title: Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis Treated With Dexamethasone

summary: Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.

ReferenceCitation: Tunkel AR, Hartman BJ, Kaplan SL, Kaufman BA, Roos KL, Scheld WM, Whitley RJ. Practice guidelines for the management of bacterial meningitis. Clin Infect Dis. 2004 Nov 1;39(9):1267-84. doi: 10.1086/425368. Epub 2004 Oct 6. No abstract available.

ReferenceCitation: de Gans J, van de Beek D; European Dexamethasone in Adulthood Bacterial Meningitis Study Investigators. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002 Nov 14;347(20):1549-56. doi: 10.1056/NEJMoa021334.

ReferenceCitation: Auburtin M, Porcher R, Bruneel F, Scanvic A, Trouillet JL, Bedos JP, Regnier B, Wolff M. Pneumococcal meningitis in the intensive care unit: prognostic factors of clinical outcome in a series of 80 cases. Am J Respir Crit Care Med. 2002 Mar 1;165(5):713-7. doi: 10.1164/ajrccm.165.5.2105110.

ReferenceCitation: Viladrich PF, Gudiol F, Linares J, Pallares R, Sabate I, Rufi G, Ariza J. Evaluation of vancomycin for therapy of adult pneumococcal meningitis. Antimicrob Agents Chemother. 1991 Dec;35(12):2467-72. doi: 10.1128/AAC.35.12.2467.

ReferenceCitation: Ricard JD, Wolff M, Lacherade JC, Mourvillier B, Hidri N, Barnaud G, Chevrel G, Bouadma L, Dreyfuss D. Levels of vancomycin in cerebrospinal fluid of adult patients receiving adjunctive corticosteroids to treat pneumococcal meningitis: a prospective multicenter observational study. Clin Infect Dis. 2007 Jan 15;44(2):250-5. doi: 10.1086/510390. Epub 2006 Dec 15.

location_facility: Service de Réanimation Médicale, CHU Louis Mourier

location_facility: Service de Réanimation Médicale, CHI Poissy-St-Germain

location_facility: Service de Réanimation Médicale, CHU Bichat


summary: Experimentally high dose of hyperoncotic human serum albumin improve neurological recovery after head injury reduce cerebral edema and normalize apparent diffusion coefficient of water after ischemia reperfusion. The main hypothesis is that early administration of hyperoncotic serum albumin is able to reduce intracranial pressure for several days after severe head injury and thus reduce mortality and morbidity.

status: Unknown status

study_type: Interventional

design_allocation: Randomized

lead_sponsor: University Hospital, Angers

location_facility: Neurosurgical intensive care. CHU de Nancy

location_facility: Neurosurgical intensive care. CHU Le Kremlin Bicêtre

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir

summary: Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Rozenberg S, Lanoy E, Bentata M, Viard JP, Valantin MA, Missy P, Darasteanu I, Roux C, Kolta S, Costagliola D; ANRS 120 Fosivir Study Group. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012 Sep;28(9):972-80. doi: 10.1089/AID.2011.0224. Epub 2012 Mar 23.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Hôpital Necker service des Maladies Infectieuses

location_facility: Service de Rhumatologie hopital Pitie-Salpetriere

location_facility: Service de Medecine Interne hopital Avicenne

status_simplified: Completed


title: Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Ducreux M, Ychou M, Laplanche A, Gamelin E, Lasser P, Husseini F, Quenet F, Viret F, Jacob JH, Boige V, Elias D, Delperro JR, Luboinski M; gastrointestinal group of the Federation Nationale des Centres de Lutte Contre le Cancer. Hepatic arterial oxaliplatin infusion plus intravenous chemotherapy in colorectal cancer with inoperable hepatic metastases: a trial of the gastrointestinal group of the Federation Nationale des Centres de Lutte Contre le Cancer. J Clin Oncol. 2005 Aug 1;23(22):4881-7. doi: 10.1200/JCO.2005.05.120. Epub 2005 Jul 11.

lead_sponsor: UNICANCER

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

lead_sponsor_type: industriel


type: EudraCT Number

title: Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach

acronym: TRANSREG

summary: TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.

enrollment_type: Actual

ReferenceCitation: Rosenzwajg M, Lorenzon R, Cacoub P, Pham HP, Pitoiset F, El Soufi K, RIbet C, Bernard C, Aractingi S, Banneville B, Beaugerie L, Berenbaum F, Champey J, Chazouilleres O, Corpechot C, Fautrel B, Mekinian A, Regnier E, Saadoun D, Salem JE, Sellam J, Seksik P, Daguenel-Nguyen A, Doppler V, Mariau J, Vicaut E, Klatzmann D. Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial. Ann Rheum Dis. 2019 Feb;78(2):209-217. doi: 10.1136/annrheumdis-2018-214229. Epub 2018 Nov 24.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repositories_concat: HAL

unpaywall_oa_status: bronze

publisher_dissemination: British Medical Journal

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Iltoo Pharma

location_facility: Service de Médecine Interne - Hôpital PITIE SALPETRIERE

location_facility: Service de Gastro Entérologie - Hôpital SAINT-ANTOINE

location_facility: Service de Rhumatologie - Hôpital SAINT-ANTOINE

location_facility: Service de Rhumatologie - Hôpital PITIE SALPETRIERE

location_facility: Service d' Hépato Gastro Entérologie - Hôpital SAINT-ANTOINE

location_facility: Service de Dermatologie - Hôpital COCHIN

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse

location_facility: Médecine interne - Hôpital Saint-Antoine


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy

summary: To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.

ReferenceCitation: Dougados M, Combe B, Braun J, Landewe R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Germany Netherlands France


title: A 12-month Prospective Cohort Study of Mental Health Care Pathways of Adolescents and Young Adults

acronym: JEMMA

summary:
The goal of this prospective cohort study is to study the evolution of adolescent and young people's mental health over a 12-month period after presentation to an emergency department or crisis service for an acute psychiatric episode.

This study aims to:

Describe the mental health care trajectories of adolescents and young adults after an acute psychiatric episode.
Identify psychiatric disorders (such as anxiety, depression, eating disorders, suicidal thoughts, sleep, etc.) at the different time points of the study (at 3, 6, 9 and 12 months after inclusion) ;
Assess the quality of life and functional capacity in daily activities of participants at each study time point ;
Determine the socio-demographic, psychosocial and environmental factors associated with improving mental health over time and with mental health help seeking.

Patients aged from 10 to 24, presenting to one of the participating centers for an acute psychiatric episode, and who agree to participate, will be included in the study. Participants will have to complete an online questionnaire every 3 months over a 12-month period (at baseline (T0), at 3 months (T3), at 6 months (T6), at 9 month (T9) and at 12 months (T12))

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier St Anne

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

location_facility: C.P.O.A (Psychiatric Emergency Department)

location_facility: ATRAP (Acute unit for child outpatients)

location_facility: Pediatric Emergency Department - Necker Hospital

location_facility: Pediatric Emergency Department - Robert Debré Hospital

location_facility: Pediatric Emergency Department - Armand Trousseau Hospital

location_facility: Adult Emergency Department - Bichât Hospital

status_simplified: Ongoing


title: Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.

acronym: BAXASSO

summary:
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.

The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.

primary_purpose: Other

lead_sponsor: CMC Ambroise Paré

location_facility:
Clinique Jouvenet
Clinique Rémusat
Hôpital Privé Paul D'Egine
Hôpital Privé Armand Brillard
Clinique Bizet
Clinique du Pré
CMC Ambroise Paré

intervention_type: Procedure


title: Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction

summary:
The aim of this study conducted in patients with high risk ST-segment elevation AMI admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome and cost-effectiveness of two reperfusion strategies:

Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case of lack of reperfusion
Elective referral for "facilitated" PTCA after early administration of Abciximab and half dose of Reteplase

ReferenceType: background

ReferenceCitation: Di Mario C, Bolognese L, Maillard L, Dudek D, Gambarati G, Manari A, Guiducci V, Patrizi G, Rusconi LC, Piovaccari G, Hibon AR, Belpomme V, Indolfi C, Olivari Z, Steffenino G, Zmudka K, Airoldi F, Panzarasa R, Flather M, Steg PG. Combined Abciximab REteplase Stent Study in acute myocardial infarction (CARESS in AMI). Am Heart J. 2004 Sep;148(3):378-85. doi: 10.1016/j.ahj.2004.03.038.

ReferenceCitation: Di Mario C, Dudek D, Piscione F, Mielecki W, Savonitto S, Murena E, Dimopoulos K, Manari A, Gaspardone A, Ochala A, Zmudka K, Bolognese L, Steg PG, Flather M; CARESS-in-AMI (Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction) Investigators. Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. Lancet. 2008 Feb 16;371(9612):559-68. doi: 10.1016/S0140-6736(08)60268-8.

lead_sponsor: Società Italiana di Cardiologia Invasiva

collaborators: Royal Brompton & Harefield NHS Foundation Trust

location_country: Italy Poland France

location_facility: Oddzial Wewnetrzny - Szpital Powiatowy w Limanowej

location_facility: Oddzial Wewnetrzny - Szpital Mijski w Krynicy

location_facility: First Dept. Cardiology - Gornoslaskiego Centrum Medycznego

location_facility: Zaklad Hemodynamiki i Angiokardiografii - Pracownia 2

location_facility: Service de Cardiologie - Hopital St. Joseph

location_facility: Fondazione Centro San Raffaele del Monte Tabor IRCCS

location_facility: Oddzial Intensywnej Opieki Kardiologicznej i Kardiologii Olgonej

location_facility: Nuovo Ospedale S. Agostino Estense - Baggiovara

location_facility: Oddzial Kardiologii Inwazijnej - Szpital im. E. Szczeklika

location_facility: Szpital Powiatowy im. Sw. Maksimiliana w Oswiecimiu

location_facility: II Oddzial Kardiologiczno - Wewnetrezny Szpital Miejski w Jawozznie

location_facility: Szpital Powiatowy im. Jana Pawla II w Wadowicach

location_facility: Zaklad Hemodynamiki i Angiokardiografii Pracownia 1

location_facility: Oddzial Wewneztrnj Okregowy Szpital Kolciowy

location_facility: Oddzial Kardiologii - Szpital Powiatowy w Zakopane

location_facility: Oddzial Kardiologii - Szpital Miejski w Tychach

intervention_type: Device


acronym: SMILE

lead_sponsor: PENTA Foundation

summary: A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Evelina Children Hospital, St Thomas's Hospital

title: A Two-arm, Phase 2/3 Multicentre, Open-label, Randomised Study Evaluating Safety and Antiviral Effect of Current Standard Antiretroviral Therapy Compared to Once Daily Integrase Inhibitor Administered With Darunavir/Ritonavir (DRV/r) in HIV-1 Infected, Virologically Suppressed Paediatric Participants.

type: Other Identifier

source: euctr

location_country:
Uganda
Portugal
United Kingdom
Argentina
Switzerland
Mexico
Spain
Thailand
South Africa
Ukraine
France


title: Multicenter Single-arm Pilot Study Evaluating Efficacy of Nilotinib in CML Patients With Molecular Relapse After Glivec Discontinuation Within the Context of the STIM Trials (STIM and STIM2)

acronym: NiloPost-STIM

summary:
Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing durable responses. However, requiring continuing IM indefinitely and the ability of IM to eradicate the CML clone was uncertain.

In a small proportion of patients, IM can induce complete molecular response (CMR) defined by the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question whether or not these patients are cured and can discontinue drug therapy has been assessed by Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in patient with a CMR of at least 2 year duration and all patients who relapsed after IM discontinuation mainly did it in the first 6 months and responded to reintroduction of imatinib.

Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved target specificity over imatinib. Its efficacy and safety in the treatment of patients who are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led to the registration in second and first line treatment of CML-CP patients. Nilotinib produces even faster and deeper responses with more occurrence of CMR than does Imatinib. Consequently, one can assume that a more potent drug such nilotinib could induce deeper and sustained CMR allowing longer period off treatment than IM.

The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Haut Lévêque, Service Hématologie

location_facility: Centre Hospitalier Lyon Sud, Service Hématologie

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot - Service de Médecine B

location_facility: CHU de Nice, Service Hématologie Clinique


title: Could Psycho-bio-social Context and Personality be a Predictive Factor of Quality of Life Amelioration After Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease Patients? - PERSO-PERF Study

acronym: PERSO-PERF

summary: Since our previous study has shown that some personality dimensions were associated with Quality of Life (QoL) amelioration after Deep Brain Stimulation (DBS) in Parkinson's disease (PD), the investigators aim to evaluate the impact of personality dimensions on therapeutic response after another second-line treatment: the continuous subcutaneous apomorphine infusion (CSAI). Moreover, the investigators would like to evaluate the potential evolution of personality dimensions through CSAI. The investigators also aim to evaluate other bio-psycho-social factors (representations of the disease, ways of copying and social support) influence on QoL amelioration after DBS.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
ELIVIE France
EVER Pharma France SAS
NHC SAS, France
Orkyn'
ETPARK Association, Toulouse, France

location_facility:
Chu de Grenoble
Chu de Rouen
Chu de Rennes
Chu de Lyon
Chu de Nice
Chu de Toulouse
Hopital Gabriel Montpied
Chu de Poitiers
Chu Limoges
Chu de Nancy

intervention_type: Other


title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity

acronym: SURMOUNT-MMO

summary: This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

status: Recruiting

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
India
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Tianjin Medical University General Hospital

location_facility: DaVita Clinical Research - North Houston

location_facility: General Practitioners Research Institute (GPRI)

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

location_facility: Centro Periférico de Especialidades Bola Azul

location_facility: Diabetes and Thyroid Center of Ft. Worth

location_facility: Unidad de Investigación Clínica y Atención Médica HEPA

location_facility: Centro de Salud e Investigaciones Médicas

location_facility: Shri Bachubhai Dahyabhai Mehta Mahavir Heart Institute

location_facility: Centro de Investigación y Gastroenterología

location_facility: Centro De Diabetes Metabolismo E Endocrinologia

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Cotton O'Neil Clinical Research Center - Central Office

location_facility: The Second Affiliated Hospital of Nanjing Medical University

location_facility: Centro de Estudios Clínicos de Querétaro (CECLIQ)

location_facility: Reinier de Graaf Ziekenhuis, locatie Delft

location_facility: Northeast Research Institute - Downtown Office

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Aydın Adnan Menderes Universitesi Hastanesi

location_facility: Centro Multidisciplinar de Estudos Clinicos

location_facility: Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: Neighborhood Healthcare Institute of Health

location_facility: Centro de Investigacion Cardiovascular y Metabólica

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Hospital Universitario Central de Asturias

location_facility: Instituto de Investigaciones Clínicas Córdoba

location_facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

location_facility: Third People's Hospital of Hainan Province

location_facility: King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

location_facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

location_facility: Centro Privado de Medicina Familiar / Mindout Research

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: 4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

location_facility: Franciscus Gasthuis & Vlietland, Locatie Gasthuis

location_facility: IBPClin - Instituto Brasil de Pesquisa Clínica

location_facility: Centro de Diagnóstico y Rehabilitación (CEDIR)

location_facility: Zentrum für klinische Studien Dr Hanusch Gmbh

location_facility: Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: St. Vincent Hospital d/b/a Prevea Health

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Pamukkale University Medical Faculty, Fahri Goksin Oncology Centre

location_facility: B_serwis Popenda Spolka Jawna Specjalistyczna Przychodnia Lekarska

location_facility: First Huai'an Hospital Affiliated to Nanjing Medical University

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Private Practice - Dr. Francisco Gerardo Padilla

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Encore Medical Research of Boynton Beach

location_facility: SN ZOZ Lege Artis Poradnia Diabetologiczna

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Universität zu Lübeck - Institut für Endokrinologie und Diabetes

location_facility: Instituto de Especialidades de la Salud Rosario

location_facility: Penn Medicine: University of Pennsylvania Health System

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Azienda Ospedaliero Universitaria S.Anna

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

location_facility: Instituto Jalisciense de Investigacion en Diabetes y Obesidad

location_facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Institut für Diabetesforschung GmbH Münster

location_facility: Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen

location_facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

location_facility: Private Practice - Dr. Cristian Podoleanu

location_facility: Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

location_facility: Fundación Cardiovascular de Aguascalientes A.C.

location_facility: Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Clalit Health Services - Sakhnin Community Clinic

location_facility: Nanjing Medical University - Nanjing Jiangning Hospital

location_facility: Northeast Research Institute - St. Augustine

location_facility: Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage

location_facility: Centro de Investigaciones Medicas Temperley

location_facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: CHUAC-Complejo Hospitalario Universitario A Coruña

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario

location_facility: Private Practice - Dr. Mercea Corina Delia

location_facility: University of Colorado Anschutz Medical Campus

location_facility: PanAmerican Clinical Research - Querétaro - Avenida Antea

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Mackay Memorial Hospital -Tamshui Branch

location_facility: Wuhan University Medical College - Hubei Zhongshan Hospital

location_facility: Instituto de Diabetes, Obesidad y Nutricion

location_facility: Sisli Etfal Training and Research Hospital

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

location_facility: University of Sydney - Charles Perkins Centre

location_facility: CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C

location_facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas

location_facility: Centro de Investigacion Medica de Occidente, S.C.

location_facility: North York Diagnostic and Cardiac Centre

location_facility: BR Trials - Ensaios Clinicos e Consultoria

location_facility: Cardiology Associates of Fairfield County, P.C.

location_facility: Yonsei University-Wonju Severance Christian Hospital

location_facility: Instituto Veracruzano en Investigación Clínica S.C.

location_facility: CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani

location_facility: Centro de Investigación Cardiometabólica de Aguascalientes

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Diseno y Planeacion en Investigacion Medica

location_facility: Texas Institute for Kidney and Endocrine Disorders

location_facility: Cardiology Consultants of Philadelphia Yardley

location_facility: Asociación de Beneficencia Hospital Sirio Libanés

location_facility: Pesquisa Clínica em Diabetes - Dra Rosângela Réa

location_facility: NSHA-QEII Health Sciences Centre-Dickson Bldg

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: KLR Business Group, Inc. dba Arkansas Clinical Research

location_facility: Institutul de Boli Cardiovasculare Timișoara

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: University Hospital Coventry & Warwickshire

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Paratus Clinical Research Western Sydney

location_facility: Wickersley Health Centre - Clifton Medical Centre

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

location_facility: Consultorio de Investigación Clínica EMO SRL

location_facility: West China Hospital of Sichuan University

location_facility: Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli

location_facility: Florida Institute For Clinical Research, LLC

location_facility: Centro de Investigaciones Clínicas Baigorria

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Lahoja. Asociacion Para La Investigacion Y La Farmacovigilancia

location_facility: South Florida Clinical Research Institute

location_facility: University of California Irvine Medical Center

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud

location_facility: Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob

location_facility: The National Diabetes & Obesity Research Institute

location_facility: Kidney & Hypertension Center - Apple Valley

location_facility: John Muir Physician Network Research Center

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi

location_facility: Instituto de Investigaciones Clinicas Rosario

location_facility: Valley Institute of Research - Fort Worth

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Southern Adelaide Diabetes & Endocrine Services

location_facility: Instituto de Pesquisa clinica de Campinas

location_facility: Center for Advanced Research & Education

location_facility: Balanced Life Health Care Solutions/SKYCRNG

location_facility: Albany Medical College, Division of Community Endocrinology

location_facility: Centro de Investigacion en Artritis y Osteoporosis SC

location_facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

location_facility: Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej

location_facility: Szent Margit Rendelőintézet Nonprofit Kft

location_facility: The People's Hospital of Liaoning Province

location_facility: Complejo Asistencial Universitario de León - Hospital de León

location_facility: Hospital General Universitario de Valencia

location_facility: The First People's Hospital of Yunnan Province

location_facility: The Second Affiliated Hospital of Zhengzhou University

location_facility: Centre de Medecine Metabolique de Lanaudiere (CMML)

location_facility: Centrul Medical Endocrinologie si Diabet Dr. Paveliu

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Kardiologicka ambulance MUDr. Ferkl s.r.o.

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul

location_facility: Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna

location_facility: VA Nebraska-Western Iowa Health Care System

location_facility: Hebei Medical University - Harrison International Peace Hospital

location_facility: Centro de Investigaciones Médicas Mar del Plata

location_facility: Hospital Universitario Fundacion ALcorcon

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Diabetologikum Ludwigshafen/Die Praxis am Ludwigsplatz

location_facility: Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

location_facility: North Hills Family Medicine/North Hills Medical Research

location_facility: Seoul National University Bundang Hospital

location_facility: Central Washington Health Services Association d/b/a Confluence Health

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: Consultorio de Medicina Especilizada del Sector Privado

location_facility: Centro Medico Privado San Vicente Diabetes

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)

location_facility: MICA - Medicina e Investigación Cardiometabólica

location_facility: University General Hospital of Heraklion

location_facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

location_facility: Albert Schweitzer Ziekenhuis, locatie Dordwijk

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Rophe Adult and Pediatric Medicine/SKYCRNG

location_facility: Brigham and Women's Hospital Diabetes Program

location_facility: Baker IDI Heart and Diabetes Institute - Melbourne

location_facility: Kingsway Hospitals (Best Multispeciality Hospital in Nagpur)

location_facility: Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC


title: TPExtreme: Randomized, Controlled Trial of Platinum-Cetuximab Combined Either With Docetaxel (TPEx) or With 5FU (Extreme) in Patients With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck

acronym: TPExtreme

summary: This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.

ReferenceCitation: Guigay J, Auperin A, Fayette J, Saada-Bouzid E, Lafond C, Taberna M, Geoffrois L, Martin L, Capitain O, Cupissol D, Castanie H, Vansteene D, Schafhausen P, Johnson A, Even C, Sire C, Duplomb S, Evrard C, Delord JP, Laguerre B, Zanetta S, Chevassus-Clement C, Fraslin A, Louat F, Sinigaglia L, Keilholz U, Bourhis J, Mesia R; GORTEC; AIO; TTCC, and UniCancer Head and Neck groups. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2021 Apr;22(4):463-475. doi: 10.1016/S1470-2045(20)30755-5. Epub 2021 Mar 5.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

collaborators: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

location_country: Germany Spain France

location_facility: Institut de Cancérologie de l'Ouest (ICO) René Gauducheau

location_facility: Centre Hospitalier de Bretagne Sud (CHBS)

location_facility: L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin


title: Efficacy of Dorso-lateral Prefrontal Cortex Stimulation by tDCS in Patients With Motor Conversion Disorder - Multicentre Randomized Double Blind Assay

acronym: CONVERSTIM

summary:
Conversion disorder refers to impaired voluntary motor or sensory functions that are not compatible with a well-known neurological condition. This disorder affects up to 30% of hospitalized patients in neurology departments and symptoms persist in 35% of patients after 12 years of evolution. Despite a poor prognosis, no treatments have been validated to date.

The development of non-invasive brain stimulation techniques has allowed the creation of treatments focused on dysfunctional brain regions associated with motor conversion disorder. Hypoactivation of prefrontal dorso-lateral cortex underlies the course of functional motor symptoms. Results of the HYCORE study conducted at Nîmes University Hospital (including 20 patients, clinicaltrial.gov NCT02329626) confirmed these results and related hypoactivation of PFDLC to persistent motor disability at 3 months and 6 months follow-up. Activation of the PFDLC could restore executive control and thus promote the recovery of motor symptoms.

However, in most repeated Transcranial Magnetic Stimulation (rTMS) the primary motor areas were targeted and the clinical improvement was related to self-suggestion induced by the motor response produced.

Among the different techniques, transcranial Direct Current Stimulation (tDCS) is a medical neuromodulation device that delivers a direct, low-intensity electric current to cortical areas, facilitating neuronal activity. Recently, PFDLC stimulation via tDCS has been used to treat several neuropsychiatric disorders and shown to be effective in depression. In addition, this technique has several advantages compared to rTMS: its use is simpler and costs 5 to 8 times less, the device is portable and there is no titration procedure. The tolerance of the tDCS is also better with no risk of epileptic seizure, neuronal depolarization being absent.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Hôpital La Colombière Service de Psychiatrie

location_facility: Hôpital Saint-Antoine Service de Psychiatrie APHP

location_facility: CHU de Montpellier Hôpital Gui De Chauliac Service de Neurologie

location_facility: Hospices Civils de Lyon Hôpital Edouard Herriot

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU NIMES

type_etablissement: CH

acronyme: CONVERSTIM

titre: Efficacité de la stimulation du cortex préfrontal dorso-latéral par tDCS chez les patients atteints de trouble de conversion moteur  Essai multicentrique randomisé en double aveugle

discipline_principale: psychiatry

nom_porteur: CONEJERO

prenom_porteur: Ismael


type: Other Grant/Funding Number

title: National Real-life Study of Tumor Mutational Burden Assessment in First-line Lung Cancer

acronym: MUBULUC

summary: Tumor mutational burden (TMB) seems to be is an important marker for immune checkpoint inhibitors efficacy. This study aims to assess the feasibility of the TMB assessment in first-line lung cancer in routine practice both on biopsy and surgical tumor samples. Results will be an element of discussion for the generalization of the TMB implementation in cancer centers.

status: Terminated

ipd_sharing_description:
Individual participant data (IPD) that underlie results in publication could be shared.

IPD detailed in the protocol of a planned metaanalysis could be shared.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Bristol-Myers Squibb

location_facility: AP-HP - Hôpital Européen Georges-Pompidou


type: Registry Identifier

title: PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study

acronym: PERFUSE

summary: A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) [adults and children] and Ulcerative Colitis (UC) [adults for both treatments and children only for Flixabi].

lead_sponsor: Biogen

location_facility:
Research Site 6
Research Site
Research Site 8
Research Site 1
Research Site 3
Research Site 5
Research Site 4
Research Site 10
Research Site 9
Research Site 2
Research Site 7


title: Same Day Ambulatory Appendectomy (SAMBA)

acronym: SAMBA

summary:
The potential benefit of outpatient care for this common digestive emergency is considerable, both for the patients themselves and for the public health system:

Optimization of the care pathway, reducing the length of stay in hospital (a major issue in the context of the COVID-19 (coronavirus disease) pandemic) liberating patient beds and staff, and reducing the risk of nosocomial exposure.
Improved patient satisfaction compared to waiting for hours in the emergency department due to lack of hospital beds.
Non-inferiority of care in an outpatient unit in terms of quality and safety in day hospitalization.
Significant decrease in the overall cost of this pathology as a result of a reduction in the hospital stay.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Réunion France

location_facility: Hôpital d'Instruction des armées Sainte Anne - BCRM Toulon

location_facility: Hôpital d'Instruction des armées Laveran

location_facility: Hôpitaux Pédiatriques de Nice CHU - Lenval


title: Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer

summary: A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

status: Active, not recruiting

primary_purpose: Supportive Care

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Stimulab

location_facility: Centre d'oncologie et radiothérapie Saint-Jean

location_facility: Sainte Catherine Institut du Cancer Avignon Provence

location_facility: Centre Hospitalier Eure-Seine - Hôpital d'Evreux


title: Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe

acronym: ABCAL

summary:
Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified.

The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics.

The secondary objectives are:

Rates of infectious complications according to duration of preoperative antibiotic
Influence of surgical drainage after surgery for occurrence of postoperative infectious complications
Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections)
Comparison of germs found in the bile during the postoperative infectious complications
Duration of hospitalization
Readmission rate for surgical site infections
Rate of reoperation for surgical site infection
Overall mortality rate at 30 days
Mortality rates specific to 30 days

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ReferenceCitation: Calpena Rico R, Sanchez Llinares JR, Candela Polo F, Perez Vazquez MT, Vazquez Rojas JL, Diego Estevez M, Compan Rosique A, Medrano Heredia J. [Bacteriologic findings as a prognostic factor in the course of acute cholecystitis]. Rev Esp Enferm Apar Dig. 1989 Nov;76(5):465-70. Spanish.

ReferenceCitation: Claesson B, Holmlund D, Matzsch T. Biliary microflora in acute cholecystitis and the clinical implications. Acta Chir Scand. 1984;150(3):229-37.

ReferenceCitation: Csendes A, Burdiles P, Maluenda F, Diaz JC, Csendes P, Mitru N. Simultaneous bacteriologic assessment of bile from gallbladder and common bile duct in control subjects and patients with gallstones and common duct stones. Arch Surg. 1996 Apr;131(4):389-94. doi: 10.1001/archsurg.1996.01430160047008.

ReferenceCitation: Jarvinen HJ. Biliary bacteremia at various stages of acute cholecystitis. Acta Chir Scand. 1980;146(6):427-30.

ReferenceCitation: Linhares MM, Paiva V, Castelo Filho A, Granero LC, Pereira CA, Machado AM, Goldenberg A, Matos D. [Study of preoperative risk factors for bacteriobilia in patients with acute calculosis cholecystitis]. Rev Assoc Med Bras (1992). 2001 Jan-Mar;47(1):70-7. doi: 10.1590/s0104-42302001000100033. French.

ReferenceCitation: Thompson JE Jr, Bennion RS, Doty JE, Muller EL, Pitt HA. Predictive factors for bactibilia in acute cholecystitis. Arch Surg. 1990 Feb;125(2):261-4. doi: 10.1001/archsurg.1990.01410140139024.

ReferenceCitation: Pitt HA, Postier RG, Cameron JL. Consequences of preoperative cholangitis and its treatment on the outcome of operation for choledocholithiasis. Surgery. 1983 Sep;94(3):447-52.

ReferenceCitation: Maluenda F, Csendes A, Burdiles P, Diaz J. Bacteriological study of choledochal bile in patients with common bile duct stones, with or without acute suppurative cholangitis. Hepatogastroenterology. 1989 Jun;36(3):132-5.

ReferenceCitation: Kimura Y, Takada T, Kawarada Y, Nimura Y, Hirata K, Sekimoto M, Yoshida M, Mayumi T, Wada K, Miura F, Yasuda H, Yamashita Y, Nagino M, Hirota M, Tanaka A, Tsuyuguchi T, Strasberg SM, Gadacz TR. Definitions, pathophysiology, and epidemiology of acute cholangitis and cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):15-26. doi: 10.1007/s00534-006-1152-y. Epub 2007 Jan 30.

ReferenceCitation: Hirota M, Takada T, Kawarada Y, Nimura Y, Miura F, Hirata K, Mayumi T, Yoshida M, Strasberg S, Pitt H, Gadacz TR, de Santibanes E, Gouma DJ, Solomkin JS, Belghiti J, Neuhaus H, Buchler MW, Fan ST, Ker CG, Padbury RT, Liau KH, Hilvano SC, Belli G, Windsor JA, Dervenis C. Diagnostic criteria and severity assessment of acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):78-82. doi: 10.1007/s00534-006-1159-4. Epub 2007 Jan 30.

ReferenceCitation: Recommandations de la SFAR. Pour la pratique de l'antibioprophylaxie en chirurgie viscérale. J Chir1999;136:211-5.

ReferenceCitation: Juvonen T, Kiviniemi H, Niemela O, Kairaluoma MI. Diagnostic accuracy of ultrasonography and C reactive protein concentration in acute cholecystitis: a prospective clinical study. Eur J Surg. 1992 Jun-Jul;158(6-7):365-9.

ReferenceCitation: Hakansson K, Leander P, Ekberg O, Hakansson HO. MR imaging in clinically suspected acute cholecystitis. A comparison with ultrasonography. Acta Radiol. 2000 Jul;41(4):322-8. doi: 10.1080/028418500127345587.

ReferenceCitation: De Vargas Macciucca M, Lanciotti S, De Cicco ML, Coniglio M, Gualdi GF. Ultrasonographic and spiral CT evaluation of simple and complicated acute cholecystitis: diagnostic protocol assessment based on personal experience and review of the literature. Radiol Med. 2006 Mar;111(2):167-80. doi: 10.1007/s11547-006-0018-3. English, Italian.

ReferenceCitation: Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.

ReferenceCitation: Weigand K, Koninger J, Encke J, Buchler MW, Stremmel W, Gutt CN. Acute cholecystitis - early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study. Trials. 2007 Oct 4;8:29. doi: 10.1186/1745-6215-8-29.

ReferenceCitation: Fuks D, Duhaut P, Mauvais F, Pocard M, Haccart V, Paquet JC, Millat B, Msika S, Sielezneff I, Scotte M, Chatelain D, Regimbeau JM. A retrospective comparison of older and younger adults undergoing early laparoscopic cholecystectomy for mild to moderate calculous cholecystitis. J Am Geriatr Soc. 2015 May;63(5):1010-6. doi: 10.1111/jgs.13330. Epub 2015 May 6.

oa_host_type: closed

publisher_dissemination: Wiley

ReferenceCitation: Regimbeau JM, Fuks D, Pautrat K, Mauvais F, Haccart V, Msika S, Mathonnet M, Scotte M, Paquet JC, Vons C, Sielezneff I, Millat B, Chiche L, Dupont H, Duhaut P, Cosse C, Diouf M, Pocard M; FRENCH Study Group. Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial. JAMA. 2014 Jul;312(2):145-54. doi: 10.1001/jama.2014.7586.

publisher_dissemination: American Medical Association

lead_sponsor: Centre Hospitalier Universitaire, Amiens

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

location_facility: Chirurgie viscérale et urologique Centre Hospitalier

location_facility: Service de Chirurgie Digestive et Viscérale

location_facility: Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire

location_facility: Centre Hospitalier de Saint-Germain en Laye

location_facility: Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire

location_facility: Service de Chirurgie Viscérale et Digestive

location_facility: Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire

location_facility: Service de Chirurgie Digetsive Centre Hopsitalier Universitaire


title: A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures

acronym: TSF

summary: A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.

lead_sponsor: Kuros Biosurgery AG

sponsor_collaborators:
Kuros Biosurgery AG
Baxter BioScience

location_country:
Finland
Germany
Italy
Slovenia
Slovakia
Hungary
Romania
Switzerland
Serbia
Bulgaria
Czech Republic
France

location_facility: MHATEM ''N.I.Pirogov'' Second clinic of Orthopaedic and Traumatology (84)

location_facility: Spitalul Universitar de Urgenta Bucuresti (87)

location_facility: Fovarosi Onkormanyzat Szent janos Korhaza (81)

location_facility: MHAT ''Sveti Georgi'', Orthopaedic and Traumatology clinic (85)


title: PROgression of FIbromuscular LEsions

acronym: PROFILE

summary: PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.

primary_purpose: Diagnostic

collaborators: Fondation de Recherche sur l'Hypertension Artérielle

location_country: Belgium France

location_facility: CHU de Clermont-Ferrand hopital Gabriel-Montpied

location_facility: Centre Hospitalier de Versailles hopital Andre Mignot

location_facility: CHU de Grenoble hopital Albert-Michallon

intervention_type: Genetic


title: Assessment of Renal and Cervical Artery DysplasIA

acronym: ARCADIA

summary:
ARCADIA is a national registry designed to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia (FMD).

FMD is a group of arterial diseases that most commonly involve renal and carotid arteries. Patients with FMD may present with renovascular hypertension and/or with cerebrovascular symptoms. Angiographic classification includes the multifocal type and the focal type. FMD may affect one or more vascular beds and progress to more severe stenosis and to renal or cerebrovascular complications. FMD may be familial (OMIM #135580).

Our main objective is to create a FMD registry that will collect standardized information from all consenting patients diagnosed with the condition in 16 participating centers. This registry, along with a collection of leukocyte DNA, will constitute a resource for further clinical research on FMD. The first application will be the assessment of the frequency of multi-site FMD, i.e. the frequency of cervical artery FMD in patients presenting with renal artery FMD and vice-versa. The second application will be a case-control study to identify susceptibility genes for FMD.

Patients are eligible in the registry if: (a) they have renal or cervical artery FMD with either multifocal or focal lesions at CT-angiography, MR-angiography, or intra-arterial angiography; (b) they give informed consent to leukocyte DNA analysis and to the collection of bioclinical and morphologic information. Phenotypic assessment will be performed in accordance with current recommendations and best clinical practice.

Given the multicenter nature of the study and the recruitment capacity of each centre, enrollment of 500 FMD cases is expected over 5 years. This number will 1) allow an accurate estimation of the frequency of multi-site FMD: when the sample size is 500, a two-sided 95% confidence interval will extend 0.035 from the observed proportion for an expected proportion of 0.20 based on a previous report and from our unpublished data. 2) In addition to a collection of 400 renal FMD already collected at HEGP, give sufficient power for a genome-wide association study seeking for susceptibility genes

ReferenceCitation: Arnaud C, Boulanger M, Lorthioir A, Amar L, Azarine A, Boyer L, Chatellier G, Di Monaco S, Jeunemaitre X, Kastler A, Mousseaux E, Oppenheim C, Thony F, Persu A, Olin JW, Azizi M, Touze E; ARCADIA Co-investigators dagger. Male Sex Is Associated With Cervical Artery Dissection in Patients With Fibromuscular Dysplasia. J Am Heart Assoc. 2021 Jun;10(11):e018311. doi: 10.1161/JAHA.120.018311. Epub 2021 May 17.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Plouin PF, Baguet JP, Thony F, Ormezzano O, Azarine A, Silhol F, Oppenheim C, Bouhanick B, Boyer L, Persu A, Hammer F, Gosse P, Mounier-Vehier C, Le Hello C, Jeunemaitre X, Azizi M, Amar L, Chatellier G, Mousseaux E, Touze E; ARCADIA Investigators. High Prevalence of Multiple Arterial Bed Lesions in Patients With Fibromuscular Dysplasia: The ARCADIA Registry (Assessment of Renal and Cervical Artery Dysplasia). Hypertension. 2017 Sep;70(3):652-658. doi: 10.1161/HYPERTENSIONAHA.117.09539. Epub 2017 Jul 17.

ipd_sharing_description: Controlled access

sponsor_collaborators: Fondation de Recherche sur l'Hypertension Artérielle


title: Efficacy and Tolerance of EGb 761® 120mg Two Times a Day on Dementia of Alzheimer Type's Onset in Patients Suffering From Memory Complaints. A Randomised, Double-blind, Multicentre, Parallel Groups, Placebo Controlled Phase IIIb/IV Study in Elderly Over 70

summary: The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.

ReferenceCitation: Vellas B, Coley N, Ousset PJ, Berrut G, Dartigues JF, Dubois B, Grandjean H, Pasquier F, Piette F, Robert P, Touchon J, Garnier P, Mathiex-Fortunet H, Andrieu S; GuidAge Study Group. Long-term use of standardised Ginkgo biloba extract for the prevention of Alzheimer's disease (GuidAge): a randomised placebo-controlled trial. Lancet Neurol. 2012 Oct;11(10):851-9. doi: 10.1016/S1474-4422(12)70206-5. Epub 2012 Sep 6.

lead_sponsor: Ipsen

location_facility: Centre Hospitalier de Purpan Service de Neurologie place du Docteur Baylac

location_facility: Hotel les Cordeliers place des Cordeliers

location_facility: Centre Commercial Tertifume 9 rue de Montreuil

location_facility: Impasse Mérite, Résidence Lamiot rue L'ecalier

location_facility: Groupe Medical de Mazargues 1 av de la Martheline

location_facility: 1 rue Franz Schubert Saint Martin d'Hères

location_facility: Centre Hospitalier Pellegrin-Tripode Service de Neurologie Place Amelie Raba-Leon

location_facility: 136 av. Ambroise Croizat Saint Martin d'Heres

location_facility: Hopital Cote de Nacre Service de Neurologie avenue de la cote de Nacre

location_facility: Hôpital Felix Marechal 1 rue Xavier Roussel

location_facility: Maison de retraite publique Centre de Memoire Route de Nimes

location_facility: Immeuble Athéna 62 bis rue Aristide Briand

location_facility: 117, avenue du Maréchal de Lattre de Tassigny

location_facility: 34 avenue de l'Europe Immeuble le Trident A1er etage

location_facility: Centre Hospitalier Jacques Coeur Hopital Taillegrain Centre de Gerontologie des Pres Fichaux 6 rue Taillegrain

location_facility: Centre de Prevention des Alpes 3 place de Metz

location_facility: Centre Commercial La Verriere place Beauval

location_facility: 9, Résidence Haut Rivage, Rue Jean Xxiii

location_facility: Residence Le Gaughin Bat 1 68 rue Borely

location_facility: Hopital STe Marguerite Unite de Neurologie 270 boulevard de STe Marguerite

location_facility: Hôpital Charles Nicolle Department de Neurologie 1, rue de Germont

location_facility: Centre Hospitalier Universitaire Hotel Dieu Gerontologie Clinique 4 rue Larrey

location_facility: Hopital de Cimiez Pavillon Mossa 4 avenue de la Reine Victoria

location_facility: Hopital Gui de Chauliac 80 rue Augustin Fliche

location_facility: Centre Hospitalier des Pyrenees Department de Psychogeriatrie 29 av du Marechal Leclerc

location_facility: Hopital St Joseph Service de Neurologie 26 boulevard Louvain

location_facility: Espace Vénitien 1 av Pres Salvador Allende

location_facility: 5 rue Daniel Casanova Le Parc des Amandiers

location_facility: Hopital Charles Foix Service de Gerontologie 37 avenue de la Republique

location_facility: Cabinet de Neurologie 4 av Charles Tillon

location_facility: Hopital Bellier Service de Geronotologie 41 rue Curie

location_facility: 7 rue Raymond Boulogne Batiment C- apt 23

location_facility: Hôtel les Cordeliers place des Cordeliers

location_facility: Hopital Roger Salengro Service de Neurologie C rue Emile Laine

location_facility: Centre Hospitalier Jacques Coeur Hôpital Taillegrain

location_facility: Résidence Mozart- Apt 56, 2 rue Jean Artus

location_facility: Residence le Paradis Bat 17, 74-78 rue Volney

location_facility: Résidence Emeraude 71 av Adolphe Geeraert

location_facility: Centre Raymond Ruffi 12 rue Alexandre Ducros

location_facility: Hôpital Broca - Service de Gérontologie Clinique 54-56 rue Pascal

location_facility: 22 avenue du Général Leclerc Les Bougainvillées


title: A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA

acronym: IMPRESS

summary: The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

ReferenceCitation: Soria JC, Wu YL, Nakagawa K, Kim SW, Yang JJ, Ahn MJ, Wang J, Yang JC, Lu Y, Atagi S, Ponce S, Lee DH, Liu Y, Yoh K, Zhou JY, Shi X, Webster A, Jiang H, Mok TS. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):990-8. doi: 10.1016/S1470-2045(15)00121-7. Epub 2015 Jul 6.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Hungary
Hong Kong
Japan
Korea, Republic of
China
Spain
Taiwan
Russian Federation
France


title: Surgery of Subclinical Cortisol Secreting Adrenal Incidentalomas

acronym: CHIRACIC

summary: The general objective is to evaluate the consequences of surgical removal of SCSI on hypertension and cardiovascular risk factors in order to determine on an evidence-based basis if surgical excision of SCSI is preferable to an intensive medical regimen in patients with hypertension.

location_country: Germany Italy France

location_facility: Service d'Endocrinologie, Diabétologie, Nutrition - CHU d'Amiens

location_facility: Service d'Endocrinologie, Diabète et Maladies Métaboliques - Assistance publique - Hôpitaux de Marseille

location_facility: Service d'Endocrinologie et Maladies Métabolique - CHU de Toulouse

location_facility: Service d'Endocrinologie - Niveau 18 - Caen CHU Côte de Nacre

location_facility: Service d'Endocrinologie et des Maladies de la Reproduction- Assistance Publique - Hôpitaux de Paris - Hôpial Bicêtre

location_facility: Endokrinologie, Diabetes und Ernährungsmedizin, Campus Mitte, Medizinische Klinik - Charité - Universitätsmedizin Berlin

location_facility: Service d'Endocrinologie, Diabétologie et Métabolisme - CHRU de LILLE

location_facility: Service d'Hypertension et de Médecine Vasculaire - Assistance Publique - Hôpitaux de Paris - Hôpital européen Georges Pompidou

location_facility: Département Endocrinologie-Diabétologie -Nutrition - CHU d'ANGERS

location_facility: Endocrinologie, Diabète et Maladies Métaboliques - CHU de Rouen

location_facility: Service Endocrinologie, Diabétologie, maladies métaboliques - CHU de Bordeaux

location_facility: Department of Internal Medicine I, Endocrine and Diabetes Uni -University Hospital Würzburg

location_facility: Assistance Publique - Hôpitaux de Paris - Hôpital COCHIN

location_facility: Service de Médecine Interne, Endocrinologie et Nutrition - CHU de Strasbourg

location_facility: CIC Endocrinologie-Nutrition - CHU de Nantes


title: OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy

summary: The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).

ReferenceCitation: Chlup R, Runzis S, Castaneda J, Lee SW, Nguyen X, Cohen O. Complex Assessment of Metabolic Effectiveness of Insulin Pump Therapy in Patients with Type 2 Diabetes Beyond HbA1c Reduction. Diabetes Technol Ther. 2018 Feb;20(2):153-159. doi: 10.1089/dia.2017.0283. Epub 2017 Dec 7.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Metzger M, Castaneda J, Reznik Y, Giorgino F, Conget I, Aronson R, de Portu S, Runzis S, Lee SW, Cohen O. Factors associated with improved glycemic control following continuous subcutaneous insulin infusion therapy in patients with type 2 diabetes uncontrolled with bolus-basal insulin regimens: An analysis from the OpT2mise randomized trial. Diabetes Obes Metab. 2017 Oct;19(10):1490-1494. doi: 10.1111/dom.12960. Epub 2017 Jul 25.

ReferenceCitation: Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.

lead_sponsor: Medtronic Diabetes

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Clinical Professor Department of Medicine University of Calgary

location_facility: Universita di Perugia - Ospedale S.M. Della Misericordia

location_facility: Zentrum für Diabetes und Gefäßerkrankungen

location_facility: Endocrinologist, 202-301 Columbia Street East

location_facility: Clinic for Endocrinology, Diabetes and Metabolic Diseases

location_facility: IJsselland Ziekenhuis Poli Interne geneeskunde

location_facility: Università degli Studi di Bari - Policlinico Universitario

location_facility: Chaim Sheba Medical center Endocrinology unit

location_facility: McGill University, McGill Nutrition and Food Science Centre

location_facility: Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic

location_facility: Canadian Centre for Research on Diabetes


title: Medico-economic Evaluation of the Care by Serious Games in Outpatient Units and at Home for Children With Autism Spectrum Disorders

acronym: e-GOLIAH-ECO

summary:
Randomized open-label study comparing children aged 3 to 6 years with autism and normal cognitive development or mild cognitive impairment receiving the usual treatment plus intensive use of eGOLIAH (experimental group) with children receiving only the usual treatment (control group).

eGOLIAH (Gaming Open Library for Intervention in Autism at Home) is an accessible online platform for digital games inspired by the principles of the Early Start Denver Model (ESDM), one of the care programs validated in the management of young ASD.

The duration per patient will be one year. The exposure to e-GOLIAH for the experimental group will be done with the recommendation of intensive exposure to the game (5 sessions> ½ hour per week).

Clinical variables will be assessed at entry, 6 months and 1 year (end of study).

The EQ5D questionnaires will be collected by the supervising therapist during the follow-up visit and at the same time as the clinical variables.

ReferenceCitation: Dawson G, Rogers S, Munson J, Smith M, Winter J, Greenson J, Donaldson A, Varley J. Randomized, controlled trial of an intervention for toddlers with autism: the Early Start Denver Model. Pediatrics. 2010 Jan;125(1):e17-23. doi: 10.1542/peds.2009-0958. Epub 2009 Nov 30.

ReferenceCitation: Jouen AL, Narzisi A, Xavier J, Tilmont E, Bodeau N, Bono V, Ketem-Premel N, Anzalone S, Maharatna K, Chetouani M, Muratori F, Cohen D; MICHELANGELO Study Group. GOLIAH (Gaming Open Library for Intervention in Autism at Home): a 6-month single blind matched controlled exploratory study. Child Adolesc Psychiatry Ment Health. 2017 Mar 22;11:17. doi: 10.1186/s13034-017-0154-7. eCollection 2017.

ReferenceCitation: Bieleninik L, Geretsegger M, Mossler K, Assmus J, Thompson G, Gattino G, Elefant C, Gottfried T, Igliozzi R, Muratori F, Suvini F, Kim J, Crawford MJ, Odell-Miller H, Oldfield A, Casey O, Finnemann J, Carpente J, Park AL, Grossi E, Gold C; TIME-A Study Team. Effects of Improvisational Music Therapy vs Enhanced Standard Care on Symptom Severity Among Children With Autism Spectrum Disorder: The TIME-A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):525-535. doi: 10.1001/jama.2017.9478. Erratum In: JAMA. 2021 Apr 13;325(14):1473.

ReferenceCitation: Billeci L, Narzisi A, Tonacci A, Sbriscia-Fioretti B, Serasini L, Fulceri F, Apicella F, Sicca F, Calderoni S, Muratori F. An integrated EEG and eye-tracking approach for the study of responding and initiating joint attention in Autism Spectrum Disorders. Sci Rep. 2017 Oct 19;7(1):13560. doi: 10.1038/s41598-017-13053-4.

ReferenceCitation: Bono V, Narzisi A, Jouen AL, Tilmont E, Hommel S, Jamal W, Xavier J, Billeci L, Maharatna K, Wald M, Chetouani M, Cohen D, Muratori F; MICHELANGELO Study Group. GOLIAH: A Gaming Platform for Home-Based Intervention in Autism - Principles and Design. Front Psychiatry. 2016 Apr 28;7:70. doi: 10.3389/fpsyt.2016.00070. eCollection 2016.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
University Hospital, Montpellier

location_facility: Assistance Publique - Hôpitaux de Paris, Site de Necker

location_facility: Centre Hospitalier Sainte-Anne / GHU Paris Psychiatrie et Neurosciences

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Fondation Lenval - Hôpitaux Pédiatriques de Nice- CHU Lenval

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Assistance Publique - Hôpitaux de Paris, Site de la Pitié-Salpêtrière

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Paris - Centre Hospitalier d'Henri Laborit

appel_a_projets: PRME

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: e-GOLIAH-ECO

titre: Évaluation médico-économique de la prise en charge par Serious Games en unités ambulatoires et à domicile des enfants atteints de troubles du spectre autistique

discipline_principale: psychiatrie / addictologie

nom_porteur: COHEN

prenom_porteur: DAVID


title: A National, Multicenter, Randomized Open-Label Study of Proctological Surgery Efficacy on Anoperineal Fistulas Healing in Crohn's Disease Patients Treated With Adalimumab. (Official French Title: "Étude Nationale, Multicentrique, randomisée et en Ouvert de l'efficacité de la Chirurgie Proctologique Sur la Cicatrisation Des Fistules anopérinéales de la Maladie de Crohn Chez Des Patients traités Par Adalimumab")

acronym: FACC

summary: The purpose of this study is to demonstrate, in patients treated with adalimumab, the efficacy of proctological surgery in anoperineal fistula healing after the removal of seton drain.

ReferenceCitation: Abramowitz L, Brochard C, Pigot F, Roumeguere P, Pillant H, Vinson Bonnet B, Faucheron JL, Senejoux A, Bonnaud G, Meurette G, Fayette JM, Train C, Staumont G, Siproudhis L, Bouchard D. Surgical closure, mainly with glue injection and anti-tumour necrosis factor alpha, in fistulizing perianal Crohn's disease: A multicentre randomized controlled trial. Colorectal Dis. 2022 Feb;24(2):210-219. doi: 10.1111/codi.15947. Epub 2021 Oct 23.

oa_host_type: repository

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

unpaywall_oa_status: green

lead_sponsor: French Society of Coloproctology

location_facility: Maison de Santé Protestante de Bordeaux Bagatelle - Department of Proctology

location_facility: CHU de Rouen - Departement of Hepato Gastroenterologie and Nutrition

location_facility: Clinique Saint Jean Languedoc - Department of Gastroenterology

location_facility: Clinique des Cèdres - Hepato-Gastroenterology Department

location_facility: Institut Mutualiste Montsouris - Proctology Unit

location_facility: Hôpital Nord de Marseille - Gastroenterology Department

location_facility: Hôpital Bichat-Claude Bernard - Gastro-enterology Department

location_facility: CHU Pontchaillou - Department of Digestive Diseases

location_facility: Institut de Proctologie Léopold Bellan - Groupe Hospitalier Paris Saint Joseph - Department of Colo-Proctology

location_facility: Hôpital Louis Mourier - Department of Hepato-Gastroentérologie

location_facility: Clinique universitaire de chirurgie Digestive et de l'urgence, Hopital Universitaire Michallon - Colorectal Surgery Unit

location_facility: CHU Bordeaux - Hôpital Saint André - Department of Hepato Gastroenterology

location_facility: Polyclinique de Franche-Comté - Department of Proctological Surgery


title: European Phase-IIb Clinical Trial Evaluating Efficacy of Low Dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes DIABIL-2

summary:
Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells, leading to an absolute deficiency in insulin.

In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and likewise prevent autoimmune diseases. Tregs are insufficient in T1D.

The investigators previously showed that administration of low doses of IL-2 induces selective expansion and activation of Tregs in mice and humans.

The investigators hypothesize that Tregs expansion and activation with low doses of IL2 could block the ongoing autoimmune destruction of insulin producing cells in patients with recently diagnosed T1D.

location_country: Germany France Netherlands Switzerland Belgium Sweden

location_facility: CIC Pédiatrique, Hôpital d'enfants Robert Debré

location_facility: Unité d'Endocrinologie et Diabétologie Pédiatriques, CHU de Marseille, Hôpital La Timone Enfants

location_facility: Service Diabétologie -Endocrinologie, CHU Jean Minjoz

location_facility: Division of Endocrinology, Diabetology and Metabolic Diseases, University Hospital of Freiburg, Department for children and adolescents

location_facility: Service Pédiatrie - Gastro-entérologie, Hépatologie, Nutrition, Diabétologie, Hôpital des Enfants Pôle Enfants

location_facility: UZ - Diabetes voor Kinderen en Adolescenten-Leuven

location_facility: Service d' Endocrinologie Diabétologie CHRU DE RENNES

location_facility: Service d'endocrinologie, diabétologie, maladies métaboliques, et nutrition, CHU de Bordeaux, Hôpital Haut Levêque

location_facility: Endocrinologie-Diabétologie-Maladies de la nutrition, Centre Hospitalier Lyon-Sud

location_facility: Structure d'Endocrinologie-Diabète-Nutrition et Addictologie HOPITAUX UNIVERSITAIRES NHC

location_facility: Endocrinologie gynécologie diabétologie pédiatriques, Hôpital Universitaire Necker Enfants Malades.

location_facility: Service d' Endocrinologie HOPITAL CAVALE BLANCHE

location_facility: Centre d'Investigations Cliniques, HÔPITAL CIVIL

location_facility: CIC pédiatrique Hôpital Necker Enfants Malades

location_facility: CIC Paris-Est (Adultes), Hôpitaux Universitaires Pitié-Salpêtrière, Charles Foix

location_facility: Division of Endocrinology and Diabetology, Department of Internal Medicine II, University Hospital of Freiburg

location_facility: Center for Pediatric and Adolescent Diabetes Care and Research

location_facility: Institute of Diabetes Research, Helmholtz Zentrum München

location_facility: Service d'Endocrinologie pédiatrique - HFME

location_facility: CHRU de Lille, Hôpital Claude Huriez Service d'endocrinologie

location_facility: Endocrinology and Diabetes department, University Hospital of Basel

location_facility: Centre d'Investigations Cliniques, CHU-HOPITAL HAUTEPIERRE

location_facility: Service d'Endocrinologie Pédiatrique, Hôpital d'enfants Robert Debré

location_facility: Hopital G&R Laënnec , Endocrinologie, Maladies Métaboliques et Nutrition

location_facility: Service de pédiatrie 1CHU de HAUTEPIERRE

location_facility: Service d' Endocrinologie, maladies métaboliques HOPITAL NORD

location_facility: Pediatric Department, Centre Hospitalier Régional de la Citadelle

location_facility: Service de Nutrition - Maladies Métaboliques - Endocrinologie HOPITAL DE LA CONCEPTION

location_facility: Dept. of Clinical Sciences Lund University, Skåne University Hospital.


lead_sponsor: Gilead Sciences

summary: This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

ReferenceCitation: Younossi ZM, Stepanova M, Racila A, Afendy A, Lawitz EJ, Schwabe C, Ruane PJ, Lalezari J, Reddy KR, Jacobson IM, Muir AJ, Gaggar A, Myers RP, Younossi I, Nader F. Long-term Benefits of Sustained Virologic Response for Patient-Reported Outcomes in Patients With Chronic Hepatitis C Virus Infection. Clin Gastroenterol Hepatol. 2020 Feb;18(2):468-476.e11. doi: 10.1016/j.cgh.2019.07.047. Epub 2019 Jul 31.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliera S. Orsola - Malpighi

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Azienda Ospedaliera - Polo Universitario Luigi Saco

location_facility: Lehigh Valley Health Network, Network Office of Research and Innovation

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: University of North Carolina at Chapel Hill

location_facility: Veterans Administration Wadsworth Medical Center

location_facility: South Florida Center of Gastroenterology, P.A.

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Université Libre de Bruxelles Hôpital Erasme

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Veterans Affairs Pittsburgh Healthcare System

location_facility: Spzoz Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego W Lodzi

location_facility: Centre Hospitalier Universitaire Bordeaux Hôpital Haut-Lévêque

location_facility: Hôpital-Saint Joseph, Service D'Hépato-Gastroentérologie

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: Binghamton Gastroenterology Associates, PC

location_facility: Ente Ospedaliero Ospedali Galliera di Genova

location_facility: Infectious Disease Specialists of Atlanta, PC

location_facility: Inova Fairfax Hospital Center for Liver Diseases

location_facility: Ospedale San Raffaele-IRCCS, Centro San Luigi - San Raffaele Turro, Unità Operativa di Malattie Infettive

location_facility: Washington University School of Medicine

location_facility: Universitair Medisch Centrum Sint Radboud

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: PraxisZentrum für Gastroenterologie und Endokrinologie

location_facility: Columbia Presbyterian Hospital, Columbia University

location_facility: Advanced Clinical Research Institute, LLC

location_facility: The North Texas Clinical Research Institute

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: The Gastroenterology Group of South Jersey

location_facility: Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

location_facility: Slezska nemocnice v Opave, Infekcni oddeleni

location_facility: Azienda Ospedaliera-universitaria Policlinico P. Giaccone

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: University of Florida Hepatology Research at CTRB

location_facility: University of California Davis Medical Center

location_facility: Sahlgrenska Universitetssjukhuset, Östra Sjukhus

location_facility: Weill Cornell Medical College of Cornell Univeristy

location_facility: Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center

location_facility: University of Pennsylvania School of Medicine

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Instituto Nationale Per Le Malattie Infettive "Lazzaro Spallanzani"

location_facility: Schleinitz Research and Gastroenterology LLC

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku

location_facility: Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Azienda Ospedaliera Padova, U.O.C. Cardiologia

location_facility: Virginia Commonwealth University Medical Center

location_facility: University of Birmingham and Queen Elizabeth Hospital Birmingham

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Centre Hospitalier de L'Universite de Montreal (CHUM)

location_facility: Community Research Initiative of New England

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Digestive Health Specialists of the Southeast, PA

location_facility: St. Luke's Health Baylor College of Medicine Medical Center

location_facility: Southwest Infectious Disease Clinical Research, Inc

location_facility: Gastroenterologische Gemeinschaftspraxis Kiel Preetzer

location_facility: University of Texas Health Science Center at Houston

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Southampton University Hospitals NHS Trust, Southampton General Hospital

title: A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection

location_country:
Germany
Italy
Poland
New Zealand
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Czechia
Canada
Estonia
Puerto Rico
France