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Phase IV (phase + iv)

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Medical Sciences	55%

Selected Abstracts

Evaluation of Tielle hydropolymer dressings in the management of chronic exuding wounds in primary care

INTERNATIONAL WOUND JOURNAL, Issue 1 2005
Article first published online: 31 MAR 200
Evaluation des pansements hydropolymère Tielle dans la prise en charge des plaies exsudatives en soins de proximité Le concept de cicatrisation en milieu humide n'est pas complètement compris en pratique quotidienne en Allemagne. C'est pourquoi l'objectif de cette etude était d'évaluer les pansements hydropolymères Tielle sur les plaies chroniques exsudatives en soins de proximité. Un total de 6993 patients présentant des escarres (26·6%), des ulcères de jambe d'origine veineuse (59·8%), une plaie du pied diabétique (9·5%) et d'autres plaies (5·1%) ont été inclus dans des études multicentriques, ouvertes, à un seul bras, prospectives, phase IV pour une période observationelle respectivement de 4 ou de 12 semaines. Durant les 4 (12) semaines d'observation sous Tielle, 43·3%(59·1%) des plaies ont guéri, 51·6%(36·9%) ont été améliorées. La surface de la plaie a été réduite de 78·2%(85·1%). "L'exsudation moyenne ou importante "a été réduite de 57·4%à 6·7%(40%). Les resultats cosmétologiques étaient "excellents ou bons" dans 96·3% En comparaison des traitements antérieurs, efficacité et la tolérabilitéétainet évaluées comme meilleure/bien meilleure respectivement dans 92·5% et 70·4%. 97·1% des patients n'ont présenté aucun évènement indésirable. La fréquence du changement de bandages était réduite de 5 à 3 par semaine (,43%). Tielle est un pansement efficace et sûr dans la prise en charge des plaies chroniques exsudatives en soins de proximité et améliore le confort des patients. Du fait d'une durée de maintien en place du pansement augmentée Tielle paut aussi être plus économique. Evaluation von Tielle Hydroploymerverbänden in der primären Wundbehandlung chronisch nässender Wunden Das Konzept der feuchten Wundbehandlung wird in Deutschland in der täglichen Praxis immer noch nicht im vollen Umfang angewandt. Gegenstand dieser Untersuchung war es, Tielle Hydroplymer -Verbände in der primären Wundbehandlung chronisch exsudativer Wunden zu evaluieren. Insgesamt wurden 6993 Patienten mit Dekubitalgeschwüren (26,6%), venös bedingten Ulzerationen (59,8%), beim diabetischen Fußsyndrom (9,5%) sowie bei Wunden anderer Genese (5,1%) in 3 prospektiven Multizenter- Phase IV- Studien über einen Beobachtungszeitraum von 4 bzw. 12 Wochen protokolliert. Im Beobachtungszeitraum von 4 [12] Wochen mit Tielle heilten 43,3%[59,1%] der Wunden, in 51,6%[36,9] kam es zu einer Verbesserung. Die Wundgröße reduzierte sich von 57,4 auf 6,7%[1,0%]. Das Kosmetische Ergebnis wurde in 96,3% als gut oder exzellent bezeichnet. Eine bessere Effektivität und Akzeptanz im Vergleich zur Vorbehandlung wurde in 92,5% bzw. 70,4% verzeichnet. In 97,1% der Patienten war kein Verfahrenswechsel erforderlich. Die Frequenz der Verbandswechsel konnte von 5 auf 3 pro Woche reduziert werden (,43%). Tielle stellt einen effektiven und sicheren Wundverband in der Behandlung chronisch nässender Wunden dar und führt zu einem verbesserten Patientenkomfort. Durch eine längere Anwendungdauer kann Tielle zusätzlich Kosten reduzieren. Valutazione della medicazione a base di idropolimeri TIELLE nella gestione di ulcere essudanti in medicina generale Il concetto di guarigione delle ferite in ambiente umido non è completamente implementato nella pratica quotidiana in Germania. Quindi l'obiettivo di questa ricerca è stato di valutare la medicazione TIELLE a base di idropolimeri su ulcere croniche essudanti nella pratica di medicina generale. Un totale di 6993 pazienti con ulcere da pressione (26·6%), ulcere venose della gamba (59·8%), sindrome del piede diabetico (9·5%) e altre ferite (5·1%) sono state arruolate all'interno di tre studi multicentrici, in aperto, a braccio singolo, prospettici e di fase IV, per un periodo osservazionale di 4 o 12 settimane rispettivamente. All'interno del gruppo di osservazione di 4 (12) settimane con TIELLE, il 43·3%(59·1%) delle ferite è andato incontro a guarigione, mentre il 51·6%(36·9%)è migliorato. La superficie di lesione si è ridotta del 78·2%(85·1%). "L'essudazione medio-intensa" si è ridotta dal 57·4% al 6·7%(4·0%). I risultati cosmetici sono stati "eccellenti o buoni" nel 96·3%. L'efficacia e tollerabilità paragonata a trattamenti precedenti è risultata come migliore/molto migliore nel 92·5% e 70·4% rispettivamente. Il 97·1% dei pazienti è rimasto libero da eventi avversi. La frequenza dei cambi di bendaggio è stata ridotta da 5 a 3 per settimana (,43%). TIELLE rappresenta una valida e sicura medicazione per ulcere croniche essudanti gestite in medicina generale per migliorare il comfort dei pazienti. Come conseguenza della ridotta frequenza di cambio, TIELLE può essere considerato in termini di contenimento dei costi di gestione Evaluación de los apósitos hidropoliméricos Tielle en el tratamiento de heridas exudativas crónicas en asistencia primaria En Alemania, el concepto de cicatrización de la herida en medio húmedo no se ha impuesto por completo en la práctica diaria. Por lo tanto, el objetivo de esta investigación era evaluar los apósitos hidropoliméricos Tielle en heridas exudativas crónicas en un contexto de asistencia primaria. Se incluyó a un total de 6·993 pacientes con úlceras por decúbito (26·6%), úlceras crurales venosas (59,8%), síndrome de pie diabético (9,5%) y otras heridas(5,1%), en tres estudios de fase IV, prospectivos, multicéntricos, en régimen abierto, de un solo brazo, durante un período de observación de 4 ó 12 semanas, respectivamente. En el curso de la observación durante 4 [12] semanas de uso del Tielle, curó el 43,3%[59,1%] de las heridas y mejoró el 51,6%[36,9%]. El área de la herida se redujo en un 78,2%[85,1%]. La exudación "moderada o intensa" se redujo del 57,4% al 6,7%[4,0%]. Los resultados cosméticos fueron "excelentes o buenos" en el 96,3% de los casos. En comparación con la eficacia y la tolerabilidad del tratamiento anterior, el actual se evaluó como mejor/mucho mejor en el 92,5% y 70,4% de los casos, respectivamente. Un 97,1% de los pacientes no sufrió efectos adversos. La frecuencia de los cambios de apósito se redujo de 5 a 3 veces por semana (,43%). Tielle ofrece un apósito eficaz y seguro para el tratamiento de heridas exudativas crónicas en asistencia primaria, lo que mejora la comodidad del paciente. Debido a los tiempos de uso más prolongados, Tielle también puede ser rentable. Utvärdering av Tielle hydropolymer sårförband i vården av kroniska vätskande sår i primärvården Begreppet fuktig sårläkning är inte fullt realiserat i daglig praktik i Tyskland. Sålunda var målet för denna studie att evaluera Tielle hydropolymer sårförband i kroniska vätskande sår i primärvården. Totalt 6993 patienter med trycksår (26·6%), venösa bensår (59·8%), diabetes fotsår (9·5%) och andra sår(5·1%) var inskrivna i tre öppna, icke-jämförande, prospektiva, fas IV multicenterprövningar för en observationsperiod av 4 eller 12 veckor. Inom 4 [12] veckors observationen med Tielle, hälnade 43·3%[59·1%] av såren, 51·6%[36·9%] förbättrades. Sårytan minskade med 78·2%[85·1%]. "Medelstark eller stark" vätskeutsöndring minskade från 57·4% till 6·7%[4·0%]. Kosmetiska resultatet var "utmärkt eller gott" i 96·3%. Jämfört med föregående behandling bedömdes effektivitet och tolerans som bättre/mycket bättre i 92·5% eller 70·4%. Av patienterna förblev 97·1% fria från avvikande reaktioner. Omläggningsfrekvensen minskade från 5 till 3 per vecka (,43%). Tielle utgör ett effektivt och tryggt sårförband i vården av kroniska vätskande sår i primärvården och förbättrar patientens välbefinnande. Tack vare längre användningstid kunde Tielle också vara kostnadssparande. [source]

Development of Geriatric Competencies for Emergency Medicine Residents Using an Expert Consensus Process

ACADEMIC EMERGENCY MEDICINE, Issue 3 2010
Teresita M. Hogan MD
Abstract Background:, The emergency department (ED) visit rate for older patients exceeds that of all age groups other than infants. The aging population will increase elder ED patient utilization to 35% to 60% of all visits. Older patients can have complex clinical presentations and be resource-intensive. Evidence indicates that emergency physicians fail to provide consistent high-quality care for elder ED patients, resulting in poor clinical outcomes. Objectives:, The objective was to develop a consensus document, "Geriatric Competencies for Emergency Medicine Residents," by identified experts. This is a minimum set of behaviorally based performance standards that all residents should be able to demonstrate by completion of their residency training. Methods:, This consensus-based process utilized an inductive, qualitative, multiphase method to determine the minimum geriatric competencies needed by emergency medicine (EM) residents. Assessments of face validity and reliability were used throughout the project. Results:, In Phase I, participants (n = 363) identified 12 domains and 300 potential competencies. In Phase II, an expert panel (n = 24) clustered the Phase I responses, resulting in eight domains and 72 competencies. In Phase III, the expert panel reduced the competencies to 26. In Phase IV, analysis of face validity and reliability yielded a 100% consensus for eight domains and 26 competencies. The domains identified were atypical presentation of disease; trauma, including falls; cognitive and behavioral disorders; emergent intervention modifications; medication management; transitions of care; pain management and palliative care; and effect of comorbid conditions. Conclusions:, The Geriatric Competencies for EM Residents is a consensus document that can form the basis for EM residency curricula and assessment to meet the demands of our aging population. ACADEMIC EMERGENCY MEDICINE 2010; 17:316,324 © 2010 by the Society for Academic Emergency Medicine [source]

Safety and efficacy of transdermal fentanyl in patients with cancer pain: phase IV, Turkish oncology group trial

EUROPEAN JOURNAL OF CANCER CARE, Issue 1 2007
. KÖMÜRCÜ md
We have performed a prospective evaluation of the efficacy, safety and convenience of the transdermal therapeutic system , fentanyl (TTS-F) in Turkish cancer patients when it was newly available in Turkey. Ninety-nine patients with historically confirmed malignancy and pain entered the study; the mean age was 55.1 (16,58) years. The study duration was 28 days. Transdermal therapeutic system , fentanyl was used in opioid-naïve or pre-treated patients. Most patients reported a decrease in pain severity. Use of rescue medication decreased from day 4 to day 28. The majority of patients rated patch convenience of use as excellent. A total of 22.2% of patients experienced adverse events that were either probably related or very likely to be related to the study drug. The majority of the adverse events mentioned were related to the digestive system. Eighteen serious adverse events were reported by 13 patients. Six events were doubtfully related, and 12 events were not related to the study drug. Four patients died during the trial. None of these deaths was attributed to the study drug. In conclusion, the trial showed that TTS-F is easily managed, effective and will help to enable the appropriate opioid administration to patients who are suffering from cancer pain in Turkey. [source]

Do phytoplankton communities correctly track trophic changes?

FRESHWATER BIOLOGY, Issue 10 2005
An assessment using directly measured, palaeolimnological data
Summary 1. Measurements of total phosphorus (TP) concentrations since 1975 and a 50-year time series of phytoplankton biovolume and species composition from Lake Mondsee (Austria) were combined with palaeolimnological information on diatom composition and reconstructed TP-levels to describe the response of phytoplankton communities to changing nutrient conditions. 2. Four phases were identified in the long-term record. Phase I was the pre-eutrophication period characterised by TP-levels of about 6 ,g L,1 and diatom dominance. Phase II began in 1966 with an increase in TP concentration followed by the invasion of Planktothrix rubescens in 1968, characterising mesotrophic conditions. Phase III, from 1976 to 1979, had the highest annual mean TP concentrations (up to 36 ,g L,1) and phytoplankton biovolumes (3.57 mm3 L,1), although reductions in external nutrient loading started in 1974. Phases II and III saw an expansion of species characteristic of higher nutrient levels as reflected in the diatom stratigraphy. Oligotrophication (phase IV) began in 1980 when annual average TP concentration, Secchi depth and algal biovolume began to decline, accompanied by increasing concentrations of soluble reactive silica. 3. The period from 1981 to 1986 was characterised by asynchronous trends. Annual mean and maximum total phytoplankton biovolume initially continued to increase after TP concentration began to decline. Reductions in phytoplankton biovolume were delayed by about 5 years. Several phytoplankton species differed in the timing of their responses to changing nutrient conditions. For example, while P. rubescens declined concomitantly with the decline in TP concentration, other species indicative of higher phosphorus concentrations, such as Tabellaria flocculosa var. asterionelloides, tended to increase further. 4. These data therefore do not support the hypotheses that a reduction in TP concentration is accompanied by (i) an immediate decline in total phytoplankton biovolume and (ii) persistence of the species composition characterising the phytoplankton community before nutrient reduction. [source]

Effect of standard medication on quality of life of patients with atopic dermatitis

THE JOURNAL OF DERMATOLOGY, Issue 1 2007
Makoto KAWASHIMA
ABSTRACT Patients with atopic dermatitis present with debilitating symptoms, including pruritus and subsequent excoriation, which significantly reduces their quality of life (QOL). At present, the standard therapy for atopic dermatitis constitutes a topical steroid and/or a topical immunomodulator, an emollient and an oral antihistamine, although few studies have reported the effect of this treatment regimen on QOL. The current study aimed to verify the efficacy of the standard therapy for both clinical symptom severity and patient QOL, assessed using the validated Skindex-16 questionnaire. Atopic dermatitis patients receiving the standard therapy (n = 771) were enrolled in the current phase IV, multicenter, 12-week, open-label study. The Rajka and Langeland scale (used to rate the severity of atopic dermatitis symptoms) and the Skindex-16 QOL questionnaire were completed at weeks 0 (baseline), 4 and 12. Of 415 patients completing the questionnaire at all time points (per-protocol population), 95.2% were prescribed the antihistamine fexofenadine HCl 60 mg. There were significant improvements in symptoms, emotions and functioning scale scores at weeks 4 and 12 compared with baseline (P < 0.005). Discomfort associated with itching, as assessed by item 1 on the Skindex-16, improved over the treatment period (score decreased by 1 and 2 in 75.2% and 50.9% of patients, respectively). Significant (P < 0.005) improvements from baseline in global scores were also observed at weeks 4 and 12, and for week 12 compared with week 4. Severity scores improved significantly (P < 0.005) from weeks 0,4 and from weeks 4,12. The standard therapy was generally well tolerated with only mild adverse events reported (0.5%). These data suggest that patients with atopic dermatitis and associated pruritus experience significant improvements in both symptom severity and QOL when receiving standard therapy. [source]

The effect of the European Clinical Trials Directive on published drug research in anaesthesia

ANAESTHESIA, Issue 9 2009
E. Walker
Summary The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment. [source]

Structure,property correlation over five phases and four transitions in Pb5Al3F19

ACTA CRYSTALLOGRAPHICA SECTION B, Issue 5 2003
S. C. Abrahams
The calorimetric and dielectric properties of Pb5Al3F19 in the five phases stable under ambient pressure are correlated with structure for fuller characterization of each phase. The first-order transition between ferroelectric phase V and antiferroelectric phase IV at TV,IV = 260,(5),K exhibits a thermal hysteresis of 135,(5),K on heating, with a maximum atomic displacement ,(xyz)max = 1.21,(6),Å; the transition from phase IV to ferroelastic phase III at 315,(5),K is also first order but with a thermal hysteresis of 10,(5),K and ,(xyz)max = 0.92,(7) ,Å; that from phase III to paraelastic phase II at 360,(5),K is second order without hysteresis and has ,(xyz)max = 0.69,(4),Å; and the transition from phase II to paraelectric phase I at 670,(5),K is second or higher order, with ,(xyz)max = 0.7,(4),Å. The measured entropy change ,S at TV,IV agrees well with ,S as derived from the increased configurational energy by Stirling's approximation. For all other phase transitions, 0.5 ,,S > 0,J,mol,1,K,1 is consistent with an entropy change caused primarily by the changes in the vibrational energy. The structure of phase III is determined both by group theoretical/normal mode analysis and by consideration of the structures of phases II, IV and V reported previously; refinement is by simultaneous Rietveld analysis of the X-ray and neutron diffraction powder profiles. The structure of prototypic phase I is predicted on the basis of the atomic arrangement in phases II, III, IV and V. The introduction of 3d electrons into the Pb5Al3F19 lattice disturbs the structural equilibrium, the addition of 0.04% Cr3+ causing significant changes in atomic positions and increasing TIV,III by ,15,K. Substitution of Al3+ by 20% or more Cr3+ eliminates the potential minima that otherwise stabilize phases IV, III and II. [source]