title: Improvement of Weaning From Mechanical Ventilation by Continuous Ultrasound Monitoring of Diaphragm Excursion: the WEAN-US Study

acronym: WEAN-US

summary:
Justification: The diaphragm is the main inspiratory muscle. Its dysfunction therefore compromises ventilation, which is necessary for gas exchange. Diaphragmatic dysfunction is frequently observed in resuscitation patients. Diaphragm ultrasound is currently a simple and validated technique for measuring the function of the diaphragm in intensive care. However, the discontinuity of the measurements is one of the major limitations of the current, standard ultrasonic evaluation of diaphragm function. Respinor AS (Oslo, Norway) has developed an ultrasound device (known as RESPINOR DXT) for continuous quantification of diaphragmatic excursion and velocity.

Aims of the study: To evaluate the feasibility of the continuous monitoring of the diaphragmatic excursion using RESPINOR DXT in patients undergoing MV in the intensive care unit, to ensure its reliability and to establish a link between the diaphragmatic excursion and the weaning outcome of MV.

Method: In addition to continuous diaphragm monitoring by RESPINOR DXT, a daily measurement of the diaphragm excursion will be performed using a conventional ultrasound system for comparison. A daily measurement of the oesophageal pressure (Pes) and the gastric pressure (Pga) will be performed, thus allowing the calculation of the transdiaphragmatic pressure (Pdi).

Analysis: The feasibility of the measurement will be evaluated through user utility questions as well as the time spent with a signal meeting specific quality criteria. Its reliability will be studied by the concordance between the measurements of the excursion measured by RESPINOR DXT and by standard ultrasound (Bland-Altman, Passing-Bablock). It will be further evaluated by the correlation between the variations of the excursion measured by RESPINOR DXT and the Pdi variations. Receiver operating characteristic (ROC) curves will be performed to identify the optimal diaphragmatic excursion threshold for predicting weaning success and prognosis.

Hypothesis: It is anticipated that the present study will show that the continuous monitoring of diaphragm excursion by RESPINOR DXT is reliable. Further, it is anticipated that there will be a statistical link between the diaphragmatic excursion and velocity of the movement measured by RESPINOR DXT before, during and after the spontaneous breathing trial.

ReferenceCitation: Jiang JR, Tsai TH, Jerng JS, Yu CJ, Wu HD, Yang PC. Ultrasonographic evaluation of liver/spleen movements and extubation outcome. Chest. 2004 Jul;126(1):179-85.

ReferenceCitation: Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305.

ReferenceCitation: Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.

family: Jaber

full_name: Samir Jaber

given: Samir

family: Petrof

full_name: Basil J. Petrof

given: Basil J.

family: Jung

full_name: Boris Jung

given: Boris

family: Chanques

full_name: Gérald Chanques

given: Gérald

family: Berthet

full_name: Jean-Philippe Berthet

given: Jean-Philippe

family: Rabuel

full_name: Christophe Rabuel

given: Christophe

family: Bouyabrine

full_name: Hassan Bouyabrine

given: Hassan

family: Courouble

full_name: Patricia Courouble

given: Patricia

family: Koechlin-Ramonatxo

full_name: Christelle Koechlin-Ramonatxo

given: Christelle

family: Sebbane

full_name: Mustapha Sebbane

given: Mustapha

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Scheuermann

full_name: Valérie Scheuermann

given: Valérie

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

family: Mornet

full_name: Dominique Mornet

given: Dominique

family: Mercier

full_name: Jacques Mercier

given: Jacques

family: Lacampagne

full_name: Alain Lacampagne

given: Alain

family: Philips

full_name: Alexandre Philips

family: Matecki

full_name: Stefan Matecki

given: Stefan

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Rapidly Progressive Diaphragmatic Weakness and Injury during Mechanical Ventilation in Humans

ReferenceCitation: Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

family: Levine

full_name: Sanford Levine

given: Sanford

family: Nguyen

title: Rapid Disuse Atrophy of Diaphragm Fibers in Mechanically Ventilated Humans

ReferenceCitation: Kim WY, Suh HJ, Hong SB, Koh Y, Lim CM. Diaphragm dysfunction assessed by ultrasonography: influence on weaning from mechanical ventilation. Crit Care Med. 2011 Dec;39(12):2627-30. doi: 10.1097/CCM.0b013e3182266408.

ReferenceCitation: Llamas-Álvarez AM, Tenza-Lozano EM, Latour-Pérez J. Diaphragm and Lung Ultrasound to Predict Weaning Outcome: Systematic Review and Meta-Analysis. Chest. 2017 Dec;152(6):1140-1150. doi: 10.1016/j.chest.2017.08.028. Epub 2017 Aug 31. Review.

ReferenceCitation: Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12. Review.

ReferenceCitation: Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.

location_facility:
CHU Angers
CH Saint Joseph Saint Luc
Hôpital Universitaire Pitié Salpêtrière


title: RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)

acronym: REUSSI-SSc

summary: As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Salaffi F, Argalia G, Carotti M, Giannini FB, Palombi C. Salivary gland ultrasonography in the evaluation of primary Sjögren's syndrome. Comparison with minor salivary gland biopsy. J Rheumatol. 2000 May;27(5):1229-36.

ReferenceCitation: Hocevar A, Ambrozic A, Rozman B, Kveder T, Tomsic M. Ultrasonographic changes of major salivary glands in primary Sjogren's syndrome. Diagnostic value of a novel scoring system. Rheumatology (Oxford). 2005 Jun;44(6):768-72. Epub 2005 Mar 1.

ReferenceCitation: Milic VD, Petrovic RR, Boricic IV, Radunovic GL, Pejnovic NN, Soldatovic I, Damjanov NS. Major salivary gland sonography in Sjögren's syndrome: diagnostic value of a novel ultrasonography score (0-12) for parenchymal inhomogeneity. Scand J Rheumatol. 2010 Mar;39(2):160-6. doi: 10.3109/03009740903270623.

ReferenceCitation: Jousse-Joulin S, Milic V, Jonsson MV, Plagou A, Theander E, Luciano N, Rachele P, Baldini C, Bootsma H, Vissink A, Hocevar A, De Vita S, Tzioufas AG, Alavi Z, Bowman SJ, Devauchelle-Pensec V; US-pSS Study Group. Is salivary gland ultrasonography a useful tool in Sjögren's syndrome? A systematic review. Rheumatology (Oxford). 2016 May;55(5):789-800. doi: 10.1093/rheumatology/kev385. Epub 2015 Dec 14. Review.

ReferenceCitation: Cornec D, Jousse-Joulin S, Pers JO, Marhadour T, Cochener B, Boisramé-Gastrin S, Nowak E, Youinou P, Saraux A, Devauchelle-Pensec V. Contribution of salivary gland ultrasonography to the diagnosis of Sjögren's syndrome: toward new diagnostic criteria? Arthritis Rheum. 2013 Jan;65(1):216-25. doi: 10.1002/art.37698.

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility:
CHU Brest Service de Rhumatologie
CHU rennes
CHU Tours, Service de médecine interne

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Chronic Pain and Functional Prognosis After Total Knee Replacement: Continuous Locoregional Analgesia by Catheter to the Femoral Triangle Versus Tissue Infiltration as Part of an Improved Rehabilitation After Surgery Approach

acronym: TKAFTER

summary:
The prevalence of Chronic Post-Surgical Pain (CPSP) after knee replacement, defined as pain greater than or equal to 4/10 on the visual analogue scale after the third postoperative month, is recognised as high, with an average of 20% (extremes of 7 to 45%).

These CPSP, when present, cause poor long-term joint functional prognosis and impaired quality of life for patients. Many predictive, pre-, per- and post-operative factors of these CPSP have been identified in recent years. The most common postoperative risk factor found in the literature is the intensity of early pain.

The treatment protocols for this early post-surgical pain are currently and mainly multimodal in nature, combining systemic analgesics (paracetamol, NSAIDs, morphine, gabapentins) and local anaesthetics, administered either in the form of peripheral nerve blocks (continuous or single injection) or in the form of tissue infiltration (TI) performed by the surgeon during the operation.

Very few of these techniques have been evaluated for their ability to reduce the incidence of CPSP. Drugs with antihyperalgesic properties such as ketamine or nefopam have been shown to be of no interest, except to reduce the proportion of pain of a neuropathic nature. Only the continuous femoral block has shown, to date, an interest in IT to reduce the incidence of these CPSP.

The main objective of this study is to show that a multimodal analgesia protocol based on continuous locoregional analgesia by femoral triangle catheterization could reduce the incidence of chronic post surgical pain compared to a protocol based on tissue infiltration.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Hôpital des Diaconesses Croix Saint Simon

intervention_type: Drug


title: Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management

acronym: BIOSUPORT

summary:
Increased indications for transplantation continue to worsen the shortage of organs and need the extension of graft sampling criteria and the search for new potential sources of organs. Despite undeniable success in the short term, due to major advances in surgery, medicine and research, transplant recipients continue to face the risk of chronic rejection and long-term complications.

The University Hospital Federation (UHF) "SUPORT" was created to optimize the chances of success of the organ transplant and improve the quality of life of the transplanted patient. UHF SUPORT 's ambition is based on a translational strategy that presents two priority areas:

Axis 1: Optimization, evaluation, conditioning of the donor, graft, recipient Axis 2: Personalized follow-up of the transplanted patient in the short and long term Identifying factors for long-term graft and patient survival through translational research from a common cohort and biological collection will predict transplant rejection, prolong graft function, or improve the patient's care.

primary_purpose: Other

ipd_sharing: No

lead_sponsor: University Hospital, Limoges

location_facility:
Tours hospital
Poitiers Hospital
Limoges hospital

intervention_type: Other


lead_sponsor: University Hospital, Lille

location_facility:
Centre hospitalier universitaire
Centre Hospitalier Universitaire
Hôpital Claude Huriez, CHU

type: EudraCT Number

source: euctr

title: A Phase III Study Comparing Lenalidomide and Subcutaneous Daratumumab (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd) in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

summary: This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel-group (each group of participants will be treated at the same time), and multicenter (when more than one hospital team work on a medical research study) study in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) and who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT). The primary hypothesis of this study is that subcutaneous Daratumumab in combination with Lenalidomide will prolong progression-free survival and likely induce less toxicity as compared with Lenalidomide and dexamethasone, in elderly frail subjects with newly diagnosed Multiple myeloma who are ineligible for high dose chemotherapy and ASCT


type: Other Identifier

title: Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences

acronym: MAPdP

summary:
Early in its development, Alzheimer's disease causes not only brain damage affecting different regions of the brain, such as the entorhinal cortex, the anterior cingulate cortex, and the prefrontal lobe, but also a cognitive deficit affecting several functions, such as episodic memory, executive functions, or working memory. Although these different areas and functions are involved in the decision-making process, few studies have focused their research on this subject in the context of Alzheimer's disease. However, a 2008 study showed an early decline in decision-making skills in the disease, but did not link this deficit to cognitive impairment. In addition, decision-making is generally assessed using a test called the Iowa Gambling Task (IGT), which, despite its many advantages, does not have established ecological validity.

In the context of pathology, however, it seems essential to evaluate decision-making in relation to daily life, especially since a deficit in this process would have considerable repercussions on quality of life.

In this study, the investigators seek to better define the disorder by decision-making in early Alzheimer's disease, to understand the links between them with the deficit of other cognitive functions, and to highlight the the consequences that this decline has on patients' daily lives.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Laboratoire d'Etude des Mécanismes Cognitifs


title: Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study

acronym: METASARC

summary:
Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals.

The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug.

Outcome (time-to-next treatment [TNT] and overall survival [OS]) will be reported according to histological subtype, as well as the association between TNT and OS.

Prognostic factors of OS will be investigated.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honoré C, Sargos P, Sunyach MP, Le Péchoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.

family: Savina

full_name: Marion Savina

given: Marion

sequence: first

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

sequence: additional

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Mir

full_name: Olivier Mir

given: Olivier

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Cousin

full_name: Sophie Cousin

given: Sophie

family: Terrier

full_name: Philippe Terrier

given: Philippe

family: Ranchere-Vince

full_name: Dominique Ranchere-Vince

family: Meeus

full_name: Pierre Meeus

given: Pierre

family: Stoeckle

full_name: Eberhard Stoeckle

given: Eberhard

family: Honoré

full_name: Charles Honoré

given: Charles

family: Sargos

full_name: Paul Sargos

given: Paul

family: Sunyach

full_name: Marie-Pierre Sunyach

given: Marie-Pierre

family: Le Péchoux

full_name: Cécile Le Péchoux

given: Cécile

family: Giraud

full_name: Antoine Giraud

given: Antoine

family: Bellera

full_name: Carine Bellera

given: Carine

family: Le Loarer

full_name: François Le Loarer

given: François

family: Italiano

full_name: Antoine Italiano

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Medicine

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 OAI-PMH doi match)

host_type: repository

location_facility: Centre Léon Bérard, Comprehensive Cancer Center

location_facility: Institut Gustave Roussy, Comprehensive Cancer Center

location_facility: Institut Bergonié, Comprehensive Cancer Center


type: Registry Identifier

title: Validation and Optimization Methods for a Quantitative Characterization of Motion Abnormalities of the Larynx With Echography

acronym: VOCALE

summary:
One of the major risks of endocrine surgery is recurrent nerve palsy (RNP), leading to vocal folds (VF) immobility. It happens in 5% of cases, leading to high morbidity: dysphonia, aspirations, impossibility to work. Guidelines recommend to systematically perform a nasofibroscopy before and after surgery to check vocal fold mobility. However, due to the decreasing number of specialists, the cost of decontamination, and discomfort of this procedure, these guidelines are insufficiently followed.

Transcutaneous Laryngeal Ultrasonography (TLU) appears a good alternative to nasofibroscopy in evaluating VF mobility, as assessed by the recent flourishing literature. Our team is a leader in this research by having developed a dedicated software, which provides objective measures of VF mobility. The aim of the present protocol is to validate the power of TLU for the diagnosis of RNP on a large cohort of patients operated on endocrine surgery. It is a prospective multicentric study that will blindly compare TLU and nasofibroscopy, the latter being the gold standard. TLU is cost effective and painless; its learning curve is fast. If validated, it may be offered as a good alternative to nasofibroscopy in RNP detection and prognosis.

ReferenceCitation: Bergeret-Cassagne H, Lazard DS, Lefort M, Hachi S, Leenhardt L, Menegaux F, Russ G, Trésallet C, Frouin F. Sonographic Dynamic Description of the Laryngeal Tract: Definition of Quantitative Measures to Characterize Vocal Fold Motion and Estimation of Their Normal Values. J Ultrasound Med. 2017 May;36(5):1037-1044. doi: 10.7863/ultra.16.05014. Epub 2017 Jan 10.

ReferenceCitation: Lazard DS, Bergeret-Cassagne H, Lefort M, Leenhardt L, Russ G, Frouin F, Trésallet C. Transcutaneous Laryngeal Ultrasonography for Laryngeal Immobility Diagnosis in Patients with Voice Disorders After Thyroid/Parathyroid Surgery. World J Surg. 2018 Jul;42(7):2102-2108. doi: 10.1007/s00268-017-4428-2.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hopital Cochin
Hopital Pitié-Salpêtrière
Hopital Avicenne

intervention_type: Device


title: Multicenter Open Pilot Study for the Use Smartphone Application to Prevent Suicidal Relapse Among 15-35 Years-old With Previous Suicide Attempted

acronym: MED COMPANION

summary:
Context: Suicide is the 2nd cause of death during adolescence Compliance with post SA care is low and variable with effective compliance ranging from 17.5% to 47% . Therefore, prevention programs should also focus on high-risk individuals with a previous history of SA.

Adolescents and young adults are considered to be digital natives, they are therefore a relevant population for the testing of Smartphone Application.

Project: The Investigators propose an innovative and new approach to prevent SA and Suicide for patients, based on a mobile healthcare application.

The program is an add-on to the usual care process.

Study: In a multicentric randomized pilot study with 15 to 35 years-old patients having previous SA, the primary goal for pilot study is to observe the filling rate of the application (feasibility).

study_start_date_type: Anticipated

status: Unknown status

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Mouchabac S, Leray P, Adrien V, Gollier-Briant F, Bonnot O. Prevention of Suicidal Relapses in Adolescents With a Smartphone Application: Bayesian Network Analysis of a Preclinical Trial Using In Silico Patient Simulations. J Med Internet Res. 2021 Sep 30;23(9):e24560. doi: 10.2196/24560.

family: Mouchabac

full_name: Stephane Mouchabac

given: Stephane

family: Leray

full_name: Philippe Leray

family: Adrien

full_name: Vladimir Adrien

given: Vladimir

family: Gollier-Briant

full_name: Fanny Gollier-Briant

given: Fanny

family: Bonnot

full_name: Olivier Bonnot

currency_apc_doaj: USD

journal_name: Journal of Medical Internet Research

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

repository_normalized: HAL

version: submittedVersion

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

title: Beyond big data in behavioral psychiatry, the place of Bayesian Network. / Example from a preclinical trial of an Innovative smartphone application to prevent suicide relapse (Preprint)

lead_sponsor: Nantes University Hospital

location_facility:
CHU d'Angers
CH Poitiers
CH Rennes

status_simplified: Unknown


title: Regulatory T-cell Induction by Low-dose Interleukin-2 in Women With Unexplained Repeated Spontaneous Early Miscarriages

summary: The purpose of this study is to demonstrate the ability of low dose IL-2 to stimulate peripheral blood Tregs of women with unexplained repeated early spontaneous miscarriages for development of a therapy to prevent fetal rejection by low dose IL-2.

location_facility: Bornes Mekinian Kayem


title: Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer

acronym: QUALITY-AGE

summary: The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
Centre François Baclesse
CHU Amiens

lead_sponsor_type: industriel


title: OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD

acronym: QUAOBARE

summary: The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre d'exploration ophtalmologique de l'odéon

status_simplified: Completed


title: Psychological and Social Determinants of Physical Activity Practice From Diagnose to Survival Among French Cancer Patients

acronym: PERTINENCE

summary: The litterature has demonstrates that physical activity can play an important role in decreasing patient mortality rates and increasing its well-being at all time of cancer. Despite this evidence, there is a weak adhesion in patients. It is therefore appropriate to look and see which may explain the high prevalence of physical inactivity in patients with cancer. The main objective of this study will be to recognize psychological and social factors which could explain the commitment or not to a physical activity in cancer patients. Besides the physical limitations related to the cancer and its treatment, socio-economic and psycho-social factors can often play an extremely important role in engagement or maintenance of sporting activity.

ReferenceCitation: Van Hoye A, Omorou Y, Rotonda C, Gendarme S, Tarquinio C, Houtmann B, Peiffert D, Longo R, Martin-Krumm C. Psychological and social determinants of physical activity from diagnosis to remission among French cancer patients (PERTINENCE): protocol for a mixed-method study. BMC Public Health. 2019 Aug 6;19(1):1053. doi: 10.1186/s12889-019-7368-y.

apc_source: openAPC

family: Van Hoye

full_name: Aurélie Van Hoye

given: Aurélie

family: Omorou

full_name: Yacobou Omorou

given: Yacobou

family: Rotonda

full_name: Christine Rotonda

given: Christine

family: Gendarme

full_name: Sophie Gendarme

family: Tarquinio

full_name: Cyril Tarquinio

given: Cyril

family: Houtmann

full_name: Bastien Houtmann

given: Bastien

family: Peiffert

full_name: Didier Peiffert

given: Didier

family: Longo

full_name: Raffaele Longo

given: Raffaele

family: Martin-Krumm

full_name: Charles Martin-Krumm

journal_name: BMC Public Health

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
Institut de Cancérologie de Lorraine
CHR Metz Thionville


title: Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria

summary: Our previous studies delineate a novel pathway of immune activation in animals that the investigators have named Anti-Virulence Immunity (AVI). Using a mice model of bacteremia, the investigators have demonstrated that Escherichia coli Cytotoxic Necrotizing Factor 1 (CNF1) activity is sensed by the immune system. This immune sensing results in a rapid bacterial clearing during bacteremia triggered by uropathogenic E. coli-expressing CNF1. The investigators already confirmed the involvement of one inflammasome using macrophages isolated from Knock-out mice. The investigators have recently determined the conservation in human monocytes of the interleukin -1beta maturation triggered by CNF1 and observed the heterogeneous capacity of monocytes to respond to the CNF1 treatment depending on the donors. Here, to determine the importance in natura of AVI the investigators will analyze the blood content of patients presenting E. coli and S. aureus bacteremia. The DNA of monocytes isolated from patients will be extracted and various genes implicated in the activity of various inflammasomes will be sequenced to identify mutations that could explain the susceptibility to bacteremia or a specific clinical presentation, i.e. requirement of a management in ICU because of organ failure.

ReferenceCitation: Lee CC, Chen SY, Chang IJ, Chen SC, Wu SC. Comparison of clinical manifestations and outcome of community-acquired bloodstream infections among the oldest old, elderly, and adult patients. Medicine (Baltimore). 2007 May;86(3):138-44. Erratum in: Medicine (Baltimore). 2013 Jul;92(4):216.

ReferenceCitation: Weinstein MP, Towns ML, Quartey SM, Mirrett S, Reimer LG, Parmigiani G, Reller LB. The clinical significance of positive blood cultures in the 1990s: a prospective comprehensive evaluation of the microbiology, epidemiology, and outcome of bacteremia and fungemia in adults. Clin Infect Dis. 1997 Apr;24(4):584-602.

ReferenceCitation: Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309-17. Epub 2004 Jul 15. Erratum in: Clin Infect Dis. 2004 Oct 1;39(7):1093. Clin Infect Dis. 2005 Apr 1;40(7):1077.

ReferenceCitation: Vallés J, Palomar M, Alvárez-Lerma F, Rello J, Blanco A, Garnacho-Montero J, Martín-Loeches I; GTEI/SEMICYUC Working Group on Bacteremia. Evolution over a 15-year period of clinical characteristics and outcomes of critically ill patients with community-acquired bacteremia. Crit Care Med. 2013 Jan;41(1):76-83. doi: 10.1097/CCM.0b013e3182676698.

ReferenceCitation: Herrmann JB, Muenstermann M, Strobel L, Schubert-Unkmeir A, Woodruff TM, Gray-Owen SD, Klos A, Johswich KO. Complement C5a Receptor 1 Exacerbates the Pathophysiology of N. meningitidis Sepsis and Is a Potential Target for Disease Treatment. mBio. 2018 Jan 23;9(1). pii: e01755-17. doi: 10.1128/mBio.01755-17.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Lenval
CH Pierre Nouveau
CHG d'Antibes

intervention_type: Genetic


ReferenceCitation: Halioua B. [Hand eczema : disability and impact]. Ann Dermatol Venereol. 2014 Jun;141 Suppl 1:S111-6. doi: 10.1016/S0151-9638(14)70148-6. Review. French.

ReferenceCitation: Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavò SP, Cristaudo A, De Pità O, Gallo R, Giannetti A, Gola M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014 Mar;70(3):158-68. doi: 10.1111/cod.12130. Epub 2013 Sep 19.

ReferenceCitation: Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.

ReferenceCitation: Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemény L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.

ReferenceCitation: Molin S, Merl J, Dietrich KA, Regauer M, Flaig M, Letulé V, Saucke T, Herzinger T, Ruzicka T, Hauck SM. The hand eczema proteome: imbalance of epidermal barrier proteins. Br J Dermatol. 2015 Apr;172(4):994-1001. doi: 10.1111/bjd.13418. Epub 2015 Feb 26.

lead_sponsor: University Hospital, Toulouse

acronym: DUPECZEMAIN

location_facility:
Larrey Hospital
Saint André Hospital
Hôpital Saint Eloi

title: DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

summary: Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.


title: Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics

acronym: OLDMUS

summary:
Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.

The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Pellegrin - service de neurologie

location_facility: Hôpital neurologique - Pierre Wertheimer


title: SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)

acronym: SAVE

summary:
Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria.

This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.

lead_sponsor: University Hospital, Tours

location_facility: Medical Oncology Service, University Hospital, Tours

location_facility: Oncological Gastroenterology Service, University Hospital, Tours


title: High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study

acronym: ODEPHI

summary: This study is a randomized controlled trial comparing high-flow nasal oxygen therapy (HFNO) versus standard oxygen therapy (nasal prongs, nasopharyngeal catheter or standard face mask) during gastrointestinal (GI) endoscopy with sedation to reduce the incidence of hypoxia.

ReferenceCitation: Qadeer MA, Lopez AR, Dumot JA, Vargo JJ. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion. 2011;84(1):37-45. doi: 10.1159/000321621. Epub 2011 Feb 8.

family: Qadeer

full_name: Mohammed A. Qadeer

given: Mohammed A.

family: Lopez

full_name: A. Rocio Lopez

given: A. Rocio

family: Dumot

full_name: John A. Dumot

given: John A.

family: Vargo

full_name: John J. Vargo

given: John J.

journal_name: Digestion

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

title: Hypoxemia during Moderate Sedation for Gastrointestinal Endoscopy: Causes and Associations

ReferenceCitation: Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.

family: Rocio Lopez

given: A.

journal_name: Digestive Diseases and Sciences

publisher_dissemination: Springer

publisher_group: Springer

title: Risk Factors for Hypoxemia During Ambulatory Gastrointestinal Endoscopy in ASA I–II Patients

ReferenceCitation: Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74.

ReferenceCitation: Griffin SM, Chung SC, Leung JW, Li AK. Effect of intranasal oxygen on hypoxia and tachycardia during endoscopic cholangiopancreatography. BMJ. 1990 Jan 13;300(6717):83-4.

ReferenceCitation: Woods A, Sanowski RA, Wadas DD, Manne RK, Friess SW. Eradication of diminutive polyps: a prospective evaluation of bipolar coagulation versus conventional biopsy removal. Gastrointest Endosc. 1989 Nov-Dec;35(6):536-40.

ReferenceCitation: Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Fromont

full_name: Lucie Fromont

given: Lucie

family: Eugene

full_name: Axelle Eugene

given: Axelle

family: Marcueyz

full_name: Jean-Louis Marcueyz

given: Jean-Louis

family: Mfam

full_name: Willy-Serge Mfam

given: Willy-Serge

family: Baert

full_name: Olivier Baert

given: Olivier

family: Remerand

full_name: Francis Remerand

given: Francis

family: Ravry

full_name: Céline Ravry

given: Céline

family: Auvet

full_name: Adrien Auvet

given: Adrien

ReferenceCitation: Eugene A, Fromont L, Auvet A, Baert O, Mfam WS, Remerand F, Boulain T, Nay MA. High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol. BMJ Open. 2020 Feb 18;10(2):e034701. doi: 10.1136/bmjopen-2019-034701.

location_facility:
Orleans Hospital Center
Hospital Center of DAX
Pole santé ORELIANCE


title: Prospective Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale

acronym: IDFFOP

summary:
Patent Foramen Ovale, is an embryonic remnant, formed by apposition of the septum primum and septum secondum composing the interatrial septum. This foramen ovale is permeable during intra-uterine life and allows inter-auricular communication. It tends to close at birth, due to increased pressure from the left atrium. However, it remains permeable in almost 25% of the general population. Several studies have shown that this cardiac "anomaly" associated with the atrial septum aneurysm (ASA), easily diagnosed by ultrasound, is more common in patients with cryptogenic stroke. The diagnosis of patent foramen ovale is performed by a cardiac ultrasound with a "bubble" test: a volume of micro-bubbles obtained by emulsion of saline (9 ml) and air (1 ml) is injected intravenously. The path of these microbubbles is observed by trans-thoracic ultrasound and can detect a shunt right / left. This test can be sensitized by Valsalva maneuver and / or cough. The shunt is quantified by the number of microbubbles flowing through the right / left shunt: positive diagnosis: more than 3 bubbles passing; minimal shunt <10 bubbles, moderate shunt between 10 and 30 bubbles, massive shunt if> 30 bubbles.

Patent Foramen Ovale Closure is an interventional cardiac catheterization procedure by venous femoral approach. Several clinical trials show that Patent Foramen Ovale closure prevents stroke recurrence in young people and that this procedure is more effective than antiplatelet therapy. Nevertheless, an increase in the incidence of peri-procedural atrial fibrillation has been observed. For some researchers, this would be explained by irritation of the atrial muscle due to the establishment of the device.

To date, only percutaneous closures made in clinical trials have been evaluated. In fact, there are no specific recommendations. The use in clinical practice of this percutaneous treatment therefore requires an evaluation of the indications but also the profile of the patients to optimize these procedures and reduce the complication rate.

The closure technique and the choice of the size of the prosthesis are not standardized. The closure is done under trans-esophageal echocardiography (invasive method) or trans-thoracic echocardiography (non-invasive method) depending on the choice of the practitioner. In CLOSE study, this rate is not specified. The procedure rate under general anesthesia is 54%. This category of patients can be assumed to use a trans-esophageal echocardiography.

The absence of specific recommendations concerning the technical modalities of this procedure lead us to study the closure of Patent Foramen Ovale standardized under trans-thoracic echocardiography and to evaluate its possible reliefs by avoiding the general anesthesia and the use of trans-esophageal echocardiography. The objective of the study is to bring elements of standardization of the technique. As part of a "real life" study, we will evaluate the success rate of procedure under local anesthesia and under trans-thoracic echocardiography control. This evaluation will be done by trans-thoracic echocardiography at 3 months, the re-endothelisation time of the medical device being between 1 and 3 months.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
Groupe Hospitalier Paris Saint-Joseph
Centre Cardiologique du Nord
Centre Chirurgical Marie Lannelongue


title: Implementation and Impact of Multidisciplinary Medication Review in Surgery Departments on Medication Management of Elderly Patients

acronym: CHIROPMEV

summary: The presence of a clinical pharmacist (for their pharmacological expertise) and a general practitioner (for their somatic expertise) in surgery departments would contribute to improve the management of medications in elderly patients.

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Toulouse
Nimes University Hospital


title: Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.

acronym: DynamicMRI

summary: To study flexor tendon excursion in the hand after surgery by dynamic MRI

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
HIA
Clinique Keraudren
CHRU de Brest


title: Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria

summary:
Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria.

Pilot clinical study, open, prospective and multicenter.

lead_sponsor: Biocodex

location_facility:
Hôpital Robert Debré
Hôpital Necker
Hôpital Tenon


title: Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)

acronym: EXOSARC

summary:
Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is very complex given the histological heterogeneity of this entity. It is therefore essential that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to adapt the therapeutic strategy as well as possible.

It has recently been discovered that sarcomas secrete many exosomes that appear to play an important role in tumorogenesis, growth, tumor progression and the onset of metastases. They contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics of the tumor. It has been shown that the amount of exosomes can be correlated with the grade of malignancy of the tumor. Present in the blood, exosomes offer the possibility of non-invasively analyzing the molecular information of the cancer cell. As a result, the study of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate cancer pathogenesis, progression, and treatment efficacy.

The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be used to monitor their disease and be used as a predictor of the risk of recurrence.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHU de Poitiers
Centre Georges François Leclerc
CHU de Besançon

intervention_type: Biological


title: Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.

acronym: 3 STIM

summary:
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.

Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.

The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.

status: Terminated

ReferenceCitation: Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.

family: Ferchaud

full_name: Virginie Ferchaud

given: Virginie

family: Garcia

full_name: Rodrigue Garcia

given: Rodrigue

family: Bidegain

full_name: Nicolas Bidegain

given: Nicolas

family: Degand

full_name: Bruno Degand

given: Bruno

family: Milliez

full_name: Paul Milliez

given: Paul

family: Pezel

full_name: Théo Pezel

given: Théo

family: Moubarak

full_name: Ghassan Moubarak

given: Ghassan

journal_name: Journal of Interventional Cardiac Electrophysiology

lead_sponsor: CMC Ambroise Paré

location_facility:
CHU Poitiers
Gehm Site D'Eaubonne
Cmc Ambroise Pare


title: French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)

acronym: APACHE

summary:
Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease, belonging to the wide spectrum of spondyloarthritis, but with the particularity to be associated with personal psoriasis or familial psoriasis. PsA can be a very disabling disease through progressive and irreversible joint damage. Long-term functional prognosis of patients with PsA is correlated with the presence and severity of the radiographic joint lesions of the disease.

However, the proportion of patients who will develop those peripheral joint damages is not yet known and less over the factors which are associated/involved in such an aggressive pattern of the disease. Early identification of this subgroup of patients is particularly important for determining early "intensive" treatment, strict management with a Treat To Target approach, and identification of new treatments with a stronger structural effect.

The main objective of this prospective 10 years cohort is to describe the 5 years structural (radiographic) severity of recent PsA with recent peripheral arthritis.Some of the secondary objectives are to describe the 10 years structural severity within those patients, and to determine the predictive factors of those 5 and 10 years radiographic lesions (genetic, environmental, clinic, therapeutic factors).

APACHE will provide a unique longitudinal standardized database concerning patients with PsA with very recent peripheral arthritis. Research projects which will based on those collected data should allow to identify the mechanisms of aggressive joint damage, to highlight mew treatments targets, to better describe the burden of the disease, to test previous or develop new assessments tolls, to develop early diagnostic criteria

location_facility:
Saint Joseph Hospital
Henri-Mondor Hospital
Lapeyronie Hospital


title: Effects of Obstructive Sleep Apnea on the Frequency of Vaso-occlusive Crises Events and Bio-physical Markers in Sickle Cell Disease

acronym: DREPAPNEE

summary: Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell population, studies focusing on the associations of the two diseases and their common pathophysiological mechanisms are scarce. OSA is one of the most common conditions responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients, could increase the risk for complications. Finally, OSA is accompanied by impaired vascular function and autonomic nervous system dysfunction in the general population. Indeed, the presence of OSA in SCD could increase the clinical severity of patients and the frequency of VOC.

primary_purpose: Basic Science

ReferenceCitation: Stauffer E, Poutrel S, Cannas G, Gauthier A, Fort R, Bertrand Y, Renoux C, Joly P, Boisson C, Hot A, Peter-Derex L, Pialoux V, PetitJean T, Connes P. Nocturnal Hypoxemia Rather Than Obstructive Sleep Apnea Is Associated With Decreased Red Blood Cell Deformability and Enhanced Hemolysis in Patients With Sickle Cell Disease. Front Physiol. 2021 Sep 24;12:743399. doi: 10.3389/fphys.2021.743399. eCollection 2021.

family: Stauffer

full_name: Emeric Stauffer

given: Emeric

family: Poutrel

full_name: Solène Poutrel

given: Solène

family: Cannas

full_name: Giovanna Cannas

given: Giovanna

family: Gauthier

full_name: Alexandra Gauthier

given: Alexandra

family: Fort

full_name: Romain Fort

given: Romain

family: Bertrand

full_name: Yves Bertrand

given: Yves

family: Renoux

full_name: Céline Renoux

family: Joly

full_name: Philippe Joly

given: Philippe

family: Boisson

full_name: Camille Boisson

given: Camille

family: Hot

full_name: Arnaud Hot

given: Arnaud

family: Peter-Derex

full_name: Laure Peter-Derex

given: Laure

family: Pialoux

full_name: Vincent Pialoux

given: Vincent

family: PetitJean

full_name: Thierry PetitJean

given: Thierry

family: Connes

full_name: Philippe Connes

journal_name: Frontiers in Physiology

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hôpital Edouard Herriot
Hôpital de la Croix Rousse
Centre Léon Berard


title: 18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy

acronym: IMMUNOPET

summary: Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.

location_facility:
Centre Hospitalier de Morlaix
CH de LANDERNEAU
CHRU de Brest


title: Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold.

Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results.

Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter ablation.

location_facility:
CHU Toulouse, Hôpital Rangueil
Cardiology-rytmology
Cardiology-rytmology service

intervention_type: Procedure


title: FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU

acronym: FURTHER

summary: Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.

location_facility:
Hopital Bichat
CH Cote Basque
Hopital Saint Louis


title: Changes in Cerebral Circulation and Oxygenation During Hemodynamic Resuscitation in Critically Ill Children Without Head Trauma

acronym: CIRCU-REAPED

summary:
The principal purpose of this study is to describe the changes in cerebral circulation (assessed by transcranial ultrasound) and oxygenation (assessed by Near InfraRed spectroscopy, NIRS) during resuscitation for hemodynamic failure (arterial hypotension or shock) in critically ill children treated with vasoactive or inotropic drugs.

The secondary objectives are :

i) to evaluate the association between an alteration of cerebral circulation and/or oxygenation and an alteration in macro-circulatory parameters (Mean Arterial Blood Pressure and cardiac output) or a bad outcome, ii) to study if cerebral autoregulation is impaired

location_facility:
Hôpital Robert Debré
Hôpital Necker
Hôpital Trousseau


title: Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique

summary: The aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by MRI.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital

location_facility:
C.H.U. de Tours
C.H.U. de Poitiers
C.H.U. d'Amiens


title: Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections

acronym: EXPIRE

summary: The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

location_facility:
CHU d'Angers
Centre de Perharidy
Hôpital Foch


title: To Demonstrate the Ability of Abatacept in Comparison to Placebo to Obtain a Low Disease Activity [PMR-AS (CRP) Lower or Equal to 10] Without GCs (Prednisone or Prednisolone) at Week 12 in Early Onset PMR Patients.

acronym: ALORS

summary:
Polymyalgia rheumatic (PMR) is a frequent inflammatory disease. It affects the elderly, with peak incidences at the age of 70 to 80 years; an age >50 years or older, is considered a criterion for the diagnosis. Polymyalgia rheumatica occurs at a frequency that is 3 to 10 times that of giant-cell arteritis. Disease risk varies according to race and geographic region. The incidence is highest among whites in northern European populations (about 20 cases per 100,000 persons older than 50 years of age); it is lower in southern European populations (about 10 cases per 100,000).The diagnosis is based on established ACR/EULAR classification criteria.

Long term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 15 to 20 mg/day progressively tapered) is the mainstay of the treatment.

The activity of PMR is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)..

Comorbidity in PMR are due to GCs and 30% of the patients underwent a relapse when tapering GCs. If the investigators able to start prednisone at a lower dosage (i.e. 8 mg then tapered for 3 to 4 months), the cumulative dosage of steroid would not have major side effects but it is not possible without new therapeutic agents.

The TENOR study (Tolerance and Efficacy of tocilizumab iN pOlymyalgia Rheumatica), a phase 2 study, demonstrated efficacy of tocilizumab as first line treatment in PMR without GCs and its ability to spare GCs. This was the first study demonstrating that a biologic may improve PMR without steroid, and that also showed that a short treatment by biologic followed by a low dose GCs therapy may be a new concept in the treatment of PMR.

Molecular studies in GCA and PMR suggest that dendritic cells initiate the pathogenic cascade and recruit T cells. Two major immune-response networks have been identified related to type 1 helper T-cell (Th1) and to helper T-cell (Th17). Abatacept is comprised of the ligand-binding domain of CTLA4 plus modified Fc domain derived from IgG1. By containing CTLA4, abatacept blocks the engagement of CD28 with its ligand, thereby inhibiting T cell activation. It has recently demonstrated its efficacy in Granulomatosis with polyangiitis (GPA) but also in giant cell arteritis (GCA). Due to its good safety profile in rheumatoid arthritis and its potential to modulate T cell activation and derived cytokines, abatacept is an attractive agent to investigate in patients with PMR.

In this randomized prospective placebo controlled study, the objective is to demonstrate the ability of abatacept to improve alone PMR and then to allow a steroid sparing effect after this induction treatment, in early onset PMR.

location_facility:
CH de Morlaix
CH Le Mans
CHRU de Brest


lead_sponsor: Institut Cancerologie de l'Ouest

primary_purpose: Supportive Care

acronym: ANTICIPUSC

location_facility:
Institut de Cancerologie de L'Ouest
Ch Du Mans
Chu D'Angers

title: Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score

summary:
Postoperative pulmonary complications are one of the most common complications after surgery.

Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications.

Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest.

The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway.

The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient.

The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.


title: Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

acronym: MEDiC

summary: Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dyspnoea is a common symptom among patients with Chronic Obstructive pulmonary Disease (COPD). Dyspnea is the primary symptom limiting exercise and daily activities in these patients. It has been reported that breathing cold air could decrease dyspnoea induced by exercise and could improve exercise performance. The aim of this study is to carry out the effect of cooling sensation induced by menthol chewing-gum on dyspnoea and exercise performance among patients with COPD.

ipd_sharing_description: Data type : deidentified participtant data

lead_sponsor: Groupe Hospitalier du Havre

location_facility:
Centre hospitalier des Pays de Morlaix
Resp'Air
Groupe Hospitalier du Havre


title: Validation of a Genetic Signature to Predict the Development of Sarcomas

acronym: PREDISARC

summary:
The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma.

Following the sequencing of the exomes of all these patients, the SARI study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. This signature is the subject of a patent (BFF 170286 / VF, filed on June 22, 2017). A final validation step with samples that have not been used to optimize this signature is now required. Moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones.

The objective of the PREDISARC study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy.

location_facility:
Institut Gustave Roussy
Centre Georges François Leclerc
Institu Bergonie


title: Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.

acronym: CITHARE

summary:
This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma.

In this phase II trial, patients will be assigned in one of the two treatment arms:

Arm A (standard arm): Chemoradiotherapy arm
Arm B (Experimental arm): Immunotherapy + Radiotherapy arm

Total duration of treatment will be 6 months (at maximum in the experimental arm).

Patients will be followed for a maximum of 2 years following the date of randomization.

status: Active, not recruiting

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse (IUCT-O)


title: Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

acronym: MODIFY

summary: Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHRU Lille
CHU Amiens-Picardie
CHU Rouen


title: Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)

acronym: PKAPIR

summary:
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs.

The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.

location_facility: Centre Universitaire Hospitalier de Dijon


title: X-linked Hypophosphatemia and Carbohydrate and Lipid Metabolism: a Role for FGF21?

acronym: XLH 21

summary:
Fibroblast Growth Factor 23 and Fibroblast Growth Factor 21 are two endocrine Fibroblast Growth Factors, requiring Klotho as a co-factor to promote their systemic actions. Fibroblast Growth Factor 21 is involved in the regulation of glucid and lipid metabolism. Fibroblast Growth Factor 21 Knock Out mice display obesity and hyperglycemia.

In investigators experience, patients with X-linked hypophosphatemia often present with early-onset over-weight that could be partly explained by decreased physical activity because of bone pains and deformations after puberty; however, patients usually display progressive over-weight earlier in life, when there is no limitation of physical activity yet.

To the knowledge of investigators the association between Fibroblast Growth Factor 23, Fibroblast Growth Factor 21 and Klotho in patients with X-linked hypophosphatemia has never been evaluated. Thus, the main objective of this study is to evaluate the glucid and lipid metabolism in patients with X-linked hypophosphatemia, the main working hypothesis being that the genetic deregulation in the Fibroblast Growth Factor 23 axis in patients with X-linked hypophosphatemia induces modifications of Klotho levels (namely decreased levels) that in turn will deregulate the Fibroblast Growth Factor 21 axis (resistance to Fibroblast Growth Factor 21 because of decreased Klotho levels).

time_perspective: Cross-Sectional

location_facility: Endocrinologie, Maladies Osseuses, Gynécologie, Génétique, Hôpital des Enfants, CHU de Toulouse

location_facility: Centre de Référence des Maladies Rénales Rares - Centre de Référence des Maladies Rares du Calcium et du Phosphate - Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant

location_facility: Centre de Référence des Maladies Rares du Calcium et du Phosphore, Service d'Endocrinologie Pédiatrique - Hôpital du Kremlin Bicêtre


title: IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic

acronym: VALIDate

summary: Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.

ReferenceCitation: Le Berre C, Bourreille A, Flamant M, Bouguen G, Siproudhis L, Dewitte M, Dib N, Cesbron-Metivier E, Goronflot T, Hanf M, Gourraud PA, Kerdreux E, Poinas A, Trang-Poisson C. Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study. BMC Gastroenterol. 2020 Apr 16;20(1):110. doi: 10.1186/s12876-020-01246-7.

family: Le Berre

full_name: C. Le Berre

given: C.

family: Bourreille

full_name: A. Bourreille

given: A.

family: Flamant

full_name: M. Flamant

given: M.

family: Bouguen

full_name: G. Bouguen

given: G.

family: Siproudhis

full_name: L. Siproudhis

given: L.

family: Dewitte

full_name: M. Dewitte

family: Dib

full_name: N. Dib

given: N.

family: Cesbron-Metivier

full_name: E. Cesbron-Metivier

given: E.

family: Goronflot

full_name: T. Goronflot

given: T.

family: Hanf

full_name: M. Hanf

family: Gourraud

full_name: P.-A. Gourraud

family: Kerdreux

full_name: E. Kerdreux

family: Poinas

full_name: A. Poinas

family: Trang-Poisson

full_name: C. Trang-Poisson

journal_name: BMC Gastroenterology

lead_sponsor: Nantes University Hospital

location_facility:
Angers University Hospital
Nantes University Hospital
Rennes University Hospital


title: Qi Gong as a Method of Craving Reduction in Severe Addict Patients

acronym: QICA

summary:
Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object.

The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias that fuels such emotional reactivity. Qi gong training may specifically target the associated learning process with an emphasis on the critical link between affect and craving in an addictive loop.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Saint ELOI
Hôpital L'ARCHET
Groupe Hospitalier Pitié Salpêtrière


title: National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment

summary: The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.

ReferenceCitation: Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Le Huec JC, Deschamps F. Percutaneous internal fixation with Y-STRUT® device to prevent both osteoporotic and pathological hip fractures: a prospective pilot study. J Orthop Surg Res. 2017 Feb 9;12(1):27. doi: 10.1186/s13018-017-0514-2.

ReferenceCitation: Cornelis FH, Deschamps F. Augmented osteoplasty for proximal femur consolidation in cancer patients: Biomechanical considerations and techniques. Diagn Interv Imaging. 2017 Sep;98(9):645-650. doi: 10.1016/j.diii.2017.06.014. Epub 2017 Jul 27. Review.

ReferenceCitation: Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Cabane V, Rodrigues L, Maas C, Deschamps F. A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study. Cardiovasc Intervent Radiol. 2017 Jul;40(7):1070-1076. doi: 10.1007/s00270-017-1613-5. Epub 2017 Feb 23.

ReferenceCitation: Szpalski M,Le Huec JC, Jayankura M, Reynders P, Maas C(2017) Contralateral Prophylactic Reinforcement in Case of First Low-Energy Hip Fracture: First-in-Man Clinical Data of a New Percutaneous Internal Fixation Device. J Osteopor Phys Act 5:202. doi:10.4172/2329-9509.100020

ReferenceCitation: Upasani VV, Robertson C, Lee D, Tomlinson T, Mahar AT. Biomechanical comparison of kyphoplasty versus a titanium mesh implant with cement for stabilization of vertebral compression fractures. Spine (Phila Pa 1976). 2010 Sep 1;35(19):1783-8. doi: 10.1097/BRS.0b013e3181b7cc5d.

ReferenceCitation: Ghofrani H, Nunn T, Robertson C, Mahar A, Lee Y, Garfin S. An evaluation of fracture stabilization comparing kyphoplasty and titanium mesh repair techniques for vertebral compression fractures: is bone cement necessary? Spine (Phila Pa 1976). 2010 Jul 15;35(16):E768-73. doi: 10.1097/BRS.0b013e3181d260bf.

ReferenceCitation: Belkoff SM, Mathis JM, Jasper LE. Ex vivo biomechanical comparison of hydroxyapatite and polymethylmethacrylate cements for use with vertebroplasty. AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1647-51.

ReferenceCitation: Rodrigues DC, Ordway NR, Ma CR, Fayyazi AH, Hasenwinkel JM. An ex vivo exothermal and mechanical evaluation of two-solution bone cements in vertebroplasty. Spine J. 2011 May;11(5):432-9. doi: 10.1016/j.spinee.2011.02.012. Epub 2011 Apr 11.

ReferenceCitation: Tutton SM, Pflugmacher R, Davidian M, Beall DP, Facchini FR, Garfin SR. KAST Study: The Kiva System As a Vertebral Augmentation Treatment-A Safety and Effectiveness Trial: A Randomized, Noninferiority Trial Comparing the Kiva System With Balloon Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures. Spine (Phila Pa 1976). 2015 Jun 15;40(12):865-75. doi: 10.1097/BRS.0000000000000906.

ReferenceCitation: Dohm M, Black CM, Dacre A, Tillman JB, Fueredi G; KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014 Dec;35(12):2227-36. doi: 10.3174/ajnr.A4127. Epub 2014 Oct 9.

ReferenceCitation: Olivarez LM, Dipp JM, Escamilla RF, Bajares G, Perez A, Stubbs HA, Block JE. Vertebral augmentation treatment of painful osteoporotic compression fractures with the Kiva VCF Treatment System. SAS J. 2011 Dec 1;5(4):114-9. doi: 10.1016/j.esas.2011.06.001. eCollection 2011.

ReferenceCitation: Wang CH, Ma JZ, Zhang CC, Nie L. Comparison of high-viscosity cement vertebroplasty and balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Pain Physician. 2015 Mar-Apr;18(2):E187-94.

ReferenceCitation: Li X, Yang H, Tang T, Qian Z, Chen L, Zhang Z. Comparison of kyphoplasty and vertebroplasty for treatment of painful osteoporotic vertebral compression fractures: twelve-month follow-up in a prospective nonrandomized comparative study. J Spinal Disord Tech. 2012 May;25(3):142-9. doi: 10.1097/BSD.0b013e318213c113.

ReferenceCitation: Deschamps F, de Baere T. Cementoplasty of bone metastases. Diagn Interv Imaging. 2012 Sep;93(9):685-689. doi: 10.1016/j.diii.2012.06.009. Epub 2012 Aug 11.

ReferenceCitation: Kobayashi N, Numaguchi Y, Fuwa S, Uemura A, Matsusako M, Okajima Y, Ishiyama M, Takahashi O. Prophylactic vertebroplasty: cement injection into non-fractured vertebral bodies during percutaneous vertebroplasty. Acad Radiol. 2009 Feb;16(2):136-43. doi: 10.1016/j.acra.2008.05.005.

ReferenceCitation: Otten LA, Bornemnn R, Jansen TR, Kabir K, Pennekamp PH, Wirtz DC, Stuwe B, Pflugmacher R. Comparison of balloon kyphoplasty with the new Kiva® VCF system for the treatment of vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):E505-12.

ReferenceCitation: Yang EZ, Xu JG, Huang GZ, Xiao WZ, Liu XK, Zeng BF, Lian XF. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila Pa 1976). 2016 Apr;41(8):653-60. doi: 10.1097/BRS.0000000000001298.

ReferenceCitation: Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Balloon kyphoplasty versus KIVA vertebral augmentation--comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine (Phila Pa 1976). 2013 Feb 15;38(4):292-9. doi: 10.1097/BRS.0b013e31826b3aef. Erratum in: Spine (Phila Pa 1976). 2013 Nov 1;38(23):E1506.

ReferenceCitation: Shindle MK, Gardner MJ, Koob J, Bukata S, Cabin JA, Lane JM. Vertebral height restoration in osteoporotic compression fractures: kyphoplasty balloon tamp is superior to postural correction alone. Osteoporos Int. 2006 Dec;17(12):1815-9. Epub 2006 Sep 16.

ReferenceCitation: Liu JT, Li CS, Chang CS, Liao WJ. Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty. J Neurosurg Spine. 2015 Jul;23(1):94-8. doi: 10.3171/2014.11.SPINE14579. Epub 2015 Apr 17.

ReferenceCitation: Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.

ReferenceCitation: Chen D, An ZQ, Song S, Tang JF, Qin H. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. 2014 Mar;21(3):473-7. doi: 10.1016/j.jocn.2013.05.017. Epub 2013 Aug 8.

ReferenceCitation: Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.

ReferenceCitation: Tan HY, Wang LM, Zhao L, Liu YL, Song RP. A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture. Pain Res Manag. 2015 Jan-Feb;20(1):e8-e11. Epub 2014 Jun 19.

ReferenceCitation: Korovessis P, Repantis T, Miller LE, Block JE. Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: a case series of 26 consecutive patients. BMC Musculoskelet Disord. 2011 Sep 22;12:206. doi: 10.1186/1471-2474-12-206.

ReferenceCitation: Yi X, Lu H, Tian F, Wang Y, Li C, Liu H, Liu X, Li H. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. 2014 Jan;134(1):21-30. doi: 10.1007/s00402-013-1886-3. Epub 2013 Nov 28.

ReferenceCitation: Vogl TJ, Pflugmacher R, Hierholzer J, Stender G, Gounis M, Wakhloo A, Fiebig C, Hammerstingl R. Cement directed kyphoplasty reduces cement leakage as compared with vertebroplasty: results of a controlled, randomized trial. Spine (Phila Pa 1976). 2013 Sep 15;38(20):1730-6. doi: 10.1097/BRS.0b013e3182a14d15.

ipd_sharing_description:
The data analysis of the investigation will carry out a final report that will be sent to the CPP and ANSM.

According to the law N°2002-303 dated March 4, 2002, the patients involved in the study will be informed on demand on the global data analysis.

Regarding publication, if the data analysis provides important and interesting information on the device and its associated procedure for the treatment of vertebral compression fracture which aims to complete the state of the art, it may be decided to publish the corresponding data. In this case, the IPD that will be shared will consists of all IPD that underlie results in this publication.

lead_sponsor: Hyprevention

location_facility:
Institut Gustave Roussy
Polyclinique Bordeaux Nord Aquitaine
APHP - Hôpital Tenon


title: Creation of a Tool to Assess Quality of Life in Patient With Auto-inflammatory Diseases

acronym: MAI-PATIENT

summary: This qualitative interview-based study aim to build a tool to assess quality of life in patients (adults or children) suffering from 6 autoinflammatory diseases (FMF, TRAPS, CAPS, MKD, Still and PFAPA).

location_facility:
TENON
CH André Mignot
Dr Maryam PIRAM


title: Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine

acronym: GEN-EPA

summary: The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.

lead_sponsor: Rennes University Hospital

location_facility: Cabinet médical des Docteurs Le Vagueres et Godard,


title: Medico-economic Assessment of a "IsereADOM" Package of Services Versus Conventional Monitoring in the Care of a Population of Frail Elderly People With Loss of Autonomy.

acronym: PARC

summary:
The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects.

There is a medico-economic goal too, is to conduct a cost-utility analysis of the IsereADOM service bundle compared to conventional 6-month follow-up from the community perspective in the cheat population at risk of re-offending.

primary_purpose: Health Services Research

ReferenceCitation: Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD007146. doi: 10.1002/14651858.CD007146.pub3. Review.

ReferenceCitation: Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204.

ReferenceCitation: Gates S, Smith LA, Fisher JD, Lamb SE. Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults. J Rehabil Res Dev. 2008;45(8):1105-16. Review.

ReferenceCitation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2.

ReferenceCitation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96.

lead_sponsor: University Hospital, Grenoble

location_facility:
Centre Hospitalier de Voiron
CHU Grenoble-Alpes
Centre Hospitalier Pierre Oudot


title: Short-, Medium- and Long-term (up to 3 Years) Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.

acronym: BIORELICA

summary: The investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.

location_facility:
CHU Nimes
Polyclinique Urbain V
Centre Régina


title: Validation of the French Version of the Three Scales for Assessing the Fear of Type 1 Hypoglycemia (HFS-C, HFS-PYC and HFS-P) in Children, Adolescents and Their Parents by a Monocentric Transverse Psychometric Study

acronym: FHS

summary:
Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. It would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal.

If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years of age, on the other hand, there are no French and no French studies have evaluated the prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes.

It is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. Having a tool in French and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) In order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia

location_facility:
Hôpital Universitaire Robert-Debré
Centre Hospitalier de Bretagne Sud
CHRU de Brest


title: Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

acronym: IPIAP-STM

summary:
This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant.

The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole

location_facility: Institut Regional Du Cancer de Montpellier (Icm)


title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER

acronym: TIMBER

summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.

ReferenceCitation: Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Jørgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5:CD012955. doi: 10.1002/14651858.CD012955.pub2.

name: Psychiatric Research Unit; Psychiatry of Region Zealand; Slagelse Denmark

name: Child and Adolescent Psychiatric Department; Region Zealand; Roskilde Denmark

name: Department of Psychology; University of Southern Denmark; Odense Denmark

family: Storebø

full_name: Ole Jakob Storebø

given: Ole Jakob

name: Department of Psychiatry and Psychotherapy; University Medical Center Mainz; Mainz Germany

family: Stoffers-Winterling

full_name: Jutta M Stoffers-Winterling

given: Jutta M

name: Department of Forensic Psychiatry, Center for Neurology; University Rostock; Rostock Germany

family: Völlm

full_name: Birgit A Völlm

given: Birgit A

name: Psychiatric Research Unit; Region Zealand Psychiatry; Slagelse Denmark

name: Department of Psychology, Faculty of Health Science; University of Southern Denmark; Odense Denmark

family: Kongerslev

full_name: Mickey T Kongerslev

given: Mickey T

family: Mattivi

full_name: Jessica T Mattivi

given: Jessica T

family: Jørgensen

full_name: Mie S Jørgensen

given: Mie S

family: Faltinsen

full_name: Erlend Faltinsen

given: Erlend

family: Todorovac

full_name: Adnan Todorovac

given: Adnan

name: Duncan MacMillan House; Nottinghamshire Healthcare NHS Foundation Trust; Nottingham UK

name: Institute of Mental Health; Department of Psychiatry & Applied Psychology; Nottingham UK

family: Sales

full_name: Christian P Sales

given: Christian P

family: Callesen

full_name: Henriette E Callesen

given: Henriette E

name: Leibniz Institute for Resilience Research (LIR); Mainz Germany

family: Lieb

full_name: Klaus Lieb

given: Klaus

family: Simonsen

full_name: Erik Simonsen

given: Erik

bso_classification: Social sciences

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

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

repository_institution: University of Nottingham - Repository@Nottingham

url: https://nottingham-repository.worktribe.com/916765/1/storeb psychol borderline protocol cochrane 2018.pdf

url_for_landing_page: https://nottingham-repository.worktribe.com/916765/1/Storeb Psychol borderline protocol Cochrane 2018.pdf

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Teti Mayer J, Nicolier M, Gabriel D, Masse C, Giustiniani J, Compagne C, Vandel P, Pazart L, Haffen E, Bennabi D. Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial. Trials. 2019 Jun 10;20(1):347. doi: 10.1186/s13063-019-3427-z.

family: Teti Mayer

full_name: Juliana Teti Mayer

given: Juliana

family: Nicolier

full_name: Magali Nicolier

given: Magali

family: Gabriel

full_name: Damien Gabriel

given: Damien

family: Masse

full_name: Caroline Masse

given: Caroline

family: Giustiniani

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy

location_facility: Centre Hospitalier Spécialisé de Rouffach


title: Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.

summary: The purpose of this study is to determine the negative predictive value of protein S100B that could exclude subarachnoid and intracranial haemorrhage for patient that present severe headache within the last 3 hours.

ReferenceCitation: Latinovic R, Gulliford M, Ridsdale L. Headache and migraine in primary care: consultation, prescription, and referral rates in a large population. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):385-7.

ReferenceCitation: Edlow JA, Panagos PD, Godwin SA, Thomas TL, Decker WW; American College of Emergency Physicians. Clinical policy: critical issues in the evaluation and management of adult patients presenting to the emergency department with acute headache. Ann Emerg Med. 2008 Oct;52(4):407-36. doi: 10.1016/j.annemergmed.2008.07.001.

ReferenceCitation: Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53.

ReferenceCitation: Gilbert JW, Johnson KM, Larkin GL, Moore CL. Atraumatic headache in US emergency departments: recent trends in CT/MRI utilisation and factors associated with severe intracranial pathology. Emerg Med J. 2012 Jul;29(7):576-81. doi: 10.1136/emermed-2011-200088. Epub 2011 Aug 19.

ReferenceCitation: Morgenstern LB, Huber JC, Luna-Gonzales H, Saldin KR, Grotta JC, Shaw SG, Knudson L, Frankowski RF. Headache in the emergency department. Headache. 2001 Jun;41(6):537-41.

ReferenceCitation: Edlow JA, Caplan LR. Avoiding pitfalls in the diagnosis of subarachnoid hemorrhage. N Engl J Med. 2000 Jan 6;342(1):29-36. Review.

ipd_sharing_description: There is no IPD sharing plan

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Hôpital d'Instruction des Armées Sainte Anne

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer


title: Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study

acronym: PRO-COG

summary:
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients.

Until recently, little information was available on the cognitive dysfunction and their evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of cortical demyelination and meningeal inflammation suggesting that the GM alteration could play a major role in the cognitive impairment in this phenotype. The cognitive evolution and the brain tissue alteration at the origin of these difficulties remain poorly understood in PPMS. The use of new techniques for morphological and functional MRI can study the contribution of diffuse White Matter (WM) alteration (probably through disconnexion of relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS patients and on their evolution.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Poitiers
CHU de Limoges
CHU de Bordeaux


title: Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).

acronym: DECLAM

summary: Neutropenia after induction or consolidation therapy for acute myeloid leukemia (AML) patients is associated with a high morbi-mortality rates, especially due to infectious complications. These are managed according to international recommandations (ECIL and IDSA) with antibiotherapy and antifungal strategy. Although the patients suffer of digestive symptoms, intestinale complications are really less explored. Neutropenic enterocolitis (NE), cytomegalovirus (CMV) colitis, Clostridium difficile colitis, specific lesion, ischemic colitis are not well-known. No prospective study evaluate NE and these digestive complications which have high morbi-mortality rates.

location_facility:
CHU de Caen
CHU Amiens-Picardie
Henri Becquerel Center


title: Assessment of Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling for ICU Patients With Mechanical Ventilation. The EVALDM Study

acronym: EVALDM

summary: Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.

lead_sponsor: Centre Hospitalier Metropole Savoie

location_facility:
Ch Bourg En Bresse
Centre Hospitalier Metropole Savoie
CHU Grenoble Alpes


title: Evaluation Study of the Prediction of the Response to Second-line Hormone Therapy by 16α- [18F] Fluoro-17β-estradiol (FES) PET in Patients With Metastatic Breast Cancer

acronym: TEP-FES

summary:
Clinicians are currently proposing second-line hormonal treatment to a metastatic patient who is progressing after first-line hormonal therapy if the initial disease was RH + with an increase in survival without recurrence more or less long. The biopsy of the metastatic site or sites is rarely performed because of the heaviness of the gesture. Clinicians are waiting for imaging, which can replace biopsy before the second-line metastatic hormone treatment in breast cancer, which will reveal the metastatic lesion heterogeneity allowing to establish if hormone therapy is the best therapeutic option for these patients and therefore lead to a personalized medicine driven by PET FES. This imaging approach seems all the more interesting as ER expression appears to evolve over time under the pressure of treatment or the natural evolution of carcinomas.

Currently, no studies in breast cancer, in an ER + population on the initial tumor and Her2 negative, are listed for the study of ER expression by PET FES before a second metastatic hormone treatment line.

location_facility:
CHU de Brest
ICO René Gauducheau
Institut de Cancerologie de l'Ouest