Preliminary Experience with Small Animal SPECT Imaging on Clinical Gamma Cameras

Directory of Open Access Journals (Sweden)

P. Aguiar

2014-01-01

Full Text Available The traditional lack of techniques suitable for in vivo imaging has induced a great interest in molecular imaging for preclinical research. Nevertheless, its use spreads slowly due to the difficulties in justifying the high cost of the current dedicated preclinical scanners. An alternative for lowering the costs is to repurpose old clinical gamma cameras to be used for preclinical imaging. In this paper we assess the performance of a portable device, that is, working coupled to a single-head clinical gamma camera, and we present our preliminary experience in several small animal applications. Our findings, based on phantom experiments and animal studies, provided an image quality, in terms of contrast-noise trade-off, comparable to dedicated preclinical pinhole-based scanners. We feel that our portable device offers an opportunity for recycling the widespread availability of clinical gamma cameras in nuclear medicine departments to be used in small animal SPECT imaging and we hope that it can contribute to spreading the use of preclinical imaging within institutions on tight budgets.

Biocontamination Control for Spacesuit Garments - A Preliminary Study

Science.gov (United States)

Rhodes, Richard A.; Orndoff, Evelyne; Korona, F. Adam; Poritz, Darwin; Smith, Jelanie; Wong, Wing

2011-01-01

This paper outlines a preliminary study that was conducted to review, test, and improve on current space suit biocontamination control. Biocontamination from crew members can cause space suit damage and objectionable odors and lead to crew member health hazards. An understanding of the level of biocontamination is necessary to mitigate its effects. A series of tests were conducted with the intent of evaluating current suit materials, ground and on-orbit disinfectants, and potential commercial off-the-shelf antimicrobial materials. Included in this paper is a discussion of the test methodology, results, and analysis method.

Towards a preliminary design of the ITER plasma control system architecture

International Nuclear Information System (INIS)

Treutterer, W.; Rapson, C.J.; Raupp, G.; Snipes, J.; Vries, P. de; Winter, A.; Humphreys, D.A.; Walker, M.; Tommasi, G. de; Cinque, M.; Bremond, S.; Moreau, P.; Nouailletas, R.; Felton, R.

2017-01-01

Highlights: • ITER control requirements and use scenarios for initial plasma operation have been analysed. • Basic choices from conceptual design could be confirmed. • Architectural design considers dynamic structure changes. • All PCS components are integrated in an exception handling hierarchy. - Abstract: Design of the ITER plasma control system is proceeding towards its next – preliminary design – stage. During the conceptual design in 2013 an overall assessment of high-level control tasks and their relationships has been conducted. The goal of the preliminary design is to show, that a reasonable implementation of the proposed concepts exists which fulfills the high-level requirements and is suitable for realistic use cases. This verification is conducted with focus on the concrete use cases of early operation and first plasma, since these phases are mandatory for ITER startup. In particular, detailed control requirements and functions for commissioning and first plasma operation including breakdown, burn-through and ramp-up in L-mode, as well as for planned or exceptional shutdown are identified. Control functions related to those operational phases and the underlying control system architecture are modeled. The goal is to check whether the flexibility of the conceptual architectural approach is adequate also in consideration of the more elaborate definitions for control functions and their interactions. In addition, architecture shall already be prepared for extension to H-mode operation and burn-control, even if the related control functions are only roughly defined at the moment. As a consequence, the architectural design is amended where necessary and converted into base components and infrastructure services allowing to deploy control and exception handling algorithms for the concrete first-plasma operation.

Towards a preliminary design of the ITER plasma control system architecture

Energy Technology Data Exchange (ETDEWEB)

Treutterer, W., E-mail: Wolfgang.Treutterer@ipp.mpg.de [Max-Planck-Institut für Plasmaphysik, Boltzmannstraße 2, 85748 Garching (Germany); Rapson, C.J.; Raupp, G. [Max-Planck-Institut für Plasmaphysik, Boltzmannstraße 2, 85748 Garching (Germany); Snipes, J.; Vries, P. de; Winter, A. [ITER Organization, Route de Vinon sur Verdon, 13067 St Paul Lez Durance (France); Humphreys, D.A.; Walker, M. [General Atomics, PO Box 85608, San Diego, CA 92186-5608 (United States); Tommasi, G. de; Cinque, M. [CREATE/Università di Napoli Federico II, Napoli (Italy); Bremond, S.; Moreau, P.; Nouailletas, R. [Association CEA pour la Fusion Contrôlée, CEA Cadarache, 13108 St Paul les Durance (France); Felton, R. [CCFE Fusion Association, Culham Centre for Fusion Energy, Culham Science Centre, Oxfordshire, OX14 3DB (United Kingdom)

2017-02-15

Highlights: • ITER control requirements and use scenarios for initial plasma operation have been analysed. • Basic choices from conceptual design could be confirmed. • Architectural design considers dynamic structure changes. • All PCS components are integrated in an exception handling hierarchy. - Abstract: Design of the ITER plasma control system is proceeding towards its next – preliminary design – stage. During the conceptual design in 2013 an overall assessment of high-level control tasks and their relationships has been conducted. The goal of the preliminary design is to show, that a reasonable implementation of the proposed concepts exists which fulfills the high-level requirements and is suitable for realistic use cases. This verification is conducted with focus on the concrete use cases of early operation and first plasma, since these phases are mandatory for ITER startup. In particular, detailed control requirements and functions for commissioning and first plasma operation including breakdown, burn-through and ramp-up in L-mode, as well as for planned or exceptional shutdown are identified. Control functions related to those operational phases and the underlying control system architecture are modeled. The goal is to check whether the flexibility of the conceptual architectural approach is adequate also in consideration of the more elaborate definitions for control functions and their interactions. In addition, architecture shall already be prepared for extension to H-mode operation and burn-control, even if the related control functions are only roughly defined at the moment. As a consequence, the architectural design is amended where necessary and converted into base components and infrastructure services allowing to deploy control and exception handling algorithms for the concrete first-plasma operation.

Opioid detoxification : from controlled clinical trial to clinical practice

NARCIS (Netherlands)

Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

2010-01-01

Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

Response of lead-acid batteries to chopper-controlled discharge: Preliminary results

Science.gov (United States)

Cataldo, R. L.

1978-01-01

The preliminary results of simulated electric vehicle, chopper, speed controller discharge of a battery show energy output losses up to 25 percent compared to constant current discharges at the same average discharge current of 100 amperes. These energy losses are manifested as temperature rises during discharge, amounting to a two-fold increase for a 400-ampere pulse compared to the constant current case. Because of the potentially large energy inefficiency, the results suggest that electric vehicle battery/speed controller interaction must be carefully considered in vehicle design.

Preliminary performance test of control rod position indicator for ballscrew type CEDM

International Nuclear Information System (INIS)

Yoo, J. Y.; Kim, J. H.; Hu, H.; Lee, J. S.; Kim, J. I.

2003-01-01

The reliability and accuracy of the information on control rod position are very important to the reactor safety and the design of the core protection system. A survey on the RSPT(Reed Switch Position Transmitter) type control rod position indication system and its actual implementation in the exiting nuclear power plants in Korea was performed first. The prototype of control rod position indicator having the high performance for the ballscrew type CEDM was developed on the basis of RSPT technology identified through the survey. The characteristics of control rod position indicator was defined and documented through design procedure and preliminary performance test

Polymerase chain reaction in the diagnosis of tuberculous meningitis: preliminary report

Directory of Open Access Journals (Sweden)

L.R. Machado

1994-09-01

Full Text Available In this preliminary report the results of PCR for detection of DNA sequences (65 KDa antigen of Mycobacterium tuberculosis in CSF samples from 20 patients are registered. In 10 patients there were clinical and laboratory findings suggesting the diagnosis of tuberculous meningitis (test group. In the other 10 patients, clinical and laboratory findings suggested meningitis or meningo-encephalitis from other etiologies (control group. In 7 patients from the test group antigenic DNA sequences of Mycobacterium tuberculosis were found in CSF by PCR; positive results were not registered in the control group.

Clinical and neuroimaging correlates of antiphospholipid antibodies in multiple sclerosis: a preliminary study

Directory of Open Access Journals (Sweden)

Gonzalez-Toledo Eduardo

2007-10-01

Full Text Available Abstract Background The presence of antiphospholipid antibodies (APLA in multiple sclerosis (MS patients has been reported frequently but no clear relationship between APLA and the clinical and neuroimaging features of MS have heretofore been shown. We assessed the clinical and neuroimaging features of MS patients with plasma APLA. Methods A consecutive cohort of 24 subjects with relapsing-remitting (RR MS were studied of whom 7 were in remission (Rem and 17 in exacerbation (Exc. All subjects were examined and underwent MRI of brain. Patients' plasma was tested by standard ELISA for the presence of both IgM and IgG antibodies using a panel of 6 targets: cardiolipin (CL, β2 glycoprotein I (β2GPI, Factor VII/VIIa (FVIIa, phosphatidylcholine (PC, phosphatidylserine (PS and phosphatidylethanolamine (PE. Results In exacerbation up to 80% of MS subjects had elevated titers of IgM antibodies directed against the above antigens. However, in remission, less than half of MS patients had elevated titers of IgM antibodies against one or more of the above antigens. This difference was significant, p Conclusion The findings of this preliminary study show that increased APLA IgM is associated with exacerbations of MS. Currently, the significance of this association in pathogenesis of MS remains unknown. However, systematic longitudinal studies to measure APLA in larger cohorts of patients with relapsing-remitting MS, particularly before and after treatment with immunomodulatory agents, are needed to confirm these preliminary findings.

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.

Quality control of software in dissimilar systems using a common clinical data base

International Nuclear Information System (INIS)

Erickson, J.J.; Price, R.R.; Touya, J.J.; Kronenberg, M.W.; Pederson, R.; Rollo, F.D.

1980-01-01

For a long time there has been widespread interest in the quality control of diagnostic instrumentation. The increasing dependence on computational systems for clinical results makes it imperative that methods for quality control of diagnostic software be developed. This paper proposes a method based on the use of a collection of patient studies for which the results have been corroborated by independent methods. The data set will be distributed in a format requiring no special handling by the system being tested and will appear identical to studies actually collected by the host system. An example of the use of a preliminary version of the data set for comparison of two systems is shown. The comparison shows that analyses performed on the two systems agree very well and can be reliably compared for follow-up studies of a patient

Feasibility and preliminary effectiveness of ice therapy in patients with an acute tear in the gastrocnemius muscle: a pilot randomized controlled trial.

Science.gov (United States)

Prins, Jan C M; Stubbe, Janine H; van Meeteren, Nico L U; Scheffers, Frans A; van Dongen, Martien C J M

2011-05-01

To investigate the feasibility of a randomized controlled trial and the preliminary effectiveness of ice therapy in the acute phase of a gastrocnemius tear for the quality of functional recovery. A pilot version of an intended prospective randomized controlled clinical trial was conducted. A total of 19 patients with an acute tear in the gastrocnemius muscle were randomly allocated to either active or control treatment. The intervention consisted of the repeated application of crushed ice. Primary outcome measures were functional capacity and reconvalescence time. Secondary outcome measures were pain and work absenteeism. The number of patients we could include within the 6-hour time window and dropping out from the pilot study were regarded as indicators of the feasibility of ice therapy. A total of 16 patients were excluded from the study because diagnosis was not made within 6 hours after onset of the complaint. The 19 patients included completed the treatment. For functional capacity, reconvalescence time, work absenteeism and pain relief, no significant differences between the intervention and control group were found. The execution of a randomized controlled trial on ice therapy for acute gastrocnemius tear is feasible though quite an enterprise. First, it is recommended to improve the recruitment processes. Second, power analysis demands inclusion of 396 participants. Preliminary effectiveness in our limited-sized trial indicates that the use of ice is not beneficial for people who receive ice therapy.

A hand-held imaging probe for radio-guided surgery: physical performance and preliminary clinical experience

International Nuclear Information System (INIS)

Pitre, S.; Menard, L.; Charon, Y.; Solal, M.; Garbay, J.R.

2003-01-01

Improvements in the specificity of radiopharmaceutical compounds have been paralleled by an upsurge of interest in developing small detectors to assist surgeons in localizing tumour tissue during surgery. This study reports the main technical features and physical characteristics of a new hand-held gamma camera dedicated to accurate and real-time intra-operative imaging. First clinical experience is also reported. The POCI (Per-operative Compact Imager) camera consists of a head module composed of a high-resolution interchangeable lead collimator and a CsI(Na) crystal plate optically coupled to an intensified position-sensitive diode. The current prototype has a 40-mm diameter field of view, an outer diameter of 9.5 cm, a length of 9 cm and a weight of 1.2 kg. Overall detector imaging characteristics were evaluated by technetium-99m phantom measurements. Three patients with breast cancer previously scheduled to undergo sentinel lymph node detection were selected for the preliminary clinical experience. Preoperative images of the lymphatic basin obtained using the POCI camera were compared with conventional transcutaneous explorations using a non-imaging gamma probe. The full-width at half-maximum (FWHM) spatial resolution was investigated in both air and scattering medium; when the phantom was placed in contact with the collimator, the POCI camera exhibited a 3.2 mm FWHM. The corresponding sensitivity was 290 cps/MBq. The preliminary clinical results showed that POCI was able to predict the number and location of all SLNs. In one case, two deep radioactive nodes missed by the gamma probe were detected on the intra-operative images. This very initial experience demonstrates that the physical performance of the POCI camera is adequate for radio-guided surgery. These results are sufficiently encouraging to prompt further evaluation studies designed to determine the specific and optimal clinical role of intra-operative imaging devices

Preliminary design for hot dirty-gas control-valve test facility. Final report

Energy Technology Data Exchange (ETDEWEB)

1980-01-01

This report presents the results of a preliminary design and cost estimating effort for a facility for the testing of control valves in Hot Dirty Gas (HDGCV) service. This design was performed by Mittelhauser Corporation for the United States Department of Energy's Morgantown Energy Technology Center (METC). The objective of this effort was to provide METC with a feasible preliminary design for a test facility which could be used to evaluate valve designs under simulated service conditions and provide a technology data base for DOE and industry. In addition to the actual preliminary design of the test facility, final design/construction/operating schedules and a facility cost estimate were prepared to provide METC sufficient information with which to evaluate this design. The bases, assumptions, and limitations of this study effort are given. The tasks carried out were as follows: METC Facility Review, Environmental Control Study, Gas Generation Study, Metallurgy Review, Safety Review, Facility Process Design, Facility Conceptual Layout, Instrumentation Design, Cost Estimates, and Schedules. The report provides information regarding the methods of approach used in the various tasks involved in the completion of this study. Section 5.0 of this report presents the results of the study effort. The results obtained from the above-defined tasks are described briefly. The turnkey cost of the test facility is estimated to be $9,774,700 in fourth quarter 1979 dollars, and the annual operating cost is estimated to be $960,000 plus utilities costs which are not included because unit costs per utility were not available from METC.

123I-tyrosine-(A14)-insulin: preparation and preliminary clinical studies

International Nuclear Information System (INIS)

Pantev, T.; Virgolini, I.; Sinzinger, H.; Prager, R.; Neuhold, N.; Angelberger, P.; Banyai, M.; Knoebl, P.; Vienna Univ.

1991-01-01

Insulin was radioiodinated with 123 I ( 123 I-tyrosine-(A14)-insulin) to a specific activity of 1 μg/mCi, corresponding to 0.025 I.U. of insulin/mCi. This preparation was used for in vitro binding experiments with adipose tissue, showing active binding to the two subunits of the known insulin receptor. In a preliminary clinical investigation, 5 adipose patients with (n = 2) and without (n = 3) diabetes mellitus Type II, were subject to in vivo injection of the same radiolabeled product using 3 mCi/patient. During the first minutes of dynamic imaging, the liver was the major organ of tracer uptake in all patients. Furthermore, the pancreas, and in one patient the kidneys, were visualised. Further studies on insulin in vivo kinetics and quantification are under way. (authors)

Neurodevelopmental delay among children under the age of three years at immunization clinics in Lagos State, Nigeria - Preliminary report.

Science.gov (United States)

Bakare, Muideen O; Bello-Mojeed, Mashudat A; Munir, Kerim M; Ogun, Oluwayemi C; Eaton, Julian

2016-04-29

Late diagnosis and interventions characterize childhood neurodevelopmental disorders in Sub-Saharan Africa. This has negatively impacted on the prognosis of the children with neurodevelopmental disorders. This study examined the prevalence and pattern of neurodevelopmental delays among children under the age of 3 years attending immunization clinics in Lagos State, Nigeria and also affords opportunity of early follow-up and interventions, which had been documented to improve prognosis. The study involved two stage assessments; which consisted of first phase screening of the children for neurodevelopmental delays in immunization clinics at primary healthcare centers Lagos State, Nigeria and second phase which consists of definitive clinical evaluation and follow-up interventions for children screened positive for neurodevelopmental delays. Twenty seven (0.9%) of a total of 3,011 children under the age of 3 years were screened positive for neurodevelopmental delays and subsequently undergoing clinical evaluation and follow-up interventions. Preliminary working diagnoses among these children include cerebral palsy, autism spectrum disorder trait, nutritional deficiency, Down syndrome and Non-specific neurodevelopmental delay with co-morbid seizure disorder accounting for 33.3%, 14.8%, 18.5%, 7.4% and 25.9% respectively. This is a preliminary report that would be followed up with information on medium and long term intervention phase.

Virtual reality therapy versus cognitive behavior therapy for social phobia: a preliminary controlled study.

Science.gov (United States)

Klinger, E; Bouchard, S; Légeron, P; Roy, S; Lauer, F; Chemin, I; Nugues, P

2005-02-01

Social phobia is one of the most frequent mental disorders and is accessible to two forms of scientifically validated treatments: anti-depressant drugs and cognitive behavior therapies (CBT). In this last case, graded exposure to feared social situations is one of the fundamental therapeutic ingredients. Virtual reality technologies are an interesting alternative to the standard exposure in social phobia, especially since studies have shown its usefulness for the fear of public speaking. This paper reports a preliminary study in which a virtual reality therapy (VRT), based on exposure to virtual environments, was used to treat social phobia. The sample consisted of 36 participants diagnosed with social phobia assigned to either VRT or a group-CBT (control condition). The virtual environments used in the treatment recreate four situations dealing with social anxiety: performance, intimacy, scrutiny, and assertiveness. With the help of the therapist, the patient learns adapted cognitions and behaviors in order to reduce anxiety in the corresponding real situations. Both treatments lasted 12 weeks, and sessions were delivered according to a treatment manual. Results showed statistically and clinically significant improvement in both conditions. The effect-sizes comparing the efficacy of VRT to the control traditional group-CBT revealed that the differences between the two treatments are trivial.

Prevalence of xerostomia in an adolescent inpatient psychiatric clinic: a preliminary study.

Science.gov (United States)

Kaur, Manvir; Himadi, Elaine; Chi, Donald L

2016-01-01

Adolescents with psychiatric conditions may be at risk for xerostomia. In this preliminary study, we estimated xerostomia prevalence in adolescents ages 9 to 17 years from an inpatient psychiatric clinic (N = 25) and examined whether: (1) gender and age were associated with xerostomia and (2) xerostomia was associated with self-reported cavities. We used a modified 11-item Xerostomia Index to identify xerostomia (no/yes) and asked if adolescents ever had or currently have cavities (no/yes). The mean age was 14 years (SD = 2.3) and 72% were male. Sixty percent reported xerostomia (SD = 50). There were no significant associations between xerostomia and gender (p = 0.99) or age (p = 0.66), or between xerostomia and past (p = 0.26) or current cavities (p = 0.11). Larger proportions of adolescents with xerostomia reported previous and current cavities. Sixty percent of adolescents from an inpatient psychiatric clinic reported having xerostomia, which may lead to increased caries risk over time. Additional research should examine the prevalence and consequences of xerostomia in high-risk adolescents. © 2015 Special Care Dentistry Association and Wiley Periodicals, Inc.

Performance adaptive training control strategy for recovering wrist movements in stroke patients: a preliminary, feasibility study

Directory of Open Access Journals (Sweden)

Sandini Giulio

2009-12-01

Full Text Available Abstract Background In the last two decades robot training in neuromotor rehabilitation was mainly focused on shoulder-elbow movements. Few devices were designed and clinically tested for training coordinated movements of the wrist, which are crucial for achieving even the basic level of motor competence that is necessary for carrying out ADLs (activities of daily life. Moreover, most systems of robot therapy use point-to-point reaching movements which tend to emphasize the pathological tendency of stroke patients to break down goal-directed movements into a number of jerky sub-movements. For this reason we designed a wrist robot with a range of motion comparable to that of normal subjects and implemented a self-adapting training protocol for tracking smoothly moving targets in order to facilitate the emergence of smoothness in the motor control patterns and maximize the recovery of the normal RoM (range of motion of the different DoFs (degrees of Freedom. Methods The IIT-wrist robot is a 3 DoFs light exoskeleton device, with direct-drive of each DoF and a human-like range of motion for Flexion/Extension (FE, Abduction/Adduction (AA and Pronation/Supination (PS. Subjects were asked to track a variable-frequency oscillating target using only one wrist DoF at time, in such a way to carry out a progressive splinting therapy. The RoM of each DoF was angularly scanned in a staircase-like fashion, from the "easier" to the "more difficult" angular position. An Adaptive Controller evaluated online performance parameters and modulated both the assistance and the difficulty of the task in order to facilitate smoother and more precise motor command patterns. Results Three stroke subjects volunteered to participate in a preliminary test session aimed at verify the acceptability of the device and the feasibility of the designed protocol. All of them were able to perform the required task. The wrist active RoM of motion was evaluated for each patient at the

Overview of the preliminary design of the ITER plasma control system

Science.gov (United States)

Snipes, J. A.; Albanese, R.; Ambrosino, G.; Ambrosino, R.; Amoskov, V.; Blanken, T. C.; Bremond, S.; Cinque, M.; de Tommasi, G.; de Vries, P. C.; Eidietis, N.; Felici, F.; Felton, R.; Ferron, J.; Formisano, A.; Gribov, Y.; Hosokawa, M.; Hyatt, A.; Humphreys, D.; Jackson, G.; Kavin, A.; Khayrutdinov, R.; Kim, D.; Kim, S. H.; Konovalov, S.; Lamzin, E.; Lehnen, M.; Lukash, V.; Lomas, P.; Mattei, M.; Mineev, A.; Moreau, P.; Neu, G.; Nouailletas, R.; Pautasso, G.; Pironti, A.; Rapson, C.; Raupp, G.; Ravensbergen, T.; Rimini, F.; Schneider, M.; Travere, J.-M.; Treutterer, W.; Villone, F.; Walker, M.; Welander, A.; Winter, A.; Zabeo, L.

2017-12-01

An overview of the preliminary design of the ITER plasma control system (PCS) is described here, which focusses on the needs for 1st plasma and early plasma operation in hydrogen/helium (H/He) up to a plasma current of 15 MA with moderate auxiliary heating power in low confinement mode (L-mode). Candidate control schemes for basic magnetic control, including divertor operation and kinetic control of the electron density with gas puffing and pellet injection, were developed. Commissioning of the auxiliary heating systems is included as well as support functions for stray field topology and real-time plasma boundary reconstruction. Initial exception handling schemes for faults of essential plant systems and for disruption protection were developed. The PCS architecture was also developed to be capable of handling basic control for early commissioning and the advanced control functions that will be needed for future high performance operation. A plasma control simulator is also being developed to test and validate control schemes. To handle the complexity of the ITER PCS, a systems engineering approach has been adopted with the development of a plasma control database to keep track of all control requirements.

Indirect zirconia-reinforced lithium silicate ceramic CAD/CAM restorations: Preliminary clinical results after 12 months.

Science.gov (United States)

Zimmermann, Moritz; Koller, Christina; Mehl, Albert; Hickel, Reinhard

2017-01-01

No clinical data are available for the new computer-aided design/computer-assisted manufacture (CAD/CAM) material zirconia-reinforced lithium silicate (ZLS) ceramic. This study describes preliminary clinical results for indirect ZLS CAD/CAM restorations after 12 months. Indirect restorations were fabricated, using the CEREC method and intraoral scanning (CEREC Omnicam, CEREC MCXL). Sixty-seven restorations were seated adhesively (baseline). Sixty restorations were evaluated after 12 months (follow-up), using modified FDI criteria. Two groups were established, according to ZLS restorations' post-processing procedure prior to adhesive seating: group I (three-step polishing, n = 32) and group II (fire glazing, n = 28). Statistical analysis was performed with Mann-Whitney U test and Wilcoxon test (P  .05). Statistically significant differences were found for criteria surface gloss for group I and group II (Mann-Whitney U test, P < .05). This study demonstrates ZLS CAD/CAM restorations have a high clinical success rate after 12 months. A longer clinical evaluation period is necessary to draw further conclusions.

Diagnosis of breast cancer using elastic-scattering spectroscopy: preliminary clinical results

Science.gov (United States)

Bigio, Irving J.; Brown, Stephen G.; Briggs, Gavin M.; Kelley, Christine; Lakhani, Sunil; Pickard, David; Ripley, Paul M.; Rose, Ian; Saunders, Christobel

2000-04-01

We report on the first stages of a clinical study designed to test elastic-scattering spectroscopy, medicated by fiberoptic probes, for three specific clinical applications in breast-tissue diagnosis: (1) a transdermal-needle (interstitial) measurement for instant diagnosis with minimal invasiveness similar to fine-needle aspiration but with sensitivity to a larger tissue volume, (2) a hand-held diagnostic probe for use in assessing tumor/resection margins during open surgery, and (3) use of the same probe for real-time assessment of the `sentinel' node during surgery to determine the presence or absence of tumor (metastatic). Preliminary results from in vivo measurements on 31 women are encouraging. Optical spectra were measured on 72 histology sites in breast tissue, and 54 histology sites in sentinel nodes. Two different artificial intelligence methods of spectral classification were studied. Artificial neural networks yielded sensitivities of 69% and 58%, and specificities of 85% and 93%, for breast tissue and sentinel nodes, respectively. Hierarchical cluster analysis yielded sensitivities of 67% and 91%, and specificities of 79% and 77%, for breast tissue and sentinel nodes, respectively. These values are expected to improve as the data sets continue to grow and more sophisticated data preprocessing is employed. The study will enroll up to 400 patients over the next two years.

Preliminary Experimental Results for Indirect Vector-Control of Induction Motor Drives with Forced Dynamics

Directory of Open Access Journals (Sweden)

Jan Vittek

2003-01-01

Full Text Available The contribution presents an extension of indirect vector control of electric drives employing induction motors to 'Forced Dynamic Control'. This method of control offers an accurate realisation of dynamic response profiles, which can be selected by the user. The developed system can be integrated into a drive with a shaft position encoder or a shaft sensoriess drive, in which only the stator currents are measured. The applied stator voltages are determined by a computed inverter switching algorithm. Simulation results and preliminary experimental results for indirect vector control of an idle running induction motor indicate good agreement with the theoretical predictions.

The relationship between self-control, job satisfaction and life satisfaction in Chinese employees: A preliminary study.

Science.gov (United States)

Dou, Kai; Nie, Yan-Gang; Wang, Yu-Jie; Liu, Yao-Zhong

2016-01-01

Previous studies have demonstrated that self-control is positively related to life satisfaction, but this association in Chinese employees and its underlying mechanism are less commonly investigated. In this preliminary study the relationships between self-control and life satisfaction and the mediating effect of job satisfaction were tested. Participants were 482 full-time employees (188 male, 294 female) from different cities in China. They answered self-report questionnaires online that assessed self-control, job satisfaction, and life satisfaction. Path analyses were conducted and bootstrap technique was used to judge the significance of the mediation. Self-control was positively related to both job and life satisfaction. More importantly, job satisfaction significantly mediated the association between self-control and life satisfaction. Furthermore, there was no significant difference in the size of the mediating effect between intrinsic and extrinsic job satisfaction. Results of this preliminary study provide further evidence of the positive association between self-control and life satisfaction. Job satisfaction is found to mediate this relationship.

78 FR 42520 - Control Technology, Inc.; Notice of Preliminary Permit Application Accepted for Filing and...

Science.gov (United States)

2013-07-16

... Technology, Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications On December 18, 2012, Control Technology, Inc. filed an... lower reservoir, (3) a reinforced concrete penstock with intake/outlet structure in the upper reservoir...

Preliminary clinical results from the EORTC 11961 trial at the petten irradiation facility

International Nuclear Information System (INIS)

Sauerwein, W.; Hideghety, K.; Vries, M.J. de

2000-01-01

Based on the pre-clinical work of the European Collaboration on Boron Neutron Capture Therapy a study protocol was prepared in 1995 to initiate Boron Neutron Capture Therapy (BNCT) in patients at the High Flux Reactor (HFR) in Petten. Bio-distribution and pharmacokinetics data of the boron drug Na 2 B 12 H 11 SH (BSH) as well as the radiobiological effects of BNCT with BSH in healthy brain tissue of dogs were considered in designing the strategy for this clinical Phase I trial. The primary goal of the radiation dose escalation study is the investigation of possible adverse events due to BNCT; i.e. to establish the dose limiting toxicity and the maximal tolerated radiation dose. The treatment is delivered in 4 fractions at a defined average boron concentration in blood. After an observation period of at least 6 months, the dose is increased by 10% for the next cohort. The preliminary results of the first cohort are presented here. The evaluated dose level can be considered to be safe. (author)

Preliminary clinical results with the ISL laser

Science.gov (United States)

Hoppeler, Thomas; Gloor, Balder

1992-08-01

The ISL laser (Intelligent Surgical Lasers, Inc.), a Nd:YLF picosecond pulse laser, is currently being used under investigational device exemption to perform microsurgery of the anterior segment of the eye. At different study sites procedures for cataract fragmentation and iridotomy, as well as for posterior capsulotomy after cataract surgery, are under evaluation. Other potential applications include: sclerostomy ab interno, the cutting of membranes in the anterior and posterior segment of the eye; corneal incisions; and corneal intrastromal effects. We discuss various clinically relevant aspects of the use of this picosecond laser. An overview of different computer controlled laser patterns is given.

Preliminary psychometric properties of the brief Negative Symptom Scale in youth at Clinical High-Risk for psychosis.

Science.gov (United States)

Strauss, Gregory P; Chapman, Hannah C

2018-03-01

Preliminary psychometric properties of an adapted version of the Brief Negative Symptom Scale (BNSS) are reported in youth at Clinical High-Risk for psychosis (CHR). Participants included 29 CHR youth who met criteria for a prodromal syndrome on the Structured Interview for Prodromal Syndromes (SIPS). The adapted BNSS demonstrated excellent internal consistency, convergent validity, and discriminant validity, suggesting that the BNSS has utility for assessing negative symptoms in a CHR population. Copyright © 2017 Elsevier B.V. All rights reserved.

A preliminary, controlled investigation of magnesium L-aspartate hydrochloride for illicit cocaine and opiate use in methadone-maintained patients.

Science.gov (United States)

Margolin, Arthur; Kantak, Kathleen; Copenhaver, Michael; Avants, S Kelly

2003-01-01

Based on pre-clinical studies suggesting that magnesium (Mg) reduces cocaine self-administration and potentiates the antinociceptive effects of morphine, we conducted a preliminary randomized clinical trial investigating Mg for the treatment of illicit cocaine and opiate use. Eighteen methadone-maintained patients who used illicit opiates and cocaine received either Mg (732 mg/day) or placebo for 12 weeks. Overall, findings showed that the percentage of urine screens testing positive for opiates in the Mg group (22.6%) was half that of the placebo group (46.4%), p = .04; the difference was even greater in the "medication compliant" sample (Mg: 16.3%, placebo: 47.9%), p = .02. Cocaine craving was lower in the Mg compared to the placebo group, but there was no difference between groups in cocaine use. These preliminary findings suggest that Mg may have a beneficial effect for reducing illicit opiate use. It is possible that a higher dose of Mg than was used in this study may be needed to decrease cocaine use.

Preliminary Marine Safety Risk Assessment, Brandon Road Lock and Dam Invasive Species Control Measures

Science.gov (United States)

2016-12-01

Decision makers must include control-measure monitoring and emergency “interventions” to insure safety. The Coast Guard operational commanders...system” incorporates a travelling car on a rail above the barge-loading wharf to prevent loading personnel, cargo surveyors, or others from falling...to the Gulf of Mexico . As “Loopers”, they will have already transited the CSSC electric barriers. Preliminary Marine Safety Risk Assessment, BRLD

Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial.

Science.gov (United States)

Sahebnasagh, Adeleh; Ghasemi, Arash; Akbari, Jafar; Alipour, Abbas; Lashkardoost, Hossein; Ala, Shahram; Salehifar, Ebrahim

2017-11-01

Acute radiation proctitis (ARP) is a common side-effect that affects up to 50% of patients receiving radiotherapy. The aim of this study was to evaluate the role of a topical preparation of Aloe vera in the treatment of ARP induced by radiotherapy of pelvic area. In this double-blind placebo-controlled trial, 20 consecutive patients with ARP after external-beam radiation therapy (46-72 Gy) of pelvic malignancies were randomized to receive either Aloe vera 3% or placebo ointment, 1 g twice daily for 4 weeks. These patients presented with at least two of the following symptoms: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. These symptoms were rated by the patients in terms of their severity (grade 0-4) for each of the symptoms mentioned earlier at baseline and then weekly for 4 weeks. A symptom index was calculated by the addition of the scores (16 most symptomatic). Radiation Therapy Oncology Group (RTOG) acute toxicity criteria and psychosocial status of the patients were also recorded weekly. The lifestyle impact of the symptoms was assessed by questionnaire grading from 0 (no effect on daily activity) to 4 (afraid to leave home). There was a significant (p Aloe vera) for diarrhea (median score: 0.67 vs. 0.11), fecal urgency (median score: 0.89 vs. 0.11), clinical presentation total (median score: 4.33 vs. 1.22), RTOG total (median score: 2.89 vs. 0.89), and lifestyle (median score: 1.1 vs. 0.33). Hemorrhage and abdominal/rectal pain did not improve significantly. The odds ratios for advantage of Aloe vera over placebo for "clinical presentation total" and "RTOG total" were 3.97 (1.3-11.9) and 5.9 (1.6-21.6), respectively. A substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment.

Greenridge Multi-Pollutant Control Project Preliminary Public Design Report

Energy Technology Data Exchange (ETDEWEB)

Connell, Daniel P

2009-01-12

the commercial readiness of an emissions control system that is specifically designed to meet the environmental compliance requirements of these smaller coal-fired EGUs. The multi-pollutant control system is being installed and tested on the AES Greenidge Unit 4 (Boiler 6) by a team including CONSOL Energy Inc. as prime contractor, AES Greenidge LLC as host site owner, and Babcock Power Environmental Inc. as engineering, procurement, and construction contractor. All funding for the project is being provided by the U.S. Department of Energy, through its National Energy Technology Laboratory, and by AES Greenidge. AES Greenidge Unit 4 is a 107 MW{sub e} (net), 1950s vintage, tangentially-fired, reheat unit that is representative of many of the 440 smaller coal-fired units identified above. Following design and construction, the multi-pollutant control system will be demonstrated over an approximately 20-month period while the unit fires 2-4% sulfur eastern U.S. bituminous coal and co-fires up to 10% biomass. This Preliminary Public Design Report is the first in a series of two reports describing the design of the multi-pollutant control facility that is being demonstrated at AES Greenidge. Its purpose is to consolidate for public use all available nonproprietary design information on the Greenidge Multi-Pollutant Control Project. As such, the report includes a discussion of the process concept, design objectives, design considerations, and uncertainties associated with the multi-pollutant control system and also summarizes the design of major process components and balance of plant considerations for the AES Greenidge Unit 4 installation. The Final Public Design Report, the second report in the series, will update this Preliminary Public Design Report to reflect the final, as-built design of the facility and to incorporate data on capital costs and projected operating costs.

Gut microbiota diversity and T1DM onset: Preliminary data of a case-control study

Directory of Open Access Journals (Sweden)

Deborah Traversi

2017-12-01

Full Text Available Type-1 diabetes incidence is increasing during the last decades. Recently, a role of microbiota alteration is proposed as pre-diabetic and diabetic risk factor. A bicentric case-control study is in progress in Northern Italy. Here preliminary results are shown. The microbiome clusterization showed a division between cases and controls even if fingerprint profiles are heterogenic. Methanobrevibacter smithii is highly present only in few patients. The diversity index and the microorganism sequenced in cases and controls, seems to be quite dissimilar. The conclusive results could show a significant predictive value for the bio-indicators evaluated. Keywords: Type 1 diabetes mellitus, Microbiota, Children, Methanobrevibacter smithii, qRT-PCR

Preliminary validation and principal components analysis of the Control of Eating Questionnaire (CoEQ) for the experience of food craving.

Science.gov (United States)

Dalton, M; Finlayson, G; Hill, A; Blundell, J

2015-12-01

The Control of Eating Questionnaire (CoEQ) comprises 21-items that are designed to assess the severity and type of food cravings an individual experiences over the previous 7 days. The CoEQ has been used in clinical trials as a multi-dimensional measure of appetite, craving and mood regulation however its underlying component structure has yet to be determined. The current paper has two aims; (1) to examine the psychometric properties, and internal consistency of the CoEQ; and (2) to provide a preliminary examination of the underlying components by exploring their construct and predictive validity. Data were pooled from four studies in which a total 215 adults (80% women; Age=29.7 ± 10.3; BMI=26.5 ± 5.2) had completed the CoEQ alongside measures of psychometric eating behaviour traits, ad libitum food intake, and body composition. A principal components analysis (PCA) and parallel analysis was conducted to examine the underlying structure of the questionnaire. The resulting subscales were tested for internal consistency (Cronbach's α=0.66-0.88). PCA revealed four components that explained 54.5% of the variance. The components were identified as: Craving Control, Positive Mood, Craving for Sweet, and Craving for Savoury. Associations between the underlying CoEQ subscales and measures of body composition and eating behaviour traits confirmed construct validity of the subscales. The associations between the subscales and snack food selection and intake of palatable snack foods supported the CoEQ's predictive validity. The CoEQ has good psychometric properties with a clear component structure and acceptable internal consistency. This preliminary validation supports the CoEQ as a measure of the experience of food cravings.

Design of a Tablet Computer App for Facilitation of a Molecular Blood Culture Test in Clinical Microbiology and Preliminary Usability Evaluation.

Science.gov (United States)

Samson, Lasse L; Pape-Haugaard, Louise; Meltzer, Michelle C; Fuchs, Martin; Schønheyder, Henrik C; Hejlesen, Ole

2016-03-18

User mobility is an important aspect of the development of clinical information systems for health care professionals. Mobile phones and tablet computers have obtained widespread use by health care professionals, offering an opportunity for supporting the access to patient information through specialized applications (apps) while supporting the mobility of the users. The use of apps for mobile phones and tablet computers may support workflow of complex tasks, for example, molecular-based diagnostic tests in clinical microbiology. Multiplex Blood Culture Test (MuxBCT) is a molecular-based diagnostic test used for rapid identification of pathogens in positive blood cultures. To facilitate the workflow of the MuxBCT, a specialized tablet computer app was developed as an accessory to the diagnostic test. The app aims to reduce the complexity of the test by step-by-step guidance of microscopy and to assist users in reaching an exact bacterial or fungal diagnosis based on blood specimen observations and controls. Additionally, the app allows for entry of test results, and communication thereof to the laboratory information system (LIS). The objective of the study was to describe the design considerations of the MuxBCT app and the results of a preliminary usability evaluation. The MuxBCT tablet app was developed and set up for use in a clinical microbiology laboratory. A near-live simulation study was conducted in the clinical microbiology laboratory to evaluate the usability of the MuxBCT app. The study was designed to achieve a high degree of realism as participants carried out a scenario representing the context of use for the MuxBCT app. As the MuxBCT was under development, the scenario involved the use of molecular blood culture tests similar to the MuxBCT for identification of microorganisms from positive blood culture samples. The study participants were observed, and their interactions with the app were recorded. After the study, the participants were debriefed to

Does mindfulness have potential in eating disorders prevention? A preliminary controlled trial with young adult women.

Science.gov (United States)

Atkinson, Melissa J; Wade, Tracey D

2016-06-01

This preliminary randomized controlled trial assessed the feasibility of a pilot mindfulness-based intervention with respect to reducing the risk of eating disorders in young women. Forty-four young adult women with body image concerns (Mage  = 20.57, SD = 3.22) were randomly allocated to a mindfulness-based or a dissonance-based intervention (3 × 1 h weekly sessions), or to assessment-only control. Self-report measures of eating disorder risk factors, symptoms and related psychosocial impairment were compared at baseline, post-intervention, and at 1- and 6-month follow up. At post-intervention, acceptability ratings for both interventions were high. Mindfulness participants demonstrated statistically significant improvements relative to control at post-intervention for weight and shape concern, dietary restraint, thin ideal internalization, eating disorder symptoms and related psychosocial impairment; however, these gains were largely lost over follow up. Dissonance participants did not show statistically significant improvements relative to control on any outcomes, despite small to moderate effect sizes. These preliminary findings demonstrate the acceptability and short-term efficacy of a mindfulness-based approach to reducing the risk of disordered eating in young women. This provides support for the continued evaluation of mindfulness in the prevention and early intervention of eating disorders, with increased efforts to produce maintenance of intervention gains. © 2014 Wiley Publishing Asia Pty Ltd.

Sexual health clinics for women led by specialist nurses or senior house officers in a central London GUM service: a randomised controlled trial.

Science.gov (United States)

Miles, K; Penny, N; Mercey, D; Power, R

2002-04-01

To assess the care process and clinical outcomes for two different models of GUM clinic for women: one led by specialist nurses and the other by senior house officers (SHOs). An open randomised controlled trial was carried out in a central London genitourinary medicine (GUM) women's clinic. Of 1172 women telephoning for an appointment, 880 were randomised to provide 169 eligible patients in the specialist nurse arm and 178 in the SHO arm. Of the eligible patients a total of 224 attended their appointment. The clinical records of the randomised women were audited for adequacy of care according to local guidelines. 30 key variables were objectively assessed and recorded on a standard audit form. An overall unitary index score (%) was calculated for each patient. The main variables associated with the outcome of specialist nurse and SHO decision making (diagnostic test request, preliminary diagnosis, and treatment provided) were then analysed independently. The median documentation audit scores for specialist nurses (n=103) and SHOs (n=121) were 92% and 85% respectively (pnurses' documentation was significantly (pnurses performed equally to the SHOs with regard to requesting the correct diagnostic tests, providing the correct preliminary diagnosis, and providing the correct treatment. A model of care using trained GUM nurses working within agreed protocols can provide comprehensive patient care for female patients that is equal to care provided by SHOs. Our results raise important issues regarding advanced GUM nursing education and training, protocol development, and accountability.

Controlled clinical trial of cannabidiol in Huntington's disease.

Science.gov (United States)

Consroe, P; Laguna, J; Allender, J; Snider, S; Stern, L; Sandyk, R; Kennedy, K; Schram, K

1991-11-01

Based on encouraging preliminary findings, cannabidiol (CBD), a major nonpsychotropic constituent of Cannabis, was evaluated for symptomatic efficacy and safety in 15 neuroleptic-free patients with Huntington's Disease (HD). The effects of oral CBD (10 mg/kg/day for 6 weeks) and placebo (sesame oil for 6 weeks) were ascertained weekly under a double-blind, randomized cross-over design. A comparison of the effects of CBD and placebo on chorea severity and other therapeutic outcome variables, and on a Cannabis side effect inventory, clinical lab tests and other safety outcome variables, indicated no significant (p greater than 0.05) or clinically important differences. Correspondingly, plasma levels of CBD were assayed by GC/MS, and the weekly levels (mean range of 5.9 to 11.2 ng/ml) did not differ significantly over the 6 weeks of CBD administration. In summary, CBD, at an average daily dose of about 700 mg/day for 6 weeks, was neither symptomatically effective nor toxic, relative to placebo, in neuroleptic-free patients with HD.

A single mothers' group for mothers of children attending an outpatient psychiatric clinic: preliminary results.

Science.gov (United States)

McNamee, J E; Lipman, E L; Hicks, F

1995-09-01

To provide a preliminary report of data from 2 support groups for single mothers, all of whom were mothers of children attending a child outpatient psychiatric clinic. The groups' 2 purposes were: 1. to assess the feasibility of adding structured evaluation to a common clinical intervention; 2. to improve single mothers' parenting skills through raised levels of self-esteem, increased capacity for family functioning and reduced levels of depression. Three structured evaluation instruments were used to measure the domains of self-esteem, family functioning and depression. These instruments were given to both groups of women on 3 occasions: 1. before the group; 2. after the group; 3. at a follow-up session 4 months after group termination. Open-ended questions were also asked at group termination. The questionnaire response rate was 100%; overall response rate for the 3 open-ended questions was 89%. Comparisons of pre-group and post-group scores showed that there was a significant increase in self-esteem (p parenting skills. Methodologic concerns and future directions are discussed.

Physiotherapy-led arthroplasty review clinic: a preliminary outcomes analysis.

Science.gov (United States)

Large, Kate E; Page, Carolyn J; Brock, Kim; Dowsey, Michelle M; Choong, Peter F M

2014-11-01

With the rising demand for Orthopaedics in the healthcare sector, service delivery innovations need to be explored to accommodate the increasing workload. Senior Musculoskeletal Physiotherapists have the specialised skills in the assessment of musculoskeletal conditions to determine the impact of surgery on patient outcomes. The aim of the present study was to compare outcomes between a physiotherapy-led arthroplasty review clinic (PT clinic) and the traditional model of orthopaedic surgeon review (OS clinic) after hip and knee replacement. This study was a retrospective case-controlled audit using a comprehensive database. Twenty-four patients who had a hip arthroplasty and 52 patients who had a knee arthroplasty were reviewed solely by the PT clinic at 3, 6 and 12 months after surgical reviews. These patients were matched 1:2 against patients seen only by the OS clinic. The outcome measures included International Knee Score (IKS), Harris Hip Score (HHS) and the Short Form (SF)-12. There were no significant differences in HHS or SF-12 scores for patients after hip arthroplasty. Significant differences for knee arthroplasty were observed favouring the PT clinic; IKS, PT clinic 147.6 (37.07), OS clinic 135.4 (35.68), P≤0.01, and physical component of the SF-12, PT clinic 41.98 (10.45), OS clinic 37.20 (10.44), Pphysiotherapy-led arthroplasty review clinic appears to be a safe and effective service alternative to reviews conducted by orthopaedic surgeons. WHAT IS KNOWN ABOUT THE TOPIC?: Osteoarthritis (OA) is a leading cause of musculoskeletal pain and disability and the burden of the disease is rapidly increasing. Joint arthroplasty surgery is the mainstay of treatment for people with end-stage OA; it is a high-cost, high-volume procedure that dominates surgical wait lists around Australia. Long-term follow up is encouraged by the Arthroplasty Society of Australia and endorsed by the Australian Orthopaedics Association, but it is acknowledged that it is impossible

Preliminary clinical results of locoregional hyperthermia for primary and secondary bone tumors

Energy Technology Data Exchange (ETDEWEB)

Zhu, J.L.; Nagata, Yasushi; Kanamori, Shuichi; Mitsumori, Michihide; Okuno, Yoshishige; Horii, Naotoshi; Nishimura, Yasumasa; Masunaga, Shinitiro; Hiraoka, Masahiro [Kyoto Univ. (Japan). Graduate School of Medicine

2000-03-01

Nineteen primary and secondary bone tumors in 16 patients were treated with hyperthermia plus radiotherapy and/or chemotherapy between 1982 and 1997 at Kyoto University Hospital. The thermometric and clinical results were analyzed retrospectively. In 55 of 86 hyperthermia sessions, the intratumor temperature was measured using a thermometer. Of the 19 tumors, 16 (84%) received heat treatment 4-7 times, and 3 (16%) received 1 or 2 treatments of hyperthermia. The mean maximum, mean minimum and average intratumor temperatures were 42.9, 40.4 and 41.6 deg C, respectively, and 12 (67%) reached a tumor maximum temperature above 42.5 deg C. The durations that intratumor points exceeded 42, 41 and 40 deg C were 27, 34 and 38 min, respectively. The local tumor response to treatment was assessed using X-ray computed tomography. The local response rate was 16% and the local pain relief rate was 63%. The 1-year cumulative survival rate was 60%. Our preliminary results indicated that thermoradiotherapy and thermochemotherapy are clinicaly feasible and potentially beneficial in the management of locally advanced bone tumors. (author)

Quality control of radiation therapy in clinical trials

International Nuclear Information System (INIS)

Kramer, S.; Lustig, R.; Grundy, G.

1983-01-01

The RTOG is a group of participating institutions which has a major interest in furthering clinical radiation oncology. They have formulated protocols for clinical investigation in which radiation therapy is the major modality of treatment. In addition, other modalities, such as chemotherapy, radiation sensitizers, and hyperthermia, are used in combined approach to cancer. Quality control in all aspects of patient management is necessary to insure quality data. These areas include evaluation of pathology, physics, and dosimetry, and clinical patient data. Quality control is both time consuming and expensive. However, by dividing these tasks into various levels and time frames, by using computerized data-control mechanisms, and by employing appropriate levels of ancillary personnel expertise, quality control can improve compliance and decrease the cost of investigational trials

An Algorithm for Glaucoma Screening in Clinical Settings and Its Preliminary Performance Profile

Directory of Open Access Journals (Sweden)

S-Farzad Mohammadi

2013-01-01

Full Text Available Purpose: To devise and evaluate a screening algorithm for glaucoma in clinical settings. Methods: Screening included examination of the optic disc for vertical cupping (≥0.4 and asymmetry (≥0.15, Goldmann applanation tonometry (≥21 mmHg, adjusted or unadjusted for central corneal thickness, and automated perimetry. In the diagnostic step, retinal nerve fiber layer imaging was performed using scanning laser polarimetry. Performance of the screening protocol was assessed in an eye hospital-based program in which 124 non-physician personnel aged 40 years or above were examined. A single ophthalmologist carried out the examinations and in equivocal cases, a glaucoma subspecialist′s opinion was sought. Results: Glaucoma was diagnosed in six cases (prevalence 4.8%; 95% confidence interval, 0.01-0.09 of whom five were new. The likelihood of making a definite diagnosis of glaucoma for those who were screened positively was 8.5 times higher than the estimated baseline risk for the reference population; the positive predictive value of the screening protocol was 30%. Screening excluded 80% of the initial population. Conclusion: Application of a formal screening protocol (such as our algorithm or its equivalent in clinical settings can be helpful in detecting new cases of glaucoma. Preliminary performance assessment of the algorithm showed its applicability and effectiveness in detecting glaucoma among subjects without any visual complaint.

Preliminary description of aging cats and dogs presented to a New Zealand first-opinion veterinary clinic at end-of-life.

Science.gov (United States)

Gates, M C; Hinds, H J; Dale, A

2017-11-01

AIMS To conduct a preliminary investigation into the chronic disease conditions and clinical signs present in aging New Zealand companion animals at end-of-life and to describe the timing, circumstances, and manner of death. METHODS The medical records database of a first-opinion, companion animal, veterinary practice in Auckland, New Zealand was searched to identify all canine and feline patients ≥7 years of age that were subjected to euthanasia or cremated in the period between July 2012-June 2014. The free-text medical notes were analysed for information on the circumstances surrounding the death, previous diagnoses of chronic disease conditions, and the presence of clinical signs associated with decreased quality-of-life at the time of euthanasia. RESULTS The median age at death was 15 (max 22) years for the 130 cats and 12 (max 17) years for the 68 dogs in the study sample. Euthanasia at the clinic was carried out for 119/130 (91%) cats and 62/68 (91%) dogs, with the remainder recorded as having an unassisted death. The frequency of deaths was highest during December for both cats and dogs. Cost was mentioned as an issue in the medical records for 39/181 (21.6%) patients that were subjected to euthanasia. At the time of euthanasia, 92/119 (77.3%) cats and 43/62 (69.4%) dogs were recorded as having >1 clinical sign associated with a decreased quality-of-life. Inappetence and non-specific decline were the two most commonly recorded clinical signs for both dogs and cats. Cardiovascular disease (44/130, 34%), renal failure (40/130, 31%), and malignant neoplasia (36/130, 28%) were the most common chronic disease conditions recorded for cats. Degenerative joint disease (22/68, 32%), malignant neoplasia (14/68, 21%), and cardiovascular disease (8/68, 12%) were the most common chronic disease conditions recorded for dogs. CONCLUSIONS AND CLINICAL RELEVANCE These preliminary findings highlight that aging companion animals in New Zealand frequently have chronic

Applying Statistical Process Control to Clinical Data: An Illustration.

Science.gov (United States)

Pfadt, Al; And Others

1992-01-01

Principles of statistical process control are applied to a clinical setting through the use of control charts to detect changes, as part of treatment planning and clinical decision-making processes. The logic of control chart analysis is derived from principles of statistical inference. Sample charts offer examples of evaluating baselines and…

Method of preliminary localization of the iris in biometric access control systems

Science.gov (United States)

Minacova, N.; Petrov, I.

2015-10-01

This paper presents a method of preliminary localization of the iris, based on the stable brightness features of the iris in images of the eye. In tests on images of eyes from publicly available databases method showed good accuracy and speed compared to existing methods preliminary localization.

Oats in the Diet of Children with Celiac Disease: Preliminary Results of a Double-Blind, Randomized, Placebo-Controlled Multicenter Italian Study

Directory of Open Access Journals (Sweden)

Simona Gatti

2013-11-01

Full Text Available A gluten-free diet (GFD is currently the only available treatment for patients with celiac disease (CD. Several clinical trials have demonstrated that most celiac patients can tolerate a medium-high quantity of oats without any negative clinical effects; however, the inclusion of oats in GFD is still a matter of debate. In this study, Italian children with CD were enrolled in a 15-month, randomized, double-blind, placebo-controlled multicenter trial. Participants were randomized in two groups following either A-B treatment (6 months of diet “A”, 3 months of standard GFD, 6 months of diet “B”, or B-A treatment (6 months of diet “B”, 3 months of standard GFD, 6 months of diet “A”. A and B diets included gluten-free (GF products (flour, pasta, biscuits, cakes and crisp toasts with either purified oats or placebo. Clinical data (Gastrointestinal Symptoms Rate Scale [GSRS] score and intestinal permeability tests (IPT, were measured through the study period. Although the study is still blinded, no significant differences were found in GSRS score or the urinary lactulose/mannitol (L/M ratio between the two groups after 6 months of treatment. These preliminary results suggest that the addition of non-contaminated oats from selected varieties in the treatment of children with CD does not determine changes in intestinal permeability and gastrointestinal symptoms.

MR elastography of the liver at 3.0 T in diagnosing liver fibrosis grades; preliminary clinical experience.

Science.gov (United States)

Yoshimitsu, Kengo; Mitsufuji, Toshimichi; Shinagawa, Yoshinobu; Fujimitsu, Ritsuko; Morita, Ayako; Urakawa, Hiroshi; Hayashi, Hiroyuki; Takano, Koichi

2016-03-01

To clarify the usefulness of 3.0-T MR elastography (MRE) in diagnosing the histological grades of liver fibrosis using preliminary clinical data. Between November 2012 and March 2014, MRE was applied to all patients who underwent liver MR study at a 3.0-T clinical unit. Among them, those who had pathological evaluation of liver tissue within 3 months from MR examinations were retrospectively recruited, and the liver stiffness measured by MRE was correlated with histological results. Institutional review board approved this study, waiving informed consent. There were 70 patients who met the inclusion criteria. Liver stiffness showed significant correlation with the pathological grades of liver fibrosis (rho = 0.89, p 3.0-T clinical MRE was suggested to be sufficiently useful in assessing the grades of liver fibrosis. MR elastography may help clinicians assess patients with chronic liver diseases. Usefulness of 3.0-T MR elastography has rarely been reported. Measured liver stiffness correlated well with the histological grades of liver fibrosis. Measured liver stiffness was also affected by necroinflammation, but to a lesser degree. 3.0-T MRE could be a non-invasive alternative to liver biopsy.

Memory-Focused Cognitive Therapy for Cocaine Use Disorder: Theory, Procedures and Preliminary Evidence From an External Pilot Randomised Controlled Trial

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John Marsden

2018-03-01

Full Text Available Background: Cocaine use disorder (CUD is a debilitating condition with no NICE-recommended medication or specific psychosocial interventions. In the United Kingdom (UK, general counselling (treatment-as-usual; TAU is widely delivered, but has limited effectiveness. We tested the feasibility, safety and preliminary efficacy of a novel, adjunctive psychosocial intervention for CUD, called ‘memory-focused cognitive therapy’ (MFCT. Methods: We did a two-arm, external pilot randomised controlled trial at a specialist community National Health Service addictions clinic in London, UK. 30 adults (≥18 years, voluntarily seeking treatment for CUD (enrolled ≥14 days; all with moderate-to-severe DSM5 CUD, were individually randomised (1:1 to a control group (ongoing TAU; 3 × 90 min CUD cognitive conceptualisation assessments; 2 × 30 min cocaine-related cue-induction procedures; and 3 × 30 min research follow-ups; or to an intervention group (ongoing TAU; 3 × 90 min cognitive conceptualisation assessments; 2 × 30 min cocaine-related cue-induction procedures; 5 × 120 min, one-to-one, MFCT sessions [in 1 week]; and 3 × 60 min research follow-ups and MFCT-relapse prevention.The primary outcome was the total percentage score on the frequency version of the Craving Experiences Questionnaire (CEQ-F at 1-month follow-up after the intensive intervention week (clinical endpoint; recall period past 2 weeks; higher score indicating greater craving. Secondary outcomes at the 1-month follow-up were percentage days abstinent (PDA from cocaine, and longest period (days of continuous abstinence (LPA in the prior 28 days.Outcomes were analysed as an unadjusted group mean difference (with Hedge's g effect size [ES] and a 95% Confidence Interval [CI] for the primary outcome and a 90% CI for the secondary outcomes. Exploratory, multivariable linear (primary outcome and Poisson regression models (secondary outcomes, with sex, age, months

Use of cross-linked carboxymethyl cellulose for soft-tissue augmentation: preliminary clinical studies

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Mauro Leonardis

2010-11-01

Full Text Available Mauro Leonardis1, Andrea Palange2, Rodrigo FV Dornelles3, Felipe Hund41Department of Plastic Surgery, Salvator Mundi International Hospital, Roma, Italy; 2Department of Aesthetic Medicine, Fisiobios, Roma, Italy; 3Department of Plastic Surgery, Núcleo de Plástica Avançada, São Paulo, SP, Brazil; 4Department of Plastic Surgery, Consultorio de Cirurgia Plastica, Criciuma, SC, BrazilPurpose: The continual search for new products for soft-tissue augmentation has in recent years led to the introduction of long lasting alternatives to hyaluronic acids and collagen that are composed of other polymers able to improve clinical persistence over time. This is the first report in which sodium carboxymethyl cellulose (CMC has been chemically treated by the cross-linking process and thus used as a hydrogel for soft-tissue augmentation through injection with thin needles. The study evaluates, from a clinical point of view, the behavior of cross-linked carboxymethyl cellulose hydrogel used in the aesthetic field and its side effects so as to check the safety and performance of the polymer following intradermal injections.Patients and methods: This work shows the preliminary results of an ongoing clinical study conducted between 2006 and 2009, performed on 84 healthy volunteers (62 females, 22 males aged between 18 and 72 years, for the treatment of 168 nasolabial folds, 45 perioral wrinkles, and 39 lip volume.Results: Study results show an excellent correction of facial defects. Tolerance and aesthetic quality of the correction obtained indicate considerable safety features and absence of side effects. From a clinical point of view, hydrogel is gradually absorbed into the injection site without migration issues.Conclusion: Cross-linked CMC hydrogel proves to be an ideal agent for soft tissue augmentation with regard to safety and ease of application. It did not cause infection, extrusion, migration, or adverse reactions in the patients who have been

Clinical study on the success of posterior monolithic zirconia crowns and fixed dental prostheses: preliminary report

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Merve Bankoğlu Güngör

2017-09-01

Full Text Available Objective: The purpose of this report was to present preliminary clinical results regarding the success rates and technical outcomes of posterior monolithic zirconia single tooth crowns (STs and fixed dental prostheses (FDPs. Materials and Method: Thirty-four patients received 43 posterior monolithic zirconia restorations as single tooth crowns (STs and/or fixed dental prostheses (FDPs, which were fabricated using a CAD-CAM (Computer Aided Design - Computer Aided Manufacturing system. At baseline and every 6 months, the restorations were examined for survival and technical outcomes. Success of the restorations was defined as the restoration remaining in situ, with no need for removal or replacement at follow-up visits. Technical outcomes were evaluated with a modified version of the United States Public Health Services criteria. Survival of restorations was estimated by using the Kaplan-Meier survival analysis. For each restoration, duration of follow-up was calculated from the time of placement to the date of its first failure. Results: After a mean observation period of 18.6 ± 3.9 months (between 8-24 months, cumulative survival rates were 86.7% and 92.3% for STs and FDPs, respectively. Technical evaluation revealed good marginal adaptation and crown contours; however, modifications were needed for shade and occlusion of restorations. Conclusion: These preliminary results revealed high survival rate and generally successful technical outcomes for posterior monolithic zirconia STs and FDPs.

Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

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Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-01-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

MRI-guided procedures in various regions of the body using a robotic assistance system in a closed-bore scanner: preliminary clinical experience and limitations.

Science.gov (United States)

Moche, Michael; Zajonz, Dirk; Kahn, Thomas; Busse, Harald

2010-04-01

To present the clinical setup and workflow of a robotic assistance system for image-guided interventions in a conventional magnetic resonance imaging (MRI) environment and to report our preliminary clinical experience with percutaneous biopsies in various body regions. The MR-compatible, servo-pneumatically driven, robotic device (Innomotion) fits into the 60-cm bore of a standard MR scanner. The needle placement (n = 25) accuracy was estimated by measuring the 3D deviation between needle tip and prescribed target point in a phantom. Percutaneous biopsies in six patients and different body regions were planned by graphically selecting entry and target points on intraoperatively acquired roadmap MR data. For insertion depths between 29 and 95 mm, the average 3D needle deviation was 2.2 +/- 0.7 mm (range 0.9-3.8 mm). Patients with a body mass index of up to approximately 30 kg/m(2) fitted into the bore with the device. Clinical work steps and limitations are reported for the various applications. All biopsies were diagnostic and could be completed without any major complications. Median planning and intervention times were 25 (range 20-36) and 44 (36-68) minutes, respectively. Preliminary clinical results in a standard MRI environment suggest that the presented robotic device provides accurate guidance for percutaneous procedures in various body regions. Shorter procedure times may be achievable by optimizing technical and workflow aspects. (c) 2010 Wiley-Liss, Inc.

Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results

Science.gov (United States)

Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero

2016-01-01

Background: To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Materials and Methods: Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. Results: A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Conclusion: Weekly cisplatin and volumetric-modulated arc therapy–simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated. PMID:27402633

Idiopathic granulomatous lobular mastitis - report of 43 cases from iran; introducing a preliminary clinical practice guideline.

Science.gov (United States)

Omranipour, Ramesh; Mohammadi, S-Farzad; Samimi, Parisa

2013-12-01

We aimed to report a large series of idiopathic granulomatous lobular mastitis (IGLM) from Iran and sketch preliminary clinical practice guidelines (CPG) for approaching an inflammatory breast mass. In a retrospective records review, 43 consecutive IGLM cases were studied. Data on baseline, clinical, imaging, and pathologic characteristics were collected. The mean age of the women was 33.5 years. All but 1 were married and had given birth. 16% had a cancer-like presentation. Inflammatory signs, architectural distortion, and a nodular pattern were the most common findings clinically, mammographically and ultrasonographically, respectively. 29.5% of the pathological reports indicated necrosis which was more common in younger subjects (p = 0.016); microabscesses were associated with a shorter lactation course (p = 0.006). Corticosteroids had been used as the initial treatment modality in 51%, immunosuppressive agents had not been administered, and a 16% relapse rate was recorded. We recognized the need for a multidisciplinary approach covering radiology, oncology, and surgery to best handle diagnostic and therapeutic issues and manage relevant infections as well as the major differential diagnosis, i.e. malignancy. We hypothesized that a shorter lactation period may cause more milk stasis and extravasation and be contributory to IGLM. CPGs are needed to incorporate the needed multidisciplinary approach and to standardize IGLM care. We present one such guideline.

Choosing a control intervention for a randomised clinical trial

Directory of Open Access Journals (Sweden)

Djulbegovic Benjamin

2003-04-01

Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

MR elastography of the liver at 3.0 T in diagnosing liver fibrosis grades; preliminary clinical experience

International Nuclear Information System (INIS)

Yoshimitsu, Kengo; Mitsufuji, Toshimichi; Shinagawa, Yoshinobu; Fujimitsu, Ritsuko; Morita, Ayako; Urakawa, Hiroshi; Takano, Koichi; Hayashi, Hiroyuki

2016-01-01

To clarify the usefulness of 3.0-T MR elastography (MRE) in diagnosing the histological grades of liver fibrosis using preliminary clinical data. Between November 2012 and March 2014, MRE was applied to all patients who underwent liver MR study at a 3.0-T clinical unit. Among them, those who had pathological evaluation of liver tissue within 3 months from MR examinations were retrospectively recruited, and the liver stiffness measured by MRE was correlated with histological results. Institutional review board approved this study, waiving informed consent. There were 70 patients who met the inclusion criteria. Liver stiffness showed significant correlation with the pathological grades of liver fibrosis (rho = 0.89, p < 0.0001, Spearman's rank correlation). Areas under the receiver operating characteristic curve were 0.93, 0.95, 0.99 and 0.95 for fibrosis score greater than or equal to F1, F2, F3 and F4, with cut-off values of 3.13, 3.85, 4.28 and 5.38 kPa, respectively. Multivariate analysis suggested that grades of necroinflammation also affected liver stiffness, but to a significantly lesser degree as compared to fibrosis. 3.0-T clinical MRE was suggested to be sufficiently useful in assessing the grades of liver fibrosis. (orig.)

MR elastography of the liver at 3.0 T in diagnosing liver fibrosis grades; preliminary clinical experience

Energy Technology Data Exchange (ETDEWEB)

Yoshimitsu, Kengo; Mitsufuji, Toshimichi; Shinagawa, Yoshinobu; Fujimitsu, Ritsuko; Morita, Ayako; Urakawa, Hiroshi; Takano, Koichi [Fukuoka University, Department of Radiology, Fukuoka (Japan); Hayashi, Hiroyuki [Fukuoka University, Department of Pathology, Faculty of Medicine, Fukuoka (Japan)

2016-03-15

To clarify the usefulness of 3.0-T MR elastography (MRE) in diagnosing the histological grades of liver fibrosis using preliminary clinical data. Between November 2012 and March 2014, MRE was applied to all patients who underwent liver MR study at a 3.0-T clinical unit. Among them, those who had pathological evaluation of liver tissue within 3 months from MR examinations were retrospectively recruited, and the liver stiffness measured by MRE was correlated with histological results. Institutional review board approved this study, waiving informed consent. There were 70 patients who met the inclusion criteria. Liver stiffness showed significant correlation with the pathological grades of liver fibrosis (rho = 0.89, p < 0.0001, Spearman's rank correlation). Areas under the receiver operating characteristic curve were 0.93, 0.95, 0.99 and 0.95 for fibrosis score greater than or equal to F1, F2, F3 and F4, with cut-off values of 3.13, 3.85, 4.28 and 5.38 kPa, respectively. Multivariate analysis suggested that grades of necroinflammation also affected liver stiffness, but to a significantly lesser degree as compared to fibrosis. 3.0-T clinical MRE was suggested to be sufficiently useful in assessing the grades of liver fibrosis. (orig.)

[Mineral trioxide aggragate pulpotomy for the treatment of immature permanent teeth with irreversible pulpitis: a preliminary clinical study].

Science.gov (United States)

Peng, Chufang; Zhao, Yuming; Yang, Yuan; Qin, Man

2015-12-01

To evaluate the preliminary clinical effect of mineral trioxide aggragate (MTA) pulpotomy on immature permanent teeth with irreversible pulpitis. Twenty-six immature permanent teeth with irreversible pulpitis were recuited from Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology. These teeth were treated with partial or full pulpotomy according to the condition of pulp bleeding. MTA was used as pulp capping material. Patients were recalled periodically after the treatment. Clinical and radiographic effects were evaluated. At one year follow-up, 20 teeth were evaluated as healed or healing, 2 teeth were evaluated as failure and 4 teeth were dropped out. The success rate was considered 91% (20/22). A dentinal bridge was radiographcally observed underneath the pulpotomy site in 13 teeth(65%, 13/20). MTA pulpotomy is an effective method for the treatment of immature permanent teeth with irreversible pulpitis. But further research with longer follow up period is required.

Excitation of rare gases in an electron-beam-controlled discharge: report on preliminary experiments

International Nuclear Information System (INIS)

Bingham, F.W.

1976-05-01

Data from the preliminary phase of a study of rare-gas-excimer production in an electron-beam-controlled discharge are presented. The results indicate that it is possible to maintain an arc-free discharge in preionized Ar and Xe gas for a period of several microseconds at applied external E/p values up to 5 V/cm/Torr. In these experiments ultraviolet radiation emitted during the discharge signaled the presence of excited rare-gas molecules. Application of the external electric field significantly enhanced the ultraviolet intensity from xenon-gas discharges but produced little enhancement from argon-gas discharges

A preliminary randomized clinical trial comparing diode laser and scalpel periosteal incision during implant surgery: impact on postoperative morbidity and implant survival.

Science.gov (United States)

Shahnaz, Aysan; Jamali, Raika; Mohammadi, Farnush; Khorsand, Afshin; Moslemi, Neda; Fekrazad, Reza

2018-01-01

The aim of this preliminary randomized clinical trial was to compare: (1) post-operative morbidity after application of laser or scalpel incision for flap advancement during implant surgery and bone grafting and (2) implant survival rate following flap advancement with laser or scalpel incision after 6 months of loading. Eighteen patients who were scheduled for dental implant placement and simultaneous bone grafting were randomly assigned to test or control groups. Diode laser (810 nm, 2 W, pulse interval 200 μs; pulse length 100 μs, 400-μm initiated fiber tip), or scalpel (control) was used to sever the periosteum to create a tension-free flap. Visual analogue scale (VAS) pain score, rate of nonsteroid anti-inflammatory drug (NSAID) consumption, intensity of swelling, and ecchymosis were measured for the six postsurgical days. Six months after loading, implant survival was assessed. VAS pain score (during the first four postoperative days), rate of NSAID consumption (during the first three postoperative days), and intensity of swelling (during the first five postoperative days) were significantly lower in the test group compared to the control group (All P values laser for performing periosteal releasing incision reduced the incidence and severity of postoperative morbidity of the patients undergone implant surgery in conjunction with bone augmentation procedure. We did not find any detrimental effect of laser incision on the implant survival within 6 months of loading.

Celiac Patients: A Randomized, Controlled Clinical Study

Directory of Open Access Journals (Sweden)

Giuseppe Mazzarella

2012-01-01

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

Advanced and controlled drug delivery systems in clinical disease management

NARCIS (Netherlands)

Brouwers, JRBJ

1996-01-01

Advanced and controlled drug delivery systems are important for clinical disease management. In this review the most important new systems which have reached clinical application are highlighted. Microbiologically controlled drug delivery is important for gastrointestinal diseases like ulcerative

PET/MRI: a novel hybrid imaging technique. Major clinical indications and preliminary experience in Brazil.

Science.gov (United States)

Vitor, Taise; Martins, Karine Minaif; Ionescu, Tudor Mihai; Cunha, Marcelo Livorsi da; Baroni, Ronaldo Hueb; Garcia, Marcio Ricardo Taveira; Wagner, Jairo; Campos, Guilherme de Carvalho; Nogueira, Solange Amorim; Guerra, Elaine Gonçalves; Amaro, Edson

2017-01-01

In recent years, medical imaging with hybrid techniques has widely accepted and employed in clinical routine. PET/MRI offers significant advantages, including excellent contrast and resolution and reduced ionizing radiation, as compared to well-established PET/CT. Therefore, PET/MRI is a promising modality for oncologic imaging of some regions, such as brain, head and neck, liver and pelvis. This article set out to analyze clinical conditions that could benefit from PET/MRI imaging based on our caseload. The potential of PET/MRI to become the imaging modality of choice for assessment of neurologic and oncologic conditions associated with soft tissues is highlighted. Clinical aspects of PET/MRI and its application to clinical cases are illustrated with examples extracted from the authors' preliminary experience. RESUMO Nos últimos anos, imagens médicas com tecnologias híbridas tornaram-se amplamente aceitas e utilizadas na prática clínica. O PET/RM possui vantagens importantes, incluindo excelentes contrastes e resolução, e menor radiação ionizante, em comparação ao PET/TC. Por isto, é uma modalidade promissora para exames de imagem de pacientes oncológicos, para avaliar o cérebro, cabeça e pescoço, o fígado e a pelve. O objetivo deste artigo foi analisar as situações clínicas que se beneficiariam de exames de PET/RM a partir de uma casuística. Destacamos o potencial desta técnica se tornar o método de imagem de escolha para doenças neurológicas e oncológicas que envolvam partes moles. Os aspectos clínicos de PET/RM e sua aplicação aos casos clínicos são ilustrados com exemplos da experiência inicial dos autores.

Preliminary Hazard Classification for the 105-B Reactor

International Nuclear Information System (INIS)

Kerr, N.R.

1997-08-01

This document summarizes the inventories of radioactive and hazardous materials present within the 105-B Reactor and uses the inventory information to determine the preliminary hazard classification for the surveillance and maintenance activities of the facility. The result of this effort was the preliminary hazard classification for the 105-B Building surveillance and maintenance activities. The preliminary hazard classification was determined to be Nuclear Category 3. Additional hazard and accident analysis will be documented in a separate report to define the hazard controls and final hazard classification

A pancreas imaging agent-131I-HIPDM: the animal experiment and preliminary clinical application

International Nuclear Information System (INIS)

Shao Hesheng

1988-01-01

131 I-HIPDM has been used clinically for studying regional cerebral perfusion. The [ 131 I] HIPDM was prepared in a kit. The labelling yields were consistently more than 95%, as analyzed by the TLC-Silica gel. The labelled compound is stable in vitro and in vivo. S D Strain rats (170-220 g) and mice (18-22 g) were used. The pancreatic uptake of [ 131 I] HIPDM is rather slow in mice and rats. At 8 hr after iv, the pancreas activity and the pancreas to liver (P/L) ratio are highest in mice and rats. The effect of carrier loading dose from 0.010 to 6.0 mg/kg on blodistribution in mice has been studied. The liver uptake was increased by adding carrier HIPDM. The result indicates that administration between 0.010 and 0.05 mg/kg carrier dose is most suitable for the pancreas imaging. Gamma camera imaging of dog at 6 hr after iv with 300 μCi [ 131 I] HIPMD, 0.05 mg/kg body weight showed clear pancreas image. The P/L ratio of the dog is 0.40. Preliminary clinical tests were satisfactory. Using 1 to 1.5 mCi of [ 131 I] HIPDM, 0.05 mg/kg, the pancreas imaging was operated in 4 cases of volunteers and pancreas cyst respectively with the good diagnostic quality. The authors are of the opinion that this pancreas imaging agent may have potential value for routine use

MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study.

Science.gov (United States)

Chopko, Bohdan; Caraway, David L

2010-01-01

Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion. When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study were treated with mild, an ultra-minimally invasive lumbar decompression procedure using a dorsal approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding muscular and skeletal structure. To assess the clinical application and patient safety and functional outcomes of the mild lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis. Multi-center, non-blinded, prospective clinical study. Fourteen US spine specialist practices. Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was available for 75 patients. Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2 Health Survey. Outcomes were assessed at baseline and 6 weeks post-treatment. There were no major device or procedure-related complications reported in this patient cohort. At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI, ZCQ, and SF-12v2 was statistically and clinically significant in this study. This is a preliminary report encompassing 6-week follow-up. There was no control group

Preliminary Experimental Analysis of Soil Stabilizers for Contamination Control

International Nuclear Information System (INIS)

Lagos, L.; Varona, J.; Zidan, A.; Gudavalli, R.; Wu, Kuang-His

2006-01-01

A major focus of Department of Energy's (DOE's) environmental management mission at the Hanford site involves characterizing and remediating contaminated soil and groundwater; stabilizing contaminated soil; remediating disposal sites; decontaminating and decommissioning structures, and demolishing former plutonium production process buildings, nuclear reactors, and separation plants; maintaining inactive waste sites; transitioning facilities into the surveillance and maintenance program; and mitigating effects to biological and cultural resources from site development and environmental cleanup and restoration activities. For example, a total of 470,914 metric tons of contaminated soil from 100 Areas remediation activities were disposed at the Environmental Restoration Disposal Facility (ERDF) during 2004. The Applied Research Center (ARC) at Florida International University (FIU) is supporting the Hanford's site remediation program by analyzing the effectiveness of several soil stabilizers (fixatives) for contamination control during excavation activities. The study is focusing on determining the effects of varying soil conditions, temperature, humidity and wind velocity on the effectiveness of the candidate stabilizers. The test matrix consists of a soil penetration-depth study, wind tunnel experiments for determination of threshold velocity, and temperature and moisture-controlled drying/curing experiments. These three set of experiments are designed to verify performance metrics, as well as provide insight into what fundamental forces are altered by the use of the stabilizer. This paper only presents the preliminary results obtained during wind tunnel experiments using dry Hanford soil samples (with 2.7% moisture by weight). These dry soil samples were exposed to varying wind speeds from 2.22 m/sec to 8.88 m/sec. Furthermore, airborne particulate data was collected for the dry Hanford soil experiments using an aerosol analyzer instrument. (authors)

Preliminary study on field buses for the control system of the high voltage of the ATLAS hadronic calorimeter

International Nuclear Information System (INIS)

Drevet, F.; Chadelas, R.; Montarou, G.

1996-01-01

We present here after a preliminary study on field buses for the control system of the high voltage of the photomultipliers of the TILECAL calorimeter. After some generalities, different commercial buses are reviewed (CAN, ARCET, WorldFIP, Profibus and LonWorks). The Profibus and LonWorks solution are more extensively studies as a possible solution for the high voltage system of the TILE hadronic calorimeter. (authors)

Idiopathic Granulomatous Lobular Mastitis – Report of 43 Cases from Iran; Introducing a Preliminary Clinical Practice Guideline

Science.gov (United States)

Omranipour, Ramesh; Mohammadi, S-Farzad; Samimi, Parisa

2013-01-01

Summary Background We aimed to report a large series of idiopathic granulomatous lobular mastitis (IGLM) from Iran and sketch preliminary clinical practice guidelines (CPG) for approaching an inflammatory breast mass. Patients and Methods In a retrospective records review, 43 consecutive IGLM cases were studied. Data on baseline, clinical, imaging, and pathologic characteristics were collected. Results The mean age of the women was 33.5 years. All but 1 were married and had given birth. 16% had a cancer-like presentation. Inflammatory signs, architectural distortion, and a nodular pattern were the most common findings clinically, mammographically and ultrasonographically, respectively. 29.5% of the pathological reports indicated necrosis which was more common in younger subjects (p = 0.016); microabscesses were associated with a shorter lactation course (p = 0.006). Corticosteroids had been used as the initial treatment modality in 51%, immunosuppressive agents had not been administered, and a 16% relapse rate was recorded. We recognized the need for a multidisciplinary approach covering radiology, oncology, and surgery to best handle diagnostic and therapeutic issues and manage relevant infections as well as the major differential diagnosis, i.e. malignancy. Conclusion We hypothesized that a shorter lactation period may cause more milk stasis and extravasation and be contributory to IGLM. CPGs are needed to incorporate the needed multidisciplinary approach and to standardize IGLM care. We present one such guideline. PMID:24550752

Preparation of the 99mTc-dextran lymphoscin tigraphic agent and its preliminary clinical application

International Nuclear Information System (INIS)

Lu Weiyue; You Dejian; Ma Yuanming; He Guangren; Zhang Wei; Tu Zhipei; Jin Bixia

1991-01-01

Dextran-70 was treated by gradient sedimentation, and that with a mean molecular weight of 105000 which was optimal for lymphatic system imaging rabbits was selected. Sn-Dextran kit was produced containing the above-mentioned dextran. Sn-Dextran kits can be stored at 4 deg C for 8 months. Its efficiency of labelling is more than 95%. The biodistribution, pharmacokinetics studies and lymphoscintigraphy in rabbits for 99m Tc-dextran showed: (1) high radioactivity in the popliteal nodes and very low redioactivity in other nontarget organs except kidneys through which it was excreted; (2) 99m Tc-dextran accumulated markedly and rapidly in lymphatic system. The lymph channels and nodes were well visualized in scintigrams; (3) 99m Tc-dextran cleared rapidly from the injection site. Radioactivity of 95% of the injected dose disappearing after 6.5h. Toxicity tests indicated that: 99m Tc-dextran is a drug of low toxicity and safe. Preliminary clinical applications of 99m Tc-dextran in 100 cases provided satisfactory results. The process of imaging usually took less than 1h after injection, and no side-effects occurred in any patient. In most cases, the results corresponded basically with the clinical diagnosis. Hence, 99m Tc-dextran is an ideal radiopharmaceutical that can be used for the visualization of the lymphatic system. It is recomminded for routine use in clincal practice

An assistive controller for a lower-limb exoskeleton for rehabilitation after stroke, and preliminary assessment thereof.

Science.gov (United States)

Murray, Spencer A; Ha, Kevin H; Goldfarb, Michael

2014-01-01

This paper describes a novel controller, intended for use in a lower-limb exoskeleton, to aid gait rehabilitation in patients with hemiparesis after stroke. The controller makes use of gravity compensation, feedforward movement assistance, and reinforcement of isometric joint torques to achieve assistance without dictating the spatiotemporal nature of joint movement. The patient is allowed to self-select walking speed and is able to make trajectory adaptations to maintain balance without interference from the controller. The governing equations and the finite state machine which comprise the system are described herein. The control architecture was implemented in a lower-limb exoskeleton and a preliminary experimental assessment was conducted in which a patient with hemiparesis resulting from stroke walked with assistance from the exoskeleton. The patient exhibited improvements in fast gait speed, step length asymmetry, and stride length in each session, as measured before and after exoskeleton training, presumably as a result of using the exoskeleton.

Preliminary comparison of the Essie and PubMed search engines for answering clinical questions using MD on Tap, a PDA-based program for accessing biomedical literature.

Science.gov (United States)

Sutton, Victoria R; Hauser, Susan E

2005-01-01

MD on Tap, a PDA application that searches and retrieves biomedical literature, is specifically designed for use by mobile healthcare professionals. With the goal of improving the usability of the application, a preliminary comparison was made of two search engines (PubMed and Essie) to determine which provided most efficient path to the desired clinically-relevant information.

A controlled clinical trial of implant-retained mandibular overdentures : Clinical aspects

NARCIS (Netherlands)

Boerrigter, EM; VanOort, RP; Raghoebar, GM; Stegenga, B; Schoen, PJ; Boering, G

In a controlled clinical trial, treatment effects of mandibular overdentures on two different implant-systems in edentulous patients were compared one year after insertion of the new dentures. The implant-systems used were the Branemark system (Bra) and the IMZ-system. Treatment was randomly

Grid-connected ICES: preliminary feasibility analysis and evaluation. Volume 2. Final report

Energy Technology Data Exchange (ETDEWEB)

1977-06-30

The HEAL Complex in New Orleans will serve as a Demonstration Community for which the ICES Demonstration System will be designed. The complex is a group of hospitals, clinics, research facilities, and medical educational facilities. The five tasks reported on are: preliminary energy analysis; preliminary institutional assessment; conceptual design; firming-up of commitments; and detailed work management plan.

Preliminary clinical applications of DTI in human cervical spinal cord

International Nuclear Information System (INIS)

Song Ting; Mai Weiwen; Liang Biling; Shen Jun; Huang Suiqiao; Hu Chunhong

2007-01-01

Objective: To condcut preliminary study of the value of DTI(diffusion tensor imaging) in human cervical spinal cord. Methods: Twenty-one patients suffering from cervical spondylotic myelopathy and twenty volunteers without any clinical symptoms underwent routine MRI and DTI examination. DTI was performed in six non-collinear directions with single-shot fast spin echo echo, planar imaging sequence(b value = 400 s·mm -2 ). ADC(apparent diffusion coefficient) and FA(fractional anisotropy)values were measured by ROIs(regions of interest) in 4 different level segment spinal cord (C 2/3 , C 3/4 , C 4/5 , C 5/6 ) in normal volunteers, in lesions and normal segmental spinal cord in clinical cases respectively. DTI original images were automatically processed by using IDL (Version 5.6) soft- ware to produce color tensor images. SPSS11.0 software for windows was used for t-test and one-way ANOVA analysis. The difference was considered statistically significant if P 2/3 , C 3/4 , C 4/5 , C 5/6 , were analyzed and it was found that FA value between them had a significant difference by ANOVA, F=159.24, P 2/3 level. However, ADC value between 4 segments had no significant difference(F=2.191, P>0.05). (2)In patients of cervical spondylotic myelopathy, routine MRI T2WI showed abnormal signal in 9 cases, and showed no abnormal signal in 12 dases. In sixteen cases it was found that abnormal patchy green signal on colorized tensor maps appeared on the normal blue spinal cord. Also, in patients of cervical spondylotic myelopathy, there was significant difference in ADC and FA value between lesions and normal spinal cord (paired t test, for ADC, t=2.88, P 2/3 level segment spinal cord in normal volunteers (0.85 ± 0.03) is the highest among other segments. FA value decreases gradually along cervical spinal cord towards the caudal direction. However, the difference of ADC values amongst 4 segments is not significant. DTI colorized tensor maps can show more lesions than routine MRI

[Critical role of clinical laboratories in hospital infection control].

Science.gov (United States)

Yagi, Tetsuya

2010-11-01

The hospital infection control and prevention is recognized to be more and more important according to the advances in modern medical treatment and care. Clinical microbiology laboratory play critical roles in the hospital infection control as a member of infection control team (ICT). They are the first in a hospital to identify outbreak of MRSA in NICU and molecular epidemiological analysis of the isolates lead proper intervention of ICT to the concerned ward. From a viewpoint of infectious disease specialist, rapid and precise microbiological information is essential for the appropriate diagnosis and treatment of infectious diseases. Each medical technologist need to make efforts to understand the characteristics of the examinations for infectious diseases and send out information useful for clinical practices. In our hospital, with the participation of all members of medical technologists, rapid reporting system was developed for blood culture examinations, which greatly contribute to the appropriate treatment of bloodstream infections. Collaborations of clinical microbiology laboratory with other members of ICT realize high quality hospital infection control. They also need to be aware of themselves as good practitioners of infection control measures to prevent hospital infections.

Preliminary clinical results: an analyzing tool for 2D optical imaging in detection of active inflammation in rheumatoid arthritis

Science.gov (United States)

Adi Aizudin Bin Radin Nasirudin, Radin; Meier, Reinhard; Ahari, Carmen; Sievert, Matti; Fiebich, Martin; Rummeny, Ernst J.; No"l, Peter B.

2011-03-01

Optical imaging (OI) is a relatively new method in detecting active inflammation of hand joints of patients suffering from rheumatoid arthritis (RA). With the high number of people affected by this disease especially in western countries, the availability of OI as an early diagnostic imaging method is clinically highly relevant. In this paper, we present a newly in-house developed OI analyzing tool and a clinical evaluation study. Our analyzing tool extends the capability of existing OI tools. We include many features in the tool, such as region-based image analysis, hyper perfusion curve analysis, and multi-modality image fusion to aid clinicians in localizing and determining the intensity of inflammation in joints. Additionally, image data management options, such as the full integration of PACS/RIS, are included. In our clinical study we demonstrate how OI facilitates the detection of active inflammation in rheumatoid arthritis. The preliminary clinical results indicate a sensitivity of 43.5%, a specificity of 80.3%, an accuracy of 65.7%, a positive predictive value of 76.6%, and a negative predictive value of 64.9% in relation to clinical results from MRI. The accuracy of inflammation detection serves as evidence to the potential of OI as a useful imaging modality for early detection of active inflammation in patients with rheumatoid arthritis. With our in-house developed tool we extend the usefulness of OI imaging in the clinical arena. Overall, we show that OI is a fast, inexpensive, non-invasive and nonionizing yet highly sensitive and accurate imaging modality.-

METHODOLOGICAL ISSUES OF CLINICAL TRIALS IN THE PEDIATRIC POPULATION

Directory of Open Access Journals (Sweden)

S.V. Topolyanskaya

2010-01-01

Full Text Available Conducting clinical trials on children population is a challenge both for organizers and pediatricians involved in trials. Difficulties in recruiting patients, a significant heterogenecity of the population, specific side reactions, difficulties in identifying the objective final points warrant the specific nature of designing clinical trials in pediatrics. The article illustrates key issues and methodology aspects: planning, design, control groups, patient recruitment. It stresses the need to carefully consider specific characteristics of a child’s system and multi-disciplinary approach involving a pediatrician at the early stages of planning, preliminary consultations with parent organizations, children and regulators.Key words: clinical trials, methodology, planning, design, patient recruitment, children. (Pediatric Pharmacology. – 2010; 7(5:6-10

Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

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Norio Sugawara

Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

Bio-Contamination Control for Spacesuit Garments - A Preliminary Study

Science.gov (United States)

Rhodes, Richard; Korona, Adam; Orndoff, Evelyn; Ott, Mark; Poritz, Darwin

2010-01-01

This paper outlines a preliminary study to review, test, and improve upon the current state of spacesuit bio-contamination control. The study includes an evaluation of current and advanced suit materials, ground and on-orbit cleaning methods, and microbial test and analysis methods. The first aspect of this study was to identify potential anti-microbial textiles and cleaning agents, and to review current microbial test methods. The anti-microbial cleaning agent and textile market survey included a review of current commercial-off-the-shelf (COTS) products that could potentially be used as future space flight hardware. This review included replacements for any of the softgood layers that may become contaminated during an extravehicular activity (EVA), including the pressure bladder, liquid cooling garment, and ancillary comfort undergarment. After a series of COTS anti-microbial textiles and clean ing agents were identified, a series of four tests were conducted: (1) a stacked configuration test that was conducted in order to review how bio-contamination would propagate through the various suit layers, (2) a individual materials test that evaluated how well each softgood layer either promoted or repressed growth, (3) a cleaning agent test that evaluated the efficacy on each of the baseline bladders, and (4) an evaluation of various COTS anti-microbial textiles. All antimicrobial COTS materials tested appeared to control bacteria colony forming unit (CFU) growth better than the Thermal Comfort Undergarment (TCU) and ACES Liquid Cooling Garment (LCG)/EMU Liquid Cooling Ventilation Garment (LCVG) materials currently in use. However, a comparison of fungi CFU growth in COTS to current suit materials appeared to vary per material. All cleaning agents tested in this study appeared to inhibit the level of bacteria and fungi growth to acceptable levels for short duration tests. While several trends can be obtained from the current analysis, a series of test improvements are

A Preliminary Fire PSA on PGSFR

International Nuclear Information System (INIS)

Kim, Kilyoo; Han, Sanghoon; Lee, KwiLim

2017-01-01

A Prototype Generation IV Sodium Fast Reactor (PGSFR) is under design with defense in depth concept with active, passive, and inherent safety features to acquire a design approval for PGSFR from Korean regulatory authority by around 2017. A preliminary fire PSA on PGSFR is done in 2016 and a final fire PSA of PGSFR will be done in 2017. The characteristics of the preliminary fire PSA on PGSFR are described in this paper. Since PGSFR is very safe reactor, it is not bad approach to use a conservative assumption in the preliminary PSA. In addition, several drawings including cable routing are not yet issued, a conservative calculation for CDF is performed. As shown in Table 2, the CDF caused by the fire in the control room takes 89% portion of total CDF. Thus, a detailed fire modeling for control room is necessary for the final fire PSA on PGSFR. Also, the increased ignition frequency due to sodium leak would be derived by considering the sodium piping complexity in the final fire PSA on PGSFR. The 4th column of Table 2 is derived the 3rd column by multiplying the factor (592/1177). The 5th column is the ignition frequency caused by the sodium leak. The 6th column is derived by summing the 4th column and the 5th column. The 7th column is the CDF portion of each fire area. The control room (fire area F-A404A) is the most important area since the control room fire takes 89% portion of total CDF.

Preliminary study on the control of direct injection diesel engine for better fuel flexibility and emissions control. Pt. 3

Energy Technology Data Exchange (ETDEWEB)

Egnell, R.; Kassem, N.; Bohlin, T.

1985-01-01

This report summarizes the results of a preliminary study on turbocharged direct injection diesel engines. The objectives and scope of this study are: 1. To explore the potential of using electronic control systems based on dynamic models of the engine in order to reduce fuel consumption, while maintaining good driveability. 2. To analyze the transient response of a turbocharged diesel engine based on experimental data collected from one of SAAB-SCANIA's test cells. 3. To survey the hardware components that would satisfy the requirements of the electronic control systems mentioned above. Part III discusses the transient response measurements obtained from two sets of experiments conducted on a six-cylinder motor working under varying conditions of load and speed. The objective of the first set of experiments was to quantify the difference in ignition delay between the transient and steady state operating conditions. The second set of experiments were aimed to provide a basis on which the engine efficiency obtained under transient conditions can be compared to that obtained from a single-cylinder motor working under steady state conditions.

Exploring the context for effective clinical governance in infection control.

Science.gov (United States)

Halton, Kate; Hall, Lisa; Gardner, Anne; MacBeth, Deborough; Mitchell, Brett G

2017-03-01

Effective clinical governance is necessary to support improvements in infection control. Historically, the focus has been on ensuring that infection control practice and policy is based on evidence, and that there is use of surveillance and auditing for self-regulation and performance feedback. There has been less exploration of how contextual and organizational factors mediate an infection preventionists (IP's) ability to engage with evidence-based practice and enact good clinical governance. A cross sectional Web-based survey of IPs in Australia and New Zealand was undertaken. Questions focused on engagement in evidence-based practice and perceptions about the context, culture, and leadership within the infection control team and organization. Responses were mapped against dimensions of Scally and Donaldson's clinical governance framework. Three hundred surveys were returned. IPs appear well equipped at an individual level to undertake evidence-based practice. The most serious set of perceived challenges to good clinical governance related to a lack of leadership or active resistance to infection control within the organization. Additional challenges included lack of information technology solutions and poor access to specialist expertise and financial resources. Focusing on strengthening contextual factors at the organizational level that otherwise undermine capacity to implement evidence-based practice is key to sustaining current infection control successes and promoting further practice improvements. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

Secure Microprocessor-Controlled Prosthetic Leg for Elderly Amputees: Preliminary Results

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S. Krut

2011-01-01

Full Text Available We introduce a new prosthetic leg design, adapted to elderly trans-femoral amputees. Technical progress in prosthesis design mainly concerns active individuals. An important number of elderly amputees are not very mobile, tire easily, present reduced muscle strength, and have difficulties managing their balance. Therefore, the needs and characteristics of this specific population are very different from those of younger ones and the prosthetic solutions are not adapted. Our artificial knee has been designed to fulfill the specific requirements of this population in terms of capabilities, transfer assistance, security, intuitiveness, simplicity of use, and types of physical activity to be performed. We particularly focused our efforts on ensuring safe and secure stand-to-sit transfers. We developed an approach to control the different states of the prosthetic joint (blocked, free, resistant, associated with different physical activities. Amputee posture and motion are observed through a single multi-axis force sensor embedded in the prosthesis. The patient behaves naturally, while the controller analyses his movements in order to detect his intention to sit down. The detection algorithm is based on a reference pattern, calibrated individually, to which the sensor data are compared, and submitted to a set of tests allowing the discrimination of the intention to sit down from other activities. Preliminary validation of the system has been performed in order to verify the applicability of the prosthesis to different tasks: walking, standing, sitting down, standing up, picking up an object from a chair, slope and stair climbing.

Development of e-Juba, a preliminary proof of concept unmanned ...

African Journals Online (AJOL)

Development of e-Juba, a preliminary proof of concept unmanned aerial vehicle designed to facilitate the transportation of microbiological test samples from remote rural clinics to National Health Laboratory Service laboratories.

Development and preliminary validation of a screen for ...

African Journals Online (AJOL)

Development and preliminary validation of a screen for interpersonal childhood trauma experiences among school-going youth in Durban, South Africa. ... validity in the sense that all scales were significantly correlated with scores on clinical measures of post-traumatic stress disorder (PTSD) and/or complex PTSD.

Acceptance and commitment therapy (ACT) for clinically distressed health care workers: Waitlist-controlled evaluation of an ACT workshop in a routine practice setting.

Science.gov (United States)

Waters, Cerith S; Frude, Neil; Flaxman, Paul E; Boyd, Jane

2018-03-01

To examine the effects of a 1-day acceptance and commitment therapy (ACT) workshop on the mental health of clinically distressed health care employees, and to explore ACT's processes of change in a routine practice setting. A quasi-controlled design, with participants block allocated to an ACT intervention or waiting list control group based on self-referral date. Participants were 35 health care workers who had self-referred for the ACT workshop via a clinical support service for staff. Measures were completed by ACT and control group participants at pre-intervention and 3 months post-intervention. Participants allocated to the waitlist condition went on to receive the ACT intervention and were also assessed 3 months later. At 3 months post-intervention, participants in the ACT group reported a significantly lower level of psychological distress compared to the control group (d = 1.41). Across the 3-month evaluation period, clinically significant change was exhibited by 50% of ACT participants, compared to 0% in the control group. When the control group received the same ACT intervention, 69% went on to exhibit clinically significant change. The ACT intervention also resulted in significant improvements in psychological flexibility, defusion, and mindfulness skills, but did not significantly reduce the frequency of negative cognitions. Bootstrapped mediation analyses indicated that the reduction in distress in the ACT condition was primarily associated with an increase in mindfulness skills, especially observing and non-reactivity. These findings provide preliminary support for providing brief ACT interventions as part of routine clinical support services for distressed workers. A 1-day ACT workshop delivered in the context of a routine staff support service was effective for reducing psychological distress among health care workers. The brief nature of this group intervention means it may be particularly suitable for staff support and primary care mental

Atypical Antipsychotics in the Treatment of Acute Bipolar Depression with Mixed Features: A Systematic Review and Exploratory Meta-Analysis of Placebo-Controlled Clinical Trials

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Michele Fornaro

2016-02-01

Full Text Available Evidence supporting the use of second generation antipsychotics (SGAs in the treatment of acute depression with mixed features (MFs associated with bipolar disorder (BD is scarce and equivocal. Therefore, we conducted a systematic review and preliminary meta-analysis investigating SGAs in the treatment of acute BD depression with MFs. Two authors independently searched major electronic databases from 1990 until September 2015 for randomized (placebo- controlled trials (RCTs or open-label clinical trials investigating the efficacy of SGAs in the treatment of acute bipolar depression with MFs. A random-effect meta-analysis calculating the standardized mean difference (SMD between SGA and placebo for the mean baseline to endpoint change in depression as well as manic symptoms score was computed based on 95% confidence intervals (CI. Six RCTs and one open-label placebo-controlled studies (including post-hoc reports representing 1023 patients were included. Participants received either ziprasidone, olanzapine, lurasidone, quetiapine or asenapine for an average of 6.5 weeks across the included studies. Meta-analysis with Duval and Tweedie adjustment for publication bias demonstrated that SGA resulted in significant improvements of (hypo-manic symptoms of bipolar mixed depression as assessed by the means of the total scores of the Young Mania Rating Scale (YMRS (SMD −0.74, 95% CI −1.20 to −0.28, n SGA = 907, control = 652. Meta-analysis demonstrated that participants in receipt of SGA (n = 979 experienced a large improvement in the Montgomery–Åsberg Depression Rating Scale (MADRS scores (SMD −1.08, 95% CI −1.35 to −0.81, p < 0.001 vs. placebo (n = 678. Publication and measurement biases and relative paucity of studies. Overall, SGAs appear to offer favorable improvements in MADRS and YMRS scores vs. placebo. Nevertheless, given the preliminary nature of the present report, additional original studies are required to allow more reliable

Preliminary performance and operating results from the integrated dry NOx/SO2 emissions control system

International Nuclear Information System (INIS)

Hunt, T.; Schott, G.; Smith, R.; Muzio, L.; Jones, D.; Mali E.; Arrigoni, T.

1993-01-01

The Integrated Dry NO x /SO 2 Emissions Control System was installed at Public Service Company of Colorado's Arapaho 4 generating station in 1992 in cooperation with the U.S. Department of Energy (DOE) and and the Electric Power Research Institute (EPRI). This full scale 100 MWe demonstration combines low-NO x burners, overfire air, and selective noncatalytic reduction (SNCR) for NO x control and dry sorbent injection with humidification for SO 2 control. Operation and testing of the Integrated Dry NO x /SO 2 Emissions Control System began in August 1992 and will continue through mid 1994. Preliminary results of the NO x control technologies show that the original system goal of 70% NO x removal has been easily met and that NO x removals of up to 80% are possible at full load with the combustion and SNCR systems. Testing of the dry sorbent injection system with low sulfur coal began in April 1993 using a calcium-based reagent. A maximum SO 2 removal of 40% has been achieved with duct injection of commercial calcium hydroxide and humidification to a 25 degrees F approach to saturation. Sodium-based dry sorbent injection is expected to achieved up to a 70% SO 2 reduction

Preliminary design data package. Appendix C

Energy Technology Data Exchange (ETDEWEB)

1979-07-25

The design requirements, design philosophy, method and assumptions, and preliminary computer-aided design of the Near-Term Hybrid Vehicle including its electric and heat power units, control equipment, transmission system, body, and overall vehicle characteristics are presented. (LCL)

Preliminary measurements of the establishment of a quality control programme for the activimeter calibration reference system

International Nuclear Information System (INIS)

Martins, Elaine W.; Potiens, Maria da Penha A.

2009-01-01

The nuclear medicine techniques efficiency and safety depends on, beside other factors, a quality control programme, mainly regards to the nuclides activimeter utilization. The Calibration Laboratory of IPEN uses as a work standard, a tertiary standard system Capintec, calibrated at the Accredited Dosimetry Calibration Laboratory of the Medical radiation Research Center - University of Wisconsin. In this work, as preliminary measurements to establish a quality control programme for the activimeter calibration procedures, initially the repeatability and reproducibility (long term stability) tests were performed using a sealed check source of 133 Ba. Later on, to complete this quality control programme other check sources ( 137 Cs, 57 Co, 60 Co) will be used to perform the same tests. A series of 80 experiments of 10 measurements each has been carried out. The reference system showed a good behaviour to the repeatability test, considering the tolerance limits of 5%. The percent deviations of all tested sources in the activity measurements were lower 1% to 133 Ba. (author)

An Adaptive Neuromuscular Controller for Assistive Lower-Limb Exoskeletons: A Preliminary Study on Subjects with Spinal Cord Injury.

Science.gov (United States)

Wu, Amy R; Dzeladini, Florin; Brug, Tycho J H; Tamburella, Federica; Tagliamonte, Nevio L; van Asseldonk, Edwin H F; van der Kooij, Herman; Ijspeert, Auke J

2017-01-01

Versatility is important for a wearable exoskeleton controller to be responsive to both the user and the environment. These characteristics are especially important for subjects with spinal cord injury (SCI), where active recruitment of their own neuromuscular system could promote motor recovery. Here we demonstrate the capability of a novel, biologically-inspired neuromuscular controller (NMC) which uses dynamical models of lower limb muscles to assist the gait of SCI subjects. Advantages of this controller include robustness, modularity, and adaptability. The controller requires very few inputs (i.e., joint angles, stance, and swing detection), can be decomposed into relevant control modules (e.g., only knee or hip control), and can generate walking at different speeds and terrains in simulation. We performed a preliminary evaluation of this controller on a lower-limb knee and hip robotic gait trainer with seven subjects ( N = 7, four with complete paraplegia, two incomplete, one healthy) to determine if the NMC could enable normal-like walking. During the experiment, SCI subjects walked with body weight support on a treadmill and could use the handrails. With controller assistance, subjects were able to walk at fast walking speeds for ambulatory SCI subjects-from 0.6 to 1.4 m/s. Measured joint angles and NMC-provided joint torques agreed reasonably well with kinematics and biological joint torques of a healthy subject in shod walking. Some differences were found between the torques, such as the lack of knee flexion near mid-stance, but joint angle trajectories did not seem greatly affected. The NMC also adjusted its torque output to provide more joint work at faster speeds and thus greater joint angles and step length. We also found that the optimal speed-step length curve observed in healthy humans emerged for most of the subjects, albeit with relatively longer step length at faster speeds. Therefore, with very few sensors and no predefined settings for

An Adaptive Neuromuscular Controller for Assistive Lower-Limb Exoskeletons: A Preliminary Study on Subjects with Spinal Cord Injury

Science.gov (United States)

Wu, Amy R.; Dzeladini, Florin; Brug, Tycho J. H.; Tamburella, Federica; Tagliamonte, Nevio L.; van Asseldonk, Edwin H. F.; van der Kooij, Herman; Ijspeert, Auke J.

2017-01-01

Versatility is important for a wearable exoskeleton controller to be responsive to both the user and the environment. These characteristics are especially important for subjects with spinal cord injury (SCI), where active recruitment of their own neuromuscular system could promote motor recovery. Here we demonstrate the capability of a novel, biologically-inspired neuromuscular controller (NMC) which uses dynamical models of lower limb muscles to assist the gait of SCI subjects. Advantages of this controller include robustness, modularity, and adaptability. The controller requires very few inputs (i.e., joint angles, stance, and swing detection), can be decomposed into relevant control modules (e.g., only knee or hip control), and can generate walking at different speeds and terrains in simulation. We performed a preliminary evaluation of this controller on a lower-limb knee and hip robotic gait trainer with seven subjects (N = 7, four with complete paraplegia, two incomplete, one healthy) to determine if the NMC could enable normal-like walking. During the experiment, SCI subjects walked with body weight support on a treadmill and could use the handrails. With controller assistance, subjects were able to walk at fast walking speeds for ambulatory SCI subjects—from 0.6 to 1.4 m/s. Measured joint angles and NMC-provided joint torques agreed reasonably well with kinematics and biological joint torques of a healthy subject in shod walking. Some differences were found between the torques, such as the lack of knee flexion near mid-stance, but joint angle trajectories did not seem greatly affected. The NMC also adjusted its torque output to provide more joint work at faster speeds and thus greater joint angles and step length. We also found that the optimal speed-step length curve observed in healthy humans emerged for most of the subjects, albeit with relatively longer step length at faster speeds. Therefore, with very few sensors and no predefined settings for

An Adaptive Neuromuscular Controller for Assistive Lower-Limb Exoskeletons: A Preliminary Study on Subjects with Spinal Cord Injury

Directory of Open Access Journals (Sweden)

Amy R. Wu

2017-06-01

Full Text Available Versatility is important for a wearable exoskeleton controller to be responsive to both the user and the environment. These characteristics are especially important for subjects with spinal cord injury (SCI, where active recruitment of their own neuromuscular system could promote motor recovery. Here we demonstrate the capability of a novel, biologically-inspired neuromuscular controller (NMC which uses dynamical models of lower limb muscles to assist the gait of SCI subjects. Advantages of this controller include robustness, modularity, and adaptability. The controller requires very few inputs (i.e., joint angles, stance, and swing detection, can be decomposed into relevant control modules (e.g., only knee or hip control, and can generate walking at different speeds and terrains in simulation. We performed a preliminary evaluation of this controller on a lower-limb knee and hip robotic gait trainer with seven subjects (N = 7, four with complete paraplegia, two incomplete, one healthy to determine if the NMC could enable normal-like walking. During the experiment, SCI subjects walked with body weight support on a treadmill and could use the handrails. With controller assistance, subjects were able to walk at fast walking speeds for ambulatory SCI subjects—from 0.6 to 1.4 m/s. Measured joint angles and NMC-provided joint torques agreed reasonably well with kinematics and biological joint torques of a healthy subject in shod walking. Some differences were found between the torques, such as the lack of knee flexion near mid-stance, but joint angle trajectories did not seem greatly affected. The NMC also adjusted its torque output to provide more joint work at faster speeds and thus greater joint angles and step length. We also found that the optimal speed-step length curve observed in healthy humans emerged for most of the subjects, albeit with relatively longer step length at faster speeds. Therefore, with very few sensors and no predefined

Brief narrative exposure therapy for posttraumatic stress in Iraqi refugees: a preliminary randomized clinical trial.

Science.gov (United States)

Hijazi, Alaa M; Lumley, Mark A; Ziadni, Maisa S; Haddad, Luay; Rapport, Lisa J; Arnetz, Bengt B

2014-06-01

Many Iraqi refugees suffer from posttraumatic stress. Efficient, culturally sensitive interventions are needed, and so we adapted narrative exposure therapy into a brief version (brief NET) and tested its effects in a sample of traumatized Iraqi refugees. Iraqi refugees in the United States reporting elevated posttraumatic stress (N = 63) were randomized to brief NET or waitlist control conditions in a 2:1 ratio; brief NET was 3 sessions, conducted individually, in Arabic. Positive indicators (posttraumatic growth and well-being) and symptoms (posttraumatic stress, depressive, and somatic) were assessed at baseline and 2- and 4-month follow-up. Treatment participation (95.1% completion) and study retention (98.4% provided follow-up data) were very high. Significant condition by time interactions showed that those receiving brief NET had greater posttraumatic growth (d = 0.83) and well-being (d = 0.54) through 4 months than controls. Brief NET reduced symptoms of posttraumatic stress (d = -0.48) and depression (d = -0.46) more, but only at 2 months; symptoms of controls also decreased from 2 to 4 months, eliminating condition differences at 4 months. Three sessions of brief NET increased growth and well-being and led to symptom reduction in highly traumatized Iraqi refugees. This preliminary study suggests that brief NET is both acceptable and potentially efficacious in traumatized Iraqi refugees. Copyright © 2014 International Society for Traumatic Stress Studies.

Effect of nonsurgical periodontal treatment on clinical response and glycemic control in type 2 diabetic patients with periodontitis: Controlled clinical trial

Directory of Open Access Journals (Sweden)

Ajitha Kanduluru

2014-01-01

Full Text Available Background: Type 2 diabetes mellitus (type 2 DM and chronic periodontitis are common chronic diseases in adults in the world population. Once periodontal disease is established, the chronic nature of this infection may contribute to worsening of diabetic status leading to more severe diabetes-related complications. It has been proposed that the relation of periodontitis and diabetes is bidirectional. Objectives: The objective was to compare the clinical response and glycemic control in type 2 DM patients with periodontitis, before and after the nonsurgical periodontal treatment with controls. Materials and Methods: A total 70 type 2 DM patients with chronic generalized moderate periodontitis was divided into 2 groups. Treatment group (35 received one stage full mouth scaling and root planning plus oral hygiene instructions; the control group (35 received only oral hygiene instructions. At baseline, 1 st month and 3 rd month, the clinical periodontal parameters (plaque index [PI], gingival index [GI], pocket depth [PD], clinical attachment loss [CAL], gingival recession [GR], and bleeding on probing [BOP] and glycemic parameters (fasting blood sugar [FBS], and postprandial blood sugar [PPBS] were recorded, whereas the glycated hemoglobin (HbA1c was recorded only at baseline and 3rd month. The collected data were subjected to statistical analysis. Results: When comparing the mean scores of clinical parameters for both the groups, there was a significant difference in all clinical parameters, that is, mean PI, GI, BOP, PD, CAL scores except mean GR, whereas for the glycemic parameters, there was a significant difference in mean FBS; PPBS values and no significant difference in mean percentage of HbA1c for treatment group at 3 rd month follow-up. Conclusion: Findings of the present study showed that nonsurgical periodontal treatment resulted in lower glycemic levels and the reduction of clinical parameters of periodontal infection, confirming the

Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

NARCIS (Netherlands)

Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

2016-01-01

Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

Concomitant Anticonvulsants With Bitemporal Electroconvulsive Therapy: A Randomized Controlled Trial With Clinical and Neurobiological Application.

Science.gov (United States)

Rakesh, Gopalkumar; Thirthalli, Jagadisha; Kumar, Channaveerachari Naveen; Muralidharan, Kesavan; Phutane, Vivek H; Gangadhar, Bangalore N

2017-03-01

Electroconvulsive therapy (ECT) is an effective treatment for major affective disorders. The combined use of ECT and anticonvulsant mood stabilizers is a common clinical scenario. There is dearth of systematic studies on the use of this combination with regard to clinical or cognitive outcomes. We aimed to compare clinical improvement and cognitive adverse effects between patients who received only ECT versus those who received ECT and anticonvulsants. We hypothesized that improvement would be fastest in patients who received only ECT. We conducted a randomized controlled trial in which patients prescribed ECT while being treated with anticonvulsants were randomized into 3 groups: full-dose (FD), half-dose (HD), and stop anticonvulsant. A blind rater assessed clinical improvement in patients using rating scales [Young's Mania Rating Scale (YMRS) and Clinical Global Impression] for clinical improvement and cognitive adverse effects (Postgraduate Institute memory scale). Analysis was done using mixed-effects modeling to delineate differences in clinical and cognitive outcomes across the 3 arms of the study over the course of ECT. Of the 54 patients recruited, 36 patients went into treatment allocation arms per the initial randomization plan. The main anticonvulsants prescribed were sodium valproate and carbamazepine. Patients in the 3 groups were comparable on clinical features. The most common diagnosis was bipolar affective disorder-with current episode of mania. Overall, there was no difference across the 3 groups in final clinical outcome scores (YMRS and Clinical Global Impression) when analyzed as intention to treat (ITT) or "as treated." In both analyses, group × time interaction was significant when comparing trend of YMRS scores between the FD anticonvulsant group and the HD group from baseline to last ECT (P = 0.0435 in ITT and P = 0.0055 in as treated). Patients in the FD group improved faster than those in the HD group. There were no differences across

The prevalence of asthma work relatedness: Preliminary data

Directory of Open Access Journals (Sweden)

Wojciech Dudek

2015-12-01

Full Text Available Objectives: About 5–10% of asthmatics do not respond well to standard treatment plan. Occupational exposure may be one of the factors that can be linked with treatment failure. The aim of the study was to assess the prevalence of work-related asthma (WRA among adult asthmatics under follow up in an outpatient allergy clinic and to create a useful tool for detecting individuals with possible WRA. Material and Methods: Preliminary 5-question questionnaire designed to recognize WRA was presented to 300 asthmatics. All patients with positive preliminary verification along with 50 subjects from control group were asked to fill up a detailed questionnaire. The WRA was diagnosed by positive match for asthma symptoms in combination with workplace exposure indicated in the detailed WRA questionnaire followed by confirmation of each WRA case by detailed exposure analysis. Results: Work-related asthma was recognized in 63 subjects (21% of study group. The preliminary questionnaire has 76.9% sensitivity and 94% specificity in recognition of WRA. Occupational exposure to irritants is a risk factor of WRA recognition (relative risk (RR = 2.09 (1.44:3.03. Working in exposure-free environment is a factor against WRA recognition (RR = 0.38 (0.24:0.61. Among subjects with work-related asthma, the uncontrolled course of the disease is significantly more frequent (p = 0.012. Subjects with WRA more often report sickness absenteeism due to asthma than those without WRA (9.6% vs. 3.2%, respectively, but the observed differences did not reach the statistical significance. Conclusions: Short 5-question questionnaire seems to be a promising tool to detect individuals with possible work-related asthma in the outpatient setting for further evaluation and additional attention.

Preliminary Clinical Evaluation of Acupuncture Therapy in Patients With Postpartum Sciatica.

Science.gov (United States)

He, Bing-Shu; Li, Yang; Gui, Tong

2018-03-01

This study evaluated clinical outcomes following acupuncture treatment of postpartum sciatica. One hundred eleven women with postpartum sciatica were enrolled in an acupuncture group (n = 86) or a control group (n = 25), according to their preference. Participants in the acupuncture group attended acupuncture therapy sessions 3 times a week for 4 weeks, while participants in the control group were assigned to bed rest. Outcome measures included the Roland Disability Questionnaire for sciatica, a visual analog scale for leg pain, and patient-reported perceived recovery. In addition, participants were surveyed after treatment to assess the acceptability of acupuncture therapy. The outcome scores for disability and leg pain were significantly lower in the acupuncture group compared with the control group (P acupuncture improved their well-being after treatment. At one month after treatment, 98% of participants in the treatment group reported recovery compared with 24% of the control group participants (P acupuncture group believed that acupuncture had no significant interference with breast milk production. No adverse effects of acupuncture were reported. All participants in the acupuncture group stated they would choose acupuncture in case of relapse. However, the recurrence rate of sciatica in the acupuncture group (32%) was comparable to that of the control group (35%) at the one-year follow-up interview. Compared with bed rest, acupuncture might be an effective and acceptable strategy to relieve symptoms of postpartum sciatica. © 2018 by the American College of Nurse-Midwives.

Clinical pharmacokinetics, safety, and preliminary efficacy evaluation of icotinib in patients with advanced non-small cell lung cancer.

Science.gov (United States)

Liu, Dongyang; Zhang, Li; Wu, Yiwen; Jiang, Ji; Tan, Fenlai; Wang, Yingxiang; Liu, Yong; Hu, Pei

2015-09-01

To receive pharmacokinetics, safety, and anti-tumor activity of icotinib, a novel epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), in patients with advanced non-small-cell lung cancer (NSCLC). Patients (n=40) with advanced NSCLC were enrolled to receive escalating doses of icotinib, which was administrated on Day 1 followed by 28-day continuous dosing starting from Day 4. Four dosing regimens, 100mg b.i.d., 150 mg b.i.d., 125 mg t.i.d., and 200mg b.i.d. were studied. Pharmacokinetics (PK), safety, and efficacy of icotinib were evaluated. Icotinib was well tolerated in Chinese patients with refractory NSCLC. No toxicity with >3 grades were reported in more than 2 patients under any dose levels. One complete response (3%) and 9 partial responses (23%) were received. Total disease control rate could reach at 73% and median progress-free survival (range) was 154 (17-462) days. PK exposure of icotinib increased with increase of dose in NSCLC patients. Food was suggested to increase PK exposure by ∼30%. Mean t1/2β was within 5.31-8.07 h. No major metabolite (>10% plasma exposure of icotinib) was found in NSCLC patients. Icotinib with up to 400 mg/day exhibited good tolerance and preliminary antitumor activity in Chinese NSCLC patients. Pharmacokinetics of icotinib and 5 major metabolites were fully investigated in NSCLC patients. Optimized biologic dose (OBD) was finally recommended to be 125 mg t.i.d. for the later clinical study. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study

Directory of Open Access Journals (Sweden)

González-Saldivar G

2016-04-01

Full Text Available Gerardo González-Saldivar,1 René Rodríguez-Gutiérrez,2 José Luis Viramontes-Madrid,3 Alejandro Salcido-Montenegro,2 Kevin Erick Gabriel Carlos-Reyna,2 Andrés Marcelo Treviño-Alvarez,2 Neri Alejandro Álvarez-Villalobos,4 José Gerardo González-González2 1Ophthalmology Department, 2Endocrinology Division, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, 3Instituto Nacional de Salud Pública, Cuernavaca, Morelos, 4Medical Statistics Department, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico Background: There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials.Methods: To assess the perception that 604 trial participants (cases and 604 nonparticipants (controls of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico.Results: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4% than controls (50.7% perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%. We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk

Preliminary design study of advanced composite blade and hub and nonmechanical control system for the tilt-rotor aircraft. Volume 1: Engineering studies

Science.gov (United States)

Alexander, H. R.; Smith, K. E.; Mcveigh, M. A.; Dixon, P. G.; Mcmanus, B. L.

1979-01-01

Composite structures technology is applied in a preliminary design study of advanced technology blades and hubs for the XV-15 tilt rotor research demonstrator aircraft. Significant improvements in XV-15 hover and cruise performance are available using blades designed for compatibility with the existing aircraft, i.e., blade installation would not require modification of the airframe, hub or upper controls. Provision of a low risk nonmechanical control system was also studied, and a development specification is given.

Causal role for inverse reasoning on obsessive-compulsive symptoms: Preliminary evidence from a cognitive bias modification for interpretation bias study.

Science.gov (United States)

Wong, Shiu F; Grisham, Jessica R

2017-12-01

The inference-based approach (IBA) is a cognitive account of the genesis and maintenance of obsessive-compulsive disorder (OCD). According to the IBA, individuals with OCD are prone to using inverse reasoning, in which hypothetical causes form the basis of conclusions about reality. Several studies have provided preliminary support for an association between features of the IBA and OCD symptoms. However, there are currently no studies that have investigated the proposed causal relationship of inverse reasoning in OCD. In a non-clinical sample (N = 187), we used an interpretive cognitive bias procedure to train a bias towards using inverse reasoning (n = 64), healthy sensory-based reasoning (n = 65), or a control condition (n = 58). Participants were randomly allocated to these training conditions. This manipulation allowed us to assess whether, consistent with the IBA, inverse reasoning training increased compulsive-like behaviours and self-reported OCD symptoms. Results indicated that compared to a control condition, participants trained in inverse reasoning reported more OCD symptoms and were more avoidant of potentially contaminated objects. Moreover, change in inverse reasoning bias was a small but significant mediator of the relationship between training condition and behavioural avoidance. Conversely, training in a healthy (non-inverse) reasoning style did not have any effect on symptoms or behaviour relative to the control condition. As this study was conducted in a non-clinical sample, we were unable to generalise our findings to a clinical population. Findings generally support the IBA model by providing preliminary evidence of a causal role for inverse reasoning in OCD. Copyright © 2017 Elsevier Ltd. All rights reserved.

Management Control Systems and Clinical Experience of Managers in Public Hospitals

Science.gov (United States)

Naranjo-Gil, David

2018-01-01

Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector. PMID:29673192

Preliminary I&C Design for LORELEI

International Nuclear Information System (INIS)

Korotkin, S.; Kaufman, Y.; Guttmann, E. B.; Levy, S.; Amidan, D.; Gdalyho, B.; Cahana, T.; Ellenbogen, A.; Arad, M.; Weiss, Y.; Sasson, A.; Ferry, L.; Bourrelly, F.; Cohen, Y.

2014-01-01

This document summarizes the preliminary I&C design for LORELEI experiment The preliminary design deals with considerations regarding appropriate safety and service instrumentation. The determined closed loop control rules for temperature and position will be implemented in the detailed design. The Computer Aided Operator Decisions System (CAODS) will be used for prediction of hot spot temperature and thickness of oxidation layer using Baker-Just correlation. The proposed hybrid simulation system comprising of both virtual and real hardware will be in-cooperated for LORELEI verification. It will perform both integration cold tests for a partial hardware loop and virtual tests for the final I&C design

Establishing quality control ranges for antimicrobial susceptibility testing of Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus: a cornerstone to develop reference strains for Korean clinical microbiology laboratories.

Science.gov (United States)

Hong, Sung Kuk; Choi, Seung Jun; Shin, Saeam; Lee, Wonmok; Pinto, Naina; Shin, Nari; Lee, Kwangjun; Hong, Seong Geun; Kim, Young Ah; Lee, Hyukmin; Kim, Heejung; Song, Wonkeun; Lee, Sun Hwa; Yong, Dongeun; Lee, Kyungwon; Chong, Yunsop

2015-11-01

Quality control (QC) processes are being performed in the majority of clinical microbiology laboratories to ensure the performance of microbial identification and antimicrobial susceptibility testing by using ATCC strains. To obtain these ATCC strains, some inconveniences are encountered concerning the purchase cost of the strains and the shipping time required. This study was focused on constructing a database of reference strains for QC processes using domestic bacterial strains, concentrating primarily on antimicrobial susceptibility testing. Three strains (Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus) that showed legible results in preliminary testing were selected. The minimal inhibitory concentrations (MICs) and zone diameters (ZDs) of eight antimicrobials for each strain were determined according to the CLSI M23. All resulting MIC and ZD ranges included at least 95% of the data. The ZD QC ranges obtained by using the CLSI method were less than 12 mm, and the MIC QC ranges extended no more than five dilutions. This study is a preliminary attempt to construct a bank of Korean QC strains. With further studies, a positive outcome toward cost and time reduction can be anticipated.

The influence of intermittent fasting on the circadian pattern of melatonin while controlling for caloric intake, energy expenditure, light exposure, and sleep schedules: A preliminary report

Directory of Open Access Journals (Sweden)

Aljohara S Almeneessier

2017-01-01

Conclusions: In this preliminary report, under controlled conditions of light exposure, meal composition, energy expenditure, and sleep-wake schedules, intermittent fasting has no significant influence on the circadian pattern of melatonin.

Thirty Meter Telescope (TMT) Narrow Field Infrared Adaptive Optics System (NFIRAOS) real-time controller preliminary architecture

Science.gov (United States)

Kerley, Dan; Smith, Malcolm; Dunn, Jennifer; Herriot, Glen; Véran, Jean-Pierre; Boyer, Corinne; Ellerbroek, Brent; Gilles, Luc; Wang, Lianqi

2016-08-01

The Narrow Field Infrared Adaptive Optics System (NFIRAOS) is the first light Adaptive Optics (AO) system for the Thirty Meter Telescope (TMT). A critical component of NFIRAOS is the Real-Time Controller (RTC) subsystem which provides real-time wavefront correction by processing wavefront information to compute Deformable Mirror (DM) and Tip/Tilt Stage (TTS) commands. The National Research Council of Canada - Herzberg (NRC-H), in conjunction with TMT, has developed a preliminary design for the NFIRAOS RTC. The preliminary architecture for the RTC is comprised of several Linux-based servers. These servers are assigned various roles including: the High-Order Processing (HOP) servers, the Wavefront Corrector Controller (WCC) server, the Telemetry Engineering Display (TED) server, the Persistent Telemetry Storage (PTS) server, and additional testing and spare servers. There are up to six HOP servers that accept high-order wavefront pixels, and perform parallelized pixel processing and wavefront reconstruction to produce wavefront corrector error vectors. The WCC server performs low-order mode processing, and synchronizes and aggregates the high-order wavefront corrector error vectors from the HOP servers to generate wavefront corrector commands. The Telemetry Engineering Display (TED) server is the RTC interface to TMT and other subsystems. The TED server receives all external commands and dispatches them to the rest of the RTC servers and is responsible for aggregating several offloading and telemetry values that are reported to other subsystems within NFIRAOS and TMT. The TED server also provides the engineering GUIs and real-time displays. The Persistent Telemetry Storage (PTS) server contains fault tolerant data storage that receives and stores telemetry data, including data for Point-Spread Function Reconstruction (PSFR).

The Asthma Control Questionnaire as a clinical trial endpoint

DEFF Research Database (Denmark)

Barnes, P J; Casale, T B; Dahl, Ronald

2014-01-01

these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly...

Biofeedback treatment for Tourette syndrome: a preliminary randomized controlled trial.

Science.gov (United States)

Nagai, Yoko; Cavanna, Andrea E; Critchley, Hugo D; Stern, Jeremy J; Robertson, Mary M; Joyce, Eileen M

2014-03-01

To study the clinical effectiveness of biofeedback treatment in reducing tics in patients with Tourette syndrome. Despite advances in the pharmacologic treatment of patients with Tourette syndrome, many remain troubled by their tics, which may be resistant to multiple medications at tolerable doses. Electrodermal biofeedback is a noninvasive biobehavioral intervention that can be useful in managing neuropsychiatric and neurologic conditions. We conducted a randomized controlled trial of electrodermal biofeedback training in 21 patients with Tourette syndrome. After training the patients for 3 sessions a week over 4 weeks, we observed a significant reduction in tic frequency and improved indices of subjective well-being in both the active-biofeedback and sham-feedback (control) groups, but there was no difference between the groups in these measurements. Furthermore, the active-treatment group did not demonstrably learn to reduce their sympathetic electrodermal tone using biofeedback. Our findings indicate that this form of biofeedback training was unable to produce a clinical effect greater than placebo. The main confounding factor appeared to be the 30-minute duration of the training sessions, which made it difficult for patients to sustain a reduction in sympathetic tone when their tics themselves were generating competing phasic electrodermal arousal responses. Despite a negative finding in this study, electrodermal biofeedback training may have a role in managing tics if optimal training schedules can be identified.

Preliminary report on management of neonatal jaundice in maternity clinics of São Paulo city, Brazil

Directory of Open Access Journals (Sweden)

Fernando Bastos

2007-03-01

Full Text Available Objective: The treatment of neonatal hyperbilirubinemia remains aproblem because it can lead to sequelae in both children and adults. Theobjective of this study was to evaluate how neonatal jaundice is treatedin maternity hospitals in the city of São Paulo. Methods: Prospective andtransversal study on maternity hospitals in the city of São Paulo, Brazil. Aquestionnaire was applied to doctors working at neonatal wards withinmaternity hospitals in the city of São Paulo, divided into public (n = 6 andprivate maternity clinics (n = 18. The results obtained from the differentitems of the questionnaire were then compared. Statistical analysis wasperformed using the Student’s t test, chi-square test and Mann-Whitneytest when appropriate, and a p value < 0.005 was considered significant.Results: There were no significant differences between the two typesof maternity hospitals in relation to the treatment method for neonataljaundice. However, among private maternities there were some that didnot have written guidelines (5/17 and those that performed exchangetransfusion (3/18. Teaching was significantly more present amongpublic (100% than private maternity hospitals (17.6%. The mean serumbilirubin levels to initiate treatment did not show significant differencesbetween the two types of maternities. Some clinical practices in use bymaternity hospitals are not evidence based. Conclusions: The presentdata were considered preliminary and showed that further research inthe area is required and if our findings are confirmed, indicate the needfor continuous medical education on the part of health professionals incharge of newborns.

Preliminary Outcomes from an Integrated Pediatric Mental Health Outpatient Clinic.

Science.gov (United States)

Maslow, Gary R; Banny, Adrienne; Pollock, McLean; Stefureac, Kristen; Rosa, Kendra; Walter, Barbara Keith; Hobbs Knutson, Katherine; Lucas, Joseph; Heilbron, Nicole

2017-10-01

An estimated 1 in 5 children in the United States meet criteria for a diagnosable mental disorder, yet fewer than 20% receive mental health services. Unmet need for psychiatric treatment may contribute to patterns of increasing use of the emergency department. This article describes an integrated pediatric evaluation center designed to prevent the need for treatment in emergency settings by increasing access to timely and appropriate care for emergent and critical mental health needs. Preliminary results showed that the center provided rapid access to assessment and treatment services for children and adolescents presenting with a wide range of psychiatric concerns. Copyright © 2017 Elsevier Inc. All rights reserved.

A controlled clinical evaluation of the Parents Plus Children's Programme for parents of children aged 6-12 with mild intellectual disability in a school setting.

Science.gov (United States)

Hand, Ailish; Raghallaigh, Ciara Ní; Cuppage, Jennifer; Coyle, Sadhbh; Sharry, John

2013-10-01

The aim of this study was to evaluate the effectiveness of the parent training, Parents Plus Children's Programme (PPCP) as an intervention for parents of children with mild intellectual disabilities. Participants were parents of children, aged six to 12, attending a special school for children with mild general learning disability (n = 29). Minor programme adaptations were made. Pre and post-assessment included the Strengths and Difficulties Questionnaire, the Parenting Stress Index, the Kansas Parent Satisfaction Scale and parent identified personal and child-related goals. A significant reduction in clinical range scores for treatment group participants (n = 16) was observed. Conversely, clinical range scores for control group participants (n = 13) increased, or remained elevated. These preliminary results suggest that PPCP may be successfully delivered as a routine community-based intervention and aid to prevent and reduce behavioural problems, reduce parent stress and increase parent confidence and satisfaction. Further investigation of programme effectiveness for parents of children with developmental disability is warranted.

DOE/NETL's phase II mercury control technology field testing program: preliminary economic analysis of activated carbon injection.

Science.gov (United States)

Jones, Andrew P; Hoffmann, Jeffrey W; Smith, Dennis N; Feeley, Thomas J; Murphy, James T

2007-02-15

Based on results of field testing conducted by the U.S. Department of Energy's National Energy Technology Laboratory (DOE/NETL), this article provides preliminary costs for mercury control via conventional activated carbon injection (ACI), brominated ACI, and conventional ACI coupled with the application of a sorbent enhancement additive (SEA) to coal prior to combustion. The economic analyses are reported on a plant-specific basis in terms of the cost required to achieve low (50%), mid (70%), and high (90%) levels of mercury removal "above and beyond" the baseline mercury removal achieved by existing emission control equipment. In other words, the levels of mercury control are directly attributable to ACI. Mercury control costs via ACI have been amortized on a current dollar basis. Using a 20-year book life, levelized costs for the incremental increase in cost of electricity (COE), expressed in mills per kilowatt-hour (mills/kWh), and the incremental cost of mercury control, expressed in dollars per pound of mercury removed ($/lb Hg removed), have been calculated for each level of ACI mercury control. For this analysis, the increase in COE varied from 0.14 mills/kWh to 3.92 mills/kWh. Meanwhile, the incremental cost of mercury control ranged from $3810/lb Hg removed to $166000/lb Hg removed.

Management Control Systems and Clinical Experience of Managers in Public Hospitals

Directory of Open Access Journals (Sweden)

Rogério Joao Lunkes

2018-04-01

Full Text Available Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector.

Ultrasound-guided genicular nerve block for pain control after total knee replacement: Preliminary case series and technical note.

Science.gov (United States)

González Sotelo, V; Maculé, F; Minguell, J; Bergé, R; Franco, C; Sala-Blanch, X

2017-12-01

Total knee arthroplasty (TKA) is an operation with moderate to severe postoperative pain. The Fast-Track models employ local infiltration techniques with anaesthetics at high volumes (100-150ml). We proposed a genicular nerve block with low volume of local anaesthetic. The aim of our study is to evaluate the periarticular distribution of these blocks in a fresh cadaver model and to describe the technique in a preliminary group of patients submitted to TKA. In the anatomical phase, 4 genicular nerves (superior medial, superior lateral, inferior medial and inferior lateral) were blocked with 4ml of local anaesthetic with iodinated contrast and methylene blue in each (16ml in total). It was performed on a fresh cadaver and the distribution of the injected medium was evaluated by means of a CT-scan and coronal anatomical sections on both knees. The clinical phase included 12 patients scheduled for TKA. Ultrasound-guided block of the 4 genicular nerves was performed preoperatively and their clinical efficacy evaluated by assessing pain after the reversal of the spinal block and at 12h after the block. Pain was measured using the numerical scale and the need for rescue analgesia was evaluated. A wide periarticular distribution of contrast was observed by CT-scan, which was later evaluated in the coronal sections. The distribution followed the joint capsule without entering the joint, both in the femur and in the tibia. The pain after the reversal of the subarachnoid block was 2±1, requiring rescue analgesia in 42% of the patients. At 12h, the pain according to the numerical scale was 4±1, 33% required rescue analgesia. The administration of 4ml of local anaesthetic at the level of the 4 genicular nerves of the knee produces a wide periarticular distribution. Our preliminary data in a series of 12 patients undergoing TKA seems to be clinically effective. Nevertheless, extensive case series and comparative studies with local infiltration techniques with anaesthetics are

Evaluation of the therapeutic results of actinic keratosis treated with topical 5% fluorouracil by reflectance confocal laser microscopy: preliminary study*

Science.gov (United States)

Ishioka, Priscila; Maia, Marcus; Rodrigues, Sarita Bartholomei; Marta, Alessandra Cristina; Hirata, Sérgio Henrique

2015-01-01

Topical treatment for actinic keratosis with 5% fluorouracil has a recurrence rate of 54% in 12 months of follow-up. This study analyzed thirteen actinic keratoses on the upper limbs through confocal microscopy, at the time of clinical diagnosis and after 4 weeks of treatment with fluorouracil. After the treatment was established and evidence of clinical cure was achieved, in two of the nine actinic keratoses, confocal microscopy enabled visualization of focal areas of atypical honeycomb pattern in the epidermis indicating therapeutic failure. Preliminary data suggest the use of confocal microscopy as a tool for diagnosis and therapeutic control of actinic keratosis. PMID:26131881

Impaired Cognitive Control of Emotional Conflict in Trait Anxiety: A Preliminary Study Based on Clinical and Non-Clinical Individuals

Directory of Open Access Journals (Sweden)

Yongju Yu

2018-04-01

Full Text Available BackgroundIt has been observed that trait anxiety easily leads to conflict maladaptation under conflict circumstances. However, it remains unclear whether the precise neural mechanisms underlying the effects of high trait anxiety (HTA on cognitive control are consistent in high trait anxious individuals, with and without anxiety disorders.MethodsThe present study recruited 29 healthy volunteers with low trait anxiety (LTA, 37 healthy volunteers with HTA, and 23 patients with generalized anxiety disorder (GAD. All participants completed demographic information and self-report measures of trait anxiety and depression. Then, they performed the emotional flanker task with event-related potentials (ERPs recorded.ResultsBehavioral data manifested that, relative to LTA individuals, GAD patients displayed prolonged response times and increased error rates, while HTA individuals showed intact response times and accuracies. Event-related potential (ERP data revealed that HTA individuals exhibited a trend toward more negative N2 amplitudes for conflict detection. By contrast, both HTA and GAD individuals displayed decreased P3 amplitudes for conflict resolution. ERP results indicated that both HTA and GAD individuals exhibited conflict maladaptation on the N2 amplitude. Correlation analyses also showed that the increased anxiety symptoms were associated with longer reaction times, more error rates, lower P3 amplitudes, and more perturbations in conflict adaptation on reaction times and N2 amplitudes.ConclusionOur results demonstrated a severely impaired cognitive control in GAD patients while a moderately impaired cognitive control in HTA individuals. Trait anxiety can indeed serve as a predominant factor at the onset and in the maintenance of GAD. Therefore, the trait anxiety reducing strategies may provide significant therapeutic gains.

Control of anxiety through music in a head and neckoutpatient clinic: a randomized clinical trial

Directory of Open Access Journals (Sweden)

Mariana Alves Firmeza

Full Text Available Abstract OBJECTIVE Evaluating the effectiveness of a musical intervention in reducing anxiety and vital parameters in people suffering from head and neck cancer. METHOD A randomized controlled clinical trial, performed in a head and neck outpatient clinic with 40 participants, subdivided into two groups (intervention and control.The classicalmusic“Spring” from The Four Seasons by Vivaldi was used as an intervention.The State-Trait Anxiety Inventory (STAI was used as the data collectioninstrument,along with an inventory of socio-demographic and clinical data. Student'st-test was used to verify intragroup and intergroup statistical significance. RESULTS Participants presented a statistically significant reduction in levels of perceived anxiety (t= 12.68; p<0.001,as well as blood pressure levels (t = 4.56; p<0.001; pulse (t = 6.15; p<0.001 and respiratory rate (t = 5.10; p<0.001. CONCLUSION Music has proven to be an effective non-pharmacological therapeutic resource in managinganxiety in an outpatient setting for people with cancer, as well as in reducing blood pressure, pulse and respiratory rate. Brazilian Registry of Clinical Trials: RBR-7W4YJJ

β-CIT labelled with 131I and its preliminary clinical practice

International Nuclear Information System (INIS)

Ye Bin; Kuang Anren; Ding Hao; Zheng Hongbo; Yuan Qiang; He Li

2002-01-01

β-CIT is labelled with 131 I by the peracetic acid method. 4 normal controls, 8 patients with PD and 3 patients with PS are studied by 131 I-β-CIT SPECT imaging. Striatal specific uptake of 131 I-β-CIT is calculated by the radioactivity ratio of striatal to cerebellar. The results shows that the radiochemical purity of 131 I-β-CIT is (97.6 +- 0.3)%. 131 I-β-CIT remains stable for at least 4 h after incubated with waters and serum respectively. The striatal specific uptake of 131 I-β-CIT in normal controls, PD and PS patients are (4.39 +- 0.14)%, (2.95 +- 0.68)% and (3.96 +- 0.52)% at 4h and (6.60 +- 0.06)%, (3.85 +- 0.71)% and (6.14 +- 0.08)% at 20 h after administration. There is a significant reduction of striatal tracer uptake in PD patients compared to the controls and PS patients. Striatal specific uptake in contralateral to the clinical symptom side is more pronounced reduced than the ipsilateral side in PD patients. 131 I-β-CIT uptake in PD patients is correlated with disease severity. These results suggest that 131 I-β-CIT can be used for the diagnosis of Parkinsion's disease

Clinical application of fast neutrons

International Nuclear Information System (INIS)

Battermann, J.J.

1981-01-01

The results of treatments and clinical experiments with neutrons (from a medical d+T neutron generator with an output of 10 12 neutrons per second) are reported and discussed. Data on RBE values are presented after single doses and multiple fractions of neutrons and 60 Co-gamma rays on pulmonary metastases. The results of pilot studies on head and neck tumours, brain tumours and pelvic tumours are discussed. The accuracy of the calculated dose is tested with some in-vivo experiments during neutron irradiation of the pelvis. Estimations of RBE values for tumour control, skin damage and intestinal damage after fractionated neutron therapy are dealt with and the results obtained in treatment of sarcomas are discussed. The preliminary results are given of some clinical trials in Amsterdam. Also some data from other centres are reviewed. From these data some remarks about the future of neutron therapy are made. (Auth.)

The preliminary clinical application of percutaneous vertebroplasty

International Nuclear Information System (INIS)

Ni Caifang; Yang Huilin; Tang Tianshi

2002-01-01

Objective: To study the method of percutaneous vertebroplasty (PVP) and investigate its clinical efficacy. Methods: Twenty five cases (13 patients with painful osteoporotic vertebral fractures, 8 cases with metastatic neoplasms and 4 cases with hemangiomas) were treated by the injection of polymethylmethacrylate (PMMA) under DSA fluoroscopic guidance. The time of follow-up ranged from 1-15 months. Results: The procedure was successful in all patients. Among 25 patients, 18 experienced with complete relief of pain, 6 with conspicuous relief, 1 with no significant change. Two patients showed transient symptom of radiculopathy and no clinical complication in others. Conclusions: PVP is a safe and feasible treatment for patients with hemangiomas as vertebral fractures caused by malignancies and osteoporosis

Cardiovascular Topics Blood pressure control at a hospital day clinic ...

African Journals Online (AJOL)

1999-02-01

Feb 1, 1999 ... control in a hospital day clinic population receiving cal- cium channel ... we had showed poor control of blood pressure in this hospital-based population .... Assessment of com- .... Program are obering: 19 almost half of newly treated hyper- tensives will di ... blood pressure control and quality of life. There is ...

Should we reconsider the routine use of placebo controls in clinical research?

Directory of Open Access Journals (Sweden)

Avins Andrew L

2012-04-01

Full Text Available Abstract Background Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. Methods We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. Results We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Conclusions Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

Should we reconsider the routine use of placebo controls in clinical research?

Science.gov (United States)

Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

2012-04-27

Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

Physical exercise as a supplement to outpatient treatment of alcohol use disorders – design and preliminary results of a randomized controlled trial

DEFF Research Database (Denmark)

Sari, Sengül; Bilberg, Randi Marie; Roessler, Kirsten Kaya

Background and aim Alcohol use disorder is a widespread problem in Denmark and has severe impacts on health and quality of life of each individual. The clinical treatment of alcohol use disorder involves evidence-based knowledge on medical treatment, physical training, and psychological management...... the study and inform about the first preliminary results. Perspectives If this study detects a positive relationship between exercise as a supplement to alcohol treatment and patients’ alcohol intake, quality of life, fitness, well-being, anxiety, depression and interpersonal problems...

Preliminary Validation of a New Clinical Tool for Identifying Problem Video Game Playing

Science.gov (United States)

King, Daniel Luke; Delfabbro, Paul H.; Zajac, Ian T.

2011-01-01

Research has estimated that between 6 to 13% of individuals who play video games do so excessively. However, the methods and definitions used to identify "problem" video game players often vary considerably. This research presents preliminary validation data for a new measure of problematic video game play called the Problem Video Game…

Controlled clinical studies of homeopathy.

Science.gov (United States)

Mathie, Robert T

2015-10-01

Observations about controlled clinical trials expressed by Max Haidvogl in the book Ultra High Dilution (1994) have been appraised from a perspective two decades later. The present commentary briefly examines changes in homeopathy research evidence since 1994 as regards: the published number of randomised controlled trials (RCTs), the use of individualised homeopathic intervention, the 'proven efficacy of homeopathy', and the quality of the evidence. The commentary reflects the details of RCTs that are available in a recently published literature review and by scrutiny of systematic reviews of RCTs in homeopathy. The homeopathy RCT literature grew by 309 records in the 18 years that immediately followed Haidvogl's article, with more than a doubling of the proportion that investigated individualised homeopathy. Discounting one prior publication, the entire systematic review literature on homeopathy RCTs post-dates 1994. A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy's clinical effectiveness; the other 20 were negative or non-conclusive. Reviews typically have been restricted in the strength of their conclusions by the low quality of the original RCT evidence. Three comprehensive systematic reviews concluded, cautiously, that homeopathy may differ from placebo; a fourth such review reached negative conclusions. A recent high-quality meta-analysis concluded that medicines prescribed in individualised homeopathic treatment may have small, specific, effects. Despite important growth in research activity since 1994, concerns about study quality limit the interpretation of available RCT data. The question whether homeopathic intervention differs from placebo awaits decisive answer. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Atomic Energy Control Board vocabulary - preliminary edition

Energy Technology Data Exchange (ETDEWEB)

Nolet, D [Public Works and Government Services Canada, Montreal, PQ (Canada). Terminology and Documentation Directorate

1995-09-01

This preliminary edition was prepared at the Board`s request to help it establish a standardized terminology. It was produced by scanning the 99 French and English documents listed at the end of this Vocabulary. The documents include legislation concerning atomic energy and the transportation of radioactive materials, as well as the Board`s publications, such as the Consultative Documents, Regulatory Documents and Notices. The terms included from the following areas are: radiation protection, reactor technology, nuclear fuel cycle, radioactive material packaging and transportation, radioactive waste management, uranium mines, and medical and industrial applications of radioelements. Also included are the titles of publications and the names of organizations and units. The vocabulary contains 2,589 concepts, sometimes accompanied by definitions, contexts or usage examples. Where terms have been standardized by the Canadian Committee for the Standardization of Nuclear Terminology, this has been indicated. Where possible, we have verified the terms using the TERMIUM, the Government of Canada Linguistic Data Bank. (author).

Atomic Energy Control Board vocabulary - preliminary edition

International Nuclear Information System (INIS)

Nolet, D.

1995-09-01

This preliminary edition was prepared at the Board's request to help it establish a standardized terminology. It was produced by scanning the 99 French and English documents listed at the end of this Vocabulary. The documents include legislation concerning atomic energy and the transportation of radioactive materials, as well as the Board's publications, such as the Consultative Documents, Regulatory Documents and Notices. The terms included from the following areas are: radiation protection, reactor technology, nuclear fuel cycle, radioactive material packaging and transportation, radioactive waste management, uranium mines, and medical and industrial applications of radioelements. Also included are the titles of publications and the names of organizations and units. The vocabulary contains 2,589 concepts, sometimes accompanied by definitions, contexts or usage examples. Where terms have been standardized by the Canadian Committee for the Standardization of Nuclear Terminology, this has been indicated. Where possible, we have verified the terms using the TERMIUM, the Government of Canada Linguistic Data Bank. (author)

Lisdexamfetamine in the treatment of moderate-to-severe binge eating disorder in adults: systematic review and exploratory meta-analysis of publicly available placebo-controlled, randomized clinical trials

Directory of Open Access Journals (Sweden)

Fornaro M

2016-07-01

Full Text Available Michele Fornaro,1,2 Marco Solmi,3–5 Giampaolo Perna,2,6 Domenico De Berardis,2,7 Nicola Veronese,5,8 Laura Orsolini,2,9 Licinia Ganança,1,10 Brendon Stubbs11,12 1New York State Psychiatric Institute, Columbia University, New York City, NY, USA; 2Polyedra Research Group®, Ascoli, 3Department of Neurosciences, University of Padua, 4Department of Mental Health, National Health Service, Padova, 5IREM Institute for Clinical Research and Education in Medicine, Padova, 6Department of Clinical Neurosciences, Hermanas Hospitalarias – Villa San Benedetto Menni Hospital, FoRiPsi, Albese con Cassano, Como, 7Department of Mental Health, Psychiatric Service of Diagnosis and Treatment, National Health Service, Hospital “G Mazzini”, Teramo, 8Department of Medicine (DIMED, University of Padua, Padova, Italy; 9Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit, School of Life and Medical Sciences, University of Hertfordshire, Hatfield, Herts, UK; 10Department of Psychiatry, School of Medicine, University of Lisbon, Lisbon, Portugal; 11Department of Health Service and Population Research, Institute of Psychiatry, King’s College London, 12Department of Physiotherapy, South London and Maudsley NHS Foundation Trust, London, UK Background: Preliminary placebo-controlled evidence paved the ground to the US Food and Drug Administration approval extension of lisdexamfetamine for the treatment of moderate-to-severe binge eating disorder (BED in adults.Objectives: To provide a preliminary qualitative and quantitative synthesis of the placebo-controlled, randomized clinical trials (RCTs considering the efficacy and tolerability of lisdexamfetamine in the acute and/or maintenance treatment of moderate-to-severe BED in adults.Methods: A preliminary, yet comprehensive, systematic review was performed by accessing a broad range of resources providing publicly available data about lisdexamfetamine at the time of inquiry (March 2016. Study

The concept of control of COPD in clinical practice

Directory of Open Access Journals (Sweden)

Soler-Cataluña JJ

2014-12-01

Full Text Available Juan José Soler-Cataluña,1,2 Bernardino Alcázar-Navarrete,3 Marc Miravitlles2,4 1Pneumology Department, Hospital Arnau de Vilanova, Valencia, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES, 3Respiratory Department, Hospital de Alta Resolucion, Granada, Spain; 4Pneumology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain Abstract: Treatment of chronic obstructive pulmonary disease (COPD requires a personalized approach according to the clinical characteristics of the patients, the level of severity, and the response to the different therapies. Furthermore, patients with the same level of severity measured by the degree of airflow obstruction or even with multidimensional indices may have very different symptoms and limitations for daily activities. The concept of control has been extensively developed in asthma but has not been defined in COPD. Here, we propose a definition of COPD control based on the concepts of impact and stability. Impact is a cross-sectional concept that can be measured by questionnaires such as the COPD Assessment Test or the Clinical COPD Questionnaire. Alternatively, impact can be assessed by the degree of dyspnea, the use of rescue medication, the level of physical activity, and sputum color. Stability is a longitudinal concept that requires the absence of exacerbations and deterioration in the aforementioned variables or in the COPD Assessment Test or Clinical COPD Questionnaire scores. Control is defined by low impact (adjusted for severity and stability. The concept of control in COPD can be useful in the decision making regarding an increase or decrease in medication in the stable state. Keywords: COPD, control, CAT, CCQ, exacerbations, prognosis

Management and Data Management Plan for Remedial Investigation at Fort George G. Meade Landfill and Preliminary Assessment/Site Investigation at the Former Gaithersburg NIKE Control and Launch Areas

National Research Council Canada - National Science Library

Edwards, D

1989-01-01

Work assignments under this contract will include a Preliminary Assessment/Site Investigation at the former Gaithersburg NIKE Control and Launch Areas and a Remedial Investigation at the Fort Meade...

Game-Based Virtual Reality Canoe Paddling Training to Improve Postural Balance and Upper Extremity Function: A Preliminary Randomized Controlled Study of 30 Patients with Subacute Stroke.

Science.gov (United States)

Lee, Myung Mo; Lee, Kyeong Jin; Song, Chang Ho

2018-04-27

BACKGROUND Virtual reality (VR) training with motion-controlled console games can be incorporated into stroke rehabilitation programs. The use of a variety of gaming software can provide the patient with an opportunity to perform activities that are exciting, entertaining, and that may not be feasible in clinical environments. The aim of this preliminary randomized controlled study was to investigate the effects of game-based VR canoe paddling training, when combined with conventional physical rehabilitation programs, on postural balance and upper extremity function in 30 patients with subacute stroke. MATERIAL AND METHODS Thirty patients, who were within six months following the diagnosis of stroke, were randomly allocated to either the experimental group (n=15) or the control group (n=15). All participants participated in a conventional rehabilitation program. Also, the experimental group (n=15) performed the VR canoe paddling training for 30 minutes each day, three times per week, for five weeks. After five weeks, outcomes of changes in postural balance and upper extremity function were evaluated and compared between the two groups. RESULTS At five weeks, postural balance and upper extremity function showed significant improvements in both patients groups when compared with the baseline measurements (pGame-based VR canoe paddling training is an effective rehabilitation therapy that enhances postural balance and upper extremity function in patients with subacute stroke when combined with conventional physical rehabilitation programs.

Preliminary study on the control of direct injection diesel engine for better fuel flexibility and emissions control. Pt. 1 and 2

Energy Technology Data Exchange (ETDEWEB)

Egnell, R.; Kassem, N.; Bohlin, T.

1985-01-01

This report summarizes the results of a preliminary study on turbocharged direct injection diesel engines. Part I reviews the qualitative dynamic aspects of turbocharged diesel engine and the factors that affect its transient behaviour. It gives a brief account of the model structure and the interrelationships between the different components of the model as well as the different types of engine models and the methods of simulation. The transient response of a turbocharged engine under changing load, speed, and ambient conditions are discussed. Methods to improve the transient response, thus reducing fuel consumption and smoke emissions are briefly reviewed. Finally, both conventional and advanced control strategies are discussed with emphasis on the control of fuel injection (Delta-control), injection time (Alfa-control), and exhaust gas recirculation (EGR-control). Part II (in Swedish) consists of a literature survey on hardware components such as sensors, actuators, and injection systems that are, or expect to be, available with reasonable commercial costs. The objective of this survey is to provide the grounds on which to decide if these components satisfy the requirements of electronic control systems. Part III (in Swedish) discusses the transient response measurements obtained from two sets of experiments conducted on a six-cylinder motor working under varying conditions of load and speed. The objective of the first set of experiments was to quantify the difference in ignition delay between the transient and steady state operating conditions. The second set of experiments were aimed to provide a basis on which the engine efficiency obtained under transient conditions can be compared to that obtained from a single-cylinder motor working under steady state conditions.

Radiological follow-up of uncemented knee prostheses. Preliminary study

International Nuclear Information System (INIS)

Martin Hervas, C.; Gomez Barrena, E.; Marquez Moreno, I.; Calle Yuste, F.; Ordonez Parra, J.M.

1993-01-01

The preliminary results of a prospective study of 40 uncemented total knee prostheses (TKP) are presented following a radiological protocol with fluoroscopic control and follow-up of over 2 years. The prosthesis-bone interface and the components alignment were assessed. Several radiological signs were studied to assess this interface with respect to the fixing of the component, but they showed little clinical correlation. Statistical significance (p<0.05, chisquare) was found only in the observation of sclerosis in areas of support for the tibital tray as a reaction of the bone. This radiological follow-up is of interest to determine the evolution of the interface and position of the implant to prevent complications (especially loosening) in patients, particularly those under 60 years old, who represent the group that can most benefit from prosthetic systems with uncemented anchorage because of their life expectation and level of activity. Author

PET/MRI: a novel hybrid imaging technique: major clinical indications and preliminary experience in Brazil; PET/RM: um novo metodo de imagem hibrida: principais indicacoes clinicas e experiencia preliminar no Brasil

Energy Technology Data Exchange (ETDEWEB)

Vitor, Taise; Martins, Karine Minaif; Ionescu, Tudor Mihai and others, E-mail: taisevitor@gmail.com [Hospital Israelita Albert Einstein, Sao Paulo, SP (Brazil)

2017-04-01

In recent years, medical imaging with hybrid techniques has widely accepted and employed in clinical routine. PET/MRI offers significant advantages, including excellent contrast and resolution and reduced ionizing radiation, as compared to well-established PET/ CT. Therefore, PET/MRI is a promising modality for oncologic imaging of some regions, such as brain, head and neck, liver and pelvis. This article set out to analyze clinical conditions that could benefit from PET/MRI imaging based on our caseload. The potential of PET/MRI to become the imaging modality of choice for assessment of neurologic and oncologic conditions associated with soft tissues is highlighted. Clinical aspects of PET/MRI and its application to clinical cases are illustrated with examples extracted from the authors' preliminary experience. (author)

Frontolimbic neural circuit changes in emotional processing and inhibitory control associated with clinical improvement following transference-focused psychotherapy in borderline personality disorder.

Science.gov (United States)

Perez, David L; Vago, David R; Pan, Hong; Root, James; Tuescher, Oliver; Fuchs, Benjamin H; Leung, Lorene; Epstein, Jane; Cain, Nicole M; Clarkin, John F; Lenzenweger, Mark F; Kernberg, Otto F; Levy, Kenneth N; Silbersweig, David A; Stern, Emily

2016-01-01

Borderline personality disorder (BPD) is characterized by self-regulation deficits, including impulsivity and affective lability. Transference-focused psychotherapy (TFP) is an evidence-based treatment proven to reduce symptoms across multiple cognitive-emotional domains in BPD. This pilot study aimed to investigate neural activation associated with, and predictive of, clinical improvement in emotional and behavioral regulation in BPD following TFP. BPD subjects (n = 10) were scanned pre- and post-TFP treatment using a within-subjects design. A disorder-specific emotional-linguistic go/no-go functional magnetic resonance imaging paradigm was used to probe the interaction between negative emotional processing and inhibitory control. Analyses demonstrated significant treatment-related effects with relative increased dorsal prefrontal (dorsal anterior cingulate, dorsolateral prefrontal, and frontopolar cortices) activation, and relative decreased ventrolateral prefrontal cortex and hippocampal activation following treatment. Clinical improvement in constraint correlated positively with relative increased left dorsal anterior cingulate cortex activation. Clinical improvement in affective lability correlated positively with left posterior-medial orbitofrontal cortex/ventral striatum activation, and negatively with right amygdala/parahippocampal activation. Post-treatment improvements in constraint were predicted by pre-treatment right dorsal anterior cingulate cortex hypoactivation, and pre-treatment left posterior-medial orbitofrontal cortex/ventral striatum hypoactivation predicted improvements in affective lability. These preliminary findings demonstrate potential TFP-associated alterations in frontolimbic circuitry and begin to identify neural mechanisms associated with a psychodynamically oriented psychotherapy. © 2015 The Authors. Psychiatry and Clinical Neurosciences © 2015 Japanese Society of Psychiatry and Neurology.

International consensus on preliminary definitions of improvement in adult and juvenile myositis.

Science.gov (United States)

Rider, Lisa G; Giannini, Edward H; Brunner, Hermine I; Ruperto, Nicola; James-Newton, Laura; Reed, Ann M; Lachenbruch, Peter A; Miller, Frederick W

2004-07-01

To use a core set of outcome measures to develop preliminary definitions of improvement for adult and juvenile myositis as composite end points for therapeutic trials. Twenty-nine experts in the assessment of myositis achieved consensus on 102 adult and 102 juvenile paper patient profiles as clinically improved or not improved. Two hundred twenty-seven candidate definitions of improvement were developed using the experts' consensus ratings as a gold standard and their judgment of clinically meaningful change in the core set of measures. Seventeen additional candidate definitions of improvement were developed from classification and regression tree analysis, a data-mining decision tree tool analysis. Six candidate definitions specifying percentage change or raw change in the core set of measures were developed using logistic regression analysis. Adult and pediatric working groups ranked the 13 top-performing candidate definitions for face validity, clinical sensibility, and ease of use, in which the sensitivity and specificity were >/=75% in adult, pediatric, and combined data sets. Nominal group technique was used to facilitate consensus formation. The definition of improvement (common to the adult and pediatric working groups) that ranked highest was 3 of any 6 of the core set measures improved by >/=20%, with no more than 2 worse by >/=25% (which could not include manual muscle testing to assess strength). Five and 4 additional preliminary definitions of improvement for adult and juvenile myositis, respectively, were also developed, with several definitions common to both groups. Participants also agreed to prospectively test 6 logistic regression definitions of improvement in clinical trials. Consensus preliminary definitions of improvement were developed for adult and juvenile myositis, and these incorporate clinically meaningful change in all myositis core set measures in a composite end point. These definitions require prospective validation, but they are now

Performance comparison between the mycobacteria growth indicator tube system and Löwenstein-Jensen medium in the routine detection of Mycobacterium tuberculosis at public health care facilities in Rio de Janeiro, Brazil: preliminary results of a pragmatic clinical trial.

Science.gov (United States)

Moreira, Adriana da Silva Rezende; Huf, Gisele; Vieira, Maria Armanda; Fonseca, Leila; Ricks, Monica; Kritski, Afrânio Lineu

2013-01-01

In view of the fact that the World Health Organization has recommended the use of the mycobacteria growth indicator tube (MGIT) 960 system for the diagnosis of tuberculosis and that there is as yet no evidence regarding the clinical impact of its use in health care systems, we conducted a pragmatic clinical trial to evaluate the clinical performance and cost-effectiveness of the use of MGIT 960 at two health care facilities in the city of Rio de Janeiro, Brazil, where the incidence of tuberculosis is high. Here, we summarize the methodology and preliminary results of the trial. (ISRCTN.org Identifier: ISRCTN79888843 [http://isrctn.org/]) In view of the fact that the World Health Organization has recommended the use of the mycobacteria growth indicator tube (MGIT) 960 system for the diagnosis of tuberculosis and that there is as yet no evidence regarding the clinical impact of its use in health care systems, we conducted a pragmatic clinical trial to evaluate the clinical performance and cost-effectiveness of the use of MGIT 960 at two health care facilities in the city of Rio de Janeiro, Brazil, where the incidence of tuberculosis is high. Here, we summarize the methodology and preliminary results of the trial. (ISRCTN.org Identifier: ISRCTN79888843 [http://isrctn.org/]).

A randomized controlled trial of metacognitive therapy vs. cognitive behavioral therapy vs. waiting list in the treatment of adults with generalized anxiety disorder: A preliminary analysis

OpenAIRE

Kvistedal, Draco Jon Torstein

2011-01-01

Forty two participants with generalized anxiety disorder were treated with either Metacognitive therapy or Cognitive Behavioral Therapy, in a randomized controlled study comparing the relative effect of the two treatments. A wait list condition comprised the control group. Statistical analysis proved MCT superior to CBT, and CBT proved superior to no treatment. Because this is a preliminary study it has some limitations, such as no follow-up data or treatment adherence control. Thus at the cu...

Design control for clinical translation of 3D printed modular scaffolds.

Science.gov (United States)

Hollister, Scott J; Flanagan, Colleen L; Zopf, David A; Morrison, Robert J; Nasser, Hassan; Patel, Janki J; Ebramzadeh, Edward; Sangiorgio, Sophia N; Wheeler, Matthew B; Green, Glenn E

2015-03-01

The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

NOS CO-OPS Water Level Data, Preliminary, 6-Minute

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — This dataset has recent, preliminary (not quality-controlled), 6-minute, water level (tide) data from NOAA NOS Center for Operational Oceanographic Products and...

NOS CO-OPS Water Level Data, Preliminary, 1-Minute

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — This dataset has recent, preliminary (not quality-controlled), 1-minute, water level (tide) data from NOAA NOS Center for Operational Oceanographic Products and...

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

African Journals Online (AJOL)

A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

A new extra-abdominal channel alternative to the mitrofanoff principle: experimental and preliminary clinical experience

Directory of Open Access Journals (Sweden)

Antonio Macedo Jr.

2009-04-01

Full Text Available INTRODUCTION: The appendix is the gold-standard channel for the Mitrofanoff principle in pediatric urology, but the search for alternatives is justified considering it may not be available or preferably used for colonic stomas (Malone antegrade continence enema. The aim of this study is to report on technical feasibility of a new approach for creating catheterizable channels in a rabbit model and to present our preliminary clinical experience. MATERIAL AND METHODS: We configured a tube from two rectangular skin flaps 1x4 cm opposite each other in the middle line of the lower inferior abdomen. The channel was anastomosed to the bladder dome with embedding sutures to create a valvular mechanism. The experimental study consisted of 12 rabbits, divided in 4 groups according to the sacrifice schedule at 2, 4, 8 and 12 weeks. At 30th postoperative day, an urodynamic evaluation was performed to record continence of the stoma. A histological analysis of the specimens stained with hematoxylin-eosin, Masson trichrome and Picrosirius red was also done in group 2 (sacrifice at 4 weeks postoperatively. We used this method in 3 patients with congenital non-neurogenic bladder disease presenting with massive residual volumes without compliance deficits. RESULT: The technique proved feasible in all animals, 9 of 12 could be easily catheterized and underwent urodynamic study. No stoma leakage was observed in 7 animals at high bladder pressures (> 50 cm H20 and only 2 animals had some leakage at 40 cm H20. Urodynamics performed through the stoma showed urethral leakage at 20 cm H20, therefore demonstrating the efficacy of the valvular mechanism. Histological analysis confirmed good integration between the tube and the bladder. Mean follow-up of the clinical series (3 patients was 7.2 months. Two patients remained continent up to 4 hours, whereas 1 patient had some leakage after 2 hours. CONCLUSION: We were able to confirm feasibility of a new extra

Process control analysis of IMRT QA: implications for clinical trials

International Nuclear Information System (INIS)

Pawlicki, Todd; Rice, Roger K; Yoo, Sua; Court, Laurence E; McMillan, Sharon K; Russell, J Donald; Pacyniak, John M; Woo, Milton K; Basran, Parminder S; Boyer, Arthur L; Bonilla, Claribel

2008-01-01

The purpose of this study is two-fold: first is to investigate the process of IMRT QA using control charts and second is to compare control chart limits to limits calculated using the standard deviation (σ). Head and neck and prostate IMRT QA cases from seven institutions in both academic and community settings are considered. The percent difference between the point dose measurement in phantom and the corresponding result from the treatment planning system (TPS) is used for analysis. The average of the percent difference calculations defines the accuracy of the process and is called the process target. This represents the degree to which the process meets the clinical goal of 0% difference between the measurements and TPS. IMRT QA process ability defines the ability of the process to meet clinical specifications (e.g. 5% difference between the measurement and TPS). The process ability is defined in two ways: (1) the half-width of the control chart limits, and (2) the half-width of ±3σ limits. Process performance is characterized as being in one of four possible states that describes the stability of the process and its ability to meet clinical specifications. For the head and neck cases, the average process target across institutions was 0.3% (range: -1.5% to 2.9%). The average process ability using control chart limits was 7.2% (range: 5.3% to 9.8%) compared to 6.7% (range: 5.3% to 8.2%) using standard deviation limits. For the prostate cases, the average process target across the institutions was 0.2% (range: -1.8% to 1.4%). The average process ability using control chart limits was 4.4% (range: 1.3% to 9.4%) compared to 5.3% (range: 2.3% to 9.8%) using standard deviation limits. Using the standard deviation to characterize IMRT QA process performance resulted in processes being preferentially placed in one of the four states. This is in contrast to using control charts for process characterization where the IMRT QA processes were spread over three of the

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

Science.gov (United States)

Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

Science.gov (United States)

Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

2015-01-01

The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

Involving clinical librarians at the point of care: results of a controlled intervention.

Science.gov (United States)

Aitken, Elizabeth M; Powelson, Susan E; Reaume, Renée D; Ghali, William A

2011-12-01

To measure the effect of including a clinical librarian in the health care team on medical residents and clinical clerks. In 2009, medical residents and clinical clerks were preassigned to one of two patient care teams (intervention and control). Each team had a month-long rotation on the general medicine teaching unit. The clinical librarian joined the intervention team for morning intake, clinical rounding, or an afternoon patient list review, providing immediate literature searches, formal group instruction, informal bedside teaching, and/or individual mentoring for use of preappraised resources and evidence-based medicine search techniques. Both intervention and control teams completed pre and post surveys comparing their confidence levels and awareness of resources as well as their self-reported use of evidence for making patient care decisions. The nonintervention team was surveyed as the control group. The clinical librarian intervention had a significant positive effect on medical trainees' self-reported ability to independently locate and evaluate evidence resources to support patient care decisions. Notably, 30 of 34 (88%) reported having changed a treatment plan based on skills taught by the clinical librarian, and 27 of 34 (79%) changed a treatment plan based on the librarian's mediated search support. Clinical librarians on the care team led to positive effects on self-reported provider attitudes, provider information retrieval tendencies, and, notably, clinical decision making. Future research should evaluate economic effects of widespread implementation of on-site clinical librarians.

SARDA HITL Preliminary Human Factors Measures and Analyses

Science.gov (United States)

Hyashi, Miwa; Dulchinos, Victoria

2012-01-01

Human factors data collected during the SARDA HITL Simulation Experiment include a variety of subjective measures, including the NASA TLX, questionnaire questions regarding situational awareness, advisory usefulness, UI usability, and controller trust. Preliminary analysis of the TLX data indicate that workload may not be adversely affected by use of the advisories, additionally, the controller's subjective ratings of the advisories may suggest acceptance of the tool.

Clinical registry for rheumatoid arthritis; a preliminary analysis

International Nuclear Information System (INIS)

Fakhr, A.; Hakim, F.; Zaidi, S.K.; Sharif, A.

2017-01-01

To establish a clinical registry for Rheumatoid Arthritis and delineate the most common symptoms that rheumatoid arthritis (RA) patients experience in our set up. Study Design: Cross sectional study. Place and Duration of Study: Study was carried out at Military Hospital (MH) Rawalpindi at Rheumatology Department during the period of Jan 2013 to Jun 2015. Material and Methods: A clinical registry for Rheumatoid Arthritis was developed as per criteria jointly developed by American College of Rheumatology (ACR) along with European League against Rheumatism (EULAR) (2010). Fifty-eight patients were registered after their informed consent and approval by Military Hospital (MH) Rawalpindi ethical committee. Age, gender and relevant clinical parameters of RA patients were recorded on case report forms and stored for analysis in the RA registry in Excel 2010. The figures were reported in frequencies and percentages. Results: Multiple joint pains (48.28%), fever (24.14%), morning stiffness of joints (22.41%) were the most common symptoms in RA patients. Other clinical manifestations included painful bilateral swollen joints (13.79%), pain in different parts of the body (10.34%), Raynaud's phenomenon (10.34%), malaise (8.62%), swollen body parts (8.62%), ulcers (8.62%), fatigue (6.90%), nodules on skin/elbow/interphalangeal joints (6.90%), deformities of fingers/ hand (3.45%), redness of eyes (3.45%), body rash (3.45%), inability to walk (3.45%), cervical lymphadenopathy (1.72%), stiffness of spine (1.72%) and myalgias (1.72%). Conclusion: It is concluded that multiple joint pains, fever and morning stiffness of joints are the most common symptoms of RA patients. (author)

[Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

Science.gov (United States)

Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

2015-06-01

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: a randomized phase I clinical trial.

Science.gov (United States)

Dotres, Carlos P; Puga, Rinaldo; Ricardo, Yariset; Broño, Carmen R; Paredes, Beatriz; Echemendía, Vladimir; Rosell, Sandra; González, Nadezhda; García-Rivera, Dagmar; Valdés, Yury; Goldblatt, David; Vérez-Bencomo, Vicente

2014-09-15

A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173. Copyright © 2014 Elsevier Ltd. All rights reserved.

[A comparative study on efficacy of glucocorticoids, mineralocorticoids and vasoactive drugs on reversing hearing loss in patients suffering idiopathic sensorineural cochlear hypoacusis. A preliminary clinical trial].

Science.gov (United States)

Campos-Bañales, Eugenia María; López-Campos, Daniel; de Serdio-Arias, José Luis; Esteban-Rodriguez, J; García-Sáinz, Mar; Muñoz-Cortés, Álvaro; López-Aguado, Daniel

2015-01-01

Sensory neural hearing loss (SNHL) is a disorder characterised by an important deterioration of the auditory function. Re-establishing normal ion homeostasis of the endolymph could be related to hearing recovery and it might be mediated by mineralocorticoids. The main purpose of this preliminary, randomized controlled clinical trial was assessing the recovery of idiopathic sensory neural cochlear hearing loss (SNHL) by comparing the efficacy of 2 types of steroids versus vasodilators. The 3-month intervention involved 70 patients, allocated into 4 different groups: a control with no medication, consisting of 14 patients (8 men and 6 women); a vasodilator group of 21 patients (11 men and 10 women); a glucocorticoid group with 16 patients (10 men and 6 women); and a mineralocorticoid therapy group, consisting of 19 patients (11 men and 8 women). The level of hearing loss and its topography were estimated using Liminal Tone Audiometry (LTA) and Auditory Brainstem Response (ABR). Our research found overall greater efficacy of mineralocorticoids versus glucocorticoids and vasodilators. There was better response in women than in men and it was higher from the left ear, regardless of patient gender. The hearing gain was significantly superior in the mineralocorticoid group, followed by the glucocorticoid group. However, the responses to vasodilators were lesser and of low statistical significance. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

On the choice of structures of equipment for preliminary data processing for a data acquisition subsystem of the automation control system for controlling technological parameters of tokamak devices

International Nuclear Information System (INIS)

Bondarenko, I.M.; Gerasimov, V.P.; Mozin, I.V.; Repin, S.S.; Skosarev, V.A.

1982-01-01

The necessity is substantiated to use a complex approach to constructing measuring channels of data acquisition subsystems in automation control systems for controlling technological processes in tokamak thermonuclear installations including preliminary data processing equipment, incorporated devices and measuring converters, which enables to minimize the whole bulk of equipment units, while attaining the best metrological features of the channels. Some examples are given designing measuring channels for different kind of signals. Special attention is paid to the choice of structures of measuring channels for signals from sensors under high voltage isolated from the ground potential. It is found reasonable to use analog-time data conversion and optoelectronic isolating elements from the viewpoint of simplicity of apparatus, good manufacturing technology and adjusting measuring channels elements

A preliminary study on the development of electronic pump system using Arduino controller

Science.gov (United States)

Salleh, Mohd Sharil; Miskon, Azizi; Hashim, Fakroul Ridzuan

2018-02-01

The implications of treatment using hemodialysis machine and equipment remain speculative. Most studies, case reviews and medical surveys have shown statistics of side effects of hypertension while undergo a treatment using hemodialysis machine. Therefore, a specific action must be taken to prevent the effects of hypertension during treatment especially using hemodialysis machine. In order to reduce this matter in terms of frequency of hypertension while undergo hemodialysis treatment, many approach have been undertaken for improvement. For the beginning, this project reviews the technique of controlling instantaneous blood pressure for normal and hypertension stage and describe the challenges faced by a researcher during experiment to match human stability. The methodology used in this project is to develop one electronics pump system using Arduino controller for transferring liquid (a tap water) from a tank to another tank. The liquid flow rate was measured by using flow sensor where it located at input and output part. This project has decided to focus on flow rate range from 300 mL/min to 900 mL/min. Results shows an efficiency for speed 30 is 97.96%, speed 50 is 100.15%, speed 130 is 99.54% and speed 200 is 99.87%. A range of efficiency for this preliminary study on the development of Electronic Pump System are from 97.96% to 100.15%. In addition, analysis and simulation of the system delivers a better performance efficiency.

Utilizing measure-based feedback in control-mastery theory: A clinical error.

Science.gov (United States)

Snyder, John; Aafjes-van Doorn, Katie

2016-09-01

Clinical errors and ruptures are an inevitable part of clinical practice. Often times, therapists are unaware that a clinical error or rupture has occurred, leaving no space for repair, and potentially leading to patient dropout and/or less effective treatment. One way to overcome our blind spots is by frequently and systematically collecting measure-based feedback from the patient. Patient feedback measures that focus on the process of psychotherapy such as the Patient's Experience of Attunement and Responsiveness scale (PEAR) can be used in conjunction with treatment outcome measures such as the Outcome Questionnaire 45.2 (OQ-45.2) to monitor the patient's therapeutic experience and progress. The regular use of these types of measures can aid clinicians in the identification of clinical errors and the associated patient deterioration that might otherwise go unnoticed and unaddressed. The current case study describes an instance of clinical error that occurred during the 2-year treatment of a highly traumatized young woman. The clinical error was identified using measure-based feedback and subsequently understood and addressed from the theoretical standpoint of the control-mastery theory of psychotherapy. An alternative hypothetical response is also presented and explained using control-mastery theory. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Using Simulated Patients to Teach Clinical Nutrition.

Science.gov (United States)

Carroll, J. Gregory; And Others

1983-01-01

"Clinical Nutrition in an Interdisciplinary Setting" is a course designed to introduce basic nutrition knowledge and concepts of nutritional assessment, counseling, and intervention in the clinical care of patients. Provides a brief course overview and descriptions of its development, use, and preliminary evaluation of the patient simulation…

Diffusion-weighted MR imaging of cystic lesions of neurocysticercosis: a preliminary study

International Nuclear Information System (INIS)

Raffin, Luciana S.; Bacheschi, Luiz A.; Machado, Luis R.; Nobrega, Jose P.S.; Coelho, Christina; Leite, Claudia C.

2001-01-01

Neurocysticercosis is an endemic disease in some developing countries. It has pleomorfic clinical and imaging findings, which are variable from patient to patient. In this preliminary note, we studied the magnetic resonance diffusion-weighted images of sixteen patients presenting with cystic lesions of this disease diagnosed by clinical and laboratorial findings. All the lesions had hypointense signal and the similar apparent diffusion coefficient values as the cerebrospinal fluid. (author)

Preliminary report. Preliminary findings and views concerning the exemption of kerojet fuels from the Mandatory Petroleum Allocation and Price Regulations

Energy Technology Data Exchange (ETDEWEB)

None

1978-01-01

Preliminary findings indicate the following: kerojet fuel is not in short supply; it will not adversely impact on the supply of other petroleum products subject to the Emergency Petroleum Allocation Act; competition and market forces are adequate; and it will not result in inequitable prices for kerojet or other products. Chapter II provides background information on the use, production, and distribution of kerojet. Chapter III analyzes the historical interaction of supply, demand, and price, and explores the market structure for kerojet during 1968 to 1976, prior to and during imposition of allocation and price controls. Chapter IV examines the effect upon kerojet supply, demand, price, and market structure of exempting kerojet from controls and indicates the benefits to be derived from such exemption. In Chapter V, the potential economic impacts of exemption are evaluated. Chapter VI provides a final summary of the DOE's findings and views in support of its preliminary judgment that kerojet should be exempted from allocation and price regulations. (MCW)

Intensity-modulated radiotherapy for pituitary adenomas: The preliminary report of Cleveland Clinic experience

International Nuclear Information System (INIS)

Mackley, Heath B.; Reddy, Chandana A. M.S.; Lee, S.-Y.; Harnisch, Gayle A.; Mayberg, Marc R.; Hamrahian, Amir H.; Suh, John H.

2007-01-01

Purpose: Intensity-modulated radiotherapy (IMRT) is being increasingly used for the treatment of pituitary adenomas. However, there have been few published data on the short- and long-term outcomes of this treatment. This is the initial report of Cleveland Clinic's experience. Methods and Materials: Between February 1998 and December 2003, 34 patients with pituitary adenomas were treated with IMRT. A retrospective chart review was conducted for data analysis. Results: With a median follow-up of 42.5 months, the treatment has proven to be well tolerated, with performance status remaining stable in 90% of patients. Radiographic local control was 89%, and among patients with secretory tumors, 100% had a biochemical response. Only 1 patient required salvage surgery for progressive disease, giving a clinical progression free survival of 97%. The only patient who received more than 46 Gy experienced optic neuropathy 8 months after radiation. Smaller tumor volume significantly correlated with subjective improvements in nonvisual neurologic complaints (p = 0.03), and larger tumor volume significantly correlated with subjective worsening of visual symptoms (p = 0.05). New hormonal supplementation was required for 40% of patients. Younger patients were significantly more likely to require hormonal supplementation (p 0.03). Conclusions: Intensity-modulated radiation therapy is a safe and effective treatment for pituitary adenomas over the short term. Longer follow-up is necessary to determine if IMRT confers any advantage with respect to either tumor control or toxicity over conventional radiation modalities

Hemozoin Inhibition and Control of Clinical Malaria

Directory of Open Access Journals (Sweden)

Chibueze Peter Ihekwereme

2014-01-01

Full Text Available Malaria has a negative impact on health and social and economic life of residents of endemic countries. The ultimate goals of designing new treatment for malaria are to prevent clinical infection, reduce morbidity, and decrease mortality. There are great advances in the understanding of the parasite-host interaction through studies by various scientists. In some of these studies, attempts were made to evaluate the roles of malaria pigment or toxins in the pathogenesis of malaria. Hemozoin is a key metabolite associated with severe malaria anemia (SMA, immunosuppression, and cytokine dysfunction. Targeting of this pigment may be necessary in the design of new therapeutic products against malaria. In this review, the roles of hemozoin in the morbidity and mortality of malaria are highlighted as an essential target in the quest for effective control of clinical malaria.

Preliminary Analysis of Aircraft Loss of Control Accidents: Worst Case Precursor Combinations and Temporal Sequencing

Science.gov (United States)

Belcastro, Christine M.; Groff, Loren; Newman, Richard L.; Foster, John V.; Crider, Dennis H.; Klyde, David H.; Huston, A. McCall

2014-01-01

Aircraft loss of control (LOC) is a leading cause of fatal accidents across all transport airplane and operational classes, and can result from a wide spectrum of hazards, often occurring in combination. Technologies developed for LOC prevention and recovery must therefore be effective under a wide variety of conditions and uncertainties, including multiple hazards, and their validation must provide a means of assessing system effectiveness and coverage of these hazards. This requires the definition of a comprehensive set of LOC test scenarios based on accident and incident data as well as future risks. This paper defines a comprehensive set of accidents and incidents over a recent 15 year period, and presents preliminary analysis results to identify worst-case combinations of causal and contributing factors (i.e., accident precursors) and how they sequence in time. Such analyses can provide insight in developing effective solutions for LOC, and form the basis for developing test scenarios that can be used in evaluating them. Preliminary findings based on the results of this paper indicate that system failures or malfunctions, crew actions or inactions, vehicle impairment conditions, and vehicle upsets contributed the most to accidents and fatalities, followed by inclement weather or atmospheric disturbances and poor visibility. Follow-on research will include finalizing the analysis through a team consensus process, defining future risks, and developing a comprehensive set of test scenarios with correlation to the accidents, incidents, and future risks. Since enhanced engineering simulations are required for batch and piloted evaluations under realistic LOC precursor conditions, these test scenarios can also serve as a high-level requirement for defining the engineering simulation enhancements needed for generating them.

Everyday episodic memory in amnestic mild cognitive impairment: a preliminary investigation.

Science.gov (United States)

Irish, Muireann; Lawlor, Brian A; Coen, Robert F; O'Mara, Shane M

2011-08-04

Decline in episodic memory is one of the hallmark features of Alzheimer's disease (AD) and is also a defining feature of amnestic Mild Cognitive Impairment (MCI), which is posited as a potential prodrome of AD. While deficits in episodic memory are well documented in MCI, the nature of this impairment remains relatively under-researched, particularly for those domains with direct relevance and meaning for the patient's daily life. In order to fully explore the impact of disruption to the episodic memory system on everyday memory in MCI, we examined participants' episodic memory capacity using a battery of experimental tasks with real-world relevance. We investigated episodic acquisition and delayed recall (story-memory), associative memory (face-name pairings), spatial memory (route learning and recall), and memory for everyday mundane events in 16 amnestic MCI and 18 control participants. Furthermore, we followed MCI participants longitudinally to gain preliminary evidence regarding the possible predictive efficacy of these real-world episodic memory tasks for subsequent conversion to AD. The most discriminating tests at baseline were measures of acquisition, delayed recall, and associative memory, followed by everyday memory, and spatial memory tasks, with MCI patients scoring significantly lower than controls. At follow-up (mean time elapsed: 22.4 months), 6 MCI cases had progressed to clinically probable AD. Exploratory logistic regression analyses revealed that delayed associative memory performance at baseline was a potential predictor of subsequent conversion to AD. As a preliminary study, our findings suggest that simple associative memory paradigms with real-world relevance represent an important line of enquiry in future longitudinal studies charting MCI progression over time.

Everyday episodic memory in amnestic mild cognitive impairment: a preliminary investigation

Directory of Open Access Journals (Sweden)

Lawlor Brian A

2011-08-01

Full Text Available Abstract Background Decline in episodic memory is one of the hallmark features of Alzheimer's disease (AD and is also a defining feature of amnestic Mild Cognitive Impairment (MCI, which is posited as a potential prodrome of AD. While deficits in episodic memory are well documented in MCI, the nature of this impairment remains relatively under-researched, particularly for those domains with direct relevance and meaning for the patient's daily life. In order to fully explore the impact of disruption to the episodic memory system on everyday memory in MCI, we examined participants' episodic memory capacity using a battery of experimental tasks with real-world relevance. We investigated episodic acquisition and delayed recall (story-memory, associative memory (face-name pairings, spatial memory (route learning and recall, and memory for everyday mundane events in 16 amnestic MCI and 18 control participants. Furthermore, we followed MCI participants longitudinally to gain preliminary evidence regarding the possible predictive efficacy of these real-world episodic memory tasks for subsequent conversion to AD. Results The most discriminating tests at baseline were measures of acquisition, delayed recall, and associative memory, followed by everyday memory, and spatial memory tasks, with MCI patients scoring significantly lower than controls. At follow-up (mean time elapsed: 22.4 months, 6 MCI cases had progressed to clinically probable AD. Exploratory logistic regression analyses revealed that delayed associative memory performance at baseline was a potential predictor of subsequent conversion to AD. Conclusions As a preliminary study, our findings suggest that simple associative memory paradigms with real-world relevance represent an important line of enquiry in future longitudinal studies charting MCI progression over time.

Everyday episodic memory in amnestic Mild Cognitive Impairment: a preliminary investigation

LENUS (Irish Health Repository)

Irish, Muireann

2011-08-04

Abstract Background Decline in episodic memory is one of the hallmark features of Alzheimer\\'s disease (AD) and is also a defining feature of amnestic Mild Cognitive Impairment (MCI), which is posited as a potential prodrome of AD. While deficits in episodic memory are well documented in MCI, the nature of this impairment remains relatively under-researched, particularly for those domains with direct relevance and meaning for the patient\\'s daily life. In order to fully explore the impact of disruption to the episodic memory system on everyday memory in MCI, we examined participants\\' episodic memory capacity using a battery of experimental tasks with real-world relevance. We investigated episodic acquisition and delayed recall (story-memory), associative memory (face-name pairings), spatial memory (route learning and recall), and memory for everyday mundane events in 16 amnestic MCI and 18 control participants. Furthermore, we followed MCI participants longitudinally to gain preliminary evidence regarding the possible predictive efficacy of these real-world episodic memory tasks for subsequent conversion to AD. Results The most discriminating tests at baseline were measures of acquisition, delayed recall, and associative memory, followed by everyday memory, and spatial memory tasks, with MCI patients scoring significantly lower than controls. At follow-up (mean time elapsed: 22.4 months), 6 MCI cases had progressed to clinically probable AD. Exploratory logistic regression analyses revealed that delayed associative memory performance at baseline was a potential predictor of subsequent conversion to AD. Conclusions As a preliminary study, our findings suggest that simple associative memory paradigms with real-world relevance represent an important line of enquiry in future longitudinal studies charting MCI progression over time.

Evaluation of a clinically intuitive quality assurance method

International Nuclear Information System (INIS)

Norris, H; Thomas, A; Oldham, M

2013-01-01

There is a pressing need for clinically intuitive quality assurance methods that report metrics of relevance to the likely impact on tumor control of normal tissue injury. This paper presents a preliminary investigation into the accuracy of a novel ''transform method'' which enables a clinically relevant analysis through dose-volume-histograms (DVHs) and dose overlays on the patient's CT data. The transform method was tested by inducing a series of known mechanical and delivery errors onto simulated 3D dosimetry measurements of six different head-and-neck IMRT treatment plans. Accuracy was then examined through the comparison of the transformed patient dose distributions and the known actual patient dose distributions through dose-volume histograms and normalized dose difference analysis. Through these metrics, the transform method was found to be highly accurate in predicting measured patient dose distributions for these types of errors.

Multilivel interfaces for power plant control rooms II: A preliminary design space

International Nuclear Information System (INIS)

Vicente, K.J.

1992-01-01

Events that are unfamiliar to operators and that have not been anticipated by designers pose the greatest threat to system safely in nuclear power plants. The abstraction hierarchy has been proposed as a representation frame-work that can be adopted to design interfaces that support operators in dealing with these unanticipated events. It consists of a multilevel representation format that represents a plant in terms of both physical and functional constraints. In a companion article, the work that has been done on this topic in academia, industry, and research laboratories was reviewed. On the basis of the results of that review, this article proposes a preliminary design space for multilevel interfaces based on the abstraction hierarchy. This space serves several worthwhile purposes: providing a unified framework within which to compare and contrast previous and future work in this area, providing a coherent research agenda by identifying some of the dimensions that can be meaningfully manipulated and evaluated in future experiments, and finally, serving as an input design by outlining the various decisions that need to be made in developing multilevel interfaces and the different options that are currently available for each of those decisions. Consequently this article should be of interest to researchers, designers, and regulators concerned with nuclear power-plant control rooms

Predicting methylphenidate response in attention deficit hyperactivity disorder: a preliminary study.

Science.gov (United States)

Johnston, Blair A; Coghill, David; Matthews, Keith; Steele, J Douglas

2015-01-01

Methylphenidate (MPH) is established as the main pharmacological treatment for patients with attention deficit hyperactivity disorder (ADHD). Whilst MPH is generally a highly effective treatment, not all patients respond, and some experience adverse reactions. Currently, there is no reliable method to predict how patients will respond, other than by exposure to a trial of medication. In this preliminary study, we sought to investigate whether an accurate predictor of clinical response to methylphenidate could be developed for individual patients, using sociodemographic, clinical and neuropsychological measures. Of the 43 boys with ADHD included in this proof-of-concept study, 30 were classed as responders and 13 as non-responders to MPH, with no significant differences in age nor verbal intelligence quotient (IQ) between the groups. Here we report the application of a multivariate analysis approach to the prediction of clinical response to MPH, which achieved an accuracy of 77% (p = 0.005). The most important variables to the classifier were performance on a 'go/no go' task and comorbid conduct disorder. This preliminary study suggested that further investigation is merited. Achieving a highly significant accuracy of 77% for the prediction of MPH response is an encouraging step towards finding a reliable and clinically useful method that could minimise the number of children needlessly being exposed to MPH. © The Author(s) 2014.

Comparison of clinical and parasitological data from controlled human malaria infection trials.

Directory of Open Access Journals (Sweden)

Meta Roestenberg

Full Text Available Exposing healthy human volunteers to Plasmodium falciparum-infected mosquitoes is an accepted tool to evaluate preliminary efficacy of malaria vaccines. To accommodate the demand of the malaria vaccine pipeline, controlled infections are carried out in an increasing number of centers worldwide. We assessed their safety and reproducibility.We reviewed safety and parasitological data from 128 malaria-naïve subjects participating in controlled malaria infection trials conducted at the University of Oxford, UK, and the Radboud University Nijmegen Medical Center, The Netherlands. Results were compared to a report from the US Military Malaria Vaccine Program.We show that controlled human malaria infection trials are safe and demonstrate a consistent safety profile with minor differences in the frequencies of arthralgia, fatigue, chills and fever between institutions. But prepatent periods show significant variation. Detailed analysis of Q-PCR data reveals highly synchronous blood stage parasite growth and multiplication rates.Procedural differences can lead to some variation in safety profile and parasite kinetics between institutions. Further harmonization and standardization of protocols will be useful for wider adoption of these cost-effective small-scale efficacy trials. Nevertheless, parasite growth rates are highly reproducible, illustrating the robustness of controlled infections as a valid tool for malaria vaccine development.

Impact of implementing electronic clinical practice guidelines for the diagnosis, control and treatment of cardiovascular risk factors: A pre-post controlled study.

Science.gov (United States)

Comin, Eva; Catalan-Ramos, Arantxa; Iglesias-Rodal, Manuel; Grau, Maria; Del Val, Jose Luis; Consola, Alicia; Amado, Ester; Pons, Angels; Mata-Cases, Manel; Franzi, Alicia; Ciurana, Ramon; Frigola, Eva; Cos, Xavier; Davins, Josep; Verdu-Rotellar, Jose M

To evaluate the impact of computerized clinical practice guidelines on the management, diagnosis, treatment, control, and follow-up of the main cardiovascular risk factors: hypertension, hypercholesterolaemia, and type 2 diabetes mellitus. Pre-post controlled study. Catalonia, autonomous community located in north-eastern Spain. Individuals aged 35-74 years assigned to general practitioners of the Catalan Health Institute. The intervention group consisted of individuals whose general practitioners had accessed the computerized clinical practice guidelines at least twice a day, while the control group consisted of individuals whose general practitioner had never accessed the computerized clinical practice guidelines platform. The Chi-squared test was used to detect significant differences in the follow-up, control, and treatment variables for all three disorders (hypertension, hypercholesterolaemia, and type 2 diabetes mellitus) between individuals assigned to users and non-users of the computerized clinical practice guidelines, respectively. A total of 189,067 patients were included in this study, with a mean age of 56 years (standard deviation 12), and 55.5% of whom were women. Significant differences were observed in hypertension management, treatment and control; type 2 diabetes mellitus management, treatment and diagnoses, and the management and control of hypercholesterolaemia in both sexes. Computerized clinical practice guidelines are an effective tool for the control and follow-up of patients diagnosed with hypertension, type 2 diabetes mellitus, and hypercholesterolaemia. The usefulness of computerized clinical practice guidelines to diagnose and adequately treat individuals with these disorders remains unclear. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Clinical evaluation of an automatic blood pressure controller during cardiac surgery

NARCIS (Netherlands)

Meijers, R.H.A.M.; Schmartz, D.; Cantraine, F.R.L.; Barvais, L.; d Hollander, A.A.; Blom, J.A.

1997-01-01

During surgery, computers can be of great use to support the anesthesiologist in providing task automation. In this paper we describe a closed loop blood pressure controller and show the results of its clinical evalua- tion.Methods. The controller is based on a simple and robust

HTGR gas turbine power plant preliminary design

International Nuclear Information System (INIS)

Koutz, S.L.; Krase, J.M.; Meyer, L.

1973-01-01

The preliminary reference design of the HTGR gas turbine power plant is presented. Economic and practical problems and incentives related to the development and introduction of this type of power plant are evaluated. The plant features and major components are described, and a discussion of its performance, economics, development, safety, control, and maintenance is presented. 4 references

Preliminary System Design of the SWRL Financial System.

Science.gov (United States)

Ikeda, Masumi

The preliminary system design of the computer-based Southwest Regional Laboratory's (SWRL) Financial System is outlined. The system is designed to produce various management and accounting reports needed to maintain control of SWRL operational and financial activities. Included in the document are descriptions of the various types of system…

Preliminary investigation of an electromyography-controlled video game as a home program for persons in the chronic phase of stroke recovery.

Science.gov (United States)

Donoso Brown, Elena V; McCoy, Sarah Westcott; Fechko, Amber S; Price, Robert; Gilbertson, Torey; Moritz, Chet T

2014-08-01

To investigate the preliminary effectiveness of surface electromyography (sEMG) biofeedback delivered via interaction with a commercial computer game to improve motor control in chronic stroke survivors. Single-blinded, 1-group, repeated-measures design: A1, A2, B, A3 (A, assessment; B, intervention). Laboratory and participants' homes. A convenience sample of persons (N=9) between 40 and 75 years of age with moderate to severe upper extremity motor impairment and at least 6 months poststroke completed the study. The electromyography-controlled video game system targeted the wrist muscle activation with the goal of increasing selective muscle activation. Participants received several laboratory training sessions with the system and then were instructed to use the system at home for 45 minutes, 5 times per week for the following 4 weeks. Primary outcome measures included duration of system use, sEMG during home play, and pre/post sEMG measures during active wrist motion. Secondary outcomes included kinematic analysis of movement and functional outcomes, including the Wolf Motor Function Test and the Chedoke Arm and Hand Activity Inventory-9. One third of participants completed or exceeded the recommended amount of system use. Statistically significant changes were observed on both game play and pre/post sEMG outcomes. Limited carryover, however, was observed on kinematic or functional outcomes. This preliminary investigation indicates that use of the electromyography-controlled video game impacts muscle activation. Limited changes in kinematic and activity level outcomes, however, suggest that the intervention may benefit from the inclusion of a functional activity component. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Translation of the Manchester Clinical Supervision Scale (MCSS) into Danish and a preliminary psychometric validation

DEFF Research Database (Denmark)

Buus, Niels; Gonge, Henrik

2013-01-01

for the translation of the MCSS from English into Danish and to present a preliminary psychometric validation of the Danish version of the scale. Methods included a formal translation/back-translation procedure and statistical analyses. The sample consisted of MCSS scores from 139 Danish mental health nursing staff...

Control of radiation-induced diarrhea with cholestyramine

International Nuclear Information System (INIS)

Heusinkveld, R.S.; Manning, M.R.; Aristizabal, S.A.

1978-01-01

Cholestyramine is a non-absorbable ion-exchange resin which specifically binds bile salts. We have treated seven patients with acute or chronic radiation-induced diarrhea that was refractory to the usual methods of control with cholestyramine. In each case, the diarrhea was controlled with cholestyramine. This observation supports previous experimental work with animals which indicated that bile salts contribute to the genesis of radiation-induced diarrhea. Cholestyramine is well-tolerated, but should not be administered with certain oral medications. The results of this small series are preliminary, but point the way toward a more extensive clinical trial to define the usefulness of cholestyramine in the treatment of refractory acute or chronic radiation-induced diarrhea

Preliminary assessment of the controlled release of radionuclides from waste packages containing borosilicate waste glass

International Nuclear Information System (INIS)

Strachan, D.M.; McGrail, B.P.; Apted, M.J.; Engle, D.W.; Eslinger, P.W.

1990-06-01

The purpose of this report is to provide a preliminary assessment of the release-rate for an engineered barriers subsystem (EBS) containing waste packages of defense high-level waste borosilicate glass at geochemical and hydrological conditions similar to the those at Yucca Mountain. The relationship between the proposed Waste Acceptance Preliminary Specifications (WAPS) test of glass- dissolution rate and compliance with the NRC's release-rate criterion is also evaluated. Calculations are reported for three hierarchical levels: EBS analysis, waste-package analysis, and waste-glass analysis. The following conclusions identify those factors that most acutely affect the magnitude of, or uncertainty in, release-rate performance

Preliminary Results of the Louisiana Sex Offender Treatment Program

Directory of Open Access Journals (Sweden)

Lee A. Underwood

2015-12-01

Full Text Available The purpose of this study was to offer preliminary support for the Louisiana Sex Offender Treatment Program (LSOTP in addressing the needs of juvenile sex offenders. Research objectives were (1 to offer statistical evidence for reductions in anxiety, depression, cognitive distortion and negative attitudes towards women comparing a group of 21 adolescents, 12 of whom received services as usual and nine of whom participated in the LSOTP. A controlled experimental evaluation design was utilized. The juvenile sex offenders were randomly assigned to the experimental group for 12 weeks receiving treatment services and a control group receiving care “as usual” in a residential group care program. Participants in the experimental group experienced statistically significant decreases in cognitive distortions related specifically to rape and molestation.The results of this study offer preliminary support of the LSOTP as a best practices alternative to other treatment modalities.

Vasectomy: preliminary report on 25 cases.

Science.gov (United States)

Lema, V M; Makokha, A E

1989-05-01

Preliminary data on 25 men who underwent vasectomy for contraception between June 1986 and May 1988 at the Marie Stopes Clinic--Nairobi is presented. The majority (76.0%) of the subjects were aged between 25 and 39 years. 68.0% had 4 living children or less. Professionals including lecturers, lawyers, teachers, engineers etc, formed 88.0% of the total. Three clients(12.0%) had documented complications; one had aseptic wound, one had haematoma and the last one had a failed vasectomy. All were treated successfully. Complications of vasectomy and the need for follow-up of vasectomised men are discussed.

Glycemic control in the infectious diseases ward; role of clinical pharmacist interventions.

Science.gov (United States)

Farsaei, Shadi; Karimzadeh, Iman; Elyasi, Sepideh; Hatamkhani, Shima; Khalili, Hossein

2014-04-15

Hyperglycemia is one of the most frequent metabolic complications in hospitalized patients. Increased risk of infection following hyperglycemia has been reported in hospitalized patients and infections may also cause insulin resistance which complicates the control of blood glucose level. In this study the impact of the clinical pharmacist interventions on the glycemic control in patients admitted to infectious diseases ward has been evaluated. We conducted a prospective, pre-post interventional study among patients with hyperglycemia. The clinical pharmacist-led multidisciplinary team managed the glycemic profile of patients according to an established insulin protocol commonly used in internal wards. Clinical pharmacists reviewed patients' medical charts for proper insulin administration, evaluated nurses' technique for insulin injection and blood glucose measurement, and educated patients about symptoms of hypoglycemia and the importance of adherence to different aspects of their glycemic management. The percentage of controlled random blood sugar increased from 13.8% in the pre-intervention to 22.3% in the post-intervention group (p value percentage of controlled fasting blood sugars in the post-intervention group was non-significantly higher than in the pre-intervention group. Pharmacists and additional health care providers from other departments such as nursing and dietary departments need to be devoted to glycemic control service. Collaborative practice agreement between physicians is necessary to promote this service and help to increase the use of such services in different settings for diabetes control.

Use of an online portal to facilitate clinical trial recruitment: a preliminary analysis of Fox Trial Finder.

Science.gov (United States)

Rocker, Charlotte; Cappelletti, Lily; Marshall, Claudia; Meunier, Claire C; Brooks, Deborah W; Sherer, Todd; Chowdhury, Sohini

2015-01-01

As in other therapeutic areas, clinical studies in Parkinson's disease (PD) face significant recruitment challenges. However, qualitative surveys suggest that individuals with PD are willing to participate in clinical research. The Michael J. Fox Foundation therefore established Fox Trial Finder in 2011 to facilitate connection between PD research teams and volunteers. Characterize the research volunteers (with and without PD) registered on Fox Trial Finder as of June 2014, and the published, recruiting studies to identify trends and highlight gaps between research requirements and available volunteers. Profiles of volunteers with and without PD were analyzed to explore trends in geography, demographics, family history and, for those volunteers with PD, disease progression and treatment history. Clinical study profiles were analyzed to determine study type, phase, sponsor, focus, location and eligibility criteria. The analysis focused on volunteers and studies based in the United States. The database contained 26,261 US-based volunteers, including 19,243 volunteers (73%) with PD and 7,018 (27%) controls without PD. The average time since diagnosis for PD volunteers was 5.7 years and the average age at diagnosis was 58 years. Control volunteers were more likely than volunteers with PD to be female (67% vs. 35%) and to have a family history of PD (49% vs. 12%). Fox Trial Finder's registration history to date demonstrates the high level of willingness among individuals affected by PD to participate in clinical research and provide a significant amount of personal health information to facilitate that participation.

Clinical pharmacists on medical care of pediatric inpatients: a single-center randomized controlled trial.

Directory of Open Access Journals (Sweden)

Chuan Zhang

Full Text Available OBJECTIVE: To explore the best interventions and working patterns of clinical pharmacists in pediatrics and to determine the effectiveness of clinical pharmacists in pediatrics. METHODS: We conducted a randomized controlled trial of 160 pediatric patients with nerve system disease, respiratory system disease or digestive system disease, who were randomly allocated into two groups, with 80 in each group. Interventions by clinical pharmacists in the experimental group included answering questions of physicians and nurses, giving advice on treating patients, checking prescriptions and patient counseling at discharge. In the control group, patients were treated without clinical pharmacist interventions. RESULTS: Of the 109 interventions provided by clinical pharmacists during 4 months, 47 were consultations for physicians and nurses, 31 were suggestions of treatment, with 30 accepted by physicians (96.77% and 31 were medical errors found in 641 prescriptions. Five adverse drug reactions were submitted to the adverse drug reaction monitoring network, with three in the experimental group and two in the control group. The average length of stay (LOS for patients with respiratory system diseases in the experimental group was 6.45 days, in comparison with 10.83 days in the control group, which was statistically different (p value<0.05; Average drug compliance rate in the experimental group was 81.41%, in comparison with 70.17% of the control group, which was statistically different (p value<0.05. Cost of drugs and hospitalization and rate of readmission in two weeks after discharge in the two groups were not statistically different. CONCLUSION: Participation by clinical pharmacists in the pharmacotherapy of pediatric patients can reduce LOS of patients with respiratory system disease and improve compliance rate through discharge education, showing no significant effects on prevention of ADR, reduction of cost of drugs and hospitalization and readmission

Preliminary report. Preliminary findings and views concerning the exemption of aviation gasoline from the Mandatory Petroleum Allocation and Price Regulations

Energy Technology Data Exchange (ETDEWEB)

None

1978-01-01

Preliminary findings indicate that: the fuel is not in short supply; exemption will not have an adverse impact on supply of any other petroleum product subject to the Emergency Petroleum allocation Act of 1973; competition and market force are adequate; exemption will not result in inequitable prices; and exemption will not have adverse state or regional impacts or any other adverse impacts. Chapter II provides background information on the use, production, and distribution of aviation gasoline. Chapter III analyzes the historical interaction of supply, demand, and price, and explores the market structure for aviation gasoline during 1968 to 1976, prior to and during imposition of allocation and price controls. Chapter IV examines aviation gasoline supply, demand, price, and market structure impacts of exempting aviation gasoline from controls. In Chapter V, the potential economic impacts of exemption are evaluated. Chapter VI provides a final summary of the DOE's findings and views in support of its preliminary judgment that aviation gasoline should be exempted from allocation and price regulations. (MCW)

SSPM based radiation sensing: Preliminary laboratory and clinical results

International Nuclear Information System (INIS)

Konnoff, Daniel C.; Plant, Thomas K.; Shiner, Elizabeth

2011-01-01

Recent Solid State Photomultiplier (SSPM) technology has matured, reaching a performance level that is suitable for replacement of the ubiquitous photomultiplier tube in selected applications for environmental radiation monitoring, clinical dosimetry, and medical imaging purposes. The objective of this work is low signal level laboratory and high signal level clinical testing of the Hamamatsu MPPC (S10362-11-050C), Photonique SSPM (0810G1), and Voxtel SiPM (SQBF-EKAA/SQBF-EIOA) SSPMs coupled to different inorganic scintillator crystals (Prelude 420, BGO), inorganic doped glass scintillator material SiO 2 :Cu 2+ and organic BCF-12 plastic scintillating fibers, used as detector elements. Plastic Optical Fibers (POFs) and Glass Optical Fibers (GOFs) are used as signal conduits for laboratory and clinical testing. Further, reduction of electron-beam-generated Cerenkov light in optical fibers is facilitated by the inclusion of metalized air-core capillary tubing between the BCF-12 plastic scintillating fiber and the POF. In a clinical setting dose linearity, percent depth dose, and angular measurements for 6 MV/18 MV photon beams and 9 MeV electron beams are compared with and without the use of the air-core capillary tubing for BCF-12 plastic scintillating fiber. These same measurements are repeated for SiO 2 :Cu 2+ scintillator material without air-core capillary tubing.

Does vitamin D deficiency predict early conversion of clinically isolated syndrome? A preliminary Egyptian study.

Science.gov (United States)

Shaheen, Hala A; Sayed, Sayed S; Daker, Lamiaa I; AbdelAziz, Hossam Eldin; Taha, Mohamed A

2018-03-15

It has been suggested that vitamin D influences the immunoregulation and subsequently affects the risk for conversion of clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (MS). There is little information regarding the relationship between levels of vitamin D and CIS conversion to MS in Egyptian patients. It is to study contribution of vitamin D deficiency to conversion of CIS to clinically definite multiple sclerosis (CDMS) and correlation of vitamin D level to cognitive and magnetic resonance imaging (MRI) results. A longitudinal prospective case control study was conducted on 43 Egyptian patients diagnosed as CIS according to McDonald criteria (2010). Clinical presentation, brain MRI and 25-hydroxyvitamin D levels were evaluated at baseline and after one-year follow-up. The CIS patients that converted to MS showed significant lower vitamin D level (p < 0.001) than the non-convertors. Multivariate logistic regression analysis revealed that the CIS patients with lower 25-hydroxyvitamin D level (p < 0.001) are at higher risk for early conversion to MS. There was a significant positive correlation between the vitamin D level and PASAT (r = 0.36, p = 0.02). It was found that there was a significant negative correlation between vitamin D level and MRI T 2 load (r = -0.38, p = 0.01). The low level of 25-hydroxyvitamin D may predict early conversion to clinically definite MS. Early vitamin D supplementation is recommended in patients with CIS.

Preliminary Development of Regulatory PSA Models for SFR

International Nuclear Information System (INIS)

Choi, Yong Won; Shin, Andong; Bae, Moohoon; Suh, Namduk; Lee, Yong Suk

2013-01-01

Well developed PRA methodology exists for LWR (Light Water Reactor) and PHWR (Pressurized Heavy Water Reactor). Since KAERI is developing a prototype SFR targeting to apply for a license by 2017, KINS needs to have a PRA models to assess the safety of this prototype reactor. The purpose of this study is to develop the regulatory PSA models for the independent verification of the SFR safety. Since the design of the prototype SFR is not mature yet, we have tried to develop the preliminary models based on the design data of KAERI's previous SFR design. In this study, the preliminary initiating events of level 1 internal event for SFR were selected through reviews of existing PRA (LWR, PRISM, ASTRID and KALIMER-600) models. Then, the event tree for each selected initiating event was developed. The regulatory PRA models of SFR developed are preliminary in a sense, because the prototype SFR design is not mature and provided yet. Still it might be utilized for the forthcoming licensing review in assessing the risk of safety issues and the configuration control of the design

A preliminary clinic dosimetry study for synchrotron radiation therapy at SSRF

International Nuclear Information System (INIS)

Li Zhaobin; Shi Zeliang; Zhang Qing; Wang Yong; Fu Shen

2013-01-01

Synchrotron radiation (SR) represents a unique and innovative anti-cancer treatment due to its unique physical features, including high flux density, and tunable and collimated radiation generation. The aim of this work is to assess the dosimetric properties of SR in Shanghai Synchrotron Radiation Facility (SSRF) for potential applications to clinical radiation oncology. The experiments were performed with 34 and 50 keV X-rays on the BL13W biomedical beamline of SSRF and the 6 MV X-rays from ARTISTE linac for the dosimetry study. The percentage depth dose (PDD) and the surface dose of the SR X-rays and the 6 MV photon beams were performed in solid water phantom with Gafchromic EBT3 films. All curves are normalized to the maximum calculated dose, The depth of full dose buildup is about 10 μm deeper for the monoenergetic X-ray beams of 34 and 50 keV. The beam transmits through the phantom, with a linear attenuation coefficient. The profile in the horizontal plane shows that the dose distribution is uniform within the facula, while the vertical profile shows a Gaussian distribution of the dose. The penumbra is less than 0.2 mm in the horizontal profile. Gafchromic EBT film may be a useful and convenient tool for dose measurement and quality control for the high space and density resolution. It is therefore important to gain a thorough understanding about the physical features of SR before this novel technology can be applied to clinical practice. (authors)

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

Science.gov (United States)

Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

Toward realization of 'mix-and-use' approach in ⁶⁸Ga radiopharmacy: preparation, evaluation and preliminary clinical utilization of ⁶⁸Ga-labeled NODAGA-coupled RGD peptide derivative.

Science.gov (United States)

Chakraborty, Sudipta; Chakravarty, Rubel; Vatsa, Rakhee; Bhusari, Priya; Sarma, H D; Shukla, Jaya; Mittal, B R; Dash, Ashutosh

2016-01-01

The present article demonstrates a 'mix-and-use' approach for radiolabeling RGD peptide derivative with (68)Ga, which is easily adaptable in hospital radiopharmacy practice. The radiotracer thus formulated was successfully used for positron emission tomography (PET) imaging of breast cancer in human patients. The conditions for radiolabeling NODAGA-coupled dimeric cyclic RGD peptide derivative [NODAGA-(RGD)2] with (68)Ga were optimized using (68)Ga obtained from a (68)Ge/(68)Ga generator developed in-house with CeO2-PAN composite sorbent as well as from a commercial (68)Ge/(68)Ga generator obtained from ITG, Germany. Preclinical studies were carried out in C57BL/6 mice bearing melanoma tumors. The radiotracer was prepared in a hospital radiopharmacy using (68)Ga obtained from ITG generator and used for monitoring breast cancer patients by positron emission tomography (PET) imaging. (68)Ga-NODAGA-(RGD)2 could be prepared with high radiolabeling yield (>98%) and specific activity (~50 GBq/μmol) within 10 min at room temperature by mixing (68)Ga with the solution of the peptide conjugate. In vivo biodistribution studies showed significant uptake (5.24±0.39% ID/g) in melanoma tumor at 30 min post-injection, with high tumor-to-background contrast. The integrin αvβ3 specificity of the tracer was corroborated by blocking study. Preliminary clinical studies in locally advanced breast cancer (LABC) patients indicated specifically high tumor uptake (SUVmax 10-15) with good contrast. This is one of the very few reports which presents preliminary clinical data on use of (68)Ga-NODAGA-(RGD)2 and the developed 'mix-and-use' holds tremendous prospect in clinical PET imaging using (68)Ga. Copyright © 2015 Elsevier Inc. All rights reserved.

A preliminary taxonomy of medical errors in family practice.

Science.gov (United States)

Dovey, S M; Meyers, D S; Phillips, R L; Green, L A; Fryer, G E; Galliher, J M; Kappus, J; Grob, P

2002-09-01

To develop a preliminary taxonomy of primary care medical errors. Qualitative analysis to identify categories of error reported during a randomized controlled trial of computer and paper reporting methods. The National Network for Family Practice and Primary Care Research. Family physicians. Medical error category, context, and consequence. Forty two physicians made 344 reports: 284 (82.6%) arose from healthcare systems dysfunction; 46 (13.4%) were errors due to gaps in knowledge or skills; and 14 (4.1%) were reports of adverse events, not errors. The main subcategories were: administrative failure (102; 30.9% of errors), investigation failures (82; 24.8%), treatment delivery lapses (76; 23.0%), miscommunication (19; 5.8%), payment systems problems (4; 1.2%), error in the execution of a clinical task (19; 5.8%), wrong treatment decision (14; 4.2%), and wrong diagnosis (13; 3.9%). Most reports were of errors that were recognized and occurred in reporters' practices. Affected patients ranged in age from 8 months to 100 years, were of both sexes, and represented all major US ethnic groups. Almost half the reports were of events which had adverse consequences. Ten errors resulted in patients being admitted to hospital and one patient died. This medical error taxonomy, developed from self-reports of errors observed by family physicians during their routine clinical practice, emphasizes problems in healthcare processes and acknowledges medical errors arising from shortfalls in clinical knowledge and skills. Patient safety strategies with most effect in primary care settings need to be broader than the current focus on medication errors.

Does structural leg-length discrepancy affect postural control? Preliminary study.

Science.gov (United States)

Eliks, Małgorzata; Ostiak-Tomaszewska, Wioleta; Lisiński, Przemysław; Koczewski, Paweł

2017-08-09

Leg-length inequality results in an altered position of the spine and pelvis. Previous studies on the influence of leg asymmetry on postural control have been inconclusive. The purpose of this paper was to investigate the effect of structural leg-length discrepancy (LLD) on the control of posture. We studied 38 individuals (19 patients with structural LLD, 19 healthy subjects). The examination included measurement of the length of the lower limbs and weight distribution as well as a static posturography. All statistical analyses were performed with Statistica software version 10.0. Non-parametrical Kruskal-Wallis with Dunn's post test and Spearman test were used. Differences between the groups and correlation between mean COP sway velocity and the value of LLD as well as the value of LLD and weight distribution were assumed as statistically significant at p  0.05). Meaningful differences in mean COP velocity in mediolateral direction between tandem stance with eyes open and closed were detected in both groups (in controls p = 0.000134, in patients both with the shorter leg in a front and rear position, p = 0.029, p = 0.026 respectively). There was a positive moderate correlation between the value of LLD and the value of mean COP velocity in normal standing in mediolateral direction with eyes open (r = 0.47) and closed (r = 0.54) and in anterioposterior plane with eyes closed (r = 0.05). The fact that there were no significant differences in posturography between the groups might indicate compensations to the altered posture and neuromuscular adaptations in patients with structural leg-length inequality. LLD causes an increased asymmetry of weight distribution. This study confirmed a fundamental role of the sight in postural control, especially in unstable conditions. The analysis of mean COP sway velocity may suggest a proportional deterioration of postural control with the increase of the value of leg-length asymmetry. Trial registry: Clinical

Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial.

Science.gov (United States)

Kon, Elizaveta; Engebretsen, Lars; Verdonk, Peter; Nehrer, Stefan; Filardo, Giuseppe

2018-01-01

Osteoarthritis (OA) is a debilitating disease resulting in substantial pain and functional limitations. A novel blood derivative has been developed to concentrate both growth factors and antagonists of inflammatory cytokines, with promising preliminary findings in terms of safety profile and clinical improvement. To investigate if one intra-articular injection of autologous protein solution (APS) can reduce pain and improve function in patients affected by knee OA in a multicenter, randomized, double-blind, saline-controlled study. Randomized controlled trial; Level of evidence, 2. Forty-six patients with unilateral knee OA (Kellgren-Lawrence 2 or 3) were randomized into the APS group (n = 31), which received a single ultrasound-guided injection of APS, and the saline (control) group (n = 15), which received a single saline injection. Patient-reported outcomes and adverse events were collected at 2 weeks and at 1, 3, 6, and 12 months through visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), Short Form-36 (SF-36), Clinical Global Impression of Severity/Change (CGI-S/C), Patient Global Impression of Severity/Change (PGI-S/C), and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rate. Imaging evaluation was also performed with radiograph and magnetic resonance imaging (MRI) before and after treatment (12 months and 3 and 12 months, respectively). The safety profile was positive, with no significant differences in frequency and severity of adverse events between groups. The improvement from baseline to 2 weeks and to 1, 3, and 6 months was similar between treatments. At 12 months, improvement in WOMAC pain score was 65% in the APS group and 41% in the saline group ( P = .02). There were no significant differences in VAS pain improvement between groups. At 12 months, APS group showed improved SF-36 Bodily Pain

The Preliminary Effects of Massage and Inhalation Aromatherapy on Chemotherapy-Induced Acute Nausea and Vomiting: A Quasi-Randomized Controlled Pilot Trial.

Science.gov (United States)

Zorba, Pinar; Ozdemir, Leyla

2017-04-20

Despite pharmacological treatment, chemotherapy-induced nausea and vomiting (CINV) are observed in patients. This quasi-randomized controlled pilot study evaluated the feasibility and preliminary effects of massage and inhalation aromatherapies on chemotherapy-induced acute nausea/vomiting. Seventy-five patients with breast cancer were randomly grouped into 1 of 3 groups: massage (n = 25), inhalation (n = 25), and control (n = 25). The patients in the massage group received 20-minute aromatherapy foot massage, whereas those in the inhalation group received 3-minute inhalation aromatherapy before their second, third, and fourth chemotherapy cycles. The control group underwent only the routine treatment. A nausea, vomiting, and retching patient follow-up form was used to evaluate nausea severity by visual analog scale and frequency of vomiting and retching. The incidence of nausea and retching was significantly higher in the control group than in the other groups in the third and fourth chemotherapy cycles (P aromatherapy groups than in the control group. Nausea and retching incidence was reduced in the aromatherapy groups compared with that in the control group. Nonpharmacological approaches are recommended for managing CINV. Massage and inhalation aromatherapy seems promising regarding the management of CINV.

Preliminary survey on tsetse flies and trypanosomosis at grazing ...

African Journals Online (AJOL)

Preliminary survey on tsetse flies and trypanosomosis were conducted between. July and August 2007 at grazing fields and villages in and around the Nech Sar national park, with the ultimate intention of forwarding baseline information on the extent of the problem and possible control strategies. . Entomological (Tsetse.

Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

Directory of Open Access Journals (Sweden)

Evelim L F D Gomes

Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

Full-mouth disinfection as a therapeutic protocol for type-2 diabetic subjects with chronic periodontitis: twelve-month clinical outcomes: a randomized controlled clinical trial.

Science.gov (United States)

Santos, Vanessa R; Lima, Jadson A; Miranda, Tamires S; Gonçalves, Tiago E D; Figueiredo, Luciene C; Faveri, Marcelo; Duarte, Poliana M

2013-02-01

The aim of this randomized controlled clinical trial was to evaluate the clinical effects of chlorhexidine (CHX) application in a full-mouth disinfection (FMD) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis. Thirty-eight subjects were randomly assigned into FMD group (n=19): full-mouth scaling and root planing (FMSRP) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group (n = 19): FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days. Clinical parameters, glycated haemoglobin and fasting plasma glucose were assessed at baseline, 3, 6 and 12 months post-therapies. All clinical parameters improved significantly at 3, 6 and 12 months post-therapies for both groups (p clinical parameters, and glycemic condition at any time-point (p > 0.05). The treatments did not differ with respect to clinical parameters, including the primary outcome variable (i.e. changes in clinical attachment level in deep pockets), for up to 12 months post-treatments. © 2012 John Wiley & Sons A/S.

Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

Science.gov (United States)

Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

2017-08-01

This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

Preliminary Design Concept for a Reactor-internal CRDM

International Nuclear Information System (INIS)

Lee, Jae Seon; Kim, Jong Wook; Kim, Tae Wan; Choi, Suhn; Kim, Keung Koo

2013-01-01

A rod ejection accident may cause severer result in SMRs because SMRs have relatively high control rod reactivity worth compared with commercial nuclear reactors. Because this accident would be perfectly excluded by adopting a reactor-internal CRDM (Control Rod Drive Mechanism), many SMRs accept this concept. The first concept was provided by JAERI with the MRX reactor which uses an electric motor with a ball screw driveline. Babcock and Wilcox introduced the concept in an mPower reactor that adopts an electric motor with a roller screw driveline and hydraulic system, and Westinghouse Electric Co. proposes an internal Control Rod Drive in its SMR with an electric motor with a latch mechanism. In addition, several other applications have been reported thus far. The reactor-internal CRDM concept is now widely adopted in many SMR designs, and this concept may also be applied in an evolutionary reactor development. So the preliminary study is conducted based on the SMART CRDM design. A preliminary design concept for a reactor-internal CRDM was proposed and evaluated through an electromagnetic analysis. It was found that there is an optimum design for the motor housing, and the results may contribute to the realization a reactor-internal CRDM for an evolutionary reactor development. More detailed analysis results will be reported later

Preliminary Effect of Synthetic Vision Systems Displays to Reduce Low-Visibility Loss of Control and Controlled Flight Into Terrain Accidents

Science.gov (United States)

Glaab, Louis J.; Takallu, Mohammad A.

2002-01-01

An experimental investigation was conducted to study the effectiveness of Synthetic Vision Systems (SVS) flight displays as a means of eliminating Low Visibility Loss of Control (LVLOC) and Controlled Flight Into Terrain (CFIT) accidents by low time general aviation (GA) pilots. A series of basic maneuvers were performed by 18 subject pilots during transition from Visual Meteorological Conditions (VMC) to Instrument Meteorological Conditions (IMC), with continued flight into IMC, employing a fixed-based flight simulator. A total of three display concepts were employed for this evaluation. One display concept, referred to as the Attitude Indicator (AI) replicated instrumentation common in today's General Aviation (GA) aircraft. The second display concept, referred to as the Electronic Attitude Indicator (EAI), featured an enlarged attitude indicator that was more representative of a glass display that also included advanced flight symbology, such as a velocity vector. The third concept, referred to as the SVS display, was identical to the EAI except that computer-generated terrain imagery replaced the conventional blue-sky/brown-ground of the EAI. Pilot performance parameters, pilot control inputs and physiological data were recorded for post-test analysis. Situation awareness (SA) and qualitative pilot comments were obtained through questionnaires and free-form interviews administered immediately after the experimental session. Initial pilot performance data were obtained by instructor pilot observations. Physiological data (skin temperature, heart rate, and muscle flexure) were also recorded. Preliminary results indicate that far less errors were committed when using the EAI and SVS displays than when using conventional instruments. The specific data example examined in this report illustrates the benefit from SVS displays to avoid massive loss of SA conditions. All pilots acknowledged the enhanced situation awareness provided by the SVS display concept. Levels of

Effect of Bundled Payments and Health Care Reform as Alternative Payment Models in Total Joint Arthroplasty: A Clinical Review.

Science.gov (United States)

Siddiqi, Ahmed; White, Peter B; Mistry, Jaydev B; Gwam, Chukwuweike U; Nace, James; Mont, Michael A; Delanois, Ronald E

2017-08-01

In an effort to control rising healthcare costs, healthcare reforms have developed initiatives to evaluate the efficacy of alternative payment models (APMs) for Medicare reimbursements. The Center for Medicare and Medicaid Services Innovation Center (CMMSIC) introduced the voluntary Bundled Payments for Care Improvement (BPCI) model experiment as a means to curtail Medicare cost by allotting a fixed payment for an episode of care. The purpose of this review is to (1) summarize the preliminary clinical results of the BPCI and (2) discuss how it has led to other healthcare reforms and alternative payment models. A literature search was performed using PubMed and the CMMSIC to explore different APMs and clinical results after implementation. All studies that were not in English or unrelated to the topic were excluded. Preliminary results of bundled payment models have shown reduced costs in total joint arthroplasty largely by reducing hospital length of stay, decreasing readmission rates, as well as reducing the number of patients sent to in-patient rehabilitation facilities. In order to refine episode of care bundles, CMMSIC has also developed other initiatives such as the Comprehensive Care for Joint Replacement (CJR) pathway and Surgical Hip and Femur Fracture (SHFFT). Despite the unknown future of the Affordable Care Act, BPCI, and CJR, preliminary results of alternative models have shown promise to reduce costs and improve quality of care. Moving into the future, surgeon control of the BPCI and CJR bundle should be investigated to further improve patient care and maximize financial compensation. Copyright © 2017 Elsevier Inc. All rights reserved.

Preliminary Monthly Climatological Summaries

Data.gov (United States)

National Oceanic and Atmospheric Administration, Department of Commerce — Preliminary Local Climatological Data, recorded since 1970 on Weather Burean Form 1030 and then National Weather Service Form F-6. The preliminary climate data pages...

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

DEFF Research Database (Denmark)

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

2018-01-01

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

Hydrogen Gas Retention and Release from WTP Vessels: Summary of Preliminary Studies

Energy Technology Data Exchange (ETDEWEB)

Gauglitz, Phillip A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Bontha, Jagannadha R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Daniel, Richard C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Mahoney, Lenna A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Rassat, Scot D. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Wells, Beric E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Bao, Jie [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Boeringa, Gregory K. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Buchmiller, William C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Burns, Carolyn A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Chun, Jaehun [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Karri, Naveen K. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Li, Huidong [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Tran, Diana N. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

2015-07-01

The Hanford Waste Treatment and Immobilization Plant (WTP) is currently being designed and constructed to pretreat and vitrify a large portion of the waste in the 177 underground waste storage tanks at the Hanford Site. A number of technical issues related to the design of the pretreatment facility (PTF) of the WTP have been identified. These issues must be resolved prior to the U.S. Department of Energy (DOE) Office of River Protection (ORP) reaching a decision to proceed with engineering, procurement, and construction activities for the PTF. One of the issues is Technical Issue T1 - Hydrogen Gas Release from Vessels (hereafter referred to as T1). The focus of T1 is identifying controls for hydrogen release and completing any testing required to close the technical issue. In advance of selecting specific controls for hydrogen gas safety, a number of preliminary technical studies were initiated to support anticipated future testing and to improve the understanding of hydrogen gas generation, retention, and release within PTF vessels. These activities supported the development of a plan defining an overall strategy and approach for addressing T1 and achieving technical endpoints identified for T1. Preliminary studies also supported the development of a test plan for conducting testing and analysis to support closing T1. Both of these plans were developed in advance of selecting specific controls, and in the course of working on T1 it was decided that the testing and analysis identified in the test plan were not immediately needed. However, planning activities and preliminary studies led to significant technical progress in a number of areas. This report summarizes the progress to date from the preliminary technical studies. The technical results in this report should not be used for WTP design or safety and hazards analyses and technical results are marked with the following statement: “Preliminary Technical Results for Planning – Not to be used for WTP Design

Family physician clinical inertia in glycemic control among patients with type 2 diabetes.

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Bralić Lang, Valerija; Bergman Marković, Biserka; Kranjčević, Ksenija

2015-02-05

Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15-25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control.

77 FR 75670 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services,Inc.

Science.gov (United States)

2012-12-21

... Registration; Fisher Clinical Services,Inc. By Notice dated September 20, 2012, and published in the Federal Register on October 2, 2012, 77 FR 60143, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... that the registration of Fisher Clinical Services, Inc., to import the basic class of controlled...

78 FR 23958 - Importer of Controlled Substances: Notice of Registration; Fisher Clinical Services, Inc.

Science.gov (United States)

2013-04-23

... Registration; Fisher Clinical Services, Inc. By Notice dated November 27, 2012, and published in the Federal Register on December 5, 2012, 77 FR 72409, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... the registration of Fisher Clinical Services, Inc., to import the basic class of controlled substance...

78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

Science.gov (United States)

2013-01-25

... Registration; Fisher Clinical Services, Inc. By Notice dated November 1, 2012, and published in the Federal Register on November 9, 2012, 77 FR 67396, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... the registration of Fisher Clinical Services, Inc., to import the basic class of controlled substance...

Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial.

Science.gov (United States)

Johannsen, M; O'Toole, M S; O'Connor, M; Jensen, A B; Zachariae, R

2017-02-01

Mindfulness-based intervention has been found efficacious in reducing persistent pain in women treated for breast cancer. Little, however, is known about possible moderators of the effect. We explored clinical and psychological moderators of the effect on pain intensity previously found in a randomized controlled trial of mindfulness-based cognitive therapy (MBCT) with women treated for breast cancer with persistent pain. A total of 129 women treated for breast cancer reporting persistent pain were randomized to MBCT or a wait-list control. The primary outcome of pain intensity (11-point numeric rating scale) was measured at baseline, post-intervention, three, and six months follow-up. Proposed clinical moderators included age, axillary lymph node dissection (ALND), radiotherapy, and endocrine treatment. Psychological moderators included psychological distress [the Hospital Anxiety and Depression Scale (HADS)], the adult attachment dimensions anxiety and avoidance [the Experiences in Close Relationships Short Form (the ECR-SF)], and alexithymia [the Toronto Alexithymia Scale (TAS-20)]. Multi-level models were used to test moderation effects over time, i.e. time × group × moderator. Only attachment avoidance (p = 0.03, d = 0.36) emerged as a statistically significant moderator. Higher levels of attachment avoidance predicted a larger effect of MBCT in reducing pain intensity compared with lower levels attachment avoidance. None of the remaining psychological or clinical moderators reached statistical significance. However, based on the effect size, radiotherapy (p = 0.075, d = 0.49) was indicated as a possible clinical moderator of the effect, with radiotherapy being associated with a smaller effect of MBCT on pain intensity over time compared with no radiotherapy. Attachment avoidance, and potentially radiotherapy, may be clinically relevant factors for identifying the patients who may benefit most from MBCT as a pain intervention. Due to

Episodic Laryngeal Breathing Disorders: Literature Review and Proposal of Preliminary Theoretical Framework.

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Shembel, Adrianna C; Sandage, Mary J; Verdolini Abbott, Katherine

2017-01-01

The purposes of this literature review were (1) to identify and assess frameworks for clinical characterization of episodic laryngeal breathing disorders (ELBD) and their subtypes, (2) to integrate concepts from these frameworks into a novel theoretical paradigm, and (3) to provide a preliminary algorithm to classify clinical features of ELBD for future study of its clinical manifestations and underlying pathophysiological mechanisms. This is a literature review. Peer-reviewed literature from 1983 to 2015 pertaining to models for ELBD was searched using Pubmed, Ovid, Proquest, Cochrane Database of Systematic Reviews, and Google Scholar. Theoretical models for ELBD were identified, evaluated, and integrated into a novel comprehensive framework. Consensus across three salient models provided a working definition and inclusionary criteria for ELBD within the new framework. Inconsistencies and discrepancies within the models provided an analytic platform for future research. Comparison among three conceptual models-(1) Irritable larynx syndrome, (2) Dichotomous triggers, and (3) Periodic occurrence of laryngeal obstruction-showed that the models uniformly consider ELBD to involve episodic laryngeal obstruction causing dyspnea. The models differed in their description of source of dyspnea, in their inclusion of corollary behaviors, in their inclusion of other laryngeal-based behaviors (eg, cough), and types of triggers. The proposed integrated theoretical framework for ELBD provides a preliminary systematic platform for the identification of key clinical feature patterns indicative of ELBD and associated clinical subgroups. This algorithmic paradigm should evolve with better understanding of this spectrum of disorders and its underlying pathophysiological mechanisms. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Heart rate control with adrenergic blockade: Clinical outcomes in cardiovascular medicine

Directory of Open Access Journals (Sweden)

David Feldman

2010-05-01

Full Text Available David Feldman1, Terry S Elton2, Doron M Menachemi3, Randy K Wexler41Heart Failure/Transplant and VAD Programs, Minneapolis Heart Institute, Minneapolis, Minnesota, USA; 2Division of Pharmacology, College of Pharmacology, The Ohio State University, Columbus, Ohio, USA; 3Heart Failure Services, Edith Wolfson Medical Center, The Heart Institute, Sakler School of Medicine, Tel-Aviv University, Holon, Israel; 4Department of Clinical Family Medicine, The Ohio State University, Columbus, Ohio, USAAbstract: The sympathetic nervous system is involved in regulating various cardiovascular parameters including heart rate (HR and HR variability. Aberrant sympathetic nervous system expression may result in elevated HR or decreased HR variability, and both are independent risk factors for development of cardiovascular disease, including heart failure, myocardial infarction, and hypertension. Epidemiologic studies have established that impaired HR control is linked to increased cardiovascular morbidity and mortality. One successful way of decreasing HR and cardiovascular mortality has been by utilizing β-blockers, because their ability to alter cell signaling at the receptor level has been shown to mitigate the pathogenic effects of sympathetic nervous system hyperactivation. Numerous clinical studies have demonstrated that β-blocker-mediated HR control improvements are associated with decreased mortality in postinfarct and heart failure patients. Although improved HR control benefits have yet to be established in hypertension, both traditional and vasodilating β-blockers exert positive HR control effects in this patient population. However, differences exist between traditional and vasodilating β-blockers; the latter reduce peripheral vascular resistance and exert neutral or positive effects on important metabolic parameters. Clinical evidence suggests that attainment of HR control is an important treatment objective for patients with cardiovascular

Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example.

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Dodick, David W; Turkel, Catherine C; DeGryse, Ronald E; Diener, Hans-Christoph; Lipton, Richard B; Aurora, Sheena K; Nolan, Marissa E; Silberstein, Stephen D

2015-02-01

In addition to headache, persons with chronic migraine (CM) experience multiple symptoms, both ictal and interictal, that may contribute to their suffering. Translating clinical trial results into practice requires assessment of the results' clinical meaningfulness. When examining treatment benefit in this disabled patient population, multiple headache-symptom measures should be considered to fully reflect clinical relevance. Currently, only onabotulinumtoxinA is approved specifically for headache prophylaxis in adults with CM. Topiramate is the only other therapeutic agent with double-blind, placebo-controlled evidence in this population. Herein we evaluate the clinical meaningfulness of onabotulinumtoxinA and topiramate as headache prophylaxis in CM by comparing primary endpoints from the placebo-controlled, double-blind phase of the Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program and the topiramate clinical trial (frequency of headache days [primary endpoint in PREEMPT; secondary in topiramate trial] and migraine/migrainous days [primary in topiramate trial, or "migraine/probable-migraine days"; secondary in PREEMPT]). Additionally, outcome measures such as responder rates, health-related quality of life, discontinuation rates, safety, and tolerability profiles are important clinical considerations. The clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate. These data support these treatments as meaningful headache prophylaxis in adults with CM. CM is a chronic pain condition. We sought to determine the clinical relevance of recent trials in this disabled population. Clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate, and support use of these treatments as meaningful headache prophylaxis in CM. Copyright © 2015 American Pain Society. Published

Role of the clinical microbiology laboratory in infection control - a Danish perspective

DEFF Research Database (Denmark)

Kolmos, H J

2001-01-01

for standardization and documentation of quality. Currently a national standard for infection control is being prepared. It consists of a main standard defining requirements for the management system and 12 subsidiary standards defining requirements for specific areas of infection control. Adoption of the standard...... will undoubtedly require additional resources for infection control at a local level, and some organizational changes may also be needed. Infection control should be maintained as an integrated part of clinical microbiology....

A randomised, controlled clinical study on total hip arthroplasty using 4 different bearings

DEFF Research Database (Denmark)

Borgwardt, Arne; Zerahn, Bo; Fabricius, Sandra D

2017-01-01

PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia...

Quality control of the translation of the laboratory research into clinical practice

International Nuclear Information System (INIS)

Denekamp, J.

1997-01-01

This paper discusses the biological basis of new treatment strategies that are being introduced into the clinic in the form of controlled clinical trials. There is an increasing awareness of the need for quality assurance in the design, execution and analysis of these trials. However there is little awareness of the need to critically assess the biological basis of the trial design, to ensure that no other biological principles have been contravened in the attempt to optimise just one of the many parameters that determine the differential in sensitivity between tumours and normal tissues. Some examples are given of the changes that have recently occurred in the laboratory interpretation of both the mechanism of action and the therapeutic gain of several novel approaches. If these are not considered, the carefully controlled clinical trials may be wasted, because of being based on an incomplete consideration of all the interconnected biological factors. (author)

78 FR 46371 - Importer of Controlled Substances; Notice of Registration; Almac Clinical Services, Inc.

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2013-07-31

... Register on April 19, 2013, 78 FR 23594, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton... registration of Almac Clinical Services, Inc., (ACSI) to import the basic classes of controlled substances is..., conventions, or protocols in effect on May 1, 1971. DEA has investigated Almac Clinical Services, Inc., (ACSI...

Proton Radiotherapy for Pediatric Ewing’s Sarcoma: Initial Clinical Outcomes

International Nuclear Information System (INIS)

Rombi, Barbara; DeLaney, Thomas F.; MacDonald, Shannon M.; Huang, Mary S.; Ebb, David H.; Liebsch, Norbert J.; Raskin, Kevin A.; Yeap, Beow Y.; Marcus, Karen J.; Tarbell, Nancy J.; Yock, Torunn I.

2012-01-01

Purpose: Proton radiotherapy (PT) has been prescribed similarly to photon radiotherapy to achieve comparable disease control rates at comparable doses. The chief advantage of protons in this setting is to reduce acute and late toxicities by decreasing the amount of normal tissue irradiated. We report the preliminary clinical outcomes including late effects on our pediatric Ewing’s sarcoma patients treated with PT at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital (Boston, MA). Methods and Materials: This was a retrospective review of the medical records of 30 children with Ewing’s sarcoma who were treated with PT between April 2003 and April 2009. Results: A total of 14 male and 16 female patients with tumors in several anatomic sites were treated with PT at a median age of 10 years. The median dose was 54 Gy (relative biological effectiveness) with a median follow-up of 38.4 months. The 3-year actuarial rates of event-free survival, local control, and overall survival were 60%, 86%, and 89%, respectively. PT was acutely well tolerated, with mostly mild-to-moderate skin reactions. At the time of writing, the only serious late effects have been four hematologic malignancies, which are known risks of topoisomerase and anthracyline exposure. Conclusions: Proton radiotherapy was well tolerated, with few adverse events. Longer follow-up is needed to more fully assess tumor control and late effects, but the preliminary results are encouraging.

Developing a manual for strengthening mental health nurses' clinical supervision

DEFF Research Database (Denmark)

Buus, Niels; Cassedy, Paul; Gonge, Henrik

2013-01-01

In this article, we report findings from a study aimed at developing the content and implementation of a manual for a research-based intervention on clinical supervision of mental health nursing staff. The intervention was designed to strengthen already existing supervision practices through...... educational preparation for supervision and systematic reflection on supervision. The intervention consists of three sessions and was implemented on two groups of mental health hospital staff. We present an outline of the manual and explain how the trial sessions made us adjust the preliminary manual....... The effects of implementing the manual will subsequently be analysed in an independent randomised controlled trial....

Treatment of Unruptured Intracranial Aneurysms and Cognitive Performance: Preliminary Results of a Prospective Clinical Trial.

Science.gov (United States)

Bründl, Elisabeth; Böhm, Christina; Lürding, Ralf; Schödel, Petra; Bele, Sylvia; Hochreiter, Andreas; Scheitzach, Judith; Zeman, Florian; Brawanski, Alexander; Schebesch, Karl-Michael

2016-10-01

Few studies have addressed the effect of treatment of unruptured intracranial aneurysm (UIA) on cognitive function. Neuropsychological assessment after UIA treatment is underreported, and prospective trials have repeatedly been demanded. In 2014, we conducted a prospective controlled study to evaluate the differences in cognitive processing caused by the treatment of anterior circulation UIAs. Thirty patients were enrolled until September 2015. Ten patients received endovascular aneurysm occlusion (EV), 10 patients were treated microsurgically (MS), and 10 patients with surgically treated degenerative lumbar spine disease (LD) served as control. All patients underwent extended standardized neuropsychological assessment before (t 1 ) and 6 weeks after treatment (t 2 ). Tests included verbal, visual, and visuospatial memory, psychomotor functioning, executive functioning, and its subdomains verbal fluency and cognitive flexibility. We statistically evaluated intragroup and intergroup changes. Intragroup comparisons and group-rate analysis showed no significant impairment in overall neuropsychological performance, either postinterventionally or postoperatively. However, the postoperative performance in cognitive processing speed, cognitive flexibility, and executive functioning was significantly worse in the MS group than in the EV (P = 0.038) and LD group (P = 0.02). Compared with the EV group, patients with MS showed significant postoperative impairment in a subtest for auditory-verbal memory (Wechsler Memory Scale, Fourth Edition, Logical Memory II; MS vs. EV P = 0.011). The MS group trended toward posttreatment impairment in subtests for verbal fluency and semantic memory (Regensburg Word Fluency Test; MS vs. EV P = 0.083) and in auditory-verbal memory (Wechsler Memory Scale, Fourth Edition, Logical Memory II; MS vs. LD P = 0.06). Our preliminary data showed no effect of anterior circulation UIA treatment on overall neuropsychological function but impaired

Preliminary stop of the TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC) trial

NARCIS (Netherlands)

Koeneman, M. M.; Kruse, Arnold-Jan; Kooreman, L. F. S.; zur Hausen, Axel; Hopman, Anton H N; Sep, S. J. S.; Van Gorp, T.; Slangen, B. F. M.; van Beekhuizen, H. J.; de Sande, Michiel A. J. van; Gerestein, Cornelis G.; Nijman, H. W.; Kruitwagen, R. F. M. P.

2017-01-01

The "TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia" (TOPIC) trial was stopped preliminary, due to lagging inclusions. This study aimed to evaluate the treatment efficacy and clinical applicability of imiquimod 5% cream in high-grade cervical intraepithelial neoplasia

Students' Entrepreneurial Inclination at a Malaysian Polytechnic: A Preliminary Investigation

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Yasin, Ahmad Yasruddin Md; Mahmood, Nik Abdul Aziz Nik; Jaafar, Nik Azyyati Nik

2011-01-01

This paper reports preliminary results of an ongoing project to examine students' inclination towards entrepreneurship at a Malaysian polytechnic. The study used a self-administered questionnaire to explore the influence of entrepreneurial intent, perceived behavioral control, self-efficacy, perceived barriers, perceived support factors and…

Preliminary Validation and Verification Plan for CAREM Reactor Protection System

International Nuclear Information System (INIS)

Fittipaldi, Ana; Maciel Felix

2000-01-01

The purpose of this paper, is to present a preliminary validation and verification plan for a particular architecture proposed for the CAREM reactor protection system with software modules (computer based system).These software modules can be either own design systems or systems based in commercial modules such as programmable logic controllers (PLC) redundant of last generation.During this study, it was seen that this plan can also be used as a validation and verification plan of commercial products (COTS, commercial off the shelf) and/or smart transmitters.The software life cycle proposed and its features are presented, and also the advantages of the preliminary validation and verification plan

Use of historical control data for assessing treatment effects in clinical trials

Science.gov (United States)

Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G.; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

2014-01-01

Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study’s control arm. There is obvious appeal in using (i.e., ‘borrowing’) this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of ‘dynamic’ (versus ‘static’) borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. PMID:23913901

Use of historical control data for assessing treatment effects in clinical trials.

Science.gov (United States)

Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

2014-01-01

Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study's control arm. There is obvious appeal in using (i.e., 'borrowing') this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of 'dynamic' (versus 'static') borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. Copyright © 2013 John Wiley & Sons, Ltd.

Volumetric modulated arc therapy with flattening filter free beams for isolated abdominal/pelvic lymph nodes: report of dosimetric and early clinical results in oligometastatic patients

Directory of Open Access Journals (Sweden)

Alongi Filippo

2012-12-01

Full Text Available Abstract Background SBRT is a safe and efficient strategy to locally control multiple metastatic sites. While research in the physics domain for Flattening Filter Free Beams (FFF beams is increasing, there are few clinical data of FFF beams in clinical practice. Here we reported dosimentric and early clinical data of SBRT and FFF delivery in isolated lymph node oligometastatic patients. Methods Between October 2010 and March 2012, 34 patients were treated with SBRT for oligometastatic lymph node metastasis on a Varian TrueBeamTM treatment machine using Volumetric Modulated Arc Therapy (RapidArc. We retrospectively evaluated a total of 25 patients for isolated lymph node metastases in abdomen and/or pelvis treated with SBRT and FFF (28 treatments. Acute toxicity was recorded. Local control evaluation was scored by means of CT scan and/or PET scan. Results All dosimetric results are in line with what published for the same type of stereotactic abdominal lymph node metastases treatments and fractionation, using RapidArc. All 25 FFF SBRT patients completed the treatment. Acute gastrointestinal toxicity was minimal: one patient showed Grade 1 gastrointestinal toxicity. Three other patients presented Grade 2 toxicity. No Grade 3 or higher was recorded. All toxicities were recovered within one week. The preliminary clinical results at the median follow up of 195 days are: complete response in 12 cases, partial response in 11, stable disease in 5, with an overall response rate of 82%; no local progression was recorded. Conclusions Data of dosimetrical findings and acute toxicity are excellent for patients treated with SBRT with VMAT using FFF beams. Preliminary clinical results showed a high rate of local control in irradiated lesion. Further data and longer follow up are needed to assess late toxicity and definitive clinical outcomes.

Preliminary Study of Plasma Exosomal Tau as a Potential Biomarker for Chronic Traumatic Encephalopathy.

Science.gov (United States)

Stern, Robert A; Tripodis, Yorghos; Baugh, Christine M; Fritts, Nathan G; Martin, Brett M; Chaisson, Christine; Cantu, Robert C; Joyce, James A; Shah, Sahil; Ikezu, Tsuneya; Zhang, Jing; Gercel-Taylor, Cicek; Taylor, Douglas D

2016-01-01

Chronic traumatic encephalopathy (CTE) is a tauopathy associated with prior exposure to repetitive head impacts, such as those incurred through American football and other collision sports. Diagnosis is made through neuropathological examination. Many of the clinical features of CTE are common in the general population, with and without a history of head impact exposure, making clinical diagnosis difficult. As is now common in the diagnosis of other neurodegenerative disorders, such as Alzheimer's disease, there is a need for methods to diagnose CTE during life through objective biomarkers. The aim of this study was to examine tau-positive exosomes in plasma as a potential CTE biomarker. Subjects were 78 former National Football League (NFL) players and 16 controls. Extracellular vesicles were isolated from plasma. Fluorescent nanoparticle tracking analysis was used to determine the number of vesicles staining positive for tau. The NFL group had higher exosomal tau than the control group (p <  0.0001). Exosomal tau discriminated between the groups, with 82% sensitivity, 100% specificity, 100% positive predictive value, and 53% negative predictive value. Within the NFL group, higher exosomal tau was associated with worse performance on tests of memory (p = 0.0126) and psychomotor speed (p = 0.0093). These preliminary findings suggest that exosomal tau in plasma may be an accurate, noninvasive CTE biomarker.

Food allergy diagnosis in patients with elimination diet history. Preliminary report

Directory of Open Access Journals (Sweden)

Elsy Maureen Navarrete-Rodríguez

2014-09-01

Full Text Available Background: Food allergy diagnosis is performed by a double blind placebo controlled challenge; however, in a lot of patients, it is only based on clinical history, skin prick tests, or parents’ perception. There is a high frequency of elimination diets without an adequate approach. Objective: To analyze the results of diagnostic tests in a group of children with elimination diet-based on suspected food allergy and verify such studies with double blind placebo-controlled test challenge. Material and method: An observational, analytical and prospective study was done in a group of patients with elimination diet for suspected food allergy. We performed prick test, Prick-to-Prick test and patch test and the positive ones were verified by double-blind placebo-controlled challenge. Results: Fourty-three patients were included within a total of 1,935 tests. Both approach for immediate and late sensitivity had not statistically significant relationship between a positive test and the elimination of food. Until now, we had 4 (8% positive challenges out of 50. Conclusion: The frequency of allergy proved by double-blind placebo-controlled test in 50 challenges was of 8% (4/50, thus, in the preliminary report we found a high frequency of elimination diets without adequate support. It is very important that food allergy diagnosis is accurate and based on an appropriate approach; since the implementation of an elimination diet in pediatric population can have a negative influence on their growth and development.

Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

Science.gov (United States)

Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

2015-11-01

To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

Novel Biomarkers of Physical Activity Maintenance in Midlife Women: Preliminary Investigation

Directory of Open Access Journals (Sweden)

Kelly A. Bosak

2018-04-01

Full Text Available The precision health initiative is leading the discovery of novel biomarkers as important indicators of biological processes or responses to behavior, such as physical activity. Neural biomarkers identified by magnetic resonance imaging (MRI hold promise to inform future research, and ultimately, for transfer to the clinical setting to optimize health outcomes. This study investigated resting-state and functional brain biomarkers between midlife women who were maintaining physical activity in accordance with the current national guidelines and previously acquired age-matched sedentary controls. Approval was obtained from the Human Subjects Committee. Participants included nondiabetic, healthy weight to overweight (body mass index 19–29.9 kg/m2 women (n = 12 aged 40–64 years. Control group data were used from participants enrolled in our previous functional MRI study and baseline resting-state MRI data from a subset of sedentary (<500 kcal of physical activity per week midlife women who were enrolled in a 9-month exercise intervention conducted in our imaging center. Differential activation of the inferior frontal gyrus (IFG and greater connectivity with the dorsolateral prefrontal cortex (dlPFC was identified between physically active women and sedentary controls. After correcting for multiple comparisons, these differences in biomarkers of physical activity maintenance did not reach statistical significance. Preliminary evidence in this small sample suggests that neural biomarkers of physical activity maintenance involve activations in the brain region associated with areas involved in implementing goal-directed behavior. Specifically, activation of the IFG and connectivity with the dlPFC is identified as a neural biomarker to explain and predict long-term physical activity maintenance for healthy aging. Future studies should evaluate these biomarker links with relevant clinical correlations.

A preliminary investigation of the imaging performance of photostimulable phosphor computed radiography using a new design of mammographic quality control test object

International Nuclear Information System (INIS)

Cowen, A.R.; Brettle, D.S.; Coleman, N.J.; Parkin, G.J.S.

1992-01-01

Leeds Test Object TOR[MAM] has been designed to supplement the current FAXIL mammography test object TOR[MAX]. It contains a range of details that have a more natural radiographic appearance and has been designed as a test that more closely approximates the image quality achieved in clinical mammography. Physical aspects of the design and implementation of TOR[MAM] are presented. The TOR[MAM] has been used in a preliminary physical evaluation of the comparative image qualities produced by conventional (screen-film) and phostostimulable phosphor computed mammography and the results are discussed. TOR[MAX] results are also presented. The influence of digital image processing (enhancement) on the image quality of computed mammograms is also considered. The results presented indicate the sensitivity of TOR[MAM]. (author)

A preliminary randomized controlled trial of a behavioral exercise intervention for smoking cessation.

Science.gov (United States)

Abrantes, Ana M; Bloom, Erika Litvin; Strong, David R; Riebe, Deborah; Marcus, Bess H; Desaulniers, Julie; Fokas, Kathryn; Brown, Richard A

2014-08-01

Previous exercise intervention studies for smoking cessation have been challenged by a number of methodological limitations that confound the potential efficacy of aerobic exercise for smoking cessation. The preliminary efficacy of a behavioral exercise intervention that incorporated features designed to address prior limitations was tested in a randomized controlled trial (RCT). Sixty-one smokers (65.6% female, mean age = 47.3 years, smoked a mean of 19.7 cigarettes/day) were randomized to receive either a 12-week exercise intervention or a 12-week health education contact control. Participants in both conditions received an 8-week telephone-delivered, standard smoking cessation protocol (with the transdermal nicotine patch). Follow-ups were conducted at the end of treatment (EOT), 6- and 12-month timepoints. There were no differences between conditions with respect to the number of weekly exercise or health education sessions attended (9.3±2.8 vs. 9.3±3.0, respectively). While not statistically significant, participants in the exercise condition demonstrated higher verified abstinence rates (EOT: 40% vs. 22.6%, odds ratio [OR] = 2.28; 6- and 12-month follow-ups: 26.7% vs. 12.9%, OR = 2.46). Irrespective of treatment condition, higher levels of moderate-to-vigorous exercise were associated with lower levels of depressive symptoms during the intervention. The results of this small RCT point toward the benefit of a behavioral exercise intervention designed to address previous methodological limitations for smoking cessation. Given the potential public health impact of the demonstrated efficacy of exercise for smoking cessation, the continued development and optimization of exercise interventions for smokers through larger RCTs merits pursuit. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Overview: clinical and physiological comparison of meditation with other self-control strategies.

Science.gov (United States)

Shapiro, D H

1982-03-01

In 1977 the American Psychiatric Association called for a critical examination of the clinical effectiveness of meditation. The author provides a review of the literature bearing on clinical and physiological comparisons of meditation with other self-control strategies. He begins by providing a definition of mediation and then cites the literature comparing mediation with such self-regulation strategies as biofeedback, hypnosis, and progressive relaxation. He pays particular attention to the "uniqueness" of mediation as a clinical intervention strategy a well as the adverse effects of meditation. Finally, he offers suggestions and guidelines for future research.

Preliminary Results on Asymptotic Stabilization of Hamiltonian Systems with Nonholonomic Constraints

NARCIS (Netherlands)

Khennouf, H.; Canudas de Wit, C.; Schaft, A.J. van der

1995-01-01

This paper presents some preliminary results on asymptotic stabilization of nonholonomic mechanical systems using the Hamiltonian formulation proposed previously. Our work seeks to establish a general formulation for designing time-varying controllers for some mechanical system described in the

Trade-off results and preliminary designs of Near-Term Hybrid Vehicles

Science.gov (United States)

Sandberg, J. J.

1980-01-01

Phase I of the Near-Term Hybrid Vehicle Program involved the development of preliminary designs of electric/heat engine hybrid passenger vehicles. The preliminary designs were developed on the basis of mission analysis, performance specification, and design trade-off studies conducted independently by four contractors. THe resulting designs involve parallel hybrid (heat engine/electric) propulsion systems with significant variation in component selection, power train layout, and control strategy. Each of the four designs is projected by its developer as having the potential to substitute electrical energy for 40% to 70% of the petroleum fuel consumed annually by its conventional counterpart.

Dynamic pelvic floor MR imaging at 3 T in patients with clinical signs of urinary incontinence-preliminary results

Energy Technology Data Exchange (ETDEWEB)

Morakkabati-Spitz, Nuschin; Willinek, Winfried A.; Traeber, Frank; Jaeger, Ursula; Schild, Hans H. [University of Bonn, Department of Radiology, Bonn (Germany); Gieseke, Juergen [University of Bonn, Department of Radiology, Bonn (Germany); Philips Medical Systems, Best (Netherlands); Bastian, Patrick J. [University of Munich, Department of Urology, Munich (Germany); Schmitz, Bettina; Mueller, Stefan C. [University of Bonn, Department of Urology, Bonn (Germany)

2008-11-15

To prospectively evaluate feasibility, image quality and diagnostic accuracy of dynamic MR imaging the pelvic floor at 3.0 T in patients with urinary incontinence and to compare these results with those of MRI performed at 1.5 T. Ten patients with the diagnosis of urinary incontinence (clinical symptoms, clinical examination, pelvic ultrasound) were examined with a dynamic balanced FFE (B-FFE) sequence at 1.5 T and 3.0 T on the same day in a randomized order. Spatial (1.5 x 1.5 x 8 mm) and temporal (0.44 s) resolution at 3.0 T were comparable to the 1.5-T B-FFE sequence. Two radiologists assessed visual signal to noise (three-point scale), artefact level (five-point scale) and final MR diagnoses with regard to pelvic floor weakness (independent analysis). The diagnoses obtained at 1.5-T field strength and the results of the clinical tests served as standard of reference. In addition, ROI-based quantitative measurements were performed to assess different tissue contrasts at both field strengths. Data were analyzed for statistical differences by using the Wilcoxon's matched pairs test and the marginal homogeneity test. Visual signal to noise was rated higher at 3.0 T for all ten studies by both radiologists. With regard to artefact level, there was no statistically significant difference between the studies obtained at 3.0 T as compared to the corresponding 1.5-T studies (marginal homogeneity test: p = 0.18 for reviewer 1 and 0.41 for reviewer 2). Mean artefact level was rated minor to moderate by both reviewers for both field strengths (excellent interobserver agreement with Kendall-W value of 0.973). Except for a higher tissue contrast between fat and urethra at 1.5 T, there were no statistically significant differences between tissue contrast at 1.5 T as compared to 3.0 T (Wilcoxon's test). Final MR diagnoses regarding pelvic floor weakness did not differ between 3.0-T and 1.5-T field strength and correlated well with the results of the clinical tests

Dynamic pelvic floor MR imaging at 3 T in patients with clinical signs of urinary incontinence-preliminary results

International Nuclear Information System (INIS)

Morakkabati-Spitz, Nuschin; Willinek, Winfried A.; Traeber, Frank; Jaeger, Ursula; Schild, Hans H.; Gieseke, Juergen; Bastian, Patrick J.; Schmitz, Bettina; Mueller, Stefan C.

2008-01-01

To prospectively evaluate feasibility, image quality and diagnostic accuracy of dynamic MR imaging the pelvic floor at 3.0 T in patients with urinary incontinence and to compare these results with those of MRI performed at 1.5 T. Ten patients with the diagnosis of urinary incontinence (clinical symptoms, clinical examination, pelvic ultrasound) were examined with a dynamic balanced FFE (B-FFE) sequence at 1.5 T and 3.0 T on the same day in a randomized order. Spatial (1.5 x 1.5 x 8 mm) and temporal (0.44 s) resolution at 3.0 T were comparable to the 1.5-T B-FFE sequence. Two radiologists assessed visual signal to noise (three-point scale), artefact level (five-point scale) and final MR diagnoses with regard to pelvic floor weakness (independent analysis). The diagnoses obtained at 1.5-T field strength and the results of the clinical tests served as standard of reference. In addition, ROI-based quantitative measurements were performed to assess different tissue contrasts at both field strengths. Data were analyzed for statistical differences by using the Wilcoxon's matched pairs test and the marginal homogeneity test. Visual signal to noise was rated higher at 3.0 T for all ten studies by both radiologists. With regard to artefact level, there was no statistically significant difference between the studies obtained at 3.0 T as compared to the corresponding 1.5-T studies (marginal homogeneity test: p = 0.18 for reviewer 1 and 0.41 for reviewer 2). Mean artefact level was rated minor to moderate by both reviewers for both field strengths (excellent interobserver agreement with Kendall-W value of 0.973). Except for a higher tissue contrast between fat and urethra at 1.5 T, there were no statistically significant differences between tissue contrast at 1.5 T as compared to 3.0 T (Wilcoxon's test). Final MR diagnoses regarding pelvic floor weakness did not differ between 3.0-T and 1.5-T field strength and correlated well with the results of the clinical tests. Dynamic

Multiple daily fractionation in radiotherapy: biological rationale and preliminary clinical experiences

Energy Technology Data Exchange (ETDEWEB)

Arcangeli, G [Instituto Medico Scientifico, Rome (Italy). Dept. of Oncology; Mauro, F; Morelli, D; Nervi, C

1979-09-01

The biological bases of radiation dose fractionation are reviewed and discussed with special emphasis on reassortment. Experimental data on animal model systems are presented to clarify that reassortment has to be added to sublethal damage repair and reoxygenation in the rationale for an optimized radiotherapy course according to tumor cell kinetics. Clinical results on several human tumors treated with twice or thrice daily fractions are described. These results show that some clinically radioresistant tumors (especially if not characterized by a relatively long clinical doubling line) can be satisfactorily dealt with using multiple daily fractionation. Clinical observations indicate that a relatively high cumulative daily dose (200 + 150 + 150 rad) can be safely administered.

Big Data in Designing Clinical Trials: Opportunities and Challenges.

Science.gov (United States)

Mayo, Charles S; Matuszak, Martha M; Schipper, Matthew J; Jolly, Shruti; Hayman, James A; Ten Haken, Randall K

2017-01-01

Emergence of big data analytics resource systems (BDARSs) as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs) have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events. BDARS present opportunities to augment and extend RCTs. Preliminary modeling using single- and muti-institutional BDARS may lead to better design and less cost. Standardizations in data elements, clinical processes, and nomenclatures used to decrease variability and increase veracity needed for automation and multi-institutional data pooling in BDARS also support ability to add clinical validation phases to clinical trial design and increase participation. However, volume and variety in BDARS present other technical, policy, and conceptual challenges including applicable statistical concepts, cloud-based technologies. In this summary, we will examine both the opportunities and the challenges for use of big data in design of clinical trials.

Big Data in Designing Clinical Trials: Opportunities and Challenges

Directory of Open Access Journals (Sweden)

Charles S. Mayo

2017-08-01

Full Text Available Emergence of big data analytics resource systems (BDARSs as a part of routine practice in Radiation Oncology is on the horizon. Gradually, individual researchers, vendors, and professional societies are leading initiatives to create and demonstrate use of automated systems. What are the implications for design of clinical trials, as these systems emerge? Gold standard, randomized controlled trials (RCTs have high internal validity for the patients and settings fitting constraints of the trial, but also have limitations including: reproducibility, generalizability to routine practice, infrequent external validation, selection bias, characterization of confounding factors, ethics, and use for rare events. BDARS present opportunities to augment and extend RCTs. Preliminary modeling using single- and muti-institutional BDARS may lead to better design and less cost. Standardizations in data elements, clinical processes, and nomenclatures used to decrease variability and increase veracity needed for automation and multi-institutional data pooling in BDARS also support ability to add clinical validation phases to clinical trial design and increase participation. However, volume and variety in BDARS present other technical, policy, and conceptual challenges including applicable statistical concepts, cloud-based technologies. In this summary, we will examine both the opportunities and the challenges for use of big data in design of clinical trials.

The Acceptability and Potential Utility of Cognitive Training to Improve Working Memory in Persons Living With HIV: A Preliminary Randomized Trial.

Science.gov (United States)

Towe, Sheri L; Patel, Puja; Meade, Christina S

HIV-associated neurocognitive impairments that impact daily function persist in the era of effective antiretroviral therapy. Cognitive training, a promising low-cost intervention, has been shown to improve neurocognitive functioning in some clinical populations. We tested the feasibility, acceptability, and preliminary effects of computerized cognitive training to improve working memory in persons living with HIV infection (PLWH) and working memory impairment. In this randomized clinical trial, we assigned 21 adult PLWH to either an experimental cognitive training intervention or an attention-matched control training intervention. Participants completed 12 training sessions across 10 weeks with assessments at baseline and post-training. Session attendance was excellent and participants rated the program positively. Participants in the experimental arm demonstrated improved working memory function over time; participants in the control arm showed no change. Our results suggest that cognitive training may be a promising intervention for working memory impairment in PLWH and should be evaluated further. Copyright © 2017 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

Quality control and data-handling in multicentre studies: the case of the Multicentre Project for Tuberculosis Research

Directory of Open Access Journals (Sweden)

Caloto Teresa

2001-12-01

Full Text Available Abstract Background The Multicentre Project for Tuberculosis Research (MPTR was a clinical-epidemiological study on tuberculosis carried out in Spain from 1996 to 1998. In total, 96 centres scattered all over the country participated in the project, 19935 "possible cases" of tuberculosis were examined and 10053 finally included. Data-handling and quality control procedures implemented in the MPTR are described. Methods The study was divided in three phases: 1 preliminary phase, 2 field work 3 final phase. Quality control procedures during the three phases are described. Results: Preliminary phase: a organisation of the research team; b design of epidemiological tools; training of researchers. Field work: a data collection; b data computerisation; c data transmission; d data cleaning; e quality control audits; f confidentiality. Final phase: a final data cleaning; b final analysis. Conclusion The undertaking of a multicentre project implies the need to work with a heterogeneous research team and yet at the same time attain a common goal by following a homogeneous methodology. This demands an additional effort on quality control.

Targeting premeal anxiety in eating disordered clients and normal controls: a preliminary investigation into the use of mindful eating vs. distraction during food exposure.

Science.gov (United States)

Marek, Ryan J; Ben-Porath, Denise D; Federici, Anita; Wisniewski, Lucene; Warren, Mark

2013-09-01

Studies have demonstrated that negative affect increases prior to food intake in individuals diagnosed with an eating disorder. Mindfulness has been supported empirically to treat experiential avoidance stemming from anxiety. Thus, the current objective in this study is to empirically compare mindfulness vs. thought suppression invention during a food exposure in both clinical and nonclinical samples. In a 2 (Group: clinical vs. nonclinical) × 2 (INTERVENTION: mindfulness vs. distraction) counterbalanced within treatment design, the current investigation sought to determine the differential effectiveness of a brief mindfulness intervention vs. a brief distraction intervention in women diagnosed with AN and BN in a clinical and nonclinical sample during a food exposure. Results indicated that the eating disorder group reported a significant increase in negative affect after the mindfulness intervention as compared to the distraction intervention, whereas the nonclinical group reported a significant decrease in negative affect after the mindfulness intervention as compared to the distraction intervention. Preliminary findings suggest that clinicians may want to proceed cautiously when using mindful eating in those with severe eating disorders during the early stages of food exposure. Limitations and future directions are discussed. Copyright © 2013 Wiley Periodicals, Inc.

The Individualized Quality Control Plan - Coming Soon to Clinical Microbiology Laboratories Everywhere!

Science.gov (United States)

Anderson, Nancy

2015-11-15

As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.

Are specialist outreach clinics for orthodontic consultation effective? A randomised controlled trial

OpenAIRE

Mandall, Nicola; O'Brien, K.

2001-01-01

Objective To develop outreach clinics for orthodontic consultation and evaluate their costs and effectiveness. Design Single centre randomised controlled trial with random allocation of referred patients to outreach or main base consultation appointments. Setting One hospital orthodontic department and three community health centre clinics in Greater Manchester. Subjects 324 patients who were referred for orthodontic treatment. Main outcome measures The outcome of consultation, the cost and d...

Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters.

Science.gov (United States)

Haass-Koffler, Carolina L; Goodyear, Kimberly; Long, Victoria M; Tran, Harrison H; Loche, Antonella; Cacciaglia, Roberto; Swift, Robert M; Leggio, Lorenzo

2017-12-01

The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled "Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers" (Haass-Koffler et al., 2017) [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK) parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73.

Randomized, controlled clinical trial evaluating the efficacy of pulsed signal therapy in dogs with osteoarthritis.

Science.gov (United States)

Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B

2013-04-01

To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.

Ablation of clinically relevant kidney tissue volumes by high-intensity focused ultrasound: Preliminary results of standardized ex-vivo investigations.

Science.gov (United States)

Häcker, Axel; Peters, Kristina; Knoll, Thomas; Marlinghaus, Ernst; Alken, Peter; Jenne, Jürgen W; Michel, Maurice Stephan

2006-11-01

To investigate strategies to achieve confluent kidney-tissue ablation by high-intensity focused ultrasound (HIFU). Our model of the perfused ex-vivo porcine kidney was used. Tissue ablation was performed with an experimental HIFU device (Storz Medical, Kreuzlingen, Switzerland). Lesion-to-lesion interaction was investigated by varying the lesion distance (5 to 2.5 mm), generator power (300, 280, and 260 W), cooling time (10, 20, and 30 seconds), and exposure time (4, 3, and 2 seconds). The lesion rows were analyzed grossly and by histologic examination (hematoxylin-eosin and nicotinamide adenine dinucleotide staining). It was possible to achieve complete homogeneous ablation of a clinically relevant tissue volume but only by meticulous adjustment of the exposure parameters. Minimal changes in these parameters caused changes in lesion formation with holes within the lesions and lesion-to-lesion interaction. Our preliminary results show that when using this new device, HIFU can ablate a large tissue volume homogeneously in perfused ex-vivo porcine tissue under standardized conditions with meticulous adjustment of exposure parameters. Further investigations in vivo are necessary to test whether large tissue volumes can be ablated completely and reliably despite the influence of physiologic tissue and organ movement.

Initial development and preliminary validation of a new negative symptom measure: the Clinical Assessment Interview for Negative Symptoms (CAINS).

Science.gov (United States)

Forbes, Courtney; Blanchard, Jack J; Bennett, Melanie; Horan, William P; Kring, Ann; Gur, Raquel

2010-12-01

As part of an ongoing scale development process, this study provides an initial examination of the psychometric properties and validity of a new interview-based negative symptom instrument, the Clinical Assessment Interview for Negative Symptoms (CAINS), in outpatients with schizophrenia or schizoaffective disorder (N = 37). The scale was designed to address limitations of existing measures and to comprehensively assess five consensus-based negative symptoms: asociality, avolition, anhedonia (consummatory and anticipatory), affective flattening, and alogia. Results indicated satisfactory internal consistency reliability for the total CAINS scale score and promising inter-rater agreement, with clear areas identified in need of improvement. Convergent validity was evident in general agreement between the CAINS and alternative negative symptom measures. Further, CAINS subscales significantly correlated with relevant self-report emotional experience measures as well as with social functioning. Discriminant validity of the CAINS was strongly supported by its small, non-significant relations with positive symptoms, general psychiatric symptoms, and depression. These preliminary data on an early beta-version of the CAINS provide initial support for this new assessment approach to negative symptoms and suggest directions for further scale development. Copyright © 2010 Elsevier B.V. All rights reserved.

A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group.

Science.gov (United States)

Buchbinder, Rachelle; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Beaton, Dorcas; Kopkow, Christian; Lenza, Mario; Jain, Nitin B; Richards, Bethan; Richards, Pamela; Voshaar, Marieke; van der Windt, Danielle; Gagnier, Joel J

2017-12-01

The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

Preliminary ECLSS waste water model

Science.gov (United States)

Carter, Donald L.; Holder, Donald W., Jr.; Alexander, Kevin; Shaw, R. G.; Hayase, John K.

1991-01-01

A preliminary waste water model for input to the Space Station Freedom (SSF) Environmental Control and Life Support System (ECLSS) Water Processor (WP) has been generated for design purposes. Data have been compiled from various ECLSS tests and flight sample analyses. A discussion of the characterization of the waste streams comprising the model is presented, along with a discussion of the waste water model and the rationale for the inclusion of contaminants in their respective concentrations. The major objective is to establish a methodology for the development of a waste water model and to present the current state of that model.

Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

Science.gov (United States)

Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

2017-08-01

Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

The Anaclitic-Introjective Depression Assessment: Development and preliminary validity of an observer-rated measure.

Science.gov (United States)

Rost, Felicitas; Luyten, Patrick; Fonagy, Peter

2018-03-01

The two-configurations model developed by Blatt and colleagues offers a comprehensive conceptual and empirical framework for understanding depression. This model suggests that depressed patients struggle, at different developmental levels, with issues related to dependency (anaclitic issues) or self-definition (introjective issues), or a combination of both. This paper reports three studies on the development and preliminary validation of the Anaclitic-Introjective Depression Assessment, an observer-rated assessment tool of impairments in relatedness and self-definition in clinical depression based on the item pool of the Shedler-Westen Assessment Procedure. Study 1 describes the development of the measure using expert consensus rating and Q-methodology. Studies 2 and 3 report the assessment of its psychometric properties, preliminary reliability, and validity in a sample of 128 patients diagnosed with treatment-resistant depression. Four naturally occurring clusters of depressed patients were identified using Q-factor analysis, which, overall, showed meaningful and theoretically expected relationships with anaclitic/introjective prototypes as formulated by experts, as well as with clinical, social, occupational, global, and relational functioning. Taken together, findings reported in this paper provide preliminary evidence for the reliability and validity of the Anaclitic-Introjective Depression Assessment, an observer-rated measure that allows the detection of important nuanced differentiations between and within anaclitic and introjective depression. Copyright © 2017 John Wiley & Sons, Ltd.

BIPS-FS preliminary design, miscellaneous notes

International Nuclear Information System (INIS)

1976-01-01

A compendium of flight system preliminary design internal memos and progress report extracts for the Brayton Isotope Power System Preliminary Design Review to be held July 20, 21, and 22, 1975 is presented. The purpose is to bring together those published items which relate only to the preliminary design of the Flight System, Task 2 of Phase I. This preliminary design effort was required to ensure that the Ground Demonstration System will represent the Flight System as closely as possible

Female Gynecologists and Their Birth Control Clinics: Eugenics in Practice in 1920s-1930s China.

Science.gov (United States)

David, Mirela

2018-01-01

Yang Chao Buwei, the first Chinese translator of Margaret Sanger's What Every Girl Should Know, was the first female gynecologist to open up a birth control clinic in China. By the 1930s, other female gynecologists, like Guo Taihua, had internalized and combined national and eugenic concerns of race regeneration to focus on the control of women's reproduction. This symbiosis between racial regeneration and birth control is best seen in Yang Chongrui's integration of birth control into her national hygiene program. This article traces the efforts of pioneer gynecologists in giving contraceptive advice at their birth control clinics, which they framed as a humanitarian effort to ease the reproductive burden of working-class women. It also examines their connections with Sanger's international birth control movement, and their advocacy of contraception as practitioners, translators, and educators. The author argues that these Chinese female gynecologists not only borrowed, but adapted, Western scientific knowledge to Chinese social conditions through their writings and translations and in their clinical work.

45 CFR 150.217 - Preliminary determination.

Science.gov (United States)

2010-10-01

... 45 Public Welfare 1 2010-10-01 2010-10-01 false Preliminary determination. 150.217 Section 150.217... Are Failing To Substantially Enforce HIPAA Requirements § 150.217 Preliminary determination. If, at... designees). (b) Notifies the State of CMS's preliminary determination that the State has failed to...

Preliminary design package for solar heating and hot water system

Science.gov (United States)

1977-01-01

The preliminary design review on the development of a multi-family solar heating and domestic hot water prototype system is presented. The report contains the necessary information to evaluate the system. The system consists of the following subsystems: collector, storage, transport, control and Government-furnished site data acquisition.

Safety performance of preliminary KALIMER conceptual design

Energy Technology Data Exchange (ETDEWEB)

Hahn Dohee; Kim Kyoungdoo; Kwon Youngmin; Chang Wonpyo; Suk Soodong [Korea atomic Energy Resarch Inst., Taejon (Korea)

1999-07-01

The Korea Atomic Energy Research Institute (KAERI) is developing KALIMER (Korea Advanced Liquid Metal Reactor), which is a sodium cooled, 150 MWe pool-type reactor. The safety design of KALIMER emphasizes accident prevention by using passive processes, which can be accomplished by the safety design objectives including the utilization of inherent safety features. In order to assess the effectiveness of the inherent safety features in achieving the safety design objectives, a preliminary evaluation of ATWS performance for the KALIMER design has been performed with SSC-K code, which is a modified version of SSC-L code. KAERI's modification of the code includes development of reactivity feedback models for the core and a pool model for KALIMER reactor vessel. This paper describes the models for control rod driveline expansion, gas expansion module and the thermal hydraulic model for reactor pool and the results of preliminary analyses for unprotected loss of flow and loss o heat sink. (author)

Safety performance of preliminary KALIMER conceptual design

International Nuclear Information System (INIS)

Hahn Dohee; Kim Kyoungdoo; Kwon Youngmin; Chang Wonpyo; Suk Soodong

1999-01-01

The Korea Atomic Energy Research Institute (KAERI) is developing KALIMER (Korea Advanced Liquid Metal Reactor), which is a sodium cooled, 150 MWe pool-type reactor. The safety design of KALIMER emphasizes accident prevention by using passive processes, which can be accomplished by the safety design objectives including the utilization of inherent safety features. In order to assess the effectiveness of the inherent safety features in achieving the safety design objectives, a preliminary evaluation of ATWS performance for the KALIMER design has been performed with SSC-K code, which is a modified version of SSC-L code. KAERI's modification of the code includes development of reactivity feedback models for the core and a pool model for KALIMER reactor vessel. This paper describes the models for control rod driveline expansion, gas expansion module and the thermal hydraulic model for reactor pool and the results of preliminary analyses for unprotected loss of flow and loss o heat sink. (author)

Quality Control Assays for Clinical-Grade Human Mesenchymal Stromal Cells: Validation Strategy.

Science.gov (United States)

Radrizzani, Marina; Soncin, Sabrina; Bolis, Sara; Lo Cicero, Viviana; Andriolo, Gabriella; Turchetto, Lucia

2016-01-01

The present chapter focuses on the validation of the following analytical methods for the control of mesenchymal stromal cells (MSC) for cell therapy clinical trials: Microbiological control for cellular product Endotoxin assay Mycoplasma assay Cell count and viability Immunophenotype Clonogenic potential (CFU-F assay) In our lab, these methods are in use for product release, process control or control of the biological starting materials. They are described in detail in the accompanying Chapter 19.For each method, validation goals and strategy are presented, and a detailed experimental scheme is proposed.

Relationship Dissolution and Psychologically Aggressive Dating Relationships: Preliminary Findings From a College-Based Relationship Education Course.

Science.gov (United States)

Negash, Sesen; Cravens, Jaclyn D; Brown, Preston C; Fincham, Frank D

This study evaluated the impact of a relationship education program, delivered as part of a college course, among students (N = 152) who reported experiencing psychological aggression in their exclusive dating relationship. Preliminary results showed that compared to those in the control group, participants receiving relationship education were significantly more likely to end their romantic relationship, even after controlling for relationship satisfaction. Furthermore, when relationship termination occurred, those in the intervention group were significantly more likely to attribute the breakup to their participation in the class as compared to those in the control group. The tentative findings are an important preliminary step in assessing the benefits of relationship education in reducing the risk of psychological aggression among college students.

Omalizumab: Clinical Use for the Management of Asthma

Directory of Open Access Journals (Sweden)

Neil C. Thomson

2012-01-01

Full Text Available Omalizumab, a humanized monoclonal antibody that binds circulating IgE antibody, is a treatment option for patients with moderate to severe allergic asthma whose asthma is poorly controlled with inhaled corticosteroids and inhaled long-acting β 2 agonist bronchodilators. This review considers the mechanism of action, pharmacokinetics, efficacy, safety and place in management of omalizumab in asthma and focuses particularly on key articles published over the last three years. Omalizumab reduces IgE mediated airway inflammation and its effect on airway remodeling is under investigation. Recent long-term clinical trials confirm the benefits of omalizumab in reducing exacerbations and symptoms in adults and in children with moderate to severe allergic asthma. No clinical or immunological factor consistently predicts a good therapeutic response to omalizumab in allergic asthma. In responders, the duration of treatment is unclear. The main adverse effect of omalizumab is anaphylaxis, although this occurs infrequently. Preliminary data from a five-year safety study has raised concerns about increased cardiovascular events and a final report is awaited. Clinical trials are in progress to determine whether omalizumab has efficacy in the treatment of non-allergic asthma.

Proton Radiotherapy for Pediatric Ewing's Sarcoma: Initial Clinical Outcomes

Energy Technology Data Exchange (ETDEWEB)

Rombi, Barbara [ATreP (Provincial Agency for Proton Therapy), Trento (Italy); DeLaney, Thomas F.; MacDonald, Shannon M. [Department of Radiation Oncology, Massachusetts General Hospital-Harvard Medical School, Boston, MA (United States); Huang, Mary S.; Ebb, David H. [Department of Pediatric Hematology and Oncology, Massachusetts General Hospital-Harvard Medical School, Boston, MA (United States); Liebsch, Norbert J. [Department of Radiation Oncology, Massachusetts General Hospital-Harvard Medical School, Boston, MA (United States); Raskin, Kevin A. [Department of Orthopaedic Surgery, Massachusetts General Hospital-Harvard Medical School, Boston, MA (United States); Yeap, Beow Y. [Department of Medicine, Massachusetts General Hospital-Harvard Medical School, Boston, MA (United States); Marcus, Karen J. [Division of Radiation Oncology, Children' s Hospital Boston, MA (United States); Tarbell, Nancy J. [Department of Radiation Oncology, Massachusetts General Hospital-Harvard Medical School, Boston, MA (United States); Yock, Torunn I., E-mail: tyock@partners.org [Department of Radiation Oncology, Massachusetts General Hospital-Harvard Medical School, Boston, MA (United States)

2012-03-01

Purpose: Proton radiotherapy (PT) has been prescribed similarly to photon radiotherapy to achieve comparable disease control rates at comparable doses. The chief advantage of protons in this setting is to reduce acute and late toxicities by decreasing the amount of normal tissue irradiated. We report the preliminary clinical outcomes including late effects on our pediatric Ewing's sarcoma patients treated with PT at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital (Boston, MA). Methods and Materials: This was a retrospective review of the medical records of 30 children with Ewing's sarcoma who were treated with PT between April 2003 and April 2009. Results: A total of 14 male and 16 female patients with tumors in several anatomic sites were treated with PT at a median age of 10 years. The median dose was 54 Gy (relative biological effectiveness) with a median follow-up of 38.4 months. The 3-year actuarial rates of event-free survival, local control, and overall survival were 60%, 86%, and 89%, respectively. PT was acutely well tolerated, with mostly mild-to-moderate skin reactions. At the time of writing, the only serious late effects have been four hematologic malignancies, which are known risks of topoisomerase and anthracyline exposure. Conclusions: Proton radiotherapy was well tolerated, with few adverse events. Longer follow-up is needed to more fully assess tumor control and late effects, but the preliminary results are encouraging.

Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

OpenAIRE

Sharp, Susan E.; Miller, Melissa B.; Hindler, Janet

2015-01-01

The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use “equivalent ...

An artificial neural network estimation of gait balance control in the elderly using clinical evaluations.

Directory of Open Access Journals (Sweden)

Vipul Lugade

Full Text Available The use of motion analysis to assess balance is essential for determining the underlying mechanisms of falls during dynamic activities. Clinicians evaluate patients using clinical examinations of static balance control, gait performance, cognition, and neuromuscular ability. Mapping these data to measures of dynamic balance control, and the subsequent categorization and identification of community dwelling elderly fallers at risk of falls in a quick and inexpensive manner is needed. The purpose of this study was to demonstrate that given clinical measures, an artificial neural network (ANN could determine dynamic balance control, as defined by the interaction of the center of mass (CoM with the base of support (BoS, during gait. Fifty-six elderly adults were included in this study. Using a feed-forward neural network with back propagation, combinations of five functional domains, the number of hidden layers and error goals were evaluated to determine the best parameters to assess dynamic balance control. Functional domain input parameters included subject characteristics, clinical examinations, cognitive performance, muscle strength, and clinical balance performance. The use of these functional domains demonstrated the ability to quickly converge to a solution, with the network learning the mapping within 5 epochs, when using up to 30 hidden nodes and an error goal of 0.001. The ability to correctly identify the interaction of the CoM with BoS demonstrated correlation values up to 0.89 (P<.001. On average, using all clinical measures, the ANN was able to estimate the dynamic CoM to BoS distance to within 1 cm and BoS area to within 75 cm2. Our results demonstrated that an ANN could be trained to map clinical variables to biomechanical measures of gait balance control. A neural network could provide physicians and patients with a cost effective means to identify dynamic balance issues and possible risk of falls from routinely collected clinical

Facial emotion perception differs in young persons at genetic and clinical high-risk for psychosis.

Science.gov (United States)

Kohler, Christian G; Richard, Jan A; Brensinger, Colleen M; Borgmann-Winter, Karin E; Conroy, Catherine G; Moberg, Paul J; Gur, Ruben C; Gur, Raquel E; Calkins, Monica E

2014-05-15

A large body of literature has documented facial emotion perception impairments in schizophrenia. More recently, emotion perception has been investigated in persons at genetic and clinical high-risk for psychosis. This study compared emotion perception abilities in groups of young persons with schizophrenia, clinical high-risk, genetic risk and healthy controls. Groups, ages 13-25, included 24 persons at clinical high-risk, 52 first-degree relatives at genetic risk, 91 persons with schizophrenia and 90 low risk persons who completed computerized testing of emotion recognition and differentiation. Groups differed by overall emotion recognition abilities and recognition of happy, sad, anger and fear expressions. Pairwise comparisons revealed comparable impairments in recognition of happy, angry, and fearful expressions for persons at clinical high-risk and schizophrenia, while genetic risk participants were less impaired, showing reduced recognition of fearful expressions. Groups also differed for differentiation of happy and sad expressions, but differences were mainly between schizophrenia and control groups. Emotion perception impairments are observable in young persons at-risk for psychosis. Preliminary results with clinical high-risk participants, when considered along findings in genetic risk relatives, suggest social cognition abilities to reflect pathophysiological processes involved in risk of schizophrenia. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A preliminary survey of Trichinella spp. in pigs raised under controlled housing conditions in Colombia: 2014–2016

Directory of Open Access Journals (Sweden)

Chaparro-Gutiérrez Jenny J.

2018-01-01

Full Text Available A preliminary survey of Trichinella spp. infection was conducted in Colombian swine herds between 2014 and 2016. A total of 1,773 pigs reared on farms under controlled housing conditions and processed in 34 slaughterhouses were tested either by the artificial digestion of pooled muscle samples (n = 1,173 or by serology (n = 600. In addition, 550 rats trapped on 29 swine farm premises were also tested by artificial digestion. No positive pig samples were detected. Similarly, no Trichinella spp. muscle larvae were detected in rats. These results are in agreement with the lack of historical Trichinella infection reports in domestic and wild animals and humans in Colombia. However, a more extensive epidemiological investigation and a continuous surveillance program are needed to continue declaring swine herds in Colombia free of Trichinella infection.

Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories.

Science.gov (United States)

Chen, Ming-Shu; Wu, Ming-Hsun; Lin, Chih-Ming

2014-04-30

The traditional criteria for acceptability of analytic quality may not be objective in clinical laboratories. To establish quality control procedures intended to enhance Westgard multi-rules for improving the quality of clinical biochemistry tests, we applied the Cp and Cpk quality-control indices to monitor tolerance fitting and systematic variation of clinical biochemistry test results. Daily quality-control data of a large Taiwanese hospital in 2009 were analyzed. The test items were selected based on an Olympus biochemistry machine and included serum albumin, aspartate aminotransferase, cholesterol, glucose and potassium levels. Cp and Cpk values were calculated for normal and abnormal levels, respectively. The tolerance range was estimated with data from 50 laboratories using the same instruments and reagents. The results showed a monthly trend of variation for the five items under investigation. The index values of glucose were lower than those of the other items, and their values were usually quality control, but also for revealing inter-laboratory qualitycontrol capability differences.

Valence effects on adsorption: a preliminary assessment of the effects on valence state control on sorption measurements

International Nuclear Information System (INIS)

Meyer, R.E.; Arnold, W.D.; Case, F.; Shiao, S.Y.; Palmer, D.A.

1983-01-01

Electrochemical arguments are advanced to illustrate that what is usually measured in practice is a mixed potential determined by the kinetics of the electrode processes occurring at the indicator electrode. Valence states can be altered electrochemically or by use of added chemical reagents, including redox couples which can hold the potential to relatively specific potentials. The disadvantage of added chemical reagents is that they may alter the characteristics of the sorption reactions by interaction with the sorbent. Electrochemical methods are versatile and do not add reagents, but in some caes the nuclide can adsorb on the electrode itself. A description is given of the application of the electrochemical method of valence control to determination of sorption of Np(V) on alumina. Valence state control and analysis can be used to study possible redox reactions on materials which might be used as backfill materials. A description is given of survey experiments with a number of sulfides and iron-containing materials. Valence state analysis is used on the initial solutions and leachate from acid leaches of the sorbent after the sorption experiment to help determine whether valence state change is occurring. The preliminary results indicate that on the sulfides tested, sorption occurs both with and without valence state change

Exploratory shaft facility preliminary designs - Permian Basin

International Nuclear Information System (INIS)

1983-09-01

The purpose of the Preliminary Design Report, Permian Basin, is to provide a description of the preliminary design for an Exploratory Shaft Facility in the Permian Basin, Texas. This issue of the report describes the preliminary design for constructing the exploratory shaft using the Large Hole Drilling method of construction and outlines the preliminary design and estimates of probable construction cost. The Preliminary Design Report is prepared to complement and summarize other documents that comprise the design at the preliminary stage of completion, December 1982. Other design documents include drawings, cost estimates and schedules. The preliminary design drawing package, which includes the construction schedule drawing, depicts the descriptions in this report. For reference, a list of the drawing titles and corresponding numbers are included in the Appendix. The report is divided into three principal sections: Design Basis, Facility Description, and Construction Cost Estimate. 30 references, 13 tables

Preliminary design study of the TMT Telescope structure system: overview

Science.gov (United States)

Usuda, Tomonori; Ezaki, Yutaka; Kawaguchi, Noboru; Nagae, Kazuhiro; Kato, Atsushi; Takaki, Junji; Hirano, Masaki; Hattori, Tomoya; Tabata, Masaki; Horiuchi, Yasushi; Saruta, Yusuke; Sofuku, Satoru; Itoh, Noboru; Oshima, Takeharu; Takanezawa, Takashi; Endo, Makoto; Inatani, Junji; Iye, Masanori; Sadjadpour, Amir; Sirota, Mark; Roberts, Scott; Stepp, Larry

2014-07-01

We present an overview of the preliminary design of the Telescope Structure System (STR) of Thirty Meter Telescope (TMT). NAOJ was given responsibility for the TMT STR in early 2012 and engaged Mitsubishi Electric Corporation (MELCO) to take over the preliminary design work. MELCO performed a comprehensive preliminary design study in 2012 and 2013 and the design successfully passed its Preliminary Design Review (PDR) in November 2013 and April 2014. Design optimizations were pursued to better meet the design requirements and improvements were made in the designs of many of the telescope subsystems as follows: 1. 6-legged Top End configuration to support secondary mirror (M2) in order to reduce deformation of the Top End and to keep the same 4% blockage of the full aperture as the previous STR design. 2. "Double Lower Tube" of the elevation (EL) structure to reduce the required stroke of the primary mirror (M1) actuators to compensate the primary mirror cell (M1 Cell) deformation caused during the EL angle change in accordance with the requirements. 3. M1 Segment Handling System (SHS) to be able to make removing and installing 10 Mirror Segment Assemblies per day safely and with ease over M1 area where access of personnel is extremely difficult. This requires semi-automatic sequence operation and a robotic Segment Lifting Fixture (SLF) designed based on the Compliance Control System, developed for controlling industrial robots, with a mechanism to enable precise control within the six degrees of freedom of position control. 4. CO2 snow cleaning system to clean M1 every few weeks that is similar to the mechanical system that has been used at Subaru Telescope. 5. Seismic isolation and restraint systems with respect to safety; the maximum acceleration allowed for M1, M2, tertiary mirror (M3), LGSF, and science instruments in 1,000 year return period earthquakes are defined in the requirements. The Seismic requirements apply to any EL angle, regardless of the

Preliminary physics calculations for the Clinch River Breeder Reactor

International Nuclear Information System (INIS)

Kalimullah.

1975-01-01

Calculations of sodium void, fuel, and clad worths, power distribution, and control rod worths have been carried out for an R-Z model of the CRBR, using diffusion theory and first-order perturbation theory for material worths. The power distribution and control rod worths have also been calculated in two-dimensional triangular mesh geometry. The present results are preliminary because of inaccuracy of the reactor model and the cross sections used, but the final results are not expected to be greatly different. (U.S.)

Life cycle analysis in preliminary design stages

OpenAIRE

Agudelo , Lina-Maria; Mejía-Gutiérrez , Ricardo; Nadeau , Jean-Pierre; PAILHES , Jérôme

2014-01-01

International audience; In a design process the product is decomposed into systems along the disciplinary lines. Each stage has its own goals and constraints that must be satisfied and has control over a subset of design variables that describe the overall system. When using different tools to initiate a product life cycle, including the environment and impacts, its noticeable that there is a gap in tools that linked the stages of preliminary design and the stages of materialization. Differen...

Relations of Anxiety Sensitivity, Control Beliefs, and Maternal Over-Control to Fears in Clinic-Referred Children with Specific Phobia.

Science.gov (United States)

Kane, Elisabeth J; Braunstein, Kara; Ollendick, Thomas H; Muris, Peter

2015-07-01

The relations of fear to anxiety sensitivity, control beliefs, and maternal overprotection were examined in 126 7- to 13-year-old clinically referred children with specific phobias. Results indicated that anxiety sensitivity and control beliefs were significant predictors of children's fear levels, accounting for approximately 48% of the total variance. Unexpectedly, age, gender, and maternal overprotection did not emerge as significant predictors of fear in the overall sample. In subsequent analyses, anxiety sensitivity was found to be a consistent, significant predictor for both girls and boys, for both younger and older children, and for children with and without an additional anxiety disorder diagnosis. Control beliefs were only a significant predictor for girls, younger children, and children with an additional anxiety diagnosis. Maternal overprotection was not a significant predictor for any group. Children with an additional anxiety disorder diagnosis had higher levels of fear, anxiety sensitivity, and maternal overprotection, as well as lower levels of control beliefs than the non-additional anxiety disorder subgroup. Future directions and clinical implications are explored.

Preliminary study on field buses for the control system of the high voltage of the ATLAS hadronic calorimeter; Etude preliminaire d`un reseau de terrain pour le systeme de controle des hautes tensions du calorimetre hadronique d`Atlas

Energy Technology Data Exchange (ETDEWEB)

Drevet, F.; Chadelas, R.; Montarou, G.

1996-12-31

We present here after a preliminary study on field buses for the control system of the high voltage of the photomultipliers of the TILECAL calorimeter. After some generalities, different commercial buses are reviewed (CAN, ARCET, WorldFIP, Profibus and LonWorks). The Profibus and LonWorks solution are more extensively studies as a possible solution for the high voltage system of the TILE hadronic calorimeter. (authors).

Effect of controlled-release PeriochipTM on clinical and microbiological parameters in patients of chronic periodontitis

Directory of Open Access Journals (Sweden)

Komal Puri

2013-01-01

Full Text Available Background: The aim of the present study was to evaluate and compare the clinical and microbiological effectiveness of Periochip TM as an adjunct to scaling and root planing (SRP with SRP alone in patients with chronic periodontitis. Materials and Methods: This randomized, split mouth, 3-month clinical and microbiological trial included 30 sites in 15 patients aged 30-50 years diagnosed with chronic periodontitis. In each patient, two bilateral pockets probing 5-7 mm were randomly assigned to test and control groups. The test group received SRP plus Periochip TM , whereas the control group received SRP alone. Clinical indices and anaerobic culture analysis was done at baseline, 1 month, and 3 months interval. Total bacterial count and analysis of four major periodontopathogenic bacteria Porphyromonas gingivalis (Pg, Prevotella intermedia (Pi, Aggregatibacter actinomycetemcomitans (Aa, and Fusobacterium nucleatum (Fn was done. Results: Significant improvement was obtained in all clinical variables in the test group as compared to the control group over the study period. Total colony counts were significantly reduced in the test group as compared to control over the period of time. At baseline Aa was recovered from 4 test group sites and 5 control group sites, Pg from 15 test group and 14 control group sites, Pi from 5 test group and 2 control group sites, Fn from 7 test and 7 control group sites. At 3 months, Aa was recovered from 1 test group and 4 control group sites, Pg from 4 test group and 8 control group sites, Pi from 1 test group and 1 control group site, Fn from 3 test and 4 control group sites. Conclusion: Periochip TM placement as an adjunct to SRP, showed promising results, when compared to SRP alone. Healthy microflora can be maintained for a longer period of time and delay in the repopulation by periodontopathic microorganisms was observed.

Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

Science.gov (United States)

Sennerby, L; Gottlow, J

2008-06-01

Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

77 FR 67396 - Importer of Controlled Substances; Notice of Application, Fisher Clinical Services, Inc.

Science.gov (United States)

2012-11-09

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application, Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on August 20, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, [[Page 67397...

77 FR 60143 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

Science.gov (United States)

2012-10-02

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on July 18, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown...

77 FR 72409 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

Science.gov (United States)

2012-12-05

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on October 16, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown...

78 FR 59064 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

Science.gov (United States)

2013-09-25

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations (CFR) 1301.34 (a), this is notice that on June 21, 2013, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown...

Habit reversal training and educational group treatments for children with tourette syndrome: A preliminary randomised controlled trial.

Science.gov (United States)

Yates, Rachel; Edwards, Katie; King, John; Luzon, Olga; Evangeli, Michael; Stark, Daniel; McFarlane, Fiona; Heyman, Isobel; İnce, Başak; Kodric, Jana; Murphy, Tara

2016-05-01

Quality of life of children with Tourette Syndrome (TS) is impacted greatly by its symptoms and their social consequences. Habit Reversal Training (HRT) is effective but has not, until now, been empirically evaluated in groups. This randomised controlled trial evaluated feasibility and preliminary efficacy of eight HRT group sessions compared to eight Education group sessions. Thirty-three children aged 9-13 years with TS or Chronic Tic Disorder took part. Outcomes evaluated were tic severity and quality of life (QoL). Tic severity improvements were found in both groups. Motor tic severity (Yale Global Tic Severity Scale) showed greatest improvements in the HRT group. Both groups showed a strong tendency toward improvements in patient reported QoL. In conclusion, group-based treatments for TS are feasible and exposure to other children with tics did not increase tic expression. HRT led to greater reductions in tic severity than Education. Implications, such as cost-effectiveness of treatment delivery, are discussed. Copyright © 2016. Published by Elsevier Ltd.

Parenting clinically anxious versus healthy control children aged 4-12 years

NARCIS (Netherlands)

van der Sluis, C.M.; van Steensel, F.J.A.; Bögels, S.M.

2015-01-01

This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to

Preliminary design package for solar hot water system

Energy Technology Data Exchange (ETDEWEB)

Fogle, Val; Aspinwall, David B.

1977-12-01

The information necessary to evaluate the preliminary design of the Solar Engineering and Manufacturing Company's (SEMCO) solar hot water system is presented. This package includes technical information, schematics, drawings and brochures. This system, being developed by SEMCO, consists of the following subsystems: collector, storage, transport, control, auxiliary energy, and Government-furnished site data acquisition. The two units being manufactured will be installed at Loxahatchee, Florida, and Macon, Georgia.

Preliminary reports in the emergency department: is a subspecialist radiologist more accurate than a radiology resident?

Science.gov (United States)

Branstetter, Barton F; Morgan, Matthew B; Nesbit, Chadd E; Phillips, Jinnah A; Lionetti, David M; Chang, Paul J; Towers, Jeffrey D

2007-02-01

To determine whether emergency department (ED) preliminary reports rendered by subspecialist attending radiologists who are reading outside their field of expertise are more accurate than reports rendered by radiology residents, and to compare error rates between radiologists and nonradiologists in the ED setting. The study was performed at a large academic medical center with a busy ED. An electronic preliminary report generator was used in the ED to capture preliminary interpretations rendered in a clinical setting by radiology residents, junior attendings (within 2 years of taking their oral boards), senior attendings, and ED clinicians between August 1999 and November 2004. Each preliminary report was later reviewed by a final interpreting radiologist, and the preliminary interpretation was adjudicated for the presence of substantial discordances, defined as a difference in interpretation that might immediately impact the care of the patient. Of the 612,890 preliminary reports in the database, 65,780 (11%) met inclusion criteria for this study. A log-linear analysis was used to assess the effects of modality and type of author on preliminary report error rates. ED clinicians had significantly higher error rates when compared with any type of radiologist, regardless of modality. Within the radiologists, residents and junior attendings had lower error rates than did senior attendings, but the differences were not statistically significant. Subspecialized attending radiologists who interpret ED examinations outside their area of expertise have error rates similar to those of radiology residents. Nonradiologists have significantly higher error rates than radiologists and radiology residents when interpreting examinations in the ED.

sup 123 I-tyrosine-(A14)-insulin: preparation and preliminary clinical studies. sup 123 I-tyrosin-(A14)-Insulin: Entwicklung und erste klinische Anwendung

Energy Technology Data Exchange (ETDEWEB)

Pantev, T; Virgolini, I; Sinzinger, H; Prager, R; Neuhold, N; Angelberger, P; Banyai, M; Knoebl, P [Oesterreichisches Forschungszentrum Seibersdorf GmbH (Austria). Inst. fuer Chemie Vienna Univ. (Austria). Abt. fuer Nuklearmedizin

1991-01-01

Insulin was radioiodinated with {sup 123}I ({sup 123}I-tyrosine-(A14)-insulin) to a specific activity of 1 {mu}g/mCi, corresponding to 0.025 I.U. of insulin/mCi. This preparation was used for in vitro binding experiments with adipose tissue, showing active binding to the two subunits of the known insulin receptor. In a preliminary clinical investigation, 5 adipose patients with (n = 2) and without (n = 3) diabetes mellitus Type II, were subject to in vivo injection of the same radiolabeled product using 3 mCi/patient. During the first minutes of dynamic imaging, the liver was the major organ of tracer uptake in all patients. Furthermore, the pancreas, and in one patient the kidneys, were visualised. Further studies on insulin in vivo kinetics and quantification are under way. (authors).

IMPACT OF A SERIOUS GAME FOR HEALTH ON CHRONIC DISEASE SELF-MANAGEMENT: PRELIMINARY EFFICACY AMONG COMMUNITY DWELLING ADULTS WITH HYPERTENSION.

Science.gov (United States)

Hickman, Ronald L; Clochesy, John M; Pinto, Melissa D; Burant, Christopher; Pignatiello, Grant

2015-01-01

Most Americans will acquire a chronic disease during their lifetime. One of the most prevalent chronic diseases that affect Americans is hypertension (HTN). Despite the known comorbidities and increased mortality rate associated with uncontrolled HTN, most community dwelling adults with HTN do not have sufficient blood pressure control Therefore, the aim of this article is to report the preliminary efficacy of a serious game for health to enhance blood pressure control among community dwelling adults with HTN. A nonprobability sample of 116 community dwelling adults with HTN participated in this nonblinded, randomized controlled trial. Participants were randomly assigned to: (1) an intervention arm that consisted of four exposures to a serious game for health known as eSMART-HD; or (2) an attentional control arm that compromised of four exposures to screen-based HTN education. The primary outcome measure for this trial was blood pressure reduction over a four month observational period. In this study, baseline characteristics and blood pressure measurements were similar between participants in each study arm. There was no significant between-group difference in blood pressure reduction over time. However, there were significant within-group reductions in systolic and diastolic blood pressures across time among favoring participants exposed to eSMART-HD. This study establishes the preliminary efficacy of eSMART-HD that can be easily administered to community dwelling adults and facilitate clinically significant reductions in systolic and diastolic blood pressures. Future studies should assess the influential components of this promising serious game for health (eSMART-HD) combined with medication management in larger and more diverse samples of community dwelling adults with HTN.

Assuring Quality Control of Clinical Education in Multiple Clinical Affiliates.

Science.gov (United States)

Davis, Judith A.

A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules, a…

Difficult-to-control hypertension: identification of clinical predictors and use of ICT-based integrated care to facilitate blood pressure control.

Science.gov (United States)

Visco, Valeria; Finelli, Rosa; Pascale, Antonietta Valeria; Mazzeo, Pietro; Ragosa, Nicola; Trimarco, Valentina; Illario, Maddalena; Ciccarelli, Michele; Iaccarino, Guido

2018-05-01

Difficult-to-control (DTC) hypertension represents a burden in real life that can be partially solved through identification of the characteristics of clinical patterns and tailoring antihypertensive strategies, including ICT-enabled integrated care (ICT-IC). In the quest for clinical predictors of DTC hypertension, we screened 482 hypertensive patients who were consecutively referred to the departmental hypertension clinic. Following a data quality check, patients were divided into controlled (C, 49.37%) and uncontrolled (UC, 50.63%) groups based on their systolic blood pressure (BP) at follow-up. We then performed statistical analysis on the demographic, clinical, laboratory, and ultrasound data and observed that older age, female sex, higher BP levels, and a family history of hypertension were predictors of DTC hypertension. We then developed a pilot service of ICT-IC, including weekly home visits by nurses and patient education on self-monitoring of BP, heart rate, body weight, and oxygen saturation using 3G-connected devices. Self-monitored data were transmitted to the hospital servers on the electronic chart of the patient for remote assessment by the hospital hypertension specialists. A total of 20 UC patients (M/F = 10/10; age: 72.04 ± 2.17 years) were enrolled to verify the efficacy of BP control without changes in medical treatment. After 1 month of the ICT-IC program, BP was reduced both at the office assessment (systolic BP (SBP): 162.40 ± 2.23 mm Hg, beginning of the program vs. 138.20 ± 4.26 mm Hg at 1 month, p ICT-IC is a feasible therapeutic strategy to achieve BP control.

Business System Planning Project, Preliminary System Design

International Nuclear Information System (INIS)

EVOSEVICH, S.

2000-01-01

CH2M HILL Hanford Group, Inc. (CHG) is currently performing many core business functions including, but not limited to, work control, planning, scheduling, cost estimating, procurement, training, and human resources. Other core business functions are managed by or dependent on Project Hanford Management Contractors including, but not limited to, payroll, benefits and pension administration, inventory control, accounts payable, and records management. In addition, CHG has business relationships with its parent company CH2M HILL, U.S. Department of Energy, Office of River Protection and other River Protection Project contractors, government agencies, and vendors. The Business Systems Planning (BSP) Project, under the sponsorship of the CH2M HILL Hanford Group, Inc. Chief Information Officer (CIO), have recommended information system solutions that will support CHG business areas. The Preliminary System Design was developed using the recommendations from the Alternatives Analysis, RPP-6499, Rev 0 and will become the design base for any follow-on implementation projects. The Preliminary System Design will present a high-level system design, providing a high-level overview of the Commercial-Off-The-Shelf (COTS) modules and identify internal and external relationships. This document will not define data structures, user interface components (screens, reports, menus, etc.), business rules or processes. These in-depth activities will be accomplished at implementation planning time

Preliminary design report for the prototypical fuel rod consolidation system

International Nuclear Information System (INIS)

Rosa, J.M.

1986-01-01

This report documents NUTECH's preliminary design of a dry, spent fuel rod consolidation system. This preliminary design is the result of Phase I of a planned four phase project. The present report on this project provides a considerable amount of detail for a preliminary design effort. The design and all of its details are described in this Preliminary Design Report (PDR). The NUTECH dry rod consolidation system described herein is remotely operated. It provides for automatic operation, but with operator hold points between key steps in the process. The operator has the ability to switch to a manual operation mode at any point in the process. The system is directed by the operator using an executive computer which controls and coordinates the operation of the in-cell equipment. The operator monitors the process using an in-cell closed circuit television (CCTV) system with audio output and equipment status displays on the computer monitor. The in-cell mechanical equipment consists of the following: (1) two overhead cranes with manipulators; (2) a multi-degree of freedom fuel handling table and its clamping equipment; (3) a fuel assembly end fitting removal station and its tools; (4) a consolidator (which pulls rods, assembles the consolidated bundle and loads the canister); (5) a canister end cap welder and weld inspection system; (6) decontamination systems; and (7) the CCTV and microphone systems

Radiology workstation for mammography: preliminary observations, eyetracker studies, and design

Science.gov (United States)

Beard, David V.; Johnston, Richard E.; Pisano, Etta D.; Hemminger, Bradley M.; Pizer, Stephen M.

1991-07-01

For the last four years, the UNC FilmPlane project has focused on constructing a radiology workstation facilitating CT interpretations equivalent to those with film and viewbox. Interpretation of multiple CT studies was originally chosen because handling such large numbers of images was considered to be one of the most difficult tasks that could be performed with a workstation. The authors extend the FilmPlane design to address mammography. The high resolution and contrast demands coupled with the number of images often cross- compared make mammography a difficult challenge for the workstation designer. This paper presents the results of preliminary work with workstation interpretation of mammography. Background material is presented to justify why the authors believe electronic mammographic workstations could improve health care delivery. The results of several observation sessions and a preliminary eyetracker study of multiple-study mammography interpretations are described. Finally, tentative conclusions of what a mammographic workstation might look like and how it would meet clinical demand to be effective are presented.

Stock Versus CAD/CAM Customized Zirconia Implant Abutments - Clinical and Patient-Based Outcomes in a Randomized Controlled Clinical Trial

NARCIS (Netherlands)

Schepke, Ulf; Meijer, Henny J. A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco

BackgroundSingle-tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. PurposeThis randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant

A controlled clinical trial of implant-retained mandibular overdentures : 10 years' results of clinical aspects and aftercare of IMZ implants and Branemark implants

NARCIS (Netherlands)

Meijer, HJA; Raghoebar, GM; Van't Hof, MA; Visser, A

The aim of this prospective randomized controlled clinical trial was to evaluate the clinical outcomes and prosthetic aftercare of edentulous patients with a mandibular overdenture retained by two IMZ implants or two Branemark implants during a 10-year period. Patients were allocated to the IMZ

Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management).

Science.gov (United States)

Little, Paul; Hobbs, F D Richard; Moore, Michael; Mant, David; Williamson, Ian; McNulty, Cliodna; Cheng, Ying Edith; Leydon, Geraldine; McManus, Richard; Kelly, Joanne; Barnett, Jane; Glasziou, Paul; Mullee, Mark

2013-10-10

To determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing. Open adaptive pragmatic parallel group randomised controlled trial. Primary care in United Kingdom. Patients aged ≥ 3 with acute sore throat. An internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the comparator group for analyses), clinical score, or antigen test used according to clinical score. During the trial a preliminary streptococcal score (score 1, n=1129) was replaced by a more consistent score (score 2, n=631; features: fever during previous 24 hours; purulence; attends rapidly (within three days after onset of symptoms); inflamed tonsils; no cough/coryza (acronym FeverPAIN). Symptom severity reported by patients on a 7 point Likert scale (mean severity of sore throat/difficulty swallowing for days two to four after the consultation (primary outcome)), duration of symptoms, use of antibiotics. For score 1 there were no significant differences between groups. For score 2, symptom severity was documented in 80% (168/207 (81%) in delayed antibiotics group; 168/211 (80%) in clinical score group; 166/213 (78%) in antigen test group). Reported severity of symptoms was lower in the clinical score group (-0.33, 95% confidence interval -0.64 to -0.02; P=0.04), equivalent to one in three rating sore throat a slight versus moderate problem, with a similar reduction for the antigen test group (-0.30, -0.61 to -0.00; P=0.05). Symptoms rated moderately bad or worse resolved significantly faster in the clinical score group (hazard ratio 1.30, 95% confidence interval 1.03 to 1.63) but not the antigen test group (1.11, 0.88 to 1.40). In the delayed antibiotics group, 75/164 (46%) used antibiotics. Use of antibiotics in the clinical score group (60/161) was 29% lower (adjusted risk ratio 0.71, 95% confidence interval 0.50 to 0.95; P=0.02) and in the

Preliminary considerations concerning actinide solubilities

International Nuclear Information System (INIS)

Newton, T.W.; Bayhurst, B.P.; Daniels, W.R.; Erdal, B.R.; Ogard, A.E.

1980-01-01

Work at the Los Alamos Scientific Laboratory on the fundamental solution chemistry of the actinides has thus far been confined to preliminary considerations of the problems involved in developing an understanding of the precipitation and dissolution behavior of actinide compounds under environmental conditions. Attempts have been made to calculate solubility as a function of Eh and pH using the appropriate thermodynamic data; results have been presented in terms of contour maps showing lines of constant solubility as a function of Eh and pH. Possible methods of control of the redox potential of rock-groundwater systems by the use of Eh buffers (redox couples) is presented

Versator divertor experiment: preliminary designs

International Nuclear Information System (INIS)

Wan, A.S.; Yang, T.F.

1984-08-01

The emergence of magnetic divertors as an impurity control and ash removal mechanism for future tokamak reactors bring on the need for further experimental verification of the divertor merits and their ability to operate at reactor relevant conditions, such as with auxiliary heating. This paper presents preliminary designs of a bundle and a poloidal divertor for Versator II, which can operate in conjunction with the existing 150 kW of LHRF heating or LH current drive. The bundle divertor option also features a new divertor configuration which should improve the engineering and physics results of the DITE experiment. Further design optimization in both physics and engineering designs are currently under way

The role of clinical toxicologists and poison control centers in public health.

Science.gov (United States)

Sutter, Mark E; Bronstein, Alvin C; Heard, Stuart E; Barthold, Claudia L; Lando, James; Lewis, Lauren S; Schier, Joshua G

2010-06-01

Poison control centers and clinical toxicologists serve many roles within public health; however, the degree to which these entities collaborate is unknown. The objective of this survey was to identify successful collaborations of public health agencies with clinical toxicologists and poison control centers. Four areas including outbreak identification, syndromic surveillance, terrorism preparedness, and daily public health responsibilities amenable to poison control center resources were assessed. An online survey was sent to the directors of poison control centers, state epidemiologists, and the most senior public health official in each state and selected major metropolitan areas. This survey focused on three areas: service, structure within the local or state public health system, and remuneration. Questions regarding remuneration and poison control center location within the public health structure were asked to assess if these were critical factors of successful collaborations. Senior state and local public health officials were excluded because of a low response rate. The survey was completed in October 2007. A total of 111 respondents, 61 poison control centers and 50 state epidemiologists, were eligible for the survey. Sixty-nine (62%) of the 111 respondents, completed and returned the survey. Thirty-three (54%) of the 61 poison control centers responded, and 36 of the 50 state epidemiologists (72%) responded. The most frequent collaborations were terrorism preparedness and epidemic illness reporting. Additional collaborations also exist. Important collaborations exist outside of remuneration or poison control centers being a formal part of the public health structure. Poison control centers have expanded their efforts to include outbreak identification, syndromic surveillance, terrorism preparedness, and daily public health responsibilities amenable to poison control center resources. Collaboration in these areas and others should be expanded. Published

77 FR 50162 - Importer of Controlled Substances; Notice of Registration; Almac Clinical Services, Inc.

Science.gov (United States)

2012-08-20

... Register on April 26, 2012, 77 FR 24985, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton... that the registration of Almac Clinical Services, Inc. (ACSI) to import the basic classes of controlled..., Inc. (ACSI) to ensure that the company's registration is consistent with the public interest. The...

The Kjeldahl method as a primary reference procedure for total protein in certified reference materials used in clinical chemistry. II. Selection of direct Kjeldahl analysis and its preliminary performance parameters.

Science.gov (United States)

Vinklárková, Bára; Chromý, Vratislav; Šprongl, Luděk; Bittová, Miroslava; Rikanová, Milena; Ohnútková, Ivana; Žaludová, Lenka

2015-01-01

To select a Kjeldahl procedure suitable for the determination of total protein in reference materials used in laboratory medicine, we reviewed in our previous article Kjeldahl methods adopted by clinical chemistry and found an indirect two-step analysis by total Kjeldahl nitrogen corrected for its nonprotein nitrogen and a direct analysis made on isolated protein precipitates. In this article, we compare both procedures on various reference materials. An indirect Kjeldahl method gave falsely lower results than a direct analysis. Preliminary performance parameters qualify the direct Kjeldahl analysis as a suitable primary reference procedure for the certification of total protein in reference laboratories.

Cognitive impairment and computer tomography image in patients with arterial hypertension -preliminary results

International Nuclear Information System (INIS)

Yaneva-Sirakova, T.; Tarnovska-Kadreva, R.; Traykov, L.; Zlatareva, D.

2012-01-01

Arterial hypertension is the leading risk factor for cognitive impairment, but it is developed only in some of the patients with pour control. On the other hand, not all of the patents with white matter changes have cognitive deficit. There may be a variety of reasons for this: the accuracy of methods for blood pressure measurement, the specific brain localization or some other reason. Here are the preliminary results of a study (or the potential correlation between self-measured, office-, ambulatory monitored blood pressure, central aortic blood pressure, minimal cognitive impairment and the specific brain image on contrast computer tomography. We expect to answer, the question whether central aortic or self-measured blood pressure have the leading role for the development of cognitive impairment in the presence of a specific neuroimaging finding, as well as what is the prerequisite for the clinical manifestation of cognitive dysfunction in patients with computer tomographic pathology. (authors)

Ior-CEA-1: Labelling, quality control and clinical evaluation

International Nuclear Information System (INIS)

Pimentel, G.J.

1998-01-01

Within the Co-ordinated Programme on Labelling, Quality Control and Evaluation of Monoclonal Antibodies, the IAEA has made a great effort to expand efficient labelling methods, mainly those with radioisotopes which have been used for radioimmunoscintigraphy. In this sense, more recently 99 Tc m has been mostly employed in the majority of the investigations due to its ideal physical characteristics. Efficient labelling of monoclonal antibodies depends on a number of factors including the method and way of the label incorporation into the protein. During the last years several direct labelling approaches have been developed, which led to attain simple and inexpensive methods for medical practice, as well as safe and stable techniques which bring accurate and good quality images. Accordingly, this paper describes the results obtained during last five years which come from the comparison among different labelling systems, passing through the quality control to test the labelled monoclonal stability and the protein bioreactivity, to continue in the clinical evaluation of ior-CEA-1, as well as the evaluation of other antibodies. Up to now we have evaluated more than 70 patients with the anti-CEA monoclonal antibody (ior-CEA-1), examined in different clinical assays such as: pilot, phase I-II and extensive phase III-IV trials, whose results are encouraging. It confirms that the employed labelling approach was safe and adequate

Effects of Intensive Control of Glycemia on Clinical Kidney Outcomes in Type 2 Diabetes Patients Compared with Standard Control: A Meta-Analysis

Directory of Open Access Journals (Sweden)

Francisco Herrera-Gómez

2017-11-01

Full Text Available Background: Association between poor control of glycemia and the onset of microvascular complications in type 2 diabetes mellitus (T2DM patients is a hard issue. However, it seems that the impact of pharmacological treatment is important only in early stages of diabetic nephropathy. We sought to examine whether intensive glycemic control is associated with improvement of clinical Chronic Kidney Disease (CKD outcomes compared to standard glycemic control.Methods: Meta-analysis of published and unpublished randomized controlled trials (RCT and post-hoc analysis of RCTs comparing anti-diabetic drugs and/or insulin (intensive control vs. dietary measures (standard control for relevant outcomes related to progression of CKD clinically manifest was undertaken. Summary estimates obtained by random effects model and funnel plots for assessing reporting bias are presented.Results: Our analysis was based on four RCTs representing 27,391 adult T2DM patients with CKD from around the world. The pooled OR for the outcomes of doubling of serum creatinine and need of dialysis were, respectively, of 0.98 with 95% confidence interval (95% CI 0.81–1.19, and 0.84 with 95% CI 0.69–1.02. The pooled OR for the outcome of death from kidney failure was 0.62 with 95% CI 0.39–0.98. Clinical differences between studies were not translated in statistical heterogeneity. Reporting bias may be present.Conclusions: Intensive glycemic control has an effect on death from kidney failure compared to standard glycemic control. Better comprehension of glycemic control effects on both T2DM patients with and without CKD is important for individualization of these two treatment modalities.

Value-based HR practices, i-deals and clinical error control with CSR as a moderator.

Science.gov (United States)

Luu, Tuan; Rowley, Chris; Siengthai, Sununta; Thanh Thao, Vo

2017-05-08

Purpose Notwithstanding the rising magnitude of system factors in patient safety improvement, "human factors" such as idiosyncratic deals (i-deals) which also contribute to the adjustment of system deficiencies should not be neglected. The purpose of this paper is to investigate the role of value-based HR practices in catalyzing i-deals, which then influence clinical error control. The research further examines the moderating role of corporate social responsibility (CSR) on the effect of value-based HR practices on i-deals. Design/methodology/approach The data were collected from middle-level clinicians from hospitals in the Vietnam context. Findings The research results confirmed the effect chain from value-based HR practices through i-deals to clinical error control with CSR as a moderator. Originality/value The HRM literature is expanded through enlisting i-deals and clinical error control as the outcomes of HR practices.

Risk factors for pulmonary tuberculosis: a clinic-based case control study in The Gambia

Directory of Open Access Journals (Sweden)

Adegbola Richard A

2006-06-01

Full Text Available Abstract Background The tuberculosis (TB epidemic in Africa is on the rise, even in low-HIV prevalence settings. Few studies have attempted to identify possible reasons for this. We aimed to identify risk factors for pulmonary tuberculosis in those attending a general outpatients clinic in The Gambia, a sub-Saharan African country with relatively low HIV prevalence in the community and in TB patients. Methods We conducted a case control study at the Medical Research Council Outpatients' clinic in The Gambia. Pulmonary TB cases were at least 15 years old, controls were age and sex matched clinic attendees. Participants were interviewed using a structured questionnaire. Results 100 sputum smear positive TB cases and 200 clinic controls were recruited. HIV prevalence was 6.1% in cases and 3.3% in controls. Multivariable assessment of host factors showed that risk of TB was increased among the Jola ethnic group and smokers, and decreased in those in a professional occupation. Assessment of environmental factors showed an increased risk with household crowding, history of household exposure to a known TB case, and absence of a ceiling in the house. In a combined multivariable host-environment model, the risk of TB increased with crowding, exposure to a known TB case, as well as amongst the Jola ethnic group. Conclusion In The Gambia, household crowding and past household exposure to a known TB case are the standout risk factors for TB disease. Further research is needed to identify why risk of TB seems to differ according to ethnicity.

Impact of implementing electronic clinical practice guidelines for the diagnosis, control and treatment of cardiovascular risk factors: A pre-post controlled study

Directory of Open Access Journals (Sweden)

Eva Comin

2017-08-01

Conclusions: Computerized clinical practice guidelines are an effective tool for the control and follow-up of patients diagnosed with hypertension, type 2 diabetes mellitus, and hypercholesterolaemia. The usefulness of computerized clinical practice guidelines to diagnose and adequately treat individuals with these disorders remains unclear.

The introduction of mobile plant clinics to Uganda

DEFF Research Database (Denmark)

Danielsen, Solveig; Mutebi, Emmanuel

Four mobile (or community-based) plant health clinics were started in Uganda on a pilot basis in 2005 as an attempt to ensure better plant health advisory services for small-scale farmers.  This new way of delivering primary plant healthcare to farmers has attracted wider interest and the Ministry......, Makerere University and CABI. The purpose of this study was to gather results and lessons learned from the pilot period to inform future plant clinic interventions. The study covers issues of organisation and management, clinic operation and performance as well as clinic use and preliminary evidence...

The clinical value of Huangqi injection in the treatment of leucopenia: a meta-analysis of clinical controlled trials.

Directory of Open Access Journals (Sweden)

Changsong Zhang

Full Text Available BACKGROUND: Huangqi injection is derived from Astragalus membranaceus root. In China, recent reports of Huangqi injection for the treatment of leucopenia have emerged. However, a systematic review of these reports has not been performed. Thus, we conducted a meta-analysis of clinical controlled trials to assess the clinical value of Huangqi injection in the treatment of leucopenia. METHODS: We searched the Chinese Biomedical Literature Database (CBM, Wanfang Database, China National Knowledge Infrastructure (CNKI, Chinese Scientific Journals Full-text Database (VIP, as well as PubMed and EMBASE to collect the data about trials of Huangqi injection for treating leucopenia. A meta-analysis was performed using RevMan 5.2 software. RESULTS: A total of 13 studies involving 841 patients were included in this study. The overall study quality was lower according to the Jadad scale. The meta-analysis showed that experimentally treated patients experienced greater therapeutic efficacy and lower white blood cell counts than control groups treated with Western medicine (P < 0.05. No publication bias was evident, according to Egger's test. CONCLUSIONS: The validity of this meta-analysis was limited by the overall poor quality of the included studies. Huangqi injection may have potential clinical value in the treatment of leucopenia, but confirmation with rigorously well-designed multi-center trials is needed.

Antibiotic treatment to prevent postextraction complications: a monocentric, randomized clinical trial. Preliminary outcomes.

Science.gov (United States)

Barone, Antonio; Marchionni, Francesco S; Cinquini, Chiara; Cipolli Panattoni, Andrea; Toti, Paolo; Marconcini, Simone; Covani, Ugo; Gabriele, Mario

2017-08-01

Tooth extraction is a very common procedure in oral surgery. Despite this, very little information is available in the literature as to the antibiotic management of the patient. The aim of this study is to evaluate whether the antibiotic prophylaxis could be beneficial in preventing postextraction local complications and whether the use of a probiotic could help reduce the antibiotic gastro-intestinal side effects. One hundred eleven patients meeting the inclusion criteria were initially included in this randomized clinical trial and randomly allocated to one of the three experimental groups according to a computer-generated randomization list. Patients allocated to the group 1 were given amoxicillin+clavulanic acid (2 g/day for 6 days), patients allocated to the group 2 received antibiotic + probiotic (Bifidobacterium longum+lactoferrin) and patients allocated to the group 3 received no antibiotic therapy after the extraction. To evaluate post-extractive complications, controls were performed at days 7, 14 and 21 after the extraction. At T1 pain at the surgical site was present in the 48%, 30% and 71.4% of the patients belonging respectively to the antibiotic alone group, to the antibiotic+probiotic group and to the control group. The mean Numeric Rating Score (NRS) score was 1.56±1.91, 1.08±1.93, 2.02±2.27 respectively (P=0.0498). Two patients belonging to the control group experienced dry socket. In addition, 9 patients (33.3%) in the antibiotic-alone group and 1 patient (2.7%) in the antibiotic+probiotic group reported intestinal distension (P=0.0012), 7 days after surgery. Finally, diarrhea was recorded in 5 patients of the antibiotic alone group (18.5%), on the other hand, no patients of the antibiotic+probiotic group and the control group reported diarrhea. Postextractive complications observed in each group have been mild and fast to resolve. The antibiotic administration showed a decrease in pain suffered by patients but a higher incidence of

Effect of clinical parameters on the control of myoelectric robotic prosthetic hands.

Science.gov (United States)

Atzori, Manfredo; Gijsberts, Arjan; Castellini, Claudio; Caputo, Barbara; Hager, Anne-Gabrielle Mittaz; Elsig, Simone; Giatsidis, Giorgio; Bassetto, Franco; Müller, Henning

2016-01-01

Improving the functionality of prosthetic hands with noninvasive techniques is still a challenge. Surface electromyography (sEMG) currently gives limited control capabilities; however, the application of machine learning to the analysis of sEMG signals is promising and has recently been applied in practice, but many questions still remain. In this study, we recorded the sEMG activity of the forearm of 11 male subjects with transradial amputation who were mentally performing 40 hand and wrist movements. The classification performance and the number of independent movements (defined as the subset of movements that could be distinguished with >90% accuracy) were studied in relationship to clinical parameters related to the amputation. The analysis showed that classification accuracy and the number of independent movements increased significantly with phantom limb sensation intensity, remaining forearm percentage, and temporal distance to the amputation. The classification results suggest the possibility of naturally controlling up to 11 movements of a robotic prosthetic hand with almost no training. Knowledge of the relationship between classification accuracy and clinical parameters adds new information regarding the nature of phantom limb pain as well as other clinical parameters, and it can lay the foundations for future "functional amputation" procedures in surgery.

Preliminary comparison of the endoscopic transnasal vs the sublabial transseptal approach for clinically nonfunctioning pituitary macroadenomas.

Science.gov (United States)

Sheehan, M T; Atkinson, J L; Kasperbauer, J L; Erickson, B J; Nippoldt, T B

1999-07-01

To assess the advantages and disadvantages of an endoscopic transnasal approach to pituitary surgery for a select group of clinically nonfunctioning macroadenomas and to compare results of this approach with the sublabial transseptal approach at a single institution. We retrospectively reviewed the records of 26 patients with clinically nonfunctioning pituitary macroadenomas approached endoscopically and 44 matched control patients with the same tumors approached sublabially between January 1, 1995, and October 31, 1997. At baseline, the groups were not significantly different for age, sex distribution, number of comorbid conditions, visual field defects, degree of anterior pituitary insufficiency, or preoperative assessment of tumor volume or invasiveness. Mean (SD) operative times were significantly reduced in the endoscopic group vs the sublabial group: 2.7 (0.7) hours vs 3.4 (0.9) hours (P working channel to the sella turcica. For these reasons, the endoscopic approach or its variation is an alternative to the sublabial approach but should be considered only by experienced pituitary neurosurgeons.

Setup of a novel biofeedback prototype for sensorimotor control of the hand and preliminary application in patients with peripheral nerve injuries.

Science.gov (United States)

Chiu, Haw-Yen; Hsu, Hsiu-Yun; Su, Fong-Chin; Jou, I-Ming; Lin, Cheng-Feng; Kuo, Li-Chieh

2013-02-01

Biofeedback training is widely used for rehabilitative intervention in patients with central or peripheral nervous impairment to train correct movement patterns; however, no biofeedback apparatus is currently available to correct pinch force ratios for patients with sensory deficiencies. A cross-sectional and longitudinal design was used in an observational measurement study for establishing a prototype and to determine the effects of biofeedback intervention, respectively. This study aimed to develop a computerized evaluation and re-education biofeedback (CERB) prototype for application in clinical settings. A CERB prototype was developed integrating pinch apparatus hardware, a biofeedback user-controlled interface, and a data processing/analysis interface to detect momentary pinch performances in 79 people with normal hand sensation. Nine patients with hand sensory impairments were recruited to investigate the effects of training hand function with the CERB prototype. Hand dominance, pinch pattern, and age significantly affected the peak pinch force and force ratio for lifting a 480-g object with a steel surface. In the case of the 79 volunteers with normal hand sensation, hand dominance affected the time lag between peak pinch force and maximum load; however, it was unaffected by pinch pattern or age. Training with the CERB prototype produced significant improvements in force ratio and better performance in the pin insertion subtests, although the results for both 2-point discriminative and Semmes-Weinstein monofilament tests did not change significantly. The intervention findings are preliminary. This study developed a conjunct system suited for evaluating and restoring sensorimotor function for patients with impaired hand sensibility. The results from the participants with normal hand sensation could serve as a reference database for comparison with patients with nerve injuries.

The use of placebo control in clinical trials: An overview of the ...

African Journals Online (AJOL)

The use of placebo control in clinical trials: An overview of the ethical issues involved for the protection of human research participants. ... A placebo looks exactly like the experimental drugs in every respect both in appearance and wrappings ...

Functional requirements regarding medical registries--preliminary results.

Science.gov (United States)

Oberbichler, Stefan; Hörbst, Alexander

2013-01-01

The term medical registry is used to reference tools and processes to support clinical or epidemiologic research or provide a data basis for decisions regarding health care policies. In spite of this wide range of applications the term registry and the functional requirements which a registry should support are not clearly defined. This work presents preliminary results of a literature review to discover functional requirements which form a registry. To extract these requirements a set of peer reviewed articles was collected. These set of articles was screened by using methods from qualitative research. Up to now most discovered functional requirements focus on data quality (e. g. prevent transcription error by conducting automatic domain checks).

Implementation of Quality Control Protocol in Mammography: A Serbian Experience

International Nuclear Information System (INIS)

Ciraj Bjelac, O.; Kosutic, D.; Arandjic, D.; Kovacevic, M.

2008-01-01

Mammography is method of choice for early detection of breast cancer. In Serbia, mammography is performed only clinically, although there is a long term plan to introduce mammography as screening method. Currently there are 60 mammography units in practice in Serbia, resulting with 70 000 mammographies annually. The purpose of this paper is preliminary evaluation of the mammography practice in Serbia, having in mind the annual number of examinations and fact that part of examination is performed on women without any clinical signs. For pilot implementation of Quality Control (QC) protocol in mammography, five hospitals with highest workload have been selected, representing the typical mammography practice in Serbia. Developed QC protocol, based on European guidelines for quality assurance in breast cancer screening and diagnosis, actual practice and resources, includes equipment testing and maintenance, staff training and QC management and allocation of responsibilities. Subsequently, it should be applied on the national scale. The survey demonstrated considerable variations in technical parameters that affect image quality and patients doses. Mean glandular doses ranged from 0.12 to 2.8 mGy, while reference optical density ranged from 1.2 to 2.8. Main problems were associated with film processing, viewing conditions and optical density control. The preliminary survey of mammography practice highlighted the need for optimization of radiation protection and training of operating staff, although the survey itself was very valuable learning process for all participants. Furthermore, systematic implementation of QC protocol should provide reliable performance of mammography units and maintain satisfactory image quality and keep patient doses as low as reasonably practical.(author)

Controlled outcome studies of child clinical hypnosis.

Science.gov (United States)

Adinolfi, Barbara; Gava, Nicoletta

2013-09-01

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

Phytotoxicity Study on Bidens sulphurea Sch. Bip. as a Preliminary Approach for Weed Control.

Science.gov (United States)

da Silva, Bruna P; Nepomuceno, Mariluce P; Varela, Rosa M; Torres, Ascensión; Molinillo, José M G; Alves, Pedro L C A; Macías, Francisco A

2017-06-28

Farmers of the Franca region in Brazil observed that Bidens sulphurea was able to eliminate the Panicum maximum weed, which infected coffee plantations, without affecting the crop. In an effort to determine if the inhibitory effects observed were due to the presence of phytotoxic compounds from leaves and roots, a biodirected isolation and spectroscopic characterization has been carried out. The leaf dichloromethane and root acetone extracts were the most active, and the former appeared to be more phytotoxic to the target species, including four weeds. A total of 26 compounds were isolated from leaves and roots, and four of them are described here for the first time. The major compounds in the leaf extract are the sesquiterpene lactones costunolide, reynosin, and santamarine, and these showed marked inhibition. Amaranthus viridis and Panicum maximum were the most sensitive species of the weeds tested. These three phytotoxic lactones were also evaluated on A. viridis and P. maximum under hydroponic conditions. A. viridis was the most affected species with the three lactones, and santamarine was the most phytotoxic compound on both. This is the first time that the phytotoxicity of sesquiterpene lactones has been evaluated on hydroponic culture. The work described here is a preliminary approach for the use of B. sulphurea for weed control in agriculture, both as a cover crop and by use of its components as natural herbicide leads.

Randomized Clinical Trial of Lansoprazole for Poorly Controlled Asthma in Children

Science.gov (United States)

Holbrook, Janet T.; Wise, Robert A.; Gold, Benjamin D.; Blake, Kathryn; Brown, Ellen D.; Castro, Mario; Dozor, Allen J.; Lima, John; Mastronarde, John G.; Sockrider, Marianna; Teague, W. Gerald

2013-01-01

Context Asymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. It is not known whether treatment of GER with a proton-pump inhibitor (PPI) improves asthma control. Objective To determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER. Design, Setting, and Patients A multicenter, randomized, masked, placebo controlled, parallel clinical trial comparing lansoprazole to placebo in children with poor asthma control on inhaled corticosteroid treatment conducted at 18 academic clinical centers. Participants were followed for 24 weeks. A subgroup had an esophageal pH study before randomization. Intervention Children received either lansoprazole (15 mg daily lansoprazole and placebo groups, respectively (P=0.12). There were no detectable treatment differences in secondary outcomes (mean (95% CI) for FEV1(0.00 (−0.08, 0.08)), asthma quality of life (−0.1 (−0.4, 0.1) or episodes of poor asthma control, hazard ratio of 1.18 (95% CI 0.91, 1.53). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole versus placebo was observed for any asthma outcome. Children treated with lansoprazole reported more upper respiratory infections (63% vs 49%, P=0.02), sore throats (52% vs 39%, P=0.02), and bronchitis (7% vs 2%, P=0.05). Conclusion Among children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, as compared to placebo, did not improve symptoms nor lung function but was associated with increased adverse events. PMID:22274684

28 CFR 2.48 - Revocation: Preliminary interview.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Revocation: Preliminary interview. 2.48....48 Revocation: Preliminary interview. (a) Interviewing officer. A parolee who is retaken on a warrant issued by a Commissioner shall be given a preliminary interview by an official designated by the Regional...

Quality of Control of Clinical-Biochemical Laboratories – Serbian Case

Directory of Open Access Journals (Sweden)

Vinko Peric

2014-06-01

Full Text Available In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories.

Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.

Science.gov (United States)

Gillick, Bernadette T; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E

2015-03-01

Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. The study was conducted in a university pediatric research laboratory. Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Adverse events/safety assessment and hand function were measured. Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. A limitation of the study was the small sample size, with data available for 11 participants. Based on the results of this study, tDCS appears to be safe

Preliminary clinical application of dopamine transporter imaging with technetium-99m TRODAT-1 and SPECT on the early and differential diagnosis of Parkinson's disease

International Nuclear Information System (INIS)

Wang Feng; Wang Zizheng; Liu Zengli; Tang Jun; Wu Jinchang; Luo Weifeng

2002-01-01

The aim of the study was to demonstrate the degeneration of the dopaminergic nigrostriatal pathway in Parkinson's disease (PD) and Essential Tremor (ET) by using the cocaine derivative 99m Tc-TRODAT-1 SPECT and correlate the findings to the clinical severities (Hoehn and Yahr scale, H/Y). 28 patients with idiopathic Parkinson's disease, 10 patients with Essential Tremor and 19 healthy volunteers were investigated. The acquisition were performed 3 h postinjection of 99m Tc-TRODAT-1, ROIs were drawn over the images of striatum and cerebellum, and ratios of striatum to cerebellar (ST/CB) were calculated. Ratios differed significantly between PD and controls, but ratios did not show significant difference between ET patients and controls. A significant correlation did not exist between ratios and clinical severities. Hemiparkinson's patients revealed significantly diminished 99m Tc-TRODAT-1 binding not only clinically affected but unaffected side. Our findings indicated that 99m Tc-TRODAT-1 SPECT is not only a reliable method to discriminate between PD and controls but also a useful tool for differential diagnosis in clinically unclear cases such as ET resembling PD

CSF flow image using phase-contrast cine MR technique : preliminary clinical application

International Nuclear Information System (INIS)

Kim, Hyae Young; Choi, Hye Young; Baek, Seung Yeon; Lee, Sun Wha; Ko, Eun Joo; Lee, Myung Sook

1997-01-01

To evaluate the clinical usefulness of 2-D Cine PC (phase contrast) technique in visualizing the pattern and the site of abnormal CSF flow and to assess the effect of a third ventriculostomy in patients with hydrocephalus. The study group consisted of three normal controls and 13 patients with hydrocephalus, as shown on CT or MRI, and two patients who had undergone their third ventriculostomy. The technique was EKG-gated 2-D Cine PC MRI with velocity encoding 5cm/sec, TR 80msec, TE 12.3-15msec, and flip angle 15-60 degrees. Image quality was analyzed for variable sequences, and CSF flow was observed along the CSF flow pathway. We analyzed continuity and intensity of the CSF flow signal, and obstruction site and flow velocity degree were then defined. Systolic high and diastolic low signal intensity along the CSF flow-pathway, with normal asynchronicity and continuation, were clearly seen in normal controls. In three patients, there was obstruction at the ventricular level while others were either normal or showed a normal pattern with a weak signal. 'Normal' was defined as noncommunicating hydrocephalus and the latter as communicating hydrocephalus. In the two patients who had undergone ventriculostomy, a signal was in one case detected at the site of the third operation. A 2-D Cine PC CSF flow study enables us to see CSF flow signals noninvasively and to detect the site of obstruction of a CSF flow-pathway. It can therefore it can be useful for determining the application of a ventriculoperitoneal shunt and assessing the effect of a third ventriculostomy

77 FR 24985 - Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI)

Science.gov (United States)

2012-04-26

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI) Pursuant to 21 U.S.C. 958(i), the Attorney General shall... on March 5, 2012, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964...

Knowledge and use of the internet as a source of controlled substances.

Science.gov (United States)

M Gordon, Susan; Forman, Robert F; Siatkowski, Candis

2006-04-01

Despite growing evidence that the internet is a source of controlled substances for nonmedical use, there is a lack of information about who is using it to obtain these drugs. One hundred adult drug-dependent inpatients in a private residential treatment program participated in a semistructured interview regarding how they obtained their drugs. Twenty-nine percent reported knowledge of the internet as a source of drugs, and 11% reported that they had used the internet to either buy drugs or locate a drug dealer. The results of this preliminary study suggest that the internet has become a source of controlled substances for some addicted individuals. Considerations for future research and clinical practice are described.

On Preliminary Test Estimator for Median

OpenAIRE

Okazaki, Takeo; 岡崎, 威生

1990-01-01

The purpose of the present paper is to discuss about estimation of median with a preliminary test. Two procedures are presented, one uses Median test and the other uses Wilcoxon two-sample test for the preliminary test. Sections 3 and 4 give mathematical formulations of such properties, including mean square errors with one specified case. Section 5 discusses their optimal significance levels of the preliminary test and proposes their numerical values by Monte Carlo method. In addition to mea...

Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application (2017

Directory of Open Access Journals (Sweden)

Ao Q

2017-12-01

Full Text Available Qiang Ao,1,* Juan Xiao,2,3,* Yanqiu Yu,4 Gengsheng Mao,2 Qingyan Zou,5 Wenyong Gao,2,3 Hongyun Huang2,3 On behalf of Neurorestoratology Professional Committee of Chinese Medical Doctor Association (Chinese Association of Neurorestoratology 1Department of Tissue Engineering, China Medical University, Shen Yang, 2Institute of Neurorestoratology, General Hospital of Armed Police Forces, Beijing, 3Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, 4Department of Pathophysiology, China Medical University, Shen Yang, 5Guangdong 999 Brain Hospital, Guangzhou, People’s Republic of China *These authors contributed equally to this work Abstract: Formulating common standards for the culture and quality control of umbilical cord mesenchymal stromal cells (MSCs is crucial for the standardization of clinical neurorestorative therapy. But to date, there have been no standardized guidelines for the culture and quality control of MSCs in neurorestorative clinical application. Based on a relatively comprehensive review of published clinical studies as well as the existing methods of MSC culture and quality control, the Chinese Association of Neurorestoratology has developed standards for the culture and quality control of umbilical cord MSCs which possess the potential in neurorestorative clinical application. These guidelines include standardized training and management procedures for laboratory operators; standardized use and management of materials and equipment; standardized collection, culture and proliferation of umbilical cord MSCs; standardized management for cell preservation, transport and related safeguard measures; as well as standardization of a clean environment, routine maintenance and related tests and examinations and so on. These guidelines represent the minimum required standards for the culture and quality control of umbilical cord MSCs for potential use in current neurorestorative clinical therapy, and will be further

A controlled clinical trial of implantretained mandibular overdentures : 10 years’ results of clinical aspects and aftercare of IMZ implants and Bra°nemark implants

NARCIS (Netherlands)

Meijer, Henny J.A.; Raghoebar, Gerry M.; Van’t Hof, Martin A.; Visser, Anita

2004-01-01

The aim of this prospective randomized controlled clinical trial was to evaluate the clinical outcomes and prosthetic aftercare of edentulous patients with a mandibular overdenture retained by two IMZ implants or two Bra°nemark implants during a 10-year period. Patients were allocated to the IMZ

Design of clinical trials involving multiple hypothesis tests with a common control.

Science.gov (United States)

Schou, I Manjula; Marschner, Ian C

2017-07-01

Randomized clinical trials comparing several treatments to a common control are often reported in the medical literature. For example, multiple experimental treatments may be compared with placebo, or in combination therapy trials, a combination therapy may be compared with each of its constituent monotherapies. Such trials are typically designed using a balanced approach in which equal numbers of individuals are randomized to each arm, however, this can result in an inefficient use of resources. We provide a unified framework and new theoretical results for optimal design of such single-control multiple-comparator studies. We consider variance optimal designs based on D-, A-, and E-optimality criteria, using a general model that allows for heteroscedasticity and a range of effect measures that include both continuous and binary outcomes. We demonstrate the sensitivity of these designs to the type of optimality criterion by showing that the optimal allocation ratios are systematically ordered according to the optimality criterion. Given this sensitivity to the optimality criterion, we argue that power optimality is a more suitable approach when designing clinical trials where testing is the objective. Weighted variance optimal designs are also discussed, which, like power optimal designs, allow the treatment difference to play a major role in determining allocation ratios. We illustrate our methods using two real clinical trial examples taken from the medical literature. Some recommendations on the use of optimal designs in single-control multiple-comparator trials are also provided. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Preliminary experience of shared clinical management between Milan and Pointe Noire using the INteractive TeleConsultation Network for Worldwide HealthcAre Services (INCAS): telemedicine between Milan and Africa.

Science.gov (United States)

Malacarne, Mara; Lesma, Alessandro; Madera, Angelo; Malfatti, Eugenio; Castelli, Alberto; Lucini, Daniela; Pizzinelli, Paolo; Pagani, Massimo

2004-01-01

This paper describes preliminary experience in shared clinical management of patients located in Pointe Noire, Africa, and a referral center, Sacco University Hospital, located in Milan, Italy. The employed infrastructure INteractive TeleConsultation Network for Worldwide HealthcAre Services (INCAS) jointly developed by CEFRIEL (Center of Excellence For Research, Innovation, Education & Industrial Labs partnership) and ENI (Ente Nazionale Idrocarburi) is based on commercial off-the-shelf technology. This minimizes maintenance problems, while permitting a simple and friendly sharing of data using the telephone and e-mail for store-and-forward applications. The critical aspect of the flow of events comprising the exchange of information is discussed. In 60% of cases, only one telemedicine consultation was required. In the remainder 40%, a number of telemedicine consultations were required for appropriate management of clinical cases. The project demonstrated flexibility as documented by the wide range of pathologies that can be dealt with it. Finally the possibility of using shared clinical management as a learning tool is highlighted by the steep and rising learning curve. We conclude, however, that the patient, although handled in a "virtual" manner, should be viewed as very "real," as some of them elected to close the gap physically between Pointe Noire and Milan, and chose to be treated at the referral site.

Novel hyperthermia applicator system allows adaptive treatment planning: Preliminary clinical results in tumour-bearing animals.

Science.gov (United States)

Dressel, S; Gosselin, M-C; Capstick, M H; Carrasco, E; Weyland, M S; Scheidegger, S; Neufeld, E; Kuster, N; Bodis, S; Rohrer Bley, C

2017-09-11

Hyperthermia (HT) as an adjuvant to radiation therapy (RT) is a multimodality treatment method to enhance therapeutic efficacy in different tumours. High demands are placed on the hardware and treatment planning software to guarantee adequately planned and applied HT treatments. The aim of this prospective study was to determine the effectiveness and safety of the novel HT system in tumour-bearing dogs and cats in terms of local response and toxicity as well as to compare planned with actual achieved data during heating. A novel applicator with a flexible number of elements and integrated closed-loop temperature feedback control system, and a tool for patient-specific treatment planning were used in a combined thermoradiotherapy protocol. Good agreement between predictions from planning and clinical outcome was found in 7 of 8 cases. Effective HT treatments were planned and verified with the novel system and provided improved quality of life in all but 1 patient. This individualized treatment planning and controlled heat exposure allows adaptive, flexible and safe HT treatments in palliatively treated animal patients. © 2017 John Wiley & Sons Ltd.

78 FR 23594 - Importer of Controlled Substances, Notice of Application, Almac Clinical Services, Inc., (ACSI)

Science.gov (United States)

2013-04-19

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances, Notice of Application, Almac Clinical Services, Inc., (ACSI) Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on March 5, 2013, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton...

Preliminary Design of Aerial Spraying System for Microlight Aircraft

Science.gov (United States)

Omar, Zamri; Idris, Nurfazliawati; Rahim, M. Zulafif

2017-10-01

Undoubtedly agricultural is an important sector because it provides essential nutrients for human, and consequently is among the biggest sector for economic growth worldwide. It is crucial to ensure crops production is protected from any plant diseases and pests. Thus aerial spraying system on crops is developed to facilitate farmers to for crops pests control and it is very effective spraying method especially for large and hilly crop areas. However, the use of large aircraft for aerial spaying has a relatively high operational cost. Therefore, microlight aircraft is proposed to be used for crops aerial spraying works for several good reasons. In this paper, a preliminary design of aerial spraying system for microlight aircraft is proposed. Engineering design methodology is adopted in the development of the aerial sprayer and steps involved design are discussed thoroughly. A preliminary design for the microlight to be attached with an aerial spraying system is proposed.

Iron in hereditary retinal degeneration: PIXE microanalysis Preliminary results

International Nuclear Information System (INIS)

Sergeant, C.; Gouget, B.; Llabador, Y.; Simonoff, M.; Yefimova, M.; Courtois, Y.; Jeanny, J.C.

1999-01-01

Several types of hereditary retinal degeneration with progressive alteration of photoreceptors exist in men and animals. Recent immunohistochemical results have shown strong degradation of transferrin, the protein responsible for iron transport, in retinas of rats with hereditary retinal degeneration. Freeze-dried thin sections of rat retinas from different stages of the disease, and respective coeval control sections, have been analyzed using nuclear microprobe. In this first part of the study, the rat retinas at post-natal stages of 35 and 45 days have been analyzed. The sample preparation and the post-irradiation staining to determine precisely the retinal layers involved are described. Preliminary results of element distributions (K, Ca, Fe) in the rat retina layers are discussed. A very high content of calcium in the choriocapillaris of dystrophic rat retinas was observed. Preliminary results on iron distribution in the rat retina layers are presented

Slow cortical potential Neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial

Directory of Open Access Journals (Sweden)

Hanna eChristiansen

2014-11-01

Full Text Available Background: Treatment for children with attention deficit/hyperactivity disorder (ADHD today is predominantly pharmacological. While it is the most common treatment, it might not always be the most appropriate one. Moreover, long term effects remain unclear. Behavior therapy and non-pharmacological treatments such as neurofeedback (NF are promising alternatives, though there are no routine outpatient care/effectiveness studies yet that have included children with medication or changes in medication.Methods/design: This paper presents the protocol of a randomized controlled trial to compare the effectiveness of a Slow Cortical Potential (SCP NF protocol with self-management (SM in a high frequent outpatient care setting. Both groups (NF/SM receive a total of 30 high frequent therapy sessions. Additionally, 6 sessions are reserved for comorbid problems. The primary outcome measure is the reduction of ADHD core symptoms according to parent and teacher ratings.Preliminary Results: Untill now 58 children were included in the study (48 males, with a mean age of 8.42 (1.34 years, and a mean IQ of 110 (13.37. Conners-3 parent and teacher ratings were used to estimate core symptom change. Since the study is still ongoing, and children are in different study stages, pre-post and follow-up results are not yet available for all children included. Preliminary results suggest overall good pre-post effects, though. For parent and teacher ratings an ANOVA with repeated measures yielded overall satisfying pre-post effects (η2 .175 to .513. Differences between groups (NF vs. SM could not yet be established (p = .81.Discussion: This is the first randomized controlled trial to test the effectiveness of a NF protocol in a high frequent outpatient care setting that does not exclude children on or with changes in medication. First preliminary results show positive effects. The rationale for the trial, the design, and the strengths and limitations of the study are

Can active music-making ameliorate neglect? An assessor-blind, within-subject, controlled clinical trial

DEFF Research Database (Denmark)

Bodak, Rebeka; Mazhari-Jensen, Daniel; Evald, Lars

-aligned instrument from the stroke survivor’s right side into their left neglected space; the control involves playing novel rhythmic patterns on a single drum at midline. We hypothesise that the stroke survivors will perform better after the intervention than after the control on clinical neglect tests......Neglect often manifests following a right hemisphere stroke, and it is a strong predictor of poor rehabilitation outcome. Although many neglect interventions exist, systematic reviews repeatedly highlight that they yield limited clinical effectiveness and that there is little to no evidence of any...... functional gains. Drawing on recent successful case study pilot work, the aim of the present study is to investigate the impact of an active music-making intervention compared with a control. Stroke survivors with a diagnosis of neglect will be invited to participate in an assessor-blind, within...

The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial.

Science.gov (United States)

Miremberg, Hadas; Ben-Ari, Tal; Betzer, Tal; Raphaeli, Hagit; Gasnier, Rose; Barda, Giulia; Bar, Jacob; Weiner, Eran

2018-04-01

Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients. We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction. This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements. A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and

Implementing self sustained quality control procedures in a clinical laboratory.

Science.gov (United States)

Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

2013-01-01

Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

The innovative viscoelastic CP ESP cervical disk prosthesis with six degrees of freedom: biomechanical concepts, development program and preliminary clinical experience.

Science.gov (United States)

Lazennec, Jean-Yves; Aaron, Alain; Ricart, Olivier; Rakover, Jean Patrick

2016-01-01

The viscoelastic cervical disk prosthesis ESP is an innovative one-piece deformable but cohesive interbody spacer. It is an evolution of the LP ESP lumbar disk implanted since 2006. CP ESP provides six full degrees of freedom about the three axes including shock absorbtion. The prosthesis geometry allows limited rotation and translation with resistance to motion (elastic return property) aimed at avoiding overload of the posterior facets. The rotation center can vary freely during motion. The concept of the ESP prosthesis is fundamentally different from that of the devices currently used in the cervical spine. The originality of the concept of the ESP® prosthesis led to innovative and intense testing to validate the adhesion of the viscoelastic component of the disk on the titanium endplates and to assess the mechanical properties of the PCU cushion. The preliminary clinical and radiological results with 2-year follow-up are encouraging for pain, function and kinematic behavior (range of motion and evolution of the mean centers of rotation). In this series, we did not observe device-related specific complications, misalignment, instability or ossifications. Additional studies and longer patient follow-up are needed to assess long-term reliability of this innovative implant.

ChronQC: a quality control monitoring system for clinical next generation sequencing.

Science.gov (United States)

Tawari, Nilesh R; Seow, Justine Jia Wen; Perumal, Dharuman; Ow, Jack L; Ang, Shimin; Devasia, Arun George; Ng, Pauline C

2018-05-15

ChronQC is a quality control (QC) tracking system for clinical implementation of next-generation sequencing (NGS). ChronQC generates time series plots for various QC metrics to allow comparison of current runs to historical runs. ChronQC has multiple features for tracking QC data including Westgard rules for clinical validity, laboratory-defined thresholds and historical observations within a specified time period. Users can record their notes and corrective actions directly onto the plots for long-term recordkeeping. ChronQC facilitates regular monitoring of clinical NGS to enable adherence to high quality clinical standards. ChronQC is freely available on GitHub (https://github.com/nilesh-tawari/ChronQC), Docker (https://hub.docker.com/r/nileshtawari/chronqc/) and the Python Package Index. ChronQC is implemented in Python and runs on all common operating systems (Windows, Linux and Mac OS X). tawari.nilesh@gmail.com or pauline.c.ng@gmail.com. Supplementary data are available at Bioinformatics online.

Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case–control study in the UK

Science.gov (United States)

Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

2014-01-01

Objective Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the UK in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. Design A prospective multicentre case–control study was conducted at six UK hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Methods Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Results Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. Conclusions This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. PMID:24687130

Preliminary results of a national quality audit programme in radiotherapy services in Cuba

International Nuclear Information System (INIS)

Dominguez Hung, L.; Larrinaga Cortina, E.F.; Campa Menendez, R.; Morales Lopez, J.L.; Garcia Yip, A.F.

2001-01-01

The current state of radiotherapy in Cuba has allowed to pass to a superior stage in the process of quality assurance, the establishment of a National Quality Audit Program (PNAC). The National Control Center for Medical Devices, as national regulator entity for the control and supervision of the medical devices of the National Health System, is responsible for the implementation of this program. This paper presents the preliminary results of the execution of the PNAC in teletherapy services with isotopic units of 60 Co. The audits were carried out according to the methodology settled down in the normalized procedure of operation of the PNAC. The physical aspects related with the treatment were audited, such as: the installation and unit's safety, mechanical and dosimetric aspects of the treatment unit and organizational aspects of the institution quality assurance program. Also carried out, in the clinical aspect, verifications of cases type planned by the qualified personnel of the service. The results corresponding to the determination of the reference dose for each institution were compared with those obtained in a postal audit with the International Atomic Energy Agency. These first audits allowed to evaluate the performance of the institutions' program of quality assurance and a feedback for the setting about to the PNAC. (author)

Preliminary results of a national quality audit programme in radiotherapy services in Cuba

Energy Technology Data Exchange (ETDEWEB)

Dominguez Hung, L; Larrinaga Cortina, E F [Centro de Control Estatal de Equipos Medicos, Havana (Cuba); Campa Menendez, R [Centro de Proteccion e Higiene de las Radiaciones, Havana (Cuba); Morales Lopez, J L; Garcia Yip, A F [Instituto Nacional de Oncologia y Radiobiologia, Havana (Cuba)

2001-03-01

The current state of radiotherapy in Cuba has allowed to pass to a superior stage in the process of quality assurance, the establishment of a National Quality Audit Program (PNAC). The National Control Center for Medical Devices, as national regulator entity for the control and supervision of the medical devices of the National Health System, is responsible for the implementation of this program. This paper presents the preliminary results of the execution of the PNAC in teletherapy services with isotopic units of {sup 60}Co. The audits were carried out according to the methodology settled down in the normalized procedure of operation of the PNAC. The physical aspects related with the treatment were audited, such as: the installation and unit's safety, mechanical and dosimetric aspects of the treatment unit and organizational aspects of the institution quality assurance program. Also carried out, in the clinical aspect, verifications of cases type planned by the qualified personnel of the service. The results corresponding to the determination of the reference dose for each institution were compared with those obtained in a postal audit with the International Atomic Energy Agency. These first audits allowed to evaluate the performance of the institutions' program of quality assurance and a feedback for the setting about to the PNAC. (author)

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

Science.gov (United States)

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

Parenting clinically anxious versus healthy control children aged 4-12 years.

Science.gov (United States)

van der Sluis, C M; van Steensel, F J A; Bögels, S M

2015-05-01

This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to assess parenting behaviors in for children hypothetically anxious situations. Results showed that parents of clinically anxious children reported more anxiety-enhancing parenting (reinforcement of dependency and punishment) as well as more positive parenting (positive reinforcement). For the clinical sample, fathers reported using more modeling/reassurance than mothers, and parents reported using more force with their 4-7-year-olds than with their 8-12-year-olds. No interaction effects were found for child gender with child anxiety status on parenting. Results indicate that for intervention, it is important to measure parenting behaviors, and to take into account father and mother differences and the age of the child. Copyright © 2015 Elsevier Ltd. All rights reserved.

Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters

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Carolina L. Haass-Koffler

2017-12-01

Full Text Available The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled “Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers” (Haass-Koffler et al., 2017 [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73. Keywords: Glutamate receptor subtype 5 (mGlu5, Allosteric modulator, GET 73, Safety, Tolerability

Control of muscle relaxation during anesthesia: a novel approach for clinical routine.

Science.gov (United States)

Stadler, Konrad S; Schumacher, Peter M; Hirter, Sibylle; Leibundgut, Daniel; Bouillon, Thomas W; Glattfelder, Adolf H; Zbinden, Alex M

2006-03-01

During general anesthesia drugs are administered to provide hypnosis, ensure analgesia, and skeletal muscle relaxation. In this paper, the main components of a newly developed controller for skeletal muscle relaxation are described. Muscle relaxation is controlled by administration of neuromuscular blocking agents. The degree of relaxation is assessed by supramaximal train-of-four stimulation of the ulnar nerve and measuring the electromyogram response of the adductor pollicis muscle. For closed-loop control purposes, a physiologically based pharmacokinetic and pharmacodynamic model of the neuromuscular blocking agent mivacurium is derived. The model is used to design an observer-based state feedback controller. Contrary to similar automatic systems described in the literature this controller makes use of two different measures obtained in the train-of-four measurement to maintain the desired level of relaxation. The controller is validated in a clinical study comparing the performance of the controller to the performance of the anesthesiologist. As presented, the controller was able to maintain a preselected degree of muscle relaxation with excellent precision while minimizing drug administration. The controller performed at least equally well as the anesthesiologist.

KALIMER fuel system preliminary design description

International Nuclear Information System (INIS)

Hwang, Woan; Lee, B.O.; Nam, C.; Paek, S.K.

1998-10-01

This document provides general design concepts, design basis, preliminary design specification and design technologies which are needed for designing the fuel/non-fuel rods and assembly ducts of the KALIMER fuel system. The core of LMFBR consists of driver fuel assembly, blanket assembly, reflector assembly, shielding assembly, control assembly and GEM (Gas Expansion Module) as well as USS, dummy assembly, detector assembly. These core components must be designed to withstand the high temperature, high flux for a long irradiation exposure time. Due to the high temperature and high flux, irradiation creep and swelling as well as thermal-mechanical deformation are occurred at the fuel/non-fuel system and cause the deformations of materials and the geometric deflections at fuel/non-fuel rods, assembly ducts and components. In order to overcome these intricate phenomena through the engineering design, the design basis including theoretical analysis methodologies and design considerations, material characteristics of fuel system, and the specifications and drawings of fuel/non-fuel rods and assembly ducts, respectively, are presented. This document is preliminary design description which is produced in the conceptual design stage, and does not present the detailed and finalized design data which can be for the manufacturing. (author). 22 refs

Design of a multi-arm randomized clinical trial with no control arm.

Science.gov (United States)

Magaret, Amalia; Angus, Derek C; Adhikari, Neill K J; Banura, Patrick; Kissoon, Niranjan; Lawler, James V; Jacob, Shevin T

2016-01-01

Clinical trial designs that include multiple treatments are currently limited to those that perform pairwise comparisons of each investigational treatment to a single control. However, there are settings, such as the recent Ebola outbreak, in which no treatment has been demonstrated to be effective; and therefore, no standard of care exists which would serve as an appropriate control. For illustrative purposes, we focused on the care of patients presenting in austere settings with critically ill 'sepsis-like' syndromes. Our approach involves a novel algorithm for comparing mortality among arms without requiring a single fixed control. The algorithm allows poorly-performing arms to be dropped during interim analyses. Consequently, the study may be completed earlier than planned. We used simulation to determine operating characteristics for the trial and to estimate the required sample size. We present a potential study design targeting a minimal effect size of a 23% relative reduction in mortality between any pair of arms. Using estimated power and spurious significance rates from the simulated scenarios, we show that such a trial would require 2550 participants. Over a range of scenarios, our study has 80 to 99% power to select the optimal treatment. Using a fixed control design, if the control arm is least efficacious, 640 subjects would be enrolled into the least efficacious arm, while our algorithm would enroll between 170 and 430. This simulation method can be easily extended to other settings or other binary outcomes. Early dropping of arms is efficient and ethical when conducting clinical trials with multiple arms. Copyright © 2015 Elsevier Inc. All rights reserved.

Laryngeal electromyography in movement disorders: preliminary data

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Kimaid Paulo A.T.

2004-01-01

Full Text Available This study describes preliminary laryngeal electromyography (LEMG data and botulinum toxin treatment in patients with dysphonia due to movement disorders. Twenty-five patients who had been clinically selected for botulinum toxin administration were examined, 19 with suspected laryngeal dystonia or spasmodic dysphonia (SD, 5 with vocal tremor, and 1 with Gilles de la Tourette syndrome (GTS. LEMG evaluations were performed before botulinum toxin administration using monopolar electrodes. Electromyography was consistent with dystonia in 14 patients and normal in 5, and differences in frequency suggesting essential tremor in 3 and Parkinson tremors in 2. The different LEMG patterns and significant improvement in our patients from botulinum toxin therapy has led us to perform laryngeal electromyography as a routine in UNICAMP movement disorders ambulatory.

Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

Science.gov (United States)

2017-07-27

The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

Effects of anodal transcranial direct current stimulation combined with virtual reality for improving gait in children with spastic diparetic cerebral palsy: a pilot, randomized, controlled, double-blind, clinical trial.

Science.gov (United States)

Collange Grecco, Luanda André; de Almeida Carvalho Duarte, Natália; Mendonça, Mariana E; Galli, Manuela; Fregni, Felipe; Oliveira, Claudia Santos

2015-12-01

To compare the effects of anodal vs. sham transcranial direct current stimulation combined with virtual reality training for improving gait in children with cerebral palsy. A pilot, randomized, controlled, double-blind, clinical trial. Rehabilitation clinics. A total of 20 children with diparesis owing to cerebral palsy. The experimental group received anodal stimulation and the control group received sham stimulation over the primary motor cortex during virtual reality training. All patients underwent the same training programme involving a virtual reality (10 sessions). Evaluations were performed before and after the intervention as well as at the one-month follow-up and involved gait analysis, the Gross Motor Function Measure, the Pediatric Evaluation Disability Inventory and the determination of motor evoked potentials. The experimental group had a better performance regarding gait velocity (experimental group: 0.63 ±0.17 to 0.85 ±0.11 m/s; control group: 0.73 ±0.15 to 0.61 ±0.15 m/s), cadence (experimental group: 97.4 ±14.1 to 116.8 ±8.7 steps/minute; control group: 92.6 ±10.4 to 99.7 ±9.7 steps/minute), gross motor function (dimension D experimental group: 59.7 ±12.8 to 74.9 ±13.8; control group: 58.9 ±10.4 to 69.4 ±9.3; dimension E experimental group: 59.0 ±10.9 to 79.1 ±8.5; control group: 60.3 ±10.1 to 67.4 ±11.4) and independent mobility (experimental group: 34.3 ±5.9 to 43.8 ±75.3; control group: 34.4 ±8.3 to 37.7 ±7.7). Moreover, transcranial direct current stimulation led to a significant increase in motor evoked potential (experimental group: 1.4 ±0.7 to 2.6 ±0.4; control group: 1.3 ±0.6 to 1.6 ±0.4). These preliminary findings support the hypothesis that anodal transcranial direct current stimulation combined with virtual reality training could be a useful tool for improving gait in children with cerebral palsy. © The Author(s) 2015.

TU-F-18A-01: Preliminary Results of a Prototype Quality Control Process for Spectral CT

International Nuclear Information System (INIS)

Nute, J; Jacobsen, M; Pennington, J; Cody, D; Chandler, A; Imai, Y; Baiu, C

2014-01-01

Purpose: A prototype quality control (QC) phantom and analysis process has been designed specifically to monitor dual-energy CT and address the current lack of quantitative oversight of the spectral capabilities of these scanners. Methods: A prototype solid water phantom was designed with multiple material inserts, and to support both head and body protocols. Inserts included tissue equivalent and material rods (iodine, iron, calcium) at various concentrations. The oval body phantom, measuring 30cm×40cm×15cm, was scanned using four dual-energy protocols with CTDIvol ranges of 19.6–62mGy (0.516 pitch) and 10.3–32.5mGy (0.984 pitch), and rotation times ranging from 0.5-1sec. The circular head phantom, measuring 22cm in diameter by 15cm, was scanned using three dual-energy protocols with CTDIvol ranges of 67–132.6mGy (0.531 pitch) and 36.7–72.7mGy (0.969 pitch), and rotation times ranging from 0.5–0.9sec. All images were reconstructed at 50, 70, 110 and 140 keV, and using a water-iodine material basis pair. The images were evaluated for iodine quantification accuracy and stability of monoenergetic reconstructions. The phantom was scanned twice on ten GE 750HD CT scanners to evaluate inter-scanner agreement, as well as ten times on a single scanner over a oneweek period to evaluate intra-scanner repeatability. Results: Preliminary analysis revealed consistent (inter- and intra-scanner) iodine quantification accuracy within 10% was only achieved for protocols in the upper half of dose levels assessed when grouped by pitch. Although all scanners undergo rigorous daily single-energy QC, iodine quantification accuracy from one scanner unexpectedly deviated from the other nine substantially. In general, inter-scanner agreement and intra-scanner repeatability varied with dose, rotation time and reconstructed keV. Conclusion: Preliminary results indicate the need for a dual-energy QC process to ensure inter-scanner agreement and intra-scanner repeatability. In

Simple Carotid-Sparing Intensity-Modulated Radiotherapy Technique and Preliminary Experience for T1-2 Glottic Cancer

International Nuclear Information System (INIS)

Rosenthal, David I.; Fuller, Clifton D.; Barker, Jerry L.; Mason, Bryan M.S.; Garcia, John A. C.; Lewin, Jan S.; Holsinger, F. Christopher; Stasney, C. Richard; Frank, Steven J.; Schwartz, David L.; Morrison, William H.; Garden, Adam S.; Ang, K. Kian

2010-01-01

Purpose: To investigate the dosimetry and feasibility of carotid-sparing intensity-modulated radiotherapy (IMRT) for early glottic cancer and to report preliminary clinical experience. Methods and Materials: Digital Imaging and Communications in Medicine radiotherapy (DICOM-RT) datasets from 6 T1-2 conventionally treated glottic cancer patients were used to create both conventional IMRT plans. We developed a simplified IMRT planning algorithm with three fields and limited segments. Conventional and IMRT plans were compared using generalized equivalent uniform dose and dose-volume parameters for in-field carotid arteries, target volumes, and organs at risk. We have treated 11 patients with this simplified IMRT technique. Results: Intensity-modulated radiotherapy consistently reduced radiation dose to the carotid arteries (p < 0.05) while maintaining the clinical target volume coverage. With conventional planning, median carotid V35, V50, and V63 were 100%, 100%, and 69.0%, respectively. With IMRT planning these decreased to 2%, 0%, and 0%, respectively (p < 0.01). Radiation planning and treatment times were similar for conventional radiotherapy and IMRT. Treatment results have been excellent thus far. Conclusions: Intensity-modulated radiotherapy significantly reduced unnecessary radiation dose to the carotid arteries compared with conventional lateral fields while maintaining clinical target volume coverage. Further experience and longer follow-up will be required to demonstrate outcomes for cancer control and carotid artery effects.

Preliminary Results of the Louisiana Sex Offender Treatment Program

OpenAIRE

Lee A. Underwood; Frances L.L. Dailey; Carrie Merino; Yolanda Crump

2015-01-01

The purpose of this study was to offer preliminary support for the Louisiana Sex Offender Treatment Program (LSOTP) in addressing the needs of juvenile sex offenders. Research objectives were (1) to offer statistical evidence for reductions in anxiety, depression, cognitive distortion and negative attitudes towards women comparing a group of 21 adolescents, 12 of whom received services as usual and nine of whom participated in the LSOTP. A controlled experimental evaluation design was utilize...

Prenatal Pregnancy Complications and Psychiatric Symptoms: Children with ASD versus Clinic Controls

Science.gov (United States)

Tudor, Megan E.; DeVincent, Carla J.; Gadow, Kenneth D.

2012-01-01

The current study examined the association between prenatal pregnancy complications (PPC) and childhood psychiatric symptoms in children with an autism spectrum disorder (ASD) and non-ASD children who were referred to a psychiatric clinic (Controls). Parents completed a "DSM-IV"-referenced rating scale and developmental history questionnaire.…

A color spectrographic phonocardiography (CSP applied to the detection and characterization of heart murmurs: preliminary results

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Hassani Kamran

2011-05-01

Full Text Available Abstract Background Although cardiac auscultation remains important to detect abnormal sounds and murmurs indicative of cardiac pathology, the application of electronic methods remains seldom used in everyday clinical practice. In this report we provide preliminary data showing how the phonocardiogram can be analyzed using color spectrographic techniques and discuss how such information may be of future value for noninvasive cardiac monitoring. Methods We digitally recorded the phonocardiogram using a high-speed USB interface and the program Gold Wave http://www.goldwave.com in 55 infants and adults with cardiac structural disease as well as from normal individuals and individuals with innocent murmurs. Color spectrographic analysis of the signal was performed using Spectrogram (Version 16 as a well as custom MATLAB code. Results Our preliminary data is presented as a series of seven cases. Conclusions We expect the application of spectrographic techniques to phonocardiography to grow substantially as ongoing research demonstrates its utility in various clinical settings. Our evaluation of a simple, low-cost phonocardiographic recording and analysis system to assist in determining the characteristic features of heart murmurs shows promise in helping distinguish innocent systolic murmurs from pathological murmurs in children and is expected to useful in other clinical settings as well.

Sexual orientations of women with polycystic ovary syndrome: Clinical observation in Taiwan

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Ching-Hui Chen

2014-12-01

Conclusion: Our preliminary data showed that sexual orientation influenced the BMI of women with PCOS, but did not affect hyperandrogenism-related clinical or biochemical characteristics. This observation requires further confirmation.

Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly

Science.gov (United States)

Christofides, Elena A

2016-01-01

In acromegaly, achieving biochemical control (growth hormone [GH] level acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

Patient Engagement in Randomized Controlled Tai Chi Clinical Trials among the Chronically Ill.

Science.gov (United States)

Jiang, Dongsheng; Kong, Weihong; Jiang, Joanna J

2017-01-01

Physicians encounter various symptom-based complaints each day. While physicians strive to support patients with chronic illnesses, evidence indicates that patients who are actively involved in their health care have better health outcomes and sometimes lowers costs. This article is to analyze how patient engagement is described when complex interventions such as Tai Chi were delivered in Randomized Controlled clinical Trials (RCTs). It reviews the dynamic patient- physician relationship in chronic illness management and to illustrate the patient engagement process, using Tai Chi as an example intervention. RCTs are considered the gold standard in clinical research. This study is a qualitative analysis of RCTs using Tai Chi as an intervention. A systematic literature search was performed to identify quality randomized controlled clinical trials that investigated the effects of Tai Chi. Selected clinical trials were classified according to research design, intervention style, patient engagement, and outcomes. Patient engagement was classified based on levels of patient participation, compliance, and selfmanagement. The chronic health conditions included in this paper are Parkinson's disease, polyneuropathy, hypertension, stroke, chronic insomnia, chronic heart failure, fibromyalgia, osteoarthritis, central obesity, depression, deconditioning in the elderly, or being pre-clinically disabled. We found that patient engagement, as a concept, was not well defined in literature. It covers a wide range of related terms, such as patient involvement, participation, shared decision- making, patient activation, adherence, compliance, and self-management. Tai Chi, as a very complex practice system, is to balance all aspects of a patient's life; however, the level of patient engagement is difficult to describe using conventional clinical trial design. To accurately illustrate the effect of a complex intervention, novel research design must explore ways to measure patient

Fabrication of preliminary fuel rods for SFR

International Nuclear Information System (INIS)

Kim, Sun Ki; Oh, Seok Jin; Ko, Young Mo; Woo, Youn Myung; Kim, Ki Hwan

2012-01-01

Metal fuels was selected for fueling many of the first reactors in the US, including the Experimental Breeder Reactor-I (EBR-I) and the Experimental Breeder Reactor-II (EBR-II) in Idaho, the FERMI-I reactor, and the Dounreay Fast Reactor (DFR) in the UK. Metallic U.Pu.Zr alloys were the reference fuel for the US Integral Fast Reactor (IFR) program. Metallic fuel has advantages such as simple fabrication procedures, good neutron economy, high thermal conductivity, excellent compatibility with a Na coolant and inherent passive safety. U-Zr-Pu alloy fuels have been used for SFR (sodium-cooled fast reactor) related to the closed fuel cycle for managing minor actinides and reducing a high radioactivity levels since the 1980s. Fabrication technology of metallic fuel for SFR has been in development in Korea as a national nuclear R and D program since 2007. For the final goal of SFR fuel rod fabrication with good performance, recently, three preliminary fuel rods were fabricated. In this paper, the preliminary fuel rods were fabricated, and then the inspection for QC(quality control) of the fuel rods was performed

23 CFR 645.109 - Preliminary engineering.

Science.gov (United States)

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Preliminary engineering. 645.109 Section 645.109 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS UTILITIES Utility Relocations, Adjustments, and Reimbursement § 645.109 Preliminary engineering. (a) As...

SUBSURFACE REPOSITORY INTEGRATED CONTROL SYSTEM DESIGN

International Nuclear Information System (INIS)

Randle, D.C.

2000-01-01

The primary purpose of this document is to develop a preliminary high-level functional and physical control system architecture for the potential repository at Yucca Mountain. This document outlines an overall control system concept that encompasses and integrates the many diverse process and communication systems being developed for the subsurface repository design. This document presents integrated design concepts for monitoring and controlling the diverse set of subsurface operations. The Subsurface Repository Integrated Control System design will be composed of a series of diverse process systems and communication networks. The subsurface repository design contains many systems related to instrumentation and control (I andC) for both repository development and waste emplacement operations. These systems include waste emplacement, waste retrieval, ventilation, radiological and air monitoring, rail transportation, construction development, utility systems (electrical, lighting, water, compressed air, etc.), fire protection, backfill emplacement, and performance confirmation. Each of these systems involves some level of I andC and will typically be integrated over a data communications network throughout the subsurface facility. The subsurface I andC systems will also interface with multiple surface-based systems such as site operations, rail transportation, security and safeguards, and electrical/piped utilities. In addition to the I andC systems, the subsurface repository design also contains systems related to voice and video communications. The components for each of these systems will be distributed and linked over voice and video communication networks throughout the subsurface facility. The scope and primary objectives of this design analysis are to: (1) Identify preliminary system-level functions and interfaces (Section 6.2). (2) Examine the overall system complexity and determine how and on what levels the engineered process systems will be monitored

Preliminary design county plan Zeeland

International Nuclear Information System (INIS)

1987-01-01

The preliminary design 'Streekplan Zeeland' (Country plan Zeeland, with regard to the location of additional nuclear power plants in Zeeland, the Netherlands) has passed through a consultation and participation round. Thereupon 132 reactions have been received. These have been incorporated and answered in two notes. This proposal deals with the principal points of the preliminary design and treats also the remarks of the committees Environmental (town and country) Planning (RO), Provincial (town and country) Planning Committee (PPC) and Association of Communities of Zeeland (VZG), on the reply notes. The preliminary design with the modifications, collected in appendix 3, is proposed to be the starting point in the drawing-up of the design-country-plan. This design subsequently will pass the formal country-plan procedure. (author). 1 fig

Clinical and imaging characteristics of the vascular dementia. Preliminary studies

International Nuclear Information System (INIS)

Gomez Viera, Nelson; Rivero Arias, Edmundo; Perez Nellar, Jesus; Begueria Santos, Ramon; Arias Sifontes, William; Raiteris Flores, Juan

1997-01-01

A descriptive prospective study was carried out in 41 patients presenting with vascular dementia from Habana Vieja municipality, Havana City, in order to know some of the clinical and imaging characteristics of this disease. The main risk factors observed were the history of cerebrovascular disease and arterial hypertension. Depression, sleeping disorders and focal and pseudo bulbar neurologic signs were the most frequent clinical findings. Folstein neuropsychological test evidenced an important disorder of attention, calculation, the evocation memory and orientation. According to this test, 29 % of the patients had a severe dementia and nearly 50 % showed a severe handicap. The most frequent imaging findings observed in the computerized axial tomography of the cranium were cerebral atrophy, and single or multiple infarctions. Multiple cerebral infarctions, the lacunar status, subcortical encephalopathy of Binswanger, and single infarction located in cerebral areas related to cognition were considered as possible psychopathological mechanisms associated with the disease

MR-monitored LITT as a palliative concept in patients with high grade gliomas: preliminary clinical experience.

Science.gov (United States)

Reimer, P; Bremer, C; Horch, C; Morgenroth, C; Allkemper, T; Schuierer, G

1998-01-01

The purpose of this study was to evaluate the clinical utility of laser-induced thermotherapy (LITT) as a palliative treatment for patients with high-grade gliomas. Four consenting patients with recurrent high grade III/IV gliomas near the primary language or motor areas were palliatively treated with LITT (2-5 W, 3-13 minutes; Neodym YAG Laser, Dornier, Friedrichshafen, Germany). Temperature monitoring was performed by T1-weighted turbo-fast low-angle shot (FLASH) imaging at 1.5 T (Siemens Magnetom SP 4000, Siemens, Erlangen, Germany). MRI studies before LITT included contrast-enhanced conventional scans and functional activation studies to localize the primary motor cortex or language areas using an echo-planar imaging (EPI) spin-echo (SE) sequence. Follow-up studies consisted of contrast-enhanced conventional scans as well as diffusion studies (contrast-enhanced Fourier-acquired steady-state technique and EPI-SE) and perfusion studies (EPI-SE with .2 mmol of gadolinium (Gd)/kg body weight) to differentiate post-therapeutic effects from residual or recurrent tumor growth. Local tumor control was achieved in areas with laser energy deposition with clinically stable conditions > or = 6 months. Conventional contrast-enhanced scans demonstrated strong enhancement surrounding ablated tumor components, which showed a reduction in CBV/CBF. Perfusion studies were useful to discriminate granulomatous tissue enhancement from residual or recurrent tumor growth. Careful application of LITT may evolve as an alternative palliative concept for patients with end-stage high-grade cerebral gliomas reducing clinical symptoms from circumscribed areas of pathology.

Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells

Directory of Open Access Journals (Sweden)

Xiao J

2017-09-01

Full Text Available Juan Xiao,1,2 Lin Chen,3 Gengsheng Mao,1 Wenyong Gao,1,2 Ming Lu,4 Xijing He,5 Hongyun Huang1,2 On behalf of the Neurorestoratology Professional Committee of Chinese Medical Doctors Association (Chinese Association of Neurorestoratology 1Institute of Neurorestoratology, The General Hospital of Chinese People’s Armed Police Forces, Beijing, People’s Republic of China; 2Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, People’s Republic of China; 3Department of Neurosurgery, Tsinghua University Yuquan Hospital, Beijing, People’s Republic of China; 4Department of Neurosurgery, 163 Hospital of PLA (Second Affiliated Hospital of Hunan Normal University, Changsha, Hunan Province, People’s Republic of China; 5Department of Orthopedics, Second Affiliated Hospital of Xi’an Jiaotong University, Xian, Shanxi Provine, People’s Republic of China Abstract: Olfactory ensheathing cells (OECs are a novel type of glial cell that can perform and promote many neurorestorative processes in vivo after transplant. To date, dozens of preclinical and clinical studies have confirmed that OECs have unique restoring effects in animal models and human subjects with neurological degeneration or damage, such as spinal cord injury, stroke, cerebral palsy, traumatic brain injury, and motor neuron disease (amyotrophic lateral sclerosis. To ensure the safety and effectiveness of clinical applications utilizing this type of cell, it is important to standardize cell-culture and quality-control processes. Based on a comprehensive review of published clinical studies, as well as existing methods of OEC culture and quality control currently utilized by hospitals and biomedical enterprises, the Chinese Association of Neurorestoratology has developed a set of standards for the culture and quality control of olfactory ensheathing cells for use in clinical applications. These guidelines include standardized training and management procedures for

Preliminary design report: Prototypical Spent Fuel Consolidation Equipment Demonstration Project: Phase 1

International Nuclear Information System (INIS)

Blissell, W.H.; Ciez, A.P.; Mitchell, J.L.; Winkler, C.J.

1986-12-01

This document describes the Westinghouse Preliminary Design for the Prototypical Consolidation Demonstration Project per Department of Energy (DOE) Contract No. DE-AC07-86ID12649 and under direction of the DOE Idaho Operations Office. The preliminary design is the first step to providing the Department of Energy with a fully qualified, licensable, cost-effective spent fuel rod consolidation system. The design was developed using proven technologies and equipment to create an innovative approach to previous rod consolidation concepts. These innovations will better enable the Westinghouse system to: consolidate fuel rods in a precise, fully-controlled, accountable manner; package all rods from two PWR fuel assemblies or from four BWR fuel assemblies in one 8.5 inch square consolidated rods canister; meet all functional requirements; operate with all fuel types common to the US commercial nuclear industry with minimal tooling changeouts; and meet consolidation production process rates, while maintaining operator and public health and safety. This Preliminary Design Report provides both detailed descriptions of the equipment required to perform the rod consolidation process and the supporting analyses to validate the design

Photorefractive keratectomy (PRK) at 193 nm using an erodible mask: new developments and clinical progress

Science.gov (United States)

Gordon, Michael; Seiler, Theo; Carey, Joseph P.; Friedman, Marc D.; Johnsson, N. M. F.; King, Michael C.; Muller, David F.

1993-06-01

This paper reports on our progress using an erodible mask to perform photorefractive keratectomy (PRK) for the correction of myopic astigmatism. We describe modifications to the mask, the mask eye cup and the surgical microscope aimed at simplifying the procedure and improving the ergonomics of the hardware. We report the clinical results of the post-op exam for 20 patients who have undergone PRK for myopic astigmatism under a Phase IIA study. The results compare favorably with an earlier Phase IIA study for performing PRK with a computer-controlled iris. Most important, the clinical data show the absence of any significant corneal haze and no significant decrease in spectacle corrected visual acuity. Although more long term follow-up is needed, the preliminary results support the safety and effectiveness of using an erodible mask to perform PRK for myopic astigmatism.

Preliminary investigation of the effect of air-pollution-control residue from waste incineration on the properties of cement paste and mortar

DEFF Research Database (Denmark)

Geiker, Mette Rica; Kjeldsen, Ane Mette; Galluci, Emmanuel

2006-01-01

For preliminary assessment of the engineering properties of concrete with air-pollution-control residue from waste incineration (APC) the possible reactivity of APC and the effect of APC on cement hydration were investigated by isothermal calorimetry, chemical shrinkage (pychnometry), thermal...... analysis (TG), X-ray diffraction (XRD) and scanning electron microscopy (SEM). Furthermore, compressive strength development was measured and impregnated plane sections were prepared. The APC was from a Danish wet process plant. Although the APC contained high amounts of chloride (approx. 10%) and heavy......% and 20% APC showed a major retarding effect of APC on the development of hydration. The APC was found to be pozzolanic. Chemical shrinkage measurements indicated early expansive reactions of pastes with the APC including evolution of air. Crack formation was observed in mortars with APC, and strength...

Problems of use of preliminary information technology in maritime passes

Directory of Open Access Journals (Sweden)

Elena I. Antonova

2017-12-01

Full Text Available The technology of preliminary informing is the priority direction of development of information technologies in the customs authorities. Russian model prior information on Maritime transport contains a number of features that distinguish it from world practice. The studied is the possibility of creating a unified information system of state regulatory bodies in the Maritime checkpoints. The article considers one of directions of automation of information interaction between Maritime stakeholders in the conduct of customs and other types of state control with the use of a single information space, based on the then-experimental solutions. Analysis of experience of implementation and operation of the software complex "Portal port" in the region of the Vladivostok customs have helped to identify problems in the application of the technology of preliminary information on Maritime transport. The proposed solutions to these problems provide an opportunity to work on improvement of this technology and to introduce mandatory preliminary notification in all sea checkpoints on the territory of the Russian Federation, will allow to optimize the performance of customs and other state Supervisory authorities at the seaport, us-blame the turnover and will contribute to the development of the far Eastern region as a whole.

Cetuximab in the treatment of head and neck cancer: preliminary results outside clinical trials

Science.gov (United States)

Dequanter, Didier; Shahla, Mohammad; Paulus, Pascal; Lothaire, Phillippe

2010-01-01

Introduction: The purpose of this study was to evaluate the clinical efficacy in our daily practice, outside clinical trials, of cetuximab plus radiotherapy in a majority of treatment-naive patients with locoregionally advanced head and neck squamous cell carcinomas. Methods: A retrospective study was performed to evaluate outcomes in patients who were treated definitively with cetuximab and radiotherapy (ExRT). Patients with stage III or IV, nonmetastatic, measurable squamous cell carcinoma of the head and neck (SCCHN) were eligible. Results: There were 18 males and two females. The median age was 61 years (range from 49 to 87 years old). Concurrent radiotherapy and cetuximab was used, in first line, in 17 patients with locally advanced disease; two patients with recurrent SCCHN, who were intolerant of Cisplatin-based regimens, were treated with radiotherapy combined with weekly cetuximab; and 1 patient received cetuximab and radiotherapy postoperatively. The median time of response was 10 months (range from 2 to 24 months). A partial response was observed in 11 cases; a complete response in nine cases. The occurrence of grade 2–3 skin toxicity was observed in 11 cases. Skin toxicity was clearly correlated with a better response and the duration of the response to the treatment. The use of cetuximab in combination with radiotherapy does not increase the side effects of radiotherapy. At the end of the follow-up, 17 patients died. Conclusion: Cetuximab, with its highly targeted mechanism of action and synergistic activity with current treatment modalities, is a valuable treatment option in head and neck patients. The effect of the epidermal growth factor receptor antagonist occurs without any change in the pattern and the severity of toxicity usually associated with head and neck radiation. Cetuximab seems not to provide the most benefit for patients with oropharyngeal cancers but will in patients with T4 tumors. However, the median duration of local control was

Cetuximab in the treatment of head and neck cancer: preliminary results outside clinical trials

International Nuclear Information System (INIS)

Dequanter, Didier; Shahla, Mohammad; Paulus, Pascal; Lothaire, Phillippe

2010-01-01

The purpose of this study was to evaluate the clinical efficacy in our daily practice, outside clinical trials, of cetuximab plus radiotherapy in a majority of treatment-naive patients with locoregionally advanced head and neck squamous cell carcinomas. A retrospective study was performed to evaluate outcomes in patients who were treated definitively with cetuximab and radiotherapy (ExRT). Patients with stage III or IV, nonmetastatic, measurable squamous cell carcinoma of the head and neck (SCCHN) were eligible. There were 18 males and two females. The median age was 61 years (range from 49 to 87 years old). Concurrent radiotherapy and cetuximab was used, in first line, in 17 patients with locally advanced disease; two patients with recurrent SCCHN, who were intolerant of Cisplatin-based regimens, were treated with radiotherapy combined with weekly cetuximab; and 1 patient received cetuximab and radiotherapy postoperatively. The median time of response was 10 months (range from 2 to 24 months). A partial response was observed in 11 cases; a complete response in nine cases. The occurrence of grade 2–3 skin toxicity was observed in 11 cases. Skin toxicity was clearly correlated with a better response and the duration of the response to the treatment. The use of cetuximab in combination with radiotherapy does not increase the side effects of radiotherapy. At the end of the follow-up, 17 patients died. Cetuximab, with its highly targeted mechanism of action and synergistic activity with current treatment modalities, is a valuable treatment option in head and neck patients. The effect of the epidermal growth factor receptor antagonist occurs without any change in the pattern and the severity of toxicity usually associated with head and neck radiation. Cetuximab seems not to provide the most benefit for patients with oropharyngeal cancers but will in patients with T4 tumors. However, the median duration of local control was less as described in the clinical trials

Lingual-Alveolar Contact Pressure during Speech in Amyotrophic Lateral Sclerosis: Preliminary Findings

Science.gov (United States)

Searl, Jeff; Knollhoff, Stephanie; Barohn, Richard J.

2017-01-01

Purpose: This preliminary study on lingual-alveolar contact pressures (LACP) in people with amyotrophic lateral sclerosis (ALS) had several aims: (a) to evaluate whether the protocol induced fatigue, (b) to compare LACP during speech (LACP-Sp) and during maximum isometric pressing (LACP-Max) in people with ALS (PALS) versus healthy controls, (c)…

Hybrid Spectral Micro-CT: System Design, Implementation, and Preliminary Results

CERN Document Server

Bennett, James R; Xu, Qiong; Yu, Hengyong; Walsh, Michael; Butler, Anthony; Butler, Phillip; Cao, Guohua; Mohs, Aaron; Wang, Ge

2014-01-01

Spectral CT has proven an important development in biomedical imaging, and there have been several publications in the past years demonstrating its merits in pre-clinical and clinical applications. In 2012, Xu et al. reported that near-term implementation of spectral micro-CT could be enhanced by a hybrid architecture: a narrow-beam spectral "interior" imaging chain integrated with a traditional wide-beam "global" imaging chain. This hybrid integration coupled with compressive sensing (CS)-based interior tomography demonstrated promising results for improved contrast resolution, and decreased system cost and radiation dose. The motivation for the current study is implementation and evaluation of the hybrid architecture with a first-of-its-kind hybrid spectral micro-CT system. Preliminary results confirm improvements in both contrast and spatial resolution. This technology is shown to merit further investigation and potential application in future spectral CT scanner design.

The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial.

Science.gov (United States)

Moattari, Marzieh; Hashemi, Maryam; Dabbaghmanesh, Mohammad H

2013-01-01

To determine the impact of electronic education on metabolic control indicators in patients with diabetes who were insulin dependent. Education can play an important role in controlling diabetes. Electronic (web-based, telehealth) education may be an efficient way to improve the patients' ability to control this disease. Randomised clinical control study. The participants in this clinical study were 48 insulin-dependent patients referred to diabetes centres in Shiraz, Iran. Serum concentrations of haemoglobin A(1C) , fasting blood sugar, triglycerides and high-density and low-density lipoprotein cholesterol were measured. Then the participants were divided randomly into control and experimental groups (n = 24). Participants in the experimental group received a specially designed electronic education programme for twelve weeks. The main components of the programme were a consultation service, quick answers to patients' questions, contact with the healthcare team and educational materials. At the end of the intervention period, all serum values were measured again in both groups. The data were compared using spss v 13·5 software. Serum concentrations of haemoglobin A(1C) (p education programme was useful in lowering two metabolic indicators of diabetes. Electronic education can be associated with increased health and patient satisfaction, and can eliminate the need to train personnel. © 2012 Blackwell Publishing Ltd.

Preliminary Test of Adaptive Neuro-Fuzzy Inference System Controller for Spacecraft Attitude Control

Directory of Open Access Journals (Sweden)

Sung-Woo Kim

2012-12-01

Full Text Available The problem of spacecraft attitude control is solved using an adaptive neuro-fuzzy inference system (ANFIS. An ANFIS produces a control signal for one of the three axes of a spacecraft’s body frame, so in total three ANFISs are constructed for 3-axis attitude control. The fuzzy inference system of the ANFIS is initialized using a subtractive clustering method. The ANFIS is trained by a hybrid learning algorithm using the data obtained from attitude control simulations using state-dependent Riccati equation controller. The training data set for each axis is composed of state errors for 3 axes (roll, pitch, and yaw and a control signal for one of the 3 axes. The stability region of the ANFIS controller is estimated numerically based on Lyapunov stability theory using a numerical method to calculate Jacobian matrix. To measure the performance of the ANFIS controller, root mean square error and correlation factor are used as performance indicators. The performance is tested on two ANFIS controllers trained in different conditions. The test results show that the performance indicators are proper in the sense that the ANFIS controller with the larger stability region provides better performance according to the performance indicators.

Exploratory shaft facility preliminary designs - Paradox Basin. Technical report

International Nuclear Information System (INIS)

1983-09-01

The purpose of the Preliminary Design Report, Paradox Basin, is to provide a description of the preliminary design for an Exploratory Shaft Facility in the Paradox Basin, Utah. This issue of the report describes the preliminary design for constructing the exploratory shaft using the Large Hole Drilling Method of construction and outlines the preliminary design and estimates of probable construction cost. The Preliminary Design Report is prepared to complement and summarize other documents that comprise the design at the preliminary stage of completion, December 1982. Other design documents include drawings, cost estimates and schedules. The preliminary design drawing package, which includes the construction schedule drawing, depicts the descriptions in this report. For reference, a list of the drawing titles and corresponding numbers is included in the Appendix. The report is divided into three principal sections: Design Basis, Facility Description, and Construction Cost Estimate. 30 references

SUBSURFACE REPOSITORY INTEGRATED CONTROL SYSTEM DESIGN

International Nuclear Information System (INIS)

C.J. Fernado

1998-01-01

The purpose of this document is to develop preliminary high-level functional and physical control system architectures for the proposed subsurface repository at Yucca Mountain. This document outlines overall control system concepts that encompass and integrate the many diverse systems being considered for use within the subsurface repository. This document presents integrated design concepts for monitoring and controlling the diverse set of subsurface operations. The subsurface repository design will be composed of a series of diverse systems that will be integrated to accomplish a set of overall functions and objectives. The subsurface repository contains several Instrumentation and Control (I andC) related systems including: waste emplacement systems, ventilation systems, communication systems, radiation monitoring systems, rail transportation systems, ground control monitoring systems, utility monitoring systems (electrical, lighting, water, compressed air, etc.), fire detection and protection systems, retrieval systems, and performance confirmation systems. Each of these systems involve some level of I andC and will typically be integrated over a data communication network. The subsurface I andC systems will also integrate with multiple surface-based site-wide systems such as emergency response, health physics, security and safeguards, communications, utilities and others. The scope and primary objectives of this analysis are to: (1) Identify preliminary system level functions and interface needs (Presented in the functional diagrams in Section 7.2). (2) Examine the overall system complexity and determine how and on what levels these control systems will be controlled and integrated (Presented in Section 7.2). (3) Develop a preliminary subsurface facility-wide design for an overall control system architecture, and depict this design by a series of control system functional block diagrams (Presented in Section 7.2). (4) Develop a series of physical architectures

SUBSURFACE REPOSITORY INTEGRATED CONTROL SYSTEM DESIGN

Energy Technology Data Exchange (ETDEWEB)

C.J. Fernado

1998-09-17

The purpose of this document is to develop preliminary high-level functional and physical control system architectures for the proposed subsurface repository at Yucca Mountain. This document outlines overall control system concepts that encompass and integrate the many diverse systems being considered for use within the subsurface repository. This document presents integrated design concepts for monitoring and controlling the diverse set of subsurface operations. The subsurface repository design will be composed of a series of diverse systems that will be integrated to accomplish a set of overall functions and objectives. The subsurface repository contains several Instrumentation and Control (I&C) related systems including: waste emplacement systems, ventilation systems, communication systems, radiation monitoring systems, rail transportation systems, ground control monitoring systems, utility monitoring systems (electrical, lighting, water, compressed air, etc.), fire detection and protection systems, retrieval systems, and performance confirmation systems. Each of these systems involve some level of I&C and will typically be integrated over a data communication network. The subsurface I&C systems will also integrate with multiple surface-based site-wide systems such as emergency response, health physics, security and safeguards, communications, utilities and others. The scope and primary objectives of this analysis are to: (1) Identify preliminary system level functions and interface needs (Presented in the functional diagrams in Section 7.2). (2) Examine the overall system complexity and determine how and on what levels these control systems will be controlled and integrated (Presented in Section 7.2). (3) Develop a preliminary subsurface facility-wide design for an overall control system architecture, and depict this design by a series of control system functional block diagrams (Presented in Section 7.2). (4) Develop a series of physical architectures that

Identification of transplanted pancreatic islet cells by radioactive Dithizone-[131I]-Histamine conjugate. Preliminary report

International Nuclear Information System (INIS)

Garnuszek, P.; Licinska, I.; Mazurek, A.P.; Mrozek, A.; Wardawa, A.; Fiedor, P.S.

2000-01-01

Background: The unique mechanism of dithizone action in the interior of the viable pancreatic islet suggests the possible development of a specific radiopharmaceutical that may have a potential clinical application in the diagnosis of the pancreatic organ allografts or islets rejection. The radiodiagnostic properties of the newly developed radioactive analogue of dithizone, i.e. Dithizone-[131I]-Histamine conjugate have been evaluated in the present study. METHODS: The four islet cells transplantation models were chosen for this purpose. The most important feature of the Dithizone-[131I]-Histamine conjugate is its possessed ability of zinc chelation. As was presented in the recent study, the conjugate stains pink-reddish the isolated pancreatic islets in vitro. Among the studied transplantation models, only the islets grafting under testis capsule enabled determination of the pancreatic islets in rats by radioactive Dithizone-[131I]-Histamine conjugate. The level of the radioactivity in the recipient testis (right) was almost two times higher compared to the controls (0.24 v. 0.13% ID/g, respectively). CONCLUSIONS: These preliminary data demonstrate the ability of the developed radioactive analogue of dithizone for in vivo identification of transplanted pancreatic islets, and suggests a potential clinical application of the radiodithizone in the diagnosis of the pancreatic islet rejection. (author)

Preliminary considerations on safety of computerized control rooms

International Nuclear Information System (INIS)

Vittet, J.

1983-02-01

Safety problems are analyzed in this report by the study of the interaction: ''human behavior in a rigid environment/information overload in perturbed situation''. For pedagogy the study is presented as a research of factors influencing operator performance in a control room and a dialogue between an analyst and a conceiving engineer. Danger of all control room where the strategy for data acquisition is too rigid and without spatial reference is stressed in conclusion. Orientations for an advanced control room are outlined [fr

Preliminary results of phase I/II study of simultaneous modulated accelerated (SMART) for nasopharyngeal carcinoma

Energy Technology Data Exchange (ETDEWEB)

Park, Jin Hong; Lee, Sang Wook; Back, Geum Mun [College of Medicine, University of Ulsan, Asan Medical Center, Seoul (Korea, Republic of)] (and others)

2006-03-15

To present preliminary results of intensity-modulated radiotherapy (IMRT) using the simultaneous modulated accelerated radiation therapy (SMART) boost technique in patients with nasopharyngeal carcinoma (NPC). Twenty patients who underwent IMRT for non-metastatic NPC at the Asan Medical Center between September 2001 and December 2003 were prospectively evaluated. IMRT was delivered using the 'step and shoot' SMART technique at prescribed doses of 72 Gy (2.4 Gy/day) to the gross tumor volume (GTV), 60 Gy (2 Gy/day) to the clinical target volume (CTV) and metastatic nodal station, and 46 Gy (2 Gy/day) to the clinically negative neck region. Eighteen patients also received concurrent chemotherapy using cisplatin once per week. The median follow-up period was 27 months. Nineteen patients completed the treatment without interruption; the remaining patient interrupted treatment for 2 weeks owing to severe pharyngitis and malnutrition. Five patients (25%) had RTOG grade 3 mucositis, whereas nine (45%) had grade 3 pharyngitis. Seven patients (35%) lost more than 10% of their pretreatment weight, whereas 11 (55%) required intravenous fluids and/or tube feeding. There was no grade 3 or 4 chronic xerostomia. All patients showed complete response. Two patients had distant metastases and loco-regional recurrence, respectively. IMRT using the SMART boost technique allows parotid sparing, as shown clinically and by dosimetry, and may also be more effective biologically. A larger population of patients and a longer follow-up period are needed to evaluate ultimate tumor control and late toxicity.

Clinical and neurobiological effects of aerobic exercise in dental phobia: A randomized controlled trial.

Science.gov (United States)

Lindenberger, Brigitt L; Plag, Jens; Schumacher, Sarah; Gaudlitz, Katharina; Bischoff, Sophie; Bobbert, Thomas; Dimeo, Fernando; Petzold, Moritz B; Kirschbaum, Clemens; Dudás, Zsuzsa; Ströhle, Andreas

2017-11-01

Physical activity has shown to be effective in anxiety disorders. For specific phobia, no studies are available that systematically examined the effects of an aerobic exercise intervention on phobic fear within a randomized-controlled design. Therefore, we investigated the acute effect of a standardized aerobic training on clinical symptoms of dental phobia as well as on stress-related neurobiological markers. Within a crossover design, 30 patients with dental phobia (mean age: 34.1 years; mean score of the Dental Anxiety Scale: 18.8) underwent two minor dental interventions separated by 7 days. Dental treatment was performed after 30 min of physical activity at either 20% VO 2 max (control) or 70% VO 2 max (intervention), respectively. To control for habituation, patients were randomly assigned to one of the two conditions prior to the first intervention. Moreover, saliva samples were collected at five times in order to determine changes in salivary cortisol (sC) and alpha-amylase (sAA) due to treatment. In comparison to baseline, aerobic exercise within 70% VO 2 max significantly reduced clinical anxiety and sC concentrations before, during, and after the dental treatment. In contrast, the control condition led to decreased sAA levels at different time points of measurement. Habituation occurred at the second study day, independent of the order. Our study provides evidence for an effect of moderate-intense exercise on clinical symptoms and sC in patients with dental phobia. Therefore, acute aerobic exercise might be a simple and low-cost intervention to reduce disorder-specific phobic fear. © 2017 Wiley Periodicals, Inc.

A realistic closed-form radiobiological model of clinical tumor-control data incorporating intertumor heterogeneity

International Nuclear Information System (INIS)

Roberts, Stephen A.; Hendry, Jolyon H.

1998-01-01

Purpose: To investigate the role of intertumor heterogeneity in clinical tumor control datasets and the relationship to in vitro measurements of tumor biopsy samples. Specifically, to develop a modified linear-quadratic (LQ) model incorporating such heterogeneity that it is practical to fit to clinical tumor-control datasets. Methods and Materials: We developed a modified version of the linear-quadratic (LQ) model for tumor control, incorporating a (lagged) time factor to allow for tumor cell repopulation. We explicitly took into account the interpatient heterogeneity in clonogen number, radiosensitivity, and repopulation rate. Using this model, we could generate realistic TCP curves using parameter estimates consistent with those reported from in vitro studies, subject to the inclusion of a radiosensitivity (or dose)-modifying factor. We then demonstrated that the model was dominated by the heterogeneity in α (tumor radiosensitivity) and derived an approximate simplified model incorporating this heterogeneity. This simplified model is expressible in a compact closed form, which it is practical to fit to clinical datasets. Using two previously analysed datasets, we fit the model using direct maximum-likelihood techniques and obtained parameter estimates that were, again, consistent with the experimental data on the radiosensitivity of primary human tumor cells. This heterogeneity model includes the same number of adjustable parameters as the standard LQ model. Results: The modified model provides parameter estimates that can easily be reconciled with the in vitro measurements. The simplified (approximate) form of the heterogeneity model is a compact, closed-form probit function that can readily be fitted to clinical series by conventional maximum-likelihood methodology. This heterogeneity model provides a slightly better fit to the datasets than the conventional LQ model, with the same numbers of fitted parameters. The parameter estimates of the clinically

Examining the Preliminary Efficacy of a Dating Violence Prevention Program for Hispanic Adolescents

Science.gov (United States)

Gonzalez-Guarda, Rosa Maria; Guerra, Jessica E.; Cummings, Amanda A.; Pino, Karen; Becerra, Maria M.

2015-01-01

The purpose of this study is to evaluate the preliminary efficacy of a dating violence (DV) prevention program for Cuban American adolescents ("JOVEN"/YOUTH: "Juntos Opuestos a la Violence Entre Novios"/Together Against Dating Violence). A randomized-controlled experimental design with a delayed condition was used to evaluate…

32 CFR 644.30 - Preliminary real estate work.

Science.gov (United States)

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Preliminary real estate work. 644.30 Section 644... PROPERTY REAL ESTATE HANDBOOK Project Planning Military (army and Air Force) and Other Federal Agencies § 644.30 Preliminary real estate work. (a) Preliminary real estate work is defined as that action taken...

Parotid salivary parameters in bulimic patients – a controlled clinical trial.

OpenAIRE

Elżbieta Paszyńska; Agnieszka Słopień; Monika Węglarz; Roger W.A. Linden

2015-01-01

Objectives The aim of this study was to determine whether patients with purging-type bulimia and/or non-bulimic patients, treated with serotonin reuptake inhibitor SI-5-HT (fluoxetine), have dental erosion and changes in selected buffer components of parotid saliva (bicarbonates, phosphates, urea), compared with the healthy population. Methods A controlled clinical trial was designed for three, age-matched, female groups of 94 patients: 1) bulimic patients treated with fluoxetin...

Development of a tissue-engineered human oral mucosa equivalent based on an acellular allogeneic dermal matrix: a preliminary report of clinical application to burn wounds.

Science.gov (United States)

Iida, Takuya; Takami, Yoshihiro; Yamaguchi, Ryo; Shimazaki, Shuji; Harii, Kiyonori

2005-01-01

Tissue-engineered skin equivalents composed of epidermal and dermal components have been widely investigated for coverage of full-thickness skin defects. We developed a tissue-engineered oral mucosa equivalent based on an acellular allogeneic dermal matrix and investigated its characteristics. We also tried and assessed its preliminary clinical application. Human oral mucosal keratinocytes were separated from a piece of oral mucosa and cultured in a chemically-defined medium. The keratinocytes were seeded on to the acellular allogeneic dermal matrix and cultured. Histologically, the mucosa equivalent had a well-stratified epithelial layer. Immunohistochemical study showed that it was similar to normal oral mucosa. We applied this equivalent in one case with an extensive burn wound. The equivalent was transplanted three weeks after the harvest of the patient's oral mucosa and about 30% of the graft finally survived. We conclude that this new oral mucosa equivalent could become a therapeutic option for the treatment of extensive burns.

Brain cortical structural differences between non-central nervous system cancer patients treated with and without chemotherapy compared to non-cancer controls: a cross-sectional pilot MRI study using clinically indicated scans

Science.gov (United States)

Shiroishi, Mark S.; Gupta, Vikash; Bigjahan, Bavrina; Cen, Steven Y.; Rashid, Faisal; Hwang, Darryl H.; Lerner, Alexander; Boyko, Orest B.; Liu, Chia-Shang Jason; Law, Meng; Thompson, Paul M.; Jahanshad, Neda

2017-11-01

Background: Increases in cancer survival have made understanding the basis of cancer-related cognitive impairment (CRCI) more important. CRCI neuroimaging studies have traditionally used dedicated research brain MRIs in breast cancer survivors with small sample sizes; little is known about other non-CNS cancers. However, there is a wealth of unused data from clinically-indicated MRIs that could be used to study CRCI. Objective: Evaluate brain cortical structural differences in those with non-CNS cancers using clinically-indicated MRIs. Design: Cross-sectional Patients: Adult non-CNS cancer and non-cancer control (C) patients who underwent clinically-indicated MRIs. Methods: Brain cortical surface area and thickness were measured using 3D T1-weighted images. An age-adjusted linear regression model was used and the Benjamini and Hochberg false discovery rate (FDR) corrected for multiple comparisons. Group comparisons were: cancer cases with chemotherapy (Ch+), cancer cases without chemotherapy (Ch-) and subgroup of lung cancer cases with and without chemotherapy vs C. Results: Sixty-four subjects were analyzed: 22 Ch+, 23 Ch- and 19 C patients. Subgroup analysis of 16 LCa was also performed. Statistically significant decreases in either cortical surface area or thickness were found in multiple ROIs primarily within the frontal and temporal lobes for all comparisons. Limitations: Several limitations were apparent including a small sample size that precluded adjustment for other covariates. Conclusions: Our preliminary results suggest that various types of non-CNS cancers, both with and without chemotherapy, may result in brain structural abnormalities. Also, there is a wealth of untapped clinical MRIs that could be used for future CRCI studies.

[Evaluation and symptomatic treatment of surinfectious exacerbations of COPD: preliminary study of antibiotic treatment combined with fenspiride (Pneumorel 80mg) versus placebo].

Science.gov (United States)

Lirsac, B; Benezet, O; Dansin, E; Nouvet, G; Stach, B; Voisin, C

2000-02-01

Exacerbations of chronic obstructive pulmonary disease (COPD) have an inflammatory component in addition to the possible infectious component. The antiinflammatory properties of fenspiride (Pneumorel(R) 80 mg) should be evaluated in this frequent clinical situation. Assess the supplementary therapeutic benefit provided by fenspiride administered in combination with antibiotics in COPD patients presenting an episode of bronchial infection. A preliminary randomized placebo-controlled double-blind study was conduced in 7 centers. Patients under 80 years of age of both sexes were included. All patients had COPD and presented a bronchial infection defined as the presence of at least 2 of the 3 criteria defined by Anthonisen. Patients were randomly assigned to group F or group P. Group F received an antibiotic therapy from day 1 to day 11 plus fenspiride (3 x 80mg/d from day 0 to day 30). Group P received the same antibiotic therapy plus placebo. Amoxicillin 500mg plus clavulanic acid 125, 3 tablets/day, was administered in both groups. Thirty-nine patients were included (group F 19 patients, group P 20 patients; 6 women and 33 men; mean age 61.1 +/- 9.8 years). The 3 Anthonisen criteria were present in 79% and 75% of the patients in group F and P respectively (NS). On day 11, expectoration resolved in 39% and 32% (NS) and cough in 44% and 16% (NS) of the patients in groups F and P respectively. Lung auscultation returned to normal in 83% of the patients in group F compared with 47% in group P (p=0.05). A composite clinical score including expectoration cough and auscultation findings showed that 28% of the patients in group F were symptom-free on day 11 compared with 0% in group P (p=0.04). On day 30, the two groups were comparable. In this preliminary study of patients with COPD presenting a bronchial superinfection, there was a significant improvement in lung auscultation and in the composite clinical score in patients given fenspiride. Fenspiride was thus found to

Reduction of missed appointments at an urban primary care clinic: a randomised controlled study

Directory of Open Access Journals (Sweden)

Calmy Alexandra

2010-10-01

Full Text Available Abstract Background Missed appointments are known to interfere with appropriate care and to misspend medical and administrative resources. The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments. Methods We conducted a randomised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients. All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention: 1. Phone call (fixed or mobile reminder; 2. If no phone response: a Short Message Service (SMS reminder; 3. If no available mobile phone number: a postal reminder. The rate of missed appointment, the cost of the intervention, and the profile of patients missing their appointment were recorded. Results 2123 patients were included: 1052 in the intervention group, 1071 in the control group. Only 61.7% patients had a mobile phone recorded at the clinic. The sequential intervention significantly reduced the rate of missed appointments: 11.4% (n = 122 in the control group and 7.8% (n = 82 in the intervention group (p 1year (OR 2.2; CI: 1.15-4.2, substance abuse (2.09, CI 1.21-3.61, and being an asylum seeker (OR 2.73: CI 1.22-6.09. Conclusion A practical reminder system can significantly increase patient attendance at medical outpatient clinics. An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders.

Effect of aromatherapy massage on menopausal symptoms: a randomized placebo-controlled clinical trial.

Science.gov (United States)

Darsareh, Fatemeh; Taavoni, Simin; Joolaee, Soodabeh; Haghani, Hamid

2012-09-01

Menopause is a significant event in most women's lives because it marks the end of a woman's natural reproductive life. The purpose of this study was to determine the effect of aromatherapy massage on menopausal symptoms. A randomized placebo-controlled clinical trial was conducted at a menopausal clinic at a gynecology hospital in Tehran. The study population comprised 90 women who were assigned to an aromatherapy massage group, a placebo massage group, or a control group. Each participant in the aromatherapy massage group received 30-minute aromatherapy treatment sessions twice a week for 4 weeks with aroma oil, whereas participants in the placebo massage group received the same treatment with plain oil. No treatment was provided to participants in the control group. The outcome measures in this study were menopausal symptoms, as obtained through the Menopause Rating Scale. The mean baseline level of the menopausal score did not differ among all groups. However, after eight sessions of intervention, the Menopause Rating Scale score differed significantly among the three groups (P aromatherapy massage group and the placebo massage group had a lower menopausal score than the control group (P aromatherapy massage and the placebo massage groups were compared, the menopausal score for the aromatherapy massage group was found to be significantly lower (P aromatherapy massage were effective in reducing menopausal symptoms. However, aromatherapy massage was more effective than only massage.

Preliminary results of a battery-based, multi megawatt 200 kA pulsed power supply.

NARCIS (Netherlands)

Karthaus, W.; Kolkert, W.J.; Nowee, J.

1989-01-01

A pulsed power supply consisting of a fast discharge battery, a switch based on silicon-controlled-rectifier SCR technology, and an energy storage/pulse transformer is discussed. Preliminary results indicate that the battery is capable of discharging current pulses with reproducible peak values of

Glucose control and diabetic neuropathy: lessons from recent large clinical trials.

Science.gov (United States)

Ang, Lynn; Jaiswal, Mamta; Martin, Catherine; Pop-Busui, Rodica

2014-01-01

Diabetic peripheral and autonomic neuropathies are common complications of diabetes with broad spectrums of clinical manifestations and high morbidity. Studies using various agents to target the pathways implicated in the development and progression of diabetic neuropathy were promising in animal models. In humans, however, randomized controlled studies have failed to show efficacy on objective measures of neuropathy. The complex anatomy of the peripheral and autonomic nervous systems, the multitude of pathogenic mechanisms involved, and the lack of uniformity of neuropathy measures have likely contributed to these failures. To date, tight glycemic control is the only strategy convincingly shown to prevent or delay the development of neuropathy in patients with type 1 diabetes and to slow the progression of neuropathy in some patients with type 2 diabetes. Lessons learned about the role of glycemic control on distal symmetrical polyneuropathy and cardiovascular autonomic neuropathy are discussed in this review.

PRELIMINARY CLINICAL STUDY OF KALANCHOE SPATHULATA DC. ON INFLAMMATORY WOUND

Science.gov (United States)

Yadav, C. L.; Yadav, C. S.

1985-01-01

Here, an attempt is made to study the clinical aspect of Kalanchoe spathulata Dc. It has been observed that would heals rapidly leaving no scar. The study clearly validates the ancient concept of Ayurveda, that without taking the help of surgery, there are several medicinal plants which may cure diseases very well. PMID:22557495

Visual Impairment/Intracranial Pressure Research Clinical Advisory Panel (RCAP) Meeting. [Summary Report

Science.gov (United States)

Villarreal, Jennifer

2014-01-01

The Visual Impairment/Intracranial Pressure (VIIP) Research and Clinical Advisory Panel convened on December 1, 2014 at the ISS Conference Facility in Houston. The panel members were provided updates to the current clinical cases and treatment plans along with the latest research activities (http://humanresearchroadmap.nasa.gov/Risks/?i=105) and preliminary study results. The following is a summary of this meeting.

Solar Central Receiver Prototype Heliostat. Volume II. Phase II planning (preliminary)

Energy Technology Data Exchange (ETDEWEB)

None

1978-06-01

A currently planned DOE program will develop and construct a 10 MW/sub e/ Pilot Plant to demonstrate the feasibility and operational characteristics of Solar Central Receiver Power Generation. The field of heliostats is a major element of the Solar Central Receiver Power Generation system. The primary objective of the program described is to establish and verify the manufacturability, performance, durability, and maintenance requirements of the commercial plant heliostat design. End products of the 16 month effort include: (1) design, fabrication, and test of heliostats; (2) preliminary designs of manufacturing, assembly, installation, and maintenance processes for quantity production; (3) detailed design of critical tooling or other special equipment for such processes; (4) refined cost estimates for heliostats and maintenance; and (5) an updated commercial plant heliostat preliminary design. The program management and control system is discussed. (WHK)

Plutonium Immobilization Can Loading Preliminary Specifications

Energy Technology Data Exchange (ETDEWEB)

Kriikku, E.

1998-11-25

This report discusses the Plutonium Immobilization can loading preliminary equipment specifications and includes a process block diagram, process description, equipment list, preliminary equipment specifications, plan and elevation sketches, and some commercial catalogs. This report identifies loading pucks into cans and backfilling cans with helium as the top priority can loading development areas.

Preliminary design of HL-2A discharge control system

International Nuclear Information System (INIS)

Jiang Chao; Song Xianming; Li Qiang

2001-01-01

HL-2A Discharge Control System consists of one or more VXI work stations so as to compose an all digital control system. The DCS are used to measure and control the poloidal coils, the main tasks of the poloidal coils are exploding, keeping and controlling the current of plasma. These coils explode plasma and keep it in the determined position

Digital assessment of preliminary impression accuracy for edentulous jaws: Comparisons of 3-dimensional surfaces between study and working casts.

Science.gov (United States)

Matsuda, Takashi; Goto, Takaharu; Kurahashi, Kosuke; Kashiwabara, Toshiya; Watanabe, Megumi; Tomotake, Yoritoki; Nagao, Kan; Ichikawa, Tetsuo

2016-07-01

The aim of this study was to compare 3-dimensional surfaces of study and working casts for edentulous jaws and to evaluate the accuracy of preliminary impressions with a view to the future application of digital dentistry for edentulous jaws. Forty edentulous volunteers were serially recruited. Nine dentists took preliminary and final impressions in a routine clinical work-up. The study and working casts were digitized using a dental 3-dimensional scanner. The two surface images were superimposed through a least-square algorithm using imaging software and compared qualitatively. Furthermore, the surface of each jaw was divided into 6 sections, and the difference between the 2 images was quantitatively evaluated. Overall inspection showed that the difference around residual ridges was small and that around borders were large. The mean differences in the upper and lower jaws were 0.26mm and 0.45mm, respectively. The maximum values of the differences showed that the upward change mainly occurred in the anterior residual ridge, and the downward change mainly in the posterior border seal, and the labial and buccal vestibules, whereas every border of final impression was shortened in the lower jaw. The accuracy in all areas except the border, which forms the foundation, was estimated to be less than 0.25mm. Using digital technology, we here showed the overall and sectional accuracy of the preliminary impression for edentulous jaws. In our clinic, preliminary impressions have been made using an alginate material while ensuring that the requisite impression area was covered. Copyright © 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

Clinical X-ray diagnostics. v. 2

International Nuclear Information System (INIS)

Baudisch, E.; Becker, T.

1981-01-01

Principles of the general procedure in radiographic examination are the subject of the introduction. Following anatomico-clinical preliminary notes and suggestions concerning radiographic examination methods and proceeding from normal findings of the bones and from the general radiographic symptomatology of skeletal diseases, developmental disturbances, system diseases, radiogenic injuries, aseptic necroses, metabolic osteopathies, damages, inflammations and tumors as well as less frequently occuring diseases are discussed. Their pathology, clinic, diagnostics, diagnosis and differential diagnosis, their therapy and prognosis are dealt with from the clinico-radiographical point of view. The diseases of the joints of the radiographically demonstrable diseases of the soft parts of the limbs are also treated

The Relations Between Temperament, Character, and Executive Functions in Children With ADHD and Clinical Controls

DEFF Research Database (Denmark)

Drechsler, Renate; Zulauf Logoz, Marina; Walitza, Susanne

2017-01-01

OBJECTIVE: The purpose of this study was to investigate the overlap between executive functions and temperament as measured by two questionnaires and to examine characteristic profiles in children with ADHD and clinical controls. METHOD: Parents of 111 clinically referred children, half of whom...... were diagnosed with ADHD and half with other or no diagnoses, completed the Behavior Rating Inventory of Executive Function (BRIEF) and the Cloninger Junior Temperament and Character Inventory (JTCI). RESULTS: Factor analysis of both instruments resulted in three common factors representing aspects...... disorder (CD/ODD) but not ADHD accounted for problems in BRIEF Emotional Control and Self-Monitor and JTCI low Cooperativeness. CONCLUSION: The two instruments only partially overlap and may complement each other....

Design and preliminary evaluation of the FINGER rehabilitation robot: controlling challenge and quantifying finger individuation during musical computer game play.

Science.gov (United States)

Taheri, Hossein; Rowe, Justin B; Gardner, David; Chan, Vicki; Gray, Kyle; Bower, Curtis; Reinkensmeyer, David J; Wolbrecht, Eric T

2014-02-04

This paper describes the design and preliminary testing of FINGER (Finger Individuating Grasp Exercise Robot), a device for assisting in finger rehabilitation after neurologic injury. We developed FINGER to assist stroke patients in moving their fingers individually in a naturalistic curling motion while playing a game similar to Guitar Hero. The goal was to make FINGER capable of assisting with motions where precise timing is important. FINGER consists of a pair of stacked single degree-of-freedom 8-bar mechanisms, one for the index and one for the middle finger. Each 8-bar mechanism was designed to control the angle and position of the proximal phalanx and the position of the middle phalanx. Target positions for the mechanism optimization were determined from trajectory data collected from 7 healthy subjects using color-based motion capture. The resulting robotic device was built to accommodate multiple finger sizes and finger-to-finger widths. For initial evaluation, we asked individuals with a stroke (n = 16) and without impairment (n = 4) to play a game similar to Guitar Hero while connected to FINGER. Precision design, low friction bearings, and separate high speed linear actuators allowed FINGER to individually actuate the fingers with a high bandwidth of control (-3 dB at approximately 8 Hz). During the tests, we were able to modulate the subject's success rate at the game by automatically adjusting the controller gains of FINGER. We also used FINGER to measure subjects' effort and finger individuation while playing the game. Test results demonstrate the ability of FINGER to motivate subjects with an engaging game environment that challenges individuated control of the fingers, automatically control assistance levels, and quantify finger individuation after stroke.

Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case-control study in the U.K.

Science.gov (United States)

Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

2014-06-01

Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the U.K. in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. A prospective multicentre case-control study was conducted at six U.K. hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

Science.gov (United States)

Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

2016-10-01

This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

WeChat Public Account Use Improves Clinical Control of Cough-Variant Asthma: A Randomized Controlled Trial.

Science.gov (United States)

Cao, Yuan; Lin, Shi-Hua; Zhu, Ding; Xu, Feng; Chen, Zhi-Hua; Shen, Hua-Hao; Li, Wen

2018-03-14

BACKGROUND WeChat is a convenient and popular social medium, and it seems to be an appropriate platform for education and management of patients. This study sought to identify usefulness in clinical control of cough-variant asthma (CVA). MATERIAL AND METHODS A randomized controlled trial was conducted among 80 CVA patients. After being assigned to either the traditional group (TG) or the WeChat group (WG), they received the same inhalation therapy, but patients in WG received additional education and instruction via our public account on the WeChat application. Questionnaires on asthma and chronic cough, data on pulmonary function, blood-related items, follow-up adherence, and Emergency Department (ED) visits were collected at the initial visit and at 3 months. RESULTS A total of 67 participants completed the trial for analysis. FEV1/predicted and FEV1/FVC were significantly increased in WG (pWeChat as part of treatment and management of CVA can help patients learn about their disease and medications, as well as improve disease control and therapy outcomes.

Design and Modelling of Thermostatically Controlled Loads as Frequency Controlled Reserve

DEFF Research Database (Denmark)

Xu, Zhao; Østergaard, Jacob; Togeby, Mikael

2007-01-01

Using demand as frequency controlled reserve (DFR) is beneficial to power systems in many aspects. To study the impacts of this technology on power system operation, control logics and simulation models of relevant loads should be carefully developed. Two advanced control logics for using demand...... frequency, is developed. The developed simulation model is able to represent a variety of aggregated thermostatically controlled loads, such as heaters or refrigerators. Uncertainties including customer behaviours and ambient temperature variation are also modelled. Preliminary simulation results...

The Epidemiology, Clinical Characteristic,Transmission Potential and Control Measures of Zika Virus Infection%The Epidemiology,Clinical Characteristic,Transmission Potential and Control Measures of Zika Virus Infection

Institute of Scientific and Technical Information of China (English)

ALOTAIBIABDULLAHSAUDM; ALANAZIMANSOURRASHEDM; AHMADMEESAQ

2017-01-01

Zika virus (ZIKV) is an emerging mosquito born positive standard RNA arbovirus of Flaviviriadae family.Zika virus has been identified sporadically in human in Africa and Asia;however,clinically consequential Zika virus disease had not been documented before to the recent outbreak in the America in 2015.It is rapidly spread across the America and its devastating outcomes for pregnant women and infants.Prior to outbreak of America,Zika virus outbreaks occurred in Yap Island in Micronesia in 2007 and in French Polynesia in 2013.The World Health Organisation (WHO) declarer a Public Health Emergency of International Concern on February 1,2016.Because of the continuous geographicexpansion of both the virus and its mosquito vectors,ZIKV poses a serious threat to public health aroundthe globe.This review summarizes a fast growing body of literature on the history,epidemiology,transmission,clinical presentation and control measures to prevent the transmission of Zika virus.

Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

Directory of Open Access Journals (Sweden)

Birtwhistle Richard

2003-12-01

Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

Discriminant analysis to predict the clinical diagnosis of primary immunodeficiencies: a preliminary report

Directory of Open Access Journals (Sweden)

Chiharu Murata

2015-04-01

Conclusions: In general, the selection of features has clinical plausibility, and the practical advantage of utilizing only clinical attributes, infecting germs and routine lab results (blood cell counts and serum immunoglobulins. The performance of the model as a diagnostic tool was acceptable. The study’s main limitations are a limited sample size and a lack of cross validation. This is only the first step in the construction of a machine learning system, with a wider approach that includes a larger database and different methodologies, to assist the clinical diagnosis of primary immunodeficiencies.

Impulse control disorders in Parkinson's disease: clinical characteristics and implications.

Science.gov (United States)

Leeman, Robert F; Potenza, Marc N

2011-04-01

Impulse control disorders (ICDs), specifically those related to excessive gambling, eating, sex and shopping, have been observed in a subset of people with Parkinson's disease (PD). Although some initial case reports claimed that dopamine replacement therapies, particularly dopamine agonists, cause ICDs, more recent, larger and better controlled studies indicate a more complicated picture. While dopamine replacement therapy use is related to ICDs, other vulnerabilities, some related to PD and/or its treatment directly and others seemingly unrelated to PD, have also been associated with ICDs in PD. This suggests a complex etiology with multiple contributing factors. As ICDs occur in a sizable minority of PD patients and can be associated with significant distress and impairment, further investigation is needed to identify factors that can predict who may be more likely to develop ICDs. Clinical implications are discussed and topics for future research are offered.

Human-FES cooperative control for wrist movement: a preliminary study

Directory of Open Access Journals (Sweden)

Kai Gui

2016-07-01

Full Text Available Functional electrical stimulation (FES sometimes applies to patients with partial paralysis, so human voluntary control and FES control both exist. Our study aims to build a cooperative controller to achieve human-FES cooperation. This cooperative controller is formed by a classical FES controller and an impedance controller. The FES controller consists of a back propagation (BP neural network-based feedforward controller and a PID-based feedback controller. The function of impedance controller is to convert volitional force/torque, which is estimated from a three-stage filter based on EMG, into additional angle. The additional angle can reduce the FES intensity in our cooperative controller, comparing to that in classical FES controller. Some assessment experiments are designed to test the performance of the cooperative controller.

Impacts of small vestibular schwannoma on community ambulation, postural, and ocular control.

Science.gov (United States)

Low Choy, Nancy L; Lucey, Mary-Therese M; Lewandowski, Susan L; Panizza, Benedict J

2017-05-01

To investigate balance, community mobility, gaze instability, and dizziness handicap and assess falls risk in people who are conservatively managed with small vestibular schwannoma (VS). Cross-sectional study with controls. The study involved 18 people (mean age 58.7 ± 12.2 years) diagnosed with VS (<12 mm) and 22 age-matched controls (mean age 56.9 ± 8.0 years). Measures included standing on firm and foam surfaces with feet apart, then together with eyes open and closed, Timed Up and Go (TUG) test and dual TUG test, Dynamic Gait Index, 6-Minute Walk Test, Halmagyi Impulse Test, Dynamic Visual Acuity Test, and the Dizziness Handicap Inventory. The clinical group failed more trials standing feet together on foam with eyes closed (P < .05); had inferior mobility and walked more slowly with divided attention (P < .05); had more difficulty walking with head movement, negotiating obstacles, and using stairs (P < .01); and walked shorter distances (P < .001) than controls. Reduced gaze stability (P < .01) and higher total (P = .007) and subcategory dizziness handicap scores (P < .05) were revealed compared to age-matched controls. Although outcomes for the clinical group are inferior to the control group across all measures and the dizziness impact is higher, the results fall in the low-risk category for falls. Preliminary data (level 4 evidence) support using a suite of clinical measures to monitor people with VS during conservative management. 4 Laryngoscope, 127:1147-1152, 2017. © 2016 The American Laryngological, Rhinological and Otological Society, Inc.

Exploratory shaft facility preliminary designs - Gulf Interior Region salt domes

International Nuclear Information System (INIS)

1983-09-01

The purpose of the Preliminary Design Report, Gulf Interior Region, is to provide a description of the preliminary design for an Exploratory Shaft Facility on the Richton Dome, Mississippi. This issue of the report describes the preliminary design for constructing the exploratory shaft using the Large Hole Drilling method of construction and outlines the preliminary design and estimates of probable construction cost. The Preliminary Design Report is prepared to complement and summarize other documents that comprise the design at the preliminary stage of completion, December 1982. Other design documents include drawings, cost estimates and schedules. The preliminary design drawing package, which includes the construction schedule drawing, depicts the descriptions in this report. For reference, a list of the drawing titles and corresponding numbers are included in the Appendix. The report is divided into three principal sections: Design Basis, Facility Description and Construction Cost Estimate

Quantitative comparison of OSEM and penalized likelihood image reconstruction using relative difference penalties for clinical PET

International Nuclear Information System (INIS)

Ahn, Sangtae; Asma, Evren; Cheng, Lishui; Manjeshwar, Ravindra M; Ross, Steven G; Miao, Jun; Jin, Xiao; Wollenweber, Scott D

2015-01-01

Ordered subset expectation maximization (OSEM) is the most widely used algorithm for clinical PET image reconstruction. OSEM is usually stopped early and post-filtered to control image noise and does not necessarily achieve optimal quantitation accuracy. As an alternative to OSEM, we have recently implemented a penalized likelihood (PL) image reconstruction algorithm for clinical PET using the relative difference penalty with the aim of improving quantitation accuracy without compromising visual image quality. Preliminary clinical studies have demonstrated visual image quality including lesion conspicuity in images reconstructed by the PL algorithm is better than or at least as good as that in OSEM images. In this paper we evaluate lesion quantitation accuracy of the PL algorithm with the relative difference penalty compared to OSEM by using various data sets including phantom data acquired with an anthropomorphic torso phantom, an extended oval phantom and the NEMA image quality phantom; clinical data; and hybrid clinical data generated by adding simulated lesion data to clinical data. We focus on mean standardized uptake values and compare them for PL and OSEM using both time-of-flight (TOF) and non-TOF data. The results demonstrate improvements of PL in lesion quantitation accuracy compared to OSEM with a particular improvement in cold background regions such as lungs. (paper)

SmallWorld Behavior of the Worldwide Active Volcanoes Network: Preliminary Results

Science.gov (United States)

Spata, A.; Bonforte, A.; Nunnari, G.; Puglisi, G.

2009-12-01

We propose a preliminary complex networks based approach in order to model and characterize volcanoes activity correlation observed on a planetary scale over the last two thousand years. Worldwide volcanic activity is in fact related to the general plate tectonics that locally drives the faults activity, that in turn controls the magma upraise beneath the volcanoes. To find correlations among different volcanoes could indicate a common underlying mechanism driving their activity and could help us interpreting the deeper common dynamics controlling their unrest. All the first evidences found testing the procedure, suggest the suitability of this analysis to investigate global volcanism related to plate tectonics. The first correlations found, in fact, indicate that an underlying common large-scale dynamics seems to drive volcanic activity at least around the Pacific plate, where it collides and subduces beneath American, Eurasian and Australian plates. From this still preliminary analysis, also more complex relationships among volcanoes lying on different tectonic margins have been found, suggesting some more complex interrelationships between different plates. The understanding of eventually detected correlations could be also used to further implement warning systems, relating the unrest probabilities of a specific volcano also to the ongoing activity to the correlated ones. Our preliminary results suggest that, as for other many physical and biological systems, an underlying organizing principle of planetary volcanoes activity might exist and it could be a small-world principle. In fact we found that, from a topological perspective, volcanoes correlations are characterized by the typical features of small-world network: a high clustering coefficient and a low characteristic path length. These features confirm that global volcanoes activity is characterized by both short and long-range correlations. We stress here the fact that numerical simulation carried out in

Clinical correlates of between-limb synchronization of standing balance control and falls during inpatient stroke rehabilitation.

Science.gov (United States)

Mansfield, Avril; Mochizuki, George; Inness, Elizabeth L; McIlroy, William E

2012-01-01

Stroke-related sensorimotor impairment potentially contributes to impaired balance. Balance measures that reveal underlying limb-specific control problems, such as a measure of the synchronization of both lower limbs to maintain standing balance, may be uniquely informative about poststroke balance control. This study aimed to determine the relationships between clinical measures of sensorimotor control, functional balance, and fall risk and between-limb synchronization of balance control. The authors conducted a retrospective chart review of 100 individuals with stroke admitted to inpatient rehabilitation. Force plate-based measures were obtained while standing on 2 force plates, including postural sway (root mean square of anteroposterior and mediolateral center of pressure [COP]), stance load asymmetry (percentage of body weight borne on the less-loaded limb), and between-limb synchronization (cross-correlation of the COP recordings under each foot). Clinical measures obtained were motor impairment (Chedoke-McMaster Stroke Assessment), plantar cutaneous sensation, functional balance (Berg Balance Scale), and falls experienced in rehabilitation. Synchronization was significantly related to motor impairment and prospective falls, even when controlling for other force plate-based measures of standing balance control (ie, postural sway and stance load symmetry). Between-limb COP synchronization for standing balance appears to be a uniquely important index of balance control, independent of postural sway and load symmetry during stance.

Clinical application of CT-controlled stereotactic aspiration for intracerebral hematoma

International Nuclear Information System (INIS)

Chen Weijian; Zhuge Qichuan; Zheng Rongyuan; Guo Xianzhong; Zhong Ming; Wu Jinsen; Qu Xuanxing

2002-01-01

Objective: To evaluate the clinical application of CT-controlled stereotactic aspiration for intracerebral hematoma. Methods: CT-guided stereotactic system was installed on the CT bed, and checked against a standard of the coordinate. According to controlled CT scan, the target can be adjusted at any time in the operation. 860 patients with cerebral hematoma underwent CT-controlled stereotactic aspiration. Of the 860 cases, basal ganglion hematoma was present in 408, thalamus and posterior limb of internal capsule hematoma in 136, cerebral lobe hematoma in 261, cerebellar hematoma in 5, ventricular hemorrhage in 10, midbrain and pons hemorrhage in 37, and medulla hemorrhage in 3. Results: Easy drainage of hematoma by aspiration was achieved in 586 cases, stickiness of hematoma with clearing away more than 50% was performed in 202 and less than 50% in 68. The operation duration ranged from 25 to 120 minutes (average 45 minutes). 693 cases survived and 167 cases died. According to the evaluation by active day life (ADL) after 3 months in survivors, ADL 1-2, ADL 3, ADL 4 and ADL 5 results were achieved in 378 cases, 166 cases, 107 cases, and 28 cases, respectively. In addition, 14 cases were lost beyond recall. Conclusion: CT-controlled stereotactic aspiration for intracerebral hematoma is a handy, less invasive, and safe procedure with high accuracy and curative effect, it is worth while popularizing the procedure

Histo-morphological findings and preliminary clinical findings after pre-operative short-term irradiation of squamous cell carcinomas of the floor of the mouth using telecobalt sources

International Nuclear Information System (INIS)

Dieckmann, J.; Morgenroth, K.; Hering, K.; Will, C.

1981-01-01

In a clinical investigation, the preoperative short-term telecobalt irradiation of patients with carcinoma of the floor of the mouth was tested. On 50 patients, the preoperative irradiation was applied after identifying the tumour by PE and fast cesion examination. Within 3 days, a focal dose of 15 to 20 Gy was applied. On the 4th day, the radical operation took place. 2-3 weeks after the operation, the saturation irradiation was carried out. For the purpose of testing, 100 patients under our usual combined treatment with radical operation plus postoperative curative telecobalt irradiation were refined to. The tissue sample before irradiation was histologically compared to the preoperatively irradiated tumour. The examinations revealed definitively a letal damage of the tumour cells. Up to the moment, the clinical results could not be received statistically because the investigation had just been finished when the draft of the speech was in preparation. But we can state, as a preliminary result, that there is a trend recognizable in which the mortality in the patients group seems to be appr. 8% lower. It is noteworthy, however, that the relapse and metastase behaviour in the group of preirradiated tumours seems to be significantly better than in the group irradiated only surgically and postoperatively: it is seen that the tumour-caused mortality in the first group is 18% less than in the latter. (orig.) [de

Effectiveness of Aerobic Exercise as an Augmentation Therapy for Inpatients with Major Depressive Disorder: A Preliminary Randomized Controlled Trial.

Science.gov (United States)

Shachar-Malach, Tal; Cooper Kazaz, Rena; Constantini, Naama; Lifschytz, Tzuri; Lerer, Bernard

2015-01-01

Physical exercise has been shown to reduce depressive symptoms when used in combination with antidepressant medication. We report a randomized controlled trial of aerobic exercise compared to stretching as an augmentation strategy for hospitalized patients with major depression. Male or female patients, 18-80 years, diagnosed with a Major Depressive Episode, were randomly assigned to three weeks of augmentation therapy with aerobic (n=6) or stretching exercise (n=6). Depression was rated, at several time points using the 21-item Hamilton Depression Scale (HAM-D), Beck Depression Inventory (BDI) and other scales. According to the HAM-D, there were four (out of six) responders in the aerobic group, two of whom achieved remission, and none in the stretching group. According to the BDI, there were two responders in the aerobic group who were also remitters and none in the stretching group. The results of this small study suggest that aerobic exercise significantly improves treatment outcome when added to antidepressant medication. However, due to the small sample size the results must be regarded as preliminary and further studies are needed to confirm the findings.

The Adolescent HIV Disclosure Cognition and Affect Scale: Preliminary Reliability and Validity.

Science.gov (United States)

Evangeli, Michael

2017-07-01

Globally, there are 2 million HIV-positive 10-19-year-olds. One challenge for this population is sharing their HIV status with others (onward HIV disclosure). There are no multi-item, multidimensional scales of HIV disclosure cognitions and affect for young people living with HIV. An 18-item measure of HIV disclosure cognition and affect was developed, administered to 65 adolescents living with HIV (aged 12-16 years). Data were explored using principal component analysis and preliminary construct and criterion validity assessed. Three factors were revealed: negative disclosure attitudes and feelings, self-efficacy, and positive disclosure attitudes and feelings. The full scale and its subscales were internally consistent. The total score showed statistically significant positive relationships with HIV disclosure in the past 6 months, HIV disclosure intention and self-perception. Preliminary evidence of the measure's good psychometric properties suggests it may be helpful in future clinical and research work. © The Author 2017. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Interactive Block Games for Assessing Children's Cognitive Skills: Design and Preliminary Evaluation

Directory of Open Access Journals (Sweden)

Kiju Lee

2018-05-01

Full Text Available Background: This paper presents design and results from preliminary evaluation of Tangible Geometric Games (TAG-Games for cognitive assessment in young children. The TAG-Games technology employs a set of sensor-integrated cube blocks, called SIG-Blocks, and graphical user interfaces for test administration and real-time performance monitoring. TAG-Games were administered to children from 4 to 8 years of age for evaluating preliminary efficacy of this new technology-based approach.Methods: Five different sets of SIG-Blocks comprised of geometric shapes, segmented human faces, segmented animal faces, emoticons, and colors, were used for three types of TAG-Games, including Assembly, Shape Matching, and Sequence Memory. Computational task difficulty measures were defined for each game and used to generate items with varying difficulty. For preliminary evaluation, TAG-Games were tested on 40 children. To explore the clinical utility of the information assessed by TAG-Games, three subtests of the age-appropriate Wechsler tests (i.e., Block Design, Matrix Reasoning, and Picture Concept were also administered.Results: Internal consistency of TAG-Games was evaluated by the split-half reliability test. Weak to moderate correlations between Assembly and Block Design, Shape Matching and Matrix Reasoning, and Sequence Memory and Picture Concept were found. The computational measure of task complexity for each TAG-Game showed a significant correlation with participants' performance. In addition, age-correlations on TAG-Game scores were found, implying its potential use for assessing children's cognitive skills autonomously.

Clinical characteristics of impulse control and related disorders in Chinese Parkinson's disease patients.

Science.gov (United States)

Zhang, Yu; He, An Qi; Li, Lin; Chen, Wei; Liu, Zhen Guo

2017-05-18

Impulse control and related disorders (ICRDs) are clinically complications in Parkinson's disease (PD). However, the clinical characteristics of ICRDs in Chinese PD patients were rarely reported. We aimed to explore the prevalence and the clinical profile of ICRDs in Chinese patients with PD. 142 Chinese PD patients were consecutively enrolled. The symptoms of ICRDs were assessed with the Questionnaire for Impulsive-Compulsive Disorders. The clinical characteristics of patients with ICRDs and without ICRDs were compared. ICRDs were present in 31% of our patients. The most common ICRDs were compulsive medication use (11.3%) and punding (9.2%); the least frequent were walkabout (1.4%). Variables independently associated with ICRDs were earlier onset of the disease (≤55 years), severe cognitive impairment (MMSE 10-20), the dose of dopamine agonist (>1 mg/d) and dyskinesia. ICRDs was commonly found in Chinese PD patients. Earlier onset of the disease, the dose of dopamine agonist, severe cognitive impairment and dyskinesia are independent factors associated with ICRDs. Our results will be benefit for clinicians to assess the risk of developing ICRDs before delivering dopaminergic medication.

An approach to quality and performance control in a computer-assisted clinical chemistry laboratory.

Science.gov (United States)

Undrill, P E; Frazer, S C

1979-01-01

A locally developed, computer-based clinical chemistry laboratory system has been in operation since 1970. This utilises a Digital Equipment Co Ltd PDP 12 and an interconnected PDP 8/F computer. Details are presented of the performance and quality control techniques incorporated into the system. Laboratory performance is assessed through analysis of results from fixed-level control sera as well as from cumulative sum methods. At a simple level the presentation may be considered purely indicative, while at a more sophisticated level statistical concepts have been introduced to aid the laboratory controller in decision-making processes. PMID:438340

Cervix cancer: clinical aspects of tumoral control and radiotherapy treatment time

International Nuclear Information System (INIS)

Petitto, J.V.

1994-01-01

The author analyzed 35 patients with recurrence or residual tumor at the end of the radiotherapy program. These patients were selected out of a group of 338 patients cervix cancer who had also undergone on the same radiotherapy program. Those patients were compared with control group of 30 patients without clinical evidence of the disease, from the same group of 338 patients. It has studied the clinical results considering the total radiotherapy time to developed the radiation program and factors that could modify the time for a longer program, and also modify the final survival results. No significant difference was shown in this study, but it should be taken in consideration the total radiotherapy time, because this is a factor that could change the final results if the time would be longer than what was shown in this work. (author). 26 refs, 10 tabs

Disciplined Decision Making in an Interdisciplinary Environment: Some Implications for Clinical Applications of Statistical Process Control.

Science.gov (United States)

Hantula, Donald A.

1995-01-01

Clinical applications of statistical process control (SPC) in human service organizations are considered. SPC is seen as providing a standard set of criteria that serves as a common interface for data-based decision making, which may bring decision making under the control of established contingencies rather than the immediate contingencies of…

Preliminary power train design for a state-of-the-art electric vehicle

Science.gov (United States)

Ross, J. A.; Wooldridge, G. A.

1978-01-01

The state-of-the-art (SOTA) of electric vehicles built since 1965 was reviewed to establish a base for the preliminary design of a power train for a SOTA electric vehicle. The performance of existing electric vehicles were evaluated to establish preliminary specifications for a power train design using state-of-the-art technology and commercially available components. Power train components were evaluated and selected using a computer simulation of the SAE J227a Schedule D driving cycle. Predicted range was determined for a number of motor and controller combinations in conjunction with the mechanical elements of power trains and a battery pack of sixteen lead-acid batteries - 471.7 kg at 0.093 MJ/Kg (1040 lbs. at 11.7 Whr/lb). On the basis of maximum range and overall system efficiency using the Schedule D cycle, an induction motor and 3 phase inverter/controller was selected as the optimum combination when used with a two-speed transaxle and steel belted radial tires. The predicted Schedule D range is 90.4 km (56.2 mi). Four near term improvements to the SOTA were identified, evaluated, and predicted to increase range approximately 7%.

American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis.