Skeletal Muscle–Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study

Background and Aims: Fecal incontinence (FI) improvement following injection of autologous skeletal muscle–derived cells has been previously suggested. This study aimed to test the efficacy and safety of said cells through a multicenter, placebo-controlled study, to determine an appropriate cell dose, and to delineate the target patient population that can most benefit from cell therapy. Methods: Patients experiencing FI for at least 6 months were randomized to receive a cell-free medium or low or high dose of cells. All patients received pelvic floor electrical stimulation before and after treatment. Incontinence episode frequency (IEF), FI quality of life, FI burden assessed on a visual analog scale, Wexner score, and parameters reflecting anorectal physiological function were all assessed for up to 12 months. Results: Cell therapy improved IEF, FI quality of life, and FI burden, reaching a preset level of statistical significance in IEF change compared with the control treatment. Post hoc exploratory analyses indicated that patients with limited FI duration and high IEF at baseline are most responsive to cells. Effects prevailed or increased in the high cell count group from 6 to 12 months but plateaued or diminished in the low cell count and control groups. Most physiological parameters remained unaltered. No unexpected adverse events were observed. Conclusions: Injection of a high dose of autologous skeletal muscle–derived cells followed by electrical stimulation significantly improved FI, particularly in patients with limited FI duration and high IEF at baseline, and could become a valuable tool for treatment of FI, subject to confirmatory phase 3 trial(s). (ClinicalTrialRegister.eu; EudraCT Number: 2010-021463-32)

Copeptin for risk stratification in non-traumatic headache in the emergency setting: a prospective multicenter observational cohort study

In the emergency setting, non-traumatic headache is a benign symptom in 80% of cases, but serious underlying conditions need to be ruled out. Copeptin improves risk stratification in several acute diseases. Herein, we investigated the value of copeptin to discriminate between serious secondary headache and benign headache forms in the emergency setting.; Patients presenting with acute non-traumatic headache were prospectively enrolled into an observational cohort study. Copeptin was measured upon presentation to the emergency department. Primary endpoint was serious secondary headache defined by a neurologic cause requiring immediate treatment of the underlying disease. Secondary endpoint was the combination of mortality and hospitalization within 3 months. Two board-certified neurologist blinded to copeptin levels verified the endpoints after a structured 3-month-telephone interview.; Of the 391 patients included, 75 (19%) had a serious secondary headache. Copeptin was associated with serious secondary headache (OR 2.03, 95%CI 1.52-2.70, p < 0.0001). Area under the curve (AUC) for copeptin to identify the primary endpoint was 0.70 (0.63-0.76). After adjusting for age > 50, focal-neurological abnormalities, and thunderclap onset of symptoms, copeptin remained an independent predictive factor for serious secondary headache (OR 1.74, 95%CI 1.26-2.39, p = 0.001). Moreover, copeptin improved the AUC of the multivariate logistic clinical model (p-LR-test < 0.001). Even though copeptin values were higher in patients reaching the secondary endpoint, this association was not significant in multivariate logistic regression.; Copeptin was independently associated with serious secondary headache as compared to benign headaches forms. Copeptin may be a promising novel blood biomarker that should be further validated to rule out serious secondary headache in the emergency department.; Study Registration on 08/02/2010 as NCT01174901 at clinicaltrials.gov

PartNet Methods Paper: Participatory Health Research Model (PHR-Model)

Das „Modell für Partizipative Gesundheitsforschung“ (PGF-Modell) beschreibt die Charakteristiken der Partizipativen Gesundheitsforschung in strukturierter Form. Es zeigt u. a. die mit der PGF einhergehenden Chancen auf, wie zum Beispiel die Entwicklung eines angemessenen Forschungsdesigns durch die partizipative Zusammenarbeit. Das Modell dient der Reflexion verschiedener Aspekte in partizipativen Forschungsprojekten. Im Forschungsprozess selbst kann es vielfältig und zu unterschiedlichen Zwecken eingesetzt werden. Ursprünglich wurde dieses Modell für die Community-basierte Forschung in den USA entwickelt. Nach einem umfassenden kontextuellen Adaptionsprozess kann das Modell nun auch in der PGF für den deutschsprachigen Raum eingesetzt werden. Das Modell unterscheidet vier Komponenten: (1) den Projektkontext, (2) die Projektstruktur sowie die Prozesse der Zusammenarbeit, (3) die Kernmerkmale des partizipativen Forschungsprozesses, und (4) die daraus resultierenden kurz-, mittel- und langfristigen Wirkungen. Das Modell stellt einen Denk- und Reflexionsrahmen dar, der für die Bedürfnisse und das Konzept des jeweiligen Projektes angepasst werden kann. Es kann in vielfältiger Weise genutzt werden und dabei unterstützen, die Bedeutung der einzelnen Komponenten für das eigene Projekt zu bewerten. Das bedeutet, dass Anwender:innen bei Bedarf einzelne Aspekte des Modells vernachlässigen sowie neue Aspekte hinzufügen können. Die hier vorliegende adaptierte Fassung wurde in einem circa zweijährigen Arbeitsprozess innerhalb einer PartNet-Arbeitsgruppe erarbeitet und pilotiert. Die an diesem Prozess Beteiligten bewerten die Anwendung des PGF-Modells zusammenfassend als sehr gewinnbringend und weisen darauf hin, dass ausreichend zeitliche Ressourcen für die Anwendung benötigt werden. Die in Kapitel 7 beigefügten Steckbriefe mit den Anwendungsbeispielen stammen aus der Erprobung. Wir freuen uns, weitere Erfahrungen mit der Anwendung des Modells zusammenzutragen. Sprechen Sie uns hierzu gerne an: Ina Schaefer ([email protected]) oder Theresa Allweiss ([email protected]).The "Model for Participatory Health Research (PGF Model)" describes the core characteristics of participatory health research. The model highlights the opportunities associated with PGF, such as the development of an appropriate research design due to participation. The model is used to reflect on different aspects of participatory research projects. In the research process itself, it can be used in variable ways and for different purposes. Originally developed for Community-Based Participatory Research (CBPR), the model can also be used in PGF and has been adapted for the German-speaking context. There were four sectors in the model: (1) The project context, (2) the project structure as well as the processes of collaboration, (3) the core attributes of the participatory research process, and (4) the resulting impact on a short-, medium-, and long-term level. The model represents a framework of thinking that can be adapted to the needs and concept of the particular project. It can be used in many ways and helps to value the meaning of each sector for the own project. If necessary, single aspects can be added or neglected. The adapted version was developed in a nearly two-year process by a PartNet working group and the adapted version was proved. In summary, the PGF model is assessed as very profitable and takes time for application. The fact sheets with the application examples attached in chapter 7 originate from the proving. We look forward to collect further experience with the application of the model. Feel free to contact: Ina Schaefer ([email protected]) or Theresa Allweiss ([email protected])

Ad R.P. Carolum Nocetium epistolae octo : de singularibus argumentis in ejusdem libro inscripto Veritas vindicata contentis : accedunt opiniones laxae quamplurimae ex variis casuistis collectae

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