title: Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis

acronym: PROPOSITIS

summary:
Acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in France). Between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support.

Non-invasive ventilation, in particular the nasal Continuous Positive Airway Pressure (nCPAP), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. Nowadays, this technique is considered as the gold standard in the pediatric intensive care units (PICU) in France. High Flow Nasal Cannula (HFNC) has been proposed as an alternative to the nCPAP because of its better tolerance and simplicity of implementation. However, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the PICU.

In a physiological study (NCT02602678, article published), it has been demonstrated that prone position (PP) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis.

Investigators hypothesize that prone position, during High Flow Nasal Cannula (HFNC), would significantly reduce the use of non-invasive ventilation (nCPAP and others) or invasive ventilation, as compared to supine position during HFNC, in infants with moderate to severe viral bronchiolitis.

location_facility: CH CHAMBERY Unité de surveillance continue pédiatrique

location_facility: Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon

location_facility: Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique

location_facility: CH VILLEFRANCHE Service de pédiatrie néonatologie

location_facility: CHU de Caen, Service de réanimation et surveillance continue pédiatrique

location_facility: CHU MONTPELLIER Service de réanimation pédiatrique

location_facility: CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant

location_facility: CHU SAINT-ETIENNE Service de réanimation pédiatrique

location_facility: CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique

location_facility: Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales

location_facility: CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant

location_facility: CRHU Nancy Réanimation Pédiatrique Spécialisée

location_facility: CHU LENVAL NICE Service de réanimation pédiatrique


title: Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial

acronym: CATHEDIA

summary: The purpose of this study is to determine whether a jugular route leads to a lower rate of complications as compared with a femoral route for catheterization in patients admitted in several intensive care units in France who develop acute renal failure requiring hemodiafiltration or hemodialysis.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Parienti JJ, Thirion M, Megarbane B, Souweine B, Ouchikhe A, Polito A, Forel JM, Marque S, Misset B, Airapetian N, Daurel C, Mira JP, Ramakers M, du Cheyron D, Le Coutour X, Daubin C, Charbonneau P; Members of the Cathedia Study Group. Femoral vs jugular venous catheterization and risk of nosocomial events in adults requiring acute renal replacement therapy: a randomized controlled trial. JAMA. 2008 May 28;299(20):2413-22. doi: 10.1001/jama.299.20.2413.

ReferenceCitation: Parienti JJ, Megarbane B, Fischer MO, Lautrette A, Gazui N, Marin N, Hanouz JL, Ramakers M, Daubin C, Mira JP, Charbonneau P, du Cheyron D; Cathedia Study Group. Catheter dysfunction and dialysis performance according to vascular access among 736 critically ill adults requiring renal replacement therapy: a randomized controlled study. Crit Care Med. 2010 Apr;38(4):1118-25. doi: 10.1097/CCM.0b013e3181d454b3.

ReferenceCitation: Parienti JJ, Dugue AE, Daurel C, Mira JP, Megarbane B, Mermel LA, Daubin C, du Cheyron D; Members of the Cathedia Study Group. Continuous renal replacement therapy may increase the risk of catheter infection. Clin J Am Soc Nephrol. 2010 Aug;5(8):1489-96. doi: 10.2215/CJN.02130310. Epub 2010 Jun 17.

ReferenceCitation: Dugue AE, Levesque SP, Fischer MO, Souweine B, Mira JP, Megarbane B, Daubin C, du Cheyron D, Parienti JJ; Cathedia Study Group. Vascular access sites for acute renal replacement in intensive care units. Clin J Am Soc Nephrol. 2012 Jan;7(1):70-7. doi: 10.2215/CJN.06570711. Epub 2011 Nov 10.

ReferenceCitation: Parienti JJ, Deryckere S, Megarbane B, Valette X, Seguin A, Sauneuf B, Mira JP, Souweine B, Cattoir V, Daubin C, du Cheyron D; Cathedia Study Group. Quasi-experimental study of sodium citrate locks and the risk of acute hemodialysis catheter infection among critically ill patients. Antimicrob Agents Chemother. 2014 Oct;58(10):5666-72. doi: 10.1128/AAC.03079-14. Epub 2014 Jun 30.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society for Microbiology

ReferenceType: derived

ReferenceCitation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_concat: PubMed Central;unige.ch

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Caen

location_facility: Medical Intensive Care Unit, CHU de Caen

location_facility: Medical and nephrologic Intensive Care Unit, CHU Amien Sud

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation d'un Prototype de Chambre Innovante adaptée au Grand Age

acronym: HOSPISENIOR

summary: The Groupement de Coopération Sanitaire des Hôpitaux Universitaires du Grand Ouest (GCS HUGO) (health cooperation group for university hospitals in the west of France), is proposing to improve the quality of geriatric care by modernizing hospital rooms. The GCS HUGO has embarked on a project to co-design a hospital room adapted for the elderly, called "Hospi'Senior", with the help of the "Dépendance et Grand âge" (Dependency and Old Age) steering committee, made up of experts from HUGO's establishments and experts from several companies.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Angers

location_facility:
Nantes University Hospital
Tours University Hospital
Angers University Hospital
Brest University Hospital
Rennes University Hospital

intervention_type: Behavioral

status_simplified: Ongoing


type: Other Grant/Funding Number

type: Other Identifier

title: Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children

acronym: PROPENSIX

summary: The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To perform this study, 80 CP patients aged of 5 to 10 years old will be included in a multicentric, double blind, prospective parallel-group randomized study. Treatment will be a pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary outcome is to increase of 60% of AHA performance. The secondary outcome are to increase Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory Evoked Potentials (SEP).

study_start_date_type: Actual

primary_purpose: Treatment

ReferenceCitation: Gerard A, Toussaint-Thorin M, Mohammad Y, Letellier G, Fritot S, Masson S, Duhamel A, Donskoff C, Zagame Y, Beghin L, Gottrand L. PROPENSIX: pressure garment therapy using compressive dynamic Lycra(R) sleeve to improve bi-manual performance in unilateral cerebral palsy: a multicenter randomized controlled trial protocol. Trials. 2022 Feb 5;23(1):117. doi: 10.1186/s13063-022-06041-1.

lead_sponsor: University Hospital, Lille

collaborators: Marc Sautelet Centre (Villeneuve d'Ascq, France)

location_facility: Centre de Soins de Suite et de Réadaptation Pédiatrique Spécialisé_Centre Paul Dottin

location_facility: Service d'Education et de Soins Spécialisés à domicile_APF de Creil

intervention_type: Device


title: Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)

summary:
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.

The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, Lyon, France

intervention_type: Other


title: HEMOTOL: Effects of New Dialysis On-line Monitoring Devices on Hemodynamic Stability During Intermittent Hemodialysis in Critically Ill Patients With Acute Kidney Injury : a Prospective Randomized Study.

acronym: HEMOTOL

summary: The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.

ReferenceCitation: du Cheyron D, Terzi N, Seguin A, Valette X, Prevost F, Ramakers M, Daubin C, Charbonneau P, Parienti JJ. Use of online blood volume and blood temperature monitoring during haemodialysis in critically ill patients with acute kidney injury: a single-centre randomized controlled trial. Nephrol Dial Transplant. 2013 Feb;28(2):430-7. doi: 10.1093/ndt/gfs124. Epub 2012 Apr 25.

location_facility: Service de Réanimation Médicale - CHU de Caen


title: Identification of Genetic Modifying Factors in Striated Muscle Laminopathies

acronym: LMNAModifier

summary:
Mutations in the LMNA gene, which codes for lamins A and C, proteins of the nuclear lamina, are responsible for a wide spectrum of pathologies, including a group specifically affecting striated skeletal and cardiac muscles, with cardiac involvement being life-threatening. At the skeletal muscle level, a wide phenotypic spectrum has been described, ranging from severe forms of congenital muscular dystrophy to less severe forms of limb-girdle muscular dystrophy. The great clinical variability of striated muscle laminopathies, both inter- and intra-familial, can be observed in the age of onset, severity of signs and progression of muscle and heart involvement. To date, more than 400 LMNA mutations have been associated with striated muscle laminopathies (www.umd.be/LMNA/), highlighting strong clinical and genetic heterogeneity. A few recurrent mutations linked to a difference in severity have been identified. However, these genotype-phenotype relationships and the rare cases of digenism reported do not explain all the clinical variability of laminopathies. Therefore, there are probably other factors of severity than the causative mutation, called "modifier genes".

Identification of such modifier genes has been initiated by studying a large family with significant clinical variability in the age of onset of muscle signs. A segregation analysis within this family identified 2 potential modifier loci. High-throughput sequencing restricted to these 2 regions according to phenotypic subgroups did not led to meaningful results so far. In addition, an international retrospective study of the natural history of early muscle laminopathies has allowed the investigators to highlight a strong inter-family clinical variability in patients carrying recurrent mutations. The investigators thus have strong preliminary data that could allow them to identify modifying genetic factors in a cohort of patients carrying a mutation in the LMNA gene.

In order to identify these factors that modulate the clinical severity of laminopathies, the investigators wish to collect biological material (muscle and/or skin biopsies) from patients carrying a mutation in the LMNA gene. The study of this biological material using multi OMICs technics will allow the investigators to identify and functionally validate the action of these modifying genes.

OMIICs is a set of techniques for characterising biological molecules using high-throughput approaches such as DNA sequencing, RNA sequencing and/or chromatin conformation (ATACseq...), proteins.

status: Recruiting

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Granger B, Gueneau L, Drouin-Garraud V, Pedergnana V, Gagnon F, Ben Yaou R, Tezenas du Montcel S, Bonne G. Modifier locus of the skeletal muscle involvement in Emery-Dreifuss muscular dystrophy. Hum Genet. 2011 Feb;129(2):149-59. doi: 10.1007/s00439-010-0909-1. Epub 2010 Nov 10.

ReferenceCitation: Ben Yaou R, Yun P, Dabaj I, Norato G, Donkervoort S, Xiong H, Nascimento A, Maggi L, Sarkozy A, Monges S, Bertoli M, Komaki H, Mayer M, Mercuri E, Zanoteli E, Castiglioni C, Marini-Bettolo C, D'Amico A, Deconinck N, Desguerre I, Erazo-Torricelli R, Gurgel-Giannetti J, Ishiyama A, Kleinsteuber KS, Lagrue E, Laugel V, Mercier S, Messina S, Politano L, Ryan MM, Sabouraud P, Schara U, Siciliano G, Vercelli L, Voit T, Yoon G, Alvarez R, Muntoni F, Pierson TM, Gomez-Andres D, Reghan Foley A, Quijano-Roy S, Bonnemann CG, Bonne G. International retrospective natural history study of LMNA-related congenital muscular dystrophy. Brain Commun. 2021 Apr 11;3(3):fcab075. doi: 10.1093/braincomms/fcab075. eCollection 2021 Jul.

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

location_facility: Centre de référence maladies neuromusculaires, Hôpital Femme Mère Enfant, CHU Lyon

location_facility: Service de cardiologie & Service de Neurophysiologie - CHU de Rouen

location_facility: Service de Neuropédiatrie, Centre de Référence Maladies Neuromusculaires, CHU de Montpellier

location_facility: Centre de référence pour les maladies cardiaques héréditaires

location_facility: Service de Neurologie, Réanimation Pédiatriques, Hôpital Raymond Poincaré, Hôpitaux Universitaires, Paris-Ile-de-France-Ouest

location_facility: Centre de référence maladies neuromusculaires, Institut de myologie, Hôpital Pitié-Salpêtrière

location_facility: Laboratoire d'Explorations Fonctionnelles - Centre de Référence Maladies Neuromusculaires Rares, CHU Nantes

location_facility: Service de Génétique médicale, CHU Rennes


title: Sevrage Tabagique à l'Aide Des Outils dédiés Selon la Préférence, un Essai randomisé contrôlé Pragmatique

acronym: STOP

summary:
- Objective:

Our study aims to evaluate the effectiveness of the "STOP" (Sevrage Tabagique à l'aide d'Outils dédiés selon la Préférence: Smoking Cessation using preference-based tools) intervention, a preference-based smoking cessation intervention for smokers with low socio-economic position (SEP).

- Methods :

STOP is a randomised, multi-centre, single blinded, intent-to-treat trial. Participating centres include primary care practices (community, municipal or general health clinics), hospital-based facilities, and healthcare institutions specialised in addiction treatment. Smokers with low SEP will be randomised into either the intervention or control group.

Persons randomised to the control group will be accompanied by their health professional according to standard practice.

Participants randomised to the intervention group will receive the same smoking cessation advice, drug (varenicline, champix,..) prescription and support as participants in the control group, but they will also have a choice of being given free Nicotine Replacement Therapy (NRT) (transdermal patch, gum, spray, inhaler, sublingual tablets/lozenges) and/or an electronic cigarette + e-liquid on the spot to aid their quit attempt.

Follow-up appointments will take place at around 7 to 14 days, 1 month, 3 months and 6 months after inclusion, according to the participant and health professional availability.

The main outcome measure of this study will be the 7-day point prevalence tobacco abstinence at 6 months after inclusion (yes/no), defined as self-reported abstinence for at least 7 days, This self-reported abstinence will be validated by measured exhaled carbon monoxide, unless this measurement is unavailable due to the ongoing covid-19 pandemic.

ReferenceCitation: El-Khoury F, El Aarbaoui T, Heron M, Hejblum G, Metadieu B, Le Faou AL, Ibanez G, Melchior M. Smoking cessation using preference-based tools among socially disadvantaged smokers: study protocol for a pragmatic, multicentre randomised controlled trial. BMJ Open. 2021 Jun 30;11(6):e048859. doi: 10.1136/bmjopen-2021-048859.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: British Medical Journal

lead_sponsor: Société de Formation Thérapeutique du Généraliste Recherche

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

location_facility: Centre d'addictologie et d'alcoologie Guillaume Broutet

location_facility: Centre municipal et universitaire de santé Marcel Trigon

lead_sponsor_type: industriel


title: Evaluation of a New Customized Removable Device With Rocker Sole for Plantar Off-Loading "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients

acronym: ORTHODIAB

summary:
Multi-center trial, randomized in 2 parallel groups, open label, with a blinded adjudication committee (PROBE methodology), comparing "Orthèse Diabète" with "conventional" removable devices in terms of healing of ulcers.

- Primary objective: Evaluate the efficiency of "Orthèse Diabète" compared to "conventional" removable devices, in terms of the proportion of diabetic patients whose principal ulcer will heal completely at 3 months.

ReferenceCitation: Malgrange D. [Physiopathology of the diabetic foot]. Rev Med Interne. 2008 Sep;29 Suppl 2:S231-7. doi: 10.1016/S0248-8663(08)73950-X. French.

ReferenceCitation: Cavanagh PR, Lipsky BA, Bradbury AW, Botek G. Treatment for diabetic foot ulcers. Lancet. 2005 Nov 12;366(9498):1725-35. doi: 10.1016/S0140-6736(05)67699-4.

ReferenceCitation: Ramsey SD, Newton K, Blough D, McCulloch DK, Sandhu N, Reiber GE, Wagner EH. Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care. 1999 Mar;22(3):382-7. doi: 10.2337/diacare.22.3.382.

ReferenceCitation: Muller IS, de Grauw WJ, van Gerwen WH, Bartelink ML, van Den Hoogen HJ, Rutten GE. Foot ulceration and lower limb amputation in type 2 diabetic patients in dutch primary health care. Diabetes Care. 2002 Mar;25(3):570-4. doi: 10.2337/diacare.25.3.570.

ReferenceCitation: Detournay B, Cros S, Charbonnel B, Grimaldi A, Liard F, Cogneau J, Fagnani F, Eschwege E. Managing type 2 diabetes in France: the ECODIA survey. Diabetes Metab. 2000 Nov;26(5):363-9.

ReferenceCitation: Detournay B, Raccah D, Cadilhac M, Eschwege E. Epidemiology and costs of diabetes treated with insulin in France. Diabetes Metab. 2005 Jun;31(3 Pt 2):3-18.

ReferenceCitation: Malgrange D, Richard JL, Leymarie F; French Working Group On The Diabetic Foot. Screening diabetic patients at risk for foot ulceration. A multi-centre hospital-based study in France. Diabetes Metab. 2003 Jun;29(3):261-8. doi: 10.1016/s1262-3636(07)70035-6.

ReferenceCitation: Apelqvist J, Larsson J, Agardh CD. Long-term prognosis for diabetic patients with foot ulcers. J Intern Med. 1993 Jun;233(6):485-91. doi: 10.1111/j.1365-2796.1993.tb01003.x.

ReferenceCitation: Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.

ReferenceCitation: Moxey PW, Hofman D, Hinchliffe RJ, Jones K, Thompson MM, Holt PJ. Epidemiological study of lower limb amputation in England between 2003 and 2008. Br J Surg. 2010 Sep;97(9):1348-53. doi: 10.1002/bjs.7092.

ReferenceCitation: Resnick HE, Carter EA, Sosenko JM, Henly SJ, Fabsitz RR, Ness FK, Welty TK, Lee ET, Howard BV; Strong Heart Study. Incidence of lower-extremity amputation in American Indians: the Strong Heart Study. Diabetes Care. 2004 Aug;27(8):1885-91. doi: 10.2337/diacare.27.8.1885.

ReferenceCitation: Fosse S, Hartemann-Heurtier A, Jacqueminet S, Ha Van G, Grimaldi A, Fagot-Campagna A. Incidence and characteristics of lower limb amputations in people with diabetes. Diabet Med. 2009 Apr;26(4):391-6. doi: 10.1111/j.1464-5491.2009.02698.x.

ReferenceCitation: Potier L, Francois M, Dardari D, Feron M, Belhatem N, Nobecourt-Dupuy E, Dolz M, Bordier L, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Gand E, Saulnier PJ, Velho G, Roussel R, Pellenc Q, Dupre JC, Malgrange D, Marre M, Mohammedi K; ORTHODIAB study group. Comparison of a new versus standard removable offloading device in patients with neuropathic diabetic foot ulcers: a French national, multicentre, open-label randomized, controlled trial. BMJ Open Diabetes Res Care. 2020 May;8(1):e000954. doi: 10.1136/bmjdrc-2019-000954.

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

version: submittedVersion

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

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

ReferenceCitation: Mohammedi K, Potier L, Francois M, Dardari D, Feron M, Nobecourt-Dupuy E, Dolz M, Ducloux R, Chibani A, Eveno DF, Crea Avila T, Sultan A, Baillet-Blanco L, Rigalleau V, Velho G, Tubach F, Roussel R, Dupre JC, Malgrange D, Marre M. The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational. J Foot Ankle Res. 2016 Aug 22;9(1):34. doi: 10.1186/s13047-016-0163-4. eCollection 2016.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

sponsor_collaborators:
Proteor Group
Société Francophone du Diabète


title: Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study

summary: There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia. The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia. This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019). Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively. The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Poitiers University Hospital

intervention_type: Drug


title: International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C Infections (PROQOL-SexLife)

acronym: SexLife

summary: To develop and validate a specific questionnaire of sexual quality of life in several languages and cultures (France, Brazil, Australia) allowing a meaningful and comprehensive assessment of the sexuality of patients infected with HIV and HCV; Propose reference scoring for sub-populations.

ReferenceCitation: WHO | Sexual health [Internet]. WHO. Available from: http://www.who.int/topics/sexual_health/en/

ReferenceCitation: Koole O, Noestlinger C, Colebunders R. Quality of life in HIV clinical trials: why sexual health must not be ignored. PLoS Clin Trials. 2007 Mar 2;2(3):e8. doi: 10.1371/journal.pctr.0020008. No abstract available.

ReferenceCitation: Marcellin F, Preau M, Ravaux I, Dellamonica P, Spire B, Carrieri MP. Self-reported fatigue and depressive symptoms as main indicators of the quality of life (QOL) of patients living with HIV and Hepatitis C: implications for clinical management and future research. HIV Clin Trials. 2007 Sep-Oct;8(5):320-7. doi: 10.1310/hct0805-320.

ReferenceCitation: Sandfort TG, Collier KL, Grossberg R. Addressing sexual problems in HIV primary care: experiences from patients. Arch Sex Behav. 2013 Oct;42(7):1357-68. doi: 10.1007/s10508-012-0009-5. Epub 2012 Sep 11.

ReferenceCitation: Meystre-Agustoni G, Jeannin A, de Heller K, Pecoud A, Bodenmann P, Dubois-Arber F. Talking about sexuality with the physician: are patients receiving what they wish? Swiss Med Wkly. 2011 Mar 8;141:w13178. doi: 10.4414/smw.2011.13178. eCollection 2011.

ReferenceCitation: Dyer K, das Nair R. Why don't healthcare professionals talk about sex? A systematic review of recent qualitative studies conducted in the United kingdom. J Sex Med. 2013 Nov;10(11):2658-70. doi: 10.1111/j.1743-6109.2012.02856.x. Epub 2012 Jul 30.

ReferenceCitation: Soykan A, Boztas H, Idilman R, Ozel ET, Tuzun AE, Ozden A, Ozden A, Kumbasar H. Sexual dysfunctions in HCV patients and its correlations with psychological and biological variables. Int J Impot Res. 2005 Mar-Apr;17(2):175-9. doi: 10.1038/sj.ijir.3901267.

lead_sponsor: University Paris 7 - Denis Diderot

sponsor_collaborators:
University Paris 7 - Denis Diderot
University of Sydney
Center of treatment HIV/Aids-São Paulo
Université de Montréal

location_country: Australia Brazil Canada France

location_facility: Centre Hépato -Biliaire de l'Hôpital Paul Brousse


title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Streptococcus (Relais Oral Dans le Traitement Des Endocardites à Streptocoques Multi-sensibles)

summary:
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.

A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Streptococcus-Enterococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.

These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.

There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.

The RODEO 2 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.

Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as amoxicillin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.

It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for streptococci, and enterococci IE with a benefit regarding costs.

The RODEO 2 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

ReferenceCitation: Lemaignen A, Bernard L, Tattevin P, Bru JP, Duval X, Hoen B, Brunet-Houdard S, Mainardi JL, Caille A; RODEO (Relais Oral Dans le traitement des Endocardites a staphylocoques ou streptOcoques) and AEPEI (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse) study groups. Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials. BMJ Open. 2020 Jul 14;10(7):e033540. doi: 10.1136/bmjopen-2019-033540.

ipd_sharing: Yes

ipd_sharing_description:
There are no plans to grant public access to the full protocol, participant-level data or statistical code. Data from the RODEO trials is stored by the promotor of the trial. Data and the personal identifiers are stored separately and a special permit is required for access to the data. Data can be available on request for academic researchers when it have been analysed and published. Qualified researchers can ask for data sharing by the first author LB after the study finalization.

Open Access This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http:// creativecommons.org/licenses/by-nc/4.0/

lead_sponsor: University Hospital, Tours

location_facility: Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes

location_facility: Service de maladies infectieuses et tropicales, Hôpital Necker, APHP

location_facility: Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand

location_facility: Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon

location_facility: CH PAU - Service de Médecine interne et Maladies infectieuses

location_facility: Service des Maladies infectieuses et tropicales, CH de Perpignan

location_facility: Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims

location_facility: Service de maladies infectieuses et tropicales, Hôpital Avicenne, APHP

location_facility: APHP Henri-Mondor - Service des maladies infectieuses et tropicales

location_facility: Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux

location_facility: Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès

location_facility: Service de Maladies infectieuses et tropicales, et pathologie VIH, Hôpital A Mignot, CH de Versailles

location_facility: Service des Maladies infectieuses et tropicales, CH Le Mans

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes

location_facility: Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen

location_facility: CHU St Etienne - Service des maladies infectieuses et tropicales

location_facility: Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin

location_facility: Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice

location_facility: Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens

location_facility: Infectiologie, médecine interne et médecine des voyages, CH d'Annecy

location_facility: Service de Médecine interne polyvalente et neurologique CH de Douai

location_facility: Service des maladies respiratoires et infectieuses, CH de St Malo

location_facility: Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy

location_facility: Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier

location_facility: Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours

location_facility: Service de Maladies infectieuses et tropicales médecine interne, CH Métropole Savoie

location_facility: Service des Maladies infectieuses, CH de Niort

location_facility: Service de médecine aigue spécifique, Hôpital Raymond Poincaré, APHP

location_facility: Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille

location_facility: Service des maladies infectieuses, Centre Hospitalier du Pays d'Aix

location_facility: Service de médecine interne, Hôpital Ambroise Paré, APHP

location_facility: Service de médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée

location_facility: Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen

location_facility: Service de Microbiologie, Hôpital Européen Georges Pompidou, APHP

location_facility: Service Universitaire des Maladies Infectieuses et du voyageur, CH de Tourcoing

location_facility: Service de maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP

location_facility: Service des Maladies infectieuses et Tropicales, Hôpital Jean Minjoz, CHU de Besançon

location_facility: Service de Médecine interne, maladies infectieuses et tropicales, CHU de Poitiers

location_facility: Département d'infectiologie, Complexe Bocage, Hôpital d'enfants, CHU de Dijon

location_facility: Service de Maladies infectieuses, Hôpital de la Cavale Blanche, CHU Brest

location_facility: Consultation de Médecine Interne, maladies infectieuses et tropicales, CH intercommunal de Villeneuve St Georges

location_facility: Service de Maladies Infectieuses et tropicales, Hôpital Dupuytren, CHU de Limoges

location_facility: Service de Maladies infectieuses et tropicales, Hôpital de la Source, CHR Orléans

location_facility: CHU ANGERS - Service des maladies infectieuses et tropicales

location_facility: APHP BICETRE - Service des maladies infectieuses et tropicales

location_facility: Service de Médecine infectieuse, Hôpital Nord Michallon, CHU de Grenoble

location_facility: Institut Mutualiste Montsouris - Service de médecine interne

location_facility: Service des Maladies infectieuses et tropicales, Hôpital de Purpan, CHU de Toulouse

location_facility: CHU Toulouse (Rangueil) Service de Cardiologie

appel_a_projets: PHRCN

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: RODEO

titre: Relais Oral Dans les Endocardites du coeur gauche à staphylOcoque multi-sensible

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: BERNARD

prenom_porteur: Louis

acronyme: RODEO 2

titre: Relais Oral Dans le traitement des Endocardites à staphylocoques, streptOcoques et entérocoques multi-sensibles


title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus (Relais Oral Dans le Traitement Des Endocardites à Staphylocoques Multi-sensibles)

summary:
Infective endocarditis (IE) is a serious infection with a significant burden for patients and hospitals (in France, median length of hospital stay = 43 days), partly due to the long duration of intravenous (IV) antibacterial treatment recommended by international guidelines, between 4 and 6 weeks in most situations.

A recent survey of practices regarding the management of IE in France showed that a switch from IV to oral antibiotics is feasible, when patients with left-sided Staphylococcus IE are stable after an initial course of IV antibiotic treatment, with or without valvular surgery.

These practices have not been associated with unfavourable outcome, while significantly reducing the duration and cost of hospitalization, the risk of nosocomial infection, and patients' discomfort.

There has been no randomized controlled trial (RCT) in the field of IE over the last 20 years; current guidelines are mostly based on expert advice, in vitro studies, animal experiments, or clinical studies performed before the 90's.

The RODEO 1 project is an unprecedented opportunity to bring back evidence-based medicine in the field of IE.

Most experts acknowledge that the pharmacological PK/PD characteristics of antibiotics such as fluoroquinolones and rifampicin allow a high level of efficacy in the treatment of IE when orally administrated after an IV period of induction.

It's needed to conduct RCTs that clearly demonstrate the clinical non-inferiority of this strategy for multisusceptible staphylococci with a benefit regarding costs.

The RODEO 1 project corresponds to one pragmatic trial assessing the impact of a switch strategy, making it a comparative effectiveness trial that should be able to feed the next revision of IE international guidelines and to change practices in IE management.

location_facility: Service des Maladies Infectieuses et Tropicales, Hôpital Carémeau, CHU de Nîmes

location_facility: Service de Médecine aigue spécifique, Hôpital Raymond Poincaré, APHP

location_facility: Service des maladies infectieuses et tropicales, Hôpital G. Montpied, CHU de Clermont-Ferrand

location_facility: Service de Cardiologie, Hôpitall Louis Pradel, Hôpitaux Est, Hospices Civils de Lyon

location_facility: CH PAU - Service de Médecine interne et Maladies infectieuses

location_facility: Service des Maladies infectieuses et tropicales, CH de Perpignan

location_facility: Service de Médecine interne, maladies infectieuses, immunologie clinique, Hôpital R. Debré, CHU de Reims

location_facility: Service des Maladies infectieuses, Centre Hospitalier du Pays d'Aix

location_facility: APHP Henri-Mondor - Service des maladies infectieuses et tropicales

location_facility: Service de Réanimation médicale, Hôpital St André, CHU de Bordeaux

location_facility: Service de Médecine post-urgence, infectiologie, Site de la Roche sur Yon, CHD Vendée

location_facility: Service de court séjour gériatrique - EMG, Centre hospitalier d'Alès

location_facility: Service des Maladies infectieuses et tropicales, CH Le Mans

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Hôtel Dieu, CHU Nantes

location_facility: Service des Maladies infectieuses et tropicales, Hôpital Charles Nicolle, CHU de Rouen

location_facility: CHU St Etienne - Service des maladies infectieuses et tropicales

location_facility: Service des Maladie infectieuses et tropicales, Hôpital d'instruction des armées Bégin

location_facility: Service d'Infectiologie, Hôpital de l'Archet, CHU de Nice

location_facility: Service de Pathologies infectieuses et tropicales, Hôpital Nord, CHU d'Amiens

location_facility: Infectiologie, médecine interne et médecine des voyages, CH d'Annecy

location_facility: Service de Maladies infectieuses et tropicales, médecine interne, CH de Chambéry

location_facility: Service de Médecine interne polyvalente et neurologique CH de Douai

location_facility: Service des maladies respiratoires et infectieuses, CH de St Malo

location_facility: Service de Maladies infectieuses, Hôpital de la Cavale Blanche

location_facility: Service des maladies infectieuses et réanimation médicale, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service de Maladies infectieuses et tropicales, Hôpitaux de Brabois, CHU de Nancy

location_facility: Service de Maladies infectieuses, Hôpital Gui de CHauliac, CHU de Montpellier

location_facility: Service de Médecine interne et maladies infectieuses, Hôpital Bretonneau, CHU de Tours

location_facility: Service de Maladies infectieuses, parasitaires et tropicales, Hôpital Bichat, APHP

location_facility: Service des Maladies infectieuses, CH de Niort

location_facility: Unité médicale d'infectiologie, Hôpital Huriez, CHU de Lille

location_facility: Service de Maladies infectieuses et tropicales, et pathologie VIH

location_facility: Service Maladies Infectieuses et tropicales, Hôpital Côte de Nacre, CHU de Caen

location_facility: Service de Médecine interne, Hôpital Ambroise Paré, APHP

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Avicenne, APHP

location_facility: Service de Maladies infectieuses et tropicales, Hôpital Necker, APHP


title: Zephyr Etude Post-Inscription (French Registry)

summary: The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

status: Active, not recruiting

ReferenceCitation: Criner GJ, Sue R, Wright S, Dransfield M, Rivas-Perez H, Wiese T, Sciurba FC, Shah PL, Wahidi MM, de Oliveira HG, Morrissey B, Cardoso PFG, Hays S, Majid A, Pastis N Jr, Kopas L, Vollenweider M, McFadden PM, Machuzak M, Hsia DW, Sung A, Jarad N, Kornaszewska M, Hazelrigg S, Krishna G, Armstrong B, Shargill NS, Slebos DJ; LIBERATE Study Group. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Respir Crit Care Med. 2018 Nov 1;198(9):1151-1164. doi: 10.1164/rccm.201803-0590OC.

ReferenceCitation: Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hubner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher_dissemination: American Thoracic Society

ReferenceCitation: Valipour A, Slebos DJ, Herth F, Darwiche K, Wagner M, Ficker JH, Petermann C, Hubner RH, Stanzel F, Eberhardt R; IMPACT Study Team. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med. 2016 Nov 1;194(9):1073-1082. doi: 10.1164/rccm.201607-1383OC.

ReferenceCitation: Klooster K, ten Hacken NH, Hartman JE, Kerstjens HA, van Rikxoort EM, Slebos DJ. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015 Dec 10;373(24):2325-35. doi: 10.1056/NEJMoa1507807.

ReferenceCitation: Klooster K, Hartman JE, Ten Hacken NH, Slebos DJ. One-Year Follow-Up after Endobronchial Valve Treatment in Patients with Emphysema without Collateral Ventilation Treated in the STELVIO Trial. Respiration. 2017;93(2):112-121. doi: 10.1159/000453529. Epub 2016 Dec 15.

lead_sponsor: Pulmonx Corporation

location_facility:
Hôpital Cochin
Hôpital François Mitterrand
Hôpital Arnaud de Villeneuve
Hôpital Calmette
Hôpital Dupuytren
Hôpital Nord
Hôpital Bichat
Nouvel Hôpital Civil
Hôpital Larrey
Hôpital La Cavale Blanche
Hôpital Charles Nicolle


title: Development and Validation of Indicators on the Appropriateness of Oral Anticoagulant Prescriptions in Adult Medicine Automated From the Hospital Information System (PACHA Study).

acronym: PACHA

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

ReferenceCitation: Petit-Moneger A, Thiessard F, Noize P, Berdai D, Jouhet V, Saillour-Glenisson F, Salmi LR; PACHA research group. Definition of indicators of the appropriateness of oral anticoagulant prescriptions in hospitalized adults: Literature review and consensus (PACHA study). Arch Cardiovasc Dis. 2018 Mar;111(3):155-171. doi: 10.1016/j.acvd.2017.05.005. Epub 2017 Sep 21.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Petit-Moneger A, Thiessard F, Jouhet V, Noize P, Berdai D, Kret M, Sitta R, Salmi LR, Saillour-Glenisson F; PACHA research group. Development and validation of hospital information system-generated indicators of the appropriateness of oral anticoagulant prescriptions in hospitalised adults: the PACHA study protocol. BMJ Open. 2017 Aug 31;7(8):e016488. doi: 10.1136/bmjopen-2017-016488.

lead_sponsor: University Hospital, Bordeaux

collaborators: Ministry for Health and Solidarity, France

location_facility: Service d'Information Médicale, Unité d'Informatique et d'Archivistique Médicale (UIAM)

location_facility: CHU de Rennes - Service d'information médicale

location_facility: Hôpital européen Georges-Pompidou - Département d'informatique Hospitalière


title: Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)

summary: OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.

lead_sponsor: Tilak Healthcare

location_facility: Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

location_facility: Institut Ophtalmologique de l'Ouest Clinique Jules Verne


title: Effectiveness of an Exercise Re-training Program on Dyspnea in Patients After Acute Respiratory Distress Syndrome Secondary to Severe COVID-19 Pneumonia in Post-ICU

acronym: RECOVER

summary:
Dyspnea is defined by a subjective sensation of respiratory discomfort, the intensity of which varies according to the terrain, the anamnesis and the cause. Resuscitation is associated with many causes of dyspnea, including initial distress, mechanical ventilation, or after-effects following the pathology and its management.

Respiratory distress is the most severe form of impaired lung function. It is the first cause of hospitalization in intensive care. This distress, indicative of the failure of the respiratory system, is always severe and potentially fatal. It therefore constitutes an absolute therapeutic emergency. Dyspnea is often the revealing symptom of the condition and the urgency surrounding its management is an additional factor of concern for the patient. As a result, dyspnea is a pejorative element associated with severity or even death.

ReferenceCitation: Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.

ReferenceCitation: Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res. 2004 Jul;14(6):760-78. doi: 10.1177/1049732304265973.

ReferenceCitation: Ek K, Andershed B, Sahlberg-Blom E, Ternestedt BM. "The unpredictable death"-The last year of life for patients with advanced COPD: Relatives' stories. Palliat Support Care. 2015 Oct;13(5):1213-22. doi: 10.1017/S1478951514001151. Epub 2014 Oct 15.

ReferenceCitation: Davidson AC; British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to? Thorax. 2016 Apr;71(4):297-8. doi: 10.1136/thoraxjnl-2016-208281. No abstract available. Erratum In: Thorax. 2016 Jun;71(6):492.

ReferenceCitation: Erratum: 'British Thoracic Society Guideline Group For The Ventilatory Management of Acute Hypercapnic Respiratory Failure in Adults. Managing acute hypercapnic respiratory failure in adults: where do we need to get to?'. Thorax. 2016 Jun;71(6):492. doi: 10.1136/thoraxjnl-2016-208281corr1. No abstract available.

ReferenceCitation: Howell MD, Davis AM. Management of ARDS in Adults. JAMA. 2018 Feb 20;319(7):711-712. doi: 10.1001/jama.2018.0307. No abstract available.

ReferenceCitation: Gloeckl R, Marinov B, Pitta F. Practical recommendations for exercise training in patients with COPD. Eur Respir Rev. 2013 Jun 1;22(128):178-86. doi: 10.1183/09059180.00000513.

ReferenceCitation: Lacasse Y, Martin S, Lasserson TJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Eura Medicophys. 2007 Dec;43(4):475-85.

ReferenceCitation: Schmidt M, Banzett RB, Raux M, Morelot-Panzini C, Dangers L, Similowski T, Demoule A. Unrecognized suffering in the ICU: addressing dyspnea in mechanically ventilated patients. Intensive Care Med. 2014 Jan;40(1):1-10. doi: 10.1007/s00134-013-3117-3. Epub 2013 Oct 17.

version: acceptedVersion

publisher_dissemination: Springer

ReferenceCitation: Rose L, Nonoyama M, Rezaie S, Fraser I. Psychological wellbeing, health related quality of life and memories of intensive care and a specialised weaning centre reported by survivors of prolonged mechanical ventilation. Intensive Crit Care Nurs. 2014 Jun;30(3):145-51. doi: 10.1016/j.iccn.2013.11.002. Epub 2013 Dec 3.

ReferenceCitation: Hough CL, Steinberg KP, Taylor Thompson B, Rubenfeld GD, Hudson LD. Intensive care unit-acquired neuromyopathy and corticosteroids in survivors of persistent ARDS. Intensive Care Med. 2009 Jan;35(1):63-8. doi: 10.1007/s00134-008-1304-4. Epub 2008 Oct 23.

ReferenceCitation: Kramer CL. Intensive Care Unit-Acquired Weakness. Neurol Clin. 2017 Nov;35(4):723-736. doi: 10.1016/j.ncl.2017.06.008.

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.

ReferenceCitation: Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.

ReferenceCitation: Binks AP, Desjardin S, Riker R. ICU Clinicians Underestimate Breathing Discomfort in Ventilated Subjects. Respir Care. 2017 Feb;62(2):150-155. doi: 10.4187/respcare.04927. Epub 2016 Dec 13.

ReferenceCitation: Romanet C, Wormser J, Fels A, Lucas P, Prudat C, Sacco E, Bruel C, Plantefeve G, Pene F, Chatellier G, Philippart F. Effectiveness of exercise training on the dyspnoea of individuals with long COVID: A randomised controlled multicentre trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101765. doi: 10.1016/j.rehab.2023.101765. Epub 2023 Jun 2.

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Hôpital Cochin
Centre Hospitalier Victor Dupouy
Groupe Hospitalier Paris Saint Joseph


title: CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Eculizumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Eculizumab is a terminal complement inhibitor that has been investigated for more than 10 years in numerous complement-mediated diseases. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Eculizumab administration to patients enrolled in the CORIMUNO-19 cohort. Eculizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Eculizumab will receive standard of care. Outcomes of Eculizumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

status: Unknown status

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Réanimation médicale
saint Louis
Saint Louis

status_simplified: Unknown


title: Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients

acronym: OPTIREG

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. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.

The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.

status: Terminated

lead_sponsor: CMC Ambroise Paré

location_facility:
CHU de Poitiers
CMC Ambroise Paré
GHEM Eaubonne


title: Anti-Angiotensin II Type 1 Receptor Antibodies and Kidney Transplant Outcomes

summary:
Incompatibility between non-genetically identical donors and recipients has been increasingly recognized as the main contributing factor to solid allograft rejection and failure, through the triggering of donor-specific responses mediated by T- and B-lymphocytes. The Human Leucocyte Antigen (HLA) system has been identified as the main target of donor-specific responses, especially through the production by the recipient of antibodies directed toward non-self donor HLA molecules expressed on the allograft endothelium. As a consequence, in organ transplantation, the current approach to immunological risk stratification, patient monitoring and rejection diagnosis is based on biomarkers derived from the HLA system. However, this approach does not provide a sufficient accuracy for the risk stratification and the diagnosis of immunological complications in solid organ transplantation, which still remain the dominant cause of allograft failure.

A recent body of evidence supports that specific non-HLA antigens expressed on the allograft endothelium may be relevant to allograft rejection, suggesting that a new strategy to transplant diagnostic testing at a non-HLA level would help to overcome the limitations of the current HLA-based approach to immunological assessment of transplant recipients. Among antibodies to non-HLA endothelial antigens, angiotensin II type 1 receptor activating antibodies have been the most widely reported antibodies to associate with the occurrence of allograft rejection, dysfunction and loss, even if their independent role, with respect to the presence of concomitant anti-HLA antibodies, has not been demonstrated.

lead_sponsor: Paris Translational Research Center for Organ Transplantation

collaborators: Center for Cardiovascular Research Berlin

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France

intervention_type: Diagnostic Test


title: Self-help Program for Hypnotics Withdrawal in Chronic Insomniac Patients: A Randomized Controlled Clinical Trial

acronym: PROPERSOM

summary:
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line treatment. French Health authorities recommend restricting the consumption of both hypnotics to no more than 4 weeks, considering their potential adverse effects (memory impairment, altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence. However, it appears that a majority of patients become chronic users. Therefore, discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound insomnia).

Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT) principles improve sleep and daily life quality leading to hypnotic taper and maintain of hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. This therapy is dependent on a therapeutic alliance between practitioner and patient. Unfortunately, there are an insufficient number of trained CBT experts especially in France.

The implementation of an internet-delivered self-help program based on time-in-bed restriction and stimulus control may be an issue within the context of general practice.

Online programs based on CBT principles have been proved to be effective in improving the sleep and daytime functioning in this population, but the studies were realized in small patients groups.

Investigators hypothesis is that a simple and internet-delivered short-term program based on sleep restriction therapy and stimulus control (following to a GP consultation) may facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia disorder still reporting sleep complaints in comparison with a tapering alone (no access to the self-help program).

ipd_sharing_description: Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).

location_facility:
APHP Hôpital Raymond Poincaré
CHRU de Lille
CHU de Montpellier
AP-HP Hôpital Pitié-Salpétrière
CHU de Bordeaux
APHP Hôtel-Dieu de Paris

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: PROPERSOM

titre: PROgramme PERsonnalisé d'aide au sevrage des patients inSOMniaques traités par hypnotiques : un essai clinique comparatif randomisé.

discipline_principale: psychiatrie / addictologie

nom_porteur: PHILIP

prenom_porteur: Pierre


title: Epidemiology and Clinical Characteristics of Non-Tuberculous Mycobacteria Infections in Cystic Fibrosis Patients.

acronym: CIMENT

summary:
An increase in the prevalence of infections due to non-tuberculous mycobacteria (NTM) is observed in many countries and recent data suggest the circulation of dominant clones with a possibility of human-to-human contamination. The hypothesis is made that these infections are also increasing in France and that dominant NTM clones are circulating. The last French study carried out in 2004 already showed prevalences of up to 10% in certain French regions. It is essential to know the prevalence 8 years later, taking advantage of the new recommendations for the management of patients and samples, which will homogenize practices on French territory.

No data are currently available in France on the prevalence of positive serological responses in cystic fibrosis patients. Serological analyzes of the sera collected during this study will enable us to evaluate the performance of serology in mycobacterial culture and to identify patients with no positive respiratory specimen in culture but with positive serology indicating potential contact with a mycobacterium. The establishment of a serological follow-up of these patients will allow to correlate this result with a clinical evolution and / or the detection of NTM in subsequent samples. Serology is an innovative aspect of the CIMENT study.

ReferenceCitation: Qvist T, Gilljam M, Jonsson B, Taylor-Robinson D, Jensen-Fangel S, Wang M, Svahn A, Kotz K, Hansson L, Hollsing A, Hansen CR, Finstad PL, Pressler T, Hoiby N, Katzenstein TL; Scandinavian Cystic Fibrosis Study Consortium (SCFSC). Epidemiology of nontuberculous mycobacteria among patients with cystic fibrosis in Scandinavia. J Cyst Fibros. 2015 Jan;14(1):46-52. doi: 10.1016/j.jcf.2014.08.002. Epub 2014 Aug 30.

ReferenceCitation: Albrecht C, Ringshausen F, Ott S, Wagner D, Rademacher J, Schneider M, Welte T, Pletz MW. Should all adult cystic fibrosis patients with repeated nontuberculous mycobacteria cultures receive specific treatment? A 10-year case-control study. Eur Respir J. 2016 May;47(5):1575-7. doi: 10.1183/13993003.01239-2015. Epub 2016 Feb 4. No abstract available.

ReferenceCitation: Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available. Erratum In: Am J Respir Crit Care Med. 2007 Apr 1;175(7):744-5. Dosage error in article text.

ReferenceCitation: Martiniano SL, Sontag MK, Daley CL, Nick JA, Sagel SD. Clinical significance of a first positive nontuberculous mycobacteria culture in cystic fibrosis. Ann Am Thorac Soc. 2014 Jan;11(1):36-44. doi: 10.1513/AnnalsATS.201309-310OC.

ReferenceCitation: Floto RA, Olivier KN, Saiman L, Daley CL, Herrmann JL, Nick JA, Noone PG, Bilton D, Corris P, Gibson RL, Hempstead SE, Koetz K, Sabadosa KA, Sermet-Gaudelus I, Smyth AR, van Ingen J, Wallace RJ, Winthrop KL, Marshall BC, Haworth CS. US Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis: executive summary. Thorax. 2016 Jan;71(1):88-90. doi: 10.1136/thoraxjnl-2015-207983.

ReferenceCitation: Jeong BH, Kim SY, Jeon K, Lee SY, Shin SJ, Koh WJ. Serodiagnosis of Mycobacterium avium complex and Mycobacterium abscessus complex pulmonary disease by use of IgA antibodies to glycopeptidolipid core antigen. J Clin Microbiol. 2013 Aug;51(8):2747-9. doi: 10.1128/JCM.00702-13. Epub 2013 Jun 5.

ReferenceCitation: Qvist T, Taylor-Robinson D, Waldmann E, Olesen HV, Hansen CR, Mathiesen IH, Hoiby N, Katzenstein TL, Smyth RL, Diggle PJ, Pressler T. Comparing the harmful effects of nontuberculous mycobacteria and Gram negative bacteria on lung function in patients with cystic fibrosis. J Cyst Fibros. 2016 May;15(3):380-5. doi: 10.1016/j.jcf.2015.09.007. Epub 2015 Oct 9.

ReferenceCitation: Qvist T, Pressler T, Taylor-Robinson D, Katzenstein TL, Hoiby N. Serodiagnosis of Mycobacterium abscessus complex infection in cystic fibrosis. Eur Respir J. 2015 Sep;46(3):707-16. doi: 10.1183/09031936.00011815. Epub 2015 Apr 30.

lead_sponsor: University Hospital, Brest

location_facility:
CHRU Brest
CHIC Créteil
Centre de Perharidy
CHU Grenoble
CHR Sud Réunion
CHU Toulouse
AP-HP Hôpital Cochin
CHU Bordeaux
CHU Rouen
CHU Lille
CHU Tours
CHU Côte de Nacre
AP-HP Hôpital Foch
CHU Amiens


type: EudraCT Number

title: Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder

summary: The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg) response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders experiencing a depressive relapse

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Iltoo Pharma


title: Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone

acronym: PROFIDYS

summary: This trial is intended to test the efficacy of an oral bisphosphonate (risedronate) to decrease bone pain and improve radiological aspect in fibrous dysplasia of bone.

collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

collaborators: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

location_country: Germany Netherlands Belgium France

location_facility:
Hopital Lariboisiere
Cliniques Universitaires Saint Luc
Hospital Benjamin Franklin
Hopital Cochin
Hopital E Herriot
Leids Universitair Medisch Centrum
Cologne Clinical Centre
Heildeberg Clinical Centre


title: Feasibility and Performances of Spleen Stiffness Measurement as Surrogate Marker for Oesophageal Varices in Cirrhotic Patients.

summary:
FibroScan® (Echosens, Paris, France) is an active non implantable medical device marketed in Europe since December 2003 and is currently used in many countries. FibroScan® is an ultrasound-based vibration-controlled transient elastography (VCTE™) device dedicated to liver stiffness measurement (LSM).

Several clinical studies have shown the accuracy of LSM by FibroScan® to predict liver fibrosis.

Some other studies have already shown the good correlation between LSM, assessed by FibroScan® based on VCTE™ technology, and the presence of portal hypertension (PHT).

PHT is a clinical condition characterized by a high blood pressure in the portal vein and its tributaries and it is defined as a gradient between portal and systemic blood pressure > 6 mmHg.

The development of oesophageal varices (OV) in cirrhotic patients, as well as their potential bleeding, represent one of the most severe and life-threatening complication of cirrhosis.

Upper endoscopy is the best diagnostic tool for detecting the presence of OV, gastric varices or congestive gastropathy, for estimating the grade of OV and for the recognition of the presence of red color signs and wale marks or other indicators of high risk for bleeding.

However these two methods are quite invasive and associated with some risks; at the same time, not all cirrhotic patients present OV at endoscopic screening.

The aim of this study is the validation of SSM, assessed by a FibroScan® with acquisition parameters and algorithm optimized for SSM, as surrogate noninvasive marker for the presence of OV in liver cirrhosis patients.

primary_purpose: Diagnostic

ReferenceCitation: Stefanescu H, Marasco G, Cales P, Fraquelli M, Rosselli M, Ganne-Carrie N, de Ledinghen V, Ravaioli F, Colecchia A, Rusu C, Andreone P, Mazzella G, Festi D. A novel spleen-dedicated stiffness measurement by FibroScan(R) improves the screening of high-risk oesophageal varices. Liver Int. 2020 Jan;40(1):175-185. doi: 10.1111/liv.14228. Epub 2019 Sep 11.

oa_host_type: closed

lead_sponsor: Echosens

location_country:
Romania
Italy
United Kingdom
France

location_facility: Seconda Divisione di Gastroenterologia Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico,

location_facility: Hôpital Haut-Lévêque, Service Hépato-gastroentérologie et Oncologie digestive

location_facility: Department of Clinical Medicine, Policlinico S. Orsola Malpighi

location_facility: Hôpital Jean Verdier, Service Hépato-gastroentérologie

location_facility: Iuliu Hatieganu University of Medicine and Pharmacy


title: Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA in the Administered Rt-PA

acronym: OPHELIE

summary: intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).

ReferenceCitation: Caparros F, Kuchcinski G, Drelon A, Casolla B, Moulin S, Dequatre-Ponchelle N, Henon H, Cordonnier C, Pruvo JP, Leys D. Use of MRI to predict symptomatic haemorrhagic transformation after thrombolysis for cerebral ischaemia. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):402-410. doi: 10.1136/jnnp-2019-321904. Epub 2020 Feb 3.

ReferenceCitation: Leys D, Hommet Y, Jacquet C, Moulin S, Sibon I, Mas JL, Moulin T, Giroud M, Sagnier S, Cordonnier C, Medeiros de Bustos E, Turc G, Ronziere T, Bejot Y, Detante O, Ouk T, Mendyk AM, Favrole P, Zuber M, Triquenot-Bagan A, Ozkul-Wermester O, Montoro FM, Lamy C, Faivre A, Lebouvier L, Potey C, Poli M, Henon H, Renou P, Dequatre-Ponchelle N, Bodenant M, Debruxelles S, Rossi C, Bordet R, Vivien D; OPHELIE investigators and the STROKAVENIR network. Proportion of single-chain recombinant tissue plasminogen activator and outcome after stroke. Neurology. 2016 Dec 6;87(23):2416-2426. doi: 10.1212/WNL.0000000000003399. Epub 2016 Nov 4.

publisher_dissemination: Wolters Kluwer Health


title: Impact of Early and Intensive Bimanual Stimulation on the Evolution of Bimanual Function in Infants With Clinical Findings Suggesting Unilateral Cerebral Palsy (BB-BIM)

acronym: BB-BIM

summary: The aim of this study is to measure the impact of early bimanual stimulation in babies with clinical signs of underuse of one hand. The observation focuses on the developmental curve of hands use. The intervention is provided by the family environment and takes place in the child's familiar surroundings.

lead_sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

collaborators: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) - France

collaborators: Laboratoire de Biomécanique et Mécanique des Chocs (LBMC) - France

location_facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues


title: Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation: a National Multicenter Randomized Clinical Trial

acronym: FAST-TB

summary:
French guidelines currently recommend to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of primary resistance to INH. Hence, early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth susceptibility testings.

the duration of treatment is 6 months or 12 months.

location_facility:
Bichat Claude Bernard Hospital
Bichat hospital


title: Observational Study of Iron Metabolism in Anemia in ICU and Post-Operative Patients, Role of Hepcidin

acronym: FAIRe

summary: Anemia in intensive care and post-operative patients is due to both blood loss (leading to iron loss) and inflammation.

collaborators: Société Française d'Anesthésie et de Réanimation


title: Evaluation of an 3D Imaging Intensifier Coupled to a Navigation Station in the Surgery of the Spine and Pelvis

acronym: FLUORONAV

summary: The purpose of this study is to demonstrate an optimization of the establishment of orthopedic implants in surgery of the spine and pelvic ring by combining 3D fluoroscopy and navigation system versus conventional method involving anatomical landmarks and 2D fluoroscopy.

lead_sponsor: AdministrateurCIC

sponsor_collaborators:
AdministrateurCIC
PRAXIM company

location_facility: Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France


title: "ShearWave" Elastography Interest in the Management of Thyroid Nodules

acronym: SWETHY

summary: Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.


title: Implementation and Effectiveness of a Reinforced Support Program for People Who Are Overweight or Obese to Improve Their Autonomy in Health and Quality of Life

acronym: Eval-Xailes

summary:
This mixed-methods prospective cohort study aims to evaluate a recently implemented reinforced support program named "X-ailes program".

The X-Ailes program is a face-to-face or telephone-based support program by health-system navigators/case-managers, funded by the French Ministry of Health (program for empowerment of care users). X-Ales is developed by an patients and public association to support overweight or obese care users facing difficulty to access to care or resources regarding the management of their health situation.

The subjects of the present study are the overweight or obese care-users followed-up by the X-Ailes program.

The aim of the study Eval-X-ailes is to assess the effect of the support program X-Ailes on quality of life, autonomy and literacy of overweight or obese care users at 12 months.

lead_sponsor: Hospices Civils de Lyon


title: Study to Establish Patient-Matched Population Norms for the MS-COG

summary: The primary objective of the study is to develop MS patient-matched healthy population norms for the Multiple Sclerosis Cognition Assessment Battery (MS-COG) that are representative of the United States (US), France, and Italy.

lead_sponsor: Biogen

location_country:
United States
Italy
France

location_facility:
Research site
Research Site


title: Genetics of Ventriculo-arterial Discordance: Towards a PRECIsion Medicine in PEDiatric Cardiology

acronym: PreciPed

summary:
Number of centres planned : 16 centres in France

Type of study / Study design : Research Involving the Human Person category 2.

Multicentric. Prospective

Planning of the study : Total duration: 22 years. Recruitment period: 24 months. Follow-up

time per patients : 20 years

Expected number of cases : 300 index cases: 150 single index cases and 150 trio families

Treatment, procedure, combination of procedures under consideration :

Blood samples for genetic analyses collected at the inclusion visit for patients and parents in case of trio families

Schedule of different visits and examinations :

Inclusion visit:

Collection of demographic, clinical data from the index case and parents
DNA sampling for genetic research (biocollection) of the index case or family trio
Completion of the quality of life questionnaire

Annual visit with a 20 year follow-up:

Retrieval of data from the index case
Completion of the quality of life questionnaire

primary_purpose: Other

lead_sponsor: Nantes University Hospital

collaborators: Clinique des Données, CIC 1413, CHU Nantes

location_facility: Groupe Hospitalier St Joseph - Hôpital Marie Lannelongue

intervention_type: Biological


title: Test of Ventricular Stimulation as Immediate Predictor of Hypovolemia After Cardiac Surgery: Non-randomized Open Label Trial.

acronym: TESTI

summary: The purpose of the study is to validate a ventricular pacing test as a predictor of preload dependency in post cardiac surgery patients.


title: Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery

acronym: Paprika

summary: Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery

ReferenceCitation: Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.

ReferenceCitation: Barberan-Garcia A, Ubre M, Pascual-Argente N, Risco R, Faner J, Balust J, Lacy AM, Puig-Junoy J, Roca J, Martinez-Palli G. Post-discharge impact and cost-consequence analysis of prehabilitation in high-risk patients undergoing major abdominal surgery: secondary results from a randomised controlled trial. Br J Anaesth. 2019 Oct;123(4):450-456. doi: 10.1016/j.bja.2019.05.032. Epub 2019 Jun 25.

ipd_sharing_description: Anonymised data will be shared with Barcelona, Köln and Gdansk: all collected IPD

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
EIT Health
Hospital Clinic of Barcelona
Universitätsklinikum Köln
University Clinical Centre, Gdansk

location_facility: Centre Hospitalier Universitaire Grenoble Alpes


title: Prevalence of Right Ventricular Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases and Its Impact on Outcomes

acronym: DVD

summary: Observational study in patients with chronic respiratory diseases (chronic obstructive pulmonary diseases, bronchiectasis, interstitial lung diseases, neuromuscular diseases, obesity-hypoventilation syndrome...) admitted in intensive care unit for acute respiratory failure. The main objective is to determine the prevalence of right ventricular (RV) dysfunction in this population and to analyze the impact of such a complication on outcomes (survival at day-28, duration of non-invasive or mechanical ventilation, duration of hospital stay). RV function will be assessed by echocardiography at admission, after 3 days and at discharge. Plasma NT-proBNP and troponin levels will be collected.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière Paris, France


title: Feasibility and Validity of an Observational Scale as a Surrogate of Dyspnea in Non-communicating Patients in the Intensive Care Unit (ICU): DYS-NOC

acronym: DYS-NOC

summary:
Background : Dyspnea is common and severely impact mechanically ventilated patients outcomes in intensive care unit (ICU). Recognize, measure and treat dyspnea have become current major therapeutic challenge. Its measurement involves a self-assessment by the patient, and by definition, a certain level of communication. Consequently, a large proportion of the ICU-population (non-communicating) misses its evaluation and potential benefits associated with its control. In other hand, electrophysiological markers that help to detect and quantify dyspnea regardless of the patient's cooperation, has been developed and validated as dyspnea surrogate, namely: 1) the electromyographic (EMG) activity of extra diaphragmatic inspiratory muscles and 2) the premotor inspiratory potentials (PIP) detected on the electroencephalogram (EEG). Because of its complex implementation in daily practice the research team has developed alternatively a behavioral score called IC-RDOS that provides reliable dyspnea assessment also without patient participation. Validated in conscious patients, it has not been yet validated in non-communicating patients.

Hypothesis : The IC-RDOS is valid for non-communicating ventilated patients and allows a simple and reliable assessment of dyspnea in this specific population.

Objective : To validate the IC-RDOS in non-communicating ICU patients under mechanical ventilation, using comparison with the tools validated for reliable measure of dyspnea in non-communicating patients (EMG, EEG).

Patients and Methods: In 40 patients will be collected simultaneously IC-RDOS, PIP (EEG) and electromyographic activity of three extra diaphragmatic inspiratory muscles (scalene, parasternal and Alae nasi) before and after intervention therapy aiming at reduce dyspnea (ventilator settings or pharmacological intervention), initiated by the clinician in charge of the patient.

Expected results : Observe a strong positive correlation between the IC-RDOS and electrophysiological markers (amplitude of the electromyogram and presence and magnitude of PIP). Observe a correlation between changes in the IC-RDOS and the electrophysiological markers after therapeutic interventions.

Optimizing patient comfort is a prominent concern in the ICU. By optimizing the detection and quantification of dyspnea in non-communicating patients, this study should ultimately improve the management and "the better living" of ventilated patients in intensive care

ReferenceCitation: Lansing RW, Gracely RH, Banzett RB. The multiple dimensions of dyspnea: review and hypotheses. Respir Physiol Neurobiol. 2009 May 30;167(1):53-60. doi: 10.1016/j.resp.2008.07.012. Epub 2008 Jul 25.

ReferenceCitation: Cherniack NS, Altose MD. Mechanisms of dyspnea. Clin Chest Med. 1987 Jun;8(2):207-14.

ReferenceCitation: Morelot-Panzini C, Demoule A, Straus C, Zelter M, Derenne JP, Willer JC, Similowski T. Dyspnea as a noxious sensation: inspiratory threshold loading may trigger diffuse noxious inhibitory controls in humans. J Neurophysiol. 2007 Feb;97(2):1396-404. doi: 10.1152/jn.00116.2006. Epub 2006 Jul 26.

ReferenceCitation: HAMMOND EC. SOME PRELIMINARY FINDINGS ON PHYSICAL COMPLAINTS FROM A PROSPECTIVE STUDY OF 1,064,004 MEN AND WOMEN. Am J Public Health Nations Health. 1964 Jan;54(1):11-23. doi: 10.2105/ajph.54.1.11. No abstract available.

ReferenceCitation: Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

ReferenceCitation: Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

ReferenceCitation: Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002 May;121(5):1434-40. doi: 10.1378/chest.121.5.1434.

ReferenceCitation: Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.

ReferenceCitation: Esteban C, Quintana JM, Aburto M, Moraza J, Egurrola M, Perez-Izquierdo J, Aizpiri S, Aguirre U, Capelastegui A. Impact of changes in physical activity on health-related quality of life among patients with COPD. Eur Respir J. 2010 Aug;36(2):292-300. doi: 10.1183/09031936.00021409. Epub 2010 Jan 14.

ReferenceCitation: Wilson PR. Clinical practice guideline: acute pain management. Clin J Pain. 1992 Sep;8(3):187-8. doi: 10.1097/00002508-199209000-00001. No abstract available.

ReferenceCitation: Pochard F, Lanore JJ, Bellivier F, Ferrand I, Mira JP, Belghith M, Brunet F, Dhainaut JF. Subjective psychological status of severely ill patients discharged from mechanical ventilation. Clin Intensive Care. 1995;6(2):57-61.

ReferenceCitation: de Miranda S, Pochard F, Chaize M, Megarbane B, Cuvelier A, Bele N, Gonzalez-Bermejo J, Aboab J, Lautrette A, Lemiale V, Roche N, Thirion M, Chevret S, Schlemmer B, Similowski T, Azoulay E. Postintensive care unit psychological burden in patients with chronic obstructive pulmonary disease and informal caregivers: A multicenter study. Crit Care Med. 2011 Jan;39(1):112-8. doi: 10.1097/CCM.0b013e3181feb824.

ReferenceCitation: Pennock BE, Crawshaw L, Maher T, Price T, Kaplan PD. Distressful events in the ICU as perceived by patients recovering from coronary artery bypass surgery. Heart Lung. 1994 Jul-Aug;23(4):323-7.

ReferenceCitation: van de Leur JP, van der Schans CP, Loef BG, Deelman BG, Geertzen JH, Zwaveling JH. Discomfort and factual recollection in intensive care unit patients. Crit Care. 2004 Dec;8(6):R467-73. doi: 10.1186/cc2976. Epub 2004 Oct 28.

ReferenceCitation: Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52. doi: 10.1097/00003246-200204000-00004.

ReferenceCitation: Cuthbertson BH, Hull A, Strachan M, Scott J. Post-traumatic stress disorder after critical illness requiring general intensive care. Intensive Care Med. 2004 Mar;30(3):450-5. doi: 10.1007/s00134-003-2004-8. Epub 2003 Sep 5.

ReferenceCitation: Campbell ML, Templin T, Walch J. A Respiratory Distress Observation Scale for patients unable to self-report dyspnea. J Palliat Med. 2010 Mar;13(3):285-90. doi: 10.1089/jpm.2009.0229.

ReferenceCitation: Campbell ML. Respiratory distress: a model of responses and behaviors to an asphyxial threat for patients who are unable to self-report. Heart Lung. 2008 Jan-Feb;37(1):54-60. doi: 10.1016/j.hrtlng.2007.05.007.

ReferenceCitation: Persichini R, Gay F, Schmidt M, Mayaux J, Demoule A, Morelot-Panzini C, Similowski T. Diagnostic Accuracy of Respiratory Distress Observation Scales as Surrogates of Dyspnea Self-report in Intensive Care Unit Patients. Anesthesiology. 2015 Oct;123(4):830-7. doi: 10.1097/ALN.0000000000000805.

ReferenceCitation: Hug F, Raux M, Morelot-Panzini C, Similowski T. Surface EMG to assess and quantify upper airway dilators activity during non-invasive ventilation. Respir Physiol Neurobiol. 2011 Sep 15;178(2):341-5. doi: 10.1016/j.resp.2011.06.007. Epub 2011 Jun 15.

ReferenceCitation: Ward ME, Corbeil C, Gibbons W, Newman S, Macklem PT. Optimization of respiratory muscle relaxation during mechanical ventilation. Anesthesiology. 1988 Jul;69(1):29-35. doi: 10.1097/00000542-198807000-00005.

ReferenceCitation: Parthasarathy S, Jubran A, Laghi F, Tobin MJ. Sternomastoid, rib cage, and expiratory muscle activity during weaning failure. J Appl Physiol (1985). 2007 Jul;103(1):140-7. doi: 10.1152/japplphysiol.00904.2006. Epub 2007 Mar 29.

ReferenceCitation: Schmidt M, Chiti L, Hug F, Demoule A, Similowski T. Surface electromyogram of inspiratory muscles: a possible routine monitoring tool in the intensive care unit. Br J Anaesth. 2011 Jun;106(6):913-4. doi: 10.1093/bja/aer141. No abstract available.

ReferenceCitation: Schmidt M, Kindler F, Gottfried SB, Raux M, Hug F, Similowski T, Demoule A. Dyspnea and surface inspiratory electromyograms in mechanically ventilated patients. Intensive Care Med. 2013 Aug;39(8):1368-76. doi: 10.1007/s00134-013-2910-3. Epub 2013 Apr 11.

ReferenceCitation: Raux M, Straus C, Redolfi S, Morelot-Panzini C, Couturier A, Hug F, Similowski T. Electroencephalographic evidence for pre-motor cortex activation during inspiratory loading in humans. J Physiol. 2007 Jan 15;578(Pt 2):569-78. doi: 10.1113/jphysiol.2006.120246. Epub 2006 Nov 16.

ReferenceCitation: Raux M, Ray P, Prella M, Duguet A, Demoule A, Similowski T. Cerebral cortex activation during experimentally induced ventilator fighting in normal humans receiving noninvasive mechanical ventilation. Anesthesiology. 2007 Nov;107(5):746-55. doi: 10.1097/01.anes.0000287005.58761.e8.

sponsor_collaborators: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil


title: Improving the Participation Rate in ColoRectal Cancer Screening by Training General Practitioners in Motivational Interviewing

acronym: AMDepCCR

summary:
Colorectal cancer is the 2nd leading cause of cancer mortality in France. However this cancer is preventable in the majority of cases by early detection of adenomas.

In France, there is organized colorectal cancer screening, which relies on general practitioners (GPs). Tests delivered by GPs are performed in 89% of cases. However, GPs do not systematically offer the test, for time management and communication reasons. Patients expect their GPs to offer the test and to focus on their expectations. A previous study conducted on GPs showed that training in communication and motivational interviewing increases the number of tests performed by 12.2%.

In order to facilitate the promotion of screening, the investigators would like to develop a training programme for GPs focusing on the application of Motivational Interviewing (MI) techniques to the promotion of colorectal cancer screening.

Motivational Interviewing is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence.

This study is a multicenter trial in general medicine. In this randomized trial the 902 subjects will be included prospectively by the general practitioners (GP) participating in the study.

As a first step, general practitioners who have never participated in Motivational Interviewing training will be recruited and split into 2 groups by randomization, an intervention group and a control group. The interventional group will then undergo a 3 times 2-day training in Motivational Interviewing.

In a second step, the patients will be included by those GP and a self-questionnaire will be send at the inclusion and after 6, 12 and 24 months. The evaluation of the number of tests performed and the analyse of the Health Belief Model (HBM) self-questionnaire will be carried out.

At 24 months, there will be an evaluation of the denial motivation questionnaire for patients who have not participated in organized colorectal cancer screening.

ReferenceCitation: Aujoulat P, Le Goff D, Dany A, Robaskiewick M, Nousbaum JB, Derrienic J, Cariou M, Guillou M, Le Reste JY. Improvement of participation rate in colorectal cancer (CRC) screening by training general practitioners in motivational interviewing (AmDepCCR). Trials. 2022 Feb 14;23(1):144. doi: 10.1186/s13063-022-06056-8.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
Dr DE LA SOUDIERE
Dr KERGASTEL
Dr CHAPOIX
Dr LE BOURHIS
Dr VIALA
Dr COGNEAU
Dr PIPET-PENIN
Dr CRENN-CORVEZ
Dr DENIEL
Dr GRALL
Dr OLIVIER
Dr JOLIVET COUTURE
Dr ABALAIN
Dr MAGADUR
Dr BECK-ROBERT
Dr AUTRET
Dr PETIT
Dr LOPIN
Dr BODIN
Dr COROLLER
Dr BLANCHARD
Dr BARAIS
Dr MAILLEUCHET
Dr LEFEVRE
Dr PITMAN
Dr BOUTERAON
Dr KERFRIDEN KERHOAS
Dr BAUTA
Dr GASNIER
Dr PREVOT
Dr PETTON-HILI
Dr LE FLOCH
Dr DAOUDAL
Dr BEURTON-COURAUD
Dr VERBEQUE MORVAN
Dr MUNCK
Dr LE GRIGNOU
Dr DROGOU
Dr HENRY
Dr KERVELLA
Dr LUCAS
Dr COUTURIER
Dr TREBAOL
Dr ATTENCOURT
Dr NICOLAS
Dr VELLY
Dr MONFORT
Dr PERRIER
Dr AOUDIA
Dr COLLETER
Dr BARCELO
Dr POINOT
Dr DESNOT

appel_a_projets: PREPS

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: AMDepCCR

titre: AMélioration du taux de participation au Dépistage du Cancer Colon Rectal par la formation des médecins généralistes.

discipline_principale: médecine générale

nom_porteur: LE RESTE

prenom_porteur: Jean Yves


title: Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation

acronym: OTRLASV

summary: Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the investigators aim to describe the clinical characteristics of patients treated with ASV and the associated device settings.

ReferenceCitation: Jaffuel D, Philippe C, Rabec C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. What is the remaining status of adaptive servo-ventilation? The results of a real-life multicenter study (OTRLASV-study) : Adaptive servo-ventilation in real-life conditions. Respir Res. 2019 Oct 29;20(1):235. doi: 10.1186/s12931-019-1221-9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories:
HAL
PubMed Central
iris.unica.it

repositories_concat: HAL;PubMed Central;iris.unica.it

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

ReferenceCitation: Jaffuel D, Rabec C, Philippe C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions. Respir Res. 2020 Sep 21;21(1):243. doi: 10.1186/s12931-020-01509-7.

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

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

ReferenceCitation: Jaffuel D, Mallet JP, Combes N, Palot A, Rabec C, Molinari N, Jaber S, Bourdin A. [Adaptive servo-ventilation after the SERVE-HF study: The swan song?]. Rev Mal Respir. 2016 Sep;33(7):641-4. doi: 10.1016/j.rmr.2016.04.001. Epub 2016 May 5. No abstract available. French.

location_facility: Arnaud de Villeneuve University Hospital