title: Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) Functional CTCs Using EPIDROP

acronym: CTC-AXL-PANC

summary: In solid cancers, some more aggressive tumor cells actively detach from the primary lesion and then travel through the circulating compartment to reach distant organs and form micro-metastases. These circulating tumor cells (CTCs) that have become disseminated tumor cells (DTCs) flourish in their new environments and may remain dormant for many years after the complete resection of the primary tumor. Detecting CTCs in the blood is also relevant for assessing tumor progression, prognosis and therapeutic follow-up. The non-invasive, highly sensitive for CTCs analysis is called "liquid biopsy". Pancreatic adenocarcinoma and breast cancer remain among cancers of very poor prognosis and thus represent a major therapeutic challenge. In recent years, the Axl membrane tyrosine kinase receptor has been the target of growing interest. Activation of the Gas6/Axl signaling pathway is associated with, among other things, tumor cell growth and survival, epithelial to mesenchymal transition (EMT) or drug resistances. In addition, Axl overexpression is frequently identified in patients with pancreatic adenocarcinoma and is associated with a poor prognosis. For example, the Laboratoire des Cellules Circulantes Rares Humaines (LCCRH) at the CHU and the University of Montpellier has developed two new "CTC-AXL" tests to detect CTCs expressing Axl: one using the CellSearch® (gold standard and FDA-approved) system and the other using the EPIDROP technique. The purpose of this research project is to assess the concordance of the "CTC-AXL" measurement by the innovative EPIDROP technique and the CellSearch® technique in patients with metastatic pancreatic or breast cancer.

ReferenceCitation: Pantel K, Alix-Panabieres C. Tumour microenvironment: informing on minimal residual disease in solid tumours. Nat Rev Clin Oncol. 2017 Jun;14(6):325-326. doi: 10.1038/nrclinonc.2017.53. Epub 2017 Apr 11. No abstract available.

ReferenceCitation: Pantel K, Alix-Panabieres C. Liquid biopsy and minimal residual disease - latest advances and implications for cure. Nat Rev Clin Oncol. 2019 Jul;16(7):409-424. doi: 10.1038/s41571-019-0187-3.

ReferenceCitation: Alix-Panabieres C. The future of liquid biopsy. Nature. 2020 Mar;579(7800):S9. doi: 10.1038/d41586-020-00844-5. No abstract available.

ReferenceCitation: Pantel K, Alix-Panabieres C. Circulating tumour cells in cancer patients: challenges and perspectives. Trends Mol Med. 2010 Sep;16(9):398-406. doi: 10.1016/j.molmed.2010.07.001. Epub 2010 Jul 29.

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

ReferenceCitation: Conroy T, Gavoille C, Adenis A. Metastatic pancreatic cancer: old drugs, new paradigms. Curr Opin Oncol. 2011 Jul;23(4):390-5. doi: 10.1097/CCO.0b013e3283473610.

ReferenceCitation: Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Sohal DPS, Kennedy EB, Cinar P, Conroy T, Copur MS, Crane CH, Garrido-Laguna I, Lau MW, Johnson T, Krishnamurthi S, Moravek C, O'Reilly EM, Philip PA, Pant S, Shah MA, Sahai V, Uronis HE, Zaidi N, Laheru D. Metastatic Pancreatic Cancer: ASCO Guideline Update. J Clin Oncol. 2020 Sep 20;38(27):3217-3230. doi: 10.1200/JCO.20.01364. Epub 2020 Aug 5.

ReferenceCitation: Koorstra JB, Karikari CA, Feldmann G, Bisht S, Rojas PL, Offerhaus GJ, Alvarez H, Maitra A. The Axl receptor tyrosine kinase confers an adverse prognostic influence in pancreatic cancer and represents a new therapeutic target. Cancer Biol Ther. 2009 Apr;8(7):618-26. doi: 10.4161/cbt.8.7.7923. Epub 2009 Apr 22.

ReferenceCitation: Leconet W, Larbouret C, Chardes T, Thomas G, Neiveyans M, Busson M, Jarlier M, Radosevic-Robin N, Pugniere M, Bernex F, Penault-Llorca F, Pasquet JM, Pelegrin A, Robert B. Preclinical validation of AXL receptor as a target for antibody-based pancreatic cancer immunotherapy. Oncogene. 2014 Nov 20;33(47):5405-14. doi: 10.1038/onc.2013.487. Epub 2013 Nov 18.

ReferenceCitation: Kariolis MS, Miao YR, Jones DS 2nd, Kapur S, Mathews II, Giaccia AJ, Cochran JR. An engineered Axl 'decoy receptor' effectively silences the Gas6-Axl signaling axis. Nat Chem Biol. 2014 Nov;10(11):977-83. doi: 10.1038/nchembio.1636. Epub 2014 Sep 21.

ReferenceCitation: Shen Y, Chen X, He J, Liao D, Zu X. Axl inhibitors as novel cancer therapeutic agents. Life Sci. 2018 Apr 1;198:99-111. doi: 10.1016/j.lfs.2018.02.033. Epub 2018 Feb 27.

ReferenceCitation: Tai KY, Shieh YS, Lee CS, Shiah SG, Wu CW. Axl promotes cell invasion by inducing MMP-9 activity through activation of NF-kappaB and Brg-1. Oncogene. 2008 Jul 3;27(29):4044-55. doi: 10.1038/onc.2008.57. Epub 2008 Mar 17.

ReferenceCitation: Li Y, Ye X, Tan C, Hongo JA, Zha J, Liu J, Kallop D, Ludlam MJ, Pei L. Axl as a potential therapeutic target in cancer: role of Axl in tumor growth, metastasis and angiogenesis. Oncogene. 2009 Oct 1;28(39):3442-55. doi: 10.1038/onc.2009.212. Epub 2009 Jul 27.

ReferenceCitation: Antony J, Huang RY. AXL-Driven EMT State as a Targetable Conduit in Cancer. Cancer Res. 2017 Jul 15;77(14):3725-3732. doi: 10.1158/0008-5472.CAN-17-0392. Epub 2017 Jun 30.

ReferenceCitation: Rankin EB, Fuh KC, Taylor TE, Krieg AJ, Musser M, Yuan J, Wei K, Kuo CJ, Longacre TA, Giaccia AJ. AXL is an essential factor and therapeutic target for metastatic ovarian cancer. Cancer Res. 2010 Oct 1;70(19):7570-9. doi: 10.1158/0008-5472.CAN-10-1267. Epub 2010 Sep 21.

ReferenceCitation: Ye X, Li Y, Stawicki S, Couto S, Eastham-Anderson J, Kallop D, Weimer R, Wu Y, Pei L. An anti-Axl monoclonal antibody attenuates xenograft tumor growth and enhances the effect of multiple anticancer therapies. Oncogene. 2010 Sep 23;29(38):5254-64. doi: 10.1038/onc.2010.268. Epub 2010 Jul 5.

ReferenceCitation: Cerchia L, Esposito CL, Camorani S, Rienzo A, Stasio L, Insabato L, Affuso A, de Franciscis V. Targeting Axl with an high-affinity inhibitory aptamer. Mol Ther. 2012 Dec;20(12):2291-303. doi: 10.1038/mt.2012.163. Epub 2012 Aug 21.

ReferenceCitation: Wilson C, Ye X, Pham T, Lin E, Chan S, McNamara E, Neve RM, Belmont L, Koeppen H, Yauch RL, Ashkenazi A, Settleman J. AXL inhibition sensitizes mesenchymal cancer cells to antimitotic drugs. Cancer Res. 2014 Oct 15;74(20):5878-90. doi: 10.1158/0008-5472.CAN-14-1009. Epub 2014 Aug 14.

ReferenceCitation: Feneyrolles C, Spenlinhauer A, Guiet L, Fauvel B, Dayde-Cazals B, Warnault P, Cheve G, Yasri A. Axl kinase as a key target for oncology: focus on small molecule inhibitors. Mol Cancer Ther. 2014 Sep;13(9):2141-8. doi: 10.1158/1535-7163.MCT-13-1083. Epub 2014 Aug 19. Erratum In: Mol Cancer Ther. 2015 Jun;14(6):1518.

ReferenceCitation: Gjerdrum C, Tiron C, Hoiby T, Stefansson I, Haugen H, Sandal T, Collett K, Li S, McCormack E, Gjertsen BT, Micklem DR, Akslen LA, Glackin C, Lorens JB. Axl is an essential epithelial-to-mesenchymal transition-induced regulator of breast cancer metastasis and patient survival. Proc Natl Acad Sci U S A. 2010 Jan 19;107(3):1124-9. doi: 10.1073/pnas.0909333107. Epub 2009 Dec 28.

ReferenceCitation: Song X, Wang H, Logsdon CD, Rashid A, Fleming JB, Abbruzzese JL, Gomez HF, Evans DB, Wang H. Overexpression of receptor tyrosine kinase Axl promotes tumor cell invasion and survival in pancreatic ductal adenocarcinoma. Cancer. 2011 Feb 15;117(4):734-43. doi: 10.1002/cncr.25483. Epub 2010 Oct 4.

ReferenceCitation: Zhang S, Xu XS, Yang JX, Guo JH, Chao TF, Tong Y. The prognostic role of Gas6/Axl axis in solid malignancies: a meta-analysis and literature review. Onco Targets Ther. 2018 Jan 23;11:509-519. doi: 10.2147/OTT.S150952. eCollection 2018.

ReferenceCitation: Yu W, Ge X, Lai X, Lv J, Wang Y. The up-regulation of Axl is associated with a poor prognosis and promotes proliferation in pancreatic ductal adenocarcinoma. Int J Clin Exp Pathol. 2019 May 1;12(5):1626-1633. eCollection 2019.

ReferenceCitation: Jacot W, Mazel M, Mollevi C, Pouderoux S, D'Hondt V, Cayrefourcq L, Bourgier C, Boissiere-Michot F, Berrabah F, Lopez-Crapez E, Bidard FC, Viala M, Maudelonde T, Guiu S, Alix-Panabieres C. Clinical Correlations of Programmed Cell Death Ligand 1 Status in Liquid and Standard Biopsies in Breast Cancer. Clin Chem. 2020 Aug 1;66(8):1093-1101. doi: 10.1093/clinchem/hvaa121.

publisher_dissemination: Oxford University Press

ReferenceCitation: Sinoquet L, Jacot W, Gauthier L, Pouderoux S, Viala M, Cayrefourcq L, Quantin X, Alix-Panabieres C. Programmed Cell Death Ligand 1-Expressing Circulating Tumor Cells: A New Prognostic Biomarker in Non-Small Cell Lung Cancer. Clin Chem. 2021 Nov 1;67(11):1503-1512. doi: 10.1093/clinchem/hvab131.

evidence: open (via crossref license)

unpaywall_oa_status: hybrid

ReferenceCitation: Alix-Panabieres C, Pantel K. Liquid Biopsy: From Discovery to Clinical Application. Cancer Discov. 2021 Apr;11(4):858-873. doi: 10.1158/2159-8290.CD-20-1311.

lead_sponsor: University Hospital, Montpellier


type: Other Identifier

title: Pulmonary Diffusion of Antibiotics During Mechanically Ventilated Pneumonia in Patients Admitted for ARDS Following SARS-CoV-2 Pneumonia

acronym: ATB-COVID

summary: Patients on mechanical ventilation (MV) following SARS-CoV-2 pneumonia frequently develop ventilator-associated pneumonia (VAP). The incidence of MVAP during SARS-CoV-2 infections ranges from 50 to nearly 90%. In addition, up to 80% of recurrences of VAP (a new episode, most often attributable to the same bacteria) have been described, reflecting the failure of the initial antibiotic therapy. This incidence is much higher than that described for other etiologies of acute respiratory distress syndrome (ARDS). The investigators hypothesize that during VAP, there is an alteration of the diffusion of intravenous antibiotics in the lung parenchyma in COVID-19 patients in relation to several factors characteristic of SARS-CoV-2 infection. This altered diffusion may explain the high number of recurrences of MVAP compared to non-COVID-19 patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique Hopitaux De Marseille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis.

acronym: IRMAA

summary:
Urinary bladder tumors with a frequency of 13000 new cases a year, have a heterogeneity in terms of survival according to the stage of local flooding.

This is an aggressive tumor because of the potential muscular infiltration. It seems important in this case (muscular invasion), to increase the global survival.

The anatomopathological analysis of the TURB (biopsy byTrans-Urethral Resection of the Bladder) is actually the gold standard for the pathology of bladder tumor.

No need an imaging to discuss about the small and non muscular invasive tumor. But in most cases, the use is to perform at last an ultrasound or a CT-Scan, specially for the invasive tumor.

A lot of studies show that CT SCAN. is not the best way of investigation for the bladder muscle invasion. However, as in the prostate cancer with the PIRADS Score, the MRI can be useful for the bladder, thanks to the sequence improvement to the machine.

The study from Panebianco 2018, starts to talk about the MRI in the urinary bladder cancer with new radiological terms. It creates a new score called VIRADS score (as the PIRADS score already used for the prostate cancer). But it is never compared with the results of the TURB.

Our study compares the results of the MRI pre operative versus the pathology results on prospective analysis.

Main objective : T tumoral score in urinary bladder tumor : MRI versus pathology results.

Secondary objectives : the contribution of diffusion weighted MRI in the bladder neoplasm.

Type of study : interventional study, prospective, mono centric, single arm, intent-to-treat

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test


title: Study by Electroencephalography of the Link Between the Lack of Self-compassion and the Disorder of Empathy in Schizophrenia

acronym: SCE-SCHIZO

summary:
This research project focuses on a fundamental element of the psychopathology of schizophrenia, that is to say, the disorders of self-awareness and on the functional alterations associated with it, that is to say, self-compassion deficit and empathy disorder.

It will be a question of better understanding the neuro-functional mechanisms which underlie the lack of self-compassion and the disorder of empathy in schizophrenia, the relationship that these disorders maintain between them but also the relationship that they maintain with the general psychopathology of schizophrenia and, in particular, with the abnormalities of the self. In other words, the overall framework of this project is that of the link between the psychopathology of schizophrenia and the functional impairment associated with it. Its specific field of application is that of the link between self-awareness disorders, self-compassion deficit and empathy disorder. For this, this project proposes a methodological approach combining the recording of intrinsic and extrinsic brain activity using high-density electroencephalography (EEG).

lead_sponsor: Centre Hospitalier Henri Laborit

intervention_type: Device


title: Role of Self-focused Attention in Depression

acronym: RFASD

summary: Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate that individuals suffering from depression focus their attention more on their reflection in the screen after recalling a failure (and this all the more so as their depressive symptomatology is strong) .

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

intervention_type: Behavioral

status_simplified: Completed


title: Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy

acronym: NARCOSPORT

summary: Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de médecine du sommeil et des maladies respiratoires


title: Evaluation of a Robotic Assistance Module for Driving Electric Wheelchairs Allowing the Avoidance of Positive and Negative Obstacles on the Driving Safety of Patients With Neurological Disorders.

acronym: SWADAPT 3

summary: The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: Pôle Saint Hélier

sponsor_collaborators:
Pôle Saint Hélier
INSA Rennes

lead_sponsor_type: industriel


title: Patient Education: Asthma and Pregnancy

acronym: TAPAGE

summary: Pregnancy may impact treatment adherence in women with asthma. This is a major risk factor for asthma exacerbation, which may have an important impact for both women and the babies. This study aims to evaluate the impact of a targeted patient education action tailored for pregnant women with asthma.

ipd_sharing: Undecided

lead_sponsor: CHU de Reims


title: Ex-vivo Examination of Excisions of Skin Tumors by Confocal Optical Coherence Tomography (LC-OCT) With Integrated Dermoscopy and Comparison With Histology (DERMOCTAV)

acronym: DERMOCTAV

summary: This project aims to validate ex vivo the use of the OCTAV® prototype integrating the "dermoscope" function before an in vivo application, by comparing images obtained by the OCTAV® prototype integrating the "dermoscope" function with the histological sections of a skin tumor excision corresponding to them exactly, at the same level.

status: Unknown status

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
European Clinical Trial Experts Network

intervention_type: Procedure

status_simplified: Unknown


title: Formation of a Patientheque in Patients With a Beginner Psychosis .

acronym: LONGIPEP

summary: Establishment of a patient library for patients who have had a first psychotic episode and who have an "at risk" status for psychotic disorder (GRD, APS, BLIPS group) or a psychosis threshold during CAARMS administration. Samples are taken on inclusion, at 2 years, and if relapse or significant clinical event within 5 years of inclusion, on 250 patients for 10 years.

primary_purpose: Basic Science

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension : PROTEO-CTEPH Study.

acronym: PROTEO-CTEPH

summary: Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) is a rare but severe complication of pulmonary embolism (PE). CTEPH is evoked in patients with persistent dyspnea. According to international guidelines, symptomatic patients with perfusion defects on lung scan and Pulmonary Hypertension (PH)-likely transthoracic echo (TTE) must be evaluated in Pulmonary Hypertension (PH)-centers with right heart catheterism, to confirm or rule out the presence of precapillary Pulmonary Hypertension (PH), and precise the group of Pulmonary Hypertension (PH).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Biological


title: Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

acronym: LSM

summary:
" Despite the medical and surgical progress of the last two decades, the selection of candidates for liver surgery remains based on old principles and insufficiently sensitive to fine-tune the gesture to patient-specific characteristics and make almost zero risks of postoperative liver failure (PLF) and death. It is therefore necessary to develop new tools that will make possible to predict the evolution of the postoperative portocaval gradient (difference of pressure between portal vein and vena cava), a well-known major risk factor for PLF. Hemodynamic modeling of the human liver during surgery will represent the purpose of this work in order to help the clinicians in their patient's selection and anticipation of postoperative risk.

The aim is to develop and validate an hemodynamics mathematical model to predict the evolution of the portocaval gradient in three surgical situations of increasing complexity: portal modulation by embolization, hepatectomy, and small partial graft liver transplantation.

The endpoints will be the estimation of the intraoperative post-procedural portocaval gradient and comparison of the estimated portocaval gradient with that measured at the end of the procedure. This pressure differential is performed before parietal closure, after surgery. "

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Institut National de Recherche en Informatique et en Automatique

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse


type: Registry Identifier

title: 3D Evaluation to Quantify Regional Volume Change Between FRC and TLC

summary: The aim of this study is first to validate an IC measurement using analysis of two 3D acquisitions, and to appreciate the inter-observer variability of this IC measurement between a trained technician of respiratory function analysis and a trained pulmonologist.

time_perspective: Retrospective

location_facility: Physiological/Respiratory functional exploration Department, Raymond Poincaré Hospital, APHP


title: Metrology to Enable Rapid and Accurate Clinical Measurements in Acute Management of Sepsis

acronym: SEPTIMET

summary:
Sepsis is a life-threatening condition that arises when a dysregulated response to infection results in multi-organ dysfunction or failure. This can affect any organ, resulting in a diverse clinical presentation. Sepsis affects more than 3.4 million Europeans a year with 700,000 deaths from the condition and an additional one third of survivors dying through complications in the year following a sepsis event.

To date, biomarkers that are used to predict bacterial infection (such as CRP or lactate) are used in combination and with other clinical symptoms due to the fact that they are non-specific for sepsis. The use of such biomarkers frequently varies between hospitals or even physicians. Biomarkers such as procalcitonin (PCT) have been reported as useful for differentiating between infectious and non-infectious causes of systemic inflammatory response syndrome. Yet calibration of PCT assays is problematic due to the absence of higher order method or international standard. External quality assessment (EQA) programs have highlighted poor comparability.

This protocol is part of the international SEPTIMET project. The Emergency Department (ED) of the Pitié-Salpêtrière hospital takes part of the project with specific objectives in order to establish a large cohort of patients at very early stage sepsis (defined by Systemic Inflammatory Response Syndrome -SIRS - due to bacterial infection or the first symptoms of sepsis before septic shock, patients consulting in the first hours of the history of the disease at the emergency department) with the idea of spotting the condition before it manifests as a more serious presentation. This will measure the clinical criteria and putative biomarkers as patients progress to more serious presentation. Moreover, an expected biobank of >200 samples will be generated to provide material for the Laboratoire National de Métrologie et d'essais (LNE) in charge of analytical studies.

location_facility: Pitié-Salpêtrière hospital / Emergency Department


title: Evaluation of the Effectiveness and Tolerance of Effaclar Ultra Concentrated Serum in Women With Mandibular Acne for 3 Months (Including 2 Months of Treatment)

summary:
The role of "dermocosmetics" in acne management is increasingly important, as many patients and even physicians now resort to them as first-line management in mild-to-moderate acne.

The aim of the study is to demonstrate the efficacy of the tested product on the appearance of acne lesions in 30 adult women suffering from acne in the mandible following an active anti-acne therapy (systemic or topical). This study includes 2 months of cosmetic treatment with EFFACLAR Ultra Concentrated Serum and one month of followup without any treatment but a moisturizer with a daily UV protection.

The investigational product has been formulated with an ultra-concentrated tri-acids complex for a synergetic action on skin and reinforced with soothing niacinamide for optimal tolerance.

This product is expected:

to leave the skin clean and smooth,
to help unblock pores,
to exfoliate dead skin cells and help the skin to appear smoother, softer and pore-less,
to be non-comedogenic.

primary_purpose: Treatment

lead_sponsor: Cosmetique Active International

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)


title: Quality of Colonoscopies Under Kalinox During the COVID 19 Epidemic

summary:
Feedback: during the COVID-19 epidemic, access to operating theaters was restricted so that anesthetists and nurse anesthetists could reinforce the resuscitation workforce.

The MEOPA was used as an alternative to sedation, allowing colonoscopies to be carried out, colon polyps and colorectal cancers to be detected.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Evaluation of the Relationship Between the Degree of Environmental Fungal Exposure in Patients' Dwellings and Clinical Symptoms of Patients With Chronic Obstructive Pulmonary Disease - Study of Feasibility

acronym: BPCO-Myc

summary:
Exposure to Aspergillus spores is associated with symptoms of asthma or airway inflammation (Chaudhary & Marr, 2011; Smith & Denning, 2011), leading to the possible onset of severe fungal complications with acute or chronic inflammation. In patients with chronic obstructive pulmonary disease (COPD), whose main etiological factor is cigarette smoke, A. fumigatus sensitization has been reported to be related to poor lung function (Bafadhel et al., 2014). Besides, COPD patients with fungal sensitization exhibit greater granulocyte count, implying more severe inflammation (Agarwal, Gaur, & Chowdhary, 2015). Fungal cultures from sputum are frequently positive in patients with asthma or with COPD (Pashley, 2014). Fungal colonization and infection have also been suspected to be related to exacerbations of COPD, but their potential role in the pathogenesis of COPD is poorly understood (Bafadhel et al., 2014). The hypothesis is that patients with COPD have a worsening of their pulmonary symptoms after exposure to fungal spores. This study will ensure the feasibility of quantifying environmental fungal exposure in patients' dwellings. For this, an electrostatic wipe will be deposited in the living room and another one in the bedroom for 12 weeks. The wipes will be analyzed by the mycology laboratory of the Croix Rousse hospital.

If the results of this first study are conclusive, it is planned to continue this analysis with a regional multicentre study.

location_facility: Service de Parasitologie et Mycologie médicale / Institut des Agents Infectieux, Hôpital de la Croix-Rousse, HCL


title: Impact of Acetabular Fractures on Sports Performance

acronym: Fracture&Sport

summary:
Acetabular fractures are complex, relatively rare lesions that are difficult to manage. Given the surgical challenge they represent, they are often managed by expert centers. The overall incidence of these fractures is around 3 fractures/100,000 persons/year.

It is now well established that the quality of the reduction obtained is an important predictive factor of the postoperative outcome in patients with displaced acetabular fractures. Obtaining an anatomical reduction, at least satisfactory, is not always easy, even in trained teams. Indeed, it can be difficult because of the structural environment. This is due to the proximity of the acetabulum to the vasculo-nervous elements, but also to the complexity of the fracture itself. The contribution of new technologies appear to be important tools to achieve this objective. Indeed, investigators have demonstrated that the use of the O-ARM imaging system (Medtronic®, Sofamor, Memphis, TN) allowed the improvement of their results.

Although they occur more frequently in the elderly population, the average incidence is maintained in the 20-59 age group. In these young populations, the fracture occurs most frequently as a result of a high-energy mechanism (road accident, more exceptionally, during a sporting activity). These patients, in the prime of their lives, are often athletic. The desire to resume sports after surgery is a powerful motivating factor for these patients. Often, it is the primary measure of surgical success from the athlete's perspective. In a previous work, Giannoudis et al. reported a 42% rate of return to activity at the previous level. The quality of the surgery is associated with the possibility of resuming sports activity after the procedure.

Thus, the objective of this work is to determine the results of acetabular surgery in a population of previously athletic patients, in particular the return to athletic performance.

ReferenceType: background

ReferenceCitation: Lundin N, Huttunen TT, Berg HE, Marcano A, Fellander-Tsai L, Enocson A. Increasing incidence of pelvic and acetabular fractures. A nationwide study of 87,308 fractures over a 16-year period in Sweden. Injury. 2021 Jun;52(6):1410-1417. doi: 10.1016/j.injury.2021.03.013. Epub 2021 Mar 14.

ReferenceCitation: Tannast M, Najibi S, Matta JM. Two to twenty-year survivorship of the hip in 810 patients with operatively treated acetabular fractures. J Bone Joint Surg Am. 2012 Sep 5;94(17):1559-67. doi: 10.2106/JBJS.K.00444.

ReferenceCitation: Giannoudis PV, Grotz MR, Papakostidis C, Dinopoulos H. Operative treatment of displaced fractures of the acetabulum. A meta-analysis. J Bone Joint Surg Br. 2005 Jan;87(1):2-9.

ReferenceCitation: Ziran N, Soles GLS, Matta JM. Outcomes after surgical treatment of acetabular fractures: a review. Patient Saf Surg. 2019 Mar 16;13:16. doi: 10.1186/s13037-019-0196-2. eCollection 2019.

ReferenceCitation: Rizkallah M, Sebaaly A, Melhem E, Moreau PE, Upex P, Jouffroy P, Riouallon G. Clinical impact of intraoperative cone beam tomography and navigation for displaced acetabular fractures: a comparative study at medium-term follow-up. Int Orthop. 2021 Jul;45(7):1837-1844. doi: 10.1007/s00264-021-05076-4. Epub 2021 May 22.

ReferenceCitation: Melhem E, Riouallon G, Habboubi K, Gabbas M, Jouffroy P. Epidemiology of pelvic and acetabular fractures in France. Orthop Traumatol Surg Res. 2020 Sep;106(5):831-839. doi: 10.1016/j.otsr.2019.11.019. Epub 2020 Feb 1.

ReferenceCitation: Doege J, Ayres JM, Mackay MJ, Tarakemeh A, Brown SM, Vopat BG, Mulcahey MK. Defining Return to Sport: A Systematic Review. Orthop J Sports Med. 2021 Jul 26;9(7):23259671211009589. doi: 10.1177/23259671211009589. eCollection 2021 Jul.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

summary: Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

lead_sponsor: Aridis Pharmaceuticals, Inc.

intervention_type: Drug


title: Evaluation of the Value of 18F-Fluoromisonidazole (18F-FMISO) Positron Emission Tomography Hypoxia Imaging in Idiopathic Pulmonary Fibrosis - A Non-randomized Proof-of-concept Study Comparing Patients With Idiopathic Pulmonary Fibrosis and Healthy Subjects

acronym: FIPOXY

summary:
Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, lethal disease of unknown etiology and with a variable course. There is currently no test in routine care that can assess both the anatomical and functional damage of the disease at an early stage. This is the first human study in IPF to evaluate the value of a non-invasive tracer, 18F-fluoromisonidazole (18F-FMISO), targeting hypoxia in IPF patients.

This is a Phase I, proof-of-concept, single-center, open-label, parallel group study.

It will include 2 groups:

1 group of 10 IPF patients
1 group of 10 healthy volunteers matched to IPF patients for age and gender

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Radiation


title: Construction and Validation of a Score Evaluating the Residual Instability of the Patient After Ankle Ligamentoplasty - Ankle Go Study

summary:
The goal of this prospective, open label study is the construction and the evaluation of a composite score evaluating the residual instability in patients who have undergone an ankle's ligamentoplasty (the Ankle Go Test score).

The main hypothesis of this study is based on the fact that the composite score "Ankle Go Test" would allow a global validation of all the criteria of scores of 4 tests and 2 questionnaires, which are performed in common pratice, evaluating the instability of the ankle after an ankle ligamentoplasty.

Participants will have to complete 2 questionnaires (FAAM, ALR RS) and to undergoe 4 tests (Single Leg Stance Test, Side Hop Test, Start Excursion Balance Test, La figure of 8), at 4, 6 and 12 months post surgery.

Researchers will compare the group of participants who undergone ankle's ligamentoplasty with a group of healthy volunteers to assess the discriminant validity of the Ankle Go Test score

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: Lopes R, Andrieu M, Cordier G, Molinier F, Benoist J, Colin F, Thes A, Elkaim M, Boniface O, Guillo S, Bauer T; French Arthroscopic Society. Arthroscopic treatment of chronic ankle instability: Prospective study of outcomes in 286 patients. Orthop Traumatol Surg Res. 2018 Dec;104(8S):S199-S205. doi: 10.1016/j.otsr.2018.09.005. Epub 2018 Sep 21.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Lopes R, Noailles T, Brulefert K, Geffroy L, Decante C. Anatomic validation of the lateral malleolus as a cutaneous marker for the distal insertion of the calcaneofibular ligament. Knee Surg Sports Traumatol Arthrosc. 2018 Mar;26(3):869-874. doi: 10.1007/s00167-016-4250-7. Epub 2016 Aug 6.

publisher_dissemination: Springer-Nature

ReferenceCitation: Jure D, Blache Y, Degot M, Vigne G, Nove-Josserand L, Godeneche A, Collotte P, Franger G, Borel F, Rogowski I, Neyton L. The S-STARTS Test: Validation of a Composite Test for the Assessment of Readiness to Return to Sport After Shoulder Stabilization Surgery. Sports Health. 2022 Mar-Apr;14(2):254-261. doi: 10.1177/19417381211004107. Epub 2021 Apr 9.

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 pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: SAGE Publications

ReferenceCitation: Blakeney WG, Ouanezar H, Rogowski I, Vigne G, Guen ML, Fayard JM, Thaunat M, Chambat P, Sonnery-Cottet B. Validation of a Composite Test for Assessment of Readiness for Return to Sports After Anterior Cruciate Ligament Reconstruction: The K-STARTS Test. Sports Health. 2018 Nov/Dec;10(6):515-522. doi: 10.1177/1941738118786454. Epub 2018 Jul 19.

oa_host_type: repository

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

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: green

ReferenceCitation: Carcia CR, Martin RL, Drouin JM. Validity of the Foot and Ankle Ability Measure in athletes with chronic ankle instability. J Athl Train. 2008 Apr-Jun;43(2):179-83. doi: 10.4085/1062-6050-43.2.179.

ReferenceCitation: Borloz S, Crevoisier X, Deriaz O, Ballabeni P, Martin RL, Luthi F. Evidence for validity and reliability of a French version of the FAAM. BMC Musculoskelet Disord. 2011 Feb 8;12:40. doi: 10.1186/1471-2474-12-40.

ReferenceCitation: Docherty CL, Arnold BL, Gansneder BM, Hurwitz S, Gieck J. Functional-Performance Deficits in Volunteers With Functional Ankle Instability. J Athl Train. 2005 Mar;40(1):30-34.

ReferenceCitation: Franck F, Saithna A, Vieira TD, Pioger C, Vigne G, Le Guen M, Rogowski I, Fayard JM, Thaunat M, Sonnery-Cottet B. Return to Sport Composite Test After Anterior Cruciate Ligament Reconstruction (K-STARTS): Factors Affecting Return to Sport Test Score in a Retrospective Analysis of 676 Patients. Sports Health. 2021 Jul-Aug;13(4):364-372. doi: 10.1177/1941738120978240. Epub 2021 Feb 6.

ReferenceCitation: Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.

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

repository_institution: University of Oxford - Oxford Academic Notes & Queries

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: Loughborough University - Loughborough University Institutional Repository

repository_institution: Radboud University - Radboud Repository

version: submittedVersion

publisher_dissemination: Journal of Orthopaedic & Sports Physical Therapy (JOSPT)

ReferenceCitation: Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.

ReferenceCitation: Rosen AB, Needle AR, Ko J. Ability of Functional Performance Tests to Identify Individuals With Chronic Ankle Instability: A Systematic Review With Meta-Analysis. Clin J Sport Med. 2019 Nov;29(6):509-522. doi: 10.1097/JSM.0000000000000535.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Sigonney F, Lopes R, Bouche PA, Kierszbaum E, Moslemi A, Anract P, Stein A, Hardy A. The ankle ligament reconstruction-return to sport after injury (ALR-RSI) is a valid and reproducible scale to quantify psychological readiness before returning to sport after ankle ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2020 Dec;28(12):4003-4010. doi: 10.1007/s00167-020-06020-6. Epub 2020 Apr 30.

oa_colors: green hybrid

license: cc-by

license_normalized: cc-by


title: Effectiveness in Real Life of the Insulia® Digital Tool in Patients With Type 2 Diabetes Treated With Basal Insulin Therapy as Part of a National Telemedicine Program (ETAPES)

acronym: INSULIA

summary:
The purpose of this study was to evaluate the INSULIA digital tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) in a single-center study.

The assumption is that a better metabolic control with this tool.


title: Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers. Single-center, Prospective, Not-controlled, Not-randomized, Open-label Study.

acronym: DEGLUTITION

summary: The objective of this study is to show the feasibility of detecting the specific activity of 2 muscles during swallowing using invasive sensors in healthy volunteers.

lead_sponsor: University Hospital, Grenoble

collaborators: Clinical Investigation Centre for Innovative Technology Network


title: Prevention of Fall Injury in Military Settings Through the Use of Body Awareness.

acronym: POSITION

summary: The POSITION project aims to investigate the cognitive mechanism of postural body awareness as a risk factor for injury and as a target for a primary prevention strategy based on the Resource Optimization of Armed Forces (ROAF) method.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children

acronym: PREMILOCAP

summary:
The risk of Arterial Hypertension (HTA) is increased in very premature infants and hydrocortisone administered in the neonatal period could modify this risk.

The main objective is to assess whether the administration of hydrocortisone in the perinatal period in children born prematurely is associated with an increase in Pulse Wave Velocity (PWV) by comparing the future of children included in the PREMILOC trial (hydrocortisone versus placebo) at the age of 7-13 years. The primary endpoint will be the carotid-femoral pulse wave velocity in m/s.


title: Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias

acronym: PROVIDENCE

summary: Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. The pathogens responsible are multiple, but enterobacteria constitute a major source of pathogens involved. Within this family, Klebsiella spp. and Escherichia coli are the two most frequent genera, with Klebsiella spp. often present in severe forms. The factors associated with the occurrence of Ventilator-associated pneumonia and its adverse course depend on host defenses and the virulence of the pathogen. The virulence of Klebsiella spp. depends on several structures, notably the presence of a capsule, the particularities of its lipopolysaccharide, its adhesins (type 3 fimbriae), its capacity to capture iron (siderophores). The objective of this work is to evaluate the role of these different virulence mechanisms in the evolution of Ventilator-associated pneumonia and the hospital prognosis.

ReferenceCitation: Bouadma L, Sonneville R, Garrouste-Orgeas M, Darmon M, Souweine B, Voiriot G, Kallel H, Schwebel C, Goldgran-Toledano D, Dumenil AS, Argaud L, Ruckly S, Jamali S, Planquette B, Adrie C, Lucet JC, Azoulay E, Timsit JF; OUTCOMEREA Study Group. Ventilator-Associated Events: Prevalence, Outcome, and Relationship With Ventilator-Associated Pneumonia. Crit Care Med. 2015 Sep;43(9):1798-806. doi: 10.1097/CCM.0000000000001091.

ReferenceCitation: Wang Y, Eldridge N, Metersky ML, Verzier NR, Meehan TP, Pandolfi MM, Foody JM, Ho SY, Galusha D, Kliman RE, Sonnenfeld N, Krumholz HM, Battles J. National trends in patient safety for four common conditions, 2005-2011. N Engl J Med. 2014 Jan 23;370(4):341-51. doi: 10.1056/NEJMsa1300991.

ReferenceCitation: Damas P, Layios N, Seidel L, Nys M, Melin P, Ledoux D. Severity of ICU-acquired pneumonia according to infectious microorganisms. Intensive Care Med. 2011 Jul;37(7):1128-35. doi: 10.1007/s00134-011-2255-8. Epub 2011 May 26.

ReferenceCitation: Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.

ReferenceCitation: Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078.

ReferenceCitation: Berra L, Panigada M, De Marchi L, Greco G, Z -Xi Y, Baccarelli A, Pohlmann J, Costello KF, Appleton J, Mahar R, Lewandowski R, Ravitz L, Kolobow T. New approaches for the prevention of airway infection in ventilated patients. Lessons learned from laboratory animal studies at the National Institutes of Health. Minerva Anestesiol. 2003 May;69(5):342-7.

ReferenceCitation: Crnich CJ, Safdar N, Maki DG. The role of the intensive care unit environment in the pathogenesis and prevention of ventilator-associated pneumonia. Respir Care. 2005 Jun;50(6):813-36; discussion 836-8.


title: Impact of Postoperative Transitional Pain on Recovery After Thoracic Surgery

acronym: TRANSAT

summary: Postoperative transitional pain corresponds to the pain occuring between acute postoperative pain and chronic postsurgical pain (defined as pain persisting for at least 3 months after surgery). We hypothesized that both trajectory and neuropathic component of transitional pain may influence the quality of recovery after thoracic surgery. To test this, we designed an observational study to identify risk factors for incomplete recovery assessed through the QoR-15 questionnaire.

lead_sponsor: University Hospital, Angers


title: DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial

acronym: DEROTOX

summary: The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.

ReferenceCitation: Badley EM, Tennant A. Changing profile of joint disorders with age: findings from a postal survey of the population of Calderdale, West Yorkshire, United Kingdom. Ann Rheum Dis. 1992 Mar;51(3):366-71. doi: 10.1136/ard.51.3.366.

ReferenceCitation: van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. doi: 10.1053/berh.1999.0021.

ReferenceCitation: Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.

ReferenceCitation: Bot SD, van der Waal JM, Terwee CB, van der Windt DA, Schellevis FG, Bouter LM, Dekker J. Incidence and prevalence of complaints of the neck and upper extremity in general practice. Ann Rheum Dis. 2005 Jan;64(1):118-23. doi: 10.1136/ard.2003.019349.

ReferenceCitation: Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, Carr A. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology (Oxford). 2006 Feb;45(2):215-21. doi: 10.1093/rheumatology/kei139. Epub 2005 Nov 1.

ReferenceCitation: Hartvigsen J, Davidsen M, Hestbaek L, Sogaard K, Roos EM. Patterns of musculoskeletal pain in the population: a latent class analysis using a nationally representative interviewer-based survey of 4817 Danes. Eur J Pain. 2013 Mar;17(3):452-60. doi: 10.1002/j.1532-2149.2012.00225.x. Epub 2012 Oct 5.

ReferenceCitation: Peters D, Davies P, Pietroni P. Musculoskeletal clinic in general practice: study of one year's referrals. Br J Gen Pract. 1994 Jan;44(378):25-9.

ReferenceCitation: van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.

ReferenceCitation: Vecchio P, Kavanagh R, Hazleman BL, King RH. Shoulder pain in a community-based rheumatology clinic. Br J Rheumatol. 1995 May;34(5):440-2. doi: 10.1093/rheumatology/34.5.440.

ReferenceCitation: Gartsman GM, Brinker MR, Khan M, Karahan M. Self-assessment of general health status in patients with five common shoulder conditions. J Shoulder Elbow Surg. 1998 May-Jun;7(3):228-37. doi: 10.1016/s1058-2746(98)90050-7.

ReferenceCitation: Ostor AJ, Richards CA, Prevost AT, Speed CA, Hazleman BL. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Rheumatology (Oxford). 2005 Jun;44(6):800-5. doi: 10.1093/rheumatology/keh598. Epub 2005 Mar 15.

ReferenceCitation: Tekavec E, Joud A, Rittner R, Mikoczy Z, Nordander C, Petersson IF, Englund M. Population-based consultation patterns in patients with shoulder pain diagnoses. BMC Musculoskelet Disord. 2012 Nov 29;13:238. doi: 10.1186/1471-2474-13-238.

ReferenceCitation: Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.

ReferenceCitation: Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.

ReferenceCitation: Wilson d'Almeida K, Godard C, Leclerc A, Lahon G. Sickness absence for upper limb disorders in a French company. Occup Med (Lond). 2008 Oct;58(7):506-8. doi: 10.1093/occmed/kqn084. Epub 2008 Jun 27.

ReferenceCitation: Benson RT, McDonnell SM, Knowles HJ, Rees JL, Carr AJ, Hulley PA. Tendinopathy and tears of the rotator cuff are associated with hypoxia and apoptosis. J Bone Joint Surg Br. 2010 Mar;92(3):448-53. doi: 10.1302/0301-620X.92B3.23074.

ReferenceCitation: Millar NL, Reilly JH, Kerr SC, Campbell AL, Little KJ, Leach WJ, Rooney BP, Murrell GA, McInnes IB. Hypoxia: a critical regulator of early human tendinopathy. Ann Rheum Dis. 2012 Feb;71(2):302-10. doi: 10.1136/ard.2011.154229. Epub 2011 Oct 4.

ReferenceCitation: Yamaguchi K, Tetro AM, Blam O, Evanoff BA, Teefey SA, Middleton WD. Natural history of asymptomatic rotator cuff tears: a longitudinal analysis of asymptomatic tears detected sonographically. J Shoulder Elbow Surg. 2001 May-Jun;10(3):199-203. doi: 10.1067/mse.2001.113086.

ReferenceCitation: Beaudreuil J, Dhenain M, Coudane H, Mlika-Cabanne N. Clinical practice guidelines for the surgical management of rotator cuff tears in adults. Orthop Traumatol Surg Res. 2010 Apr;96(2):175-9. doi: 10.1016/j.otsr.2010.02.002.

ReferenceCitation: Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.

ReferenceCitation: Placzek R, Drescher W, Deuretzbacher G, Hempfing A, Meiss AL. Treatment of chronic radial epicondylitis with botulinum toxin A. A double-blind, placebo-controlled, randomized multicenter study. J Bone Joint Surg Am. 2007 Feb;89(2):255-60. doi: 10.2106/JBJS.F.00401.

ReferenceCitation: Wuelker N, Schmotzer H, Thren K, Korell M. Translation of the glenohumeral joint with simulated active elevation. Clin Orthop Relat Res. 1994 Dec;(309):193-200.

ReferenceCitation: Collin P, Matsumura N, Ladermann A, Denard PJ, Walch G. Relationship between massive chronic rotator cuff tear pattern and loss of active shoulder range of motion. J Shoulder Elbow Surg. 2014 Aug;23(8):1195-202. doi: 10.1016/j.jse.2013.11.019. Epub 2014 Jan 14.

ReferenceCitation: Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.

ReferenceCitation: Jobe FW, Moynes DR. Delineation of diagnostic criteria and a rehabilitation program for rotator cuff injuries. Am J Sports Med. 1982 Nov-Dec;10(6):336-9. doi: 10.1177/036354658201000602.

ReferenceCitation: Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Merz Pharmaceuticals GmbH


title: Chest and Abdominal Compression Versus PROne Position

summary:
Acute respiratory distress syndrome (ARDS) is a severe pulmonary insult responsible for major, life-threatening hypoxemia. The alteration of hematosis is secondary to alveolar edema, following damage to the alveolocapillary barrier in response to a systemic inflammatory process. The presence of fluid effusion within the alveolar sacs and the modification of type II pneumocyte activity due to the presence of numerous pro-inflammatory mediators will lead to a quantitative and qualitative alteration of the surfactant. At the same time, leukocyte infiltration will lead to an alteration of the support tissue and to the accumulation of cellular debris. All these elements will lead to a heterogeneous loss of aeration of the lung. In addition, the alveolar units are compressed by the entire lung parenchyma due to the effect of gravity on the edematous tissue.

The treatment of ARDS is based on the antagonistic need to maintain hematosis and reduce parenchymal insult secondary to mechanical ventilation. Optimization of mechanical ventilation consists in reducing the volume of gas administered at each respiratory cycle and in limiting thoracic parietal stress by the use of curares. More recently, the interest of the ventral decubitus position has been demonstrated. During such a maneuver, the posterior pulmonary parenchymatous zones, usually subjected to gravity in the supine position, will be able to re-expand under the effect of the prone position and of the positive pressure induced by the ventilator. The increase in parietal elastance, due to the compression of the thorax between the posterior part of the trunk and the bed, also contributes to an improvement in the distribution of inhaled gases within the pulmonary parenchyma by limiting the loss of energy, transmitted directly to the wall. The ventral decubitus position allows to redistribute the ventilation in territories which were not aired before but which participate to the respiratory exchanges because they are still perfused and thus to improve the pulmonary compliance measured.

Although described as an atypical form, SARS-CoV-2 infection can lead to ARDS with severe forms of viral pneumonia and thus require prone positioning.

While this results in improved oxygenation and compliance, prone positioning is accompanied by a risk of complications such as pressure sores, described as the most frequent. In addition, the massive influx of patients and more generally the lack of personnel during pandemic peaks has made the application of prone position sometimes complex because it requires human resources. As a result, the benefit/risk ratio of the maneuver is difficult to determine because not all patients respond in the same way to prone positioning. It appeared essential to be able to predict the expected benefit of the prone position before performing the procubitus maneuver.

The application of thoracic and abdominal pressures, as part of the respiratory management of patients, is a technique commonly used by physiotherapists. Investigators have demonstrated a similar change in measured lung parenchymal compliance during manual compression of a patient's chest and during prone positioning. In the context of the epidemic, investigators used this test systematically to determine which patients were most likely to benefit from prone positioning and for whom the available resources should be concentrated at any given time.

ReferenceCitation: Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.

ReferenceCitation: Villar J. What is the acute respiratory distress syndrome? Respir Care. 2011 Oct;56(10):1539-45. doi: 10.4187/respcare.01395.

ReferenceCitation: Fan E, Brodie D, Slutsky AS. Acute Respiratory Distress Syndrome: Advances in Diagnosis and Treatment. JAMA. 2018 Feb 20;319(7):698-710. doi: 10.1001/jama.2017.21907.

ReferenceCitation: Munshi L, Del Sorbo L, Adhikari NKJ, Hodgson CL, Wunsch H, Meade MO, Uleryk E, Mancebo J, Pesenti A, Ranieri VM, Fan E. Prone Position for Acute Respiratory Distress Syndrome. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2017 Oct;14(Supplement_4):S280-S288. doi: 10.1513/AnnalsATS.201704-343OT.

ReferenceCitation: Tirolien JA, Garnier M. [COVID-19, an atypical acute respiratory distress syndrome]. Prat Anesth Reanim. 2020 Sep;24(4):225-229. doi: 10.1016/j.pratan.2020.07.001. Epub 2020 Jul 10. French.

ReferenceCitation: Borges LF, Saraiva MS, Saraiva MAS, Macagnan FE, Kessler A. Expiratory rib cage compression in mechanically ventilated adults: systematic review with meta-analysis. Rev Bras Ter Intensiva. 2017 Jan-Mar;29(1):96-104. doi: 10.5935/0103-507X.20170014.


title: Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study

acronym: ETADOL

summary:
The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place.

Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period.

In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.

ReferenceCitation: Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.

ReferenceCitation: Sullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Efficacy of a Low FODMAP Diet According to Colonic pH Measured by Wireless Motility Capsule in Irritable Bowel Syndrome Patients

acronym: FOSIIL

summary:
Treatments efficacy in irritable bowel syndrome (IBS) patients is inconstant and predictive factors of their efficacy are needed. The role of dysbiosis in IBS is well-known. Another way to identify microbiota differences is to assess its metabolic activity. It has been demonstrated that colonic pH in IBS patients is lower than in healthy volunteers, reflecting a highest colonic fermentation. Colonic acidification is able to sensitize colonic mechano-receptors to distension. Microbiota profile is able to predict the response to a low Fermentable Oligo, Di, Monosaccharides And Polyols (FODMAPs) diet, but is not available in clinical routine.

The aim of our study is to assess the link between colonic fermentation (measured by colonic pH) and the efficacy of a low FODMAPs diet in IBS patients (measured by IBS severity scoring system (IBS-SSS)). We hypothesis that IBS patients with a lower colonic pH will have a better efficacy of the low FODMAPs diet. It might allow in the future personalized medicine.

50 IBS patients according to Rome IV criteria will be included in our study. All patients will have a measure of their colonic pH by wireless motility capsule. Patients will follow a low FODMAPs diet for 6 weeks after an education by a trained dietician. All participants will fill validated questionnaires before and after 6 weeks of low FODMAPs diet: IBS-SSS, Gastro Intestinal Quality of Life Index (GIQLI), Hospital Anxiety and Depression (HAD) scale. Microbiota, metabolomic and short chain fatty acid will be analysed before and after the intervention. The number of patients was calculated to assess the correlation between colonic pH and the variation of IBS-SSS before and after the intervention.

ipd_sharing_description: upon request

lead_sponsor: University Hospital, Rouen

intervention_type: Dietary Supplement


title: Pilot Clinical Investigation of Adaptive Eyeglasses for the Correction of Presbyopia

summary: This study is a pilot clinical investigation of adaptive eyeglasses for the correction of presbyopia. The goal of this clinical investigation is to assess IMD safety and to obtain patient feedback on the usefulness of the Laclarée eyeglasses, through subjective clinical measures and qualitative evaluations. This is an exploratory investigation.

primary_purpose: Supportive Care

ipd_sharing_description: Not planned

lead_sponsor: Laclaree

sponsor_collaborators:
Laclaree
Iris Pharma

location_facility: CHU Saint-Etienne Hôpital Nord, Service d'Ophtalmologie 25, boulevard Pasteur


title: Optimization of Sequences to Improve the Quality and Comfort of the Magnetic Resonance Imaging Examination

acronym: OPTIM

summary: The people included will carry out an MRI comprising the sequence currently used in routine care and the different variants of the sequence being tested, for the optimization of the parameters. The duration of the examination (or the extension of the examination planned as part of patient care) will be from a few minutes to an hour depending on the sequences to be optimized. Subjects who agree to research for more than 30 minutes in the MRI machine will be compensated with a multi-brand gift voucher worth 30 euros.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

acronym: APOLLO

summary: The objective of APOLLO is therefore to identify biomarkers associated with the CNS involvement phenotype in early MS patients.

lead_sponsor: Rennes University Hospital


title: The Diagnostic Observatory: Combating Diagnostic Wandering and Impasse Within the AnDDI-Rares Network

acronym: Obs du Diag

summary:
The Direction Générale de l'Organisation des Soins (DGOS) and the Banque Nationale de Données Maladies Rares (BNDMR) have launched a call for a letter of commitment for the implementation of a diagnostic observatory in order to fight against diagnostic wandering and impasse. In this context, the AnDDI-Rares network proposes 3 work packages (WP) to respond to the missions entrusted to it.

Work package 1 of the diagnostic observatory includes a retrospective and prospective study to evaluate how diagnostic wandering and impasse has evolved within the network, with regard to the integration of new technologies, and the expectations of patients and their families.

Work package 2 of the diagnostic observatory includes a reassessment of sporadic copy number variations (CNV) of unknown significance of more than 1 Mb obtained since the beginning of CGH array analyses in the territory.

Work package 3 of the diagnostic observatory aims to help put an end to diagnostic wandering for patients with certain emblematic syndromes by proposing genome and RNA analysis, which provides a certain diagnosis and negative targeted molecular study.


title: Impact of Sarcopenia on Post-operative Course for Cancer Patients Operated of Colorectal Surgery Using a Simple Measurement Method of the Psoas Muscle Surface Area

acronym: ISEPAM

summary: The purpose of this study is to compare the post-operative course in patients suffering from sarcopenia who had colorectal surgery for cancer. Our primary outcome is the comparaison of the length of hospital stay in sarcopenic and non sarcopenic patients.

ReferenceCitation: Wing JS, Brender JD, Sanderson LM, Perrotta DM, Beauchamp RA. Acute health effects in a community after a release of hydrofluoric acid. Arch Environ Health. 1991 May-Jun;46(3):155-60. doi: 10.1080/00039896.1991.9937443.

ReferenceCitation: Langdon RB, Freeman JA. Pharmacology of retinotectal transmission in the goldfish: effects of nicotinic ligands, strychnine, and kynurenic acid. J Neurosci. 1987 Mar;7(3):760-73. doi: 10.1523/JNEUROSCI.07-03-00760.1987.

ReferenceCitation: Raab W. [Occupational dermatoses: clinical picture, noxious compounds, prevention]. Wien Med Wochenschr. 1989 Nov 30;139(22):515-8. German.

ReferenceCitation: Miyagi K, Koh CS, Inoue A, Tsukada N, Yanagisawa N. [A case of dysthyroid ophthalmopathy with chronic thyroiditis and anti-extraocular muscle antibody]. Rinsho Shinkeigaku. 1988 Apr;28(4):396-400. No abstract available. Japanese.

lead_sponsor: Hôpital NOVO


summary:
The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in cord blood.

The main objective is to demonstrate that Letermovir administered to women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir.

In each group , the proportion of asymptomatic neonates and the number and type of long-term sequelae at 2 years will also be assessed and compared.

title: Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir (Step 2)

type: EudraCT Number

source: euctr


title: Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis

acronym: CiGal-EI-TEP

summary: CiGal-EI-TEP is an exploratory study that aim to assess the diagnostic performance of 68Ga Positron emission tomography (PET) / Computed Tomography (CT) for the diagnosis of prosthetic valve infective endocarditis in comparison with the final diagnosis established according to the ESC 2015 criteria, after 3 months of follow-up, by a panel of experts.

lead_sponsor: University Hospital, Bordeaux


title: Comparison of a Low Dose to a Standard Dose of Insulin in Adult Diabetic Ketoacidosis in ICU to Reduce Metabolic Complications : a Randomized, Controlled Study

acronym: LOSTINDIAB

summary:
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss).

Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more a matter of insulin resistance than an absolute deficiency. However, international guidelines recommend a similar dose of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.

During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.

The research hypothesis is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: LOSTINDIAB

titre: Comparaison d'une faible dose à une dose standard d'insulinothérapie dans l'acidocétose diabétique de l'adulte en réanimation et unité de surveillance continue pour diminuer les complications métaboliques : un essai contrôlé randomisé

discipline_principale: autre

nom_porteur: ROUX

prenom_porteur: Damien


title: Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication

acronym: PTHVarus

summary: The objective of this study is to compare the long-term survival as well as the functional and radiographic results of the rods in the alignment of the varus to the stems in the neutral alignment by comparing 2 groups of implanted Total Hip Arthroplasty. 1 group of stems implanted in varus position. 1 group of stems implanted in neutral position

ReferenceCitation: Batailler C, Fary C, Servien E, Lustig S. Influence of femoral broach shape on stem alignment using anterior approach for total hip arthroplasty: A radiologic comparative study of 3 different stems. PLoS One. 2018 Oct 5;13(10):e0204591. doi: 10.1371/journal.pone.0204591. eCollection 2018.

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_normalized: HAL

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

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

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

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Murphy CG, Bonnin MP, Desbiolles AH, Carrillon Y, Asmall yi, Ukrainiant Si Selmi T. Varus will have varus; a radiological study to assess and predict varus stem placement in uncemented femoral stems. Hip Int. 2016 Nov 10;26(6):554-560. doi: 10.5301/hipint.5000412. Epub 2016 Oct 15.

ReferenceCitation: Fottner A, Woiczinski M, Kistler M, Schroder C, Schmidutz TF, Jansson V, Schmidutz F. Varus malalignment of cementless hip stems provides sufficient primary stability but highly increases distal strain distribution. Clin Biomech (Bristol, Avon). 2018 Oct;58:14-20. doi: 10.1016/j.clinbiomech.2018.07.006. Epub 2018 Jul 5.

lead_sponsor: University Hospital, Brest


title: Protective Effect Assessment Foto Ultra Isdin Solar Allergy Fusion Fluid (Isdin, s.a.) on the Ultraviolet A Induced Polymorphic Light Eruption

summary:
The primary objective of this Clinical Investigation was to assess the protective efficacy of a medical device (FOTO ULTRA ISDIN® SOLAR ALLERGY FUSION FLUID) against the polymorphic light eruption induced by the UVA.

The secondary objective of this Clinical Investigation was to assess the local safety and the overall tolerability of the test MD on the basis of AE/SAE reporting.

ReferenceType: derived

ReferenceCitation: Duteil L, Queille-Roussel C, Aladren S, Bustos X, Trullas C, Granger C, Krutmann J, Passeron T. Prevention of Polymorphic Light Eruption Afforded by a Very High Broad-Spectrum Protection Sunscreen Containing Ectoin. Dermatol Ther (Heidelb). 2022 Jul;12(7):1603-1613. doi: 10.1007/s13555-022-00755-5. Epub 2022 Jun 18.

license: cc-by-nc

license_normalized: cc-by-nc

ipd_sharing_description: No plan to make individual participant data (IPD) available to other researchers

lead_sponsor: Centre de Pharmacologie Clinique Applique a la Dermatologie


title: Toxicological Analysis in Chemical Submission

acronym: TANCS

summary: The purpose of this study is to carry out a systematic toxicological analysis of all the patients, examined at the UMJ of the Hôtel-Dieu following a complaint for suspected chemical submission. By comparing the toxicological data with the clinical examination data (e.g. treatment intake), the investigators could determine the number of confirmed chemical submissions and the substances involved.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Sarcopenia and Short Bowel Syndrome: the Microbiota-gut-muscle Axis

acronym: SARCO-SGC

summary: Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. An overabundance of fecal Lactobacillus was found but not yet linked to adaptation or sarcopenia. The objectives are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS.

location_facility: Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière


title: TULIP et MASC : Premiers Usages

acronym: TEMPUS

summary:
The aim of this work is to propose two new questionnaires (TULIP and MASC) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up.

The TULIP questionnaire aims to characterize the symptoms suggestive of Thoracic Outlet Syndrome (TOS). The MASC questionnaire aims to assess the functional maintenance of TOS in a simpler way (fewer questions) than the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and in a lateralized way.


title: Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

acronym: HIATUS

summary: The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.

ReferenceCitation: Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.

ReferenceCitation: Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636.

ReferenceCitation: Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.

location_facility: Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP


title: Assessing Women's Preferences for Postpartum Thromboprophylaxis: the PREFER-PostPartum

acronym: PREFER-PP

summary:
The risk of venous thromboembolism (VTE), which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE), increases during pregnancy and most strikingly in the postpartum period (6 weeks after delivery). Extensive research efforts have led to the identification of many risk factors for VTE events. Examples of such factors include maternal characteristics (personal history of VTE, thrombophilia, obesity, race) and obstetrical characteristics (methods of delivery, pre-term delivery, growth retardation). These allow care providers to risk stratify women at the time of delivery into low, moderate and high-risk women, based on experts' opinion. Further, a risk score, which was recently developed and validated on English and Swedish populations, estimates the risk of postpartum VTE in individuals.

Thromboprophylaxis (TPX) focuses on the use of short-term low-molecular-weight heparin (LMWH). LMWH is believed to reduce the risk of VTE by 50-70%, but the evidence is indirect, with a lack of large-scale randomized trial in the setting of the postpartum period. Further, LMWH is both inconvenient (subcutaneous injections) and possibly associated with haemorrhagic side effects. Alternative drugs do not exist, because direct oral anticoagulants (DOAC) and aspirin are not studied in this setting and because DOAC are contra-indicated in pregnancy and breastfeeding.

Given the unclear balance of benefits and risks, current guidelines vary greatly in the proportion of women with recommended TPX. Gassmann et al. have recently demonstrated, among a cohort of parturients at the Geneva University Hospitals: a recommendation of postpartum TPX in 40.1% of women, with an estimated mean risk of postpartum VTE of 0.12%, according to the 2015 UK guidelines (RCOG), and a recommendation of postpartum TPX in 8.7% of women, with an estimated mean risk of postpartum VTE of 0.20%, according to the 2018 US guidance (ACOG).These low risks of VTE to trigger a recommendation of TPX use contrast with that of experts' opinions, which advocate for a threshold of VTE risk of 1-3% to recommend the use of TPX. Currently, all women delivering by C-section in Geneva receive TPX regardless of their VTE risk.

This dramatic discrepancy of TPX guidance between guidelines, and between guidelines and individual experts, highlights the uncertainty in this setting. Womens' preferences would be critically important here, to guide a rationale and desired use of TPX. Quite surprisingly, such preferences have never been elicited, in spite of the very large number of births every year (5 and 4 million in Europe and the US, respectively).

To inform prescription patterns of postpartum TPX, investigators propose to conduct this prospective study to elicit values and preferences of pregnant and postpartum women.

ReferenceCitation: Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31.

ReferenceCitation: Blondon M, Quon BS, Harrington LB, Bounameaux H, Smith NL. Association between newborn birth weight and the risk of postpartum maternal venous thromboembolism: a population-based case-control study. Circulation. 2015 Apr 28;131(17):1471-6; discussion 1476. doi: 10.1161/CIRCULATIONAHA.114.012749. Epub 2015 Mar 5.

ReferenceCitation: Blondon M, Harrington LB, Boehlen F, Robert-Ebadi H, Righini M, Smith NL. Pre-pregnancy BMI, delivery BMI, gestational weight gain and the risk of postpartum venous thrombosis. Thromb Res. 2016 Sep;145:151-6. doi: 10.1016/j.thromres.2016.06.026. Epub 2016 Jun 24.

ReferenceCitation: Sultan AA, West J, Grainge MJ, Riley RD, Tata LJ, Stephansson O, Fleming KM, Nelson-Piercy C, Ludvigsson JF. Development and validation of risk prediction model for venous thromboembolism in postpartum women: multinational cohort study. BMJ. 2016 Dec 5;355:i6253. doi: 10.1136/bmj.i6253.

ReferenceCitation: Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.

ReferenceCitation: Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.

ReferenceCitation: Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.


title: Comparison of the Effects of Two Concentrations of Adrenaline (0.33 mg/l vs 1 mg/l) in the Irrigation Serum of Arthroscopic Shoulder Surgery.

acronym: PINHAR

summary:
The addition of adrenaline to the arthroscopic irrigation serum is used during rotator cuff surgery to limit intraoperative bleeding and ensure a clear view. Two concentrations of adrenaline are commonly used in practice: 1mg/L or 0.33 mg/L.

The aim of this study is to determine which of these two doses provides better clarity of the surgical field with less impact on the patient's cardiovascular parameters.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Incidence of Weaning-induced Pulmonary Oedema (The WIPO Study)

acronym: WIPO

summary: During weaning from mechanical ventilation, the shift from positive to negative pressure ventilation may be responsible for a cardiac dysfunction that can lead to the development of pulmonary oedema (weaning-induced pulmonary oedema, WIPO) and to the failure of spontaneous breathing trials. However, the incidence and risk factors for WIPO development are not well defined and have been investigated only by a few studies.

ReferenceCitation: Dres M, Teboul JL, Monnet X. Weaning the cardiac patient from mechanical ventilation. Curr Opin Crit Care. 2014 Oct;20(5):493-8. doi: 10.1097/MCC.0000000000000131.

ReferenceCitation: Teboul JL. Weaning-induced cardiac dysfunction: where are we today? Intensive Care Med. 2014 Aug;40(8):1069-79. doi: 10.1007/s00134-014-3334-4. Epub 2014 May 27.

publisher_dissemination: Springer

ReferenceCitation: Lemaire F, Teboul JL, Cinotti L, Giotto G, Abrouk F, Steg G, Macquin-Mavier I, Zapol WM. Acute left ventricular dysfunction during unsuccessful weaning from mechanical ventilation. Anesthesiology. 1988 Aug;69(2):171-9. doi: 10.1097/00000542-198808000-00004.

ReferenceCitation: Liu J, Shen F, Teboul JL, Anguel N, Beurton A, Bezaz N, Richard C, Monnet X. Cardiac dysfunction induced by weaning from mechanical ventilation: incidence, risk factors, and effects of fluid removal. Crit Care. 2016 Nov 12;20(1):369. doi: 10.1186/s13054-016-1533-9. Erratum In: Crit Care. 2017 Mar 8;21(1):50.

ReferenceCitation: Lamia B, Maizel J, Ochagavia A, Chemla D, Osman D, Richard C, Teboul JL. Echocardiographic diagnosis of pulmonary artery occlusion pressure elevation during weaning from mechanical ventilation. Crit Care Med. 2009 May;37(5):1696-701. doi: 10.1097/CCM.0b013e31819f13d0. Erratum In: Crit Care Med. 2009 Jul;37(7):2331.

ReferenceCitation: Grasso S, Leone A, De Michele M, Anaclerio R, Cafarelli A, Ancona G, Stripoli T, Bruno F, Pugliese P, Dambrosio M, Dalfino L, Di Serio F, Fiore T. Use of N-terminal pro-brain natriuretic peptide to detect acute cardiac dysfunction during weaning failure in difficult-to-wean patients with chronic obstructive pulmonary disease. Crit Care Med. 2007 Jan;35(1):96-105. doi: 10.1097/01.CCM.0000250391.89780.64.

ReferenceCitation: Dres M, Teboul JL, Anguel N, Guerin L, Richard C, Monnet X. Extravascular lung water, B-type natriuretic peptide, and blood volume contraction enable diagnosis of weaning-induced pulmonary edema. Crit Care Med. 2014 Aug;42(8):1882-9. doi: 10.1097/CCM.0000000000000295.

ReferenceCitation: Perren A, Domenighetti G, Mauri S, Genini F, Vizzardi N. Protocol-directed weaning from mechanical ventilation: clinical outcome in patients randomized for a 30-min or 120-min trial with pressure support ventilation. Intensive Care Med. 2002 Aug;28(8):1058-63. doi: 10.1007/s00134-002-1353-z. Epub 2002 Jul 13.

ReferenceCitation: Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

ReferenceCitation: Cabello B, Thille AW, Roche-Campo F, Brochard L, Gomez FJ, Mancebo J. Physiological comparison of three spontaneous breathing trials in difficult-to-wean patients. Intensive Care Med. 2010 Jul;36(7):1171-9. doi: 10.1007/s00134-010-1870-0. Epub 2010 Mar 30.

ReferenceCitation: Dres M, Teboul JL, Anguel N, Guerin L, Richard C, Monnet X. Passive leg raising performed before a spontaneous breathing trial predicts weaning-induced cardiac dysfunction. Intensive Care Med. 2015 Mar;41(3):487-94. doi: 10.1007/s00134-015-3653-0. Epub 2015 Jan 24.

oa_host_type: publisher

ReferenceCitation: Caille V, Amiel JB, Charron C, Belliard G, Vieillard-Baron A, Vignon P. Echocardiography: a help in the weaning process. Crit Care. 2010;14(3):R120. doi: 10.1186/cc9076. Epub 2010 Jun 22.

lead_sponsor: Bicetre Hospital


title: Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits

acronym: CAPROG

summary: The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.

ReferenceCitation: Riemann BL, Lephart SM. The Sensorimotor System, Part II: The Role of Proprioception in Motor Control and Functional Joint Stability. J Athl Train. 2002 Jan;37(1):80-4.

ReferenceCitation: Johansson H, Sjolander P, Sojka P. Receptors in the knee joint ligaments and their role in the biomechanics of the joint. Crit Rev Biomed Eng. 1991;18(5):341-68.

ReferenceCitation: Wikstrom EA, Tillman MD, Chmielewski TL, Borsa PA. Measurement and evaluation of dynamic joint stability of the knee and ankle after injury. Sports Med. 2006;36(5):393-410. doi: 10.2165/00007256-200636050-00003.

ReferenceCitation: Fremerey RW, Lobenhoffer P, Zeichen J, Skutek M, Bosch U, Tscherne H. Proprioception after rehabilitation and reconstruction in knees with deficiency of the anterior cruciate ligament: a prospective, longitudinal study. J Bone Joint Surg Br. 2000 Aug;82(6):801-6. doi: 10.1302/0301-620x.82b6.10306.

ReferenceCitation: Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3.

lead_sponsor: Thuasne


title: Genetic Predisposition in Cerebral Palsy

acronym: PREGENE PC

summary:
Cerebral palsy (CP) is a major neurodevelopmental disorder with an estimated prevalence of approximately one in 500 children. It is characterised by permanent developmental disorders of movement and posture, responsible for activity limitations, caused by non-progressive damage to the brain of the fetus, newborn or infant during development. The neurobiological mechanisms involved in CP remain poorly understood, although the interruption of cerebral oxygen supply during pregnancy or at the time of delivery is classically considered to be the main factor causing neurodevelopmental sequelae. CP also occurs in full-term infants without a clearly identifiable etiology.

Data from the literature suggest the existence of other pathophysiological processes than only acquired brain lesions related to pregnancy and delivery, such as genetic or epigenetic factors. According to some research teams, nearly one third of CP could have a genetic cause or could be favoured by genetic variants.

Preliminary research has made significant progress in revealing unusual copy number variants and/or mutations in single genes in children with CP. Several of the identified genes are involved in neurodevelopment and neuronal connectivity. Nevertheless, the identification of these abnormalities in CP may contribute to a better understanding of the pathophysiology of this complex and multifactorial disorder. It could also shed new light on the analysis of medico-legal files and bring encouraging perspectives by targeting new therapeutic interventions.

The main hypothesis is that a certain number of cerebral palsies are related to - or favoured by - genetic abnormalities that we will search for with genetic screening tests.

primary_purpose: Screening

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant

intervention_type: Genetic


title: MITAORTA - Role of Mitochondrial Dynamic in Aneurysm and Dissection of Ascending Thoracic Aorta

acronym: MITAORTA

summary: The main objective is to compare the mitochondrial dynamic between patients operated for aneurysm of ascending aorta or type A aortic dissection (AAD) or control group

ReferenceCitation: Trabado S, Al-Salameh A, Croixmarie V, Masson P, Corruble E, Feve B, Colle R, Ripoll L, Walther B, Boursier-Neyret C, Werner E, Becquemont L, Chanson P. The human plasma-metabolome: Reference values in 800 French healthy volunteers; impact of cholesterol, gender and age. PLoS One. 2017 Mar 9;12(3):e0173615. doi: 10.1371/journal.pone.0173615. eCollection 2017.

ReferenceCitation: Robert P, Nguyen PMC, Richard A, Grenier C, Chevrollier A, Munier M, Grimaud L, Proux C, Champin T, Lelievre E, Sarzi E, Vessieres E, Henni S, Prunier D, Reynier P, Lenaers G, Fassot C, Henrion D, Loufrani L. Protective role of the mitochondrial fusion protein OPA1 in hypertension. FASEB J. 2021 Jul;35(7):e21678. doi: 10.1096/fj.202000238RRR.

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

repositories_concat: HAL

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

publisher_dissemination: Wiley

ReferenceCitation: Toda M, Yamamoto K, Shimizu N, Obi S, Kumagaya S, Igarashi T, Kamiya A, Ando J. Differential gene responses in endothelial cells exposed to a combination of shear stress and cyclic stretch. J Biotechnol. 2008 Jan 20;133(2):239-44. doi: 10.1016/j.jbiotec.2007.08.009. Epub 2007 Aug 9.

ReferenceCitation: Archer SL. Mitochondrial dynamics--mitochondrial fission and fusion in human diseases. N Engl J Med. 2013 Dec 5;369(23):2236-51. doi: 10.1056/NEJMra1215233. No abstract available.

ReferenceCitation: Piquereau J, Caffin F, Novotova M, Prola A, Garnier A, Mateo P, Fortin D, Huynh le H, Nicolas V, Alavi MV, Brenner C, Ventura-Clapier R, Veksler V, Joubert F. Down-regulation of OPA1 alters mouse mitochondrial morphology, PTP function, and cardiac adaptation to pressure overload. Cardiovasc Res. 2012 Jun 1;94(3):408-17. doi: 10.1093/cvr/cvs117. Epub 2012 Mar 8.

ReferenceCitation: Le Page S, Niro M, Fauconnier J, Cellier L, Tamareille S, Gharib A, Chevrollier A, Loufrani L, Grenier C, Kamel R, Sarzi E, Lacampagne A, Ovize M, Henrion D, Reynier P, Lenaers G, Mirebeau-Prunier D, Prunier F. Increase in Cardiac Ischemia-Reperfusion Injuries in Opa1+/- Mouse Model. PLoS One. 2016 Oct 10;11(10):e0164066. doi: 10.1371/journal.pone.0164066. eCollection 2016.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

ipd_sharing_description: The data will be collected in a coded manner: first letter of the surname, first letter of the patient's first name, serial number of inclusion in the center by the physicians investigating the study in the electronic observation notebook managed by the DRCI of University Hospital of Angers

sponsor_collaborators:
University Hospital, Angers
Fondation de l'Avenir


title: Study of the Dynamics of Human Papillomavirus (HPV) Clearance in Post-treatment of High-grade Intraepithelial Lesions (HGIL).

acronym: PAPOTHE

summary: In recent years, studies have multiplied to demonstrate the value of performing an HPV test compared to a cervical smear test (CSP) in cervical cancer screening but also in the follow-up of surgical removal of high-grade intraepithelial lesions (HGILs). Thus, since June 2019, the High Health Authority recommends performing HPV genome testing by PCR for primary cervical cancer screening. Since September 2019, the National Cancer Institute recommends an HPV test in the follow-up of HGILs 6 months after conization. However, this delay was determined thanks to the previous recommendations which advocated a cervical smear test 6 months after conization. Thus, the kinetics of HPV clearance in the immediate postoperative period and in the 6 months following surgical excision remain unknown to this day. A better knowledge of the clearance of HPV postoperatively would allow to adapt and simplify the follow-up of the patients and to personalize it according to the type of HPV.

location_facility: Service : Chirurgie et oncologie gynécologique et mammaire, Hôpital Pitié Salpêtrière


title: Identification of Non-motor Brain Areas Involved in Upper Limb Motor Recovery After Stroke

acronym: NOMO-Stroke

summary:
Why: Upper-limb recovery post-stroke is challenging. Rehabilitation, aiming to induce plasticity takes an important place in patients' treatment. The last years, non-invasive brain stimulation of the primary motor cortex has gained the communities' interest, allowing direct modification of neural excitability and thus impacting plasticity. Yet, research outcomes remain inconclusive to date. It's expected this to be related to patient heterogeneity including mild to severe motor deficits, and suboptimal site of stimulation. It might be questioned whether M1 stimulation is preferable over that of higher association areas like the parietal or premotor cortex.

What: The aim of the study is to identify alternative brain regions to stimulate, related to improved motor quality after a severe initial deficit. How: by following motor recovery over time, by co-recording movement kinematics and brain activity.

Because: Stimulation of the novel identified regions may improve motor recovery after stroke.

lead_sponsor: University Hospital, Montpellier

collaborators: Centre Hospitalier Universitaire de Nīmes


title: Multi-family Therapy and School Refusal: an Exploratory Study With Adolescents and Their Families

acronym: Multi-Fast

summary: The purpose of this study is to determine whether multi-family therapy is effective in the treatment of school refusal with anxiety in adolescence.

location_facility: Maison de Solenn Maison des Adolescents, Cochin Hospital


title: Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study

acronym: ANTIMIG

summary: The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

lead_sponsor: Société Française d'Endoscopie Digestive


title: Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients: A Retrospective Series

acronym: CITRA-SAFE

summary:
Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients.

The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice.

Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population.

The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients.

ipd_sharing_description: NC


title: Immuno-epidemiological and Socio-behavioral Evaluation of Release of Sterile Male Aedes Albopictus Mosquitoes on Human-vector Contacts

acronym: EXPOCAP

summary:
This trial is based on 2 complementary components, named ExpAlbo Biomarker and CAPAlbo Questionnaire

ExpAlbo Biomarker (Exposure to the Aedes albopictus mosquito): This component concerns the epidemiological evaluation of the effectiveness of the release of sterile male mosquitoes on the level of exposure of individuals to the bites of the tiger mosquito through the use of a new immunological biomarker of the human-vector contact, developed over the past 20 years by the IRD-MIVEGEC team. Indeed, when a person is bitten by a mosquito, he or she develops a defence reaction, called an immune reaction, against the mosquito's saliva. The main objective of this study is to measure this immune response, and more specifically the antibody response specifically directed against compounds (peptide = small fragment of a protein) in mosquito saliva, and to determine whether this anti-saliva antibody response, and therefore exposure to mosquito bites, decreases when the mosquito control strategy is applied.
CAPAlbo Questionnaire: This component is concerned with assessing the impact of sterile male mosquito releases on perceptions and practices related to exposure to Aedes albopictus based on population-based questionnaire surveys. The main objective of these surveys is to determine whether changes in objective exposure to Aedes albopictus mosquitoes are associated with changes in the perception of the nuisance and in the lifestyle habits of respondents, particularly those related to the prevention of mosquito bites (such as the use of repellents or mosquito nets).

lead_sponsor: Institut de Recherche pour le Developpement

location_facility: population générale (quartier Duparc (Sainte Marie) et Quartier Bois rouge)