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CORDIS - Resultados de investigaciones de la UE
CORDIS

PCOS IN ADOLESCENT GIRLS AND YOUNG WOMEN: TOWARD A TREATMENT GUIDED BY PATHOPHYSIOLOGY

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

First study subject approval package (se abrirá en una nueva ventana)

Will include:--- Templates of the Informed Consent Document (in language and terms intelligible to the participants), and details on how the consent of the legal representatives (and assent, when applicable) will be acquired-- Approvals required for invitation / enrolment of first subject in at least one clinical centre: ethics committees, national competent authorities and copies of opinion or confirmation by the competent Institutional Data Protection Officer (DPO) and/or authorization or notification by the National Data Protection Authority-- Registration number of clinical study in a WHO- or ICMJE- approved registry that also allows later posting of study results:-- Final version of study protocol as approved by first regulator / ethics committee(s), including: The procedures to be adopted to ensure the sensitive management of the participation of vulnerable individuals must be described and submitted as a deliverable; Details on incidental findings policy; The measures that will be adopted, at the end of the trial, with regard to the individuals to whom the placebo has not been administered.-- A document enclosing details on the type of cells and tissues from biobanks used in the project, as well as biobanks details (including but not limited to access restrictions). A paragraph has been added to section 5.1.4 Human Cells and TissuesM12

Report on communication and dissemination activities (se abrirá en una nueva ventana)

A detailed list of dissemination activities carried out halfway through the project, with assessment of their impact, the degree of compliance with the plan, and a description of foreseen dissemination activities until the end of the project.Update 1 - month 24Update 2 - month 36Update 3 - month 48Update 4 - month 60

Project Website (se abrirá en una nueva ventana)

A specific website for the project as described in task 6.3 will be developed. A document including screenshots and the link to the website will be generated.

Publicaciones

study protocol for a multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial (se abrirá en una nueva ventana)

Autores: Garcia-Beltran, Cristina; Malpique, Rita; Andersen, Marianne S.; Bas, Firdevs; Bassols, Judit; Darendeliler, Feyza; Díaz, Marta; Dieris, Barbara; Fanelli, Flaminia; Fröhlich-Reiterer, Elke; Gambineri, Alessandra; Glintborg, Dorte; López-Bermejo, Abel; Mann, Christopher; Marin, Silvia; Obermayer-Pietsch, Barbara; Ødegård, Rønnaug; Ravn, Pernille; Reinehr, Thomas; Renzulli, Matteo; Salvado
Publicado en: Crossref, Edición 4, 2023, ISSN 1539-3704
Editor: PubMed
DOI: 10.1186/s13063-023-07593-6

Adolescent PCOS: a postpubertal central obesity syndrome (se abrirá en una nueva ventana)

Autores: Lourdes Ibáñez and Francis de Zegher
Publicado en: Trends in Molecular Medicine, 2023, ISSN 1471-499X
Editor: Trends in Molecular Medicine
DOI: 10.1016/j.molmed.2023.02.006

ODP426 SPIOMET4HEALTH: a 4-Arm Trial to Test the Effects of Lifestyle Intervention plus either Placebo, or Pioglitazone (PIO), or Spironolactone-Pioglitazone (SPIO), or Spironolactone-Pioglitazone-Metformin (SPIOMET) in Adolescent Girls and Young Women with PCOS (se abrirá en una nueva ventana)

Autores: Lourdes Ibanez; Francis de Zegher; Rita Malpique; Firdevs Bas; Feyza Darendeliler; Flaminia Fanelli; Alessandra Gambineri; Judit Bassols; Abel Lopez-Bermejo; Barbara Obermayer-Pietsch; Veronika Tandl; Dorte Glintborg; Pernille Ravn; Barbara Dieris; Viola Singer; Thomas Reinehr; Ronnaug Odegard; Eszter Vanky
Publicado en: Crossref, Edición 7, 2022, ISSN 2472-1972
Editor: Jorunal of the Endocrine Society
DOI: 10.1210/jendso/bvac150.1382

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