reduces setup logistics and schedule time for mandatory code inspections. Rather than installing a large structure to access the entire weld inspection area from its flange attachment, the compact robot examines welds in overlapping patches from a suction cup anchor to the shell wall. The compact robot size allows two robots to be operated in the vessel simultaneously. This significantly reduces the time required to complete the inspection. Experience to date indicates that time for vessel examinations can be reduced to fewer than four days. (author)

  6. Investigations of efficacy of intramammary applied antimicrobials and glucocorticosteroides in the treatment of subclinical and clinical mastitis in cows

    OpenAIRE

    Vakanjac, Slobodanka; Pavlović, Vojislav; Magaš, Vladimir; Pavlović, Miloš; Đurić, Miloje; Maletić, Milan; Nedić, Svetlana; Sočo, Ivan

    2013-01-01

    Inflammation of the mammary gland, mastitis in cows, presents one of the most acute problems in intensive dairy production, inflicting huge economic losses. In the course of one year, 80 samples were taken at investigated farms from udder quarters of cows with clinical mastitis and 160 samples from udder quarters of cows with subclinical mastitis. The efficacy of three preparations, A, B, and C, was examined in the treatment of clinical and subclinical mast...

  7. A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

    Science.gov (United States)

    Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

    2013-10-01

    Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

  8. Clinical Investigation of Adrenal Incidentalomas in Japanese Patients of the Fukuoka Region with Updated Diagnostic Criteria for Sub-clinical Cushing's Syndrome.

    Science.gov (United States)

    Abe, Ichiro; Sugimoto, Kaoru; Miyajima, Tetsumasa; Ide, Tomoko; Minezaki, Midori; Takeshita, Kaori; Takahara, Saori; Nakagawa, Midori; Fujimura, Yuki; Kudo, Tadachika; Miyajima, Shigero; Taira, Hiroshi; Ohe, Kenji; Ishii, Tatsu; Yanase, Toshihiko; Kobayashi, Kunihisa

    2018-04-27

    Objectives We retrospectively investigated the clinical and endocrinological characteristics of adrenal incidentalomas. Methods We studied 61 patients who had been diagnosed with adrenal incidentalomas and had undergone detailed clinical and endocrinological evaluations while hospitalized. We used common criteria to diagnose the functional tumors, but for sub-clinical Cushing's syndrome, we used an updated set of diagnosis criteria: serum cortisol ≥1.8 μg/dL after a positive response to a 1-mg dexamethasone suppression test if the patient has a low morning ACTH level (Cushing's syndrome and sub-clinical Cushing's syndrome), and 25 (41.0%) had non-functional tumors. Compared with the non-functional tumor group, the primary aldosteronism group and the cortisol-secreting adenoma group were significantly younger and had significantly lower rates of hypokalemia, whereas the pheochromocytoma group had significantly larger tumors and a significantly lower body mass index. Conclusion Our study found a larger percentage of functional tumors among adrenal incidentalomas than past reports, partly because we used a lower serum cortisol level after a dexamethasone suppression test to diagnose sub-clinical Cushing's syndrome and because all of the patients were hospitalized and could therefore receive more detailed examinations. Young patients with hypokalemia or lean patients with large adrenal tumors warrant particularly careful investigation.

  9. Laser Safety Inspection Criteria

    International Nuclear Information System (INIS)

    Barat, K

    2005-01-01

    A responsibility of the Laser Safety Officer (LSO) is to perform laser safety audits. The American National Standard Z136.1 Safe use of Lasers references this requirement in several sections: (1) Section 1.3.2 LSO Specific Responsibilities states under Hazard Evaluation, ''The LSO shall be responsible for hazards evaluation of laser work areas''; (2) Section 1.3.2.8, Safety Features Audits, ''The LSO shall ensure that the safety features of the laser installation facilities and laser equipment are audited periodically to assure proper operation''; and (3) Appendix D, under Survey and Inspections, it states, ''the LSO will survey by inspection, as considered necessary, all areas where laser equipment is used''. Therefore, for facilities using Class 3B and or Class 4 lasers, audits for laser safety compliance are expected to be conducted. The composition, frequency and rigueur of that inspection/audit rests in the hands of the LSO. A common practice for institutions is to develop laser audit checklists or survey forms. In many institutions, a sole Laser Safety Officer (LSO) or a number of Deputy LSO's perform these audits. For that matter, there are institutions that request users to perform a self-assessment audit. Many items on the common audit list and the associated findings are subjective because they are based on the experience and interest of the LSO or auditor in particular items on the checklist. Beam block usage is an example; to one set of eyes a particular arrangement might be completely adequate, while to another the installation may be inadequate. In order to provide more consistency, the National Ignition Facility Directorate at Lawrence Livermore National Laboratory (NIF-LLNL) has established criteria for a number of items found on the typical laser safety audit form. These criteria are distributed to laser users, and they serve two broad purposes: first, it gives the user an expectation of what will be reviewed by an auditor, and second, it is an

  10. [Investigation of in vitro metronidazole resistance in the clinical isolates of Trichomonas vaginalis].

    Science.gov (United States)

    Ertabaklar, Hatice; Yaman Karadam, Senem; Malatyalı, Erdoğan; Ertuğ, Sema

    2016-10-01

    -sensitive isolates were 27.17 µg/ml in aerobic and 7.75 µg/ml in anaerobic conditions. The rate of metronidazole resistance detected in this study was higher than most of reports from different countries. Despite being limited to the isolates from Aydin province (located at Agean region of Turkey), the present study has a value as it presented the existence of metronidazole-resistant isolates in Turkey for the first time. More research from other parts of Turkey is needed to better understand the metronidazole resistance at a national scale and to investigate novel strategies for the treatment. Moreover, further studies need to be carried out in order to clarify the relationship between clinical treatment response and in vitro metronidazole resistance in trichomoniasis.

  11. National Program of Inspection of Non-Federal Dams, Tennessee. Lambert Dam (Inventory Number TN 00901), Little Tennessee River Basin, near Six Mile, Blount County, Tennessee. Phase I Investigation Report,

    Science.gov (United States)

    1981-09-01

    the aam was inspected on October 17, 1963 by William P. Clark of the Tennessee Valley Authority. A written report and photos of this...region is characterized by series of alternate linear ridges and valleys extending in the southwest-northeast direction. The over- burden at the dam site...dozen homes are located along An earthei, dam impounding the six mile creek below the dam about 15 acres of water slowly in the Chota

  12. Clinical characteristics of polycystic ovary syndrome: investigating differences in White and South Asian women.

    Science.gov (United States)

    Mani, Hamidreza; Davies, Melanie J; Bodicoat, Danielle H; Levy, Miles J; Gray, Laura J; Howlett, Trevor A; Khunti, Kamlesh

    2015-10-01

    To understand the phenotypic presentation of women with polycystic ovary syndrome (PCOS) of different ethnicities and at different ages. Cross-sectional, retrospective data analysis (1988 - 2009). Specialist clinic in a University Hospital, Leicestershire, UK. Women with PCOS, n = 1310 (mean age 26·2 years), 70·9% White and 29·1% South Asian (SA) attending a speciality clinic in Leicester UK. Clinical and demographic characteristics of women with PCOS including age at first clinic appointment, signs and symptoms, body mass index (BMI) and blood pressure (BP). Compared to White women, the SA were younger (24·3 vs 27·1 years, P women with PCOS appear to be significantly different depending on ethnicity, obesity and age. This has implications for management strategies in these groups. © 2015 John Wiley & Sons Ltd.

  13. Clinical investigation on Theileria equi and Babesia caballi infections in Italian donkeys.

    Science.gov (United States)

    Laus, Fulvio; Spaterna, Andrea; Faillace, Vanessa; Veronesi, Fabrizia; Ravagnan, Silvia; Beribé, Francesca; Cerquetella, Matteo; Meligrana, Marina; Tesei, Beniamino

    2015-04-28

    Interest in the welfare and diseases of donkeys is constantly increasing in several countries. Despite this, clinical research into donkeys needs to be in continual development since they show different reactions compared to horses in many conditions, including infectious diseases, and need specific clinical and therapeutic approaches. No reports are currently available on clinical and clinical pathology data regarding donkeys with natural piroplasms infection. Venous blood samples were taken from one hundred and thirty eight donkeys and underwent indirect fluorescent antibody test (IFAT) to detect IgG antibodies against Theileria equi and Babesia caballi and real-time polimerase chain reaction (PCR) to detect Babesia spp. and Theileria spp. Clinical examinations, haematological analyses and serum bilirubin evaluation were also performed and compared with positive or negative status. A seroprevalence of 40.6% and 47.8% was found for T. equi and B. caballi, respectively; double positivity was detected in 19.6% of the animals. PCR results showed that 17.4% of the animals tested positive for T.equi and 3.6% for B. caballi with no double positivity. Twelve donkeys (8.7%) had clinical signs consistent with chronic forms of the disease and no acute forms were detected. Fifty-eight donkeys had haematological and serum bilirubin alterations and 56 (96.6%) of them were IFAT and/or PCR positive. Changes in erythrocyte number, packed cell volume, hemoglobin concentration, mean corpuscular hemoglobin, platelets number and total bilirubin were significantly associated with positive and symptomatic animals. Nonspecific clinical presentation seems to be very common in donkeys and several clinical pathology alterations persist after natural infection. Therefore, apparently healthy donkeys can have masked but severe clinical pathology alterations. Acute forms are very seldom observed in donkeys. Clinical monitoring of chronically infected donkeys is recommended since such animals

  14. A Novel Electronic Device for Measuring Urine Flow Rate: A Clinical Investigation

    OpenAIRE

    Aliza Goldman; Hagar Azran; Tal Stern; Mor Grinstein; Dafna Wilner

    2017-01-01

    Objective: Currently, most vital signs in the intensive care unit (ICU) are electronically monitored. However, clinical practice for urine output (UO) measurement, an important vital sign, usually requires manual recording of data that is subject to human errors. In this study, we assessed the ability of a novel electronic UO monitoring device to measure real-time hourly UO versus current clinical practice. Design: Patients were connected to the RenalSense Clarity RMS Sensor Kit with a sensor...

  15. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

    DEFF Research Database (Denmark)

    Schulman, S; Angerås, U; Bergqvist, D

    2010-01-01

    in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...... of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols....

  16. Short notice inspections

    International Nuclear Information System (INIS)

    Pouchkarev, V.

    1998-01-01

    For 30 years the IAEA safeguards system have evolved and have been strengthened by the regular introduction of new methods and techniques, improving both its effectiveness and efficiency. The member States of the IAEA have indicated their willingness to accept new obligations and associated technical measure that greatly strengthen the nuclear safeguards system. One element of this is the extent to which the IAEA inspectors have physical access to relevant locations for the purpose of providing independent verification of the exclusively peaceful intent of a State nuclear program. The Protocol to Safeguards granted new legal authority with respect to information on, and short notice inspector access to, all buildings on a nuclear site and administrative agreements that improve the process of designating inspectors and IAEA access to modern means of communication. This report is a short description of unannounced or short notice inspections as measures on which the new strengthened and cost efficient system will be based

  17. Emerging biomarkers in anaplastic oligodendroglioma: implications for clinical investigation and patient management.

    Science.gov (United States)

    Sahebjam, Solmaz; McNamara, Mairéad G; Mason, Warren P

    2013-07-01

    Oligodendrogliomas are heterogeneous tumors with a variable response to treatment. This clinical variability underlines the urgent need for markers that can reliably aid diagnosis and guide clinical decision-making. Long-term follow-up data from the EORTC 26951 and RTOG 9402 clinical trials in newly diagnosed anaplastic oligodendroglioma have established chromosome 1p19q codeletion as a predictive marker of response to procarbazine, lomustine and vincristine chemotherapy in anaplastic oligodendrogliomas. In addition, MGMT promoter hypermethylation has been strongly associated with glioma CpG island hypermethylation phenotype (G-CIMP+) status, this has been suggested as an epiphenomenon of genome-wide methylation, conferring a more favorable prognosis. Molecular profiling of these tumors has identified several other markers with potential clinical significance: mutations of IDH, CIC, FUBP1 and CDKN2A require further validation before they can be implemented as clinical decision-making tools. Additionally, recent data on the clinical significance of intrinsic glioma subtyping appears promising. Indeed, existing evidence suggests that comprehensive analyses such as intrinsic glioma subtyping or G-CIMP status are superior to single molecular markers. Clearly, with evolving treatment strategies and in the era of individualized therapy, broader omics-based molecular evaluations are required to improve outcome prediction and to identify patients who will benefit from specific treatment strategies.

  18. Molecular investigation of virulence factors of Brucella melitensis and Brucella abortus strains isolated from clinical and non-clinical samples.

    Science.gov (United States)

    Mirnejad, Reza; Jazi, Faramarz Masjedian; Mostafaei, Shayan; Sedighi, Mansour

    2017-08-01

    Brucella is zoonotic pathogen that induces abortion and sterility in domestic mammals and chronic infections in humans called Malta fever. It is a facultative intracellular potential pathogen with high infectivity. The virulence of Brucella is dependent upon its potential virulence factors such as enzymes and cell envelope associated virulence genes. The aim of this study was to investigate the Brucella virulence factors among strains isolated from humans and animals in different parts of Iran. Seventy eight strains of Brucella species isolated from suspected human and animal cases from several provinces of Iran during 2015-2016 and identified by phenotypic and molecular methods. The multiplex-PCR (M-PCR) assay was performed in order to detect the ure, wbkA, omp19, mviN, manA and perA genes by using gene specific primers. Out of 78 isolates of Brucella spp., 57 (73%) and 21 (27%) isolates were detected as B. melitensis and B. abortus, respectively, by molecular method. The relative frequency of virulence genes ure, wbkA, omp19, mviN, manA and perA were 74.4%, 89.7%, 93.6%, 94.9%, 100% and 92.3%, respectively. Our results indicate that the most of Brucella strains isolated from this region possess high percent of virulence factor genes (ure, wbkA, omp19, mviN, manA and perA) in their genome. So, each step of infection can be mediated by a number of virulence factors and each strain may have a unique combination of these factors that affected the rate of bacterial pathogenesis. Copyright © 2017 Elsevier Ltd. All rights reserved.

  19. Clinical reasoning in neurology: use of the repertory grid technique to investigate the reasoning of an experienced occupational therapist.

    Science.gov (United States)

    Kuipers, Kathy; Grice, James W

    2009-08-01

    The aim of this paper is to describe the use of a structured interview methodology, the repertory grid technique, for investigating the clinical reasoning of an experienced occupational therapist in the domain of upper limb hypertonia as a result of brain injury. Repertory grid interviews were completed before and after exposure to a protocol designed to guide clinical reasoning and decision-making in relation to upper limb neurological rehabilitation. Data were subjected to both qualitative and quantitative analyses. Qualitative analysis focussed on clinical reasoning content. Common themes across the pre- and post-exposure interviews were the use of theoretical frameworks and practice models, the significance of clinical expertise, and discrimination of 'broad' and 'specific' aspects, as well as differentiation between 'therapist and client-related' aspects of the clinical situation. Quantitative analysis indicated that for both pre- and post-exposure repertory grids, clinical reasoning was structured in terms of two main concepts. In the pre-exposure grid, these were related to the therapist's role, and to the 'scope' of practice tasks (either broad or specific). In the post-exposure grid the two main concepts were upper limb performance, and client-centred aspects of the therapy process. The repertory grid technique is proposed as an effective tool for exploring occupational therapy clinical reasoning, based on its capacity for accessing personal frames of reference, and elucidating both the meaning and the structure supporting clinical reasoning.

  20. Inspection of disposal canisters components

    International Nuclear Information System (INIS)

    Pitkaenen, J.

    2013-12-01

    This report presents the inspection techniques of disposal canister components. Manufacturing methods and a description of the defects related to different manufacturing methods are described briefly. The defect types form a basis for the design of non-destructive testing because the defect types, which occur in the inspected components, affect to choice of inspection methods. The canister components are to nodular cast iron insert, steel lid, lid screw, metal gasket, copper tube with integrated or separate bottom, and copper lid. The inspection of copper material is challenging due to the anisotropic properties of the material and local changes in the grain size of the copper material. The cast iron insert has some acoustical material property variation (attenuation, velocity changes, scattering properties), which make the ultrasonic inspection demanding from calibration point of view. Mainly three different methods are used for inspection. Ultrasonic testing technique is used for inspection of volume, eddy current technique, for copper components only, and visual testing technique are used for inspection of the surface and near surface area

  1. MTR fuel inspection at CERCA

    International Nuclear Information System (INIS)

    Fanjas, Y.

    1992-01-01

    The stringent specifications for MTR fuel plates and fuel elements require various sophisticated inspection techniques. In particular, the development of low enriched silicide fuels made it necessary to adapt these techniques to high density plates. This paper presents the status of inspection technology at CERCA. (author)

  2. 1990 waste tank inspection program

    International Nuclear Information System (INIS)

    McNatt, F.G.

    1990-01-01

    Aqueous radioactive wastes from Savannah River Site separations processes are contained in large underground carbon steel tanks. Tank conditions are evaluated by inspection using periscopes, still photography, and video systems for visual imagery. Inspections made in 1990 are the subject of this report

  3. Computerized automated remote inspection system

    International Nuclear Information System (INIS)

    The automated inspection system utilizes a computer to control the location of the ultrasonic transducer, the actual inspection process, the display of the data, and the storage of the data on IBM magnetic tape. This automated inspection equipment provides two major advantages. First, it provides a cost savings, because of the reduced inspection time, made possible by the automation of the data acquisition, processing, and storage equipment. This reduced inspection time is also made possible by a computerized data evaluation aid which speeds data interpretation. In addition, the computer control of the transducer location drive allows the exact duplication of a previously located position or flaw. The second major advantage is that the use of automated inspection equipment also allows a higher-quality inspection, because of the automated data acquisition, processing, and storage. This storage of data, in accurate digital form on IBM magnetic tape, for example, facilitates retrieval for comparison with previous inspection data. The equipment provides a multiplicity of scan data which will provide statistical information on any questionable volume or flaw. An automatic alarm for location of all reportable flaws reduces the probability of operator error. This system has the ability to present data on a cathode ray tube as numerical information, a three-dimensional picture, or ''hard-copy'' sheet. One important advantage of this system is the ability to store large amounts of data in compact magnetic tape reels

  4. Experimenting Clinical Pathways in General Practice: a Focus Group Investigation with Italian General Practitioners

    Science.gov (United States)

    Zannini, Lucia; Cattaneo, Cesarina; Peduzzi, Paolo; Lopiccoli, Silvia; Auxilia, Francesco

    2012-01-01

    Background Clinical governance is considered crucial in primary care. Since 2005, clinical pathways have been experimentally implemented at the Local Health Authority of Monza Brianza (ASLMB), Italy, to develop general practitioners’ (GPs) care of patients affected by some chronic diseases. The experimentation was aimed at introducing clinical governance in primary care, increasing GPs’ involvement in the care of their patients, and improving both patients’ and professionals’ satisfaction. In the period 2005-2006, 12% of the 763 employed GPs in the ASLMB were involved in the experiment, while this percentage increased to 15-20% in 2007-2008. Design and Methods Twenty-four GPs were purposively sampled, randomly divided into two groups and asked to participate in focus groups (FGs) held in 2008, aimed at evaluating their perception of the experiment. The FGs were audio-recorded, dialogues were typed out and undergone to a thematic analysis, according to the Interpretative Phenomenological Approach. Results Four major themes emerged: i) clinical pathways can result in GPs working in a more efficient and effective fashion; ii) they can assure higher levels of both patient and professional satisfaction, since they sustain a caring approach and strengthen the GPs’ role; iii) nevertheless, clinical pathways increase the bureaucratic workload and problems can arise in relationships among GPs and the LHA; iv) the implementation of clinical pathways can be improved, especially by reducing bureaucracy and by assuring their continuity. Conclusions Managerial aspects should be considered with care in order to experimentally introduce clinical pathways in general practice, and continuity of the experimentation should be guaranteed to improve GPs’ adherence and commitment. Acknowledgments the Authors thank Dr. AP. Cantù and Dr D. Cereda who participated in the two focus groups as observers. PMID:25181354

  5. Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: methodology and external validation.

    Science.gov (United States)

    Vranckx, Pascal; McFadden, Eugene; Cutlip, Donald E; Mehran, Roxana; Swart, Michael; Kint, P P; Zijlstra, Felix; Silber, Sigmund; Windecker, Stephan; Serruys, Patrick W C J

    2013-01-01

    Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical-TLRs and considered 1 TV-MI as no event. A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. Experimenting clinical pathways in general practice: a focus group investigation with Italian general practitioners

    Directory of Open Access Journals (Sweden)

    Lucia Zannini

    2012-07-01

    Full Text Available Background. Clinical governance is considered crucial in primary care. Since 2005, clinical pathways have been experimentally implemented at the Local Health Authority of Monza Brianza (ASLMB, Italy, to develop general practitioners’ (GPs care of patients affected by some chronic diseases. The experimentation was aimed at introducing clinical governance in primary care, increasing GPs’ involvement in the care of their patients, and improving both patients’ and professionals’ satisfaction. In the period 2005-2006, 12% of the 763 employed GPs in the ASLMB were involved in the experiment, while this percentage increased to 15-20% in 2007-2008. Design and Methods. Twenty-four GPs were purposively sampled, randomly divided into two groups and asked to participate in focus groups (FGs held in 2008, aimed at evaluating their perception of the experiment. The FGs were audio-recorded, dialogues were typed out and undergone to a thematic analysis, according to the Interpretative Phenomenological Approach. Results. Four major themes emerged: i clinical pathways can result in GPs working in a more efficient and effective fashion; ii they can assure higher levels of both patient and professional satisfaction, since they sustain a caring approach and strengthen the GPs’ role; iii nevertheless, clinical pathways increase the bureaucratic workload and problems can arise in relationships among GPs and the LHA; iv the implementation of clinical pathways can be improved, especially by reducing bureaucracy and by assuring their continuity. Conclusions. Managerial aspects should be considered with care in order to experimentally introduce clinical pathways in general practice, and continuity of the experimentation should be guaranteed to improve GPs’ adherence and commitment.

  7. Technology Assessment of the Inspection Readiness Plan in Chemical Weapons Convention Challenge Inspections

    National Research Council Canada - National Science Library

    Woodley, Anthony

    1998-01-01

    ...) Challenge Inspections. The CWC is an intrusive inspection. The Challenge Inspection allows for a team of international inspectors to inspect on very short notice a naval facility suspected of violating the CWC...

  8. Process Improvement to the Inspection Readiness Plan in Chemical Weapons Convention Challenge Inspections

    National Research Council Canada - National Science Library

    Triplett, William

    1997-01-01

    ...) Challenge Inspection. The CWC is an intensive inspection. The Challenge Inspection allows for a team of international inspectors to inspect a naval facility suspected of violating the CWC on very short notice...

  9. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

    Science.gov (United States)

    Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

    2016-12-15

    Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

  10. Inspection methods progression of diabetic optic neuropathy

    Directory of Open Access Journals (Sweden)

    Yan Sun

    2015-06-01

    Full Text Available Increasing incidence of diabetes, diet restructuring with excessive intake of high-calorie foods closely related with this. Currently diabetes prevalence rate increased from 7% in 2003 to 14% in 2010. Diabetes can cause a variety of eye diseases, such as corneal ulcers, glaucoma, vitreous hemorrhage and so on. Diabetic retinopathy and cataract are the most common and greater impact on patients. At present, study for diabetic retinopathy(DRis wider than diabetes optic neuropathy(DON. Clinical manifestations of DON are not specific, but DON occurred extensively, also contributed to an important cause of blindness.In this paper, we collected a variety of inspection and early diagnosis methods, try to achieve early detection, interventional therapy and good treatment for this disease. Here to make a presentation on the various types of inspection methods.

  11. International cooperation in production inspections

    International Nuclear Information System (INIS)

    Limousin, S.

    2009-01-01

    Nuclear pressure equipment, like the reactor pressure vessel or steam generators, are manufactured in many countries all around the world. As only few reactors were built in the 90's, most of the nuclear safety authorities have lost part of their know how in component manufacturing oversight. For these two reasons, vendor inspection is a key area for international cooperation. On the one hand, ASN has bilateral relationships with several countries (USA, Finland, China...) to fulfill specific purposes. On the other hand, ASN participates in international groups like the MDEP ( Multinational Design Evaluation Program). A MDEP working group dedicated to vendor inspection cooperation enables exchanges of informations (inspection program plan, inspection findings...) among the regulators. Join inspections are organized. International cooperation could lead in the long term to an harmonization of regulatory practices. (author)

  12. [What are Considerations for Clinical Investigation of New Drugs and Treatment Techniques for Major Depressive Disorders?].

    Science.gov (United States)

    Nakabayashi, Tetsuo

    2015-01-01

    Major depressive disorder treatments remain unsatisfactory, and the development of novel antidepressants is continuing. Therefore, not only the establishment of therapeutic strategies to accumulate evidence on existing therapies, but also the development of novel therapies is required in order to improve the medical standards. In principle, parallel, double-blind, randomized, placebo-controlled trials are necessary to assess new compounds for the treatment of major depressive disorders from a scientific perspective. To provide unambiguous evidence of antidepressant activity, well-controlled studies with adequate designs must show efficacy with a statistically significant effect on a clinically meaningful endpoint. For this purpose, it is important to examine all aspects of factors that adversely affect the efficacy and safety assessment in the planning stage of clinical trials and reduce these factors. There are several specific characteristics of clinical trials for neuropsychiatric disorders. Some typical features are as follows: 1) a high and variable response, 2) impact on the effect of the baseline severity of disorders, 3) high dropout rates, 4) biases related to subjective measures of clinical symptoms. In this paper, considerations for the planning and performing of clinical trials for major depressive disorders will be discussed based on these features.

  13. Clinical impact of diagnostic SPET investigations with a dopamine re-uptake ligand

    International Nuclear Information System (INIS)

    Loekkegaard, Annemette; Werdelin, Lene M.; Friberg, Lars

    2002-01-01

    The diagnosis of Parkinson's disease is based on clinical features with pathological verification. However, autopsy has been found to confirm a specialist diagnosis in only about 75% of cases. Especially early in the course of the disease, the clinical diagnosis can be difficult. Imaging of presynaptic dopamine transporters (DAT receptors) has provided a possible diagnostic probe in the evaluation of Parkinson's disease. The cocaine analogue [ 123 I]-2-β-carboxymethoxy-3-β(4-iodophenyl)tropane ([ 123 I]-β-CIT) is one of several radioligands that have been developed for single-photon emission tomography (SPET). The purpose of this study was to evaluate the impact of [ 123 I]-β-CIT SPET on the diagnosis and clinical management of patients with a primary, tentative diagnosis of parkinsonism. We undertook a retrospective evaluation of the clinical records of 90 consecutive patients referred to [ 123 I]-β-CIT SPET from the neurological department, Bispebjerg Hospital. In 58 subjects the scans revealed altered tracer uptake consistent with Parkinson's disease, progressive supranuclear palsy and multiple system atrophy. A significant change in the management or treatment because of the scan was found in 25 patients (28%). The sensitivity of the examination was 97% and the specificity 83%. In conclusion, a significant clinical impact of DAT receptor SPET imaging was found. DAT receptor imaging is a useful diagnostic probe in patients with a possible diagnosis of parkinsonism. (orig.)

  14. Model for investigating the benefits of clinical supervision in psychiatric nursing: a survey study.

    Science.gov (United States)

    Gonge, Henrik; Buus, Niels

    2011-04-01

    The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sample was 136 nursing staff members in permanent employment on nine general psychiatric wards and at four community mental health centres at a Danish psychiatric university hospital. Data were collected by means of a set of questionnaires. Participation in clinical supervision was associated with the effectiveness of clinical supervision, as measured by the Manchester Clinical Supervision Scale (MCSS). Furthermore, MCSS scores were associated with benefits, such as increased job satisfaction, vitality, rational coping and less stress, emotional exhaustion, and depersonalization. Multivariate analyses indicated that certain individual and workplace factors were related to subscales of the MCSS, as well as some of the benefits. The study supported the suggested model, but methodological limitations apply. © 2011 The Authors. International Journal of Mental Health Nursing © 2011 Australian College of Mental Health Nurses Inc.

  15. [Is the structure of surgical clinics in Germany changing? A current investigation into the structure of surgical clinics in the Federal Republic of Germany].

    Science.gov (United States)

    Lob, G; Lob, T; Bauer, H; Niethard, F; Polonius, J; Siebert, H

    2009-04-01

    Medical developments have led to extensive specialization in the field of surgery. This has already been reflected for many years in altered structure and organization forms of surgical clinics. Indispensable quality standards, statutory general conditions, increasing competition in service providers and health insurance with transparency of the service procedure all intensify this trend. The aim of this investigation was, therefore, to determine how far this differentiation of service supply in the field of surgery is also reflected in the area and in surgical departments and clinics of basic and routine supply. To achieve this, all available published information on the structure and organization of surgical clinics in the Federal Republic of Germany was classified according to current departmentalization into "undivided" or general/visceral surgery facilities compared to orthopedic/trauma surgery departments.

  16. Chronic recurrent multifocal osteomyelitis: a radiological and clinical investigation of five cases

    International Nuclear Information System (INIS)

    Demharter, J.; Bohndorf, K.; Michl, W.; Vogt, H.

    1997-01-01

    Objective. To make a detailed evaluation of the clinical and radiological course of five children with chronic recurrent multifocal osteomyelitis (CRMO). Emphasis was laid on the correlation between clinical data and radiological findings. Design and patients. Clinical data, histology (n=11), bone scintigraphy (n=17), and the plain radiographs (n=198) of these patients were reviewed. The mean time of observation was 6.6 years (range 1-14.5 years). Thirty-two lesions seen at the time of primary diagnosis (n=22) or during the course of the disease (n=10) were evaluated. Twenty-seven foci were located in bone; in five cases the sacroiliac joints were involved. Results. Bone scintigrams showed nearly all foci (31/32) and were especially helpful in clinically asymptomatic lesions (14/32) or foci which were radiographically difficult to detect or not seen at all (8/32). Only 14 of 32 foci were locally symptomatic clinically. In all cases with a short interval (≤3 weeks) between the onset of local symptoms and evaluation by plain radiographs (n=5) osteolysis was shown without a sclerotic margin. All bone lesions with a longer duration of local symptoms (n=7) revealed a variable radiographic pattern: osteolysis with sclerotic rim in three, a mixed lytic-sclerotic lesion in three and pure sclerosis in one. In two cases low back pain could be ascribed to sacroiliitis. Conclusion. Only careful correlation between clinical, scintigraphy and radiographic features permits an accurate assessment of disease activity in CRMO. The bone lesions detected radiographically soon after the onset of symptoms resemble those of acute osteomyelitis. (orig.)

  17. Funding opportunities for clinical investigators in the early stages of career development in cardiovascular research.

    Science.gov (United States)

    Mentz, Robert J; Becker, Richard C

    2013-11-01

    Contemporary cardiovascular research offers junior investigators the opportunity to explore the gamut of biomedical questions. Despite the recent reduction in the availability of funding mechanisms that have historically served as the primary pathways for investigators in the early stages of career development, there remain numerous traditional and non-traditional funding opportunities. This article highlights these opportunities in order to assist early career investigators in the development of a personalized research trajectory, which optimizes the potential for career success.

  18. Funding opportunities for clinical investigators in the early stages of career development in cardiovascular research

    OpenAIRE

    Mentz, Robert J.; Becker, Richard C.

    2013-01-01

    Contemporary cardiovascular research offers junior investigators the opportunity to explore the gamut of biomedical questions. Despite the recent reduction in the availability of funding mechanisms that have historically served as the primary pathways for investigators in the early stages of career development, there remain numerous traditional and non-traditional funding opportunities. This article highlights these opportunities in order to assist early career investigators in the developmen...

  19. Madigan Army Medical Center Department of Clinical Investigation Annual Progress Report Fiscal Year 1999

    Science.gov (United States)

    1999-09-30

    ferrets with diseased adrenal glands are usually unremarkable, occasionally a complete blood count may reveal regenerative or nonregenerative anemia and...renal failure and hypertension in non-pregnant individuals, and in pregnant women with preeclampsia . To date there exist no studies demonstrating the...Investigator: CDR Sylvia Y . N. Young, MC, USN Department: Preventive Medicine Facility: MAMC Associate Investigator(s): LTC Jeffrey D. Gunzenhauser, MC

  20. Investigating factors determining the use of the clinical care module by nurses through the UTAUT model

    CSIR Research Space (South Africa)

    Zhou, M

    2016-04-01

    Full Text Available conditions, and treatment plans. A clinical decision based on information that has been efficiently managed and processed lends itself to quality care outcomes.’ The Ministry of Health and Child Care (MoHCC) and the hospital health authorities have managed... : The Eighth International Conference on eHealth, Telemedicine, and Social Medicine (with DIGITAL HEALTHY LIVING 2016 / MATH 2016) Electronic Health (E-Health) projects rolled out do not offer the clinical services module to aid clinicians during decision...

  1. Comparison of criminal procedure and inspection

    International Nuclear Information System (INIS)

    Hyung, Sang Cheol

    2009-01-01

    While a criminal investigation and international inspection are similar in the purpose of identifying any possible violator, there are also differences between them. Especially in the case of a criminal procedure, the defendants are presumed to be innocent until he or she is convicted, but states must make efforts to prove their nuclear transparency. Let's compare both of them to find out the reason why these different points have happened

  2. An investigation of clinical studies suggests those with multiple objectives should have at least 90% power for each endpoint.

    NARCIS (Netherlands)

    Borm, G.F.; Houben, R.; Welsing, P.M.J.; Zielhuis, G.A.

    2006-01-01

    BACKGROUND AND OBJECTIVES: Many clinical studies have more than one objective, either formally or informally, but this is not usually taken into account in the determination of the sample size. We investigated the overall power of a study, that is, the probability that all the objectives will be

  3. Preclinical and clinical investigation of a CCR5 antagonist, AZD5672, in patients with rheumatoid arthritis receiving methotrexate

    NARCIS (Netherlands)

    Gerlag, Daniëlle M.; Hollis, Sally; Layton, Mark; Vencovský, Jiří; Szekanecz, Zoltán; Braddock, Martin; Tak, Paul P.; Oparanov, Boycho; Stoilov, Rumen; Yaneva, Tanya; Batalov, Anastas; Arteaga, Edgardo Tobias; Escalante, William Otero; Velez, Patricia; Restrepo, Jose Molina; Augustinova, Sevda; Blahova, Anna; Dvorak, Zdenek; Novosad, Libor; Rosa, Jan; Stehlikova, Helena; Vitek, Petr; Balazs, Tibor; Seregely, Katalin; Szombati, Istvan; Tarjan, Katalin; Csengei, Gabor; Galeazzi, Mauro; Saleniece, Sarmite; Saulite-Kandevica, Daina; Coleiro, Bernard; Badurski, Janusz; Brzosko, Marek; Chudzik, Dariusz; Gruszecka-Marczynska, Katarzyna; Hensel, Joanna; Pokrzywnicka-Gajek, Ines; Korpanty-Danda, Joanna; Sochocka-Bykowska, Malgorzata; Tlustochowicz, Witold; Stopinska-Polaszewska, Maria; Gluszko, Piotr; Nedelcovici, Corina; Radulescu, Florin; Gavrila, Mirea; Tanasescu, Coman; Korshunov, Nikolay; Matsievskaia, Galina; Damjanov, Nemanja; Dimic, Aleksandar

    2010-01-01

    To investigate both the preclinical effects of blocking the chemokine receptor CCR5 and the clinical effects of this approach on the signs and symptoms of rheumatoid arthritis (RA) in patients with active disease. Preclinical evaluations of AZD5672, a small-molecule antagonist of CCR5, were

  4. An investigation on clinical, radiological and biochemical methods for assessing periodontitis activity

    International Nuclear Information System (INIS)

    Janssen, P.T.M.

    1987-01-01

    In order to recognize in which stage rapidly progressing destruction of periodontal ligament fibers occurs, a number of diagnostic methods are studied in this thesis. It turns out that the actual much utilized clinical methods can not be improved while radiological and biochemical diagnositic methods are much more promising. 106 refs.; 20 figs.; 36 tabs

  5. An investigation into the bacterial contamination of goniolenses in use in clinical practice.

    Science.gov (United States)

    Grundon, Rachael; Scurrell, Emma; Mould, John; Hayton-Lee, Emma; Heinrich, Christine

    2017-12-18

    Objectives To report the incidence and evaluate the clinical significance of goniolens bacterial contamination in clinical use in dogs with three different usage protocols and one with an added cleaning protocol. Animals Studied and Methods Three groups of twenty dogs undergoing gonioscopy at a private practice in the UK had the goniolenses swabbed for bacteriology culture and identification prior to placement on the cornea. Three protocols of lens use, with 2 different types of goniolens, were studied. One protocol was then repeated with 21 dogs with a lens cleaning protocol prior to storage. Results Low levels of bacterial contamination were found in all 3 initial groups (10-15%). No correlation was found between usage protocol used and rate of contamination and no correlation was found between length of storage between use and contamination. All bacteria cultured were considered naturally occurring commensals for the canine eye and environment. The group with a cleaning protocol had a 4.7% contamination rate. This was not statistically different from the non-cleaning groups. Conclusions The rate of bacterial contamination of goniolenses in clinical practice is low and the bacterial contaminants consist of commensal bacteria, unlikely to be of detriment to the eye. Minimal contamination of the goniolenses was found and this did not appear to be of clinical significance. The introduction of a simple cleaning protocol did not produce a statistically significant reduction in bacterial contamination. © 2017 American College of Veterinary Ophthalmologists.

  6. SES, Ethnic, and Gender Differences in Young Children's Informal Addition and Subtraction: A Clinical Interview Investigation

    Science.gov (United States)

    Ginsburg, Herbert P.; Pappas, Sandra

    2004-01-01

    The main goal of this study was to examine possible socioeconomic status (SES) differences in 4- and 5-year-old children's informal mathematical knowledge. One hundred and two children, 32 from lower, 39 from middle, and 31 from upper SES families participated in the study. Each participant was given a clinical interview involving several addition…

  7. Definition and drivers of acute traumatic coagulopathy: clinical and experimental investigations

    NARCIS (Netherlands)

    Frith, D.; Goslings, J. C.; Gaarder, C.; Maegele, M.; Cohen, M. J.; Allard, S.; Johansson, P. I.; Stanworth, S.; Thiemermann, C.; Brohi, K.

    2010-01-01

    Background: Acute traumatic coagulopathy (ATC) is an impairment of hemostasis that occurs early after injury and is associated with a 4-fold higher mortality, increased transfusion requirements and organ failure. Objectives: The purpose of the present study was to develop a clinically relevant

  8. Risk Based Monitoring (RBM: A global study focusing on perception and merits among clinical investigational sites

    Directory of Open Access Journals (Sweden)

    Prajna P. Kumar

    2016-12-01

    Conclusion: This unique study performed across ten emerging and developed countries strongly supported the need for systematic global training, education, and implementation of RBM regulatory guidance, with an aim for better safety of subjects and improved quality of clinical trial data. Furthermore, studies with larger sample sizes are recommended to provide an evidence-based approach.

  9. Molecular epigenetics in the management of ovarian cancer: Are we investigating a rational clinical promise?

    Directory of Open Access Journals (Sweden)

    Ha eNguyen

    2014-04-01

    Full Text Available Epigenetics is essentially a phenotypical change in gene expression without any alteration of the DNA sequence; the emergence of epigenetics in cancer research and mainstream oncology is fueling new hope. However, it is not yet known whether this knowledge will translate to improved clinical management of ovarian cancer. In this malignancy, women are still undergoing chemotherapy similar to what was approved in 1978, which to this day represents one of the biggest breakthroughs for treating ovarian cancer. While liquid tumors are benefitting from epigenetically-related therapies, solid tumors like ovarian cancer are not (yet?. Herein we will review the science of molecular epigenetics, especially DNA methylation, histone modifications and microRNA, but also include transcription factors since they, too, are important in ovarian cancer. Preclinical and clinical research on the role of epigenetic modifications is summarized as well. Sadly, ovarian cancer remains an idiopathic disease, for the most part, and there are many areas of patient management which could benefit from improved technology. This review will also highlight the evidence suggesting that epigenetics may have preclinical utility in pharmacology and clinical applications for prognosis and diagnosis. Lastly, drugs currently in clinical trials (i.e. histone deacetylase inhibitors are discussed along with the promise for epigenetics in the exploitation of chemoresistance. Whether epigenetics will ultimately be the answer to better management in ovarian cancer is currently unknown; what we have now is hope.

  10. Investigation of the causes of clinical symptom aggravation in process of intravenous thrombolysis with alteplase

    Directory of Open Access Journals (Sweden)

    LI Chen-hua

    2013-04-01

    Full Text Available Objective To explore the causes of aggravation of microcirculation disorders in the process of intravenous thrombolysis with alteplase and the clinical outcomes. Methods The clinical data of the aggravated signs and symptoms of 13 cases treated by alteplase were reported, and the onset characteristics and clinical outcomes were analysed to summarize emergency experiences. Results There were 13 patients with stenosis of intracranial large arteries occurred perforating branch infarctions caused by the blocking of carried arteries (8 cases in internal carotid system, 5 cases in vertebral-basilar system. In the process of thrombolytic therapy, main aggravated presentations including cortical ischemic symptom, quadriplegia, exacerbated disturbance of consciousness were seen. Imaging examinations showed multiple new petechial ischemic foci in cortex and watershed region or increasing of infarct foci in cerebellum and brain stem. The prognosis was favorable after expectant treatment. NIHSS score was 8.69 ± 3.42 at 24 h after treatment, and mRS score was 0.94 ±0.37 at 3 month-follow-up. Neurologic deficit and quality of life were evidently improved. Conclusion In the course of intravenous thrombolytic therapy with alteplase. Aggravated clinical signs and symptoms may be related to various factors. Emboli disintegration inducing microcirculation disorder is inferred to be the main cause. For patients presenting aggravated signs and symptoms in thrombolysis process, favorable outcomes may occur as long as intensive care and timely treatment are performed.

  11. 77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

    Science.gov (United States)

    2012-11-20

    ...) is needed in order to assure the protection of the rights and welfare of human subjects in clinical... responsibilities. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and FDA have been actively working to...

  12. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1991-02-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organizations during the period from October 1990 through December 1990

  13. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1993-05-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organizations during the period from January 1993 through March 1993

  14. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1991-05-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organization during the period from January 1991 through March 1991

  15. Licensee contractor and Vendor Inspection status report

    International Nuclear Information System (INIS)

    1993-01-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organizations during the period from October 1992 through December 1992

  16. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1989-12-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organizations during the period from July 1989 through September 1989

  17. Lean Construction Applications for Bridge Inspection

    Science.gov (United States)

    2017-10-01

    Lean philosophy was used to analyze the efficiency of bridge inspection. Emphasis was put on identifying activities that add value to the final output, an owner approved bridge inspection report. 26 bridge inspections were shadowed. Time spent on bri...

  18. Licensee Contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1992-01-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organization during the period from October through December 1991

  19. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1993-08-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organizations during the period from April through June 1993

  20. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1991-09-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organization during the period from April 1991 through June 1991

  1. Automated visual inspection of moving custom parts

    CSIR Research Space (South Africa)

    Davrajh, S

    2008-01-01

    Full Text Available frequencies than batched produced parts. This higher frequency of inspection significantly impacts inspection times, and inherently, production rates. An effective, diverse, accurate, robust, and time efficient method for inspecting custom parts is therefore...

  2. Licensee contractor and Vendor Inspection status report

    International Nuclear Information System (INIS)

    1992-05-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organizations during the period from January through March 1992

  3. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1990-07-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organization during the period from January 1990 through March 1990

  4. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1990-01-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organizations during the period from October 1989 through December 1989

  5. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1992-11-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organization during the period from July 1992 through September 1992

  6. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1991-10-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organization during the period from July 1991 through September 1991

  7. Licensee contractor and vendor inspection status report

    International Nuclear Information System (INIS)

    1990-11-01

    This periodical covers the results of inspections performed by the NRC's Vendor Inspection Branch that have been distributed to the inspected organization during the period from April 1990 through June 1990

  8. Encountering aged care: a mixed methods investigation of medical students' clinical placement experiences.

    Science.gov (United States)

    Annear, Michael J; Lea, Emma; Lo, Amanda; Tierney, Laura; Robinson, Andrew

    2016-02-04

    Residential aged care is an increasingly important health setting due to population ageing and the increase in age-related conditions, such as dementia. However, medical education has limited engagement with this fast-growing sector and undergraduate training remains primarily focussed on acute presentations in hospital settings. Additionally, concerns have been raised about the adequacy of dementia-related content in undergraduate medical curricula, while research has found mixed attitudes among students towards the care of older people. This study explores how medical students engage with the learning experiences accessible in clinical placements in residential aged care facilities (RACFs), particularly exposure to multiple comorbidity, cognitive impairment, and palliative care. Fifth-year medical students (N = 61) completed five-day clinical placements at two Australian aged care facilities in 2013 and 2014. The placements were supported by an iterative yet structured program and academic teaching staff to ensure appropriate educational experiences and oversight. Mixed methods data were collected before and after the clinical placement. Quantitative data included surveys of dementia knowledge and questions about attitudes to the aged care sector and working with older adults. Qualitative data were collected from focus group discussions concerning medical student expectations, learning opportunities, and challenges to engagement. Pre-placement surveys identified good dementia knowledge, but poor attitudes towards aged care and older adults. Negative placement experiences were associated with a struggle to discern case complexity and a perception of an aged care placement as an opportunity cost associated with reduced hospital training time. Irrespective of negative sentiment, post-placement survey data showed significant improvements in attitudes to working with older people and dementia knowledge. Positive student experiences were explained by in

  9. Inspection of licensed nuclear power plants in the United States

    International Nuclear Information System (INIS)

    Thornburg, H. D.

    1977-01-01

    Inspection of licensed nuclear power plants in the United States is performed by the Office of Inspection and Enforcement (IE), United States Nuclear Regulatory Commission. IE has several key functions : a) Inspection of licensees and investigation of incidents, occurrences and allegations. b) Detection and correction of safety and security problems. c) Enforcement of rules, regulations, and Commission orders. d) Feedback to the industry and others regarding safety experience. e) Informing the public and others. Major enforcement actions and events involving operating power reactors for the past several years will be summarized. (author)

  10. Fully Employing Software Inspections Data

    Science.gov (United States)

    Shull, Forrest; Feldmann, Raimund L.; Seaman, Carolyn; Regardie, Myrna; Godfrey, Sally

    2009-01-01

    Software inspections provide a proven approach to quality assurance for software products of all kinds, including requirements, design, code, test plans, among others. Common to all inspections is the aim of finding and fixing defects as early as possible, and thereby providing cost savings by minimizing the amount of rework necessary later in the lifecycle. Measurement data, such as the number and type of found defects and the effort spent by the inspection team, provide not only direct feedback about the software product to the project team but are also valuable for process improvement activities. In this paper, we discuss NASA's use of software inspections and the rich set of data that has resulted. In particular, we present results from analysis of inspection data that illustrate the benefits of fully utilizing that data for process improvement at several levels. Examining such data across multiple inspections or projects allows team members to monitor and trigger cross project improvements. Such improvements may focus on the software development processes of the whole organization as well as improvements to the applied inspection process itself.

  11. An Intelligent Computerized Stretch Reflex Measurement System For Clinical And Investigative Neurology

    Science.gov (United States)

    Flanagan, P. M.; Chutkow, J. G.; Riggs, M. T.; Cristiano, V. D.

    1987-05-01

    We describe the design of a reliable, user-friendly preprototype system for quantifying the tendon stretch reflexes in humans and large mammals. A hand-held, instrumented reflex gun, the impactor of which contains a single force sensor, interfaces with a computer. The resulting test system can deliver sequences of reproducible stimuli at graded intensities and adjustable durations to a muscle's tendon ("tendon taps"), measure the impacting force of each tap, and record the subsequent reflex muscle contraction from the same tendon -- all automatically. The parameters of the reflex muscle contraction include latency; mechanical threshold; and peak time, peak magnitude, and settling time. The results of clinical tests presented in this paper illustrate the system's potential usefulness in detecting neurologic dysfunction affecting the tendon stretch reflexes, in documenting the course of neurologic illnesses and their response to therapy, and in clinical and laboratory neurologic research.

  12. Advanced ultrasonic inspections

    International Nuclear Information System (INIS)

    Ghia, S.

    1990-08-01

    Acoustic Emission (AE) continuous monitoring and periodical inspections by advanced ultrasonic have been applied to evaluate defect evolution within a PWR reduced scale (1:5) pressure vessel subjected to cyclic mechanical fatigue test. This experimental activity has been carried out in the frame of the Primary Circuit Component Life Prediction programme. In the time period covered by this report actions were performed as following: (1) Ultrasonic examination by multifrequency acoustic holography to evaluate defect evolution subsequently repair and heat treatment of the R2 vessel carried out in March 1988. For the purpose, measurements were performed both at 0 and 200 bar of internal pressure. As uniformity of the procedures adopted, for calibration and testing, made the results comparable with the previous ones no evidence for significant growing of the examined defects has been found. (2) Acoustic emission monitoring has then been carried out during fatigue test from 416000 to 565000 fatigue cycles. Analysis of a large amount of data has been performed paying particular attention to the distinction between friction phenomena and crack growth in order to obtain a correct diagnosis of flaw evolution. The signal duration distribution and the correlation of AE appearance time versus load cycle phase were considered to characterise stick-slip processes. A general intensification of AE activity has been recorded during this last period of monitoring and previous known AE sources were confirmed together with the appearance of new AE sources some of them correlable with real defects

  13. Disc pathology after whiplash injury. A prospective magnetic resonance imaging and clinical investigation.

    Science.gov (United States)

    Pettersson, K; Hildingsson, C; Toolanen, G; Fagerlund, M; Björnebrink, J

    1997-02-01

    This study was used to evaluate the relationship between magnetic resonance imaging findings and clinical findings after whiplash injury. To identify initial soft-tissue damage after whiplash injury, the development of disc pathology, and the relationship of disc pathology to clinical findings. Although a few studies have reported pathological magnetic resonance imaging findings after whiplash injuries, there is no prospective study published to our knowledge. Thirty-nine patients, 20 women and 19 men with a mean age of 32 years, were treated for whiplash injury. Magnetic resonance imaging and clinical examination were performed in a blinded manner at a mean of 11 days after trauma. The procedure was repeated at a 2-year follow-up visit. Two patients could not be examined with the second magnetic resonance imaging because of claustrophobia and pregnancy, respectively. The authors found 13 patients (33%) with disc herniations with medullary (six cases) or dura (seven cases) impingement over the 2-year follow-up period. At the follow-up examination all patients with medullary impingement had persistent or increased symptoms, and three of 27 patients (11%) with no or slight changes on magnetic resonance imaging had persistent symptoms. No ligament injuries were diagnosed. Although disc pathology seems to be one contributing factor in the development of chronic symptoms after whiplash injury, it may be unnecessary to examine these patients in the acute phase with magnetic resonance imaging; correlating initial symptoms and signs to magnetic resonance imaging findings is difficult because of the relatively high proportion of false-positive results. Magnetic resonance imaging is indicated later in the course of treatment in patients with persistent arm pain, neurologic deficits or clinical signs of nerve root compression to diagnose disc herniations requiring surgery.

  14. Preclinical and clinical investigation of the efficacy of “burst ketamine” for chronic pain

    OpenAIRE

    Mak, Plato

    2017-01-01

    For over a decade, many clinics have offered multiday infusions of ketamine in conjunction with opioids as an off-label treatment for intractable chronic pain. Originally termed “burst ketamine” (BK), the proposed therapeutic effects of this treatment are to (1) provide lasting pain relief otherwise unattainable with standard pharmacotherapy, and (2) reduce opioid tolerance and thereby improve analgesic opioid response (i.e. an opioid dose-sparing effect). Although the use of BK is incre...

  15. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1986,

    Science.gov (United States)

    1986-10-01

    sure tracings and the presence or absence of a clinically signif- icant patent ductus arteriosus (PDA) in the neonate and to deter- *? mine if there is...Neck Surg 94:47-55, 1986. Fiore AC, Ivey TO, Misbacli GA, McKeown P, Allen M, Dillard D): Patch Closure of Aortic Annulus Mycotic Aneurysms. Ann Thoracic...Apr 86. Carter PL: Surgery of Morbid obesity. Tacoma Surgical Club, Tacoma, WA, Apr 86. Carter PL, Deyo GA: Pitfalls in Delayed Primary Closure . Ann

  16. From PISC to risk informed inspection

    International Nuclear Information System (INIS)

    Crutzen, S.; Lemaitre, P.; Fabbri, L.

    1998-01-01

    In this paper the correlation between inspection effectiveness, inspection qualification and risk informed inspection will be treated in view of harmonisation of inspection of nuclear plant components. Through the different phases of the PISC programme the necessity has been demonstrated to show the effectiveness of the inspection through a formal process of qualification in order to ensure that a certain level of effectiveness has been reached. Inspection qualification is indeed the way to quantify the capability level of inspection techniques used. The targets to be met by the inspection is information which should be obtained from risk based analyses. (author)

  17. Decisions to withhold diagnostic investigations in nursing home patients with a clinical suspicion of venous thromboembolism.

    Directory of Open Access Journals (Sweden)

    Henrike J Schouten

    Full Text Available This study aimed to gather insights in physicians' considerations for decisions to either refer for- or to withhold additional diagnostic investigations in nursing home patients with a suspicion of venous thromboembolism.Our study was nested in an observational study on diagnostic strategies for suspected venous thromboembolism in nursing home patients. Patient characteristics, bleeding-complications and mortality were related to the decision to withhold investigations. For a better understanding of the physicians' decisions, 21 individual face-to-face in-depth interviews were performed and analysed using the grounded theory approach.Referal for additional diagnostic investigations was forgone in 126/322 (39.1% patients with an indication for diagnostic work-up. 'Blind' anticoagulant treatment was initiated in 95 (75.4% of these patients. The 3 month mortality rates were higher for patients in whom investigations were withheld than in the referred patients, irrespective of anticoagulant treatment (odds ratio 2.45; 95% confidence interval 1.40 to 4.29 but when adjusted for the probability of being referred (i.e. the propensity score, there was no relation of non-diagnosis decisions to mortality (odds ratio 1.75; 0.98 to 3.11. In their decisions to forgo diagnostic investigations, physicians incorporated the estimated relative impact of the potential disease; the potential net-benefits of diagnostic investigations and whether performing investigations agreed with established management goals in advance care planning.Referral for additional diagnostic investigations is withheld in almost 40% of Dutch nursing home patients with suspected venous thromboembolism and an indication for diagnostic work-up. We propose that, given the complexity of these decisions and the uncertainty regarding their indirect effects on patient outcome, more attention should be focused on the decision to either use or withhold additional diagnostic tests.

  18. Investigation of clinical and histopathological effects of Rofecoxib after surgical trauma of the gum in rabbit

    Directory of Open Access Journals (Sweden)

    Ali Rezaie

    2007-05-01

    Full Text Available In this study, clinical and histopathological effects of Rofecoxib, which is usually used in surgery as an analgesic and anti inflammatory drug is evaluated on the process of healing following surgical trauma. 15 New Zealand white rabbits with the same condition were selected and after numbering, divided to three different groups so that there were 5 rabbits per group. Then in each group after anesthesia  with Xylazine and Ketamine a circular surgical trauma was created in the right lateral region of mandible using punch biopsy and after 12 days, clinical and histopathological effects of treatment with low dose (6 mg/kg/day and high dose (12 mg/kg/day Rofecoxib was compared with control group that received placebo. It was evident that use of this drug had positive effects on healing which was obvious from clinical findings and comparison of photomicrographs of the healing site in both low dose and high dose treatment groups compared with control group. Also it was determined that use of high dose of Rofecoxib had better effects on healing process compared to low dose of this drug.

  19. Investigation of ultra low-dose scans in the context of quantum-counting clinical CT

    Science.gov (United States)

    Weidinger, T.; Buzug, T. M.; Flohr, T.; Fung, G. S. K.; Kappler, S.; Stierstorfer, K.; Tsui, B. M. W.

    2012-03-01

    In clinical computed tomography (CT), images from patient examinations taken with conventional scanners exhibit noise characteristics governed by electronics noise, when scanning strongly attenuating obese patients or with an ultra-low X-ray dose. Unlike CT systems based on energy integrating detectors, a system with a quantum counting detector does not suffer from this drawback. Instead, the noise from the electronics mainly affects the spectral resolution of these detectors. Therefore, it does not contribute to the image noise in spectrally non-resolved CT images. This promises improved image quality due to image noise reduction in scans obtained from clinical CT examinations with lowest X-ray tube currents or obese patients. To quantify the benefits of quantum counting detectors in clinical CT we have carried out an extensive simulation study of the complete scanning and reconstruction process for both kinds of detectors. The simulation chain encompasses modeling of the X-ray source, beam attenuation in the patient, and calculation of the detector response. Moreover, in each case the subsequent image preprocessing and reconstruction is modeled as well. The simulation-based, theoretical evaluation is validated by experiments with a novel prototype quantum counting system and a Siemens Definition Flash scanner with a conventional energy integrating CT detector. We demonstrate and quantify the improvement from image noise reduction achievable with quantum counting techniques in CT examinations with ultra-low X-ray dose and strong attenuation.

  20. An Investigation of Job Stress and Job Burnout in Iranian Clinical Pharmacist

    Directory of Open Access Journals (Sweden)

    Armaghan Eslami

    2016-05-01

    Full Text Available Background: Stress is an important element of organization ineffectiveness and since it leads to sickness, eventually it reduces quality and quantity of health care, lead to expansion of it costs and low job satisfaction. Stress comes along with consequences, one of this reactions which comes along with horrible effects is job burnout. Health care are more exposed for job burnout. We examined the relationship between job stress and job burnout in Iranian clinical pharmacist.Methods: Sample was 50 of men and women of clinical pharmacist. Parker and De cotiis  scale (1983 and Maslach Burnout Inventory (MBI, 1981 were used to asses clinical pharmacist stress and burnout. Data were analyzed by applying regression method.Results: Results indicated that there is strong relationship between stress and burnout and its three dimensions. The result also indicated that stress have the highest impact on emotional exhaustion and the least on the depersonalization.Conclusion: Burnout is a result of stress in human services career. Human service needs are vary from other professions since in these jobs in order to fulfill the clients’ needs, employees should use themselves as the required technology, and in return they do not receive gratitude or appreciation.

  1. Investigation on physiological and clinical effects of different light sources in TMJ photobiomodulation therapy

    Science.gov (United States)

    Kamenoff, J.

    2017-02-01

    Introduction Laser light Electromagnetic energy has some typical properties for discussions on laser irradiation abilities to control the acute and chronic disorders in TMJ. Material and Methods During the last six years we have been completed well controlled clinical trials based on the criteria of the American Academy of orofacial pain. The study over the 600 patients (300 women and 300 men), mean age of 47 years have been developed. Patients have been selected on the main clinical sign of TMJ pain and have been divided into four main groups according to the type of PDT method. Based on the action spectra, various wavelengths have been used for TMJ Photodynamic Therapy. Constant dose and time of exposition, as well as various range of frequencies have been applied. In this way the Laser biostimulation response has been directly proportional to the total energy dose, depending of light intensity. Physiological and clinical effects of the followed "active regions"- 660 - 680, 760 - 780, 810 - 830 and 904 - 987 nm have been valued by method of comparative analysis. Methods applied: LLLT - TENS - red surface laser acupuncture (LA), PIPBM - LA, Laser bioenergetics approach, Complex therapeutic program (CTP). Results evaluation will be demonstrated by comparative digital ortopantomograph analysis, EEG brain maps, VAS, a metric analysis of the level of the maximum active Mandible opening and EPST through electrophysiological signal evaluation of the patient's body.

  2. Plant inspection and maintenance technology

    International Nuclear Information System (INIS)

    Miyahara, Masatoshi; Kanazawa, Masafumi

    1995-01-01

    The article reports on information systems and related tools that support routine inspection and preventive maintenance activities, which contribute to safer plant operation and increase plant operating duty. Tools include the Mitsubishi Electric Reliability and Availability Upgrade Program-Nuclear (MELRAP-N), which supports the general evolution of industry operating experiences, periodic component replacement management, management of discontinued and modified components, periodic inspection item management, and periodic inspection workplace management. The article also introduces a comprehensive preventive maintenance management system currently under development. (author)

  3. Non-destructive inservice inspections

    International Nuclear Information System (INIS)

    Kauppinen, P.; Sarkimo, M.; Lahdenperae, K.

    1998-01-01

    In order to assess the possible damages occurring in the components and structures of operating nuclear power plants during service the main components and structures are periodically inspected by non-destructive testing techniques. The reliability of non-destructive testing techniques applied in these inservice inspections is of major importance because the decisions concerning the needs for repair of components are mainly based on the results of inspections. One of the targets of this research program has been to improve the reliability of non-destructive testing. This has been addressed in the sub-projects which are briefly summarised here. (author)

  4. Radionuclide investigations in clinical cardiology - 10 years of cooperation in Frankfurt/FRG

    International Nuclear Information System (INIS)

    Klepzig, H. Jr.; Kaltenbach, M.

    1989-01-01

    Radionuclide investigations today are an important tool in cardiology. They close the diagnostic gap in cases where non-invasive procedures of cardiological diagnosis such as ecg, exercise-ecg, echocardiography and chest-x-ray remains unrevealing. Further, they are helpful when an exact quantitation of the disease or a precise follow-up is required. Radionuclide techniques are very useful to detect myocardial ischemia in patients with coronary heart disease and to judge myocardial function in patients with aortic or mitral regurgitation. Follow-up investigations after therapy (aortocoronary bypass, PTCA, valve replacement) permit conclusions regarding the benefit of these measures. Results of radionuclide investigations should consider the Bayes' theorem in order to keep false-negative and false-positive reports as low as possible. (orig.) [de

  5. Inspection technology for high pressure pipes

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Jae H.; Lee, Jae C.; Eum, Heung S.; Choi, Yu R.; Moon, Soon S.; Jang, Jong H

    2000-02-01

    Various kinds of defects are likely to be occurred in the welds of high pressure pipes in nuclear power plants. Considering the recent accident of Zuruga nuclear power plant in Japan, reasonable policy is strongly requested for the high pressure pipe integrity. In this study, we developed the technologies to inspect pipe welds automatically. After development of scanning robot prototype in the first research year, we developed and implemented the algorithm of automatic tracking of the scanning robot along the weld line of the pipes. We use laser slit beam on weld area and capture the image using digital camera. Through processing of the captures image, we finally determine the weld line automatically. In addition, we investigated a new technology on micro systems for developing micro scanning robotic inspection of the pipe welds. The technology developed in this study is being transferred to the industry. (author)

  6. Investigation of blended learning video resources to teach health students clinical skills: An integrative review.

    Science.gov (United States)

    Coyne, Elisabeth; Rands, Hazel; Frommolt, Valda; Kain, Victoria; Plugge, Melanie; Mitchell, Marion

    2018-04-01

    The aim of this review is to inform future educational strategies by synthesising research related to blended learning resources using simulation videos to teach clinical skills for health students. An integrative review methodology was used to allow for the combination of diverse research methods to better understand the research topic. This review was guided by the framework described by Whittemore and Knafl (2005), DATA SOURCES: Systematic search of the following databases was conducted in consultation with a librarian using the following databases: SCOPUS, MEDLINE, COCHRANE, PsycINFO databases. Keywords and MeSH terms: clinical skills, nursing, health, student, blended learning, video, simulation and teaching. Data extracted from the studies included author, year, aims, design, sample, skill taught, outcome measures and findings. After screening the articles, extracting project data and completing summary tables, critical appraisal of the projects was completed using the Mixed Methods Appraisal Tool (MMAT). Ten articles met all the inclusion criteria and were included in this review. The MMAT scores varied from 50% to 100%. Thematic analysis was undertaken and we identified the following three themes: linking theory to practice, autonomy of learning and challenges of developing a blended learning model. Blended learning allowed for different student learning styles, repeated viewing, and enabled links between theory and practice. The video presentation needed to be realistic and culturally appropriate and this required both time and resources to create. A blended learning model, which incorporates video-assisted online resources, may be a useful tool to teach clinical skills to students of health including nursing. Blended learning not only increases students' knowledge and skills, but is often preferred by students due to its flexibility. Copyright © 2018 Elsevier Ltd. All rights reserved.

  7. Zirconia Dental Implants: Investigation of Clinical Parameters, Patient Satisfaction, and Microbial Contamination.

    Science.gov (United States)

    Holländer, Jens; Lorenz, Jonas; Stübinger, Stefan; Hölscher, Werner; Heidemann, Detlef; Ghanaati, Shahram; Sader, Robert

    2016-01-01

    In recent years, dental implants made from zirconia have been further developed and are considered a reliable treatment method for replacing missing teeth. The aim of this study was to analyze dental implants made from zirconia regarding their clinical performance compared with natural teeth (control). One hundred six zirconia implants in 38 adults were analyzed in a clinical study after 1 year of loading. The plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD), probing attachment level (PAL), and creeping or recession (CR/REC) of the gingiva were detected and compared with natural control teeth (CT). Furthermore, the papilla index (PAP), Periotest values (PTV), microbial colonization of the implant/dental sulcus fluid, and patient satisfaction were assessed. The survival rate was 100%. No statistical significance was observed between implants and teeth regarding BOP, PPD, and PAL. A statistical significance was detected regarding PI and CR/REC with significantly less plaque accumulation and recession in the study group. Mean PAP was 1.76 ± 0.55, whereas the mean PTV was -1.31 ± 2.24 (range from -5 to +6). A non-statistically significant higher colonization of periodontitis/peri-implantitis bacteria was observed in the implant group. The questionnaire showed that the majority of the patients were satisfied with the overall treatment. One-piece zirconia dental implants exhibited similar clinical results (BOP, PPD, and PAL) compared with natural teeth in regard to adhesion of plaque (PI) and creeping attachment (CR/REC); zirconia implants performed even better. The favorable results for PAL and CR/REC reflect the comparable low affinity of zirconia for plaque adhesion. Patient satisfaction indicated a high level of acceptance for zirconia implants. However, a long-term follow-up is needed to support these findings.

  8. IMAGe syndrome: clinical and genetic implications based on investigations in three Japanese patients.

    Science.gov (United States)

    Kato, Fumiko; Hamajima, Takashi; Hasegawa, Tomonobu; Amano, Naoko; Horikawa, Reiko; Nishimura, Gen; Nakashima, Shinichi; Fuke, Tomoko; Sano, Shinichirou; Fukami, Maki; Ogata, Tsutomu

    2014-05-01

    Arboleda et al. have recently shown that IMAGe (intra-uterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita and genital abnormalities) syndrome is caused by gain-of-function mutations of maternally expressed gene CDKN1C on chromosome 11p15.5. However, there is no other report describing clinical findings in patients with molecularly studied IMAGe syndrome. Here, we report clinical and molecular findings in Japanese patients. We studied a 46,XX patient aged 8·5 years (case 1) and two 46,XY patients aged 16·5 and 15·0 years (cases 2 and 3). Clinical studies revealed not only IMAGe syndrome-compatible phenotypes in cases 1-3, but also hitherto undescribed findings including relative macrocephaly and apparently normal pituitary-gonadal endocrine function in cases 1-3, familial glucocorticoid deficiency (FGD)-like adrenal phenotype and the history of oligohydramnios in case 2, and arachnodactyly in case 3. Sequence analysis of CDKN1C, pyrosequencing-based methylation analysis of KvDMR1 and high-density oligonucleotide array comparative genome hybridization analysis for chromosome 11p15.5 were performed, showing an identical de novo and maternally inherited CDKN1C gain-of-function mutation (p.Asp274Asn) in cases 1 and 2, respectively, and no demonstrable abnormality in case 3. The results of cases 1 and 2 with CDKN1C mutation would argue the following: [1] relative macrocephaly is consistent with maternal expression of CDKN1C in most tissues and biparental expression of CDKN1C in the foetal brain; [2] FGD-like phenotype can result from CDKN1C mutation; and [3] genital abnormalities may primarily be ascribed to placental dysfunction. Furthermore, lack of CDKN1C mutation in case 3 implies genetic heterogeneity in IMAGe syndrome. © 2013 John Wiley & Sons Ltd.

  9. Blood stream infections caused by Acinetobacter baumannii group in Japan - Epidemiological and clinical investigation.

    Science.gov (United States)

    Fujikura, Yuji; Yuki, Atsushi; Hamamoto, Takaaki; Kawana, Akihiko; Ohkusu, Kiyofumi; Matsumoto, Tetsuya

    2016-06-01

    Acinetobacter calcoaceticus-Acinetobacter baumannii complex, especially A. baumannii, Acinetobacter pittii and Acinetobacter nosocomialis, constitutes an important group of nosocomial pathogens; however, epidemiological or clinical characteristics and prognosis is limited in Japan. From 2009 to 2013, 47 blood stream infection cases resulting from A. baumannii group were reviewed at the National Defense Medical College, an 800-bed tertiary hospital. To determine the genospecies, further comparative nucleotide sequence analyses of the RNA polymerase b-subunit (rpoB) gene were performed. Sequence analysis of rpoB gene showed that 25 (49.0%), 17 (33.3%) and 5 (9.8%) cases were caused by A. baumannii, A. pittii and A. nosocomialis, respectively. The 30-day and in-hospital mortality rates of A. baumannii were 8.5% and 25.5%, respectively, and there were no significant differences between Acinetobacter species. Clinical characteristics were statistically insignificant. Multidrug-resistant Acinetobacter species were detected in 3 cases (5.9%) with same pulsed-field gel electrophoresis (PFGE) pattern and A. baumannii was less susceptible to amikacin and levofloxacin. In this study, the mortality and clinical characteristics were similar among A. baumannii group isolate cases despite some showing drug resistance. However, identification of Acinetobacter species helps to initiate appropriate antibiotic therapy in earlier treatment phase, because A. baumannii shows some drug resistance. Copyright © 2016 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  10. Automated radiosynthesis of [{sup 11}C]morphine for clinical investigation

    Energy Technology Data Exchange (ETDEWEB)

    Fan Jinda [Department of Radiology, Washington University School of Medicine, 510 South Kingshighway Blvd. St. Louis, MO 63110 (United States); Meissner, Konrad [Department of Anesthesiology, Washington University School of Medicine, 510 South Kingshighway Blvd. St. Louis, MO 63110 (United States); Gaehle, Gregory G.; Li Shihong [Department of Radiology, Washington University School of Medicine, 510 South Kingshighway Blvd. St. Louis, MO 63110 (United States); Kharasch, Evan D. [Department of Anesthesiology, Washington University School of Medicine, 510 South Kingshighway Blvd. St. Louis, MO 63110 (United States); Mach, Robert H. [Department of Radiology, Washington University School of Medicine, 510 South Kingshighway Blvd. St. Louis, MO 63110 (United States); Tu Zhude, E-mail: tuz@mir.wustl.ed [Department of Radiology, Washington University School of Medicine, 510 South Kingshighway Blvd. St. Louis, MO 63110 (United States)

    2011-02-15

    To meet a multiple-dose clinical evaluation of the P-gp modulation of [{sup 11}C]morphine delivery into the human brain, radiosynthesis of [{sup 11}C]morphine was accomplished on an automated system by N-methylation of normorphine with [{sup 11}C]CH{sub 3}I. A methodology employing optimized solid phase extraction of the HPLC eluent was developed. Radiosynthesis took 45 min with a radiochemical yield ranging from 45% to 50% and specific activity ranging from 20 to 26 Ci/{mu}mol (decay corrected to end-of-bombardment); radiochemical and chemical purities were >95% (n=28).

  11. Disc pathology after whiplash injury. A prospective magnetic resonance imaging and clinical investigation

    International Nuclear Information System (INIS)

    Pettersson, K.; Hildingsson, C.; Toolanen, G.; Fagerlund, M.; Bjornebrink, J.

    1997-01-01

    Although disc pathology seems to be one contributing factor in the development of chronic symptoms after whiplash injury, it may be unnecessary to examine these patients in the acute phase with magnetic resonance imaging ; correlating initial symptoms and signs to magnetic resonance imaging findings is difficult because of the relatively high proportion of false-positive results. Magnetic resonance imaging is indicated later in the course of treatment in patients with persistent arm pain, neurologic deficits, or clinical signs of nerve root compression to diagnose disc herniations requiring surgery. (authors)

  12. A novel robotic system for single-port urologic surgery: first clinical investigation.

    Science.gov (United States)

    Kaouk, Jihad H; Haber, Georges-Pascal; Autorino, Riccardo; Crouzet, Sebastien; Ouzzane, Adil; Flamand, Vincent; Villers, Arnauld

    2014-12-01

    The idea of performing a laparoscopic procedure through a single abdominal incision was conceived with the aim of expediting postoperative recovery. To determine the clinical feasibility and safety of single-port urologic procedures by using a novel robotic surgical system. This was a prospective institutional review board-approved, Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) phase 1 study. After enrollment, patients underwent a major urologic robotic single-port procedure over a 3-wk period in July 2010. The patients were followed for 3 yr postoperatively. Different types of urologic surgeries were performed using the da Vinci SP Surgical System. This system is intended to provide the same core clinical capabilities as the existing multiport da Vinci system, except that three articulating endoscopic instruments and an articulating endoscopic camera are inserted into the patient through a single robotic port. The main outcomes were the technical feasibility of the procedures (as measured by the rate of conversions) and the safety of the procedures (as measured by the incidence of perioperative complications). Secondary end points consisted of evaluating other key surgical perioperative outcomes as well as midterm functional and oncologic outcomes. A total of 19 patients were enrolled in the study. Eleven of them underwent radical prostatectomy; eight subjects underwent nephrectomy procedures (partial nephrectomy, four; radical nephrectomy, two; and simple nephrectomy, two). There were no conversions to alternative surgical approaches. Overall, two major (Clavien grade 3b) postoperative complications were observed in the radical prostatectomy group and none in the nephrectomy group. At 1-yr follow-up, one radical prostatectomy patient experienced biochemical recurrence, which was successfully treated with salvage radiation therapy. The median warm ischemia time for three of the partial nephrectomies was 38 min. At 3-yr follow-up all

  13. Clinical, biochemical and molecular investigations of three Taiwanese children with Laron syndrome.

    Science.gov (United States)

    Yang, Chen; Chen, Julia Yi-Ru; Lai, Chien-Cherng; Lin, Hsiu-Chen; Yeh, Geng-Chang; Hsu, Hsun-Hui

    2004-02-01

    Three children of two Taiwanese families were diagnosed with Laron syndrome, two sisters and one boy. Both sets of parents were consanguineous. Clinically, all three presented with the typical craniofacies of Laron syndrome, consisting of prominent forehead and hypoplastic nasal bridge, high-pitched voice, short stature, and central obesity. Biochemically, their levels of serum IGF-I were less than 5 microg/ml before and after an IGF-I generation test, and levels of IGFBP-3 were reduced in all three patients. Sequence analysis of the growth hormone receptor gene revealed that all three carried a homozygous missense D152G mutation in exon 6.

  14. Are exposure index values consistent in clinical practice? A multi-manufacturer investigation

    International Nuclear Information System (INIS)

    Butler, M. L.; Rainford, L.; Last, J.; Brennan, P. C.

    2010-01-01

    The advent of digital radiography poses the risk of unnoticed increases in patient dose. Manufacturers have responded to this by offering an exposure index (EI) value to the clinician. Whilst the EI value is a measure of the air kerma at the detector surface, it has been recommended by international agencies as a method of monitoring radiation dose to the patient. Recent studies by the group have shown that EI values are being used in clinical practice to monitor radiation dose and assess image quality. This study aims to compare the clinical consistency of the EI value in computed radiography (CR) and direct digital radiography (DR) systems. An anthropomorphic phantom was used to simulate four common radiographic examinations: skull, pelvis, chest and hand. These examinations were chosen as they provide contrasting exposure parameters, image detail and radiation dose measurements. Four manufacturers were used for comparison: Agfa Gaevert CR, Carestream CR, Philips Digital Diagnost DR and Siemens DR. For each examination, the phantom was placed in the optimal position and exposure parameters were chosen in accordance with European guidelines and clinical practice. Multiple exposures were taken and the EI recorded. All exposure parameters and clinical conditions remained constant throughout. For both DR systems, the EI values remained consistent throughout. No significant change was noted in any examination. In both CR systems, there were noteworthy fluctuations in the EI values for all examinations. The largest for the Agfa system was a variation of 1.88-2.21 for the skull examination. This represents to the clinician a doubling of detector dose, despite all exposure parameters remaining constant. In the Kodak system, the largest fluctuation was seen for the chest examination where the EI ranged from 2560 to 2660, representing approximately an increase of 30% in radiation dose, despite consistent parameters. The fluctuations seen with the CR systems are most likely

  15. Quality of clinical trials: A moving target

    Science.gov (United States)

    Bhatt, Arun

    2011-01-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

  16. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  17. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

    Science.gov (United States)

    Schulman, S; Angerås, U; Bergqvist, D; Eriksson, B; Lassen, M R; Fisher, W

    2010-01-01

    The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.

  18. Clinical Investigation and Treatment of Thyroid Disease with Radioactive Iodine (131I)

    International Nuclear Information System (INIS)

    Lee, Mun Ho; Koh, Chang Soon; Ro, Heung Kyu; Koo, In Seu; Suh, Whan Jo; Lee, Kyung Ja; Lee, Hong Kyu; Lee, Chung Sang

    1970-01-01

    A summary of the clinical data of the 131 I-thyroid function tests and the therapeutic results of 131 I among the 2,658 patients of various thyroid diseases treated over the past 10 years from May 1960 to Oct. 1969 at the Radioisotope Clinic and Laboratory, SNUH were presented and discussed. 1) The patients examined consisted of 929 cases (34.9%) of diffuse toxic goiter, 762 cases (28.7%) of diffuse nontoxic goiter, 699 cases (26.3%) of nodular nontoxic goiter, 58 cases (2.2%) of nodular toxic goiter and 210 cases (7.9%) of hypothyroidism. 2) There were 300 (11.4%) male and 2358 (88.6%) female, showing a ratio of 1 : 8. 3) The majority of patients (79.1%) were in the 3rd-5th decade of their lives. 3) The normal ranges, diagnostic values of 131 I uptake test, 48 hrs serum activity, BMR and main subjective symptoms of various thyroid diseases were discussed. 5) In the 579 patients among 867 cases with hyperthyroidism treated with 131 I, 47.8% were confirmed to be cured completely after single therapeutic doses. 6) The complications of 131 I therapy were discussed and myxedema had developed in 6.75% of our patients. 7) The results of 131 I thyroid function tests were analysed among the 160 cases of thyroid diseases which were confirmed the diagnosis with histopathological measures.

  19. Terbinafine hydrochloride nanovesicular gel: In vitro characterization, ex vivo permeation and clinical investigation.

    Science.gov (United States)

    AbdelSamie, Sara M; Kamel, Amany O; Sammour, Omaima A; Ibrahim, Shady M

    2016-06-10

    In this work, nanovesicular chitosan gels were prepared for dermal delivery of terbinafine hydrochloride (TBN HCl). Ethosomes and vesicles containing different types of penetration enhancers (PEs) viz. Terpenes (cineole and limonene), labrasol and transcutol were developed. The prepared vesicles were evaluated for physical characteristics as well as skin interaction. The selected vesicles were incorporated into chitosan gel. An in vivo animal study was done on rat induced superficial Candida infection model. Moreover, randomized double blind clinical study was done on patients to compare the effect of the selected nanovesicular gel against the market product. Results showed the formation of nearly spherical, mostly deformable vesicular systems with size range of 95.5-530nm, zeta potential range of -0.1 to 15mV and entrapment efficiency range of 20-96.7%. Penetration enhancer vesicles (PEVs) prepared with 4% limonene (ELI4) showed the highest percent of drug deposition in the skin (53%) and the highest local accumulation efficiency value (35.3). In vivo animal study showed that the lowest fungal burden produced with ELI4 chitosan gel. Clinical studies showed cure rate of 86% within 7days treatment in case of limonene nanovesicular gel compared to 20% for market product (Lamisil® cream). Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Interventional management of spine eosinophilic granuloma in children: preliminary investigation of its clinical value

    International Nuclear Information System (INIS)

    He Yu; Wu Chungen; Gu Yifeng; Cheng Yongde

    2011-01-01

    Objective: To assess the clinical value of interventional management in treating spine eosinophilic granuloma in children. Methods: Interventional therapies, including per cutaneous biopsy and percutaneous vertebroplasty (PVP), were carried out in three child patients with five pathologically-proved eosinophilic granuloma lesions, which were localized in the vertebrae. The clinical data were retrospectively analyzed. Visual analogue pain scale (VAS) and Oswesty disability index (ODI) were assessed before and after operation. Results: A total of four operations were successfully carried out in all of three patients. The mean VAS score reduced from 7 before treatment of 1 after treatment. The mean ODI decreased from preoperative 52.5% to postoperative 10.5%. During procedures no significant complications occurred except for cement leakage in some cases. Pain relief and daily activity were remarkably improved after treatment. All patients were followed up for 3 months to 5 years. Conclusion: For the treatment of spine eosinophilic granuloma in children, interventional techniques are mini-invasive, safe and effective therapeutic methods. (authors)

  1. Clinical and experimental investigation on small intestinal injury following radiation therapy for carcinoma of uterine cervix

    International Nuclear Information System (INIS)

    Asakura, Midori

    1977-01-01

    Radiation injury of the small bowel was observed in 6 of 460 patients with carcinoma of uterine cervix who were treated by radiation between April 1966 and December 1973 at Tokyo Women's Medical College, Department of Radiology. Three of these 6 patients were treated conservatively and the other 3 others underwent surgery but died subsequently. Clinically and surgically these 6 patients showed marked adhesions of intestinal loops, which may be accounted for by the radiation injury of the small bowel. Clinical experience has shown that it is necessary to use a small radiation field to decrease small bowel injury from radiation. An experiment using abdominal radiation in mice confirmed that LD sub(50/30) is larger with a center split, maintaining equal integral doses. In adult dogs, severe small bowel obstruction was observed with over 4000 rad irradiation. Small bowel injury was milder in case with center split, intracavitary irradiation, and small radiation field. It was concluded that center split is one of the methods of preventing radiation injury of the small bowel. (Evans, J.)

  2. Multifamily Housing Physical Inspection Scores

    Data.gov (United States)

    Department of Housing and Urban Development — HUD's Real Estate Assessment Center conducts physical property inspections of properties that are owned, insured or subsidized by HUD, including public housing and...

  3. Incore inspection and repairing device

    International Nuclear Information System (INIS)

    Ito, Arata; Kimura, Motohiko

    1998-01-01

    The present invention provides a device for inspecting and repairing the inside of a reactor container even if it is narrow, with no trouble by using a swimming-type operation robot. Namely, the device of the present invention conducts inspection and repairing operations for the inside of the reactor by introducing a swimming type operation robot into the reactor container. The swimming-type operation robot comprises a robot main body having a propeller, a balancer operably disposed to the robot main body and an inspection and repairing unit attached detachable to the balancer. In the device of the present invention, since the inspection and preparing unit is attached detachably to the swimming robot, a robot which transports tools is formed as a standard product. As a result, the production cost can be reduced, and the reliability of products can be improved. Appropriate operations can be conducted by using best tools. (I.S.)

  4. In-service inspection techniques

    International Nuclear Information System (INIS)

    Backfisch, W.; Zipser, R.R.

    1980-01-01

    The owner of a nuclear power plant (NPP) is obligated and interested to maintain - by regular maintenance and in-service inspections - the operational safety and availability of the plant for the subsequent operating period in a condition, as is specified as the basis of the erection and the last operational permits. In-service inspections are performed to verify the operational safety, and maintenance work is performed to guarantee the availability. Below, the typical in-service inspections of a light-water reactor NPP (operated on a pressurized-water reactor or on a boiling-water reactor) are described with details and examples of typical inspections, especially of recurrent performance tests of the systems. (orig./RW)

  5. Knowledge-Based Inspection Capabilities

    National Research Council Canada - National Science Library

    Marrano, Lance R; Grussing, Michael N

    2006-01-01

    ... does not present a compelling safety hazard. Abandoning certain inspection programs to reduce costs is not a viable alternative, however, because that could degrade real property investments, soldier quality of life, and mission-readiness...

  6. Construction inspection manual of procedures

    Science.gov (United States)

    2009-01-01

    This manual provides highway construction personnel with relevant, practical information in order to perform accurate inspections and provide relevant construction procedural information for the various roadway and structures items of work. It is the...

  7. National Automated Conformity Inspection Process -

    Data.gov (United States)

    Department of Transportation — The National Automated Conformity Inspection Process (NACIP) Application is intended to expedite the workflow process as it pertains to the FAA Form 81 0-10 Request...

  8. Public Housing Physical Inspection Scores

    Data.gov (United States)

    Department of Housing and Urban Development — HUD's Real Estate Assessment Center conducts physical property inspections of properties that are owned, insured or subsidized by HUD, including public housing and...

  9. Ultrasonic inspection of austenitic welds

    Energy Technology Data Exchange (ETDEWEB)

    Tomlinson, J R; Wagg, A R; Whittle, M J [N.D.T. Applications Centre, CEGB, Manchester (United Kingdom)

    1980-11-01

    The metallurgical structure of austenitic welds is described and contrasted with that found in ferritic welds. It is shown that this structure imparts a marked elastic anisotropy in the ultrasonic propagation parameters. Measurements of variations in the apparent attenuation of sound and deviations in the beam direction are described. The measurements are interpreted in terms of the measured velocity anisotropy. Two applications of the fundamental work are described. In the first it is shown how, by using short pulse compression wave probes, and with major modification of the welding procedure, a stainless steel fillet weld in an AGR boiler can be inspected. In the second application, alternative designs of a transition butt weld have been compared for ease of ultrasonic inspection. The effects of two different welding processes on such an inspection are described. Finally, the paper examines the prospects for future development of inspection and defect-sizing techniques for austenitic welds. (author)

  10. Sea bed mapping and inspection

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-07-01

    The conference has 24 presentations on the topics: Sea bed mapping, inspection, positioning, hydrography, marine archaeology, remote operation vehicles and computerized simulation technologies, oil field activities and plans, technological experiences and problems. (tk)

  11. The Effects of Sex Steroids on Spatial Performance: A Review and an Experimental Clinical Investigation.

    Science.gov (United States)

    Liben, Lynn S.; Susman, Elizabeth J.; Finkelstein, Jordan W.; Chinchilli, Vernon M.; Kunselman, Susan; Schwab, Jacqueline; Dubas, Judith Semon; Demers, Laurence M.; Lookingbill, Georgia; D'Arcangelo, M. Rose; Krogh, Holleen R.; Kulin, Howard E.

    2002-01-01

    Investigated the relationship between sex hormones and spatial performance among adolescents treated with sex steroids for delayed puberty. Found that spatial performance varied according to gender but did not vary with levels of actively circulating sex steroids. Reviewed physiological mechanisms, developmental periods, and past empirical work…

  12. 75 FR 31794 - Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked...

    Science.gov (United States)

    2010-06-04

    ... various blocks within the form, and when the form might need to be updated. In addition, we clarify... outside the United States that may or may not be under an investigational new drug application. This... guidance represents the agency's current thinking on completing the Form FDA 1572. It does not create or...

  13. Clinical FDG PET CT in the Investigation of Suspected Inflammatory and Infective Conditions

    DEFF Research Database (Denmark)

    Lorenz, Eleanor; Wig, Surabhi; Prakash, Vineet

    scanning after multiple diagnostic investigations failed to determine a diagnosis.                   RESULTS          PET CT was useful in all 59 cases; revealing malignancy in 11 (2 of whom had associated myositis), systemic vasculitis in 9, inflammatory arthropathy in 5, infectious/other inflammatory...

  14. Investigating the mobilome in clinically important lineages of Enterococcus faecium and Enterococcus faecalis

    NARCIS (Netherlands)

    Mikalsen, Theresa; Pedersen, Torunn; Willems, Rob; Coque, Teresa M; Werner, Guido; Sadowy, Ewa; van Schaik, Willem; Jensen, Lars Bogø; Sundsfjord, Arnfinn; Hegstad, Kristin

    2015-01-01

    BACKGROUND: The success of Enterococcus faecium and E. faecalis evolving as multi-resistant nosocomial pathogens is associated with their ability to acquire and share adaptive traits, including antimicrobial resistance genes encoded by mobile genetic elements (MGEs). Here, we investigate this

  15. Investigating the mobilome in clinically important lineages of Enterococcus faecium and Enterococcus faecalis

    DEFF Research Database (Denmark)

    Mikalsen, Theresa; Pedersen, Torunn; Willems, Rob

    2015-01-01

    Background: The success of Enterococcus faecium and E. faecalis evolving as multi-resistant nosocomial pathogens is associated with their ability to acquire and share adaptive traits, including antimicrobial resistance genes encoded by mobile genetic elements (MGEs). Here, we investigate this mob...

  16. Assessing the Effectiveness of Parent-Child Interaction Therapy with Language Delayed Children: A Clinical Investigation

    Science.gov (United States)

    Falkus, Gila; Tilley, Ciara; Thomas, Catherine; Hockey, Hannah; Kennedy, Anna; Arnold, Tina; Thorburn, Blair; Jones, Katie; Patel, Bhavika; Pimenta, Claire; Shah, Rena; Tweedie, Fiona; O'Brien, Felicity; Leahy, Ruth; Pring, Tim

    2016-01-01

    Parent-child interaction therapy (PCIT) is widely used by speech and language therapists to improve the interactions between children with delayed language development and their parents/carers. Despite favourable reports of the therapy from clinicians, little evidence of its effectiveness is available. We investigated the effects of PCIT as…

  17. Investigating factors determining the use of the clinical care module by nurses through the UTAUT model

    CSIR Research Space (South Africa)

    Zhou, M

    2016-08-22

    Full Text Available Nurses can be empowered in the decision making process if provided with objective diagnostic data. This research applied the Unified Theory of Acceptance and Use of Technology model to investigate the usage of electronic health systems and analyse...

  18. Gravity Probe B Inspection

    Science.gov (United States)

    2000-01-01

    The space vehicle Gravity Probe B (GP-B) is the relativity experiment developed at Stanford University to test two extraordinary predictions of Albert Einstein's general theory of relativity. The experiment will measure, very precisely, the expected tiny changes in the direction of the spin axes of four gyroscopes contained in an Earth-orbiting satellite at a 400-mile altitude. So free are the gyroscopes from disturbance that they will provide an almost perfect space-time reference system. They will measure how space and time are very slightly warped by the presence of the Earth, and, more profoundly, how the Earth's rotation very slightly drags space-time around with it. These effects, though small for the Earth, have far-reaching implications for the nature of matter and the structure of the Universe. GP-B is among the most thoroughly researched programs ever undertaken by NASA. This is the story of a scientific quest in which physicists and engineers have collaborated closely over many years. Inspired by their quest, they have invented a whole range of technologies that are already enlivening other branches of science and engineering. In this photograph, engineer Gary Reynolds is inspecting the inside of the probe neck during probe thermal repairs. GP-B is scheduled for launch in April 2004 and managed for NASA by the Marshall Space Flight Center. Development of the GP-B is the responsibility of Stanford University along with major subcontractor Lockheed Martin Corporation. (Image credit to Russ Leese, Gravity Probe B, Stanford University)

  19. Clinical and neurophysiological investigation of a large family with dominant Charcot-Marie-Tooth type 2 disease with pyramidal signs

    Directory of Open Access Journals (Sweden)

    Eduardo Luis de Aquino Neves

    2011-06-01

    Full Text Available Charcot-Marie-Tooth (CMT disease is a hereditary neuropathy of motor and sensory impairment with distal predominance. Atrophy and weakness of lower limbs are the first signs of the disease. It can be classified, with the aid of electromyography and nerve conduction studies, as demyelinating (CMT1 or axonal (CMT2. OBJECTIVE: Clinical and neurophysiological investigation of a large multigenerational family with CMT2 with autosomal dominant mode of transmission. METHOD: Fifty individuals were evaluated and neurophysiological studies performed in 22 patients. RESULTS: Thirty individuals had clinical signs of motor-sensory neuropathy. Babinski sign was present in 14 individuals. Neurophysiological study showed motor-sensory axonal polyneuropathy. CONCLUSION: The clinical and neurophysiological characteristics of this family does not differ from those observed with other forms of CMT, except for the high prevalence of Babinski sign.

  20. Nuclear reactor vessel inspection apparatus

    International Nuclear Information System (INIS)

    Blackstone, E.G.; Lofy, R.A.; Williams, L.P.

    1979-01-01

    Apparatus for the in situ inspection of a nuclear reactor vessel to detect the location and character of flaws in the walls of the vessel, in the welds joining the various sections of the vessel, in the welds joining attachments such as nozzles, elbows and the like to the reactor vessel and in such attachments wherein an inspection head carrying one or more ultrasonic transducers follows predetermined paths in scanning the various reactor sections, welds and attachments

  1. Austenitic stainless steel weld inspection

    International Nuclear Information System (INIS)

    Mech, S.J.; Emmons, J.S.; Michaels, T.E.

    1978-01-01

    Analytical techniques applied to ultrasonic waveforms obtained from inspection of austenitic stainless steel welds are described. Experimental results obtained from a variety of geometric and defect reflectors are presented. Specifically, frequency analyses parameters, such as simple moments of the power spectrum, cross-correlation techniques, and adaptive learning network analysis, all represent improvements over conventional time domain analysis of ultrasonic waveforms. Results for each of these methods are presented, and the overall inspection difficulties of austenitic stainless steel welds are discussed

  2. Automated visual inspection of textile

    DEFF Research Database (Denmark)

    Jensen, Rune Fisker; Carstensen, Jens Michael

    1997-01-01

    A method for automated inspection of two types of textile is presented. The goal of the inspection is to determine defects in the textile. A prototype is constructed for simulating the textile production line. At the prototype the images of the textile are acquired by a high speed line scan camera...... the protype to a production line system we only need to gain a speed factor of 4....

  3. Radiochemistry, pre-clinical studies and first clinical investigation of 90Y-labeled hydroxyapatite (HA) particles prepared utilizing 90Y produced by (n,γ) route

    International Nuclear Information System (INIS)

    Vimalnath, K.V.; Chakraborty, Sudipta; Rajeswari, A.; Sarma, H.D.; Nuwad, Jitendra; Pandey, Usha; Kamaleshwaran, K.; Shinto, Ajit; Dash, Ashutosh

    2015-01-01

    Introduction: The scope of using no carrier added (NCA) 90 Y [T 1/2 = 64.1 h, E β(max) = 2.28 MeV] obtained from 90 Sr/ 90 Y generator in radiation synovectomy (RSV) is widely accepted. In the present study, the prospect of using 90 Y produced by (n,γ) route in a medium flux research reactor for use in RSV was explored. Methods: Yttrium-90 was produced by thermal neutron irradiation of Y 2 O 3 target at a neutron flux of ~ 1 × 10 14 n/cm 2 .s for 14 d. The influence of various experimental parameters were systematically investigated and optimized to arrive at the most favorable conditions for the formulation of 90 Y labeled hydroxyapatite (HA) using HA particles of 1–10 μm size range. An optimized kit formulation strategy was developed for convenient one-step compounding of 90 Y-HA, which is easily adaptable at hospital radiopharmacy. The pre-clinical biological evaluation of 90 Y-HA particles was studied by carrying out biodistribution and bioluminiscence imaging studies in Wistar rats. The first clinical investigation using the radiolabeled preparation was performed on a patient suffering from chronic arthritis in knee joint by administering 185 MBq 90 Y-HA formulated at the hospital radiopharmacy deploying the proposed strategy. Results: Yttrium-90 was produced with a specific activity of 851 ± 111 MBq/mg and radionuclidic purity of 99.95 ± 0.02%. 90 Y-labeled HA particles (185 ± 10 MBq doses) were formulated in high radiochemical purity (> 99%) and excellent in vitro stability. The preparation showed promising results in pre-clinical studies carried out in Wistar rats. The preliminary results of the first clinical investigation of 90 Y-HA preparation in a patient with rheumatoid arthritis in knee joints demonstrated the effectiveness of the formulation prepared using 90 Y produced via (n,γ) route in the management of the disease. Conclusion: The studies revealed that effective utilization of 90 Y produced via (n,γ) route in a medium flux research

  4. Ultrasonic inspection of inpile tubes

    International Nuclear Information System (INIS)

    Boyd, D.M.; Bossi, H.

    1985-01-01

    The in-service inspection (ISI) of inpile tubes can be performed accurately and safely with a semiautomatic ultrasonic inspection system. The ultrasonic technique uses a set of multiple transducers to detect and size cracks, voids, and laminations radially and circumferentially. Welds are also inspected for defects. The system is designed to inspect stainless steel and Inconel tubes ranging from 53.8 mm (2.12 in.) to 101.6 mm (4 in.) inner diameter with wall thickness on the order of 5 mm. The inspection head contains seven transducers mounted in a surface-following device. Six angle-beam transducers generate shear waves in the tubes. Two of the six are oriented to detect circumferential cracks, and two detect axial cracks. Although each of these four transducers is used in the pulse-echo mode, they are oriented in aligned sets so pitch-catch operation is possible if desired. The remaining angle-beam transducers are angulated to detect flaws that are off axial or circumferential orientation. The seventh transducer is used for longitudinal inspection and detects and sizes laminar-type defects

  5. Is daily routine important for sleep? An investigation of social rhythms in a clinical insomnia population.

    Science.gov (United States)

    Moss, Taryn G; Carney, Colleen E; Haynes, Patricia; Harris, Andrea L

    2015-02-01

    Social rhythms, also known as daily routines (e.g. exercise, of school or work, recreation, social activities), have been identified as potential time cues to help to regulate the biological clock. Past research has shown links between regularity and healthy sleep. This study examined the regularity and frequency of daytime activities in a clinical insomnia population and a good sleeper comparison group. Participants (N = 69) prospectively monitored their sleep and daily activities for a 2-week period. Although participants with insomnia and good sleepers had similar levels of activity, relative to good sleepers, those with insomnia were less regular in their activities. Findings from this study add to the growing number of studies that highlight the relative importance of the regularity of daytime activities on sleep. Accordingly, future research should test treatment components that focus on regulating daytime activities, which would likely improve treatment outcomes.

  6. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

    DEFF Research Database (Denmark)

    Schulman, S; Angerås, U; Bergqvist, D

    2010-01-01

    subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used......The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its...... in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...

  7. Development and internal structure investigation of the Dimensional Clinical Personality Inventory

    Directory of Open Access Journals (Sweden)

    Lucas de Francisco Carvalho

    2015-06-01

    Full Text Available This study aimed to develop a dimensional instrument to assess personality disorders based on Millon's theoretical perspective and on DSM-IV-TR diagnoses criteria, and seek validity evidence based on internal structure and reliability indexes of the factors. In order to do that, a self-report test composed of 215 items, the Dimensional Clinical Personality Inventory (DCPI was developed and applied to 561 respondents aged between 18 and 90 years (M = 28,8; SD = 11.4, with 51.8% females. Exploratory factor analysis and verification of reliability were performed using Cronbach's alpha. Data provided validity evidence based on internal structure of the instrument according to the theory of Millon and DSM-IV-TR.

  8. Resorption behavior of a nanostructured bone substitute: in vitro investigation and clinical application.

    Science.gov (United States)

    Reichert, Christoph; Götz, Werner; Reimann, Susanne; Keilig, Ludger; Hagner, Martin; Bourauel, Christoph; Jäger, Andreas

    2013-03-01

    To develop an in vitro assay for quantitative analysis of the degradation to which a bone substitute is exposed by osteoclasts. The aim of establishing this method was to improve the predictability of carrying out tooth movements via bone substitutes and to provide a basis for verification in exemplary clinical cases. After populating a bone substitute (NanoBone®; ArtOss, Germany) with osteoclastic cells, inductively-coupled mass spectrometry was used to evaluate changing calcium levels in the culture medium as a marker of resorption activity. It was observed that calcium levels increased substantially in the culture medium with the cells populating the bone substitute. This in vitro assay is a valid method that can assist clinicians in selecting the appropriate materials for certain patients. While tooth movements occurring through this material were successful, uncertainty about the approach will remain as long-term results are not available.

  9. Early vascular ageing in translation: from laboratory investigations to clinical applications in cardiovascular prevention.

    Science.gov (United States)

    Nilsson, Peter M; Boutouyrie, Pierre; Cunha, Pedro; Kotsis, Vasilios; Narkiewicz, Krzysztof; Parati, Gianfranco; Rietzschel, Ernst; Scuteri, Angelo; Laurent, Stephane

    2013-08-01

    The ageing of the vascular tree is a fundamental reflection of biological ageing in general and a determinant of organ function. In the arterial wall this is characterized by a reduction in the elastin content, as well as by an increased content of collagen and its cross-linkages, leading to increased arterial stiffness and elevated central as well as brachial blood pressure, accompanied by increased SBP variability. In recent years a better understanding of these processes have led to the proposal of a condition named early vascular ageing (EVA) in patients with increased arterial stiffness for their age and sex. This is a condition that could increase cardiovascular risk and is associated with various degrees of cognitive dysfunction, as well as other features of biological ageing. This brief review aims to give an update on EVA and how the concept can be used in clinical practice.

  10. Molecular testing for clinical diagnosis and epidemiological investigations of intestinal parasitic infections.

    Science.gov (United States)

    Verweij, Jaco J; Stensvold, C Rune

    2014-04-01

    Over the past few decades, nucleic acid-based methods have been developed for the diagnosis of intestinal parasitic infections. Advantages of nucleic acid-based methods are numerous; typically, these include increased sensitivity and specificity and simpler standardization of diagnostic procedures. DNA samples can also be stored and used for genetic characterization and molecular typing, providing a valuable tool for surveys and surveillance studies. A variety of technologies have been applied, and some specific and general pitfalls and limitations have been identified. This review provides an overview of the multitude of methods that have been reported for the detection of intestinal parasites and offers some guidance in applying these methods in the clinical laboratory and in epidemiological studies.

  11. A Novel Electronic Device for Measuring Urine Flow Rate: A Clinical Investigation

    Directory of Open Access Journals (Sweden)

    Aliza Goldman

    2017-09-01

    Full Text Available Objective: Currently, most vital signs in the intensive care unit (ICU are electronically monitored. However, clinical practice for urine output (UO measurement, an important vital sign, usually requires manual recording of data that is subject to human errors. In this study, we assessed the ability of a novel electronic UO monitoring device to measure real-time hourly UO versus current clinical practice. Design: Patients were connected to the RenalSense Clarity RMS Sensor Kit with a sensor integrated within a standard sterile urinary catheter drainage tube to monitor urine flow in real time. The Clarity RMS Sensor Kit was modified to incorporate a standard urinometer (Unomedical for the nursing staff to record UO as per their standard practice. The drainage bag was placed in a container on a scientific scale (Precisa BJ to be used as the gold standard. Interventions: Nursing records for hourly UO were collected and compared with the electronically recorded UO. Sensor measurements and nursing staff manual records of UO were compared with the scale data. Setting: The study setting was the ICU of Hadassah Hospital, Jerusalem. Patients: Data from 23 patients with a urinary catheter were observed in this study. Measurements and main results: A total of 1046 hours of UO were recorded from 23 subjects. Compared with the scale data, the measurements of hourly urine flow measured with the RenalSense system were closer, had a better correlation, and narrower limits of agreement to gravimetrically determined values than the measurements obtained by the nurses. In addition, continuous monitoring of UO provided graphical display of response to repeated diuretic administration. Conclusions: An electronic device for recording UO has been shown to provide more reliable information of UO records and patient fluid status than current practice. Future applications of this device will provide valuable information to help set protocol goals such as decisions for

  12. A pilot investigation of food insecurity among children seen in an outpatient pediatric nephrology clinic

    Directory of Open Access Journals (Sweden)

    Michelle C. Starr

    2018-06-01

    Full Text Available Food insecurity (FI is common - affecting one in six American households with children. FI is defined as limited or uncertain availability of nutritionally adequate and safe foods. Awareness of food insecurity and its impact on health has increased since the American Academy of Pediatrics 2015 policy statement, “Promoting Food Security for All Children.” Though FI is frequently addressed in general pediatric primary care, it is not routinely identified in patients with chronic medical problems. Patients with complex care needs, prescription medication, or restrictive nutritional requirements may be at higher risk of food insecurity. The prevalence of FI in patients with chronic disease, including pediatric patients with kidney disease, remains unknown. We sought to determine the prevalence of FI among our pediatric nephrology clinic patients with a cross-sectional screening pilot study. Nearly 35% of 118 children seen in our pediatric nephrology outpatient clinic lived in food insecure households, a prevalence rate more than double the general pediatric population (16%. Barriers to food security were variable; common themes included challenges with restricted diet and available food, identifying and accessing community resources, and not qualifying for support. For physicians, dietitians, and other health providers that counsel patients with kidney disease on dietary interventions, it is important to be aware of food security status. To our knowledge, this is the first study to assess the prevalence of food insecurity in pediatric patients with kidney disease. Further studies of food insecurity and social determinants of heath in this patient population are needed. Keywords: Kidney disease, Pediatrics, Child, Healthcare utilization, Food insecurity, Nutritional status

  13. Online Multi-Spectral Meat Inspection

    DEFF Research Database (Denmark)

    Nielsen, Jannik Boll; Larsen, Anders Boesen Lindbo

    2013-01-01

    We perform an explorative study on multi-spectral image data from a prototype device developed for fast online quality inspection of meat products. Because the camera setup is built for speed, we sacrifice exact pixel correspondences between the different bands of the multi-spectral images. Our...... work is threefold as we 1) investigate the color distributions and construct a model to describe pork loins, 2) classify the different components in pork loins (meat, fat, membrane), and 3) detect foreign objects on the surface of pork loins. Our investigation shows that the color distributions can...

  14. Preclinical and clinical investigations as an approach to rational phytotherapy in prostate diseases

    OpenAIRE

    Weisskopf, Marianne

    2004-01-01

    Phytotherapeuticals have gained widespread usage in the treatment of symptomatic benign prostatic hyperplasia (BPH). Among these phytotherapeutics, the most popular and extensively studied are extracts of the dried ripe fruit of Serenoa repens (SRE). The commercially available hydroethanolic (96%) SRE, Me180, is already used as a medical treatment of symptomatic BPH. However, this extract was so far neither investigated in vitro nor in vivo. The other extracts tested herein, de...

  15. Annual Progress Report (Fiscal Year 1978) of the Clinical Investigation Service

    Science.gov (United States)

    1978-01-01

    FY-78 0). 2521 Reaction Times of Stutterers and Nonstutterers (FY-78 0). 2522 ^fonaural Versus Binaural Amplification for Hearing Impaired...4113 Cooperative Gynecoloeic-Oncolosv Croup (FY-72 0). 401 4116 The Evaluation of Fetal Systolic Time Intervals and 402 Beat to Beat ...wmmm mmnv r-T" IÜP WORK UNIT NUMBER: 2522 TITLE; Monaural Versus Binaural Amplification for Hearing Impaired Listeners INVESTIGATORS

  16. Cleveland Clinic Lerner College of Medicine: an innovative approach to medical education and the training of physician investigators.

    Science.gov (United States)

    Fishleder, Andrew J; Henson, Lindsey C; Hull, Alan L

    2007-04-01

    Cleveland Clinic Lerner College of Medicine (CCLCM) is an innovative, five-year medical education track within Case Western Reserve University School of Medicine (Case) with a focused mission to attract and educate a limited number of highly qualified persons who seek to become physician investigators. CCLCM curriculum governance, faculty appointments and promotions, and admissions committees are integrated with respective Case committees. The CCLCM curriculum is based on faculty-defined professional attributes that graduates are expected to develop. These attributes were used to create curricular and assessment principles that guided the development of an integrated basic science, clinical science, and research curriculum, conducted in an active learning environment. An organ-system approach is used to solidify an understanding of basic science discipline threads in the context of relevant clinical problems presented in PBL and case-based discussion formats. Clinical skills are introduced in the first year as part of the two-year longitudinal experience with a family practice or internal medicine physician. The research program provides all students with opportunities to learn and experience basic and translational research and clinical research before selecting a research topic for their 12- to 15-month master-level thesis project. All Case students participate in required and elective clinical curriculum after the second year, but CCLCM students return to the Cleveland Clinic on selected Friday afternoons for program-specific research and professionalism-learning activities. A unique portfolio-based assessment system is used to assess student achievements in nine competency areas, seven of which reflect the Accreditation Council for Graduate Medical Education competencies.

  17. Task of radiation hygiene inspection at NPPs

    International Nuclear Information System (INIS)

    Shevts, J.; Kunz, Eh.

    1983-01-01

    The task and functions of the radiation-hygiene inspection in Czechoslovakia are presented. The radiation safety related information amounts that are to be presented to the hygiene inspection institutions are determined. The hygiene inspection content and forms at the stages of NPP designing, construction and operation are discussed. The hygiene inspection place is determined within the general radiation safety system [ru

  18. Automated ultrasonic inspection of nuclear plant components

    International Nuclear Information System (INIS)

    Baron, J.A.; Dolbey, M.P.

    1982-01-01

    For reasons of safety and efficiency, automated systems are used in performing ultrasonic inspection of nuclear components. An automated system designed specifically for the inspection of headers in a nuclear plant is described. In-service inspection results obtained with this system are shown to correlate with pre-service inspection results obtained by manual methods

  19. [The para-clinic investigation of temporo-mandibular joint changes in patients with acromegaly].

    Science.gov (United States)

    Morăraşu, C; Burlui, V; Olaru, C; Boza, C; Bortă, C; Morăraşu, G; Brînză, M

    2001-01-01

    The Acromegaly is an endocrinological disease determined by the hypersecretion of STH in a certain period of the body evolution and it causes the hypertrophy of bones in general and of mandible and cranio-facial bones, determining a disorder due to this development of bones, associated with troubles in the activity of muscles and of the phospho-calcium metabolism. This study was made on a group of 33 acromegaly patients. Their temporo-mandibular joint was investigated by ortopantomography, tomography, computer tomography and scintigraphy. All of these exams shows the changes in temporo-mandibular joint due to the cells hyperactivity determined by the hypersecretion of STH.

  20. ROBOTIC TANK INSPECTION END EFFECTOR

    International Nuclear Information System (INIS)

    Rachel Landry

    1999-01-01

    The objective of this contract between Oceaneering Space Systems (OSS) and the Department of Energy (DOE) was to provide a tool for the DOE to inspect the inside tank walls of underground radioactive waste storage tanks in their tank farms. Some of these tanks are suspected to have leaks, but the harsh nature of the environment within the tanks precludes human inspection of tank walls. As a result of these conditions only a few inspection methods can fulfill this task. Of the methods available, OSS chose to pursue Alternating Current Field Measurement (ACFM), because it does not require clean surfaces for inspection, nor any contact with the Surface being inspected, and introduces no extra by-products in the inspection process (no coupling fluids or residues are left behind). The tool produced by OSS is the Robotic Tank Inspection End Effector (RTIEE), which is initially deployed on the tip of the Light Duty Utility Arm (LDUA). The RTEE combines ACFM with a color video camera for both electromagnetic and visual inspection The complete package consists of an end effector, its corresponding electronics and software, and a user's manual to guide the operator through an inspection. The system has both coarse and fine inspection modes and allows the user to catalog defects and suspected areas of leakage in a database for further examination, which may lead to emptying the tank for repair, decommissioning, etc.. The following is an updated report to OSS document OSS-21100-7002, which was submitted in 1995. During the course of the contract, two related sub-tasks arose, the Wall and Coating Thickness Sensor and the Vacuum Scarifying and Sampling Tool Assembly. The first of these sub-tasks was intended to evaluate the corrosion and wall thinning of 55-gallon steel drums. The second was retrieved and characterized the waste material trapped inside the annulus region of the underground tanks on the DOE's tank farms. While these sub-tasks were derived from the original intent

  1. Clinical and X-ray investigations on congenital radio-ulnar synostosis

    International Nuclear Information System (INIS)

    Heisel, A.

    1982-01-01

    Out of 13 patients with cogenital radio-ulnar synostosis, 10 could be subjected to clinical and X-ray examination and chromosome analysis. In all the family histories the radio-ulnar synostosis was an isolated event. In no case was definite heredity of the same malformation confirmed. In most cases the radio-ulnar synostosis was an isolated malformation. 7 patients were of female, 6 of male sex. In 5 cases the synostosis was bi-lateral, in 8 cases it was unilateral without preference of either side of the body. In 2 out of 10 patients subjected to chromosome analysis gonosomal aneuploidy was found. More often than hitherto supposed, radio-ulnar synostosis seems to be associated with lower forms of polysomia of the x-chromosomes. 15 out of 18 synostoses belonged to type II, 3 to type I. The different types represent merely differring degrees of manifestation of the same deformity occurring bilaterally in one person. All patients with radio-ulnar synostosis exhibited a high degree of functional tolerance to the malformation. The development in child age and the educational and professional record were hardly impaired. (orig./MG) [de

  2. Clinicians' emotional responses and Psychodynamic Diagnostic Manual adult personality disorders: A clinically relevant empirical investigation.

    Science.gov (United States)

    Gazzillo, Francesco; Lingiardi, Vittorio; Del Corno, Franco; Genova, Federica; Bornstein, Robert F; Gordon, Robert M; McWilliams, Nancy

    2015-06-01

    The aim of this study is to explore the relationship between level of personality organization and type of personality disorder as assessed with the categories in the Psychodynamic Diagnostic Manual (PDM; PDM Task Force, 2006) and the emotional responses of treating clinicians. We asked 148 Italian clinicians to assess 1 of their adult patients in treatment for personality disorders with the Psychodiagnostic Chart (PDC; Gordon & Bornstein, 2012) and the Personality Diagnostic Prototype (PDP; Gazzillo, Lingiardi, & Del Corno, 2012) and to complete the Therapist Response Questionnaire (TRQ; Betan, Heim, Zittel-Conklin, & Westen, 2005). The patients' level of overall personality pathology was positively associated with helpless and overwhelmed responses in clinicians and negatively associated with positive emotional responses. A parental and disengaged response was associated with the depressive, anxious, and dependent personality disorders; an exclusively parental response with the phobic personality disorder; and a parental and criticized response with narcissistic disorder. Dissociative disorder evoked a helpless and parental response in the treating clinicians whereas somatizing disorder elicited a disengaged reaction. An overwhelmed and disengaged response was associated with sadistic and masochistic personality disorders, with the latter also associated with a parental and hostile/criticized reaction; an exclusively overwhelmed response with psychopathic patients; and a helpless response with paranoid patients. Finally, patients with histrionic personality disorder evoked an overwhelmed and sexualized response in their clinicians whereas there was no specific emotional reaction associated with the schizoid and the obsessive-compulsive disorders. Clinical implications of these findings were discussed. (c) 2015 APA, all rights reserved).

  3. A Clinical Trial to Investigate the Effect of Cynatine HNS on Hair and Nail Parameters

    Directory of Open Access Journals (Sweden)

    Christina Beer

    2014-01-01

    Full Text Available Objective. A new, novel product, Cynatine HNS, was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized, double-blind, placebo-controlled clinical trial. Methods. A total of 50 females were included and randomized into two groups. The active group (n=25 received 2 capsules containing Cynatine HNS, comprised of Cynatine brand keratin (500 mg plus vitamins and minerals, per day, and the placebo group (n=25 received 2 identical capsules of maltodextrin per day for 90 days. End points for hair loss, hair growth, hair strength, amino acid composition, and hair luster were measured. End points were also measured for nail strength and the appearance of nails. Results. The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo. Conclusion. Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less. EudraCT number is 2014-002645-22.

  4. Computed tomographic, electrocardiographic and clinical investigations in patients with ischemic strokes

    International Nuclear Information System (INIS)

    Manchev, L.; Mitev, M.; Milanova, V.; Zafirova, E.; Manolova, T.; Manchev, I.; Toneva, J.

    2013-01-01

    The Computed Tomography (CT) is a widely available and reliable method for the diagnosis of cerebrovascular disease. It allows in the first hours of the occurrence of vascular events to be established the type of brain stroke and creates conditions for timely fibrinolytic or surgical treatment. In many cases where it cannot be performed echocardiographic examination modern electrocardiography (ECG) makes it possible to demonstrate the presence of cardiac disease. These two methods in combination with neurological status create conditions for determining the treatment strategy for ischemic brain stroke (IBS). We studied 222 patients (92 men and 110 women with a middle age 59.7 years) selected randomized. At a computed tomography study in the early hours of IBS were found pathological findings in 115 patients (51.8%) slightly more often in women. IBS in the carotid system were greatly predominant in comparison with those in the vertebrobasilar system (VBS), which can be explained with the blood flow to the brain stem. When ECG is most commonly met diagnosis: hypertension HSSN 111 stage II - III functional class NYUHA, ischemic cardiomyopathy in 64 patients overall, with almost equal frequency in men 30 (17.5%) and women - 34 (19.8%). In neurological examination significantly predominant clinical symptoms karoditnata vasculature, in 154 patients (69.3%) compared to that of the VBS- 68 (30.7%). Fulfilled study shows the need for better coordination of the activities of specialists in diagnostic imaging and neurologists for their work in specialized hospitals (Stroke Units). (authors)

  5. Investigation of barriers to clinical practice guideline-recommended pharmacotherapy in the treatment of COPD.

    Directory of Open Access Journals (Sweden)

    Price L

    2007-06-01

    Full Text Available Background: The adoption of clinical practice guideline recommendations for COPD is suboptimal. Determining the barriers to the implementation of these practice guidelines may help improve patient care.Objective: To determine whether barriers to the use of pharmacotherapy according to practice guidelines are related primarily to patient or prescriber factors.Methods: Retrospective cohort study. Members of a health maintenance organization identified as having spirometry-defined COPD ranging from stage II to IV. Electronic medical records were reviewed for documentation of the following: 1 patient affordability issues, 2 history of an adverse drug reaction, 3 history of inefficacy to therapy, and 4 prescription history.Results: A total of 111 medical records were reviewed. There were 51% of patients who had not filled medications that had been prescribed in accordance with guidelines and 43% did not have the guideline recommended medications prescribed in the previous year. Only 4% and 2% of patients had documented inefficacy and affordability issues, respectively. There were no reported cases of adverse drug reactions. Conclusions: This study provides insight to the acceptance of COPD treatment recommendations by patients and providers. Further research is needed to design interventions to reduce barriers and optimize COPD treatment.

  6. Clinical and immunological investigations of respiratory disease in workers using reactive dyes.

    Science.gov (United States)

    Docker, A; Wattie, J M; Topping, M D; Luczynska, C M; Newman Taylor, A J; Pickering, C A; Thomas, P; Gompertz, D

    1987-01-01

    A questionnaire survey of over 400 workers handling reactive dyes showed that over 15% had work related respiratory or nasal symptoms. Forty nine employees with symptoms were referred to chest clinics for detailed assessment. It was considered that in 19 the symptoms could be attributed to an irritant response to a variety of chemicals, including hydrochloric acid vapour, sulphur dioxide, and reactive dyes. Symptoms in 24 were attributed to an allergic reaction to a specific agent; in most (21) to one or more reactive dyes. Two patterns of allergic lower respiratory symptoms were identified; an immediate response of short duration and a longer lasting response, usually of several hours, sometimes accompanied by nocturnal asthma. A radioallergosorbent test (RAST) screen containing the most commonly used reactive dyes was used to detect specific IgE. Allergic symptoms to reactive dyes were strongly associated with specific IgE (17/21 employees) and atopy (18/21). Irritant symptoms were also associated with atopy (13/19) but only weakly associated with specific IgE (7/19). PMID:3651352

  7. Clinical and Individual Variables in Children's Dental Fear: A School-Based Investigation.

    Science.gov (United States)

    Silveira, Ethieli Rodrigues da; Goettems, Marília Leão; Demarco, Flávio Fernando; Azevedo, Marina Sousa

    2017-01-01

    This cross-sectional study evaluated the prevalence of dental fear and associated factors in schoolchildren aged 8 to 12 years old, in Pelotas, southern Brazil. Schoolchildren enrolled in 20 public and private schools were selected using a multi-stage sample design. Sociodemographic characteristics, children's dental visit and oral hygiene habits were assessed by questionnaires. The Dental Anxiety Question was used to measure dental fear prevalence. Children's clinical examination evaluated presence of dental caries (DMFT/dmft index) and gingival bleeding. Data were analyzed using Poisson regression with robust variance (prevalence ratio; 95% confidence interval). One thousand two hundred and two children were included. Dental fear prevalence was 24.6%. After the adjustment, girls [PR=1.71 (CI 95%: 1.31-2.22)], children from poorer families [PR=1.96 (CI 95%: 1.36-2.83)], those who had decayed teeth (D/d index>0)[PR=1.32 (CI 95%: 1.01-1.72), and who had never been at the dentist [PR=1.85 (CI 95%: 1.42-2.41) remained significantly associated with dental fear. The prevalence of dental fear indicates that it is a common problem among schoolchildren. Early dental care and dental caries prevention are important factors to prevent dental fear.

  8. Clinical investigation of flat panel CT following middle ear reconstruction: a study of 107 patients

    Energy Technology Data Exchange (ETDEWEB)

    Zaoui, K. [University Hospital Heidelberg, Ruprecht Karls University, Department of Otorhinolaryngology, Head and Neck Surgery, Heidelberg (Germany); Kromeier, J. [St. Josefs Hospital, RkK, Department of Radiology, Freiburg (Germany); Neudert, M.; Beleites, T.; Zahnert, T. [University Hospital Dresden, Technical University, Department of Otorhinolaryngology, Head and Neck Surgery, Dresden (Germany); Laszig, R.; Offergeld, C. [University Hospital Freiburg, Albert Ludwigs University, Department of Otorhinolaryngology, Head and Neck Surgery, Freiburg (Germany)

    2014-03-15

    After middle ear reconstruction using partial or total ossicular replacement prostheses (PORP/TORP), an air-bone gap (ABG) may persist because of prosthesis displacement or malposition. So far, CT of the temporal bone has played the main role in the diagnosis of reasons for postoperative insufficient ABG improvement. Recent experimental and clinical studies have evaluated flat panel CT (fpCT) as an alternative imaging technique that provides images with high isovolumetric resolution, fewer metal-induced artefacts and lower irradiation doses. One hundred and seven consecutive patients with chronic otitis media with or without cholesteatoma underwent reconstruction by PORP (n = 52) or TORP (n = 55). All subjects underwent preoperative and postoperative audiometric testing and postoperative fpCT. Statistical evaluation of all 107 patients as well as the sole sub-assembly groups (PORP or TORP) showed a highly significant correlation between hearing improvement and fpCT-determined prosthesis position. FpCT enables detailed postoperative information on patients with middle ear reconstruction. FpCT is a new imaging technique that provides immediate feedback on surgical results after reconstructive middle ear surgery. Specific parameters evaluated by fpCT may serve as a predictive tool for estimated postoperative hearing improvement. Therefore this imaging technique is suitable for postoperative quality control in reconstructive middle ear surgery. (orig.)

  9. Long-term clinical investigation of patients with ankylosing spondylitis treated with /sup 224/Ra

    Energy Technology Data Exchange (ETDEWEB)

    Schmitt, E [Universitatsklinik Friedrichsheim, Frankfurt, West Germany; Ruckbeil, C; Wick, R R

    1983-01-01

    Between 1952 and 1980 about 250 patients with ankylosing spondylitis were treated with /sup 224/Ra at the Orthopaedic University Hospital of Frankfurt/M. In 1970, 119 of them were examined and X-rayed as was another group of 40 patients in 1980. The results of those examined could be compared with a group of 40 patients treated without /sup 224/Ra. Patients with /sup 224/Ra demonstrated a long-lasting period of subjective improvement after the treatment, with reduced consumption of antirheumatoid and analgesic drugs, on the average. Blood examinations show inflammatory activities. Nevertheless, the ankylosing spondylitis proceeded. In the final stages of the disease, neither the clinical aspects nor the X-rays showed any specific changes. We observed no case of malignant bone tumor. Of the 169 examined patients, 22 had a total of 32 children after the treatment with /sup 224/Ra. Among these was a set of twins with cerebral palsy and diabetes insipidus renalis. In conclusion, /sup 224/Ra in ankylosing spondylitis is a recommended treatment without higher risk compared to the common therapy with drugs.

  10. Clinical investigation: Regional nodal failure patterns in breast cancer patients treated with mastectomy without radiotherapy

    International Nuclear Information System (INIS)

    Strom, Eric A.; Woodward, Wendy A.; Katz, Angela; Buchholz, Thomas A.; Perkins, George H.; Jhingran, Anuja; Theriault, Richard; Singletary, Eva; Sahin, Aysegul; McNeese, Marsha D.

    2005-01-01

    Purpose: The purpose of this study was to describe regional nodal failure patterns in patients who had undergone mastectomy with axillary dissection to define subgroups of patients who might benefit from supplemental regional nodal radiation to the axilla or supraclavicular fossa/axillary apex. Methods and Materials: The cohort consisted of 1031 patients treated with mastectomy (including a level I-II axillary dissection) and doxorubicin-based systemic therapy without radiation on five clinical trials at M.D. Anderson Cancer Center. Patient records, including pathology reports, were retrospectively reviewed. All regional recurrences (with or without distant metastasis) were recorded. Median follow-up was 116 months (range, 6-262 months). Results: Twenty-one patients recurred within the low-mid axilla (10-year actuarial rate 3%). Of these, 16 were isolated regional failures (no chest wall failure). The risk of failure in the low-mid axilla was not significantly higher for patients with increasing numbers of involved nodes, increasing percentage of involved nodes, larger nodal size or gross extranodal extension. Only 3 of 100 patients with 20% involved axillary nodes, and the presence of gross extranodal extension (10-year actuarial rates 15%, 14%, and 19%, respectively, p 20% involved axillary nodes, or gross extranodal extension are at increased risk of failure in the supraclavicular fossa/axillary apex and should receive radiation to undissected regions in addition to the chest wall

  11. Clinical Assessment and Management of Spondyloarthritides in the Middle East: A Multinational Investigation

    Directory of Open Access Journals (Sweden)

    Mohammed Hammoudeh

    2015-01-01

    Full Text Available Data on spondyloarthritis (SpA from the Middle East are sparse and the management of these diseases in this area of the world faces a number of challenges, including the relevant resources to enable early diagnosis and referral and sufficient funds to aid the most appropriate treatment strategy. The objective was to report on the characteristics, disease burden, and treatment of SpA in the Middle East region and to highlight where management strategies could be improved, with the overall aim of achieving better patient outcomes. This multicenter, observational, cross-sectional study collected demographic, clinical, laboratory, and treatment data on 169 consecutive SpA patients at four centers (Egypt, Kuwait, Qatar, and Saudi Arabia. The data collected presents the average time from symptom onset to diagnosis along with the presence of comorbidities in the region and comparisons between treatment with NSAIDs and biologics. In the absence of regional registries of SpA patients, the data presented here provide a rare snapshot of the characteristics, disease burden, and treatment of these patients, highlighting the management challenges in the region.

  12. OSE inspection of protection program operations field perspective of inspections

    International Nuclear Information System (INIS)

    Brown, R.W.; Martin, H.R.

    1987-01-01

    Protection Program Operations includes three functional areas: Physical Protection Systems, Protective Forces, and System Performance Testing. The Office of Security Evaluations (OSE) inspects field offices in these areas by evaluating programs relative to Standards and Criteria and by performing a variety of exercises and other types of tests to assure protective systems are effective and maintained at a proper level to meet the defined threat. Their perception of the OSE inspections has been positive. The approach taken by ID, with key areas/activities emphasized, during each phase of the field inspection process is described in this report. The most important areas for field offices to concentrate are: inspection preparations through self-evaluation, improving communications, assigning knowledgeable trusted agents, increasing awareness of facility procedures and operations, and assuring daily validations of inspected areas. Emphasis is placed on striving for a balance in reporting both positive and negative findings, and for consistency between ratings and the importance of report findings. OSE efforts to develop improved rating methodologies are encouraged

  13. Clinical investigation on angle-closure glaucoma patients with cataract treated by phacoemulsification combined with trabeculectomy

    Directory of Open Access Journals (Sweden)

    Yu-Sheng Wang

    2013-11-01

    Full Text Available AIM: To investigate the effectiveness of phacoemulsification with intraocular lens(IOLimplantation combined with trabeculectomy in patients with cataract and angle-closure glaucoma.METHODS: In 36 cases(46 eyesof angle-closure glaucoma with cataract, phacoemulsification with foldable IOL implantation combined with trabeculectomy was performed. Data of pre- and post-operation, including visual acuity, intraocular pressure, filtering bleb, anterior chamber depth, chamber angle, and funds were all recorded and analyzed in detail.RESULTS: During the follow-up of 3 months to 2 years,visual acuity of 43 eyes(93.5%got improved, and intraocular pressure in 44 eyes(95.7%were controlled in normal range(CONCLUSION: Phacoemulsification with IOL implantation combined with trabeculectomy is an effective and safe surgical technique for patients with angle-closure glaucoma and cataract, with satisfied control of intraocular pressure, deepening of anterior chamber, opening of anterior chamber angle, and improving visual function.

  14. An expanding universe of noncoding RNAs between the poles of basic science and clinical investigations.

    Science.gov (United States)

    Weil, Patrick P; Hensel, Kai O; Weber, David; Postberg, Jan

    2016-03-01

    The Keystone Symposium 'MicroRNAs and Noncoding RNAs in Cancer', Keystone, CO, USA, 7-12 June 2015 Since the discovery of RNAi, great efforts have been undertaken to unleash the potential biomedical applicability of small noncoding RNAs, mainly miRNAs, involving their use as biomarkers for personalized diagnostics or their usability as active agents or therapy targets. The research's focus on the noncoding RNA world is now slowly moving from a phase of basic discoveries into a new phase, where every single molecule out of many hundreds of cataloged noncoding RNAs becomes dissected in order to investigate these molecules' biomedical relevance. In addition, RNA classes neglected before, such as long noncoding RNAs or circular RNAs attract more attention. Numerous timely results and hypotheses were presented at the 2015 Keystone Symposium 'MicroRNAs and Noncoding RNAs in Cancer'.

  15. Frequency, clinical correlates and rating of behavioural changes in primary brain tumour patients: A preliminary investigation.

    Directory of Open Access Journals (Sweden)

    Grahame K Simpson

    2015-04-01

    Full Text Available PurposeFew studies have addressed the specific behavioural changes associated with primary brain tumour (PBT. This paper will report on the frequency and demographic/clinical correlates of such behaviours, and the reliability of rating such behaviours amongst people with PBT, family informants and clinicians. The association of behavioural changes and patient functional status will also be discussed.MethodsA total of 57 patients with 37 family informants were recruited from two large Australian metropolitan hospitals. Each completed three neuro-behavioural self-report measures. Patients also completed a depression symptom measure. Functional status was defined by clinician-rated Karnofsky Performance Status.ResultsPatients were on average 52 years old, a median of four months (range 1-82 post-diagnosis, with high grade (39%, low grade (22% or benign tumours (39%. Patients reported frequency rates of 7-40% across various behavioural domains including anger, inappropriate behaviour, apathy, inertia and executive impairment. The presence of epileptic seizures was associated with significantly higher levels of behavioural changes. Notably, behaviour did not correlate with tumour grade or treatment modality. There was moderate agreement between patients and relatives on the presence or absence of behavioural changes, and substantial agreement between relative and clinician ratings. Depressed patients did not generally report more changes than non-depressed patients. Increases in the relative and clinician-rated behaviour scores were significantly correlated with decreasing functional status in the patient.ConclusionsBehavioural changes were a common sequela of both benign and malignant PBT. Larger scale studies are required to confirm these results. The results suggest the importance of including behaviour in brain cancer psychosocial assessments and the need to develop interventions to treat these patients and reduce the burden of care on families.

  16. Clinical investigation on usefulness of MRI in the diagnosis of mediastinal masses

    Energy Technology Data Exchange (ETDEWEB)

    Oyama, Takao (Kagoshima Univ. (Japan). Faculty of Medicine)

    1994-02-01

    This study evaluated the utility of magnetic resonance imaging (MRI) in diagnosing mediastinal masses. The subjects were 96 patients with pathologically (n=82) and clinically (n=14) proven mediastinal masses, consisting of thymomas (30), teratomas (4), other thymic tumors (5), intrathoracic goiters (4), neurogenic tumors (7), congenital cysts (12), mesenchymal tumors (10), vascular masses (5), phrenic hernia (3), malignant lymphomas (6), and sarcoidosis (10). MRI findings, including marginal and capsular appearances, internal structures and signal intensities, were analyzed. Internal structure characteristic to thymomas were seen in 24 teratoma patients (80%). In 4 teratomas, MRI was capable of distinguishing benign (2) from malignant (2) ones. In the other 5 thymic tumors, MRI delineated chemical characteristics of fluids for thymic cysts (2) and internal structures for thymic cancer (2) and lipoma (one). It also delineated the continuity of intrathoracic goiter from the cervical to intrathoracic regions. For neurogenic tumors, MRI was capable of distinguishing neurofibromas from schwannomas and also benign from malignant schwannomas. A well-defined smooth margin and very high signal intensity, which were characteristic to congenital cysts, were seen on T2-weighted images. Signal intensities on T1-weighted images reflected fluid features in cysts. For mesenchymal tumors, consisting of hemangioma, hemangiosarcoma, malignant melanoma, aneurysmal bone cyst and osteosarcoma, lymphangioma and chondrosarcoma, all but osteosarcoma showed their respective characteristic MRI findings. Vascular masses were delineated as flow void structures. MRI delineated herniated contents. Malignant lymphoma was shown as irregular and inhomogeneous swollen lymph nodes, but sarcoidosis was shown as regular and homogeneous ones on MRI. In conclusion, MRI is a useful, informative modality for diagnosing mediastinal masses. (N.K.) 84 refs.

  17. Clinical investigation on usefulness of MRI in the diagnosis of mediastinal masses

    International Nuclear Information System (INIS)

    Oyama, Takao

    1994-01-01

    This study evaluated the utility of magnetic resonance imaging (MRI) in diagnosing mediastinal masses. The subjects were 96 patients with pathologically (n=82) and clinically (n=14) proven mediastinal masses, consisting of thymomas (30), teratomas (4), other thymic tumors (5), intrathoracic goiters (4), neurogenic tumors (7), congenital cysts (12), mesenchymal tumors (10), vascular masses (5), phrenic hernia (3), malignant lymphomas (6), and sarcoidosis (10). MRI findings, including marginal and capsular appearances, internal structures and signal intensities, were analyzed. Internal structure characteristic to thymomas were seen in 24 teratoma patients (80%). In 4 teratomas, MRI was capable of distinguishing benign (2) from malignant (2) ones. In the other 5 thymic tumors, MRI delineated chemical characteristics of fluids for thymic cysts (2) and internal structures for thymic cancer (2) and lipoma (one). It also delineated the continuity of intrathoracic goiter from the cervical to intrathoracic regions. For neurogenic tumors, MRI was capable of distinguishing neurofibromas from schwannomas and also benign from malignant schwannomas. A well-defined smooth margin and very high signal intensity, which were characteristic to congenital cysts, were seen on T2-weighted images. Signal intensities on T1-weighted images reflected fluid features in cysts. For mesenchymal tumors, consisting of hemangioma, hemangiosarcoma, malignant melanoma, aneurysmal bone cyst and osteosarcoma, lymphangioma and chondrosarcoma, all but osteosarcoma showed their respective characteristic MRI findings. Vascular masses were delineated as flow void structures. MRI delineated herniated contents. Malignant lymphoma was shown as irregular and inhomogeneous swollen lymph nodes, but sarcoidosis was shown as regular and homogeneous ones on MRI. In conclusion, MRI is a useful, informative modality for diagnosing mediastinal masses. (N.K.) 84 refs

  18. The clinical course and pathophysiological investigation of adolescent gestational diabetes insipidus: a case report.

    Science.gov (United States)

    Kondo, Tatsuya; Nakamura, Miwa; Kitano, Sayaka; Kawashima, Junji; Matsumura, Takeshi; Ohba, Takashi; Yamaguchi, Munekage; Katabuchi, Hidetaka; Araki, Eiichi

    2018-01-30

    Gestational diabetes insipidus (GDI) is a rare endocrine complication during pregnancy that is associated with vasopressinase overproduction from the placenta. Although increased vasopressinase is associated with placental volume, the regulation of placental growth in the later stage of pregnancy is not well known. A 16-year-old pregnant woman was urgently transferred to our hospital because of threatened premature labor when the Kumamoto earthquakes hit the area where she lived. During her hospitalization, she complained of gradually increasing symptoms of polyuria and polydipsia. The serum level of arginine vasopressin (AVP) was 1.7 pg/mL, which is inconsistent with central DI. The challenge of diagnostic treatment using oral 1-deamino-8-D-AVP (DDAVP) successfully controlled her urine and allowed for normal delivery. DDAVP tablets were not necessary to control her polyuria thereafter. Based on these observations, clinical diagnosis of GDI was confirmed. Pathophysiological analyses revealed that vasopressinase expression was more abundant in the GDI patient's syncytiotrophoblast in placenta compared with that in a control subject. Serum vasopressinase was also observed during gestation and disappeared soon after delivery. Vasopressinase is reportedly identical to oxytocinase or insulin regulated aminopeptidase (IRAP), which is an abundant cargo protein associated with the glucose transporter 4 (GLUT4) storage vesicle. Interestingly, the expression and subcellular localization of GLUT4 appeared to occur in a vasopressinase (IRAP)-dependent manner. Because placental volume may be associated with vasopressinase overproduction in GDI, vasopressinase (IRAP)/GLUT4 association appears to contribute to the growth of placenta in this case.

  19. Do school inspections improve primary school performance?

    OpenAIRE

    Dinand Webbink; Rob Luginbuhl; I. de Wolf

    2007-01-01

    Inspectors from the Dutch Inspectorate of Education inspect primary schools, write inspection reports on each inspected school, and make recommendations as to how each school can improve. We test whether these inspections result in better school performance. Using a fixed-effects model, we find evidence that school inspections do lead to measurably better school performance. Our assessment of school performance is based on the Cito test scores of pupils in their final year of primary school. ...

  20. Development of Inspection Robots for Bridge Cables

    Directory of Open Access Journals (Sweden)

    Hae-Bum Yun

    2013-01-01

    Full Text Available This paper presents the bridge cable inspection robot developed in Korea. Two types of the cable inspection robots were developed for cable-suspension bridges and cable-stayed bridge. The design of the robot system and performance of the NDT techniques associated with the cable inspection robot are discussed. A review on recent advances in emerging robot-based inspection technologies for bridge cables and current bridge cable inspection methods is also presented.

  1. Development of inspection robots for bridge cables.

    Science.gov (United States)

    Yun, Hae-Bum; Kim, Se-Hoon; Wu, Liuliu; Lee, Jong-Jae

    2013-01-01

    This paper presents the bridge cable inspection robot developed in Korea. Two types of the cable inspection robots were developed for cable-suspension bridges and cable-stayed bridge. The design of the robot system and performance of the NDT techniques associated with the cable inspection robot are discussed. A review on recent advances in emerging robot-based inspection technologies for bridge cables and current bridge cable inspection methods is also presented.

  2. Pyrexia in cats: Retrospective analysis of signalment, clinical investigations, diagnosis and influence of prior treatment in 106 referred cases.

    Science.gov (United States)

    Spencer, Sarah E; Knowles, Toby; Ramsey, Ian K; Tasker, Séverine

    2017-11-01

    The main aim of the study was to describe the features and diagnoses of a population of cats referred with pyrexia. Other aims were to report and evaluate the utility of clinical investigations performed, and describe any effect of treatment before referral on temperature at presentation and ability to make a diagnosis. Clinical records of cats with pyrexia (⩾39.2°C) documented at least twice were retrospectively reviewed. Cases were assigned to disease categories (infectious, inflammatory, immune-mediated, neoplastic, miscellaneous and no diagnosis [pyrexia of unknown origin, PUO]) based on diagnosis. The overall value of clinical investigations was assessed by classifying them as 'enabling', 'assisting' or 'no assistance' in achieving each diagnosis. The effect of treatment before referral was assessed for any association with temperature at presentation and ability to make a diagnosis (PUO vs other disease categories). One hundred and six cases were identified. The most common cause of pyrexia was feline infectious peritonitis (22 cats, 20.8%) and the largest disease category was infectious (41/106, 38.7%). Inflammatory conditions were found in 19 (17.9%) cats, neoplasia in 13 (12.3%), miscellaneous causes in 11 (10.4%) and immune-mediated disease in six (5.7%). No diagnosis was reached in 16 (15.0%) cats, often despite extensive diagnostic investigations. Cytology and histopathology most often 'enabled' or 'assisted' in obtaining a diagnosis. Most cats (91, 85.8%) received treatment before referral, with antimicrobial treatment given to 87 (82.1%). Prior treatment before referral was not associated with temperature at presentation nor with success in establishing a diagnosis. This is the first study investigating causes of pyrexia in cats. Infectious diseases were most common and immune-mediated diseases were comparatively rare.

  3. Examination of the association between announced inspections and inspection scores.

    Science.gov (United States)

    Waters, A Blake; VanDerslice, James; Porucznik, Christina A; Kim, Jaewhan; DeLegge, Royal; Durrant, Lynne

    2013-09-01

    In 2010 the Salt Lake Valley Health Department conducted a pilot of an announced inspection program utilizing a randomized assignment of restaurants to an intervention group with announced inspections and a control group that remained on the usual schedule of unannounced inspections. After adjusting for food type, visible kitchen, outside quality assurance, season, and standardized inspector, significant reductions were found in the odds ratios of personal hygiene (adjusted odds ratios [aOR] = 0.11, p = .00) and equipment cleanliness (aOR = 0.19, p = .00) violations. In the models for the control group, none of the odds ratios were statistically different from one, indicating no change in the postintervention time period as compared to the preintervention period.

  4. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Science.gov (United States)

    Hwang, Thomas J

    2013-01-01

    For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67%) positive and 8 (33%) negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%), and for oncologic (N = 7, 29%) and neurologic (N = 6, 24%) indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02) for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04) for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33). For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03), and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer than

  5. Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

    Science.gov (United States)

    Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

    2018-01-08

    The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

  6. Traceable working standards with SI units of radiance for characterizing the measurement performance of investigational clinical NIRF imaging devices

    Science.gov (United States)

    Zhu, Banghe; Rasmussen, John C.; Litorja, Maritoni; Sevick-Muraca, Eva M.

    2017-03-01

    All medical devices for Food and Drug market approval require specifications of performance based upon International System of Units (SI) or units derived from SI for reasons of traceability. Recently, near-infrared fluorescence (NIRF) imaging devices of a variety of designs have emerged on the market and in investigational clinical studies. Yet the design of devices used in the clinical studies vary widely, suggesting variable device performance. Device performance depends upon optimal excitation of NIRF imaging agents, rejection of backscattered excitation and ambient light, and selective collection of fluorescence emanating from the fluorophore. There remains no traceable working standards with SI units of radiance to enable prediction that a given molecular imaging agent can be detected in humans by a given NIRF imaging device. Furthermore, as technologies evolve and as NIRF imaging device components change, there remains no standardized means to track device improvements over time and establish clinical performance without involving clinical trials, often costly. In this study, we deployed a methodology to calibrate luminescent radiance of a stable, solid phantom in SI units of mW/cm2/sr for characterizing the measurement performance of ICCD and IsCMOS camera based NIRF imaging devices, such as signal-to-noise ratio (SNR) and contrast. The methodology allowed determination of superior SNR of the ICCD over the IsCMOS system; comparable contrast of ICCD and IsCMOS depending upon binning strategies.

  7. Diagnosis of pulmonary hypertension and pulmonary heart at Berylliosis and plutonium pneumosclerosis (Clinical-functional investigation)

    International Nuclear Information System (INIS)

    Metlyaeva, N. A.

    2004-01-01

    The subject of the research was 54 workers with Beryllium and Plutonium incorporation from 33 to 60 old, all of them had 41- Berylliosis and 13- Plutonium pneumosclerosis. Patient were investigated with ECG, pulmonary, kinetocordiography, echocardiography. Hypertension in the pulmonary artery developed due to a combination of anatomical and functional disturbances and also with increasing of a stroke and minutely volumes at a definite stage of the disease with Beryllium and Plutonium pneumosclerosis. Two type of hypertension were discovered with pulmonary reography in the Beryllium and the Plutonium pneumosclerosis patients: hyper volume and hypertension type. Hyper volume type of pulmonary circulation (31.7% and 53.8%) consist ed of a high amplitude systolic wave. It was revealed in patients at the early stage of disease, when the pulmonary vessels stretching and right ventricle function kept still at a good condition. Hypertensive type of pulmonary circulation (68.3% and 46.2%) had a low amplitude systolic wave. The low amplitude systolic wave caused by increasing resistance of the pulmonary vessels, decreasing in the flow of blood in arterial system and the injection fraction and a low circulatory volume. (Author) 17 refs

  8. First animal experiments and clinical investigations with sup(99m)Tc-bilirubin

    International Nuclear Information System (INIS)

    Schneider, G.; Kaempfer, I.; Blottner, A.; Rogos, R.; Deckart, H.

    1986-01-01

    Labelling of bilirubin with sup(99m)Tc is described. The distribution and elimination of the labelled substance was investigated in mice, rabbits, dogs and pigs. Within 5 minutes p.i. the labelled substance accumulated in the liver and was eliminated within several hours. Comparative studies of 14 C bilirubin and 14 C sup(99m)Tc bilirubin showed identical distribution patterns. Clinial trials were conducted in 60 patients who received 0.0015 mg/kg i.v. (total dose, 60-80 MBq of sup(99m)Tc bilirubin -> 1.6 - 2.2 mCi). Images were obtained in the first 20 min p.i. as well as after 2 and 24 hours. To determine the blood clearance blood samples were taken in the first hours and activity curves were recorded over the cardiac and temporal regions. As elimination from the liver was slow, gall bladder and bile duct imaging was not successful before 1 to 3 hours p.i. The severity of liver damage can be established on the basis of blood clearance, onset of active liver uptake, elimination from the liver and 24 hours excretion in percent. Labelled bilirubin is a suitable material for morphologic and dynamic functional imaging of the liver (e.g. for SPECT studies). Incidents were absent throughout. (Author)

  9. Investigation in clinical potential of polarization sensitive optical coherence tomography in laryngeal tumor model study

    Science.gov (United States)

    Zhou, Xin; Oak, Chulho; Ahn, Yeh-Chan; Kim, Sung Won; Tang, Shuo

    2018-02-01

    Polarization-sensitive optical coherence tomography (PS-OCT) is capable of measuring tissue birefringence. It has been widely applied to access the birefringence in tissues such as skin and cartilage. The vocal cord tissue consists of three anatomical layers from the surface to deep inside, the epithelium that contains almost no collagen, the lamina propria that is composed with abundant collagen, and the vocalis muscle layer. Due to the variation in the organization of collagen fibers, the different tissue layers show different tissue birefringence, which can be evaluated by PS-OCT phase retardation measurement. Furthermore, collagen fibers in healthy connective tissues are usually well organized, which provides relatively high birefringence. When the collagen organization is destroyed by diseases such as tumor, the birefringence of the tissue will decrease. In this study, a rabbit laryngeal tumor model with different stages of tumor progression is investigated ex-vivo by PS-OCT. The PS-OCT images show a gradual decrease in birefringence from normal tissue to severe tumor tissue. A phase retardation slope-based analysis is conducted to distinguish the epithelium, lamina propria, and muscle layers, respectively. The phase retardation slope quantifies the birefringence in different layers. The quantitative study provides a more detailed comparison among different stages of the rabbit laryngeal tumor model. The PS-OCT result is validated by the corresponding histology images of the same samples.

  10. Clinical investigation of serum CEA in 120 patients with colorectal cancer

    International Nuclear Information System (INIS)

    Li Yusheng; Yang Liting; Yu Yunyun; Yu Suqing; Ma Shuqin

    2003-01-01

    To investigate the correlation between serum CEA and colorectal cancer, the pre-and postoperative serum CEA in 120 patients with colorectal cancer was measured by RIA, with other 24 cases of healthy donors as control. The results showed that serum CEA in control group and patient group were 9.84±2.44 ng/mL, 38, 85±19.21 ng/mL respectively, while colonic cancer group 37.43±18.58 ng/mL, rectal cancer group 39.72±20.67 ng/mL. There was significant difference between patient group and control group (P 0.05). Serum CEA of 37 among 44 cases with positive CEA findings decreased to 11.21±3.65 ng/mL during two months follow-up post-operation, whereas 50.63±24.38 ng/mL in 7/44 cases undergoing non-radical operation. The serum CEA of 41 recurrence cases was 43.12±17.15 ng/mL at six-year post-operation, with 87.80% of three-year recurrence rate. It suggested that the serum CEA test is a convenient method for colorectal cancer to preoperatively diagnose it, evaluate postoperative curative effect and detect tumor recurrence and metastasis

  11. Automated ultrasonic inspection using PULSDAT

    International Nuclear Information System (INIS)

    Naybour, P.J.

    1992-01-01

    PULSDAT (Portable Ultrasonic Data Acquisition Tool) is a system for recording the data from single probe automated ultrasonic inspections. It is one of a range of instruments and software developed by Nuclear Electric to carry out a wide variety of high quality ultrasonic inspections. These vary from simple semi-automated inspections through to multi-probe, highly automated ones. PULSDAT runs under the control of MIPS software, and collects data which is compatible with the GUIDE data display system. PULSDAT is therefore fully compatible with Nuclear Electric's multi-probe inspection systems and utilises all the reliability and quality assurance of the software. It is a rugged, portable system that can be used in areas of difficult access. The paper discusses the benefits of automated inspection and gives an outline of the main features of PULSDAT. Since April 1990 PULSDAT has been used in several applications within Nuclear Electric and this paper presents two examples: the first is a ferritic set-through nozzle and the second is an austenitic fillet weld. (Author)

  12. Measuring Outcomes of Clinical Care: Victorian Emergency Laparotomy Audit Using Quality Investigator.

    Science.gov (United States)

    Stevens, Claire L; Brown, Christopher; Watters, David A K

    2018-07-01

    The Australian and New Zealand Audit of Surgical Mortality (ANZASM) National Report 2015 found that within the cohort of audited deaths, 85% were emergencies with acute life-threatening conditions, and by far, the most common procedures were laparotomy and colorectal procedures. Emergency laparotomy outcomes have shown improvement through audit and reporting in the UK. The purpose of this study was to determine the outcome of emergency laparotomy in the state of Victoria, Australia. The Dr Foster Quality Investigator (DFQI) database was interrogated for a set of Australian Classification of Health Intervention (ACHI) codes defined by the authors as representing an emergency laparotomy. The dataset included patients who underwent emergency laparotomy from July 2007 to July 2016 in all Victorian hospitals. There were 23,115 emergency laparotomies conducted over 9 years in 66 hospitals. Inpatient mortality was 2036/23,115 (8.8%). Mortality in the adult population increased with age and reached 18.1% in those patients that were 80 years or older. 51.3% were females, and there was no significant difference in survival between genders. Patients with no recorded comorbidities had a mortality of 4.3%, whereas those with > 5 comorbidities had 19.3% mortality. Administrative data accessed via a tool such as DFQI can provide useful population data to guide further evidence-based improvement strategies. The mortality for emergency laparotomy within Victorian hospitals is comparable, if not better than that seen in overseas studies. There is a need to continue routine audit of mortality rates and implement systems improvement where necessary.

  13. Clinical course of cor pulmonale investigated after an interval of one year by thallium-201 myocardial SPECT scintigraphy

    International Nuclear Information System (INIS)

    Yamaoka, Shimpachi; Nishimura, Kouichi; Kuno, Kenshi; Yonekura, Yoshiharu; Koide, Harutoshi.

    1988-01-01

    Cor pulmonale was evaluated in 13 patients with chronic lung disease by thallium-201 myocardial SPECT scintigraphy together with pulmonary function tests and right heart catheterization. One year later, we performed this scintigraphy again to investigate the clinical course of the cor pulmonale. In 6 of 13 patients with respiratory failure (Pao 2 less than 60 Torr), a remarkable progression in cor pulmonale was noted after one year, despite outpatient oxygen therapy. If the patients were admitted because of acute exacerbation of respiratory failure, the cor pulmonale was found to have worsened. In contrast, patients with acute exacerbation due to respiratory infection or causes other than respiratory failure, showed little change in cor pulmonale. Although patients with a marked progression of cor pulmonale tended to have poor pulmonary function data and elevated pulmonary arterial pressure, the clinical course of cor pulmonale could not be predicted from the initial pulmonary function tests or right heart catheterization. (author)

  14. Investigating the mobilome in clinically important lineages of Enterococcus faecium and Enterococcus faecalis.

    Science.gov (United States)

    Mikalsen, Theresa; Pedersen, Torunn; Willems, Rob; Coque, Teresa M; Werner, Guido; Sadowy, Ewa; van Schaik, Willem; Jensen, Lars Bogø; Sundsfjord, Arnfinn; Hegstad, Kristin

    2015-04-10

    The success of Enterococcus faecium and E. faecalis evolving as multi-resistant nosocomial pathogens is associated with their ability to acquire and share adaptive traits, including antimicrobial resistance genes encoded by mobile genetic elements (MGEs). Here, we investigate this mobilome in successful hospital associated genetic lineages, E. faecium sequence type (ST)17 (n=10) and ST78 (n=10), E. faecalis ST6 (n=10) and ST40 (n=10) by DNA microarray analyses. The hybridization patterns of 272 representative targets including plasmid backbones (n=85), transposable elements (n=85), resistance determinants (n=67), prophages (n=29) and clustered regularly interspaced short palindromic repeats (CRISPR)-cas sequences (n=6) separated the strains according to species, and for E. faecalis also according to STs. RCR-, Rep_3-, RepA_N- and Inc18-family plasmids were highly prevalent and with the exception of Rep_3, evenly distributed between the species. There was a considerable difference in the replicon profile, with rep 17/pRUM , rep 2/pRE25 , rep 14/EFNP1 and rep 20/pLG1 dominating in E. faecium and rep 9/pCF10 , rep 2/pRE25 and rep 7 in E. faecalis strains. We observed an overall high correlation between the presence and absence of genes coding for resistance towards antibiotics, metals, biocides and their corresponding MGEs as well as their phenotypic antimicrobial susceptibility pattern. Although most IS families were represented in both E. faecalis and E. faecium, specific IS elements within these families were distributed in only one species. The prevalence of IS256-, IS3-, ISL3-, IS200/IS605-, IS110-, IS982- and IS4-transposases was significantly higher in E. faecium than E. faecalis, and that of IS110-, IS982- and IS1182-transposases in E. faecalis ST6 compared to ST40. Notably, the transposases of IS981, ISEfm1 and IS1678 that have only been reported in few enterococcal isolates were well represented in the E. faecium strains. E. faecalis ST40 strains harboured

  15. Investigation of the use of MOSFET for clinical IMRT dosimetric verification

    International Nuclear Information System (INIS)

    Chuang, Cynthia F.; Verhey, Lynn J.; Xia Ping

    2002-01-01

    With advanced conformal radiotherapy using intensity modulated beams, it is important to have radiation dose verification measurements prior to treatment. Metal oxide semiconductor field effect transistors (MOSFET) have the advantage of a faster and simpler reading procedure compared to thermoluminescent dosimeters (TLD), and with the commercial MOSFET system, multiple detectors can be used simultaneously. In addition, the small size of the detector could be advantageous, especially for point dose measurements in small homogeneous dose regions. To evaluate the feasibility of MOSFET for routine IMRT dosimetry, a comprehensive set of experiments has been conducted, to investigate the stability, linearity, energy, and angular dependence. For a period of two weeks, under a standard measurement setup, the measured dose standard deviation using the MOSFETs was ±0.015 Gy with the mean dose being 1.00 Gy. For a measured dose range of 0.3 Gy to 4.2 Gy, the MOSFETs present a linear response, with a linearity coefficient of 0.998. Under a 10x10 cm 2 square field, the dose variations measured by the MOSFETs for every 10 degrees from 0 to 180 degrees is ±2.5%. The percent depth dose (PDD) measurements were used to verify the energy dependence. The measured PDD using the MOSFETs from 0.5 cm to 34 cm depth agreed to within ±3% when compared to that of the ionization chamber. For IMRT dose verification, two special phantoms were designed. One is a solid water slab with 81 possible MOSFET placement holes, and another is a cylindrical phantom with 48 placement holes. For each IMRT phantom verification, an ionization chamber and 3 to 5 MOSFETs were used to measure multiple point doses at different locations. Preliminary results show that the agreement between dose measured by MOSFET and that calculated by Corvus is within 5% error, while the agreement between ionization chamber measurement and the calculation is within 3% error. In conclusion, MOSFET detectors are suitable for

  16. Missed Opportunities for TB Investigation in Primary Care Clinics in South Africa: Experience from the XTEND Trial.

    Directory of Open Access Journals (Sweden)

    Violet N Chihota

    Full Text Available 40 primary health clinics (PHCs in four provinces in South Africa, June 2012 -February 2013.To determine whether health care worker (HCW practice in investigating people with TB symptoms was altered when the initial test for TB was changed from smear microscopy to Xpert MTB/RIF.Cross-sectional substudy at clinics participating in a pragmatic cluster randomised trial, Xpert for TB: Evaluating a New Diagnostic "XTEND", which evaluated the effect of Xpert MTB/RIF implementation in South Africa.Consecutive adults exiting PHCs reporting at least one TB symptom (defined as any of cough, weight loss, night sweats and fever were enrolled. The main outcome was the proportion who self-reported having sputum requested by HCW during the clinic encounter just completed.3604 adults exiting PHCs (1676 in Xpert arm, 1928 in microscopy arm were enrolled (median age 38 years, 71.4% female, 38.8% reported being HIV-positive, 70% reported cough. For 1267 participants (35.2% the main reason for attending the clinic was TB symptom(s. Overall 2130/3604 (59.1% said they reported their symptom(s to HCW. 22.7% (818/3604 reported having been asked to give sputum for TB investigation. Though participants in the Xpert vs. microscopy arm were more likely to have sputum requested by HCW, this was not significantly different: overall (26.0% [436/1676] vs 19.8% [382/1928]; adjusted prevalence ratio [aPR] 1.31, [95% CI 0.78-2.20] and when restricted to those presenting at clinics due to symptoms (49.1% [260/530] vs 29.9% [220/737]; aPR 1.38 [0.89-2.13] and those reporting being HIV-positive (29.4% [190/647] vs 20.8% [156/749]; aPR 1.38[0.88-2.16]. Those attending clinic due to TB symptoms, were more likely to have sputum requested if they had increasing number of symptoms; longer duration of cough, unintentional weight loss and night sweats and if they reported symptoms to HCW.A large proportion of people exiting PHCs reporting TB symptoms did not get tested. Implementation of

  17. Improvement of foundation for inspection

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-08-15

    Japan Nuclear Energy Safety Organization has been carrying out improvement of inspection system for nuclear plants in Japan since 2003FY. The new inspection system was introduced into nuclear power plants in{sub -}2008FY. In this project, improvement of comprehensive plant performance assessment and management tool for the new inspection system are developed. In 2012FY, a trend analysis method of the plant performance was developed with reference to the IAEA literature. And the trend analysis was tried based on the results of the comprehensive plant performance assessment of all domestic plants except Fukushima-Daiichi Nuclear Power Station. In addition, the teaching materials for QMS training guideline were made. And improvement of a quality management system evaluation support tool was performed. (author)

  18. Ultrasonic inspection development at HEDL

    International Nuclear Information System (INIS)

    Day, C.K.; Mech, S.J.; Michaels, T.E.; Dixon, N.E.

    1978-01-01

    Ultrasonic testing methods and equipment are being developed to support preservice and in-service inspection of selected FFTF welds. A digital computer system is employed in the analysis of both simulated FFTF pipe sections and plate specimens containing fatigue cracks. It is anticipated that test evaluation standards containing fatigue cracks will partially eliminate questions formerly associated with weld test calibration producers by providing natural cracks which follow grain boundaries and stress patterns resembling piping situ conditions. Studies have revealed that commercial transducers may satisfy LMFBR ultrasonic pipe inspection applications: The test system evaluation included transducers and wedge coupling and fluid coupling materials which exhibited acceptable performance at temperatures to 2300C. Results are presented that demonstrate the feasibility of ultrasonic inspection of components immersed in sodium at temperatures to 2600C. (UK)

  19. [PICS: pharmaceutical inspection cooperation scheme].

    Science.gov (United States)

    Morénas, J

    2009-01-01

    The pharmaceutical inspection cooperation scheme (PICS) is a structure containing 34 participating authorities located worldwide (October 2008). It has been created in 1995 on the basis of the pharmaceutical inspection convention (PIC) settled by the European free trade association (EFTA) in1970. This scheme has different goals as to be an international recognised body in the field of good manufacturing practices (GMP), for training inspectors (by the way of an annual seminar and experts circles related notably to active pharmaceutical ingredients [API], quality risk management, computerized systems, useful for the writing of inspection's aide-memoires). PICS is also leading to high standards for GMP inspectorates (through regular crossed audits) and being a room for exchanges on technical matters between inspectors but also between inspectors and pharmaceutical industry.

  20. Holography for fast reactor inspection

    International Nuclear Information System (INIS)

    Tozer, B.A.

    1980-01-01

    Holography, an optical process whereby an image of the original subject can be reconstructed in three dimensions, is being developed for use as an optical inspection tool. With a potential information storage density of 10 16 bits/m 2 , the ability to reconstruct in 3 dimensions, a depth of field of up to 8 metres, extremely wide angle of view, and potentially diffraction limited resolution, holography should be invaluable for the optical recording of fast reactors during construction, and the inspection of optically accessible regions during operation, or maintenance down-times. The photographic emulsions used for high resolution holography are fine-grained and fog only very slowly when subjected to γ-radiation, so that inspection of highly radio-active regions and components can be effected satisfactorily. Some of the practical limitations affecting holography are described and ways of overcoming them discussed. Some preliminary results are presented. (author)

  1. Improvement of foundation for inspection

    International Nuclear Information System (INIS)

    2013-01-01

    Japan Nuclear Energy Safety Organization has been carrying out improvement of inspection system for nuclear plants in Japan since 2003FY. The new inspection system was introduced into nuclear power plants in - 2008FY. In this project, improvement of comprehensive plant performance assessment and management tool for the new inspection system are developed. In 2012FY, a trend analysis method of the plant performance was developed with reference to the IAEA literature. And the trend analysis was tried based on the results of the comprehensive plant performance assessment of all domestic plants except Fukushima-Daiichi Nuclear Power Station. In addition, the teaching materials for QMS training guideline were made. And improvement of a quality management system evaluation support tool was performed. (author)

  2. Validation of Sizewell ''B'' ultrasonic inspections -- Messages for performance demonstration

    International Nuclear Information System (INIS)

    Conroy, P.J.; Leyland, K.S.; Waites, C.

    1994-01-01

    At the time that the decisions leading to the construction of the Sizewell ''B'' plant were being made, public concern over the potential hazards of nuclear power was increasing. This concern was heightened by the accident at USA's Three Mile Island plant. The result of this and public pressure was that an extensive public inquiry was held in addition to the UK's normal licensing process. Part of the evidence to the inquiry supporting the safety case relied upon the ability of ultrasonic inspections to demonstrate that the Reactor Pressure Vessel (RPV) and other key components were free from defects that could threaten structural integrity. Evidence from a variety of trials designed to investigate the performance capability of ultrasonic inspection revealed that although ultrasonic inspection had the potential to satisfy this requirement its performance in practice was heavily dependent upon the details of application. It was therefore generally recognized that some form of inspection validation was required to provide assurance that the equipment, procedures and operators to be employed were adequate for purpose. The concept of inspection validation was therefore included in the safety case for the licensing of Sizewell ''B''. The UK validation trials covering the ultrasonic inspections of the Sizewell ''B'' PWR Reactor Pressure Vessel are now nearing completion. This paper summarizes the results of the RPV validations and considers some of the implications for ASME 11 Appendix 8 the US code covering performance demonstration

  3. Radiation control in the nondestructive inspection

    International Nuclear Information System (INIS)

    Kariya, Yukihiro

    1982-01-01

    In the early days of radiation nondestructive inspection about ten years ago, the loss of radiation sources and careless radiation exposure gave the impression of radiography inspection being immediately slipshod management. In this problem, the peculiar nature of the business in this field is involved. In Nondestructive Inspection Co., Ltd., besides the safety management of radioisotopes, the radiation exposure control of personnel in the regular inspection of nuclear power plants has become increasingly important. The following matters are described: radiation utilization in nondestructive inspection (X- and #betta#-ray radiography, #betta#-ray leak test on shield), radiation control problems in nondestructive inspection business (the peculiar aspects of the business, the analysis of the incidents related with nondestructive inspection), and the practice of radiation control in nondestructive inspection in Nondestructive Inspection Co., Ltd. (Mori, K.)

  4. Internal ultrasonic inspection of flexible pipe

    Energy Technology Data Exchange (ETDEWEB)

    Baltzersen, O. (IKU Petroleumsforskning A/S, Trondheim (Norway) Norwegian Inst. of Tech., Trondheim (Norway). Div. of Petroleum Engineering and Applied Geophysics); Waag, T.I. (IKU Petroleumsforskning A/S, Trondheim (Norway))

    1993-10-01

    Methods for internal ultrasonic inspection of flexible pipe have been investigated through experiments with a short sample of Coflexip pipe. Ultrasonic backscatter methods using normal and non-normal incidence have been used for qualitative high contrast ultrasonic imaging of the inner surface of the pipe. Analysis of the internal cross-section has been performed based on the use of a non-contact ultrasonic caliper, and processing procedures which enable calculation of, and compensation for, eccentricity of the tool in the pipe. The methods developed can be used to quantitatively estimate the thickness of the internal carcass, and perform high resolution topographic mapping of the inner surface. (Author)

  5. Distillation columns inspection through gamma scanning

    International Nuclear Information System (INIS)

    Garcia, Marco

    1999-09-01

    The application of nuclear energy is very wide and it allows the saving of economic resources since the investigation of a certain process is carried out without stop the plant. The gamma scanning of oil c racking c olumns are practical examples, they allow to determine the hydraulic operation of the inspected columns. A source of Co-60 22mCi and a detector with a crystal of INa(TI) are used. This paper shows the results got from a profile carried out in a column distillation

  6. Rail inspection of RCF defects

    Directory of Open Access Journals (Sweden)

    Z. Popović

    2013-10-01

    Full Text Available Rail defects due to rolling contact fatigue (RCF threaten the traffic safety around the world. That hazard is more distinct on railways without adequate maintenance strategy. Realization of interoperability of European railway network demands from every infrastructure manager to have a maintenance plan for the infrastructure subsystem. Besides that, this plan includes rail inspection and strategy against RCF defects. This paper emphasizes the importance of rail inspection and early detection of RCF because the most of RCF crack should be removed in rail grinding campaigns (preventive, cyclical and corrective activities during the whole rail service life.

  7. Evaluation of inservice inspection examinatiions

    International Nuclear Information System (INIS)

    Aldrich, D.A.; Cook, J.F.

    1990-05-01

    In order to evaluate the effectiveness of Section 11, Division 1, ''Rules for Inservice Inspection of Nuclear Power Plant Components,'' of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel Code examinations, 26 inservice inspection (ISI) summary reports from 24 facilities were reviewed. It was found that these ASME Code examinations and tests are instrumental in revealing indications and defects in welds and plant components. In addition, this study uncovered that fact that some of the Section 11 requirements are apparently not clear and are misunderstood by some of the facilities. Also, the need for more stringent requirements was evaluated and some Code changes are recommended

  8. Guided acoustic wave inspection system

    Science.gov (United States)

    Chinn, Diane J.

    2004-10-05

    A system for inspecting a conduit for undesirable characteristics. A transducer system induces guided acoustic waves onto said conduit. The transducer system detects the undesirable characteristics of the conduit by receiving guided acoustic waves that contain information about the undesirable characteristics. The conduit has at least two sides and the transducer system utilizes flexural modes of propagation to provide inspection using access from only the one side of the conduit. Cracking is detected with pulse-echo testing using one transducer to both send and receive the guided acoustic waves. Thinning is detected in through-transmission testing where one transducer sends and another transducer receives the guided acoustic waves.

  9. Holographic inspection of nuclear plant

    International Nuclear Information System (INIS)

    Gordon, A.L.; Armour, I.A.; Glanville, R.; Malcolm, G.J.; Wright, D.G.

    1988-01-01

    The high resolution, enormous depth of field and high tolerance to radiation of holography mean that it has great potential as an inspection tool in the nuclear industry. In addition, the ability of double-pulse holography to yield detailed information on vibration over the whole field of both large and small structures provides measurements that often cannot be obtained in any other way. This paper reviews the development of equipment for the holographic inspection of nuclear fuel elements; a portable holocamera for use inside reactors; and the application of holographic techniques for vibration measurements in a nuclear power station. (author)

  10. Operational phase of inspection prioritization

    International Nuclear Information System (INIS)

    Campbell, D.J.; Guthrie, V.H.; Flanagan, G.F.

    1986-01-01

    Inspectors must make many decisions on the allocation of their efforts. To date, these decisions have been made based upon their own judgment and guidance from inspection procedures. Our goal is to provide probabilistic risk assessment (PRA) information as an additional aid to inspectors. A structured approach for relating PRA information to specific inspection decisions has been developed. The use of PRA information as an aid in optimal decision making: (1) in response to the current plant status and (2) in the scheduling of effort over an extended period of time is considered

  11. RIMACS, Reactor Inspection Main Control System

    International Nuclear Information System (INIS)

    2008-01-01

    1 - Description of program or function: RIMACS prepares for automatic inspection files on each inspection item for the reactor. These automatic inspection files provide the data to move RIROB (Reactor Inspection Robot) with laser by interpreting the coordinates of LASPO (Laser Positioner) and the laser detecting device of RIROB in three dimensional space. In addition, when RIROB arrives at the inspecting location, the files provide all values of the manipulator's motions to acquire the ultrasonic data. RIMACS provides various modules in order to perform these complex functions, and the functions are programmed on graphic user interface for the convenience of the user. RIMACS provides various functions, such as insertion of reactor production data, selection of the reactor for inspection, the creation of automatic inspection file, the selection of the inspection item, inspection simulation, and automatic inspection procedures. It also provides all other functions, which are necessary for the inspection, such as operating program download and manual control of LASPO and RIROB, the inspection simulation and the inspection status display by means of the graphic screen, and SODAS (ultra-Sonic Data Acquisition System) drive verification. 2 - Methods: Moving path and operation procedures for inspection robot are generated automatically with Kinematics algorithm. 3 - Restrictions on the complexity of the problem: A graphics display with MS-Window capability is required

  12. Northeast Inspection Services, Inc. boresonic inspection system evaluation

    International Nuclear Information System (INIS)

    Nottingham, L.D.; Sabourin, P.F.; Presson, J.H.

    1993-04-01

    Turbine rotor reliability and remaining life assessment are continuing concerns to electric utilities. Over the years, boresonic inspection and evaluation have served as primary components in rotor remaining life assessment. Beginning with an evaluation of TREES by EPRI in 1982, a series of reports that document the detection and sizing capabilities of several boresonic systems have been made available. These studies should provide utilities with a better understanding of system performance and lead to improved reliability when predicting rotor remaining life. In 1990, the procedures followed for evaluating rotor boresonic performance capabilities were changed to transfer a greater portion of the data analysis function to the participating vendor. This change from previous policy was instituted so that the evaluation results would better reflect the ''final answer'' that a vendor would provide in a real rotor inspection and also to reduce the cost of an evaluation. Among the first vendors to participate in the new performance demonstration was Northeast Inspection Services, Inc. (NISI). The tests reported herein were conducted by NISI personnel under the guidelines of the new plan. Details of the new evaluation plan are also presented. Rotor bore blocks containing surface-connected fatigue cracks, embedded glass beads, and embedded radial-axial oriented disks were used in the evaluation. Data were collected during twenty-five independent passes through the blocks. The evaluation consisted of statistical characterization of the detection capabilities, flaw sizing and location accuracy, and repeatability of the inspection system. The results of the evaluation are included in this report

  13. Investigating the role of Clinical Nurse Consultants in one health district from multiple stakeholder perspectives: a cooperative inquiry.

    Science.gov (United States)

    Walsh, Kenneth; Bothe, Janine; Edgar, Denise; Beaven, Geraldine; Burgess, Bernadette; Dickson, Vhari; Dunn, Stephen; Horning, Lynda; Jensen, Janice; Kandl, Bronia; Nonu, Miriam; Owen, Fran; Moss, Cheryle

    2015-01-01

    The impetus for this research came from a group of 11 Clinical Nurse Consultants (CNCs) within a health service in NSW, Australia, who wanted to investigate the CNC role from multiple stakeholder perspectives. With support from academic researchers, the CNCs designed and implemented the study. The aim of this research project was to investigate the role of the CNC from the multiple perspectives of CNCs and other stakeholders who work with CNCs in the Health District. This was a co-operative inquiry that utilised qualitative descriptive research approach. Co-operative inquiry methods enabled 11 CNCs to work as co-researchers and to conduct the investigation. The co-researchers implemented a qualitative descriptive design for the research and used interviews (7) and focus groups (16) with CNC stakeholders (n = 103) to gather sufficient data to investigate the role of the CNC in the organisation. Thematic analysis was undertaken to obtain the results. The CNC role is invaluable to all stakeholders and it was seen as the "glue" which holds teams together. Stakeholder expectations of the CNC role were multiple and generally agreed. Five themes derived from the data are reported as "clinical leadership as core", "making a direct difference to patient care", "service development as an outcome", "role breadth or narrowness and boundaries", and "career development". There was clear appreciation of the work that CNCs do in their roles, and the part that the CNC role plays in achieving quality health outcomes. The role of the CNC is complex and the CNCs themselves often negotiate these complexities to ensure beneficial outcomes for the patient and organisation. For the wider audience this study has given further insights into the role of these nurses and the perspectives of those with whom they work.

  14. Advanced Inspection and Repair Welding Techniques for SCC Countermeasures

    International Nuclear Information System (INIS)

    Takagi, T.; Nishimoto, K.; Uchimoto, T.

    2012-01-01

    Feasibility studies of advanced inspection and repair welding techniques were conducted in the framework of the Nuclear and Industry Safety Agency of Japan (NISA) project on the enhancement of ageing management and maintenance of NPPs. In this paper, features of NDE methods investigated in the projects, main results of research activities and prospect of nickel based alloy weld inspection are discussed. We also make a review for the integrity and reliability evaluation techniques for repair welding of ageing plants which were intensively investigated in view of regulatory criteria, in NISA project. (author)

  15. The Nuclear Regulatory Commission's research reactor inspection program

    International Nuclear Information System (INIS)

    Constable, George L.

    1977-01-01

    The Division of Reactor Inspection Program's functional responsibilities are presented. The include (a) inspections and investigations necessary to determine whether licensees are complying with license provisions and rules, and to ascertain whether licensed operations are being conducted safely; (b) establishment of bases for the issuance or denial of a construction permit or license; (c) investigation of accidents, incidents, and theft or diversion of special nuclear materials; (d) enforcement actions; and (e) evaluation of licensed operations as a basis for recommending changes to standards and license conditions and for issuance of reports to the nuclear industry and the public

  16. Integrated inspection of services for people with learning disabilities in Scotland: the way forward?

    Directory of Open Access Journals (Sweden)

    Martin Campbell

    2007-10-01

    Full Text Available Purpose: The article summarises the process and the results of the first, integrated inspection of managed care services for people with learning disabilities in Scotland. The multi-agency model used was developed to be congruent with the existing performance inspection models, used by single agency inspection. The inspection activities and main outcomes are described, and suggestions are made for improvements. Context of case: In 2006 an inspection model was devised to assess the quality of health, social services and education services for people with learning disabilities in one geographical area of Scotland, as a precursor to a programme of inspections nationally. The first joint, integrated inspection of all services for people with learning disabilities in Scotland took place in June 2006, and the report was published in March 2007. This was the first multi-agency inspection of its kind in the UK, and the first to involve carers and people with learning disabilities on the inspection team. Data sources: A number of data sources were used to check existing practice against agreed Quality Outcome indicators. Primary sources of data were social work records, health records, education records, staff surveys, carer surveys, interviews with staff, family carers and people with learning disabilities, and self evaluations completed by the services being inspected. Eleven different domains, each with sub-indicators were investigated. Case description: This paper summarises the process of an integrated, multi-agency inspection, how the inspection activities were conducted and the main findings of this inspection. Practical improvements to the process are suggested, and these may be of use to other services and inspectorates. Conclusions and discussion: The integrated inspection was a qualified success. Most major objectives were achieved. The sharing of data amongst inspection agencies, establishing the level of commitment to integrated inspection

  17. Investigating the Experiences of Childhood Cancer Patients and Parents Participating in Optional Nontherapeutic Clinical Research Studies in the UK.

    Science.gov (United States)

    Errington, Julie; Malik, Ghada; Evans, Julie; Baston, Jenny; Parry, Annie; Price, Lisa; Johnstone, Hina; Peters, Selena; Oram, Victoria; Howe, Karen; Whiteley, Emma; Tunnacliffe, Jane; Veal, Gareth J

    2016-07-01

    While the majority of childhood cancer clinical trials are treatment related, additional optional research investigations may be carried out that do not directly impact on treatment. It is essential that these studies are conducted ethically and that the experiences of families participating in these studies are as positive as possible. A questionnaire study was carried out to investigate the key factors that influence why families choose to participate in optional nontherapeutic research studies, the level of understanding of the trials involved, and the experiences of participation. A total of 100 participants from six UK centers were studied; 77 parents, 10 patients >16 years, and 13 patients aged 8-15 years. Ninety-seven percent of parents and 90% of patients felt that information provided prior to study consent was of the right length, with 52% of parents and 65% of patients fully understanding the information provided. Seventy-four percent of parents participated in research studies in order to "do something important", while 74% of patients participated "to help medical staff". Encouragingly, <5% of participants felt that their clinical care would be negatively affected if they did not participate. Positive aspects of participation included a perception of increased attention from medical staff. Negative aspects included spending longer periods in hospital and the requirement for additional blood samples. Ninety-six percent of parents and 87% of patients would participate in future studies. The study provides an insight into the views of childhood cancer patients and their parents participating in nontherapeutic clinical research studies. Overwhelmingly, the findings suggest that participation is seen as a positive experience. © 2016 The Authors. Pediatric Blood & Cancer, published by Wiley Periodicals, Inc.

  18. Investigating the effect of clinical governess approach on patients' length of stay in emergency department: an action research study.

    Directory of Open Access Journals (Sweden)

    Tahmine Salehi

    2014-02-01

    Full Text Available Over the past decade, clinical governance approach with aims to improve the quality of health services has been proposed in Iran. Considering the obvious problems especially patients' length of stay (LOS in the emergency departments (EDs; the present study has been carried out with the purpose of Investigating the effect of clinical governess approach on patients' LOS in the one of the largest medical centers in the country. After the problem was specified by the 17 interviews with employees and managers of the ED; the emergency clinical governance committee was formed by two academic researchers and seven ED staff (key participants that had the most involvement with the subject of study. The activities of the committee, including planning, acting, observing and reflecting, was organized by using participatory action research approach and action research cycle (Kemmis 1995. During this time, three formal meetings with key participants were held in 6-month intervals. Monthly records of patients' average LOS and interview with ED staff were used to analyze the findings. The research was completed with two cycles in one year. Committee members took the following actions. As a result, the patients' LOS reduced from 2.68 days to 1.73 days. Make regular patients visits by medical groups especially orthopedists and neurologists; Decision making about patients situation by emergency physicians and transferring patients to the relevant units by bed managers; Refusing to admit elective patients during overcrowding times; to regulate the list of patients requiring ICU by anesthesiologists. Prolonged LOS can be due to various causes and a team approach, which is one of the requirements of clinical governance approach, is needed to manage it. The results showed that the multidisciplinary team could make positive changes and reduce LOS in emergency setting.

  19. Ankle foot orthosis-footwear combination tuning: an investigation into common clinical practice in the United Kingdom.

    Science.gov (United States)

    Eddison, Nicola; Chockalingam, Nachiappan; Osborne, Stephen

    2015-04-01

    Ankle foot orthoses are used to treat a wide variety of gait pathologies. Ankle foot orthosis-footwear combination tuning should be routine clinical practice when prescribing an ankle foot orthosis. Current research suggests that failure to tune ankle foot orthosis-footwear combinations can lead to immediate detrimental effect on function, and in the longer term, it may actually contribute to deterioration. The purpose of this preliminary study was to identify the current level of knowledge clinicians have in the United Kingdom regarding ankle foot orthosis-footwear combination tuning and to investigate common clinical practice regarding ankle foot orthosis-footwear combination tuning among UK orthotists. Cross-sectional survey. A prospective study employing a multi-item questionnaire was sent out to registered orthotists and uploaded on to the official website of British Association of Prosthetists and Orthotists to be accessed by their members. A total of 41 completed questionnaires were received. The results demonstrate that only 50% of participants use ankle foot orthosis-footwear combination tuning as standard clinical practice. The most prevalent factors preventing participants from carrying out ankle foot orthosis-footwear combination tuning are a lack of access to three-dimensional gait analysis equipment (37%) and a lack of time available in their clinics (27%). Although, ankle foot orthosis-footwear combination tuning has been identified as an essential aspect of the prescription of ankle foot orthoses, the results of this study show a lack of understanding of the key principles behind ankle foot orthosis-footwear combination tuning. © The International Society for Prosthetics and Orthotics 2014.

  20. Inservice Inspection in the Fugen

    OpenAIRE

    1983-01-01

    Pressure tube type reactors have specific components orstructures,compared with light water reactors.They are(1) steam drums(2) reactor inlet headers(3) reactor inlet and outlet pipies(4) pressure tubes.Much attention is paid upon Inservice Inspection (ISI)of the above components.

  1. Nuclear fuel shipping inspection device

    International Nuclear Information System (INIS)

    Takahashi, Toshio; Hada, Koji.

    1988-01-01

    Purpose: To provide an nuclear fuel shipping inspection device having a high detection sensitivity and capable of obtaining highly reliable inspection results. Constitution: The present invention concerns a device for distinguishing a fuel assembly having failed fuel rods in LMFBR type reactors. Coolants in a fuel assembly to be inspected are collected by a sampling pipeway and transferred to a filter device. In the filter device, granular radioactive corrosion products (CP) in the coolants are captured, to reduce the background. The coolants, after being passed through the filter device, are transferred to an FP catching device and gamma-rays of iodine and cesium nuclides are measured in FP radiation measuring device. Subsequently, the coolants transferred to a degasing device to separate rare gas FP in the coolants from the liquid phase. In a case if rare gas fission products are detected by the radiation detector, it means that there is a failed fuel rod in the fuel assembly to be inspected. Since the CP and the soluble FP are separated and extracted for the radioactivity measurement, the reliability can be improved. (Kamimura, M.)

  2. FAA Fluorescent Penetrant Laboratory Inspections

    Energy Technology Data Exchange (ETDEWEB)

    WINDES,CONNOR L.; MOORE,DAVID G.

    2000-08-02

    The Federal Aviation Administration Airworthiness Assurance NDI Validation Center currently assesses the capability of various non-destructive inspection (NDI) methods used for analyzing aircraft components. The focus of one such exercise is to evaluate the sensitivity of fluorescent liquid penetrant inspection. A baseline procedure using the water-washable fluorescent penetrant method defines a foundation for comparing the brightness of low cycle fatigue cracks in titanium test panels. The analysis of deviations in the baseline procedure will determine an acceptable range of operation for the steps in the inspection process. The data also gives insight into the depth of each crack and which step(s) of the inspection process most affect penetrant sensitivities. A set of six low cycle fatigue cracks produced in 6.35-mm thick Ti-6Al-4V specimens was used to conduct the experiments to produce sensitivity data. The results will document the consistency of the crack readings and compare previous experiments to find the best parameters for water-washable penetrant.

  3. Artificial Intelligence Assists Ultrasonic Inspection

    Science.gov (United States)

    Schaefer, Lloyd A.; Willenberg, James D.

    1992-01-01

    Subtle indications of flaws extracted from ultrasonic waveforms. Ultrasonic-inspection system uses artificial intelligence to help in identification of hidden flaws in electron-beam-welded castings. System involves application of flaw-classification logic to analysis of ultrasonic waveforms.

  4. Clinical Investigation Program.

    Science.gov (United States)

    1981-10-01

    0. Effect of VaStUS Medialis £1 Obliquus Strength on Chondromalacia Patella. (0) 17,󈨒 Kearney, J. 3. Human Irplantation of Intraocular q, Lenses. (C...to: . 8i I - rot rlo Sat : Te (,t- i ricl teo TI~i:I valuation of Iowor caitruiitctiral leediro (I o occpy Wie v,, I(V O V as an /’.,i~nct Lu Lori!;i...ntrations. Pht [l /, ’A ,,T-: ipididyral fat pads arc re ovcd fr . ra ;vit’ rI.1 . I -l fat cells are -repared Ly shakir c at 7 t for (f, "i. ,tcs iv

  5. Clinical Investigation Program Report.

    Science.gov (United States)

    1981-10-01

    Resident Surgical Instructional Experience. (T) 41 1979 Routine Use of Serum Uric Acid Levels at 36 Weeks Gestation as Screening Test for Preeclampsia as...Occup Med, 23(l):49-51, Jan 1981. Kleyn, J.G., Johnson, W.M. and Wetzler, T.F.: Microbial Aerosols and Actinomycetes in Etiological Considerations of...severe) complication in patients with fractures of the long bones and/or severe trauma. The etiological mechanism of this syndrome is still unsettled

  6. Clinical Investigation Program Report.

    Science.gov (United States)

    1983-10-01

    blood cell function in 48 noninsulin dependent diabetes melitus during improved control after treatment with insulin and after treatment using a m...underway comparing the activity of normal leukocytes with those from diabetic patients. ൦ -A2’ r,. L ") Detail Sum mary Sheet Date: 1 Oct83 Prot. No.: C...white blood cell function in non-insulin depeldent diabetes mellitus during improved control after treatment with insulin and after treatment using a

  7. Clinical Investigations Service.

    Science.gov (United States)

    1979-09-30

    to determine whether the distension of the abdomen with ’-)0 causes significant com- promise in patients’ airflow or limg vohme. We expect to see a...the abdominal cavity. Nitrous oxide will be introduced into the abdominal cavity. When adequate abdominal distension has been obtained, the...fails to accomplish the second trimester abortion within 24 hours, the intra- muscular IS methyl Prostaglandin F2a will be administered according to

  8. Clinical Investigation Program

    Science.gov (United States)

    1990-09-30

    87/351 C GOG 85 - Comparison of Hydroxyurea versus Cis- platinum and 5FU as an Adjunct to Radiation Therapy in Patients with Advanced Carcinoma of The...ST segment depression . Two patients have completed the study. These two individuals responded well to the study druq with marked improvement in

  9. Clinical Investigation Program.

    Science.gov (United States)

    1982-09-30

    J.J., Collins, M.T., Mc’Clatchy, J.K.: Urease Testing of Mycobacteria with BPCTK Radiometric Instrumentation. J Clin Micro 15:478-480, 1982.(C) Darato...on mnrT male dops. Three week-, later a two layer microsurgical anastr~mo-is isini 1l)-O nylon is completed. Three weeks later the dog i sacrific-ee...Human tumor cell lines are established in mono- layer culture. After purification and cell type varification, replicate cultures are subjected to

  10. Clinical Investigation Program.

    Science.gov (United States)

    1987-09-30

    Mexico , September 1987. Publications: None ! ~t 4, FAMC A.P.R. (RCS MED 300) Detail Summary Sheet (HSCR 40-23 as amended) (1) Date: 30 Sep 87 (2...Infection: A Prospective Study. Presented: 2nd Annual Symposium of the Rocky Moun-tain Flow Cytometry Users Group, Albuquerque, New Mexico , 10-11...COL, MC (9) Dept/Sv:Pe-at (10) Associate Tnvestigators (lI) Tey WoJr--s: Myron J. Levin, M.D. varicella vaccine U Co. HSC (12) Accumu tEve MEDCASE:* 1

  11. Clinical Investigation Program Report

    Science.gov (United States)

    1992-10-01

    alchemists claim of transmutation of metals by asserting the fundamental differen- ii ces of metals. His medical masterwork was the Canon which remained an...1992. Blount BW: Sexually transmitted disease update. Am Acad Fam Phy, Washington, DC, Oct 1991. Blount BW: A comparison of Family Practice content

  12. Clinical Investigation Program.

    Science.gov (United States)

    1979-10-01

    sympathomimetic amines (alpha, beta and dopamine , vasodilators, dextran, and diuretics). PROGRESS: The project has progressed well, and a preliminary...treatment of childhood psychosis (infantile autism , childhood schizophrenia, atypical development). TECHNICAL APPROACH: Children stabilized on a

  13. The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC): verification of nasal allergen challenge procedures in a study utilizing an investigational immunotherapy for cat allergy.

    Science.gov (United States)

    Neighbour, Helen; Soliman, Mena; Steacy, Lisa M; Hickey, Pascal; Forbes, Beth; Larché, Mark; Ellis, Anne K

    2018-01-01

    The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC) is a network of experienced Allergic Rhinitis (AR) researchers developing better research tools based on the nasal allergen challenge (NAC). A key objective of such is the ability to detect efficacy in a small population. AR-CIC sought to test its NAC protocol as a secondary objective in two small mechanistic research trials of a novel form of immunotherapy [Cat Peptide Antigen Desensitisation (Cat-PAD)] for which efficacy had previously been demonstrated. The primary objective (not presented here) was to identify potential biomarkers of efficacy for peptide immunotherapy, and this provided an ideal opportunity to corroborate the NAC protocol. We aim to clinically validate the AR-CIC NAC methodology in a pooled analysis of secondary endpoints measured in two open label mechanistic studies of cat allergic participants treated with Cat-PAD. Cat allergic AR sufferers with ongoing cat exposure were included. Participants had to demonstrate a total nasal symptom score (TNSS) of at least 8 (max 12) and/or achieve a reduction in peak nasal inspiratory flow (PNIF) of ≥ 50% during a screening titrated NAC. Eligible participants then underwent a baseline NAC visit with the allergen dose that produced a positive challenge at screening, followed by four monthly injections of 6 nmol Cat-PAD. A follow up NAC visit documented changes in nasal response 1 month following the completion of treatment. Nineteen subjects completed the study protocol in the two studies combined. Four injections of Cat-PAD resulted in a significant reduction in TNSS responses generated via NAC following allergen challenge (15 min p  < 0.05, 30 min p  < 0.05, 1 h p  < 0.01, 2 h p  < 0.05). There was modest correlation between symptom scores and PNIF measurements. This study supports the validity of the AR-CIC's optimised NAC protocol for conducting research of the potential efficacy of novel therapeutics in multi

  14. A retrospective review of how nonconformities are expressed and finalized in external inspections of health-care facilities.

    Science.gov (United States)

    Hovlid, Einar; Høifødt, Helge; Smedbråten, Bente; Braut, Geir Sverre

    2015-09-23

    External inspections are widely used in health care as a means of improving the quality of care. However, the way external inspections affect the involved organization is poorly understood. A better understanding of these processes is important to improve our understanding of the varying effects of external inspections in different organizations. In turn, this can contribute to the development of more effective ways of conducting inspections. The way the inspecting organization states their grounds for noncompliant behavior and subsequently follows up to enforce the necessary changes can have implications for the inspected organization's change process. We explore how inspecting organizations express and state their grounds for noncompliant behavior and how they follow up to enforce improvements. We conducted a retrospective review, in which we performed a content analysis of the documents from 36 external inspections in Norway. Our analysis was guided by Donabedian's structure, process, and outcome model. Deficiencies in the management system in combination with clinical work processes was considered as nonconformity by the inspecting organizations. Two characteristic patterns were identified in the way observations led to a statement of nonconformity: one in which it was clearly demonstrated how deficiencies in the management system could affect clinical processes, and one in which this connection was not demonstrated. Two characteristic patterns were also identified in the way the inspecting organization followed up and finalized their inspection: one in which the inspection was finalized solely based on the documented changes in structural deficiencies addressed in the nonconformity statement, and one based on the documented changes in structural and process deficiencies addressed in the nonconformity statement. External inspections are performed to improve the quality of care. To accomplish this aim, we suggest that nonconformities should be grounded by

  15. Implementation of a Quality Management System in regulatory inspection activities

    International Nuclear Information System (INIS)

    Pires do Rio, Monica; Ferreira, Paulo Roberto; Cunha, Paulo G. da; Acar, Maria Elizabeth

    2005-01-01

    The Institute for Radioprotection and Dosimetry - IRD -, of the Brazilian National Nuclear Energy Commission, CNEN, started in 2001, the implementation of a quality management system (SGQ), in the inspection, testing and calibration activities. The SGQ was an institutional guideline and is inserted in a larger system of management of the IRD started in 1999, with the adoption of the National Quality Award criteria - PNQ, within the Project for Excellence in Technological Research of Associacao Brasileira das Instituicoes de Pesquisas Tecnologicas - ABIPTI (Brazilian Association of Technological Research institutions). The proposed quality management system and adopted at the IRD was developed and implemented in accordance with the requirements of NBR ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, and ISO/IEC 17020 - General criteria for operation of various types of bodies performing inspections. For regulatory inspection activities, the quality system was implemented on three program inspection services of radiological protection led, respectively, by clinics and hospitals that operate radiotherapy services; industries that use nuclear gauges in their control or productive processes and power reactor operators (CNAAA) - just the environmental part. It was formed a pioneering team of inspectors for standardizing the processes, procedures and starting the implementation of the system in the areas. This work describes the implementation process steps, including difficulties, learning and advantages of the adoption of a quality management system in inspection activities

  16. A clinical study on the investigation of the cause of a patient's death after cardiopulmonary arrest on arrival

    International Nuclear Information System (INIS)

    Kato, Akihito; Sato, Keizo; Fujishiro, Masaya

    2011-01-01

    The investigation of the cause of a patient's death after cardiopulmonary arrest (CPA) on arrival usually requires an autopsy. In most areas in Japan, however, such an autopsy is rarely performed, except for those areas with a medical examiner system. No reports demonstrating how to investigate the cause of the patient's death after CPA on arrival were found to our knowledge. From September 1, 2007 to August 31, 2010, 1121 CPA patients died in spite of cardiopulmonary resuscitation in the Emergency and Critical Care Center at Showa University Fujigaoka Hospital. In this paper, causes of their death were reexamined using medical records, roentgenograms of their chest and abdomen in addition to computed tomography (CT) films when taken. Further, the means by which to investigate the cause of death was studied. The detailed reexamination resulted in the estimation for causes of 652 (58.2%) patients' death as follows: 67 cardiac, 61 aortic, 75 respiratory, 44 cerebral, 25 alimentary, 20 renal, 57 systemic diseases and 303 external deaths. Causes of 469 (41.8%) patients' death were unknown. Although CT examination was performed for 219 patients (26.0%), the cause of 75 patient deaths could not be estimated. Reexaminations of medical records revealed 379 prodromes of 300 CPA patients (26.8%), but no prodromes indicated any specific disease. Anamneses were partly useful for specifying causes of their death. On the other hand, CT examinations were highly useful for not only diagnosing the specific disease but also denying it. Even when causes of their death could not be specified, reexaminations of both CT findings and other clinical data resulted in possible diagnoses of the disease for most cases. The spread of a medical examiner system throughout Japan is the most desirable for investigating causes of CPA patients' death. The postmortem CT examination seems to be preferable for such an investigation. (author)

  17. 49 CFR 213.365 - Visual inspections.

    Science.gov (United States)

    2010-10-01

    ... initiate remedial action. (e) Each switch, turnout, track crossing, and lift rail assemblies on moveable bridges shall be inspected on foot at least weekly. The inspection shall be accomplished in accordance...

  18. CAT -- computer aided testing for resonant inspection

    International Nuclear Information System (INIS)

    Foley, David K.

    1998-01-01

    Application of computer technology relates to inspection and quality control. The computer aided testing (CAT) can be used to analyze various NDT technologies, such as eddy current, ultrasonics, and resonant inspection

  19. Allegheny County Housing and Community Environment Inspections

    Data.gov (United States)

    Allegheny County / City of Pittsburgh / Western PA Regional Data Center — Residential housing inspections and inspections in response to complaints for community environment problems, such as open vacant structures, vacant lots with...

  20. Machine vision inspection of railroad track

    Science.gov (United States)

    2011-01-10

    North American Railways and the United States Department of Transportation : (US DOT) Federal Railroad Administration (FRA) require periodic inspection of railway : infrastructure to ensure the safety of railway operation. This inspection is a critic...