title: Bronchiolitis Clearance Airways With Seaserum : a Doubled Blind Randomized Study

acronym: B-CLASS

summary:
The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year.

B-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Morlaix hospital
Tours, University hospital
Brest, University Hospital
Saint-Joseph hospital
Le Mans hospital
Rennes, University hospital
Lille, University hospital
Nantes, University Hospital

status_simplified: Ongoing


type: Other Identifier

title: Anatomical-Clinical Base of Adenocarcinoma Pancreatic

summary: BACAP-2 is a prospective biobank dedicated to the pancreatic adenocarcinoma including clinical data and biological samples from tumor. The aim is to enrich the previous propective collection BACAP in order to support future research projects.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Toulouse

location_facility:
Béthune hospital center
Saint Eloi Hospital
PAU hospital
Huriez Hospital
Jean Mermoz private hosptila
Rangueil hospital
Haut-Lévêque Hospital
Regional Cancer Center From Montpellier

intervention_type: Other

lead_sponsor_type: academique


title: Evaluation of Integrated Versus Parallel Continuous Renal Replacement Therapy Connection in ECMO Patients: a Randomized Controlled Trial

acronym: EPIC-ECMO

summary:
Extracorporeal membrane oxygenation (ECMO) is an extra-corporeal assistance used in case of respiratory or circulatory failure. In case of circulatory failure, ECMO is in the veno-arterial configuration (VA-ECMO). VA-ECMO patients are at high risk of developing acute kidney injury (AKI) and renal replacement therapy (RRT) may be needed in 50% of ECMO patients. Although the administration of RRT in ECMO patients has major implications, no specific recommendations are currently available. The 2020 Kidney Disease: Improving Global Outcomes (KDIGO) international conference identified the evaluation of RRT in these ECMO patients as a research priority.

In 2023, the two main configurations used to administer RRT in ECMO patients are an independent delivery on a separate vascular access (parallel connection) or an integration of the RRT machine directly into the ECMO circuit (integrated connection). The integrated connection may reduce infectious and bleeding complications associated with the use of a second vascular access. However, it can expose the hemofilter and circuit to excessive positive pressures that can trigger pressure alarms in the RRT machine and expose the patient to a theoretical risk of air embolism or hemolysis. Furthermore, there is currently no robust data comparing the hemofilter lifespan with the parallel or with the integrated connection, although the filter lifespan is a crucial parameter to assess the quality of the RRT delivery in the ICU. The investigators recently performed a survey of practices in this context of ECMO patients. The investigators found that both strategies (parallel and integrated connection) are widely used and can be seen as common patient care.

The hypothesis tested in this study is the following: when RRT is integrated to the ECMO circuit, the hemofilter lifespan is non inferior to the one when RRT is delivered on a separate vascular access. Only VA-ECMO patients will be enrolled in this trial.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU de Clermont Ferrand, Pôle de médecine péri-opératoire/Chirurgie cardiaque, Hôpital Gabriel Montpied

location_facility: Hospices Civils de Lyon, Service d'Anesthésie-Réanimation cardiovasculaire, Hôpital Louis Pradel

location_facility: CHU de Bordeaux, GH Sud, Service d'anesthésie-réanimation cardiovasculaire, Hôpital cardiologique

location_facility: APHP, Institut de cardiologie, Service de Médecine Intensive Réanimation, Hôpital Pitié-Salpêtrière

location_facility: CHU de Saint Etienne, Hôpital Bellevue, Service de Réanimation polyvalente et soins intensifs post-opératoires

location_facility: CHU de Montpellier, Département d'anesthésie-réanimation, Pôle Cœur-poumons, Hôpital Arnaud de Villeneuve

location_facility: APHP, Institut de Cardiologie, Service d'anesthésie-réanimation cardiovasculaire, Hôpital de la Pitié-Salpêtrière

location_facility: CHU de Grenoble, Service de réanimation cardiovasculaire et thoracique, Pôle anesthésie réanimation, Hôpital Nord

intervention_type: Procedure


title: Tucatinib in Combination With Oral Etoposide (VP16) - Trastuzumab in Patients With Metastatic HER2+ Breast Cancer After Progression Under Tucatinib-Capecitabine-Trastuzumab or Toxicity Related to Capecitabine: a Multicenter Phase II

acronym: TUC-TOC

summary: This is an open-label, multicenter, phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics of the combination of tucatinib-Oral VP16-trastuzumab in patients with HER2-positive metastatic breast cancer (HER2+ MBC) after progression on tucatinib-capecitabine-trastuzumab or capecitabine-related toxicity.

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing_description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
Seagen Inc.

location_facility:
Institut Du Cancer Montpellier
Oncopole Claudius Regaud
Hopital Saint-Louis Ap-Hp Senopole
Centre Georges-François Leclerc
Centre François Baclesse
Centre Jean Perrin
Institut Curie

intervention_type: Drug


title: MyocardON-TTR - Myocardial Effects in Patients With Hereditary Transthyretin-mediated Amyloidosis With Polyneuropathy Treated With Patisiran or Vutrisiran

acronym: MyocardON-TTR

summary:
ATTRv amyloidosis is a systemic disease with two clinical forms, neurological and cardiological, which are sometimes combined (so-called mixed forms).

Patisiran and vutrisiran have shown protective effects on the progression of neurological damage.

The effects of Patisiran or vutrisiran on the heart remain incompletely understood. The aim of this study is to better understand the morphological and functional cardiac consequences in ATTRv patients with stage 1 or 2 polyneuropathy with a mixed form treated with Patisiran or vutrisiran

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility:
CHU Rangueil Toulouse
CHU Bordeaux Haut-Levêque
CHU Rennes
APHM Timone
CHU Nancy Institut Louis Mathieu
APHP Henri Mondor
CHU Grenoble Alpes
APHP Bichat


type: EudraCT Number

title: Randomised, Open-label, Phase II-III Study Evaluating the Benefit of Adding Ipilimumab to the Combination of Atezolizumab and Bevacizumab in Patients With Hepatocellular Carcinoma Receiving First-line Systemic Therapy

acronym: TRIPLET

summary: TRIPLET HCC is a phase II-III trial that assess the effectivness of addition of ipilimumab to the combination atezolizumab-bevacizumab, on global survival and response to the treatment, for patients with advanced or metastatic hepatocellular carcinoma. The theoretical duration of the study is 5 years. In the scope of this study, each patient will have 2 years of treatment and 2 years of follow-up from their enrollment date.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Chu La Croix Rousse
Chu Saint Antoine
Chu Francois Mitterand
Chu Henri Mondor
Chu La Pitie Salpetriere
Chu L'Archet
Chu Dupuytren
Chu Haut Leveque

lead_sponsor_type: industriel


title: REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy

acronym: RESIST

summary:
Data evaluating and quantifying real-world outcomes of patients post-ibrutinib discontinuation, as well as outcomes of patients who have progressed on a Bruton tyrosine kinases inhibitors (BTKi) and received prior venetoclax are very limited. There are no robust studies specifically designed to assess outcomes of patients with chronic lymphocytic leukemia (CLL) receiving third line or subsequent treatments. As such, there is no established standard of care for these multiple Relapsed/Refractory (RR) patients. Furthermore, despite new oral agents approved in third-line RR CLL, there are limited published data on how to best sequence these agents and how to manage patients who fail these therapies. As the best salvage therapy in patients who fail all available oral these agents is unknown, this is a population of patients with unmet medical need.

The aim of this study is to determine unmet need and treatment patterns of data from two types of populations, all previously exposed to ibrutinib (or other BTKi) for the full patient population and both ibrutinib (or other BTKi and venetoclax) for the narrow patient population, where these agents failed these subcategories of patient populations, at least in 3rd line therapy (in other words, having at least received two lines of therapy before)

Patients with prior treatment with BTKi (full patient population) - Underlying tenet: these patients have been treated with a BTKi in at least one of two or more prior lines of therapy and progressed - FULL POPULATION
Patients who progressed BTKi and failed VEN (defined as patients who discontinued venetoclax (VEN) due to disease progression, intolerability, or failure to achieve an objective response within 3 months of initiating therapy; small patient population) - Tenet: these patients have been treated with both BTKi and VEN in any one of the prior two lines of therapy and progressed. - NARROW POPULATION

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Bristol-Myers Squibb

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Institut Paoli-Calmettes - Hématologie Clinique

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique


title: Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia

acronym: REG-HYPO

summary: The purpose of this study is to assess medical events during follow-up of adult patients having hypophosphatasia and consulting rheumatologists.

time_perspective: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Les hôpitaux universitaires de Strasbourg


title: Prospective, Multicenter, First Part Randomized, Placebo-controlled, Parallel-group, Double-blind Period Followed by Open-label Trial Period to Evaluate Clinical Safety & Efficacy of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease: Proof-of-concept Study

summary: This proof-of-concept study will assess safety, tolerance, and efficacy of NanoLithium® NP03 in patients with mild-to-severe Alzheimer's Disease (AD).

lead_sponsor: Medesis Pharma SA

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: Hôpital des Charpennes - Hospices Civils de Lyon

location_facility: CHU Toulouse - Hôpital La Grave - Cité de la Santé


title: Automatisation du Recueil d'Indicateurs de Pertinence de Prescription d'Antibiotiques : Développement, Validation et efficacité d'un Outil Utilisant Les systèmes d'Information d'un Groupement Hospitalier de Territoire

acronym: ARIPPA

summary: This research focuses on the development and validation of indicators on the relevance of antibiotic prescriptions. The investigators want to propose transferable tools to other healthcare institutions to allow automated construction of quality indicators as part of a structured approach to improve future practices. The main objective of the study is to develop indicators on the appropriateness of antibiotic prescriptions and on surgical prophylaxis automated from the hospital information system and to assess their criterion validity.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
University of Bordeaux

location_facility:
Charles Perrens Hospital
Cadillac Hospital
Arcachon Hospital
Libourne Hospital
Sainte Foy la Grande Hospital
Sud-Gironde Hospital
Blaye Hospital
Bordeaux University Hospital

appel_a_projets: PREPS

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: ARIPPA

titre: Automatisation du recueil d'indicateurs de pertinence de prescription d'antibiotiques : développement, validation et efficacité d'un outil utilisant les systèmes d'information d'un groupement hospitalier de territoire

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: THIESSARD

prenom_porteur: Frantz


title: Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients: A Randomized, Multicenter Trial

acronym: PEPITS

summary:
Schizophrenia affects about 0.7% of the population. Poor insight, which is common in this disease, linked to poor drug compliance is leads to rehospitalisation with major impact on quality of life. Indeed, many patients relapse with exacerbation of symptoms.

Psychoeducation can improve therapeutic alliance and medication compliance.

In this context, an individual psycho-education program (PEPITS) has been developed. PEPITS carried out by nurses during the initial stages of hospitalisation.

The hypothesis is that PEPITS program will decrease relapse and improve the compliance and insight and and so the quality of life.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Tours

location_facility:
Service de psychiatrie
Serrvice de Psychiatrie

intervention_type: Diagnostic Test

appel_a_projets: PHRIP

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: PEPITS

titre: Evaluation du programme de Psychoéducation Précoce en Individuel des Troubles Schizophréniques du patient hospitalisé : essai randomisé multicentrique

discipline_principale: psychiatrie / addictologie

nom_porteur: CHESSÉ

prenom_porteur: Arnaud


title: Prevalence of Impaired Executive Functions in Institutionalized Elderly

acronym: EXEPA

summary: The evaluation of executive functions, as well as the means of stimulating and preserving them, are at the heart of the challenges for maintaining a level of functional autonomy in the elderly, but also during the loss of this functional autonomy and when entering a situation of dependence and/or dementia. Research that has demonstrated the preponderant role of executive functions on functional abilities are examples of this. Components such as planning, organization, initiation, mental flexibility appear to be strongly correlated with the effective performance of complex activities of daily living. In addition, the capacities for autonomy were found to be significantly reduced, and significantly with the severity of the executive deficits. In addition, if these data have since contributed to determining a level of impairment of the executive processes specific to an early loss of autonomy, they are so in the context of early diagnosis of dementia and validation of a detection tool, early loss of autonomy. The scientific advances of the last five years contribute to a better understanding of the impact of executive disorders, but on the other hand, the diversity of the explanatory phenomena of these disorders considerably complicates their nosology within neuro-evolutionary pathologies. Ultimately, an analysis of executive function disorders must take into account cognitive and behavioral aspects, that is to say, beyond performance on tests identified as involving executive functions, behavioral disorders, emotional status and level of autonomy in activities of daily living. In the state of our knowledge, the consideration of executive functions represents a strategic point at the crossroads of the evaluation of the act of care and treatment. Establishing data on the prevalence of alterations in the executive functions of residents, exploring the possibilities of evaluation with a battery of tests little used in this context and linking "executive" profiles and clinical situations seems to us a relevant and interesting first step. However essential to provide a beginning of answer to these questions. This study being an exploratory study. The results of this study will constitute new prevalence data in the population of residents of nursing homes. The aim here is to establish data on the prevalence of alterations in the executive functions of residents, to explore the possibilities of evaluation with a battery of tests little used in this context and to relate the profiles "executives" and clinical situations. This in order to develop a methodology to draw up a general assessment, and to make comparisons of the different profiles, inter/intra pathologies and stages of evolution. Thus, a more in-depth knowledge of the specific profiles of Nursing Home residents will also lead to the reflection of pharmacological and non-pharmacological therapeutic strategies. Finally, it will ultimately be a question of presenting an inventory of the situation of Nursing Home to alert public policies. The main objective is to study the prevalence of impaired executive functions in nursing home residents. The secondary objectives are to explore the feasibility of carrying out executive function tests and to examine the coorelationbetween the levels of impairment of executive functions and the clinical and functional characteristics of residents.

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

ReferenceType: background

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ReferenceCitation: Makino T, Umegaki H, Suzuki Y, Yanagawa M, Nonogaki Z, Nakashima H, Kuzuya M. Relationship between small cerebral white matter lesions and cognitive function in patients with Alzheimer's disease and amnestic mild cognitive impairment. Geriatr Gerontol Int. 2014 Oct;14(4):819-26. doi: 10.1111/ggi.12176. Epub 2013 Nov 12.

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ReferenceCitation: Robert PH, Clairet S, Benoit M, Koutaich J, Bertogliati C, Tible O, Caci H, Borg M, Brocker P, Bedoucha P. The apathy inventory: assessment of apathy and awareness in Alzheimer's disease, Parkinson's disease and mild cognitive impairment. Int J Geriatr Psychiatry. 2002 Dec;17(12):1099-105. doi: 10.1002/gps.755.

ReferenceCitation: Roussel M, Lhommee E, Narme P, Czernecki V, Gall DL, Krystkowiak P, Diouf M, Godefroy O; GREFEX study group. Dysexecutive syndrome in Parkinson's disease: the GREFEX study. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2017 Sep;24(5):496-507. doi: 10.1080/13825585.2016.1226248. Epub 2016 Sep 1.

ReferenceCitation: Salthouse TA, Toth J, Daniels K, Parks C, Pak R, Wolbrette M, Hocking KJ. Effects of aging on efficiency of task switching in a variant of the trail making test. Neuropsychology. 2000 Jan;14(1):102-11.

ReferenceCitation: Stuss DT. Functions of the frontal lobes: relation to executive functions. J Int Neuropsychol Soc. 2011 Sep;17(5):759-65. doi: 10.1017/S1355617711000695. Epub 2011 May 24.

ReferenceCitation: Stuss DT, Alexander MP, Shallice T, Picton TW, Binns MA, Macdonald R, Borowiec A, Katz DI. Multiple frontal systems controlling response speed. Neuropsychologia. 2005;43(3):396-417. doi: 10.1016/j.neuropsychologia.2004.06.010.

ReferenceCitation: Tomaszewski Farias S, Cahn-Weiner DA, Harvey DJ, Reed BR, Mungas D, Kramer JH, Chui H. Longitudinal changes in memory and executive functioning are associated with longitudinal change in instrumental activities of daily living in older adults. Clin Neuropsychol. 2009 Apr;23(3):446-61. doi: 10.1080/13854040802360558. Epub 2008 Sep 23.

ReferenceCitation: Torralva T, Roca M, Gleichgerrcht E, Bekinschtein T, Manes F. A neuropsychological battery to detect specific executive and social cognitive impairments in early frontotemporal dementia. Brain. 2009 May;132(Pt 5):1299-309. doi: 10.1093/brain/awp041. Epub 2009 Mar 31.

ReferenceCitation: Torralva T, Roca M, Gleichgerrcht E, Lopez P, Manes F. INECO Frontal Screening (IFS): a brief, sensitive, and specific tool to assess executive functions in dementia. J Int Neuropsychol Soc. 2009 Sep;15(5):777-86. doi: 10.1017/S1355617709990415. Epub 2009 Jul 28. Erratum In: J Int Neuropsychol Soc. 2010 Sep;16(5):737.

ReferenceCitation: Tosto G, Zimmerman ME, Hamilton JL, Carmichael OT, Brickman AM; Alzheimer's Disease Neuroimaging Initiative. The effect of white matter hyperintensities on neurodegeneration in mild cognitive impairment. Alzheimers Dement. 2015 Dec;11(12):1510-1519. doi: 10.1016/j.jalz.2015.05.014. Epub 2015 Jun 13.

lead_sponsor: Fondation Korian pour le Bien Vieillir

sponsor_collaborators:
Fondation Korian pour le Bien Vieillir
Gerontopôle des Pays de la Loire

location_facility:
Korian Bois Robillard
Korian Villa Louisa
Korian Le Baron
Korian Le Catelli
KORIAN La Côte Sauvage
Korian Les Arcades
Korian Villa Evora
Korian Doubs Rivage

status_simplified: Completed


title: Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

summary: The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.

lead_sponsor: Dedienne Sante S.A.S.

sponsor_collaborators:
Dedienne Sante S.A.S.
EVAMED

location_facility: Hôpital d'Instruction des Armées Saint-Anne

intervention_type: Device


title: Analysis of Emergency Department Visits According to Incidence of Covid-19 in French Metropolis : a One-year Multicenter Observational Retrospective Study.

summary: With lockdown, Emergency Departments (ED) visits decrease, principally for visits unrelated with Covid-19. In this study, the investigators aimed to find a correlation between ED visits and incidence rate of Covid-19 in a French metropolis.

ReferenceCitation: Kain T, Fowler R. Preparing intensive care for the next pandemic influenza. Crit Care. 2019 Oct 30;23(1):337. doi: 10.1186/s13054-019-2616-1.

ReferenceCitation: Sivey P, McAllister R, Vally H, Burgess A, Kelly AM. Anatomy of a demand shock: Quantitative analysis of crowding in hospital emergency departments in Victoria, Australia during the 2009 influenza pandemic. PLoS One. 2019 Sep 24;14(9):e0222851. doi: 10.1371/journal.pone.0222851. eCollection 2019.

ReferenceCitation: Lum ME, McMillan AJ, Brook CW, Lester R, Piers LS. Impact of pandemic (H1N1) 2009 influenza on critical care capacity in Victoria. Med J Aust. 2009 Nov 2;191(9):502-6. doi: 10.5694/j.1326-5377.2009.tb02914.x.

ReferenceCitation: Schanzer DL, Schwartz B. Impact of seasonal and pandemic influenza on emergency department visits, 2003-2010, Ontario, Canada. Acad Emerg Med. 2013 Apr;20(4):388-97. doi: 10.1111/acem.12111.

ReferenceCitation: Yang L, Chan KH, Suen LK, Chan KP, Wang X, Cao P, He D, Peiris JS, Wong CM. Impact of the 2009 H1N1 Pandemic on Age-Specific Epidemic Curves of Other Respiratory Viruses: A Comparison of Pre-Pandemic, Pandemic and Post-Pandemic Periods in a Subtropical City. PLoS One. 2015 Apr 30;10(4):e0125447. doi: 10.1371/journal.pone.0125447. eCollection 2015. Erratum In: PLoS One. 2015;10(7):e0133946.

ReferenceCitation: Kollek D. Response of a community hospital and its emergency department to the H1N1 pandemic influenza. Radiat Prot Dosimetry. 2010 Nov;142(1):12-6. doi: 10.1093/rpd/ncq271.

ReferenceCitation: Kuitunen I, Ponkilainen VT, Launonen AP, Reito A, Hevonkorpi TP, Paloneva J, Mattila VM. The effect of national lockdown due to COVID-19 on emergency department visits. Scand J Trauma Resusc Emerg Med. 2020 Dec 4;28(1):114. doi: 10.1186/s13049-020-00810-0.

ReferenceCitation: Boserup B, McKenney M, Elkbuli A. The impact of the COVID-19 pandemic on emergency department visits and patient safety in the United States. Am J Emerg Med. 2020 Sep;38(9):1732-1736. doi: 10.1016/j.ajem.2020.06.007. Epub 2020 Jun 6.

ReferenceCitation: Westgard BC, Morgan MW, Vazquez-Benitez G, Erickson LO, Zwank MD. An Analysis of Changes in Emergency Department Visits After a State Declaration During the Time of COVID-19. Ann Emerg Med. 2020 Nov;76(5):595-601. doi: 10.1016/j.annemergmed.2020.06.019. Epub 2020 Jun 11.

ReferenceCitation: Kim HS, Cruz DS, Conrardy MJ, Gandhi KR, Seltzer JA, Loftus TM, Fant AL, McCarthy DM. Emergency Department Visits for Serious Diagnoses During the COVID-19 Pandemic. Acad Emerg Med. 2020 Sep;27(9):910-913. doi: 10.1111/acem.14099. Epub 2020 Aug 17. No abstract available.

ReferenceCitation: Giannouchos TV, Biskupiak J, Moss MJ, Brixner D, Andreyeva E, Ukert B. Trends in outpatient emergency department visits during the COVID-19 pandemic at a large, urban, academic hospital system. Am J Emerg Med. 2021 Feb;40:20-26. doi: 10.1016/j.ajem.2020.12.009. Epub 2020 Dec 9.

ReferenceCitation: Baugh JJ, White BA, McEvoy D, Yun BJ, Brown DFM, Raja AS, Dutta S. The cases not seen: Patterns of emergency department visits and procedures in the era of COVID-19. Am J Emerg Med. 2021 Aug;46:476-481. doi: 10.1016/j.ajem.2020.10.081. Epub 2020 Nov 5.

ReferenceCitation: Friedman AB, Barfield D, David G, Diller T, Gunnarson C, Liu M, Vicidomina BV, Zhang R, Zhang Y, Nigam SC. Delayed emergencies: The composition and magnitude of non-respiratory emergency department visits during the COVID-19 pandemic. J Am Coll Emerg Physicians Open. 2021 Jan 14;2(1):e12349. doi: 10.1002/emp2.12349. eCollection 2021 Feb.

ReferenceCitation: Casalino E, Choquet C, Bouzid D, Peyrony O, Curac S, Revue E, Fontaine JP, Plaisance P, Chauvin A, Ghazali DA. Analysis of Emergency Department Visits and Hospital Activity during Influenza Season, COVID-19 Epidemic, and Lockdown Periods in View of Managing a Future Disaster Risk: A Multicenter Observational Study. Int J Environ Res Public Health. 2020 Nov 10;17(22):8302. doi: 10.3390/ijerph17228302.

ReferenceCitation: Wongtanasarasin W, Srisawang T, Yothiya W, Phinyo P. Impact of national lockdown towards emergency department visits and admission rates during the COVID-19 pandemic in Thailand: A hospital-based study. Emerg Med Australas. 2021 Apr;33(2):316-323. doi: 10.1111/1742-6723.13666. Epub 2020 Nov 2.

ReferenceCitation: Cikrikci Isik G, Cevik Y. Impact of COVID-19 pandemic on visits of an urban emergency department. Am J Emerg Med. 2021 Apr;42:78-82. doi: 10.1016/j.ajem.2021.01.011. Epub 2021 Jan 14.

ReferenceCitation: Butt AA, Azad AM, Kartha AB, Masoodi NA, Bertollini R, Abou-Samra AB. Volume and Acuity of Emergency Department Visits Prior To and After COVID-19. J Emerg Med. 2020 Nov;59(5):730-734. doi: 10.1016/j.jemermed.2020.08.013. Epub 2020 Aug 7.

ReferenceCitation: Delforge C. Analyse de l'évolution de la gravité des patients hospitalisés pour un autre motif au cours de la pandémie COVID-19 au Centre Hospitalier de Roubaix [Internet]. Université de Lille; 2020 [cité 28 mai 2021]. Disponible sur: https://pepite.univ-lille.fr/ori-oai-search/notice/view/univ-lille-30333

ReferenceCitation: Référentiels SFMU - Motifs de recours [Internet]. 2010 [cité 27 mai 2021]. Disponible sur: https://www.sfmu.org/fr/vie-professionnelle/outils-professionnels/referentiels-sfmu/le-thesaurus-des-motifs-de-recours/ref_id/22

ReferenceCitation: Référentiels SFMU - Thésaurus [Internet]. 2009 [cité 27 mai 2021]. Disponible sur: https://www.sfmu.org/fr/vie-professionnelle/outils-professionnels/referentiels-sfmu/le-thesaurus-de-medecine-d-urgence/ref_id/23

lead_sponsor: Centre Hospitalier de Roubaix

sponsor_collaborators:
Centre Hospitalier de Roubaix
University Hospital, Lille

location_facility: Emergency Department, University Hospital

location_facility: Emergency Department, GHICL Saint-Vincent

location_facility: Emergency Department, GHICL Saint-Philibert


title: Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study

acronym: CROHN-PREP

summary:
The European guidelines currently recommend to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, up to now, no studies have been conducted to specifically evaluate bowel preparation modalities before small bowel capsule endoscopy in patients with Crohn's disease.

In patients with Crohn's disease and small bowel ulcers, polyethylene glycol may remove some fibrin from these ulcers and alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence.

In a preliminary retrospective study, it has been suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol.

Thus, the aim of the study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.

primary_purpose: Other

lead_sponsor: Nantes University Hospital

location_facility:
Brest University hospital
Rennes University hospital
Clinique Jules Verne
Nantes University Hospital
Vendée departmental hospital
Angers University Hospital
Hopital privé Confluent
Cholet hospital


title: The Remedee Solution for Improving the Quality of Life of Fibromyalgia Patients: a Multicenter, Randomized, Controlled Efficacy Trial

acronym: Fibrepik

summary:
Fibromyalgia is a chronic and complex condition with symptoms that have a strong impact of patients' quality of life, including musculoskeletal pain, insomnia, fatigue, and stiffness. These symptoms are due to a dysfunction of the central nervous system, namely increased sympathetic and decreased parasympathetic levels of activity, and a deficit in endogenous pain inhibition.

Remedee Labs is developing a unique technology using millimeter waves to stimulate subcutaneous nerve receptors of the wrist, sending a message to the brain, which in turn releases endorphins. These endorphins induce a hypoalgesic effect and activate the parasympathetic nervous system, which reduces pain, stress, and improves sleep.

The Remedee Solution evaluated in this study is a wristband designed to deliver millimeter wave, a mobile application that allows the patient to follow his treatment sessions and a personalized support which aims to improve patient adherence to the technology and to increase compliance and effectiveness of the treatment.

The hypothesis of this study is that regular use of the Remedee Solution for three months improves the quality of life of fibromyalgia patients.

ReferenceType: derived

ReferenceCitation: Chipon E, Bosson JL, Minier L, Dumolard A, Vilotitch A, Crouzier D, Maindet C. A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial. Trials. 2022 Sep 5;23(1):740. doi: 10.1186/s13063-022-06693-z.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Remedee SA

location_facility: Hôpital Lariboisière - Assistance Publique Hôpitaux de Paris


title: Development of a Severity Assessment Score for Nasosinus Polyposis (PSI Score)

acronym: PSI

summary: nasosinus polyposis (=PNS) is a chronic inflammatory disease of the nasal cavity and sinus cavity with a prevalence of 2 to 4% in the general population. The functional impact of PNS has a major impact on one's quality of life.Medical treatment, nasal irrigations and local glucocorticoids as well as short treatment of oral glucocorticoids have shown a short-term benefit versus placebo. Surgery improves the efficacy of local treatments, but 40% of patients have a recurrence of polyps at 18 months and 20% of patients require a surgery recovery at 5 years. The development of monoclonal antibodies directly targeting the inflammatory way is a real public health issue. Bachert C. et al recently demonstrated the efficacy of Dupilumab (anti-IL-4/13 antibody) injected subcutaneously on the overall symptomatology of PNS. The marketing authorization (AMM) for the first biotherapy to be available soon includes PNS's severe nature and resistance to treatment, although there is no consensus definition or score to characterize this severity. This study aims at developping a score for assessing severity in PNS. We suggest that this assessment strategy could be applied to the PNS. The originality and the innovative character of this project is the statistical modeling behind the creation of the score. Thus, the importance of symptoms, anatomical and biological factors, the estimation of the quality of life of the patients, the level of care use and the number of surgeries all become measurable indicators that are a direct reflexion of the severity and the control of PNS, called latent variables because they cannot be directly measured. To consider this detail, modeling using structural equations seems optimal to develop a severity score (PSI score) of PNS in order to personalize the therapeutic care of patients. Main Objective: To develop a severity score for PNS using latent variable modeling: Polyps Severity Index (PSI)

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Hôpitaux Universitaires de Marseille Conception

location_facility: Centre Hospitalier Intercommunal de Créteil


title: A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

summary: The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.

lead_sponsor: Concert Pharmaceuticals

location_country: Germany Poland Hungary Spain France

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: OT.CO Clinic Klinika Osipowicz & Turkowski sp. z o.o

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont, Bor-, Nemikortani es Onkodermatologiai Klinika

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Clinical Research Center for Hair and Skin Science, Dept of Dermatology, Charité Universitätsmedizin Berlin

location_facility: Klinikum Rechts der Isar, Technische Universität München, Hautklinik

location_facility: Service de Dermatologie CHRU de Brest - Hopital Morvan

location_facility: Service de Dermatologie Centre Hospitalier Universitaire de Nice - Hopital Archet 2

location_facility: Klinik für Dermatologie und Venerologie, Zentrale Studienkoordination für innovative Dermatologie (ZiD)

location_facility: WroMedica I. Bielicka, A. Strazalkowska s.c.

location_facility: Specjalistyczny Gabinet Dermatologiczny s.c.

location_facility: SZTE AOK Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika

location_facility: Semmelweis Egyetem AOK, Bor-, Nemikortani es Boronkologiai Klinika

location_facility: Hôpital Saint Louis, Centre de Santé Sabouraud

location_facility: NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL

location_facility: Hopital Saint-Louis - GH De La Rochelle-Re-Aunis

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol


title: SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

acronym: SATORI

summary: Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de Brest
CHU de Marseille
Hôpital de la Salpétrière
CHU de Tours
CHU d'ANGERS
CH de Quimper
CHU de LILLE
CHU de Bordeaux


title: Impact on Quality of Life With Pulmonary RehAbilitation After Pulmonary eMBOlism: RAMBO Study

acronym: RAMBO

summary: Pulmonary Embolism (PE) is a common and serious disease. Indeed, the annual incidence is 1/1000 patients per year and the 3-month mortality is 10%, which is twice that of myocardial infarction. The treatment is based on anticoagulation for at least 3 months. However, after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases. Several mechanisms explain dyspnea and impairment of quality of life after PE, such as residual pulmonary artery obstruction, exercise deconditioning, depressive syndrome or development of a cardio-respiratory pathology. Pulmonary rehabilitation (PR) has been shown to be effective on dyspnea and quality of life and is included in the therapeutic management of chronic respiratory diseases such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis. Furthermore, PR is also used after a myocardial infarction. However, PR after PE is still not included in therapeutic management of PE while outpatient management is recommended for the majority of patients after an acute PE episode. Study hypothesis is that PR has the potential to improve quality of life and dyspnea perception in patients who have received anticoagulation for at least 3 months after PE and who present an impairment of quality of life and/or a persistent dyspnea. This study presents several innovative aspects. First, to our knowledge, This study is the first large randomized trial assessing PR at least 3 months after acute symptomatic PE. Only one small randomized trial on 18 patients evaluating the impact of PR after PE has been published; as PR was performed just after the acute phase of PE in this trial, the clinical status improvement observed in this study could not be explained by PR alone, but also by anticoagulation. In this study, the investigators will include 112 patients at least 3 months after PE in order to exclude the bias related to anticoagulation effect. Second, This study is the first large randomized trial. Third, this study is the first that have the potential to demonstrate efficacy and safety of delayed PR after PE in patients with impaired quality of life due to persistent residual dyspnea.

location_facility:
CH Morlaix
Centre de santé de Roscoff
CHBS Lorient
CHU Saint-Etienne
CHU Brest
CHU Tours
Hegp (Ap-Hp)
CHU Angers

appel_a_projets: PHRCN

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: RAMBO

titre: Etude de l'altération de la qualité de vie au décours d'une embolie pulmonaire

discipline_principale: pneumologie

nom_porteur: TROMEUR

prenom_porteur: Cécile


title: Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy

acronym: SILENCE

summary:
Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life.

Non invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea.

This study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.

location_facility:
Ch Chateauroux
Ch Orleans
CHRU Bretonneau
Chru Morvan
CH BLOIS
Ch Chinon
Clinique Victor Hugo
CORT37


title: Postoperative Pain Evaluation After Definitive Root Canal Obturation With Zinc Oxide/Eugenol-type Sealer Containing or Not 1% Prednisolone Acetate - Steroid Anti-inflammatory Agent: a Comparative, Randomized Clinical Trial.

summary:
The study design is a multicentric randomized controlled clinical trial. 238 subjects (teeth) requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (119 in each group).

The aim is to assess the effectiveness and utility of the ancillary drug substance, prednisolone acetate (1%) contained in CORTISOMOL SP (Zinc Oxide/Eugenol-type sealer) to help to decrease the possible postoperative painful reactions after root canal treatment. SEALITE REGULAR, which has a similar formulation except it is prednisolone acetate-free, is used as the comparator sealer.

Procedures of root canal treatment will be conventional and standardized for all investigational centers. The canals will be cleaned, shaped and then obturated using a Zinc oxide/Eugenol-type sealer (CORTISOMOL SP or SEALITE REGULAR) and gutta-percha.

Patients assess their pain for 7 days after permanent root canal obturation.

lead_sponsor: ACTEON Group

sponsor_collaborators:
ACTEON Group
Slb Pharma

location_facility:
CHU Rennes - Centre de Soins Dentaires
Cabinet dentaire


title: Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study

acronym: TRUST

summary: This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin

lead_sponsor: Institut Bergonié

collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

location_facility:
IUCT Oncopole
Centre Léon Bérard
Institut Paoli Calmette
Institut Bergonie
CHU Poitiers
Institut Gustave Roussy
Centre Georges François Leclerc
Institut Curie


title: Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study

acronym: CANNAPSYSTIM

summary: Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles

location_facility: Service Hospitalo-Universitaire d'Addictologie CHU de Dijon

location_facility: CH Saint-Cyr-au-Mont-d'Or service de psychiatrie

location_facility: CHU de Clermont-Ferrand Service de Psychiatrie

location_facility: CH Le Vinatier Service universitaire d'addictologie de Lyon

location_facility: CHU Pôle de Psychiatrie Neurologie et Rééducation


title: Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study

acronym: PADIS

summary: The originality of this study is the comparison of different distractibility techniques (hypnosis and virtual reality) in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.

lead_sponsor: Lille Catholic University

location_facility: Fondation Ellen Poidatz - Centre de Rééducation Fonctionnelle

region: Hauts-de-France

nom_etablissement: GCS GHICL DES HOPITAUX DE L'ICL

type_etablissement: GCS

acronyme: PADIS

titre: Efficacité antalgique de l'hypnose et de la réalité virtuelle lors de soins douloureux répétés : étude contrôlée, randomisée, en cross-over, ouverte, multicentrique

discipline_principale: anesthésiologie / réanimation

nom_porteur: QUERUEL

prenom_porteur: Philippe


acronym: COPreDex

lead_sponsor: Hôpital NOVO

summary: The aim of the study is to evaluate two differents regimens of corticosteroids (prednisolone versus dexamethasone) on D28 mortality in patients with CoViD 19 pneumonia requiring oxygen supplementation

location_facility: Department of Pneumology and Infectious Medicine, Hospital Carnelle Portes de l'Oise

location_facility: Department of Infectious and respiratory Diseases, Hospital Delafontaine

location_facility: Department of Internal Medicine, Hospital Emile Roux - Le Puy-en-Velay

location_facility: Department of Pneumology and Infectious Diseases, Hospital of Saint-Quentin

location_facility: Department of Infectious and Tropical Diseases, Hospital René Dubos,

location_facility: Department of Emergency, Hospital Victor Dupouy

location_facility: Department of Infectious and Tropical Diseases, Hospital Simone Veil

location_facility: Department of Infectious Medicine, Hospital of Gonesse

title: Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study

source: euctr


title: Comprehensive Chromosomal Testing of Trophectoderm Biopsies of Blastocysts to Improve Live Birth Rates After in Vitro Fertilization: a Prospective Randomized Trial

acronym: Devit

summary:
Preimplantation embryo aneuploidy is a major source of adverse outcomes in human reproduction since it leads to implantation failure, early pregnancy loss or severe chromosomal diseases. The risk of embryos aneuploidy is drastically increased after 35 years old. The intra uterine transfer of euploid embryos assessed through such techniques as next-generation sequencing (NGS) based Comprehensive chromosomal Testing of Trophectoderm (TE) biopsies of Blastocysts (CTTEB), may improve implantation and live birth rates, and decrease miscarriage rates. But no randomized controlled trial (RCT) was ever performed to test the interest of CTTEB for women that really needed it (≥35 to ≤ 41 years old). In this multicentre randomized-controlled-trial, the investigators will compare live birth rate obtained after the first single frozen-thawed blastocyst transfer cycle following the freeze-all-Intracytoplasmic sperm injection cycle in infertile and old couples between two different strategies of Day 5/6 blastocyst selection:

Control group: morphological criteria (Istanbul consensus)
Interventional group: international recommendations after CTTEB (www.pgdis.org; Newsletter May 27, 2019).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Antoine Béclère
CHU Nantes
Hôpital Cochin
Hôpital Arnaud de Villeneuve
CHU Clermont-Ferrand
Hopital Tenon
CHU Dijon
CHU Strasbourg

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: DEVIT

titre: L'Identification d'aneuploïdies sur biopsie de trophectoderme améliore-t-elle le taux de naissances après Fécondation in Vitro ? Une étude prospective randomisée

discipline_principale: médecine de la reproduction

nom_porteur: PATRAT

prenom_porteur: Catherine


title: A Randomized Study to Investigate the Efficacy and Safety of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Previously Treated Patients With Advanced Stage or Metastatic Soft-tissue Sarcoma

acronym: FLASH

summary: Open label, randomized, controlled phase II study preceded by a safety run-in part in subjects with advanced or metastatic soft-tissue sarcoma.

lead_sponsor: Philogen S.p.A.

location_country: Germany Italy Poland Spain France

location_facility: Maria Sklodowska Curie National Research Institute of Oncology

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: IRCCS Fondazione del Piemonte per l'Oncologia Istituto per la Ricerca e la Cura del Cancro di Candiolo

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Institut régional du Cancer de Montepellier - ICM Val d'Aurelle


title: Comparison of the Efficacy and Safety of Budesonide/Formoterol Turbuhaler® Versus Terbutaline Nebulization as Reliever Therapy in Children With Asthma Presenting at the Emergency Room for Moderate Exacerbation

acronym: ASTHMAFAST

summary: Combined use of inhaled corticosteroids and long-acting β-agonists (LABAs) as the controller and the quick relief therapy termed single maintenance and reliever therapy (SMART) is a potential therapeutic regimen for the management of persistent asthma. A recent systematic review supports the combined use of inhaled corticosteroids and LABA as both the controller and quick relief therapy (SMART) among patients aged 12 years. In Emergency room (ER), Meta-analysis showed that using salbutamol (or albuterol) by meter doses inhaler (MDI) with a valved holding chamber (VHC) in children with moderate-severe acute asthma exacerbation was more effective, that is, fewer hospital admissions, more clinical improvement, and had fewer adverse effects (tremor and tachycardia) than salbutamol by nebulizer. Therefore, several international guidelines recommend the use of salbutamol by MDI rather than by nebulizer for moderate-severe asthma exacerbations. In children older than 8 years old, dry-powder inhaler (DPI), a device that delivers medication to the lungs in the form of a dry powder is currently used for maintenance and reliever therapy rather than MDI. In this context, we aim to assess the use of combined inhaled corticosteroids and long-acting β-agonists (LABAs) as a quick relief therapy in children older than 8 years old presenting at the ER with moderate asthma exacerbation. Acute asthma patients who had severe exacerbation were excluded from this study (these patients receiving systematically continuous nebulized salbutamol and/or intravenous salbutamol upon their arrival)

status: Terminated

sponsor_collaborators: Centre Hospitalier Intercommunal Creteil

location_facility:
CHU Ambroise Paré
CHI Villeneuve-Saint-Georges
Grand Hôpital de l'Est Francilien
CHI Créteil
CHU Bicêtre
CHU Lille
Centre Hospitalier Sud Francilien
CHU Antoine Béclère

status_simplified: Unknown


title: Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

summary:
Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications.

This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.

Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.

Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.

The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Hopital Saint Joseph
Institut Curie - Site de Paris
Institut de cancérologie de Montpellier
Centre Antoine Lacassagne
Institut Bergonie
IUCT-O
Institut de Cancérologie de l'Ouest
ICO - Site Paul Papin

appel_a_projets: PHRCK

region: Pays de la Loire

nom_etablissement: ICO - SITE PAUL PAPIN

type_etablissement: CLCC

titre: Impact de l'HORmonothérapie NEOadjuvante sur la prise en charge chirurgicale des carcinomes in Situ étendu

discipline_principale: cancer

nom_porteur: BRILLAUD-MEFLAH

prenom_porteur: Victoire


title: Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumour VOLUME in Patients Treated for Classical HODgkin's Lymphoma.

acronym: REVOLUMHOD

summary:
Anti-PD-1antibodies (iPD-1) are indicated as monotherapy in the treatment of adult patients with classical LH. The recommended dosage in LH is based on solid tumour experience and no dose-concentration-effect studies have been conducted.

According to the literature, therapeutic efficacy appears to be highly variable, and could be related to differences in treatment exposure.

Since Total metabolic tumor volume (TMTV) is a prognostic factor in LH and the clearance of iPD-1, and thus exposure to iPD-1, is related to clinical efficacy, we hypothesize that TMTV influences the exposure to iPD-1 and thus its therapeutic efficacy.

The aim of this study is to evaluate the relationship between TMTV and anti-PD-1 exposure in refractory or relapsed LH.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Nantes
CHU Rennes
CH Orléans
CHBA Vannes
CHU Poitiers
CHU Dijon
CHU Tours
CHU Angers

appel_a_projets: PRTK

nom_etablissement: CHRU RENNES

acronyme: REVOLUMHOD

titre: Evaluation de la relation entre exposition aux anti-PD-1 et volume tumoral chez le patient traité pour un lymphome de Hodgkin classique.

nom_porteur: HOUOT

prenom_porteur: Roch


title: Relapse in Previously Irradiated Prostate Bed : a Phase I/II Study of Stereotactic Ablative Reirradiation Potentiated by Metformin

summary: This phase I/II escalation dose study is assessing the efficacy of the recommended dose of stereotactic re-irradiation (SBRT) of relapses within the prostatectomy bed, potentiated by metformin

design_allocation: Non-Randomized

location_facility:
CHRU de BREST - HOPITAL MORVAN
Chru Bretonneau
Centre GEORGES FRANCOIS LECLERC
Centre Eugene Marquis
Centre LEON BERARD
Institut de Cancerologie de L'Ouest
Centre OSCAR LAMBRET

appel_a_projets: PHRCI

acronyme: REPAIR

titre: RElapse in previously irradiated Prostate bed : a phase I/II study of stereotactic Ablative reIRradiation

discipline_principale: cancérologie / radiothérapie

nom_porteur: GUIMAS

prenom_porteur: VALENTINE


title: ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis

acronym: PAMOCOS

summary: COVID-19 is a worldwide pandemic. Around 5% of infected patients are admitted in ICU, mainly for respiratory failure. Outcome of these patients is linked to other organ failures. Optimal therapies are not defined so far. The sponsor want to assess the role of MR-ProADM as prognostic biomarker, and the impact of treatments (including supportive treatments) on MOF occurrence and outcome.

lead_sponsor: Centre Hospitalier de Lens

location_facility:
Hospital of Boulogne/mer
Hospitalier of Valenciennes
Hospital of Roubaix
Hospital of Dunkerque
Hospital Dr Schaffner
Hospital of Arras
Hospital of Tourcoing
Hospital of DOUAI


title: Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)

acronym: QFK

summary:
KC is a degenerative disorder of the cornea. Keratoconus etiopathogenesis remains unclear and may rely on environmental and genetic factors. Usually considered as a rare disease (<1/2000), but the prevalence is nowadays growing worldwide up to 1/500. In that pathology, cornea progressively gets thinner, and there is a deformation of the corneal surface which can induce high order optical aberrations and visual impairment.

Eye rubbing is certainly the main factor in the progression or development of keratoconus (KC), yet it is only very partially evaluated and quantified in current management. Environmental and clinical factors will be collected and associated with a eye rubbing Questionnaire, specifically pointing out eye rubbing.

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre National Ophtalmologique des Quinze Vingt


title: Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer

acronym: XOFIGO

summary:
Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.

bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.

Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.

Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

ReferenceType: result

ReferenceCitation: Harrison MR, Wong TZ, Armstrong AJ, George DJ. Radium-223 chloride: a potential new treatment for castration-resistant prostate cancer patients with metastatic bone disease. Cancer Manag Res. 2013;5:1-14. doi: 10.2147/CMAR.S25537. Epub 2013 Jan 8.

license: cc-by-nc

license_normalized: cc-by-nc

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

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Informa

ReferenceCitation: Nilsson S, Strang P, Aksnes AK, Franzen L, Olivier P, Pecking A, Staffurth J, Vasanthan S, Andersson C, Bruland OS. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012 Mar;48(5):678-86. doi: 10.1016/j.ejca.2011.12.023. Epub 2012 Feb 15.

ReferenceCitation: Parker CC, Pascoe S, Chodacki A, O'Sullivan JM, Germa JR, O'Bryan-Tear CG, Haider T, Hoskin P. A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer. Eur Urol. 2013 Feb;63(2):189-97. doi: 10.1016/j.eururo.2012.09.008. Epub 2012 Sep 13.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility:
Chu Grenoble
UP Clermont Ferrand
APHP Hopital Cochin
IPC Marseille
ONCOLOPE
CRLC de Nantes
ICO Bordeaux
Icm Val D'Aurelle


title: Phase II Study to Assess Preoperative Hypofractionated Stereotactic Radiotherapy of Brain Metastases

acronym: STEP

summary: STEP is a French multicentre, prospective, non-randomized, phase II study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (SRS) for patients with brain metastases

ReferenceCitation: Ginzac A, Dupic G, Brun L, Molnar I, Casile M, Durando X, Verrelle P, Lemaire JJ, Khalil T, Biau J. Preoperative stereotactic radiosurgery for brain metastases: the STEP study protocol for a multicentre, prospective, phase-II trial. BMC Cancer. 2021 Jul 28;21(1):864. doi: 10.1186/s12885-021-08602-0.

lead_sponsor: Centre Jean Perrin

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation (AURA)

location_facility: Institut de cancérologie de la Loire Lucien Neuwirth

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)


title: Characterization of a Functional Test for Mediterranean Family Fever Screening - 2

acronym: DEPIST-FMF 2

summary:
Familial Mediterranean fever (FMF) is the most common auto-inflammatory disease (prevalence: 1-5 / 10,000 inhabitants). It is caused by mutations in the MEFV gene, which encodes variants of the Pyrine inflammasome. Inflammasomes are protein complexes of the innate immunity that produce pro-inflammatory cytokines (interleukin-1β).

In vitro, our preliminary results demonstrated that the activation of the inflammatory pyrine (measured by the concentration of interleukin-1β) by kinase inhibitors is significantly increased in FMF patients compared to healthy subjects. Furthermore, a measurement of cell death gave significant results in differentiating the patients from the controls.

The performance of this functional has been tested, fast and simple diagnostic test on common mutations and wish to assess its characteristics for MEFV mutations.

The investigators hypothesize that this quick and simple functional test can serve as a diagnostic tool for FMF and can quantitatively discriminate against patients with different mutations (genotypes).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Pédiatrie - CHU de Nîmes - Hôpital Carémeau

intervention_type: Biological


title: Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients

acronym: ERCO-Park

summary:
The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

ReferenceCitation: Fabbri M, Leung C, Baille G, Bereau M, Brefel Courbon C, Castelnovo G, Carriere N, Damier P, Defebvre L, Doe de Maindreville A, Fluchere F, Fuzzatti M, Grabli D, Maltete D, Rousseau V, Sommet A A, Thalamas C, Thiriez C, Rascol O, Ory-Magne F. A French survey on the lockdown consequences of COVID-19 pandemic in Parkinson's disease. The ERCOPARK study. Parkinsonism Relat Disord. 2021 Aug;89:128-133. doi: 10.1016/j.parkreldis.2021.07.013. Epub 2021 Jul 13.

oa_colors: green other

evidence: open (via free pdf)

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

lead_sponsor: University Hospital, Toulouse

location_facility: Centre Hospitalier Universitaire de Marseille

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Régionale Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de la Pitié-Salpêtrière

location_facility: Centre Hospitalier Universitaire de Nîmes - Caremeau


title: Amplatzer™ Trevisio™ Delivery System Post-Approval Study

acronym: Trevisio PAS

summary: A single-arm, non-randomized, multi-center clinical study of the Amplatzer™ Trevisio™ Intravascular Delivery System for facilitating percutaneous, transcatheter implantation of the Amplatzer™ Occluder Devices

lead_sponsor: Abbott Medical Devices

location_country: Germany Italy Poland Netherlands Switzerland Spain France

location_facility: Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca ul.

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: The Cardinal Stefan Wyszynski Institute of Cardiology

location_facility: Fondazione Toscana Gabriele Monasterio Via Aurelia Sud

location_facility: Hospital Universitario de la Paz - Pediatrico

location_facility: Centre Médico Chirurgical Marie Lannelongue

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel


acronym: ICING

lead_sponsor: UNICANCER

summary:
This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial.

This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.

ReferenceCitation: Saint A, Van Obberghen-Schilling E. The role of the tumor matrix environment in progression of head and neck cancer. Curr Opin Oncol. 2021 May 1;33(3):168-174. doi: 10.1097/CCO.0000000000000730.

publisher_dissemination: Wolters Kluwer Health

sponsor_collaborators:
UNICANCER
Merck KGaA, Darmstadt, Germany

location_facility:
Centre Léon Bérard
Centre Antoine Lacassagne
CHU La Timone
Institut de cancérologie de Lorraine
Institut Claudius Régaud
Gustave Roussy Cancer Campus
CHU de Bordeaux
Institut Curie

title: A Phase II Trial Assessing Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in a Pre-operative Setting for Resectable and Untreated Head and Neck Squamous Cell Carcinoma

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.


title: Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context

acronym: RHUMAJICOVID

summary: The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is concerns by these fears (the patient and their parents). Patients are treated by several classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs, corticosteroids and disease modifying anti-rheumatic drugs. The present study will characterize this issue by defining the proportion of patients whose usual treatment of Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis, and also to return to school.

status: Unknown status

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de Brest
CHU de Nancy
CHU de Poitiers
CHU de Strasbourg
CH de Belfort
AP-HP Hôpital Kremlin-Bicêtre
CHU de Rennes
CHU de Bordeaux


title: TROPHAMET, a Phase I/II Trial of Avelumab and METhotrexate in Low-risk Gestational TROPHoblastic Neoplasias as First Line Treatment

acronym: TROPHAMET

summary:
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole.

Low-risk GTN patients (FIGO score ≤ 6) are commonly treated with single agent treatment (methotrexate or actinomycin-D) The cure rate, assessed by hCG normalization, is obtained in 65 to 75% of patients with these agents GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens, such as EMA-CO or BEP regimen.

Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life

There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating :

Spontaneous regressions of metastastic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells.
Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center.
Complete and durable responses to pembrolizumab were reported in 3 patients with multi-chemoresistant GTN in United Kingdom.
Three cases of hCG normalization with avelumab in 6 patients with chemo-resistant GTN enrolled in TROPHIMMUN cohort A (resistant to a mono-chemotherapy).
Cytotoxicity of avelumab is mediated through antibody dependent cell cytotoxicity (ADCC) by NK cells.

sponsor_collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

location_facility:
Institut Bergonié
Institut Paoli-Calmettes
Centre Antoine Lacassagne
Assistance Publique Hôpitaux de Paris
Centre Oscar Lambret
Centre Eugène Marquis
Centre François Baclesse
Centre Hospitalier Lyon Sud


title: Study of the Kinetics of the Immune Response During the Intensive Care Unit Stay in Adult Patients Infected With SARS-CoV-2: Multicentric Non Interventional Study

acronym: RICO

summary:
Infection with the SARS-CoV-2 coronavirus (COVID-19) has recently been identified as a pandemic due to the speed and global scale of its transmission. In Auvergne-Rhône-Alpes region (AURA), the epidemic began in February 2020 and the number of infected people is still important. Between 15 and 20% of COVID-19 patients develop an acute respiratory distress syndrome (ARDS) leading to their hospitalization in intensive care. Their clinical progression can be rapidly harmful with the development of severe ARDS associated with an increased risk of death.

Preliminary data on the immune response of COVID-19 patients describe the induction of a moderate inflammatory response and the occurrence of major progressive lymphopenia over time associated with potential immunosuppression. Up to 50% of secondary infections are reported in deceased COVID-19 patients. However, no prospective study has exhaustively described the kinetics of the immune response of COVID-19 patients in intensive care.

The precise description of the immune response over time in adult patients with a proven infection with the SARS-CoV-2 virus and the study of the relation between this response and the increased risk of organ failure (severe ARDS), death or nosocomial infection will allow us to better understand the pathophysiology of the immune response induced by COVID-19 in order to (i) identify new therapeutic strategies targeting the host response in patients in intensive care (ii) to develop biological markers to stratify patients for future clinical trials evaluating these immunoadjuvant treatments in COVID-19.

ReferenceCitation: Bidar F, Hamada S, Gossez M, Coudereau R, Lopez J, Cazalis MA, Tardiveau C, Brengel-Pesce K, Mommert M, Buisson M, Conti F, Rimmele T, Lukaszewicz AC, Argaud L, Cour M, Monneret G, Venet F; RICO Study Group. Recombinant human interleukin-7 reverses T cell exhaustion ex vivo in critically ill COVID-19 patients. Ann Intensive Care. 2022 Mar 5;12(1):21. doi: 10.1186/s13613-022-00982-1. Erratum In: Ann Intensive Care. 2022 Apr 1;12(1):30.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

sponsor_collaborators:
Hospices Civils de Lyon
BioMérieux

location_facility: Centre hospitalier universitaire de Grenoble Alpes


title: Chronic Fatigue Etiology and Recovery in Covid-19 Patients : the Role of Fatigability and Stay in Intensive Care

summary:
Chronic fatigue is the most common and debilitating symptom in intensive care unit (ICU) survivors. Indeed, it has been widely reported that patients who stayed in ICU for prolonged periods report a feeling of tiredness for months to years after ICU discharge. This symptom seems particularly pronounced in Covid-19 patients and may affect their quality of life by decreasing their capacity to perform simple tasks of daily life.

The aim of the present project is to determine whether deteriorated neuromuscular function (i.e. increased fatigability) is involved in the feeling of fatigue of Covid-19 patients. Because the causes of this feeling are multi-dimensional, a large battery of tests will allow us to better understand the origin of chronic fatigue. A better knowledge of chronic fatigue etiology and its recovery will allow to optimize rehabilitation treatments to shorten the persistence of chronic fatigue and in fine improve life quality.

collaborators: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hôpital privé de la Loire
Chu Saint-Etienne
Hôpital Henry Gabrielle
Clinique Mutualiste Saint Etienne
CHU de Grenoble
Centre Hospitalier de Lyon Sud
Hôpital Croix Rousse - HCL
Clinique de la Sauvegarde - Lyon


acronym: PREP-COVID

summary: The Investigators propose to set up a preventive trial of infection in hospital workers at risk of coronavirus infection by comparing the rate of SARS-Cov-2 infection in a population of negative SARS-Cov-2 hospital workers receiving preventively azithromycin, hydroxychloroquine or a Placebo

location_facility:
Hôpital européen Georges Pompidou
Hôpital Saint Antoine
Hôpital Cochin
Hôpital GHU Paris Saclay
Hopial Avicenne
Hôpital Broca
Hôpital La Pitié-Salpétrière
Hôpital Necker

title: Randomized Multicenter Study Evaluating the Efficacy of Azithromycin and Hydroxychloroquine in the Prevention of SARS-CoV-2 Infection in the Hospital Population Exposed to Virus


title: Cardiovascular Complications in Patients With COVID-19

acronym: CovCardioVasc

summary: Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

ReferenceCitation: Ferrari E, Sartre B, Squara F, Contenti J, Occelli C, Lemoel F, Levraut J, Doyen D, Dellamonica J, Mondain V, Chirio D, Risso K, Cua E, Orban JC, Ichai C, Labbaoui M, Mossaz B, Moceri P, Appert-Flory A, Fischer F, Toulon P. High Prevalence of Acquired Thrombophilia Without Prognosis Value in Patients With Coronavirus Disease 2019. J Am Heart Assoc. 2020 Nov 3;9(21):e017773. doi: 10.1161/JAHA.120.017773. Epub 2020 Sep 25.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ipd_sharing_description: no data sharing plan has been established.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpitaux Universitaires Paris Centre - Hôpital Cochin


title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Tocilizumab Trial - CORIMUNO-19 - TOCI (CORIMUNO-TOCI)

acronym: CORIMUNO-TOC

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Tocizilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Tocilizumab administration to patients enrolled in the COVIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.

ReferenceCitation: Tleyjeh IM. The Misleading "Pooled Effect Estimate" of Crude Data from Observational Studies at Critical Risk of Bias: The Case of Tocilizumab in Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2021 Jun 15;72(12):e1154-e1155. doi: 10.1093/cid/ciaa1735. No abstract available.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Hermine O, Mariette X, Tharaux PL, Resche-Rigon M, Porcher R, Ravaud P; CORIMUNO-19 Collaborative Group. Effect of Tocilizumab vs Usual Care in Adults Hospitalized With COVID-19 and Moderate or Severe Pneumonia: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jan 1;181(1):32-40. doi: 10.1001/jamainternmed.2020.6820. Erratum In: JAMA Intern Med. 2021 Jan 1;181(1):144. JAMA Intern Med. 2021 Jul 1;181(7):1021.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

location_facility:
Institut Gustave Roussy
APHP - Hopital Necker
APHP- Hopital Tenon
APHP - Bichat
APHP - Beaujon
CHU Strasbourg
APHP - Pitié Salpêtrière
APHP - Saint Louis


title: OP2C : Prialt® Observatory in Clinical Practice

summary: Ziconotide (Prialt®) is a powerful analgesic, approved in Europe since 2005, and reserved for the intrathecal route. Ziconotide is a protein of 2500 Daltons isolated from a cone-snail: Conus Magus, acting by blocking the N-type voltage-sensitive calcium channels. Its efficacy has been proven by 3 randomized clinical trials. It is particularly effective on chronic refractory neuropathic pain, and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis. However, during these studies many adverse reactions became evident, especially neuropsychiatric reactions, which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment. There is a lack of data on the current use of ziconotide in current practice. The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide in different settings of patients with severe chronic pain requiring intrathecal analgesia.

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Esteve

location_facility: Centre Hospitalier Departemental La Roche Sur Yon


title: Management of Anticoagulant Therapy Monitored by an Implantable Device With Telecardiology in Patients With Acute Coronary Syndrome Associated With de Novo Atrial Fibrillation Arrhythmia: A Prospective Multicenter Study

acronym: SCA FA

summary: Patients with Acute Coronary Syndrome associated with de novo atrial fibrillation are randomized to benefit from either a conventional therapy associating dual antiplatelet therapy (DAPT) and anticoagulant or DAPT and an implantable monitoring device with a follow-up by telecardiology

lead_sponsor: Centre Hospitalier de PAU

location_facility: Centre hospitalier Chartres Louis Pasteur le Coudray


title: Evaluation of Positioning Protocols With an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke

acronym: POSIT-HEMI

summary: The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Groupement Hospitalier Intercommunal du Vexin

location_facility: Centre de Rééducation et de Réadaptation Fonctionnelles


title: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial

acronym: Optim-UCPVax

summary:
Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide.

The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches.

The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients.

Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC.

UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

ReferenceCitation: Adotevi O, Dosset M, Galaine J, Beziaud L, Godet Y, Borg C. Targeting antitumor CD4 helper T cells with universal tumor-reactive helper peptides derived from telomerase for cancer vaccine. Hum Vaccin Immunother. 2013 May;9(5):1073-7. doi: 10.4161/hv.23587. Epub 2013 Jan 28.

ReferenceCitation: Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619. doi: 10.4161/onci.21513.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators:
Bristol-Myers Squibb
Fondation ARC

location_facility:
Institut de Cancérologie Privé CCGM
CHU of Besançon
Institut Jean Godinot
CHU de Nîmes
CH Mulhouse
CHU Bordeaux
Institut de Cancérologie de l'Ouest
Centre Georges François Leclerc


acronym: COLIBRI

lead_sponsor: ARCAGY/ GINECO GROUP

summary: This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Bristol-Myers Squibb

location_facility: Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, CARIO-HPCA

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

title: A Multicenter, Pilot Study Evaluating Immune Impact and Safety of Nivolumab in Combination With Ipilimumab (Immune Combination) Before Initial RT-CT Treatment for Cervix Cancer.: the French GINECO - COLIBRI Study


title: Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

acronym: BICOLDER

summary: Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
Hopital L'Archet
Hopital Hotel Dieu
Hôpital Hotel Dieu
Hopital Bretonneau
CH de Saint Nazaire
Hopital Gustave Dron
Bichat Hospital
Hopital Sainte Marguerite


title: A Phase II Study Assessing Safety and Efficacy of Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure

summary: Assess efficacy and safety of cabozantinib in monotherapy in advanced/metastatic cervical cancer (CC) after failure of platinum-based regimen treatment.

ReferenceCitation: Coquan E, Brachet PE, Licaj I, Leconte A, Castera M, Lequesne J, Meriaux E, Bonnet I, Lelaidier A, Clarisse B, Joly F. CABOCOL-01 trial: a single-arm phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure. BMC Cancer. 2021 Sep 25;21(1):1054. doi: 10.1186/s12885-021-08758-9.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Léon Bérard
Institut de Cancérologie de Montpellier
Centre François Baclesse
Institut de cancérologie de l'Ouest
Institut Gustave Roussy
Centre Oscar LAMBRET
Institut CURIE


title: Precision Medicine Phase II Study Evaluating the Efficacy of a Double Immunotherapy by Durvalumab and Tremelimumab Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes Mutation in Response or Stable After Olaparib Treatment

summary: The study propose to generate a clinical trial based on precision medicine to evaluate the use of immunotherapy in patients with altered homologous recombination repair genes and without progression after prior targeted therapy.

ReferenceCitation: Fumet JD, Limagne E, Thibaudin M, Truntzer C, Bertaut A, Rederstorff E, Ghiringhelli F. Precision medicine phase II study evaluating the efficacy of a double immunotherapy by durvalumab and tremelimumab combined with olaparib in patients with solid cancers and carriers of homologous recombination repair genes mutation in response or stable after olaparib treatment. BMC Cancer. 2020 Aug 10;20(1):748. doi: 10.1186/s12885-020-07253-x.

lead_sponsor: Centre Georges Francois Leclerc

sponsor_collaborators:
Centre Georges Francois Leclerc
AstraZeneca

location_facility:
Institut Bergonié
CHRU Jean Minjoz
CHU François Mitterrand
Centre Leon Berard
Institut Hospitalier Franco-Britannique
Centre Oscar Lambret
Centre Georges François Leclerc
CHU Amiens


title: Impact of a Strategy Combining the Rapid Polymerase Chain Reaction Platform FilmArray® and the Intervention of an Antimicrobial Stewardship Team in Hospital-acquired Pneumonia in Non-mechanically Ventilated Patients: a Randomized Controlled Trial.

acronym: SHARP

summary:
Hospital-Acquired Pneumonia (HAP) is the second most frequent hospital-acquired infection in the US and Europe and accounts for a large proportion of antibiotics prescribed in hospitals. Conventional methods to identify causative microorganisms (virus, bacteria) are time-consuming and sometimes inaccurate, leading to inadequate treatment in a large proportion of HAP patients.

The FILMARRAY® Pneumonia Panel (FA-PP, bioMérieux) is an automated diagnostic device, allowing detection of multiple pathogens and resistance markers in one hour. Strategies combining rapid diagnostic testing and intervention of specialists in infectious diseases (i.e. antimicrobial stewardship -AMS - experts) showed significant synergistic impact on antibiotic use, mortality and costs in bloodstream infections.

The trial hypothesis is that a strategy combining antimicrobial stewardship and FA-PP improves quality of care in HAP patients, as compared to antimicrobial stewardship alone.

The trial will include patients hospitalized for ≥ 48 hours, aged 18 years or older, who have criteria of pneumonia: new lung infiltrate on a chest-x ray, plus evidence that the infiltrate is of an infectious origin (i.e. new onset of fever and/or purulent sputum and/or leukocytosis and/or decline in oxygenation).

After informed consent, participants will be randomly allocated to either the intervention or the control arm.

In the control arm, management of HAP patients will include clinical examination and conventional microbiological tests. Antibiotic choice will be discussed between AMS experts and the physician in charge of the patient.

In the intervention arm, in addition to the procedures above, the strategy will include rapid testing using the FA-PP on a respiratory specimen, obtained by either invasive or non-invasive sampling. No additional invasive procedures will be required for the study, and FA-PP will be performed on samples collected as part as routine care.

Investigators will visit the patient at inclusion, on day 3 and on day 30 (or at hospital discharge) to collect data on comorbidities, clinical outcomes, results of microbiological tests and antibiotics. At the end of follow-up, we will compare the number of days on broad-spectrum antibiotics, the incidence of negative outcomes, the length of stay and costs in the two arms.

The use of the FA-PP is expected to prompt early adjustment of antibiotic therapy, improve outcomes, decrease length of stay, and to reduce the use of broad-spectrum antibiotics. The antibiotic saving may reduce the selection pressure, incidence of colonization with multidrug-resistant bacteria and incidence of hospital-acquired superinfections, both at an individual and hospital level. Moreover, this trial relies on the intervention of multidisciplinary AMS teams that are currently being implemented in many health facilities. Their transversal position offers opportunities for recruitment of patients from a wide range of medical and surgical departments. This project evaluates the feasibility of clinical trials based on the intervention of these teams, and will provide a high level of evidence regarding their impact on the prognosis of patients, appropriate use of antibiotics, and antimicrobial resistance.

ReferenceCitation: Kalil AC, Metersky ML, Klompas M, Muscedere J, Sweeney DA, Palmer LB, Napolitano LM, O'Grady NP, Bartlett JG, Carratala J, El Solh AA, Ewig S, Fey PD, File TM Jr, Restrepo MI, Roberts JA, Waterer GW, Cruse P, Knight SL, Brozek JL. Management of Adults With Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clin Infect Dis. 2016 Sep 1;63(5):e61-e111. doi: 10.1093/cid/ciw353. Epub 2016 Jul 14. Erratum In: Clin Infect Dis. 2017 May 1;64(9):1298. Clin Infect Dis. 2017 Oct 15;65(8):1435. Clin Infect Dis. 2017 Nov 29;65(12):2161.

ReferenceCitation: Messika J, Stoclin A, Bouvard E, Fulgencio JP, Ridel C, Muresan IP, Boffa JJ, Bachmeyer C, Denis M, Gounant V, Esteso A, Loi V, Verdet C, Prigent H, Parrot A, Fartoukh M. The Challenging Diagnosis of Non-Community-Acquired Pneumonia in Non-Mechanically Ventilated Subjects: Value of Microbiological Investigation. Respir Care. 2016 Feb;61(2):225-34. doi: 10.4187/respcare.04143. Epub 2015 Dec 8.

ReferenceCitation: Gadsby NJ, Russell CD, McHugh MP, Mark H, Conway Morris A, Laurenson IF, Hill AT, Templeton KE. Comprehensive Molecular Testing for Respiratory Pathogens in Community-Acquired Pneumonia. Clin Infect Dis. 2016 Apr 1;62(7):817-823. doi: 10.1093/cid/civ1214. Epub 2016 Jan 7.

ReferenceCitation: Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.

ReferenceCitation: Bookstaver PB, Nimmich EB, Smith TJ 3rd, Justo JA, Kohn J, Hammer KL, Troficanto C, Albrecht HA, Al-Hasan MN. Cumulative Effect of an Antimicrobial Stewardship and Rapid Diagnostic Testing Bundle on Early Streamlining of Antimicrobial Therapy in Gram-Negative Bloodstream Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00189-17. doi: 10.1128/AAC.00189-17. Print 2017 Sep.

ReferenceCitation: Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpitaux Universitaires Paris Nord Val de Seine - MIR (Bichat)

location_facility: Hôpitaux Universitaires Paris Centre (Cochin) - service Médecine Intensive - Réanimation

location_facility: Hôpitaux Universitaires Paris Nord Val de Seine - EPRI (Bichat)

location_facility: Hôpitaux Universitaires Paris Centre-Site Cochin

location_facility: Hôpitaux Universitaires Paris Nord Val de Seine-Site Bichat (SMIT)

acronyme: SHARP

titre: Impact d'une stratégie associant le dispositif automatisé de diagnostic rapide par PCR FilmArray® et l'intervention d'une équipe de conseil en antibiothérapie dans la pneumonie acquise à l'hôpital chez les patients non intubés ventilés: un essai contrôlé randomisé

discipline_principale: infectiology / biology of infectious agents / hygiene

nom_porteur: KERNEIS

prenom_porteur: Solen


title: A Prospective Study Aiming to Determine the Cartography of Virological Reservoir Related to Antiretroviral Concentrations in Chronic HIV-1 Patients Treated With a First Line of Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors (NRTIs).

acronym: DOLUVOIR

summary: The main objective of the study is to characterize the diffusion of dolutegravir and associated backbone (abacavir/lamivudine or tenofovir/emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

primary_purpose: Basic Science

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
ViiV Healthcare

location_facility:
Hotel Dieu Hospital
Pitie Salpetriere Hospital
Saint Antoine Hospital
Bicetre Hospital
Bichat Hospital
Antoine-Beclere Hospital
Tourcoing Hospital
Necker Hospital